Newman in dissent: The district court has greatly mischaracterized Apple’s proffered evidence.

Judge Newman's dissent in In re Apple included the text


My colleagues defend the district court’s conclusion
that it was unable to evaluate the convenience of witnesses in its transfer
analysis because Apple failed to name its witnesses. The district court has
greatly mischaracterized Apple’s proffered evidence. Apple may not have
identified specific witnesses or singled out individual
documents; however, the evidence proffered makes it clear
that all relevant Apple witnesses and documents are
located in the Northern District of California. The evi-
dence also shows that the suppliers of the accused components are located in California
—
Qualcomm Incorporated
is based in San Diego and Intel Corporation is based in
Santa Clara. Under a proper transfer analysis, these
facts lead to only one conclusion
—
this case should be
transferred to the Northern District of California.



AND


Finally, I am struck by how heavily the local interest
factor favors the Northern District of California. Apple is
a robust company that supports the local economy of
Cupertino, California, employing over 13,000 people.
Core Wireless, on the other hand, is a non-United States
corporation with one employee that exists solely to license
its patent portfolio. To carry out this task, Core Wireless
employs 6 people through a subsidiary in Plano, Texas.
Apple’s impact on the local economy in the Northern
District of California is clearly much greater than that of
Core Wireless in the Eastern District of Texas.

Steven Salzberg's concerns over Woo-Suk Hwang's US 8,647,872 not well-founded

In a post US Issues Patent For A Fraudulent Human Embryonic Stem Cell Method , Steven Salzberg writes


Hwang himself admitted the data were fake! As I’ve written previously, the USPTO simply can’t keep up with biotechnology, and the courts don’t do any better. In this case, it’s hard to imagine a more obvious example of a patent that should be denied: the papers were retracted, and the lead scientist lost his job after his own university concluded that the data was fabricated. And yet the patent office is standing by their decision.


As a first point, the patent community, including the USPTO, has been aware of the issues with the Hwang work for some time. An article titled Lessons to be Learned from the Hwang Matter: Analyzing Innovation the Right Way was published in March 2006 in 88 J. Pat. & Trademark Off. Soc'y 239. This paper is cited in the book by Russell Korobkin titled Stem Cell Century: Law and Policy for a Breakthrough Technology .

As a second point, the first claim of US 8,647,872, with second named inventor Woo-Suk Hwang, recites


An embryonic stem cell line derived from a nucleus-transferred oocyte prepared by transferring a nucleus of a human somatic cell into an enucleated human oocyte, which is a cell line deposited under the accession number KCLRF-BP-00092.



The claim requires that the embryonic cell line be derived from the cell line deposited under accession number KCLRF-BP-00092. A cell line not so derived does not fall within the literal scope of claim 1. If someone wants to claim stem cell lines derived from a fraudulent stem line, and pay for the prosecution, that's up to them.


Now that Hwang's US patent has issued, the cell line is available to the public for investigation.

Oregon follows Vermont in passing anti-patent troll legislation

The bill passed the Oregon legislature on Fe. 25, 2014.

CAFC in Elcommerce v. SAP: attorney argument is not evidence

The level of evidence to show structure in 112 P 6 claims was at issue. Judge Newman wrote for the majority in a 2-1 vote.

From Judge Newman's opinion in Elcommerce.com v. SAP


The burden was on SAP to prove by clear and convinc- ing evidence that a person of ordinary skill in the field of the invention would be unable to recognize supporting structure and acts in the written description and associate it with the corresponding function in the claim. See TecSec, Inc. v. Int’l Bus. Machs. Corp., 731 F.3d 1336, 1349 (Fed. Cir. 2013) (“The party alleging that the specification fails to disclose sufficient corresponding structure must make that showing by clear and convincing evidence.”). While “the person of ordinary skill in the art” is a legal construct, like “the reasonable man,” and claim construction is ultimately a matter for the judges, it cannot be assumed that judges are persons of ordinary skill in all technological arts.

Nor can it be assumed that, without evidence, a general purpose judge could ascertain the position of persons of skill in the art and conclude that there is not a shred of support for any of the eleven interrelated means-plus- function claim limitations, as argued by SAP. The district court rightly was concerned about what a person of skill in the art might make of the lengthy written description and flow-charts and the multiple claimed functions. The judge repeatedly asked for evidence of what such a person would understand in this particular setting. Instead of evidence, SAP submitted only attorney argument.

The district court accepted SAP’s position that no ex- ternal evidence was “required” and could be relied upon to show how a person of ordinary skill would understand the descriptive text and flowcharts and diagrams in the patent. However, the adequacy of a particular description is a case-specific conclusion, not an all-purpose rule of law. Findings as to what is known, what is understood, and what is sufficient, must be based on evidence.
Without evidence, ordinarily neither the district court nor this court can decide whether, for a specific function, the description in the specification is adequate from the viewpoint of a person of ordinary skill in the field of the invention. We do not of course hold that expert testimony will always be needed for every situation; but we do hold that there is no Federal Circuit or other prohibition on such expertise. See Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579 (1993). The district court persistently asked for evidence and was given none. Without more SAP cannot overcome the presumption of patent validity.

We conclude that the district court erred in granting summary judgment without a proper evidentiary basis for its conclusion. The burden was on SAP to prove its case, and in the absence of evidence provided by technical experts who meet the Daubert criteria there is a failure of proof. Attorney argument is not evidence.

CAFC affirms meaning of "intelligent gateway" in Starhome v. AT&T

Starhome loses.

CAFC finds written description adequate in Glaxo v. Banner

Defendants argued"solvate" was not adequately described. They lost.

Peanut butter pretzel saga

Maxim Marketing is suing Trader Joe's and Conagra, after Trader Joe's went to Conagra as supplier for its peanut butter pretzels. Maxim was a middle man, getting the pretzels from Conagra and than sellng to Trader Joe's. The legal theories of Maxim are antitrust violations and breach of contract. There is an issue about disclosure of confidential information.


See Sticky situation: Trader Joe's sued over peanut butter pretzel 'monopoly'


From within the post Pretzel Supplier Alleges Twisted Tale



“They were working on co-extrusion with pretzels, which was unheard of at that time,” he said. “I didn’t know of anyone other than an outfit in Germany that was doing that.”

Co-extrusion is a process by which multiple layers of a food product are processed simultaneously. Visualize a pipe within a pipe, the outer one pumping out pretzel dough, the inner one pumping out a filling. The idea that Max Reisman, Reisman’s president, had was to pump out a strip of filled pretzel dough on a mechanized belt, slice it up and bake the pieces in the plant’s massive 100-foot ovens.

But there were challenges. The filling had to have enough liquidity to be pumped, but if it held too much water, the product would disintegrate. Adding oil instead would introduce a possible fire hazard if it seeped out.

Several fillings were experimented with before a peanut butter mixture with peanut oil was chosen. There were other pitfalls. If the pretzel was too thin or the filling too liquid, the product would explode.

“We had blowouts,” Kroll said. “If you really want to see a plant manager mad, get him to clean up a 100-foot oven full of peanut butter. We had to work and work on that.”

Also brought in on the project was Bruce Gutterman, a peanut butter expert in Kingston, Pa., who pioneered the introduction of peanut butter flavors into ice cream in the 1970s, and had become the go-to guy for pourable peanut butter.


--Merely fyi

US 6,386,097, System and method for filling a nugget transported on a conveyor ; also US 6,468,572

--
US 6,863,911, Bakeable, lubricious, sweet, creamy, low-moisture filler products and process for preparation

--

"A Fragile Trust," on the Jayson Blair plagiarism affair

See Documentary revisits NY Times plagiarism scandal, talks ethics

CAFC in Lighting Ballast: Cybor stays

The Cybor standard of de novo review of claim construction continues, by a 6-4 vote.

From Lighting Ballast v. Philips , in an opinion by Judge Newman:



For the reasons we shall discuss, we apply the principles of stare decisis, and confirm the Cybor standard of de novo review of claim construction, whereby the scope of the patent grant is reviewed as a matter of law. After fifteen years of experience with Cybor, we conclude that the court should retain plenary review of claim construc- tion, thereby providing national uniformity, consistency, and finality to the meaning and scope of patent claims. The totality of experience has confirmed that Cybor is an effective implementation of Markman II, and that the criteria for departure from stare decisis are not met.



Of stare decisis



The proponents of stare decisis point to the courts’ and patent community’s fifteen years of experience with Cybor, and argue that this experience supports retention of the Cybor principle. Emphasizing the potential multi- case and multi-forum litigation of patents on today’s technologies, they argue that it is particularly important that this court be able to resolve claim construction defin- itively as a matter of precedent, rather than allow differ- ing trial court constructions of the same patent, as may result from deferential review of close questions.
(...)
Stare decisis is of “fundamental importance to the rule of law.” Hilton v. S. Carolina Pub. Ry. Comm’n, 502 U.S. 197, 202 (1991) (quoting Welch v. Texas Dep’t of Highways & Pub. Transp., 483 U.S. 468, 494 (1987)). The doctrine of stare decisis enhances predictability and efficiency in dispute resolution and legal proceedings, by enabling and fostering reliance on prior rulings. CSX Transp. Inc. v. McBride, 131 S. Ct. 2630, 2641 (2011). By providing stability of law that has been decided, stare decisis is the foundation of a nation governed by law. The Supreme Court has said: “we will not depart from the doctrine of stare decisis without some compelling justification.” Hilton, 502 U.S. at 202 (citing Arizona v. Rumsey, 467 U.S. 203, 212 (1984)); see Dickerson v. United States, 530 U.S. 428, 443 (2000) (“special justification” is needed to overrule precedent).

Stability in procedural as well as substantive law, on which the public and the courts can rely, guards against the expenditure of time and resources on aspects that have been resolved. These values come to the fore when a court undertakes to reexamine its own precedent, for stare decisis implements the “prudential and pragmatic consid- erations designed to test the consistency of overruling a prior decision with the ideal of the rule of law, and to gauge the respective costs of reaffirming and overruling a prior case.” Planned Parenthood of S.E. Pa. v. Casey, 505 U.S. 833, 854 (1992). The principles and policies of stare decisis operate with full force where, as here, the en banc court is considering overturning its own en banc prece- dent.

The presumption that a court will adhere to its prior rulings has “‘special force’” for precedents that resolve non-constitutional issues, for “‘Congress remains free to alter what we have done.’” J.R. Sand & Gravel Co. v. United States, 552 U.S. 130, 139 (2008) (quoting Patterson v. McLean Credit Union, 491 U.S. 164, 172–73 (1989)). In Patterson the Court observed that the same issue had previously divided the Court and that “[s]ome Members of this Court believe that [the precedent] was decided incor- rectly”; the Court discussed the principles of stare decisis, and concluded that “no special justification has been shown for overruling” the prior decision, for neither “the growth of judicial doctrine or further action taken by Congress. . . . have removed or weakened the conceptual underpinnings from the prior decision.” 491 U.S. at 171-173. The Court observed that no “later law has rendered the decision irreconcilable with competing legal doctrines or policies.” Id. at 173.


Of experts


Similarly, experts in the science or technology may assist the court in understanding the meaning and usage of a claim term, but this does not morph the question into one of fact. Cf. United States v. Stone & Downer Co., 274 U.S. 225 (1927) (relying on expert testimony on the mean- ing of the tariff term “clothing wool” in the custom of the trade). The Court stated in Markman II:
in theory there could be a case in which a simple credibility judgment would suffice to choose be- tween experts whose testimony was equally con- sistent with a patent’s internal logic. But our own experience with document construction leaves us doubtful that trial courts will run into many cases like that. In the main, we expect, any credibility determinations will be subsumed within the nec- essarily sophisticated analysis of the whole docu- ment, required by the standard construction rule that a term can be defined only in a way that comports with the instrument as a whole.
517 U.S. at 389.



Of the opinion of the legal community


Our colleagues in dissent offer a few arguments that warrant response. First, referring to “the materials submitted to the court,” the dissent states that “a sub- stantial proportion of the legal community” believes that Cybor was “wrongly decided.” Diss. at 6. The materials tell a different tale.
(...)
Contrary to the dissent’s statements, all of the technology industries that offered advice to the court, urge retention of Cybor’s standard.
(...)
The dissent appears unconcerned that the major in- dustrial amici urge retention of the Cybor standard, and instead announces that “no one in the legal community— except perhaps the members of the majority—has come to believe that either the wisdom or vitality of Cybor is settled,” Diss. at 6. This conclusion is curious. For exam- ple, the amicus brief of Google, Amazon, Hewlett-Packard, Red Hat and Yahoo! states that departing from Cybor would “make worse” the uncertainty of claim construction:

[T]he root causes of uncertainty in claim con- struction are vaguely drafted claims and contra- dictory claim-construction methodologies, not appellate review. Deference would not ameliorate those causes of uncertainty; it would make them worse.
** *
[T]reating claim construction as a factual question subject to clear-error review would only aggravate the uncertainty and cost issues plagu- ing our patent-litigation system.



Of horizontal and vertical uncertainty:


Clear scope is important to all potential mar- ket entrants. This kind of horizontal certainty is important to the entire industry. By contrast, the concern that de novo review increases the “dura- tion” of a single patent litigation until a final deci- sion is reached in that particular case (Cybor, 138 F.3d at 1476 (Rader, J., dissenting))—what might be called vertical uncertainty—matters only in the small fraction of cases that reach an appeal. Ver- tical uncertainty is more visible than horizontal uncertainty, but, as often is the case, here it is the unseen effects that are greater. Cf. Frédéric Bas- tiat, What Is Seen and What Is Not Seen (1848), available at http://www.econlib.org/library/- Bastiat/basEss1.html.

For this reason, it is not merely the overarch- ing principles of claim construction, but their ap- plication, that must be consistent. In claim construction as elsewhere, “the relevant legal principle can be given meaning only through its application to the particular circumstances of a case.” Miller, 474 U.S. at 114.
Brief of Amicus Curiae Cisco et al. at 19.



Of golden words of the past



While it is comforting to know that our golden words of the past are not forgotten, those of us with the majority today who have questioned aspects of Cybor in the past, now decide this case on the record of the present and with an eye to the future. The dissent would discard the experience of the past fifteen years. However, the court is not now deciding whether to adopt a de novo standard in 1998. Today we decide whether to cast aside the standard that has been in place for fifteen years.


Work by Peter Menell is dismissed as relating to obsolete data:


Our colleagues in dissent, citing the obsolete data, argue that the de novo standard “adds considerable uncer- tainty and expense to patent litigation,” Diss. at 4, stating that this standard increases appeals, discourages settle- ment, and increases the length and cost of litigation. No evidence of this effect is offered, and all of the amici curiae who are frequent litigants state the contrary position. The data published by the Administrative Office of the United States Courts point the other way.



Finally


We conclude that the criteria are not met for overruling or modifying the Cybor standard of de novo review of claim construction as a matter of law.

CAFC in Takeda: patent valid but no infringement

The result in Takeda v. Zydus


Zydus Pharmaceuticals USA, Inc. and Cadila Healthcare Limited (“appellants” or “Zydus”) appeal from a final judgment of the U.S. District Court for the District of New Jersey finding that appellants had infringed claim 1 of U.S. Patent No. 6,328,994 (“’994 patent”) and had failed to establish that it was invalid. For the reasons stated below, we reverse the district court’s finding of infringement, but affirm its ruling on invalidity.



Thus, patent valid but no infringement.

PatentlyO questions validity under 35 USC 112 of Butamax claims in US 7,993,889

In a post on February 18, 2014, the blog PatentlyO takes on the patent drafting skills of Butamax [attorney: Lhulier; Christine M.] in the case of US 7,993,889 (issued August 9, 2011). Text from PatentlyO:


Now, the claims [of US 7,993,889] are interesting. Claim 1 is directed to a “method for producing isobutanol” that uses the “recombinant yeast microorganism.” Claim 12 is directed to “The recombinant yeast microorganism of claim 1.” Patent professionals will recognize the unusuality of this claim structure. Usually, a dependent claim is narrower than its referenced independent parentage. However, Butamax’s dependent claim 12 here is broader (in some ways) than the referenced claim 1.
(...)
In my mind, the Butamax claim structure does not fit within the structure authorized by §112(d) because the full effect of the “method” limitation is not included in the dependent composition claim. The result then, could be invalidity either as indefinite or for failure to comply with §112(d). See Pfizer, Inc. v. Ranbaxy Laboratories Ltd., 457 F.3d 1284 (Fed. Cir. 2006) (claim invalid for failure to properly structure the dependent claim).

(...)
Here, the Butamax claim is not directed to a resulting process but instead to a component used in the method, but perhaps that is not a worthwhile distinction. The appeal here arises from a district court finding that the claims were invalid on other grounds. On appeal, the Federal Circuit vacated that decision and remanded for reconsideration by the district court. Perhaps we’ll see the 112(d) issue briefed next time around.

Once an independent claim is found patentable, examiners often give short consideration to the subsequent dependent claims. That time-saving measure makes follows some logic since the dependent claims are supposed to be narrower than the allowed claim and thus should also be patentable over the prior art. Of course, this is one situation where that logic fails.



The case reference is to the attack on Lipitor claims by Ranbaxy.

IPBiz has covered this litigation for some time.

For example

Claim construction in Butamax/Gevo case by Judge Robinson (D. Del.) questioned by CAFC

Another round in Gevo/Butamax fight in D. Delaware


The Court of Appeals for the Federal Circuit hands Gevo a big loss in the Butamax/Gevo patent wars

In the meantime, one wonders if Butamax will be seeking an injunction against Gevo.

CAFC analyzes improper application of the doctrine of claim vitiation in Ring & Pinion Service v. Arb

In Ring & Pinion v. Arb , there is discussion of foreseeability in the context of the doctrine of equivalents:



In ruling on the parties’ summary judgment motions, the district court held that “foreseeability at the time of [patent] drafting alone[] is not a formally recognized limitation on the doctrine of equivalents.” Ring & Pinion Serv. Inc. v. ARB Corp., No. 09-586, 2013 WL 414220, at *7 (W.D. Wash. Feb. 1, 2013). R&P argues that the district court erred. Relying principally on Sage Products, Inc. v. Devon Industries, Inc., 126 F.3d 1420 (Fed. Cir. 1997), R&P contends that we have found that the doctrine of equivalents does not apply to equivalents that were foreseeable at the time of the patent application. It argues in the alternative that the doctrine of equivalents has been found to exclude foreseeable equivalents under certain circumstances and that we should extend those exclusions to create a per se foreseeability bar to applica- tion of the doctrine.

We do not agree. There is not, nor has there ever been, a foreseeability limitation on the application of the doctrine of equivalents. It has long been clear that known interchangeability weighs in favor of finding infringement under the doctrine of equivalents. Warner-Jenkinson Co. v. Hilton Davis Chem. Co., 520 U.S. 17, 36 (1997) (“The known interchangeability of substitutes for an element of a patent is one of the express objective factors . . . bearing upon whether the accused device is substantially the same as the patented invention.”); Graver Tank & Mfg. Co. v. Linde Air Prods. Co., 339 U.S. 605, 609 (1950) (holding that “whether persons reasonably skilled in the art would have known of the interchangeability of an ingredient not contained in the patent with one that was” is an “important factor” weighing in favor of equivalence); Abraxis Bioscience, Inc. v. Mayne Pharma (USA) Inc., 467 F.3d 1370, 1382 (Fed. Cir. 2006) (finding that “known interchangeability” is a “factor to consider in a doctrine of equivalents analysis” that “aids the fact-finder in as- sessing the similarities and differences between a claimed and an accused element.”); Interactive Pictures Corp. v. Infinite Pictures, Inc., 274 F.3d 1371, 1383 (Fed. Cir. 2001) (holding that “the known interchangeability test looks to the knowledge of a skilled artisan to see whether that artisan would contemplate the interchange as a design choice.”); Corning Glass Works v. Sumitomo Elec. U.S.A., Inc., 868 F.2d 1251, 1261 (Fed. Cir. 1989) (finding that “the substitution of an ingredient known to be an equivalent to that required by the claim presents a classic example for a finding of infringement under the doctrine of equivalents.”). Excluding equivalents that were fore- seeable at the time of patenting would directly conflict with these holdings that “known interchangeability” supports infringement under the doctrine of equivalents. We conclude that the foreseeability of an equivalent at the time of patenting is not a bar to a finding of infringement under the doctrine of equivalents.
R&P’s reliance on Sage Products to argue that a gen- eral foreseeability bar to the doctrine of equivalents exists is misplaced. Sage Products held that claim vitiation, not foreseeability, prevented the application of the doctrine of equivalents in that case because its application “would have utterly written” express limitations “out of the claim.” Overhead Door Corp. v. Chamberlain Grp., Inc., 194 F.3d 1261, 1271 (Fed. Cir. 1999) (citing 126 F.3d at 1423–25). “[B]ecause the scope of the claim” in Sage Products “was limited in a way that plainly and necessari- ly excluded a structural feature that was the opposite of the one recited in the claim, that different structure could not be brought within the scope of patent protection through the doctrine of equivalents.” SciMed Life Sys., Inc. v. Advanced Cardiovascular Sys., Inc., 242 F.3d 1337, 1346 (Fed. Cir. 2001) (citing 126 F.3d at 1425).




Chiuminatta is cited:


Relying on our holding in Chiuminatta Concrete Concepts, Inc. v. Cardinal Industries, Inc., 145 F.3d 1303 (Fed. Cir. 1998), R&P argues that there is a foreseeability bar to the application of the doctrine of equivalents for means-plus-function limitations. R&P misstates the law. There is no such foreseeability limit on the doctrine of equivalents, nor did we create one in Chiuminatta.

In Chiuminatta, we explained that there are two dif- ferences between the equivalence determination made for literal infringement purposes under § 112(f) and a doc- trine of equivalents determination for the same limita- tion: timing and function. 145 F.3d at 1310. Equivalence under section 112(f) is evaluated at the time of issuance. Al-Site Corp. v. VSI Int’l, Inc., 174 F.3d 1308, 1320 (Fed. Cir. 1999). Equivalence under the doctrine of equivalents, in contrast, is evaluated at the time of infringement. Id. Hence, an after-arising technology, a technology that did not exist at the time of patenting, can be found to be an equivalent under the doctrine of equivalents even though it cannot be an equivalent under the literal infringement analysis of § 112(f). Id.

The Court of Appeals for the Federal Circuit hands Gevo a big loss in the Butamax/Gevo patent wars

As was quite foreseeable in 2012 (see IPBiz Claim construction in Butamax/Gevo case by Judge Robinson (D. Del.) questioned by CAFC ), the Court of Appeals for the Federal Circuit on February 18, 2014 basically undid rulings by Judge Robinson which had favored Gevo.

From the conclusion of Butamax v. Gevo


For the forgoing reasons, this court vacates the district court’s denial of Butamax’s motion for summary judgment of literal infringement of the asserted claims of the ’188 and ’889 patents and remands the question of infringement to the district court for reconsideration under the claim construction set forth herein. Further, this court likewise vacates and remands the district court’s grant of Gevo’s motion for summary judgment of noninfringement under the doctrine of equivalents. The court further reverses the district court’s grant of Gevo’s motion for summary judgment of invalidity for lack of written description of claims 12 and 13 of the ’889 patent and the district court’s order that those same claims are invalid for lack of enablement.



Of interest at the end of the opinion was a reference to "scrivener's error":


In its order, the district court summarily concluded that claims 12 and 13 were invalid for lack of enablement. However, its memorandum opinion does not reflect that judgment, nor did Gevo move for invalidity of those claims on this basis. On appeal, Gevo does not defend the judg- ment. It thus appears that the judgment was a scrivener’s error, and this court reverses the judgment that the claims are invalid for lack of enablement.



Things did not work out well for Gevo on the substantive issues, either.

A major issue was the definition of an enzyme, which Gevo attempted to limit to NADPH-dependent. The CAFC however did not so limit and merely found:


For all of the foregoing reasons, the term “acetohydroxy acid reductoisomerase” [sometimes denoted KARI] is construed as “an enzyme, whether naturally occurring or otherwise, known by the EC number 1.1.1.86 that catalyzes the conversion of acetolactate to 2,3-dihydroxyisovalerate.”



with the additional text



However, as discussed above, the ordinary meaning of KARI is not cofactor dependent, and this subsequent extrinsic evidence does not clearly express an intent at the time of the invention to redefine KARI to use one cofactor over another. The subsequent discovery of the beneficial results obtained by the use of NADH does not support the conclusion that it was understood to be excluded as a cofactor at the time the patents-in-suit were filed.


This definition is not good for Gevo in the infringement case against Gevo.

A matter of "incorporation by reference" arose:


Gevo makes much of the fact that Dickinson, though cited in the ’889 patent, was not cited in connection with the deactivation of this pathway and was not incorporated by reference into the patent. Nonetheless, Dickinson’s teachings still reflect what was known in the art. See Falko-Gunter Falkner v. Inglis, 448 F.3d 1357, 1368 (Fed. Cir. 2006) (holding that where “accessible literature sources clearly provided” a description of the teachings at issue, the written description requirement does not require their incorporation by reference). Dickinson does show that persons of ordinary skill in the art could deactivate the pathway in question, and though it appears that accord- ing to Dickinson the claimed invention would not have worked particularly well (isobutanol production would be “virtually abolished”),



As to "written description,"


The district court found that both claims were inadequately described and thus invalid because the specification does not sufficiently describe how to inactivate genes to disable the competing synthetic pathway.
When determining whether a specification con- tains adequate written description, one must make an “objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art.” [Citation.] Because the specification is viewed from the perspective of one of skill, in some circumstances, a patentee may rely on information that is “well-known in the art” for purposes of meeting the written de- scription requirement.
Boston Scientific Corp. v. Johnson & Johnson, 647 F.3d 1353, 1366 (Fed. Cir. 2011) (citation omitted).
(...)
Butamax also relies on extrinsic evidence purportedly teaching how to deactivate the pathway. Butamax submitted the declaration of Alexander M. Klibanov, who opined that it would have been well-known to a person of ordinary skill in the art how to deactivate the genes, citing to seven references that purportedly describe organisms with reduced or inactivated pyruvate decarboxylase activity. Appellant’s Br. 67; J.A. 3141. The district court does not appear to have addressed Mr. Klibanov’s testimony or six of the references he cited.

US 8,647,872, titled Human embryonic stem cell line prepared by nuclear transfer of a human somatic cell into an enucleated human oocyte

Back in 2005, South Korean scientist Woo-Suk Hwang published a landmark paper on stem cells in the journal Science. The underlying data were later determined to be inaccurate, if not fraudulent. Nine years later, one has a related US Patent. The first claim of US 8,647,872, with second named inventor Woo-Suk Hwang, recites


An embryonic stem cell line derived from a nucleus-transferred oocyte prepared by transferring a nucleus of a human somatic cell into an enucleated human oocyte, which is a cell line deposited under the accession number KCLRF-BP-00092.



The claim requires that the embryonic cell line be derived from the cell line deposited under accession number KCLRF-BP-00092. A cell line not so derived does not fall within the literal scope of claim 1.


Now that Hwang's US patent has issued, the cell line is available to the public for investigation.

The assignee of the issued patent is H. Bion Co., Ltd. (Seoul, KR) .

The priority claim of US '872 is as follows: This application is a continuation of U.S. patent application Ser. No. 12/591,505, filed on Nov. 20, 2009, which was a continuation of U.S. patent application Ser. No. 10/584,255, filed on Jun. 28, 2007 (now abandoned), which was a 35 U.S.C. .sctn.371 National Phase Entry Application from PCT/KR2004/003528, filed Dec. 30, 2004, and designating the United States, which claims priority under 35 U.S.C. .sctn.119 to PCT/KR03/002899 filed Dec. 30, 2003, which are incorporated herein in their entireties.

Note that the more recent applications in the priority chain were filed long after the fraud associated with the journal article was known.

Further, the '872 patent, which issued on February 11, 2014 , comes years after the problems with Hwang's science publications were uncovered.

See for example the article by LBE in JPTOS which discussed some aspects of Science's publishing of the fraudulent work by Hwang Woo Suk (Analyzing Innovation the Right Way, 88 JPTOS 239). Mentioned in The Scientist on peer review

Also, from What is the timetable for cures through human embryonic stem cells?

--
One year ago, in March 2006, LBE published a paper on the fraud of Hwang Woo-Suk which included the text:

Hwang's 2005 paper begins with the text: "Many human injuries and diseases result from defects in a single cell type. If defective cells could be replaced with appropriate stem cells, progenitor cells, or cells differentiated in vitro, and if immune rejection of transplanted cells could be avoided, it might be possible to treat disease and injury at the cellular level in the clinic. By generating hESCs [human embryonic stem cells] from human blastocysts, in which the somatic cell nucleus comes from the individual patient -- a situation where the nuclear [though not mitochondrial DNA (mtDNA)] genome is identical to that of the NT donor -- the possibility of immune rejection might be eliminated if these cells were to be used for human treatment." n46 [See 88 JPTOS 239, 248 (2006)]

The reviewers of Science accepted the truth of this statement back in March 2005, when the second paper of Hwang in Science was submitted. Two years later, in March 2007, the statement is still true. It is quite relevant to any realization of cures or treatment through human embryonic stem cells.


--

See also the article in the New York Times by Andrew Pollack Disgraced Scientist Granted U.S. Patent for Work Found to be Fraudulent

Cross-reference

Inventions using publicly available stem cell lines involving destruction of human embryos found unpatentable under the EPC

Intellectual Ventures lays off 5% of workforce

In a post titled Big patent owner Intellectual Ventures cuts staff 5 pct , Reuters stated



IV has over 800 employees, according to its website, so a five percent reduction would impact at least 40 people. The bulk of the staff cuts involved attorneys and engineers who worked for IV's large patent acquisition funds, three sources familiar with the company said.


The Times of India had a headline Patent troll Intellectual Ventures lays off 5% employees

IV had sued Google's Motorola Mobility unit in D. Delaware.

Genifuel's US 20140045229 re-writes "ethyl" history

Note paragraph 7 of Genifuel's US 20140045229 relates the "ethyl" trademark to ethanol, rather than to gasoline with tetraethyllead, an antiknock additive.

From paragraph 7:


The use of biofuels generally is by no means a new or novel idea. In fact, some of the earliest internal combustion engines ran on biofuels. When Rudolf Diesel developed the diesel engine, the fuel he used was peanut oil. Henry Ford was committed to the use of ethanol in his cars, and one of the best-known early trademarks for fuel stations in the US was "Ethyl." Both peanut oil and ethanol were, of course, displaced by petroleum-based products including diesel fuel and gasoline as those products became abundant and cheap. Because of the economic, environmental, and political factors mentioned above, however, the advantage of petroleum is now disappearing and biofuels are once again becoming a top candidate fuel for vehicles.



Note from the case Ethyl Gasoline Corporation v. Craver, 4 F.Supp. 264 (1933) :


It is alleged by plaintiff that it is the owner of sundry registered trade-marks either
arising from purchase or otherwise, and that said trade-marks contain the arbitrary word "Ethyl," which it says was adopted as a distinguishing mark for a compound developed by plaintiff or its predecessors.

On August 5, 1924, it caused a registration of its said trade-mark, and thereafter registered such word in connection with other compounds seven times, the last one being August 2, 1932. It is charged in the bill that the compound thus developed by the plaintiff became popular in the operation of automobiles, both as a fuel and otherwise, and, by reason of its wide advertisement, was used extensively throughout the United States, and that the trade-mark "Ethyl" became associated and identified with plaintiff's product.



And within


The court held that, because of the registrations and use of the word by plaintiff, this gave it absolute ownership, and that the defendant was without right to appropriate and use said word. Judge Atwell went further, and indicated that, wholly apart from the registration, "the name `Ethyl,' and the phrase `Ethyl Gasoline Corporation,' have acquired and now possess a distinct and identifying significance and refer to the complainant's products and motor fuels, with which complainant's anti-knock compound is mixed, and to complainant's business generally."

Strong dissent by Judge Newman in Solvay v. Honeywell: The new general rule here adopted contravenes the policy and the letter of patent law

The issue in Solvay v. Honeywell


The question at the heart of this appeal is when an invention conceived by a foreign inventor and reduced to practice in the United States qualifies as prior art under § 102(g)(2)



The position of appellee-Honeywell


Here, Honeywell contends that the invention was con- ceived by Russian inventors outside the United States and reduced to practice in the United States by Honeywell personnel following the Russian inventors’ instructions before the ’817 patent’s priority date. It follows, argues Honeywell, that the invention qualifies as §102(g)(2) prior art.


The details


The priority date for Solvay’s ’817 patent is October 23, 1995. The parties do not dispute that if the Russians conceived the invention and reduced it to practice in this country before that date without abandoning, suppress- ing, or concealing it, claim 1 of Solvay’s ’817 patent is invalid under § 102(g)(2).



On waiver


The general rule is that “an appellate court does not give consideration to issues not raised below.” Hormel v. Helvering, 312 U.S. 552, 556 (1941); see also Singleton v. Wulff, 428 U.S. 106, 120 (1976). The doctrine of waiver “has been applied to preclude a party from adopting a new claim construction position on appeal.” Interactive Gift Express, Inc. v. Compuserve Inc., 256 F.3d 1323, 1346 (Fed. Cir. 2001). A claim construction argument is consid- ered “new” if a party “change[s] the scope of the claim construction” rather than “clarifying or defending the original scope of its claim construction” or “supporting its existing claim construction position with new citations to the specification.” Id.



On inurement


Assuming that the inurement doctrine governs, inurement does not require that the inventor expressly request or direct the non-inventor to perform reductive work. To be sure, no inurement can arise from a third party’s “unwarranted and hostile use” of another’s inven- tion, Burgess v. Wetmore, 1879 Dec. Comm’r Pat. 237, 240 (no inurement of reduction to practice built by rival applicant), but an express request or direction is not required. (...)

Rather, inurement exists if the inventor authorizes another to reduce his invention to practice. Here, the research agreement between the RSCAC and Honeywell confirms that the RSCAC authorized Honeywell to prac- tice its invention in the United States and contemplated that Honeywell would do so. (...)

We therefore agree with the district court that the process invented by the Russian engineers was made in this country when Honeywell successfully performed the process because the Russians authorized Honeywell personnel to practice the invention and specifically con- templated that they would do so.



Note footnote 11:



The dissent argues that the majority is improperly incorporating concepts from interferences into the in- fringement context, and is allowing “secret prior art” to invalidate a patent. Dissent at 1–3, 8–9. The dissent is incorrect. We have repeatedly held that prior invention by another is a defense to infringement. See, e.g., Checkpoint Sys., Inc. v. U.S. Int’l Trade Comm’n, 54 F.3d 756, 761–62 (Fed. Cir. 1995) (“However, § 102(g) is applicable in other contexts as well, such as when it is asserted as a basis for invalidating a patent in defense to an infringement suit.”)


Judge Newman's dissent begins:


The court today creates a new class of secret prior art, holding that a privately performed experiment, without publication or public knowledge or use or sale or inclusion in a United States patent application, is invalidating “prior art.” Heretofore the role of secret prior art has been carefully circumscribed. The new general rule here adopted contravenes the policy and the letter of patent law, wherein inventors are charged only with knowledge of what is known or knowable as defined by statute, subject to special limited circumstances.



Also


In the prior appeal of this case, Solvay S.A. v. Honey- well Int’l, Inc., 622 F.3d 1367 (Fed. Cir. 2010) (Solvay I), this court confirmed that the Russian invention was conceived and reduced to practice in Russia, and that Honeywell’s repetition of the process in the United States was not an invention made in the United States. Testing the invention of another is not an act of invention by the tester. This aspect was finally resolved in Solvay I, the court describing Honeywell’s work in the United States as a “derivation” of the Russian invention. The matter was finally decided; it is not open for redetermination.

Undaunted, the panel majority now rules that Hon- eywell’s activity was a “reduction to practice” of the Russian process. The private/secret duplication of the prior invention of another does not convert either that prior invention or its duplication into prior art. The issue here is not priority between the Russian invention and the Solvay invention; the issue is prior art against the world.
The Honeywell test of the Russian process was a pri- vate experiment. No United States patent application was filed on the Russian process, not by Honeywell and not by the Russian inventors. A private experiment is not prior art, when it is not published, nor used, sold or otherwise made known, nor included in a United States patent application.



Kimberly–Clark Corp. v. Johnson & Johnson is cited:


Invalidation by secret prior art is disfavored. See OddzOn Prods, Inc. v. Just Toys, Inc., 122 F.3d 1396, 1402 (Fed. Cir. 1997) (“Thus, the patent laws have not generally recognized as prior art that which is not acces- sible to the public.”); Kimberly–Clark Corp. v. Johnson & Johnson, 745 F.2d 1437, 1446 (Fed. Cir. 1984) (defining § 102 “prior art” as “technology already available to the public,” and stating that “secret prior art” may not be used to invalidate a patent under § 102(g)). The majori- ty’s spin on § 102(g) takes “secret prior art” into unin- tended territory.



AND

The court’s ruling that prior art includes secret information is of far-reaching potential impact.

In re Warner (1967) cited to reverse examiner in Ex parte GLEISSNER

Ex parte GLEISSNER:


Rejections based on § 103(a) must rest on a factual basis with these facts being
interpreted without hindsight reconstruction of the invention from the prior
art. See In re Warner , 379 F.2d 1011, 1017 (CCPA 1967)

Consumer Watchdog and standing: "the pragmatic catastrophe of its suggestion"

Patent Docs discusses the standing issue of Consumer Watchdog to pursue an appeal:


In December, the Federal Circuit invited the United States to address the issue of whether Consumer Watchdog had Article III standing to pursue an appeal of a decision by the Board of Patent Appeals and Interferences affirming the patentability of U.S. Patent No. 7,029,913, which is assigned to the Wisconsin Alumni Research Foundation (WARF). The appeal arose from an inter partes reexamination of the '913 patent that Consumer Watchdog filed in 2006.




Within the Patent Docs text


The brief [of Consumer Watchdog] criticizes the government's failure "to address the pragmatic catastrophe of its suggestion," asking whether the Court will need to schedule preliminary standing hearings in all such cases before it can reach the merits.



Recall that the patent in question, US 7,029,913 to inventor James Thomson, relates to stem cells. The first published claim:

A replicating in vitro cell culture of human embryonic stem cells comprising cells which (i) are capable of proliferation in in vitro culture for over one year without the application of exogenous leukemia inhibitory factor, (ii) maintain a karyotype in which the chromosomes are euploid through prolonged culture, (iii) maintain the potential to differentiate to derivatives of endoderm, mesoderm, and ectoderm tissues throughout the culture, and (iv) are inhibited from differentiation when cultured on a fibroblast feeder layer.



Note earlier posts by IPBiz, including
More on the PubPat loss in the re-exam of WARF's US 7,029,913

IPBiz has criticized John M. Simpson of Consumer Watchdog for his incorrect assertions about fighter planes in World War I.

From
PubPat continues its confused ways :

In an IPBiz post on May 28, there was discussion of a CIRM document from an April 27 meeting of CIRM's IP Task Force: There was a conclusion about the U.S. aviation patent pool in World War I: "and that's what led to fighter planes being built for World War I."

IPBiz noted that there were no U.S. - built fighter planes ever used in World War I. For example, US ace Eddie Rickenbacker flew Nieuport 28 and SPAD XIII aircraft (French).

It's likely that Simpson knows even less about continuing applications than he did about patent pools, but ignorance doesn't seem to slow him down.

CAFC finds fault with PTAB in Tempo v. Tivoli

In the case Tempo v. Tivoli, defendant-Tempo had requested inter partes reexamination with the PTO of plaintiff-Tivoli's patent. In the appeal before the Board of the re-exam, the Board (Board) reversed the examiner’s rejection of claims 1–3 and 6–13 of U.S. Patent No. 6,554,446 (’446 patent). Tempo Lighting, Inc. (Tempo) appeals that decision. Because the Board’s decision lacks the support of substantial evidence in the record and because the Board erred in concluding that Tempo waived certain arguments, this court vacates the decision in-part and remands.

At issue on appeal to the CAFC, Tempo advances three arguments. Tempo argues that the Board erred in construing “inert to light” differently from the examiner. Even assuming the Board’s construction was correct, Tempo also argues that the Board erred by relying on the examiner’s factual findings under a different claim construction. Finally, Tempo argues that it did not waive its arguments con- cerning alternative grounds for affirming the examiner’s rejections under Tivoli’s proposed construction of “inert to light.”

The CAFC alluded to In re Lovin. Finally, this court accepts the Board’s interpretation of PTO regulations unless that interpretation is “plainly erroneous or inconsistent with the regulation.” In re Lovin, 652 F.3d 1349, 1356 (Fed. Cir. 2011).

Of interest: Moreover, the Board properly avoided the circularity inherent in any attempt to construe claims with an eye to preserving their validity, a doctrine of “limited utility.” See Phillips v. AWH Corp., 415 F.3d 1303, 1328 (Fed. Cir. 2005). Thus, even in the unlikely event that it adopted a construction for “inert to light” that might render the claims invalid under § 112, the Board did not err in reaching that meaning based on the intrinsic evidence. In any event, if the stayed litigation proceeds anew before the District Court, Tempo will have an opportunity to challenge the claims under § 112 at that time.

The problem for the Board: Having corrected the examiner’s claim construction, however, the Board erred by relying on factual findings resting on that incorrect claim construction. In its opin- ion, the Board states “we agree with Patent Owner that the combination of prior art does not result in a lighting apparatus that is ‘inert to light’ when the term is properly construed. In this regard, the Examiner expressly found that each of the primary references . . . lacks this claimed feature.” J.A. 15–16. The Board’s reasoning is deficient. The Board states that the prior art references do not disclose the “inert to light” limitation as properly con- strued, but only cites to the examiner’s findings under the reversed—and substantially different—claim construc- tion. On remand, the PTO will have the opportunity to make new factual findings under the proper construction.

AND

Third-party requester cross-appeals are governed by 37 C.F.R. § 41.61(b). That regulation states, in relevant part, that “a requester who has not filed a notice of appeal may file a notice of cross appeal with respect to any final decision favorable to the patentability, including any final determination not to make a proposed rejection, of any original, proposed amended, or new claim of the patent.” 37 C.F.R. § 41.61(b) (emphasis added). Thus, one of the threshold conditions for a cross-appeal is a final decision favorable to patentability. In this case, the examiner rejected all the claims. Thus, the record presented no decision favorable to patentability for Tempo to appeal.
Contrary to the Board’s assertion, each of the examin- er’s determinations against Tempo’s proposed rejections is not a distinct decision favorable to patentability necessi- tating an appeal.

In this case, Tempo has the right to defend the examiner’s final decision on any ground supported by the record. Rexnord Indus., LLC v. Kappos, 705 F.3d 1347, 1356 (Fed. Cir. 2013). Through- out the reexamination, Tempo argued that the primary references anticipate the claims under Tivoli’s construction. J.A. 440–47. While Tempo argued in favor of the examiner’s construction and rejections, this did not fore- close Tempo from also advancing arguments under the construction proposed by Tivoli. Contrary to the Board’s decision, and Tivoli’s arguments, Tempo’s conduct does not rise to the level of waiver or invoke judicial estoppel. Accordingly, the Board erred by not considering Tempo’s additional arguments.

Also of interest: As this reexam- ination has lasted nearly a decade, this court urges the PTO to provide a speedy resolution to this dispute as envisioned under 35 U.S.C. § 314(c).

From business wire in the year 2004:



Tivoli, LLC filed a complaint for patent infringement on February 27, 2004 in Santa Ana Federal Court against Tempo Lighting, Inc., doing business as Tempo Industries. Plaintiff alleges that Defendant deliberately knocked off and copied Tivoli's '446 Step Illumination patent and has been advertising it on the Internet and via its catalog under the name Sentinal System. Tivoli, LLC also charges Tempo Industries with false advertising and unfair competition. Plaintiff seeks damages and a permanent injunction against Tempo Industries, as well as punitive damages. Judge David O. Carter will preside over the matter. Tivoli, LLC is represented by William E. Levin and Edward O'Connor with Levin & O'Connor in Laguna Beach, CA. Tivoli, LLC vs. Tempo Lighting, Inc., Case No. SACV 04-00223 DOC (VBKx).

Review by Third Circuit of Lamictal case likely

Does a promise not to market an "authorized generic" amount to a reverse payment?

Look at post District court holds that under FTC v. Actavis, “pay for delay” means money relevant to a possible appeal of In re: Lamictal, No. 12-cv-995, 2012 WL 6725580 (D.N.J. Dec. 6, 2012)

US Trade Representative Hearing in February 2014: designate India a “Priority Foreign Country”?

SpicyIP notes:


In pursuance to its investigation into India’s trade, investment and industrial policies, the U.S. International Trade Commission (USITC) is holding a public hearing on February 13, 2014. Professor Srividhya Ragavan (University of Oklahoma College of Law), Brook Baker (Northeastern University School of Law), and Sean Flynn (American University Washington College of Law) submitted a statement to the USITC on issues pertaining to India’s patent regime.



The statement includes the text


Specifically, TRIPS Article 31 permits compulsory licenses for ANY reason, including the historically sanctioned grounds of insufficient working of an invention in the country. This flexibility was explicitly clarified in the 2001 Doha Declaration on the TRIPS Agreement and Public Health. Similarly, TRIPS leaves countries free to define patentability criteria, including to define what is not an invention. Along the same lines, each member of the WTO has the sovereign right to determine andestablish the threshold for the nonobviosuness/inventive-step requirement. Thus, India is within its rights to establish that the new forms or uses of existing and known molecules that do not significantly increase the therapeutic effectiveness of such substances are not entitled to patent protection.



Within the full body


Historically, India embraced process-patent-only protection in specified fields rather than product patent protection, particularly for food and pharmaceuticals, in order to prioritize domestic issues like access to medication and food security. India was not alone. In the period before TRIPS, nearly 50 countries exempted pharmaceuticals from product patent protection and an additional 10 exempted pharmaceuticals from process patents as well.5

The Indian Patent Act of 1970,6 (IP70) along with other mechanisms such as drug and industrial policies were all part of the repertoire of tools used by India to achieve its national priorities. In gist, the process patent regime of IP70 excluded protection of the end-product, but protected the method or the process of making the product. The process patent regime encouraged competitive innovation in the methods of making known products, thus, it enabled production of products patented elsewhere using different processes, incentivizing the development of more efficient production processes. The system’s encouragement for process innovation was the first step to establishing India’s generic drug industry, much like how Germany established its chemical process industries in the 1800s. Under IP70, the term of process protection over food, drug, and medical inventions was limited to five years.7 A license of right 8 authorized any person to manufacture a patented product, without having to seek the patentee’s approval. Inventions relating to food, chemicals, and pharmaceuticals, were automatically deemed to be endorsed with a license of right three years after the patent issues. Further, the government could, in the public interest, compulsorily license the patent if the invention was either not reasonably priced or not worked to satisfy the reasonable requirements of the public.



As to fulfilling TRIPS


India’s definition of novelty or “new invention” includes world-wide prior art which was was much broader than the requirement that prevailed in the United States under 35 U.S.C. § 102, under which any use of the application material within the United States (only) defeated novelty. Only in 2011 would the America Invents Act introduce the concept of worldwide novelty,9 even though this provision was heavily criticized as obstructing small-scale industries.
India’s inventive step requirement requires that the “feature of an invention that involves technical advance as compared to the existing knowledge or having economic significance or both and that makes the invention not obvious to a person skilled in the art.”10 This requirement for inventive step has been widely noted as being much more stringent than the nonobvious requirement in the United States, but 11 many countries have different, indeed stricter standards for inventive step than does the United States. In fact, the U.S.’s weak standard has been a significant causative factor for the degenerating quality of the patents in the U.S.
India has also adopted, within the framework of allowable pluralism under TRIPS, a stronger definition of industrial applicability than the United States. The United States’ weaker standard of utility has historically allowed the patenting of business methods and other more abstract innovations, unlike India and many other countries that either exclude such matters as unpatentable or consider them not to have industrial applicability. This is one of many permissible policy differences allowed under TRIPS. In this regard, it is also important to note that India has codified a number of exclusions to patentability that are similarly excluded by many other countries – abstract ideas, theories of science, plants and animals, etc., even where the same creations could subject to patent in the U.S. Perhaps the most important exclusion from patentability, discussed further below, is India’s Section 3(d).



The authors cited Pfizer v. Apotex



The logic of this interesting provision is along the exact lines of the opinion of the Court of Appeals for the Federal Circuit (CAFC) in the case of Pfizer v. Apotex involving the Pfizer’s patenting of the besylate form of amlodipine (salt form) which Apotex claimed was obvious in the light of Pfizer’s own patent on the base compound amlodipine.16 The CAFC, in agreeing with Apotex that the patent on the besylate form was invalid, highlighted the besylate form lacked the unexpected superior results from the base compound in order for the salt form to be patented.17 Indeed, the Manual for Patent Examination Procedure in section 716.02 and in 2144.09 specifically memorializes unexpected results as a test to demonstrate nonobviousness of structurally similar compounds like isomers and homologues.18 Thus, India’s standard is well within the lines of what has been allowed in the United States.


As to a higher standard



TRIPS does not require its member countries to be persuaded by the issue patents of other countries. The argument that several other countries agreed that Gleevec was patentable despite being a mere variation of an existing, previously patented chemical entity is inconsequential to India’s own patent determination. If a country chooses to adopt a higher bar for determining patentable subject matter and/or inventive step under TRIPS, it is well within the member’s rights to do so. Indeed, Japan has a record of allowing approximately 14% of patents that are granted in the United States.

"60 Minutes" on February 9, 2014

First, Lesley Stahl on dosing medicines as between men and women.

Second, giving apartments to homeless people.

Third, Steve Kroft gives a reprise of an interview with Philip Seymour Hoffman.

FDA last year [ On January 10, 2013 ] cut the dose for women for Ambien (zolpidem) by 50%. [ The United States patent for zolpidem was held by the French pharmaceutical corporation Sanofi-Aventis. ] For drug dosage, sex matters. Larry Cahill of UCal/Irvine noted Ambien is a case in point. Women have been prescribed a does that is twice as much as needed. Dr. Sandra Queter of FDA/Office of New Drugs: women metabolize Ambien differently. (45%). In the original review in 1992: Cmax and AUC were 45% higher in females. Gender related difference. Clinical pharmacology. Bikini medicine. There was an assumption that women were men, with pesky hormones. Heart disease. Cedar-Sinai: women differ from men in the way they have heart attacks. Women might have stomach upsets. Men get clogs in major arteries; women get clogs in minor arteries. Dr. Melina Kibby at Northwestern Medical School. Most researchers just study male rate. Doris Taylor at Texas Heart Institute, works on stem cells. Give female animals, male stem cells. Merely to track cells. Only the female stem cells got rid of the plaque. Male vs. female animals gave different results. Men's stem cells are less powerful and prone to aging. If whole pipeline is male dominated, but sex matters, one has a problem. Muddling up the understanding of what's going on. Need to review everything. The assumption that sex does not matter is not a valid assumption. So far, zolpidem is the only drug on the market that has different recommended dosages for men and for women. [Footnote: According to the U.S. Drug Enforcement Administration, zolpidem may be overtaking illegal sedatives as the most common date-rape drug. ]

IPBiz query on Ambien. The gist of the "60 Minutes" story was dosage of drugs, men vs. women, based upon the FDA determination for Ambien (zolpidem). One thing not addressed was controlled release formulations. Ambien CR is the “controlled–release“ (CR) formulation of Ambien, and was on-patent after the original Ambien went off-patent. It is standard practice in the pharmaceutical industry to create “extended release,“ “sustained release“ or “controlled release“ versions of drugs that go off patent. See a post by Consumer Reports. If Ambien is not metabolized quickly by women, a controlled release formulation might not be a good idea.

Anderson Cooper on the "100,000 homes" campaign. Nashville has joined the campaign. Ingrid McIntire. Robert McMurty lived in a storage bin; aged 48 years old. "Open Table Nashville". Robert was given a 1-bedroom, 1-bathroom apartment. The hardcore homeless. Becky Kanis of Community Solutions. More than 60% of chronic homeless have drug or alcohol problems. Becky is a West Point graduate. Boots on the ground intelligence. Plan: spend three nights for homeless. Kirby Davis. Homeless ranked according to medical risk. Frank Clements, former criminal. "giving them a second chance." Goal: get 100,000 people off the streets.

Steve Kroft noted Hoffman was intense, introspective and gave an interview to 60 minutes in 2006. The interview was at 8am in Greenwich Village. 40 films in 14 years. The Talented Mr. Ripley; Scent of a Woman; Boogie Nights. Scruffy wardrobe. Part of being an actor is staying private. You don't want people to know about your personal life. You want your audience to think you are some one else. His role as Truman Capote. The 6 years writing "In Cold Blood."
Bennett Miller. Capote was an iconic figure. Capote's ambition, drive. Stubborn single-minded zeal for perfection.
Clip of final scene from Capote. Hoffman took 9 months on Capote. "If I start drinking again..." There are things I want to do...Rehab was a respite... Hoffman began drinking in 2012 during role of Willy Loman. Broadway went dark in Hoffman's honor. ...when I went to sleep peacefully, that's as good as it gets.

Apple takes on the patent assertion entity (“PAE”)

A Los Angeles Times post Apple complains of 'patent trolls' obliquely refers to Apple's amicus brief in Highmark v. Allcare.

Cited within the amicus brief is Mark A. Lemley, Are Universities Patent Trolls?, 18(3) Fordham Intell. Prop. Media & Ent. L.J. 611 (2008) as to the text:


No bargaining chip is more valuable than the “lack of a quick and reasonably priced method for resolving disputes regarding the bounda- ries of the rights,” id. at 258—in other words, the enormous cost of patent litigation. And altogether too many PAEs are in the business of leveraging this feature of patent litigation “to capture not just the value of what they contributed to an invention, but also a disproportionate share of somebody else’s product.” Mark A. Lemley, Are Universities Patent Trolls?, 18(3) Fordham Intell. Prop. Media & Ent. L.J. 611, 613-14 (2008). Economists call this rent seeking. Securities lawyers call it strike litigation. The most appropriate label might be extortion.



And the next paragraphs have allusions to James Bessen:



Allcare illustrates how PAEs have reduced this profiteering to a science. To begin with, their very defining feature—that they do not practice their patents—is an adaptation meant to tilt the bargaining table. For operating companies, the risk of a coun- tersuit factors heavily into the decision whether to file suit against a competitor. But an entity that never makes anything can never be counter-sued. Bessen & Meurer, supra, at 29. This means PAEs have less at stake during litigation than the operating companies they target, and far lower discovery costs. Id. Their greater tolerance for drawn-out liti- gation makes PAEs’ in terrorem demands all the more credible.

PAEs then amplify this advantage through two primary strategies. Some are volume scorers. These PAEs live in the “gap between what is truly innova- tive and what is permissibly patented and asserted.” Merges, supra, at 1589. They buy up weak or vague patents and assert them against dozens of operating companies. See Bessen & Meurer, supra, at 8, 20. Because the patents are of low quality, the PAEs are often “willing to settle for small payments, often no more than the amount a defendant would spend on legal fees to defend the case.” Id. But “[i]f a fraction of these attempts succeed, a revenue stream can be developed without resort to litigation.” Chien, Liti- gation of High Tech Patents, supra, at 1580.



Judge Richard Posner is mentioned:


A party’s motivations in litigation may not be readily apparent in every case, but in some it is all too obvious. In Highmark, for instance, Allcare used the explicit threat of exorbitant litigation costs from the get-go to gain the upper hand. It had conducted no pre-suit investigation, so its litigation cannot pos- sibly have been motivated by the bona fide desire to protect its patent rights. And even after its position was exposed as wholly untenable, Allcare persisted, a decision that can be explained only as an attempt to run up its opponent’s costs. Highmark has all the markings of a case in which one party litigated pure- ly for what Judge Posner called “strategic purposes.”



Apple's conclusion:


For the foregoing reasons, the Court should adopt a test for determining whether a case brought under the patent laws is “exceptional” that takes in- to account the nature and motivations of the parties to the litigation, the merits of the parties’ positions, and the parties’ conduct both before and during liti- gation.



Cross-reference There’s a Secret War on Apple Few Know About by Victor Luckerson

The Dreamliner 787 and lithium batteries

On January 14, 2014, there was a minor incident involving a lithium battery on a Boeing 787 Dreamliner.
Boeing confirms new 787 Dreamliner battery incident

The Financial Times noted




Nick Cunningham, analyst at Agency Partners, said lithium-ion batteries had “a tendency to overheat and catch fire unpredictably, which is never a welcome characteristic of anything used on board an aeroplane”.

But he said the energy density of these batteries – they can store considerably more electrical charge in a smaller and lighter package than alternative technologies – was important to Boeing.

This is because the Dreamliner relies more heavily on electrical power compared to previous aircraft, and the 787 needs batteries as back-up in the event of its generators failing.




Daily Finance had quoted Michel Armand, who has worked in lithium batteries for over 40 years:


Michel Armand, a professor of chemistry at the University of Picardie and a research director at the French government's Centre National de la Recherche Scientifique, told Barron's: "Using these batteries in planes makes no sense, with all the lives potentially at stake. These batteries are unpredictable and prone to thermal runaway and fires."



GS Yuasa makes the batteries for Boeing. As to patents related to the batteries, see
The Patents Behind the Plane.

For example Yuasa has US 7,393,476, with abstract:

A positive active material for lithium secondary batteries, includes a composite oxide including an oxide which is represented by the composite formula LixMnaNibCocO2 and has an α-NaFeO2 structure, and an impurity phase including Li2MnO3. The values a, b, and c are within such a range that in a ternary phase diagram showing the relationship among these, (a, b, c) is present on the perimeter of or inside the quadrilateral ABCD defined by point A (0.5, 0.5, 0), point B (0.55, 0.45, 0), point C (0.55, 0.15, 0.30), and point D (0.15, 0.15, 0.7) as vertexes, and 0.95

HTC agrees to settle patent dispute with Nokia

from Bloomberg: HTC to Pay Nokia Royalties to End Smartphone Patent Dispute


“Nokia has one of the most preeminent patent portfolios in the industry,” HTC General Counsel Grace Lei said in the statement. “As an industry pioneer in smartphones with a strong patent portfolio, HTC is pleased to come to this agreement, which will enable us to stay focused on innovation for consumers.”

Many of Nokia’s patents cover technology that’s used across the industry. The case is part of a broader debate over whether patents that cover fundamental technology related to industry standards should be treated differently than, for instance, patents on specialized features.

The Obama administration has come out for limited restrictions on so-called standard essential patents. It overturned an import ban won by Samsung against Apple because it said the ITC didn’t fully address the criteria the administration laid out to determine if an import ban is appropriate.

Patentee prevails in Pfizer v. Teva over GABA enantiomer/racemate issue. Conflict with Sanofi v. Apotex?

Relating to the drug Lyrica, the CAFC decision in Pfizer v. Teva has some interesting statements about enablement and written description in the context of having patent coverage on a separated enantiomer with a disclosure of only the racemate.

The appellants (Teva, et al.) argued that merely obtaining the racemate, without teaching "how" to isolate the enantiomer did not satisfy enablement under 35 USC 112:


Appellants also contend that the ’692 application provides nothing more than boilerplate language pointing to unspecified prior art as the basis for making the claimed invention, and fails to disclose the required starting materials, reaction conditions, and other working examples.



However, the CAFC found that making the racemate (not the resolved enantiomer) was enough:



First, there is no requirement that a specification must “disclose what is routine and well known in the art.” Genentech, Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1366 (Fed. Cir. 1997). Second, as the district court found, there is no dispute in the record that the co-inventors of the ’819 patent were the first to create and claim the chemical compound 3-isobutylGABA. District Court Opinion, at 689. It is also undisputed that the parent application discloses the method for synthesizing the compound and states that the compound’s “enantiomers may be prepared or isolated by methods already well known in the art.” J.A. 3012-14. The district court found support for this fact in the prior art, the prosecution history, and witness- es’ trial testimonies. See District Court Opinion, at 683- 87; see also J.A. 3012-14, 21196-203, 21168-69, 21172-80, 20622-24, 21205-06. The court also acknowledged that the same conclusion was reached by the PTO Examiner, who withdrew an enablement rejection on that very basis during prosecution of the patent. District Court Opinion, at 689 n.41.



AND


Second, according to Sun, despite the patentee describing the separation of the racemate (i.e., isolation of the enan- tiomers) as anything but routine in later applications, at the time of the ’692 application, both inventors readily admitted that they had not yet separated the racemic mixture to obtain a purified enantiomer. See J.A. 20814- 18.



Within the Pfizer v. Teva decision, one will not find a reference to SANOFI SYNTHELABO v. APOTEX INC (CAFC 2008). The result in Pfizer v. Teva is in tension with the result in Sanofi v. Apotex.

The Pfizer court: compound’s “enantiomers may be prepared or isolated [from racemates] by methods already well known in the art.”
The Sanofi court: However, as the witnesses agreed, all of the compounds in the ′596 patent are racemates, and neither the twenty-one specific examples nor any other part of the specification shows their separation into enantiomers.   The district court reasoned that a person of ordinary skill in the field of the invention would not have been guided to either the dextrorotatory enantiomer of PCR 4099 or its bisulfate salt.

In the Sanofi case, the patent at issue was United States Patent No. 4,847,265 (the ′265 patent), owned by Sanofi-Synthelabo and related companies, and which covered the pharmaceutical product having the common name clopidogrel bisulfate and the brand name Plavix®.  Clopidogrel is the common name of the dextrorotatory enantiomer of methyl alpha-5(4,5,6,7-tetrahydro(3,2-c)thienopyridyl)(2-chlorophenyl)-acetate. The 2008 appeal was focused on the question of patentability of this dextrorotatory isomer in view of its known racemate described in earlier Sanofi patents, specifically, Sanofi's United States Patent No. 4,529,596 (the ′596 patent) and Canadian Patent No. 1,194,875 (the ′875 patent).

Of relevance to Pfizer v. Teva: In the district court, experts for both sides explained the difficulty of separating enantiomers, for they are identical except for the spatial arrangement at one of the carbon atoms. (...)
The record shows five months of experimentation by Mr. Badorc, and eventually the successful separation using a technique called diastereomeric salt formation.   This procedure, which originated with Louis Pasteur, is based on the trial of diverse salt-forming compositions and conditions, in the hope of coming upon a lucky combination of reagents that will preferentially select one of the enantiomers and crystallize from the solution in optically pure form.

An issue before the CAFC in Sanofi was whether synthesis of the racemate anticipated the enantiomer:


Claimed subject matter is “anticipated” when it is not new;  that is, when it was previously known.   Invalidation on this ground requires that every element and limitation of the claim was previously described in a single prior art reference, either expressly or inherently, so as to place a person of ordinary skill in possession of the invention.   See Schering Corp. v. Geneva Pharms., Inc., 339 F.3d 1373, 1379 (Fed.Cir.2003);  Continental Can Co. USA v. Monsanto Co., 948 F.2d 1264, 1267-69 (Fed.Cir.1991). An anticipating reference must be enabling;  that is, the description must be such that a person of ordinary skill in the field of the invention can practice the subject matter based on the reference, without undue experimentation.   See Amgen Inc. v. Hoechst Marion Roussel, Inc., 457 F.3d 1293, 1306-07 (Fed.Cir.2006);  Elan Pharms., Inc. v. Mayo Found. for Med. Educ. & Research, 346 F.3d 1051, 1054 (Fed.Cir.2003).   Anticipation is a question of fact, and the district court's finding of this issue is reviewed for clear error.   See Merck & Co. v. Teva Pharms. USA, Inc., 347 F.3d 1367, 1369 (Fed.Cir.2003). (...)

The court heard expert witnesses for both sides, who agreed that persons of ordinary skill in this field would have known that compounds that contain an asymmetric carbon atom have enantiomers.   The [PRIOR ART] ′596 specification states:  “These compounds having an asymmetrical carbon may exist in the form of two enantiomers.   The invention relates both to each enantiomer and their mixture.”  ′596 patent, col. 1, lines 39-41.   However, as the witnesses agreed, all of the compounds in the ′596 patent are racemates, and neither the twenty-one specific examples nor any other part of the specification shows their separation into enantiomers.   The district court reasoned that a person of ordinary skill in the field of the invention would not have been guided to either the dextrorotatory enantiomer of PCR 4099 or its bisulfate salt.



The patent challenger in Sanofi v. Apotex, which was Apotex, took the position of the patent defender in Pfizer v. Teva: Apotex states that the separation of enantiomers is routine, even if time-consuming or requiring some experimentation, and thus that that the separation need not have been performed or described in the reference.   Apotex states that the properties of the enantiomers of PCR 4099 are inherently and necessarily present in its known racemate, such that when the enantiomers are separated the previously observed properties are “immediately recognized” in one or the other enantiomer.

But Apotex LOST.


Apotex thus argues that the dextrorotatory enantiomer of MATTPCA cannot be deemed novel, as a matter of law.   However, as the district court recognized, that is not the correct view of the law of anticipation, which requires the specific description as well as enablement of the subject matter at issue.   To anticipate, the reference “must not only disclose all elements of the claim within the four corners of the document, but must also disclose those elements ‘arranged as in the claim.’ ”  Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1369 (Fed.Cir.2008) (quoting Connell v. Sears, Roebuck & Co., 722 F.2d 1542, 1548 (Fed.Cir.1983));  see also, e.g., In re Arkley, 59 C.C.P.A. 804, 455 F.2d 586, 587 (1972) (“[The] reference must clearly and unequivocally disclose the claimed [invention] or direct those skilled in the art to the [invention] without any need for picking, choosing, and combining various disclosures not directly related to each other by the teachings of the cited reference” (emphasis in original)). (...)

Apotex states that it is irrelevant whether the separation of this specific enantiomer is shown in the references, because a person of ordinary skill in this field would know all of the existing techniques for separating stereoisomers, and would presumptively succeed in this particular separation.   Apotex points out that the method that was eventually used by Sanofi was a well-known method, even if it involved some experimentation.



The CAFC noted


The ′596 patent reference states only that “if desired, its enantiomers are separated,” and similarly for the Canadian counterpart.   The district court found that these references contain no description of how to separate the enantiomers of PCR 4099, and that “[d]iscovering which method and what combination of variables is required is sufficiently arduous and uncertain as to require undue experimentation, even by one skilled in the relevant art.”  Sanofi III, 492 F.Supp.2d at 387.   This finding has not been shown to be clearly erroneous.  


As to obviousness in Sanofi v. Apotex:



The district court assumed that Apotex had made a prima facie case of obviousness based on the reference patents' disclosure of the PCR 4099 racemate, the statements in the patents concerning enantiomers, and the general knowledge that enantiomers may be separated and may differ from each other in biological properties.   Upon consideration of the Graham factors, the court held that the unpredictable and unusual properties of the dextrorotatory enantiomer and the therapeutic advantages thereby provided, weighed in favor of nonobviousness, and that Apotex had not met its burden of establishing otherwise.
(...)
However, the experts also agreed that it was not predictable whether such differences, if any, would be weak, moderate, or strong, or how they would be manifested.   The experts agreed that no known scientific principle allows prediction of the degree to which stereoisomers will exhibit different levels of therapeutic activity and toxicity.   The experts agreed that weak stereoselectivity of biological properties is more common than strong stereoselectivity, and that absolute stereoselectivity is rare.   Sanofi witnesses testified as to the research team's belief, based on the earlier separations of two other thienopyridines, that separation of enantiomers was unlikely to be productive.  


See the 2008 post on IPBiz
Sanofi prevails on PLAVIX at CAFC: enantiomer patentable over racemate

See also the 2004 post on IPBiz
Enantiomers, racemates, and the chiral switch

More recently, in Canada Sanofi’s Patent for Clopidogrel (PLAVIX) Found Valid and Infringed on Appeal; Apotex’s Appeal on Costs Moot

Of Pfizer v. Teva, Patent Docs has the text


In addition, the court had found that the specification stated that "enantiomers may be prepared or isolated by methods already well known in the art," and that there was sufficient support for this statement based on "the prior art, the prosecution history, and witnesses' trial testimonies." Id. at 12.

The Federal Circuit did not believe that this determination was clearly erroneous, and therefore it affirmed that claim 2 was not invalid for lack of enablement. In response to the Appellants' contention that the specification provides no guidance as to how to purify the two enantiomers, the Federal Circuit stated that "the inventors were not required to provide a detailed recipe for preparing every conceivable permutation of the compound they invented to be entitled to a claim covering that compound." Id.



Within Sanofi v. Apotex, the CAFC had stated:


The district court found that these references contain no description of how to separate the enantiomers of PCR 4099, and that “[d]iscovering which method and what combination of variables is required is sufficiently arduous and uncertain as to require undue experimentation, even by one skilled in the relevant art.”  Sanofi III, 492 F.Supp.2d at 387.   This finding has not been shown to be clearly erroneous.  


Hmmm, opposite conclusions, neither of which is clearly erroneous?? A house divided against itself cannot stand.
Pfizer v. Teva is wrongly decided. To have a valid claim to the enantiomer one must enable possession of the enantiomer. Having the racemate is not the same thing as having the enantiomer. Merely because Pasteur, and others, separated enantiomers does not establish enablement for separating a particular enantiomer from its corresponding racemate.

***Some other points related to Pfizer v. Teva at the district court

On March 1, 2011, the PTO issued a Certification of Correction, correcting the "Related Application Data" field on the '175 Patent to read "Divisional of Ser. No. 08/420,905, filed Apr. 11, 1995." With this correction, the '175 Patent claims priority to the '692 application, filed on November 27, 1990, through the '080, '285, and '905 applications.

Within the district court decision: For the reasons that follow, the court finds that the asserted claims of the '819 Patent and claim 1 of the '175 Patent are entitled to priority filing dates of November 27, 1990.

AND

The Federal Circuit has also instructed that "[i]t is unnecessary to spell out every detail of the invention in the specification" to satisfy the enablement requirement and the patent application does not need to disclose specific examples corresponding to every claimed embodiment. See Falko-Gunter Falkner v. Inglis, 448 F.3d 1357, 1366 (Fed. Cir. 2006). On the contrary, § 112 requires only a "reasonable correlation" between the disclosure and the claims. Invitrogen Corp v. Clontech Labs., Inc., 429 F.3d 1052, 1071 (Fed. Cir. 2005). Importantly, the Federal Circuit has established that an issued patent is presumed valid by statute. See 35 U.S.C. § 282. That presumption can be overcome only by clear and convincing evidence, which is defined as evidence that "proves in the mind of the trier of fact an abiding conviction that the truth of [the] factual contentions [is] highly probable." Intel Corp. v. U.S.Int'l Trade Comm'n, 946 F.2d 821, 830 (Fed. Cir. 1991).

The issue at district court:


The plaintiffs assert that claims 1, 2, and 4 of the '819 Patent are entitled to a priority date of November 27, 1990, the date of U.S. Patent Application No. 07/619,692, the Initial Application that led to the '819 Patent, because the '692 application would have enabled persons of ordinary skill in the art to make S-3-isobutylGABA and its single optical isomers without undue experimentation, by a variety of methods. (D.I. 351 at 3.) Conversely, the defendants challenge that claims l, 2, and 4 of the '819 Patent are entitled only to a priority filing date of May 20, 1992, the date of the first continuation-in-part of the Initial Application, U.S. Patent Application No. 07/886,080, because the '692 application did not enable the S enantiomer of3- isobutylGABA as a single optical isomer. (D.I. 352 at 2; D.!. 349 at 24.)



Some evidence from the defendants


In making this argument, the defendants reject the notion that the R and S enantiomers of
3-isobutylGABA were enabled by the '692 application because they could be "prepared or isolated by methods already well known in the art," as the application stated. (Id.) The defendants' expert, Dr. Davies, testified that, as of November 1990, there were three teclmiques that could be used to attempt to obtain a single enantiomer: (1) classical resolution by making diastereomeric salts or derivatives; (2) chiral chromatography; and (3) chiral synthesis34 (!d. (citing Tr. at 603:23-604:19,612:5-14, 612:22-613:2 (Davies)).) The defendants assert that three highly skilled scientists, all employing each approach, attempted and failed to isolate the S enantiomer of 3-isobutylGABA contemporaneously with the filing of the '692 application and after, such that the '692 application's description that the S enantiomer could be resolved by routine methods known in the art was incorrect and, therefore, not enabled. (Id.)
Specifically, the defendants, rely upon the testimony of their expert, Dr. Davies, to argue that Drs. Andruszkiewicz, Pavia, and, at the outset, Yuen, were unable to make the individual enantiomers of S- and R-3-isobutylGABA or non-racemic mixtures of the two. First, the defendants note that while Dr. Andruszkiewicz was able to separate enantiomers of 3- methylGABA, he failed, after extensive experimentation with classic resolution and PLE, to separate the enantiomers of 3-ethylGABA and did not attempt separation of 3-isobuty!GABA because he believed that the available techniques would not work. (...)
Third, the defendants argue that the work of Dr. Yuen, a chemist who was instmcted by Pfizer to separate 3-isobutylGABA's enantiomers and successfully did so, establishes by clear and convincing evidence that separation of the R and S enantiomers could not be accomplished by routine methods available in the 1990 prior art. Specifically, Dr. Yuen testified that, upon reviewing Dr. Pavia's work, he concluded that the classic resolution and PLE methods would prove ineffective. (...)
Dr. Y uen subsequently obtained S-3- isobutylGABA on September 30, 1991, ten months after the filing of the '692 application. (!d. (citing Tr. at 580:19-581:6 (Yuen); DTX-968A at PFE- LYR- 0097732).) (...)
Thus, the defendants argue, in sum, that the '819 Patent is not entitled to the priority filing date of the '692 application, November 27, 1990, because that application provides no direction, guidance, or working examples concerning how to make individual enantiomers or non-racemic mixtures of 3-isobutylGABA other than to state that "[t]he individual diastereomers or enantiomers may be prepared or isolated by methods already well known in the art." Because, the defendants argue, separation of the R and S enantiomers could not be accomplished by metl1ods already known in the art without "undue experimentation" and required Dr. Yuen's invention, the '692 application is not enabled and the appropriate priority filing date for the '819 Patent is May 20, 1992.



The district court rejected the defendants arguments:


Contrary to the defendants' assertions, where a court, as it has here, construes a claim to cover a chemical compound, the specification is not deficient merely because it does not disclose how to prepare a particular form of that compound.40 See In re Hogan, 559 F.2d 595,
606 (C.C.P.A. 1977) (noting that requiring a specification to disclose how to make each particular form of a compound would "impose an impossible burden on inventors and thus on the patent system" and concluding that "[t]here cannot, in an effective patent system, be such a burden placed on the right to broad claims").



Here, of course, THE effective form is the particular form.

Appellant fails to make argument in opening brief and loses under Ex parte Borden

A failure to raise an issue in the opening brief was costly to Appellant in Ex parte Bopp.


It is well established that arguments not raised in the opening Brief are deemed waived. Cross Med. Prods. Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1320-21 n.3 (Fed. Cir. 2005). “The reply brief is not an opportunity to make arguments that could have been made during prosecution, but were not. Nor is the reply brief an opportunity to make arguments that could have been made in the principal brief on appeal to rebut the Examiner’s rejections, but were not.” Ex parte Borden, 93 USPQ2d 1473, 1474 (BPAI 2010) (Informative).

Failure to file a "reply brief" costly to Appellant

In Ex parte Hudgens, a failure to file a "reply brief" proved fatal to the appellant.

In passing, Ovonyx appears as a "sound alike" to Ovonics.

Mixed result in Ex parte GRIESELHUBER

Ex parte GRIESELHUBER

The bottom line result in the case handled by Cooley:



We affirm the rejection of claims 6, 17, and 37 under 35 U.S.C. § 103(a) based on Schachter and Horowitz. Claims 9, 24, 27, 35, and 38 fall with claims 6, 17, and 37. See 37 C.F.R. § 41.37(c)(1)(vii).

We affirm the rejection of claims 11, 29, and 39 under 35 U.S.C.
§ 103(a) based on Schachter, Horowitz, and Hartog, because Appellants rely solely on their argument with regard to claim 6 (App. Br. 9-10), which was not persuasive.

We reverse the rejection of claims 7, 8, 10, 12-16, 18, 25, 26, 28, 30- 34, and 36.

HP loses in Ex parte Menninger

On obviousness from Ex parte MENNINGER


See also In re Sneed, 710 F.2d 1544, 1550, (Fed. Cir. 1983) ("[I]t is not necessary that the inventions of the references be physically combinable to render obvious the invention under review."); and In re Nievelt, 482 F.2d 965, (CCPA 1973) ("Combining the teachings of references does not involve an ability to combine their specific structures.").



Rejection against Hewlett-Packard represented by Foley & Lardner affirmed.