Thursday, the Federal Circuit held oral arguments in In re Kubin, a biotechnology case involving a patent over a gene sequence in humans, and specifically whether the claims were obvious.  This was the first precedential decision by the Board of Patent Appeals and Interferences on the issue of obviousness in this field after KSR, so how the Federal Circuit comes out on the issue has the potential to greatly affect examination of biotechnology applications at the USPTO.  We previously covered the Board's decision in the case in July.

The key issues addressed in oral arguments were whether the prior art, particularly Valiente (a reference teaching a similar protein in mice), rendered the claimed invention obvious, and whether the disclosure of essentially one sequence was sufficient to provide written description for all sequences with 80% similarity that still retain the function of the original gene.  Oral argument focused largely on the obviousness issue.  Many attended the arguments, including representatives from our office.

Click below for more detail of the arguments in In re Kubin.

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In a decision last week, the Federal Circuit affirmed a district court's holding that a prior art patent was not enabling and thus did not anticipate the patent-in-suit.  Applying the In re Wands factors, the district court held undue experimentation would be required in order to produce the claimed invention based on the prior art's disclosure.

The Federal Circuit affirmed, and observed the asserted prior art was broad and general without sufficient direction to practice the claimed invention.  Moreover, the asserted prior art provided no working examples of the invention claimed in the patent-in-suit.  Finally, the court held the district court correctly placed the burden of proving non-enablement on the patentee, given the prior art reference was an issued U.S. Patent, but it was not necessary for the district court to specifically articulate its burden-shifting framework.

More on Impax Labs, Inc. v. Aventis Pharms Inc., after the jump.

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In a decision last week, the Federal Circuit affirmed a district court's permanent injunction against a defendant to prevent infringement of a patent.  The district court held the patent not invalid and infringed, based in part on a claim construction that construed the word "and" to mean "or."  Specifically, based on the specification and other claims, the court determined such a construction was consistent with the intrinsic evidence.  The court also rejected each of the defendant's affirmative defenses.

The Federal Circuit affirmed.  Turning first to claim construction, the court held "and" can be interpreted to mean "or" in claim language when the specification warrants that construction.  In this case, interpreting "and" as requiring both elements would have rendered some dependent claims meaningless, as well as excluded the preferred embodiment from the claims.  The court also affirmed the rejection of the affirmative defenses of inequitable conduct, obviousness, enablement.  Notably, in discussing the obviousness issue, the court stated:  "a flexible TSM test remains the primary guarantor against a non-statutory hindsight analysis such as occurred in this case."  It will be interesting to see whether the non-TSM grounds for an obviousness rejection outlined in the USPTO's examination guidelines will survive scrutiny by the Federal Circuit.

More detail of Ortho-McNeil Pharm., Inc. v. Mylan Labs., Inc. after the jump.

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In a decision last week, the Federal Circuit affirmed a district court's decision holding several claims of two patents invalid for lack of enablement.  The district court held that while a portion of the scope of the claims was enabled, the full breadth of the claims were not, and as a result, the claims did not meet the enablement requirement of § 112.

The Federal Circuit affirmed.  The court stated that even if the claims were enabled for one embodiment, they were not enabled for a second embodiment also falling within the claim scope.  The court analogized another recent case with similar facts where although two embodiments were covered by the claims, only one was enabled by the specification, leading to a conclusion of invalidity.

The patentee's case was also not saved by the proffered expert testimony, as the plaintiff's expert was an expert in only one of the two applicable fields, and as a result could not opine competently regarding the enablement of the claims in the second field.  As such, because the full scope of the claims was not enabled, the court affirmed the summary judgment of no enablement.

More detail of Sitrick v. Dreamworks, LLC after the jump.

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In a decision this week, the Federal Circuit vacated and remanded the district court's determination that the plaintiff's patents-in-suit were invalid as anticipated by another paper that was publicly available via the patentee's FTP site before the critical date for the span of one week, finding genuine issues of material fact as to whether the paper was "publicly accessible" as required by 35 U.S.C. § 102(b) as of the critical date of the patents.  The court, however, affirmed the grant of summary judgment by finding one patent invalid as anticipated by the patentee's own previous paper, as that paper was sufficiently enabled to constitute prior art.

More detail of SRI Int'l, Inc. v. Internet Security Sys., Inc. after the jump.

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In a battle between two agricultural heavyweights, Monsanto and Syngenta, the Federal Circuit affirmed a district court's ruling that Syngenta did not infringe two Monsanto patents and that a third was invalid for lack of enablement.  The patents relate to tolerance to the herbicide glyphosate.

The court affirmed the district court's claim construction, noting that certain claims directed toward manipulating a plant obtained by the process in another claim were properly considered dependent claims.  Because it was undisputed that Monsanto performed the three claimed steps to produce the original plant and Syngenta only performed the final step in the dependent claim, Syngenta was not liable for direct infringement under § 271(a).  Also, because Monsanto had performed the three initial steps before the patent issued, there could be no infringement under § 271(g).

With regard to enablement, the court affirmed the invalidity of claims directed toward a chimeric gene that functions "in plant cells."  As of the patent's priority date, transformation of monocots had not yet been successfully completed, and as a result, the specification did not enable the gene to function in all plant cells.  Accordingly, the invalidity of those claims was affirmed.

More detail of Monsanto Co. v. Syngenta Seeds, Inc. after the jump.

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The Federal Circuit yesterday affirmed a district court's holding of invalidity based on lack of enablement.  At issue was a claim that encompassed two different types of structures for side-impact sensing in motor vehicles, a mechanical sensor and an electronic sensor.  The court noted that the full scope of a claim must be enabled in order to satisfy § 112, and that "the specification, not the knowledge of one of ordinary skill in the art . . . must supply the novel aspects of an invention in order to constitute adequate enablement."  

The court held that while the mechanical sensor was adequately enabled, the electronic sensor was not.  As a result, the full scope of the claim was not enabled, and the district court's invalidity ruling was affirmed.

More detail of Auto. Techs. Int'l, Inc. v. BMW of N. Am., Inc. after the jump.

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In a decision Friday, the Federal Circuit affirmed in part and reversed in part a district court's decision granting summary judgment of noninfringement and invalidity.  The Federal Circuit found that the district court had properly construed most of the asserted claims as being limited to "automatic computer determination of the finish positions of teeth" based on the specification and prosecution history of the patents and related patents. 

Some claims, however, were not directed toward determination of finish tooth positions, but instead were focused on initial data gathering to assist in further treatment or modeling, and as a result, those claims were improperly narrowed.  The court held that because the defendant's process relied on human operators, rather than a fully automated process, to determine the finish position of the teeth, the district court's grant of summary judgment of noninfringement of those claims that required an automated process was appropriate. 

The court also found the patents at issue lacked enablement because one of ordinary skill in the art did not and could not accomplish "automatic computer determination of teeth finish positions" based on the patent's specification.  The court found the fact that the patentee itself had not successfully developed a program that could, via a fully automated process, determine the finish positions of teeth because of variations in human anatomy particularly persuasive.

More details of Ormco Corp. v. Align Tech., Inc. after the jump.

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As mentioned previously, the BPAI designated an opinion as precedential today addressing the issues of obviousness, enablement, and the written description requirement in the context of biotechnology inventions. These issues were addressed in the context of patenting a gene involved in regulating the immune system.

Addressing the obviousness issue, the board determined that the previous knowledge of the protein sequence in other species combined with the limited number of approaches to isolate the gene rendered the invention obvious under the "obvious to try" standard. Citing to KSR, the Board determined that the results obtained were merely the product of ordinary skill and common sense and affirmed the rejection of the examiner.

The enablement and written description issues stemmed from the claim of sequences with at least 80% identity to the isolated sequence. The enablement rejection was reversed because while extensive experimentation may be required, the experimentation would have been routine, not undue. However, the board upheld the written description rejection on the grounds that the two exemplary sequences provided in the specification were not sufficiently different to demonstrate possession of the entire genus claimed (all sequences with 80% similarity).

More detail of Ex parte Kubin after the jump.

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