Howson & Howson

In AMP v. Myriad Genetics (Federal Circuit, July 29, 2011), the Federal Circuit addressed whether two types of claimed subject matter are patentable subject matter under 35 USC § 101.  More particularly, the issues were whether composition claims drawn to “isolated” DNA molecules and method claims directed to “analyzing” or “comparing” DNA sequences are patentable.  

With respect to the “isolated” DNA sequences, the court found a distinction between a product of nature and a human-made invention for purposes of § 101.  The court maintained that there is a change in the claimed composition’s identity compared with what exists in nature.  In the opinion authored by Judge Lourie, the Federal Circuit panel referenced the line drawn by the US Supreme Court between compositions that, even if combined or altered in a manner not found in nature, have similar characteristics as in nature, and compositions that human intervention has given “markedly different,” or “distinctive,” characteristics.

Applying this test to the isolated DNAs in this case, the Federal Circuit concludes that the challenged claims are drawn to patentable subject matter because the claims cover molecules that are markedly different—have a distinctive chemical identity and nature—from molecules that exist in nature.  In this case, the Federal Circuit drew a distinction between “isolated” molecules and those which are merely purified.  The Court concluded that “isolated” DNA has to be chemically cleaved from their chemical combination with other genetic materials.  The court stated that when cleaved, an isolated DNA molecule is not a purified form of a natural material, but a distinct chemical entity. Attention was also drawn to the fact that some forms of isolated DNA require no purification at all, because DNAs can be chemically synthesized directly as isolated molecules.

With respect to the method claims, the court started with the machine-or-transformation test to assess whether the claims include transformative steps.   Claims which recited only “comparing” or “analyzing” two gene sequences were considered to fall outside the scope of § 101 because they claim only abstract mental processes.  However, where the claims included the step of “growing” transformed cells in the presence or absence of a potential cancer therapeutic, the presence of mental steps within the claim did not defeat the patent eligibility of the claims, because the steps involved physical manipulation of the cells and these steps were central to the purpose of the claimed process.

In summary, the Federal Circuit concluded that “isolated” the claimed DNA molecules were patentable subject matter under 35 USC § 101.  In addition, they concluded that a method claim which contains solely mental “comparing” or “analyzing” steps do not contain patentable subject matter.

In the June 7, 2011 Official Gazette, the US Patent and Trademark Office (USPTO) released the details regarding the “Full First Action Interview Pilot Program”.  In summary, the USPTO expanded the “Enhanced First Action Interview Pilot Program” to all utility art areas.

Previous to the First Action Interview Pilot Program, the granting of interviews for utility patent application prior to the receipt of a First Office Action was at the discretion of the Examiner.  Briefly, the requirements¹ for participating in this program include the following:

1. The application must be a non-reissue, non-provisional utility application filed under 35 USC 111(a), or an international application that has entered the national stage under 35 USC 371(c).
2. No more than three independent claims and twenty total claims are permitted.
3. The subject matter of the claims must be drawn to a single invention.
4. The Request for a first action interview must be filed electronically.
5. The Request must be filed at least one day before a first Office Action on the merits.
6. The Request must include a statement that applicant agrees not to file a request for a refund of the search fee and any excess claim fees.

This program is expected to continue until at least May 16, 2012.

This OG Notice can be found at: http://www.uspto.gov/web/offices/com/sol/og/2011/week23/TOC.htm#ref11

In Rogers v. Tristar Products, Inc., Judge Robreno ruled June 2, 2011, that the qui tam provision of the False Marking Statute (35 U.S.C. s 292) violates the Take Care Clause of Article II of the United States Constitution.  The opinion cites delegation of criminal enforcement to private entities, without US DOJ supervision, as failing “to provide the Executive Branch with sufficient safeguards to ensure that the President is able to perform his constitutionally assigned duties.”  The provisions of 35 U.S.C. 292 are contrasted with the qui tam provision of the False Claims Act as supporting the deficiency.  This decision adds to a growing body of jurisprudence curbing the substantial volume of qui tam actions filed since the Federal Circuit Court of Appeals’ 2009 ruling that the up to $500 penalty for false marking was applicable on a per article (vs. per occurrence) basis.

Full opinion located at:  http://www.paed.uscourts.gov/documents/opinions/11D0613P.pdf

On May 31, 2011, the Supreme Court issued a decision in Global-Tech Appliances, Inc. v. SEB S. A., holding that induced infringement requires knowledge that the induced acts constitute patent infringement.  Justice Alito, writing for the majority, specifically rejected the CAFC’s test which required only deliberate indifference to a known risk that a patent exists.

Although the Court had previously decided that actual knowledge of the patent was needed in order to find contributory infringement (Aro Mfg. Co. v. Convertible Top Replacement Co., 377 U. S. 476), this issue of inducement of infringement was a case of first impression for the Court.  Looking to the doctrine’s common origin with contributory infringement, the Court looked to pre-1952 law, including an 1895 article by Hubert Howson, in considering the standard of requisite knowledge.

On May 25, 2011, the CAFC issued an opinion in Therasense, Inc. v. Becton, Dickinson and Co., (Fed. Cir. 2011) (en banc) providing bright line rules for finding inequitable conduct in patent cases.  Many times inequitable conduct claims arise when the applicant fails to disclose a reference which, the alleged infringer asserts, is material to patentability of the invention.  However, in recent years inequitable conduct claims have been asserted in as many as eighty percent of patent infringement cases¹.  Chief Judge Rader, writing for the majority, highlights the broad sweeping reach of the inequitable conduct doctrine and its unfettered expansion from its beginnings in three egregious “unclean hands” cases decided by the Supreme Court to a “litigation tactic” which has “plagued not only the courts but also the entire patent system”.²

The court tightens the standards for intent and materiality, rejecting the prior tests including the “sliding scale” in which the standard for intent was lessened with an increase in the materiality of the evidence.  The court holds that a finding of specific intent requires that the applicant “knew of the reference, knew that it was material, and made a deliberate decision to withhold it.”³ Because direct evidence of intent is rare, intent may be inferred from indirect and circumstantial evidence.  However, the court indicated that the inference made from the evidence must be “the single most reasonable inference”.  If another reasonable inference is possible, the inference of no intent should be taken.  Further, the accused infringer must prove a threshold level of intent by clear and convincing evidence before the patentee needs to provide a good faith explanation for non-disclosure.

The court also clamped down on the standard for materiality, imposing a “but-for” standard which requires a finding that the “PTO would not have allowed the had it been aware of the undisclosed prior art”.⁴

Keeping in line with the Supreme Court precedent from which the doctrine derives, the court held that affirmative egregious misconduct is always material since “a patentee is unlikely to go to great lengths to deceive the PTO with a falsehood unless it believes that the falsehood will affect issuance of the patent”.⁵

However, in most cases, where the assertion of inequitable conduct derives from the failure of an applicant to disclose a reference, “claims of inequitable conduct that are based on such omissions require proof of but-for materiality”.⁶

The court’s tightening of the intent and materiality standards should lead to a sigh of relief in the patent prosecution community as many practitioners had taken a practice of over-disclosure in an effort to ward off the specter of an inevitable inequitable conduct claim down the line.