U.S. Patent Office Publishes Examination Guidelines for Determining Obviousness of Inventions in Wake of KSR

Summary:  The U.S. Patent & Trademark Office today issued a press release concerning long-awaited Examination Guidelines to help Examiners make appropriate decisions regarding the obviousness of claimed inventions in light of the Supreme Court’s decision in KSR International Co. v. Teleflex Inc.


     Mention "KSR" and "obviousness" to patent practitioners and you'll get a wide range of responses, with some claiming the Supreme Court's decision in KSR International Co. v. Teleflex Inc., 550 U.S. __, 82 USPQ2d 1385 (2007) will lead to fewer inventions being patented, and others predicting the opinion will eventually jeopardize the validity of many previously-issued patents.

     One thing most practitioners will agree upon, however, is that uniform and concrete guidance is needed from the PTO (and eventually the courts) to remove the guesswork out of predicting how the PTO and courts will deal with inventions under the KSR standard. After all, when it can cost upwards of $50,000 to $100,000 to prosecute a patent application (U.S. and internationally), inventors and their employers are understandably wary about making the investment in today's uncertain environment. 

     The PTO took steps today to alleviate some of that concern. Today, the PTO issued its long-awaited PTO Examination Guidelines concerning KSR, which had been tied up in the Office of Management and Budget (OMB) through much of the summer and early fall (see related post here). Below is a summary of the Guidelines.

   As stated in the PTO's press release:

“The Guidelines stress that the familiar factual inquiries announced by the Supreme Court in its much earlier decision, Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), remain the basis for every decision regarding obviousness,” noted Commissioner for Patents John Doll. “That is, patent examiners will continue to consider (1) the scope and content of the prior art, (2) the differences between the claimed invention and the prior art, (3) the level of ordinary skill in the pertinent art, and (4) objective evidence relevant to the issue of obviousness.”

The Guidelines also note that patent examiners must continue to explain the reasoning that leads to a legal conclusion of obviousness when rejecting claims on that ground. The reasoning may still include the established Court of Appeals for the Federal Circuit standard that a claimed invention may be obvious if the examiner identifies a prior art teaching, suggestion, or motivation (TSM) to make it. However, in keeping with the KSR decision, the Guidelines explain that there is no requirement that patent examiners use the TSM approach in order to make a proper obviousness rejection. Furthermore, the Guidelines point out that even if the TSM approach cannot be applied to a claimed invention, that invention may still be found obvious.

To help patent examiners make obviousness rejections that are supported by appropriate facts and reasoning, the Guidelines identify a number of rationales suggested by the Supreme Court in the KSR decision. For each rationale, the Guidelines explain the underlying factual findings, and provide guidance about how to reason from the facts to the legal conclusion of obviousness. The Guidelines emphasize, however, that the identified rationales are only examples, and that any explanation of facts and reasoning based on the Graham inquiries may be used to support a rejection for obviousness."

     Below is a list of the "rationale" mentioned above, each of which is explained in detail in the Guidelines:

  • Combining prior art elements according to known methods to yield predictable results; 


  • Simple substitution of one known element for another to obtain predictable results;


  • Use of known technique to improve similar devices (methods, or products) in the same way;


  • Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;


  • ‘‘Obvious to try’’—choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;


  • Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations would have been predictable to one of ordinary skill in the art;

  • Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.

     The Guidelines, as noted above, emphasizes that the so-called "teaching, suggestion, and motivation" test (the last bullet) is available to Examiners, but that Examiners shouldn't rely on that test to the exclusion of one or more of the other enumerated rationale for rejecting claims set forth in KSR. That is, if the TSM test comes up negative (i.e., no prima facie case of obviousness), the Examiner shouldn't stop there because one of the other rationale may suggest that the invention is obvious despite the lack of a teaching, suggestion, or motivation to modify or combine prior art.

     More on the Guidelines latter, but like the rest of you, I need to read through the Notice and sort through the document to see how it will impact my practice and the clients I work with. Between these Guidelines and the new "claims and continuation" rules effective November 1, 2007, there certainly is a lot to digest.

Patent Office Must Consider Relevant Rebuttal Evidence, Says Federal Circuit

Summary: The PTO must consider “relevant rebuttal evidence” submitted by patent applicants to overcome a prima facie case of obviousness. Such evidence must  be in the record. Cite: In Re Sullivan, No. 2006, Civ. 1507 (Fed. Cir. 2007).


     At issue in this appeal from the PTO's Board of Patent Appeals and Interferences, was joint inventor Sullivan’s and Russell’s U.S. patent application Serial No. 08/405,454, which is directed to an antivenom composition. The application had been finally rejected by the PTO as being obvious under 35 U.S.C. § 103(a) over the inventors’ own prior art publication in view of a publication by Coulter, a decision that was affirmed by the Board in two PTO appeals. During those appeals, the Board concluded that “the [antivenom] composition taught by the combination of Sullivan and Coulter would have been expected by a person of ordinary skill in the art at the time the invention was made to neutralize the lethality of the venom of a rattlesnake” (the underlined portion was added during prosecution).

     On appeal to the Court of Appeals for the Federal Circuit (CAFC), the Federal Circuit found that the Board’s obviousness conclusion was not unreasonable, in that one skilled in the art of snake venom could consider that a fragment of a whole antibody that neutralizes one type of venom (i.e., the prior art) might be used to neutralize the venom of another species (citing from KSR Int’l Co. v. Teleflex Inc.: “if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill”).  However, the Federal Circuit also found that “the claimed composition cannot be held to have been obvious if competent evidence rebuts the prima facie case of obviousness.” The PTO (the Board, in this case) must consider any “relevant rebuttal evidence” when an applicant puts forth such evidence in response to an obvious rejection (in this case three declarations containing evidence of unexpected result from use of the claimed composition, how the prior art taught away from the composition, and how a long-felt need existed for a new antivenom composition).

     Conclusion: the Board failed to give any weight to rebuttal evidence of record regarding the nonobviousness of the invention. Vacated and remanded to the Board to consider the evidence.

Patent Reform Act of 2007 - Update (Part 5)

     In an earlier post, the proposed new 35 U.S.C. § 103(a), set forth in the Patent Reform Act of 2007, was summarized.  To illustrate how an obviousness analysis might be approached under the new § 103(a), assume I “invent or discover” a new invention on Day 1 in the U.S., reduce the invention to practice on Day 60, file a provisional patent application in the PTO on Day 80 (without any claims), and file a nonprovisional application on Day 250 (claiming the invention).  Under this scenario, Day 80 could be my “effective filing date” even though the provisional application did not include any claims:

“The ‘effective filing date of a claimed invention' is--(1) the filing date of the patent or the application for patent containing the claim to the invention; or `(2) if the patent or application for patent is entitled to a right of priority of any other application under section 119, 365(a), or 365(b) or to the benefit of an earlier filing date in the United States under section 120, 121, or 365(c), the filing date of the earliest such application in which the claimed invention is disclosed in the manner provided by the first paragraph of section 112.”   See proposed new § 100(h).

     However, if the invention is not adequately disclosed in the provisional application, my “effective filing date” could be Day 250. 

     It would appear, then, that, subject to the exceptions under proposed new section § 102(b) (see related post), any prior art available between Day 1 and Day 80 (or Day 250, as the case may be) could be used in an obviousness analysis by the PTO to reject my claims.  In other words, under the new first-to-file system, I would not be able to swear behind prior art using evidence of an earlier conception and reduction to practice.  Eligible prior art available between Day 1 and Day 80 (or Day 250) could include patents, printed publications, public uses, and sales of inventions. See new § 102(a).

 

Comments:

  • Clearly the proposed new § 103(a) statutory framework encourages me to rush to the Patent Office to file a patent application as soon as possible after my invention/discovery on Day 1.

  • It wouldn't be too much of a stretch to say that many organizational patent departments operate in a somewhat leisurely manner (or carefully and calculating, depending on your perspective) when it comes to processing invention disclosures.  That's understandable, given that under the first-to-invent system currently in place in the U.S., there is no real urgency when it comes to submitting a patent application to the PTO (absent the need to protect the invention for foreign filing purposes, or if there is a current infringer in the market knocking off your invention).  Invention disclosures will obviously need to be handled in a more expeditious manner under the first-to-file system.

Patent Reform Act of 2007 - Update (Part 4)

          The doctrine of obviousness has been called the “cornerstone of American patent law.” That could explain why the Supreme Court’s KSR v. Teleflex decision, which arguably tightened the doctrine in a way that could make it increasingly harder for inventors to obtain patents in the U.S., has resonated so loudly over the last several weeks. On the heels of KSR, however, is another possible shake up of the doctrine, this time emanating from the Legislative Branch in the name of Patent Reform. While it may be too early to ascertain whether the Patent Reform Act of 2007 will make the prospects of obtaining patents in the U.S. more uncertain, it is clear that it will affect the way inventions are analyzed under the doctrine of obviousness.

          Traditionally, the question of whether an invention was obvious under 35 U.S.C. § 103(a) involved considering the four “Graham factors”: (1) the scope and content of the prior art; (2) the level of ordinary skill in the prior art; (3) the differences between the claimed invention and the prior art; and (4) objective evidence of nonobviousness. Graham v. John Deere, 383 U.S. 1 (1966). However, under the proposed new § 103(a), as shown in the table below (juxtaposed with the current version of the law and showing proposed changes), the Graham factors may need to be applied in a different manner in the future.

 

          A key difference between the existing and proposed § 103(a) is the respective time periods defining eligible prior art. Traditionally, prior art been defined as what was available to those of ordinary skill in the art on or before the date the invention was made, which means the date of “discovery” (see the existing definition of “invention” in § 100(a), which is “invention or discovery”). Under the new law, however, prior art could be defined somewhat broader as what was available to those of ordinary skill before the effective filing date of the claimed invention (see the proposed definition of “claimed invention” in new § 100(i), which could be defined as “the subject matter defined by a claim in a patent or an application for a patent”). Those two dates—the invention/discovery date and the application filing date—could be months, or even years, apart. And during that intervening time period, a considerable amount of new prior art could be developed and used against a patent applicant. 

          Check back for a subsequent post that will summarize how the new § 103(a) could affect the approach to analyzing the nonobviousness of a new invention using the Graham factors.

Comments:

  • The versions of the Patent Reform Act of 2007 introduced in the Senate and House are S.1145 and H.R.1908, respectively

Coming Soon: KSR Training Guidelines for Patent Examiners

          According to the U.S. Patent & Trademark Office (PTO) web site, the PTO has sent to the Office of Management and Budget (OMB) for review draft final guidance for use by patent examiners in determining if an invention is obvious in view of the U.S. Supreme Court’s decision in KSR v. Teleflex.  The PTO will reportedly make the final guidance document available on its web site after OMB concludes its review (a link to the guidelines will be posted on this web site when they become available).  Until the guidelines are finalized, the PTO will train its examiners on how to implement KSR.  Practitioners should expect to see more Office Actions containing rejections based on KSR in the immediate future.