Determination of Obviousness Practice Under the Genus-Species Guidelines and In re Ochiai; In re Brouwer Sreeni Padmanabhan & James Wilson Supervisory Patent Examiners Art Unit 1617 & 1624 March 07, 2006

Examination of claims directed to sub- genus/species of chemical compounds A single prior art reference discloses a genus that encompasses the claimed species or subgenus, but does not expressly disclose or otherwise anticipate the claimed compounds. Reproduced in MPEP Genus-Species Guidelines

Purpose of Genus-Species Guidelines The fact that a claimed species or subgenus is encompassed by a prior art genus is not sufficient by itself to establish a prima facie case of obviousness. In re Baird, 16 F.3d 380, 382, 29 USPQ2d 1550, 1552 (Fed. Cir. 1994) Patentability is determined in view of the totality of the facts. There are no per se rules in determining obviousness.

When should the Genus-Species Guidelines be followed? When a single prior art reference discloses a genus encompassing the claimed species or subgenus wherein the reference does not anticipate the claimed species or subgenus AND The examiner does not find additional prior art to show that the differences between the prior art primary reference and the claimed invention as a whole would have been obvious.

Examination Steps Prior to Any Obviousness Analysis 1.The examiner should analyze the claims as a whole in light of and consistent with the specification. 2.The examiner should conduct a thorough search of the prior art and identify relevant prior art references. 3.The examiner should then determine whether the prior art is anticipatory.

What happens when a single prior art reference disclosing a genus encompassing the claimed species or subgenus is the sole reference utilizable as non-anticipatory art? The Examiner should use the Genus- Species Guidelines to determine whether the claims would have been prima facie obvious.

Does a Genus-Species Analysis differ from any other under 35 U.S.C. §103? No!  To establish prima facie case of obviousness, Examiners utilize the “Graham v Deere Analysis”. §103 requirement for nonobviousness is no different in chemical cases: Determine scope and content of the prior art, Ascertain the differences between the prior art and the claims at issue, Determine the level of ordinary skill in the pertinent art.

Genus-Species Guidelines focus on specific motivational considerations or prior art suggestions used in determining prima facie obviousness The following key issues are considered relevant when making a proper Genus-Species analysis (when present): Consider the size of the genus Consider the express teachings of the reference Consider the teachings of structural similarity Consider the teachings of similar properties or uses Consider the predictability of the technology Consider any other teaching to support the selection of the species or subgenus

Example 1

Analysis of Example 1

Genus-Species Motivation Analysis 1.Are there express teachings that would have motivated the selection of the claimed sub- genus? 2.Are there teachings of similar properties or uses? 3.Is the art predictable such that similar properties or uses would be expected?

Determine whether a Prima Facie Case of Obviousness Exists Based on Entire Record Initially Before PTO Consider Graham v Deere Analysis Determine Whether There Would Have Been Motivation to Select the Claimed Species or Subgenus

Processes Which Employ Nonobvious Products Considering Ochiai, Brouwer and §103(b)

In re Ochiai, 71 F.3d 1565, 37 USPQ2d 1127 (Fed. Cir. 1995) In re Brouwer, 77 F.3d 422, 37 USPQ2d 1663 (Fed. Cir. 1996) 35 U.S.C. §103(b) Treatment of Product and Process Claims in light of:

Question ? Can an otherwise conventional process or method be patented if limited to making or using a nonobvious product?

The collective teachings of the prior art must have suggested to one of ordinary skill in the art that, at the time the invention was made, Applicants’ claimed invention would have been obvious. TES T

1.Use of per se rules is improper in applying the test for obviousness. 2.There was no suggestion or motivation in the prior art to make or use non- obvious products. 3.Rejections based upon S103(a) were overturned. Decision

RESTRICTION Product(s) & Process(es) may still initially be restricted in compliance with MPEP et seq (Related Inventions) and MPEP 808 (Reasons for Insisting Upon Restriction). Restriction was not an issue before the court in the Ochiai and Brouwer cases. The propriety of any restriction requirement should be reconsidered when all the claims directed to the elected invention are in condition for allowance. See MPEP et seq for rejoinder practice.

REJOINDER MPEP (b) – Rejoinder of Process Requiring an Allowable Product Applicant elects a product invention and all claims directed thereto are subsequently found allowable. Withdrawn process claims which depend from or otherwise require all the limitations of an allowable product claim will be considered for rejoinder. All claims directed to a nonelected process invention must depend from or otherwise require all the limitations of an allowable product claim for that process invention to be rejoined.

REJOINDER (cont.) Upon rejoinder of claims directed to a previously nonelected process invention, the restriction requirement between the elected product and rejoined process(es) will be withdrawn. If applicant cancels all the claims directed to a nonelected process invention before rejoinder occurs, the examiner should not withdraw the restriction requirement. This will preserve applicant’s rights under 35 U.S.C. 121.

Rejoinder Considerations 1.Process claims which are not commensurate in scope with allowed product will not be rejoined. 2.Process(es), if rejoined will be subject to examination for patentability in accordance with 37 CFR May have 35 U.S.C st or 2 nd paragraph considerations. - Matter(s) of form

For Biotechnological Processes only - subsection 35 USC 103(b) Effective Date of Inventions Ownership Term of Inventions Biotechnological Process Definition Timely election under provisions as of §103(b).

Thanks Sreeni Padmanabhan Contacts at USPTO