DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This is a Final Office Action.
Election/Restrictions
Applicant’s election of Group (II) in the reply filed on December 17, 2024 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Group (II), drawn to a method for preventing or treating certain diseases or conditions, comprising administering a compound of formula (I), embraced by claims 1-5 and 7-11 was elected by Applicant. Applicant has not pointed to any errors in the Examiner’s analysis of the different inventions. The requirement is still deemed proper and is therefore made FINAL.
Applicant elected the following species: (R)-3-mercapto-N-((R)-3-mercapto-1-(methylamino)-1-oxoprop-2-yl)-2- (methylamino)propionamide and stroke for initial examination. Applicant indicated claims 1-5 and 7-9 read on said species.
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Claims 1, 4, 5, 7-11 and 14-19 are currently pending and claims 1, 4, 5, 7-9 and 15-19 are under examination. Claims 15-19 are new claims. Claims 10, 11 and 14 are withdrawn based on the species election.
Claim Rejections - 35 USC § 112
Claim 1 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for the phrase “namely cerebral ischemia reperfusion injury” is withdrawn based on the amendments.
Claim 1 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for the phrase “(cerebral hemorrhage, cerebral thrombosis)” is withdrawn based on the amendments.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Rejections - 35 USC § 102
The rejection of claim(s) 1, 4 and 5 under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Tian et al. (WO 2018041245), is withdrawn based on the amendments.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 4, 5, 7-9 and 15-19 are rejected under AIA 35 U.S.C. 103(a) as being unpatentable over Tian et al. (CA 3035989) in view of Navi et al. (Ann. Neurol., 2018, 83(5), 873-883).
The present application claims a method of treating ischemic stroke comprising administering the following compound to a subject.
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The ‘989 reference states, “The present invention also provides the use of the above compound or the pharmaceutical composition thereof in the preparation of anti-tumor drugs,” see the top of page 9, lines 24-25.
The ‘989 reference does not teach the treatment of ischemic stroke.
Navi et al. teach, “The mechanisms underlying cancer-mediated hypercoagulability are multifold. Tumors, particularly carcinomas, can release circulating microparticles into the bloodstream triggering thrombosis… Increased stroke risk in cancer patients could also be a consequence of anti-neoplastic treatments. Several retrospective studies have reported that platinum-based chemotherapy and angiogenesis inhibitors increase the risk of stroke and other thromboembolism,” see page 4, first and third full paragraphs. Ischemic stroke and/or acute ischemic stroke is noted throughout the article, e.g., see page 5.
Additionally, the wherein clause of claims 7-9 does not require additional steps to be performed and simply express a property of the compound or an intended result of the process made obvious by the prior art. MPEP 2111.04 states: “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “ adapted to ” or “adapted for ” clauses;
(B) “ wherein ” clauses; and
(C) “ whereby ” clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “whereby’ clause states a condition that is material to patentability; it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted (quoting Minton v. Nat ’l Ass ’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” (Emphasis added).
Thus, it is obvious to treat ischemic stroke by administering the compound in the ‘989 reference, because said compound is known as anti-tumor agent, and Navi et al. teach that ischemic stroke is a disease related to tumors.
Applicant may overcome the rejection by adding the disease or condition is not due to chemotherapeutics and or a tumor to the proviso at the end of claim 1.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSANNA MOORE whose telephone number is (571)272-9046. The examiner can normally be reached Monday - Friday, 10:00 am to 7:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray, can be reached on 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUSANNA MOORE/Primary Examiner, Art Unit 1624
