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 .
Claim Status
Claims 1–10 are pending. Claims 1–10 are rejected.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 9 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 9 recites the limitation "the pro-inflammatory factor" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
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.
Claim(s) 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over WO2004019882A2 by Grennfield et al. as evidenced by Sarkar, Sibani, et al. "Cerebral ischemic stroke: cellular fate and therapeutic opportunities." Frontiers in Bioscience-Landmark 24.3 (2019): 415-430.
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
The prior art teaches “methods of screening for compounds that modulate TAFIa activity, compounds, and methods of using the compounds” (title). Grennfield et al. disclose a method of treating a thrombotic disorder such as acute ischemic stroke in a patient in need thereof comprising administering a pharmaceutical composition comprising gentisic acid represented below (page 55, claims 21-23):
PNG
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430
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Gentisic acid is embraced by formula I where X is O, and each of R1 and R2 are OH.
Claim 5 further limits pharmaceutical salts however the claim does not require that the pharmaceutical composition comprises a pharmaceutically acceptable salt of the compound therefore the claim is obvious in view of the prior art method of administering gentisic acid.
Claims 6-10 provide limitations for further uses of the pharmaceutical composition including improving/alleviating the inflammatory response caused by cerebral ischemic stroke, reducing the expression level of pro-inflammatory factors, etc. These features are additional advantages which would flow naturally from following the suggestion of the prior art.
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
The prior art method of treatment is embraced by claims 1-10 however, Grennfield et al. do not describe the acute ischemic stroke as cerebral ischemic stroke or disclose an embodiment in which gentisic acid was administered to a patient.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
Sarkar et al. discuss (title) “Cerebral ischemic stroke: cellular fate and therapeutic opportunities" and teach the following about cerebral ischemic strokes (page 436):
Cerebral ischemia occurs when there is insufficient blood flow to the brain (18) so that cerebral hypoxia develops through limited oxygen supply which leads to death of the cerebral tissues. This sudden destruction of brain tissue is called as cerebral infarction or ischemic stroke in the brain (19).
A person of ordinary skill seeking to practice the prior art method of treating thrombotic disorders such as cerebral ischemic strokes would have been motivated to administer a pharmaceutical composition comprising gentisic acid to improve therapeutic outcomes.
Conclusion
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/A.A.C./Examiner, Art Unit 1626
/MATTHEW P COUGHLIN/Primary Examiner, Art Unit 1626
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