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 .
DETAILED ACTION
This is a response to Applicant’s communication filed on July 27, 2023. Application No. 18/263,191, is a 371 of PCT/CN2022/073910, filed January 26, 2022, and claims foreign priority to Chinese application No. CHINA 202110122555.3, filed January 29, 2021. In a preliminary amendment filed July 27, 2023, Applicant added new claim 11. Claims 1-11 are pending.
Claim Rejections - 35 USC § 103(a)(1)
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 for establishing a background for determining obviousness under 35 U.S.C. 103 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.
Claims 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over Yamamoto et al., A Combined Treatment for Acute Larger Lacunar-Type Infarction, 20(5) J. Stroke & Cerebrovascular Dis., 387-394 (2011) (cited on the July 27, 2023, IDS). Yamamoto teaches that the combination of cilostazol and edaravone improves the functional results of patients with lucunar infraction and motor lacunar syndrome. Yamamoto et al., p. 388, 1st Col., 1st para. Yamamoto also teaches a composition component weight ratio of 10:3. Id., 2nd Col., 2nd para, Treatment Regimen. The difference between the prior art and present invention is the disclosure of a composition as a co-formulation.
In this case it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose. See MPEP 2144.06, Art Recognized Equivalence for the Same Purpose. The idea of combining them flows logically from their having been individually taught in the prior art. Id., citing In re Kerkhoven, 626 F.2d. 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
With respect to component ratios of dependent claims 2-8, the difference in component ratios does not support the patentability of the claimed invention. In this case, there is no evidence indicating the claimed ratios are critical to the invention.
“[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997).
(MPEP 2144.05.) It would have been obvious to one of ordinary skill in the art at the time of the invention to adjust the component ratios as a matter of routine optimization.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 10 and 11 are rejected under 35 U.S.C. 112(a), because the specification, while being enabling for a method of treating cerebrovascular diseases, the specification does not reasonably provide enablement for preventing cerebrovascular diseases. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
Factors to be considered when determining whether claims in an application for patent are enabling include (1) the breadth of the claims, (2) the nature of the invention, (3) the state of the prior art, (4) the level of one of ordinary skill, (5) the level of predictability in the art, (6) the amount of direction provided by the inventor, (7) the existence of working examples, and (8) the quantity of experimentation needed to make or use the invention based on the content of the disclosure. See MPEP § 2164.08, citing In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
The claims are drawn to a method of preventing cerebrovascular diseases. The specification teaches that the coformulation of cilostazol and edaravone showed improved cerebral infarction results in mice. (Specification, p 5-18.) There is no evidence linking or even suggesting that cerebral infarction can be prevented. In addition, the prior art fails to provide compensatory guidance. There is no correlation between improving cerebral infarction in mice and preventing all cerebrovascular diseases. Accordingly, it would require undue experimentation for the artisan to practice the invention as broadly claimed.
Claim Rejections - 35 USC § 112/(b)
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.
Claims 10 and 11 are rejected under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. The term "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Conclusion
No claims are allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY R ROZOF whose telephone number is (571)270-5992. The examiner can normally be reached Monday - Friday, 9:00 a.m. -5:00 p.m..
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/TIMOTHY R ROZOF/Primary Examiner, Art Unit 1625