The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-16, are pending in this application.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
The following is a quotation 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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 of carrying out his invention.
Claims 1-16, are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
There is no support in the specification for enablement of formula I, wherein the “OH groups within and at the periphery of the core, have an average molecular weight from 5 to 100kDa”, e.g. claim 1. Dendritic polyglycerol is prepared in a well-controlled synthesis. https://pubmed.ncbi.nlm.nih.gov, visited 10/5/25. The specification discloses generic procedures, not specific enablement for formula I as claimed. The claims invite a POSA to make the compounds using any means/procedure known to the artisan. There is no incorporation of US publication(s) where the enablement can be found. Appropriate correction is required.
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.
Claims 1-16, are 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.
“[P]eripheryu”, claim 1, line 7, renders the claims unclear, and therefor indefinite. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-14, are rejected under 35 U.S.C. 102(a)(1) as being anticipated0 by Haag et al., WO2016/166317, which teaches formula 2b, medicament (composition) thereof, useful for treating microbial infections and inflammation. See the entire document, particularly the abstract.
The formula by the prior art is non-limiting. Therefore, the claimed compound is embraced by the prior art. Also, the claims cite inherent property of compounds of formula I: the DF. Under the US patent practice, inherent property is not a limitation of a product or compound. See In re Best, 562 F.2d 1252; 195 USPQ 430 (CCPA, 1977), Titanium Metals Corp. v Banner, 778 F.2d 775 (Fed. Cir. 1985), Continental Can Co. v Monsanto Co., 948 F.2d 1264 (Fed. Cir. 1991), In re Cruciferous Sprout Litig., 301 F.3d 1343 (Fed. Cir. 2002), In re Crish, 393 F.3d 1253 (Fed. Cir. 2004).
Claims 11, 13-14, cite intended use of the compound or composition. Under the US patent practice intended use is not a limitation of a product or compound. In re Hack, 114USPQ 161 (CCPA, 1957); In re Craig, 90 USPQ 33 (CCPA, 1951); In re Brenner, 82 USPQ 49 (CCPA, 1949).
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.
Claims 1-16, are rejected under 35 U.S.C. 103 as being unpatentable over Haag et al., WO2016/166317 in view of Jones et al., US2019/0275073 A1, and Farag et al., Int J Biochem Cell Bio (2020), 122:105738, pp. 1-11, published on line 3/7/20.
Haag et al., teaches as set forth above under anticipatory rejection. The prior art teaches treatment of microbial infections instead of viral infection: HIV, HSV, HCMV HPV, RSV, influenza virus, filoviruses, in the instant. The invention is still obvious from the prior art in view of the following:
Jones et al., teaches virucidal compounds and composition thereof, useful for treating HIV, HSV, HCMV HPV, RSV, influenza virus, filoviruses, [0004], [0031]. The compounds are dendritic polymer derivatives, and can be administered in various forms and in combination therapy, [0034]-[0036], [0040], [0052]. See also the entire document.
Farag et al., teaches inflammatory response is induced by viral infections, e.g. SARs, HCV, HIV, RSV, MERS, Cov, CSFV. See the entire document, particularly table 1, figs. 1-3.
Having known that 1) the compound by Haag et al., is useful for treating inflammatory response and microbial infections, 2) Jones et al., teaches treatment of the instant viral infections with similar compound, and 3) that they induced inflammatory response, a POSA would have known and be motivated to treat the viral infections with the compounds by Haag et al., at the time the invention was made, with reasonable expectation of success. The motivation is also because the invention and the prior arts and in the same field of endeavor.
The claims are not allowable over the combination of the prior arts and knowledge well-known in the art.
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Taofiq A. Solola, whose telephone number is (571) 272-0709.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Andy Kosar, can be reached on (571) 272-0913. The fax phone number for this Group is (571) 273-8300.
Any inquiry of a general nature or relating to the status of this application or proceeding should be directed to the Group receptionist whose telephone number is (571) 272-1600.
/TAOFIQ A SOLOLA/ Primary Examiner, Art Unit 1625
October 6, 2025
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