DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendments
Applicant's amendments filed 4/24/2026 has been entered. Claims 1, 8-10, and 13-20 remain pending, and are subject to the election requirement dated 2/25/2026. References not included with this Office action can be found in a prior action.
Election/Restrictions
Applicant’s election without traverse of Group I, presently claims 1, 8-10, 13, 14, and 18-20, in the reply filed on 4/24/2026 is acknowledged.
Claims 15-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 4/24/2026.
Claims 1, 8-10, 13, 14, and 18-20 are under consideration on the merits.
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.
Claims 9 and 20 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.
The term “about” in claim 9 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree (such as but not limited to a controlling definition of the term), and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Correction is required.
For claim 20, a composition/product claim which further recites the method steps of using the product is indefinite under 35 U.S.C. § 112(b) or pre-AIA 35 U.S.C. § 112, second paragraph, as such a claim creates confusion as to when direct infringement occurs. See M.P.E.P. § 2173.05(p) for an analogous fact pattern regarding apparatus/device claims and methods steps of using the apparatus/device in the same claim. in this case, claim 20 recites method steps of using the product of claim 1. Correction is required.
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 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, 8-10, 13, 14, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Gansert et al. (US 2021/008135; provided in the IDS dated 12/20/2023) in view of Yvin et al. (US 2005/065114; provided in the IDS dated 12/20/2023).
In view of the indefiniteness rejection above and in the interest of compact prosecution, claim 20 is interpreted as a limitation of intended use of the claimed composition; see M.P.E.P. § 2111.02.
Gansert teaches a composition comprising talimogene laherparepvec (i.e. Tvec) and a species anti-PD1 receptor antibody, Pembrolizumab, and which has anti-tumor activity in vivo (Example 3), reading in-part on the composition of claim 1. Gansert envisions treating subjects suffering from prostate cancer ([0012]) with an effective dosage of the composition ([0147]), reading on the intended use of claims 1, 8, and 20 and reading on an effective dosage of the Tvec and anti-PD antibody of claim 8. Gansert teaches providing each therapeutic agent in a separate medicaments to be administered
concurrently ([0162]),reading on claim 10. Gansert formulating the composition for local or system administration ([0193]), reading in-part on claim 14.
Regarding claim 1, Gansert does not teach β(1,3)glucan. Regarding claims 8, 9, 13, 18, and 19, Gansert does not teach any concentration or dosage of β(1,3)glucan. Regarding claim 14, Gansert does not teach β(1,3)glucan formulating for oral administration.
Yvin teaches a therapeutic composition comprising β(1,3)glucan (Abstract), and which would be particularly useful as an immunostimulant (i.e. adjuvant) when administered to subjects (¶0002-0004), reading claim 1. Yvin teaches methods of treating a tumor or cancer in subjects with the therapeutic composition comprising β(1,3)glucan (claim 1), treating subjects for prostate cancer (claims 7 and 8), and an Yvin teaches an effective dosage of β(1,3)glucan to treat said cancer ([0011]), reading on claims 1 and 8. Yvin teaches an effective dosage of β(1,3)glucan would control (the growth of) or destroy cancer cells without producing unacceptable toxic symptoms and will vary with factors such as the particular condition being treated, the physical condition of the patients and the duration of the treatment ([0012]), reading in-part on claims 9, 13, 18, and 19. Yvin teaches that dosages of 50, 100, or 250 μga per mouse was effective to induce cytotoxic T lymphocyte activation as measured by blood TNF-α concentrations (Example 7 and particularly [0159]), reading in-part on claims 9, 13, 18, and 19.
Regarding claim 1 and 8, it would have been obvious to a person of ordinary skill in the art before the invention was filed to add the β(1,3)glucan of Yvin to the composition of Gansert. A person of ordinary skill in the art would have had a
reasonable expectation of success to do so because both Yvin and Gansert are directed towards methods of treating tumors or cancer in subjects. The skilled artisan would have been motivated to do so because Yvin teaches that β(1,3)glucan is a known immunostimulant/adjuvant and so the addition would predictably improve upon Gansert’s treatment methods.
Regarding the β(1,3)glucan dosages of claims 9, 13, 18, and 19, generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[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). Also see M.P.E.P. § 2144.05 (II) and (III). In the instant case, Yvin teaches that the β(1,3)glucan is a result effective variable tto induce cytotoxic T lymphocyte activation as measured by blood TNF-α concentrations, and further teaches that any effective dosage of β(1,3)glucan would control (the growth of) or destroy cancer cells without producing unacceptable toxic symptoms and will vary with factors (e.g. need to be optimized) such as the particular condition being treated, the physical condition of the patients and the duration of the treatment Thus, the burden is shifted back to establish criticality of the claimed β(1,3)glucan by objective evidence.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Conclusion
No claims are allowed. No claims are free of the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN C BARRON whose telephone number is (571)270-5111. The examiner can normally be reached 7:30am-3:30pm EDT/EST (M-F).
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/Sean C. Barron/Primary Examiner, Art Unit 1653
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