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
The claim set filed June 15, 2026 and Applicant’s remarks have been entered.
Claims 2, 9-11, 16 and 23 are canceled.
Claims 17-18, 22 and 24-25 continue to be withdrawn from further consideration as being drawn to a non-elected invention.
Thus, claims 1, 3-8, 12-15 and 19-21 as amended are examined on the merits herein.
Withdrawn Objections and Rejections
With respect to the objections and/or rejections mailed in the non-final office action on March 13, 2026:
(I) The objection to claims 3, 6, 13 and 21 is withdrawn in view of Applicant’s amendment to these claims.
(II) The rejection of claim 6 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph is withdrawn in view of Applicant’s amendment to this claim.
Response to Arguments
(I) The rejection of claims 1, 3-4, 6-8, 12-13, 15 and 19-21 under 35 U.S.C. 102(a)(1) is maintained.
Applicant argues:
(A) Schlom does not provide an enabling disclosure for the use of 100% deacetylated chitosan; as the 100% deacetylated chitosan taught by Schlom is a single instance among numerous potential chitosan preparation; Scholm does not provide an example of 100% deacetylated chitosan as presently claimed; and Schlom explicitly notes a preferred range of deacetylation of between 70-80%”, see Applicant’s remarks, pg. 7 of 11, last paragraph – pg. 8 of 11, first paragraph.
With respect to Applicant’s argument (A), the Examiner respectfully notes Schlom’s teachings within the maintained 102 rejection below; and notes for convenience Schlom’s teachings of compositions and methods for chitosan enhanced immune response;
treating or preventing cancer in a subject comprising the step of administering a depot composition comprising one or more antigens and chitosan thereby treating or preventing the cancer; and
the chitosan is deacetylated, where 100% deacetylation of the chitosan is taught.
Applicant argues Schlom’s teachings are not enabled because Schlom does not provide an example where the chitosan used is 100% deacetylated.
However, the Examiner notes the teachings of Schlom above; and further notes Schlom teaches chitosan for enhanced immune response which is particularly useful in treating or preventing cancer using the depot composition comprising chitosan taught by Schlom above.
Additionally, the Examiner notes within Schlom, see ¶ [0123], the chitosan can be partially deacetylated, e.g. 10-99%, or 100% deacetylated (e.g. fully deacetylated).
Moreover, Schlom teaches the properties of chitosans depend upon inter alia the degree of deacetylation and molecular weight, (see ¶ [0121]); and explicitly teaches the optimization of chitosan in Example 21, where chitosan adjuvant properties can be modified in three ways; including the chitosan molecule itself by controlling degree of deacetylation (see ¶ [0221]).
Furthermore, with particular attention to Applicant’s argument that Schlom prefers a range of deacetylation between 70-80%; the Examiner reiterates above and notes in ¶ [0123] of Schlom the range of 70-80% was an exemplified range within the broader teaching of the chitosan having at least 70% deacetylation and was not taught as a preferred range of deacetylation by Schlom as argued by Applicant.
(B) Schlom is silent regarding the use of 100% deacetylated chitosan in free chain form as presently claimed, and Schlom teaches that chitosan can be modified with additional components, see Applicant’s arguments, pg. 8 of 11, paragraph 2.
With respect to Applicant’s argument (B), the Examiner respectfully reiterates above, and further respectfully notes within the maintained 102 rejection below that the Examiner reasonably interpreted the “free chain form” limitation recited in claim 1 was a physical limitation of said chitosan when mixed in the depot composition of Schlom as said chitosan of Schlom is not attached to any component within the composition.
Additionally, the Examiner thought said interpretation reasonable as claim 1 only requires a combination of a tumor antigen and an adjuvant, wherein the adjuvant is 100% deacetylated chitosan.
Moreover, the specification discloses the polyglucosamine is in free chain (e.g. non-aggregate) form, (see pg. 4, lines 28-30), where polyglucosamine is used interchangeably with 100% de-acetylated chitin" (i.e. chitosan polymer that is free of acetyl groups) (see pg. 4, lines 9-12); and where the polyglucosamine is positively charged such that is it in chain form, for example in a composition (see pg. 4, lines 30-31.
Furthermore, the Examiner’s reasonable interpretation is further supported by the teachings of Schlom as a whole, where Schlom teaches pharmaceutical compositions of the invention can comprise pH buffering agents to maintain the pH of the formulation in the range of about 3.0 to about 9.0, (see ¶ [0153]); and as evidenced by Shagdarova et al. (Published 04 March 2026, Biochemistry (Moscow), Vol. 91, pp. S193-S224, PTO-892), Shagdarova discloses chitosan’s amino groups become protonated in acidic solutions, see pg. S200, left column, last paragraph.
Accordingly, the Examiner notes the teachings of Schlom read on the limitation of 100% deacetylated chitosan in free chain form as recited in claim 1.
(C) The Inventors have demonstrated the use of 100% deacetylated chitosan in free chain form provides significant and unexpected benefits compared to chitosan that is less than or equal to 90%, see Applicant’s remarks, pg. 8 of 11, last paragraph.
With respect to Applicant’s arguments (C), the Examiner respectfully reiterates as discussed above and further notes MPEP 2131.04 states “Evidence of secondary considerations, such as unexpected results or commercial success, is irrelevant to 35 U.S.C. 102 rejections and thus cannot overcome a rejection so based”.
(II) The rejection of claim 5 under 35 U.S.C. 103 is maintained.
Applicant argues:
(D) Komada relates to the use of particulate chitosan and not chitosan in free chain form; thus, one of ordinary skill would not have modified Schlom to use 100% deacetylated chitosan in free chain form based on the disclosure of Kodama, see Applicant’s remarks, pg. 9 of 11, Schlom-1 & Kodama, paragraph 2.
With respect to Applicant’s argument (D), the Examiner respectfully reiterates above; and further respectfully notes Kodama was used to teach the tumor antigen comprises a tumor lysate as required by claim 5, and not the 100% deacetylated chitosan in free chain form as argued by Applicant above.
(III) The rejection of claim 14 under 35 U.S.C. 103 is maintained.
Applicant argues:
(E) Schlom-2 is silent regarding the use of 100% deacetylated chitosan in free chain form as presently claimed, see pg. 10 of 11, paragraph 2.
With respect to Applicant’s argument (E), the Examiner respectfully reiterates above; and further respectfully notes Schlom-2 was used to teach the recited checkpoint inhibitor as required by claim 14, and not the 100% deacetylated chitosan in free chain form as argued by Applicant above.
Thus, Applicant’s arguments (A)-(E) have been fully considered but are not found persuasive for the reasons discussed above.
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.
Claims 1, 3-4, 6-8, 12-13, 15 and 19-21 remain rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schlom et al. (Published 17 June 2010, US-20100150960-A1, PTO-892).
Regarding claims 1, 3-4, 6-8, 12-13, 15 and 19-21, Schlom teaches compositions and methods for chitosan enhanced immune response (e.g. a method of immunotherapy, required in claim 1, line 1; claim 7, line 1; and claim 19, line 1), see title.
Schlom teaches treating or preventing cancer in a subject comprising the step of administering a depot composition comprising one or more antigens and chitosan thereby treating or preventing the cancer, (e.g. prevention or treatment of cancer, required in claim 1, lines 1-2 and claim 19, lines 1-2), see paragraph [0014].
Schlom teaches a vaccine depot composition for administration to the subject for the treatment or prevention of cancer, wherein the depot composition comprises one or more cancer antigens and chitosan, see paragraph [0046].
Schlom teaches the chitosan is deacetylated. Schlom exemplifies the chitosan is 100% deacetylated (e.g. 100% deacetylated chitosan, required in claim 1, line 4). See paragraph [0123].
Schlom teaches the agent is selected from the group consisting of point mutated ras oncogene and point mutated p53 (e.g. a neo-antigen, required in claims 3-4), see paragraph [0047].
Schlom teaches in an embodiment the depot composition further comprises an additional adjuvant wherein the adjuvant is selected from the group consisting of and including CpG motifs (e.g. the adjuvant, required in claim 6, line 2), see paragraph [0062]. Schlom teaches the vaccine depot composition further includes a cytokine (e.g. another therapeutically or prophylactically active ingredient, see claim 6, line 2-3), see paragraph [0145].
Schlom defines “cancer” to refer to any disease that is caused by or results in inappropriately high levels of cell division, inappropriately low levels of apoptosis; and exemplifies prostate cancer (e.g. a solid-tumor, required in claim 7, line 1 and claim 19, line 1), see paragraph [0107].
Schlom teaches in a particular embodiment the antigen and chitosan are mixed; and the composition is administered by one or more routes selected from the group consisting of and including intratumoral injection (e.g. intratumoral administration, required in claim 7, line 3 and claim 20, line 2), see paragraph [0063].
The Examiner respectfully notes the vaccine depot composition of Schlom comprises an adjuvant, an antigen, chitosan and a cytokine which reads on the vaccine combination required in claim 6, lines 1-3. The Examiner also respectfully notes that any or all of the adjuvant or the cytokine of Schlom reads on the limitation of “another therapeutic” as recited in claim 13, line 2 and claim 15, lines 2-3.
Schlom teaches the weight average molecular weight of the chitosan is ≥ 100 kDa (e.g. the molecular weight, required in claim 8 and claim 12), see paragraph [0123].
Schlom contemplates depot compositions comprising one or more antigens and chitosan; depot compositions comprising one or more cytokines and chitosan (e.g. the deacetylated chitosan is not administer in combination with an antigen, required in claim 21, line 3); or depot compositions comprising one or more antigens, one or more cytokines and chitosan, see paragraph [0144].
Schlom teaches the compositions should contain a therapeutically effective amount of the antigens, chitosan and cytokine in a unit of weight or volume suitable for administration of a subject (e.g. a therapeutically effective amount of 100% deacetylated chitosan, required in claim 19, lines 2-3), see paragraph [0144].
With respect to the limitation of the 100% deacetylated chitosan is in free chain form, required in claim 1, line 4; claim 7, line 2; and claim 19, line 3; the Examiner reasonably interprets this limitation has a physical limitation of said chitosan when mixed in the depot composition of Schlom as said chitosan is not attached to any component within the composition; and wherein the Examiner’s interpretation is further supported as evidenced by the specification which discloses the adjuvant (e.g. 100% deacetylated chitosan) are advantageously free chains, and not in clumps, as the free amino acids may not be attached to anything (see pg. 2, line 30 – pg. 3, line 5).
Therefore, the physical limitation of “chitosan is in free chain form” as discussed above is met by the teachings of Schlom as discussed above.
Thus, the teachings of Schlom as discussed above anticipate claims 1, 3-4, 6-8, 12-13, 15 and 19-21.
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.
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.
(I) Claim 5 remains rejected under 35 U.S.C. 103 as being unpatentable over Schlom et al. (Published 17 June 2010, US-20100150960-A1, PTO-892) as applied to claims 1, 3-4, 6-8, 12-13, 15 and 19-21 above, and further in view of Kodama et al. (Published 05 March 2020, WO-2020045679-A1, IDS filed 05/26/2023; Citations from the English machine translation, PTO-892).
Schlom addresses claims 1, 3-4, 6-8, 12-13, 15 and 19-21 as written above. Schlom further teaches the cancer antigen is selected from the group consisting of and including tumor-associated antigen (TAA) and whole tumor cells, see paragraph [0014].
Although, Scholm does not teach wherein the tumor antigen comprises a tumor lysate, required in claim 5.
However, in the same field of endeavor of the treatment or prevention of cancer, Kodama teaches uses of immunostimulants for treatment or prevention of cancer, for example in vaccine therapy, immunotherapy for cancer and the like, see pg. 13, last paragraph of the page.
Kodama exemplifies the immunostimulant as containing chitosan and a toll-like receptor (TLR), see pg. 2, abstract (English).
Kodama teaches the immunostimulant may contain an antigen, see pg. 11, second to last paragraph from the bottom of the page.
Kodama teaches the immunostimulatory agent is administered to a subject, see pg. 13, target for administration of immunostimulant, paragraph 2.
Kodama teaches the antigen is not particular limited and includes for example cancel cell antigens and cancer cell lysates are more preferred (e.g. tumor lysate, required in claim 5, line 2), see pg. 11, last paragraph of the page.
It would have been prima facie obvious to one of ordinary skill in the art before the invention was filed to have incorporated the cell lysate of Komdama into the composition(s) of Schlom as within the scope of the artisan as combining prior art elements according to known compositions and methods to yield predictable results. One of ordinary skill in the art would have been motivated to treat or prevent the cancer of the subject of Schlom as discussed above. One of ordinary skill in the art would have had a reasonable expectation of success to have incorporated the teachings of Komdama into the composition(s) as taught by Schlom as discussed above, because both Schlom and Kodama are drawn to treating or preventing cancer in a subject by administering compositions comprising chitosan and cancer antigens; and wherein Schlom teaches said antigen is a tumor-associated antigen exemplified as a point mutated p53 or whole cancer cells as taught by Schlom above.
Thus, the claimed invention as a whole would have been prima facie obvious over the combined teachings of the prior art.
(II) Claim 14 remains rejected under 35 U.S.C. 103 as being unpatentable over Schlom et al. (hereafter referred to as "Schlom-1", Published 17 June 2010, US-20100150960-A1, PTO-892) as applied to claims 1, 3-4, 6-8, 12-13, 15 and 19-21 above, and further in view of Schlom et al. (hereafter referred to as "Schlom-2", US-20190046619-A1, PTO-892).
Schlom-1 addresses claims 1, 3-4, 6-8, 12-13, 15 and 19-21 as written above. Scholm-1 further teaches the method for treating or preventing cancer in the subject comprises the step of administering a depot composition comprising antibodies or fragments thereof and chitosan to the subject thereby treating or preventing the cancer, see paragraph [0038].
Schlom-1 teaches the antibody or fragments thereof is selected from the group consisting of and including monoclonal antibodies, see paragraph [0039].
Although, Schlom-1 does not teach the recited checkpoint inhibitor, required in claim 14.
However, in the same field of endeavor of treatment or prevention of prostate cancer, Schlom-2 teaches inducing CD8+ Brachyury specific T cells, by using a Brachyury protein, a Brachyury polypeptide, nucleic acids encoding the Brachyury protein and/or Brachyury polypeptides, or host cells expressing the Brachyury protein or polypeptide. See paragraph [0014].
Schlom-2 teaches these agents can be administered in conjunction with another agent, such as a cytokine and/or another cancer therapy, see paragraph [0014].
Schlom-2 teaches treating a subject with a cancer, such as and including prostate cancer, or for preventing this cancer in a subject, see paragraph [0014].
Schlom-2 teaches Brachyury is expressed in numerous human cancers, such as in cancer of the prostate. Therefore, Brachyury protein, Brachyury polypeptides, and nucleic acids encoding Brachyury protein and/or polypeptides, can be used to produce Brachyury specific CD8+ T cells that can be used for the treatment or prevention of cancer, see paragraph [0013].
Schlom-2 teaches the subject is administered a Brachury protein, a Brachyury polypeptide, a nucleic acid encoding a Brachyury protein, or a host cell expressing the Brachyury protein, and is administered an additional agent, see paragraph [0271].
Schlom-2 teaches the additional agent can include monoclonal antibodies and/or checkpoint inhibitors, such as anti-PD-1, anti-PD-L1, and anti-CTLA-4 (e.g. the checkpoint inhibitor, required in claim 14), see paragraph [0272].
Therefore, it would have been prima facie obvious to one of ordinary skill in the before the invention was filed to have incorporated the combination therapy which includes checkpoint inhibitors as taught by Schlom-2 above into the method of treatment or prevention of cancer as taught by Schlom-1 above as within the scope of the artisan as combining prior art elements according to known compositions and methods to yield predictable results. One of ordinary skill would have been motivated to treat or prevent prostate cancer in the subject of Schlom-1 as discussed above.
One of ordinary skill in the art would have had a reasonable expectation of success of incorporating the combination as taught by Schlom-2 above into the method of treatment or prevention of prostate cancer in the subject of Schlom-1 above, because both Schlom-1 and Schlom-2 are both drawn to compositions in the treatment or prevention of prostate cancer; and in particular Schlom-2 teaches a combination comprising a Brachury protein, a Brachyury polypeptide, a nucleic acid encoding a Brachyury protein, or a host cell expressing the Brachyury protein; and wherein Brachyury is expressed in numerous human cancers, such as in cancer of the prostate as taught by Schlom-2 as discussed above.
Thus, the claimed invention as a whole would have been prima facie obvious over the combined teachings of the prior art.
Conclusion
No claims are allowed in this action.
THIS ACTION IS MADE FINAL. 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 JARET J CREWS whose telephone number is (571)270-0962. The examiner can normally be reached Monday-Friday: 9:00am-5:30pm EST.
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/JARET J CREWS/Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691
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