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 .
Election/Restrictions
Applicant’s election without traverse of:
Group I (e.g. claims 1-15 and 19-21) directed to immunotherapy for cancer in an subject comprising administering polyglucosamine;
Species (I): the adjuvant is polyglucosamine, see claims 1, 7, 19 and 22;
Species (II): the tumor antigen is a neoantigen, see claim 1; and
Species (III): the type of cancer is a solid tumor cancer, see claims 1, 7, and 19 in the reply filed on December 29, 2025 is acknowledged.
The Examiner respectfully notes claims 1, 3-8, 12-15 and 19-21 read on the elected group and species discussed above.
Accordingly, claims 17-18, 22 and 24-25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 December 29, 2025.
The Examiner also respectfully notes within the claim set filed December 29, 2025, claims 19-21 have the status identifier of (Withdrawn – Currently Amended), however as the Examiner stated above claims 19-21 are within elected Group I and read on the elected species, therefore claims 19-21 are not withdrawn. Thus, the Examiner respectfully notes the status identifier for claims 19-21 is (Currently Amended).
Information Disclosure Statement
The Information Disclosure Statement (IDS) filed on 05/26/2023 has been considered by the Examiner inasmuch as foreign documents have been submitted into the file wrapper in English.
Claim Status
The claim set filed December 29, 2025 has been entered. Claims 2, 9-11,16 and 23 are canceled. Claims 17-18, 22 and 24-25 are withdrawn for further consideration as being drawn to an non-elected invention as discussed in greater detail in the Election/Restrictions section above.
Thus, claims 1, 3-8, 12-15 and 19-21 as amended are examined on the merits herein.
Claim Objections
Claims 3, 6, 13 and 21 are objected to because of the following informalities:
(I) Claim 3, line 2, recites the phrase “TAA (tumor associated antigen)” where the phrase “tumor associated antigen” is enclosed with parentheses, implying said phrase is not necessarily needed in the claim.
Therefore, to promote clarity the Examiner suggests replacing the phrase “TAA (tumor associated antigen)” with the phrase tumor associated antigen (TAA)”.
(II) Claim 3, line 4, recites “Neo-antigen” which the Examiner notes is already recited within claim 3, line 3, and therefore is redundant.
Therefore, to promote clarity the Examiner suggests deleting the redundant recitation of “Neo-antigen” as recited in claim 3, line 4 as discussed above.
Moreover, the Examiner encourages the Applicant to review the entirety of claim 3 to ensure if any additional redundant antigens are recited within the claim they are deleted.
(III) Claim 6, line 4 and Claim 13, pg. 4 of 8, line 2, each recite the phrase “CpG” which is an uncommon abbreviation. The Examiner notes “CpG” is referred to in the specification as “CpG oligodeoxynucleotides”, see pg. 13, line 5.
Therefore, to promote clarity the Examiner suggests replacing “CpG” with the phrase “CpG oligodeoxynucleotides” as discussed above.
Moreover, the Examiner encourages the Applicant to review the entire claim set to ensure if any additional uncommon abbreviations are recited within a claim, they are replaced in accordance with the specification.
(IV) Claim 21, line 1, recites “The method according to claim 19 wherein” which is missing a comma immediately before the recitation of the word “wherein”.
Therefore, to promote clarity the Examiner suggests inserting a comma immediately before the word “wherein” as discussed above.
(V) Claim 21, line 2, recites the phrase “and/or the not administered in combination with a vaccine or antigen”. The Examiner respectfully notes the word “the” recited immediately after “not” is not grammatically correct when referring to the administered combination.
Therefore, to promote clarity the Examiner suggests replacing the word “the” with the word “is” as discussed above.
Appropriate correction is required.
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 6 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 6 recites the limitation "the anti-tumor antigen" in line 1. There is insufficient antecedent basis for this limitation in the claim. The Examiner respectfully notes claim 6 depends from claim 1. The Examiner further respectfully notes claim 1 recites “a tumor antigen” and does not recite “an anti-tumor antigen”.
In the interest of compact prosecution, the Examiner will interpret the “anti-tumor antigen” is “the tumor antigen” as recited in claim 1 as 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 are 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 is 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 is 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.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor can be reached at (571) 272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JARET J CREWS/Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691