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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Response to Amendment
The amendment filed February 9, 2026 has been entered. Claims 1, 6-8, 17, 19-21, and 26-33 have been amended, and claims 2-5, 10-14, 16, 18, and 22 are cancelled. Applicant’s amendments to the claims have overcome the objections to the claims and drawings, the 112(a) rejections, the 112(b) rejections, the 102 rejections, and the 103 rejections over Ishii previously set forth in the Non-Final Office Action mailed November 10, 2025. Applicants cancellation of claims 2-5 have rendered the corresponding rejections/objections moot. As such, these rejections and objections are hereby withdrawn.
Applicant’s arguments filed February 9, 2026 with respect to the 103 rejections over Sakurai were fully considered but they were not persuasive. Modified/New rejections necessitated by Applicant’s amendment and response to arguments are addressed below.
Claims 1, 6-9, 15, 17, 19-21, and 23-33 are pending in this application.
Priority
This application is a 371 of PCT/JP2021/041490 filed November 11, 2021 and claims foreign priority to JP 2020-189032 filed November 12, 2020. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has received. The Examiner notes that no English language translation has been provided.
Claim Interpretation
Regarding the phrase “controlled particle size”, the broadest reasonable interpretation of the phrase encompasses particle sizes which are manipulated at some level during production.
Modified/New 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, 6-9 and 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Sakurai (WO 2016/098832, IDS filed September 11, 2023). The English translation provided by Applicant was relied upon for citation.
Regarding claims 1, 6-9, 26-27: Sakurai teaches a polynucleotide/schizophyllan composite that includes schizophyllan (i.e. a β(1[Wingdings font/0xE0]3) glucan) and a polynucleotide or a polynucleotide derivative that has a CpG sequence and is hydrogen bonded to the schizophyllan and pharmaceutical compositions thereof (abstract). Sakurai teaches the compositions can be used for treatment of cancer or infections (English translation, pg. 15, para. 0058). Sakurai teaches the complexation of CPG DNA 5 '-{dA) 40-ATCGACTCTCGAGCGTTCTC -3 '{SEQ ID NO: 1; (dA) 40-K3) with poly dA tail: (dA) 40 added as K-type CpG DNA with schizophyllan (English translation, pg. 20, paras. 0073-0074). The phosphate backbones of DNA are phosphorothioate (English translation, pg. 20, para. 0073). The poly dA (deoxyadenosine) tail was attached the 3’ end (English translation, pg. 20, para. 0073). Sakurai teaches a method of producing the complex utilizing different molecular weights of schizophyllan (English translation, pg. 20, para. 0073). Sakurai teaches the difference in molecular weight of the complex can be manipulated in order to isolate the product (English translation, pg. 21, para. 0076). Sakurai teaches that the particle size of the complexes formed depend on the molecular weight of schizophyllan utilized, wherein the radii increase with an increase in molecular weight of schizophyllan (i.e. particle size is manipulated, and thereby controlled, English translation, pg. 22-23, para. 0080, pg. 23, table 6). Wherein Sakurai teaches production of the complex using the molecular weight of schizophyllan, the limitation of the claim is met.
Sakurai does not explicitly teach wherein the complex has the average particle size range of 80 to 130 nm or 130 nm to 180 nm as recited by instant claims 2-3.
However, Sakurai teaches that the method of production utilizing different molecular weights of schizophyllan results in different particle sizes of the complex, with ranges of 5-8, 8-10, 20-70, 30-70, 70-100, and 100-150 nm (English translation, pg. 23, paras. 0081-0082). Sakurai further establishes that molecular weight of schizophyllan has an impact on particle size, and subsequently impact on physiological activity (English translation, pgs. 22-23, para. 0080). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (See MPEP 2144.05 (I)).
Claims 15, 17, 19-21, 28-30 are rejected under 35 U.S.C. 103 as being unpatentable over Sakurai (WO 2016/098832, IDS filed September 11, 2023) as applied to claims 1, 6-9 and 26-27 above in view of Ishii (US 2016/0208260, IDS filed September 11, 2023).
Regarding claims 15, 17, 19-21, 28-30: As discussed above, Sakurai renders obvious the composition of claim 9 and a method of treating influenza virus or respiratory syncytial virus.
Sakurai does not teach wherein the composition comprises an antigen from an RS virus (i.e. comprising a constituent element naturally contained within the pathogen) or from a protein, sugar chain, or peptide expressed by a cancer cell. Sakurai does not teach a method of treating influenza virus or respiratory syncytial virus.
However, Ishii teaches an oligodeoxynucleotide containing humanized K type CpG oligodeoxynucleotide and poly deoxyadenylate, wherein the poly deoxyadenylate is placed on the 3'-side of the humanized K type CpG oligodeoxynucleotide complexed with a β-1,3 glucan (abstract). Ishii teaches the complex forms a high-order nanoparticle (i.e. controlled particle size, pg. 2, para. 0041). Ishii teaches the nanoparticle has an average diameter of 30 nm (pg. 14, para. 0272). Ishii teaches a complex comprising schizophyllan (SPG) or lentinan (LNT) (pg. 1, para. 0005, pg. 2, para. 0041). Ishii teaches the K-type CPG oligonucleotide can be SEQ ID 1, which has phosphorothioate bonds and is bound to a poly(A) group at the 3’ position (pg. 11, para. 200, table 1). Ishii teaches compositions comprising complex and an antigen derived from a pathogen or cancer (pg. 9, para. 0178, pg. 10, para. 0184, pg. 11, para. 0194). Ishii teaches the antigen related to cancer cells include protein, sugar chain, peptide that are specifically expressed by cancer cells (pg. 10, para. 0192). The pathogen can be a virus wherein the virus is an RS virus or influenza virus (pg. 4, paras. 0080-0083). Ishii teaches administration of the complex for providing infection defense ability for RSV infection (pg. 17, para. 0287). Ishii teaches administration of the complex/compositions for treatment of RS virus or influenza (pg. 3, para. 0067-0072, pg. 4, paras. 0076-0083). Ishii teaches the composition can be used to treat cancer (pg. 3, para. 0058).
Taken together, it would have been prima facie obvious to a person of ordinary skill in the art to modify the composition of Sakurai such that the composition comprises an antigen from an RS virus for the treatment of respiratory syncytial virus or can comprise an antigen from a protein, sugar chain, or peptide expressed by a cancer cell as taught by Ishii. A person of ordinary skill in the art would have had the motivation to do so with a reasonable expectation of success as the art establishes schizophyllan complexed with oligodexoynucleotides can comprise such antigens from an RS virus that can be used specifically for the treatment of RS virus or can comprise or from a protein, sugar chain, or peptide expressed by a cancer cell for the purpose of treating cancer.
Claims 23-25 and 31-33 are rejected under 35 U.S.C. 103 as being unpatentable over Sakurai (WO 2016/098832, IDS filed September 11, 2023) and Ishii (US 2016/0208260, IDS filed September 11, 2023) as applied to claims 1, 6-9, 15, 17, 19-21, and 26-30 above in view of Adamus (Contemp Oncol. (Pozn), 2017, cited in previous action).
Regarding claims 23-25 and 31-33: As discussed above, the prior art renders obvious the complex of claim 1 and method of claim 27. Ishii teaches the complex of CpG oligodeoxynucleotide (ODN) and a B-glucan possess immunostimulant activity (pg. 1, para. 0001).
Ishii does not teach wherein the complex is co-administered with another anticancer agent, such as a CTLA-4 inhibitor.
However, Adamus teaches CpG ODN-based strategies can greatly benefit from combination with strategies targeting immune checkpoint regulation in order to generate more effective and safer cancer immunotherapies (abstract). Adamus teaches a synergistic result from the combination of CTLA-4 inhibition, such as with CTLA-4 antibodies, and CPG-ODN mediated activation of antigen presenting cells in melanoma mouse models (pg. 57, col. 2, middle of page).
Taken together, it would have been prima facie obvious to a person of ordinary skill in the art to modify the composition/method comprising CpG oligonucleotide of Sakurai and Ishii, such that the complex was combined and co-administered with an anticancer agent, such as a CTLA-4 inhibitor, as taught by Adamus. A person of ordinary skill in the art would have had the motivation to do so with a reasonable expectation of success as combination therapies comprising CpG ODN therapies and CTLA-4 inhibition are known in the art for the purpose of treating cancer in a subject. Adamus suggests that such a combination can generate more effective and safer cancer immunotherapies
Response to Arguments
Applicant’s arguments filed February 9, 2026 with respect to the 103 rejections over Sakurai have been fully considered but they are not persuasive.
On page 11 of Applicant’s response, Applicant argues the tables of 6-7 of Sakurai et al represent the radius of gyration, wherein the average particle diameter can be approximated as twice the radius of gyration, thus Sakurai discloses complexes having particle diameters of approximately 10-16 nm, 16-20 nm, 40-140 nm, 60-140 nm, and 200-300 nm (para. 2). Applicant argues that within the radius of gyration of 8-150 nm (i.e. 16-300 diameter), activity is rated as “o”, and would not be expected that a region exhibiting particularly superior activity exists within this range. On pages 11-12 of Applicants response, Applicant argues the instant specification demonstrates controlling the molecular weight of schizophyllan enables precise control of the complex particle size as shown in table 8 of the instant specification and discovered that average particle size in the range of 80 nm to 130 nm exhibit remarkably high pharmacological activity which could not have been predicted from Sakurai (bridging para.).
However, Sakurai teaches particle size range of schizophyllan with 60-140 nm diameter which significantly overlaps with the claimed range of 80 nm to 130 nm while also demonstrating a correlation between molecular weight and final particle size. Per tables 6-7 of Sakurai, lower diameters are associated with lower activity as are higher diameters on the extreme end (i.e. 150-200 radii, 300-400 diameter). Sakurai recognizes the general trend of increased activity of the complex with larger molecular weight and larger inertial radius (i.e. particle size) (English translation, pgs. 22-23, para. 0080). Thus it cannot be considered unexpected that larger particle sizes are more active as demonstrated by Applicant.
On page 11 of Applicant’s response, Applicant argues that Sakurai does not teach a single specific value but only has a range having a certain width, and once the radius of gyration reaches about 20 nm or more (i.e. particle diameter of about 40 nm or more), the range becomes considerable broader and no sample is reported with a width of 25 nm or less (i.e. particle diameter of 50 nm or less) (para. 3).
However, the instant claims are not directed towards a single specific value, but rather an average particle size range, which necessarily possesses a range of different particle sizes. As discussed previously, Sakurai teaches particle size range of schizophyllan with 60-140 nm diameter which significantly overlaps with the claimed range of 80 nm to 130 nm while also demonstrating a correlation between molecular weight and final particle size. It is not clear from the arguments that the controlled particle size schizophyllan of Sakurai is significantly different from that which is instantly claimed.
Applicant’s reply is considered to be a bona fide attempt at a response and is being accepted as a complete response. The 35 USC § 103 rejections are maintained for reason of record and foregoing discussion.
Conclusion
No claims are allowed in this action.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/S.L.G./Examiner, Art Unit 1693
/ANDREA OLSON/Primary Examiner, Art Unit 1693