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 . Preliminary amendment filed on 02/27/2024 has been entered. Claims 1-19 are pending in this application and are currently under examination.
Priority
This application is a 371 of PCT/JP2022/032351 filed on 08/29/2022 and claims foreign priority of JAPAN 2021-139683 filed on 08/30/2021.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e). Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 02/27/2024, 03/29/2024, 11/04/2025, and 08/21/2026 with appropriate assertion under 37 CFR 1.98 have been considered.
Claim Objections
Claims 1-3, 13, 18, and 19 are objected to because of the following informalities: In claim 1, change the incorrect recitation “wherein the modified amphiphilic polymer is an amphiphilic polymer in which a hydrophobic segment is poly(hydroxy acid) and a hydrophilic segment is polysaccharide and to which an immuno-stimulating factor is bound” (lines 2-5) to “wherein a hydrophobic segment of the modified amphiphilic polymer is poly(hydroxy acid), a hydrophilic segment of the modified amphiphilic polymer is polysaccharide, and an immuno-stimulating factor is bound in the modified amphiphilic polymer” to avoid redundancy and to tie with the preceding recitation. In claim 2, insert the missing word “further” immediately before the recitation “comprise” (line 2) because some antigens contain lipid. In claim 3, change the incorrect recitation “wherein the non-modified amphiphilic polymer is an amphiphilic polymer in which a hydrophobic segment is poly(hydroxy acid) and a hydrophilic segment is polysaccharide and to which no immuno-stimulating factor is bound” (lines 2-5) to “wherein a hydrophobic segment of the non-modified amphiphilic polymer is poly(hydroxy acid), a hydrophilic segment of the non-modified amphiphilic polymer is polysaccharide, and no immuno-stimulating factor is bound in the non-modified amphiphilic polymer” to avoid redundancy and to tie with the preceding recitation. In claim 13, change the incorrect recitation “to one molecule” (line 3) to “in one molecule” because the immune-stimulating factor is component of the modified amphiphilic polymer. In claims 18 and 19, insert the missing phrase “in need thereof” immediately after the recitation “a subject” because only those in need require the administration. Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-6 and 9-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon or a product of nature without significantly more. The 2019 Revised Patent Subject Matter Eligibility Guidance (issued January 7, 2019)” (https://www.govinfo.gov/content/pkg/FR-2019-01-07/pdf/2018-28282.pdf) and “October 2019 Update: Subject Matter Eligibility (issued October 17, 2019)” (https://www.uspto.gov/sites/default/files/documents/peg_oct_2019_update.pdf), are followed here. The claim is directed to a statutory category, e.g., a composition of matter (Step 1: YES). The claim is then analyzed in Step 2A (Prong one) to determine whether it is directed to any judicial exception. The claims 1-6 and 9-17 recite a composition (or a medicine; or a vaccine) comprising a modified amphiphilic polymer (defined as “The term "modified amphiphilic polymer" refers to a polymer obtained by binding an immuno-stimulating factor to the amphiphilic polymer. The binding herein may he noncovalent binding or covalent binding” in the Specification) and an antigen (e.g., peptide), wherein a hydrophobic segment of the modified amphiphilic polymer is poly(hydroxy acid) (e.g., polybutyrate), a hydrophilic segment of the modified amphiphilic polymer is polysaccharide (e,g,, black yeast glucan), and an immuno-stimulating factor (e.g., lipopolysaccharide) is bound in the modified amphiphilic polymer, that are products of nature. Accordingly, the claim is directed to at least one exception (Step 2A, prong one: YES). The claim is then analyzed in Step 2A (Prong two) and is determined that this judicial exception is not integrated into a practical application because there is no indication that mixing them in the recited particle, 1 to 100 molar ratio of the immuno-stimulating factor over the amphiphilic polymer or particle size of 0.1 to 50 μm changes the structure, function, or other properties of the antigen, poly(hydroxy acid), polysaccharide, and an immuno-stimulating factor in any marked way. Instead, the antigen, poly(hydroxy acid), polysaccharide, or an immuno-stimulating factor retains its naturally occurring structure and properties (e.g., immunization or immuno-stimulating). Thus, the claimed mixture as a whole does not display markedly different characteristics compared to the closest naturally occurring counterpart. Accordingly, the Step 2A (Prong two) is NO. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because prior to applicant’s invention and at the time of filing the application, mixing of antigen, poly(hydroxy acid), polysaccharide, and an immuno-stimulating factor in a particle form was well-understood, routine and conventional in the field, as evidenced by the reference under the 102 rejection below. The recitation of specific molar ratio, or particle size does not affect this analysis, because it was also well-understood, routine and conventional at the time to apply specific molar ratio or particle size, e.g., to achieve commercially acceptable chemical complex for different purposes. Thus, the mixing of antigen, poly(hydroxy acid), polysaccharide, and an immuno-stimulating factor in a particle form, when recited at this high level of generality, does not meaningfully limit the claim, and the claim as a whole does not amount to significantly more than each “product of nature” by itself (Step 2B: NO). The claim does not qualify as eligible subject matter.
Claim Rejections - 35 USC § 102/103
(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.
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.
Claims 1-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Koshi et al. (US 2016/0256543, Sep. 8, 2016, hereinafter referred to as Koshi ‘543, also listed in IDS filed on 02/27/2024) incorporated by Berti et al. (US 2010/026662, Oct. 21, 2010, hereinafter referred to as Berti ‘662).
With regard to structural limitations “a composition (or a medicine; or a vaccine) containing a particle (or 0.1 to 50 μm) comprising a modified amphiphilic polymer and an antigen, wherein a hydrophobic segment of the modified amphiphilic polymer is poly(hydroxy acid) (or poly(lactic-co-glycolic acid), polylactic acid, or polyglycolic acid), a hydrophilic segment of the modified amphiphilic polymer is polysaccharide (or ß-glucan; or ß-glucan containing ß-1,3 and/or ß-1,6 linkage; or black yeast glucan, e.g., Aureobasidium pullulans glucan; curdlan; or pachyman), and an immuno-stimulating factor (or TLR 4 or MPLA; or TLR9 or unmethylated CpG DNA; or 1 to 100 molar ratio to the modified amphiphilic polymer) is bound (or covalently; or to the hydrophilic segment) in the modified amphiphilic polymer (further comprising a non-modified amphiphilic polymer comprising poly(hydroxy acid) and polysaccharide without bound immune-stimulating factor)” (claims 1-17) and “a method comprising administering the composition for enhancing immunogenicity according to claim 1 to a subject in need thereof” (claims 18 and 19):
Koshi ‘543 disclosed an immunopotentiator comprising, as an active ingredient, a modified ß-glucan which ß-glucan and poly(hydroxy acid) are covalently bonded. Examples of ß-glucan that contains at least one ß-1,3 bond include curdlan, pachyman, laminaran, lichenan, sizofiran, lentinan, scleroglucan, Aureobasidium pullulans glucan (preferably Aureobasidium pullulans-derived ß-1,3 glucan or ß-1,6 glucan), or pachymaran. Preferable specific examples of poly(hydroxy acid) include polyglycolic acid, polylactic acid, poly(2-hydroxybutyric acid), poly(2-hydroxyvaleric acid), poly(2-hydroxycaproic acid), poly(2-hydroxycapric acid), poly(malic acid), or a derivative and a copolymer of these high molecular compounds, and poly(lactic-co-glycolic acid), polylactic acid, or polyglycolic acid is more preferable, and poly(lactic-co-glycolic acid) is still more preferable. When an immunopotentiator is administered in vivo, particle is preferable in terms of ease of administration. On the surface of a modified ß-glucan particle, a surface modifier used in the production process may be bound. The term bond here may be noncovalent bond or covalent bond. The immunopotentiator can be used as a medicine alone or in combination with other drugs and an antigen is preferably used. The term antigen here is a substance that induces immunity in vivo and utilized as a vaccine for the treatment and/or prevention of diseases. Other preferable examples of an antigen include cancer antigen (page 14/28, [0053, 0055, 0061]; pages 15/28 to 16/28, [0074, 0085]; page 16/28, [0088-0091]). The mean particle size of the particle is preferably 0.01 to 10 μm, and more preferably 0.1 to 1 μm. A method for immunopotentiation, including administering an immunopotentiator or a medicine to an organism (a subject). When an immunopotentiator is used as a medicine (including vaccine), formulation may be performed by combining various pharmaceutically useful additives (page 16/28, [0086, 0094, 0095]). An immunopotentiator is a drug that activates immune response in vivo. The type of immune response to be caused include Th1 immune response or Th2 immune response. The immunopotentiating effect of ß-glucans cannot be said to be potent, and concomitant use with other immunopotentiators to obtain sufficient effects has been investigated (see Patent Document 2, Japanese Patent Application Laid-Open Publication No. 2011-504487) (page 16/28, [0087]; page 13/28, [0003, 0008]). Berti ‘662 (corresponding to the Japanese Patent Application Laid-Open Publication No. 2011-504487, and thus incorporated as the reference in its entirety here) disclosed a composition comprising: a conjugate of (i) a ß-glucan and (ii) a carrier molecule; and an adjuvant. The adjuvant includes microparticles (i.e. a particle of ̴̴100 nm to ̴̴ 150 µm in diameter, more preferably ̴̴ 200 nm to ̴̴ 30 µm in diameter) formed from materials (e.g. a poly(α-hydroxy acid), a polyhydroxybutyric acid, a polyanhydride, a polycaprolactone, etc.), with poly(lactide-co-glycolide) being preferred. Compositions may include two or more said adjuvants. As shown in the examples, such combinations can improve the immune response elicited by glucan conjugates. Individual adjuvants may preferentially induce either a Th1 response or a Th2 response, and useful combinations of adjuvants can include both a Th2 adjuvant (e.g. an oil-in-water emulsion or an aluminium salt) and a Th1 adjuvant (e.g. 3dMPL, a saponin, or an immunostimulatory oligonucleotide). An immunostimulatory oligonucleotide, such as one containing a CpG motif. A CpG sequence may be directed to TLR9, such as the motif GTCGTT or TTCGTT. The 3dMPL is 3-O-deacylated monophosphoryl lipid A (page 25/42, [0078, 0079]; page 28/42, [0109], page 32/42, 0147); pages 28/42 to 29/42, [0119, 0121).
Thus, these teachings of Koshi ‘543 incorporated by Berti ‘662 anticipate Applicant’s claims 1-19 because (a) Koshi ‘543 teaches an immunopotentiator comprising a particle of conjugated ß-glucan and poly(hydroxy acid), in which a surface modifier may be bound, to activate Th1 immune response and/or Th2 immune response, and (b) Berti ‘662 teaches a specific Th1 adjuvant, e.g., 3dMPLA (a TLR4 ligand according to claim 12 of this Application) or an immunostimulatory oligonucleotide, such as a CpG sequence directed to TLR9 to enhance immunopotentiating effect of ß-glucans, described above. Or, in an alternative, skilled artisan would follow the teachings of Koshi ‘543 incorporated by Berti ‘662 to combine the immunopotentiator comprising a particle of conjugated ß-glucan and poly(hydroxy acid) with the specific Th1 adjuvant, e.g., 3dMPLA or an immunostimulatory oligonucleotide, described above. The composition of Koshi ‘543 incorporated by Berti ‘662 meets all structural limitation of claimed composition and would also carry the same properties or intended results as recited in claim 13.
Conclusion
No claims are allowed.
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/YIH-HORNG SHIAO/Primary Examiner, Art Unit 1691
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