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 1 (claims 1,2,6,7,15-17 and 19) in the reply filed on 8/7/2026 is acknowledged.
The requirement is deemed proper and is therefore made FINAL.
Status of Application, Amendments, And/Or Claims
Claims 1-2, 6-7, 15-17, 19, and 59-66 are pending and are under examination.
Information Disclosure Statement
The Information Disclosure Statements (IDSs) filed on 2/27/2024, 9/10/2024 (2), 12/10/2025, 4/14/2026 and 7/7/2026 have been considered.
Specification
The disclosure is objected to because of the following informalities: The brief description of the drawings has several references to colored items. For example, the specification discloses:
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Also see Figure 3, pg. 88-89; Figure 15, line 3; Figure 38, pages 99-100.
Thus, it appears that some of applicant’s drawing may need to be submitted in color to distinguish these details. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Applicants are reminded that color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the
following language as the first paragraph of the brief description of the drawings section of the specification: Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (see pg. 13, line 22). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Appropriate correction is required.
Drawings
Figure 3b – Nucleotide and/or amino acid sequences appearing in the drawings are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Sequence identifiers for nucleotide and/or amino acid sequences must appear either in the drawings or in the Brief Description of the Drawings.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-2 and 6-7 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
The written description in this case only sets forth a composition comprising: (i) a monovalent antigen particle comprising an antigenic portion comprising not more than one antigenic structure capable of inducing an antibody mediated immune response against a target antigen, and(ii) a polyvalent antigen particle comprising an antigenic portion comprising more than one antigenic structure capable of inducing an antibody mediated immune response against the target antigen and wherein the more than one antigenic structure is cross-linked, wherein the antigenic structure of monovalent antigen particle and the antigenic structure of polyvalent antigen particles are different from one another, and therefore the written description is not commensurate in scope with “a composition comprising : (i) a monovalent antigen particle comprising an antigenic portion comprising not more than one antigenic structure capable of inducing an antibody mediated immune response against a target antigen, and(ii) a polyvalent antigen particle comprising an antigenic portion comprising more than one antigenic structure capable of inducing an antibody mediated immune response against the target antigen and wherein the more than one antigenic structure is cross-linked, wherein the antigenic structure of monovalent particle and the antigenic structure of the polygenic particles are same as recited in claim 1”. However, disclosure of an antigen fully characterized by its structure, formula, chemical name, physical properties, or deposit in a public depository does not, without more, provide an adequate written description of an antibody claimed by its binding affinity to that antigen, even when preparation of such an antibody is routine and conventional. See Amgen Inc. V. Sanofi, 872 F.3d 1367, 1378, 124 USPQ2d 1354, 1361 (Fed.Cir. 7)("knowledge of the chemical structure of an antigen [does not give] the required kind of structure-identifying information about the corresponding antibodies"); see also Centocor Ortho Biotech, Inc. V. Abbott Labs., 636 F.3d 1341, 1351-52, 97 USPQ2d 1870, 1877 (Fed. Cir. 2011) (patent disclosed the antigen the claimed antibody was supposed to bind, but did not disclose any antibodies with the specific claimed properties). See also MPEP 2163.II.А.3(a).
Sarvas et al. (IDS, Eur. J. Immunol. 1974; 4:255-261) teaches a composition teach a mixture of monovalent carrier and polyvalent conjugate wherein the antigen structure for monovalent and polyvalent are different (abstract, and Materials and methods (pg.255)). The specification discloses using soluble insulin-A derived peptide as monovalent antigenic particle and a peptide derived from insulin c-peptide attached to KLH as a polymeric antigen particle (pg. 106-107).
Claim Rejections - 35 USC § 112-scope of enablement
Claims 15-17, 19, and 59-66 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of eliciting B-cell mediated target antigen-specific immune response comprising (a) contacting one or more B-cells with the composition of claim 1, and (b) eliciting B-cell mediated target antigen-specific immune response, does not reasonably provide enablement for a method of modulating any B-cell modulate target antigen-specific immune response comprising: contacting one or more B-cells with the composition of claim 1 and modulating (decreasing or some time decreasing and then increasing) immune response. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
In In re Wands, 8USPQ2d, 1400 (CAFC 1988) page 1404, the factors to be considered in determining whether a disclosure would require undue experimentation include: (1) Nature of the invention, (2) the state of the prior art, (3) the predictability or lack thereof in the art, (4) the amount of direction or guidance present, (5) the presence or absence of working examples, (6) the breath of the claims, (7) the quantity of experimentation needed, (8) relative skill of those in the art.
The instant disclosure fails to meet the enablement requirement for the following reasons:
Claims 15-17, 19, 59-66 are broadly drawn to a method for modulating any B-cell modulate target antigen-specific immune response comprising: contacting one or more B-cells with the composition of claim 1 and modulating (decreasing or some time decreasing and then increasing) immune response.
The state of the prior art and the predictability or lack thereof in the art:
Sarvas et al. (IDS, Eur. J. Immunol. 1974; 4:255-261) teaches a composition teach a mixture of monovalent carrier and polyvalent conjugate wherein the antigen structure for monovalent and polyvalent are different (abstract, and Materials and methods (pg.255)). Mond et al. (IDS of 7/7/2026, WO 2014/018858) teach multimerizing antigens to enhance their immunogenicity using a fusion protein with two antigens separated by a linker and an oligomerization domain that results in enhanced immunogenicity (abstract, pg. 5 [0015]). The art does not disclose that the use of multivalent antigen and monovalent antigen together can modulate or reduce immunity in a subject in need thereof. Therefore, it is unpredictable and would require a large number experimentation to determine if a monovalent antigen particles and polyvalent antigen particle can reduce or modulate B-cell mediated target-specific immune response in a subject in need thereof.
The amount of direction and guidance present and the presence or absence of working examples: Given the teachings found in the art, detailed teachings are required to be present in the disclosure in order to enable the skilled artisan to practice the invention as claimed. These teachings are absent. The specification Example 6 (pg. 111) and Example 9 (pg. 114) disclose increased immunity in IgD deficient mice by immunization. The specification does not disclose any example to administer a monovalent antigen particle and a polyvalent particle to reduce or modulate immunity of a subject in need thereof. Therefore, it is unpredictable how one of the skill in the art can practice the instantly claimed invention.
The breadth of the claims and the quantity of experimentation needed: Due to the large quantity of experimentation necessary to use monovalent antigen particle and a polyvalent antigen particle to reduce or modify B-cell mediated target antigen-specific immune response in a subject in need thereof, the lack of direction/guidance presented in the specification regarding the same, the absence of working examples directed to same, the state of the prior art which establishes the unpredictability about a composition comprising a monovalent antigen particle and a polyvalent particle to reduce or modify B-cell mediated target antigen-specific immune response, undue experimentation would be required of the skilled artisan to make and/or use the claimed invention in its full scope.
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.
Claim(s) 1-2 and 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sarvas et al (IDS, Eur. J. Immunol. 1974, 4: 255-261).
The instant claims are broadly drawn to a composition, comprising:(i) a monovalent antigen particle comprising an antigenic portion comprising not more than one antigenic structure capable of inducing an antibody mediated immune response against a target antigen, and(ii) a polyvalent antigen particle comprising an antigenic portion comprising more than one antigenic structure capable of inducing an antibody mediated immune response against the target antigen and wherein the more than one antigenic structure is cross-linked, wherein polyvalent antigen particle comprises multiple antigenic structure (claim 2), wherein polyvalent antigen particle comprises at least two copies of the antigenic structure in spatial proximity to each other (claim 6).
Sarvas et al. teach a composition comprising a mixture of monovalent carrier and polyvalent conjugate wherein the antigen structure for monovalent and polyvalent are different (abstract, and Materials and methods (pg.255)). They also compared the immunological response in comparison with a monovalent and polyvalent antigen response separately ( pg. 257, 3.2.). Therefore, the prior art of record implicitly or explicitly anticipates the instantly claimed invention.
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.
Claim(s) 1-2 and 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Sarvas et al. (IDS, Eur. J. Immunol. 1974, 4: 255-261) in view of Mond et al. (IDS of 7/7/2026, WO 2014/018858) and Setz (IDS, The EMBO J. 38: 1-17 (2019)).
The instant claims are broadly drawn to a composition, comprising:(i) a monovalent antigen particle comprising an antigenic portion comprising not more than one antigenic structure capable of inducing an antibody mediated immune response against a target antigen, and(ii) a polyvalent antigen particle comprising an antigenic portion comprising more than one antigenic structure capable of inducing an antibody mediated immune response against the target antigen and wherein the more than one antigenic structure is cross-linked, wherein polyvalent antigen particle comprises multiple antigenic structure (claim 2), wherein polyvalent antigen particle comprises at least two copies of the antigenic structure in spatial proximity to each other (claim 6) and wherein at least two copies of the antigenic structure are within a range of 3 nm to 20 nm to each other (claim 7), and method of eliciting immune response using the same (claims 15-17, 19, 59-66).
The teachings of Sarvas are set forth above. Sarvas et al. teach that haptenated proteins induce IgM immunity Sarvas et al do not teach that polygenic antigen structures are in a range of 3 nm to 20 nm.
Mond et al teach multivalent antigenic protein to enhance their immunogenicity using a fusion protein with two antigens separated by a linker and an oligomerization domain that results in enhanced immunogenicity (abstract, pg. 5 [0015]). They teach that polyvalent proteins extensively cross link cell surface immunoglobulin of B cells and activate the B cells (pg. 2 lines2+).
Therefore, it would have been prima facie obvious to one ordinary skill in the art at the time of invention to make polyvalent antigen having two or more antigenic structure in a close spatial proximity including 3-20 nm by separating structures by a linker as taught by Mond et al. in a composition to elicit immunological response as taught by Sarvas et al. Additionally, one would have been motivated to do so because Mond et al teach using polyvalent antigen separated by a linker to enhance immunity. Further, one would have a reasonable expectation of success in using a composition wherein polyvalent antigen of two or more antigens to elicit immunity as taught by Mond et al. in a composition as taught by Sarvas et al. Therefore, the instantly claimed invention would have been obvious over the combined teachings of the prior art.
Conclusion
No claim is allowed.
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/GYAN CHANDRA/Primary Examiner, Art Unit 1674
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