DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
The preliminary amendment filed on 1/17/2025 is acknowledged. Claims 2-40 have been cancelled. New claims 41-48 have been added. Claims 1 and 41-48 are pending and are currently under examination.
Information Disclosure Statement
The information disclosure statements filed on 4/2/2025 have been considered. Signed copies are enclosed.
Claim Objections
Claims 45-46 are objected to because of the following informalities: Claim 45 states: “bound by of an antibody,” which is grammatically incorrect. Claim 46 states: “further comprising further,” which is grammatically incorrect. 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 41 and 45 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. The claims are directed to compositions comprising an O25b antigen and a carrier. The O25b antigen is naturally produced by certain strains of E. coli. The invention lacks markedly different characteristics from the naturally occurring counterpart (O25b antigen found on E. coli). As stated above, O25b antigen is naturally produced by E. coli. The carriers listed in the claims include water, which is naturally occurring. Although the combination of O25b and water does not specifically occur in nature, there is no indication that mixing these components changes the structure, function, or other properties of the antigen or the water in any marked way. Instead, the antigen retains its naturally occurring structure and properties (both chemical and immunological) and is merely located in water. Thus, the claimed mixture does not display markedly different characteristics from the naturally occurring counterpart. The claims do not include any additional required elements.
Claim Rejections - 35 USC § 112
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 45-48 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The instant claims are drawn to immunogens comprising an epitope specifically bound by an antibody light chain comprising the variable region encoded by the coding sequence of the plasmid comprised in the host cell DSM 26763 and an antibody heavy chain comprising the variable region encoded by the coding sequence of the plasmid comprised in the host cell DSM 26762.
The specification mentions antibodies designated as 8D5-1G10, and states that these are characterized by deposited biological material. DSM 26763 is a host cell transformed with a plasmid comprising the variable domain coding sequence of the 8D5-1G10 light chain. DSM 26762 is a host cell transformed with a plasmid comprising the variable domain coding sequence of the 8D5-1G10 heavy chain. No further antibodies (including any variants or any antibodies with only the light or heavy chains of are described and no further information regarding the structure of these antibodies is provided. Antibody 8D5-1G10 is shown to bind to the O25b antigen. The specification does not provide any information on the epitopes that are bound by these or any other antibodies and no information is provided on the structure of 8D5-1G10.
Because the specification lacks any description of the antibodies designated as 8D5-1G10, there is no description of antibodies designated as 8D5-1G10. There is no information provided as to the sequences that encode these antibodies. Further, there is no description of the epitopes that are bound by these undescribed antibodies encoded by an undescribed sequence.
The functional characteristics of antibodies (including binding specificity and affinity are dictated on their structure. Amino acid sequence and conformation of each of the heavy and light chain CDRs are critical in maintaining the antigen binding specificity and affinity which is characteristic of the parent immunoglobulin. For example, Vajdos et al. (J Mol Biol. 2002 Jul 5;320(2):415-28 at 416; IDS filed 4/2/2025) teaches that, “ … Even within the Fv, antigen binding is primarily mediated by the complementarity determining regions (CDRs), six hypervariable loops (three each in the heavy and light chains) which together present a large contiguous surface for potential antigen binding. Aside from the CDRs, the Fv also contains more highly conserved framework segments which connect the CDRs and are mainly involved in supporting the CDR loop conformations, although in some cases, framework residues also contact antigen. As an important step to understanding how a particular antibody functions, it would be very useful to assess the contributions of each CDR side-chain to antigen binding, and in so doing, to produce a functional map of the antigen-binding site." The art shows an unpredictable effect when making single versus multiple changes to any given CDR. For example, Brown et al. (J Immunol. 1996 May;156(9):3285-91 at 3290 and Tables 1 and 2; IDS filed 4/2/2025), describes how the VH CDR2 of a particular antibody was generally tolerant of single amino acid changes, however the antibody lost binding upon introduction of two amino changes in the same region.
As the specification lacks any description of plasmids found within the deposited cells, it lacks any description of the structure of the antibody chains encoded by said plasmids. As the antibody chains are not described, the epitopes they bind are also not described; either by what they bind or by their structure.
Therefore, neither the art nor the specification provide a sufficient description of the claimed epitopes to meet the written description requirements.
Claims 45-48 are rejected under 35 U.S.C.§112, first paragraph, as containing subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
It is apparent that the host cell DSM 26762 and DSM 26763 are required to practice the claimed invention. As such they must be readily available or obtainable by a repeatable method set forth in the specification, or otherwise readily available to the public. If it is not so obtainable or available, the requirements of 35 USC 112, first paragraph, may be satisfied by a deposit of the host cells.
It is noted that Applicants have referred to a deposit of the host cells, but there is no indication in the specification as to public availability. The mere reference to a deposit or the biological material itself in any document or publication does not necessarily mean that the deposited biological material is readily available. Even a deposit made under the Budapest Treaty and referenced in a United States or foreign patent document would not necessarily meet the test for known and readily available unless the deposit was made under conditions that are consistent with those specified in these rules, including the provision that requires, with one possible exception (37 CFR 1.808(b)), that all restrictions on the accessibility be irrevocably removed by the applicant upon the granting of the patent. Ex parte Hildebrand, 15 USPQ2d 1662 (Bd. Pat. App. & Int. 1990).
If a deposit is made under the terms of the Budapest Treaty, then an affidavit or declaration by Applicants, or a statement by an attorney of record over his or her signature and registration number, stating that the instant invention will be irrevocably and without restriction released to the public upon the issuance of a patent, would satisfy the deposit requirement made herein. If a deposit has not been made under the Budapest Treaty, then in order to certify that the deposit meets the criteria set forth in 37 CFR 1.801-1.809 and MPEP 2402-2411.05, Applicant may provide assurance of compliance by affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number showing that:
(a) during the pendency of the application, access to the invention will be afforded to the Commissioner upon request;
(b) all restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
(c) the deposit will be maintained in a public depository for a period of 30 years, or 5 years after the last request or for the enforceable life of the patent, whichever is longer;
(d) a test of the viability of the biological material at the time of deposit (see 37 CFR 1.807); and
(e) the deposit will be replaced if it should ever become inviable.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 41 and 45 are rejected under pre-AIA 35 U.S.C. 102b as being anticipated by Szijarto et al. (FEMS Microbiol. Lett., 332:131-136, 2012; IDS filed 4/2/2025).
The instant claims are drawn to compositions comprising an O25b antigen in combination with a carrier.
Szijarto et al. disclose a composition comprising E. coli ST131 and glycerol (see page 132, column 1, paragraph 1). According to the instant specification, the ST131 strain produces the O25b antigen. Glycerol is a known pharmaceutical carrier. Therefore, a composition with E. coli ST131 and glycerol is an immunogenic composition comprising O25b antigen in combination with a pharmaceutically acceptable carrier. It would elicit an immune response if administered to a subject.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claim 1 is rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 1 of prior U.S. Patent No. 10940191. This is a statutory double patenting rejection.
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 41, 44-46, and 48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 10,206,992. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
The instant claims are drawn to an immunogen comprising O25b antigen and an immunogen comprising an epitope bound by antibodies that bind to O25B antigen, and to compositions comprising said antigen and methods of eliciting an immune response against said antigen.
The patented claims are drawn to vaccine compositions comprising the same O25b antigen and an adjuvant. A vaccine is meant to be administered, so one would clearly desire to administer the composition in order to elicit an immune response.
Claims 41-48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 10,206,992 in view of Finn et al (British Med. Bull., 70:1-14, 2004).
The instant claims are drawn to an immunogen comprising O25b antigen and an immunogen comprising an epitope bound by antibodies that bind to O25B antigen, and to compositions comprising said antigen and methods of eliciting an immune response against said antigen.
The patented claims are drawn to vaccine compositions comprising the same O25b antigen and an adjuvant. A vaccine is meant to be administered, so one would clearly desire to administer the composition in order to elicit an immune response.
The patented claims differ from the instant claims in that they do not disclose a second antigen that is not natively associated with the O25b antigen.
Finn et al disclose the use of polysaccharide antigen-carrier protein conjugate vaccines (see abstract). The authors state that polysaccharide antigens are poorly immunogenic as a vaccine, particularly in children and that covalent conjugation of polysaccharides to protein carriers renders them capable of inducing humoral immune responses with responses with memory, affinity maturation, and immunogenicity in children (see pages 2-3). The most commonly used protein carriers are CRM197 and tetanus toxoid (see Table 1). Conjugation of the O25b antigen to CRM197 or tetanus toxoid would make the composition a multivalent vaccine.
It would have been obvious, at the time of invention, to conjugate the polysaccharide antigen recited in the patented claims to a carrier protein such as CRM197 or tetanus toxoid because it would make the polysaccharide capable of inducing a humoral immune response. One would have had a reasonable expectation of success because polysaccharide conjugate vaccines have been created for multiple types of polysaccharides.
Claims 41, 44-46, and 48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 11,529,405. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
The instant claims are drawn to an immunogen comprising O25b antigen and an immunogen comprising an epitope bound by antibodies that bind to O25B antigen, and to compositions comprising said antigen and methods of eliciting an immune response against said antigen.
The patented claims are drawn to vaccine compositions comprising the same O25b antigen and an adjuvant. A vaccine is meant to be administered, so one would clearly desire to administer the composition in order to elicit an immune response.
Claims 41-48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 11,529,405 in view of Finn et al (British Med. Bull., 70:1-14, 2004).
The instant claims are drawn to an immunogen comprising O25b antigen and an immunogen comprising an epitope bound by antibodies that bind to O25B antigen, and to compositions comprising said antigen and methods of eliciting an immune response against said antigen.
The patented claims are drawn to vaccine compositions comprising the same O25b antigen and an adjuvant. A vaccine is meant to be administered, so one would clearly desire to administer the composition in order to elicit an immune response.
The patented claims differ from the instant claims in that they do not disclose a second antigen that is not natively associated with the O25b antigen.
Finn et al disclose the use of polysaccharide antigen-carrier protein conjugate vaccines (see abstract). The authors state that polysaccharide antigens are poorly immunogenic as a vaccine, particularly in children and that covalent conjugation of polysaccharides to protein carriers renders them capable of inducing humoral immune responses with responses with memory, affinity maturation, and immunogenicity in children (see pages 2-3). The most commonly used protein carriers are CRM197 and tetanus toxoid (see Table 1). Conjugation of the O25b antigen to CRM197 or tetanus toxoid would make the composition a multivalent vaccine.
It would have been obvious, at the time of invention, to conjugate the polysaccharide antigen recited in the patented claims to a carrier protein such as CRM197 or tetanus toxoid because it would make the polysaccharide capable of inducing a humoral immune response. One would have had a reasonable expectation of success because polysaccharide conjugate vaccines have been created for multiple types of polysaccharides.
Claims 41, 44-46, and 48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 12,274,742. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
The instant claims are drawn to an immunogen comprising O25b antigen and an immunogen comprising an epitope bound by antibodies that bind to O25B antigen, and to compositions comprising said antigen and methods of eliciting an immune response against said antigen.
The patented claims are drawn to vaccine compositions comprising the same O25b antigen and an adjuvant. A vaccine is meant to be administered, so one would clearly desire to administer the composition in order to elicit an immune response.
Claims 41-48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 12,274,742 in view of Finn et al (British Med. Bull., 70:1-14, 2004).
The instant claims are drawn to an immunogen comprising O25b antigen and an immunogen comprising an epitope bound by antibodies that bind to O25B antigen, and to compositions comprising said antigen and methods of eliciting an immune response against said antigen.
The patented claims are drawn to vaccine compositions comprising the same O25b antigen and an adjuvant. A vaccine is meant to be administered, so one would clearly desire to administer the composition in order to elicit an immune response.
The patented claims differ from the instant claims in that they do not disclose a second antigen that is not natively associated with the O25b antigen.
Finn et al disclose the use of polysaccharide antigen-carrier protein conjugate vaccines (see abstract). The authors state that polysaccharide antigens are poorly immunogenic as a vaccine, particularly in children and that covalent conjugation of polysaccharides to protein carriers renders them capable of inducing humoral immune responses with responses with memory, affinity maturation, and immunogenicity in children (see pages 2-3). The most commonly used protein carriers are CRM197 and tetanus toxoid (see Table 1). Conjugation of the O25b antigen to CRM197 or tetanus toxoid would make the composition a multivalent vaccine.
It would have been obvious, at the time of invention, to conjugate the polysaccharide antigen recited in the patented claims to a carrier protein such as CRM197 or tetanus toxoid because it would make the polysaccharide capable of inducing a humoral immune response. One would have had a reasonable expectation of success because polysaccharide conjugate vaccines have been created for multiple types of polysaccharides.
Conclusion
No claim is allowed.
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/BRIAN GANGLE/Primary Examiner, Art Unit 1645
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