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 .
Information Disclosure Statement
The information disclosure statements (IDS) filed 11/30/2023, 01/08/2026, and 01/26/2026 have been considered and the references therein are of record.
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.
Claims 3, 5-7, 10-11, and 13 are 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.
Claims 3, 5-7, 10-11, and 13 are indefinite in the recitation of the phrase “preferably” because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP
§2173.05(d).
Claims 6-7 are rejected for recitation of intended result/effect without conferring some structural or material difference on the scope of the claim. The claims recite the functional language of a modulator, agonist, antagonist, and activator without specifying any specific structures required to perform the requisite functions. The claims are indefinite because it is unclear as to what structures are necessary to provide the claimed modulatory, agonistic, antagonistic, and activating activity. The mechanism steps and requisite structure are merely implied by the functional language and thus the scope of the claim is undefined. Absent additional active method steps and structure, it is unclear how these claims further limit the scope of the parent claim. MPEP 2173.05(g) states: “the use of functional language in a claim may fail ‘to provide a clear-cut indication of the scope of the subject matter embraced by the claim' and thus be indefinite.” It further states: “Examiners should consider the following factors when examining claims that contain functional language to determine whether the language is ambiguous: (1) whether there is a clear cut indication of the scope of the subject matter covered by the claim; (2) whether the language sets forth well-defined boundaries of the invention or only states a problem solved or a result obtained; and (3) whether one of ordinary skill in the art would know from the claim terms what structure or steps are encompassed by the claim.” The claims are rejected since they fail to meet all (3) criteria set forth in MPEP 2173.05(g).
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 1-15 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 claims contain 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.
In making a determination of whether the application complies with the written description requirement of 35 U.S.C. 112, first paragraph, it is necessary to understand what Applicant has possession of and what Applicant is claiming. The claims 1-2, 4-5, and 8-15 recite adenoviral vectors encoding one or more adjuvants, an antigen, combination of antigens, nucleic acids encoding antigens, vectors encoding antigens, adenoviral vectors encoding antigens, modulators of an immune checkpoint molecule, agonists of OX40, agonist of ICOS, agonist of CD40, ER sorting signal, and a vaccine composition comprising an adenoviral vector encoding an adjuvant and an antigen that is capable of treatment or prophylaxis of a disease, each of which encompasses a genus of agents. These claims do not require that the genera of the claims possess any particular structure or other distinguishing feature that is characteristic of the genera as a whole. Therefore the claims are drawn to genera for which there is inadequate written description.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see MPEP 2163(II)(3)(a)(i)(A), reduction to drawings MPEP 2163(II)(3)(a)(i)(B), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus MPEP 2163(II)(3)(a)(i)(C).
The specification provides evidence that the applicant is in possession of human Ad5 and Ad6 encoding anti-CLTA-4 that can be with or without a transmembrane and ER sorting signal, gorilla Ad20 encoding anti-CTLA-4, chimpanzee Ad68 encoding anti-CTLA-4, human Ad6 encoding OX40L, human Ad6 encoding ICOSL, and gorilla Ad encoding adenocarcinoma neoantigens, colon carcinoma neoantigens, and hHer2 that can stimulate an immune response. The specification also provides evidence for a composition comprising a gorilla Ad encoding colon carcinoma neoantigens and a human Ad6 encoding anti-CTLA-4 that can treat a colon carcinoma mouse model. The specification does not provide evidence of possession of a representative number of species for the vast claimed genera, such as any adenoviral vector encoding any antigen, any human adenoviral vector, any modulator of an immune checkpoint molecule, any agonist of the stated proteins, any transmembrane, and any ER sorting signal sequence. Further, the specification provides no evidence of possession of a composition that can treat and prevent any disease. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics of the genus as a whole, or representative number of species within the genus, the specification does not provide adequate written description of the claimed genus.
Claims 1-15 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 the making of a composition described in the Examples and used to treat colon carcinoma, does not reasonably provide enablement for the immensely vast genera of adenoviral vectors encoding one or more adjuvants, an antigen, combination of antigens, nucleic acids encoding antigens, vectors encoding antigens, adenoviral vectors encoding antigens, modulators of an immune checkpoint molecule, agonists of OX40, agonist of ICOS, agonist of CD40, transmembrane domain, ER sorting signal, and a vaccine composition comprising an adenoviral vector encoding an adjuvant and an antigen that is capable of treatment or prophylaxis of a disease. 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 use the invention commensurate in scope with these claims.
In AMGEN INC. ET AL. v. SANOFI ET AL. (No. 21-757, decided May 18, 2023), the Supreme Court held that Amgen was not enabled for “the entire genus” of antibodies that (1) “bind to specific amino acid residues on PCSK9,” and (2) “block PCSK9 from binding to [LDL receptors]” (872 F. 3d 1367, 1372) even though Amgen identified the amino acid sequences of 26 antibodies that perform these two functions.
The case law applies to the instant claims which require multiple genera of vectors capable of encoding bioactive agents and compositions with the functional capability of treating and preventing any disease. Said another way, a person having ordinary skill in the art would not know how to make any and all agents that possess the claimed capabilities and then use them in the claimed composition to treat and prevent any and all diseases.
In Amgen, the Supreme Court has stated:
“An antibody' s structure does much to dictate its function—its ability to bind to an antigen and, in some instances, to block other molecules in the body from doing the same. ‘For an antibody to bind to an antigen, the two surfaces have to fit together and contact each other at multiple points.' Id., at 11. But just because an antibody can bind to an antigen does not mean that it can also block. To bind and block, the antibody must establish a sufficiently broad, strong, and stable bond to the antigen. See ibid. Different antibodies have different binding and blocking capacities based on the amino acids that compose them and their three-dimensional shapes. See id., at 11–12.
Despite recent advances, aspects of antibody science remain unpredictable. For example, scientists understand that changing even one amino acid in the sequence can alter an antibody' s structure and function. See id., at 14. But scientists cannot always accurately predict exactly how trading one amino acid for another will affect an antibody' s structure and function. Ibid.”
A patent is granted for a completed invention, not the general suggestion of an idea and how that idea might be developed into the claimed invention. In the decision of Genentec, Inc., V. Novo Nordisk, 42 USPQ 2d 100, (CAFC 1997), the court held that: "[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable" and that "[t]ossing out the mere germ of an idea does not constitute enabling disclosure". The court further stated that "when there is no disclosure of any specific starting material or of any of the conditions under which a process is to be carried out, undue experimentation is required; there is a failure to meet the enablement requirements that cannot be rectified by asserting that all of the disclosure related to the process is within the skill of the art","[i]t is the specification, not the knowledge of one skilled in the art, that must supply the novel aspects of an invention in order to constitute adequate enablement". The instant specification is not enabling for the full scope of the claimed invention because one cannot follow the guidance presented therein and practice the claimed method without first making a substantial inventive contribution.
Given that structure is essential to function; and given the unpredictability within the art with respect to creating antibodies, agonists, binding agents, and disease treatments, a person having ordinary skill in the art would have to perform further experimentation in order to make the vast array of species within the genera of adenoviral vectors encoding one or more adjuvants, an antigen, combination of antigens, nucleic acids encoding antigens, vectors encoding antigens, adenoviral vectors encoding antigens, modulators of an immune checkpoint molecule, agonists of OX40, agonist of ICOS, agonist of CD40, ER sorting signal, and a vaccine composition comprising an adenoviral vector encoding an adjuvant and an antigen that is capable of treatment or prophylaxis of a disease encompassed by the claims and use them in the method claimed, commensurate in scope with the breadth of the claims. Given the nature of the invention, a skilled artisan would have to make many vectors, then use those in the method claimed of treating and preventing any and all diseases in order to demonstrate making and using with a reasonable expectation of success. This amount of experimentation goes beyond what is considered “a reasonable degree of experimentation” and constitutes undue further experimentation in order to enable the method for the breadth of what is claimed. Thus, claims 1-15 lack enablement.
Claim Rejections - 35 USC § 102
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.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 6-7, and 10-11 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Tang et al., 2019 (US20190381157A1) (see instant PTO-892).
The instant claims are drawn to a vaccine composition comprising a first set of adenoviral vectors that encode one or more adjuvants, and an antigen/combination of antigens/nucleic acid encoding the antigens. The instant claims are drawn to the adjuvant being one or more of an immune checkpoint molecule, cytokine, cytokine receptor activator of interferon genes, adenosine deaminase (ADA), proliferator-activated receptor gamma coactivator 1- alpha, or polynucleotide adjuvant. The instant claims are drawn to an agonist of OX40, an agonist of ICOS, an agonist of CD40, and an antagonistic CTLA-4 specific antibody or antibody like protein. The instant claims are drawn to the one or more antigens being cancer antigens, tumor associated antigens, or cancer neo-antigens. The instant claims are further drawn to a method of administering the vaccine for treatment or prophylaxis of a disease. The instant claims are also drawn to the vaccine or vaccine kit administered within a time interval of 30min or less by intramuscular, subcutaneous, intradermal, intra-peritoneal or intra-pleural injection. The instant claims are further drawn to a vaccination regimen comprising a first step of administering adenoviral vectors that encode for one or more adjuvants followed by a second step of administering vectors that encode for one or more antigens.
Tang teaches a vaccine composition that can comprise one or more sets of nucleic acid vectors including adenoviral vectors, that can encode for one or more immune checkpoint inhibitor adjuvants including an antagonistic CTLA-4 antibody, that can encode for one or more cancer neo-antigens, that can be administered together or sequentially, intramuscularly, and across multiple time intervals to raise an immune response in a patient to treat cancer (abstract, claims, para[0005-0018, 0023, 0056, 0061, 0075-0076, 0080, 0083-0087, 0091, 0113-0115, 0125-0126, 0131, 0148, & 0160]).
Therefore, Tang anticipates instant claims 1, 6-7, and 10-11.
Claim Rejections - 35 USC § 103
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.
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.
Claims 2-5, 8-9, and 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Tang et al., 2019 (US20190381157A1) as applied to claims 1, 6-7, and 10-11 above in view of Colloca et al., 2011 (US20110217332A1) and Hu et al., 2020 (CN110856751A) (see instant PTO-892).
The instant claims are drawn to a vaccine composition comprising a first set of human adenoviral vectors that encode one or more adjuvants, a first set of non-human Great Ape-derived adenoviral vectors that encode one or more adjuvants, and an antigen/combination of antigens/nucleic acid encoding the antigens. The instant claims are drawn to the human adenoviral vector being hAd6, hAd5, or hAd57. The instant claims are also drawn to a vaccine or vaccine kit for inducing an immune response against an antigen or combination of antigens by administering a first and second set of vectors within 20cm and 30 minutes of each other in a location that drains to a lymph node The instant claims are drawn to the one or more adjuvants comprising a transmembrane domain and an ER sorting signal.
The teachings of Tang are recited above. Tang further teaches that the vaccine composition can be administered sequentially and to a sentinel draining lymph node (para[0083 &0160]).
Tang does not explicitly teach human and non-human primate adenoviral vectors. Tang does not explicitly teach a transmembrane and ER sorting signal. Colloca and Hu remedy these deficiencies. Tang does not explicitly teach that the vaccine compositions should be administered sequentially within 20cm of each other and within 30 minutes.
Colloca teaches a vaccine composition for treating cancer that can comprise the human adenoviral vectors hAd5 and/or a chimpanzee-derived adenoviral vectors that encode for tumor-associated antigens and further comprise adjuvants (title, abstract, claims, & para[0002-0005 & 0162]).
Hu teaches a nucleic acid vaccine composition for treating cancer that includes a tumor-associated antigen (TAA) and a transmembrane ER sorting signal, which enables the TAA encoded by the nucleic acid to be properly introduced into the ER so that the antigen can enter the MHC class I antigen presentation pathway (claims, Background Technique, & Detailed Ways). Although Hu used the term “transmembrane ER retention signal,” instead of “transmembrane ER sorting signal,” the structure and function are the same.
It would have been prima facie obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to arrive at the claimed invention from the disclosures of Tang, Colloca, and Hu. First, it would be obvious to an ordinary artisan that the sequentially administered vaccine compositions can be administered to a location within 20cm of each other for them to target the same lymph node and within 30 minutes of each other from the teachings of Tang. Although Tang does not explicitly state that the two vaccines can be injected within 20 cm of each other and within 30 minutes, an ordinary artisan would readily understand and find it obvious from Tang’s teaching that “sequentially” and to a sentinel draining lymph node would imply that the vaccines can be administered to a location within 20 cm of each other and within 30 minutes. Furthermore, an ordinary artisan would be motivated from Tang’s teaching to try administering multiple doses of the compositions to a location within 20 cm of each other and within a 30-minute time frame to the same lymph node in the pursuit of optimize the administration regimen to make the most effective vaccine. In regard to the teaching of Colloca, since Tang is silent on which specific adenoviral vectors to use in the composition, an ordinary artisan would be motivated to search for specific adenoviral vectors that would be useful and suitable to make and use the composition. An ordinary artisan would readily recognize and find it obvious from the teachings of Colloca that human Ad5 and a chimpanzee-derived adenoviral vector would be suitable options from which to pick and choose in the pursuit of testing various components to make the optimal vaccine composition. Moreover, an ordinary artisan would be motivated to try various available adenoviral vectors in the pursuit of making the most effective composition. Therefore, an ordinary artisan would find it obvious to combine the teachings of Tang and Colloca. Further, an ordinary artisan would be motivated from the teachings of Hu to incorporate a transmembrane ER sorting signal into the nucleic acid of the composition because Hu teaches that this signal enables the nucleic acid to be properly introduced into the ER so that the antigen can enter the MHC class I antigen presentation pathway. An ordinary artisan would readily understand and find it obvious that incorporating the transmembrane ER sorting signal into the composition would improve the immune response against the antigen. Therefore, an ordinary artisan would be motivated to combine the teachings of Hu with the teachings of Tang and Colloca to make and use the claimed invention. The person of ordinary skill in the art would have had a reasonable expectation of success based on the disclosures of these prior art references. Therefore, claims 2-5, 8-9, and 12-15 are obvious.
Conclusion
No claims are allowed.
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/JOSEPH D. CESARE/
Examiner, Art Unit 1675
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675
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