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 .
DETAILED ACTION
1. Applicant’s election without traverse of Group I and species (deletion; SEQ ID NO: 1; virus; Wuhan-1 strain SARS-CoV-2 spike protein with both S-2P and S-CSM mutations) in the reply filed on 7/20/2026 is acknowledged.
Claims 14, 18, 19, 28, 31, 39 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/20/2026.
Claims 1-13 are under consideration.
Information Disclosure Statement
2. The information disclosure statement (IDS) was submitted on 1/8/2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Nucleotide and/or Amino Acid Sequence Disclosures
3. Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter “Legal Framework”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation by reference statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
Specific deficiency - Sequences appearing in the specification on pages 2, 34, 39 are not identified by sequence identifiers (i.e., “SEQ ID NO:X” or the like) in accordance with 37 CFR 1.831(c).
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required sequence identifiers, consisting of:
• A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
• A copy of the amended specification without markings (clean version); and
• A statement that the substitute specification contains no new matter.
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.
4. Claims 1-13 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.
See claims 1-13 as submitted 1/8/2024.
As to claim 1, the claim recites “a deletion (elected species) or addition of a heterologous sequence.” It is not clear if “a heterologous sequence” applies to deletion or merely addition (non-elected species). It is not clear if the claim intends to also recite “a deletion … of a heterologous sequence” or not. For improved clarity, the claim should recite language such as “comprises an addition of a heterologous sequence or a deletion for improved…”. Further the claim recites “improved cell-surface expression”. The term “improved” is a relative term which renders the claim indefinite. The term “improved” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Claims 2-13 depends on this claim.
Further as to claim 3, it is not clear if the domain has an ER export signal both before and after the modification (deletion) recited in claim 1 or not.
Further as to claim 4, it is not clear if the lack of HDEL (elected species) is an additional deletion to that as recited in claim 1 or if claim 4 is intended to read on the deletion in claim 1 or not.
Further as to claim 5, it is not clear if the comprised sequence is at the carboxy-terminus both before and after the modification (deletion) recited in claim 1 or not.
Further as to claim 6, it is not clear if the comprised sequence is at the carboxy-terminus both before and after the modification (deletion) recited in claim 1 or not.
Further as to claims 11, 12, it is not clear if the removed sequence of the cytoplasmic domain of the SARS-CoV-2 spike is both before and after the modification (deletion) as recited in claim 1 or not, or if the recitation in claims 11, 12 is intended to read on the deletion in claim 1 or not.
Further as to claim 13, the claim recites “the SARS-CoV-2 spike protein”. There is no antecedent basis for this term in the claim or claim 1.
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.
5. Claims 1-13 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.
See claims 1-13 as submitted 1/8/2024.
See also the 35 U.S.C. 112(b) rejection above.
Each of the claims is drawn, inherently or explicitly, to any cytoplasmic domain deletion (elected species) for improved cell-surface expression of the protein relative to the protein prior to the deletion (elected species). Thus, the claims are drawn to compositions comprising a genus of polypeptides comprising cytoplasmic domain deletions, and having the ability to show improved cell-surface expression of the protein relative to the protein prior to the deletion.
The following quotation from section 2163 of the Manual of Patent Examination
Procedure is a brief discussion of what is required in a specification to satisfy the 35 U.S.C. 112 written description requirement for a generic claim covering several distinct inventions:
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..., reduction to drawings..., 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... See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. 'A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
Thus, when a claim covers a genus of inventions, the specification must provide written description support for the entire scope of the genus. Support for a genus is generally found where the applicant has provided a number of examples sufficient so that one in the art would recognize from the specification the scope of what is being claimed.
In the present case, the application teaches: generally, deletion or addition of a heterologous sequence for improved cell-surface expression of the protein relative to the protein prior to the deletion or addition of the sequence [0009]; wherein combining 2P, tail deletion and ER export signal maximizes surface expression of SD614G (coronavirus)[0026, 0123].
However, the application does not teach a representative number of species of such cytoplasmic domain deletions. Further, there is no apparent common structure to the different truncated cytoplasmic domains that distinguishes those deletions that lead to improved cell-surface expression of the protein relative to the protein prior to the deletion. There is therefore a high level of uncertainty as to which cytoplasmic domain deletions fall within the scope of the indicated genus.
With respect to the art, amino acid deletions can have variant effects. For example, Bultmann et al. (cited below) teaches for HIV proteins, wherein it is difficult to identify negative sequence elements regulating steady-state surface expression of Env at the post-ER level (abstract); they “generated a synthetic gp160 gene with synonymous codons, the transcripts of which are not retained within the nucleus. In accordance with the results in heterologous systems, an internal deletion of both elements considerably increased surface expression of gp160.” Constructs with carboxy-terminal deletions were localized in the Golgi compartment, but shorter deletion mutants showed significant surface expression (p. 5270)
Further, it is well known in the art that even minor changes in amino acid sequences can alter function. For example, Rudikoff et al. ("Single amino acid substitution altering antigen-binding specificity," Proc Natl Acad Sci USA 79:1979-1983 (1982)(See PTO-892: Notice of References Cited) teaches: that the alteration of a single amino acid in the CDR of a phosphocholine-binding myeloma protein resulted in the loss of antigen-binding function (p. 1979). Further, Lucchese et al. (“How a single amino acid change may alter the immunological information of a peptide,” Frontiers in Bioscience E4: 1843-1852 (2012))(See PTO-892: Notice of References Cited) teaches: a single amino acid change may alter the immunological information of a peptide (title).
In view of the fact that the examples provided do not demonstrate possession of such cytoplasmic domain deletion, and that the application has identified no structure correlating with such deletions of cytoplasmic domains, there is insufficient written description support for the indicated genus of such cytoplasmic domain deletion, and therefore for the methods of using them.
In the present case, applicant has identified such cytoplasmic domain deletions and modified cytoplasmic domains as claimed useful in the claimed methods only by function: the ability to improved cell-surface expression of the protein relative to the protein prior to the deletion.
However, while the application identifies coronavirus embodiment SD614G, it does not identify a representative sample of such cytoplasmic domain deletions as claimed. Thus, the application does not identify species clearly within the claimed genus.
Nor does the application provide a specific structure of the modified cytoplasmic domains as claimed within the genus that correlates with the required function. Because there is no identification of structures common to each such modified cytoplasmic domain as claimed, nor sufficient representative examples of the modified cytoplasmic domains as claimed by which such a structure may be determined, the application also fails to provide sufficient written description support for the identified genus of modified cytoplasmic domains as claimed through identification of a structure and function. While all of the cytoplasmic domain deletions are required to improve cell-surface expression of the protein relative to the protein prior to the deletion, this is not alone sufficient structure to correlate with the function. This is because the mere presence of a cytoplasmic domain deletion as claimed does not demonstrate that such a modified cytoplasmic domain would be able to improve cell-surface expression of the protein relative to the protein prior to the deletion.
For the reasons above, and in view of the uncertainty as to which cytoplasmic domain deletions would be able to improve cell-surface expression of the protein relative to the protein prior to the deletion, the application has not provided sufficient written description support for the use of the genus of modified cytoplasmic domains identified in claim 1.
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.
6. Claims 1-4, 7 are rejected under 35 U.S.C. 103 as being unpatentable over Bultmann et al. ("Identification of Two Sequences in the Cytoplasmic Tail of the
Human Immunodeficiency Virus Type 1 Envelope Glycoprotein That Inhibit Cell Surface
Expression," J Virol 75(11):5263-5276 (2001); cited in applicant's IDS submitted 1/8/2024).
See claims 1-4, 7 as submitted 1/8/2024.
See also the 35 U.S.C. 112(b) rejection above.
Bultmann et al. teaches: heterologous systems with immunoglobulin
extracellular/transmembrane domains in combination with gp160 (HIV) cytoplasmic domains
(abstract)(as recited in claims 1, 2, 7); wherein carboxy-terminal end of gp41 cytoplasmic domain influences incorporation of glycoproteins into virions (p. 5274); wherein constructs with carboxy-terminal deletions were localized in the Golgi compartment, but shorter deletion mutants showed significant surface expression (p. 5270)(as recited in claim 1). As Bultmann et al. still teaches wherein gp160 is retained in ER, but wherein surface expression of gp160 was increased with internal deletions (abstract), the construct is still considered to have ER export signal (as recited in claim 3). Bultmann et al. does not teach HDEL (SEQ ID NO: 1)(as recited in claim 4).
In view of the foregoing, all the claimed limitations are found in one reference and are taught to be optional variations to a ‘base’ protein they exemplify. As such, the claimed protein is within the scope of Bultmann et al., and thus Bultmann et al. renders the protein prima facie obvious. The rationale to support this conclusion of obviousness is that Bultmann et al. provides a teaching, suggestion, and motivation to substitute different variables disclosed within the reference. Furthermore, there is no evidence on the record that indicates that the claimed supplement exhibits any unexpected results compared to the prior art.
7. Claims 1-4, 7, 8 are rejected under 35 U.S.C. 103 as being unpatentable over Mamoun et al. (FR2950350A1)(See PTO-892: Notice of References Cited)(See also the WIPO English translation of FR2950350A1)(See PTO-892: Notice of References Cited).
See claims 1-4, 7, 8 as submitted 1/8/2024.
See also the 35 U.S.C. 112(b) rejection above.
Mamoun et al. teaches: polynucleotides and chimeric polypeptides; enabling secretion of a polypeptide of interest in association with exosomes, and their use for the production of immunogenic compositions (p. 1); chimeric polypeptides comprising several polypeptide domains (p. 1 of English translation); including peptide or polypeptide of interest; cytoplasmic domain of membrane protein (p. 10); including mutated derivative of CD domain, with deletions (p. 11)(as recited in claim 1); including mutated CD and two other domains (p. 12); wherein polypeptide of interest can be soluble, membrane, transmembrane and/or multimeric protein (pp. 31-32); wherein peptide or polypeptide of interest is derived from virus (p. 33); including wherein embodiments include peptide or polypeptide of interest, transmembrane domain, CD domain or its mutated derivative (p. 37)(as recited in claim 1); wherein peptide or polypeptide of interest can be extracellular or surface protein (p. 43)(as recited in claim 1); including receptor or viral protein (p. 44)(as recited in claims 2, 7); may comprise signal peptide for import into ER (p. 48)(as recited in claim 3); does not teach HDEL (SEQ ID NO: 1)(as recited in claim 4); coronavirus (p. 46)(as recited in claim 8).
As to “for improved cell-surface expression of the protein relative to the protein prior to the deletion or addition of the sequence”, see 35 U.S.C. 112(b) rejection above. As Mamoun et al. teaches: enabling secretion of a polypeptide of interest in association with exosomes, and their use for the production of immunogenic compositions (p. 1), such language is interpreted as a statement of intended use in view of the teachings or suggestions of Mamoun et al. (See MPEP 2111.02: During examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether or not the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim. See, e.g., In re Otto, 312 F.2d 937, 938, 136 USPQ 458, 459 (CCPA 1963) (The claims were directed to a core member for hair curlers and a process of making a core member for hair curlers. The court held that the intended use of hair curling was of no significance to the structure and process of making.); In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962) (statement of intended use in an apparatus claim did not distinguish over the prior art apparatus). To satisfy an intended use limitation which is limiting, a prior art structure which is capable of performing the intended use as recited in the preamble meets the claim. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997)).
In view of such teachings or suggestions, the protein as recited in claim 1 is considered an obvious embodiment in view of Mamoun et al. In view of the foregoing, all the claimed limitations are found in one reference and are taught to be optional variations to a ‘base’ protein they exemplify. As such, the claimed embodiment is within the scope of Mamoun et al., and thus Mamoun et al. renders the composition prima facie obvious. The rationale to support this conclusion of obviousness is that Mamoun et al. provides a teaching, suggestion, and motivation to substitute different variables disclosed within the reference. Furthermore, there is no evidence on the record that indicates that the claimed supplement exhibits any unexpected results compared to the prior art.
8. Claims 5, 6 are rejected under 35 U.S.C. 103 as being unpatentable over Mamoun et al. as applied to claims 1-4, 7, 8 above, and further in view of Parks et al. (WO2021168318)(See PTO-892: Notice of References Cited).
See claims 5, 6 as submitted 1/8/2024.
See also the 35 U.S.C. 112(b) rejection above.
See the teachings of Mamoun et al. above. It is noted Mamoun et al. teaches: use of Rhabdoviridae (p. 46).
Mamoun et al. does not teach: comprising the sequence KLKHTKKRQIYTDIEMNRLGK (SEQ ID NO:3) at the carboxy-terminus of the
protein; comprising the sequence Tyr19-Thr20-Asp21-Ile22-Glu23-Met24 (SEQ ID NO:4) of vesicular stomatitis virus glycoprotein (VSV G) tail at the carboxy-terminus of the protein.
Parks et al. teaches: use of VSV vector (of Rhabdoviridae)(p. 77); SEQ ID NO: 185, which has 100% identity with instant SEQ ID NO: 3 (See Result 1 of STIC Sequence Search Result 20260816_112242_us-18-577-642-3.rag in Supplemental Content Tab)(as recited in claim 5). It is noted that SEQ ID NO: 4 is contained within SEQ ID NO: 3 (as recited in claim 6).
One of ordinary skill in the art would have been motivated to use viral protein as taught by Parks et al. with the protein as taught by Mamoun et al. Mamoun et al. teaches use of Rhabdoviridae and viral protein, and Parks et al., which also teaches use of Rhabdoviridae and viral protein. teaches such a protein (See MPEP 2144.06: Substituting equivalents known for the same purpose).
One of ordinary skill in the art would have had a reasonable expectation of success for using protein as taught by Parks et al. with the protein as taught by Mamoun et al. There would have been a reasonable expectation of success given the underlying materials (viral proteins as taught by Mamoun et al. and Parks et al.) and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
9. Claims 9, 10 are rejected under 35 U.S.C. 103 as being unpatentable over Mamoun et al. as applied to claims 1-4, 7, 8 above, and further in view of Wu et al. (“A new coronavirus associated with human respiratory disease in China,” Nature, Vol. 579: 265-269 (2020))(See
PTO-892: Notice of References Cited).
See claims 9, 10 as submitted 1/8/2024.
See also the 35 U.S.C. 112(b) rejection above.
See the teachings of Mamoun et al. above. It is noted Mamoun et al. teaches coronavirus (p. 46) and spike protein (p. 47)(as recited in claim 10).
Mamoun et al. does not teach SARS-CoV-2.
Wu et al. teaches: SARS-CoV-2 (abstract).
One of ordinary skill in the art would have been motivated to use coronavirus as taught by Wu et al. as coronavirus as taught by Mamoun et al. Mamoun et al. teaches coronavirus, and Wu et al. teaches such a coronavirus (See MPEP 2144.06: Substituting equivalents known for the same purpose).
One of ordinary skill in the art would have had a reasonable expectation of success for using coronavirus as taught by Wu et al. with the protein as taught by Mamoun et al. There would have been a reasonable expectation of success given the underlying materials (coronavirus as taught by Mamoun et al. and Wu et al.) and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
10. Claims 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Mamoun et al. in view of Wu et al. as applied to claims 9, 10 above, and further in view of Diamond et al. (WO2021236550A1)(See PTO-892: Notice of References Cited).
See claims 11-13 as submitted 1/8/2024.
See also the 35 U.S.C. 112(b) rejection above.
See the teachings of Mamoun et al. in view of Wu et al. above.
Mamoun et al. in view of Wu et al. does not teach: wherein all or part of the sequence of the cytoplasmic domain of the SARS-CoV-2 spike protein is removed; wherein the sequence
KFDEDDSEPVLKGVKLHYTCOOH (SEQ ID NO:5) in the cytoplasmic domain of the spike protein is removed; the Wuhan-1 strain SARS-CoV-2 spike protein with
both S-2P and S-CSM mutations.
Diamond et al. teaches: coronavirus vaccines (title); mutated spike protein (p. 3); wherein 682-685 RRAR are mutated to GSAS (p. 3)(as recited in claim 13); 2P mutations (p. 3)(as recited in claim 13); wherein 19 amino acid residues at C-terminus of S protein are deleted (claim 11 of Diamond et al.); BKH90824 or SEQ ID NO: 65 (See BKH90824, duplicate of Result 1 of STIC Sequence Search Result 20260914_154547_us-18-577-642-5.rag in Supplemental Content Tab) teaching spike protein with deletions.
One of ordinary skill in the art would have been motivated to use protein as taught by Diamond et al. with the protein as taught by Mamoun et al. in view of Wu et al. Mamoun et al. in view of Wu et al. teaches use of mutations and mutated coronavirus spike protein, and Diamond et al. teaches such mutations and mutated coronavirus spike protein (See MPEP 2144.06: Substituting equivalents known for the same purpose).
One of ordinary skill in the art would have had a reasonable expectation of success for using protein as taught by Diamond et al. with the protein as taught by Mamoun et al. in view of Wu et al. There would have been a reasonable expectation of success given the underlying materials (spike proteins as taught by Diamond et al. and Mamoun et al. in view of Wu et al.) and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Conclusion
11. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to M FRANCO G SALVOZA whose telephone number is (571)272-4468. The examiner can normally be reached M-F 8:00 to 5:00.
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/M FRANCO G SALVOZA/Primary Examiner, Art Unit 1672
