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 .
Claim Status
Claims 1, 6-9, 12, 14-16, 19 and 24-28 are pending.
Claims 15-16 and 24-28 are withdrawn.
Claims 1, 6-9, 12, 14 and 19 are under examination.
Withdrawn Claim Objections
The objection to claim 7 due to informalities as set forth in the previous office action is withdrawn in view of Applicant’s amendments.
New Claim Objections
Claim 19 is objected to because of the following informalities:
Claim 19 recites “the composition of claim 12” while claim 12 recites “a pharmaceutical composition.” While it is clear that “the composition of claim 12” refers back to the pharmaceutical composition, it is recommended Applicant amend claim 19 to recite “the pharmaceutical composition of claim 12” to improve the clarity.
Appropriate correction is required.
Withdrawn Claim Rejections - 35 USC § 112(a)
Written Description
The rejection of claims 1, 6, 9-12, 14, and 19 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paragraph, as failing to comply with the written description requirement as set forth in the previous office action is withdrawn in view of Applicant’s amendments.
The rejection of claims 2 and 4-5 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 as set forth in the previous office action is rendered moot by the cancellation of these claims.
Claim Rejections - 35 USC § 112(a)
Written Description
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 7-8 remain 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.
The purpose of the written description requirement is to ‘ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor’s contribution to the field of art as described in the patent specification.” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1353-54 (Fed. Cir. 2010) (en banc) (quoting Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920 (Fed. Cir. 2004)). To satisfy the written description requirement, the specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562-63, 19 USPQ2d 1111 (Fed. Cir. 1991). See also MPEP 2163.04.
For a claim to a genus, a generic statement that defines a genus of substances by only their functional activity does not provide an adequate written description of the genus. Reagents of the University of California v. Eli Lilly, 43 USPQ2d 1398 (CAFC 1997).
To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include a disclosure of a representative number of species to describe the complete structure of the claimed genus and/or disclosure of a complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, and any combination thereof.
Scope of the Claims
In the instant case, the genera are:
coronavirus spike protein (S) proteins with at least 90% sequence identity to SEQ ID NO: 3 (instant claim 7).
The broadest reasonable interpretation of the scope of this genus is encompasses all possible sequences with at least 90% sequence identity to SEQ ID NO: 3 with all possible mismatches, insertions, or deletions as long as they meet the sequence identity. SEQ ID NO: 3 is 1273 bp long, the claimed 90% sequence identity allows for up to 127 mismatches. To demonstrate the breadth of these genera, an estimation can be made that for each potential mismatch, there can be one of the 4 nucleotide or no nucleotides. For 90% identity to SEQ ID NO: 3, this would arrive at 5127 possible sequences. Because the broadest reasonable interpretation includes insertions of any lengths, this is an underestimation of the vast breadth of the claimed genus of sequences.
coronavirus spike protein (S) proteins with at least 90% sequence identity to SEQ ID NO: 3 having K986P and V987P mutations (instant claim 8)
The broadest reasonable interpretation of the scope of this genus is encompasses all possible sequences with at least 90% sequence identity to SEQ ID NO: 3 that also have the K986P and V987P mutations with all possible mismatches, insertions, or deletions as long as they meet the sequence identity. SEQ ID NO: 3 is 1273 bp long, the claimed 90% sequence identity allows for up to 127 mismatches. To demonstrate the breadth of these genera, an estimation can be made that for each potential mismatch, there can be one of the 4 nucleotide or no nucleotides. For 90% identity to SEQ ID NO: 3, this would arrive at 5127 possible sequences. Because the broadest reasonable interpretation includes insertions of any lengths, this is an underestimation of the vast breadth of the claimed genus of sequences.
Disclosure of Structure and Disclosure of Species
Regarding coronavirus spike protein (S) proteins with at least 90% sequence identity to SEQ ID NO: 3, Applicant discloses SEQ ID NO: 3, which encodes the SARS-CoV-2 spike (S);
SEQ ID NO: 3 having K986P and V987P mutations; and
SEQ ID NO: 3 having a D614G mutation (see para. [0016])
Regarding coronavirus spike protein (S) proteins with at least 90% sequence identity to SEQ ID NO: 3 having K986P and V987P mutations, Applicant discloses the one specific species of SEQ ID NO: 3 having K986P and V987P mutations (see para. [0016]).
Structure/Function Relationship
SARS-CoV-2 spike, SEQ ID NO: 3 and SEQ ID NO: 3 having K986P and V987P mutations
Regarding the sequences with at least 90% sequence identity to SEQ ID NO: 3 and with at least 8 90% sequence identity to SEQ ID NO: 3 having K986P and V987P mutations as stated above, each of these genera encompasses a large number of structurally diverse sequences. Since it is well known in the art that even one amino acid change can unpredictably perturb the function of the protein, one of ordinary skill would not be able to envision the required structural elements at the time of filing to arrive at the required function of the coronavirus spike protein as part of an adenoviral vector.
Applicant has not provided a nexus between the claimed sequence identity and the function as part of the adenoviral vector and Applicant has not provided a mapping or sufficient information on which of the claimed 90% must be preserved and which can be modified in order to maintain the function as part of the adenoviral vector. As such, one of ordinary skill would not be able to envision the requisite structural elements at the time of filing, and Applicant has not shown possession of the full breadth of the genera of sequences as claimed.
Written Description - Conclusion
Therefore, the examiner concludes there is insufficient written description support for the instantly claimed genera.
Specifically, Applicant discloses 3 specific species of spike proteins with homology to SEQ ID NO: 3. 3 species is not representative of such a diverse genus as coronavirus spike protein (S) proteins with at least 90% sequence identity to SEQ ID NO: 3 which encompasses more than 5127 structurally diverse sequences.
Applicant discloses 1 specific species of SEQ ID NO:3 with K986P and V987P mutations. One species is not representative of such a diverse genus as coronavirus spike protein (S) proteins with at least 90% sequence identity to SEQ ID NO: 3 having K986P and V987P mutations, which encompasses more than 5127 structurally diverse sequences.
There is no description of the structure/function correlation that would allow one of ordinary skill in the art to reasonably ascertain which substitutions, deletions or insertions can be performed. As such, one of ordinary skill in the art could not envision all the embodiments that fall outside of the description provide by the specification and the art and Applicant has not shown possession of the full breadth of the genera of sequences as claimed.
Response to Arguments
Applicant’s arguments, filed 20th, January, 2026, have been fully considered but are not found persuasive.
Applicant argues “the disclosure provides ample written description to support the spike protein, for example, at paragraphs 00129, 00139, 00143, and 00148. Further, as disclosed in the application at paragraphs 00105-00106, amino acid substitutions can be conservative substitutions that do not substantially affect or decrease a function of a protein. Therefore, one of ordinary skilled in the art would recognize that the inventors were in possession of a spike protein having a sequence with at least 90% sequence identity and similar function. Thus, Applicant submits that the instant specification provides sufficient written description for the sequence identities recited in the pending claims” (pg. 6).
In response, as discussed above, the instant disclosure provides only 3 specific species of SARS-CoV-2 spike protein (S) proteins with at least 90% sequence identity to SEQ ID NO: 3 and 1 species proteins with at least 90% sequence identity to SEQ ID NO: 3 having K986P and V987P mutations. As discussed above, each of these genera encompass a massive number of structurally and functionally diverse sequences with an estimate of each encompassing more than 5127 structurally diverse sequences. Applicants disclosure of 3 or 1 species is not representative of such a massive genera of structurally and functionally diverse sequences. Applicant has not provided a nexus between the structure of the claimed sequences and their required function as the transgene.
Applicant is directed to MPEP 2163 which states that 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. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (Claims directed to a functionally defined genus of antibodies were not supported by a disclosure that "only describe[d] one type of structurally similar antibodies" that "are not representative of the full variety or scope of the genus."). The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure "indicates that the patentee has invented species sufficient to constitute the gen[us]." See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004) ("[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated."). "A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when … the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed." In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004). In the instant case, because it is well known in the art that even a single amino acid change can unpredictably disrupt the function of a protein, the 3 or 1 species disclosed by Applicant does not indicate that the patentee has invented species sufficient to constitute the genus.
Withdrawn Claim Rejections - 35 USC § 112(b)
The rejection of claims 7-9 and 19 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite as set forth in the previous office action is withdrawn in view of Applicant’s amendments.
Withdrawn Claim Rejections - 35 USC § 102
The rejection of claims 1, 12, 14 and 19 under 35 U.S.C. 102(a)(1) as being anticipated by Roy et al. (US 2017/0183636-A1; see IDS filed 19th, October, 2023; henceforth “Roy”) as set forth in the previous office action is withdrawn in view of Applicant’s amendments. The rejection of claims 2, 4 and 11 is rendered moot by the cancellation of those claims.
Withdrawn Claim Rejections - 35 USC § 103
The rejection of claims 1, 7, 9, 12, 14 and 19 under 35 U.S.C. 103 as being unpatentable over Roy et al. (US 2017/0183636-A1; see IDS filed 19th, October, 2023; henceforth “Roy”) in view of Qin et al. (CN-111088283-A; see IDS filed 19th, October, 2023; citations refer to attached English translation; henceforth “Qin”) as set forth in the previous office action is withdrawn in view of Applicant’s amendments.
The rejection of claims 2, 4 and 10-11 under 35 U.S.C. 103 as being unpatentable over Roy et al. (US 2017/0183636-A1; see IDS filed 19th, October, 2023; henceforth “Roy”) in view of Qin et al. (CN-111088283-A; see IDS filed 19th, October, 2023; citations refer to attached English translation; henceforth “Qin”) as set forth in the previous office action is rendered moot by the cancellation of this claim.
The rejection of claim 5 under 35 U.S.C. 103 as being unpatentable over Roy et al. (US 2017/0183636-A1; see IDS filed 19th, October, 2023; henceforth “Roy”) in view of Qin et al. (CN-111088283-A; see IDS filed 19th, October, 2023; citations refer to attached English translation; henceforth “Qin”) as applied to claim 1 above, and in further view of Roy et al. (PLoS Pathog. 2009 Jul;5(7):e1000503. Epub 2009 Jul 3.; henceforth “Roy2”) as evidenced by GenBank: FJ025917.1 (2008, accessed at: https://www.ncbi.nlm.nih.gov/nucleotide/FJ025917.1?report=genbank&log$=nucltop&blast_rank=1&RID=C6KKPHEF014) as set forth in the previous office action is rendered moot by the cancellation of this claim.
The rejection of claims 6 and 8 under 35 U.S.C. 103 as being unpatentable over Roy et al. (US 2017/0183636-A1; see IDS filed 19th, October, 2023; henceforth “Roy”) in view of Qin et al. (CN-111088283-A; see IDS filed 19th, October, 2023; citations refer to attached English translation; henceforth “Qin”) as applied to claim 1 above, and in further view of Wrapp et al. (Science. 2020 Mar 13;367(6483):1260-1263. Epub 2020 Feb 19.; see IDS filed 11th, October, 2024; henceforth “Wrapp”) as set forth in the previous office action is withdrawn in view of Applicant’s amendments.
New 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.
Claims 1, 7, 9, 12, 14, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Roy et al. (US 2017/0183636-A1; see IDS filed 19th, October, 2023; henceforth “Roy1”) in view of Qin et al. (CN-111088283-A; see IDS filed 19th, October, 2023; citations refer to attached English translation; henceforth “Qin”) and Roy et al. (PLoS Pathog. 2009 Jul;5(7):e1000503. Epub 2009 Jul 3.; henceforth “Roy2”) as evidenced by GenBank: FJ025917.1 (2008, accessed at: https://www.ncbi.nlm.nih.gov/nucleotide/FJ025917.1?report=genbank&log$=nucltop&blast_rank=1&RID=C6KKPHEF014).
Regarding claim 1, Roy1 discloses an adenoviral vector comprising the genome of a non-human adenovirus (simian adenovirus), wherein the genome of the adenovirus has been modified such that the vector lacks the native E1 (“the site of a functional E1 deletion” para. [0056]), and comprises a transgene (“selected heterologous gene” para. [0055]) operably linked to expression control sequences which direct transcription, translation, and/or expression in a host cell (“regulatory elements necessary to drive translation, transcription and/or expression of the gene product in a host cell” para. [0055]), wherein the transgene encodes a coronavirus spike protein (E2 (also called Sor Spike protein); para. [0124]) (see also abstract; claims 1-7; Examples 3-5) wherein the non-human adenovirus is a simian adenovirus (SAdV) (“simian adenovirus” or SAdV; abstract; Figure 1; para. [007-0013, 0022-0024, 0026-0027, 0030-0034, 0036-0047, 0049, 0052-0058, 0062, 0089, 0099-0102, 0117, 0119, 0123, 0130, 0132-0135, 0139-0140, 0145, 0147, 0151-0155, 0161-0169, 0179-0180, 0183, 0186-0187, 0189-0192, 0199-0203, 0205, 0211]; Tables 1-2; claims 1-10 and 18).
However, regarding claim 1, although Roy1 discloses the transgene encodes a coronavirus spike protein (E2 (also called Sor Spike protein); para. [0124]), and Roy1 discloses using the adenoviral vector as a vaccine (“vaccine compositions contain the adenoviral vectors carrying an inserted heterologous molecule” para. [0011]; see also para. [0027, 0055, 0070, 0119, 0121]), Roy1 does not disclose the transgene encodes a SARS-CoV-2 spike (S) protein.
Nevertheless, regarding claim 1, Qin teaches a viral vector vaccine comprising transgene that encodes a SARS-CoV-2 spike (S) protein (SEQ ID NO: 2; claim 6).
Therefore, regarding claim 1, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to prepare the adenoviral vector of Roy1, and simply substitute the known prior art element of the transgene that encodes a coronavirus SARS-CoV-2 spike protein of Qin for the transgene that encodes a coronavirus spike protein of Roy to obtain the predictable result of an adenoviral vector that encodes a SARS-CoV-2 spike protein (see MPEP 2143 Exemplary Rationale (B) which states that simple substitution of one known element for another to obtain predictable result as a rationale to support a conclusion of obviousness). Regarding the reasonable expectation of success, Roy1 evidences preparation of adenoviral vectors with transgenes (Examples 3 and 5).
However, regarding claim 1, although Roy1 discloses the adenoviral genome is the adenoviral genome is an SAdV-36 (SEQ ID NO: 1 of Roy) which is 99.97% identical to instant SEQ ID NO: 4, Roy1 is silent to an adenoviral genome that has the sequence of SEQ ID NO: 4 and is 100% identical.
Nevertheless, regarding claim 1, Roy2 teaches an SAdV-36 genomic sequence (SadV-36; Figure 1). GenBank: FJ025917.1 evidences the SAdV-36 genomic sequence is 100% identical to instant SEQ ID NO: 4 (see attached NCBI BLAST Result 1).
Therefore, regarding claim 1, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to prepare the adenoviral vector as suggested by Roy1 in view of Qin, and simply substitute the known prior art element of the SAdV-36 genomic sequence of Roy2 for the SAdV-36 genomic sequence of Roy1 to obtain the predictable result of an adenoviral vector. Regarding the reasonable expectation of success, Roy1 evidences the preparation of an adenoviral vector with an SAdV-36 genomic sequence (Examples 3 and 5).
Regarding claim 7, further to the discussion of claim 1 above, Qin suggests a transgene that encodes SEQ ID NO: 2 of Qin (claim 6; SEQ ID NO: 2), which is 100% identical to instant SEQ ID NO: 3 (see SCV rag file dated 23th, September, 2025 result 1).
Regarding claim 9, further to the discussion of claim 1 above, as stated above (see claims 1 and 7 rejection above) Qin suggests a transgene that encodes SEQ ID NO: 2 of Qin (claim 6; SEQ ID NO: 2), which is 100% identical to instant SEQ ID NO: 3 (see SCV rag file dated 23th, September, 2025 result 1), which is structurally indistinguishable to the SARS-CoV-2 spike protein from the WA1/2020 variant.
Regarding claim 9, it is noted that the claimed term “from a” variant is product-by-process language. Applicant is reminded that product-by process claims are not limited by the manipulation of the recited steps, only the structure implied by the steps. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (see MPEP 2113). In the instant case, the spike protein taught by Qin is capable of being “from” the WA1/2020 variant and therefore meets instant claims.
Regarding claim 12, further to the discussion of claim 1 above, Roy1 teaches a pharmaceutical composition, comprising the adenoviral vector and a pharmaceutically acceptable carrier (“biologically compatible solution or pharmaceutically acceptable delivery vehicle” para. [0105]; claim 16; see also para. [0033, 0105, 0107, 0136-0137]).
Regarding claim 14, further to the discussion of claim 1 above, Roy1 teaches an immunogenic composition comprising the adenoviral vector (“vectors may also be employed as immunogenic compositions” para. [0119]).
Regarding claim 19, further to the discussion of claim 1 above, as stated above (see claim 1 rejection above), Roy1 in view of Qin and Roy2 suggest the structural requirements of the adenovirus vector of claim 1.
Regarding the preamble of claim 19, the preamble merely states the purpose or intended use of the invention (coronavirus vaccine), rather than any distinct definition of any of the claimed invention’s limitations and therefore then the preamble is not considered a limitation and is of no significance to claim construction (see MPEP 2111.02) See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) ("where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation"). Furthermore, it is noted that Roy1 teaches vaccines comprising the adenovirus vector (“vaccine compositions contain the adenoviral vectors carrying an inserted heterologous molecule” para. [0011]; see also para. [0027, 0055, 0070, 0119, 0121]).
Hence, the claimed invention as a whole was prima facie obvious.
Examiner’s Remark
Applicant’s arguments necessitated the new grounds of rejection above. For the sake of compact prosecution, arguments considered pertinent to the new grounds of rejection are addressed below.
Response to Arguments
Applicant’s arguments, filed 20th, January, 2026, have been fully considered but are not found persuasive. Applicant’s arguments were considered to the extent that they apply the new grounds of rejection of claims 1, 7, 9, 12, 14, and 19 above under 35 U.S.C. 103 as being unpatentable over Roy1 and Roy2 as evidenced by GenBank.
Applicant argues “none of the cited publications teach an adenoviral vector with the sequence of SEQ ID NO: 2, SEQ ID NO: 4, SEQ ID NO: 5, or SEQ ID NO: 6 encoding a SARS-CoV-2 spike (S) protein” (pg. 8). Applicant argues “Qin, Roy2, or Wrapp does not cure the deficiencies of Roy1. Qin merely discloses a non-viral expression vector based on human cell genome AAVS1 and H11 safe harbor site integration for improving expression of a recombinant protein and does not teach an adenoviral vector with the sequence of SEQ ID NO: 2, SEQ ID NO: 4, SEQ ID NO: 5, or SEQ ID NO: 6 encoding a SARS-CoV-2 spike (S) protein. Roy2 discloses characterizations of various adenoviruses by genomic sequencing, one of which is simian adenovirus 36. Roy2 does not teach or suggest an adenoviral vector encoding a SARS-CoV-2 spike (S) protein, as required by claim 1. Wrapp allegedly discloses a stabilized prefusion conformation of the SARS-CoV-2 spike protein, but does not disclose an adenoviral vector with the sequence of SEQ ID NO: 2, SEQ ID NO: 4, SEQ ID NO: 5, or SEQ ID NO: 6 encoding a SARS-CoV-2 spike (S) protein. Accordingly, none of the cited publications provides the necessary disclosure or guidance for a person of skill in the art to arrive at the adenoviral vector encoding a SARS-CoV-2 spike (S) protein, as encompassed by the pending claims (pg. 8).
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In the instant case the claimed invention is prima facie obvious by the combination of Roy in view of Qin and Roy2 as evidence by GenBank: FJ025917.1 for the reasons set forth above.
Applicant argues unexpected results. Specifically, Applicant argues “the adenoviral vector encompassed by the pending claims provides improved mucosal immunity when administered intranasally (see paragraph 00244-00246). Specifically, intranasal delivery resulted in remarkable protective efficacy with an absence of infectious virus in the lungs, and almost negligible viral RNA in the lung, spleen, heart, nasal turbinates, and nasal washes (see FIGs. 9A-9B). None of the cited publications provide any teaching or suggestion of an adenoviral vector encoding the Spike protein with such remarkable effects. Therefore, the adenoviral vector encoding a SARS-CoV-2 spike (S) protein recited in the pending claims exhibit unexpected results that outweigh any prima facie obviousness of the claims” (pg. 9).
In response to Applicant’s arguments, arguments of counsel cannot take the place of
factually supported objective evidence in the record. See In re Schulze, 346 F.2d 500, 602, 145
USPQ 716, 718 (CCPA 1965), In re Huang, 100 F.3d 135, 139-40, 40 USPQ2d 1685, 1689 (Fed.
Cir. 1996); In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984). Thus,
Attorney statements regarding the unexpected result are not evidence without a supporting declaration. Specifically, Applicant has not provided objective scientific evidence on the record that the remarkable protective efficacy with an absence of infectious virus in the lungs, and almost negligible viral RNA in the lung, spleen, heart, nasal turbinates, and nasal washes is in fact unexpected and is also facilitated over prior art products.
Concerning the alleged unexpected results, the burden is on the Applicant to establish results are unexpected and significant (MPEP 716.02(b)(I)), Applicants have the burden of explaining the proferred data (and MPEP 716.02(b)(II)), and the objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support (MPEP 716.02(d)(I)).
The evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992) (Mere conclusions in appellants’ brief that the claimed polymer had an unexpectedly increased impact strength "are not entitled to the weight of conclusions accompanying the evidence, either in the specification or in a declaration."); Ex parte C, 27 USPQ2d 1492 (Bd. Pat. App. & Inter. 1992) (Applicant alleged unexpected results with regard to the claimed soybean plant, however there was no basis for judging the practical significance of data with regard to maturity date, flowering date, flower color, or height of the plant.). See also In re Nolan, 553 F.2d 1261, 1267, 193 USPQ 641, 645 (CCPA 1977) and In re Eli Lilly, 902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir. 1990) as discussed in MPEP § 716.02(c) (MPEP 716.02(b)(I)). Evidence of unexpected properties may be in the form of a direct or indirect comparison of the claimed invention with the closest prior art which is commensurate in scope with the claims. See In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980) and MPEP § 716.02(d) - § 716.02(e). See In re Blondel, 499 F.2d 1311, 1317, 182 USPQ 294, 298 (CCPA 1974) and In re Fouche, 439 F.2d 1237, 1241-42, 169 USPQ 429, 433 (CCPA 1971) for examples of cases where indirect comparative testing was found sufficient to rebut a prima facie case of obviousness. (MPEP 716.02(b)(II)).
In the instant case, Applicant’s alleged unexpected results are insufficient to overcome the rejection of record under 35 U.S.C. 103 for several reasons. First, as discussed above, the alleged unexpected results are not supported by factually objective evidence on the record. Next, the data cited by Applicant appears to be compared to a control and is not compared to the closest prior art. Because the data cited by Applicant is not compared to the closest prior art, the statistical and practical significance of the date (required by MPEP 716.02(b)(II); see above) are not apparent. Finally, the alleged unexpected results do not appear to be in scope with the claimed invention, as the cited results appear to correspond to a specific adenoviral genome sequences and a specific transgene sequence.
New Claim Rejections - 35 USC § 103
Claims 6 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Roy et al. (US 2017/0183636-A1; see IDS filed 19th, October, 2023; henceforth “Roy”) in view of Qin et al. (CN-111088283-A; see IDS filed 19th, October, 2023; citations refer to attached English translation; henceforth “Qin”) and Roy et al. (PLoS Pathog. 2009 Jul;5(7):e1000503. Epub 2009 Jul 3.; henceforth “Roy2”) as evidenced by GenBank: FJ025917.1 (2008, accessed at: https://www.ncbi.nlm.nih.gov/nucleotide/FJ025917.1?report=genbank&log$=nucltop&blast_rank=1&RID=C6KKPHEF014) as applied to claim 1, 7, 9, 12, 14, and 19 above, and in further view of Wrapp et al. (Science. 2020 Mar 13;367(6483):1260-1263. Epub 2020 Feb 19.; see IDS filed 11th, October, 2024; henceforth “Wrapp”).
The teachings of Roy, Qin, Roy2 and GenBank: FJ025917.1 above are relied upon and are hereby incorporated in their entirety.
Regarding claims 6 and 8, further to the discussion of claim 1 above, although Qin teaches the SARS-CoV-2 spike protein that is 100% identical to SEQ ID NO: 3 (claim 6; SEQ ID NO: 2; see SCV rag file dated 23th, September, 2025 result 1 and claims 1 and 7 rejection above), Roy, Qin and Roy2 are silent to a stabilized prefusion form of the SARS-CoV-2 spike protein (instant claim 6), and Roy, Qin and Roy2 are silent to the K986P and V987P mutations (instant claim 8).
Nevertheless, regarding claims 6 and 8, Wrapp teaches the stabilized prefusion conformation of the SARS-CoV-2 spike protein as a target for antibody-mediated neutralization for vaccine design and development (pg. 1 col. 3 1st para.), and Wrapp teaches preparation of the stabilized prefusion conformation of the SARS-CoV-2 spike protein by including the K986P and V987P mutations (“proline substitutions at residues 986 and 987” Supplementary Materials, Materials and Methods “Protein expression and purification”; Figure S5).
Therefore, regarding claims 6 and 8, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to prepare the adenoviral vector as suggested by Roy in view of Qin and Roy2, and combine the known prior art element of the K986P and V987P mutations (instant claim 8), which would make the stabilized prefusion form of the SARS-CoV-2 spike protein (instant claim 6) to obtain the predictable result of an adenoviral vector comprising a prefusion spike structure. One of ordinary skill would have been motivated to do so as taught by Wrapp because the stabilized prefusion form of the SARS-CoV-2 spike protein is target for antibody-mediated neutralization of SARS-CoV-2 spike protein (pg. 1 col. 3 1st para.). Regarding the reasonable expectation success, Wrapp evidences preparation of the stabilized prefusion form of the SARS-CoV-2 spike protein comprising K986P and V987P mutations (“proline substitutions at residues 986 and 987” Supplementary Materials, Materials and Methods “Protein expression and purification”; Figure S5).
Hence, the claimed invention as a whole was prima facie obvious.
Withdrawn Provisional Non-Statutory Double Patenting
Co-Pending Application No. 18/834,113
The provisional rejection of claims 2, 4-5 and 10-11 on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 8, 10 and 12-13 of copending application No. 18/834,113 in view of Roy et al. (US 2017/0183636-A1; see IDS filed 19th, October, 2023; henceforth “Roy”) as set forth in the previous office action is made moot by the cancellation of these claims.
Double Patenting
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Provisional Non-Statutory Double Patenting
Co-Pending Application No. 18/834,113
Claims 1, 6-7, 9, 12, 14 and 19 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 8, 10 and 12-13 of copending application No. 18/834,113 in view of Roy et al. (US 2017/0183636-A1; see IDS filed 19th, October, 2023; henceforth “Roy”).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented
The subject matter claimed in the instant application is disclosed in the referenced application as follows: the adenoviral vector makes obvious the adenoviral vector of instant application.
Although the claims at issue are not identical, they are not patentably distinct for the reasons stated below.
Regarding claim 1, U.S. Co-pending App ‘113 claims an adenoviral vector comprising the genome of a non-human adenovirus, wherein the genome of the adenovirus has been modified such that the vector lacks the native E1 and optionally, the E3 or E3B locus, and comprises a transgene,
wherein the transgene encodes a SARS-CoV-2 spike (S) protein (nucleic
acid sequence encoding a SARS-CoV-2 spike (S) protein with an amino acid sequence at least 80% identical to any of SEQ ID NOS: 10, 12, 20, or 21; claim 1), U.S. Co-pending App ‘113 claims the non-human adenovirus is a simian adenovirus (SAdV) (claim 2), and U.S. Co-pending App ‘113 claims the simian adenovirus genome Chimpanzee adenoviral vector 36 (claim 11) which is 100% identical to instant SEQ ID NO: 4 (see NCBI Blast result 1), and it would be obvious to combine these separately claimed embodiments.
However, regarding claim 1, U.S. Co-pending App ‘113 does not claim the transgene is operably linked to expression control sequences which direct transcription, translation, and/or expression in a host cell.
Nevertheless, regarding claim 1, Roy teaches an adenoviral vector comprising the genome of a non-human adenovirus (simian adenovirus), wherein the genome of the adenovirus has been modified such that the vector lacks the native E1 (“the site of a functional E1 deletion” para. [0056]), and comprises a transgene (“selected heterologous gene” para. [0055]) operably linked to expression control sequences which direct transcription, translation, and/or expression in a host cell (“regulatory elements necessary to drive translation, transcription and/or expression of the gene product in a host cell” para. [0055])(see also abstract; claims 1-7 and Examples 3-5).
Therefore, regarding claim 1, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to prepare the adenoviral vector as claimed by U.S. Co-pending App ‘113 and combine the known prior art element operably linking the transgene to expression control sequences which direct transcription, translation, and/or expression in a host cell of Roy to obtain the predicable result of an adenoviral vector for expressing a transgene in a host cell. One of ordinary skill would have been motivated to do so as taught by Roy to drive translation, transcription and/or expression of the gene product in a host cell (para. [0055]). Regarding the reasonable expectation of success, Roy evidences preparation of adenoviral vectors that comprise expression control sequences (Example 3; see also Examples 4-5).
Regarding claim 6, further to the discussion of claim 1 above, U.S. Co-pending App ‘113 claims the transgene has stabilizing mutations (claim 8) and therefore the transgene encodes a stabilized prefusion form of the SARS-CoV-2 spike (S) protein.
Regarding claim 7, further to the discussion of claim 1 above, as stated above (see claim 1 rejection above), U.S. Co-pending App ‘113 claims a SARS-CoV-2 spike (S) protein (nucleic acid sequence encoding a SARS-CoV-2 spike (S) protein with an amino acid sequence at least 80% identical to any of SEQ ID NOS: 10, 12, 20, or 21; claim 1) and U.S. Co-pending App ‘113 also claims an amino acid sequence with at least 90% sequence identity to one or more of SEQ ID NOS: 10-12, 20 or 21 (claim 3) and it would be obvious to combine this separately claimed embodiment.
Regarding claim 9, further to the discussion of claim 1 above, although U.S. Co-pending App ‘113 does not claim the transgene is a coronavirus S protein from a WA1/2020 variant, this is a product-by-process limitation. The transgene of U.S. Co-pending App ‘113 is capable of being “from” the claimed variant and therefore meets instant claims.
Regarding claim 12, further to the discussion of claim 1 above, U.S. Co-pending App ‘113 claims a pharmaceutical composition, comprising the adenoviral vector (claim 12).
Regarding claim 14, further to the discussion of claim 1 above, U.S. Co-pending App ‘113 claims an immunogenic composition comprising the adenoviral vector (claim 13).
Regarding claim 19, further to the discussion of claims 1 and 12 above, the vector as claimed by U.S. Co-pending App ‘113 in view of Roy suggests the structural requirements of the adenovirus vector of claim 1 and claims a pharmaceutical composition, comprising the adenoviral vector. Because the preamble merely states the purpose or intended use of the invention (coronavirus vaccine), and the suggested vector is capable of meeting the intended use, it meets the instant claims .
Since the instant application claims are obvious over cited application claims, in view of Roy, said claims are not patentably distinct.
Claims 6 and 8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 8, 10 and 12-13 of copending application No. 18/834,113 in view of Roy et al. (US 2017/0183636-A1; see IDS filed 19th, October, 2023; henceforth “Roy”) as applied to claim 1 above, and in further view of Wrapp et al. (Science. 2020 Mar 13;367(6483):1260-1263. Epub 2020 Feb 19.; see IDS filed 11th, October, 2024; henceforth “Wrapp”). The teachings of Roy above are hereby incorporated in their entirety.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented
The subject matter claimed in the instant application is disclosed in the referenced application as follows: the adenoviral vector makes obvious the adenoviral vector of instant application.
Although the claims at issue are not identical, they are not patentably distinct for the reasons stated below.
Regarding claims 6 and 8, further to the discussion of claim 1 above, although U.S. Co-pending App ‘113 claims stabilizing mutations, U.S. Co-pending App ‘113 does not specifically claim a stabilized prefusion form of the SARS-CoV-2 spike protein (instant claim 6), U.S. Co-pending App ‘113 does not claim the K986P and V987P mutations (instant claim 8).
Nevertheless, regarding claims 6 and 8, Wrapp teaches the stabilized prefusion conformation of the SARS-CoV-2 spike protein as a target for antibody-mediated neutralization for vaccine design and development (pg. 1 col. 3 1st para.), and Wrapp teaches preparation of the stabilized prefusion conformation of the SARS-CoV-2 spike protein by including the K986P and V987P mutations (“proline substitutions at residues 986 and 987” Supplementary Materials, Materials and Methods “Protein expression and purification”; Figure S5).
Therefore, regarding claims 6 and 8, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to prepare the adenoviral vector as claimed by U.S. Co-pending App ‘113 in view of Roy, and combine the known prior art element of the K986P and V987P mutations (instant claim 8), which would make the stabilized prefusion form of the SARS-CoV-2 spike protein (instant claim 6) to obtain the predictable result of an adenoviral vector comprising a prefusion spike structure. One of ordinary skill would have been motivated to do so as taught by Wrapp because the stabilized prefusion form of the SARS-CoV-2 spike protein is target for antibody-mediated neutralization of SARS-CoV-2 spike protein (pg. 1 col. 3 1st para.). Regarding the reasonable expectation success, Wrapp evidences preparation of the stabilized prefusion form of the SARS-CoV-2 spike protein comprising K986P and V987P mutations (“proline substitutions at residues 986 and 987” Supplementary Materials, Materials and Methods “Protein expression and purification”; Figure S5).
Since the instant application claims are obvious over cited application claims, in view of Roy and Wrapp, said claims are not patentably distinct.
Examiner’s Remark
As set forth previously, the Examiner notes that Sequences 100% identical to SEQ ID NO: 2, 5 and 6 appear to be free of the prior art. However, no claim is allowable for the reasons stated above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
No claim is allowable.
Correspondence
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/BRIANA N EBBINGHAUS/Examiner, Art Unit 1632 /VALARIE E BERTOGLIO/Primary Examiner, Art Unit 1632