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
In the amendment filed on 28th, July, 2026, Applicant added new claims 38-41.
Claims 1, 6-9, 12, 14-16, 19, 24-28 and 38-41 are pending.
Claims 15-16 and 24-28 are withdrawn.
Claims 1, 6-9, 12, 14, 19 and 38-41 are under examination.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 28th, July, 2026 has been entered.
Withdrawn Claim Objections
The objection to claim 19 as set forth in the previous office due to informalities as set forth in the previous office action is withdrawn in view of Applicant’s amendments.
Duplicate Claim Warning
Applicant is advised that should claim 9 be found allowable, claim 41 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
New Claim Objections
Claims 1, 7-9 and 38-41 are objected to because of the following informalities:
Claims 1, 7-8 and 38-40 each refer to the sequence identifier rather than the sequence as set forth in the sequence identifier.
To overcome this objection, it is recommended that Applicant amend to refer to the sequence as set forth on the SEQ ID NO: (e.g. “comprising the nucleic acid sequence selected from the sequence as set forth in SEQ ID NO: 2, SEQ ID NO: 5 and SEQ ID NO: 6” in claim 1).
Appropriate correction is required.
Withdrawn Claim Rejections - 35 USC § 112(a)
The rejection of claims 7-8 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paragraph, as failing to comply with the written description requirement as set forth in the previous office action is withdrawn in view of Applicant’s amendments.
New Claim Rejections - 35 USC § 112 (b)
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.
Claim 41 is 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.
Claim 41 recites “The pharmaceutical composition of claim 1,” however, claim 1, upon which claim 41 depends, does not recite a pharmaceutical composition. Therefore, it is unclear what the scope of “The pharmaceutical composition” encompasses or whether it is intended to encompass additional unrecited elements, and what those elements are. Hence, there is improper antecedent basis for “The pharmaceutical composition” and the scope of the claim is indefinite.
Generally, when the claims are indefinite, vague or unclear, they cannot be construed without speculation or conjecture; therefore, the indefinite claims are not treated on the merits with respect to prior art. See In re Steele, 305 F.2d 859, 862 (CCPA 1962) (A prior art rejection cannot be sustained if the hypothetical person of ordinary skill in the art would have to make speculative assumptions concerning the meaning of claim language.); see also In re Wilson, 424 F.2d 1382, 1385 (CCPA 1970) ("If no reasonably definite meaning can be ascribed to certain terms in the claim, the subject matter does not become obvious-the claim becomes indefinite."). Notwithstanding Steele, the Office has made every attempt to construe the claims in what the Office believes is the intent of the Applicants in the interest of compact prosecution.
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 “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$=nucltop&blast_rank=1&RID=C6KKPHEF014) as set forth in the previous office action is withdrawn in view of Applicant’s amendments.
The rejection of claims 6 and 8 under 35 U.S.C. 103 as being unpatentable over Roy et al. (US 2017/0183636-A1; see IDS filed 19th, October, 2023; henceforth “Roy”) in view of Qin et al. (CN-111088283-A; see IDS filed 19th, October, 2023; citations refer to attached English translation; henceforth “Qin”) and Roy et al. (PLoS Pathog. 2009 Jul;5(7):e1000503. Epub 2009 Jul 3.; henceforth “Roy2”) as evidenced by GenBank: FJ025917.1 (2008, accessed at: https://www.ncbi.nlm.nih.gov/nucleotide/FJ025917.1?report=genbank&log$=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”) 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 38-40 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”), Roy et al. (PLoS Pathog. 2009 Jul;5(7):e1000503. Epub 2009 Jul 3.; henceforth “Roy2”) and Wrapp et al. (Science. 2020 Mar 13;367(6483):1260-1263. Epub 2020 Feb 19.; see IDS filed 11th, October, 2024; henceforth “Wrapp”) 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 38, Roy1 discloses pharmaceutical composition, comprising adenoviral vector an adenoviral vector (“biologically compatible solution or pharmaceutically acceptable delivery vehicle” para. [0105]; claim 16; see also para. [0033, 0105, 0107, 0136-0137]) 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 SAdV-36 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 38, 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 38, 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 38, 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 38, although Roy1 teaches intranasal as a method of vaccine administration (para. [0106]), Roy1 does not specifically disclose a pharmaceutical composition formulated for intranasal administration.
Nevertheless, regarding claim 38, Qin teaches a pharmaceutical composition that is a vaccine for a Coronavirus SARS-CoV-2 and is formulated for intranasal administration (“nasal drip or oral and other routes for vaccination;” pg. 5 2nd para.; see also “Nasal drip” pg. 5, 7, 9-12). Qin teaches nasal drip method mainly activated IgA mucosal immunity (pg. 12 and FIG. 4B). Qin teaches nasal drop administration simulated nervous system infection (pg. 7). Qin teaches that the body cannot induce effective mucosal immune response of removing mucosa infection pathogen (pg. 3 2nd para.). Qin teaches conventional vaccines typically does not induce specific mucosal immune response and to induce mucosal immune response the target antigen usually needs mucosa position for inoculation (pg. 3 3rd para.) Qin teaches APC uptake can be in the mucosal tissue and presenting, further activating the mucosal immune system and induction of strong mucosal immune response (pg. 3 3rd para.). Qin teaches the particular mode of administration (mucosal route of administration) can significantly enhance specific mucosal immune response (pg. 5 4th para.). Qin teaches that through mucosal infection mucosa of prophylactic or therapeutic vaccine of the pathogen, the vaccine of the invention is capable of inducing an SARS-CoV-2 specific mucosal IgA and systemic IgG (pg. 5 5th para.).
Therefore, regarding claim 38, 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 pharmaceutical composition suggested by Roy1 in view of Qin above, and combine the known prior art element of the nasal drip formulation for intranasal administration of Qin to obtain the predictable result of a pharmaceutical composition. One of ordinary skill would have been motivated to do so as taught by Qin to induce specific mucosal immune response and induce a SARS-CoV-2 specific mucosal IgA and systemic IgG response (pg. 5 5th para.). Regarding the reasonable expectation of success, Qin evidences preparation of a pharmaceutical composition including a viral vector as a nasal drip which is a type of formulation for intranasal administration (pg. 3 2nd , 3rd para.; pg. 5, 7, 9-12; Figure 4B).
However, regarding claim 38, 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 38, 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 38, 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).
However, regarding claims 38 and 40, although Qin teaches the SARS-CoV-2 spike protein that is 100% identical to SEQ ID NO: 3, Roy1, Qin and Roy2 are silent to a stabilized prefusion form of the SARS-CoV-2 spike protein (instant claim 38), and Roy1, Qin and Roy2 are silent to the K986P and V987P mutations (instant claim 40).
Nevertheless, regarding claims 38 and 40, 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 38 and 40, 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 Roy2, and combine the known prior art element of the K986P and V987P mutations (instant claim 40), which would make the stabilized prefusion form of the SARS-CoV-2 spike protein (instant claim 38) 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).
Regarding claim 39, further to the discussion of claim 38 above, the SARS-CoV-2 spike (S) protein suggested and made obvious by Qin above (see claim 38 rejection above), comprises the amino acid sequence of SEQ ID NO: 3 (claim 6; SEQ ID NO: 2 is 100% identical to instant SEQ ID NO: 3; see SCV rag file dated 23th, September, 2025 result 1).
Hence, the claimed invention as a whole was prima facie obvious.
Examiner’s Remark
It is noted that 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.
Examiner’s Remark
In the amendment filed 28th, July, 2026, Applicant amended claim 1 to remove SEQ ID NO:4 and therefore overcame the previous rejections of record under 35 U.S.C. 103 as stated above. SEQ ID NO:4 is a required limitation of new claims 38-41 and therefore, for the sake of compact prosecution, arguments considered pertinent to the new grounds of rejection are considered below.
Response to Arguments
Applicant’s arguments, filed 28th, July, 2026 have been fully considered but are not found persuasive.
Applicant argues “Accordingly, even when the cited publications are considered in combination, there is no teaching or suggestion for a person of ordinary skill in the art to have selected the specific SEQ ID NO:4 adenoviral genome, incorporated a stabilized prefusion SARS-CoV-2 spike protein, formulated the resulting construct for intranasal administration, and reasonably expected the resulting
composition to possess the properties demonstrated in the present application. 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. 9).
In response, each of the claimed elements is made obvious by the combination of Roy1, Qin, and Roy2 with a reasonable expectation of success for the reasons set forth in the new grounds of rejection above.
Concerning Applicant’s arguments that “the resulting composition to possess the properties demonstrated in the present application” these features are not claimed. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “the properties demonstrated in the present application” ) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Concerning the reasonable expectation of success, Applicant is reminded that conclusive proof of efficacy is not required to show a reasonable expectation of success. OSI Pharm., LLC v. Apotex Inc., 939 F.3d 1375, 1385, 2019 USPQ2d 379681 (Fed. Cir. 2019) ("To be clear, we do not hold today that efficacy data is always required for a reasonable expectation of success. Nor are we requiring ‘absolute predictability of success.’"); Acorda Therapeutics, Inc. v. Roxane Lab., Inc., 903 F.3d 1310, 1333, 128 USPQ2d 1001, 1018 (Fed. Cir. 2018) ("This court has long rejected a requirement of ‘[c]onclusive proof of efficacy’ for obviousness." (citing to Hoffmann-La Roche Inc. v. Apotex Inc., 748 F.3d 1326, 1331 (Fed. Cir. 2014); PharmaStem Therapeutics, Inc. v. ViaCell, Inc., 491 F.3d 1342, 1364 (Fed. Cir. 2007); Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364, 1367–68 (Fed. Cir. 2007) (reasoning that "the expectation of success need only be reasonable, not absolute")).
Furthermore, Applicant is directed to MPEP 2143.02 which states that where there is a reason to modify or combine the prior art to achieve the claimed invention, the claims may be rejected as prima facie obvious provided there is also a reasonable expectation of success. The reasonable expectation of success requirement refers to "the likelihood of success" in combining or modifying prior art disclosures to meet the limitations of the claimed invention. See Elekta Ltd. v. ZAP Surgical Sys., Inc., 81 F.4th 1368, 1375, 2023 USPQ2d 1100 (Fed. Cir. 2023) and Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1367, 119 USPQ2d 1171, 1176 (Fed. Cir. 2016). In other words, while the prior art suggests the reason for modification, it is the preparation of the modification that requires a reasonable expectation of success. Achievement of the desired result, is not necessarily required. In the instant case, the claims are drawn to products of an adenoviral vector, a vaccine, and a pharmaceutical composition and therefore the reasonable expectation of success refers to the ability of one of ordinary skill to prepare the product of the claims in view of the teachings of the prior art. A reasonable expectation of success for each teaching is set forth in the grounds of rejection above. The features of “the properties demonstrated in the present application” argued by Applicant are not required by instant claims and therefore the combination of prior art is not required to teach them or provide a reasonable expectation of success in achieving them.
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). In contrast, intramuscular administration did not confer a sterilizing immunity, as evidenced by detectable viral RNA levels in several tissues including the lung and induction of anti-NP antibody responses (FIGs. 5C, 5G, and 9E). The differences in efficacy based on route of administration show that there is a high degree of unpredictability in the art as to whether any means of administration
would work. None of the cited publications provide any teaching or suggestion of an adenoviral vector encoding the Spike protein for intranasal administration. Thus, the skilled person would not have arrived at the claimed invention solely as a matter of noninventive routine manipulation of the art” (pg. 9).
Concerning Applicant’s arguments, as stated above, although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Because the features cited by Applicant are not recited in instant claims, they are not required to be taught or made obvious with a reasonable expectation of success.
Concerning the element of “administered intranasally” formulation for intranasal administration is made obvious with a reasonable expectation of success by the art of Qin above for the reasons set forth above and absolute predictability is not required.
While Applicant does not specifically recite an argument of an unexpected results, the features alleged by Applicant are considered as an alleged potential unexpected result for the sake of compact prosecution. In response, these results (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) argued by Applicant on pg. 9) are not a sufficient showing of unexpected results for the reasons stated below.
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 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 and also compares to intramuscular injection and not to the 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 sequence and a specific transgene sequence (ChAd-SARS-C0V-2-A; para. [0081]; see “ChAd-SARS-CoV-2-S encodes for SARS-CoV-2 S protein with the two indicated proline mutations” para. [0073]).
Furthermore, it is noted that the prior art of Qin above specifically teaches intranasal administration and also specifically teaches nasal administration can significantly enhance specific mucosal immune response (pg. 5 4th para. and Figure 4B) and resulted in inducing an SARS-CoV-2 specific mucosal IgA and systemic IgG generated (pg. 5 5th para.) and therefore immune response in the lungs and nasal areas (mucosal areas) as well as in the spleen and the heart appear (systemic areas) to be an obvious and expected result n view of Qin which evidences that intranasal administration resulting in both mucosal and systemic immune responses.
Withdrawn Provisional Non-Statutory Double Patenting
Co-Pending Application No. 18/834,113
The provisional rejection of claims 1, 6-7, 9, 12, 14 and 19 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 for the in the previous office action are withdrawn in view of Applicant’s amendments
The provisional rejection of claims 6 and 8 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”) as set forth in the previous office action is withdrawn in view of Applicant’s amendments.
New 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.
New Provisional Non-Statutory Double Patenting
Co-Pending Application No. 18/834,113
Claims 38-40 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 8, 10, 12-13 and 15 of copending application No. 18/834,113 (claim set filed 27th, July, 2026) in view of Roy et al. (US 2017/0183636-A1; see IDS filed 19th, October, 2023; henceforth “Roy”) and of Wrapp et al. (Science. 2020 Mar 13;367(6483):1260-1263. Epub 2020 Feb 19.; see IDS filed 11th, October, 2024; henceforth “Wrapp”).
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 38, U.S. Co-pending App ‘113 claims a pharmaceutical composition (claim 12) comprising 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), 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), U.S. Co-pending App ‘113 claims the transgene has stabilizing mutations (claim 8), and U.S. Co-pending App ‘113 claims the composition is formulated for intranasal administration (claim 15), and it would be obvious to combine these separately claimed embodiments.
However, regarding claim 38, 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 38, 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 38, 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).
However, regarding claim 38, 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 and U.S. Co-pending App ‘113 does not claim the K986P and V987P mutations.
Nevertheless, regarding claim 38, 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 claim 38, 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 which would make the stabilized prefusion form of the SARS-CoV-2 spike protein 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 a 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).
Regarding claims 39-40, further to the discussion of claim 38, above, U.S. Co-pending App ‘113 claims a SARS-CoV-2 spike protein sequence of SEQ ID NO: 20 (claims 1 and 3) which is at least 95% identical to SEQ ID NO: 3.
Regarding claims 39-40, further to the discussion of claim 38 above, as stated above (see claim 38 rejection above), Wrapp suggests and makes obvious the K986P and V987P mutations.
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
It is noted that the transgene of U.S. Co-pending App ‘113 is capable of being “from” the claimed variant WA1/2020.
Allowable Subject Matter
Sequences 100% identical to SEQ ID NO: 2, 5 and 6 are free of the prior art and therefore claims 1, 6-9, 12, 14, 19 and 41 are free of the prior art.
However, these claims are not allowable because claims 1, 7-8 and 40 are objected to above, claim 9 appears to be a substantially duplicate claim to claim 41, and claims 6, 9, 12, 14, 19 and 41 are dependent on claim 1 which is objected to above.
Conclusion
No claim is allowable.
Correspondence
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/BRIANA N EBBINGHAUS/Examiner, Art Unit 1632
/EMILY A CORDAS/Primary Examiner, Art Unit 1632
