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 .
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Election/Restrictions
Applicant’s amendment filed 7/8/2026 is acknowledged. Claim 59 is canceled.
Applicant’s election without traverse of the required species in the reply filed on 9/26/2024 is acknowledged.
Applicant elected the following species:
Pediatric subject’s age: at least 6 months but less than 9 years.
Number of doses of the composition according to age: two doses.
Claim 9 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9/26/2024.
Claims 1, 3-6, 11-21, and 58 are under examination on the merits.
Information Disclosure Statement
The Information Disclosure Statement (IDS) submitted on 7/8/2026 is in compliance with 37 CFR 1.97. Accordingly, the references listed in the IDS are being considered by the examiner.
Response to Arguments
Applicant's arguments filed 7/8/2026 have been fully considered but they are not persuasive. See below.
Withdrawn Objections
The previous objections are hereby withdrawn due to Applicant’s amendment submitted on 7/8/2026:
Specification
Withdrawn Rejections
The previous rejections are hereby withdrawn due to Applicant’s amendment submitted on 7/8/2026:
35 U.S.C. §112(a) – New Matter
Maintained Rejections
Claim Rejections - 35 USC § 112
(Previous Rejection Maintained) Claims 1, 3-6, 11-21, and 58 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. The rejection of claim 59 is withdrawn due to cancellation of that claim.
Applicant presents the following arguments:
Regarding the lack of definition of the term “serious adverse event,” Applicant respectfully notes that the provisional application specifically defines this term as follows: ”A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically important due to other reasons than the above mentioned criteria.” Provisional application 62/782,733 at p. 193. The provisional application was incorporated in its entirety into the present specification in paragraph [0001]. Additionally, this is a term of art that would be well understood by a skilled practitioner with knowledge of vaccine clinical trials and safety evaluations, especially in view of the definition particularly provided in the provisional application.
Applicant’s arguments have been carefully considered but are found unpersuasive because:
Rule 1.57 states that “Essential material” may be incorporated by reference, but only by way of an incorporation by reference to a U.S. patent or U.S. patent application publication, which patent or patent application publication does not itself incorporate such essential material by reference (35 CFR 1.57(d)). The rule clarifies that “[e]ssential material” is material is material that is necessary to: [..] (2) Describe the claimed invention in terms that particularly point out and distinctly claim the invention as required by 35 U.S.C. 112(b). Thus, a definition of “serious adverse event” may only be incorporated by reference to a U.S. patent or U.S. patent application publication, rather than reference to a provisional application, as Applicant has done here. Notably, Rule 1.57 allows for, if all or a portion of the specification or drawing(s) is inadvertently omitted from an application, but the application contains a claim under §1.78 for benefit of a prior-filed provisional application, that was present on the filing date of the application, and the inadvertently omitted portion of the specification or drawing(s) is completely contained in the prior-filed application, the claim under §1.78 shall also be considered an incorporation by reference of the prior-filled application as to the inadvertently omitted portion of the specification or drawing(s). (35 CFR 1.57(b)). However, Applicant has not stated that there was an inadvertent omission of the specification or drawing(s), and so that is not applicable at present. Absent a specific definition, “serious adverse event” remains unclear, renders the claims indefinite, and the rejection is maintained.
Claim Rejections - 35 USC § 103
(Previous Rejection Maintained) Claims 1, 3-6, 11-21, and 58 are rejected under 35 U.S.C. 103 as being unpatentable over Richardson, et al. (PGPub US 20160000899 A1, published 1/7/2016; hereinafter referred to as "Richardson") as evidenced by Malm, et al. (Mol Immunol. 2016 78:27-37. doi: 10.1016/j.molimm.2016.08.009 Epub 2016 Aug 29. PMID: 27573255; hereinafter referred to as "Malm") in view of Coit, et al. (PGPub US 20110014652 A1, published 1/20/2011; hereinafter referred to as "Coit"). The rejection of claim 59 is hereby withdrawn due to cancellation of the claim.
Applicant presents the following arguments in traversal of the rejection:
Applicant respectfully submits, as noted above, that the term “serious adverse event” was defined in the provisional application at p. 193, and the provisional application was incorporated by reference in its entirety into the present application. Furthermore, even assuming that the skilled practitioner may have expected the vaccine to be relatively safe, the remarkable safety of the vaccine is noteworthy, as there were no vaccine-related serious adverse events in the entire clinical trial documented in Example 1, which would not have been possible to predict based on the disclosures of the cited references. The amended claims are therefore non-obvious. For at least the foregoing reasons, Applicant submits that a case of obviousness has not been established and respectfully requests withdrawal of the rejection under 35 U.S.C. §103.
Applicant's arguments have been carefully considered but are found unpersuasive:
In response to applicant’s argument that it would not have been possible to predict that the obvious method would result in no vaccine-related serious adverse events, the fact that applicant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
With respect to any asserted unexpected results, Applicant must show proper statistics for the data to be persuasive. MPEP 716.02(b) states that 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).
Additionally, unexpected results must be commensurate in scope to the claims, and that must be evaluated against the closest prior art. In the instant case, Applicant asserts unexpected safety results from data presented in Example 1, however, the instant claims and Example 1 are not commensurate in scope. For example, claim 1 is generic to the dose (weight) of VLPs administered, yet Example 1 only studies particular amounts. While some later claims require particular amounts of VLPs, they are not identical to those of Example 1, as the claims recite “about” prior to the claimed weights. Additionally, the clinical trial described in Example 1 utilized a vaccine that included 500 µg Al(OH)3, whereas independent claim 1 does not require any adjuvant, and only claim 18 requires the composition comprises 500 µg of aluminum hydroxide. Along those lines, Example 1 utilized specific GI.1/GII.4c VLPs, whereas most of the instant claims are generic to the Norovirus genogroup I and genogroup II VLPs encompassed. Regarding the pediatric subjects’ age, Example 1 describes male and female participants aged between 6 weeks and less than 9 years at the time of enrollment (para. [0070]), while the claims require “between about 5 months and about 9 years of age”.
It is noted however that exact efficacy amount and exact safety measurement are not required for obviousness. These art data obtained after a method is done. However, obvious methods are not done in the prior art. Therefore, there is no need for such data here from the prior art. Furthermore, some efficacy and safety are expected owed to the fact that clinical trials are performed with the agents of instant claims. Therefore, the practitioners prior to filing of the instant case were confident enough in their methods to use them on patients. Therefore, one of ordinary skill in this art would share such confidence. Furthermore, as highlighted in a recent decision by the Federal Circuit in Janssen Pharmaceuticals, Inc v. Teva Pharmaceuticals USA, Inc (Case: 22-1258, Decided 04/01/2024), a court should not emphasize a protocol’s lack of results and also fail to consider that the art would fairly suggest to POSA (Pg. 22, Paragraph, second). Again, the clinical trial would suggest to POSA sufficient safety and efficacy to render obvious the claims, particularly when the drugs of the obvious method are already used to treat the target patients as discussed on record. Therefore, it is clear that no specific safety or efficacy data is required for the obvious method to be found obvious for treatment of a single patient.
In response to applicant’s argument that [1], the fact that applicant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). “[M]ere recognition of those latent properties does not render the otherwise obvious [method] unobvious and thereby patentable.” In re Prindle, 297 F.2d 251, 254 (CCPA 1962).
Double Patenting
(Previous Rejection Maintained) Claims 1, 3-6, 11-21, and 58 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 11-13, & 16-18 of U.S. Patent No. 9801934 in view of Richardson, et al. (PGPub US 20160000899 A1, published 1/7/2016; hereinafter referred to as "Richardson") as evidenced by Malm, et al. (Mol Immunol. 2016 Oct;78:27-37. Doi: 10.1016/j.molimm.2016.08.009. Epub 2016 Aug 29. PMID: 27573255; hereinafter referred to as "Malm") in view of Coit, et al. (PGPub US 20110014652 A1, published 1/20/2011; hereinafter referred to as "Coit"). The rejection of claim 59 is withdrawn due to cancellation of the claim.
(Previous Rejection Maintained) Claims 1, 3-6, 11-21, and 58 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6, 9-10, & 14-15 of U.S. Patent No. 9867876 in view of Richardson, et al. (PGPub US 20160000899 A1, published 1/7/2016; hereinafter referred to as "Richardson") as evidenced by Malm, et al. (Mol Immunol. 2016 Oct;78:27-37. Doi: 10.1016/j.molimm.2016.08.009. Epub 2016 Aug 29. PMID: 27573255; hereinafter referred to as "Malm") in view of Coit, et al. (PGPub US 20110014652 A1, published 1/20/2011; hereinafter referred to as "Coit"). The rejection of claim 59 is withdrawn due to cancellation of the claim.
(Previous Rejection Maintained) Claims 1, 3-6, 11-21, and 58 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10, 12, 15-16, 20 21 outs. Patent No. 11701420 in view of Richardson, et al. (PGPub US 20160000899 A1, published 1/7/2016; hereinafter referred to as "Richardson") as evidenced by Malm, et al. (Mol Immunol. 2016 t;78:27-37. Doi: 10.1016/j.molimm.2016.08.009. Epub 2016 Aug 29. PMID: 27573255; hereinafter referred to as "Malm") in view of Coit, et al. (PGPub US 20110014652 A1, published 1/20/2011; hereinafter referred to as "Coit"). The rejection of claim 59 is withdrawn due to cancellation of the claim.
Applicant presents the following arguments in traversal of the rejection:
Applicant respectfully submits that these rejections should be withdrawn for the same reasons as explained above for the rejection under §103. In view of the surprising safety attributes recited in the amended claims, i.e., the complete absence of vaccine-related serious adverse events in pediatric subjects, the claims would not have been obvious based on the claims of the cited patents and the disclosures of the secondary references Malm and Coit. Reconsideration and withdrawal of the rejections for alleged nonstatutory double patenting are respectfully requested.
Applicant's arguments have been carefully considered but are found unpersuasive:
As discussed above, the examiner has determined that the rejection under 35 U.S.C. §103 is proper and maintained. Therefore, Applicant’s argument against nonstatutory double patenting are unpersuasive, and the nonstatutory double patenting rejections remain proper and are maintained.
New Objections
Claims 1, 6, 12, 13, and 58 recite the term “about.” The language of the claims would be improved if “about” were removed. Appropriate correction is required.
Conclusion
THIS ACTION IS MADE FINAL. 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 allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEFFREY MARK SIFFORD whose telephone number is (571)272-7289. The examiner can normally be reached 8:30 a.m. - 5:30 p.m. ET with alternating Fridays off.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Allen can be reached at 571-270-3497. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JEFFREY MARK SIFFORD/Examiner, Art Unit 1671 /Michael Allen/Supervisory Patent Examiner, Art Unit 1671
