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.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/15/2025 has been entered.
Election/Restrictions
Applicant’s amendment filed 12/15/2025 is acknowledged.
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Claim 9 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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, 58, and 59 are under examination on the merits.
Information Disclosure Statement
The Information Disclosure Statement (IDS) submitted on 12/16/2025 is in compliance with 37 CFR 1.97. Accordingly, the IDS is being considered by the examiner.
Rejections Removed
The following rejection has been withdrawn due to abandonment of the copending application:
Claims 1, 3-6, 11-21, 58, and 59 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 22-31, 33-34, 37, & 39 of copending Application No. 18/322,679 in view of Richardson, et al. (PGPub US 20160000899 A1, published 1/7/2016).
Response to Arguments
Applicant's arguments filed 12/15/2025 have been fully considered but they are not persuasive regarding the previous rejections under 35 U.S.C. §§103 and 112(b), or for the remaining double patenting. See response below.
A new rejection under 35 U.S.C. §112(a) and objection to the specification are raised below.
New Objection
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: claims 1 and 58 recite the limitation "and wherein the method has ≤5% risk of inducing a serious adverse event in the pediatric subject" (lines 7 and 8, respectively). The specification does not provide antecedence for this claim limitation.
New Rejection
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.
(New Rejection) Claims 1, 3-6, 11-21, 58, and 59 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
This is a New Matter rejection.
The term “the method has ≤5% risk of inducing a serious adverse event in the pediatric subject” as recited in claims 1 and 58 is not supported by the original disclosure.
Applicant’s amendment filed 12/15/2025 directs support to paragraph [0082].
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Notably, the specification as filed does not define “severe adverse event”. Further, paragraph [0082] of the specification does not state “≤5% risk of inducing a serious adverse event”, but rather “severe symptoms being relatively infrequent (≤5% of subjects)”.
Such limitation recited in the present claims, which did not appear in the specification, as filed, introduces new concepts and violates the description requirement of the first paragraph of 35 U.S.C. §112. Applicant is required to cancel the new matter in response to this Office Action. Alternatively, Applicant is invited to provide sufficient written support for the “limitation” indicated above. See MPEP §714.02, §2163.05-06, and §2173.05(i).
Rejections Maintained
Claim Rejections - 35 USC § 112
(Previous Rejection Maintained) Claims 1, 3-6, 11-21, 58, and 59 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 independent claims 1 and 58 recite the limitation “ wherein the method has ≤5% risk of inducing a serious adverse event in the pediatric subject” on lines 6-7 and 10-11, respectively. The specification does not specifically define “a serious adverse event”, and the metes and bounds of the limitation are unclear. Claims 3-6, 11-21, and 59 depend from claim 1 but do not resolve the lack of clarity associated with the limitation, and thus are also rejected as indefinite.
Applicant presents the following arguments in traversal of the rejection:
Without acquiescing to the merits of the rejection, and solely in the interest of expediting patent prosecution and allowance of the instant application, Applicant has amended claims 1 and 58 to recite that the method has a ≤5% risk of inducing a serious adverse event. Support for this amendment may be found in the specification, at, e.g., para. [0082], which recites that a method according to the claims resulted in a safety profile “with severe symptoms being relatively infrequent (≤5% of subjects).” Amended claims 1 and 58, and all claims depending therefrom, are submitted to be clear and definite.
Applicant’s arguments have been carefully considered but are found unpersuasive:
The specification does not specifically define a “serious adverse event”. It is unclear what events would constitute a “serious adverse event”, and thus whether a method reads on “≤5% risk of inducing a serious adverse event”.
Claim Rejections - 35 USC § 103
(Previous Rejection Maintained) Claims 1, 3-6, 11-21, 58, and 59 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 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 claimed invention encompasses a method for inducing protective immunity against Norovirus infection in a pediatric subject, comprising administering to the subject a composition comprising Norovirus virus like particles (VLPs) in a dosing regimen, wherein the composition comprises Norovirus genogroup I VLPs and Norovirus genogroup II VLPs, wherein the dosing regimen comprises administering the composition in at least a first dose and a second dose, wherein the pediatric subject is between about 6 months to about 9 years of age, and wherein the method has ≤5% risk of inducing a serious adverse event in the pediatric subject, as recited in claim 1. In one embodiment, the composition comprises genogroup I, genotype 1 (GI.1) VLPs and genogroup II, genotype 4 (GII.4) VLPs, as recited in claim 3. In a more specific embodiment, the GII.4 VLPs are derived from expression of a consensus sequence of circulating strains of GII.4, as recited in claim 4, or the GII.4 VLPs comprise a capsid protein comprising a sequence of SEQ ID NO: 1, as recited in claim 5. The composition may comprise about 50 μg Norovirus genogroup I VLPs and about 150 μg Norovirus genogroup II VLPs, as recited in claim 6.
In one embodiment, the composition is administered to the subject in no more than two doses, as recited in claim 11. Alternatively, the first and second doses are administered to the subject about 1, about 2, or about 3 months apart, as recited in claim 12. In a specific embodiment, the second dose is administered about 2 months after the first dose, as recited in claim 13.
In particular embodiments, the composition is administered to the subject intramuscularly, as recited in claim 14, comprises an adjuvant, as recited in claim 15, a single adjuvant, as recited in claim 16, the adjuvant is aluminum hydroxide, as recited in claim 17, or the composition comprises 500 μg of aluminum hydroxide, as recited in claim 18.
In another embodiment, the method elicits at least a three-fold increase in Norovirus-specific serum antibody titer as compared to the titer in the subject prior to administration of the composition, as recited in claim 19. Alternatively, the method has a ≤24% chance of inducing pain; a ≤29% chance of inducing irritability; and/or a ≤23% chance of inducing drowsiness in the pediatric subject, as recited in claim 20. In a specific embodiment, the method induces cross-reactivity to one or more viral strains not present in the composition, as recited in claim 21.
The Prior Art
Richardson teaches methods for inducing protective immunity to Norovirus in a subject, the method comprising administering to the subject a composition comprising a genogroup I norovirus VLP and a genogroup II Norovirus VLP (claims 22 & 30). The genogroup I Norovirus VLP may be GI.1, and the genogroup II Norovirus VLP may be GII.4 (claims 23-24). Further, Richardson teaches that the VLPs may be derived from expression of a consensus sequence of circulating strains of Norovirus genogroup II, genotype 4 (para. [0029]). Richardson teaches the composition further comprising an adjuvant (claims 25 & 47), including aluminum salts such as aluminum hydroxide (claims 26 & 49). Richardson also teaches that the genogroup II Norovirus VLPs may comprise a capsid protein having a sequence of SEQ ID NO: 1, which is 100% identical to SEQ ID NO: 1 of the instant application (para. [0009]; Appendix A: alignment of instant SEQ ID NO: 1 and Richardson SEQ ID NO: 1). Malm teaches that VLPs comprising Norovirus capsid protein (such as SEQ ID NO: 1) stimulate cross-reactive antibody and T-cell responses to other Norovirus strains when administered (Fig. 2; Malm, generally). Richardson also teaches varying dosing amounts of the vaccine composition, for instance the composition may comprise about 50 μg of genogroup I Norovirus VLPs and 150 μg of genogroup II Norovirus VLPs. (paras. [0050] & [0063]). Additionally, Richardson discloses embodiments of its methods where no more than a single dose of a vaccine composition is administered (claim 37). Richardson further teaches administration of two doses of intramuscular or intranasal vaccine formulations (para. [0020]; Fig. 10). The Norovirus VLP vaccines were generally well tolerated (paras. [0097] & [0102]). Richardson’s methods result in the composition eliciting at least a three-fold increase in Norovirus-specific serum antibody titer as compared to the titer in a subject prior to administration of the composition (claim 31; para. [0062]). However, it does not teach methods for inducing protective immunity against Norovirus infection in a pediatric subject.
Coit teaches compositions and methods related to immunogenic viral polypeptides and virus-like particles (VLPs) from one or more strains of Norovirus to elicit immune response against Norovirus. (Abstract; paras. [0002], [0008]-[0009]). Coit further describes dosing regimens as depending on factors including the age of the subject and mode of administration of the composition, and that immune responses generated by delivery of the composition, such as activation of Norovirus-specific T cells, can be enhanced by varying the dosage, route of administration, or boosting regions (para. [0661]). Specifically, Coit describes dosage treatment as a single dose schedule or a multiple dose schedule, wherein for multiple dose schedules, the various doses may be administered by the same or different routes, e.g., a parenteral prime and mucosal boost, mucosal prime and parental boost, etc. (para. [0615]). Compositions taught by Coit may be given in a single dose schedule, or in a multiple dose schedule in which a primary course of vaccination includes 1-10 separate doses, followed by other doses given at subsequence time intervals required to maintain and/or reinforce an immune response, for example at 1-4 months for a second dose (para. [0662]). Coit also teaches that the compositions may include one or more antigens suitable for use in pediatric subjects, wherein the pediatric subjects are typically less than about 3 years old (para. [0531]). Administration can be by any means known in the art, including parenteral, intranasal, intramuscular, or subcutaneous injection (para. [0659]). Aluminum salts, including aluminum hydroxide, may be used as adjuvants, at a dose of between 0.2 and 1.0 mg (200-1000 μg) per dose (paras. [0420-0424].
It would have been obvious to one of ordinary skill in the art to modify the method for inducing protective immunity taught by Richardson to incorporate the dosing and use on pediatric subjects, as taught by Coit. Richardson teaches compositions and methods for inducing protective immunity to Norovirus in a subject, wherein Norovirus genogroup I and II (and specifically GI.1 and GII.4) VLPs are used, and teaches the GII.4 VLP comprising a capsid protein comprising SEQ ID NO: 1. One of ordinary skill in the art would, based on evidence provided in Malm that VLPs comprising Norovirus capsid protein stimulate cross-reactive immune responses to other Norovirus strains, expect that the compositions of Richardson to similarly stimulate cross-reactivity to one or more viral strains not present in the composition. One of skill in the art would similarly expect the vaccines to be well tolerated in a pediatric subject, since the vaccines of Richardson were well tolerated in older subjects. Richardson further teaches the quantities of Norovirus VLPs to use. Coit teaches that Norovirus VLP compositions can be administered to children at the claimed ages and dosing parameters. Determining the subject’s age is inherent in the teachings of Coit, which describes pediatric vaccines typically being applied to children at particular ages. One of ordinary skill in the art would be motivated to combine the teachings of Richardson and Coit to yield a method of inducing protective immunity against Norovirus infection in a pediatric subject. Therefore, the claimed invention was prima facie obvious to one of ordinary skill in the art before the priority date of the instant application.
Applicant presents the following arguments in traversal of the rejection:
Applicant respectfully disagrees with the obviousness rejection of the present claims at least because i) neither Richardson nor Coit discloses or suggests the pediatric safety profile of the present claims; ii) there is no suggestion or motivation to combine the references to arrive at the safety profile of the present methods; iii) the person of skill in the art would not have had a reasonable expectation of success in arriving at the claimed methods, with their recited safety profile in pediatric populations, on the basis of the disclosures of Richardson and Coit; iv) the non-obviousness of the claims is further supported by unexpected safety profile associated therewith, especially in view of the present amendments to claims 1 and 58, which now recite that the method has a ≤5% risk of inducing a serious adverse event in the pediatric subject; v) the Office has not given sufficient consideration to the safety requirements recited in the claims, which per Allergan Sales LLC v. Sandoz, Inc., should be given patentable weight.
Neither Richardson nor Coit discloses or suggests the methods of the present claims, and the pediatric safety profile recited therein. Neither Richardson nor Coit discloses or suggests a method for inducing protective immunity against Norovirus infection in a pediatric subject 6 months to 9 years of age, comprising administering Norovirus GI and GII VLPs, wherein the method has a ≤5% risk of inducing a serious adverse event. As acknowledged by the Office, Richardson does not teach methods for inducing protective immunity against Norovirus infection in a pediatric subject. In fact, Richardson is entirely silent on pediatric populations and methods pertaining thereto. While Coit is cited by the Office for suggestion to administer pediatric antigens to children, this is a generic and purely prophetic suggestion, as Coit does not exemplify such an administration anywhere in its disclosure, nor does it provide guidance for how such could be carried out safely. Neither Richardson nor Coit provides any disclosure or suggestion regarding the pediatric safety profile recited in the presently amended claims: specifically a ≤5% risk of inducing a serious adverse event in a pediatric population. Richardson is entirely silent on the subject of pediatrics, and Coit, while mentioning administration of antigens to pediatric subjects in general, fails to provide any data or teaching regarding the safety or efficacy of such compositions in children, let alone a method resulting in a ≤5% risk of serious adverse events. The cited references are silent as to the unique safety challenges and outcomes associated with vaccine administration in pediatric populations, and do not disclosure or suggest the favorable safety profile recited in the claimed methods.
There is no suggestion or motivation in Richardson or Coit to combine the references to arrive at the safety profile of the present methods. In the present instance, the Office has relied on Coit for providing the motivation to apply the methods of Richardson to a pediatric population. To support the motivation to combine, the Office asserts that Richardson does not ever teach against giving the formulations to a human within the claimed group, and appears to use this as the basis for combining Richardson’s teachings with those of Coit. However, the absence of a formal teaching away in one reference does not automatically establish a motivation to combine it with another reference in the same field. In this case, Applicant submits that the skilled person would not have been motivated to combine the cited references in the manner suggested because 1) Richardson does not provide any evidence of efficacy or safety of norovirus VLP compositions in children, and 2) the disclosure of Coit related to “pediatric subjects” is generic and prophetic, and does not provide any evidence or guidance as to how to carry out such methods in pediatric subjects. The person of skill in the art would not have been motivated by Coit’s generic disclosure to modify the methods of Richardson to apply to a pediatric subject between the ages of about 6 months and 9 years of age with the claimed dosing regimen, especially in view of Richardson’s silence on this subject population. This is moreover the case in view of the complete absence of any evidence of, e.g., human trials or dosing in the disclosure of Coit. There is no suggestion or motivation in the cited references to combine their teachings in a manner that would result in the specific pediatric safety profile recited in the claims. The prior art does not address, let alone motivate, the development of Norovirus VLP compositions with a demonstrated ≤5% risk of SAEs in pediatric subjects. Absent any teaching, suggestion, or motivation in the references to arrive at such a safety profile, the combination proposed by the Office is based on hindsight rather than a reasoned basis supported by the prior art.
No reasonable expectation of success in achieving the claimed pediatric safety profile. The Office’s assertion that the skilled person would expect similar safety results in pediatric subjects on the basis of the results in older subjects is mere conjecture. As taught by Kern, clinicians face physiological and pharmacometrics challenges in the pediatric population. In addition, Kern states that “heterogeneity within a pediatric population is likely to be significantly larger than that observed in an adult population,” since the age range includes children of significantly varied ages. Furthermore, Applicant disagrees with the Office’s allegation that Richardson’s VLPs may be empty (no genome) so in one sense they can be considered safe, and Applicant has not established that the norovirus antigens of Richardson and Coit are dangerous. In contrast to these assertions, Kern teaches that “the need to create pediatric-appropriate formulations for adult medicines can be very challenging as compounds that are generally regarded as safe for adults may not have similar designation in children”. Absent any evidence in support of Norovirus VLP vaccine safety in a pediatric population, the Office does not have any grounds for asserting that the results observed in adults would equally be expected in children. On the contrary, the pediatric population is notoriously difficult for vaccine development, since vaccines that are well tolerated by adults may induce serious adverse events in children.
Applicant submits that the non-obviousness of the claimed methods is further supported by the unexpected results associated therewith. The present claims recite a method of inducing protective immunity against norovirus in a pediatric population, with a ≤5% risk of inducing serious adverse events. These claims are based on the novel disclosure of the present application, documenting the results of a clinical trial of a norovirus VLP vaccine administered to pediatric subjects, which demonstrated a remarkably safe adverse event profile in this patient population. Paragraph [0082] of the instant specification teaches the following: no vaccine-related severe adverse events (SAEs) or fatal SAEs were reported [ .. ] with severe symptoms being relatively infrequent (≤5% of subjects). These results demonstrate a complete absence of vaccine-related SAEs and an overall SAE incidence of ≤5% overall, which results are all the more noteworthy because the pediatric population is a notoriously difficult patient population for clinical trials of novel medications. The present application is significant in disclosing the unexpected result that methods of administering norovirus VLP vaccine compositions per the claims are “associated with a surprisingly safe adverse event profile in a pediatric population” (para. [0058]) and have “an acceptable safety profile in this population of patients, even in the context of 2 or 3 doses (para. [0086]). Even the most frequent symptoms of pain, irritability, and drowsiness were reported for fewer than one third of the patients after any vaccine dose (para. [0085]).
As held in Allergan Sales, LLC v. Sandoz, Inc., wherein clauses specifying minimum safety and efficacy requirements are material to patentability and limiting. Such claim limitations must be given patentable weight and cannot be dismissed as mere statements of intended use or result. The safety limitation now recited in independent claims 1 and 58, specifically, a ≤5% risk of serious adverse events in pediatric subjects, is a substantive requirement that distinguishes the claimed methods from the prior art. Neither Richardson nor Coit discloses any details of the safety or a norovirus VLP vaccine in a pediatric population, let alone in the age range of about 6 months to about 9 years of age recited in the claims. The person of skill in the art would not have been able to predict the particularly safe adverse event profile or norovirus VLP vaccines across the heterogenous pediatric population recited in the claims, which spans multiple age ranges, based on the disclosure of these references, alone or in combination. The foregoing deficiencies are not cured by the evidentiary reference Malm, which discloses antibody responses in immunized mice, and provides no teachings related to the pediatric population or adverse event profile recited in the claims.
Applicant’s arguments have been carefully considered but are found unpersuasive:
As discussed above in the rejection under 35 U.S.C. §112(b), the limitation “wherein the method has a ≤5% risk of inducing a serious adverse event in the pediatric subject is unclear. Applicant argues that the unexpected result is ≤5% risk of inducing a serious adverse event in the pediatric subject, but it is unclear to the examiner what a “serious adverse event” is, and so it is not clear how that result can be unexpected, particularly when the prior art does not describe serious adverse events at 5% or higher frequency. Applicant argues that the Office needs to consider the safety profile of the claimed invention, but it is unclear what that encompasses. It is not clear how one of skill in the art would know whether or not their method reduced the risk of such events, because the events are not defined.
Richardson states that they want to formulate their norovirus compositions to help with viral infections in humans. That generic term of human includes infants, adults, and elderly. The working examples do focus on adults, but Richardson does not ever teach against giving the formulations to a human within the claimed age group.
Coit is focused on norovirus and sapovirus VLPs/antigens. While paragraph [0531] does list several antigens, the paragraph also ends in saying “Examples of specific antigens derived from these pathogens are described above.” Paragraph [0514] also mentions “Calciviridae; Viral antigens may be derived from Calciviridae, such as Norwalk virus, and Norwalk-like viruses, such as Hawaii Virus and Snow Mountain Virus.” Coit also mentions that they are focused on all genogroups of norovirus (Genogroups GI-GIV), paragraph [0198]. With the focus by Coit of their application being norovirus and sapovirus antigens (as stated by the title), and with the additional disclosure that they want to administer antigens to pediatric subjects, which are humans, and examples of such antigens including norovirus antigens/VLPs (based on para. [0531] and the those preceding it), one of ordinary skill in the art would be motivated to combine these teachings with those of Richardson et al.
The motivation to use the teachings of Coit to modify Richardson is that Richardson is focused on helping humans fight off infections by norovirus. Humans in the claimed age group are not immune to norovirus, therefore, they should be considered and Coit provides such motivation. Even though Coit does not provide a specific example of providing the VLP composition to children, it does identify children as a vulnerable population and contemplates their treatment.
In response to applicant’s argument that the examiner’s conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant’s disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
It is noted however that exact efficacy amount and exact safety measurement are not required for obviousness. These are 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 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. “[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, 58, and 59 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 instant application and U.S. Patent No. 9801934 are not identical but are not patentably distinct from each other in view of Richardson as evidenced by Malm, and in further view of Coit. The differences in the instant and U.S. Patent No. 9801934 are that while the instant application is drawn to a method of eliciting protective immunity against Norovirus infection in a pediatric subject, U.S. Patent No. 9801934 is drawn to compositions and methods for inducing an immune response in a subject. There are also several differences between the dosing regimens and administration forms. However, Richardson and Coit teach such dosing regimens and administration forms of the instant application. Both the instant application and U.S. Patent No. 9801934 teach use of compositions comprising VLPs derived from the same genogroups and genotypes, with adjuvants. They also each encompass the genogroup II Norovirus VLP comprising a capsid protein sequence derived from a consensus sequence of Norovirus genogroup II VLPs. Although US Patent No. 9801934 does not teach use of a genogroup II Norovirus VLP that comprises a capsid protein having the sequence of SEQ ID NO: 1, it is still obvious since Richardson teaches its use. Determining the subject’s age is inherent in the teachings of Coit, which describes pediatric vaccines typically being applied to children at particular ages, including those in the instant application such as between 6 months and less than 9 years of age. Furthermore, Coit teaches use of the adjuvant aluminum hydroxide at 200 μg to 1 mg per dose.
(Previous Rejection Maintained) Claims 1, 3-6, 11-21, 58, and 59 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 instant application and U.S. Patent No. 9867876 are not identical but are not patentably distinct from each other in view of Richardson as evidenced by Malm, and in further view of Coit. The differences in the instant and U.S. Patent No. 9867876 are that while the instant application is drawn to a method of eliciting protective immunity against Norovirus infection in a pediatric subject, U.S. Patent No. 9867876 is drawn to compositions and methods for inducing protective immunity to Norovirus in a subject. There are also several differences between the dosing regimens and administration forms. However, Richardson and Coit teach such dosing regimens and administration forms of the instant application. Both the instant application and U.S. Patent No. 9867876 teach use of compositions comprising VLPs derived from the same genogroups and genotypes, with adjuvants. Although US Patent No. 9801934 does not teach the genogroup II Norovirus VLP comprising a capsid protein sequence derived from a consensus sequence of Norovirus genogroup II VLP, or use of a genogroup II Norovirus VLP that comprises a capsid protein having the sequence of SEQ ID NO: 1, they are still obvious since Richardson teaches their use. Determining the subject’s age is inherent in the teachings of Coit, which describes pediatric vaccines typically being applied to children at particular ages, including those in the instant application such as between 6 months and less than 9 years of age. Furthermore, Coit teaches use of the adjuvant aluminum hydroxide at 200 μg to 1 mg per dose.
(Previous Rejection Maintained) Claims 1, 3-6, 11-21, 58, and 59 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10, 12, 15-16, 20-21 of U.S. 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 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 instant application and U.S. Patent No. 11701420 are not identical but are not patentably distinct from each other in view of Richardson as evidenced by Malm, and in further view of Coit. The differences in the instant and U.S. Patent No. 11701420 are that while the instant application is drawn to a method of eliciting protective immunity against Norovirus infection in a pediatric subject, U.S. Patent No. 11701420 is drawn to methods of eliciting protective immunity against Norovirus in a human. Additionally, US Patent No. 11701420 is drawn to methods where the composition comprises a genogroup I Norovirus VLP or a genogroup II Norovirus VLP, whereas some embodiments of the instant application are drawn to the composition comprising both Norovirus genogroup I VLPs and Norovirus genogroup II VLPs. But, Richardson teaches combination of Norovirus genogroup I VLPs and Norovirus genogroup II VLPs in a single composition. There are also several differences between the dosing regimens and administration forms. However, Richardson and Coit teach such dosing regimens and administration forms of the instant application. Both the instant application and U.S. Patent No. 11701420 teach use of compositions comprising VLPs derived from the same genogroups and genotypes, with adjuvants. Both the instant application and US Patent No 11701420 teach use of a genogroup II Norovirus VLP that comprises a capsid protein having the sequence of SEQ ID NO: 1. Although US Patent No. 11701420 does not teach the genogroup II Norovirus VLP comprising a capsid protein sequence derived from a consensus sequence of Norovirus genogroup II VLP, it is still obvious since Richardson teaches their use. Determining the subject’s age is inherent in the teachings of Coit, which describes pediatric vaccines typically being applied to children at particular ages, including those in the instant application such as between 6 months and less than 9 years of age. Furthermore, Coit teaches use of the adjuvant aluminum hydroxide at 200 μg to 1 mg per dose.
Applicant presents the following arguments in traversal of the rejection:
None of the claims of the recited patents recite a method of inducing protective immunity against norovirus in a pediatric subject, comprising administering at least two doses of norovirus GI and GII VLPs, wherein the method has a ≤5% risk of inducing a serious adverse event in the pediatric subject. With respect to the cited claims, the Office acknowledges that the cited patents do not pertain to pediatric methods. However, the Offices alleges that Richardson and Coit teach dosing regimens and administration forms for pediatric subjects that, in combination with the claims of the cited patents, would render obvious the present claims.
The patent claims do not recite a method of inducing protective immunity in a pediatric subject, while the claims of the instant application explicitly recite methods restricted to pediatric subjects. It appears that Richardson and Coit are relied on by the Office to explain why a person of ordinary skill in the art would conclude that the invention defined in the application claims at issue would have been an obvious variation of the invention defined in the claims of the cited patents. However, the Office’s statements regarding the teachings of Richardson and Coit make it clear that the Examiner is relying on the combination of teachings from the cited patent claims (methods of inducing protective immunity) and the disclosure of Richardson and Coit (particular dosing regimens and administration forms) to arrive at the present claims. This does not constitute a proper obviousness-type double patenting rejection. The Examiner has not explained why the presently rejected claims are an obvious variant of the cited patent claims, without relying on combination with the disclosure of a secondary reference.
At most, the Office may rely on a secondary reference to help explain why the application claims are allegedly an obvious variant of the referenced patent claims. However, neither Richardson nor Coit render obvious the present claims, which recite a ≤5% risk of inducing an SAE in a pediatric subject. Richardson and Coit are entirely silent on the safety or efficacy of norovirus VLPs in pediatric subjects and do not render obvious the surprising safety profile now recited in the claims. Richardson and Coit thus provide no reason why a person of ordinary skill in the art would conclude that the invention defined in the claims of the instant application would have been an obvious variation of the invention defined in the claims of the cited patents. Therefore, the Office has not established a proper non-statutory obviousness-type double patenting rejection.
Applicant respectfully requests rejoinder of claim 9, which was previously withdrawn from consideration pursuant to the restriction requirement and species election. As the claims currently under examination are believed to be allowable, Applicant submits that claim 9 is now eligible for rejoinder in accordance with MPEP §821.04.
Applicant’s arguments have been carefully considered but are found unpersuasive:
The cited patents encompass compositions and methods of eliciting immunity against Norovirus in a subject. It is permissible to rely on a secondary reference to provide motivation in an obviousness-type double patenting rejection. MPEP §804(II)(B)(3) states, “[a]ny secondary reference used to support an obviousness analysis for a nonstatutory double patenting rejection must be prior art under 35 U.S.C. 102 or pre-AIA 35 U.S.C. 102.” In the instant case, both Richardson and Coit qualify as prior art under 35 U.S.C. §102.
Rejoinder of claim 9 is improper because the examined claims are not allowable.
Conclusion
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.
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/JEFFREY MARK SIFFORD/Examiner, Art Unit 1671 /BENJAMIN P BLUMEL/Primary Examiner, Art Unit 1671