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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed on 28 September 2023. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Election/Restrictions
Applicant’s election without traverse of Group I, corresponding to claims 1-6, 12, 14-16, and 18-19, the norovirus genotype in claims 2, 6, and 19, and SEQ ID NOs for epitopes A (5), D (431), E (354), and F (392), in the reply filed 27 May 2026 is acknowledged. Claims 10-11, 17, and 20-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 27 May 2026.
Claim Status
Claims 1-6, 10-12, and 14-28 are pending. Claims 10-11, 17, and 20-24 are withdrawn. Claims 1-6, 12, 14-16, 18-19, and 26-28 were considered on the merits.
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.
Claims 1-6, 12, 14-16, 18-19, and 25-28 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.
Regarding claim 1, the phrase "a portion of an amino acid sequence" renders the claim indefinite because it is unclear what is considered a portion. The broadest reasonable interpretation of the claim would include di- and tri-peptide sequences and up to the entire P domain minus a single amino acid. In addition, paragraph 0032 in the specification recites that "the peptide of the present invention can have any amino acid sequence inside the epitope or on the N-terminal side or C-terminal side thereof, and can have an amino acid sequence not derived from naturally occurring norovirus or a non-natural amino acid sequence", it is deemed that the peptide specified by the above-mentioned recitation of Claim 1 includes any peptide containing two or more amino acid residues, and the extension of the invention according to Claim 1 in indefinite. The dependent claims (2-3, 5-6, 12, 14-16, and 18-20) do not add additional clarity and, therefore, are also indefinite.
Regarding claims 1, 5, 15, and 18 the phrase “(except genotype 4)” renders the claim indefinite because it is unclear whether the limitation(s) following in the parentheses are part of the claimed invention or an example. See MPEP § 2173.05(d).
Claim 4 recites the limitation "the epitope" in lines 1, 3, 5, and 7. There is insufficient antecedent basis for this limitation in the claim because the epitope is not recited previously in the claim or claim 1 for which claim 4 is dependent on and it is unclear what the epitope entails as it is not clearly defined.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 15-16 and 18-19 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The limitations “for use in inducing protective immunity…” (15-16) and “for use in treating an infection…” (18-19) are intended uses that do not further the claims, embodiments that have the prescribed function, as they do not provide further structure to the composition.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claims 25-28 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The limitations that the epitopes have an amino acid sequence “at least 90% identical” does not further limit the claim on which it depends (claim 4), as claim 4 requires the peptide to consist of the amino acid sequence which means having 100% sequence identity. Therefore, claims 25-28 broaden the limitations of claim 4 rather than narrow.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 3, 14-16, 18-19, and 25-28 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus. See, e.g., Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1340, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010); University of California v. Eli Lilly & Co., 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997) at 1406; Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330, 1337, 2021 USPQ2d 893 (Fed. Cir. 2021) ("[T]he written description must lead a person of ordinary skill in the art to understand that the inventor possessed the entire scope of the claimed invention. Ariad, 598 F.3d at 1353–54 ('[T]he purpose of the written description requirement is to ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification.' (internal quotation marks omitted).").
A “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014). The issue is whether the skilled artisan would understand inventor to have invented, and been in possession of, the invention as claimed.
The Federal Circuit has clarified the application of the written description requirement to inventions in the field of biotechnology. See University of California v. Eli Lilly and Co., 119 F.3d 1559, 1568,43 USPQ2d l398, 1406 (Fed. Cir. 1997). The Court stated that a written description of an invention requires a precise definition, one that defines the structural features of the chemical genus that distinguishes it from other chemical structures. A definition by function does not suffice to define the genus because it is only an indication of what the genus does, rather than what it is. Further, the Court held that to adequately describe a claimed genus, an applicant must describe a representative number of species of the claimed genus, and that one of skill in the art should be able to “visualize or recognize the identity of the members of the genus.”
Claim 3
Instant claim 3 is drawn to the whole amino acid sequence of a neutralizing epitope (epitope A, D, E, or F), which has written description support. However, the instant claims also broadly encompass portions of these neutralizing epitopes.
The Specification has failed to sufficiently describe the amino acids that must be retained by the members of the claimed genus as to establish a structure-function relationship with respect to the ability of the epitopes to elicit a neutralizing immune response to epitopes A, D, E, or F.
Portions of the A, D, E, or F epitopes encompasses a vast genus of proteins and the Specification does not adequately describe the necessary amino acids that must remain for the amino acid sequences to be able to elicit a neutralizing immune response.
While the instant claims are drawn to a genus that comprises innumerable permutations of sequences, the Specification has only adequately described and successful reduced to practice proteins that elicit a neutralizing antibody response with the full-length epitopes (A, D, E, or F). As such, the Specification reasonably demonstrates that Applicant was in possession of the full-length A, D, E, and F epitopes. However, this is not representative of the extremely large genus of proteins since only the full-length protein are supported and not the innumerable sequences or proteins contained within a genus of a portion of an amino acid sequence of epitopes A, D, E, or F.
The data generated for the proteins that elicit a neutralizing antibody response with the full-length epitopes (A, D, E, or F) cannot be reasonably extrapolated and applied to support possession of the entire claimed genus of proteins because no one species, combination, or variant accounts for the variability among the claimed genus. As in Ariad, merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials consisting the genus and showing that one has invented a genus and not just a species. “A patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion.” Brenner v. Manson, 383 U.S. 519, 536 (1966).
Lindesmith, et al. (Immunity. 2019 Jun 18;50(6):1530-1541.e8.) provides a review of epitopes A, D, and E as neutralizing epitopes from noroviruses, the full-length epitope is the neutralizing epitope, not portions. While Applicant may may have possession of the proteins of portions of the epitopes, as the portions have not been sown to elicit a neutralizing immune response, portions would not be considered neutralizing epitopes.
Claims 14-16 and 18-19
Instant claims 14-16 and 18-19 are drawn to a vaccine that induces protective immunity and is used to treat infections comprising a peptide that is a neutralizing epitope (A, D, E, or F) of a P domain of a VP1 protein of a norovirus, which has written description support. However, the instant claims also broadly encompass vaccines comprising other portions of the P domain as well as portions of the neutralizing epitopes.
The Specification has failed to sufficiently describe the amino acids that must be retained by the members of the claimed genus as to establish a structure-function relationship with respect to the ability of the epitopes to elicit an immune response to the neutralizing epitopes.
Portions of the P domain of a VP 1 protein of a norovirus encompasses a vast genus of proteins and the Specification does not adequately describe the necessary amino acids that must remain for the amino acid sequences to be able to elicit a neutralizing immune response.
While the instant claims are drawn to a genus that comprises innumerable permutations of sequences, the Specification has only adequately described and successful reduced to practice vaccines with the full-length epitopes (A, D, E, or F). As such, the Specification reasonably demonstrates that Applicant was in possession of the full-length A, D, E, and F epitope vaccines. However, this is not representative of the extremely large genus of proteins since only the full-length protein vaccines are supported and not the innumerable sequences or proteins contained within a genus of a vaccine comprising portion of an amino acid sequence of a P domain of a VP1 protein of a norovirus.
The data generated for the vaccines that elicit a neutralizing antibody response with the full-length epitopes (A, D, E, or F) cannot be reasonably extrapolated and applied to support possession of the entire claimed genus of vaccines because no one species, combination, or variant accounts for the variability among the claimed genus. As in Ariad, merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials consisting the genus and showing that one has invented a genus and not just a species. “A patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion.” Brenner v. Manson, 383 U.S. 519, 536 (1966).
Lindesmith provides a review of epitopes A, D, and E as neutralizing epitopes from noroviruses, the full-length epitope is the neutralizing epitope, not portions. While Applicant may may have possession of the proteins of portions of the epitopes, as the portions have not been shown to elicit a neutralizing immune response, portions would not be considered vaccines.
Claims 25-28
Instant claims 25-28 are drawn to the whole amino acid sequence of an epitope (epitope A, D, E, or F), which has written description support. However, the instant claims also broadly encompass sequences at least 90% identical to the full-length epitopes.
The Specification has failed to sufficiently describe the amino acids that must be retained by the members of the claimed genus as to establish a structure-function relationship with respect to the ability of the epitopes to elicit a neutralizing immune response to epitopes A, D, E, or F.
At least 90% identical to the full-length A, D, E, or F epitopes encompasses a vast genus of proteins and the Specification does not adequately describe the necessary amino acids that must remain for the amino acid sequences to be able to elicit a neutralizing immune response.
While the instant claims are drawn to a genus that comprises innumerable permutations of sequences, the Specification has only adequately described and successful reduced to practice proteins that elicit a neutralizing antibody response with the full-length epitopes (A, D, E, or F). As such, the Specification reasonably demonstrates that Applicant was in possession of the full-length A, D, E, and F epitopes. However, this is not representative of the extremely large genus of proteins since only the full-length protein are supported and not the innumerable sequences or proteins contained within a genus of a portion of an amino acid sequence of epitopes A, D, E, or F.
The data generated for the proteins that elicit a neutralizing antibody response with the full-length epitopes (A, D, E, or F) cannot be reasonably extrapolated and applied to support possession of the entire claimed genus of proteins because no one species, combination, or variant accounts for the variability among the claimed genus. As in Ariad, merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials consisting the genus and showing that one has invented a genus and not just a species. “A patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion.” Brenner v. Manson, 383 U.S. 519, 536 (1966).
Lindesmith provides a review of epitopes A, D, and E as neutralizing epitopes from noroviruses, the full-length epitope is the neutralizing epitope, not portions. While Applicant may may have possession of the proteins of portions of the epitopes, as the portions have not been sown to elicit a neutralizing immune response, portions would not be considered neutralizing epitopes.
Accordingly, the claims as currently written are not adequately described and one of skill in the art would readily appreciate that Applicant was not in possession of the claimed genus at the time of filing.
Claims 15-16 and 18-19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the Specification, while being enabling for using the full-length neutralizing epitopes for inducing an immune response or treating an infection, does not reasonably provide enablement for all portions of an amino acids sequence of a P domain of a VP1 protein of a norovirus. The Specification does not enable any person skilled in the area to which it is most nearly connected, to use the invention commensurate in scope with these claims.
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue.” These factors include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
In re Wands, 858 F.2d 732, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
The breadth of claims 15-16 and 18-19 broadly encompasses using a portion of an amino acid sequence of a P domain of a VP1 protein of a norovirus to induce an immune response or treat an infection.
The embodiments of using non-immune response eliciting portions of the P domains to induce an immune response or treat infection are not enable because these portions do not induce an immune response and therefore, cannot treat an infection. The level of skill in the art is high and would include, e.g. PhD level scientists.
The Specification only provides working examples of the peptide portions being used to elicit an immune response/treat an infection when the portion is a full-length neutralizing epitope (pgs. 27-28) but does not provide any working examples of other portions of the P domain or portions of the neutralizing epitopes.
Lindesmith provides a review of epitopes A, D, and E as neutralizing epitopes from noroviruses, the full-length epitope is the neutralizing epitope, not portions. Lindesmith demonstrates that the ability of the neutralizing epitopes to be used for inducing an immune response or treating an infection is not reasonably predictive of the ability of other portions of the P domain to induce an immune response or treat infections because the other regions of the P domain do not retain the structure required to induce an immune response. The neutralizing epitopes are situated as to be accessed by the immune system while other portions of the sequence are hidden.
In view of the breadth of the claims, the limited teachings of the Specification and the examples regarding using portions of the P domain to induce an immune response or treat infection, the state of the art, and the low predictability with regard to the ability of other P domain portions to induce an immune response or treat an infection, it would require undue experimentation to practice the claimed uses of the composition.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-6, 12, 14-16, 18-19, and 25-28 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. This judicial exception is not integrated into a practical application and the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons set forth below. See MPEP § 2106 for analysis framework.
The instant claims are broadly drawn to a peptide that comprises a portion of an amino acid sequence of a P domain of a VP1 protein of a GII norovirus and compositions comprising the same. As such, the instant claims are drawn to a composition of matter, which is a statutory category of invention (STEP 1: YES).
The instant Specification evidences that VP1 is a naturally occurring protein in GII noroviruses (¶0016). As such, noroviruses would naturally create this protein, including portions of the protein. Given the breadth of “a portion … of a P domain of a VP1 protein of a norovirus”, natural dipeptides (i.e. glycyl-leucine) would also be naturally occurring peptides.
Expressing naturally occurring proteins or portions of these proteins would not, absent evidence to the contrary, result in any markedly different characteristics with respect to structure, function, or any other property to distinguish the claimed protein or portions of the protein from their naturally occurring counterparts.
Accordingly, the instant claims recite a natural phenomenon, i.e. naturally occurring VP1 protein, which is a judicial exception (JE) (STEP 2A, Prong One: Yes).
The instant claims are drawn solely to the JE, and not a method of using the JE for, e.g. a specific treatment or prophylaxis. As such, the instant claims do not recite any additional elements that integrate the JE into a practical application (STEP 2A, Prong Two: NO).
Since the instant claims are limited to only the JE, the instant claims do not recite any additional elements that amount to significantly more than the JE (STEP 2B: NO).
In view of the foregoing, the instant claims do not constitute patent eligible subject matter under 35 U.S.C. §101.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 5-6, 12-13, 15-16, and 18-19 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Nilsson, et al. (US 20210069310 A1, hereinafter “Nilsson”).
Regarding claims 1-3, 5-6, 15-16, and 18-19, Nilsson discloses a peptide which comprises a glycyl-leucine dipeptide (REF SEQ ID NO: 307) is a portion of an amino acid sequence of a P domain of a VP1 protein of a GII.2 norovirus, more specifically, a portion of the D epitope (see instant SEQ ID NO: 431 residues 1 and 2).
For claims 15-16 and 18-19, as stated in the above 112(d) rejection, the “for use” phrases do not further limit the claim.
Regarding claims 5-6, Nilsson discloses that the peptide further comprises the amino acids Trp-Glu-Ala-Gly-Ser-Ala which is an amino acid sequence that is not present in a P domain of a VP1 protein of a GII.2 norovirus (REF SEQ ID NO: 307).
Regarding claims 12-13, Nilsson discloses that the peptide can be used for a vaccine (Claim 29).
Accordingly, the claimed inventions are anticipated by Nilsson.
Claim 1 is rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Rauch, et al. (US 20190125857 A1, hereinafter “Rauch”).
Regarding claims 1, 12, 14, 15-16, and 18-19, Rauch discloses norovirus vaccines that include fragments of a P domain of a VP1 of a norovirus (¶0007).
For claims 15-16 and 18-19, as stated in the above 112(d) rejection, the “for use” phrases do not further limit the claim. Even if the function is required, the prior peptide is capable of the function as the portion of the norovirus protein can be used as a vaccine which induces an immune response or treats an infection (¶0007) and that the protein comes from a GII.2 norovirus (¶0156).Accordingly, the claimed invention is anticipated by Rauch.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 4 and 25-28 are rejected under 35 U.S.C. 103 as being unpatentable over Rauch as applied to claim 1 above, and further in view of Seis, et al. (Viruses. 2019 May 10;11(5):432., hereinafter “Seis”).
As described above, claim 1 was anticipated by Rauch.
Regarding claims 4 and 25-28, Rauch teaches a peptide comprising a portion of the P domain of a VP1 protein of a norovirus (¶0007). Rauch does not teach that the portions are specially the A, D, E and F epitopes. However, Seis teaches that epitopes A, D, E and F are known neutralizing epitopes (pgs. 12 and 13), more specifically blockade epitopes to which antibodies bind to prevent binding of virus to host receptor.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to have combined the teachings of Rauch for a vaccine comprising a portion of the P epitope of a VP1 of a norovirus and the teachings of Seis for the known blockade epitopes A, D, E, and F. Seis provides motivation by teaching that the epitopes help produce antibodies that prevent viral biding to host receptors (pg. 12 and 13). One of skill in the art would have a reasonable expectation of success in combining the teachings of Rauch and Seis because they both teach norovirus epitopes. Furthermore, one of skill in the art would arrive to instant SEQ ID NOs: 5, 431, 354, and 392 as these are known sequences of epitopes A, D, E, and F, respectively, for norovirus GII.2 as seen by REF SEQ ID NOs: 2546, 2547, 1427, 436, 3996, 1890, and 1883 which all contain SEQ ID NOs: 5, 431, 354, and 392. One of skill in the art would have a reasonable expectation of success in creating a peptide with these epitopes as they are known epitopes and sequences of norovirus.
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art before the effective filing date, especially in the absence of evidence to the contrary.
Conclusion
NO CLAIMS ARE ALLOWED
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Cassandra Senn Grizer whose telephone number is (571)272-2292. The examiner can normally be reached M-Th 0630 - 1700 ET.
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/CASSANDRA SENN GRIZER/ Examiner, Art Unit 1672
/THOMAS J. VISONE/ Supervisory Patent Examiner, Art Unit 1672
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