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 .
Election/Restrictions
Applicant's election without traverse of Group I claims 16-30 and the species of a), b) h) or i) in the reply filed on September 9, 2025 is acknowledged. Claims 31-35 are withdrawn as being drawn to non-elected invention. Claims 16-30 are under examination in this Office action.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on November 25, 2025, September 8, 2025, April 22, 2025 and May 25, 2022 has been considered by the examiner.
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 16-17 and 19-30 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims are directed to an immunogenic composition comprising a peptide comprising at least 10 consecutive amino acids of the region from 649-658 of HBV polymerase comprising the amino acid sequence sent forth in SEQ ID NO: 19 (p649-658) and/or SEQ ID NO: 20 (p650-658). Claims are also drawn to HBV peptide epitopes comprising SEQ ID NO: 1, SEQ ID NO: 2 and SEQ ID NO: 31.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims recite naturally occurring peptide epitopes of HBV that are naturally processed and presented on HLA class I molecules in humans, as short peptides, as further discussed below.
Sette et al. (US Patent 6,689,363) discloses a naturally occurring HBV peptide epitope comprising a sequence identical with present SEQ ID NO: 19 and comprising present SEQ ID NO: 20 (see SEQ ID NO: 1785).
Krebber et al. (US Patent 10,898,567) disclose a naturally occurring HBV peptide epitope comprising a sequence identical with present SEQ ID NO: 1 (CGYPALMPLY).
Grey et al. (US Patent 9,340,577) discloses an HBV peptide comprising a naturally occurring HBV peptide epitope comprising a sequence identical with present SEQ ID NO: 2 (GPCALRFTS).
Georges et al. (US Patent 10,300,132) teaches an HBV epitope identical with present SEQ ID NO: 31 (HLSLRGLPVCAFSSAGPCALRFTSA).
The amino acid sequences of present SEQ ID NO: 1, 2, 19, 20 and 31, represent naturally occurring HBV-X amino acid epitopes. The present claims fail to recite significantly more than the judicial exception.
The recitation of “pharmaceutically acceptable carrier” does not make claim 16 eligible under 35 U.S.C. 101 because the pharmaceutically acceptable carrier could be water which is naturally occurring. The recitation of “adjuvant” in claim 17 does not make claim 17 eligible under 35 U.S.C. 101 because the adjuvant could be water which is naturally occurring. See Subject Matter Eligibility Example 28 claim 3. The structure of the naturally occurring peptide dispersed in water is not changed to render it distinct from the naturally occurring structure.
It is noted that claim 18 is not rejected since an immune potentiating adjuvant does not naturally exist together with an immunogenic peptide.
Regarding present claim 28, reciting “the fragment comprising at least 10 consecutive amino acids of the region from position 57 to position 78 of HBV-X. The 10 consecutive amino acids of the region from position 57 to position 78 of HBV-X are represent a naturally occurring fragment of HBV-X.
Association for Molecular Pathology v. Myriad Genetics, Inc. (2013): The Supreme Court held that naturally occurring DNA segments are not patent eligible merely because they have been "isolated" from the body, as the act of isolation does not change their fundamental nature or the genetic information they encode. The court established that a product must have "markedly different characteristics" from its natural counterpart to be eligible for a patent.
In the present case, the amino acid sequences recited in the present claims are naturally occurring fragments of HBV polymerase. Thus, since the present claims fail to recite significantly more than the judicial exception, the claims are rejected under 35 U.S.C. 101.
Claim Rejections - 35 USC § 112
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 19, 23 and 24 re 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. 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 19 depends from claim 16. Claim 16 lists species of a) through m). Claim 19 fails to recite the species for i), k), l), and m). Thus claim 19 fails to further limit the i), k), l), and m) species of claim 16.
Claim 23, depends from claim 16 and recites further limitations regarding the species of a), b) and c). Claims 23 fails to further limit claim 16 with regard to species d), e), f), g), h), i), k), l), and m).
Claim 24, recites wherein the peptide comprises or consists of a sequence selected from SEQ ID NO: 31. Claim 24 fails to further limit claim 16 from which it depends because it does not state whether the peptide further comprises or consists of SEQ ID NO: 31. Applicant is suggested to amend claim 24 to recite: “wherein the peptide further comprises SEQ ID NO: 31 (…)”.
Correction is required.
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)(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 16-18, 20-22, 24, 25, and 30 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Georges et al. (US Patent 10,300,132).
Georges et al., disclose an immunogenic composition comprising HBV polymerase peptide epitopes comprising at least two peptides from 20 to 34 amino acids in length comprising a sequence identical with present SEQ ID NO: 19 (CGYPALMPLY), SEQ ID NO: 20 (GYPALMPLY), and SEQ ID NO: 31 comprising an immune potentiating adjuvant (see sequence alignment below, and columns 8-10, Example 2 and claims 1-8).
Regarding present claim 24 and 30, in view of the rejection under 35 U.S.C. 112(d) pre-AIA 35 U.S.C. 112, 4th paragraph, the claims are interpreted as being drawn to either SEQ ID NO: 19, 20 and/or 31. Georges et al., discloses the SEQ ID NO: 19, 20 and 31 in alternative and together. Thus, either interpretation is anticipated by Georges.
Present SEQ ID NO: 19 comprising present SEQ ID NO: 20 and SEQ ID NO: 129 in Georges
Query Match 100.0%; Score 60; Length 19;
Best Local Similarity 100.0%;
Matches 10; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 CGYPALMPLY 10
||||||||||
Db 4 CGYPALMPLY 13
Present SEQ ID NO: 31 and SEQ ID NO: 52 in Georges
Query Match 100.0%; Score 131; Length 52;
Best Local Similarity 100.0%;
Matches 25; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 HLSLRGLPVCAFSSAGPCALRFTSA 25
|||||||||||||||||||||||||
Db 1 HLSLRGLPVCAFSSAGPCALRFTSA 25
Thus, by this disclosure Georges et al., anticipates the present claims.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 16-30 are rejected under 35 U.S.C. 103 as being unpatentable over Georges et al. (US Patent 10,300,132) as applied to claim 16 and further in view of Krebber et al. (US Patent 10,898,567) and Grey et al. (US Patent 9,340,577).
Georges et al., teaches an immunogenic composition comprising HBV polymerase peptide epitopes comprising at least two peptides from 20 to 34 amino acids in length comprising a sequence identical with present SEQ ID NO: 19 (CGYPALMPLY), SEQ ID NO: 20 (GYPALMPLY), and SEQ ID NO: 31 comprising an immune potentiating adjuvant (see sequence alignment below, and columns 8-10, Example 2 and claims 1-8).
Present SEQ ID NO: 19 comprising present SEQ ID NO: 20 and SEQ ID NO: 129 in Georges
Query Match 100.0%; Score 60; Length 19;
Best Local Similarity 100.0%;
Matches 10; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 CGYPALMPLY 10
||||||||||
Db 4 CGYPALMPLY 13
Present SEQ ID NO: 31 and SEQ ID NO: 52 in Georges
Query Match 100.0%; Score 131; Length 52;
Best Local Similarity 100.0%;
Matches 25; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 HLSLRGLPVCAFSSAGPCALRFTSA 25
|||||||||||||||||||||||||
Db 1 HLSLRGLPVCAFSSAGPCALRFTSA 25
Regarding present claim 19. Krebber discloses a sequence identical with present SEQ ID NO: 1. It would have been prima facie obvious to provide the HBV peptide sequences of Georges further comprising a sequence identical with present SEQ ID NO: 1 of Krebber, because Krebber teaches that HBV peptides identical with present SEQ ID NO: 1 have been shown to have immunogenic properties in immunized subjects (see Examples in columns 38-42).
Regarding present claim 23. The claim fails to further limit the examined species i) of claim 16, however claim 23 is interpreted to being drawn to a peptide fragment comprising present SEQ ID NO: 1 and SEQ ID NO: 2. Krebber discloses present SEQ ID NO: 1 (see sequence alignment below and Table 4). Grey et al. discloses an HBV peptide identical with present SEQ ID NO: 2 (GPCALRFTS).
Present SEQ ID NO: 1 and SEQ ID NO: 1002 in Krebber
Query Match 100.0%; Score 42; Length 10;
Best Local Similarity 100.0%;
Matches 9; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 ALRFTSARR 9
|||||||||
Db 1 ALRFTSARR 9
It would have been prima facie obvious to provide the HBV peptide sequences of Georges further comprising a sequence identical with present SEQ ID NO: 1 of Krebber and a sequence identical with present SEQ ID NO: 2 of Grey, because Krebber teaches that HBV peptides identical with present SEQ ID NO: 1 have been shown to have immunogenic properties in immunized subjects (see Examples in columns 38-42) and because Grey teaches that sequences comprising an HBV peptide identical with present SEQ ID NO: 2 has immunogenic properties (see Examples 1-8).
Thus, the present invention would have been prima facie obvious at the time the invention was made.
Regarding present claim 28. The claim requires a 10 amino acid long peptide comprising any of the below SEQ ID NOs.
at least 10 consecutive amino acids of the region from position 57 to position 78 of HBV-X, preferably comprising: [0024] the amino acid sequence set forth in SEQ ID NO:1(x70-78), and/or [0025] the amino acid sequence set forth in SEQ ID NO:2(x67-75), and/or [0026] the amino acid sequence set forth in SEQ ID NO:3(x62-73), and/or [0027] the amino acid sequence set forth in SEQ ID NO:4(x58-66), and/or [0028] the amino acid sequence set forth in SEQ ID NO:5(x57-66),
GPCALRFTSLPVCAFSSALPVCAFSSAGPCALRFTSALRFTSARR (amino acids 57-78 comprising present SEQ ID NO: 1 and SEQ ID NO: 2).
It would have been prima facie obvious to provide the HBV peptide sequences of Georges further comprising a sequence identical with present SEQ ID NO: 1 of Krebber and a sequence identical with present SEQ ID NO: 2 of Grey together, because Krebber teaches that HBV peptides identical with present SEQ ID NO: 1 have been shown to have immunogenic properties in immunized subjects (see Examples in columns 38-42) and because Grey teaches that a sequence comprising an HBV peptide identical with present SEQ ID NO: 2 has immunogenic properties (see Examples 1-8).
Thus, in view of the above, the present invention would have been prima facie obvious at the time the invention was made.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AGNIESZKA BOESEN whose telephone number is (571)272-8035. The examiner can normally be reached on 8:30 - 5:00 PM.
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/AGNIESZKA BOESEN/Primary Examiner, Art Unit 1648