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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 7/14/2026 has been entered.
Withdrawn Rejections
The rejection of claim(s) 43-49, under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Tangy (US 9,005,925; pub date:4/14/2015; effectively filed 6/20/2003), is withdrawn. Tangy does not disclose a polynucleotide encoding a fragment of TRP3 as set forth in SEQ ID NO:2 comprising at least one antigenic epitope from 7 to 15 contiguous amino acids in length, as claimed by amendment.
The rejection of claims 43-49, 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112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement, is withdrawn. The genus of variant has been removed by amendment to the claims.
The rejection of claim(s) 43-49, under 35 U.S.C. 103 as being unpatentable over Tangy (US 9,005,925; pub date:4/14/2015; effectively filed 6/20/2003), as applied to claims 43-49 above, and further in view of Wang (Wang et al. The Journal of Experimental Medicine • Volume 184 December 1996 2207–2216), is withdrawn. Tangy does teach an attenutated MSV strain that serves as a vaccine but does not teach or suggest additional comprising sequence encoding TRP2. Further MSV does not provide sufficient motivation to include a sequence encoding TRP2 or the fragment taught by Wang.
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 44 and 45 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.
Regarding claim 44, it recites that said fragment further comprises a sequence from 7 to 9 contiguous amino acids. This limitation means that the at least one antigenic epitope of TRP3 from 7 to 15 contiguous amino acid further comprises (i.e. additionally comprises) a sequence from 7 to 9 contiguous amino acids. As such, the claim is broadening the number of amino acids from 7-15 to 7-15 + 7-9 additional aa. This improperly broadens the scope of the base claim.
Regarding claim 45, it specifies the TRP-2 as human TRP-2. However, the base claim has been modified to limit the TRP-2 to that of SEQ ID NO:2 which is the human TRP-2 sequence. As such, claim 45 is reciting a limitation already inherent to its base claims and thus not further limiting its base claim.
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 § 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.
Claim(s) 43-49 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weadock (US2016/0074626 A1 Pub date:3/17/2016; effectively filed 9/15/2014) in further view of Fotin-Mleczek (US 10,293,058 B2 pub date:5/21/2019; effectively filed 4/22/2015) and Wang (Wang et al. The Journal of Experimental Medicine • Volume 184 December 1996 2207–2216; of record).
Regarding claim 43, Weadock discloses a novel method and a system to deliver therapeutic agents to a target tissue. The term target tissue as used herein is defined to mean any tissue known or suspected of having benign, pre-cancerous, or malignant tumor cells within it ([0034]). In one embodiment, the therapeutic agent is a vaccine. Cancer treatment vaccines are designed to treat cancers that have already developed rather than to prevent them in the first place. Cancer treatment vaccines contain cancer-associated antigens to enhance the immune system's response to a patient's tumor cells. The cancer-associated antigens can be proteins or another type of molecule found on the surface of or inside cancer cells that can stimulate B cells or killer T cells to attack them ([0041]). In one embodiment, the therapeutic agent is an oncolytic virus. Oncolytic virus therapy is an experimental form of biological therapy that involves the direct destruction of cancer cells. Oncolytic viruses infect both cancer and normal cells, but they have little effect on normal cells. In contrast, they readily replicate, or reproduce, inside cancer cells and ultimately cause the cancer cells to die. Some viruses, such as reovirus, Newcastle disease virus, and mumps virus, are naturally oncolytic, whereas others, including measles virus, adenovirus, and vaccinia virus, can be adapted or modified to replicate efficiently only in cancer cells. In addition, oncolytic viruses can be genetically engineered to preferentially infect and replicate in cancer cells that produce a specific cancer-associated antigen such as EGFR or HER-2 ([0042]). Thus Weadock discloses a replication competent recombinant virus of the family Paramyxoviridae comprising an expressible polynucleotide encoding a tumor specific antigen.
Weadock does not that the specific species of tumor specific antigen is TRP2 as set forth in SEQ ID NO:2 or a fragment thereof comprising at least one antigenic epitope of TRP2 from 7 to 15 contiguous amino acids in length.
However, Fotin-Mleczek teaches a nucleic acid (particularly RNA) composition for treatment of tumor and/or cancer disease (col 16, lines 40-43). Preferably, the composition comprises nucleic acids encoding at least one tumor antigen or a fragment or variant thereof, which are used for vaccination to induce an adaptive immune response according to the invention (col 59, section 8, lines 53-58). Preferably the tumor specific antigen can be TRP-2 (col 62, line 36). Further Table 9 discloses SEQ ID NO:3806 which comprises a nucleic acid sequence encoding TRP-2 with 100% sequence identity to SEQ ID NO:2 of the instant claims. As such, Fotin-Mleczek teaches a polynucleotide encoding TRP-2 as set for the in SEQ ID NO:2 or a fragment thereof.
However, Wang teaches Here we report that TRP-2 was identified as a second tumor antigen recognized by a HLA-A31–restricted CTL clone derived from the TIL586 cell line. The peptide LLPGGRPYR epitope was subsequently identified from the coding region of TRP-2 based on studies of the recognition of truncated TRP-2 cDNAs and the HLA-A31 binding motif. This epitope peptide was capable of sensitizing target cells for lysis by a CTL clone (abstract). Figure 4 on page 2211 discloses the nucleic acid sequence for the epitope.
As such, it would have been obvious to an artisan of ordinary skill before the time of effectively filing to specifically use the nucleic acid sequence encoding the tumor specific antigen TRP-2 set forth in SEQ ID NO:3806 for targeted cancer vaccine, taught by Fotin-Mleczek, as the cancer specific antigen coding sequence in the replication competent oncolytic cancer vaccine of Weadock to predictably arrive at the limitations of the replication competent virus encoding the TRP sequence of SEQ ID NO:2. Alternatively, the nucleic acid sequence encoding the LLPGGRPYR epitope (i.e 9 contiguous amino acid sequence of TRP set forth in SEQ ID NO:2), taught by Wang in the the replication competent oncolytic cancer vaccine of Weadock to predictably arrive at the limitations of the replication competent virus encoding the TRP sequence of SEQ ID NO:2 7 to 15 aa fragment of TRP as claimed. Further full length sequence of SEQ ID NO:3806 and the fragment sequence of can be used to make obvious variants of the epitope identified by Wang or to find additional epitope present in the full length SEQ ID NO:3806 to find additional 7 to 15 contiguous amino acid sequences in the TRP-2 sequence of SEQ ID NO:3608 using routine experimentation by recombinant technologies well established in the prior art. Even further, one would particularly be motivated to use nucleic acid sequences of SEQ ID NO:3608, taught by Fotin-Mleczek, or the LLPGGRPYR epitope taught by Wang, or variant sequences encoding 7 to 15 contiguous amino acid sequence of Fotin-Mleczek or Wang because both teach that TRP sequences target cancer cells for lysis, as taught by both Fotin-Mleczek and Wang. As such, Weadock in view of Fotin-Mleczek and Wang render claim 43 obvious.
Regarding claim 44, Weadock in view of Folin-Mlexzek and Wang as discussed above teach the ability to arrive at the additional 7-9 amino acid encoded sequence.
Regarding claim 45, Fotin-Mleczek and Wang both teach the human TRP-2.
Regarding claims 46 and 47, Weadock teaches the measles virus as discussed above.
Regarding claims 48 and 49, Weadock teach including one cancer antigen sequences such as sequences encoding EGFR or HER-2 ([0042]).
As such, the claims are all rendered obvious by Weadock in view of Fotin-Mleczek and Wang.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCIA STEPHENS NOBLE whose telephone number is (571)272-5545. The examiner can normally be reached M-F 9-5:30.
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, Peter Paras can be reached at 571-272-4517. 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.
MARCIA S. NOBLE
Primary Examiner
Art Unit 1632
/MARCIA S NOBLE/Primary Examiner, Art Unit 1632
Prosecution Insights