DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant's amendment and remarks, filed 6/24/26, are acknowledged.
Claims 1-11 have been cancelled.
Claim 19 has been added.
Claims 14-19 are pending
Claims 14-18 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claim 19 is being acted upon.
The previous grounds of rejection are withdrawn in view of Applicant’s amendment. It is also noted that Applicant’s declaration establishing that the date that Melcarne was available to the public was 6/20/20 disqualifies the reference under the 102(b)(1) exception, since it is an inventor disclosure within the grace period.
The following are new grounds of rejection necessitated by Applicant’s claim amendments. Applicant’s arguments relevant to the new grounds of rejection will be addressed below.
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.
Claim 19 is 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.
Claim 19 contains the trademark/trade name MONTANIDETM ISA. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a particular type of adjuvant and, accordingly, the identification/description is indefinite.
The scope of the tumor associated peptides required in claim 19 is unclear and indefinite. The claim recites a “combination of tumor-associated peptides comprising amino acid sequences SEQ ID NO: 1-4, 7, and 9-12 and immunogenic fragments thereof”. For example, would the claims encompass a composition comprising tumor associated peptide consisting of the amino acid sequences of SEQ ID NO 1-4, 7, and 9-12, respectively? Would this meet the limitation of “immunogenic fragments”, since each peptide would also contain a subsequence of “fragment” thereof, or does the claim intend that the composition must have a peptide of SEQ ID NO: 1 and a peptide consisting of an immunogenic fragment thereof? It is also unclear if the claim would encompass a combination of peptides, wherein each peptide comprises SEQ ID NO: 1-4, 7, and 9-12. Or does the claim require more than one type of different peptide to provide the combination? The scope of the claim is unclear and indefinite.
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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.
Claim 19 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
The specification and the claims as originally filed do not provide support for the invention as now claimed, specifically:
An immunogenic composition comprising “a dendritic cell”, or an immunogenic composition comprising “MontanideTM ISA”.
It is noted that applicant has not cited any support for the new limitation in the specification. A review of the specification fails to reveal support for the new limitations.
At page 7, the specification discloses an immunogenic composition comprising one or more tumor associated peptides of SEQ ID NO: 1-4 and 6-13, one or more isolated nucleic acid sequences encoding the tumor associated peptides, and/or one or more “APC as above defined”, and a pharmaceutically acceptable vehicle. However, all of the above defined APCs (which include dendritic cells) are carrying one or more of the tumor associated peptides. In contrast, the present claim encompass an immunogenic composition comprising “a dendritic cell”. In other words, the dendritic cells of new claim 19 do not need to carry or be loaded with the tumor associated peptides, and are thus broader than the APC or dendritic cells disclosed by the instant specification. Furthermore, the instant specification does not disclose a pharmaceutically acceptable vehicle comprising “MontanideTM ISA”. At page 8, the specification discloses on pages 13-14 that thanks to the properties of the tumor-associated peptides of the invention, the immunogenic composition according to the present invention is particularly suitable for use as a vaccine, and that an adjuvant can be added to the immunogenic composition for use as a vaccine. A list of adjuvants types is disclosed, but “MontanideTM ISA” is not disclosed, and the specification does not provide support for a composition comprising “MontanideTM ISA”.
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.
Claim(s) 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Saxena, 2017.
Saxena teach an immunogenic vaccine composition comprising dendritic cells and MontanideTM IFA adjuvant (i.e. MontanideTM ISA, see page 35-36, in particular).
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) 19 is/are rejected under 35 U.S.C. 103 as obvious over US 2018/0346513 (of record), in view of Aucouturier, 2006.
The ‘513 publication teaches an immunogenic composition comprising tumor associated peptides that are secreted from salmonella infected 624.38 melanoma tumor cells into the supernatant (see paragraphs 25, 145, 198, and 217 in particular). The instant specification on page 27 discloses that the peptides of SEQ ID NO: 1-4, 7, and 9-12 were sequenced from the secretome of melanoma cell line 624.38 following Salmonella infection. Therefore, the peptide composition taught in the ‘513 publication, which is produced in an identical manner (i.e. from the secretome of salmonella infected 624.38 cells), would inherently comprise peptides comprising each of SEQ ID NO: 1-4, 7, and 9-12, and immunogenic fragments thereof. The ‘513 publication teaches the use of said composition as a vaccine said composition and a pharmaceutically acceptable vehicle and further comprising an adjuvant, such as incomplete Freund’s adjuvant (IFA, see paragraphs 25, 53, 58-59, and 176, in particular).
The reference differs from the claimed invention in that it does not explicitly teach MONTANIDETM ISA.
Aucouturier teaches water in oil emulsions are used as adjuvants, and that that MONTANIDETM ISA is a new generation of water in oil adjuvants that has improved properties and better safety.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to use MONTANIDETM ISA, as taught by Aucouturier, as the type of IFA adjuvant in the immunogenic compositions of the ‘513 publication. The ordinary artisan at the time the invention was made would have been motivated to do so with a reasonable expectation of success, because Aucouturier teaches that that MONTANIDETM ISA is a new generation of water in oil adjuvant that has improved properties and better safety
Applicant’s arguments filed 6/25/26 have been fully considered, but they are not persuasive.
Applicant argues that the record does not establish inherency, which requires the examiner to provide a basis in fact and/or technical reasoning that the inherent characteristic necessarily flows from the teachings of the prior art.
The instant specification discloses that the claimed immunogenic peptides were produced by sequencing the supernatant from Salmonella infected melanoma cell line 624.38 (see Fig. 2, and pages 26-28 of the instant specification). The prior art teaches the same product, i.e. a supernatant secretome from melanoma cell line 624.38 infected with Salmonella which comprises a combination of immunogenic peptides. Thus, it necessarily flows that the supernatant/secretome would comprise the peptides of SEQ 1-4, 7, and 9-12, and immunogenic fragments thereof. This is a basis in fact and technical reasoning. Applicant provides no evidence or reasoning as to why this is not correct. Once a reference teaching product appearing to be substantially identical is made the basis of a rejection, and the examiner presents evidence or reasoning to show inherency, the burden of production shifts to the applicant “[T]he PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. 102, on ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same.” In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977). See MPEP 2112.
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY E JUEDES whose telephone number is (571)272-4471. The examiner can normally be reached on M-F from 7am to 3pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached on 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from Patent Center. Status information for published applications may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center for authorized users only. Should you have questions about access to Patent Center, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
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) Form at https://www.uspto.gov/patents/uspto-automated- interview-request-air-form.
Amy E. Juedes
Patent Examiner
Technology Center 1600
/AMY E JUEDES/Primary Examiner, Art Unit 1644
Prosecution Insights