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 .
DETAILED ACTION
This office action is written in response to the papers received 1/27/2023.
Claims 1-20 are pending and are examined on the merits.
Priority
Applicant’s claim for the filing date for this application as a continuation of US Patent application 17/366,885 is given to the date 6/29/2018, that is acknowledged.
Information Disclosure Statement
The information disclosure statement (s) (IDS) submitted on 1/27/2023 and 3/9/2023 are/is considered by the examiner and initialed copies/copy of the PTO-1449 are/is enclosed.
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 1-13 and 18-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without inventive concept/Significantly more.
The claims are directed to an isolated peptide consisting of AVYNYPEGAAY (SEQ ID NO: 252) in the form of a pharmaceutically acceptable salt or in the form of a salt, wherein the pharmaceutically acceptable salt including chloride salt, acetate salt etc.
The specification teaches that the peptide AVYNYPEGAAY (SEQ ID NO: 252) is a fragment of naturally produced human protein expressed by ESR1 gene (table 1b). The peptide AVYNYPEGAAY (SEQ ID NO: 252) is no difference from the naturally existed sequence in the structure. Therefore, the isolated peptide is not sufficient to qualify as patent-eligible practical application that is something difference than a Judicial Exception (abstract ideas, laws of nature/natural principle, natural phenomena, and Natural Products). The claimed pharmaceutical composition comprising the peptide fragment from the natural protein ESR1 or the peptide in the form of pharmaceutical acceptable salt does not markedly difference from naturally occurring product ESR1 because the genetic structure and sequence of the extracellular domain of the protein has not been altered.
The following inquiries are used to determine whether a claim is drawn to patent-eligible subject matter:
Step 1. Is the claim directed to a process, machine, manufacture, or composition of matter?
Answer is Yes, all of the claims are directed to a composition of matter.
Step 2A. Is the claim directed to a law of nature, a natural product or an abstract idea (judicially recognized exception) and does the claim recite additional elements that integrate the judicial exception into a practical application?
Answer is Yes, the claims recite natural product, but the additional elements do not integrate the judicial exception into a practical application.
Step 2B - Does the claim recite additional elements that amount to significantly more than the judicial exception?
Answer is No. The pharmaceutically acceptable salt, water or a buffer included in the composition does not provide additional element that amount to stigmatically more than the judicial exception.
Accordingly, it is determined that the instant claims are not directed to patent eligible subject matter
For more information and analysis, applicant is also directed to the new 2024 update Guidance under 35 USC § 101 on the website below (Examples 3, 7, and 49 in particular):
Determine Subject Matter Eligibility of Claims Reciting or Involving Law of Nature, Natural Phenomena, & Natural Products, Issued Dec, 2014 and revised May, 2016, Jan, 2019 and July 2024 at http://www.uspto.gov/patents/law/exam/examguide.jsp
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
An obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claim not is patentably distinct from the reference claim(s) because the examined claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Over Patent:
Claims 1-13 and 18-20 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,576,955 (original application 17/876899). Although the conflicting claims are not identical, they are not patentably distinct from each other because the patent claims a method of using the same material that is claimed in the instant application. The claims of the patent would anticipate the claimed invention.
The instant claims are drawn to
A peptide consisting of the amino acid sequence of AVYNYPEGAAY (SEQ ID NO: 252) in the form of pharmaceutically acceptable salt,
A composition comprising a peptide consisting of the amino acid sequence of AVYNYPEGAAY (SEQ ID NO: 252) in the form of pharmaceutically acceptable salt and an immune-stimulating adjuvant, wherein the adjuvant is selected from anti-CD40 antibody, imiquimod, resiquimod, GM-CSF, cyclophosphamide, sunitinib, bevacizumab, interferon-alpha, interferon-beta, CpG oligonucleotides and derivatives, poly-(I:C) and derivatives, RNA, sildenafil, particulate formulations with poly(lactide co-glycolide) (PLG), virosomes, interleukin (IL)-1, IL-2, IL-4, IL-7, IL-12, IL- 13, IL-15, IL-21, and IL-23.
The claims of ‘955 patent are drawn to
A method of eliciting an immune response in a patient who has uterine cancer cell expressing a ESR1 polypeptide comprising the amino acid sequence of AVYNYPEGAAY (SEQ ID NO: 252) comprising administering to the patient a composition comprising an effective number of activated T cells that selectively recognize the cancer cells,
wherein the activated T cells comprise cytotoxic T cells produced by contacting CD8+ T cells with an antigen presenting cell that expresses the peptide consisting of the amino acid sequence of AVYNYPEGAAY (SEQ ID NO: 252) in a complex with an MHC molecule on the surface of the antigen presenting cell in vitro, for a period of time sufficient to activate said T cell,
wherein the composition further comprising an adjuvant selected from of anti-CD40 antibody, imiquimod, resiquimod, GM-CSF, cyclophosphamide, sunitinib, bevacizumab, interferon-alpha, interferon-beta, CpG oligonucleotides and derivatives, poly-(I:C) and derivatives, RNA, sildenafil, particulate formulations with poly(lactide co-glycolide) (PLG), virosomes, interleukin (IL)-1, IL-2, IL-4, IL-7, IL-12, IL- 13, IL-15, IL-21, and IL-23.
Both sets of the claims encompass the same peptide of SEQ ID NO: 252 or method of using the peptide of SEQ ID NO: 252. The method of using the same material (peptide) would anticipate the same material (peptide) recited in the claims.
Applicant is noted that the instant application and the US patent 10, 11,576,955 (original application 17/876899) are from the same family and have the same effective filing date. However, there is no restriction requirement between the two applications. Filing terminal disclaimer is required and necessary to overcome the rejection.
Conclusion
Claims 14-17 are allowed.
Claims 1-13 and 18-20 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lei Yao, whose telephone number is (571) 272-3112. The examiner can normally be reached on 8:00am-6:00pm Monday-Friday.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis, can be reached on (571) 270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LEI YAO/Primary Examiner, Art Unit 1642