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
Applicants’ election without traverse of Group II (claims 37, 41, and 51-52) in the reply filed on June 30, 2025 is acknowledged. Applicants further elected SEQ ID NO: 204 as the species of the nucleic acid encoding a chimeric polypeptide. However, none of claims 37, 41, or 51-52 claim that the sequence of the nucleic acid encoding the chimeric polypeptide is SEQ ID NO: 204.
Claims 1-2, 6, 10-18, 20, 23-27, 31, 36-36, 55, 62, 65, and 74-75 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 June 30, 2025.
Claims 37, 41, and 51-52 are under examination.
Information Disclosure Statement
The Information Disclosure Statements filed June 13, 2023 and April 7, 2025 have been considered.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency - The Incorporation by Reference paragraph required by 37 CFR 1.821(c)(1) is missing or incomplete. See item 1) a) or 1) b) above.
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Specification
The disclosure is objected to because of the following informalities:
The Table at page 61 is not numbered.
Appropriate correction is required.
The use of the terms FORTESSA® at paragraphs [0179], [0204], [0209], [0211], [0213], and [02150], DYNABEADS® at paragraphs [0204] and [0211], CELLTRACE® at paragraphs [0204] and [0209], BIOLEGEND® at paragraph [0217], DRAQ7® at paragraph [0217], FACSYMPHONY® at paragraph [0217], and FLOWJO® at paragraph [0217], which are trade names or marks used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claims 37, 41, and 51-52 are objected to because of the following informalities:
At claim 37, line 2, “a” should be changed to “the.”
At claim 41, line 1, “a” should be changed to “the.”
At claim 51, line 1, “a” should be changed to “the.”
At claim 52, line 2, “a” should be changed to “the.”
Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 37, 41, and 51-52 are rejected under 35 U.S.C. 103 as being unpatentable over Choe et al. (PCT Patent Application Publication No. WO 2019/099689, published May 23, 2019, filed November 15, 2018, and claiming priority to U.S. Provisional Patent Application Nos. 62/587,296 and 62/588,079, filed November 16, 2017 and November 17, 2017, respectively, and cited in the Information Disclosure Statement filed June 13, 2023) in view of Riesbeck et al. (U.S. Patent Application Publication No. 2012/0017288, published January 19, 2012, and cited in the Information Disclosure Statement filed June 13, 2023).
Regarding claim 37, Choe discloses a nucleic acid encoding a chimeric polypeptide that comprises an extracellular ligand-binding domain, a linking polypeptide, a linking polypeptide, a transmembrane domain comprising a ligand-inducible proteolytic cleavage site, and an intracellular domain (paragraphs [0005], [0050]-[0053], [00131]-[00135] and [00258]).
Regarding claim 41, Choe discloses a eukaryotic cell comprising the nucleic acid encoding the chimeric polypeptide (paragraph [00281]).
Regarding claim 51, Choe discloses a cell culture comprising the nucleic acid that expresses the chimeric polypeptide (paragraph [00305]).
Regarding claim 52, Choe discloses administration of a cell expressing the chimeric polypeptide, which is interpreted as the cell expressing the chimeric polypeptide being a pharmaceutical composition including a pharmaceutically acceptable carrier (paragraph [00305]).
Choe fails to disclose or suggest that the nucleic acid encoding the chimeric polypeptide includes a sequence encoding a stop-transfer sequence, which is heterologous to the transmembrane domain.
Riesbeck discloses nucleic acids encoding a chimeric protein comprising an effector domain and a region which can anchor the effector domain in a cell membrane (paragraph [0024]). Riesbeck discloses that the chimeric protein includes a stop-transfer sequence (paragraphs [0082], [0096] and Figure 1).
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to include the stop-transfer sequence of Riesbeck in the nucleic acid encoding the chimeric polypeptide of Choe in order to increase and optimize functionality, including the production of the properly membrane-integral form of the chimeric polypeptide and to ensure compatibility with the cytosolic portion of the chimeric peptide, which ensures the release and transcriptional regulation activity of the intracellular portion of the receptor.
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 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 37, 41, and 51-52 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 14-19 of U.S. Patent No. 11,202,801.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the ‘801 patent and the instant application claim a nucleic acid molecule encoding a chimeric polypeptide having the same components, including an extracellular ligand-binding domain, a linking polypeptide having a hinge domain, a transmembrane domains, a stop-transfer sequence, and an intracellular domain. Both the ‘801 patent and the instant application claim cells comprising the nucleic acid, which is interpreted as including a cell culture. While the ‘801 patent does not claim a pharmaceutical composition comprising the nucleic acid and a pharmaceutically acceptable carrier, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to provide the nucleic acid to the cells because this will allow the cells to express the chimeric polypeptide, which can then mediate a disease or condition that requires treatment.
Claims 37, 41, and 51-52 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 14-21 of U.S. Patent No. 11,617,766.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the ‘766 patent and the instant application claim a nucleic acid molecule encoding a chimeric polypeptide having the same components, including an extracellular ligand-binding domain, a linking polypeptide, a transmembrane domains, a stop-transfer sequence, and an intracellular domain. Both the ‘766 patent and the instant application claim cells comprising the nucleic acid, which is interpreted as including a cell culture. The ‘766 patent claims a method of treatment using the claimed recombinant cells, which comprise the claimed nucleic acid and which is interpreted as a pharmaceutical composition comprising the nucleic acid and a pharmaceutically acceptable carrier.
Claims 37, 41, and 51-52 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 13 of U.S. Patent No. 11,897,932.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the ‘932 patent claims a chimeric polypeptide having an extracellular ligand-binding domain, a linking polypeptide having a hinge domain, a transmembrane domains, a stop-transfer sequence, and an intracellular domain. The instant application claims a nucleic acid and cell/pharmaceutical composition comprising the nucleic acid encoding a chimeric polypeptide having the same components. Both the ‘932 patent and the instant application claim cells, which is interpreted as including a cell culture. While the ‘932 patent does not claim a pharmaceutical composition comprising the nucleic acid and a pharmaceutically acceptable carrier, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to provide the nucleic acid to the cells because this will allow the cells to express the chimeric polypeptide for the treatment of a disease or condition.
Claims 37, 41, and 51-52 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 36, 40, and 51-52 of copending Application No. 17/762,685 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the ‘685 application and the instant application claim a nucleic acid molecule encoding a chimeric polypeptide having the same components, including an extracellular ligand-binding domain, a linking polypeptide, a transmembrane domains, a stop-transfer sequence, and an intracellular domain. Both the ‘685 application and the instant application claim cells and cell cultures comprising the nucleic acid. Both the ‘685 application and the instant application claim a pharmaceutical composition comprising the nucleic acid and a pharmaceutically acceptable carrier. Therefore, the claims of the ‘685 application anticipate the claims of the instant application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 37, 41, and 51-52 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1,3, 45, 49, and 59-60 of copending Application No. 17/762,687 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the ‘687 application and the instant application claim a nucleic acid molecule encoding a chimeric polypeptide having the same components, including an extracellular ligand-binding domain, a linking polypeptide, a transmembrane domains, a stop-transfer sequence, and an intracellular domain. Both the ‘687 application and the instant application claim cells and cell cultures comprising the nucleic acid. Both the ‘687 application and the instant application claim a pharmaceutical composition comprising the nucleic acid and a pharmaceutically acceptable carrier. Therefore, the claims of the ‘687 application anticipate the claims of the instant application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 37, 41, and 51-52 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 43, 52, 62, and 66 of copending Application No. 17/763,122 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the ‘122 application and the instant application claim a nucleic acid molecule encoding a chimeric polypeptide having the same components, including an extracellular ligand-binding domain, a linking polypeptide, a transmembrane domains, a stop-transfer sequence, and an intracellular domain. Both the ‘122 application and the instant application claim cells and cell cultures comprising the nucleic acid. Both the ‘122 application and the instant application claim a pharmaceutical composition comprising the nucleic acid and a pharmaceutically acceptable carrier. Therefore, the claims of the ‘122 application anticipate the claims of the instant application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 37, 41, and 51-52 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 49, and 54 of copending Application No. 17/995,765 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the ‘751 application and the instant application claim a nucleic acid molecule encoding a chimeric polypeptide having the same components, including an extracellular ligand-binding domain, a linking polypeptide, a transmembrane domains, a stop-transfer sequence, and an intracellular domain. Both the ‘751 application and the instant application claim cells and cell cultures comprising the nucleic acid. While the ‘751 application does not claim a pharmaceutical composition comprising the nucleic acid and a pharmaceutically acceptable carrier, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to provide the nucleic acid to the cells because this will allow the cells to express the chimeric polypeptide for the treatment of a disease or condition.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 37, 41, and 51-52 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 43, 52, 62, and 66 of copending Application No. 17/995,765 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the ‘765 application and the instant application claim a nucleic acid molecule encoding a chimeric polypeptide having the same components, including an extracellular ligand-binding domain, a linking polypeptide, a transmembrane domains, a stop-transfer sequence, and an intracellular domain. Both the ‘765 application and the instant application claim cells and cell cultures comprising the nucleic acid. Both the ‘765 application and the instant application claim a pharmaceutical composition comprising the nucleic acid and a pharmaceutically acceptable carrier. Therefore, the claims of the ‘765 application anticipate the claims of the instant application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 37, 41, and 51-52 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 31-32 and 49-55 of copending Application No. 18/178,440 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the ‘440 application and the instant application claim a nucleic acid molecule encoding a chimeric polypeptide having the same components, including an extracellular ligand-binding domain, a linking polypeptide, a transmembrane domains, a stop-transfer sequence, and an intracellular domain. Both the ‘440 application and the instant application claim cells comprising the nucleic acid, which is interpreted as including a cell culture. While the ‘440 application does not claim a pharmaceutical composition comprising the nucleic acid and a pharmaceutically acceptable carrier, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to provide the nucleic acid to the cells because this will allow the cells to express the chimeric polypeptide, which can then mediate a disease or condition that requires treatment.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 37, 41, and 51-52 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21 and 31 of copending Application No. 18/393,538 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘538 application claims a method of treating cancer by administration of cells that comprise a chimeric polypeptide comprising the same components encoded by the instantly claimed nucleic acid, cells, cell culture, and pharmaceutical composition. While the ‘538 application does not claim the nucleic acid, cells/cell culture comprising the nucleic acid, or a pharmaceutical composition comprising the nucleic acid and a pharmaceutically acceptable carrier, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to provide the nucleic acid to the cells in the cancer treatment of the ‘538 application because this will allow the cells to express the chimeric polypeptide, which can then mediate cancer and treatment thereof.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 37, 41, and 51-52 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 26, 38, 42, and 56 of copending Application No. 18/551,931 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the ‘931 application and the instant application claim a nucleic acid molecule encoding a chimeric receptor (polypeptide) having the same components, including an extracellular ligand-binding domain, a linking polypeptide, a transmembrane domains, a stop-transfer sequence, and an intracellular domain. Both the ‘931 application and the instant application claim cells comprising the nucleic acid, which is interpreted as including a cell culture. Both the ‘931 application and the instant application claim a pharmaceutical composition comprising the chimeric polypeptide (receptor) or nucleic acid encoding the polypeptide (receptor).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 37, 41, and 51-52 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 23, 40, and 44 of copending Application No. 18/551,935 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the ‘935 application and the instant application claim a nucleic acid molecule encoding a chimeric receptor (polypeptide) having the same components, including an extracellular ligand-binding domain, a linking polypeptide, a transmembrane domains, a stop-transfer sequence, and an intracellular domain. Both the ‘935 application and the instant application claim cells comprising the nucleic acid, which is interpreted as including a cell culture. While the ‘935 application does not claim a pharmaceutical composition comprising the nucleic acid and a pharmaceutically acceptable carrier, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to provide the nucleic acid to the cells because this will allow the cells to express the chimeric polypeptide, which can then mediate a disease or condition that requires treatment.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 37, 41, and 51-52 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of copending Application No. 18/551,931 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the ‘931 application and the instant application claim a nucleic acid molecule encoding a chimeric receptor (polypeptide) having the same components, including an extracellular ligand-binding domain, a linking polypeptide, a transmembrane domains, a stop-transfer sequence, and an intracellular domain. Both the ‘931 application and the instant application claim cells comprising the nucleic acid, which is interpreted as including a cell culture. Both the ‘931 application and the instant application claim a pharmaceutical composition comprising the chimeric polypeptide (receptor) or nucleic acid encoding the polypeptide (receptor).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 37, 41, and 51-52 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 37, 42, and 52-53 of copending Application No. 18/552,141 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the ‘141 application and the instant application claim a nucleic acid molecule encoding a chimeric polypeptide having the same components, including an extracellular ligand-binding domain, a linking polypeptide, a transmembrane domains, a stop-transfer sequence, and an intracellular domain. Both the ‘141 application and the instant application claim cells comprising the nucleic acid, which is interpreted as including a cell culture. Both the ‘1411 application and the instant application claim a pharmaceutical composition comprising the chimeric polypeptide or nucleic acid encoding the polypeptide.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Emtage et al. (U.S. Patent Application Publication No. 2020/0384030, published December 10, 2020, filed February 20, 2019, and claiming priority to U.S. Provisional Patent Application No. 62/633,543, filed February 21, 2018) disclose a chimeric transmembrane receptor and nucleic acids encoding the receptor (abstract, paragraphs [0005] and [0012], and Figure 1). Emtage discloses a sequence that has 84.1% sequence identity to instant SEQ ID NO: 204 (Appendix I, SEQ ID NO: 20).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NANCY J LEITH whose telephone number is (313)446-4874. The examiner can normally be reached Monday - Thursday 8:00 AM - 6:30 PM.
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, NEIL HAMMELL can be reached at (571) 270-5919. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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NANCY J. LEITH
Primary Examiner
Art Unit 1636
/NANCY J LEITH/Primary Examiner, Art Unit 1636