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
Claim status
Claims 1-2, 5-13, 16-31, 39-40 are pending
Claims 1-2, 5-13, 16-31, 39-40 are under examination
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 7/13/2022 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
However, Applicant is reminded that 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.
Objection to Drawings
Sequence Compliance
Figures 2-4 of the Specification do not conform to sequence rules, requiring the use of “SEQ ID NO:” (37 CFR 1.821-1.825).
Where the description or claims of a patent application discuss a sequence that is set forth in the “Sequence Listing” in accordance with paragraph (c) of this section, reference must be made to the sequence by use of the sequence identifier, preceded by “SEQ ID NO:” in the text of the description or claims, even if the sequence is also embedded in the text of the description or claims of the patent application. 37 CFR 1.821 (d). Specifically, the cited section indicates that nucleotide and/or amino acid sequences are an unbranched sequence of 4 or more amino acids or an unbranched sequence of 10 or more nucleotides. Branched sequences are specifically excluded from this definition. Sequences with fewer than four specifically defined nucleotides or amino acids are specifically excluded from this section.
The applicant is reminded that the specification must be amended in order to comply with regulations cited above. All references to sequences in claims and specification should be referred to as “SEQ ID NO:1”, for example. To avoid all doubts of the examiner and to ensure correct interpretation of the claims and specification, the identification of sequences with proper sequence identifiers is required.
Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Allowable subject matter
Claims 5 and 16 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Specifically, the prior art does not teach nor reasonable suggest a truncated murine constant region of the alpha chain according to SEQ ID NO:2 or the a truncated murine constant region of the beta chain according to SEQ ID NO:15, wherein the first four amino acids of the alpha chain (residues 1-4 of SEQ ID NO:2) and the first six amino acids of the beta chain (residues 1-6 of SEQ ID NO:15) are deleted, and the adjacent positions 5-18 of SEQ ID NO:2 are substituted with the corresponding human amino acids, and the adjacent positions 7-25 of SEQ ID NO:15 are substituted with the corresponding human amino acids .
These aforementioned truncated human/mouse chimera and the claimed SEQ ID NOs that contain them (i.e., the “N.Rec-1” constructs of SEQ ID NOs:11-13, and 34) are free of the prior art. Although the closest prior art of Chaudhary teaches a truncated human TCR alpha constant region wherein the first four amino acids are deleted, they do not do so in the human/mouse chimera recited above. Furthermore, unexpectedly, Applicant has demonstrated that TCRs containing these truncated constant regions function better than TCRs comprising the full length constant regions (p. 42, last para. of Example 10). However, Applicant also teaches that if more than 4 or 6 amino acids are deleted in these truncated TCRs (e.g., “N.Rec-2” and “N.Rec-3” constructs of SEQ ID NO:35 and 36, respectively), functional activity is lost (see more below).
New Claim Rejections - 35 USC § 112(a)
(Written Description)
The following is a quotation of the first paragraph 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 the first paragraph of pre-AIA 35 U.S.C. 112:
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.
Claims 1-2, 6-13, 17-31, 39-40 are 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.
Claims 1-2, 6-11, 13, 17-31, 39-40 encompass a genus of synthetic TCRs (STARs) and host T cells that are capable of binding a genus of target antigens.
Dependent claim 12 encompass a genus of STARs that comprise SEQ ID NO:35 or 36.
Under the new Written Description Guidelines for antigen binding proteins molecules, the Examiner is directed to determine whether one skilled in the art would recognize that the applicant was in possession of the claimed invention as a whole at the time of filing. The following considerations are critical to this determination: on 22 February 2018, the USPTO provided a Memorandum clarifying the Written Description Guidelines for claims drawn to antibodies, which can be found at www.uspto.gov/sites/default/files/documents/amgen_22feb2018.pdf. That Memorandum indicates that, in compliance with recent legal decisions, the disclosure of a fully characterized antigen no longer is sufficient written description of an antibody to that antigen. Accordingly, the instant claims have been re-evaluated in view of that guidance.
“[T]he purpose of the written description requirement is to ‘ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor’s contribution to the field of art as described in the patent specification.’” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1353-54 (Fed. Cir. 2010) (en banc) (quoting Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920 (Fed. Cir. 2004)). To satisfy the written description requirement, the specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562-63, 19 USPQ2d 1111 (Fed. Cir. 1991). See also MPEP 2163.04.
ACTUAL REDUCTION TO PRACTICE
In regard to Claims 1-2, 6-11, 13, 17-31, 39-40 encompassing a genus of synthetic TCRs (STARs) and host T cells that are capable of binding a genus of target antigens, Applicant discloses a genus of STARs that are capable of binding target antigens (Figs. 5-10, Examples 1-17)
In regard to dependent claim 12 encompassing a genus of STARs that comprise SEQ ID NO:35 or 36, Applicant discloses that the 8 amino acid truncation (N.Rec-2) and the 12 amino acid truncation (N.Rec-3) in the N-terminus of the constant region of a human/mouse chimeric TCR alpha chain, despite being expressed in a cell (Fig. 6A), does not appear to reach the cell membrane (Fig. 6B), nor lyse a target cell (Fig. 6C). Applicant concludes, this specific sequence at the N terminus of the constant region of the STAR when deleted made the STAR lose function (p. 41, Example 10).
Thus, as stated supra, Applicant was not in possession of a STAR comprising SEQ ID NOs: 35 or 36 that was capable of binding a target antigen.
DISCLOSURE OF STRUCTURE
The Applicant has provided sequence listings of the human and mouse TCR constant domains, as well as the truncation mutants. Certainly, with the help of a cell facility, a skilled artisan could make the STARs comprising SEQ ID NOs:35 and 36. However, neither the specification nor the art indicate a relationship between the structure of the claimed genus of STARs comprising SEQ ID NOs:35 and 36 and the ability to produce functional synthetic TCRs.
STATE OF THE ART & QUANTITY OF EXPERIMENTATION
The method of making the claimed invention comprising SEQ ID NOs:35 and 36 is not well established. Although the making of synthetic TCRs was routine and conventional, one of skill in the art would neither expect nor predict the appropriate functioning of a STAR comprising SEQ ID NO:35 or 36.
Applicant has claimed a genus of STARs that comprise SEQ ID NOs:35 or 36, yet the specification has only managed to identify very specific N-terminal sequences in the constant domain that can be used STARs.
Not knowing, absent further experimentation and screening, which modifications function and which do not, when using a STAR comprising SEQ ID NOs:35 or 36, leads to one have no predictability or expectation of success for the function of any given STAR modification. Such random experimentation to identify at a later time what structure or variant or modification is or is not functional and is embraced by Applicant’s claims is undue experimentation. Furthermore, functionally defined genus claims (i.e., “bind to a target antigen”) can be inherently vulnerable to invalidity challenge for lack of written description support, especially in technology fields that are highly unpredictable, where it is difficult to establish a correlation between structure and function for the whole genus or to predict what would be covered by the functionally claimed genus. See ABBVIE DEUTSCHLAND GMBH & 2 CO. v. JANSSEN BIOTECH, INC., Appeals from the United States District Court for the District of Massachusetts in Nos. 09-CV-11340-FDS, 10-CV-40003-FDS, and 10-CV-40004-FDS, Judge F. Dennis Saylor, IV. See also Ariad, 598 F.3d at 1351 (“[T]he level of detail required to satisfy the written description requirement varies depending on the nature and scope of the claims and on the complexity and predictability of the relevant technology.”); see also Centocor Ortho Biotech, Inc. v. Abbott Labs., 636 F.3d 1341, 1352 (Fed. Cir. 2011) (noting the technical challenges in developing fully human antibodies of a known human protein).
CONCLUSION
Therefore, the examiner concludes that there is insufficient written description of the instantly claimed genus STARs that comprise SEQ ID NOs:35 or 36. Specifically, there is limited description of the structure-function relationship between the claimed genus of STARs and their ability to produce functional TCRs that bind a target antigen, and the Examiner further concludes a skilled artisan would find the specification inadequately describes functional TCRs encompassed by the claimed genus of STARs comprising SEQ ID NOs: 35 or 36.
Claim Rejections - 35 USC § 112(b)
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.
Claims 2, 8, 13, 21, 24-27, 29-31 are 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 pre-AIA the applicant regards as the invention.
Claims 2, 13, and 21 recite the limitation that the searching “preferably”. A claim may be rendered indefinite by reference to subjective term (see MPEP 2173.05(b), IV). Specifically, the tern “preferably” is a subjective term which renders the claim indefinite. The term "preferably" is not defined by the claim, the specification does not provide a standard for some standard for measuring the scope of the term, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Furthermore, regarding claims 2, 13, 24, 26, and 29, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Furthermore, regarding claim 8, 21, and 27, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Furthermore, regarding claim 29, the phrase "according to claim 29" renders the claim indefinite because of improper dependency. In light of the specification, and for the sake of compact prosecution, instant claim is being interpreted as dependent on claim 28.
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 1-2, 13, 20-21, 28, 39-40 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more. The claim(s) recite(s) a modified which is not markedly different from its naturally occurring counterpart. This judicial exception is not integrated into a practical application because the natural product is not linked to a particular technology. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional limitations are well-understood, routine and conventional in cell biology and immunology.
Applicant is directed to the 2019 Revised Patent Subject Matter Eligibility Guidance published in the Federal Register (84 FR 50) on 1/07/2019, which is found at: https://www.govinfo.gov/content/pkg/FR-2019-01-07/pdf/2018-28282.pdf; and the October 2019 Update: Subject Matter Eligibility, which is found at https://www.uspto.gov/sites/default/files/documents/peg_oct_2019_update.pdf.
Briefly summarized here, the new guidance cites a two part test: is the claimed invention directed to a statutory class of invention (Step 1), if so then is the claimed invention as a whole directed to a law of nature, natural phenomena, or an abstract idea (i.e. set forth or described in the claim) (Step 2A, prong one), if so then is the claimed invention recite additional elements that integrate the judicial exception into a practical application (Step 2A, prong two), if not then does the claim as a whole amount to significantly more than the judicial exception (Step 2B).
In regard to Step 1, Claims 1-2, 13, 20-21, 28, 39-40 are drawn to a composition of matter-a TCR and T cell.
[AltContent: textbox ([img-media_image1.png])]In regard to Step 2A prong one, Claims 1-2, 13, 20-21, 28, 39-40 are drawn to a nature-based product which is not markedly different from its naturally occurring counterpart. Specifically, independent claim 1 is directed to a synthetic TCR that is a variant of a natural TCR, claim 28 is directed to synthetic or natural TCR, and claim 30 is directed to a T cell. These, are nature-based products. Specifically, Applicant is directed to the publication of Neunkircher et al., (J Immuno, 2011, 187:4077-4087), which demonstrates that T cells isolated from birch pollen-allergic patients were sequenced and the DNA encoding the TCR alpha constant region is a variant of the natural TCR sequence. Specifically, the variant TCR alpha chain (lower sequences) comprises a D->N and N->K substitutions in the N-terminus. Note that although Applicant’s specification defines “N-terminal modification” as meaning that the N-terminal of the referred amino acid sequence comprises a substitution, deletion and/or addition of one or more amino acids, Applicant’s specification provides no definition of the “natural” TCR, but only indicates that SEQ ID NO:1 and 2 are the “WT” sequences for the constant regions of human and mouse TCR alpha chains, respectively. Thus, the TCR alpha chain of Neunkirchner is a variant of the natural sequences in the constant region.
In regard to claims 20 and 28, Neunkirchner teaches the variable domains of the alpha and beta chains which bind in combination with different CDRs to different regions of the same MHC presented allergen peptide (Fig. 1).
In regard to claim 21, as stated supra, the target antigen is a allergic disease related antigen.
In regard to claim 40, the phrase “pharmaceutically acceptable carrier” is so broadly defined that it includes all solvents, dispersion media, isotonic agents and the like that are physiologically compatible, and would be necessarily present with the T cells isolated from birch pollen-allergic patients.
These claims encompass a naturally occurring TCR and T cell. This option of the claims is a naturally occurring product. Applicant is reminded that, “a new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter” under Section 101. Diamond v. Chakrabarty, 447 U.S. 303, 309, 206 USPQ 193, 197 (1980).
Because instant claims are directed to a nature-based product, i.e., a TCR and T cell, the nature-based product is analyzed to determine whether it has markedly different characteristics from any naturally occurring counterpart(s) in their natural state. However, instant claims encompass TCRs that are identical (no difference in structural or functional characteristics) to naturally occurring TCRs from birch allergic patients.
Furthermore, the fact that instant claim recites “synthetic” does not differentiate it from the proteins of Neunkirchner because although the claimed proteins may be man-made they are identical to what exists in nature (i.e., same structure and function). As the Supreme Court made clear, neither naturally occurring compositions of matter, nor synthetically created compositions that are structurally identical to the naturally occurring compositions, are patent eligible.”). Thus, a synthetic, artificial, or non-naturally occurring product is not automatically eligible because it was created by human ingenuity or intervention. See, e.g.,In re Roslin Institute (Edinburgh), 750 F.3d 1333, 1337, 110 USPQ2d 1668, 1671-72 (Fed. Cir. 2014) (cloned sheep); cf. J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred Int’l, Inc., 534 U.S. 130-132, 60 USPQ2d 1868-69 (2001) (hybrid plant). Instead, the key to the eligibility of all non-naturally occurring products is whether they possess markedly different characteristics from any naturally occurring counterpart.
In regard to Step 2A prong two, the judicial exception is not integrated into a practical application. In particular, instant claims recite no additional elements to integrate the claimed TCR and T cell into a practical application. Moreover, Claim 40 recites a single additional element- that the T cell is in a pharmaceutically acceptable carrier. As stated above, the phrase is extremely broad and encompasses many types of sterile physiological solutions, including culturing buffers. Thus, merely placing the natural product into a generic buffer so that the cell may maintain its structure and function does not add a meaningful limitation as it is a nominal extra-solution component of the claim as is a necessary precursor for all of the uses of cells, and is nothing more than an attempt to generally link the protein product to a particular biotechnology. Clearly, combining the natural cell in a pharmaceutical composition on its own does nothing to improve a technology, effect a particular treatment, or implement with a particular device to provide a meaningful limitation on the judicial exception.
In regard to Step 2B, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As stated supra, instant claims recite no additional elements to the protein. In regard to Claim 40, which recites a single additional element as a pharmaceutically acceptable carrier, as discussed above with respect to the integration of the natural product into a practical application, the additional element of combining a pharmaceutical composition amounts to no more than a sterile physiological buffer to keep the cell alive, and do not provide an inventive concept.
Therefore, instant claims are directed to a natural product, that is not markedly different from its natural counterpart, is not integrate a practical application, and does not include elements that amount to significantly more than the natural product itself and do not qualify as patent eligible subject matter under 35 U.S.C. § 101.
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)(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.
(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.
Claim 1-2, 13, 20-21, 28, 39-40 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Neunkircher et al., (J Immuno, 2011, 187:4077-4087), as evidenced by GenBank ADD84718 (10/18/2011).
With respect to claims 1-2, 13, 28, and 39, Neunkircher teaches T cells isolated from birch pollen-allergic patients were sequences and the cDNA encoding alpha and beta chains of a TCR were sequenced and deposited in the GenBank database (Abstract, Materials and Methods, p.4078).
As can be seen in the alignments of the TCR alpha constant region, Neunkircher demonstrates that the first constant region of the alpha chain is a variant of the natural TCR sequence. Specifically, the variant TCR alpha chain (lower sequences) comprises a D->N and N->K substitutions in the N-terminus. Note that although Applicant’s [AltContent: textbox ([img-media_image1.png])]specification defines “N-terminal modification” as meaning that the N-terminal of the referred amino acid sequence comprises a substitution, deletion and/or addition of one or more amino acids, Applicant’s specification provides no definition of the “natural” TCR, but only indicates that SEQ ID NO:1 and 2 are the “WT” sequences for the constant regions of human and mouse TCR alpha chains, respectively. Thus, the TCR alpha chain of Neunkirchner is a variant of the natural sequences in the constant region.
In regard to claims 20 and 28, Neunkirchner teaches the variable domains of the alpha and beta chains which bind in combination with different CDRs to different regions of the same MHC presented allergen peptide (Fig. 1).
In regard to claim 21, as stated supra, the target antigen is a allergic disease related antigen.
In regard to claim 40, the phrase “pharmaceutically acceptable carrier” is so broadly defined that it includes all solvents, dispersion media, isotonic agents and the like that are physiologically compatible, and would be necessarily present with the T cells isolated from birch pollen-allergic patients.
Accordingly, Neunkircher anticipates instant claims.
Claim 1-2, 6-13, 17-21, 28, 39-40 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Gros and Rosenberg (WO2016/179006, filed 4/29/2016, published 11/10/2016).
In regard to claims 1, 2, and 28, Gros teaches a synthetic TCR comprising the mouse TCR alpha chain of SEQ ID NO:59 that targets the tumor suppressor MED13 ([0079, 00187], Table 13, see Claim 29 of Gros).
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In regard to claims 6-7, the mouse TCR alpha chain of SEQ ID NO:59 of Gros comprises a T48C mutation (see bolded residue) according to SEQ ID NO:2.
In regard to claims 8-10, the mouse TCR alpha chain of SEQ ID NO:59 of Gros comprises a transmembrane portion comprising S112L, M114I, and GII5V mutations according to SEQ ID NO:2.
In regard to claim 11, the mouse TCR alpha chain of SEQ ID NO:49 of Gros comprises a transmembrane portion that is 100% identical to instant SEQ ID NO:8 (see shade sequence LLVIVLRIL).
In regard to claim 12, the mouse TCR alpha chain constant region of SEQ ID NO:59 of Gros is 100% identical to instant SEQ ID NO:10.
In regard to claims 13, 17, 18 and 19 vi), Gros teaches the beta chain of the anti-MED13 TCR, which comprises a constant region that is 100% identical to SEQ ID NO:20 (see below):
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In regard to claim 20, as shown supra, Gros teaches the variable domains of the alpha and beta chains which bind in combination with different CDRs to different regions of the same MHC presented MED13 peptide.
In regard to claim 21, as stated supra, MED13 is a disease-related antigen.
In regard to claims 39 and 40, Gros teaches a therapeutic T cells comprising the anti-MED13 TCRa/b and a pharmaceutically acceptable carrier.
Accordingly, Gros anticipates instant claims.
Claim 1-2, 13, 20-31, and 39-40 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Chaudhary (WO2018/102795, filed 12/02/2017, published 6/07/2018)
[AltContent: textbox ([img-media_image4.png])]In regard to claims 1-2, 13, and 28, Chaudhary teaches a synthetic TCR such as a double chain chimeric receptor, comprising variants the human TCR alpha/beta constant regions (see Fig. 11, adjacent). Specifically , Chaudhary teaches the synthetic TCR comprises a constant region of the TCR beta chain comprises mutations (Seq id 3024-3044) and alpha chain comprises mutations (Seq id 3010-3023) ([0090-0097], Tables 1-3, see Claim 117 and 120 of Chaudhary). Specifically, Chaudhary teaches a human TCR alpha constant region of SEQ ID NO:3016, wherein the first four (4) amino acids are deleted, and comprises a cysteine mutation of T48C. Furthermore, Cahudhary teaches the human TCR beta constant region of SEQ ID NO: 3027, which comprising a cysteine mutation of S57C.
In regard to claim 20, 22, 24-26 and 29, Chaudhary teaches the synthetic TCR comprises a scFv which bind a target antigen in combination ([0010, 0042], Fig. 8A-D, see also claims 13 and 122 of Chaudhary).
In regard to claims 20, 21, 27, and 31, Chaudhary teaches the synthetic TCR comprises an antigen binding domain that targets CD19 and/or CD20 ([0038, 0211-0212, 0234-0238], Fig. 7, see also claim 12 and 121 of Chaudhary).
In regard to claims 23 and 30, in one embodiment, Chaudhary teaches the anti-CD20 scFv comprises the heavy chain and light chain variable regions of the “2C6” clone (see Table 5, see “CD20-2C6-vL” on p.117, and “CD20-2C6-vH” on p. 128). Specifically, Chaudhary teaches the anti-CD20 heavy chain and light chain variable sequences of SEQ ID NO: 12189 and 12071, respectively, which are 100% identical to instant SEQ ID NO:46 and 47, respectively.
In regard to claims 39 and 40, Chaudhary teaches the synthetic TCR is in a T cell and pharmaceutically acceptable carrier ([0027,0116, 0160, 0419], see claim 166 and 195 of Chaudhary).
Accordingly, Chaudhary anticipates instant claims.
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.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-2, 6-13, 17-26, 28-30, 39-40 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1-33 of copending Application No. 18/278,639. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented
The subject matter claimed in the instant application is disclosed in the referenced application as follows: the anti-GPC3 TCR and T cell composition of cited application anticipates the composition of instant application. It is clear that elements of the cited application claims are to be found in instant claims. The difference between the cited application claims and the instant claims lies in the fact that the cited application claims are much more specific with respect to the target antigen. Thus the invention of said claims of the cited application are in effect “species” of the “generic” invention of the instant claim. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
Since the instant application claims are anticipated by cited application claims, said claims are not patentably distinct.
Claims 1-2, 6-13, 17-31, 39-40 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 66-88, 90-118 of copending Application No. 18/008,278. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented
The subject matter claimed in the instant application is disclosed in the referenced application as follows: the TCR-OXA fusion and T cell composition of cited application anticipates the composition of instant application. It is clear that elements of the cited application claims are to be found in instant claims. The difference between the cited application claims and the instant claims lies in the fact that the cited application claims are much more specific with respect to the signaling domain. Thus the invention of said claims of the cited application are in effect “species” of the “generic” invention of the instant claim. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
Since the instant application claims are anticipated by cited application claims, said claims are not patentably distinct.
Claims 1-2, 6-13, 17-31, 39-40 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1-34, 36-67 of copending Application No. 17/927,072. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented
The subject matter claimed in the instant application is disclosed in the referenced application as follows: the TCR and T cell composition of cited application anticipates the composition of instant application. It is clear that elements of the cited application claims are to be found in instant claims. The difference between the cited application claims and the instant claims lies in the fact that the cited application claims are much more specific to the CD19/CD20 target antigen. Thus the invention of said claims of the cited application are in effect “species” of the “generic” invention of the instant claim. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
Since the instant application claims are anticipated by cited application claims, said claims are not patentably distinct.
Conclusion
No claims are allowed.
Claims 5 and 16 are objected to as allowable.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARTHUR S LEONARD whose telephone number is (571)270-3073. The examiner can normally be reached on Mon-Fri 9am-5pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Doug Schultz can be reached on 571-272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ARTHUR S LEONARD/Examiner, Art Unit 1631