DETAILED ACTION
This Action is in response to the communication filed on 05/02/2025.
Claims 1-27 are pending.
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
Applicant’s election without traverse of Group I and the species: SEQ ID NO: 6, T cell, CD19, CAR, SEQ ID NO: 76 , and SEQ ID NO: 77 in the reply filed on 05/02/2025 is acknowledged.
Claims 23-27 and the non-elected species are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 05/02/2025.
Claims 1-22 are examined herein, as they read on the elected species.
Improper Markush Group
Claim 1 is rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of claim 1 is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: the claim includes a Markush grouping of nucleotide sequences identified as SEQ ID Nos: 1-20 and 75; however, each nucleotide sequence is different from the others and there does not appear to be any structural similarity common to all of the nucleotide sequences (i.e., there is not a single structural similarity). Furthermore, it does not appear that all of the alternatives are members of the same recognized physical or chemical class or the same art-recognized class as they appear to be generic nucleotide sequences.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Claim Rejections - 35 USC § 112
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 1-22 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The fundamental factual inquiry is whether the specification conveys with reasonable clarity to those skilled in the art that, as of the filing date sought, applicant was in possession of the invention as now claimed. See, e.g., Vas-Cath, Inc., 935 F.2d at 1563-64, 19 USPQ2d at 1117.
To satisfy the written description requirement, MPEP §2163 states, in part “…a patent 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.” Moreover, the written description requirement for a genus may be satisfied through sufficient description of a representative number of species by “…disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between functional and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus.”
All claims encompass a cell comprising an exogenous composition, wherein the exogenous composition is integrated up to about 10kb upstream or downstream or within a locus of the genome of the cell, wherein the locus can comprise a nucleotide sequence “at least about 80% identical to” any of a number of different nucleotide sequences including SEQ ID NO: 6 (the elected species; see claim 1). There are two specific issues: the genus of exogenous compositions and the genus of nucleotide sequences encompassed by the claims.
Regarding “exogenous compositions” the application discloses “In certain embodiments, the exogenous composition disclosed herein comprises a transgene disclosed herein (e.g., disclosed in Section 5.4).” (See paragraph [0236]of the published application U.S. 2022/0211761). Accordingly, the specification only appears to disclose that the exogenous composition can be a transgene. It is noted, however, that the term “exogenous composition” is not defined as being limited to a transgene. Therefore, the claim broadly encompasses a genus of exogenous compositions but only identifies one specific member of the genus, a transgene.
Regarding nucleotide sequences “at least about 80% identical to” the different nucleotide sequences including SEQ ID NO: 6, it is noted that the specification does not identify any nucleotide sequence that is less than 100% identical to any of the claimed SEQ ID Nos, including SEQ ID NO: 6 (the elected species). Furthermore, no nucleotide sequence at least about 80% identical to SEQ ID NO: 6 was found in the prior art. It is also noted that the disclosure does not identify any particular domains or other structural elements of SEQ ID NO: 6 (or any of the other SEQ ID Nos) that must be conserved among the any variant sequences that are less than 100% identical to SEQ ID NO: 6.
The limited disclosure of the specification in view of the vast genus of exogenous compositions and variant nucleotide sequences that are at least about 80% identical to SEQ ID NO: 6 encompassed by the claims does not adequately describe the entire genus of exogenous compositions and variant nucleotide sequences encompassed by the claims
“Possession may not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features.” Ex parte Kubin, 83 USPQ2d 1410, 1417 (Bd. Pat. App. & Int. 2007) citing University of Rochester, 358 F.3d at 927, 69 USPQ2d at 1895. Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states that “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116).
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co., the court stated:
“A written description of an invention involving a chemical genus, like a description of a chemical species, 'requires a precise definition, such as by structure, formula, [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials. Fiers, 984 F.2d at 1171, 25 USPQ2d at 1606; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284-85 (CCPA 1973) ("In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus. . . ."). Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP further states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is “not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.” MPEP 2163. The MPEP does state that for generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. MPEP 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP 2163. Although the MPEP does not define what constitute a sufficient number of representative, the Courts have indicated what do not constitute a representative number species to adequately describe a broad generic. In Gosteli, the Court determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gosteli, 872 F.2d at 1012, 10 USPQ2d at 1618.
The court and the Board have repeatedly held (Amgen Inc. v. Chugai Pharmaceutical Co. Ltd.,18 USPQ2d 1016 (CA FC, 1991); Fiers v. Revel, 25 USPQ2d 1601 (CA FC 1993); Fiddes v. Baird, 30 USPQ2d 1481 (BPAI 1993) and Regents of the Univ. Calif. v. Eli Lilly & Co., 43 USPQ2d 1398 (CA FC, 1997)) that an adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it, irrespective of the complexity or simplicity of the method; what is required is a description of the nucleic acid itself.
The specification does not disclose any exogenous composition other than a transgene and does not disclose any variant of SEQ ID NO: 6 that is at least about 80% identical to SQE ID NO: 6, nor are any found in the prior art. Thus one of skill at the time of the invention could not have concluded that Applicant was in possession of the genus of exogenous compositions that can be integrated into or within 10kb of the genus of nucleotide sequence at least about 80% identical to SEQ ID NO: 6. It is noted that limiting the genus of exogenous compositions to a transgene and limiting the nucleotide sequence to SEQ ID NO: 6 (i.e., not variants that are at least about 80% identical to SEQ ID NO: 6) would obviate this rejection.
Relevant Post Filed Art
Wagner and Mamonkin; Blood (2023) vol. 144 (22):2665-2666 is not eligible as prior art as it was published after the effective filing date of the claimed invention, but is made of record as it is considered relevant to the understanding of the claimed invention and the state of the art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to J. E. Angell whose telephone number is (571)272-0756. The examiner can normally be reached Monday-Friday (8:30-5:00).
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J. E. Angell
Primary Examiner
Art Unit 1637
/J. E. ANGELL, Ph.D./Primary Examiner, Art Unit 1637