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
Applicant’s election without traverse of Group VII, claims 42-44, 48 in the reply filed on 8/15/2025 is acknowledged.
Claims 1, 2, 4, 5, 8, 9, 21, 22, 24, 34, 38, 39, 40, 47, 60-62, 72, 73, 76, 78-87 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected groups, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 8/15/2025.
Regarding the Election of Species required in the Restriction requirement dated 6/11/2025, Applicant was required to elect one of the arginine transporters recited in claim 43. Applicant was further requested to identify SEQ ID Nos in claim 44 that are associated with the elected transporter. Applicant has elected CAT-2 and identified SEQ ID NOs: 184-188, 196-197, 201-203 as corresponding sequences (page 9, last para).
Specification
The use of the terms Opti-MEM, PLUS, LTX, GlutaMAX, ImmunoCult, CliniMACS, TexMACS, TransAct, which are trade names or marks used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears 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 Suggestion
Claim 43 recites “the arginine transporter”. The claim depends from claim 42 that recites “a recombinant arginine transporter”. Although it is clear that the arginine transporter in claim 43 refers to the recombinant arginine transporter of claim 42, for the sake of consistency across the claims, following language is recommended for claim 43: “the recombinant arginine transporter”.
Claim 44 recites “90%, 95% or 99% percent identity”. The use of the word ‘percent’ and its symbol % is repetitive. Use of one or the other is recommended. For example, claim 44 may be amended to recite: “90%, 95% or 99% identity”.
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 44 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.
On line 4, Claim 44 recites “a nucleic acid expressing a sequence having about 90% [….] percent identity to a nucleic acid sequence selected from the group consisting of: SEQ ID NO: 180, […]”. It is unclear how a nucleic acid expresses another nucleic acid? The specification defines the term ‘express’ and thus provides guidance regarding the term ‘expressing’ in [0052]: “As used herein, the terms "express" and "expression" mean allowing or causing the information in a gene or DNA sequence to become manifest, for example producing a protein such as a CAR or an amino acid transporter by activating the cellular functions involved in transcription and translation of a corresponding gene or DNA sequence”. Thus nucleic acids, such as DNA, may be expressed via transcription into RNA and RNA maybe expressed via translation into proteins. The recited SEQ IDs are DNA and thus it is unclear what is the nature of the ‘a nucleic acid’ that expresses these DNA sequences. For the purpose of compact prosecution, the claim(s) 44 is/are interpreted as “a nucleic acid
The term “about” in claim 44 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. When disclosing percent identity between nucleic acids, the specification does not identify the range embraced by the use of the term ‘about’. Thus, it is unclear when two nucleic acid sequences are ‘about’ 90%, 95%, 99% identical.
Claim Rejections - 35 USC § 112
Claims 43, 44 are rejected on the basis that they contain 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.
Members of a Markush group share a "single structural similarity" when they belong to the same recognized physical or chemical class or to the same art-recognized class. A recognized physical class, a recognized chemical class, or an art-recognized class is a class wherein there is an expectation from the knowledge in the art that members of the class will behave in the same way in the context of the claimed invention. In other words, each member could be substituted one for the other, with the expectation that the same intended result would be achieved.
The Markush grouping of CAT-1, CAT-2, CAT-3, CAT-4, y+LAT1 and 4F2hc, y+LAT2 and 4F2hc, b0,+AT and rBAT, and ATB0,+ in Claim 43 and associated nucleic acid sequences recited in claim 44 are 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 claimed ‘arginine transporters’ belong to at least three distinct art-recognized groups of amino acid transporters that are both structurally and functionally distinct. ATB0,+ is the most distinct, belonging to the SLC6 family of amino acid transporters and is generally considered to have several unique characteristics (see Abstract in Karunakaran et al (THE JOURNAL OF BIOLOGICAL CHEMISTRY VOL. 286, NO. 36, pp. 31830–31838, September 9, 2011)). Its transport function is controlled by the concentration gradient of both Na+ and Cl- ions while it transports nearly all essential amino acids, albeit to a low level (Introduction, para 1 and 2). This transporter is distinct from the CAT, LAT and BAT transporters recited.
Fotiadis et al (Molecular Aspects of Medicine 34 (2013) 139–158) provides a recent review of the amino acid transporters from the SLC3 and SLC7 families of amino acid transporters that cover the CAT, LAT and BAT transporters. They teach that SLC7 family of transporters comprise two distinct families: Cationic amino acid transporters (CATs; CAT1-4) and the L-type amino acid transporters (LATs; y+LAT1, 2) (Introduction, para 1). These two groups are structurally and functionally distinct. While CATs are homomeric transmembrane proteins, LATs form heteromers (i.e. Heteromeric Amino acid transporters, HATs) with subunits from the SLC3 family (4F2hc, rBAT) and require these heteromeric structure to function (see exemplar structural difference in Figure 1, Introduction, para 1). Furthermore, while CATs are facilitated transporters for cationic amino acids, in contrast HATs are exchangers for a wide spectrum of amino acids (Introduction, paras 2-3; Table 1). Thus, the group, as a whole, does not share a substantial structural feature and a common use that flows from the substantial structural feature such that “single structural similarity” could be recognized.
Critically, there is an no expectation from the knowledge in the art that members of the class will behave in the same way in the context of the claimed invention i.e. as arginine transporters that when expressed in T-cells would increase arginine concentration in the T cell.
For example, even within the CAT family of transporters, functional differences were known amongst CAT4 and CAT1-3 transporters. CAT4 is considered an orphan transporter because it appears to not transport amino acids (See 2.4. CAT-4 (SLC7A4) and SLC7A14 in Fotiadis).
Similarly, substrate selectivity and ion coupling differ among LATs/HATs and “Thus, these transporters correspond to system L (4F2hc/LAT1 and 4F2hc/LAT2), system y+L (4F2hc/y+LAT1 and 4F2hc/y+LAT2), system xc- (4F2hc/xCT), system asc (4F2hc/Asc-1 and Asc-2 linked to an unknown heavy subunit) and system b0,+ (rBAT/b0,+AT)” (See 4. HATs and their light subunits in Fotiadis). Thus, the group, as a whole, could not be considered to belong to an art-recognized class that were considered functionally equivalent resulting in a common use.
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 § 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 42-44, 48 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 significantly more.
A three-part inquiry has been established to determine subject matter eligibility under 35 U.S.C. 101 for process claims that involve laws of nature. See Subject Matter Eligibility Guidance in MPEP 2106. This inquiry comprises answering: 1) Is the claimed invention directed to one of the four statutory patent-eligible subject matter categories: process, machine, manufacture, or composition of matter? 2A) Does the claim recite or involve one or more judicial exceptions? Judicial exceptions include abstract ideas, laws of nature/natural principles, natural phenomena, and natural products. 2B) Does the claim as a whole recite something significantly more than the judicial exception(s)?
Claim Interpretation: With respect to claims 42, applicant' s invention is interpreted as comprising a T-cell that are genetically modified to express a transporter capable of transporting arginine. Claim 43 limits the transporters to the listed transporters (CAT-1, CAT-2, CAT-3, CAT-4, y+LAT1 and 4F2hc, y+LAT2 and 4F2hc, b0,+AT and rBAT, and ATB0,+). Although claim 44 does not explicitly recites that the listed SEQ IDs are for sequences that encode transporters capable of transporting arginine, most of these sequences are disclosed as sequences for naturally occurring CAT-1, CAT-2, CAT-3, CAT-4, y+LAT1 and 4F2hc, y+LAT2 and 4F2hc, b0,+AT and rBAT, and ATB0,+ or their variants (Table 1). Therefore, claims 43 and 44 comprise T-cells that are genetically modified to expresses the specifically listed transporters capable of transporting arginine. Claim 48 is directed to a pharmaceutical composition comprising the cell of claim 42 in a pharmaceutically acceptable excipient.
Analysis in View of Claim Interpretation and Subject Matter Eligibility Guidance:
1) Statutory Subject Matter: Claims 42-44 are directed to a cell, which is a product. Claims 48 is directed to a pharmaceutical composition, which is a product . Therefore, claims 42-44, 48 are directed to statutory subject matter.
2) Judicial Exception Analysis:
2A) Judicial Exception
(i) Does the claim recite a judicial exception? Claim 42 recites a judicial exception because it embraces nature-based products that are not markedly different from the naturally occurring counterpart. See MPEP 2106.04(c) for The Markedly Different Characteristics Analysis.
The naturally occurring counterpart of the claimed T cells that are genetically modified to expresses any recombinant arginine transporter are naturally occurring T cells. The claimed T cells has the same phenotypic characteristics as the naturally occurring T cells such that the claimed cells would be indistinct from their naturally occurring counterparts. Although the claim recites “a recombinant arginine transporter”, no structure is recited such that a recombinant arginine transporter is distinct from a naturally occurring arginine transporter. Similarly, although the claim recites that T cell is “genetically modified to express” the transporter, no modification or structure is recited for the T cell such that the claimed T cell is structurally distinct from a naturally occurring T cell.
Human T cells were to known express several arginine transporters and the expression of these naturally occurring arginine transporters were known to fluctuate, even increase, under conditions that occur in nature. Werner et al (Eur. J. Immunol. 2016. 46: 92–103; ref of record) show that primary human T cell express CAT1, CAT3, y+LAT1, y+LAT2, bo,+AT, ATB0,+ and that their expression changes in response to T cell stimulation (Figure 2). Thus, to the extent that claim 43 recites CAT1, CAT3, y+LAT1, y+LAT2, bo,+AT, ATB0,+ as arginine transporters expressed in the claimed T cell, claim 43 also recites a judicial exception since T cells naturally express these transporters. Sequences recited in claim 44 that correspond with naturally occurring sequences of CAT1, CAT3, y+LAT1, y+LAT2, bo,+AT, ATB0,+ also result in the claim 44 embracing cells that are not markedly different from the naturally occurring T cells and thus reciting a judicial exception (SEQ ID NO: 180, 204, 205, 214, 215, 220-222, 227-230, 234-236, 242, and 246).
Claim 48 recited the T cell of claim 42 in a pharmaceutical composition that additionally comprises a “pharmaceutically acceptable excipient” however does not recite any specific excipient. As such, some pharmaceutically acceptable excipients are also naturally occurring such as blood that have the T cells. Thus, claim 48 also embraces compositions that are not markedly different from a naturally occurring T cell in blood.
(ii) Does the claim recite additional elements that integrate the judicial exception into a practical application? Claim 42 do not recite additional elements that integrate the judicial exception into a practical application because only the T cell with the arginine transporter is recited. Claim 43, 44 do not recite additional elements that integrate the judicial exception into a practical application because only the T cell with the specifically listed arginine transporters are also naturally occurring are recited.
Claim 48 recites an additional element of “pharmaceutically acceptable excipient” however, as noted above, it does not recite any specific excipient and embraces naturally occurring excipient such as blood that have the T cells. Furthermore, even in case, the generically recited “pharmaceutically acceptable excipient” is not naturally occurring, other consideration are relevant when evaluating whether the additional element integrates the exception into a practical application. MPEP 2106.04(d) presents the considerations that relevant to this analysis. In the instant case, the additional element of “pharmaceutically acceptable excipient” does not apply or use the judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition. Furthermore, the use of pharmaceutically acceptable excipient in pharmaceutical composition is routine such that the recited additional element is an insignificant extra-solution activity to the judicial exception. Thus, claim 48 does not recite an additional elements that integrate the judicial exception into a practical application.
2B) Significantly More
The claims 42-44 do not include additional elements that are sufficient to amount to significantly more than the judicial exception because claims 42-44 do not recite any additional element that could suggest that they could amount to an inventive concept.
Regarding claim 48, inclusion of the T cell in a generically recited pharmaceutically acceptable excipient was not found to integrate the judicial exception into a practical application. Furthermore, inclusion of additional elements that are well-understood, routine, conventional elements could not amount to an inventive concept that could provide significantly more to the judicial exception. Considering use of pharmaceutically acceptable excipient in making compositions is routine, claim 48 does not provide significantly more to the judicial exception.
Summary
On balance the relevant factors weigh against eligibility and claims 42-44, 48 do not qualify as 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.
Claim(s) 42-43 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by London et al (WO 2018/138522 A1; 02 August 2018; IDS 8/15/2025) as evidenced by Fotiadis et al (Molecular Aspects of Medicine 34 (2013) 139–158) and Karunakaran et al (THE JOURNAL OF BIOLOGICAL CHEMISTRY VOL. 286, NO. 36, pp. 31830–31838, September 9, 2011).
Regarding claim 42 and 43, London discloses T cells expressing amino acid transporters such as SLC7A1, SLC7A2, SLC7A3, SLC7A4, SLC7A6, SLC7A9, SLC3A1, SLC3A2, SLC6A14; which transport arginine (page 3-4, bridging para; page 4, last para). See Table 1 and 2 in Fotiadis as evidence that CAT1 = SLC7A1, CAT2 = SLC7A2, CAT3 = SLC7A3, CAT4 = SLC7A4, y+LAT1 = SLC7A7, 4F2hc = SLC3A2, y+LAT2 = SLC7A6, b0,+AT = SLC7A9 and rBAT = SLC3A1 and that these transport arginine. See Abstract and Introduction-para 2 in Karunakaran as evidence that ATB0,+ = SLC6A14 and this transports all essential amino acids, thus transports arginine.
London also discloses using vectors comprising nucleic acids encoding recombinant amino acid transporters recited above, the use of these vectors to transduce/transfect T cells and T cells transduced/transfected with such vectors (claims 14-17; claim 22; page 12, para 2).
Taken together, London discloses T cells genetically modified using vectors comprising nucleic acids encoding recombinant amino acid transporters recited above which are arginine transporters.
London discloses the elected species of CAT-2 in claim 43.
Therefore, London anticipates the claimed invention.
Claim Rejections - 35 USC § 103
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.
Claim(s) 44 is/are rejected under 35 U.S.C. 103 as being unpatentable over London as applied to claim 42, 43 above, and further in view of NM_001008539.4 (May 7 2019; in PTO-892; Sequence alignment with SEQ ID NO: 184 in PTO-892), NM_001164771.2 (May 7 2019; IDS 8/15/2025), NM_001370337.1 (May 7 2019; IDS 8/15/2025), NM 001370338.1 (May 7 2019; IDS 8/15/2025), NM_003046.6 (May 7 2019; IDS 8/15/2025) or Bancel et al (US 2014/0010861 A1, Jan. 9, 2014).
Regarding claim 44, in view of the 112b issues noted, London teaches the T cell of claims 42 and 43 that expresses the CAT-2 (=SLC7A2; see analysis in U.S.C 102 rejection above; page 3-4, bridging para; page 4, last para; claims 14-17; claim 22; page 12, para 2). London also teaches the use of vectors comprising nucleic acids that encode recombinant amino acid transporters such as CAT-2 to transduce/transfect T cells to generate T cells expressing recombinant amino acid transporters such as CAT-2 (claims 14-17; claim 22; page 12, para 2).
London does not teach the exact sequence of CAT-2 gene, mRNA or protein coding sequence (CDS). However, these sequences were known in the art.
NM_001008539.4 is the mRNA sequence of CAT-2 which is identical to SEQ ID NO: 184 (See Sequence alignment with SEQ ID NO: 184 in PTO-892).
NM_001164771.2 is the mRNA sequence of CAT-2 which is identical to SEQ ID NO:185.
NM_001370337.1 is the mRNA sequence of CAT-2 which is identical to SEQ ID NO:186.
NM 001370338.1 is the mRNA sequence of CAT-2 which is identical to SEQ ID NO:187 and comprises the CDS sequence identical SEQ ID NO: 197.
NM_003046.6 is the mRNA sequence of CAT-2 which is identical to SEQ ID NO:188 and comprises the CDS sequence identical SEQ ID NO: 196.
Bancel teaches optimized cDNA sequence for CAT-2 CDS as SEQ ID No: 100229 which is 88.2-88.4% identical (i.e. about 90%) to SEQ ID NOs: 201-203 (See Sequence alignment with SEQ ID NO: 201-203 in PTO-892; [0229]).
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to use the known sequences for CAT-2 as taught by any one of NM_001008539.4, NM_001164771.2, NM_001370337.1, NM 001370338.1, NM_003046.6 or Bancel in the nucleic acids of London that encode CAT-2. An ordinary artisan would be motivated to use the sequences taught by any one of NM_001008539.4, NM_001164771.2, NM_001370337.1, NM 001370338.1, NM_003046.6 or Bancel because London does not teach the exact sequence. An ordinary artisan would reasonably expect to generate a T cell expressing CAT-2 using the sequences taught by any one of NM_001008539.4, NM_001164771.2, NM_001370337.1, NM 001370338.1, NM_003046.6 or Bancel because London teaches methods to generate vectors using sequences that encode amino acid transporters and methods to use such vectors to generate T cells (Example 1-4).
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in
the art at the effective time of filing of the invention, especially in the absence of evidence to the
contrary.
Claim(s) 48 is/are rejected under 35 U.S.C. 103 as being unpatentable over London as applied to claim 42 above, and further in view of Mussai et al (WO 2019/122936 A1, 27 June 2019; IDS 8/15/2025).
London teaches the T cell of claims 42 that expresses an arginine transporter; for example, SLC7A2 (see analysis in U.S.C 102 rejection above; page 3-4, bridging para; page 4, last para; claims 14-17; claim 22; page 12, para 2).
Regarding claim 48, London teaches pharmaceutical composition comprising the T cell and contemplates their use in treating cancer (page 13, para 3; claims 19-20). London does not explicitly teach that the pharmaceutical composition comprising the T cell also comprises a pharmaceutically acceptable excipient. However, use of excipients in pharmaceutical compositions, including pharmaceutical compositions comprising T cells, is common and routine in the art.
Mussai is also directed at use of T cells for cancer treatment (page 9, para 1-5) and teaches use of pharmaceutically acceptable carriers such as excipients in pharmaceutical compositions comprising T cells (page 44, para 3 and 5). Mussai teaches that “A pharmaceutically acceptable carrier" refers to an ingredient in a pharmaceutical formulation, other than an active ingredient, which is nontoxic to a subject.” (page 44, para 5). Mussai teaches various excipients such as sterile water, physiological saline, glucose, dextrose, or the like which are selected depending upon the route of administration and the preparation desired (page 47, para 1). Mussai notes that “Standard texts may in some aspects be consulted to prepare suitable preparations.” (page 47, para 1).
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to include pharmaceutically acceptable excipients taught by Mussai in the pharmaceutical composition of London that also comprises T cells. An ordinary artisan recognizes the routine use of excipients in manufacture of pharmaceutical compositions, such as also noted by Mussai. An ordinary artisan would be motivated to include an excipient in London’s pharmaceutical compositions to generate a desired preparation of the pharmaceutical composition, such as also taught by Mussai, and such an inclusion would not require inventive ingenuity. Considering that excipients in pharmaceutical compositions are not the active therapeutic and Mussai teaches several excipients, an ordinary artisan reasonably expects to include a pharmaceutically acceptable excipient in London’s pharmaceutical composition.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective time of filing of the invention, especially in the absence of evidence to the contrary.
Conclusion
No claim is allowed.
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/MATASHA DHAR/Examiner, Art Unit 1632