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
Claims 1-2, 5, 7, 10, 12-13, 16, 18, 20, 24-25, 33-34, 39, 43-46, 48, and 51 are pending.
Applicant's election with traverse of Group IV, claims 24-25 and 43 in the reply filed on 08/27/2025 is acknowledged.
While Applicant’s election of a recombinant immune cell comprising a polynucleotide encoding a SLAMF7-CAR polypeptide as defined in SEQ ID NO: 8 is non-responsive, the response appears to be bona fide.
During a telephone conversation with James Keddie on 09/16/2025 a election was made with traverse to the species of a recombinant immune cell comprising a polynucleotide according to claim 12, corresponding to claims 24 and 25. Affirmation of this election must be made by applicant in replying to this Office action.
In regards to the Groups, traversal is on the grounds that there is no burden (citing MPEP 803) (Remarks, p1-2).
This is not found persuasive, because as discussed in the Office Action on 07/02/2025, the groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons: Groups I-VI lack unity of invention because even though the inventions of these groups require the technical feature of a SLAMEF7 binding chimeric antigen receptor (CAR) polypeptide, comprising at least: one extracellular ligand binding domain, a transmembrane domain and at least one intracellular signalling domain, wherein said extracellular ligand binding domain comprises a SLAMF7-binding element and an IgG4-FC spacer domain, wherein said transmembrane domain comprises a CD28 transmembrane domain, and wherein said intracellular signalling domain comprises a costimulatory domain and a CD3 zeta domain, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Chen et al, (WO2019241358, 2019, on IDS 12/15/2022) who teaches a CS1 (SLAMF7)-binding CAR polypeptide comprising an extracellular ligand binding domain comprising SLAMF7-binding element and a lgG4 spacer, a CD28-derived transmembrane domain, and an intracellular domain comprising a costimulatory domain and a CD3 zeta domain (Claims 1, 69, 72; Fig. 1B; paragraphs [0038-39]).
In regards to the species, Applicant argues that the identified species have the same scope (see Interview Summary).
This is not found persuasive, because the technical feature is not a special technical features as discussed above and in the Office Action on 07/02/2025.
Additionally, it is noted that the species of recombinant immune cells corresponding to the immune cells of species a) (claims 24-25) or species b) (claim 43) do not in fact have the same scope. For example, species b) requires that the recombinant immune cell be made by the method of claim 33 which the recombinant immune cell of claim 24 does not require.
Therefore, the requirement is still deemed proper and is therefore made FINAL.
Claims 1-2, 5, 7, 10, 12-13, 16, 18, 20, 33-34, 39, 43-46, 48, and 51 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions or species, there being no allowable generic or linking claim. Applicant timely traversed the restriction requirement in the reply filed on 07/02/2025. Applicant timely traversed the restriction requirement in the reply filed on 07/02/2025. Applicant timely traversed the species election requirement in communications on 09/16/2025.
Claims 24 and 25 have been examined on their merits.
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.
Claim 25 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.
Claim 25 is drawn to “The recombinant immune cell according to claim 25.”
The claim further states, “wherein the polynucleotide is located in the nuclear genome of the immune cell, optionally, wherein the polynucleotide is expressed, wherein said recombinant immune cell is a recombinant lymphocyte, optionally, wherein said recombinant lymphocyte is a recombinant T cell, wherein said recombinant T cell is a recombinant CD4+ cell or a recombinant CD8+ cell,
optionally further expressing EGFRt, wherein said recombinant immune cell is a recombinant human cell, further optionally, wherein said recombinant immune cell does not comprise an amino acid sequence of the SB transposase as represented by SEQ ID NO: 13 or fragments thereof in a detectable amount at day 14 after gene transfer”.
It is noted that there are no conjunctions (i.e., no “and” or “or”) either separating or unifying clauses in the cited text.
The claim is indefinite because it is unclear which clauses are optional and which are required.
For example, while the claim appears to require that the “polynucleotide is located in the nuclear genome of the immune cell”, it is unclear if the clause “wherein said recombinant T cell is a recombinant CD4+ cell or a recombinant CD8+ cell” is required or if it is considered to be part of the preceding clause “optionally, wherein the polynucleotide is expressed.”
While the “wherein” clauses could be interpreted as required, with the “optionally” clauses interpreted as optional, the claim is not internally consistent because it is specifically unclear if the phrase “optionally, wherein said recombinant lymphocyte is a recombinant T cell, wherein said recombinant T cell is a recombinant CD4+ cell or a recombinant CD8+ cell” requires a T cell or not.
Again, as above, there is no conjunction (i.e., “and” or “or”) separating clauses and therefore, there is no indication of the grammatical relationship between clauses.
For compact prosecution and giving the claim its broadest reasonable interpretation, the phrase “where the polynucleotide is located in the nuclear genome of the immune cell” has been interpreted as limiting, but the remaining clauses have been interpreted as optional, only further describing the cause “optionally, wherein the polynucleotide is expressed.”
Furthermore, claim 25 contains the term “SB” which is an abbreviation for “Sleeping Beauty” (see paragraph [0280]). Sleeping Beauty is a trademark/trade name where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a synthetic gene transfer system and, accordingly, the identification/description is indefinite.
Appropriate clarification is required.
Claim Rejections - 35 USC § 102
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 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.
Claims 24 and 25 are rejected under 35 U.S.C. 102(a)(1) or 35 U.S.C. 102(a)(1) as being anticipated by Chen et al. (WO2019241358, 2019, on IDS 12/15/2022, previously cited).
In regards to claim 24, Chen discloses a chimeric immune cell comprising a polynucleotide (Claims 119, 121-122; paragraph [0219]).
Chen discloses that the polynucleotide encodes a CS1 (SLAMF7)-binding CAR polypeptide comprising an extracellular ligand-binding domain (ECD) comprising a SLAMF7-binding element and an IgG4 spacer, a CD28-derived transmembrane domain (TMD), and an intracellular domain (ICD) comprising a co-stimulatory domain and a CD3 zeta domain (Claims 1, 69, 72; Fig. 1B; paragraphs [0004, 0038-0039]) (and thus, the polynucleotide according to claim 12, and the polynucleotide encoding a SMALF7-CAR polypeptide according to claim 1).
In regards to claim 25, Chen discloses that the polynucleotide (the “nucleic acid”) is integrated into the cell’s genome (claim 120; paragraph [0050]).
While interpreted as optional as discussed above, Chen also discloses that the recombinant immune cell is a human lymphocyte and a CD4+ T cell specifically (claim 122-125; paragraphs [0051, 0219])).
Therefore, Chen anticipates the invention as claimed.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Danhof et al. (Blood, 2015).
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH (PAUL) MIANO whose telephone number is (571)272-0341. The examiner can normally be reached Mon-Fri from 8:30am to 5:30pm.
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/JOSEPH PAUL MIANO/Examiner, Art Unit 1631