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 .
Applicant's amendments and arguments filed on 01-19-2026 have been received and entered. Claims 1, 3, 45 have been amended. Claims 8, 11-19, 21, 28, 30, 32, 34, and 37-42 have been cancelled. Claims 1-7, 9-10, 20, 22-27, 29, 31, 33, 35-36, 43-51 are pending in the instant application.
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-7, 9-10, 20-21, 35-36, 41-42, and species of a chimeric antigen receptor (CAR) cell in the reply filed on 01-16-2025 is acknowledged. The traversal is on the ground(s) that the claims do not lack unity of invention because the claims are no longer directed to CD16 or CD32, only CD64. Neither of the references of record recite CD64. This is not found persuasive because the special technical feature linking the invention must have been cell expressing CD16 or CD32 that were pending in previous claim set. Even though the claims have been amended to only recite CD64, that feature did not contribute over prior art as described in the preceding OAs mailed on 09-24-2025 and 03-27-2025. The technical feature also does not appear to contribute over prior art as set forth below in the USC 102 rejection.
The requirement is still deemed proper and is therefore made FINAL as described in the preceding OAs mailed on 09-24-2025 and 03-27-2025.
Claims 22-27, 29, 31, 33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected subject matter, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 01-16-2025.
Claims 1-7, 9-10, 20, 35-36, 43-51, and species of a chimeric antigen receptor (CAR) cell are under consideration.
Priority
This application is a 371 of PCT/US20/55120 filed on 10/09/2020 that claims priority from US provisional application No 62/915,601 filed on 10/15/2019.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 02-24-2026, 01-19-2026, and 01-07-2026 are in compliance with the provisions of 37 CPR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
An IDS was received on 02-24-2026, 01-19-2026, and 01-07-2026. All references have been considered; however, due to the voluminous number of references in the IDS they have been only briefly considered. It is noted that the cloaking of a relevant reference by inclusion in a long list of citations may not comply with the Applicant' s duty of disclosure. Penn Yan Boats, Inc. v. Sea Lark Boats, Inc., 359 F. Supp. 948 (S.D. Fla. 1972). Therefore, the applicant is encouraged to present a concise statement as to the relevance of any particular documents known to be material for patentability as defined by 37 C.F.R. § 1.56.
Withdrawn- Claim Rejections - 35 USC § 112
Claims 1-7, 9-10, 20, 22-27, 29, 31, 33, 35-36 were 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. In view of Applicants' amendment of base claim 1, the previous rejections of claims are hereby withdrawn. Applicants' arguments with respect to the withdrawn rejections are thereby rendered moot.
Withdrawn- Claim Rejections - 35 USC § 103
Claims 1, 6-7, 9-10, 20, 35-36 and 43, 48-51 were rejected under 35 U.S.C. 103 as being unpatentable over Rosen et al (Pub .No.: US 2019 /0282618 A1, Pub. Date: Sep . 19, 2019) as evidenced by Davis et al (The Journal of Rheumatology 2007; 34:11). In view of Applicants' amendment of base claim 1, the previous rejections of claims are hereby withdrawn. Applicants' arguments with respect to the withdrawn rejections are thereby rendered moot. The claims are however subject to new rejections over the prior art of record, as set forth below.
Claims 2-3, 44-45 were rejected under 35 U.S.C. 103 as being unpatentable over Rosen et al (Pub .No.: US 2019 /0282618 A1, Pub. Date: Sep . 19, 2019) as evidenced by Davis et al (The Journal of Rheumatology 2007; 34:11) as applied to claims 1, 6-7, 9-10, 20, 35-36 and 43, 48-51 above and further in view of Bandara et al (Pub.. No .: US 2022/0089718 A1, Foreign Application Priority Data May 21 , 2018). The rejection is withdrawn for the reasons discussed above.
Claims 4-5, 46-47 were rejected under 35 U.S.C. 103 as being unpatentable over Rosen et al (Pub .No.: US 2019 /0282618 A1, Pub. Date: Sep . 19, 2019) as evidenced by Davis et al (The Journal of Rheumatology 2007; 34:11) as applied to claims 1, 6-7, 9-10, 20, 35-36 and 43, 48-51 above and further in view of and Schrepfer et al (WO-2018132783-A1, 19 July 2018). The rejection is withdrawn for the reasons discussed above.
Claim Rejections - 35 USC § 112
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 20 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 20, which depends from claim 1, recites the term “said derivative cell”. However, there is insufficient antecedent basis for this limitation in the claim because claim 1 does not recite any derivative cell.
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.
Claim(s) 1-2 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Allen et al (Science . 1989 Jan 20;243(4889):378-81. doi: 10.1126/science.2911749.), as evidenced by Indik et al (Exp Hematol. 1994 Jul;22(7):599-606.)
Claim interpretation:
The specification of the claimed invention teaches that receptors that recognize the Fc portion of IgG are divided into four different classes: FcγRI (CD64), FcγRII (CD32), FcγRIII (CD16), and FcγRIV ([0010], page 3) . Thus, CD64 is interpreted as IgG Fc receptor.
Regarding to claim 1, Allen et al teach isolation of cDNA clones encoding the human FcRI by a ligand-mediated selection technique, and expression of the cDNAs in COS cells gave rise to immunoglobulin G binding of the expected affinity and subtype specificity (Abstract).
Regarding the first wherein clause recited in the claim, Allen et al teach “DNA was prepared from individual colonies and transfected into COS cells. Expression of Fc receptors was determined by indirect immunofluorescence after 48 hours. Three clones, p135, p90, and p98/X2 were selected for further study” (Page 378, 2nd column, 1st para.). Specifically, Allen et al teach Figure 1 to show COS cells transfected with CD64 variants in vectors p135, p90, and p98/X2 which express CD64 in COS cells. A comparison of lanes 3-5 to lane 6 shows that COS cells transformed with a vector encoding a CD64 variant showed more expression of the Fc receptor than Cos cell transformed with the vector alone. Thus, Allen et al meet the limitation recited in claim 1 of the modified cell expressing an elevated level of CD64 as compared to a parental version of the modified cell.
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Regarding the second wherein clause recited in the claim that requires the elevated expression level causes the modified cell to be less susceptible to antibody dependent cellular cytotoxicity (ADCC) or complement-dependent cytotoxicity (CDC), this limitation appears to be inherently met by the modified cells taught by Allen et al. For example, as evidenced by the specification of the claimed invention, “modified cell has an elevated level of CD16, CD32, or CD64 protein expression ……said elevated protein expression causes said modified pluripotent cell to be less susceptible to antibody dependent cellular cytoxicity (ADCC) or complement-dependent cytotoxicity (CDC)” ([0017], page 4). Thus, as evidenced by applicants’ own disclosure, increased expression of factors such as Fc receptor in modified cells such as taught by Allen et al would causes said modified cell to be less susceptible to antibody dependent cellular cytoxicity (ADCC) or complement-dependent cytotoxicity (CDC).
Regarding the third wherein clause recited in the claim as evidenced by Indik et al who teach that “COS-1 cells which lack endogenous Fc receptors have phagocytic potential, and …. FcγRI, unlike FcγRIIIA with its -γ subunit or FcγRIIA, does not induce the phagocytosis of IgG-sensitized cells (EA) in transfected COS-1 cells” (Page 601, left column, last para.). Indik et al who teach “FcγRI does not contain cytoplasmic tyrosines and does not induce phagocytosis in COS-1 transfectants. We transfected wild-type (WT) and mutant (MT) Fc-yRI lacking the cytoplasmic domain into COS-1 cells ….. FcγRI, in contrast to FcγRIIA, did not induce phagocytosis in COS cells” (Abstract).
Regarding to claim 2, Allen et al teach translated amino acid sequence of the FcRI sequence (Page 380). The sequence of the coding region of p135 which is 98.66% identical to SEQ ID NO:7 (see the alignment below).
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Thus, claims 1-2 are anticipated by Allen et al.
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Allen et al (Science . 1989 Jan 20;243(4889):378-81. doi: 10.1126/science.2911749.), as evidenced by Indik et al (Exp Hematol. 1994 Jul;22(7):599-606.) in view of Esworth (Pub. No.: US 2008/0219978 A1, Pub. Date: Sep. 11, 2008).
The teachings of Allen et al and Indik et al above are incorporated herein in their entirety.
Although Allen et al teach amino acid sequence of the FcRI sequence which is 98.66% identical to SEQ ID NO:7, Allen et al do not teach sequence 100% identical to SEQ ID NO:7. Esworth cures the deficiency.
Regarding to claim 3, Esworth teaches FcγRIA polypeptide compositions and related methods of using such polypeptides (Abstract ), and production of FcγRIA polynucleotides or genes: polynucleotides encoding a human FcγRIA receptor gene can be obtained by screening a human cDNA or genomic library using polynucleotide probes ([0118], page 10). Esworth teaches “mammalian cells suitable for use in expressing FcγRIA receptors, including the soluble FcγRIA polypeptides of the invention include …. BHK, COS-1 and CHO cells” ([0152], page 16). Esworth teaches SEQID NO:2 sequence which is 100% identical to SEQ ID NO:7.
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Therefore, it would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the rejected claims to combine the teachings of prior art to modify the COS cells of Allen et al by using SEQID NO:2 sequence as taught by Esworth as instantly claimed, with a reasonable expectation of success. Said modification amounting to combining prior art elements according to known methods to yield predictable results. One of ordinary skill in the art would have been motivated to do so because Esworth teaches “An FcγRIA-encoding cDNA can be isolated by a variety of methods, …. A cDNA can also be cloned using the polymerase chain reaction with primers designed from the representative human FcγRIA sequences disclosed herein. In addition, a cDNA library can be used to transform or transfect host cells, and expression of the cDNA of interest can be detected with an antibody to an FcγRIA polypeptide” ([0125], page 12), and “Introduction of preferential codon sequences into recombinant DNA can, for example, enhance production of the protein by making protein translation more efficient within a particular cell type or species” ([0124], page 12). One of ordinary skill in the art would have had a reasonable expectation of success in doing so because Esworth was successful in transfecting recombinant FcγRIA-encoding cDNA for generating FcγRIA polypeptides, with working examples and data.
Claim Objections
Claims 4-7, 9-10, 20, 35-36 are objected to as being dependent upon a rejected base claim, but would be free of prior arts if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Claims 1, 2, and 3 are rejected.
Claims 4-7, 9-10, 20, 35-36 are objected.
Claims 43-51 are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KHOA NHAT TRAN whose telephone number is (571)270-0201. The examiner can normally be reached M-F (9-5).
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/KHOA NHAT TRAN/Examiner, Art Unit 1632
/PETER PARAS JR/Supervisory Patent Examiner, Art Unit 1632
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