DETAILED ACTION
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 amendment and remarks, filed 6/23/26, are acknowledged.
Claims 81-83, 86-89, 91, and 96 have been amended.
Claims 81-91 and 96 are pending and are under examination.
In view of Applicant’s claim amendments, the rejection of claims 81-83, 85-91, and 96 under 35 U.S.C. 112b and the rejection under 35 U.S.C. 103 are withdrawn.
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 84 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.
The phrase “"preferably" renders claim 84 indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For the purposes of examination, the limitations are being interpreted as optional.
Applicant’s arguments filed 6/23/26 have been fully considered, but they are not persuasive.
Applicant argues that the amendment overcomes the rejections.
This is persuasive for claims 82-83, 85-91, and 96, however, claim 84 still recites “preferably” which is indefinite for the reasons set forth above.
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 81-91 and 96 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. Specifically, there is insufficient written description to demonstrate that applicant was in possession of the claimed genus of extracellular ligand binding domain comprising “an amino acid sequence shown in”, for example SEQ ID NO: 25, or “an amino acid sequence having at least 90% identity to an amino acid sequence shown in”, for example, SEQ ID NO: 25.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or 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 function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. See MPEP 2163.
The instant claims are drawn to a siglec-6 binding polypeptide comprising a sigle-6 binding CAR, wherein the CAR comprises an extracellular ligand binding domain comprising “an amino acid sequence shown in”, for example SEQ ID NO: 25, or “an amino acid sequence having at least 90% identity to an amino acid sequence shown in”, for example, SEQ ID NO: 25. SEQ ID NO: 25 is the sequence of a JML-1 scFv, and comprises a VH comprising 3 CDR sequences and a VL comprising 3 CDR sequences. For example, a single CDR, could be within the scope of “an amino acid sequence shown in” SEQ ID NO: 25. The claims also encompass sequences having 90% identity to SEQ ID NO: 25, which would encompass numerous additions, deletions or substitutions to the scFV in SEQ ID NO: 25, including in the CDR regions.
The state of the art is such that the 6 CDRs of an antibody are critically involved in antigen binding, that even single amino acid changes can alter antigen specificity of binding, and that CDR mutations are unpredictable in terms of affinity, specificity, and solubility, and are also context dependent (see Hall, 1992, and Rabia, 2018). The only species of extracellular ligand binding domain that functions to bind to siglec-6 disclosed by the instant specification is SEQ ID NO: 25. This is not sufficiently representative of the genus of different ligand binding domains that function to bind to siglec-6, which would encompass those having a single CDR of SEQ ID NO: 25 (i.e. “an amino acid sequence” shown in SEQ ID NO: 25) or those varying by up to 10% in any region shown in SEQ ID NO: 25, including the CDRs.
The instant application has not provided a sufficient description showing possession of the necessary functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the genus of extracellular binding domains. Further, the Court has interpreted 35 U.S.C. §112, first paragraph, to require the patent specification to “describe the claimed invention so that one skilled in the art can recognize what is claimed. Enzo Biochem, Inc. v. Gen-Probe Inc, 63 USPQ2d 1609 and 1618 (Fed. Cir. 2002).
In evaluating whether a patentee has fulfilled this requirement, our standard is that the patent’s “disclosure must allow one skilled in the art ‘to visualize or recognize the identity of’ the subject matter purportedly described.” Id. (quoting Regents of Univ. of Cal. v. Eli Lilly & Co., 43 USPQ2d 1398 (Fed Cir. 1997)).
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear 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.)
Also, it is noted that the Court has held that the disclosure of screening assays and general classes of compounds was not adequate to describe compounds having the desired activity: without disclosure of which peptides, polynucleotides, or small organic molecules have the desired characteristic, the claims failed to meet the description requirement of § 112. See University of Rochester v. G.D. Searle & Co., lnc., 69 USPQ2d 1886,1895 (Fed. Cir. 2004).
Meeting the written description threshold requires showing that the applicant was in “possession” of the claimed invention at the time of filing. Vas-Cath, 935 F.2d at 1563-1564. Support need not describe the claimed subject matter in exactly the same terms as used in the claims. Eiselstein v. Frank, 52 F.3d 1035, 1038 (Fed. Cir. 1995). This support cannot be based on obviousness reasoning – i.e., what the written description and knowledge in the art would lead one to speculate as to modifications the inventor might have envisioned, but failed to disclose. Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997). Ariad points out, the written description requirement also ensures that when a patent claims a genus by function, the specification recites sufficient materials to accomplish that function - a problem that is particularly acute in biological arts." Ariad, 598 F.3d at 1352-3. Note the following Court Decisions regarding the written description of antibodies in the context of the current claims.
Thus, one of skill in the art would conclude that the specification fails to provide adequate written description to demonstrate that Applicant was in possession of the claimed genus. See Eli Lilly, 119 F. 3d 1559, 43, USPQ2d 1398.
Applicant’s arguments filed 6/23/26 have been fully considered, but they are not persuasive.
Applicant argues that the amendment to recite the VH and VL SEQ ID NOs overcomes the rejection.
Claim 81, as amended, encompasses two alternative embodiments (i) or (ii). Applicant has amended only embodiment (i) to require that the siglec 6 binding element comprises a VH having an amino acid sequence set forth in SEQ ID NO: 3 and a VL having an amino acid sequence set forth in SEQ ID NO: 7. “An” amino acid sequence set forth in SEQ ID NO: 3 could encompass a subsequence. For example, a CDR would be “an” amino acid sequence set forth in SEQ ID NO: 3. Amendment to recite a VH region having “the” amino acid sequence set forth in SEQ ID NO: 3 and a VL region having “the” amino acid sequence set forth in SEQ ID NO: 7 would be remedial for embodiment (i).
In embodiment (ii), in addition to the issue noted above, the claim recites that the polypeptide comprises an amino acid sequence having at least 90% identity to SEQ ID NO: 33. Said SEQ ID NO: 33 is a CAR sequence comprising the siglec binding polypeptide of SEQ ID NO: 25. Thus, embodiment (ii) still lacks written description for the same reasons set forth above, i.e. it encompass CDR mutations in the binding domain of SEQ ID NO: 25, which is found with SEQ ID NO: 33.
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)(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(s) 81-91 and 96 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by WO 2020/254591.
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
WO 2020/254591 teaches a siglec-6 binding CAR comprising a Sigle-6 binding scFv having SEQ ID NO: 14, which is identical to SEQ ID NO: 25 of the instant application, and further comprising an IgG3 spacer, a transmembrane domain, and an intracellular domain (see pages 9-10, 27, and 52 in particular). WO 2020/254591 teaches an immune cell, such as a T cell, expressing the CAR from a polynucleotide encoding the CAR and pharmaceutical compositions thereof (see page 12, in particular). WO 2020/254591 teaches CAR comprising a CD28 transmembrane domain and a 4-1BB and CD3 zeta intracellular domain (See pages 38 and 96, in particular). WO 2020/254591 teaches a polynucleotide encoding the CAR, expression vectors comprising said polynucleotide, and wherein the vector is a lentiviral vector or a non-viral vector circularized vector (i.e. minimal DNA expression cassette, see page 60 and 127-128). WO 2020/254591 teaches expression vectors having a transposon with flanking IR/DR segments in the 5’ and 3’ direction (see page 60, and 127-128, in particular).
Applicant argues that the reference is disqualified under the 102(b)(2)(c) common ownership exception.
Applicant has attempted to invoke the 102(b)(2)(c) exception by indicating that the current application “at the time the current case application was filed” was owned by the same entity as WO 2020/254591. To invoke the 102(b)(2)(c) exception Applicant establish that common ownership existed “not later than the effective filing date” of the claimed invention. Applicant statement that common ownership existed “at the time the current case application was filed” is not sufficient (the statement could refer to the US filing date, and not the effective filing date, for example). To invoke the 102(b)(2)(c) exception, Applicant should submit a statement that the subject matter in the WO 2020/254591 document and the claimed invention were, not later than the effective filing date of the claimed invention, owned by, or subject to an obligation of assignment, to the same person. See 37 CFR 1.104(c)(4)(i).
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 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 81-91 and 96 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 52-56, 68-71 of copending Application No. 17/619,569 in view of US 20120121504, US 20160051651, and Chang, 2018..
The ’569 application claims a CAR comprising an extracellular antigen binding domain, a spacer domain, a transmembrane domain, and an intracellular domain, wherein the spacer domain is an IgG3 hinge region. The ‘569 application claims that the extracellular ligand binding domain is an scFv. The ‘569 application claims an immune cell, preferably a T cell, expressing said CAR. The ‘569 application claims that the scFv binds to Siglec-6.
Although not specifically claimed in the ‘569 application, it would be obvious to use the Siglec-6 scFv made obvious by the ‘504 publication, the ‘651 publication, and Chang, as set forth above, as the Siglec-6 scFv. The ordinary artisan at the time the invention was made would have been motivated to do so with a reasonable expectation of success, because the ‘504 publication teaches that the scFv is effective for targeting CLL, and as taught by Chang, it binds Siglec-6. Furthermore, constructing the scFV in Vh-linker-VL orientation, expression from a vector, such as a non-viral vector or transposon, or using CD28 transmembrane domain, 4-1BB and CD3 zeta intracellular domain as taught by the ‘504 publication and the ‘651 publication would involve choosing among a finite number of predictable options which could be pursued with a reasonable expectation of success. A person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense (see KSR International Co. V. Telefex Inc 82 USPQ2d 1385).
This is a provisional nonstatutory double patenting rejection.
Applicant’s statement that the rejection be held in abeyance until the time of allowance is acknowledged.
The following are new grounds of rejection necessitated by Applicant’s claim amendments.
Claims 81-91 and 96 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 81 recites "the costimulatory domain” in line 9. There is insufficient antecedent basis for these limitations in the claim. Furthermore, although there is inherent antecedent basis for “the” amino acid sequence shown in SEQ ID NO: 25, there is a lack of antecedent basis for “the amino acid sequence” having at least 90% identity to an amino acid sequence showing SEQ ID NO: 25. Amendment to recite “an” amino acid sequence having at least 90% identity to “the” amino acid sequence shown in SEQ ID NO: 25 would be remedial for this issue.
Claim 90 recites the limitation "the polynucleotide or set of polynucleotides” in lines 1-2 There is insufficient antecedent basis for this limitation in the claim.
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 81-91 and 96 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20120121504, in view of US 20160051651 (both of record) and US 20180371052, and as evidenced by Chang, 2018 (of record).
The ‘504 publication teaches a CAR comprising a scFv extracellular binding domain that targets B-CLL, said scFv having a VH of SEQ ID NO: 18 and a VL of SEQ ID NO: 1, wherein the CAR further comprising an IgG hinge (i.e. spacer), a transmembrane domain, and an intracellular TCR signaling domain including CD3 and 4-1BB (see paragraphs 27-30 and 41, in particular). Said SEQ ID NO: 18 and SEQ ID NO: 1 are 100% identical to the VH and VL of SEQ ID NO; 3 and 7, respectively, of the present claims. The ‘504 publication teaches a T cells expressing said CAR (i.e. immune cells comprising a polynucleotide encoding said CAR, see paragraph 41, in particular). The ‘504 publication teaches that said VH/VL are from antibody JML-1. As evidenced by Chang, the JML-1 antibody binds to Siglec-6 on B-CLL. Thus, binding Siglec-6 is an inherent or latent property of the CAR taught by the ‘504 publication. The ‘504 publication teaches pharmaceutical compositions (see paragraphs 51-55, in particular).
The reference differs from the claimed invention in that it does not explicitly teach SEQ ID NO: 25, that the CD3 domain is CD3-zeta with SEQ ID NO: 10, a mixture of CD4 and CD8 T cells, or the details of the polynucleotide/expression vector for expressing the CAR.
The ‘651 publication teaches CAR that target CLL cells having an scFv, wherein the scFv can be constructed in an orientation of heavy chain variable region-linker-light chain variable region, wherein the linker can be a Gly4-Ser linker with 3 repeats (See paragraph 13 and 432, in particular). The ‘651 publication teaches that transmembrane domains for use in CAR can include CD28 transmembrane domain and that the preferred CD3 intracellular domain is CD3 zeta with SEQ ID NO: 10 (See paragraphs 20-21 and 447, in particular). The ‘651 publication teaches that CAR can be expressed from a polynucleotide using lentivirus vectors or non-viral vectors, such as a plasmids or minicircles (see paragraphs 55-56 and 613, in particular). The ‘651 publication teaches that the polynucleotides and expression vectors can comprise a transposon with inverted repeats flanking the CAR (i.e. flanking elements in 5’ direction and 3’ direction and a nucleotide encoding a left IR/DR, a polynucleotide encoding the CAR, and a nucleotide encoding a right IR/DR, see paragraphs 568-575, in particular). The ‘651 publication teaches that T cells used for CAR expression can be a mixture of CD4 and CD8 human T cells (See paragraph 708, in particular).
The ‘052 publication teaches that CAR are composed of an extracellular antigen binding domain joined via a hinge/spacer domain to a transmembrane region and to an intracellular signaling region. The ‘052 publication teaches that first generation CAR has only CD3 zeta signaling domain, and second generation CAR have said CD3zeta plus costimulatory signaling domain, such as from 4-1BB (See paragraphs 86 in particular). The ‘052 publication teaches that IgG hinge sequences used in CAR constructs can be from either IgG1, IgG2, IgG3, or IgG4 (See paragraph 105, in particular).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to construct the scFv in the VH-linker-VL orientation with a Gly4Ser linker with 3 repeats, as taught by the ‘651 publication, as the scFv in the CAR of the ‘504 publication. The ordinary artisan at the time the invention was made would have been motivated to do so with a reasonable expectation of success, because the ‘651 publication teaches that doing so is effective in construction of CAR that target CLL. Furthermore, doing so would involve choosing among a finite number of predictable options which could be pursued with a reasonable expectation of success. A person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense (see KSR International Co. V. Telefex Inc 82 USPQ2d 1385). Constructing a scFV with SEQ ID NO: 18 (VH) Gly4Ser 3 repeat linker, SEQ ID NO: 1 (VL) would result in an amino acid sequence 100% identical to SEQ ID NO: 25 of the instant application (See previously attached alignment). Regarding the limitation of an IgG3 spacer, it is noted that any hinge domain from any IgG would comprise a sequence from IgG3 hinge. For example, an IgG3 hinge comprises a sequence of amino acids PPCP, and said sequence is also found in every other IgG hinge. In other words, every IgG hinge has some sequence identity, such as residues PPCP. Therefore, using an IgG hinge, as taught in the ‘651 publication would necessarily include a sequence from IgG3 hinge, which would be within the scope of the claimed “IgG3 spacer domain”. Alternatively, selecting IgG3 hinge as the type of IgG hinge, as taught by the 052 publicatoin, would involve choosing among a finite number of predictable options which could be pursued with a reasonable expectation of success.
Likewise, selecting from known transmembrane and CD3 signaling domains for use in CAR, types of T cells, or expression vectors for expressing a CAR in an immune cells would also involve choosing among a finite number of predictable options which could be pursued with a reasonable expectation of success (this is pertinent to claim 82, 84-88, and 96). Regarding the limitation of SEQ ID NO: 19 from claim 82, said SEQ ID NO: 10, as taught in the ‘651 publication, is 100% identical to SEQ ID NO: 19 of the instant application, meeting the limitation of the claim.
Regarding claim 83, selecting from the known nucleic acid codons that can encode SEQ ID NO: 25 would also involve choosing among a finite number of predictable options which could be pursued with a reasonable expectation of success.
Applicant’s arguments filed 6/23/26 have been fully considered, but they are not persuasive.
Applicant argues that the ‘504 publication does not teach an IgG3 hinge, any specific transmembrane domain, and an intracellular signaling domain of CD3zeta and 4-1BB and there would be no incentive to piece together the missing components from the other cited references.
As an initial matter, it is noted that at least claim 81 does not require any particular transmembrane domain nor does it require CD3zeta, as argued by Applicant. Claim 81 requires an IgG3 spacer and a 4-1BB costimulatory domain. The ‘504 publication teaches an IgG hinge and a TCR signaling domain such as CD3 and a costimulatory domain, such as 4-1BB costimulatory domain which meets the limitations for the reasons set forth above. Alternatively, selecting an IgG3 hinge would also be obvious based on the teachings of the ‘052 publication. Regarding the dependent claims, it is well known in the art that CAR constructs can be constructed as second generation CAR with a CD3zeta and 4-1BB signaling domains having the recited sequences as taught by the ‘651 publication and the ‘052 publication. Selecting from known domains for CAR construction is well within the purview of the ordinary artisan and would involve choosing among a finite number of predictable options which could be pursued with a reasonable expectation of success.
Applicant further argues that one would not have predicted that the CARs of the ‘504 publication would be safe and effective for treating lymphoma.
The ‘504 publication specifically teach the use of CAR for treating B cell lymphoma (see paragraphs 44-45, in particular).
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
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Amy E. Juedes
Patent Examiner
Technology Center 1600
/AMY E JUEDES/Primary Examiner, Art Unit 1644
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