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 .
Status of the Claims
Claims 1, 4-5, 7-10, 12, 15-20, 22, 46, 58-60, and 74 are currently pending and are subject to this Office Action.
Information Disclosure Statement
The references cited on the information disclosure statement(s) were considered and have been made of record.
Priority
As set forth in the previous action, the earliest effective U.S. filing date afforded the instantly claimed invention has been determined to be 06 March 2020, the priority date of PCT/US21/21363 to which the instant national stage 371 application claims priority. PCT/US21/21363, filed on 08 March 2021, claims the benefit of priority to Provisional Patent Application No. 62/986,310, filed on 06 March 2020.
Withdrawn Claim Rejections
In view of the Applicant’s claim amendments: the previous objections as well as the previous rejections under 35 U.S.C. 112(b), 35 U.S.C. 103, and NSDP are hereby withdrawn.
Claim Rejections, Necessitated by Amendment - 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.
Claims 16-19 are rejected under 35 U.S.C. 112(b) as failing to set forth 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.
Claims 16-19 involve a second antigen binding peptide and a third multiple myeloma antigen when claim 1, from which claims 16-19 depend, recites only one antigen binding polypeptide, and a first and second multiple myeloma antigen. Accordingly, there is insufficient antecedent basis for these limitations in the claim.
Claim Rejections, Necessitated by Amendment - 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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 4-5, 7-10, 12, 15-20, 22, 46, 58-60, and 74 are rejected under 35 U.S.C. 103 as being unpatentable over Hilbert1 in view of Smith2, Timmers3 and Hoos4.
Hilbert discloses a method of treating a subject having relapsed multiple myeloma5, the method comprising administering an adapter (i.e., a fusion protein) comprising (i) an antigen binding domain that binds to a first antigen6, and (ii) a second antigen, BCMA, as required by instant claim 1(b), wherein the patient received an anti-BCMA CAR-cell7 (reads on claims 1, 9, 27, 58-60). Hilbert further discloses: wherein the ACT comprises administering a cell selected from those listed in instant claim 4 (see, e.g., claim 5; para [84] to [86], [105], [110], [323]; reads on claim 4); reducing the level of expression of the second multiple myeloma antigen (see, e.g., claims; para. [0429] to [0433], [0478], [0513], [0668] to [0670]; reads on claim 10); the term “treat/treating/treatment”, as claimed, encompasses obtaining beneficial results (see, e.g., claims; para. [0145]; reads on claims 15, 308); wherein the fusion protein comprises two or more antigen binding peptides (see, e.g., para. [0268] to [0270]; reads on claim 16-17); wherein the fusion protein comprises a third multiple myeloma antigen different from the first two (see, e.g., para. [0249]; reads on claims 18-20, and 22); administering to the to the subject a viral vector comprising a nucleic acid encoding a fusion protein (see, e.g., para. [0134], [0312]; reads on claims 46);
The prior art of Hilbert differs from the instantly claimed invention as follows: Hilbert does not expressly teach the multiple myeloma antigen, GPRC5D, as required by claim 1(a), as well as the limitations set forth in claims 1(ii)-(iii), 5, 7-8, 10, and 12.
However, the disclosures/teachings of prior art references, Timmers and Hoos, remedy the deficiencies of Hilbert by disclosing/teaching the following:
Smith identifies the antigen, GPRC5D, as a new target highly expressed in multiple myeloma, and further demonstrates that CAR T cells against GPRC5D are effective in mouse models, even those with tumors that are resistant to the earlier CARs, and they are safe in mice and primates (see Smith, e.g., at the abstract).
Timmers teaches that while BCMA CAR-T therapy produces high objective response rates, the therapeutic effects are often temporary and relapses are common with the median progression-free survival being 12 months9 (reads on claims 1(ii)-(iii) and 7-8).
Hoos discloses pre-screening for patient selection based on BCMA expression, and further teaches that patients may have received prior cancer treatments (see, e.g., p.29, lines 27-33: "Subjects may be pre-screened in order to be selected for treatment with the combinations described herein. In one embodiment, a sample from the subject is tested for expression of BCMA prior to treatment with the combinations described herein. Subjects may have had at least one prior cancer therapy before being treated with the combinations of the present invention.”; reads on claims 5, 10, 12, and 74).
Obviousness Analysis: In light of these teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have arrived at the presently claimed invention in view of the prior art because it amounts to no more than:
simple substitution of one known element for another to obtain predictable results; e.g., substituting an adapter comprising an ADBD directed to GPRC5D for one directed to the other multiple myeloma associated antigens disclosed by Hilbert, as the prior art of Smith demonstrates GPRC5D to be an effective target in multiple myeloma therapy, even those with tumors that are resistant to earlier treatments (i.e., in relapsed MM) (See MPEP 2143(I)(B),(G); renders obvious claims 1(a));
combining prior art elements according to known methods to yield predictable results; the method of Hilbert, which combines a CAR-cell therapy with an adapter therapy, e.g., an anti-BCMA CAR-T cell therapy and a fusion protein comprising BCMA antigen and a binding protein directed to a second multiple myeloma antigen, as disclosed, is a known treatment for relapsed multiple myeloma. While BCMA CAR-T therapy is known to be effective for treating multiple myeloma, the therapeutic effects are often temporary and relapses are common. Thus, it would have been obvious to an artisan skilled in the field to have applied the method of Hilbert to a patient with relapsed multiple myeloma who previously exhibited at least one beneficial response to the CAR-cell treatment followed by at least one nonbeneficial response, e.g., relapse due to BCMA downregulation, as the fusion protein of Hilbert redirects the CAR-cells to the cancer cells (See MPEP 2143(I)(A),(G); renders obvious claims 1(ii)-(iii) and 7-8); and
applying a known technique (e.g., the method of measuring expression levels of the second multiple myeloma antigen, e.g., BCMA, as taught by Hoos) to a known method (e.g., the method of Hilbert) ready for improvement to yield predictable results, namely effectively treating relapsed multiple myeloma caused by downregulation of BCMA (MPEP 2143(I)(A), (D), (G); renders obvious claims 5, 10, 12)
Additionally, there would be a reasonable expectation of success because the prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)). Furthermore, it is well-within the ordinary skill in the art to simply utilize known methods of measuring antigen expression levels prior to administering a therapy meant to treat a cancer that has relapsed due to antigen escape. Thus, a skilled artisan could have predictably and reasonably developed the claimed method.
Accordingly, claims 1, 4-5, 7-10, 12, 15-20, 22, 46, 58-60, and 74 are rejected.
Claim Rejections, Necessitated by Amendment - Double Patenting
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.
Copending Application No. 18/854,250 (PG PUB Np. US20260027203)
Claims 1, 4-5, 7-10, 12, 15-20, 22, 46, 58-60, and 74 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 39-45 of copending Application No. 18/854,250 (reference application; unpublished) ) in view of Hilbert (supra), Timmers (supra) and Hoos (supra).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The disclosures of Hilbert, Smith, Timmers and Hoos are discussed above and are incorporated herein.
MPEP § 804(II)(B)(2)-(3) identifies that a Nonstatutory Double Patenting Rejection may be appropriate based upon either an anticipation analysis or an obviousness analysis (see, e.g., MPEP § 804(II)(B)(2)-(3)). The following rejection is based upon an obviousness analysis.
Obviousness analysis: Regarding instant claims 1, 4-5, 7-10, 12, 15-20, 22, 46, 58-60, and 74, claims 39-45 of the reference application explicitly claim a method of treating cancer in a subject comprising administering a fusion protein comprising an antigen binding polypeptide and an antigen, wherein the antigens are those set forth in instant claim 1 (see reference claims 39-45). While the methods claimed by the reference application are not specific to a subject having relapsed multiple myeloma previously treated with a CAR-cell therapy, the prior art disclosures/teachings of Hilbert, Smith, Timmers and Hoos remedy these deficiencies, as discussed above. Accordingly, the present claims are directed to obvious variants of the reference claims because it is well-within the ordinary skill in the art to combine the prior art elements set forth in Hilbert, Timmers and Hoos by simply applying the methods of the reference application to relapsed multiple myeloma (see, e.g., MPEP § 804(II)(B)(3)(C)-(D); see also MPEP § 2143(A), (D), (G)).
Accordingly, instant claims 1, 4-5, 7-10, 12, 15-20, 22, 46, 58-60, and 74 are not patentably distinct relative to claims 39-45 of the reference application.
Response to Arguments
Applicant's arguments filed 29 December 2025 have been fully considered but they are not persuasive. Applicable arguments pertaining to the rejections are addressed below.
In view of the Applicant’s claim amendments, the previous claim objections and rejections under 35 U.S.C. 112(b), 35 U.S.C. 103, and NSDP are rendered moot.
The previous claim rejections under 35 U.S.C. 103 and NSDP are revised in view of the Applicant’s claim amendments, as set forth above.
In response to Applicant’s argument that “based on the teachings of Hilbert, the skilled person would at most select an "Adapter" including a D domain for the ADBD, but is provided with no guidance at all for a particular AD. There is no teaching or suggestion that would lead to the presently claimed combination to treat relapsed multiple myeloma”: the cited prior art of Hilbert provides support for selecting an adapter comprising an ABDB directed to a multiple myeloma antigen and an AD that is BCMA, while the cited prior art of Smith provides motivation for targeting the multiple myeloma antigen, GPRC5D, as discussed above.
Furthermore, in response to applicant's arguments against the references individually, particularly when stating “Timmers and Hoos do not provide the teaching, suggestions, or guidance that Hilbert lacks.”, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Moreover, it is the Examiner’s understanding that Applicant alleges “There is no teaching or suggestion that would lead to the presently claimed combination to treat relapsed multiple myeloma. The additional documents cited by the examiner also do not assist the skilled person in arriving at the combination of features recited in the present claims when starting from Hilbert… Timmers does not provide any guideposts that would lead one of skill in the art to try a fusion protein whether the protein taught by Hilbert or the one presently claimed. Moreover, Timmers would teach one of skill in the art to forgo a solution that included BCMA as a CAR-T antigen”. Presumably, the Applicant is alleging that one of ordinary skill in the protein formulation arts (a) could not use modern search engines to find relevant prior art, (b) would otherwise be unaware of the prior art, or (c) just dismiss the existence of the reference. This is not persuasive because, per MPEP § 2141.03, “The person of ordinary skill in the art is a hypothetical person who is presumed to have known the relevant art at the relevant time” (see, e.g., MPEP § 2141.03(I)). Here, the Applicant does not dispute that all references constitute “prior art”. Furthermore, the Applicant does not dispute that prior art pertaining to multiple myeloma treatment strategies, e.g., the prior art of Timmers, is “relevant art”, Therefore, the reference constitutes “relevant art” available “at the relevant time”.
Further, it is the Examiner's understanding that Applicant is attempting to rebut a determination of obviousness based upon the difference statements set forth in the rejections under 35 USC § 103. This is not persuasive because, as noted at MPEP § 2141.02, ascertaining the differences between the prior art and the claims at issue is part of the formation of a proper rejection under 35 USC § 103 (see also MPEP § 2141(II), discussing the basic factual inquiries of an obviousness determination). Accordingly, any argument premised upon the identification of differences set forth by the Examiner are insufficient to establish non-obviousness absent evidence addressing the remainder of the rejection. Here, the claimed invention has been identified as obvious for multiple exemplary rationales, including MPEP § 2143(I)(A), (B), (D), and (G), (see above). In the absence of evidence that the elements of such rationales were not fully satisfied, a prima facie case of obviousness has presumably been established based upon at least one or more of such rationales.
In response to Applicant’s argument that “Timmers goes on to describe dual CAR-T therapy as a potential solution to antigen escape. Thus, Timmers teaches one of skill to identify alternative antigens targeted by CAR-T”, it is the Examiner’s understanding that Applicant is alleging that the individual references address additional facts and scientific issues that are not all relevant to the instant invention, and were not relied upon by the Examiner. The relevance of the additional teachings is not unambiguously explained by the Applicant. It is neither disputed nor dispositive of obviousness that the prior art references inform artisans of additional information. However, the prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)), including “all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments” (see, e.g., MPEP § 2123(I)), and here the additional information does not detract or erase the disclosures, particularly Timmer’s teaching of targeting additional multiple myeloma antigens, e.g., GPRC5D, as taught by Smith, relied upon by the Examiner in the rejection of record. Also, it is noted that preferred embodiments do not constitute a teaching away from nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). “A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use.” In re Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994)
Furthermore, if Applicant is attempting to allege that the prior art is not enabling or inoperable Applicant is directed to MPEP § 2121(I), which notes that the prior art is presumed fully enabled for all that it discloses, and the burden is on the Applicant to rebut the presumption of operability (see, e.g., MPEP § 2121(I); MPEP § 716.07). No evidence of inoperability commensurate in scope with the requirements of MPEP § 716.07 have been placed on record at this time; critically, arguments of counsel cannot take the place of evidence in the record (see, e.g., In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965), and evidence is required to rebut the presumption of operability.
Accordingly, any arguments suggesting that a reasonable artisan in the arts would be unaware of the reference or otherwise just dismiss the reference is not persuasive, because such arguments amount to an attempt to simply dismiss the existence of the prior art teachings for multiple myeloma treatment strategies set forth in Hilbert, Smith, Timmers, and Hoos. Rather, the reference is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)), including “all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments” (see, e.g., MPEP § 2123(I)).
Further, in the absence of any unexpected results demonstrated in selecting GPRC5D as the target antigen for the antigen binding polypeptide, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have arrived at the presently claimed invention in view of the prior art because it amounts to no more than simply substituting one known multiple myeloma antigen for another to obtain predictable results; e.g., substituting an adapter comprising an ADBD directed to GPRC5D for one directed to the other multiple myeloma associated antigens disclosed by Hilbert, as the prior art of Smith demonstrates GPRC5D to be an effective target in multiple myeloma therapy, even those with tumors that are resistant to earlier treatments (i.e., in relapsed MM) (See MPEP 2143(I)(B),(G)), as discussed above.
Lastly, in response to the Applicant’s request that the NSDP rejection be reconsidered and withdrawn in light of Applicant arguments that state the “failings of Hilbert, Timmers, and Hoos to teach or suggest the subject matter of the present claims”, and after further consideration, the prior examiner’s NSDP rejections on the Copending Application No. 18/854,250 have been updated, and are now fully supported through the incorporation of an additional reference, as discussed above.
Conclusion
No claims are 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEA S O'BRIEN whose telephone number is (703)756-4793. The examiner can normally be reached Monday - Friday 5:00AM - 2:30PM PT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gregory Emch can be reached on (571) 272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LEA S O'BRIEN/Examiner, Art Unit 1646
/MARK HALVORSON/Primary Examiner, Art Unit 1646
1 WO2019099440A1; cited in the previous action
2 Smith et al., “GPRC5D is a target for the immunotherapy of multiple myeloma with rationally designed CAR T cells”. Sci. Transl. Med.11,eaau7746(2019).DOI:10.1126/scitranslmed.aau7746; cited in the IDS filed 11/02/2023
3 Timmers et al. "Chimeric Antigen Receptor-Modified T Cell Therapy in Multiple Myeloma: Beyond B Cell Maturation Antigen". Front. Immunol., 15 July 2019. Sec. Cancer Immunity and Immunotherapy Volume 10 - 2019.
4 WO2019053613A2; cited in the IDS and on the Written Opinion of the ISA for corresponding Int. Application, PCT/US21/21363; cited in the previous action
5 See, e.g., claims 9, 12; para. [536.]: “In some embodiments, the patient has relapsed multiple myeloma. In some embodiments, the patient has multiple myeloma that relapsed following treatment with a biologic agent, for example, antibody or CAR-T cell”, [538]: “In some embodiments, the patient has multiple myeloma that relapsed following treatment with antibody or CAR-T cell that targeted CS1 or BCMA.”
6 See, e.g., claims 11(k); para. [0196.]: “In some embodiments, the ADBD (e.g., of an Adapter and/or CAR) binds a cancer antigen. In some embodiments, the ADBD binds to a cancer-associated antigen. In some embodiments, the ADBD binds to a cancer-specific antigen”
7 See, e.g., claim 8: “administering an adapter to the patient, wherein the patient has been treated with a cell expressing a CAR, wherein the CAR comprises an antigenic determinant binding domain (ADBD) that binds to a first antigenic determinant (AD) on said target cell… wherein the adapter comprises said first AD and an ADBD that binds to a second AD on said target cell”, claim 10.p.: “wherein the CAR binds to BCMA”, claim 11.b.: “wherein the adapter comprises an AD of a tumor antigen wherein the tumor antigen is BCMA”, claim 26; para. [543]: “a method of treating multiple myeloma in a patient comprises administering a cell expressing a CAR and an Adapter to the patient… In one embodiment, a first AD ( e.g., BCMA) and a second AD (e.g., CS1) are present on the multiple myeloma cell, the Adapter comprises (i) said first AD (i.e., BCMA) and (ii) an ADBD that binds to the second AD (i.e., CS1) on said multiple myeloma cell; and the CAR comprises (i) an ADBD that binds to said first AD (i.e., BCMA) on the multiple myeloma cell”; Examples 3-13.
8 The recitation “wherein after administration… the subject exhibits…” and “wherein administration… is more effective” are merely statements of an intended results. The court has noted that a "‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003). See MPEP § 2111.04. Intended results are not given patentable weight, and therefore, do not limit the claim.
9 See, e.g., p. 2 col. 1 last para.: “BCMA CAR-T cell therapy produces objective response rates of up to 88% (Table 1). Nevertheless, the therapeutic effect is often temporary and relapses are commonly being reported. As shown in Table 1, the median progression-free survival of BCMA CAR-T cell therapy is in the range of 12 months. Downregulation or loss of BCMA expression is likely an important mechanism underlying these relapses. Hence, alternatives for BCMA are now under intensive investigation in the field of CAR-T cell therapy for MM.”
Prosecution Insights