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 89-118 are pending.
Claims 89-93, 96, and 98 are newly amended.
Claims 99-118 are newly added.
Applicant’s election without traverse of Group I (pending claims 89-95 and 99-118) and the species of the now cancelled claims 66, 72, and 74 (which corresponds to the newly added instant pending claims 106, 110, and 112, respectively) in the reply filed on 11/28/748 is acknowledged.
While Applicant elects without traverse, Applicant argues that Groups II and III (claims 96-98) for a special technical feature, and therefore, there is unity of invention (Remarks, p18).
Applicant’s arguments, filed 11/28/748 have been fully considered, but are not found persuasive. Even though both inventions require the technical feature of administering adaptor compounds, activity modifying compounds, and CAR T cells, this is not a “special technical feature” because Low et al. (WO2014100615A1, on IDS 12/18/2025, hereafter “Low I”) in view of Low et al. (WO2020033129A1, published 02/13/2020, on IDS 09/06/2022, previously cited, hereafter “Low II”) teaches this feature as discussed in-depth below.
However, because the independent claims, as amended, of Groups II and III overlap in scope upon further consideration, the restriction requirement between these groups has been withdrawn. Furthermore, upon further consideration because the species overlap in scope, the restriction requirement between these species has been withdrawn.
Claims 89-118 have been examined on their merits.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Specifically see paragraph [0125] which contains hypertext directed to an “accelrys” website.
Allowable Subject Matter
Claim 112 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim Rejections - 35 USC § 112(d)
Claim 117 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 117, requires that the subject has cancer. However, claim 89, from which it depends is performed “in a subject with cancer and/or treater a cancer”, which in both instances requires cancer in a subject. Therefore, claim 117 is not further limiting.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
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 89-111, 113, and 115-118 are rejected under 35 U.S.C. 103 as being unpatentable over Low et al. (WO2014100615A1, on IDS 12/18/2025, hereafter “Low I”) in view of Low et al. (WO2020033129A1, published 02/13/2020, on IDS 09/06/2022, previously cited, hereafter “Low II”).
In regards to claims 89, 91, 99-100, and 117, Low I teaches a method for treating cancer in subject (Claims 28-30).
In regards to step (a), Low I teaches that the method comprises administering a small molecule conjugate (a compound) comprising a targeting moiety (a first moiety) conjugated to a tumor receptor ligand (i.e., a small molecule; e.g., folate, a well-known small molecule) (Claims 1, 13, and 28-30). Low I teaches that the targeted moiety and the ligand (small molecule) are conjugated via a linker domain (first linker, claims 2, 4, and 40). Since the compound as taught by Low I is linked (bridged) it is an “adapter compound” (see paragraph [0009] of instant specification).
In regards to step (b), Low I does not explicitly teach administering an activity modifying compound as in step (b).
However, Low II (who is noted is the same as Low I and a named inventor of the instant application) teaches a system for rejuvenating CAR T cells comprising at least a conjugate (compound) comprising a targeting ligand (second moiety) linked by a linker domain (second linker) to a payload drug (a rejuvenating compound) (claims 1 and 5-6; Fig. 2, Fig. 9A).
A person of ordinary skill in the art would have been motivated to administer an activity modifying compound as in step (b), in order to rejuvenate and deliver payloads to antigen exhausted CAR T cells, as taught by Low II (p1, Field of Invention; p18-19).
Furthermore, because Low II teaches that these compounds can be used to rejuvenate cells (claim 18) and teaches that the system can be used to deliver payloads to cancer antigen exhausted CAR T cells in vivo (p1, Field of Invention; p18-19), it could have been done with predictable results and a reasonable expectation of success.
In regards to step (c), Low I teaches the method for treating cancer further comprises transfecting and administering a lymphocyte (T cell) population with a vector encoding a CAR (Claims 28-30). A person of ordinary skill in the art would have recognized that vectors encoding proteins such as a CAR would be operably linked to a promoter (indeed, Low I teaches specific embodiments of CAR promoters (paragraph [00108]). Low I teaches that the CAR has specificity to (it direct to) the (first) targeting moiety (claims 28-30).
In regards to claim 90, in specific embodiments, Low I teaches that the small molecule ligand can be a folate ligand or DUPA (Claims 1, 13, 39). It is well-known in the art that folate receptors and PSMA (the receptor for DUPA) are overexpressed in cancer cells and that folate and DUPA, respectively are specific for these receptors.
In regards to a first and second adaptor compound, Applicant should note that it is prima facie obvious to duplicate parts (see MPEP 2144.04(VI(B)). Indeed, because Low I teaches that the small molecule conjugate (adaptor compound) can be “FITC-folate [or] FITC DUPA” (claim 19), the disclosure of Low I suggests that the use of multiple adaptor compounds are within the scope of the invention.
In regards to claim 92, Low II teaches that the compound comprises FK506 (tacrolimus) (claim 2), which is a well-known immunosuppressive.
A person of ordinary skill in the art would have been motivated to select tacrolimus because Low II teaches tacrolimus (FK506) is useful for targeting T cells for rejuvenation (claims 1-2). Furthermore, because Low II teaches that CAR T cells can be rejuvenated by being contacted with compounds comprising tacrolimus as a targeting moiety (claims 18 and 21) and recommends their use in vivo (p1, Field of Invention; p18-19), it could have been done with predictable results and a reasonable expectation of success.
In regards to claim 93, as above, Low I teaches that the small molecule ligand can be folate (Claims 1, 13, 39).
In regards to claim 94, Low I teaches that the first targeting moiety can ben FITC (claims 17, 19, 38).
In regards to claim 95, Low II teaches that the rejuvenating compound can be a TLR agonist (claims 8 and 10).
A person of ordinary skill in the art would have been motivated to select a TLR7 agonist because Low II teaches that TLR7 agonists are useful for rejuvenating T cells (claims 1-2). Furthermore, because Low II teaches that CAR T cells can be rejuvenated with TLR7 agonists (claims 8 and 24) and recommends their use in vivo (p1, Field of Invention; p18-19), it could have been done with predictable results and a reasonable expectation of success.
In regards to claim 96, in regards to step (a)(i), as discussed above, Low I teaches a method of treating subject comprising administering a small molecule conjugate (a compound) comprising a targeting moiety conjugated to a tumor receptor ligand (i.e., a small molecule; e.g., folate, a well-known small molecule) (Claims 1, 13, and 28-30). Low I teaches that the targeted moiety and the ligand (small molecule) are conjugated via a linker domain (claims 2 and 14). Since the compound as taught by Low I is linked (bridged) it is an “adapter compound” (see paragraph [0009] of instant specification).
In regards to step (a)(ii), as above, Low I teaches administering CAR T cells (Claims 28-30). In specific embodiments, Low I teaches “(iv) administering a formulation comprising the transfected lymphocytes to a subject having cancer, and (v) administering a formulation comprising SCM to the subject” (paragraph [0094]), which suggests that the CAR T administration step occurs specifically prior to administration of the adapter compound (SCM). Indeed, in the following paragraph, Low I explicitly states “The invention also includes variations on this theme such, as administering the formulation comprising SMC to the subject before the formulation comprising the transfected lymphocytes, or at the same time as the formulation comprising the transfected lymphocytes. A further variation includes culturing the formulation comprising the transfected lymphocytes with the SCM prior to administration to the subject” (paragraph [0095]). Therefore, a person of ordinary skill in the art would have recognized that the embodiment described in paragraph [0094]) refers to administrating CAR T cells before administering compounds.
In regards to step (b), as above, Low I does not explicitly teach administering an activity modifying compound as in step (b).
However, as above, Low II teaches a system for rejuvenating CAR T cells comprising at least a conjugate (compound) comprising a targeting ligand (moiety) linked by a linker domain to a payload drug (a rejuvenating compound) (claims 1 and 5-6; Fig. 2, Fig. 9A).
A person of ordinary skill in the art would have been motivated to administer an activity modifying compound as in step (b), in order to rejuvenate and deliver payloads to antigen exhausted CAR T cells, as taught by Low II (p1, Field of Invention; p18-19).
Furthermore, because Low II teaches that these compounds can be used to rejuvenate cells (claim 18) and teaches that the system can be used to deliver payloads to cancer antigen exhausted CAR T cells in vivo (p1, Field of Invention; p18-19), it could have been done with predictable results and a reasonable expectation of success.
In regards to claim 97, as above, Low II teaches that the rejuvenating compound can be a TLR agonist (claims 8 and 10).
A person of ordinary skill in the art would have been motivated to select a TLR agonist because Low II teaches that TLR agonists are useful for rejuvenating T cells (claims 1-2). Furthermore, because Low II teaches that CAR T cells can be rejuvenated with TLR agonists (claims 8 and 24) and recommends their use in vivo (p1, Field of Invention; p18-19), it could have been done with predictable results and a reasonable expectation of success.
In regards to claim 98, as above, both Low I and Low II teach that ligands/compounds are linked to targeting moieties by a linker domain (claims 2, 14, and 40; clams 5 and 6, respectively).
In regards to claims 101-102 and 115, Low I teaches that the CAR has a scFV that binds to the targeted moiety (Claim 34). As the targeting moiety in both Low I and Low II can be FTIC (Low I, claim 17, etc. ; Low II claim 2, etc.), the scFV (or CAR) would be capable of binding to both first and second moieties. Low I teaches that the CAR can have an affinity of at least 100 pM (paragraph [0015]) (which is in a “sub-nanomolar” range), which is understood to refer to a high affinity in the art.
In regard to claim 103, Low I teaches that the scFV is an anti-FITC antibody (claims 8, 34).
In regards to claim 104, Low I teaches that the adapter compound can be a FITC-folate (claim 19), which does not comprise an antibody or fragment of an antibody.
In regards to claim 105, Low I teaches that the adapter compound can be a FITC-folate (claim 19), which does not comprise a peptide epitope.
In regards to claim 106, both Low I and Low II teach that linkers can be PEG linkers (claim 16; claim 12, respectively).
In regards to claim 107, Low I teaches that the linker can also be a polyproline (claim 16). As above, Low II teaches that the linker can be a PEG (claim 12, which has the formula as in claim 107). Thus, first and second linkers can be different.
In regards to claims 108 and 109, Low II teaches that the rejuvenating compound can comprise a TLR7 agonist with at least the first chemical structure as in claim 109 (claims 8 and 10).
A person of ordinary skill in the art would have been motivated to select a TLR7 agonist because Low II teaches that TLR7 agonists are useful for rejuvenating T cells (claims 1-2). Furthermore, because Low II teaches that CAR T cells can be rejuvenated with TLR7 agonists with the same formula (claim 8) and recommends their use in vivo (p1, Field of Invention; p18-19), it could have been done with predictable results and a reasonable expectation of success.
In regards to claim 110, as above, Low I teaches that the linker can also be a PEG (claim 16).
In regards to claim 111, as above, as above, Low I and Low II teach that linkers can be PEG linkers (claim 16; claim 12, respectively).
In regards to claim 113, Low II teaches that the compound can have an identical structure to the first structure in claim 113 (claim 11, fluorescein-TLR7).
A person of ordinary skill in the art would have been motivated to select a fluorescein-TLR7 because Low II teaches that fluorescein-TLR7 agonists are useful for rejuvenating T cells (claims 1-2 and 11). Furthermore, because Low II teaches that CAR T cells can be rejuvenated with fluorescein-TLR7 with the same structure (claim 11) and recommends their use in vivo (p1, Field of Invention; p18-19), it could have been done with predictable results and a reasonable expectation of success.
In regards to claim 116, Low II teaches that the binding recognition sequence (targeting ligand) has the property of being internalized by a bound CAR T cell (Claim 1; Fig. 2).
In regards to claim 118, Low I teaches that the cancer can be lung cancer (claim 48; paragraph [0051]).
Therefore, the combined teachings of Low I and Low II renders the invention unpatentable as claimed.
Claim 114 is rejected under 35 U.S.C. 103 as being unpatentable over Low et al. (WO2014100615A1, on IDS 12/18/2025, hereafter “Low I”) in view of Low et al. (WO2020033129A1, published 02/13/2020, on IDS 09/06/2022, previously cited, hereafter “Low II”) as applied to claim 89 above, and further in view of Low et al. (US20160166679A1, 2016, hereafter “Low III”).
In regards to claim 114, in regards to small molecule ligand structure of an adaptor compound comprising a structure having the generic formula as in claim 114, it is noted that this is a folate variant.
While, as above, Low I teaches that the small molecule ligand can be folate (Claims 1, 13, and 28-30) and teaches folate structures (paragraphs [0073-0074]), the folate structures as taught by Low I, while similar, does not appear the be the same structure as in claim 114 (specially, group corresponding to X1 in Low I is a carbonyl (C=O), which is not a group as identified in claim 114 as corresponding to X1).
However, folate variants with the structure as in claim 114, were known before the effective filing date.
For example, Low III (again, who is both the same inventor as Low I and is a named instant inventor) teaches a folate which overlaps in structure with the structure as in claim 114 (claim 7).
In particular, in the left-most bicyclic structure of Low III (claim 7), T1 can be —N═C(X)— which results in a structure that is identical to N=C(X1) as in claim 114 (both the X in Low III and X1 in instant claim 114 can be hydrogen). The remaining structural elements are likewise the same or overlap.
A person of ordinary skill in the art would have been motivated to use folate with this generic structure because Low III teaches that this molecule is suitable for treating a wide range of cancers (claims 3 and 4). Furthermore, because Low I and III both teach treating cancer patients with folates linked to targeting molecules (claim 1 of Low III) and because Low III teaches that folate compounds can have the same generic structure as in claim 114, it could have been done with predictable results and a reasonable expectation of success.
Therefore, the combined teachings of Low I, Low II, and Low III renders the invention unpatentable as claimed.
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.
Claims 89, 92, 95-98, 108-109, 113, and 116 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-14 of U.S. Patent No. 12,240,870 in view of Low et al. (WO2020033129A1, published 02/13/2020, on IDS 09/06/2022, previously cited, hereafter “Low II”).
Claims 89, 91, 93-94, 96-111, 113, and 116-118 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-14 of U.S. Patent No. 12,240,870 in view of Low et al. (WO2020033129A1, published 02/13/2020, on IDS 09/06/2022, previously cited, hereafter “Low II”) and Low et al. (WO2014100615A1, on IDS 12/18/2025, hereafter “Low I”).
Claims 89 and 114 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-14 of U.S. Patent No. 12,240,870 in view of Low et al. (WO2020033129A1, published 02/13/2020, on IDS 09/06/2022, previously cited, hereafter “Low II”), Low et al. (WO2014100615A1, on IDS 12/18/2025, hereafter “Low I”), and Low et al. (US20160166679A1, 2016, hereafter “Low III”).
In regards to the instant claims 89, 92, 95-98, 108-109, 113, and 116, while the instant claims and the claims of U.S. Patent No. 12,240,870, are not identical, they are not patentably distinct because the claims of both inventions are drawn to a method for treating cancer comprising administering a compound comprising a small molecule ligand linked to a targeting moiety, wherein the small molecule folate and the targeting moiety is a fluorescein-derivative and CAR T cells.
While the cited patent does not explicitly require a step of administering an activity modifying compound as in claim 89, as above, Low II teaches a system for rejuvenating CAR T cells comprising at least a conjugate (compound) comprising a targeting ligand (second moiety) linked by a linker domain (second linker) to a payload drug (a rejuvenating compound) with the different claimed embodiments (claims 1 and 5-6; Fig. 2, Fig. 9A).
A person of ordinary skill in the art would have been motivated to administer an activity modifying compound as in step (b), in order to rejuvenate and deliver payloads to antigen exhausted CAR T cells, as taught by Low II (p1, Field of Invention; p18-19).
In regards to claims 89, 91, 93-94, 96-111, 113, and 116-118, while the cited patent does not specifically claim the specific embodiments as in these claims, these are all embodiments taught by Low I (as discussed in depth above). A person of ordinary skill in the art would have been motivated to incorporate these embodiments because Low I teaches that they are useful for treating cancer (claims 28 and 29). Furthermore, because Low I is drawn to a method that comprises administering a small molecule conjugate (a compound) comprising a targeting moiety (a first moiety) conjugated to a tumor receptor ligand (i.e., a small molecule; e.g., folate, a well-known small molecule) (Claims 1, 13, and 28-30) with a linker domain (claims 2, 4, and 40), it could have been done with predictable results and a reasonable expectation of success.
In regards to claim 114, in regards to small molecule ligand structure of an adaptor compound comprising a structure having the generic formula as in claim 114, it is noted that this is a folate variant.
While, as above, Low I teaches that the small molecule ligand can be folate (Claims 1, 13, and 28-30) and teaches folate structures (paragraphs [0073-0074]), the folate structures as taught by Low I, while similar, does not appear the be the same structure as in claim 114 (specially, group corresponding to X1 in Low I is a carbonyl (C=O), which is not a group as identified in claim 114 as corresponding to X1).
However, folate variants with the structure as in claim 114, were known before the effective filing date.
For example, Low III (again, who is both the same inventor as Low I and is a named instant inventor) teaches a folate which overlaps in structure with the structure as in claim 114 (claim 7).
In particular, in the left-most bicyclic structure of Low III (claim 7), T1 can be —N═C(X)— which results in a structure that is identical to N=C(X1) as in claim 114 (both the X in Low III and X1 in instant claim 114 can be hydrogen). The remaining structural elements are likewise the same or overlap.
A person of ordinary skill in the art would have been motivated to use folate with this generic structure because Low III teaches that this molecule is suitable for treating a wide range of cancers (claims 3 and 4). Furthermore, because Low I and III both teach treating cancer patients with folates linked to targeting molecules (claim 1 of Low III) and because Low III teaches that folate compounds can have the same generic structure as in claim 114, it could have been done with predictable results and a reasonable expectation of success.
Claims 89, 92, 95-98, 108-109, 113, and 116 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-42 of U.S. Patent No. 11,779,602 in view of Low et al. (WO2020033129A1, published 02/13/2020, on IDS 09/06/2022, previously cited, hereafter “Low II”).
Claims 89, 91, 93-94, 96-111, 113, and 116-118 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-42 of U.S. Patent No. 11,779,602 in view of Low et al. (WO2020033129A1, published 02/13/2020, on IDS 09/06/2022, previously cited, hereafter “Low II”) and Low et al. (WO2014100615A1, on IDS 12/18/2025, hereafter “Low I”).
Claims 89 and 114 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-42 of U.S. Patent No. 11,779,602 in view of Low et al. (WO2020033129A1, published 02/13/2020, on IDS 09/06/2022, previously cited, hereafter “Low II”), Low et al. (WO2014100615A1, on IDS 12/18/2025, hereafter “Low I”), and Low et al. (US20160166679A1, 2016, hereafter “Low III”).
In regards to the instant claims 89, 92, 95-98, 108-109, 113, and 116, while the instant claims and the claims of U.S. Patent No. 11,779,602, are not identical, they are not patentably distinct because the claims of both inventions are drawn to a method for treating cancer comprising administering a compound comprising a small molecule ligand linked to a targeting moiety, wherein the small molecule folate and the targeting moiety is a fluorescein-derivative and CAR T cells.
While the cited patent does not explicitly require a step of administering an activity modifying compound as in claim 89, as above, Low II teaches a system for rejuvenating CAR T cells comprising at least a conjugate (compound) comprising a targeting ligand (second moiety) linked by a linker domain (second linker) to a payload drug (a rejuvenating compound) with the different claimed embodiments (claims 1 and 5-6; Fig. 2, Fig. 9A).
A person of ordinary skill in the art would have been motivated to administer an activity modifying compound as in step (b), in order to rejuvenate and deliver payloads to antigen exhausted CAR T cells, as taught by Low II (p1, Field of Invention; p18-19).
In regards to claims 89, 91, 93-94, 96-111, 113, and 116-118, while the cited patent does not specifically claim the specific embodiments as in these claims, these are all embodiments taught by Low I (as discussed in depth above). A person of ordinary skill in the art would have been motivated to incorporate these embodiments because Low I teaches that they are useful for treating cancer (claims 28 and 29). Furthermore, because Low I is drawn to a method that comprises administering a small molecule conjugate (a compound) comprising a targeting moiety (a first moiety) conjugated to a tumor receptor ligand (i.e., a small molecule; e.g., folate, a well-known small molecule) (Claims 1, 13, and 28-30) with a linker domain (claims 2, 4, and 40), it could have been done with predictable results and a reasonable expectation of success.
In regards to claim 114, in regards to small molecule ligand structure of an adaptor compound comprising a structure having the generic formula as in claim 114, it is noted that this is a folate variant.
While, as above, Low I teaches that the small molecule ligand can be folate (Claims 1, 13, and 28-30) and teaches folate structures (paragraphs [0073-0074]), the folate structures as taught by Low I, while similar, does not appear the be the same structure as in claim 114 (specially, group corresponding to X1 in Low I is a carbonyl (C=O), which is not a group as identified in claim 114 as corresponding to X1).
However, folate variants with the structure as in claim 114, were known before the effective filing date.
For example, Low III (again, who is both the same inventor as Low I and is a named instant inventor) teaches a folate which overlaps in structure with the structure as in claim 114 (claim 7).
In particular, in the left-most bicyclic structure of Low III (claim 7), T1 can be —N═C(X)— which results in a structure that is identical to N=C(X1) as in claim 114 (both the X in Low III and X1 in instant claim 114 can be hydrogen). The remaining structural elements are likewise the same or overlap.
A person of ordinary skill in the art would have been motivated to use folate with this generic structure because Low III teaches that this molecule is suitable for treating a wide range of cancers (claims 3 and 4). Furthermore, because Low I and III both teach treating cancer patients with folates linked to targeting molecules (claim 1 of Low III) and because Low III teaches that folate compounds can have the same generic structure as in claim 114, it could have been done with predictable results and a reasonable expectation of success.
Claims 89, 92, 95-98, 108-109, 113, and 116 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-14 of U.S. Patent No. 12,114,850 in view of Low et al. (WO2020033129A1, published 02/13/2020, on IDS 09/06/2022, previously cited, hereafter “Low II”).
Claims 89, 91, 93-94, 96-111, 113, and 116-118 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-14 of U.S. Patent No. 12,114,850 in view of Low et al. (WO2020033129A1, published 02/13/2020, on IDS 09/06/2022, previously cited, hereafter “Low II”) and Low et al. (WO2014100615A1, on IDS 12/18/2025, hereafter “Low I”).
Claims 89 and 114 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-14 of U.S. Patent No. 12,114,850 in view of Low et al. (WO2020033129A1, published 02/13/2020, on IDS 09/06/2022, previously cited, hereafter “Low II”), Low et al. (WO2014100615A1, on IDS 12/18/2025, hereafter “Low I”), and Low et al. (US20160166679A1, 2016, hereafter “Low III”).
In regards to the instant claims 89, 92, 95-98, 108-109, 113, and 116, while the instant claims and the claims of U.S. Patent No. 12,114,850, are not identical, they are not patentably distinct because the claims of both inventions are drawn to a method for treating cancer comprising administering a compound comprising a small molecule ligand linked to a targeting moiety, wherein the small molecule folate and the targeting moiety is a fluorescein-derivative and CAR T cells.
While the cited patent does not explicitly require a step of administering an activity modifying compound as in claim 89, as above, Low II teaches a system for rejuvenating CAR T cells comprising at least a conjugate (compound) comprising a targeting ligand (second moiety) linked by a linker domain (second linker) to a payload drug (a rejuvenating compound) with the different claimed embodiments (claims 1 and 5-6; Fig. 2, Fig. 9A).
A person of ordinary skill in the art would have been motivated to administer an activity modifying compound as in step (b), in order to rejuvenate and deliver payloads to antigen exhausted CAR T cells, as taught by Low II (p1, Field of Invention; p18-19).
In regards to claims 89, 91, 93-94, 96-111, 113, and 116-118, while the cited patent does not specifically claim the specific embodiments as in these claims, these are all embodiments taught by Low I (as discussed in depth above). A person of ordinary skill in the art would have been motivated to incorporate these embodiments because Low I teaches that they are useful for treating cancer (claims 28 and 29). Furthermore, because Low I is drawn to a method that comprises administering a small molecule conjugate (a compound) comprising a targeting moiety (a first moiety) conjugated to a tumor receptor ligand (i.e., a small molecule; e.g., folate, a well-known small molecule) (Claims 1, 13, and 28-30) with a linker domain (claims 2, 4, and 40), it could have been done with predictable results and a reasonable expectation of success.
In regards to claim 114, in regards to small molecule ligand structure of an adaptor compound comprising a structure having the generic formula as in claim 114, it is noted that this is a folate variant.
While, as above, Low I teaches that the small molecule ligand can be folate (Claims 1, 13, and 28-30) and teaches folate structures (paragraphs [0073-0074]), the folate structures as taught by Low I, while similar, does not appear the be the same structure as in claim 114 (specially, group corresponding to X1 in Low I is a carbonyl (C=O), which is not a group as identified in claim 114 as corresponding to X1).
However, folate variants with the structure as in claim 114, were known before the effective filing date.
For example, Low III (again, who is both the same inventor as Low I and is a named instant inventor) teaches a folate which overlaps in structure with the structure as in claim 114 (claim 7).
In particular, in the left-most bicyclic structure of Low III (claim 7), T1 can be —N═C(X)— which results in a structure that is identical to N=C(X1) as in claim 114 (both the X in Low III and X1 in instant claim 114 can be hydrogen). The remaining structural elements are likewise the same or overlap.
A person of ordinary skill in the art would have been motivated to use folate with this generic structure because Low III teaches that this molecule is suitable for treating a wide range of cancers (claims 3 and 4). Furthermore, because Low I and III both teach treating cancer patients with folates linked to targeting molecules (claim 1 of Low III) and because Low III teaches that folate compounds can have the same generic structure as in claim 114, it could have been done with predictable results and a reasonable expectation of success.
Claims 89, 92, 95-98, 108-109, 113, and 116 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-9 of U.S. Patent No. 12,269,862 in view of Low et al. (WO2020033129A1, published 02/13/2020, on IDS 09/06/2022, previously cited, hereafter “Low II”).
Claims 89, 91, 93-94, 96-111, 113, and 116-118 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-9 of U.S. Patent No. 12,269,862 in view of Low et al. (WO2020033129A1, published 02/13/2020, on IDS 09/06/2022, previously cited, hereafter “Low II”) and Low et al. (WO2014100615A1, on IDS 12/18/2025, hereafter “Low I”).
Claims 89 and 114 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-9 of U.S. Patent No. 12,269,862 in view of Low et al. (WO2020033129A1, published 02/13/2020, on IDS 09/06/2022, previously cited, hereafter “Low II”), Low et al. (WO2014100615A1, on IDS 12/18/2025, hereafter “Low I”), and Low et al. (US20160166679A1, 2016, hereafter “Low III”).
In regards to the instant claims 89, 92, 95-98, 108-109, 113, and 116, while the instant claims and the claims of U.S. Patent No. 12,269,862, are not identical, they are not patentably distinct because the claims of both inventions are drawn to a method for treating cancer comprising administering a compound comprising a small molecule ligand linked to a targeting moiety, wherein the small molecule folate and the targeting moiety is a fluorescein-derivative and CAR T cells.
While the cited patent does not explicitly require a step of administering an activity modifying compound as in claim 89, as above, Low II teaches a system for rejuvenating CAR T cells comprising at least a conjugate (compound) comprising a targeting ligand (second moiety) linked by a linker domain (second linker) to a payload drug (a rejuvenating compound) with the different claimed embodiments (claims 1 and 5-6; Fig. 2, Fig. 9A).
A person of ordinary skill in the art would have been motivated to administer an activity modifying compound as in step (b), in order to rejuvenate and deliver payloads to antigen exhausted CAR T cells, as taught by Low II (p1, Field of Invention; p18-19).
In regards to claims 89, 91, 93-94, 96-111, 113, and 116-118, while the cited patent does not specifically claim the specific embodiments as in these claims, these are all embodiments taught by Low I (as discussed in depth above). A person of ordinary skill in the art would have been motivated to incorporate these embodiments because Low I teaches that they are useful for treating cancer (claims 28 and 29). Furthermore, because Low I is drawn to a method that comprises administering a small molecule conjugate (a compound) comprising a targeting moiety (a first moiety) conjugated to a tumor receptor ligand (i.e., a small molecule; e.g., folate, a well-known small molecule) (Claims 1, 13, and 28-30) with a linker domain (claims 2, 4, and 40), it could have been done with predictable results and a reasonable expectation of success.
In regards to claim 114, in regards to small molecule ligand structure of an adaptor compound comprising a structure having the generic formula as in claim 114, it is noted that this is a folate variant.
While, as above, Low I teaches that the small molecule ligand can be folate (Claims 1, 13, and 28-30) and teaches folate structures (paragraphs [0073-0074]), the folate structures as taught by Low I, while similar, does not appear the be the same structure as in claim 114 (specially, group corresponding to X1 in Low I is a carbonyl (C=O), which is not a group as identified in claim 114 as corresponding to X1).
However, folate variants with the structure as in claim 114, were known before the effective filing date.
For example, Low III (again, who is both the same inventor as Low I and is a named instant inventor) teaches a folate which overlaps in structure with the structure as in claim 114 (claim 7).
In particular, in the left-most bicyclic structure of Low III (claim 7), T1 can be —N═C(X)— which results in a structure that is identical to N=C(X1) as in claim 114 (both the X in Low III and X1 in instant claim 114 can be hydrogen). The remaining structural elements are likewise the same or overlap.
A person of ordinary skill in the art would have been motivated to use folate with this generic structure because Low III teaches that this molecule is suitable for treating a wide range of cancers (claims 3 and 4). Furthermore, because Low I and III both teach treating cancer patients with folates linked to targeting molecules (claim 1 of Low III) and because Low III teaches that folate compounds can have the same generic structure as in claim 114, it could have been done with predictable results and a reasonable expectation of success.
Claims 89, 92, 95-98, 108-109, 113, and 116 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-31 of U.S. Patent No. 12,150,981 in view of Low et al. (WO2020033129A1, published 02/13/2020, on IDS 09/06/2022, previously cited, hereafter “Low II”).
Claims 89, 91, 93-94, 96-111, 113, and 116-118 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-31 of U.S. Patent No. 12,150,981 in view of Low et al. (WO2020033129A1, published 02/13/2020, on IDS 09/06/2022, previously cited, hereafter “Low II”) and Low et al. (WO2014100615A1, on IDS 12/18/2025, hereafter “Low I”).
Claims 89 and 114 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-31 of U.S. Patent No. 12,150,981 in view of Low et al. (WO2020033129A1, published 02/13/2020, on IDS 09/06/2022, previously cited, hereafter “Low II”), Low et al. (WO2014100615A1, on IDS 12/18/2025, hereafter “Low I”), and Low et al. (US20160166679A1, 2016, hereafter “Low III”).
In regards to the instant claims 89, 92, 95-98, 108-109, 113, and 116, while the instant claims and the claims of U.S. Patent No. 12,150,981, are not identical, they are not patentably distinct because the claims of both inventions are drawn to a method for treating cancer comprising administering a compound comprising a small molecule ligand linked to a targeting moiety, wherein the small molecule folate and the targeting moiety is a fluorescein-derivative and CAR T cells.
While the cited patent does not explicitly require a step of administering an activity modifying compound as in claim 89, as above, Low II teaches a system for rejuvenating CAR T cells comprising at least a conjugate (compound) comprising a targeting ligand (second moiety) linked by a linker domain (second linker) to a payload drug (a rejuvenating compound) with the different claimed embodiments (claims 1 and 5-6; Fig. 2, Fig. 9A).
A person of ordinary skill in the art would have been motivated to administer an activity modifying compound as in step (b), in order to rejuvenate and deliver payloads to antigen exhausted CAR T cells, as taught by Low II (p1, Field of Invention; p18-19).
In regards to claims 89, 91, 93-94, 96-111, 113, and 116-118, while the cited patent does not specifically claim the specific embodiments as in these claims, these are all embodiments taught by Low I (as discussed in depth above). A person of ordinary skill in the art would have been motivated to incorporate these embodiments because Low I teaches that they are useful for treating cancer (claims 28 and 29). Furthermore, because Low I is drawn to a method that comprises administering a small molecule conjugate (a compound) comprising a targeting moiety (a first moiety) conjugated to a tumor receptor ligand (i.e., a small molecule; e.g., folate, a well-known small molecule) (Claims 1, 13, and 28-30) with a linker domain (claims 2, 4, and 40), it could have been done with predictable results and a reasonable expectation of success.
In regards to claim 114, in regards to small molecule ligand structure of an adaptor compound comprising a structure having the generic formula as in claim 114, it is noted that this is a folate variant.
While, as above, Low I teaches that the small molecule ligand can be folate (Claims 1, 13, and 28-30) and teaches folate structures (paragraphs [0073-0074]), the folate structures as taught by Low I, while similar, does not appear the be the same structure as in claim 114 (specially, group corresponding to X1 in Low I is a carbonyl (C=O), which is not a group as identified in claim 114 as corresponding to X1).
However, folate variants with the structure as in claim 114, were known before the effective filing date.
For example, Low III (again, who is both the same inventor as Low I and is a named instant inventor) teaches a folate which overlaps in structure with the structure as in claim 114 (claim 7).
In particular, in the left-most bicyclic structure of Low III (claim 7), T1 can be —N═C(X)— which results in a structure that is identical to N=C(X1) as in claim 114 (both the X in Low III and X1 in instant claim 114 can be hydrogen). The remaining structural elements are likewise the same or overlap.
A person of ordinary skill in the art would have been motivated to use folate with this generic structure because Low III teaches that this molecule is suitable for treating a wide range of cancers (claims 3 and 4). Furthermore, because Low I and III both teach treating cancer patients with folates linked to targeting molecules (claim 1 of Low III) and because Low III teaches that folate compounds can have the same generic structure as in claim 114, it could have been done with predictable results and a reasonable expectation of success.
Claims 89, 92, 95-98, 108-109, 113, and 116 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-10 of U.S. Patent No. 11,759,480 in view of Low et al. (WO2020033129A1, published 02/13/2020, on IDS 09/06/2022, previously cited, hereafter “Low II”).
Claims 89, 91, 93-94, 96-111, 113, and 116-118 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-10 of U.S. Patent No. 11,759,480 in view of Low et al. (WO2020033129A1, published 02/13/2020, on IDS 09/06/2022, previously cited, hereafter “Low II”) and Low et al. (WO2014100615A1, on IDS 12/18/2025, hereafter “Low I”).
Claims 89 and 114 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-10 of U.S. Patent No. 11,759,480 in view of Low et al. (WO2020033129A1, published 02/13/2020, on IDS 09/06/2022, previously cited, hereafter “Low II”), Low et al. (WO2014100615A1, on IDS 12/18/2025, hereafter “Low I”), and Low et al. (US20160166679A1, 2016, hereafter “Low III”).
In regards to the instant claims 89, 92, 95-98, 108-109, 113, and 116, while the instant claims and the claims of U.S. Patent No. 12,269,862, are not identical, they are not patentably distinct because the claims of both inventions are drawn to a method for treating cancer comprising administering a compound comprising a small molecule ligand linked to a targeting moiety, wherein the small molecule folate and the targeting moiety is a fluorescein-derivative and CAR T cells.
While the cited patent does not explicitly require a step of administering an activity modifying compound as in claim 89, as above, Low II teaches a system for rejuvenating CAR T cells comprising at least a conjugate (compound) comprising a targeting ligand (second moiety) linked by a linker domain (second linker) to a payload drug (a rejuvenating compound) with the different claimed embodiments (claims 1 and 5-6; Fig. 2, Fig. 9A).
A person of ordinary skill in the art would have been motivated to administer an activity modifying compound as in step (b), in order to rejuvenate and deliver payloads to antigen exhausted CAR T cells, as taught by Low II (p1, Field of Invention; p18-19).
In regards to claims 89, 91, 93-94, 96-111, 113, and 116-118, while the cited patent does not specifically claim the specific embodiments as in these claims, these are all embodiments taught by Low I (as discussed in depth above). A person of ordinary skill in the art would have been motivated to incorporate these embodiments because Low I teaches that they are useful for treating cancer (claims 28 and 29). Furthermore, because Low I is drawn to a method that comprises administering a small molecule conjugate (a compound) comprising a targeting moiety (a first moiety) conjugated to a tumor receptor ligand (i.e., a small molecule; e.g., folate, a well-known small molecule) (Claims 1, 13, and 28-30) with a linker domain (claims 2, 4, and 40), it could have been done with predictable results and a reasonable expectation of success.
In regards to claim 114, in regards to small molecule ligand structure of an adaptor compound comprising a structure having the generic formula as in claim 114, it is noted that this is a folate variant.
While, as above, Low I teaches that the small molecule ligand can be folate (Claims 1, 13, and 28-30) and teaches folate structures (paragraphs [0073-0074]), the folate structures as taught by Low I, while similar, does not appear the be the same structure as in claim 114 (specially, group corresponding to X1 in Low I is a carbonyl (C=O), which is not a group as identified in claim 114 as corresponding to X1).
However, folate variants with the structure as in claim 114, were known before the effective filing date.
For example, Low III (again, who is both the same inventor as Low I and is a named instant inventor) teaches a folate which overlaps in structure with the structure as in claim 114 (claim 7).
In particular, in the left-most bicyclic structure of Low III (claim 7), T1 can be —N═C(X)— which results in a structure that is identical to N=C(X1) as in claim 114 (both the X in Low III and X1 in instant claim 114 can be hydrogen). The remaining structural elements are likewise the same or overlap.
A person of ordinary skill in the art would have been motivated to use folate with this generic structure because Low III teaches that this molecule is suitable for treating a wide range of cancers (claims 3 and 4). Furthermore, because Low I and III both teach treating cancer patients with folates linked to targeting molecules (claim 1 of Low III) and because Low III teaches that folate compounds can have the same generic structure as in claim 114, it could have been done with predictable results and a reasonable expectation of success.
Claims 89, 92, 95-98, 108-109, 113, and 116 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 46-49, 51, 53, 57-58, 60-62, 64, 70-73, and 102 of copending Application No. 18/869,271 in view of Low et al. (WO2020033129A1, published 02/13/2020, on IDS 09/06/2022, previously cited, hereafter “Low II”).
Claims 89, 91, 93-94, 96-111, 113, and 116-118 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 46-49, 51, 53, 57-58, 60-62, 64, 70-73, and 102 of copending Application No. 18/869,271 in view of Low et al. (WO2020033129A1, published 02/13/2020, on IDS 09/06/2022, previously cited, hereafter “Low II”) and Low et al. (WO2014100615A1, on IDS 12/18/2025, hereafter “Low I”).
Claims 89 and 114 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 46-49, 51, 53, 57-58, 60-62, 64, 70-73, and 102 of copending Application No. 18/869,271 in view of Low et al. (WO2020033129A1, published 02/13/2020, on IDS 09/06/2022, previously cited, hereafter “Low II”), Low et al. (WO2014100615A1, on IDS 12/18/2025, hereafter “Low I”), and Low et al. (US20160166679A1, 2016, hereafter “Low III”).
In regards to the instant claims 89, 92, 95-98, 108-109, 113, and 116, while the instant claims and the claims of copending Application No. 18/869,271, are not identical, they are not patentably distinct because the claims of both inventions are drawn to a method for treating cancer comprising administering a compound comprising a small molecule ligand linked to a targeting moiety, wherein the small molecule folate and the targeting moiety is a fluorescein-derivative and CAR T cells.
While the cited co-pending application does not explicitly require a step of administering an activity modifying compound as in claim 89, as above, Low II teaches a system for rejuvenating CAR T cells comprising at least a conjugate (compound) comprising a targeting ligand (second moiety) linked by a linker domain (second linker) to a payload drug (a rejuvenating compound) with the different claimed embodiments (claims 1 and 5-6; Fig. 2, Fig. 9A).
A person of ordinary skill in the art would have been motivated to administer an activity modifying compound as in step (b), in order to rejuvenate and deliver payloads to antigen exhausted CAR T cells, as taught by Low II (p1, Field of Invention; p18-19).
In regards to claims 89, 91, 93-94, 96-111, 113, and 116-118, while the cited co-pending application does not specifically claim the specific embodiments as in these claims, these are all embodiments taught by Low I (as discussed in depth above). A person of ordinary skill in the art would have been motivated to incorporate these embodiments because Low I teaches that they are useful for treating cancer (claims 28 and 29). Furthermore, because Low I is drawn to a method that comprises administering a small molecule conjugate (a compound) comprising a targeting moiety (a first moiety) conjugated to a tumor receptor ligand (i.e., a small molecule; e.g., folate, a well-known small molecule) (Claims 1, 13, and 28-30) with a linker domain (claims 2, 4, and 40), it could have been done with predictable results and a reasonable expectation of success.
In regards to claim 114, in regards to small molecule ligand structure of an adaptor compound comprising a structure having the generic formula as in claim 114, it is noted that this is a folate variant.
While, as above, Low I teaches that the small molecule ligand can be folate (Claims 1, 13, and 28-30) and teaches folate structures (paragraphs [0073-0074]), the folate structures as taught by Low I, while similar, does not appear the be the same structure as in claim 114 (specially, group corresponding to X1 in Low I is a carbonyl (C=O), which is not a group as identified in claim 114 as corresponding to X1).
However, folate variants with the structure as in claim 114, were known before the effective filing date.
For example, Low III (again, who is both the same inventor as Low I and is a named instant inventor) teaches a folate which overlaps in structure with the structure as in claim 114 (claim 7).
In particular, in the left-most bicyclic structure of Low III (claim 7), T1 can be —N═C(X)— which results in a structure that is identical to N=C(X1) as in claim 114 (both the X in Low III and X1 in instant claim 114 can be hydrogen). The remaining structural elements are likewise the same or overlap.
A person of ordinary skill in the art would have been motivated to use folate with this generic structure because Low III teaches that this molecule is suitable for treating a wide range of cancers (claims 3 and 4). Furthermore, because Low I and III both teach treating cancer patients with folates linked to targeting molecules (claim 1 of Low III) and because Low III teaches that folate compounds can have the same generic structure as in claim 114, it could have been done with predictable results and a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection.
Claims 89, 92, 95-98, 108-109, 113, and 116 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25, 31, 37-41 of copending Application No. 18/260,273 in view of Low et al. (WO2020033129A1, published 02/13/2020, on IDS 09/06/2022, previously cited, hereafter “Low II”).
Claims 89, 91, 93-94, 96-111, 113, and 116-118 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25, 31, 37-41 of copending Application No. 18/260,273 in view of Low et al. (WO2020033129A1, published 02/13/2020, on IDS 09/06/2022, previously cited, hereafter “Low II”) and Low et al. (WO2014100615A1, on IDS 12/18/2025, hereafter “Low I”).
Claims 89 and 114 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25, 31, 37-41 of copending Application No. 18/260,273 in view of Low et al. (WO2020033129A1, published 02/13/2020, on IDS 09/06/2022, previously cited, hereafter “Low II”), Low et al. (WO2014100615A1, on IDS 12/18/2025, hereafter “Low I”), and Low et al. (US20160166679A1, 2016, hereafter “Low III”).
In regards to the instant claims 89, 92, 95-98, 108-109, 113, and 116, while the instant claims and the claims of copending Application No. 18/260,273, are not identical, they are not patentably distinct because the claims of both inventions are drawn to a method for treating cancer comprising administering a compound comprising a small molecule ligand linked to a targeting moiety, wherein the small molecule folate and the targeting moiety is a fluorescein-derivative and CAR T cells.
While the cited co-pending application does not explicitly require a step of administering an activity modifying compound as in claim 89, as above, Low II teaches a system for rejuvenating CAR T cells comprising at least a conjugate (compound) comprising a targeting ligand (second moiety) linked by a linker domain (second linker) to a payload drug (a rejuvenating compound) with the different claimed embodiments (claims 1 and 5-6; Fig. 2, Fig. 9A).
A person of ordinary skill in the art would have been motivated to administer an activity modifying compound as in step (b), in order to rejuvenate and deliver payloads to antigen exhausted CAR T cells, as taught by Low II (p1, Field of Invention; p18-19).
In regards to claims 89, 91, 93-94, 96-111, 113, and 116-118, while the cited co-pending application does not specifically claim the specific embodiments as in these claims, these are all embodiments taught by Low I (as discussed in depth above). A person of ordinary skill in the art would have been motivated to incorporate these embodiments because Low I teaches that they are useful for treating cancer (claims 28 and 29). Furthermore, because Low I is drawn to a method that comprises administering a small molecule conjugate (a compound) comprising a targeting moiety (a first moiety) conjugated to a tumor receptor ligand (i.e., a small molecule; e.g., folate, a well-known small molecule) (Claims 1, 13, and 28-30) with a linker domain (claims 2, 4, and 40), it could have been done with predictable results and a reasonable expectation of success.
In regards to claim 114, in regards to small molecule ligand structure of an adaptor compound comprising a structure having the generic formula as in claim 114, it is noted that this is a folate variant.
While, as above, Low I teaches that the small molecule ligand can be folate (Claims 1, 13, and 28-30) and teaches folate structures (paragraphs [0073-0074]), the folate structures as taught by Low I, while similar, does not appear the be the same structure as in claim 114 (specially, group corresponding to X1 in Low I is a carbonyl (C=O), which is not a group as identified in claim 114 as corresponding to X1).
However, folate variants with the structure as in claim 114, were known before the effective filing date.
For example, Low III (again, who is both the same inventor as Low I and is a named instant inventor) teaches a folate which overlaps in structure with the structure as in claim 114 (claim 7).
In particular, in the left-most bicyclic structure of Low III (claim 7), T1 can be —N═C(X)— which results in a structure that is identical to N=C(X1) as in claim 114 (both the X in Low III and X1 in instant claim 114 can be hydrogen). The remaining structural elements are likewise the same or overlap.
A person of ordinary skill in the art would have been motivated to use folate with this generic structure because Low III teaches that this molecule is suitable for treating a wide range of cancers (claims 3 and 4). Furthermore, because Low I and III both teach treating cancer patients with folates linked to targeting molecules (claim 1 of Low III) and because Low III teaches that folate compounds can have the same generic structure as in claim 114, it could have been done with predictable results and a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection.
Claims 89, 92, 95-98, 108-109, 113, and 116 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-7, 12-13, 16, 18-20, 22, 25-26, 30-33, and 39-43 of copending Application No. 18/255,094 in view of Low et al. (WO2020033129A1, published 02/13/2020, on IDS 09/06/2022, previously cited, hereafter “Low II”).
Claims 89, 91, 93-94, 96-111, 113, and 116-118 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-7, 12-13, 16, 18-20, 22, 25-26, 30-33, and 39-43 of copending Application No. 18/255,094 in view of Low et al. (WO2020033129A1, published 02/13/2020, on IDS 09/06/2022, previously cited, hereafter “Low II”) and Low et al. (WO2014100615A1, on IDS 12/18/2025, hereafter “Low I”).
Claims 89 and 114 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-7, 12-13, 16, 18-20, 22, 25-26, 30-33, and 39-43 of copending Application No. 18/255,094 in view of Low et al. (WO2020033129A1, published 02/13/2020, on IDS 09/06/2022, previously cited, hereafter “Low II”), Low et al. (WO2014100615A1, on IDS 12/18/2025, hereafter “Low I”), and Low et al. (US20160166679A1, 2016, hereafter “Low III”).
In regards to the instant claims 89, 92, 95-98, 108-109, 113, and 116, while the instant claims and the claims of copending Application No. 18/255,094, are not identical, they are not patentably distinct because the claims of both inventions are drawn to a method for treating cancer comprising administering a compound comprising a small molecule ligand linked to a targeting moiety, wherein the small molecule folate and the targeting moiety is a fluorescein-derivative and CAR T cells.
While the cited co-pending application does not explicitly require a step of administering an activity modifying compound as in claim 89, as above, Low II teaches a system for rejuvenating CAR T cells comprising at least a conjugate (compound) comprising a targeting ligand (second moiety) linked by a linker domain (second linker) to a payload drug (a rejuvenating compound) with the different claimed embodiments (claims 1 and 5-6; Fig. 2, Fig. 9A).
A person of ordinary skill in the art would have been motivated to administer an activity modifying compound as in step (b), in order to rejuvenate and deliver payloads to antigen exhausted CAR T cells, as taught by Low II (p1, Field of Invention; p18-19).
In regards to claims 89, 91, 93-94, 96-111, 113, and 116-118, while the cited co-pending application does not specifically claim the specific embodiments as in these claims, these are all embodiments taught by Low I (as discussed in depth above). A person of ordinary skill in the art would have been motivated to incorporate these embodiments because Low I teaches that they are useful for treating cancer (claims 28 and 29). Furthermore, because Low I is drawn to a method that comprises administering a small molecule conjugate (a compound) comprising a targeting moiety (a first moiety) conjugated to a tumor receptor ligand (i.e., a small molecule; e.g., folate, a well-known small molecule) (Claims 1, 13, and 28-30) with a linker domain (claims 2, 4, and 40), it could have been done with predictable results and a reasonable expectation of success.
In regards to claim 114, in regards to small molecule ligand structure of an adaptor compound comprising a structure having the generic formula as in claim 114, it is noted that this is a folate variant.
While, as above, Low I teaches that the small molecule ligand can be folate (Claims 1, 13, and 28-30) and teaches folate structures (paragraphs [0073-0074]), the folate structures as taught by Low I, while similar, does not appear the be the same structure as in claim 114 (specially, group corresponding to X1 in Low I is a carbonyl (C=O), which is not a group as identified in claim 114 as corresponding to X1).
However, folate variants with the structure as in claim 114, were known before the effective filing date.
For example, Low III (again, who is both the same inventor as Low I and is a named instant inventor) teaches a folate which overlaps in structure with the structure as in claim 114 (claim 7).
In particular, in the left-most bicyclic structure of Low III (claim 7), T1 can be —N═C(X)— which results in a structure that is identical to N=C(X1) as in claim 114 (both the X in Low III and X1 in instant claim 114 can be hydrogen). The remaining structural elements are likewise the same or overlap.
A person of ordinary skill in the art would have been motivated to use folate with this generic structure because Low III teaches that this molecule is suitable for treating a wide range of cancers (claims 3 and 4). Furthermore, because Low I and III both teach treating cancer patients with folates linked to targeting molecules (claim 1 of Low III) and because Low III teaches that folate compounds can have the same generic structure as in claim 114, it could have been done with predictable results and a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection.
Claims 89, 92, 95-98, 108-109, 113, and 116 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of copending Application No. 18/963,158 in view of Low et al. (WO2020033129A1, published 02/13/2020, on IDS 09/06/2022, previously cited, hereafter “Low II”).
Claims 89, 91, 93-94, 96-111, 113, and 116-118 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of copending Application No. 18/963,158 in view of Low et al. (WO2020033129A1, published 02/13/2020, on IDS 09/06/2022, previously cited, hereafter “Low II”) and Low et al. (WO2014100615A1, on IDS 12/18/2025, hereafter “Low I”).
Claims 89 and 114 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of copending Application No. 18/963,158 in view of Low et al. (WO2020033129A1, published 02/13/2020, on IDS 09/06/2022, previously cited, hereafter “Low II”), Low et al. (WO2014100615A1, on IDS 12/18/2025, hereafter “Low I”), and Low et al. (US20160166679A1, 2016, hereafter “Low III”).
In regards to the instant claims 89, 92, 95-98, 108-109, 113, and 116, while the instant claims and the claims of copending Application No. 18/963,158, are not identical, they are not patentably distinct because the claims of both inventions are drawn to a method for treating cancer comprising administering a compound comprising a small molecule ligand linked to a targeting moiety, wherein the small molecule folate and the targeting moiety is a fluorescein-derivative and CAR T cells.
While the cited co-pending application does not explicitly require a step of administering an activity modifying compound as in claim 89, as above, Low II teaches a system for rejuvenating CAR T cells comprising at least a conjugate (compound) comprising a targeting ligand (second moiety) linked by a linker domain (second linker) to a payload drug (a rejuvenating compound) with the different claimed embodiments (claims 1 and 5-6; Fig. 2, Fig. 9A).
A person of ordinary skill in the art would have been motivated to administer an activity modifying compound as in step (b), in order to rejuvenate and deliver payloads to antigen exhausted CAR T cells, as taught by Low II (p1, Field of Invention; p18-19).
In regards to claims 89, 91, 93-94, 96-111, 113, and 116-118, while the cited co-pending application does not specifically claim the specific embodiments as in these claims, these are all embodiments taught by Low I (as discussed in depth above). A person of ordinary skill in the art would have been motivated to incorporate these embodiments because Low I teaches that they are useful for treating cancer (claims 28 and 29). Furthermore, because Low I is drawn to a method that comprises administering a small molecule conjugate (a compound) comprising a targeting moiety (a first moiety) conjugated to a tumor receptor ligand (i.e., a small molecule; e.g., folate, a well-known small molecule) (Claims 1, 13, and 28-30) with a linker domain (claims 2, 4, and 40), it could have been done with predictable results and a reasonable expectation of success.
In regards to claim 114, in regards to small molecule ligand structure of an adaptor compound comprising a structure having the generic formula as in claim 114, it is noted that this is a folate variant.
While, as above, Low I teaches that the small molecule ligand can be folate (Claims 1, 13, and 28-30) and teaches folate structures (paragraphs [0073-0074]), the folate structures as taught by Low I, while similar, does not appear the be the same structure as in claim 114 (specially, group corresponding to X1 in Low I is a carbonyl (C=O), which is not a group as identified in claim 114 as corresponding to X1).
However, folate variants with the structure as in claim 114, were known before the effective filing date.
For example, Low III (again, who is both the same inventor as Low I and is a named instant inventor) teaches a folate which overlaps in structure with the structure as in claim 114 (claim 7).
In particular, in the left-most bicyclic structure of Low III (claim 7), T1 can be —N═C(X)— which results in a structure that is identical to N=C(X1) as in claim 114 (both the X in Low III and X1 in instant claim 114 can be hydrogen). The remaining structural elements are likewise the same or overlap.
A person of ordinary skill in the art would have been motivated to use folate with this generic structure because Low III teaches that this molecule is suitable for treating a wide range of cancers (claims 3 and 4). Furthermore, because Low I and III both teach treating cancer patients with folates linked to targeting molecules (claim 1 of Low III) and because Low III teaches that folate compounds can have the same generic structure as in claim 114, it could have been done with predictable results and a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection.
Claims 89, 91, 93-94, 96-111, 113, and 116-118 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 and 8 of copending Application No. 18/687,785 in view of Low et al. (WO2014100615A1, on IDS 12/18/2025, hereafter “Low I”) and Low et al. (WO2020033129A1, published 02/13/2020, on IDS 09/06/2022, previously cited, hereafter “Low II”).
Claims 89 and 114 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of copending Application No. 18/963,158 in view of Low et al. (WO2014100615A1, on IDS 12/18/2025, hereafter “Low I”), Low et al. (WO2020033129A1, published 02/13/2020, on IDS 09/06/2022, previously cited, hereafter “Low II”), and Low et al. (US20160166679A1, 2016, hereafter “Low III”).
In regards to the instant claim 89, while the instant claims and the claims of copending Application No. 18/687,785, are not identical, they are not patentably distinct because the claims of both inventions are drawn to a method for treating cancer comprising administering a first compound comprising a small molecule ligand linked to a targeting moiety; a compound comprising a TLR agonist linked to a second targeting moiety, and administering CAR T cells.
In regards to claims 89, 91, 93-94, 96-111, 113, and 116-118, while the cited co-pending application does not specifically claim the specific embodiments as in these claims, these are all embodiments taught by Low I or Low II corresponding to the first and second compounds (as discussed in depth above). A person of ordinary skill in the art would have been motivated to incorporate these embodiments for the first compound because Low I teaches that they are useful for treating cancer (claims 28 and 29). A person of ordinary skill in the art would have been motivated to incorporate the second compound because Low II teaches that they are use for rejuvenating T cells (claims 1 and 5-6; Fig. 2, Fig. 9A; p1, Field of Invention; p18-19).
Furthermore, because Low I is drawn to a method that comprises administering a small molecule conjugate (a compound) comprising a targeting moiety (a first moiety) conjugated to a tumor receptor ligand (i.e., a small molecule; e.g., folate, a well-known small molecule) (Claims 1, 13, and 28-30) with a linker domain (claims 2, 4, and 40), it could have been done with predictable results and a reasonable expectation of success. Additionally, because Low II teaches that these compounds can be used to rejuvenate cells (claim 18) and teaches that the system can be used to deliver payloads to cancer antigen exhausted CAR T cells in vivo (p1, Field of Invention; p18-19), it could have been done with predictable results and a reasonable expectation of success.
In regards to claim 114, in regards to small molecule ligand structure of an adaptor compound comprising a structure having the generic formula as in claim 114, it is noted that this is a folate variant.
While, as above, Low I teaches that the small molecule ligand can be folate (Claims 1, 13, and 28-30) and teaches folate structures (paragraphs [0073-0074]), the folate structures as taught by Low I, while similar, does not appear the be the same structure as in claim 114 (specially, group corresponding to X1 in Low I is a carbonyl (C=O), which is not a group as identified in claim 114 as corresponding to X1).
However, folate variants with the structure as in claim 114, were known before the effective filing date.
For example, Low III (again, who is both the same inventor as Low I and is a named instant inventor) teaches a folate which overlaps in structure with the structure as in claim 114 (claim 7).
In particular, in the left-most bicyclic structure of Low III (claim 7), T1 can be —N═C(X)— which results in a structure that is identical to N=C(X1) as in claim 114 (both the X in Low III and X1 in instant claim 114 can be hydrogen). The remaining structural elements are likewise the same or overlap.
A person of ordinary skill in the art would have been motivated to use folate with this generic structure because Low III teaches that this molecule is suitable for treating a wide range of cancers (claims 3 and 4). Furthermore, because Low I and III both teach treating cancer patients with folates linked to targeting molecules (claim 1 of Low III) and because Low III teaches that folate compounds can have the same generic structure as in claim 114, it could have been done with predictable results and a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims are allowed.
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/JOSEPH PAUL MIANO/Examiner, Art Unit 1631
/JAMES D SCHULTZ/Supervisory Patent Examiner, Art Unit 1631