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 .
DETAILED ACTION
The species election filed October 20, 2025, is acknowledged and has been entered. Applicant has elected without traverse the species of antigen of TK1.
Claims 1-20 are under consideration.
Claim Rejections-35 U.S.C. § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 9-10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claims 9-10 are indefinite in the recitation of “the method of claim 1" in claim 9 (claim 10 depends from claim 9 and recites “the method of claim 9”) because claim 9 depends from claim 1 which is not drawn to a method. Therefore, the recitation lacks proper antecedent basis and it cannot be determined which (if any) method is being referred to.
Accordingly, the metes and bounds of the claim cannot be properly determined and the invention is not set forth with the clarity and particularity necessary to satisfy the requirement set forth 35 U.S.C. 112, second paragraph, so as permit the skilled artisan to know or determine infringing subject matter.
For the purposes of compact prosecution, the claims will be interpreted as being drawn to the chimeric antigen receptor of claim 1.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-8 and 11-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by WO 2017/019848 A1 (Gill et al, IDS).
With respect to claims 1 and 5-8, Gill et al disclose human macrophages expressing CARs, wherein the CAR comprises a constitutively active antibody fragment and a cytoplasmic signaling domain from TLR4 (see abstract, pages 2-7, 37 and 42 and figures) and using the cells expressing CARs of the invention to treat cancer (see pages 4 and 20). Gill et al teach that the antibody can be an scFv derived from a murine monoclonal antibody that binds CEA which is an antigen expressed by cancer cells (see pages 23 and 33-40).
With respect to claims 11-16, Gill et al disclose vectors in human macrophages, wherein the vector comprises a sequence that encodes such CARs and comprising a suitable promoter that constitutively activates expression of the CAR and the vectors in macrophages (see pages 10, 42-46 and 62). Gill et al teach that the cells can be activated with a co-stimulatory molecule (see figures and pages 21 and 33-40).
With respect to claims 2-4 and 17-20, Gill et al disclose human macrophages expressing CARs and human macrophages comprising a vector that expresses CARs, as set forth above, that are materially indistinguishable from the instantly claimed macrophages, and Applicant is reminded that products of identical composition cannot have mutually exclusive functions. Therefore, while Gill does do not expressly disclose the functions of claims 2, 4 and 17-18 the products of the prior art necessarily meet these limitations, absent a showing otherwise.
Therefore, the products of Gill et al are deemed to anticipate the claimed products absent a showing otherwise.
Claim Rejections - 35 USC § 103
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over US WO 2017/019848 A1 (Gill et al, IDS) and US 2010/0266495 A1 (O’Neill, Kim, IDS).
With respect to claims 1 and 5-8, Gill et al disclose human macrophages expressing CARs, wherein the CAR comprises a constitutively active antibody fragment and a cytoplasmic signaling domain from TLR4 (see abstract, pages 2-7, 37 and 42 and figures) and using the cells expressing CARs of the invention to treat cancer (see pages 4 and 20). Gill et al teach that the antibody can be an scFv derived from a murine monoclonal antibody that binds CEA which is an antigen expressed by cancer cells (see pages 23 and 33-40).
With respect to claims 11-16, Gill et al disclose vectors in human macrophages, wherein the vector comprises a sequence that encodes such CARs and comprising a suitable promoter that constitutively activates expression of the CAR and the vectors in macrophages (see pages 10, 42-46 and 62). Gill et al teach that the cells can be activated with a co-stimulatory molecule (see figures and pages 21 and 33-40).
With respect to claims 2-4 and 17-20, Gill et al disclose human macrophages expressing CARs and human macrophages comprising a vector that expresses CARs, as set forth above, that are materially indistinguishable from the instantly claimed macrophages, and Applicant is reminded that products of identical composition cannot have mutually exclusive functions. Therefore, while Gill does do not expressly disclose the functions of claims 2, 4 and 17-18 the products of the prior art necessarily meet these limitations, absent a showing otherwise.
Gill et al does not disclose the antigen TK1 as set forth in claims 9-10.
O’Neill discloses that TK1 is involved in the salvage pathway of DNA synthesis and that TK1 is elevated in malignancies. O’Neill disclose using TK1 antibodies to treat cancer (see entire document, e.g., abstract, figures, examples, claims, and page 1).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art at the time the claimed invention was made to predictably use a single chain fragment variable TK1 antibody in a chimeric antigen receptor as taught by Gill et al and place it in vectors in human macrophages to express the CAR for use in methods of targeting TK1-expressing cancers. Notably, the art recognized that TK1 is an antigen overexpressed frequently in cancers so that macrophage cells expressing a single chain fragment variable TK1 antibody linked to macrophage TLR4 cytoplasmic signaling domains would be recognized as an advantageous product that would have wide applicability in treating cancers. Furthermore, one of skill in the art would have expected success in making such constructs as genetic engineering techniques to make CARs were known in the art as evidenced by Gill.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-20 are rejected on the grounds of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-6 of US Patent 11,052,138, IDS in view of US WO 2017/019848 A1 (Gill et al, IDS) and US 2010/0266495 A1 (O’Neill, Kim, IDS). Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons:
Claims 1-6 of the patents recite:
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Gill et al and O’Neill disclose that which is set forth above.
Accordingly, some of the instant claims are anticipated by the patented claims and based on Gill and O’Neill it would have been prima facie obvious to one of ordinary skill in the art at the time the claimed invention was made to predictably use a single chain fragment variable TK1 antibody in a chimeric antigen receptor as taught by Gill et al and place it in vectors in human macrophages to express the CAR for use in methods of targeting TK1-expressing cancers. Notably, the art recognized that TK1 is an antigen overexpressed frequently in cancers so that macrophage cells expressing a single chain fragment variable TK1 antibody linked to macrophage TLR4 cytoplasmic signaling domains would be recognized as an advantageous product that would have wide applicability in treating cancers. Furthermore, one of skill in the art would have expected success in making such constructs as genetic engineering techniques to make CARs were known in the art as evidenced by Gill.
Accordingly, the subject matter claimed in the instant application would be seen as an obvious variation of the subject matter claimed in the patent in view of the state of art.
Claims 1-20 are rejected on the grounds of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-12 of US Patent 11,352,439, IDS in view of US WO 2017/019848 A1 (Gill et al, IDS) and US 2010/0266495 A1 (O’Neill, Kim, IDS). Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons:
Claims 1-12 of the patents recite:
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Gill et al and O’Neill disclose that which is set forth above.
Accordingly, while the patented claims are method claims, one would need to make CARs that bind to TK1 and that which comprises a TLR4 intracellular domain to practice such methods, so it would have been prima facie obvious to one of ordinary skill in the art at the time the claimed invention was made to predictably use a single chain fragment variable TK1 antibody in a chimeric antigen receptor as taught by Gill et al and place it in vectors in human macrophages to express the CAR for use in methods of targeting TK1-expressing cancers. Notably, the art recognized that TK1 is an antigen overexpressed frequently in cancers so that macrophage cells expressing a single chain fragment variable TK1 antibody linked to macrophage TLR4 cytoplasmic signaling domains would be recognized as an advantageous product that would have wide applicability in treating cancers. Furthermore, one of skill in the art would have expected success in making such constructs as genetic engineering techniques to make CARs were known in the art as evidenced by Gill.
Accordingly, the subject matter claimed in the instant application would be seen as an obvious variation of the subject matter claimed in the patent in view of the state of art.
Claims 1-20 are rejected on the grounds of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-8 of US Patent 12,076,378 in view of US WO 2017/019848 A1 (Gill et al, IDS) and US 2010/0266495 A1 (O’Neill, Kim, IDS). Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons:
Claims 1-8 of the patents recite:
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Gill et al and O’Neill disclose that which is set forth above.
Accordingly, some of the instant claims are anticipated by the patented claims and based on Gill and O’Neill it would have been prima facie obvious to one of ordinary skill in the art at the time the claimed invention was made to predictably use a single chain fragment variable TK1 antibody in a chimeric antigen receptor as taught by Gill et al and place it in vectors in human macrophages to express the CAR for use in methods of targeting TK1-expressing cancers. Notably, the art recognized that TK1 is an antigen overexpressed frequently in cancers so that macrophage cells expressing a single chain fragment variable TK1 antibody linked to macrophage TLR4 cytoplasmic signaling domains would be recognized as an advantageous product that would have wide applicability in treating cancers. Furthermore, one of skill in the art would have expected success in making such constructs as genetic engineering techniques to make CARs were known in the art as evidenced by Gill.
Accordingly, the subject matter claimed in the instant application would be seen as an obvious variation of the subject matter claimed in the patent in view of the state of art.
Conclusion
No claims are allowed. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
WO 2016/033331 A1 (Short, Jay, IDS), teach macrophages expressing CAR.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brad Duffy whose telephone number is (571) 272-9935. The examiner can normally be reached on Monday through Thursday 8:15 AM to 5:45 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Julie Wu can be reached on (571) 272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Respectfully,
Brad Duffy
571-272-9935
/Brad Duffy/
Primary Examiner, Art Unit 1643
January 15, 2026