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 .
Information Disclosure Statement
The information disclosure statements (IDS) filed 12/01/2023 and 04/08/2024 have been considered and the references therein are of record.
Election/Restrictions
Applicant’s election without traverse of C2 (SEQ ID NOs: 22 & 24-30) as the antibody and a CAR T cell comprising a Th9 polarized T cell as the antigen binding molecule in the reply filed on 06/22/2026 is acknowledged.
Claim Rejections - 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.
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 1 and 6-14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is indefinite for the recitation of “in the context of.” The term “in the context of” is not defined by the claim, the specification does not provide a definition, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear as to whether the peptide must be bound to HLA-A2, must be near HLA-A2, or some other “context” of HLA-A2 for the unspecified molecule to bind. For the purpose of compact prosecution, “in the context of” will be interpreted to mean the peptide bound to HLA-A2.
The claims 1 and 6-14 are rejected for recitation of intended result/effect without conferring some structural or material difference on the scope of the claim. The claims recite, or are dependent upon, the functional language of an unspecified molecule capable of selectively binding to Dickkpf-1 (DKK1) peptide P20 in the context of HLA-A2 (claim 1), a method of treating any cancer using the unspecified molecule (claim 11), and an unspecified binding molecule capable of binding DKK1 (claim 13) without specifying any specific structures required to perform the functions. Claims 1, 11, and 13 do not provide the necessary structures that must be present to perform the requisite functions. The mechanism steps and requisite structure are merely implied by the functional language and thus the scope of the claims is undefined. Dependent claims 6-10, 12, and 14 fail to define these limitations and are therefore included in the rejection. Absent additional active method steps and structure, it is unclear how these claims further limit the scope of the parent claim. MPEP 2173.05(g) states: “the use of functional language in a claim may fail ‘to provide a clear-cut indication of the scope of the subject matter embraced by the claim' and thus be indefinite.” It further states: “Examiners should consider the following factors when examining claims that contain functional language to determine whether the language is ambiguous: (1) whether there is a clear cut indication of the scope of the subject matter covered by the claim; (2) whether the language sets forth well-defined boundaries of the invention or only states a problem solved or a result obtained; and (3) whether one of ordinary skill in the art would know from the claim terms what structure or steps are encompassed by the claim.” The claims are rejected since they fail to meet all (3) criteria set forth in MPEP 2173.05(g).
Claim Rejections - 35 USC § 112(a) – Written Description
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 6-7, and 9-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In making a determination of whether the application complies with the written description requirement of 35 U.S.C. 112, first paragraph, it is necessary to understand what Applicant has possession of and what Applicant is claiming. The claims recite an unspecified molecule capable of selectively binding to Dickkpf-1 (DKK1) peptide P20 in the context of HLA-A2 (claim 1), a method of treating any cancer (including leukemia) using the unspecified molecule (claim 11-12), and an unspecified binding molecule capable of binding DKK1 (claim 13), each of which encompasses a genus of agents. Claims 6-7, 9-10, and 14 do not materially limit the genera of agents, and are therefore included in the rejection. These claims do not require that the genera of the claims possess any particular structure or other distinguishing feature that is characteristic of the genera as a whole. Therefore the claims are drawn to genera for which there is inadequate written description.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see MPEP 2163(II)(3)(a)(i)(A), reduction to drawings MPEP 2163(II)(3)(a)(i)(B), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus MPEP 2163(II)(3)(a)(i)(C).
It is clear from the specification that applicant is in possession of the elected species of an antigen binding molecule with SEQ ID NOs: 22 and 24-30 that’s capable of treating pancreatic cancer, non-small cell lung cancer, breast cancer, and myeloma, as demonstrated by in vitro and in vivo mouse models. In regards to claim 12, there is no evidence that the antigen binding molecule can treat leukemia. The claims, however, are not limited to those species. The specification fails to provide a representative number of species within the recited genera. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics of the genera as a whole, or representative number of species within the genera, the specification does not provide adequate written description of the claimed genera.
Claim Rejections - 35 USC § 112(a) – Enablement
Claims 1, 6-7, 9-11, and 13-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the elected species of an antibody binding molecule with SEQ ID NOs: 22 and 24-30 that’s capable of treating pancreatic cancer, non-small cell lung cancer, breast cancer, and myeloma, does not reasonably provide enablement for the genera of molecules capable of selectively binding to Dickkpf-1 (DKK1) peptide P20 in the context of HLA-A2 (claim 1), methods of treating any cancer (including leukemia) using the molecules (claim 11-12), and molecules capable of binding DKK1 (claim 13). Claims 6-7, 9-10, and 14 do not materially limit the genera, and are therefore included in the rejection. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
In AMGEN INC. ET AL. v. SANOFI ET AL. (No. 21-757, decided May 18, 2023), the Supreme Court held that Amgen was not enabled for “the entire genus” of antibodies that (1) “bind to specific amino acid residues on PCSK9,” and (2) “block PCSK9 from binding to [LDL receptors]” (872 F. 3d 1367, 1372) even though Amgen identified the amino acid sequences of 26 antibodies that perform these two functions.
The case law applies to the instant claims which require genera of antigen binding molecules, yet the inventors have disclosed no amino acid sequences for the entirety of the claimed genera and have only disclosed use of the antigen binding molecules disclosed in the specification’s examples, figures, and sequence listing, including an antibody binding molecule with SEQ ID NOs: 22 and 24-30 that’s capable of treating pancreatic cancer, non-small cell lung cancer, breast cancer, and myeloma.
In Amgen, the Supreme Court has stated:
“An antibody' s structure does much to dictate its function—its ability to bind to an antigen and, in some instances, to block other molecules in the body from doing the same. ‘For an antibody to bind to an antigen, the two surfaces have to fit together and contact each other at multiple points.' Id., at 11. But just because an antibody can bind to an antigen does not mean that it can also block. To bind and block, the antibody must establish a sufficiently broad, strong, and stable bond to the antigen. See ibid. Different antibodies have different binding and blocking capacities based on the amino acids that compose them and their three-dimensional shapes. See id., at 11–12.
Despite recent advances, aspects of antibody science remain unpredictable. For example, scientists understand that changing even one amino acid in the sequence can alter an antibody' s structure and function. See id., at 14. But scientists cannot always accurately predict exactly how trading one amino acid for another will affect an antibody' s structure and function. Ibid.”
A patent is granted for a completed invention, not the general suggestion of an idea and how that idea might be developed into the claimed invention. In the decision of Genentec, Inc., V. Novo Nordisk, 42 USPQ 2d 100, (CAFC 1997), the court held that: "[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable" and that "[t]ossing out the mere germ of an idea does not constitute enabling disclosure". The court further stated that "when there is no disclosure of any specific starting material or of any of the conditions under which a process is to be carried out, undue experimentation is required; there is a failure to meet the enablement requirements that cannot be rectified by asserting that all of the disclosure related to the process is within the skill of the art","[i]t is the specification, not the knowledge of one skilled in the art, that must supply the novel aspects of an invention in order to constitute adequate enablement". The instant specification is not enabling for the full scope of the claimed invention because one cannot follow the guidance presented therein and practice the claimed method without first making a substantial inventive contribution.
Given that structure is essential to function; and given the unpredictability within the art with respect to creating antibodies, a person having ordinary skill in the art would have to perform further experimentation in order to make the genera of the antigen binding molecules encompassed by the claims and use them in the method claimed, commensurate in scope with the breadth of the claims. Given the nature of the invention, a skilled artisan would have to make many antigen binding molecules, then use those in the method claimed of treating any cancer in order to demonstrate making and using with a reasonable expectation of success. This amount of experimentation goes beyond what is considered “a reasonable degree of experimentation” and constitutes undue further experimentation in order to enable the method for the breadth of what is claimed. Therefore, the claims lack enablement.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 13-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a mental process/abstract idea judicial exception without significantly more. The claims recite the abstract ideas of detecting cancer by comparing the presence of DKK1 to the absence of DKK1 (a negative control). MPEP 2106 sets forth the multistep process for determining subject matter eligibility.
The claims are directed to a method of detecting cancer by obtaining a sample and assaying the sample for the presence DKK1 by using the unspecified binding molecules of claim 1. Methods and products are statutory categories of inventions (STEP 1:YES)
These claims recite measuring the amount of DKK1 and comparing to a negative control. Both measuring and comparing are abstract mental concepts that belong to the enumerated groups of mathematical concepts and mental processes within the Abstract Idea Groupings described in MPEP § 2106.04(a): Mathematical concepts – mathematical relationships, mathematical formulas or equations, mathematical calculations; Mental processes — concepts performed in the human mind (including an observation, evaluation, judgment, opinion). Therefore the claims recite at least one judicial exception (STEP 2A, Prong One: YES).
According to Step 2A, Prong Two, set forth in MPEP 2106.04, the claims are next evaluated with respect to whether the judicial exception is integrated into a practical application. This analysis turns to the additional steps/elements recited by the claims. Claim 13 requires the additional steps of using the unspecified binding molecules of claim 1 and obtaining a tissue sample of a suspected cancerous tissue from a subject. Claim 14 requires the additional step of using enzyme linked immunosorbent assays (ELISAs), enzyme linked immunospot assay (ELISpot), radioimmunoassays (RIA), radioimmune precipitation assays (RIPA), immunobead capture assays, and/or flow cytometry to determine the presence of or amount of the unspecified antigen binding molecules of claim 1.
MPEP 2106.04(d) directs to 2106.05(g) stating “when determining whether a claim integrates the judicial exception into a practical application in Step 2A Prong Two or recites significantly more in Step 2B is whether the additional elements add more than insignificant extra-solution activity to the judicial exception. The term "extra-solution activity" can be understood as activities incidental to the primary process or product that are merely a nominal or tangential addition to the claim. Extra-solution activity includes both pre-solution and post-solution activity. An example of pre-solution activity is a step of gathering data for use in a claimed process, e.g., a step of obtaining information about credit card transactions, which is recited as part of a claimed process of analyzing and manipulating the gathered information by a series of steps in order to detect whether the transactions were fraudulent...As explained by the Supreme Court, the addition of insignificant extra-solution activity does not amount to an inventive concept, particularly when the activity is well-understood or conventional. Parker v. Flook, 437 U.S. 584, 588-89, 198 USPQ 193, 196 (1978).” MEPE 2106.05(g) provides an example of “mere data gathering” as “performing clinical tests on individuals to obtain input for an equation, In re Grams, 888 F.2d 835, 839-40; 12 USPQ2d 1824, 1827-28 (Fed. Cir. 1989).”
The following prior art teaches it was well established in the field of technical expertise to assay for the presence of or amount of an antigen binding molecule to detect the expression or level of a peptide to diagnose cancer by using enzyme linked immunosorbent assays (ELISAs), enzyme linked immunospot assay (ELISpot), radioimmunoassays (RIA), radioimmune precipitation assays (RIPA), immunobead capture assays, and/or flow cytometry (Peter et al., 2017). Therefore, the additional elements are insignificant extra-solution activities well-known by an ordinary artisan as they amount to mere data gathering that is conventional in the art and does not integrate the judicial exception into a practical application (Step 2A, Prong Two: NO)
According to Step 2B, set forth in MPEP 2106.05, the claims are next evaluated as to whether any additional element, or combination of additional elements, in the claims are sufficient to ensure that the claim as a whole amounts to significantly more than the judicial exception. As stated above, Peter teaches the additional elements are well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality. Therefore, the additional elements amount to adding insignificant extra-solution activity to the judicial exception, as well as simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality because the claims require an unspecified binding molecule, to the judicial exception and do not amount to significantly more. (STEP 2B: NO)
Therefore, claims 13-14 are rejected.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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 1-2, 4, 6, and 9-14 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Yl et al., 2020 (WO2020160532A1) (see instant PTO-892).
The elected embodiment is drawn to an antigen binding molecule that selectively binds to Dickkpf-1 (DKK1) peptide P20 in the context of HLA-A2, comprising heavy chain CDRs as set forth in SEQ ID NOs: 25-27 and light chain CDRs as set forth in SEQ ID NOs: 28-30. The elected embodiment is drawn to the antigen binding molecule comprising a bi-specific antibody that also binds CD3. The elected embodiment is drawn to a hybridoma cell line expressing the antigen binding molecule. The elected embodiment is drawn to a method of treating a cancer in a subject comprising administering to the subject the antigen binding molecule. The elected embodiment is drawn to the cancer comprising pancreatic cancer, non-small cell lung carcinoma, bre-ast cancer, myeloma, or leukemia. The elected embodiment is drawn to a method of detecting a cancer in a subject comprising (a.) obtaining a tissue sample of a suspected cancerous tissue from the subject; and (b.) assaying for the presence or overexpression of DKK1 with the antigen binding molecule, wherein the presence of the DKK1 in the tissue sample not present in a negative control tissue sample or overexpression of the DKK1 in the tissue sample relative to a negative control tissue sample indicates the presence of a cancer in the subject. The elected embodiment is drawn to the presence of or amount of the antigen binding molecule is determined by enzyme linked immunosorbent assays (ELISAs), enzyme linked immunospot assay (ELISpot), radioimmunoassays (RIA), radioimmune precipitation assays (RIPA), immunobead capture assays, and/or flow cytometry. For the purpose of compact prosecution, “in the context of” will be interpreted to mean the peptide bound to HLA-A2.
Yl teaches a DKK1 peptide-loaded MHC-targeted antibody heavy chain CDR1 having the sequence set forth in SEQ ID NO: 2 (Db) that has 100% sequence identity to instant SEQ ID NO: 25 (Qy), as shown below.
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Yl teaches a DKK1 peptide-loaded MHC-targeted antibody heavy chain CDR2 having the sequence set forth in SEQ ID NO: 3 (Db) that has 100% sequence identity to instant SEQ ID NO: 26 (Qy), as shown below.
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Yl teaches a DKK1 peptide-loaded MHC-targeted antibody heavy chain CDR3 having the sequence set forth in SEQ ID NO: 4 (Db) that has 100% sequence identity to instant SEQ ID NO: 27 (Qy), as shown below.
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Yl teaches a DKK1 peptide-loaded MHC-targeted antibody light chain CDR1 having the sequence set forth in SEQ ID NO: 5 (Db) that has 100% sequence identity to instant SEQ ID NO: 28 (Qy), as shown below.
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Yl teaches a DKK1 peptide-loaded MHC-targeted antibody light chain CDR2 having the sequence set forth in SEQ ID NO: 6 (Db) that has 100% sequence identity to instant SEQ ID NO: 29 (Qy), as shown below.
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Yl teaches an DKK1 peptide-loaded MHC-targeted antibody light chain CDR3 having the sequence set forth in SEQ ID NO: 7 (Db) that has 100% sequence identity to instant SEQ ID NO: 30 (Qy), as shown below.
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Yl teaches an antigen binding molecule that selectively binds to Dickkpf-1 (DKK1) peptide P20 in the context of HLA-A2 (claims). Yl teaches the antigen binding molecule comprises a CAR T cell (para[00161-00162]). Yl teaches the antigen binding molecule can comprise a bi-specific antibody (claim 10 & 16; para[0011]) and bind to CD3 (para[0081, 00141-149, 00158, & 00161]). Yl teaches a hybridoma cell line expressing the antigen binding molecule (Example 1; claim 19; para[0012, 0037, 0039, 0049, 0059, 0064-0067, & 0072]). Yl teaches a method of treating a cancer in a subject comprising administering to the subject the antigen binding molecule, where the cancer is pancreatic cancer, lung cancer, breast cancer, or myeloma (claims; para[0013 & 00131]; examples). Yl teaches a method of detecting the presence of cell surface DKK1 peptide/HLA-A2 complexes on cancer cells, the method comprising contacting the cancer cells with a DKK1 peptide-loaded MHC-targeted antibody or antibody fragment (claims; para[0017-0018, 0024-0035]). Yl teaches the antibody binds specifically to cancer cells that express the DKK1 peptide/HLA-A2 complexes and not to cells that lack either the DKK1 peptide or HLA-A2 (negative controls), that this can be measured by various methods including ELISA and flow cytometry, and further used in diagnostic kits (examples, figures, & para[0037, 0061, & 00169-00181]).
Therefore, the claims are anticipated by the prior art.
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.
Claims 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over Yl et al., 2020 (WO2020160532A1), as applied to claims 1-2, 4, 6, and 9-14 above, in view of Lui et al., 2020 (see instant PTO-892).
Instant claims 1-2, 4, 6, and 9-14 are recited above. The elected embodiment of instant claims 3, 5, and 7-8 is drawn to a humanized antigen binding molecule that selectively binds to Dickkpf-1 (DKK1) peptide P20 in the context of HLA-A2, comprising heavy chain variable domain as set forth in SEQ ID NO: 22, light chain variable domain as set forth in SEQ ID NO: 24, and a Th9 polarized CAR T cell.
The teachings of Yl and how they meet the limitations of claims 1-2, 4, 6, and 9-14 are outlined above in the preceding rejection and are hereby incorporated. Yl further teaches that the antigen binding molecules can be humanized by using human framework and constant regions with the mouse CDRs, thereby altering the framework while leaving the CRDs intact (claim 14 & para[0011, 0039, 0049-0050, & 0060]). Yl teaches a DKK1 peptide-loaded MHC-targeted antibody heavy chain variable region having the sequence set forth in SEQ ID NO: 8 (Db) that has 23.7% sequence identity, and 91% local sequence identity, to instant SEQ ID NO: 22 (Qy), as shown below. Importantly, heavy chain CDRs 1-3 having sequence set forth in instant SEQ ID NOs: 25-27 are encompassed by SEQ ID NO: 8 (Db), having 100% sequence identity to SEQ ID NO: 8 (Db).
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Yl teaches a DKK1 peptide-loaded MHC-targeted antibody light chain variable region having the sequence set forth in SEQ ID NO: 9 (Db) that has 39.4% sequence identity, and 83.2% local sequence identity, to instant SEQ ID NO: 24 (Qy), as shown below. Importantly, light chain CDRs 1-3 having sequence set forth in instant SEQ ID NOs: 28-30 are encompassed by SEQ ID NO: 9 (Db), having 100% sequence identity to SEQ ID NO: 9 (Db).
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Yl does not explicitly teach the antigen binding molecule comprising a humanized antibody comprising 100% sequence identity to SEQ ID NO: 22 & 24 and a Th9 polarized CAR T cell.
Lui teaches that Th9 polarized CAR T cells have enhanced antitumor activity compared to non-Th9 polarized CAR T cells in the treatment of human cancers (abstract & introduction).
It would have been prima facie obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to arrive at the claimed invention from the disclosures of Yl and Lui. Both Yl and Lui teach compositions that are useful for the same purpose of treating cancer. Section 2144.06 of the MPEP provides guidance as to obviousness of art recognized equivalents for the same purpose. The court has held that it is obvious to combine two elements/compositions each of which is taught by the prior art to be useful for the same purpose. No specific teaching or suggestion is needed for combination – the idea of combining them flows logically from them having been individually taught in the prior art as useful for the same purpose. See In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). As such, it would be logical and obvious to combine Yl and Lui to make a more effective cancer treatment. But nevertheless, one with ordinary skill in the art would be motivated to make and use the claimed invention to make an improved cancer treatment because Lui teaches an improvement to Yl’s composition by Th9 polarizing the CAR T cell. The improvement being to enhance the anticancer activity of the composition by using a Th9 polarized CAR T cell instead of a nonpolarized CAR T cell. Furthermore, an ordinary artisan would find it obvious in view of Yl to alter and humanize the framework regions around the CDRs in the heavy and light chain variable regions so that the antigen binding molecules comprising the improved CAR T cell could be used to treat human patients. An ordinary artisan would be motivated to humanize the framework regions to use the antigen binding molecules in a human patient. An ordinary artisan would readily understand that as long as the CDRs are not changed, the framework around the CDRs can be altered, including to humanize the regions so the antigen binding molecule can be effectively used in a composition comprising a Th9 polarized CAR-T cell to optimize its anticancer activity in a human patient. The person of ordinary skill in the art would have had a reasonable expectation of success based on the disclosures of these prior art references. Thus, the claims do not contribute anything non-obvious over the prior art.
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 1-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 10 of Patent No. US12275781B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
Instant claims 1-2 and 4 recite an antigen binding molecule that selectively binds to Dickkpf-1 (DKK1) peptide P20 in the context of HLA-A2 with heavy chain CDRs 25-27 and light chain CDRs 28-30. Instant claims 11-12 recite a method of treating a cancer in a subject by administering the antigen binding molecule, where the cancer is pancreatic cancer, non-small cell lung carcinoma, breast cancer, myeloma, or leukemia.
Patented claim 1 recites a monoclonal antibody or antibody fragment, wherein the antibody or antibody fragment comprises: a heavy chain variable region (VH) comprising a VHCDR1 amino acid sequence of SEQ ID NO: 2, a VHCDR2 amino acid sequence of SEQ ID NO: 3, and a VHCDR3 amino acid sequence of SEQ ID NO: 4; and a light chain variable region (VL) comprising a VLCDR1 amino acid sequence of SEQ ID NO: 5, a VLCDR2 amino acid sequence of SEQ ID NO: 6, and a VLCDR3 amino acid sequence of SEQ ID NO: 7. Patented claim 10 recites a method of treating a patient having multiple myeloma, lymphoma, prostate, or breast cancer, and wherein the patient is positive for both DKK1 and HLA-A*0201, the method comprising administering an effective amount of an antibody or antibody fragment that targets a DKK1 peptide-loaded MHC, wherein the DKK1 peptide-loaded MHC antibody or antibody fragment comprises: a heavy chain variable region (VH) comprising a VHCDR1 amino acid sequence of SEQ ID NO: 2, a VHCDR2 amino acid sequence of SEQ ID NO: 3, and a VHCDR3 amino acid sequence of SEQ ID NO: 4; and a light chain variable region (VL) comprising a VLCDR1 amino acid sequence of SEQ ID NO: 5, a VLCDR2 amino acid sequence of SEQ ID NO: 6, and a VLCDR3 amino acid sequence of SEQ ID NO: 7.
The patented claims anticipate the antigen binding molecule and method recited in instant claims 1-2 and 4. Instant SEQ ID NOs: 25-27, which are the heavy chain CDRs 1-3, have 100% identical sequence identity to the patented heavy chain CDRs 1-3 as set forth in patented SEQ ID NOs: 2-5. The patented antibody and the antigen binding molecule of the instant claims have identical heavy and light chain CDRs. Heavy chain CDRs 1-3 of the antigen binding molecule, as set forth in instant SEQ ID NOs: 25-27, have 100% sequence identity to the heavy chain CDRs 1-3 of the patented antibody, as set forth in patented SEQ ID NOs: 2-4. Light chain CDRs 1-3 of the antigen binding molecule, as set forth in instant SEQ ID NOs: 28-30, have 100% sequence identity to the light chain CDRs 1-3 of the patented antibody, as set forth in patented SEQ ID NOs: 5-7. Therefore, the patented claims anticipate the instant claims by requiring the same CDRs and using the antigen binding molecule to treat myeloma and breast cancer. As instant claims 3 and 5-10 are dependent on claim 1, they are included in this rejection.
Conclusion
No claims are allowed.
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/JOSEPH D. CESARE/ Examiner, Art Unit 1675
/JEFFREY STUCKER/
Supervisory Patent Examiner, Art Unit 1675
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