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
Election/Restrictions
Applicant’s election of group 1 (claims 85-89) in the reply filed on 12/17/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1-84 have been cancelled.
Claims 85-89 are pending and examined for a composition comprising antibody binding to a polypeptide encoding by cancer stem cell (CSC) associated gene (PD-1) expressed on ABCB5+ CSC cell, are examined on merits.
Information Disclosure Statement
The information disclosure statement (s) (IDS) submitted on 5/23/2023 and 12/17/2025 are/is considered by the examiner and initialed copies/copy of the PTO-1449 are/is enclosed.
Claim Objections
Claim 88 is objected to for typographical error as:
The composition of claim 85, wherein therapeutic agent is a chemotherapeutic agent”
Amending the claim to “
The composition of claim 85, wherein the therapeutic agent is a chemotherapeutic agent”
would obviate this objective. Appropriate correction is required.
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)(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.
Claim(s) 85-89 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Korman et al (WO2006121168 published Nov 2006, and its national stage application publication US20090217401, filed May 2006, for text presentation).
Korman et al teach a monoclonal antibody specifically binding to PD-1 and pharmaceutical composition comprising thereof, wherein the antibody is human, humanized, or chimeric antibodies which are produced in varies methods including in HuMab mouse (Medarex) and the antibodies are conjugated with chemotherapeutic agent or radioactive isotope including Iodine131, lutetium 177 etc. (abstract, pages 19- 22: section producing antibody and immunoconjugate). Korman et al also teach in vivo tumor models of the anti-PD-1 antibody or antibody conjugate on inhibiting tumor cell growth (examples 10-12 and figures 20-25).
Without contrary in the field, the anti-PD-1 antibodies disclosed by Korman et al would bind to polypeptide PD-1 encoded by CSC-associated gene expressed on an ABCB5+ (ATP-binding cassette sub-family B member 5) cancer stem cell (CSC) and inhibit the activity of ABCB5+ CSC because polypeptides encoded by the PD-1 gene in immune T cells and an ABCB5+ CSC cell (intrinsic PD-1) are considered having the same structure.
Alternatively, regarding this limitation of the polypeptide encoding by a Cancer Stem Cells (CSC)- associated gene (PD-1) expressed on an ABCB5+ CSC set forth in claim 85, the Office does not have the facilities and resources to provide the factual evidence needed in order to establish that the product of the prior art does not possess the same material, structural and functional characteristics of the claimed product. In the absence of evidence to the contrary, the burden is on the applicant to prove that the claimed product is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
The Office has shown a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not" (In re Spada; MPEP 2112.01(I)), Thus, the burden has been shifted to applicant to prove that the product of the prior art does not have the characteristics as-claimed ('characteristics' meaning physical or functional characteristics).
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 of this title, 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 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.
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Claims 85-89 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wong et al (International Immunology 19:1223-1234, 2007) or Thompson et al (Clin Cancer Res 23:1757-1761, March 2007) in view of Reuter et al (US20010055751, published Dec 2001) or Korman et al (WO2006121168 published Nov 2006, and its national stage application publication US20090217401, filed May 2006 for text presentation).
Wong et al teach fully human anti-PD-1 antibody binding to human PD-1, wherein the antibody is produced from mice with human Ig loci transgene (page 1224, method). Wong et al teach that the PD-1 antibody has function of human vaccine-induced CD8+ T cells specific for the melanoma-associated antigens glycoprotein and melanoma antigen recognized by T cell (abstract). The human antibody would bind to polypeptide PD-1 encoded by a CSC-associated gene expressed on a human ABCB5+ (ATP-binding cassette sub-family B member 5) cancer stem cell (CSC) and inhibit the activity of ABCB5+ CSC because polypeptides encoded by the PD-1 gene in immune T cells and an ABCB5+ CSC cell (intrinsic PD-1) are considered having the same structure.
Thompson et al teach anti-PD-1 antibody binding to PD-1 expressed in human renal cell carcinoma (RCC) (page 1758, left col). Thompson et al teach also teach that PD-1 protein expressed by tumor infiltrated immune cells and associated with poor outcome for the patient with Renal cell carcinoma (entire document). The antibody would bind to polypeptide PD-1 encoded by CSC-associated gene expressed on a human ABCB5+ (ATP-binding cassette sub-family B member 5) cancer stem cell (CSC) and inhibit the activity of ABCB5+ CSC because polypeptides encoded by the PD-1 gene in immune T cells and an ABCB5+ CSC cell (intrinsic PD-1) are considered having the same structure.
Wong and Thompson et al do not teach the antibody being conjugated to a therapeutic agent including chemotherapeutic agent or a toxin including radioisotope.
Reuter et al teach antibody conjugate, comprising an antibody linked to a chemotherapeutic agent and radioisotope including 131I, 90Y, 186Re etc. for cancer therapy ([0145, 0298] and claims 17+). Reuter et al also teach the antibody being antigen binding fragment comprising Fab, Fv scFv etc (claim 15).
Korman et al also teach antibody conjugate comprising anti-PD-1 antibody conjugate as set forth above.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention was made to combine the teachings to make a composition comprising an anti-PD-1 antibody conjugate binding to the PD-1 encoded by a gene expressed on ABCG5+ CSC with expected result. In order to benefit the treatment for cancers including RCC and melanoma, one of ordinary skill in the art before the effective filing date of was made would have been motivated with reasonable expectation of success to combine the teachings to form a PD-1 antibody conjugate in pharmaceutical composition because Wong and Thompson et al have shown anti-PD-1 antibodies and its function of restoring cytotoxic T cell activity toward to a cancer cell growth and Korman et al have shown anti-PD-1 antibody and conjugate as well as in vivo model of inhibitory function for cancer cell growth. One of ordinary skill in the art at the time the invention was made would have had a reasonable expectation of success for combining the teachings to form a composition comprising anti-PD-1 antibody conjugate because Wong and Thompson et al have shown anti-PD-1 antibody and Reuter et al have shown method of forming antibody conjugate with chemotherapeutic agent and radioisotope to increase effectiveness of cancer therapy. Therefore, the references in combination teach every limitation of the claims and the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention was made, absent unexpected results.
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.
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 (MPEP 9th Ed, Feb 2023).
An obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claim not is patentably distinct from the reference claim(s) because the examined 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).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Over Patents
1. Claims 85-89 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 10,316085 (‘085, original application 14/868126). Although the conflicting claims are not identical, they are not patentably distinct from each other because the patent claims a method of using the same material that is claimed in the instant application. The claims of the patent would anticipate and be obvious on the presently claimed invention.
The instant claims are drawn to
A composition comprising: an antibody or antigen binding fragment thereof that selectively binds to a polypeptide encoded by a CSC-associated gene expressed on an ABCB5+ cancer stem cell, wherein the CSC- associated gene is Programmed Death-1 (PD-1), wherein the antibody or antigen binding fragment is conjugated to a therapeutic agent selected from: a toxin and a chemotherapeutic agent, wherein the composition inhibits the activity of the ABCB5+ cancer stem cell,
wherein the toxin is a radioisotope.
wherein therapeutic agent is a chemotherapeutic agent.
The claims of ‘085 patent are drawn to
A method of treating melanoma in an individual, comprising: isolating an ATP binding cassette subfamily B member 5 (ABCB5)+ stem cell sample from the individual having melanoma, determining an expression level of a cancer stem cell (CSC)-associated gene in the ABCB5+ stem cell sample of an individual, wherein the CSC-associated gene is programmed cell death protein 1 (PD-1); comparing the expression level of the CSC-associated gene to a reference value and administering to the individual a PD-1 antibody, wherein the PD-1 antibody binds to PD-1 on the surface of the ABCB5+ cancer stem cell and inhibits ABCB5+ cancer stem cell activity in order to treat the cancer based on a higher level of PD-1 expression in the ABCB5+ stem cell relative to expression levels in a ABCB5 (−) cancer bulk populations.
wherein the determining step comprises detecting in the ABCB5+ stem cell sample a mRNA that is encoded by the CSC-associated gene.
wherein the determining step comprises detecting in the ABCB5+ stem cell sample a polypeptide that is encoded by the CSC-associated gene.
Both sets of the claims encompass anti-PD-1 antibody in a composition or a method of using. They are not patentably distinct from each other because the patent ‘085 claims a method of using the same material that is claimed in the instant application. The product used in the method claimed in the ‘085 patent would anticipate and be obvious on the product claimed in the present application.
The patent ‘085 (original application 14/868126) is a continuation application of the present application. However, there is no restriction issued in the process of examining the original application. Therefore, the ODP is made and a terminal disclaimer should be filed to overcome the rejection.
2. Claims 85-89 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,542,328 (‘328, original application 16/435,929). Although the conflicting claims are not identical, they are not patentably distinct from each other because the patent claims a method of using the same material that is claimed in the instant application. The claims of the patent would anticipate and be obvious on the presently claimed invention.
The instant claims are set forth above
The claims ‘328 are drawn to
A method for treating an individual having, cancer, comprising: administering a therapeutically effective amount of a composition that targets a polypeptide encoded by a CSC-associated gene, wherein the composition is an isolated molecule that selectively binds to the polypeptide that is encoded by a CSC-associated gene and expressed on an ABCB5+ cancer stem cell of the individual, wherein the CSC-associated gene is Programmed Death-1 (PD-1), wherein the isolated molecule is conjugated to a therapeutic agent, and, wherein the isolated molecule is an antibody or antigen binding fragment, wherein the composition inhibits the activity of the ABCB5+ cancer stem cell, and wherein the cancer is a melanoma.
wherein the therapeutic agent is selected from: a toxin and a chemotherapeutic agent.
wherein the toxin is a radioisotope……
Both sets of the claims encompass anti-PD-1 antibody in a composition or a method of using. They are not patentably distinct from each other because the patent ‘328 claims a method of using the same material that is claimed in the instant application. The product used in the method claimed in the ‘328 patent would anticipate and be obvious on the product claimed in the present application.
Applicant is noted that the instant application was filed as a continuation of the original application 16/435,929 patented with US Patent No. 11,542,328, in the process of examination, Election/Restriction was issued on 7/28/2021 between product (molecule, antibody binding to a peptide) and method of using. If applicant changes the instant application status from continuation to divisional application, the rejection would be reconsidered.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lei Yao, whose telephone number is (571) 272-3112. The examiner can normally be reached on 8:00am-6:00pm Monday-Friday.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis, can be reached on (571) 270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LEI YAO/Primary Examiner, Art Unit 1642