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
Applicant's election with traverse of Group I, claims 1-9 in the reply filed on 06/08/2026 is acknowledged. The traversal is on the ground(s) that the three groups share a common technical feature of 'pertaining to targeting RPTPα'. This is not found persuasive because the technical feature of 'targeting RPTPα' is overly general. The three groups encompass different scopes of 'targeting RPTPα'. Group I is drawn to treating an autoimmune disease, specifically, with any RPTPα antagonist. Group II is drawn to treating any disease with a peptide that causes declustering of RPTPα. Group I's antagonist is drawn more broadly than a peptide, and so the scopes of Group I and Group II are different. Moreover, Group III is drawn to an antibody that binds to RPTPα. Group I, being drawn to any antagonist, and Group II, being drawn to any peptide that disrupts clustering of RPTPα, comprise different scopes than that of Group III. Therefore, groups I-III do not share a common technical feature and are drawn to different inventions. Examiner notes that Applicant also traverses on the grounds of MPEP §803, which is drawn to restriction in cases filed under 35 USC 111(a). The instant case is filed under 35 USC 371 and does not consider the independent and distinct analysis set forth in MPEP §803. See MPEP §823.
The requirement is still deemed proper and is therefore made FINAL.
Claims 10-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 06/08/2026.
Status of Claims
Claims 6, 8, and 9 were previously amended, in the amendment filed 1/19/2024. There are no claims added and no claims cancelled. Claims 1-18 are pending. Claims 10-18 are withdrawn. Claims 1-9 will be examined on the merits.
Priority
Provisional application 63/228,083 is acknowledged as disclosing the claimed invention and the effective filing date is 07/31/2021.
Information Disclosure Statement
The Information Disclosure Statements filed on 1/19/2024 and 2/25/2024 have been considered. Signed copies are enclosed.
Claim Rejections - 35 USC § 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.
Claim 9 is 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.
The term “RPTPα activity” in claim 9 is a relative term which renders the claim indefinite. The term “RPTPα activity” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Examiner was unable to find an explicit definition of RPTPα activity in the instant specification. It is unclear what activity the claim refers to; the enzymatic activity, the dimerization activity, or a downstream effect of RPTPα induced signaling. The instant specification does not describe any measurement of RPTPα activity. Therefore, one of ordinary skill in the art would be unable to determine the metes and bounds of the claim. For the purposes of applying prior art, RPTPα activity will include dimerization activity.
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 1-8 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by US 2017/0247469 A1, published 08/31/2017, hereinafter Bottini et al, as evidenced by the UCSD Thesis/Dissertation by Lee, 2019.
The instant claims are drawn to a method of treating an autoimmune disease comprising administering to a subject in need an effective amount of an RPTPα antagonist, wherein the antagonist reduces invasiveness or migration of the subject’s fibroblast-like synoviocytes (FLS), wherein the antagonist is an antibody that binds to the extracellular portion of RPTPα and inhibits dimerization, and wherein the autoimmune disease is an arthritis or selected from a larger group.
Bottini et al. teach a method of treating an autoimmune disease in a subject in need thereof, the method including administering to the subject an effective amount of a PTPRA antagonist in claim 1 and paragraph [0007]. PTPRA is an alternate term for RPTPα, as evidenced by Bottini et al. paragraph [0005] and the instant specification, paragraph [0081]. Therefore, claim 1 of Bottini et al. anticipates instant claim 1. Additionally, Bottini et al. recite in paragraph [0011], a method of decreasing invasiveness or migration of a fibroblast-like synoviocyte via treatment with a RPTPα antagonist, thereby anticipating claim 2. Paragraphs [0100] and [0119] and claim 2 of Bottini et al. recite that the antagonist is an anti-RPTPα antibody, anticipating claim 3. Paragraph [0120] and claim 3 of Bottini et al. recite the anti- RPTPα antibody is directed to an extracellular portion of RPTPα, anticipating claim 4. Claim 4 and paragraph [0121] of Bottini et al. recite that the antibody is an anti- RPTPα dimer inhibiting antibody, anticipating claim 5. Paragraphs [0110-0111] and claim 15 of Bottini et al. recite that the autoimmune disease being treated is arthritis or a fibroblast mediated disease, anticipating claim 6. Claim 16 and paragraph [0110] of Bottini et al. recite that the arthritis is rheumatoid, psoriatic, or osteoarthritis. Claim 17 and paragraph [0109] recite a list of diseases that include those of instant claim 8, anticipating instant claim 8.
Finally, instant claim 9 is drawn to a method of treating autoimmune disease by administering to a subject an RPTPα antagonist, wherein the subject comprises FLS comprising clustered RPTPα and increased RPTPα activity. As stated above, “RPTPα activity” is indefinite as it is not defined in the specification or the claim, and is interpreted as any of enzymatic activity, downstream signaling activity, or dimerization activity.
Paragraph [0113] of Bottini et al. recites that the subject presents with FLS that express high levels of PTPRA relative to a standard control. Paragraph [0115] of Bottini et al. recites that the method for decreasing expression of PTPRA in FLS, comprising administering any of the RPTPα antagonists, includes decreasing TNF, IL-1, and/or PDGF activity in the FLS, which are mediated by SRC. RPTPα is known in the art to activate SRC signaling by removing the phosphate from a negative-regulatory residue (see Bottini et al., paragraph [0213]). Increased SRC signaling, therefore, is an indicator of increased RPTPα activity. Bottini et al. show RPTPα impacts SRC signaling in rheumatoid arthritis FLS, indicating increased RPTPα activity in FLS (see Example 5, figures 3-4). Between this finding and the increased expression of RPTPα in RA FLS, Bottini et al. demonstrate increased RPTPα activity in RA FLS.
Additionally, Lee teaches high levels of dimerization in RA FLS (see page 12-14), as well as clustering of these dimers in ‘hot spots’, indicating increased levels of dimerization activity. Lee also shows high association of RPTPα with SRC (pages 15-18) and increased migration of cells with functional RPTPα as opposed to RPTPα mutants unable to dimerize as a standard control (pages 19-20). As migration is a known downstream effect of RPTPα (see Lee, page 2, and Bottini et al., paragraph [0214]), this is also a measure of RPTPα activity. Therefore, Lee shows that RA FLS have increased RPTPα activity and clustering of RPTPα, indicating that rheumatoid arthritis is an autoimmune disease wherein the subject comprises FLS comprising clustered RPTPα and increased RPTPα activity. As Bottini et al. teach administering the RPTPα antagonist to a subject with rheumatoid arthritis (see paragraph [0110], claim 16), Bottini et al. teach a method of treating an autoimmune disease comprising administering an RPTPα antagonist to a subject that comprises FLS comprising RPTPα clustering and increased RPTPα activity.
Therefore, Bottini et al. anticipates instant claims 1-9, as evidenced by Lee.
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, 2, and 6-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 10,604,585 in view of Stanford et al. (2016) Arthritis & Rheumatology 68(2):359-369.
The claims of '585 are drawn to a method of inhibiting RPTPα activity via use of an RPTPα antagonist, wherein the cell is a fibroblast-like synoviocyte. Stanford et al. teach that RPTPα mediates proinflammatory and proinvasive signaling in rheumatoid arthritis FLS, correlating with the promotion of disease progression (see abstract, whole document). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the invention of ‘585, for inhibiting RPTPα activity, and apply it to treating rheumatoid arthritis, an autoimmune disease. One would have a reasonable expectation of success because Stanford et al. show that inhibiting RPTPα with an antagonist like that disclosed by ‘585 results in decreased inflammatory cytokine secretion (figures 1, 4) and decreased invasion of FLS (figure 2). Therefore, it would have been obvious to use the method of ‘585 as a treatment for RA before the effective filing date, thereby rendering obvious claims 1, 2, and 6-8 of the instant application.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Su et al. (1999) Current Biology, 9(10), 505-511: Su et al. disclose an antibody that binds to the extracellular domain of RPTPα. This is the antibody used in the instant specification. As the antibody of Su has identical structure and function to that used in the instant specification, the antibody of Su therefore binds the same epitopes as that of the disclosed antibody. Therefore, the antibody of Su anticipates the antibody in the specification however, Su does not teach nor reasonably suggest treating an autoimmune disease.
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/AMELIA STEPHENS/Examiner, Art Unit 1645
/ANNE M. GUSSOW/Supervisory Patent Examiner, Art Unit 1683
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