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 .
Claims Status
Claim(s) 1-20 is/are currently pending and presented for examination on the merits.
Response to Amendment and Arguments
The objection(s) to claim(s) 3, the drawings, and/or the specification have been withdrawn in view of the Amendment filed on 30Jun2026.
The rejection(s) of claim(s) 1-20 under 35 U.S.C. § 112(a), and of claim(s) 7-8, 8-19 under 35 U.S.C. § 112(b) have been withdrawn in view of the recent claim amendment filed on 30Jun2026, which added new limitations to the claim(s) not previously considered, necessitating new rejection(s) and/or objection(s).
As all previously presented rejection(s) and/or objection(s) have been withdrawn, Applicant arguments are not addressed herein as they do not pertain to the new rejections.
New Rejections Necessitated by Claim Amendments
Claim Rejections - 35 USC § 112(b)
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 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.
Claim(s) 1-20 is/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(s) 1-20 recites the limitation "said anti-CD antibody" in line 8 of claim 1, line 5 of claim 14, and line 5 of claim 20. There is insufficient antecedent basis for this limitation in the claim. For the purposes of compact prosecution, the phrase is considered to read “said anti-CD6 antibody”. Claim(s) 1, 14, and 20 can overcome this rejection by amending the claims as recited above or to otherwise provide proper antecedent basis. Claim(s) 2-13, and 15-19 can overcome this rejection by amending claims 1 and 14 as recited above.
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.
Claim(s) 1-3, 5-6, 8-10, 14, 15-17, 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/362331 A1 (hereinafter “US331”), in view of Victor et al. (Annual Reports in Medicinal Chemistry, Vol 47, 2012, ps. 349-366; hereinafter “Victor”), as evidenced by Li et al. (Front. Pharmacol., 11Jul2017, Vol. 8, Article 460; hereinafter “Li”).
Regarding instant claim(s) 1-3, 5-6, 8, 14, 15-17, 19, US331 teaches a method of treating a T-cell mediated disease or disorder in a subject by administering to the subject a therapeutically effective amount of an anti-CD6 antibody [e.g., title, abstract; ¶ 0006]. US331 further teaches the disease is multiple sclerosis [e.g., ¶ 0005, 0008, 0052], and that the anti-CD6 antibody comprises a VH of SEQ ID NO: 23 and VL of SEQ ID NO: 25 [e.g., ¶ 0027-0028, 0136], which are the same as the instant-claimed anti-CD6 VH/VL of SEQ ID NOs: 27/29 (see alignments below). US331 teaches a composition comprising said antibody [e.g., ¶ 0054-0055].
Alignment of instant anti-CD6 ADC VH (SEQ ID NO: 27), with US331 (Anti-CD6 Fab6 clone antibody (VH6-hIgG1CH) amino acid sequence, SEQ 23):
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659
559
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Alignment of instant anti-CD6 ADC VL (SEQ ID NO: 29), with US331 (Anti-CD6 antibody (VL-hIgG1CH) amino acid sequence, SEQ 25):
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486
620
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Regarding instant claim(s) 9, US331 teaches the subject is human [e.g., ¶ 0006, 0033].
Regarding instant claim(s) 10, US331 teaches the dose depends on a variety of factors and that suitable doses can be from about 0.1 mg/kg to about 10.0 mg/kg [e.g., ¶ 0053, 0057].
US331 does not expressly teach that (1) the anti-CD6 antibody is an ADC comprising (a) MMAE or etoposide, and/or (b) a cleavable linker, or (2) that the anti-CD6 ADC is administered at about 0.1- 2 mg/kg.
Regarding claims 1-3, 5-6, 8-10, 14, 15-17, 19, Victor teaches ADCs for targeted anti-cancer therapies comprising an antibody conjugated to a cytotoxic molecule by a linker [e.g., pg. 350, ¶ 1]. Victor further teaches the cytotoxic agent MMAE conjugated to an antibody of choice by cleavable linker [e.g., pgs. 354-355; pg. 357, “4. Intracellular Catabolism of ADCs”]. Victor further etoposide as another ADC cytotoxic molecule [e.g., pg. 363, ¶ 2]. ADCs were mainstream therapeutics for autoimmune diseases at the time of filing, as evidenced by Li [e.g., pg. 8, col. 3, ¶ 2].
It would have been prima facie obvious to a person having ordinary skill in the art (PHOSITA) before the effective filing date of the claimed invention to combine the treatment of T-cell mediated disorders or diseases comprising administration of an anti-CD6 antibody as taught by US331, with the drug conjugates and linkers for antibodies as taught by Victor, to arrive at the instant method of treating a T cell mediated disorder comprising administration of an anti-CD6 ADC, wherein the drug conjugate is MMAE or etoposide, and/or the linker is cleavable. A PHOSITA would have been motivated to combine the method of treating a T cell mediated disorder comprising administration of an anti-CD6 antibody as taught by US331 with the drug conjugates and linkers for antibodies as taught by Victor, because US331 teaches anti-CD6 antibodies as T cell disorder therapeutics, disclosing autoimmune (see above) and cancer [e.g., ¶ 0065] as conditions treatable with anti-CD6 antibodies; Victor teaches the general principals and benefits of an ADC [e.g., “1. Introduction”], cytotoxic drugs for conjugation including MMAE and etoposide, and cleavable linkers (see above), and a skilled artisan would understand that ADCs were mainstream therapeutics for autoimmune diseases at the time of filing, as evidenced by Li. Further, while Victor discloses additional drug conjugates and linkers not recited herein, there are a limited number, it would also be obvious for a skilled artisan to try various combinations of drugs and/or linkers when developing an anti-CD6 ADC to determine which drug/linker combination(s) are optimal, which is well within the purview of those in the art. There would have been a reasonable expectation of success for a PHOSITA to combine the method of treating a T cell mediated disorder comprising administration of an anti-CD6 antibody as taught by US331 with the drug conjugates and linkers for antibodies as taught by Victor, because US331 teaches the anti-CD6 antibody for treatment of T cell mediated disorders (e.g., cancer, autoimmune), Victor teaches the benefits and construction of ADCs, and the use of ADCs was common in the art at the time of filing for cancer and autoimmune indications. This rationale aligns with the principles of applying a known technique to a known method to yield predictable results, and with choosing from a finite number of identified, predictable solutions with a reasonable expectation of success, supporting a conclusion of obviousness (see MPEP § 2143).
Further, it would have been obvious to a PHOSITA to modify the modified method of treating a T cell mediated disorder comprising administration of an anti-CD6 ADC as taught by US331 and Victor (see above) to include that the anti-CD6 ADC is administered at about 0.1- 2 mg/kg. The prior art does not specifically teach the instant dose range, however, US331 teaches that the dose depends on a variety of factors and that suitable doses can be from about 0.1 mg/kg to about 10.0 mg/kg (see above), which encompasses the instant claimed dose range. Further, in regard to the specific dosage amounts recited in the instant claims "[w]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), and see M.P.E.P. § 2144.05 II.A. Moreover, it is well settled that "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." In re Boesch, 617 F.2d 272,276, 205 USPQ 215, 219 (CCPA 1980). See also Merck & Co. v. Biocraft Labs. Inc., 874 F.2d 804,809, 10 USPQ2d 1843, 1847-48 (Fed. Cir. 1989). This because, as is made clear from the prior art, the determination of the dosage regimen of a known drug is well within the purview of one of ordinary skill in the art at the time the invention was made, and it would have been obvious to one of ordinary skill in the art at the time Applicants' invention was made to determine operable and/or optimal doses of treatment because optimal dose is an art-recognized result-effective variable which would have been routinely determined and optimized in the pharmaceutical art. Therefore, it would be conventional and within the skill of the art to identify the optimal dosages administered to achieve therapeutically effective doses. Further, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. It is clear that both the prior art and claimed method perform the same protocol to achieve the same results. It would be conventional and within the skill of the art to determine the optimal treatment regimens. Accordingly, one can see that the courts, over a period of over 50 years, have consistently held that treatment (i.e. dosage) optimization is obvious.
Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/362331 A1 (hereinafter “US331”) and Victor et al. (Annual Reports in Medicinal Chemistry, Vol 47, 2012, ps. 349-366; hereinafter “Victor”), as evidenced by Li et al. (Front. Pharmacol., 11Jul2017, Vol. 8, Article 460; hereinafter “Li”) as applied to claim(s) 1 above, and further in view of Zhang et al. (Journal of Autoimmunity 90 (2018) 84-93; hereinafter “Zhang”).
The teachings of US331 and Victor as recited above are applied.
US331 does not expressly teach that the T cell mediated disorder is autoimmune uveitis.
Regarding instant claim 4, Zhang teaches CD6 as a target for treating T cell mediated diseases, and specifically that CD6 targeted therapies are promising for the treatment of autoimmune uveitis [e.g., title, abstract].
Further, it would have been obvious to a PHOSITA to modify the modified method of treating a T cell mediated disorder comprising administration of an anti-CD6 ADC as taught by US331 and Victor (see above) to include the treatment of the T-cell mediated disorder autoimmune uveitis, as taught by Zhang, because US331 and Vitor teach the based method for treating T cell mediated disorders comprising administration of an anti-CD6 ADC, and Zhang teaches that autoimmune uveitis is a T cell mediated disorder and that CD6 directed therapies (e.g., an anti-CD6 ADC) are a promising therapy for autoimmune uveitis. There is an expectation of success for a PHOPSITA to include the treatment of autoimmune uveitis taught by Zhang (see above) as a target indication in the method of treating T cell mediated disorder comprising anti-CD6 ADC administration as taught by US331 and Victor (see above), because US331 and Victor teach a method of treating T cell mediated disorders comprising administration of an anti-CD6 ADC, and Zhang teaches CD6 directed therapy is promising for the T cell mediated disorder autoimmune uveitis. This rationale aligns with the principle of applying a known technique to a known method to yield predictable results, supporting a conclusion of obviousness, supporting a conclusion of obviousness (see MPEP § 2143).
Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
Claim(s) 11-13, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/362331 A1 (hereinafter “US331”) and Victor et al. (Annual Reports in Medicinal Chemistry, Vol 47, 2012, ps. 349-366; hereinafter “Victor”), as evidenced by Li et al. (Front. Pharmacol., 11Jul2017, Vol. 8, Article 460; hereinafter “Li”) as applied to claim(s) 1 above, and further in view of Consuegra-Fernández et al. (Autoimmunity Reviews 17 (2018) 493-503; hereinafter “Consuegra-Fernández”).
The teachings of US331 and Victor as recited above are applied.
US331 does not expressly teach that the treatment of T-cell lymphoma or B-cell lymphoma.
Regarding instant claims 11-13, Consuegra-Fernández teaches clinical and experimental evidence for targeting CD6 in immune-based disorders [e.g., title, abstract], and that CD6 is expressed on Mantle Cell Lymphoma [e.g., pg. 494, col. 2, “2.2…”, ¶ 3] and T cell lymphoma [e.g., pg. 499, col. 2, “3.2.2…”, ¶ 1]. Regarding instant claim 20, Consuegra-Fernández further teaches an in vitro studies (e.g., an in vitro system) comprising an anti-CD6 antibody and leukemic cells (e.g., T cells or B cells) [e.g., pg. 499, col. 2, “3.2.2…”, ¶ 2].
Further, it would have been obvious to a PHOSITA to modify the modified method of treating a T cell mediated disorder comprising administration of an anti-CD6 ADC as taught by US331 and Victor (see above) to include the treatment of the T-cell lymphoma (TCL) and/or Mantle Cell Lymphoma (MCL) as taught by Consuegra-Fernández, because US331 and Vitor teach the based method for treating T cell mediated disorders comprising administration of an anti-CD6 ADC, and Consuegra-Fernández teaches that CD6 is expressed on TCL cells (e.g., a T cell mediated disorder) and MCL cells (see above for details). There is an expectation of success for a PHOPSITA to include the treatment of TCL and/or MCL as taught by Consuegra-Fernández (see above) as target indication(s) in the method of treating T cell mediated disorder comprising anti-CD6 ADC administration as taught by US331 and Victor (see above), because US331 and Victor teach a method of treating T cell mediated disorders comprising administration of an anti-CD6 ADC, and Consuegra-Fernández teaches CD6 is expressed on TCL and MCL cells. This rationale aligns with the principle of applying a known technique to a known method to yield predictable results, supporting a conclusion of obviousness, supporting a conclusion of obviousness (see MPEP § 2143).
Further, it would have been obvious to a PHOSITA to make an in vitro assay for testing the anti-CD6 ADC of the modified comprising administration of an anti-CD6 ADC to treat TCL and/or MCL as taught by US331, Victor, and Consuegra-Fernández (see above), to arrive at an in vitro system comprising an anti-CD6 ADC and TCL or MCL (e.g., a subtype of B cell lymphoma) target cells, as in vitro drug candidate (e.g., anti-CD6 ADC) testing against target indications (e.g., TCL, MCL, etc.) is a common practice in the art, as evidenced by the teachings of Consuegra-Fernández (see above). A PHOSITA would understand the benefits of in vitro drug candidate (e.g., anti-CD6 ADC) testing include but are not limited to being more cost and time efficient than animal testing for screening drug candidate(s) against target indication(s). There is an expectation of success for a PHOPSITA to make an in vitro assay for testing the anti-CD6 ADC of the modified comprising administration of an anti-CD6 ADC to treat TCL and/or MCL as taught by US331, Victor, and Consuegra-Fernández (see above), as in vitro drug candidate testing against target cells is a common practice in the art, as evidenced by the teachings of Consuegra-Fernández. This rationale aligns with the principle of applying a known technique to a known method to yield predictable results, supporting a conclusion of obviousness, supporting a conclusion of obviousness (see MPEP § 2143).
Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
Free From the Prior Art
During the course of examination, the anti-CD6 antibody drug conjugate (ADC) and antigen binding fragment(s) thereof comprising (1) a VH/VL of SEQ ID NOs: 1/2; (2) a VH/VL of SEQ ID NOs: 3/4; (3) a VH/VL of SEQ ID NOs: 5/6; (4) a VH/VL of SEQ ID NOs: 7/8; (5) a VH/VL of SEQ ID NOs: 9/10; (6) a VH/VL of SEQ ID NOs: 11/12; (7) a VH/VL of SEQ ID NOs: 13/14; or (8) a VH/VL of SEQ ID NOs: 15/16, were found to nonobvious in view of the closest prior art (summary table provided below for ease of review). Briefly, a sequence search of the prior art returned no 100% sequence identity matches to any of the instant claimed VL sequences, and therefore cannot return any 100% matches to any of the instant claimed VH/VL pairs (see closest prior art alignments below).
Anti-CD6 antibody VH/VL pairs:
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150
400
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Alignment of anti-CD6 ACD VL (SEQ ID NO: 2) with US2017362331-A1 (Anti-CD6 mouse humanized antibody (Fab2) light chain, SEQ ID 2):
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230
614
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Alignment of anti-CD6 ACD VL (SEQ ID NO: 4) with US2017362331-A1 (Anti-CD6 mouse humanized antibody mutant VL, SEQ ID 13):
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228
616
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Alignment of anti-CD6 ACD VL (SEQ ID NO: 6) with US2017362331-A1 (Anti-CD6 mouse humanized antibody (Fab2) light chain, SEQ ID 2):
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238
621
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Alignment of anti-CD6 ACD VL (SEQ ID NO: 8) with US2017362331-A1 (Anti-CD6 mouse humanized antibody (Fab2) light chain, SEQ ID 2):
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235
622
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Alignment of anti-CD6 ACD VL (SEQ ID NO: 10) with US2017362331-A1 (Anti-CD6 mouse humanized antibody (Fab2) light chain, SEQ ID 2):
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233
626
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Alignment of anti-CD6 ACD VL (SEQ ID NO: 12) with US2017362331-A1 (Anti-CD6 mouse humanized antibody (Fab2) light chain, SEQ ID 2):
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235
619
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Alignment of anti-CD6 ACD VL (SEQ ID NO: 14) with US2017362331-A1 (Anti-CD6 mouse humanized antibody (Fab2) light chain, SEQ ID 2):
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234
617
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Alignment of anti-CD6 ACD VL (SEQ ID NO: 16) with US2017362331-A1 (Anti-CD6 mouse humanized antibody (Fab2) light chain, SEQ ID 2):
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236
617
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Conclusion
No claims are currently allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY M CHATTIN whose telephone number is (571)270-0646. The examiner can normally be reached T-F 0600-1600 PST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Julie Wu can be reached at (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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/AMY M. CHATTIN/Examiner, Art Unit 1643
/GARY B NICKOL/Primary Examiner, Art Unit 1643
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