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 .
Claim Status
Claims 3-5, and 28 are pending.
Claims 3-5, and 28 are currently amended and claims 3-4 are rejoined as a result of claim amendment.
Claims 1-2, 6-27, and 29-31 are cancelled.
Claims 3-5, and 28 have been examined.
Priority
This application is a 371 of PCT/IB2019/059873 11/18/2019, which claims foreign priority of INDIA 201821043455 filed on 11/19/2018 and INDIA 201821022667 filed on 12/18/2018.
New Ground of Objection and Rejection
Claim Objections
Claims 3-5 and 28 are objected to because of the following informalities:
Applicant is advised that should claim 3 be found allowable, claim 4 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
The examiner’s suggestion may overcome objection (not 112(d) rejection) is shown as follows:
Suggestion of amendment to claims 3:
The method of claim 5, wherein the recombinant lectin protein and gemcitabine are administered simultaneously, separately or sequentially.
Suggestion of amendment to claims 4:
The method of claim 5, wherein the recombinant lectin protein and gemcitabine are administered simultaneously, separately or sequentially.
Suggestion of amendment to claims 5 and 28:
Claim 5: A method of treating bladder cancer in a subject in need thereof, wherein the method comprises administering to the subject a combination comprising a recombinant lectin protein derived from Sclerotium rolfsii and gemcitabine, wherein gemcitabine is administered at a concentration of 1-300 µM, wherein the recombinant lectin protein comprises the amino acid sequence of SEQ ID NO: 1 and is administered at a concentration of 2.5-80 µg/mL, and wherein the recombinant lectin protein and gemcitabine are administered simultaneously, separately or sequentially.
Claim 28: The method of claim 5, wherein the recombinant lectin protein and gemcitabine are in a pharmaceutical composition comprising one or more pharmaceutically acceptable excipients.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 3-4 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 3-4 fail to include all the limitations in claim 5. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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 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 3-5 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Theodorescu et al. (WO 2008/027912 A2, previously cited 7/25/2024) in view of Yu (Glycoconj J (2007) 24:411-420, previously cited 7/25/2024) and Swamy et al. (WO 2010/095143 A2, previously cited 7/25/2024).
Claim 5 is drawn to a combination therapy comprising administering a combination comprising (i) a recombinant lectin protein derived from of Sclerotium rolfsii lectin of SEO ID NO: 1 at a dose of 2.5-80 μg/mL and (ii) 1-300 μM of Gemcitabine simultaneously, separately or sequentially for the treatment of bladder cancer; and
wherein Gemcitabine is administered simultaneously, separately or sequentially for the treatment of bladder cancer.
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Theodorescu et al. teach administration of Gemcitabine to treat bladder cancer cells SW1710 and UMUC9 [0020] shown in Fig 6A as follows. Theodorescu et al. teach in clinical practice, combination treatments significantly outperform single drug counterparts in treating different types of cancer, either by additive or synergistic drug action [00199]. Theodorescu et al. further suggest the effective amount of Gemcitabine can be optimized among 0.001, 0.01, 0.1, 1, 10, 100 μM [00140] in a combination therapy, reading on the limitation (ii). Theodorescu et al. further teach a combination of drugs administered simultaneously to treat cancer cells [00196], reading on the wherein clause.
Theodorescu et al. do not teach a combination comprising Gemcitabine and 2.5-80 μg/mL of the instant SEQ ID NO: 1.
Yu teaches the oncofetal Thomsen–Friedenreich carbohydrate antigen (Galβ1-3GalNAcα1-Ser/Thr TF or T antigen) is a pan-carcinoma antigen highly expressed by about 90% of all human carcinomas (Abstract) comprising colon, breast, bladder, prostate, liver, ovary cancers known in the art (p411, col 2, para 2). Consistently, Swamy et al. teach changing in carbohydrate structures on the cell surfaces are a hallmark during cancer. Such changes results in exposure of tumor associated carbohydrate structures. Amongst them, is the increased occurrence of Thomsen-Friedenreich (TF) antigen, a disaccharide Galβ1-3GalNAcα1-Ser/Thr known in the art (p1, line 22-25). Swamy et al. teach Sclerotium rolfsii lectin (SRL) purified from Sclerotium rolfsii specifically binds to oncofetal antigen, a disaccharide Galβ1-3GalNAc α ser/thr expressed on cell surfaces in different cancers (p2, 18-22). Swamy et al. teach a recombinant lectin of SEQ ID NO: 2 derived from Sclerotium rolfsii lectin, SRL, (p3, line 3-10) with 100% identity to the instant SEQ ID NO: 1 shown as follows. Swamy et al. show a
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recombinant lectin at 25 µg/ml able to kill cancer cells (p2, line 25-28; p16, Table 2). Because (i) an oncofetal Thomsen–Friedenreich carbohydrate antigen is expressed by bladder cancers known in the art (See Yu, p411, col 2, para 2 and Swamy et al. p1, line 22-25) and (ii) Swamy et al. suggest a recombinant lectin protein of SEQ ID NO: 2 derived from Sclerotium rolfsii lectin, SRL, (p3, line 3-10) at 25 µg/ml able to kill cancer cells expressing Thomsen–Friedenreich carbohydrate antigen (p2, line 25-28; p16, Table 2), one or ordinary skill in the art would have found it obvious to beneficially combine Theodorescu’s Gemcitabine and Swamy’s a recombinant lectin of SEQ ID NO: 2 for the same purpose of treating a bladder cancer expressing Thomsen-Friedenreich (TF) antigen of a disaccharide Galβ1-3GalNAcα1-Ser/Thr, reading on the limitation (i).
One of ordinary skill in the art before the effective filing date of this invention would have found it obvious to combine (i) Theodorescu’s Gemcitabine with (ii) a recombinant lectin protein derived from Sclerotium rolfsii taught by Yu and Swamy because (a) Theodorescu et al. show a subset of bladder cancer cells intrinsically are resistant to Gemcitabine (Fig 7C) and suggest a combination treatments significantly outperform single drug counterparts in treating different types of cancer with synergistic drug action [00199], (b) Yu teaches the oncofetal Thomsen–Friedenreich carbohydrate antigen (Galβ1-3GalNAcα1-Ser/Thr TF or T antigen) is a pan-carcinoma antigen highly expressed by about 90% of all human carcinomas (Abstract) comprising colon, breast, bladder, prostate, liver, ovary cancers known in the art (p411, col 2, para 2), and (c) Swamy et al. teach Sclerotium rolfsii lectin (SRL) purified from Sclerotium rolfsii specifically binds to oncofetal antigen, a disaccharide Galβ1-3GalNAc α ser/thr expressed on cell surfaces in different cancers (p2, 18-22; p16, Table 2) resulting in antiproliferation and/or apoptosis in Thomsen–Friedenreich carbohydrate antigen (Galβ1-3GalNAcα1-Ser/Thr TF or T antigen) cancer cells (p2, 25-28). The combination would have reasonable expectation of success because Theodorescu et al. suggest a beneficial combination treatments significantly outperform single drug counterparts in treating bladder cancer and other types of cancers with synergistic drug action [00199].
With respect to claims 3-4, Theodorescu et al. in view of Yu and Swamy et al. the limitations in claims 3-4. See the rejection of claim 5 described above not repeated here.
With respect to claim 28, Theodorescu et al. teach anticancer compounds formulated in a pharmaceutical composition with a pharmaceutically acceptable carrier such as water or sterile isotonic saline as well as one or more additional ingredients including suspending, stabilizing, or dispersing agents, reading on pharmaceutically acceptable excipients [0089].
Applicant’s Arguments
None of the cited publications discloses combining Sclerotium rolfsii-derived lectin protein SEQ ID NO: 1 with Gemcitabine (Remarks, p5, para 1-5).
Table 24 of the present application demonstrates that the claimed ranges of both lectin protein and Gemcitabine are critical to achieving the synergistic results achieved by the invention. Evidence of unexpected results can overcome prima facie case of obviousness (Remarks, p6, para (Remarks, p5, last para to p6, whole page).
Response to Arguments
Applicant's arguments filed 11/20/2025 have been fully considered but they are not persuasive for the reasons as follows.
Applicant’s argument (i) is nor persuasive because applicant argues the cited references individually whereas the rejection is based on the combination of cited references.
In particular, Theodorescu et al. suggest a beneficial combination treatments significantly outperform single drug counterparts in treating bladder cancer and other types of cancers with synergistic drug action [00199]. One or ordinary skill in the art would have found it obvious to beneficially combine Theodorescu’s Gemcitabine and Swamy’s a recombinant lectin of SEQ ID NO: 2 for the same purpose of treating a bladder cancer expressing Thomsen-Friedenreich (TF) antigen of a disaccharide Galβ1-3GalNAcα1-Ser/Thr described above not repeated here. It is noted that one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091,231 USPQ 375 (Fed. Cir. 1986).
Applicant’s argument (ii) is nor persuasive because (a)it is expected to beneficially combine Gemcitabine at a dosage range between 0.1-100 μM (Theodorescu et al. 00140) with Swamy’s recombinant lectin of SEQ ID NO: 2 (p3, line 3-10) for the same purpose of treating bladder cancer by Theodorescu teaching that combination treatments significantly outperform single drug counterparts in treating bladder cancer and other types of cancers with synergistic drug action [00199] and (b) Theodorescu’s drug for combination with Gemcitabine is not limited to a particular drug of Cisplatin as argued by applicant. The evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992). See MPEP. 716.02(b).
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 3-5 and 28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,291,733 B2 (the ‘733 patent) in view of Theodorescu et al. (WO 2008/027912 A2, previously cited 7/25/2024) in view of Yu (Glycoconj J (2007) 24:411-420, previously cited 7/25/2024) and Swamy et al. (WO 2010/095143 A2, previously cited 7/25/2024, previously cited 7/25/2024).
Claim 1 of the ‘733 patent disclosed a recombinant lectin protein of SEQ ID NO: 1 with 100% identity to this instant SEQ ID NO: 1.
Claim 1 of the ‘733 patent did not teach administration of the recombinant lectin protein of SEQ ID NO: 1 in a combination to treat bladder cancer.
The relevancy of Theodorescu et al. in view of Yu and Swamy et al. teach a beneficial combination of Gemcitabine and the recombinant lectin protein of SEQ ID NO: 1 to treat bladder cancer as applied to claims 3-5 and 28 described above not repeated here.
Because Theodorescu et al. in view of Yu and Swamy et al. suggest a combination of Gemcitabine and the recombinant lectin protein of SEQ ID NO: 1 (disclosed in claim 1 of the ‘733 patent) to treat bladder cancer with synergistic effect, one of ordinary skill in the art would have found it obvious to beneficially combine claim 1 of the ‘733 patent with Theodorescu et al. in view of Yu and Swamy et al.
Thus, claim 1 of the ‘733 patent in view of Theodorescu et al., Yu and Swamy et al. are obvious to the instant claims 3-5 and 28.
Response to Arguments
Applicant's arguments filed 11/20/2025 have been fully considered but they are not persuasive. See response to arguments above.
Claims 3-5 and 28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 17,623,748 (the ‘748 application, 9/22/2025; NOA mailed 11/13/2025) in view of Theodorescu et al. (WO 2008/027912 A2, previously cited 7/25/2024) in view of Yu (Glycoconj J (2007) 24:411-420, previously cited 7/25/2024) and Swamy et al. (WO 2010/095143 A2, previously cited 7/25/2024, previously cited 7/25/2024).
Claim 1 of the ‘748 application disclosed a recombinant lectin protein of SEQ ID NO: 1 with 100% identity to this instant SEQ ID NO: 1.
Claim 1 of the ‘748 application disclosed a pharmaceutical composition comprising a recombinant lectin protein comprising the instant Seq ID NO: 1 derived from Sclerotium rolfsii lectin and pharmaceutically acceptable excipients.
Claim 1 of the ‘748 application did not teach administration of the recombinant lectin protein of SEQ ID NO: 1 in a combination therapy to treat bladder cancer.
The relevancy of Theodorescu et al. in view of Yu and Swamy et al. teach a beneficial combination of Gemcitabine and the recombinant lectin protein of SEQ ID NO: 1 to treat bladder cancer as applied to claims 3-5 and 28 described above not repeated here.
Because Theodorescu et al. in view of Yu and Swamy et al. suggest a combination of Gemcitabine and the recombinant lectin protein of SEQ ID NO: 1 (disclosed in claim 1 of the ‘748 application) to treat bladder cancer with synergistic effect, one of ordinary skill in the art would have found it obvious to beneficially combine claim 1 of the ‘748 application with Theodorescu et al. in view of Yu and Swamy et al.
Thus, claim 1 of the ‘748 application in view of Theodorescu et al., Yu and Swamy et al. are obvious to the instant claims 3-5 and 28.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 11/20/2025 have been fully considered but they are not persuasive. See response to arguments above.
Claims 3-5 and 28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10-11, and 29 of copending Application No. 17,923,732 (the ‘732 application, 11/7/2022) in view of Theodorescu et al. (WO 2008/027912 A2, previously cited 7/25/2024) in view of Yu (Glycoconj J (2007) 24:411-420, previously cited 7/25/2024) and Swamy et al. (WO 2010/095143 A2, previously cited 7/25/2024, previously cited 7/25/2024).
Claim 1 of the ‘732 application disclosed administration of a recombinant lectin to treat cancer by inducing apoptosis.
Claim 10 of the ‘732 application disclosed the recombinant lectin protein as SEQ ID NO; 2 with 100% homology to the instant SEQ ID NO: 1.
Claim 11 of the ‘732 application disclosed a range of effective dosage from 0.1 μg/mL to about 200 μg/mL.
Claim 29 of the ‘732 application disclosed a pharmaceutically composition comprising a recombinant lectin protein and a pharmaceutically acceptable excipient.
Claims 1, 10-11, and 29 of the ‘732 application do not teach the pharmaceutical comprising Gemcitabine in a combination to treat bladder cancer.
The relevancy of Theodorescu et al. in view of Yu and Swamy et al. teach a beneficial combination of Gemcitabine and the recombinant lectin protein of SEQ ID NO: 1 to treat bladder cancer as applied to claims 3-5 and 28 described above not repeated here.
Because Theodorescu et al. in view of Yu and Swamy et al. suggest a combination of Gemcitabine and the recombinant lectin protein of SEQ ID NO: 1 (disclosed in claim 10 of the ‘732 application) to treat bladder cancer with synergistic effect, one of ordinary skill in the art would have found it obvious to beneficially combine claims 1, 10-11, and 29 of the ‘732 application with Theodorescu et al. in view of Yu and Swamy et al.
Thus, claims 1, 10-11, and 29 of the ‘732 application in view of Theodorescu et al., Yu and Swamy et al. are obvious to the instant claims 3-5 and 28.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 11/20/2025 have been fully considered but they are not persuasive. See response to arguments above.
Claims 3-5 and 28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8, and 10 of copending Application No. 18,577,495 (the ‘495 application, 2/8/2024) in view of Theodorescu et al. (WO 2008/027912 A2, previously cited 7/25/2024) in view of Yu (Glycoconj J (2007) 24:411-420, previously cited 7/25/2024) and Swamy et al. (WO 2010/095143 A2, previously cited 7/25/2024, previously cited 7/25/2024).
Claims 1 and 8 of the ‘495 application disclosed a composition comprising a recombinant lectin protein of SEQ ID NO: 1 with 100% identity to the instant SEQ ID NO: 1.
Claim 10 of the ‘495 application disclosed the composition comprising pharmaceutically acceptable excipient of L-arginine hydrochloric acid.
Claims 1, 8, and 10 of the ‘495 application do not teach the composition further comprising Gemcitabine in a combination to treat bladder cancer.
The relevancy of Theodorescu et al. in view of Yu and Swamy et al. teach a beneficial combination of Gemcitabine and the recombinant lectin protein of SEQ ID NO: 1 to treat bladder cancer as applied to claims 3-5 and 28 described above not repeated here.
Because Theodorescu et al. in view of Yu and Swamy et al. suggest a combination of Gemcitabine and the recombinant lectin protein of SEQ ID NO: 1 (disclosed in claim 8 of the ‘495 application) to treat bladder cancer with synergistic effect, one of ordinary skill in the art would have found it obvious to beneficially combine claims 1, 8, and 10 of the ‘495 application with Theodorescu et al. in view of Yu and Swamy et al.
Thus, claims 1, 8, and 10 of the ‘495 application in view of Theodorescu et al., Yu and Swamy et al. are obvious to the instant claims 3-5 and 28.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 11/20/2025 have been fully considered but they are not persuasive. See response to arguments above.
Conclusion
No claim is 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.
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/J.L/Examiner, Art Unit 1658
12-December-2025
/LI N KOMATSU/ Primary Examiner, Art Unit 1658
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