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
1. Claims 1-15 have been canceled. Claims 16-33 have been added. Claims 16-33 are currently pending and subject to the restriction requirement as set forth below.
Please note the current bib data sheet does not accurately account for the cross references as recited in the specification.
Election/Restriction
2. Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 16-32, drawn to methods of treating urothelial carcinoma, classified in A61K2039/80.
II. Claim 33, drawn to a composition comprising an effective amount of nitroxoline, a chemotherapeutic agent and a carrier, classified in A61K47/6809.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case, Invention I can be accomplished via surgery, chemotherapy, radiation therapy, immunotherapy, as well as targeted therapy.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
The inventions above are patentably distinct. The search for each of the above inventions would not be co-extensive in scope particularly with regard to the literature search. Burden consists not only of specific searching of Cooperative Patent Classification, classes and subclasses, but also of searching multiple databases for foreign references and literature searches. Burden also resides in the examination of independent claim sets for clarity, enablement, and double patenting issues. Further, a reference that would anticipate the invention of one group would not necessarily anticipate or even make obvious another group. Finally, the consideration for patentability is different in each case. Thus, it would be an undue burden to examine all of the above inventions in one application and the restriction for examination purposes as indicated above is deemed proper.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Ming He on August 31, 2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 16-32. Affirmation of this election must be made by applicant in replying to this Office action. Claim 33 is withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention. Claims 16-32 are currently under examination.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Claims 16-32 are currently under examination.
Information Disclosure Statement
3. The information disclosure statement (IDS) submitted on April 25, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. An initialed copy is attached hereto.
Claim Objections
4. Claims 20 and 22 are objected to because of the following informalities: in the third line of each claim there is a double space between the words “amount of” and “the anti-PD-1”. Appropriate correction is required.
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.
5. Claims 16-22 and 25-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 11,324,739 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the pending claims are drawn methods of treating urothelial carcinoma comprising administering to a subject in need thereof an effective amount of nitroxoline, an analogue or pharmaceutically acceptable salt thereof, and an effective amount of a second agent, wherein the combination of nitroxoline, an analogue or pharmaceutically acceptable salt thereof and the second agent results in a synergistic effect, wherein the analogue is selected from the group consisting of oxyquinoline, clioquinol, and iodoquinol, and wherein the second agent is an immunotherapy agent or a chemotherapeutic agent.
Meanwhile, the patented claims are drawn to a method of treating bladder cancer comprising administering to a subject in need thereof an effective amount of nitroxoline, an analogue or pharmaceutically acceptable salt thereof, and an effective amount of an immunotherapy agent, wherein the combination of nitroxoline, the analogue or pharmaceutically acceptable salt thereof and the immunotherapy agent results in a synergistic effect, wherein the analogue is selected from the group consisting of oxyquinoline, clioquinol, and iodoquinol, and wherein the immunotherapy agent is an anti-PD-1 (programmed cell death protein 1) antibody or an antigen binding fragment thereof, an anti-PD-L1 (programmed cell death ligand 1) antibody or an antigen binding fragment thereof, or a Bacillus Calmette-Guerin (BCG) therapy.
The patented claims anticipate the co-pending claims.
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.
6. Claim(s) 16 and 27-30 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Liu et al., US 8,729,097 B2; Published 5/20/14.
Independent claim 16 is drawn to a method of treating urothelial carcinoma comprising administering to a subject in need thereof an effective amount of nitroxoline, an analogue or pharmaceutically acceptable salt thereof, and an effective amount of a second agent, wherein the combination of nitroxoline, an analogue or pharmaceutically acceptable salt thereof and the second agent results in a synergistic effect, wherein the analogue is selected from the group consisting of oxyquinoline, clioquinol, and iodoquinol, and wherein the second agent is an immunotherapy agent or a chemotherapeutic agent.
Liu discloses methods of treating bladder cancer administering nitroxoline (see column 18, lines 29-31, 37-41). The present compounds may be used to treat subjects including animals, and in particular, mammals, including humans, as patients suffering from diseases or disorders related to hMetAP and/or angiogenesis (i.e. bladder cancer), can be treated, ameliorated or prevented by administering to the patient an effective amount of one or more of the compounds according to the present invention or its derivative or a pharmaceutically acceptable salt thereof optionally in a pharmaceutically acceptable carrier or diluent, either alone, or in combination with other known pharmaceutical agents (depending upon the disease to be treated). Treatment according to the present invention can also be administered in conjunction with other conventional therapies, e.g., cancer therapy, such as radiation treatment or surgery (see column 18, lines 29-31, 41; column 29; lines 15-29; meets claim 16).
The anti-compounds of the invention may be utilized in combination with at least one known other therapeutic agent, or a pharmaceutically acceptable salt of said agent. Examples of known therapeutic agents which can be used for combination therapy include, but are not limited to, cis-platin, mitomycin C, and carboplatin; as well as antimitotic agents such as paclitaxel, docetaxel and epirubicin (see column 29; lines 30-50; meets claims 27-28).
Liu discloses that administration of the active compound may range from continuous (intravenous drip) to several oral administrations per day (for example, Q.I.D.) and may include intravenous and directly into tumors (see column 34; lines 20-35; meets claim 30). Lastly, application of the subject therapeutics may be local, so as to be administered at the site of interest. Various techniques can be used for providing the subject compositions at the site of interest, such as injection and use of catheters (see column 37, lines 47-50; meets 29).
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.
7. Claim(s) 17-18, 25-26 and 31-32 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al., US 8,729,097 B2; Published 5/20/14 as applied to claims 16 and 27-30 above, and further in view of Matsushima et al., Oncology Letters, 2011; 2:13-19.
Liu et al. teach Liu discloses methods of treating bladder cancer administering nitroxoline (see column 18, lines 29-31, 37-41). The present compounds may be used to treat subjects including animals, and in particular, mammals, including humans, as patients suffering from diseases or disorders related to hMetAP and/or angiogenesis (i.e. bladder cancer), can be treated, ameliorated or prevented by administering to the patient an effective amount of one or more of the compounds according to the present invention or its derivative or a pharmaceutically acceptable salt thereof optionally in a pharmaceutically acceptable carrier or diluent, either alone, or in combination with other known pharmaceutical agents (depending upon the disease to be treated). Treatment according to the present invention can also be administered in conjunction with other conventional therapies, e.g., cancer therapy, such as radiation treatment or surgery (see column 18, lines 29-31, 41; column 29; lines 15-29; meets claim 16).
The anti-compounds of the invention may be utilized in combination with at least one known other therapeutic agent, or a pharmaceutically acceptable salt of said agent. Examples of known therapeutic agents which can be used for combination therapy include, but are not limited to, cis-platin, mitomycin C, and carboplatin; as well as antimitotic agents such as paclitaxel, docetaxel and epirubicin (see column 29; lines 30-50; meets claims 27-28).
Liu teaches that administration of the active compound may range from continuous (intravenous drip) to several oral administrations per day and may include intravenous and directly into tumors (see column 34; lines 20-35; meets claim 30). Lastly, application of the subject therapeutics may be local, so as to be administered at the site of interest. Various techniques can be used for providing the subject compositions at the site of interest, such as injection and use of catheters (see column 37, lines 47-50; meets 29).
Liu et al. do not specifically teach that their immunotherapy agent is Bacillus Calmette-Guerin.
Matsushima teaches that intravesical immunotherapy with bacillus Calmette Guerin (BCG) is currently the most successful adjuvant agent for the treatment and/or prophylaxis of non-muscle-invasive bladder cancer (NMIBC). Patients that do not respond to intravesical BCG therapy are considered to be a challenge for urologists. Thus, novel conservative possibilities should be explored. To test the efficacy of a novel therapeutic approach, we examined the antitumor effect of combination therapy by intravesical administration of mitomycin C (MMC) plus BCG, infusing the two drugs simultaneously, in an orthotopic bladder cancer model. Intravesical BCG and MMC administration showed a dose-dependent survival (n=8 per group). The combination of MMC and BCG provided a significant survival advantage compared to the BCG-alone (p=0.035) and MMC-alone groups (p=0.040) (n=8 per group). The group with combined MMC/BCG exhibited a survival period similar to that achieved with an amount eight times higher that of BCG (n=10 per group). Ki-67 labeling index of cancer cells, showing tumor proliferation, was significantly lower in the combined group compared to the BCG-alone. The results suggest that the combined intravesical MMC/BCG treatment induced an enhanced antitumor effect against bladder tumors. The combined MMC/BCG treatment also showed a survival period similar to that achieved using a dose eight times higher of BCG-alone.
BCG is currently regarded as the most successful immunotherapy for solid tumors. The intravesical instillation of BCG is the most effective means of prophylaxis for the recurrence and progression of non-muscle-invasive bladder cancer.
Regarding the specific concentrations and amounts to be administered listed in instant claim 26 and 31-32, MPEP 2144.05 states, “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997).”
Limitations such as administration or weight ratios are being viewed as limitations of optimizing experimental parameters.
It would have been obvious before the effective filing date of the presently claimed invention to employ immunotherapy agents from Bacillus Calmette Guerin because it is a claimed elements known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention. See the recent Board decision Ex parte Smith,--USPQ2d--, slip op. at 20, (Bd. Pat. App. & Interf. June 25, 2007) (citing KSR, 82 USPQ2d at 1396).
The skilled artisan would have been motivated to make this modification because BCG is regarded as the most successful immunotherapy for solid tumors. The intravesical instillation of BCG is the most effective means of prophylaxis for the recurrence and progression of non-muscle-invasive bladder cancer. Combining the mitomycin C of Liu with the BCG treatment of Matsushima provides for a survival period similar to that achieved using a dose eight times higher of BCG-alone. The skilled artisan would have had a reasonable expectation of success because each of the documents teach methods for treating cancer.
Accordingly, the subject matter of the claimed invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention, absent evidence to the contrary.
8. Claim(s) 17-24 and 31-32 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al., US 8,729,097 B2; Published 5/20/14 as applied to claims 16 and 27-30 above, and further in view of Philips et al. International Immunology 2014, 27(1):39-46.
Liu et al. teach the limitations as set forth supra.
Liu et al. do not specifically teach that their immunotherapy agent are immune checkpoint inhibitors, specifically, anti-PD-1, anti-PD-L1 and CTLA-4.
Philips teaches that in recent years, immune checkpoints that maintain physiologic self-tolerance have been implicated in the down-regulation of anti-tumor immunity. Efforts to restore latent anti-tumor immunity have focused on antibody-based interventions targeting CTL antigen 4 (CTLA-4) and programmed cell death protein 1 (PD-1) on T lymphocytes and its principal ligand (PD-L1) on tumor cells. Ipilimumab, an antibody targeting CTLA-4, appears to restore tumor immunity at the priming phase, whereas anti-PD-1/PD-L1 antibodies restore immune function in the tumor microenvironment. Although ipilimumab can produce durable long-term responses in patients with advanced melanoma, it is associated with significant immune-related toxicities. By contrast, antibodies targeting either PD-1 or PD-L1 have produced significant anti-tumor activity with considerably less toxicity. Activity was seen in patients with melanoma and renal cancer, as well as those with bladder cancer.
Regarding the specific concentrations and amounts to be administered listed in instant claims 20, 22, 24 and 31-32, MPEP 2144.05 states, “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997).”
Limitations such as administration or weight ratios are being viewed as limitations of optimizing experimental parameters.
It would have been obvious before the effective filing date of the presently claimed invention to employ immunotherapy agents from immune checkpoint inhibitors because they are claimed elements known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention. See the recent Board decision Ex parte Smith,--USPQ2d--, slip op. at 20, (Bd. Pat. App. & Interf. June 25, 2007) (citing KSR, 82 USPQ2d at 1396).
The skilled artisan would have been motivated to make this modification because an antibody targeting CTLA-4 restores tumor immunity at the priming phase, whereas anti-PD-1/PD-L1 antibodies restore immune function in the tumor microenvironment. Antibodies targeting either PD-1 or PD-L1 have produced significant anti-tumor activity with considerably less toxicity. The skilled artisan would have had a reasonable expectation of success because each of the documents teach methods for treating cancer.
Accordingly, the subject matter of the claimed invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Conclusion
9. No claim is allowed.
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAKIA J JACKSON-TONGUE whose telephone number is (571)272-2921. The examiner can normally be reached Monday-Friday 930AM-530PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Gussow can be reached at (571) 272-6047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAKIA J JACKSON-TONGUE/Examiner, Art Unit 1645 September 30, 2026
/BRIAN GANGLE/Primary Examiner, Art Unit 1645
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