Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of pancreatic cancer, taxane and water in the reply filed on 12/10/2025 is acknowledged.
Status of the Claims
Claims 1-23 are pending in this application.
Claims 14-21 are withdrawn from consideration as being drawn to a non-elected species/invention.
Claims 1-13 and 22-23 are presently under consideration as being drawn to the elected species/invention.
Claim Objections
Claims 1, 8 and 11 objected to because of the following informalities: Claim 1 should be rewritten to recite “…agent or therapy.and about 0.8 to 3.2 mg/kg…..”. Claim 11 should be rewritten to recite “….wherein CEND-1 is . Appropriate correction is required.
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.
Claims 6-7 and 10 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.
The term “small molecule” in claim 6 is a relative term which renders the claim indefinite. The term “small molecule” 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.
Regarding claim 6, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 7, which depends from claim 6, is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as this claim incorporates by dependency the indefiniteness of claim 6. Furthermore, the phrase "….an antibody such,…." is unclear. One of ordinary skill in the art would not understand what is being claimed.
Claim 10 recites the limitation "the cancer therapy" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Duplicate claims
Applicant is advised that should claim 22 be found allowable, claim 23 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 § 706.03(k).
Claim 23 is drawn to the same subject matter of claim 22 because the only step is to measure efficacy or clinical activity. The result of such step is irrelevant, since the patient population is the same.
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.
Claims 1-8, 10-13 and 22-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sengupta et al. (US 2015/0174263), as evidenced by Hopkins Medicine (downloaded from URL:<https://www.hopkinsmedicine.org/health/conditions-and-diseases/pancreatic-cancer/pancreatic-cancer-types>).
With respect to claim 1, Sengupta et al. teach treating a cancer by administering iRGD (i.e. CEND-1) in combination with at least one anti-cancer agent or therapy (claims 75 and 78).
With respect to claims 2-3, Sengupta et al. teach that the cancer is breast cancer (claim 79) or pancreatic cancer (para [0114]), both of which are malignant solid tumor characterized by dense tumor stroma.
With respect to claims 4-5, as evidenced by Hopkins Medicine, “pancreatic cancer” refers to adenocarcinoma (page 1, 1st para). Hopkins Medicine also teach that “[E]xocrine pancreatic cancer develops from exocrine cells, which make up the exocrine gland and ducts of the pancreas” (page 2, 1st para). Therefore, one of ordinary skill in the art would have at once envisaged treating ductal adenocarcinoma, which is a primary pancreatic cancer.
With respect to claims 6-7, Sengupta et al. teach that the chemotherapeutic agent is taxane (claim 65; para [0008]).
With respect to claim 8, Sengupta et al. teach that the therapeutic amount is 0.5 mg/kg, 1.0 mg/kg, 2.0 mg/kg, 2.5 mg/kg, 5 mg/kg, 10 mg/kg, 15 mg/kg, or 20 mg/kg (para [0133]).
With respect to claim 10, Sengupta et al. teach that the method comprises co-administering the conjugate and an anti-cancer agent or chemotherapeutic agent to the subject (para [0129]), and further teach that examples of dosing and/or treatment schedules are administration daily, twice daily, three times daily or four or more times daily over a period of 1 week, 2 weeks, 3 weeks, 4 weeks, or 1 month (para [0135]).
With respect to claims 11-12, Sengupta et al. teach that suitable vehicles that can be used to provide parenteral dosage forms of the composition include water (para [0122]).
With respect to claim 13, Sengupta et al. teach intravenous administration (paras [0116] and [0129]).
With respect to claim 22, Sengupta et al. teach determining overall survival (para [0387]).
With respect to claim 23, it is noted that, as discussed above, this claim is drawn to the same subject matter of claim 22. Thus, it is anticipated.
Claims 1-7 and 10-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ruoslahti et al. (US 2010/0322862).
With respect to claim 1, Ruoslahti et al. teach treating orthopic MIA PaCa-2 human pancreatic carcinoma by administering iRGD (i.e. CEND-1) (paras [0079] and [0435]), and further teach that “[T]umor-penetrating CendR peptides can be used, for example, to augment tumor imaging and tumor treatment with anti-cancer drugs. FDA-approved imaging agents, such as iron oxide nanoparticle MRI contrast agent, can be injected into tumor-bearing mice with a tumor-homing CendR peptide, or with a combination of peptides, followed by imaging. Any known or future drug can be used with CendR peptides to affect and inhibit tumor growth. For example, the co-composition can be any clinically used anti-cancer drugs” (para [0111]).
One of ordinary skill in the art would have at once envisaged administering iRGD in combination with anti-cancer drugs.
With respect to claims 2-3, it is noted that pancreatic cancer is a malignant solid tumor characterized by dense tumor stroma.
With respect to claims 4-5, it is noted that the MIA PaCa-2 cell line is a model for human pancreatic ductal adenocarcinoma.
With respect to claim 6, Ruoslahti et al. teach that the composition comprises iRGD in combination with a therapeutic protein, a therapeutic compound, a therapeutic composition, a cancer chemotherapeutic agent, a toxin, a cytotoxic agent, an anti-inflammatory agent, an anti-arthritic agent, a growth factor, a cytokine, a chemokine, a compound that modulates one or more signaling pathways, an antibody, a nucleic acid, a nucleic acid analog, a cell, a virus, a phage, a viral particle, a phage particle, a viral capsid, a phage capsid, a virus-like particle, a liposome, a micelle, a bead, a nanoparticle, a microparticle, a chemotherapeutic agent, a contrast agent, an imaging agent, a label, a labeling agent, an anti-angiogenic agent, or a pro-angiogenic agent (paras [0029] and [0158]-[0159]; claims 38 and 124).
With respect to claim 7, Ruoslahti et al. teach that the chemotherapeutic agent is taxane (para [0338]).
With respect to claim 10, Ruoslahti et al. teach that “[T]he disclosed CendR peptides (and other CendR forms) and co-compositions can be administered together or separately; in the same form and manner or in different forms and/or manners; at the same time or at different times; with the CendR peptide (or other CendR form) administered first or second. Administration can be, for example, co-administration (at the same time and by the same or different route/means/form)” (para [0273]).
With respect to claims 11-12, Ruoslahti et al. teach that suspensions of the active ingredients can be prepared as appropriate oily or water-based injection suspensions (para [0368]).
With respect to claim 13, Ruoslahti et al. teach intravenous administration (para [0358]).
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.
Claims 1-13 and 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Sengupta et al. (US 2015/0174263).
The teachings of Sengupta et al. with respect to claims 1-8, 10-13 and 22-23 have been discussed above.
Sengupta et al. do not teach administering 3.2 mg/kg body weight/per dose.
However, Sengupta et al. teach that “[T]he dosage of a composition as described herein can be determined by a physician and adjusted, as necessary, to suit observed effects of the treatment. With respect to duration and frequency of treatment, it is typical for skilled clinicians to monitor subjects in order to determine when the treatment is providing therapeutic benefit, and to determine whether to increase or decrease dosage, increase or decrease administration frequency, discontinue treatment, resume treatment, or make other alterations to the treatment regimen (para [0135]).
Furthermore, the MPEP 2144.05 A states that “[G]enerally, 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)”.
Since Applicant has not disclosed that the specific limitations recited in the instant claims are for any particular purpose or solve any stated problem, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable dosage by normal optimization procedures known in the pharmaceutical art.
Claims 1-13 are rejected under 35 U.S.C. 103 as being unpatentable over Ruoslahti et al. (US 2010/0322862).
The teachings of Ruoslahti et al. with respect to claims 1-7 and 10-13 have been discussed above.
Ruoslahti et al. do not teach the claimed amount of CEND-1.
However, Ruoslahti et al. teach that “[D]etermination of a therapeutically effective amount is well within the capability of those skilled in the art (para [0373]).
Furthermore, the MPEP 2144.05 A states that “[G]enerally, 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)”.
Since Applicant has not disclosed that the specific limitations recited in the instant claims are for any particular purpose or solve any stated problem, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable dosage by normal optimization procedures known in the pharmaceutical art.
Claims 1-7, 10-13 and 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Ruoslahti et al. (US 2010/0322862) in view of Sengupta et al. (US 2015/0174263).
The teachings of Ruoslahti et al. with respect to claims 1-7 and 10-13 have been discussed above.
Ruoslahti et al. further teach that anti-tumor efficacy can be determined using known techniques (para [0111]).
Ruoslahti et al. do not teach measuring efficacy or clinical activity by determining ORR, PFS and/or OS.
Sengupta et al. teach treating a cancer by administering iRGD (i.e. CEND-1) in combination with at least one anti-cancer agent or therapy (claims 75 and 78).
Sengupta et al. also teach determining overall survival (para [0387]).
It would have been obvious for one of ordinary skill to measure overall survival (OS) because Ruoslahti et al. teach that anti-tumor efficacy can be determined using known techniques, and Sengupta et al. teach determining overall survival in the same patient population of Ruoslahti et al. being administered the same composition (i.e. CEND-1 in combination with at least one anti-cancer agent or therapy).
With respect to claim 23, it is noted that, as discussed above, this claim is drawn to the same subject matter of claim 22. Thus, it is obvious.
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 1-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-198 of U.S. Patent No. 10370245, as evidenced by Hopkins Medicine (downloaded from URL:<https://www.hopkinsmedicine.org/health/conditions-and-diseases/pancreatic-cancer/pancreatic-cancer-types>).
With respect to claims 1 and 6, ‘245 teaches a method of enhancing internalization, penetration, or both of a co-composition into or through a cell, tissue, or both, the method comprising: administering a composition comprising a CendR element and a co-composition to a subject, wherein the cell, tissue, or both is in the subject, whereby internalization, penetration, or both of the co-composition into or through the cell, tissue, or both is enhanced (claim 112), wherein the CendR element is associated with one or more accessory molecules (claim 114), wherein at least one of the accessory molecules comprises an RGD peptide, iRGD (i.e. CEND-1), a Lyp-1 peptide, a NGR peptide, iNGR, an RGR peptide, a HER2 binding peptide, or a combination (claim 118), wherein the co-composition comprises a therapeutic protein, a therapeutic compound, a therapeutic composition, a cancer chemotherapeutic agent, a toxin, a cytotoxic agent, an anti-inflammatory agent, an anti-arthritic agent, a growth factor, a cytokine, a chemokine, a compound that modulates one or more signaling pathways, an antibody, a nucleic acid, a nucleic acid analog, a cell, a virus, a phage, a viral particle, a phage particle, a viral capsid, a phage capsid, a virus-like particle, a liposome, a micelle, a bead, a nanoparticle, a microparticle, a chemotherapeutic agent, a contrast agent, an imaging agent, a label, a labeling agent, an anti-angiogenic agent, a pro-angiogenic agent, or a combination (claim 137), and wherein the CendR element selectively homes to brain cells, tissue, or both, 5 kidney cells, tissue, or both, skin and tendon cells, tissue, or both, lung cells, tissue, or both, pancreatic cells, tissue, or both, intestinal cells, tissue, or both, adrenal gland cells, tissue, or both, retinal cells, tissue, or both, liver cells, tissue, or both, prostate cells, tissue, or both, endometriosis cells, tissue, or both, ovary cells, tissue, or both, heart cells, tissue, or both, tumor cells, tumors, tumor blood vessels, or a combination (claim 122).
One of ordinary skill in the art would have at once envisaged administering CEND-1 in combination with a chemotherapeutic agent for treating pancreatic cancer.
With respect to claims 2-3, it is noted that pancreatic cancer is a malignant solid tumor characterized by dense tumor stroma.
With respect to claims 4-5, as evidenced by Hopkins Medicine, “pancreatic cancer” refers to adenocarcinoma (page 1, 1st para). Hopkins Medicine also teach that “[E]xocrine pancreatic cancer develops from exocrine cells, which make up the exocrine gland and ducts of the pancreas” (page 2, 1st para). Therefore, one of ordinary skill in the art would have at once envisaged treating ductal adenocarcinoma, which is a primary pancreatic cancer.
With respect to claim 7, ‘245 teaches that the chemotherapeutic agent is a taxane such as docetaxel (column 94, lines 45-47). Please note that it is proper to turn to and rely on the disclosure of a patent application to ascertain what constitutes an obvious modification. This position is supported by the courts. See In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970).
With respect to claims 8-9, ‘245 teaches that “[D]etermination of a therapeutically effective amount is well within the capability of those skilled in the art (column 102, lines 28-29).
Furthermore, the MPEP 2144.05 A states that “[G]enerally, 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)”.
Since Applicant has not disclosed that the specific limitations recited in the instant claims are for any particular purpose or solve any stated problem, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable dosage by normal optimization procedures known in the pharmaceutical art.
With respect to claim 10, ‘245 teaches that “[T]he disclosed CendR peptides (and other CendR forms) and co-compositions can be administered together or separately; in the same form and manner or in different forms and/or manners; at the same time or at different times; with the CendR peptide (or other CendR form) administered first or second. Administration can be, for example, co-administration (at the same time and by the same or different route/means/form), separate administration (parallel administration by the same or different route/means/form), sequential administration (at different times by the same or different route/means/form), etc.” (column 77, lines 22-32).
With respect to claims 11-12, ‘245 teaches that the active ingredient can be in powder form for constitution with a suitable vehicle, e.g., sterile, pyrogen-free water-based solution, before use (column 102, lines 11-13).
With respect to claim 13, ‘245 teaches intravenous administration (column 100, line 37; Figs. 2, 4A-4C, 9A-9D; passim).
Claims 1-13 and 22-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-198 of U.S. Patent No. 10370245 in view of Sengupta et al. (US 2015/0174263).
The teachings of ‘245 with respect to claims 1-13 have been discussed above.
‘245 further teaches that anti-tumor efficacy can be determined using known techniques (column 26, lines 7-10).
‘245 does not teach measuring efficacy or clinical activity by determining ORR, PFS and/or OS.
Sengupta et al. teach treating a cancer by administering iRGD (i.e. CEND-1) in combination with at least one anti-cancer agent or therapy (claims 75 and 78).
Sengupta et al. also teach determining overall survival (para [0387]).
It would have been obvious for one of ordinary skill to measure overall survival (OS) because ‘245 teaches that anti-tumor efficacy can be determined using known techniques, and Sengupta et al. teach determining overall survival in the same patient population of ‘245 being administered the same composition (i.e. CEND-1 in combination with at least one anti-cancer agent or therapy).
With respect to claim 23, it is noted that, as discussed above, this claim is drawn to the same subject matter of claim 22. Thus, it is obvious.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SERGIO COFFA whose telephone number is (571)270-3022. The examiner can normally be reached M-F: 6AM-4PM.
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/SERGIO COFFA Ph.D./
Primary Examiner
Art Unit 1658
/SERGIO COFFA/Primary Examiner, Art Unit 1658