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 .
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 1-4, 6, 8, 10-11, 14, 21, 23, 24, 27, 33, and 55 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6, 8, 10-12, 19, 21-22, 25, 31, and 53 of copending Application No. 18/713,550 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Instant claims 1-4, 6, 8, 10-11, 14, 21, 23, 24, 27, 33, and 55 differ from the claims of the reference application in that -R6 and -R9 together may form an oxo group and R7 is optionally substituted –[NC5H5]. At least Compound 1 recited in claim 11 of the reference application anticipates a compound of instant formula (I). It would have been prima facie obvious to select/employ Compound 1 from the finite list of compounds recited in claim 11 in a pharmaceutical composition of the reference application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 46-47, 49, and 52-53 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6, 8, 10-11, 14, 21, 23, 24, 27, 33, and 55 of copending Application No. 18/713,550 (reference application) as applied to claims 1-4, 6, 8, 10-11, 14, 21, 23, 24, 27, 33, and 55 above. Although the claims at issue are not identical, they are not patentably distinct from each other because for the reasons set forth above regarding claims 1-4, 6, 8, 10-11, 14, 21, 23, 24, 27, 33, and 55.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 1-4, 6, 8, 10-11, 13-14, 21, 23-24, 27, 33, 46-47, 49, 52-53, and 55 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.
Regarding claims 1, 3-4, 6, 8, 10-11, 13, 24, 55, and dependent claims thereof, said claims read upon an improper Markush group as the last two members of a list are not separated by proper conjunction (e.g., “and”, “or”, etc.). For example, in claim 1, regarding variable “R1”, the text “selected from…or –(C(S)-N(R3)2”. A similar deficiency exists variables R2, R3, R4, Ra, R6, and R7. Regarding claim 4, for example, the text “group selected from:
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” reads upon an improper Markush group as the last two saccharidyl groups are not separated by a proper conjunction (e.g., “and”). A similar issue exists in claim 13 regarding the list of depicted compounds not being separated by a proper conjunction (e.g., “or”). When materials recited in a claim are so related as to constitute a proper Markush group, they may be recited in the conventional manner, or alternatively. For example, if "wherein R is a material selected from the group consisting of A, B, C and D" is a proper limitation, then "wherein R is A, B, C or D" shall also be considered proper.
Regarding claims 14, 27, 46-47, and 53, the parenthetical phrase(s) “(preferably severe acute…(SARS-CoV-2))” and/or “(chicken)” render(s) the claim indefinite because it is unclear whether the limitations within the parentheses are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 33, the parenthetical phrase(s) “(including intravenous…and epidural)”, “(aerosol)”, and/or “(including buccal…and sublingual)” render(s) the claim indefinite because it is unclear whether the limitations within the parentheses are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-4, 6, 14, 21, 23, 27, and 33 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Zhou et al. CN 113461697A (Zhou). For convenience, English equivalent US 2022/0281883 A1 is used for citations.
Zhou relates to medicines , and more particularly to a chlorin compound , and a preparation and application thereof [0002]. Zhou teaches that, as one of the primary persistent ailments, cancer has attracted worldwide attention for a long term, and extensive researches have been conducted to explore a safe and reliable therapy [0003]. Photodynamic therapy (PDT) has emerged as an effective clinical treatment tool for cancers in the past 30 years. In addition to the treatment of malignant tumors, PDT also appears to be promising in the treatment of many other diseases.
Zhou provides a compound of formula (I), or a salt, a stereoisomer, a hydrate, a solvate or a prodrug thereof:
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.
See [0014 – 0022]. Exemplary compounds include the compounds of Examples 5-15, wherein R = -(CH2)11CH3, -(CH2)10CH3, -(CH2)9CH3, -(CH2)8CH3, -(CH2)7CH3, -(CH2)6CH3, -(CH2)4CH3, -(CH2)3CH3, -(CH2)2CH3, -CH2CH3, or -CH3. See Table 3.
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Zhou further provides a use of the above-mentioned compound, or a salt, a stereoisomer, a hydrate, a solvate or a prodrug thereof in the preparation of a drug, where the drug is a photosensitizer for photodynamic therapy or a sonosensitizer for sonodynamic therapy [0048]. Zhou teaches, in an embodiment, the solid tumor is selected from the group consisting of glioma, bladder cancer, esophageal cancer, bronchial cancer, oral and maxillofacial cancer, nasopharyngeal cancer, pleural mesothelioma, liver cancer, pancreatic cancer, skin cancer, penile cancer, cervical cancer, breast cancer and subcutaneous metastatic nodules after radical mastectomy, perianal tumor and residual cancer after extended resection of the perianal tumor, Kaposi's sarcoma, lung cancer, gastric cancer, cholangiocarcinoma, prostate cancer, melanoma and brain tumor [0053].
Zhou provides a pharmaceutical composition, comprising: the above-mentioned compound, a salt, a stereoisomer, a hydrate, a solvate or a prodrug thereof; and one or more pharmaceutically acceptable excipients [0057 – 0059]. Zhou teaches that the compounds provided therein can be prepared in any appropriate galenic form and can be administered by any appropriate route [0083]. The compound and the mixture provided herein can be prepared into solutions, suspensions, emulsions and lyophilized preparations for injection (e.g., intraarterial injection, intravenous injection, intramuscular injection, subcutaneous injection and intraperitoneal injection) or infusion. The compound and the mixture provided therein can also be prepared into tablets, solutions and capsules for oral administration; prepared into ointments, creams, suppositories and patches for topical application; and prepared into aerosols, sprays, and powders for inhalation. The preferred administration routes are generally injection/infusion, oral and topical administration. The injection/infusion enables the rapid distribution equilibrium of the compounds provided herein, for example, the distribution equilibrium is reached within 24 hours.
Zhou teaches that when taken as a photosensitizer, the compound provided therein can be used in combination with any known excitation light source corresponding to hematoporphyrin photosensitizers in the art [0086]. Zhou teaches that the irradiation wavelength is preferably 660±5 nm, and the irradiation dose is 50-200 J/cm2, preferably 75-150 J/cm2.
Zhou teaches that, in general, the effective amount of the compound provided herein for animals, such as humans, is 0.01-10 mg/kg body weight, preferably 0.05-4 mg/kg body weight, and more preferably 0.1-2 mg/kg body weight [0085]. Whereas it should be understood that the effective amount of the compound provided herein or the mixture thereof can be determined by the researchers or clinicians based on reasonable medical judgment. The specific effective amount will depend on many factors, such as the specific disease and its severity, the specific compound, the wavelength, the light energy flow rate and the irradiation time, the age, weight, and general health status of the subject, the treatment duration, drug combination and other factors well known in the medical field. In some cases, the effective amount may be higher than the upper limit of the aforementioned range or lower than the lower limit of the aforementioned range.
At least the compounds of Examples 5-15 are embraced by a compound of instant formula (I), wherein R1 = H; R6 = -O(CH2)11CH3, -O(CH2)10CH3, -O(CH2)9CH3, -O(CH2)8CH3, -O(CH2)7CH3, -O(CH2)6CH3, -O(CH2)4CH3, -O(CH2)3CH3, -O(CH2)2CH3, -OCH2CH3, or -OCH3; R7 = COOH; and R9 = H. Zhou provides a pharmaceutical composition, comprising: the above-mentioned compound, a salt, a stereoisomer, a hydrate, a solvate or a prodrug thereof; and one or more pharmaceutically acceptable excipients.
Zhou teaches all of the claimed elements. Thus, claims 1-4, 6, 14, 21, 23, 27, and 33 are anticipated.
Claim(s) 46-47, 49, and 52-53 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Zhou et al. CN 113461697A (Zhou) as applied to claims 1-4, 6, 14, 21, 23, 27, and 33 above.
Zhou teaches or reasonably suggests a method comprising the administration of a compound (e.g., a compound of Examples 5-15) to a human having cancer (e.g., a malignant tumor, such as bladder cancer).
Zhou teaches all of the claimed elements. Thus, claims 1-4, 6, 14, 21, 23, 27, and 33 are anticipated.
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) 24 and 55 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhou et al. CN 113461697A (Zhou) as applied to claims 1-4, 6, 14, 21, 23, 27, and 33 above, and further in view of Jeong, Young-IL, et al. "Chlorin e6-conjugated and PEGylated immune checkpoint inhibitor nanocomposites for pulmonary metastatic colorectal cancer." ACS omega 4.20 (2019): 18593 (Jeong).
Zhou differs from the instantly claimed invention in that Zhou does not explicitly teach a composition further comprising polyvinylpyrrolidone or an immune checkpoint inhibitor; however, this deficiency would have been obvious in view of the teachings of Jeong.
In the instant case, the references may be combined to show obviousness because Zhou and Jeong are each drawn to chlorin or a derivative thereof useful for treating a tumor. They are from the same field of endeavor, and/or are reasonably pertinent to a pharmaceutical composition comprising a compound of formula (I) or a complex of formula (II) and polyvinylpyrrolidone or an immune checkpoint inhibitor.
Jeong teaches that immune checkpoint inhibitors (ICIs) have been extensively investigated in the recent decade since the inhibition of immune checkpoint expression in immune cells or cancer cells is believed to be a safer and more efficient therapeutic regimen for cancer patients than conventional therapy (Introduction). Jeong demonstrated theragnostic immune checkpoint inhibitor nanocomposites (ICI NC) having an improved tumor targeting ability in pulmonary metastatic colon cancer model (Abstract). Jeong teaches that atezolizumab, a PD L1 antibody, was conjugated with methoxy poly(ethylene glycol) (MePEG) and chlorin e6 (Ce6) via cathepsin-B-sensitive peptide as a linkage (named as ICI nanocomposites, ICI NC). This ICI NC is delivered to tumor sites enriched with tumor-specific enzymes such as cathepsin B, whereas undesired ICI exposure to normal tissue is avoided. When ICI NC were incubated with cathepsin B, Ce6 was released from ICI NC with increased fluorescence intensity in cathepsin B dose dependent manner, which was by degradation of the peptide and then liberated Ce6 was activated in the aqueous solution. In animal pulmonary metastasis model using CT26 cells, ICI NC showed superior tumor targetability, i.e., fluorescence intensity was significantly strong in the mouse lung having metastatic tumor. On the contrary, cathepsin-B-deficient carriers such as atezolizumab-Ce6 conjugates or atezolizumab-Ce6/MePEG conjugates showed strong fluorescence intensity in the liver as well as lung. Our proposed ICI NC may be used for theragnostic cancer therapy with superior tumor specificity of releasing ICI and Ce6 into tumor microenvironment, thereby showing an efficient inhibitory effect on pulmonary metastasis of CT26 cells.
It would have been obvious to combine a compound of Zhou with an immune checkpoint inhibitor as both possess antitumor activity. Use of materials in combination, each of which is known to function for intended purpose, is generally held to be prima facie obvious as the idea of combining them flows logically from their having been individually taught in the prior art. In the instant case, Zhou provides a use of the chlorin compound, or a salt, a stereoisomer, a hydrate, a solvate or a prodrug thereof in the preparation of a drug, where the drug is a photosensitizer for photodynamic therapy or a sonosensitizer for sonodynamic therapy. Jeong teaches that immune checkpoint inhibitors (ICIs) have been extensively investigated in the recent decade since the inhibition of immune checkpoint expression in immune cells or cancer cells is believed to be a safer and more efficient therapeutic regimen for cancer patients than conventional therapy. Thus, claims that require no more than the combination of two anticancer compositions together in order to treat cancer in a patient set forth prima facie obvious subject matter.
All of the instant limitations are taught by the combination of Zhou and Jeong. A person of ordinary skill in the art would have had a reason to combine the teachings of Zhou and Jeong. A person of ordinary skill in the art would have had a reasonable expectation of success in combining the teachings of Zhou and Jeong. Thus, claims 24 and 55 would have been obvious based on the preponderance of the evidence.
Conclusion
Claims 1-4, 6, 8, 10-11, 13-14, 21, 23-24, 27, 33, 46-47, 49, 52-53, and 55 are pending. Claims 1-4, 6, 8, 10-11, 13-14, 21, 23-24, 27, 33, 46-47, 49, 52-53, and 55 are rejected. No claims are allowed.
Contacts
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PATRICK T LEWIS whose telephone number is (571)272-0655. The examiner can normally be reached Monday to Friday, 10 AM to 4 PM EST (Maxi Flex).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor can be reached at (571) 272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PATRICK T LEWIS/Primary Examiner, Art Unit 1691
/PL/
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