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
2. Claims 1 – 27 are pending in this application. Applicant’s preliminary amendment, submitted May 5, 2025, is entered, wherein no claims have been amended.
Priority
3. This application is a national stage application of PCT/US2021/055383, filed October 18, 2021, which claims benefit of domestic application, filed October 16, 2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/12/2023 was filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code in line 21 of page 10, line 1 of page 11, and line 8 of page 28. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
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.
Claims 1 – 23 and 25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chen (WO2019/157195A1).
a. Independent claim 1 is directed to a method of administering a therapeutic agent to a central nervous system of mammal, wherein the method comprises administering a monoterpene before or concurrently with the therapeutic agent. Dependent claim 2 is directed to the method, wherein the central nervous system is the brain. Dependent claim 3 is directed to the method, wherein the monoterpene is perillyl alcohol. Dependent claim 4 is directed to the method, wherein the perillyl alcohol is administered intraarterially. Dependent claim 5 is directed to the method, wherein the perillyl alcohol is administered at a dose ranging from about 0.050 mg/kg to about 500 mg/kg of body weight. Dependent claim 6 is directed to the method, wherein the mammal is a human. Dependent claims 7 – 8 are directed to the method, wherein the monoterpene is administered from about 0.2 minutes to about 60 minutes and about 1 minute to about 15 minutes before the therapeutic agent is administered. Dependent claims 9 – 10 are directed to the method, wherein the monoterpene and the therapeutic agent are administered separately and concurrently. Dependent claim 11 is directed to the method, wherein the monoterpene and the therapeutic agent are administered together in a pharmaceutical composition. Dependent claim 12 is directed to the method, wherein the therapeutic agent is a chemotherapeutic agent. Dependent claim 13 is directed to the method, wherein the chemotherapeutic agent is a DNA alkylating agent, a topoisomerase inhibitor, an endoplasmic reticulum stress inducing agent, a platinum compound, an antimetabolite, an enzyme inhibitor, a receptor antagonist, a therapeutic antibody, or combinations thereof. Dependent claim 14 is directed to the method, wherein the chemotherapeutic agent is dimethyl-celecoxib (DMC), irinotecan (CPT-11), temozolomide, or rolipram. Dependent claim 15 is directed to the method, wherein the therapeutic agent is an antibody. Dependent claim 16 is directed to the method, wherein the therapeutic agent is an immune cell expressing a chimeric antigen receptor. Dependent claim 17 is directed to the method, wherein the immune cell is a T cell. Dependent claim 18 is directed to the method, wherein the therapeutic agent is a CAR-T cell. Dependent claims 19 and 25 are directed to the method, wherein the monoterpene is administered by inhalation or intranasally, orally, intravenously, subcutaneously or intramuscularly. Dependent claim 20 is directed to the method, wherein the mammal has cancer. Dependent claim 21 is directed to the method, wherein the cancer is a tumor of the nervous system. Dependent claim 22 is directed to the method, wherein the tumor is glioblastoma. Dependent claim 23 is directed to the method, wherein the method further comprises treating the mammal with radiation.
Chen teaches an invention relates to using monoterpene to permeabilize the blood brain barrier (Abstract). Perillyl alcohol (POH), a naturally occurring monoterpene, has been suggested to be an effective agent against a variety of cancers, including CNS cancer, breast cancer, pancreatic cancer, lung cancer, melanoma, and colon cancer (page 3, lines 23 – 25). Chen teaches a method of administering a therapeutic agent to a central nervous system of a mammal, such as human, wherein the method comprising administering a monoterpene before, after or concurrently with the therapeutic agent. The central nervous system may be the brain and the monoterpene may be POH. POH may be administered into a vascular system of the mammal intraarterially, via inhalation, or intranasally. POH may be administered at a dose ranging from about 0.050 mg/kg to about 500 mg/kg of body weight. The administration is about 0.2 minutes to about 60 minutes or about 1 minute to about 15 minute before the therapeutic agent is administered. The POH and the therapeutic agent may be administered separately or concurrently. In one embodiment, the POH and the therapeutic agent are administered together in a pharmaceutical composition. The therapeutic agent may be a chemotherapeutic agent, wherein the chemotherapeutic agents is a DNA alkylating agent, a topoisomerase inhibitor, an endoplasmic reticulum stress inducing agent, a platinum compound, an antimetabolite, an enzyme inhibitor, a receptor antagonist, a therapeutic antibody, or combinations thereof and the chemotherapeutic agent may be DMC, CPT-11, temozolomide, or rolipram. The therapeutic agent may also be an antibody or immune cell expressing a chimeric antigen receptor. The immune cell may be a T cell. In one embodiment, the therapeutic agent is a CAR-T cell. The mammal may have cancer, such as a tumor of the nervous system, such as glioblastoma. The method further comprises the step of treating the mammal with radiation (page 5, lines 1 – 31).
For the reasons above, Chen anticipates the claimed invention.
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:
i. Determining the scope and contents of the prior art.
ii. Ascertaining the differences between the prior art and the claims at issue.
iii. Resolving the level of ordinary skill in the pertinent art.
iv. Considering objective evidence present in the application indicating obviousness or
nonobviousness.
Claims 1 – 27 are rejected under 35 U.S.C. 103 as being unpatentable over Chen (WO2019/157195A1) in view of Peralta et al. (US2020/0237689A1) and Najjar et al. (Journal of Neuroinflammation, 2020, Vol. 17, Issue 1, Reference included with PTO-892). Claims 1 – 23 and 25 are rejected here because they have been rejected by the primary reference under 102.
b. Regarding claims 1 – 27, Chen teaches an invention relates to using monoterpene to permeabilize the blood brain barrier (BBB) (Abstract). Perillyl alcohol (POH), a naturally occurring monoterpene, has been suggested to be an effective agent against a variety of cancers, including CNS cancer, breast cancer, pancreatic cancer, lung cancer, melanoma, and colon cancer (page 3, lines 23 – 25). Chen teaches a method of administering a therapeutic agent to a central nervous system of a mammal, such as human, wherein the method comprising administering a monoterpene before, after or concurrently with the therapeutic agent. The central nervous system may be the brain and the monoterpene may be POH. POH may be administered into a vascular system of the mammal intraarterially, via inhalation, or intranasally. POH may be administered at a dose ranging from about 0.050 mg/kg to about 500 mg/kg of body weight. The administration is about 0.2 minutes to about 60 minutes or about 1 minute to about 15 minute before the therapeutic agent is administered. The POH and the therapeutic agent may be administered separately or concurrently. In one embodiment, the POH and the therapeutic agent are administered together in a pharmaceutical composition. The therapeutic agent may be a chemotherapeutic agent, wherein the chemotherapeutic agents is a DNA alkylating agent, a topoisomerase inhibitor, an endoplasmic reticulum stress inducing agent, a platinum compound, an antimetabolite, an enzyme inhibitor, a receptor antagonist, a therapeutic antibody, or combinations thereof and the chemotherapeutic agent may be DMC, CPT-11, temozolomide, or rolipram. The therapeutic agent may also be an antibody or immune cell expressing a chimeric antigen receptor. The immune cell may be a T cell. In one embodiment, the therapeutic agent is a CAR-T cell. The mammal may have cancer, such as a tumor of the nervous system, such as glioblastoma. The method further comprises the step of treating the mammal with radiation (page 5, lines 1 – 31). Moreover, Chen discloses that monoterpene can be used to deliver at least one therapeutic agent across the BBB (page 8, lines 4 – 5) and the monoterpene may be used in combination with antiviral agents (page 8, lines 23 – 24).
However, Chen does not explicitly teach that the therapeutic agent is remdesivir.
Peralta et al. teach a method of preventing or reducing the risk of infection in a subject caused by exposure to a coronavirus, wherein the method further comprises administration of one or more antiviral drugs, such as remdesivir (para. [0012]). In some embodiments, the therapeutic or active agent is administered intranasally (para. [0160]).
Najjar et al. teach that neurological complications of SAR-CoV-2 infection are high among those with severe and critical illnesses. Najjar et al. also teach that CNS complications associated with COVID-19 attributes to primary CNS involvement due to rare direct neuroinvasion and more commonly secondary CNS sequelae due to exuberant systemic innate-mediated hyper-inflammation. Systemic hyper-inflammation provoked by maladaptive innate immunity may impair neurovascular endothelial function, disrupt BBB, activate CNS innate immune signaling pathways, and induce para-infectious autoimmunity, potentially contributing to the CNS complications associated with SARS-CoV-2 infection (Abstract).
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to substitute the therapeutic agent, such as antiviral drugs, in the composition of monoterpene as taught by Chen with remdesivir in view of Peralta et al., as motivated by Najjar et al, in order to enhance CNS delivery of remdesivir using a monoterpene because Chen explicitly teaches that the therapeutic agent may be an antiviral agent and monoterpenes help BBB permeability for antiviral agents, Peralta et al. teach that remdesivir is a known antiviral agent for coronavirus, and Najjar et al. teach that coronavirus will invade CNS. One would have been motivated to substitute the therapeutic agent, such as antiviral drugs, in the composition of monoterpene as taught by Chen with remdesivir in view of Peralta et al., as motivated by Najjar et al, in order to enhance CNS delivery of remdesivir using a monoterpene because Najjar et al. teach that SARS-CoV-2 infection contributes to CNS complications, which provides the motivation to deliver antiviral agent to the CNS. It would have been obvious to combine the teachings because said combination will yield predictable results that is a composition comprising remdesivir and monoterpene with the ability to cross BBB. Therefore, one of the ordinary skill in the art would have had a reasonable expectation of success to substitute the therapeutic agent, such as antiviral drugs, in the composition of monoterpene as taught by Chen with remdesivir in view of Peralta et al., as motivated by Najjar et al, in order to enhance CNS delivery of remdesivir using a monoterpene because Chen discloses the drug formulation for CNS delivery and Peralta et al. and Najjar et al. provide the motivation for combining remdesivir and monoterpene.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1 – 23 and 25 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1 – 23 of copending Application No. 16/967,549 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Claims 1, 3 – 11, 15, 19 – 23, and 25 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1 – 10 and 12 – 17 of copending Application No. 18/190,643 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Claims 1 – 3, 5 – 11, 16 – 18, and 20 – 23 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1 – 13 of copending Application No. 18/984,062 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Claims 1 – 3, 5 – 11, 16 – 18, and 20 – 23 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1 – 13 of prior U.S. Patent No. 12208066B2. This is a statutory double patenting rejection.
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, 10 – 11, 19, and 25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7 and 9 of copending Application No. 18/557,650 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘650 anticipates the claimed invention.
a. Independent claim 1 is directed to a method of administering a therapeutic agent to a CNS of a mammal, wherein the method comprising administering a monoterpene before or concurrently with the therapeutic agent. Dependent claim 10 is directed to the method, wherein the monoterpene and the therapeutic agent are administered concurrently. Dependent claim 11 is directed to the method, wherein the components are administered together in a pharmaceutical composition. Dependent claims 19 and 25 are directed to the method, wherein the monoterpene is administered intranasally.
‘650 teaches a method of treating one or more symptoms in a patient that has Parkinson’s Disease, wherein the method comprises administering a pharmaceutical composition to a patient, wherein the pharmaceutical composition comprising POH and L-Dopa (claim 7). The pharmaceutical composition is administered intranasally (claim 9).
Although ‘650 does not explicitly recite administering a therapeutic agent to the CNS, the method disclosed includes administration of POH, a known monoterpene as a BBB permeation enhancer. As such, it would have been understood by one of ordinary skill in the art that the co-administration of POH and L-Dopa would inherently result in increased CNS delivery of the L-Dopa due to POH’s known effect on enhancing BBB permeability.
For these reasons above, ‘650 anticipates the claimed invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1 – 2, 9 – 12, 19 – 23, and 25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3 – 6, and 8 – 17 of copending Application No. 15/997,300 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘300 anticipates the claimed invention.
b. Independent claim 1 is directed to a method of administering a therapeutic agent to a central nervous system of mammal, wherein the method comprises administering a monoterpene before or concurrently with the therapeutic agent. Dependent claim 2 is directed to the method, wherein the central nervous system is the brain. Dependent claims 9 – 10 are directed to the method, wherein the monoterpene and the therapeutic agent are administered separately and concurrently. Dependent claim 11 is directed to the method, wherein the monoterpene and the therapeutic agent are administered together in a pharmaceutical composition. Dependent claim 12 is directed to the method, wherein the therapeutic agent is a chemotherapeutic agent. Dependent claims 19 and 25 are directed to the method, wherein the monoterpene is administered by inhalation or intranasally, orally, intravenously, subcutaneously or intramuscularly. Dependent claim 20 is directed to the method, wherein the mammal has cancer. Dependent claim 21 is directed to the method, wherein the cancer is a tumor of the nervous system. Dependent claim 22 is directed to the method, wherein the tumor is glioblastoma. Dependent claim 23 is directed to the method, wherein the method further comprises treating the mammal with radiation.
‘300 teaches a method for treating a disease in a mammal, comprising the step of administering to the mammal a therapeutically effective amount of an isoperillyl alcohol or isoperillyl alcohol carbamate (claims 1 and 11). The disease treated is a cancer, wherein the cancer is a tumor of the nervous system, wherein the tumor is glioblastoma (claims 3 – 5 and 12 – 14). ‘300 teaches that the method further comprises the step of treating the mammal with radiation and the step of administering to the mammal a chemotherapeutic agent (claims 6, 8, and 15 – 16), wherein the isoperillyl alcohol is administered before, during, or after the administration of the chemotherapeutic agent (claim 9). The route of administration is intranasal (claims 10 and 17).
Although ‘300 does not explicitly recite administering a therapeutic agent to the CNS, the method disclosed includes administration of POH, a known monoterpene as a BBB permeation enhancer. As such, it would have been understood by one of ordinary skill in the art that the co-administration of POH and chemotherapeutic agent would inherently result in increased CNS delivery of the chemotherapeutic agent due to POH’s known effect on enhancing BBB permeability.
For these reasons above, ‘300 anticipates the claimed invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1 – 2, 10 – 15, 19 – 23, and 25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3 – 6, and 8 – 17 of U.S. Patent No. 9700524B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘524B2 anticipates the claimed invention.
c. Independent claim 1 is directed to a method of administering a therapeutic agent to a central nervous system of mammal, wherein the method comprises administering a monoterpene before or concurrently with the therapeutic agent. Dependent claim 2 is directed to the method, wherein the central nervous system is the brain. Dependent claim 10 is directed to the method, wherein the monoterpene and the therapeutic agent are administered concurrently. Dependent claim 11 is directed to the method, wherein the monoterpene and the therapeutic agent are administered together in a pharmaceutical composition. Dependent claim 12 is directed to the method, wherein the therapeutic agent is a chemotherapeutic agent. Dependent claim 13 is directed to the method, wherein the chemotherapeutic agent is a DNA alkylating agent, a topoisomerase inhibitor, an endoplasmic reticulum stress inducing agent, a platinum compound, an antimetabolite, an enzyme inhibitor, a receptor antagonist, a therapeutic antibody, or combinations thereof. Dependent claim 14 is directed to the method, wherein the chemotherapeutic agent is dimethyl-celecoxib (DMC), irinotecan (CPT-11), temozolomide, or rolipram. Dependent claim 15 is directed to the method, wherein the therapeutic agent is an antibody. Dependent claims 19 and 25 are directed to the method, wherein the monoterpene is administered by inhalation or intranasally, orally, intravenously, subcutaneously or intramuscularly. Dependent claim 20 is directed to the method, wherein the mammal has cancer. Dependent claim 21 is directed to the method, wherein the cancer is a tumor of the nervous system. Dependent claim 22 is directed to the method, wherein the tumor is glioblastoma. Dependent claim 23 is directed to the method, wherein the method further comprises treating the mammal with radiation.
‘524B2 teaches a method for treating a tumor of the nervous system, comprising the step of delivering to a subject in need thereof a therapeutically effective amount of (S)-perillyl alcohol (claim 1). The tumor is a glioblastoma (claim 2). The method further comprises a step of treating the subject in need thereof with radiation and a step of delivering to the subject in need thereof a chemotherapeutic agent (claims 3 – 4), wherein the chemotherapeutic agent is a DNA alkylating agent, a topoisomerase inhibitor, an endoplasmic reticulum stress inducing agent, a platinum compound, an antimetabolite, an enzyme inhibitor, a receptor antagonist, or a therapeutic antibody (claim 5). The chemotherapeutic agent is a DMC (claim 6). The (S)-perillyl alcohol is delivered by intranasally (claim 7) and is admixed or coformulated with a therapeutic agent (claim 8).
Although ‘524B2 does not explicitly recite administering a therapeutic agent to the CNS, the method disclosed includes administration of POH, a known monoterpene as a BBB permeation enhancer. As such, it would have been understood by one of ordinary skill in the art that the co-administration of POH and chemotherapeutic agent would inherently result in increased CNS delivery of the chemotherapeutic agent due to POH’s known effect on enhancing BBB permeability.
For these reasons above, ‘524B2 anticipates the claimed invention.
Claims 1 – 2, 10 – 14, 19, and 25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 30 and 32 of copending Application No. 18/461,562 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘562 anticipates the claimed invention.
d. Independent claim 1 is directed to a method of administering a therapeutic agent to a central nervous system of mammal, wherein the method comprises administering a monoterpene before or concurrently with the therapeutic agent. Dependent claim 2 is directed to the method, wherein the central nervous system is the brain. Dependent claim 10 is directed to the method, wherein the monoterpene and the therapeutic agent are administered concurrently. Dependent claim 11 is directed to the method, wherein the monoterpene and the therapeutic agent are administered together in a pharmaceutical composition. Dependent claim 12 is directed to the method, wherein the therapeutic agent is a chemotherapeutic agent. Dependent claim 13 is directed to the method, wherein the chemotherapeutic agent is a DNA alkylating agent, a topoisomerase inhibitor, an endoplasmic reticulum stress inducing agent, a platinum compound, an antimetabolite, an enzyme inhibitor, a receptor antagonist, a therapeutic antibody, or combinations thereof. Dependent claim 14 is directed to the method, wherein the chemotherapeutic agent is dimethyl-celecoxib (DMC), irinotecan (CPT-11), temozolomide, or rolipram. Dependent claims 19 and 25 are directed to the method, wherein the monoterpene is administered by inhalation or intranasally, orally, intravenously, subcutaneously or intramuscularly.
‘562 teaches a pharmaceutical composition comprising a perillyl alcohol; a therapeutic agent, wherein the therapeutic agent is DMC; and a statin (claim 30). The pharmaceutical composition is administered intranasally (claim 32).
Although ‘562 does not explicitly recite administering a therapeutic agent to the CNS, the method disclosed includes administration of POH, a known monoterpene as a BBB permeation enhancer. As such, it would have been understood by one of ordinary skill in the art that the co-administration of POH and therapeutic agent would inherently result in increased CNS delivery of the chemotherapeutic agent due to POH’s known effect on enhancing BBB permeability.
For these reasons above, ‘562 anticipates the claimed invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1 – 2, 9, 12 – 15, and 20 – 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 3 and 6 of U.S. Patent No. 11970436B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘436B2 anticipates the claimed invention.
e. Independent claim 1 is directed to a method of administering a therapeutic agent to a central nervous system of mammal, wherein the method comprises administering a monoterpene before or concurrently with the therapeutic agent. Dependent claim 2 is directed to the method, wherein the central nervous system is the brain. Dependent claim 9 is directed to the method, wherein the monoterpene and the therapeutic agent are administered separately. Dependent claim 12 is directed to the method, wherein the therapeutic agent is a chemotherapeutic agent. Dependent claim 13 is directed to the method, wherein the chemotherapeutic agent is a DNA alkylating agent, a topoisomerase inhibitor, an endoplasmic reticulum stress inducing agent, a platinum compound, an antimetabolite, an enzyme inhibitor, a receptor antagonist, a therapeutic antibody, or combinations thereof. Dependent claim 14 is directed to the method, wherein the chemotherapeutic agent is dimethyl-celecoxib (DMC), irinotecan (CPT-11), temozolomide, or rolipram. Dependent claim 15 is directed to the method, wherein the therapeutic agent is an antibody. Dependent claim 20 is directed to the method, wherein the mammal has cancer. Dependent claim 21 is directed to the method, wherein the cancer is a tumor of the nervous system.
‘436B2 teaches a method for treating a central nervous system cancer, comprising administering intraarterially to a patient a therapeutically effective amount of (S)-perillyl alcohol (claim 1). The method further comprises the step of delivering to the patient a chemotherapeutic agent, wherein the chemotherapeutic agent is a DNA alkylating agent, a topoisomerase inhibitor, an endoplasmic reticulum stress inducing agent, a platinum compound, an antimetabolite, an enzyme inhibitor, a receptor antagonist, or a therapeutic antibody (claims 2 – 3). The chemotherapeutic agent is DMC (claim 6).
For these reasons above, ‘436B2 anticipates the claimed invention.
Conclusion
No claim is found to be allowable.
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/H.Y.L./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693