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
This action is in response to papers filed December 17, 2025. Applicant’s reply to the restriction/election requirement of June 18, 2025 has been entered. Claims 5-7 and 13-15 have been amended. Claims 1-15 are pending in the application.
Priority
Applicant’s claim for the benefit of prior-filed WIPO International Application No. PCT/US2021/059117, filed November 12, 2021 under 35 U.S.C. 365(c), which claims the benefit of prior-filed U.S. Provisional Patent Application No.63/112,799, filed November 12, 2020 under 35 U.S.C. 119(e), is acknowledged.
Election/Restrictions
Applicant’s elections of i) “perillyl alcohol” as the species of composition constituent, ii) “a chemotherapeutic agent” as the species of further treatment, iii) “dimethyl-celecoxib” as the species of chemotherapeutic agent, iv) “intranasally” as the species of route of administration of the composition, v) “a nebulizer” as the species of nasal delivery device, vi) “perillyl alcohol conjugated with dimethyl celecoxib” as the species of perillyl alcohol carbamate are all acknowledged. The Examiner has determined that claims 1-3, 5-9, 11, and 13-15 read on the elected subject matter.
Accordingly, claims 4, 10, and 12 are hereby withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected subject matter, there being no allowable generic or linking claim. Because Applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Election was made without traverse in the reply filed on December 17, 2025. Claims 1-3, 5-9, 11, and 13-15 are under examination.
Abstract
The abstract of the disclosure is objected to because of the following:
1. The abstract should be a concise summary of the key technical aspects of the invention which are new to the art to which the invention pertains. If the invention pertains to a composition, the abstract should recite the key requisite ingredients. If the invention pertains to a method, the abstract should recite the key requisite active steps.
2. In this case, the abstract merely informs the reader that the invention is an intranasal glioblastoma therapy with perillyl alcohol. This is not new to the art at all.
3. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art. However, this is precisely what the abstract does.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Obviousness-Type Double Patenting (I and II)
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.
I. Claims 1-3, 5-9, 11, and 13-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10-17 of U.S. Patent No. 9,499,461, in view of Parsons et al. (Science. 2008; 321: 1807-1812).
Applicant’s elected subject matter is directed to a method of treating glioblastoma in a patient that has a mutated isocitrate dehydrogenase 1 (IDH1) gene comprising administering intranasally to the patient via a nebulizer a composition comprising perillyl alcohol and dimethyl celecoxib.
Claims 10-17 of U.S. Patent No. 9,499,461 disclose a method of treating e.g. glioblastoma in a patient comprising administering e.g. intranasally to the patient a composition comprising e.g. perillyl alcohol and dimethyl celecoxib. U.S. Patent No. 9,499,461 discloses that by intranasal administration is meant e.g. with a nebulizer.
Parsons et al. disclose that a mutated isocitrate dehydrogenase 1 (IDH1) gene is a marker for human glioblastoma occurring specifically in a large fraction of young patients and in most patients with secondary glioblastoma.
Although claims 10-17 of U.S. Patent No. 9,499,461 do not explicitly disclose that the patient being treated has a mutated isocitrate dehydrogenase 1 (IDH1) gene, since Parsons et al. disclose that a mutated isocitrate dehydrogenase 1 (IDH1) gene is a marker for human glioblastoma occurring specifically in a large fraction of young patients and in most patients with secondary glioblastoma; one of ordinary skill in the art would thus be motivated to apply the method of claims 10-17 of U.S. Patent No. 9,499,461 specifically to those patients diagnosed with glioblastoma that have a mutated isocitrate dehydrogenase 1 (IDH1) gene, with the reasonable expectation that the method will successfully treat the cancer.
II. Claima 1-3, 5-9, 11, and 13-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 9,700,524 in view of Parsons et al. (Science. 2008; 321: 1807-1812).
Applicant’s elected subject matter is directed to a method of treating glioblastoma in a patient that has a mutated isocitrate dehydrogenase 1 (IDH1) gene comprising administering intranasally to the patient via a nebulizer a composition comprising perillyl alcohol and dimethyl celecoxib.
Claims 1-9 of U.S. Patent No. 9,700,524 disclose a method of treating e.g. glioblastoma in a patient comprising administering e.g. intranasally to the patient a composition comprising e.g. perillyl alcohol and dimethyl celecoxib. U.S. Patent No. 9,700,524 discloses that by intranasal administration is meant e.g. with a nebulizer.
Parsons et al. disclose that a mutated isocitrate dehydrogenase 1 (IDH1) gene is a marker for human glioblastoma occurring specifically in a large fraction of young patients and in most patients with secondary glioblastoma.
Although claims 1-9 of U.S. Patent No. 9,700,524 do not explicitly disclose that the patient being treated has a mutated isocitrate dehydrogenase 1 (IDH1) gene, since Parsons et al. disclose that a mutated isocitrate dehydrogenase 1 (IDH1) gene is a marker for human glioblastoma occurring specifically in a large fraction of young patients and in most patients with secondary glioblastoma; one of ordinary skill in the art would thus be motivated to apply the method of claims 1-9 of U.S. Patent No. 9,700,524 specifically to those patients diagnosed with glioblastoma that have a mutated isocitrate dehydrogenase 1 (IDH1) gene, with the reasonable expectation that the method will successfully treat the cancer.
Claim Rejections - 35 USC § 112(b)
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 1-3. 5-9, 11, and 13-15 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.
Claim 1 is indefinite for the following reasons:
1. Claim 1 is directed to a method of treating a patient with a tumor by administering to the patient a composition comprising perillyl alcohol. The term “patient” appears to be more limited in scope and nuanced compared to a more generic term like e.g. “subject”. One of ordinary skill in the art cannot definitively ascertain the metes and bounds of “patient”. For example, is a patient necessarily one under the general care of any healthcare worker? Or rather, is a patient necessarily under the general care of a licensed medical doctor (MD)? Is a patient necessarily in a hospital, whether formally admitted or not? Or rather is a patient necessarily formally admitted to the hospital? Or what?
2. Claim 1 is directed to a method of treating a tumor of the nervous system, which involves administering a composition comprising perillyl alcohol or perillyl alcohol carbamate, wherein the perillyl alcohol carbamate is defined as “perillyl alcohol covalently bound via a carbamate linking group to a therapeutic agent”. One of ordinary skill in the art would understand perillyl alcohol itself to be an anti-tumor agent. Hence, in the case of perillyl alcohol carbamate linked to the “therapeutic agent” one of ordinary skill in the art cannot definitively ascertain whether the “therapeutic agent” is necessarily limited only to anti-tumor agents, or rather broadly includes any therapeutic agent, such as an agent that treats pain or inflammation but is not necessarily an anti-tumor agent.
Claims 5 and 6 each depend from claim 11. Prior to claims 5 and 6, however, there is no claim 11. There is thus insufficient antecedent basis for any claim 11.
Claim 11, which depends from claim 1, stipulates the step of “further administering to the patient a chemotherapeutic agent”. Claim 1 already requires the administration to the patient of perillyl alcohol, which would be understood by one of ordinary skill in the art as a chemotherapeutic agent. Hence, the limitation of claim 11 appears to be incongruous, and one of ordinary skill in the art cannot definitively ascertain the metes and bounds of the claimed subject matter.
Claims 13-15 are indefinite for the following reasons:
1. Claims 13-15, which depend (ultimately) from claim 1, stipulate in a wherein clause that the perillyl alcohol has a “purity” as recited, e.g. greater than about 99% (w/w). Claim 1, however, is directed to a method of treating a tumor in a patient, and requires the administration of a composition that comprises perillyl alcohol. In other words, claim 1 is not directed to perillyl alcohol itself, but rather a composition that includes perillyl alcohol and, in view of the “comprising” transitional phrase, could include just about anything else in one amount or another (i.e. nothing is necessarily excluded). In this context, the limitations of claims 13-15 appear to be effectively meaningless. One of ordinary skill in the art thus cannot definitively ascertain what element(s) are necessarily further included in or excluded from the composition being administered by the purity limitations recited in claims 13-15.
2. Claims 13-15 employ the expression “greater than about”, e.g. “greater than about 99.0% (w/w)”. While “greater than” or “about” when employed individually are generally considered definite, the expression “greater than about” is generally considered indefinite.
3. Claim 13 recites a broader range, i.e. “greater than about 99.0%”, together with a narrower range, i.e. “greater than about 99.5%”, which falls within the broader range, in the alternative in the same claim, which is indefinite.
Claims 2, 3, 5-9, 11, and 13-15 are (also) indefinite for depending from an indefinite claim.
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.
Claims 1-3, 5-9, 11, and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (U.S. Patent Application Pub. No. 2016/0158162), in view of Parsons et al. (Science. 2008; 321: 1807-1812).
Applicant Claims
Applicant’s elected subject matter is directed to a method of treating glioblastoma in a patient that has a mutated isocitrate dehydrogenase 1 (IDH1) gene comprising administering intranasally to the patient via a nebulizer a composition comprising perillyl alcohol and dimethyl celecoxib.
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
Chen et al. disclose a method of treating e.g. glioblastoma in a patient comprising administering e.g. intranasally to the patient via a nebulizer a composition comprising e.g. perillyl alcohol and dimethyl celecoxib (see e.g. abstract; paragraphs 0005, 0012, 0013, 0073, 0074, 0084, 0112, 0152; claims 8, 10, 14, 15).
Parsons et al. disclose that a mutated isocitrate dehydrogenase 1 (IDH1) gene is a marker for human glioblastoma occurring specifically in a large fraction of young patients and in most patients with secondary glioblastoma.
Ascertainment of the Difference Between the Scope of the Prior Art and the Claims (MPEP §2141.02)
Chen et al. do not explicitly disclose that the patients with glioblastoma being treated have a mutated isocitrate dehydrogenase 1 (IDH1) gene. This deficiency is cured by the teachings of Parsons et al.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious for one of ordinary skill in the art at the time the present application was filed to combine the respective teachings of Chen et al. and Parsons et al., outlined supra, to devise Applicant’s presently claimed method.
Chen et al. disclose a method of treating cancer in a patient comprising administering e.g. intranasally to the patient via a nebulizer a composition comprising e.g. perillyl alcohol and dimethyl celecoxib; wherein the cancer can be glioblastoma. Since Parsons et al. disclose that a mutated isocitrate dehydrogenase 1 (IDH1) gene is a marker for human glioblastoma occurring specifically in a large fraction of young patients and in most patients with secondary glioblastoma; one of ordinary skill in the art would thus be motivated to apply Chen et al.’s glioblastoma treatment specifically to those patients diagnosed with glioblastoma that have a mutated isocitrate dehydrogenase 1 (IDH1) gene, with the reasonable expectation that the method, applied specifically to these patients diagnosed with glioblastoma and that have a specific marker for glioblastoma, will successfully treat the cancer.
In light of the foregoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID BROWE whose telephone number is (571)270-1320. The examiner can normally be reached Monday - Friday, 9:30 AM to 6 PM EST.
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/DAVID BROWE/Primary Examiner, Art Unit 1617