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
Applicant’s amendment filed on 09/24/2025, wherein claim 1 has been amended, and claims 2-9 have been cancelled.
Claims 1, 10-13 are pending and examined herein on the merits.
Any rejection from the previous office action which is not restated herein, is withdrawn.
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, 10-13 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.
It is not clear if the recitation “(POH-TMZ-LA)” in claim 1 is part of the claim. If it is intended to be part of the claim as a limitation, it cannot be enclosed in the parenthesis.
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.
1) Claims 1, 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (US 20160237092, PTO-892), in view of Mayo Clinic (09 February 2019, PTO-1449).
Chen et al. teaches a method of treating cancer in a mammal such as human (see para [0093] for human) comprising administering a perillyl alcohol carbamate (POH carbamate) wherein the perillyl alcohol is a triple conjugate of conjugated temozolomide (TMZ), perillyl alcohol (POH) and linoleic acid. See claims 3, 4, 5. Cancers that can be treated can be lymphoma such as Non-Hodgkin’s lymphoma. See para [0074]. It is taught that the mammal is further treated with radiation; further comprising administering a chemotherapeutic agent to the mammal. See para [0070]. It is taught that the route of administration can be inhalation, intranasal, oral intravenous, subcutaneous or intramuscular (meets instant claim 12). See claim 11
Chen et al. does not explicitly teach treating a non-Hodgkin lymphoma condition such as cutaneous T cell lymphoma mycosis fungoides comprising administering a therapeutically effective amount of perillyl alcohol carbamate wherein the perillyl alcohol carbamate is a triple conjugate of temozolomide (TMZ), perillyl alcohol (POH) and linoleic acid.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to administer to a human suffering from primary cutaneous T cell lymphoma mycosis fungoides a therapeutically effective amount of perillyl alcohol carbamate wherein the perillyl alcohol carbamate is a triple conjugate of temozolomide (TMZ), perillyl alcohol (POH) and linoleic acid because Chen et al. teaches a method of treating cancer in a mammal such as human (see para [0093] for human) comprising administering a perillyl alcohol carbamate (POH carbamate) wherein the perillyl alcohol carbamate is a triple conjugate of temozolomide (TMZ), perillyl alcohol (POH) and linoleic acid (see claims 3, 4, 5); Cancers that can be treated can be lymphoma such as Non-Hodgkin’s lymphoma (see para [0074]). One of ordinary skill in the art would be motivated to administer to a human suffering from primary cutaneous T cell lymphoma mycosis fungoides a therapeutically effective amount of perillyl alcohol carbamate, wherein the perillyl alcohol carbamate is a triple conjugate of temozolomide (TMZ), perillyl alcohol (POH) and linoleic acid with reasonable expectation of success of treating cutaneous lymphoma mycosis fungoides.
Mayo teaches that primary cutaneous T-cell lymphoma (CTCL) is a rare type of cancer that begins in white blood cells T cells (T lymphocytes). Mycosis fungoides is a type of cutaneous T-cell lymphoma; CTCL is a type of Non-Hodgin’s lymphoma. See the Entire article.
Further, it would be obvious to a person of ordinary skill in the art to administer to a human suffering from primary cutaneous T cell lymphoma mycosis fungoides a therapeutically effective amount of perillyl alcohol carbamate wherein the perillyl alcohol carbamate is a triple conjugate of temozolomide (TMZ), perillyl alcohol (POH) and linoleic acid because 1) Chen et al. teaches a method of treating cancer in a mammal such as human (see para [0093] for human) comprising administering a perillyl alcohol carbamate (POH carbamate) wherein the perillyl alcohol carbamate is a triple conjugate of temozolomide (TMZ), perillyl alcohol (POH) and linoleic acid (see claims 3, 4, 5); Cancers that can be treated can be lymphoma such as Non-Hodgkin’s lymphoma (see para [0074]); and 2) it is well known and Mayo teaches that primary cutaneous T cell lymphoma mycosis fungoides is a condition associated with a type of Non-Hodgkin’s lymphoma.
Response to Arguments
Applicant’s arguments with respect to claim(s) have been considered but are not persuasive because the new ground of rejection necessitated by Applicant’s amendment does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
1) Claims 1, 10-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6 of U.S. Patent No. 9,522,918, in view of Chen et al. (US 20160237092, PTO-892), and further in view of Mayo Clinic (09 February 2019, PTO-1449).
Instant claims are drawn to a method for treating a primary cutaneous lymphoma mycosis fungoides in a mammal, the method comprising administering to the mammal a therapeutically effective amount of a perillyl alcohol carbamate; wherein the perillyl alcohol carbamate is a triple conjugate of temozolomide (TMZ), perillyl alcohol (POH) and linoleic acid.
Claims of ‘918 are drawn to a composition comprising a perillyl alcohol carbamate, wherein the perillyl alcohol carbamate is a triple conjugate of temozolomide (TMZ), perillyl alcohol (POH) and linoleic acid; drawn to a method for treating melanoma in a mammal, comprising the step of delivering to the mammal a therapeutically effective amount of the perillyl alcohol carbamate of claim 1.
“918 does not teach treating a non-Hodgkin lymphoma condition such as cutaneous T cell lymphoma mycosis fungoides comprising administering a therapeutically effective amount of perillyl alcohol carbamate wherein the perillyl alcohol carbamate is a triple conjugate of temozolomide (TMZ), perillyl alcohol (POH) and linoleic acid.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to administer orally to a human suffering from primary cutaneous T cell lymphoma mycosis fungoides a therapeutically effective amount of perillyl alcohol carbamate, wherein the perillyl alcohol carbamate is a triple conjugate of temozolomide (TMZ), perillyl alcohol (POH) and linoleic acid because 1) ‘918 teaches a composition comprising a perillyl alcohol carbamate, wherein the perillyl alcohol carbamate is a triple conjugate of temozolomide (TMZ), perillyl alcohol (POH) and linoleic acid; ‘918 teaches a method for treating melanoma in a mammal, comprising the step of delivering to the mammal a therapeutically effective amount of the perillyl alcohol carbamate of claim 1; 2) Chen et al. teaches a method of treating cancer in a mammal such as human (see para [0093] for human) comprising administering a perillyl alcohol carbamate (POH carbamate) wherein the perillyl alcohol carbamate is a triple conjugate of temozolomide (TMZ), perillyl alcohol (POH) and linoleic acid (see claims 3, 4, 5); Cancers that can be treated can be lymphoma such as Non-Hodgkin’s lymphoma (see para [0074]); Chen et al. teaches that the administration can be inhalation, intranasal, oral intravenous, subcutaneous or intramuscular (meets instant claim 12); and 3) it is well known and Mayo teaches that primary cutaneous T cell lymphoma mycosis fungoides is a condition associated with a type of Non-Hodgkin’s lymphoma. One of ordinary skill in the art would be motivated to administer to a human suffering from primary cutaneous T cell lymphoma mycosis fungoides a therapeutically effective amount of perillyl alcohol carbamate wherein the perillyl alcohol carbamate is a triple conjugate of temozolomide (TMZ), perillyl alcohol (POH) and linoleic acid with reasonable expectation of success of treating cutaneous lymphoma mycosis fungoides.
Further, it would have been obvious to a person of ordinary skill in the art to treat the mammal with radiation; or further administer the mammal with a chemotherapeutic agent because Chen et al. teaches that the mammal is further treated with radiation; and Chen et al. teaches further administering a chemotherapeutic agent to the mammal.
2) Claims 1, 10-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 10,696,680, in view of Chen et al. (US 20160237092, PTO-892), and further in view of Mayo Clinic (09 February 2019, PTO-1449).
Instant claims are drawn to a method for treating a primary cutaneous lymphoma mycosis fungoides in a mammal, the method comprising administering to the mammal a therapeutically effective amount of a perillyl alcohol carbamate; wherein the perillyl alcohol carbamate is a triple conjugate of temozolomide (TMZ), perillyl alcohol (POH) and linoleic acid.
Claims of ‘680 are drawn to a method of treating cancer in a mammal comprising administering a composition comprising a perillyl alcohol carbamate, wherein the perillyl alcohol carbamate is a triple conjugate of temozolomide (TMZ), perillyl alcohol (POH) and linoleic acid; wherein the perillyl alcohol carbamate is administered by inhalation, intranasally, orally, intravenously, subcutaneously or intramuscularly; drawn to a method for treating a glioblastoma in a mammal, comprising the step of delivering to the mammal a therapeutically effective amount of the perillyl alcohol carbamate of claim 1.
“680 does not teach treating a non-Hodgkin lymphoma condition such as cutaneous T cell lymphoma mycosis fungoides comprising administering a therapeutically effective amount of perillyl alcohol carbamate wherein the perillyl alcohol carbamate is a triple conjugate of temozolomide (TMZ), perillyl alcohol (POH) and linoleic acid.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to administer to a human suffering from primary cutaneous T cell lymphoma mycosis fungoides a therapeutically effective amount of perillyl alcohol carbamate wherein the perillyl alcohol carbamate is a triple conjugate of temozolomide (TMZ), perillyl alcohol (POH) and linoleic acid because 1) ‘680 teaches a method of treating cancer in a mammal comprising administering a composition comprising a perillyl alcohol carbamate, wherein the perillyl alcohol carbamate is a triple conjugate of temozolomide (TMZ), perillyl alcohol (POH) and linoleic acid; 2) Chen et al. teaches a method of treating cancer in a mammal such as human (see para [0093] for human) comprising administering a perillyl alcohol carbamate (POH carbamate) wherein the perillyl alcohol carbamate is a triple conjugate of temozolomide (TMZ), perillyl alcohol (POH) and linoleic acid (see claims 3, 4, 5); Cancers that can be treated can be lymphoma such as Non-Hodgkin’s lymphoma (see para [0074]); and 3) it is well known and Mayo teaches that primary cutaneous T cell lymphoma mycosis fungoides is a condition associated with a type of Non-Hodgkin’s lymphoma. One of ordinary skill in the art would be motivated to administer to a human suffering from primary cutaneous T cell lymphoma mycosis fungoides a therapeutically effective amount of perillyl alcohol carbamate wherein the perillyl alcohol carbamate is a triple conjugate of temozolomide (TMZ), perillyl alcohol (POH) and linoleic acid with reasonable expectation of success of treating cutaneous lymphoma mycosis fungoides.
Further, it would have been obvious to a person of ordinary skill in the art to treat the mammal with radiation; or further administer the mammal with a chemotherapeutic agent because Chen et al. teaches that the mammal is further treated with radiation; Chen et al. teaches further administering a chemotherapeutic agent to the mammal.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHOBHA KANTAMNENI, Ph.D whose telephone number is (571)272-2930. The examiner can normally be reached on Monday to Friday; 8.00 am-4.30 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel, Ph.D can be reached on 571-270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHOBHA KANTAMNENI/ Primary Examiner, Art Unit 1627