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 .
Status of Claims
Claims 1 and 3-12 are pending in the instant application.
Claim 2 has been canceled.
Withdrawn Objections/Rejections
Applicant’s replacement drawing sheets filed March 19th, 2026 are sufficient to overcome the objection to the drawings raised in the non-final rejection mailed December 8th, 2025. This objection is hereby withdrawn.
Applicant has canceled Claim 2, rendering the rejection thereof under 35 U.S.C. 112(d) moot. This rejection is hereby withdrawn.
Applicant’s amendment is sufficient to overcome the rejection of Claims 1-12 under 35 U.S.C. 112(b). Claim 2 has been canceled, rendering the rejection thereof moot. This rejection is hereby withdrawn.
Applicant’s amendment is sufficient to overcome the rejection of Claims 1-12 under 35 U.S.C. 101. Claim 2 has been canceled, rendering the rejection thereof moot. This rejection is hereby withdrawn.
The following rejections are necessitated by amendment:
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 4-12 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding Claim 4, “for inhibiting cell-mediated immunity” is a recitation of intended use.
Regarding Claim 5, “for the treatment of allograft rejection” is a recitation of intended use.
Regarding Claim 6, “for the treatment of autoimmune diseases” is a recitation of intended use.
Regarding Claim 7, “for the treatment of cancer” is a recitation of intended use.
Regarding Claim 8, “for the treatment of psoriasis” is a recitation of intended use.
Regarding Claim 9, “for the treatment of atopy” is a recitation of intended use.
Regarding Claim 10, “for the treatment of insulin-dependent diabetes mellitus” is a recitation of intended use.
Regarding Claim 11, “for the treatment of multiple sclerosis” is a recitation of intended use.
Regarding Claim 12, “for the treatment of rheumatoid arthritis” is a recitation of intended use.
Per MPEP 211.02, II., “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.” In the instant case, the recitations of intended use do not provide a further structural limitation to the composition recited at Claim 1, from which the instant Claims 4-12 depend. Therefore, dependent Claims 4-12 are not further limiting of instant Claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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.
Claims 1 and 3-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dubois et. al. (WO 98/35650; hereinafter referred to as Dubois).
At Page 1, under “TECHNICAL FIELD” Dubois states “The present invention relates to personal care and pharmaceutical compositions for use on the skin, hair, and mucosa.” At Page 2, Dubois states, “… an object of the present invention to provide personal care and pharmaceutical compositions…”. Further, at Page 3, under “DETAILED DESCRIPTION OF THE INVENTION”, Dubois states “The compositions of the present invention are suitable for topical application to the skin, hair, or mucosa. These compositions comprise alcohol, a personal care polymer, and a perfumery component which substantially masks or reduces the odor or aroma of alcohol and the stinging or burning sensation of alcohol in the nose or throat when the compositions are used by spraying or atomizing.” Therefore, a person having ordinary sill in the art would recognize the compositions taught by Dubois as pharmaceutical compositions, reading on the instantly recited limitation at Claim 1.
At Page 18, Fifth Paragraph, Dubois teaches cis-3-hexenyl salicylate as a suitable ester for use in the disclosed compositions. At Page 19, Fourth Paragraph, cis-3-hexenyl salicylate is listed as a preferred alcohol-masking perfumery compound for use in the disclosed invention. At Pages 33-37, Dubois teaches Examples I-XXIV as compositions comprising cis-3-hexenyl salicylate. Examples XIII-XVI are disclosed as topical analgesic compositions, reading on the limitation of a pharmaceutical composition.
For clarity of the record, cis-3-hexenyl salicylate is a compound of the following structure:
PNG
media_image1.png
218
486
media_image1.png
Greyscale
This compound reads on a compound of Formula 1 as instantly recited when the variables are defined as follows: R is a 6-carbon linear alkyl group containing one carbon-carbon double bond, X is an ester, and Y is a hydroxyl group. Therefore, the compositions taught by Dubois anticipate Claims 1 and 3.
Regarding Claim 4, “for inhibiting cell-mediated immunity” is a recitation of intended use. Per MPEP 211.02, II., “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.” In the instant case, the recited intended use does not provide a further structural limitation to the composition recited at Claim 1, from which the instant Claim 4 depends. Therefore, Dubois, as noted above, additionally anticipates instant Claim 4.
Regarding Claim 5, “for the treatment of allograft rejection” is a recitation of intended use. Per MPEP 211.02, II., “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.” In the instant case, the recited intended use does not provide a further structural limitation to the composition recited at Claim 1, from which the instant Claim 5 depends. Therefore, Dubois, as noted above, additionally anticipates instant Claim 5.
Regarding Claim 6, “for the treatment of autoimmune diseases” is a recitation of intended use. Per MPEP 211.02, II., “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.” In the instant case, the recited intended use does not provide a further structural limitation to the composition recited at Claim 1, from which the instant Claim 6 depends. Therefore, Dubois, as noted above, additionally anticipates instant Claim 6.
Regarding Claim 7, “for the treatment of cancer” is a recitation of intended use. Per MPEP 211.02, II., “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.” In the instant case, the recited intended use does not provide a further structural limitation to the composition recited at Claim 1, from which the instant Claim 7 depends. Therefore, Dubois, as noted above, additionally anticipates instant Claim 7.
Regarding Claim 8, “for the treatment of psoriasis” is a recitation of intended use. Per MPEP 211.02, II., “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.” In the instant case, the recited intended use does not provide a further structural limitation to the composition recited at Claim 1, from which the instant Claim 8 depends. Therefore, Dubois, as noted above, additionally anticipates instant Claim 8.
Regarding Claim 9, “for the treatment of atopy” is a recitation of intended use. Per MPEP 211.02, II., “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.” In the instant case, the recited intended use does not provide a further structural limitation to the composition recited at Claim 1, from which the instant Claim 9 depends. Therefore, Dubois, as noted above, additionally anticipates instant Claim 9.
Regarding Claim 10, “for the treatment of insulin-dependent diabetes mellitus” is a recitation of intended use. Per MPEP 211.02, II., “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.” In the instant case, the recited intended use does not provide a further structural limitation to the composition recited at Claim 1, from which the instant Claim 10 depends. Therefore, Dubois, as noted above, additionally anticipates instant Claim 10.
Regarding Claim 11, “for the treatment of multiple sclerosis” is a recitation of intended use. Per MPEP 211.02, II., “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.” In the instant case, the recited intended use does not provide a further structural limitation to the composition recited at Claim 1, from which the instant Claim 11 depends. Therefore, Dubois, as noted above, additionally anticipates instant Claim 11.
Regarding Claim 12, “for the treatment of rheumatoid arthritis” is a recitation of intended use. Per MPEP 211.02, II., “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.” In the instant case, the recited intended use does not provide a further structural limitation to the composition recited at Claim 1, from which the instant Claim 12 depends. Therefore, Dubois, as noted above, additionally anticipates instant Claim 12.
Claims 1 and 3-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Reed et. al. (WO 2012/034232 A1; hereinafter referred to as Reed).
At Page 5, Fourth Paragraph, Reed states “The present application further provides pharmaceutical compositions for treating neurological conditions, said compositions comprising a terpene analogue of Formula 1”.
At Page 10, Reed states exemplary terpene analogues are shown in Table 1, and at Page 11, entry 2987, teaches a terpene analogue of the structure:
PNG
media_image2.png
56
193
media_image2.png
Greyscale
This compound reads on a compound of Formula 1 as recited at instant Claim 1 when the variables are recited as follows:
R is a branched alkyl group having 10 carbon atoms and 2 carbon-carbon double bonds, X is an amide, and Y is a hydroxyl group. Therefore, the compositions taught by Reed anticipate Claims 1 and 3.
Regarding Claim 4, “for inhibiting cell-mediated immunity” is a recitation of intended use. Per MPEP 211.02, II., “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.” In the instant case, the recited intended use does not provide a further structural limitation to the composition recited at Claim 1, from which the instant Claim 4 depends. Therefore, Reed, as noted above, additionally anticipates instant Claim 4.
Regarding Claim 5, “for the treatment of allograft rejection” is a recitation of intended use. Per MPEP 211.02, II., “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.” In the instant case, the recited intended use does not provide a further structural limitation to the composition recited at Claim 1, from which the instant Claim 5 depends. Therefore, Reed, as noted above, additionally anticipates instant Claim 5.
Regarding Claim 6, “for the treatment of autoimmune diseases” is a recitation of intended use. Per MPEP 211.02, II., “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.” In the instant case, the recited intended use does not provide a further structural limitation to the composition recited at Claim 1, from which the instant Claim 6 depends. Therefore, Reed, as noted above, additionally anticipates instant Claim 6.
Regarding Claim 7, “for the treatment of cancer” is a recitation of intended use. Per MPEP 211.02, II., “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.” In the instant case, the recited intended use does not provide a further structural limitation to the composition recited at Claim 1, from which the instant Claim 7 depends. Therefore, Reed, as noted above, additionally anticipates instant Claim 7.
Regarding Claim 8, “for the treatment of psoriasis” is a recitation of intended use. Per MPEP 211.02, II., “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.” In the instant case, the recited intended use does not provide a further structural limitation to the composition recited at Claim 1, from which the instant Claim 8 depends. Therefore, Reed, as noted above, additionally anticipates instant Claim 8.
Regarding Claim 9, “for the treatment of atopy” is a recitation of intended use. Per MPEP 211.02, II., “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.” In the instant case, the recited intended use does not provide a further structural limitation to the composition recited at Claim 1, from which the instant Claim 9 depends. Therefore, Reed, as noted above, additionally anticipates instant Claim 9.
Regarding Claim 10, “for the treatment of insulin-dependent diabetes mellitus” is a recitation of intended use. Per MPEP 211.02, II., “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.” In the instant case, the recited intended use does not provide a further structural limitation to the composition recited at Claim 1, from which the instant Claim 10 depends. Therefore, Reed, as noted above, additionally anticipates instant Claim 10.
Regarding Claim 11, “for the treatment of multiple sclerosis” is a recitation of intended use. Per MPEP 211.02, II., “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.” In the instant case, the recited intended use does not provide a further structural limitation to the composition recited at Claim 1, from which the instant Claim 11 depends. Therefore, Reed, as noted above, additionally anticipates instant Claim 11.
Regarding Claim 12, “for the treatment of rheumatoid arthritis” is a recitation of intended use. Per MPEP 211.02, II., “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.” In the instant case, the recited intended use does not provide a further structural limitation to the composition recited at Claim 1, from which the instant Claim 12 depends. Therefore, Reed, as noted above, additionally anticipates instant Claim 12.
Conclusion
Claims 1 and 3-12 are rejected.
No claim is 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 DANIEL JOHN BURKETT whose telephone number is (703)756-5390. The examiner can normally be reached Monday - Friday.
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, Jeffrey Murray can be reached at (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/D.J.B./ Examiner, Art Unit 1624
/JEFFREY H MURRAY/ Supervisory Patent Examiner, Art Unit 1624
Prosecution Insights