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 the Claims
Per Applicant’s amendment to the claims, submitted on 07/14/2025, claims 11, 13, and 16 are amended. Claims 1-10 and 17-18 were previously withdrawn as being directed to non-elected subject matter. Currently, claims 11-16 are pending examination in the instant application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/14/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections – Necessitated by Amendment
Claim 12 is objected to because of the following informalities: Incorrect status identifier or claim draft error. Currently, claim 12 recites “AZBlagoskonny 055” in the recited Markush group of mTORC1 inhibitors. This appears to be change from claim 12 of the previously submitted claim set (08/11/2021) where the same entry is recited as “AZD8055”. Applicant must either update the status indicator to reflect the amendment, or revert the change if it was unintentional. Appropriate correction is required.
Claim Rejections - 35 USC § 112 Second Paragraph – Necessitated by Amendment
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 14-16 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 14 is indefinite for reciting the phrase “wherein the fibroblast is a dermal fibroblast” because a person of ordinary skill in the art would not reasonably be able to understand the metes and bounds of the claim. Claim 11 to which the instant claim is dependent upon, has been amended to recite “a mammalian dermal fibroblast”. Accordingly, the instant claim does not further limit claim 11, as the recited limitation is redundant.
Claim 15 is indefinite for reciting the phrase “wherein the dermal fibroblast is in vivo and part of a mammalian subject’s skin”, because a person of ordinary skill in the art would not reasonably be able to understand the metes and bounds of the claim. The instant claim seeks to further limit claim 14 which, as discussed above, is considered as indefinite. Accordingly, the instant claim would also be considered as not further limiting. Applicant may overcome this rejection by shifting dependency of the instant claim to claim 11.
Claim 16 is indefinite for reciting the phrase “wherein the composition is applied topically to the mammalian subject’s skin”, because a person of ordinary skill in the art would not reasonable be able to understand the metes and bounds of the claim. As discussed above, claim 15 is considered as indefinite for attempting to further limit an indefinite claim. The instant claim which seeks to further limit claim 15 would be considered as indefinite for the same reasons. Applicant may overcome this rejection by shifting dependency of claim 15 to claim 11.
Claim Rejections - 35 USC § 102 – Withdrawn
Rejections of claims 11-16:
In light of Applicant’s amendment to the claims, the rejections of claims 11-16 are hereby withdrawn. Applicant has amended claim 11 to specify a dermal fibroblast, topical composition, and amount of mTORC1 inhibitor in a range of about 0.001-0.01% w/w. Blagoskonny teaches the application of mTORC1 inhibitor rapamycin to WI-38 fibroblasts, and further suggests compositions comprising mTORC1 inhibitors in a range of about 0.001-1% w/w. Blagoskonny no longer anticipates a method of claim 11 for at least the reasons that WI-38 fibroblasts are derived from lung tissue, and no suggestion is made for a composition with an anticipatory amount of mTORC1 inhibitor.
Double Patenting – Maintained
Claims 11-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 10695326 (herein the ‘326 patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims at hand are significantly overlapping in subject matter.
Claims 11-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11179374 (herein the ‘374 patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims at hand are significantly overlapping in subject matter.
Rejections of claims 11-16:
The rejections of claims are hereby maintained. While the claims of the method of the instant application has been amended, the current claims are still considered to have overlapping claim scope with both the ‘326 and ‘374 patents. As Applicant has neither submitted a Terminal Disclaimer over the indicated patents or provided remarks rebutting the outstanding double patenting rejections, the rejections are hereby maintained.
The outstanding double patenting rejections will be reiterated below for the purposes of clarity and record.
Reiterated Rejections:
Claims 11-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 10695326 (herein the ‘326 patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims at hand are significantly overlapping in subject matter.
Claim 11 of the instant application recites a method of increasing the lifespan, preserving cell organization, or preventing or minimizing senescence of a mammalian fibroblast, the method comprising contacting the fibroblast with a composition comprising an effective amount of a mTORC1 inhibitor or a salt, solvate, enantiomer or diastereoisomer thereof.
Claim 13 of the instant application recites the method of claim 11 wherein the mTORC1 inhibitor comprises rapamycin.
Claim 16 of the instant application recites the method of claim 11 wherein the composition is applied topically to the skin.
Claim 1 of the ‘326 patent recites a method of treating an age-related dermal disorder in a mammalian subject, the method comprising topically administering to the subject a composition consisting essentially of about 0.001-0.01% (w/w) of a mTORC1 inhibitor wherein the mTORC1 inhibitor is rapamycin, or a salt, solvate, enantiomer, or diastereoisomer thereof, wherein the proliferative potential of dermal cells is maintained; and wherein the age-related dermal disorder is at least one selected from the group consisting of age-related dermal atrophy, seborrheic or actinic keratosis, pseudoscars, lentigines, focal areas of dermal thickening, and coarse wrinkles.
As can be seen from the claims above, both the instant application and the ‘326 patent are drawn to topically administering compositions comprising mTORC1 inhibitors, and more specifically wherein the mTORC1 inhibitor is rapamycin. There exists a difference in recitation with regards to the condition being treated. The instant application targets lifespan and senescence of dermal fibroblasts, while the ‘326 patent targets age-related dermal disorders. As cell senescence is generally understood to the be the aging of cells and eventual arresting of cell growth, conditions related to such aging (i.e., age related dermal disorders) would be considered as inextricably linked to cell senescence. Accordingly, the claims at hand cannot be considered as patentably distinct from one another.
Claims 11-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11179374 (herein the ‘374 patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims at hand are significantly overlapping in subject matter.
Claim 11 of the instant application recites a method of increasing the lifespan, preserving cell organization, or preventing or minimizing senescence of a mammalian fibroblast, the method comprising contacting the fibroblast with a composition comprising an effective amount of a mTORC1 inhibitor or a salt, solvate, enantiomer or diastereoisomer thereof.
Claim 1 of the ‘374 patent recites a method of treating or ameliorating an age-related dermal disorder in a mammalian subject in need thereof, the method comprising: topically administering to the subject a composition consisting essentially of—about 0.001-0.01% (w/w) of a mTORC1 inhibitor, or a salt, solvate, enantiomer or diastereoisomer thereof, wherein the proliferative potential of dermal cells in the subject is maintained; and wherein the age-related dermal disorder is at least one selected from the group consisting of dermal atrophy, seborrheic or actinic keratosis, pseudoscars, lentigines, focal areas of dermal thickening, and coarse wrinkles.
As can be seen from the claims above, both the instant application and the ‘374 patent are drawn to topically administering compositions comprising mTORC1 inhibitors. There exists a difference in recitation with regards to the condition being treated. The instant application targets lifespan and senescence of dermal fibroblasts, while the ‘374 patent targets age-related dermal disorders. As cell senescence is generally understood to the be the aging of cells and eventual arresting of cell growth, conditions related to such aging (i.e., age related dermal disorders) would be considered as inextricably linked to cell senescence. Accordingly, the claims at hand cannot be considered as patentably distinct from one another.
Conclusion
Claims 11-16 are rejected.
THIS ACTION IS MADE FINAL. 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 ERIC TRAN whose telephone number is (571)272-7854. The examiner can normally be reached Mon-Fri 8:00-5:00.
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 S Lundgren can be reached at (571) 272-5541. 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.
/ERIC TRAN/Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629