DETAILED ACTION
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 .
Information Disclosure Statement
The information disclosure statement submitted on 09/18/2025 has been considered by the Examiner.
Status of the Claims
Claims 1-5, 8, 10, 12, 14-15, 17-21, 23-24, 28, and 30-31 are pending.
Claim 23 is newly amended
Claims 5, 8, 10, 12, 15, 17-19, 28 and 30-31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/09/2025 and made FINAL.
Claims 1-4, 14, 20-21, and 23-24 have been examined on their merits.
Withdrawn Objections & Rejections
The objections and rejections presented herein represent the full set of objections and rejections currently pending in the application. Any objections or rejections not specifically reiterated are hereby withdrawn.
The rejection of claim 23 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 is maintained as discussed below.
The rejection of claims 1-2, 4, 14, and 20-21 under 35 U.S.C. 102(a)(1) or 35 U.S.C. 102(a)(2) as being anticipated by Kishimoto et al. (WO2013036303A2, 2013, on IDS 02/18/2022, previously cited) is maintained as discussed below.
The rejection of claim 3 under 35 U.S.C. 103 as being unpatentable over Kishimoto et al. (WO2013036303A2, 2013, on IDS 02/18/2022, previously cited) in view of Heber-Katz (US20030037345A1, 2003) is maintained as discussed below.
The rejection of claims 23 and 24 under 35 U.S.C. 103 as being unpatentable over Kishimoto et al. (WO2013036303A2, 2013, on IDS 02/18/2022, previously cited) in view Yang et al. (Invest New Drugs, published online 07/04/2019, on IDS 01/17/2024) is maintained as discussed below.
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.
Claim 23 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 23 contains the Gardiquimod. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe specific TLR7 agonist, and accordingly, the identification/description is indefinite.
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.
(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 1-2, 4, 14, and 20-21 are rejected under 35 U.S.C. 102(a)(1) or 35 U.S.C. 102(a)(2) as being anticipated by Kishimoto et al. (WO2013036303A2, 2013, on IDS 02/18/2022, previously cited).
In regards to claim 1, Kishimoto disclose treating patients with dendritic cells (claim 1) to treat alopecia (p58, line 19). Kishimoto discloses that the dendritic cells can be plasmacytoid dendritic cells (pDCs) (p34, lines 30-34), and that the cells can be administered to the skin (p3, lines 13-20).
In regards to claim 2, Kishimoto discloses that the dendritic cells may be administered (delivered) intradermally (thus, beneath the surface of the skin) (p3, lines 13-20).
In regards to claims 4 and 14, Kishinoto discloses that the subject has alopecia areata (p58, line 19).
In regards to claim 20, Kishimoto discloses that the subject is human (p23, line 4).
In regards to claim 21, Kishimoto discloses that the cells are obtained from the subject to which (to whom) the composition has been administered (p22, lines 22-25).
Therefore, Kishimoto anticipates the invention as claimed.
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Kishimoto et al. (WO2013036303A2, 2013, on IDS 02/18/2022, previously cited) in view of Heber-Katz (US20030037345A1, 2003, previously cited).
In regards to claim 3, Kishimoto teaches that DCs can be administered to skin (p3, lines 9-20), but is silent on whether the cells can be administered topically.
However, topical administration of therapeutic cells to treat damaged skin was known in the art. As taught by Heber-Katz, compositions, such as gels and creams, comprising cells, which in specific embodiments are dendritic cells, can be to treat skin damage (claim 1, paragraphs [004, 0015, 0056, 0096, 0189-191]. A person of ordinary skill in the art would have been motivated to modify the method of Kishimoto and deliver pDCs topically in order to treat epidermal layers of skin, and to improve damage (such as inflammation) to this layer. Furthermore, because Herber-Katz teaches cells can be applied topically, and gives specific embodiments where dendritic cells are utilized to improve would healing, and because Kishimoto and Heber-Katz are in the same technical field of using dendritic cells to treat pathologies of the skin, it could have been done with predictable results and a reasonable expectation of success.
Therefore, the combined teachings of Kishimoto and Heber-Katz render the invention unpatentable as claimed.
Claims 23 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Kishimoto et al. (WO2013036303A2, 2013, on IDS 02/18/2022, previously cited) in view Yang et al. (Invest New Drugs, published online 07/04/2019, on IDS 01/17/2024, previously cited).
In regards to claims 23, Kishimoto teaches that DCs can be stimulated or enriched with TLR agonists and that it is known in the art that this activates these cells (p19, lines 5-11; p31, lines 1-22; p37, lines 15-20), but does not explicitly teach that pDCs can be administered with a specific TLR agonist.
However, a person of ordinary skill in the art would have been motivated to administer pDCs with a TLR agonist, such as TLR7 agonist imiquimod because Yang teaches that it is known in the art that imiquimod can induce hair follicles to enter growing phase in advance, and that topical application of imiquimod can cause transient hair growth (Introduction, p79-80). Furthermore, because Yang teaches TLR7 agonists can be used to treat patients and recommends its use for treating alopecia (Title, Summary, Introduction, p79-80), it could have been done with predictable results and a reasonable expectation of success.
In regards to claim 24, similarly as above, Kishimoto teaches that DCs can be stimulated or enriched with TLR agonists and that it is known in the art that this activates these cells (p19, lines 5-11; p31, lines 1-22; p37, lines 15-20), which suggests that that can be performed prior to administration, but is silent on the specific TLR.
However, a person of ordinary skill in the art would have been motivated to select a TLR7 agonist because Yang teaches that it is known in the art that TLR7 agonist imiquimod can induce hair follicles to enter growing phase in advance, and that topical application of imiquimod can cause transient hair growth (Introduction, p79-80).
Furthermore, because Yang teaches TLR7 agonists can be used to treat patients and recommends its use for treating alopecia (Title, Summary, Introduction, p79-80), and because Kishimoto teaches that DCs can be stimulated with TLR agonists, it could have been done with predictable results and a reasonable expectation of success.
Therefore, the combined teachings of Kishimoto and Yang renders the invention unpatentable as claimed.
Response to Arguments
Applicant argues that in order to anticipate a claim, a reference must be enabled (citing MPEP 2131) (Remarks, p5). However, Applicant argues that Kishimoto lists a large number of different diseases and conditions that can be treated, with no common feature diseases and conditions, and it cannot be said that just being on such a long list, without more, is sufficient to enable treatment of any of the diseases and conditions (Remarks, p5).
Therefore, Applicant concludes that the examples of Kishimoto are prophetic and the only data was obtained with an animal model of Type 1 diabetes with do not use pDCs (Remarks, p5).
Applicant also argues that Kishomoto only mentions the use of pDCs generally and only once, but there is no specific connection with alopecia areata (remarks, p5)
As a result, Applicant concludes that Kishimoto is not enabling for the treatment of alopecia areata (Remarks, p6).
Applicant's arguments filed 09/18/2025 have been fully considered but they are not persuasive.
It is noted that the only method step in claim 1 are administering pDCs to the skin, while the intended use of the preamble is to prevent or treat alopecia in a subject.
In regards to anticipation, according to MPEP 2131, “A claim is anticipated only if each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior art reference.” Verdegaal Bros. v. Union Oil Co. of California, 814 F.2d 628, 631, 2 USPQ2d 1051, 1053 (Fed. Cir. 1987). “When a claim covers several structures or compositions, either generically or as alternatives, the claim is deemed anticipated if any of the structures or compositions within the scope of the claim is known in the prior art.” Brown v. 3M, 265 F.3d 1349, 1351, 60 USPQ2d 1375, 1376 (Fed. Cir. 2001).
As discussed above, Kishimoto discloses a method of treating patients with dendritic cells (claim 1). Kishimoto discloses that the dendritic cells can be plasmacytoid dendritic cells (pDCs) (p34, lines 30-34), and can be administered to the skin (p3, lines 13-20). Kishimoto discloses that the method can be used to treat alopecia specifically (p58, line 19).
Therefore, Kishimoto teaches each and every element as set forth in the claim.
While Kishimoto discloses that the method can be used to treat other diseases, “[W]hether a generic disclosure necessarily anticipates everything within the genus … depends on the factual aspects of the specific disclosure and the particular products at issue.” Sanofi-Synthelabo v. Apotex, Inc., 550 F.3d 1075, 1083, 89 USPQ2d 1370, 1375 (Fed. Cir. 2008). See also Osram Sylvania Inc. v. American Induction Tech. Inc., 701 F.3d 698, 706, 105 USPQ2d 1368, 1374 (Fed. Cir. 2012) (“how one of ordinary skill in the art would understand the relative size of a genus or species in a particular technology is of critical importance”).
However, a reference disclosure can anticipate a claim when the reference describes the limitations but "'d[oes] not expressly spell out' the limitations as arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination.” Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381, 114 USPQ2d 1250, 1254 (Fed. Cir. 2015) (quoting In re Petering, 301 F.2d 676, 681(CCPA 1962)).
As discussed above, Kishimoto discloses treating patients with dendritic cells, which can be pDCs specifically, can be administering DCs to the skin. Again, Kishimoto explicitly states that alopecia is a disease (a specific autoimmune disease) that the discloses methods can be used to treat.
Therefore, a person of ordinary skill in the art would have at once envisioned that the method of Kishimoto could be used specifically to treat alopecia.
In regards to an enabling disclosure, according to MPEP 2121.02(I), a reference is presumed operable until applicant provides facts rebutting the presumption of operability. In re Sasse, 629 F.2d 675, 207 USPQ 107 (CCPA 1980). Therefore, applicant must provide evidence showing that a process for making was not known at the relevant time.
In the instant case, Applicant has not demonstrated that the method as disclosed by Kishimoto was not known at the relevant time, but rather only argued that Kishimoto discloses other embodiments.
However, according to MPEP 2121.02(II), the fact that an author of a publication did not attempt to make the compound disclosed, without more, will not overcome a rejection based on that publication. In re Donohue, 766 F.2d 531, 226 USPQ 619 (Fed. Cir. 1985).
Applicant argues that Heber-Katz does not cure the deficiencies of Kishomoto (Remarks, p6).
Applicant's arguments filed 09/18/2025 have been fully considered but they are not persuasive because Kishimoto is not deficient for the reasons discussed above.
Yang does not does not cure the deficiencies of Kishomoto and that although the authors sought novel TLR7 agonists, the compounds generated were either TLR7 agonists or had undiscovered mechanisms (citing p88-89).
Applicant's arguments filed 09/18/2025 have been fully considered but they are not persuasive because Kishimoto is not deficient for the reasons discussed above.
In regards to other compounds discovered by Yang, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
As discussed above, a person of ordinary skill in the art would have been motivated to administer pDCs with a TLR agonist, such as TLR7 agonist imiquimod because Yang teaches that it is known in the art that imiquimod can induce hair follicles to enter growing phase in advance, and that topical application of imiquimod can cause transient hair growth (Introduction, p79-80). Furthermore, because Yang teaches TLR7 agonists can be used to treat patients and recommends its use for treating alopecia (Title, Summary, Introduction, p79-80), it could have been done with predictable results and a reasonable expectation of success.
Conclusion
No claims are allowed.
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 JOSEPH (PAUL) MIANO whose telephone number is (571)272-0341. The examiner can normally be reached Mon-Fri from 8:30am to 5:30pm.
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/JOSEPH PAUL MIANO/Examiner, Art Unit 1631
/ARTHUR S LEONARD/Examiner, Art Unit 1631