DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission, filed 05/23/2025, has been entered.
Status of Application
Receipt of the amendments to the claims and applicant arguments/remarks, filed 05/23/2025, is acknowledged.
Claims 1-12 are pending in this action. Claims 1, 3-4, 6, 10-11 have been amended. Claims 1-12 are currently under consideration.
Any rejection or objection not reiterated in this action is withdrawn. Applicant's amendments necessitated new ground(s) of rejection presented in this office action.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
This application is a continuation-in-part of PCT/US2021/32217, filed May 13, 2021, which claims benefit of provisional U.S. Application No. 63/074,288, filed September 3, 2020, and U.S. Application No. 63/024,398, filed May 13, 2020.
Claim Objections
Claims 1-2, 4-6, 10-11 are objected to because of the following informalities:
Claim 1 comprises the typographic error “Butoxycarbonyl” that needs to be corrected to “butoxycarbonyl”. Similar is applied to claims 4, 10, 11.
Claims 1-2, 4-5, 10-11 comprise acronym “Boc”. The acronym should be given once in parenthesis after the first use of the full term, and then the acronym is used alone thereafter if needed.
Claim 6 comprises the typographic error “target of interest wherein” that needs to be corrected to “target of interest, wherein”.
Appropriate correction is required.
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 1-12 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 pre-AIA the applicant regards as the invention.
Newly amended claim 1 recites the limitation “the imine analog is created by reacting a carbonyl moiety of the ketone-containing UV filter with a primary or secondary amine” that is unclear and indefinite, because it is unclear what compounds (here as imine analogs of ketone-containing UV filters) are produced/claimed as the claim is broadly claiming the use of secondary amine or primary amine selected from a derivative of ammonia. As stated previously, “[i]f a claim is amenable to two or more plausible constructions, applicant is required to amend the claim to more precisely define the metes and bounds of the claimed invention or the claim is indefinite under §112, ¶ 2. Ex parte Miyazaki, 89 USPQ2d 1207 (BPAI 2008) (expanded panel).” Further, the instant claim discloses “an imine analog of the ketone-containing UV filers”, wherein the ketone-containing UV filters are disclosed as recited low molecular compounds (i.e., avobenzone, diethylamino hydroxybenzoyl hexyl benzoate, sulisobenzone, andoxybenzone), and the primary amine can be amodimethicone (i.e., a silicone-based polymer). Therefore, it is unclear what is understood as “analog”. The term "an imine analog " is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Similar is applied to claims 4, 10, 11. Clarification is required.
As stated previously, claim 1 recites the compounds “Na-(tert-Butoxycarbonyl)-lysine” and “N-Boc-1,6-hexanediamine”. In the present case, neither the claims nor the specification provides a definition for the term/abbreviation “Boc”, therefore it is unclear if said symbol “Boc” defines “tert-butyloxycarbonyl” or another compound. Similar is applied to claims 2, 4, 5, 10, 11. Clarification is required.
In response to applicant’s argument that the term “Boc” is a common term in the art, it is noted that clear definition for said acronym should be provided for clarity, OR said acronym can be replaced by the full term for clarity.
Claim 6 recites the limitation “filter is capable of being covalently conjugated to a target of interest” that is indefinite, because it is susceptible to more than one plausible construction. To this point, as stated previously, “[i]f a claim is amenable to two or more plausible constructions, applicant is required to amend the claim to more precisely define the metes and bounds of the claimed invention or the claim is indefinite under §112, ¶ 2. Ex parte Miyazaki, 89 USPQ2d 1207 (BPAI 2008) (expanded panel).” Clarification is required.
Claim 6 (dependent on claim 4, 5) recites the limitation “wherein the addition”. In the present case, it is noted that claims 4 and/or 5 do not include or identified the role/use of “an addition". Thus, there is insufficient antecedent basis for this limitation in the claim. Therefore, the metes and bounds of the claim cannot be determined. Clarification is required.
Claim 7 recites the limitation “a cosmetic or pharmaceutical preparation comprising the sunscreen composition of claim 1 or 2… and a cosmetically or pharmaceutically acceptable carrier” that is not reasonably clear. To this point, as stated previously, claims 1 and/or 2 disclose “a composition comprising…”, i.e., allow the presence of other compounds/components/carriers even in large amounts. Therefore, it is unclear how claim 7 narrows the scope of the claim(s) upon which it depends. Similar is applied to claims 8, 9, 12. Clarification is required.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of copending Application No. 18/709,341.
Although the conflicting claims are not identical, they are not patentably distinct from each other, because the subject matter claimed in the instant application is fully disclosed in the referenced copending application and would be covered by any patent granted on that copending application, since the referenced copending application and the instant application are claiming common subject matter, as follows: A sunscreen composition comprising at least one ketone-containing UV filter and at least one primary or secondary amine, wherein the ketone-containing UV filter and the at least one primary or secondary amine react to form an imine analog of the ketone-containing UV filter. In the present case, copending application claims are merely broader than instant claims that include additional limitation (i.e., specified compounds to be used as ketone-containing UV filters; primary amines as derivatives of ammonia) and therefore are more specific. Therefore, the claimed invention is directed to the same invention or is an obvious variation of the inventions claimed in the said copending applications.
This is a provisional obviousness-type double patenting rejection, because the conflicting claims have not in fact been patented.
Response to Arguments
Applicant's arguments, filed 05/23/2025, have been fully considered, but they are moot in view of amendments to the claims. New arguments and rejections have been added to the record to address newly introduced amendments and/or to clarify the position of the examiner. Applicant is advised to clarify the claim language, the scope of the claims, the structure of the claimed compositions and/or the compounds to be included into the claimed compositions, and clearly point out the patentable novelty, which the applicant thinks the claims present in view of the state of the art, to place the application in condition for allowance.
As best understood, the applicant discloses the modified UV filters having structures as disclosed in claims 2 and 5, wherein said modified UV filters can be included into cosmetic or pharmaceutical compositions in combination with additional active compounds/drugs, and wherein said modified UV filters allow extending UV protection into a visible region equal to or greater than 400 nm, are water resistant, and/or allow avoiding skin penetration.
Conclusion
No claim is allowed at this time.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLGA V. TCHERKASSKAYA whose telephone number is (571)270-3672. The examiner can normally be reached 9 am - 6 pm, 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, Robert A. Wax can be reached on (571) 272-0623. 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.
/OLGA V. TCHERKASSKAYA/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615