DETAILED ACTION
Status of Application
Receipt of the response to the non-final office action, the amendments to the specification and claims as well as applicant arguments/remarks, filed 10/01/2025, is acknowledged. Amendments to the specification have been entered.
Claims 19-20, 24-38 are pending in this action. Claim 21 has been cancelled. Claims 1-18, 22-23 have been cancelled previously. Claim 19 has been amended. Claims 19-20, 24-38 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Any rejection or objection not reiterated in this action is withdrawn.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 is being examined under the pre-AIA first to invent provisions. 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 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.
Priority
This application is a continuation of U.S. Patent Application No. 17/163,811, filed February 1, 2021 and now abandoned, which is continuation of U.S. Patent Application No. 16/429,816, filed June 3, 2019 and now abandoned, which is continuation of U.S Patent Application No. 15/619,253, filed June 9, 2017 and now issued as U.S., Patent No. 10,350,168, which is a continuation of U.S. Patent Application No. 14/259,010, filed April 22, 2014 and now issued as U.S., Patent No. 9,707,177, which is a continuation of U.S. Patent Application No. 13/858,677, filed April 8, 2013 and now abandoned, which is continuation of U.S. Patent Application No. 12/742,235, filed April 12, 2011, now issued as U.S. Patent No. 8,445,002, which claims a benefit of the national state entry of PCT/US2010/0333942, filed May 6, 2010, which claims priority under 35 U.S.C. § 119 of U.S. Provisional Application No. 61/176,057, filed May 6, 2009.
Terminal Disclaimer
The terminal disclaimer, previously filed on 06/27/2024, disclaiming the terminal portion of any patent granted on this application, which would extend beyond the expiration date of the prior Patent Nos. 8,445,002, 9,095,510, 9,192,673, 9,539,266, 9,707,177, 10,080,764, 10,350,168, 10,653,707, 10,857,077, and any patent granted on pending reference application Nos. 17/193366 and 18/230840, have been reviewed and is accepted. The terminal disclaimer has been recorded.
Information Disclosure Statement
The information disclosure statement, filed 12/23/2025, is acknowledged and has been considered. Please see the attached initialed PTO-1449.
Claim Rejections - 35 USC § 112 (pre-AIA )
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 19-20, 24-38 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 19 recites the limitation “porous calcium phosphate particles loaded with the active agent such that the active agent is bound to the porous calcium phosphate particles and does not dissociate from the particles in any substantial amount when the particles are present in the topical composition” that is unclear and indefinite, because the structure of the compositions to be used in the claimed method is not clearly delineated. In the present case, it is noted that if a claim is amenable to two or more plausible constructions (e.g., particle sizes, porosity, internal surface area, etc.), 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. See Ex parte Miyazaki, 89 USPQ2d 1207 (BPAI 2008) (expanded panel).” Furthermore, “Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Clarification is required.
Newly amended claim 19 recites the term “substantial” that is a relative term, which renders the claim indefinite. This term is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, but teaches that the amount of active agent that does dissociate from the particles can be from 30% to 5% or less by weight of the originally bound amount of active agent. Therefore, one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Clarification is required.
Claims 20, 24-38 are rejected as being dependent on rejected independent claim 19 and failing to cure the defect.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 19-20, 24-38 are rejected under 35 U.S.C. 103(a) as being unpatentable over Monsouri, US 6,579,516 (cited in IDS) in view of Bell, US 2009/0041812A1; Lee, US 2005/0234114 (cited in IDS); and Tanaka et al., US 2006/0257658 (cited in IDS; hereinafter referred to as Tanaka).
Monsouri teaches methods of delivering materials into the skin of a subject by applying to and leaving on the skin topical antimicrobial, cleansing and moisturizing compositions (Title; Abstract) comprising: (i) calcium phosphate porous spheres/particles having a diameter of 1-10 µm, that absorb, carry, and subsequently release components of the composition with which it has been formulated, e.g., ceramic hydroxyapatite Ca10(PO4)6(OH)2 as an absorption promoter (Col. 2, Lns. 13-38; Col. 5, Lns. 7-35 as applied to claims 19-20); (ii) antimicrobial moisturizing active ingredients which functions to inhibit the growth of pathogenic or potentially pathogenic bacteria and fungi and allow to protect the integrity of the skin (Col. 2, Ln. 57-Col. 3, Ln.18; Col. 4, Lns. 25-45 as applied to claim 19); and (iii) other additives, e.g., preservatives, e.g., methyl paraben, propyl paraben, etc. (Col. 8, Lns. 20-24); topical delivery vehicle (Col. 6, Ln. 18 - Col. 7, Ln. 2), etc.; and wherein (iv) said compositions can be in a form of a solution emulsion, gel, cream (Col. 6, Ln. 57-Col. 7, Ln. 2 as applied to claims 24-26, 28), a lotion (Claims 1, 11-12; Col. 11, Lns. 45-50 as applied to claim 27).
Monsouri does not teach the use of compositions in a form of an ointment or a spray (claim 29, 30), and applying compositions to various topical locations as claimed in claims 31-38.
Bell teaches therapeutic spherical calcium phosphate particles to be used as carriers for active ingredients for topical delivery/treatment of skin, e.g., face, neck, decollete, back, hands (Claims 1-5; Title; Abstract; Para. 0003, 0016, 0045-0049), wherein said particles can be incorporated into a cream, a gel, an ointment, a lotion, an oil, or any other delivery vehicle (Para. 0056). Bell also teaches that compositions comprising said particles can be applied topically to a skin for a treatment of different skin conditions (Claim 2; Para. 0014, 0016, 0018, 0045-0047).
Lee teaches spherical calcium phosphate nanoparticles having a size of less than 1000 nm and methods of using them as carriers for delivery of biologically active ingredients (Abstract; Para. 0003, 0014-0015, 0019, 0039-0040, 0045). Lee also teaches that said particles can be delivered as a spray, an ointment, a gel, a suspension, or combination thereof (Para. 0075).
Tanaka teaches a composition comprising uniform, rigid, spherical nanoporous calcium phosphate particles (Abstract, 0017-0019), wherein said particles have an average particle diameter of 0.1-100 µm (Para. 0009, 0022) and are complexed with an active agent (Para. 0009, 0014, 0015, 0020, 0030). Tanaka teaches that said particles have a pore volume of 20% or more (Para. 0009, 0025) and a pore size below 100 nm (Para. 0041 and Fig. 3). Tanaka teaches the amount of active agent complexed with the particles ranges from 0.0001 to 10 wt% (Para. 0009). Tanaka also teaches that said particles have several biomedical applications (Para. 0003).
Therefore, the examiner maintains the position that it would have been obvious to one of ordinary skill in the art at the time the invention was made to try/utilize/incorporate spherical porous calcium phosphate particles with an active agent as taught by Monsouri into a cream, a gel, an ointment, a lotion, an oil, or any other drug delivery compositions/vehicles for a topical drug delivery as taught by Bell, Lee, Tanaka. One would do so with expectation of beneficial results, because said approach would allow (i) to prepare the compositions in different forms (i.e., a cream, a spray, an ointment, a lotion, etc.), and (ii) to deliver topical compositions comprising said particles to various topical locations to be used for treatment of various skin conditions.
In response to applicant’s argument that the cited prior art does not teach “calcium phosphate particles loaded with the active agent”, it is noted that cited prior art teaches the use of calcium phosphate particles as a carrier of an active agent. To this point, it is noted that (i) Monsouri teaches the use of ceramic hydroxyapatite porous spheres/particles that absorb, carry, and subsequently release components with which it has been formulated (Col. 5, Lns. 17-24); (ii) Tanaka teaches calcium phosphate particles carrying or coated with a bio-material (e.g., polymers; Para. 0030, 0031) and also teaches that controlling porosity and size of uniform, rigid, spherical calcium phosphate particles allow controlling the binding affinity of active compounds to said particles; (iii) Bell teaches the use of spherical calcium phosphate particles as carriers for biologically active materials that can be dispersed or impregnated within said particles or coated on said particles (Para. 0011, 0012); (iv) Lee teaches spherical calcium phosphate nanoparticles complexed with biologically active material for providing a controlled release of said active material (Para. 0033, 0075). Therefore, the examiner maintains the positions that the cited prior art teaches the use of calcium phosphate particles as delivery systems for active agents, wherein said active agent interacts with calcium phosphate.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 2005/0013874, US 6,395,311, US 2005/0234114 (cited in IDS) - teach calcium phosphate particles that can be used for providing controlled delivery of active compounds (e.g., cyclic adenosine monophosphate) to a target location.
US 6,573,249 (cited in IDS) - teaches various active compounds that can be used in combination with calcium phosphate for enhancing deep wound healing.
US 5,158,756 (cited in IDS) – teaches compositions comprising uniform, rigid, spherical porous calcium phosphate particles (Abstract, Col. 1, Lns. 43-50; Col. 2, Lns. 20-45), wherein said particles have an average size of 1-40 microns (Col. 2, Lns. 1-2; Col. 3, Lns. 53-57; Col. 4, Lns. 1-5), can be complexed with a biological agent (Applications 1-7), and have various biomedical applications (Col. 1, Lns. 15-20). The particles have a pore volume of more than 5 % (Col. 1, Ln. 65; Col. 3, Lns. 46-51; Table 1 and Fig. 3) and a pore size of 10-400 nm (Col. 1, Lns.58-61; Col. 3, Lns. 21-30); and also teaches a method of preparation of said particles (Col. 2, Lns. 3-20; Col. 4, Ln. 64-Col. 5, Ln. 17).
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 19-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 16-18 of copending Application No. 18/693,708.
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 method of applying a topical composition to a skin, wherein the composition comprises a non-triclosan antimicrobial agent; a calcium phosphate component; and a topical delivery vehicle. The coppending application also teaches the use of porous calcium phosphate particles, and further teaches and/or claims that the calcium phosphate component comprises calcium phosphate particles, wherein the calcium phosphate is calcium phosphate hydroxyapatite Ca10(PO4)6(OH)2. Therefore, the claimed invention is directed to the same invention or is an obvious variation of the inventions claimed in said copending application. Further, it is noted that the instant claims are merely broader than copending application claims that include additional limitation (i.e., a non-triclosan antimicrobial agent) and therefore are more specific. This is a provisional obviousness-type double patenting rejection, because the conflicting claims have not in fact been patented.
In response to applicant’s argument that this double-patenting rejection should be withdrawn, because the present application has an earlier effective U.S. filing date than co-pending Application No. 18/693,708, it is noted that this double patenting rejection is not the only remaining rejection (see MPEP 804(I)(B)(1)(b)(i)). The provisional double patenting rejection(s) is maintained for the reasons discussed herein. It will be maintained until the applicant submits properly executed terminal disclaimer or arguments that effectively overcome the rejections of record.
Response to Arguments
Applicant's arguments, filed 10/01/2025, have been fully considered, but they were not found to be persuasive for the reasons set forth above. New arguments have been added to the record to address newly introduced amendments and/or to clarify the position of the examiner. Additional examiner’s comments are set forth next.
In response to applicant's argument that cited prior art does not teach the delivery of an active agent through the stratum corneum (i.e., the outermost layer of the skin), as stated previously, the cited prior art teaches compositions comprising compounds as instantly claimed (i.e., an active agent and calcium phosphate particles), wherein said compositions are applied to the skin for delivering said active agents/materials into the skin (e.g., Monsouri). Therefore, the applicant’s argument is not persuasive.
Applicant is advised to clarify the structure of the claimed composition to be used in the claimed method, and clearly point out the patentable novelty, which the applicant thinks the claims present in view of the state of the art disclosed by the references cited, to place the application in condition for allowance.
Conclusion
No claim is allowed at this time.
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.
Correspondence
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.
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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.
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/OLGA V. TCHERKASSKAYA/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615