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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/05/2026, has been entered.
Status of Application
Receipt of the amendments to the claims and applicant arguments/remarks, filed 03/30/2026 (Response After Final Action), is acknowledged.
Claims 19-20, 24-35, 37-39 are pending in this action. Claim 36 has been cancelled. Claims 1-18, 21-23 have been cancelled previously. No claim has been amended. New claim 39 has been added. No new matter was added. Claims 19-20, 24-35, 37-39 are currently under consideration.
Any rejection or objection not reiterated in this action is withdrawn. 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.
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, 24-35, 37-39 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.
As stated previously, 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.
As stated previously, 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, 24-35, 37-39 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, 24-35, 37-39 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 31-35, 37-38).
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 the cited prior art teaches that said approach would allow to (i) prepare the compositions in different forms (i.e., a cream, a spray, an ointment, a lotion, etc.), and (ii) deliver topical compositions comprising said particles to various topical locations to be used for treatment of various skin conditions.
Regarding the limitation “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. Claim 39 is rejected as being dependent on rejected base claim.
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.
Response to Arguments
Applicant's arguments, filed 03/30/2026 (Response After Final Action), have been fully considered, but they were not found to be persuasive for the reasons set forth above. Additional examiner’s comments are set forth next.
In response to applicant’s argument that limitations/terms “such that’ “does not dissociate”, “substantial” will be understood in the light of specification, it is noted that “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). Further, it is noted that “Claiming a result without reciting what materials produce that result is the epitome of an indefinite claim. Such a claim fails to delineate with any reasonable certainty the requirements of the formulation.” See Forest Labs., Inc. v. Teva Pharms. USA, Inc. 2017 U.S. App. LEXIS 24877. Furthermore, it is noted that “[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).” Therefore, the examiner maintains the positions that clarification of the claim language and/or scope is required.
In response to the applicant's arguments against the references individually, it is noted that one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). 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. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1323, 76 USPQ2d 1662, 1685 (Fed. Cir. 2005); In re Linter, 458 F.2d 1013, 173 USPQ 560 (CCPA 1972); In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990), cert. denied, 500 U.S. 904 (1991). In the present case, all cited references are reasonably drawn to the same field of endeavor that is delivering materials into the skin of a subject by applying to and leaving on the skin topical compositions comprising calcium phosphate porous particles that absorb/carry and release active ingredients. Therefore. the examiner maintains the position that the claimed invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, because every element of the invention has been collectively taught by the combined teachings of the references.
In response to the applicant's argument regarding the unexpected results, i.e., "The work reported in the present application describes for the first time that active agents (pg. 10-36) could be delivered through the stratum corneum when loaded (pg. 5-6) with porous calcium phosphate particles” it is noted that 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, it is expected that since the prior art is comprised of the same components, the same beneficial properties and effects would also be provided. Further, it is noted that "The fact that applicant has recognized another advantage, which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). 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.
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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/OLGA V. TCHERKASSKAYA/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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