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 .
DETAILED ACTION
Claims 1-20 are currently pending and the claims as originally filed on 12/12/2024 are acknowledged.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Information Disclosure Statement
The three (3) information disclosure statements (IDS) submitted on 12/30/2024; 05/17/2025; 03/02/2026 were filed before the mailing date of the instant first action on the merits. The submissions thereof are in compliance with the provisions of 37 CFR 1.97. It is noted that the foreign references have only been considered to the extent that an English language abstract, translation or statement of relevance has been provided to the examiner. Accordingly, the information disclosure statements have been considered by the examiner, and signed and initialed copies are enclosed herewith.
Claim Rejections - 35 USC § 112
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 9 is 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.
Specifically, Claim 9 depending from claim 8 recites “the sunscreen” in line 1. But base claim 8 recites “said at least one sunscreen agent”, and therefore, claim 9 lacks of antecedent basis because ambiguity arises to determine whether a dependent claim (the/said) limitation refers to one or more than one elements that is previously presented, either in the same claim or a preceding claim. See also MPEP 2173.05(e). Applicant may amend claim 9 to recite either “the said at least one sunscreen agent” or “the at least one sunscreen agent”. Appropriate correction is requested.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claims 1-3, 6-11, 13, and 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Fitzgerald et al., (US2012/0148647A1, IDS of 12/30/2024) as evidenced by as evidenced by Sun et al., “Transparent PMMA/ZnO nanocomposite films based on colloidal ZnO quantum dots”, IOP Publishing Ltd, 2007, pp. 1-7 (IDS of 12/30/2024).
Applicant claims including claims 1-2 filed 12/12/2024:
PNG
media_image1.png
340
832
media_image1.png
Greyscale
Level of Ordinary Skill in the Art
(MPEP 2141.03)
The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The examiner must ascertain what would have been obvious to one of ordinary skill in the art at the time the invention was made, and not to the inventor, a judge, a layman, those skilled in remote arts, or to geniuses in the art at hand. Environmental Designs, Ltd. v. Union Oil Co., 713 F.2d 693, 218 USPQ 865 (Fed. Cir. 1983), cert. denied, 464 U.S. 1043 (1984).
The level of ordinary skill will often predetermine whether an implicit suggestion exists to modify the prior art. Persons of varying degrees of skill not only possess varying bases of knowledge, they also possess varying levels of imagination and ingenuity in the relevant field, particularly with respect to problem-solving abilities. If the level of skill is low, for example that of a mere technician, then it may be rational to assume that such an artisan would not think to combine references absent explicit direction in a prior art reference. If, however, the level of skill is that of a cosmetic research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from cosmetics, pharmacy, physiology and chemistry— without being told to do so.
Prior Art
Fitzgerald teaches a microcapsule composition containing sunscreen agent and photo-responsive acid or base generating system when the composition is exposed to UV radiation (claim 1 of prior art); the microcapsules have core-shell structure ([0142]) wherein the core is enclosed with the shell and the core contains non-aqueous sunscreen agents e.g., benzophenone (claim 5 of prior art) and the shell is made of polyacrylates, polymethacrylates, etc. ([0118] and Examples 3, 4 and 6), and the microcapsules have an average diameter of between about 50 nm and 250 microns ([0144]) which overlaps the instant ranges of 1-30microns or 2-15 microns. MPEP 2144.05: “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976) (instant claims 1, 10-11 and 17); further, this prior art defines “microcapsules” refers to a structure that has an average largest dimension, preferably a diameter, of about 1, 2, 10, 20, 50, 75, 100 μm([0144]) which is within the instant range of 1-100 or 1-30 μm and at least one sunscreen agent is contained in the core-shell formulation ([0160]-[0161], [0196]-[0197]) and the sunscreen agent is UVA and/or UVB blocking agent (claim 4 of prior art) and includes organic sunscreen agent such as diethylamino hydroxybenzoyl hexyl benzoate, benzophenone-3 (=oxybenzone), benzophenone-8 (=dioxybenzone), ethylhexyl triazone, bis-ethylhexyloxyphenol methoxyphenyl triazine (=bemotrizionl), and inorganic sunscreen agent such as titanium dioxide or zinc oxide ([0195]-[0195] and claims 5, 6 and 15 of prior art) (instant claims 6-9); the inorganic sunscreen agent is present in an amount of between about 1 and 30% ([0195]); Fitzgerald further teaches photostabilizer such as avobenzone, including diethylhexyl 2,6-naphthalate, octocrylene, and methylbenzylidene camphor has been used ([0013]) and as the organic sunscreen agent, this prior art also teaches 4-methylbenzylidene camphor, octocrylene, etc. and thus, when those of materials would be added in the microcapsule and/or composition, it would implicitly act as the photostabilizer, in the absence of evidence to the contrary (instant claims 13 and 19); the prior art teach a sunscreen formulation comprising microcapsules contain core containing sunscreen agent and photoacid progenitor compound in poly(methylmethacrylate) (=PMMA) shell having Mw 15000 (e.g., Example 3-4 and 6) wherein the shell do not require plasticizer (instant claim 15) and the PMMA is transparent as evidenced by Sun disclosing “PMMA is transparent thermoplastic material” (see page 1 of evidence) (instant claim 16). In matrix encapsulation, the core material is distributed homogeneously into the shell material or they may form clusters of microcapsules which reads on the claimed plurality of microcapsules ([0142] and Fig. 6) and in particular embodiments, the composition comprises a plurality of microcapsules comprising mixture including two or three sunscreen agents and carrier ([0083], Figs. 6, 8 and claim 15 of prior art), and the cosmetic sunscreen formulation comprising the sunscreen composition or the microcapsules in combination with a cosmetically acceptable carrier (claim 20 of prior art), and this prior art teaches the microcapsules have either mononuclear, polynuclear, or matrix morphology wherein the mononuclear (core-shell) microcapsules contain the shell around the core, while polynuclear capsules have many cores enclosed within the shell (instant claims 17-18 and 20).
Regarding the limitations of “being non-breakable when rubbed or pressed on the skin” of instant claim 2, and “being non-breakable when subjected to homogenization at 2000 rpm for 10 minutes and/or to ultra-sonication at 15 W and 28 kHz for 1 minute” of instant claim 3, they would be inherent properties because Fitzgerald teaches the same microcapsule comprising at least one organic/inorganic non-aqueous sunscreen agent-containing core and polyacrylate or polymethacrylate shell having Mw 15,000 (=PMMA) which is within applicant's disclosure polymer range (see page 15, line 25 of instant specification); teaches the microcapsule is ruptured upon UV radiation (claim 11 of prior art) which may mean microcapsule is not breakable upon rubbing or pressing on skin, but is breakable upon application of UV radiation. Therefore, the claimed properties would be inherent because the product and its properties are inseparable, in the absence of evidence to the contrary. See In this context, see MPEP 2112.01 II.COMPOSITION CLAIMS — IF THE COMPOSITION IS PHYSICALLY THE SAME, IT MUST HAVE THE SAME PROPERTIES “Products of identical chemical composition cannot have mutually exclusive properties. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).” See also, MPEP 2112 II: “II. INHERENT FEATURE NEED NOT BE RECOGNIZED AT THE TIME OF THE INVENTION There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003).” (instant claims 2-3).
In light of the foregoing, instant claims 1-3, 6-11, 13, and 15-20 are obvious over Fitzgerald.
Claims 1 (other species), 4, 5, 12 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Fitzgerald et al., (US2012/0148647A1, IDS of 12/30/2024) as evidenced by as evidenced by Sun et al., “Transparent PMMA/ZnO nanocomposite films based on colloidal ZnO quantum dots”, IOP Publishing Ltd, 2007, pp. 1-7 (IDS of 12/30/2024) as applied to instant claims 1-3, 6-11, 13 and 15-20 and further in view of Sente et al. (US2010/0040696A1, IDS of 12/30/2024).
Level of Ordinary Skill in the Art (MPEP 2141.03) was applied hereto.
Fitzgerald was discussed above with respect to claims 1-3, 6-11, 13 and 15-20.
However, Fitzgerald does not expressly teach at least one shell polymer is comprised of a cellulose ether or cellulose ester of instant claims 1 and 12; the amounts of sunscreen agent and shell polymer of instant claims 4 and 5; and the amount of photostabilizer of instant claim 14. The deficiencies are cured by Sente.
Sente teaches topical compositions containing a dispersion of composite particles where each of such composite particles contains one or more core particles encapsulated or entrapped in a polymeric shell and the particles can be readily formulated into topical sunscreen compositions with organic sunscreen agents to provide improved protection against skin damage caused by exposure to UV light (e.g., abstract, Fig. 1 and [0010]); the core particles comprise a metal oxide such as Ti02 and/or ZnO (claims 2-4 of prior art) in combination with organic UV screen agents (abstract, Fig. 1, [0010], [0015], [0032], [0034] and claims 22 and 24 of prior art) where the organic sunscreen agents include benzophenones and derivatives, e.g., oxybenzone, dioxybenzone, anthranilate, avobenzone, 3-benzylidenecamphor, 4-methylbenzylidenecamphor, octocrylene, octyl salicylate, octyi-p-methoxycinnamate, diethylhexyl-2,6-naphthalate, 2,4-bis-{[4-(2-ethyl-hexyloxy)-2-hydroxy]-phenyl}-6-(4-methoxyphenyl)-1,3,5-triazine (=bemotrizinol), etc., ([0015] and [0033]). Further it is noted that such sunscreen agents such as octocrylene, diethylhexyl-2,6-naphthalate, or 4-methylbenzylidenecamphor also read on the instant photostabilizer because the said organic screen agent which can also act as photostabilizer can be used in an amount of about 0.1 to 45% ([0032]) which overlaps the instant range of 5 to 25% (instant claim 14). The prior art composite particles comprise the same sunscreen agent includes either with Ti02 or ZnO or different sunscreen agents (either Ti02 and ZnO with or without the said organic sunscreen agent), and a plurality of sunscreen agent; and the composite particles have an average particle size ranging from about 1 to about 100 microns and the core particles may account for from about 5 to about 90% of the total weight of the resulting composite particles ([0027]) which overlaps the instant range of 40-80%. MPEP 2144.05 states that [l]n the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976) (instant claim 4); further, the prior art polymeric shell comprises polyacrylate, polymethylmethacrylate (PMMA), cellulose acetate, etc. ([0017]) which reads on the instant wall-forming polymeric shell cellulose ester (instant claim 12); and the polymeric shell may account for from about 5-75% or about 10-60% or about 30-50% of total weight of composite particles which overlaps the instant range of about 20-50%. MPEP 2144.05 In re Wertheim above (instant claim 5). Further, the said composite particles can be added to any pharmaceutically or cosmetically acceptable carrier to form a cosmetic or topical composition ([0028]). The composite particles containing iron oxide, zinc oxide and/or titanium dioxide can be formulated with one or more organic sunscreen agent susceptible to oxidative decomposition or degradation, thereby forming sunscreen compositions that that are not only characterized by high SFP values (e.g., SPF 30 or more), but also surprisingly and unexpectedly improved overall stability and prolonged shelf life (abstract).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
1. The difference between the instant application and Fitzgerald is that Fitzgerald does not expressly teach the amounts of sunscreen agents, polymer shell and photostabilizer of instant claims 4, 5 and 14. The deficiencies are cured by Sente.
2. The difference between the instant application and Fitzgerald is that Fitzgerald does not expressly teach cellulose ester polymer shell of instant claim 12. The deficiency in Fitzgerald is cured by Sente.
Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
1. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to adjust or optimize prior art ranges of sunscreen agent and wall-forming polymer with the claimed ranges without undue experimentation because Sente teaches overlapping ranges thereof. See MPEP 2144.05 In re Wertheim above. Thus, in the absence of criticality evidence, the claimed ranges are obvious from the prior art ranges.
2. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to replace PMMA or polyacrylate shell material of Fitzgerald with cellulose ester, e.g., cellulose acetate of Sente as a matter of choice or design and this is an obvious variation from the standpoint of the ordinary artisan. Since as the wall-forming shell polymers, PMMA, polyacrylate, cellulose ester or ether are equivalent and selection any of them or replacing PMMA of Fitzgerald with cellulose ester of Sente would have yielded no more than predictable results, devoid of evidence to the contrary.
This rejection is based on the well-established proposition of patent law that no invention resides in combining old ingredients of known properties where the results obtained thereby are no more than the additive effect of the ingredients, In re Sussman, 1943 C.D. 518. From MPEP 2143 A: “…all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at ___, 82 USPQ2d at 1395; Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson ’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atlantic & P. Tea Co. v. Supermarket Equipment Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950).”
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
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 double patenting rejection is appropriate where the claims at issue 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, 3 and 4-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of patent no. 12,201,708.
Although the claims at issue are not identical, they are not patentably distinct from each other because both claims require a microcapsule comprising a core comprising at least one sunscreen agent including bemotrizinol, isocotrizinol, ethylhexyl triazone, hydroxybenzoyl hexyl benzoate, and a transparent shell polymer (=wall polymer) enveloping the core, said the shell composed of at least one polymer or copolymer selected from polyacrylate, polymethacrylate, cellulose ether, cellulose ester, the shell is devoid of plasticizer, the microcapsule being non-breakable when rubbed or pressed on the skin and when subjected to homogenization at 2000rpm for 10 minutes, the microcapsule further comprises a photostabilizer. Further, the microcapsules of patent ‘708 has a size of 1-100microns or 1-30 microns or 2-15 microns, which is identical to or overlaps the instant range of 1-100 micron, the sunscreen gent of patent ‘709 is used in an amount of 40-80% which identical to the claimed range of 40-80%, and the wall polymer of patent ‘709 is used in an amount of about 20-about 50% which is identical to the claimed range. Further, both claims require a composition comprising a plurality of microcapsules. The difference between the instant claims and the patent ‘709 is that instant claimed invention include inorganic sunscreen agent while patent ‘709 does not. However, it would have been obvious to replace, select, or add such inorganic sunscreen agent of patent ‘709 to the composition of instant order to enhance sunscreen activities.
Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the copending subject matter.
Conclusion
All examined claims are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYUNG S CHANG whose telephone number is (571)270-1392. The examiner can normally be reached M-F 8-5.
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, Yong (Brian-Yong) S Kwon can be reached at 571-272-0581. 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.
/KYUNG S CHANG/Primary Examiner, Art Unit 1613
Prosecution Insights