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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 on 1/15/26 has been entered.
Claim Status
Claims 1-20, 22-31 are cancelled.
Claim 41 is new.
Claims 21 and 32-41 are pending.
Claims 36, 38 and 39 are withdrawn.
Claims 21, 32-35, 37 and 40-41 are presented for examination.
Withdrawn rejections
Applicant's amendments and arguments filed 1/15/26 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below is herein withdrawn.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
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.
Claims 21, 32-35, 37 and 40-41 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 21 contains the trademark/trade names: “uvinul” “Tinosorb” “uvosorb” “uvasorb” “neo heliopan” “mexoryl” “parsol”. 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 the UV-filter and, accordingly, the identification/description is indefinite. Dependent claims are rejected as indefinite because they are dependent from an indefinite base claim. The Examiner suggests deleting the trademark names.
The terms: “padimate O” and “Padimiate A” appear to just be other names for 2-ethylhexyl 4-(dimethylamino)benzoate and octyl dimethyl 4-aminobenzoic acid, respectively, and are not a trademark names.
Claim Rejections - 35 USC § 103
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 21, 32-35, 37 and 40-41 are rejected under 35 U.S.C. 103 as being unpatentable over Deng et al. (US20180256480) and Panyam et al. (WO2008091465) and Thermo Fisher Scientific ([online] retrieved on 10/31/24 from: https://www.thermofisher.com/us/en/home/life-science/protein-biology/protein-biology-learning-center/protein-biology-resource-library/pierce-protein-methods/polyethylene-glycol-peg-pegylation-proteins.html; 14 pages.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103, the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103.
Applicant claims a set of particles comprising at least one bioadhesive particle as described in claim 21.
Claim interpretation: B comprises: 1) poly(ethylene glycol); or 2) -[Y-(CH2)q]k-(O-CH2-CH2)p- (II); when k is 0 and p is 1, then [Y-(CH2)q] would not be present and B is a repeating chain of –(O-CH2-CH2).
Level of Ordinary Skill in the Art
(MPEP 2141.03)
MPEP 2141.03 (I) states: “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 level of skill is that of a medical/pharmaceutical drug delivery research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from drug delivery systems and techniques and pharmaceutical chemistry— without being told to do so.
In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Regarding claims 21 and 32, Deng et al. teach a core-shell structure particles that adhere to tissue, cells or extracellular materials, hence bioadhesive particles, and topical sunblock compositions (Abstract) comprising a core of PLA (poly(lactic acid) and copolymers thereof poly(lactic acid-co-glycolic acid) (PLGA) and a functionalized polymer with functional groups (Claims 1-3; [0071, 0073, 0223-0225]), (component A) where the functionalized polymers can be polyglycerols (Claim 5), which have hydroxyl groups, and the one or more reactive functional groups can be aldehydes, amines, O-substituted oximes and combinations thereof (Claim 6) and sunblock/sunscreen agents including UV filters are encapsulated (Claims 8-11; [0109]). In claim 11, Deng et al. name UV-filters: “selected from the group consisting of zinc oxide (ZnO), titanium dioxide (TiO2), avobenzone, tinosorb S, mexoryl SX, mexoryl XL, helioplex, octinoxate, octocrylene, oxybenzone, octisalate, homosalate, uvinul T 150, cinoxate, aminobenzoic acid, padimate O, ensulizole, dioxybenzone, meradimate, sulisobenzone, trolamine salicylate, enzacamene, bisdisulizole di sodium, uvinul A Plus, uvasorb HEB, parsol SLX, amiloxate, p-aminobenzoic acid (PABA), phenylbenzimidazole sulfonic acid, cinoxate, menthyl anthranilate, sulisobenzone, parsol compounds, tinosorb compounds, heliopan compounds, and combinations thereof.” So, Deng et al. teach a polymer core of the elected species and there is at least 1 functional group C, so m ≥ 1, and X is a UV-filter claimed. The particles of Deng et al. are made of the elected species and therefore are implicitly bioadhesive. Deng et al. even state that the particles can adhere to the skin (Claim 1; [0098]). Deng et al. also teach that the particles can release molecules to be encapsulated or attached [0071, 0098, 0108].
Regarding claims 21 and 32, Deng et al. teach embodiments with the linear linker PEG (component B) [0032, 0071, 0158-0160, 0280-0282, 0285], so n = 1. Thus, “B” comprises at least one residue of poly(ethylene glycol). Deng teach employing PEG5000 [0266], thus p = 1 and m is between 1 and 1025.
Regarding claims 21 and 32, the linear linker PEG has a hydroxyl functional group C and can be further functionalized with amines, hydrazines and thiols [0159-0160, 0266] and maleimides, a type of amine (component C), as reactive coupling groups [0064]. Deng et al. also suggest that coupling could be done with streptavidin and biotin [0118].
Regarding claims 33-35 and 40, Deng et al. teach formulating with other excipients [0132] and in the form of a topical formulation (Claim 22; [0185-0187]) also for use in hair treatment products (Claim 12), such as hair coloring/dye [0027, 0236-0238], and wound dressings (Claim 15; [0026, 0239-0244]) and to add skin soothing emollients [0195] and skin repair/anti-aging products [0234-0235], which would provide care to the skin with a composition comprising a set of particles. Deng et al. also teach adding anti-aging components (Claim 13) to the topical composition for application to the skin (Claims 1 and 7; claim 23), thus making it a cosmetic composition and a composition for skin care, hair care, etc., and the wound dressing is a medical device.
Regarding claim 37, the spray, liquid or powder formulations (Claim 12) of Deng et al. implicitly have a “washing composition” added as defined by the instant specification (Page 3, lines 11-16). Optional components are not required.
Regarding claim 41, Deng et al. teach that the particles are designed to release molecules to be encapsulated or attached covalently or non-covalently [0071, 0098, 0107-0108] where in preferred embodiments the molecules to be attached are particles blocking or filtering UV radiation [0109].
Regarding claims 21 and 32, Panyam et al. disclose a method that employs a composition of nanoparticles, thus reading on a set of particles, comprising at least one polymer and at least one therapeutic agent joined thereto (Claim 1) where the polymer is poly(lactic acid), poly(lactide), poly(glycolic acid), (poly(lactic-co-glycolic acid) (Claims 3-4), the therapeutic agent can be a polysaccharide, a peptide, a polypeptide, a nucleic acid, a vitamin, a mineral, a vaccine, a cytokine, an apoptotic agent, a cytotoxic agent, and a pharmaceutical drug (Claims 5-6), which is encapsulated (Page 39, lines 10-12) and the nanoparticle can further comprise a functional group joined thereto that is alkane, alkene, alkyne, amide, amine, imide, phosphine, phosphodiester, phosphonic acid, phosphate, sulfide, imidazole and oxazole (Claim 8) and a specific example with maleimide (Page 43, Example 8 and see page 24, line 38 through page 25, line 6 for functional groups within the scope of the claims), which means at least 1 functional group.
Regarding claims 21 and 32 where n = 1 such that linear linker B “polyalkylene glycols” is present, Panyam et al. disclose nanoparticles comprising PLGA with a diblock copolymer polylactide-polyethylene glycol with terminal maleimide functional group and c(RGD) peptide (Example 8) and a diblock copolymer polylactide-polyethylene glycol with terminal amine functional group and FLUORESCEIN ISOTHIOCYANATE (Example 9). Polyethylene glycol has a repeat unit of (O-CH2-CH2) with p = 1, thus reading on at least the conditions of: A comprises at least one residue of poly(lactic acid), B comprises at least one residue of poly(ethylene glycol), C is maleimide or a derivative thereof, and m is comprised between 1 and 1025.
Regarding claims 21 and 32, Thermo Fisher Scientific teaches commercially available polyethylene glycols with 2-24 PEG units that also have a maleimide group at one end (bottom of page 5 into page 6; Bifunctional pegylated crosslinkers) as well as amine to sulfhydryl crosslinkers with PEG spacer arms of 2-24 ethylene glycol units (Page 6).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02) and Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
The difference between the instant application and Deng et al. is that Deng et al. do not expressly teach an embodiment where n is 1 and C represents a maleimide group and the UV-filter is attached to the particle or adding instructions. This deficiency in Deng et al. is cured by the teachings of Panyam et al. and Thermo Fisher Scientific.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to encapsulate or attach any of the UV-filters claimed to the particle of Deng et al. where n is 1 and C represents a maleimide group and produce the instant invention. One of ordinary skill in the art would have been motivated to do this because Deng et al. teach and suggest encapsulating or attaching a UV-filters and having the linear linker PEG has a hydroxyl functional group C and can be further functionalized with amines such as maleimides and provide the methods for attaching molecules with various functional groups. It is simple selection of a maleimide reactive group, as suggested by Deng et al., where Panhyam et al. teaches using PLA-PEG(maleimide) or PLA-PEG(NH2) (Page 41, line 15-16; Example 8) and Thermo Fisher Scientific teaches commercially available polyethylene glycols with 2-24 PEG units that also have a maleimide group at one end (bottom of page 5 into page 6; Bifunctional pegylated crosslinkers). It is then obvious to employ a maleimide reactive groups in the topical formulation particles of Deng et al. as Panhyam et al. provide examples of use and Thermo Fisher Scientific provides a commercial source to obtain the maleimides, with a reasonable expectation of success. Moreover, adding instructions to a kit on how to apply the product is obvious to the artisan. One would do so to ensure that the product is properly applied by the lay person and not improperly used. One would do so with a reasonable expectation of success.
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.
From the combined 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 combined references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant’s arguments filed 1/15/26 have been carefully considered but are not persuasive.
On page 5 of remarks, Applicant asserts that: “In the nanoparticles of Deng et al., the PLA-PEG corresponds to the linker and the functional group. Therefore, Deng et al. do not disclose bioadhesives particles of formula (I) comprising a polymer core, a linear linker, and a maleimide group, that encapsulate or are attached to a UV-filter.” Respectfully, the Examiner has a different perspective. As the shown above, Deng et al. do teach a polymer core as claimed, a linear linker as claimed and suggest a maleimide reactive group as claimed with an encapsulated or attached UV-filter. Applicant asserts that Panyam et al. and Thermo Fisher Scientific do not remedy the defects of Deng et al. However, Deng et al. teach maleimides and both Panyam et al. and Thermo Fisher Scientific provide evidence that not only are maleimides routinely employed in the art but are also readily available to the ordinary artisan. Respectfully, Applicant’s arguments are not persuasive.
On page 6 of remarks, Applicant asserts that Deng et al. teach nanoparticles loaded with the dye Did which his not a UV-filter. Respectfully, that is too narrow of an interpretation of Deng et al. The dye was employed to test for skin penetration [0318] and Deng et al. expressly teach sunscreens based on the nanoparticles [0322] and provide padimate O loaded nanoparticles embodiments (Examples 5-9, [0232-0356]; claims 10-11). The secondary references of Panyam et al. and Thermo Fisher are relied upon as applied in the rejection and not as characterized by Applicant. Applicant’s arguments are not persuasive.
Respectfully, the Examiner has carefully considered Applicant’s arguments but finds that the instant claims are not patentable in view of the preponderance of evidence and consideration of all the facts, which is more convincing than the evidence which has been offered in opposition to it.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERNST V ARNOLD whose telephone number is (571)272-8509. The examiner can normally be reached M-F 7-3:30.
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/ERNST V ARNOLD/Primary Examiner, Art Unit 1613