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 .
Notice of Pre-AIA or AIA Status
DETAILED ACTION
Status of the Claims
Claims 1-20 are pending and under examination.
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 .
Priority
This application is a national stage entry of PCT/FR2022/051365 filed on 7/7/2022, which claims priority from French application FR2107441 filed on 7/8/2021.
Information Disclosure Statement
The information disclosure statement filed on 12/08/2023 has been considered by the examiner.
Claim Objections
Claim 1 is objected to for missing an “and” between “both UVBs and UVAs;” and “- at least one organic UVA…” in the claim.
Claim 16 is objected to for not having a conjunction (an “and” or “or”) between the last 2 options of agents in the claim.
Appropriate corrections are 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 1-20 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.
Claims 1, and 15-17 are indefinite for the recitation of “it”, as there is ambiguity to what “it” is referring to. It cannot be presumed to be referring to the composition necessarily. It is recommended to change “it” to “the composition” if that it was applicant intends to refer to.
Claims 2-14 and 18-20 are rejected as being directly or indirectly dependent on indefinite claims.
Claim 4 is indefinite for use of “as well as” to connect the items of the group as this language suggests it is part of a whole of all the items listed in the group. Thus, it is unclear if all the items in the group are necessary to meet the limitation or if “as well as” is just being used as a conjunction for a group of alternative items. The word “and” is more appropriate in a Markush claim with “selected from the group consisting of…..and…..”.
Claim 5 is indefinite for the recitation of “selected from the group comprising” for the group of items as it is unclear if this is meant to be a Markush group limited to only those items in the group or if the group is open to other items of the art. For the purpose of compact prosecution, the examiner will consider the claim as it is open to other UVA screening agents of the prior art. The applicant may use “selected from the group consisting of” language or change the language to “….said at least one organic UVA screening agent comprises…….or…..”.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
In the present instance, claim 5 recites the broad recitation “butyl methoxydibenzoylmethane, diethylamino hydroxybenzoyl hexyl benzoate, bis- (diethylaminohydroxybenzoyl benzoyl) piperazine, disodium phenyl dibenzimidazole tetrasulfonate”, and the claim also recites “in particular butyl methoxydibenzoylmethane and _ diethylamino hydroxybenzoyl hexyl benzoate”, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
In the present instance, claim 15 recites the broad recitation “butyl methoxydibenzoylmethane, diethylamino hydroxybenzoyl hexyl benzoate, bis- (diethylaminohydroxybenzoyl benzoyl) piperazine, disodium phenyl dibenzimidazole tetrasulfonate”, and the claim also recites “in particular butyl methoxydibenzoylmethane and _ diethylamino hydroxybenzoyl hexyl benzoate, advantageously butyl methoxydibenzoylmethane and _ diethylamino hydroxybenzoyl hexyl benzoate”, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claims 6 and 9 recite the limitation "said at least one organic UVB screening agent" in the claim, but claim 1 only provides for “at least two organic screening agents chosen from organic UVB screening agents and/or broad-spectrum organic screening agents absorbing both UVBs and UVAs”. This seems to suggest basis for “at least two…” from claim 1. There is insufficient antecedent basis for this limitation in the claim. Applicant may amend claim 1 to indicate “at least two organic screening agents chose from at least one organic UVB screening agent….” so that there is proper antecedent basis for “said at least one organic UVB screening agent” in claims 6 and 9.
Claims 7 and 11 recite the limitation "said at least one broad-spectrum organic screening agent" in the claim, but claim 1 only provides for “at least two organic screening agents chosen from organic UVB screening agents and/or broad-spectrum organic screening agents absorbing both UVBs and UVAs”. This seems to suggest basis for “at least two…” from claim 1. There is insufficient antecedent basis for this limitation in the claim. Applicant may amend claim 1 to indicate “at least two organic screening agents chosen from at least one organic UVB screening agent and/or at least one broad-spectrum organic screening agent absorbing both UVBs and UVAs” so that there is proper antecedent basis for “said at least one broad-spectrum organic screening agent" in claims 7 and 11.
Claim 14 recite the limitation "the organic UCA screening agent.." in the claim, but claim 1 provides for “at least one organic UVA screening agent”. There is insufficient antecedent basis for this limitation in the claim. Applicant may amend the limitation to “the at least one organic UVA screening agent”.
Claims 2, 3, 19 and 20 are indefinite for the use of “type” after the group formula as it makes it unclear if type is meant to allow for other variations of the mentioned group or if the group should conform to the exact formula that is provided before the word “type”. For the purpose of compact prosecution, the examiner will consider the group as provided in the claim and reasonable variations of it for searching the prior art. Applicant is suggested to remove the “-type” from the claims.
Claim Rejections – 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 5, 6, 8-11, 17 and 18 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Osati US20240254096A1 (effective filing date of July 7, 2021).
Osati teaches a composition with compound of formula 38 (paragraph 183) at 1%
PNG
media_image1.png
185
350
media_image1.png
Greyscale
that also contains octocrylene (3%), Avobenzone (3%), homosalate (8%) (paragraph 253, example 59). Compound 38 is the MAA of formula IA. Octocrylene absorbs UVB and UVA rays, avobenzone absorbs UVA rays and homosalate absorbs UVB rays. As Osati teaches a formulation of claim 1 with two organic screening agents selected from UVB screening agents and broad spectrum screening agents along with one UVA screening agent and 1% MAA compound with concentrations in applicant’s claimed ranges, it will have an SPF equal or greater than 20. In regards to other MAA compounds, see compounds of formulae 53, 55, 67, and 68 and close structural formulae 60-65 to formula IB. Osati teaches “the method is for preventing the harmful effects of UV and/or visible radiations on a subject such as a human and includes the steps of applying a formulation and/or a composition comprising one or more of the compounds of the present technology onto the skin of the human subject” (paragraph 135). Osati teaches sunscreen (abstract).
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 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.
Claims 7, 12, 13, 14, 15 and 16 in addition to Claims 1, 5, 6, 8-11, 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Osati US20240254096A1 (effective filing date of July 7, 2021).
Osati also teaches “Examples of agents that block both UVA and UVB include, but are not limited to, bemotrizinol (Tinosorb S) (aka BEMT), benzophenones 1-12, ioxybenzone, drometrizole trisiloxane (Mexoryl XL), iscotrizinol (Uvasorb HEB)(aka DHBT), octocrylene, oxybenzone (Eusolex 4360), sulisobenzone, hybrid (chemical/physical): bisoctrizole (Tinosorb M)” (paragraph 111). Osati teaches “Examples of UVB-blocking agents include, but are not limited to, 4-Aminobenzoic acid (PABA), cinoxate, ethylhexyl triazone (Uvinul T 150), homosalate, 4-Methylbenzylidene camphor (Parsol 5000), octyl methoxycinnamate (octinoxate), octyl salicylate (Octisalate), padimate 0 (Escalol 507)” (paragraph 111). Osati teaches “Examples of UVA-absorbing agents include, but are not limited to, avobenzone (Parsol 1789), bisdisulizole disodium (Neo Heliopan AP), diethylamino hydroxybenzoyl hexyl benzoate (Uvinul A Plus)” (paragraph 111). Amounts of the compounds of formulae in Osati are from 0.1 to about 25% by wt (paragraph 107). Osati teaches “A SPF value of 2 generally absorbs 50% UVB, a SPF value of 15 generally absorbs 93.3% UVB, SPF 30 absorbs 96.7% UVB and SPF 50 absorbs 98% UVB.” (paragraph 110). Thus, higher SPFs absorb more UVB.
One of ordinary skill in the art before the time of filing would have combined other known UV screening agents of the prior art in amounts used by Osati in order to provide new, optimized sunscreen formulations. Additionally, Osati provides for other UVA/UVB agents, and thus, would be able to replace octocrylene in its formulations with agents such as Tinosorb S and Uvasorb HEB as acceptable alternatives. There would be a reasonable expectation of success in using teachings of Osati to arrive at claimed compositions with improved sunscreen properties.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Llewellyn WO2002039974A1 (in applicant’s IDS) and Abou-Khalil US20150152046A1.
Llewellyn teaches personal care compositions comprise sunscreen compounds which are mycosprorine-like amino acids (MAAs) (abstract). Llewellyn teaches example 1 with Butylmethoxy dibenzoyl methane 1.2% (UVA agent), Octyl methoxy cinnamate (Octinoxate) 1.0% (UVB agent), and Di octyl Butamido triazone (Uvasorb HEB) 1.0% (UVA/UVB agent) along with sun filters that are MAAs. Example 2 teaches a composition with Butylmethoxy dibenzoyl methane 1.2% (UVA agent), Octyl methoxy cinnamate 1.0% (UVB agent), and Benzylidene Camphor 2.0% (UVB agent) along with MAA. Llewellyn teaches “a) para-aminobenzoic acids, esters and derivatives thereof, for example, 2- ethylhexyl para-dimethylaminobenzoate and the octyl ester of para- aminobenzoic acid; b) methoxycinnamate esters such as 2-ethylhexyl para-methoxycinnamate, 2- ethoxyethyl para-methoxycinnamate or α,β-di-(para-methoxycinnamoyl)-α'- (2-ethylhexanoyl)-glycerin; c) benzophenones such as oxybenzone; d) dibenzoylmethanes such as 4-(tert-butyl-4'-methoxydibenzoylmethane; e) 2-phenylbenzimidazole-5 sulfonic acid and its salts and disodium phenyl dibenzimidazole tetrasulfonate; f) alkyl-β,β-diphenylacrylates for example alkyl α-cyano-β,β-diphenylacrylates such as octocrylene; g) triazines such as 2,4,6-trianilino-(p-carbo-2-ethyl-hexyl-1-oxi)-1 ,3,5 triazine; h) camphor derivatives such as methylbenzylidene camphor and terphthalylidene dicamphor sulfonic acid; i) organic pigments sunscreening agents such as methylene bis-benzotriazole tetramethyl butylphenol; j) silicone based sunscreening agents such as drometrizole trisiloxane benzylidene malonate polysiloxane and dimethicodiethyl benzal malonate; and k) salicylates such as octyl salicylates. The additional sunscreening agent may be present in an amount of 0.1 to 25% by weight of the composition.” (pages 9 and 10). The description of Llewellyn provides for topical application to provide protection against the sun’s rays or other sources of UV radiation (page 1). Llewellyn’s compositions of examples 3-5 have an SPF of 25. The example 4 composition has Butylmethoxy dibenzoyl methane, Methylene bis-benzotriazole tetramethyl butylphenol and octyl methoxy cinnamate. Example 4 teaches mycosporine glycine at 5% and N-methyl mycosporine threonine at 5%.
Llewellyn teaches sunscreens having formulations with MAAs along with combinations of UVA and at least two UVB and/or UVA/UVB screening agents, but does not teach MAAs of the applicant claims nor some of the other UV agents provided in the claims.
Abou-Khalil teaches “The present invention relates to compounds that absorb ultraviolet radiations and that protect biological materials as well as non-biological materials from damaging exposure to ultraviolet radiations.” (paragraph 2). Abou-Khalil teaches compounds of formula I-
PNG
media_image2.png
143
386
media_image2.png
Greyscale
(abstract). Abou-Khalil teaches compounds of formula IA
PNG
media_image3.png
190
409
media_image3.png
Greyscale
(claim 102 of Abou-Khalil). Abou-Khalil teaches compounds that fit formula I and Ia in paragraph 9.
PNG
media_image4.png
406
358
media_image4.png
Greyscale
. Both these compounds have an R2 that is a carboxyl group and a methoxy group at the R1 position. Abou-Khalil teaches “Examples of UVB-blocking agents include, but are not limited to, 4-Aminobenzoic acid (PABA), cinoxate, ethylhexyl triazone (Uvinul T 150), homosalate, 4-Methylbenzylidene camphor (Parsol 5000), octyl methoxycinnamate (octinoxate), octyl salicylate (Octisalate), padimate O (Escalol 507), phenylbenzimidazole sulfonic acid (Ensulizole), polysilicone-15 (Parsol SLX) and trolamine salicylate.” (paragraph 116). Abou-Khalil teaches “Examples of UVA-absorbing agents include, but are not limited to, avobenzone (Parsol 1789), bisdisulizole disodium (Neo Heliopan AP), diethylamino hydroxybenzoyl hexyl benzoate (Uvinul A Plus), ecamsule (Mexoryl SX) and methyl anthranilate” (paragraph 115). Abou-Khalil teaches “Examples of agents that block both UVA and UVB include, but are not limited to, bemotrizinol (Tinosorb S), Bbenzophenones 1-12, ioxybenzone, drometrizole trisiloxane (Mexoryl XL), iscotrizinol (Uvasorb HEB), octocrylene, oxybenzone (Eusolex 4360), sulisobenzone, hybrid (chemical/physical): bisoctrizole (Tinosorb M)” (paragraph 117). Abou-Khalil teaches “The compounds may be incorporated into cosmetic and/or personal care products formulations or compositions in an amount of from about 0.2% to about 30% of the weight of the formulation or the composition, more preferably from about 1% to about 15% of the weight of the formulation or the composition.” (paragraph 120).
One of ordinary skill in the art before the time of filing would have looked to the teachings of Abou-Khalil to include new mycosporine-like amino acids and other UV screening agents into MAA sunscreen formulations taught by Llewellyn in order to provide improved UV screening formulations to better protect the skin from damaging UV radiation. There was a reasonable expectation of success in combining the teachings of the references in order to provide other formulations for improved UV protection of skin and more absorbance/blocking of UVA and UVB radiation.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARK V STEVENS whose telephone number is (571)270-7080. The examiner can normally be reached M-F 9:00 am to 6:00 pm EST.
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, Brian-Yong 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.
/MARK V STEVENS/Primary Examiner, Art Unit 1613