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 1-10 are pending in the application. Claims 1-10 are rejected.
Priority
This application is a 35 U.S.C. 371 National Stage Filing of International Application No. PCT/KR2023/002922, filed March 3rd, 2023, which claims priority under 35 U.S.C. 119(a-d) to KR10-2022-0028028 and KR10-2023-0028185, filed March 4th, 2022 and March 3rd, 2023.
Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
Information Disclosure Statement
The Examiner has considered the Information Disclosure Statement(s) filed on December 23rd, 2025 and September 4th, 2024.
Specification
The amendment filed September 4th, 2024 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: “which are all hereby incorporated by reference in their entirety” with respect to the foreign priority documents.
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Applicant is directed to MPEP 211.02 (I), which particularly addresses incorporation by references filed after a filing date as follows:
For applications filed on or after September 21, 2004, a claim under 35 U.S.C. 119(e) or 120 and 37 CFR 1.78 for benefit of a prior-filed provisional application, nonprovisional application, or international application designating the United States that was present on the filing date of the continuation or divisional application, or the nonprovisional application claiming benefit of a prior-filed provisional application, is considered an incorporation by reference of the prior-filed application as to inadvertently omitted material, subject to the conditions and requirements of 37 CFR 1.57(a). The purpose of 37 CFR 1.57(a) is to provide a safeguard for applicants when all or a portion of the specification and/or drawing(s) is (are) inadvertently omitted from an application. See MPEP §201.06 and 201.17. However, applicants are encouraged to provide in the specification an explicit incorporation by reference statement to the prior-filed application(s) for which benefit is claimed under 35 U.S.C. 119(e) or 120 if applicants do not wish the incorporation by reference to be limited to inadvertently omitted material pursuant to 37 CFR 1.57(a). See 37 CFR 1.57(b). Se MPEP §§ 201.17 and 608.01(p).
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When a benefit claim is submitted after the filing of an application, and the later-filed application as filed did not incorporate the prior-filed application by reference, applicant cannot add an incorporation by reference statement of the prior application. An incorporation by reference statement added after an application’s filing date is not effective because no new matter can be added to an application after its filing date (see 35 U.S.C. 132(a)).
See Dart Indus. v. Banner, 636 F.2d 684, 207 USPQ 273 (C.A.D.C. 1980). See also 37 CFR 1.57(a).
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In the instant application, the incorporation by reference statement is being added after the application's filing date (PCT filing date of March 3rd, 2023) which is after September 21st, 2004 when there was a rule change. Therefore, the “incorporation by reference” being added to the specification per the Amendment filed September 4th, 2024 is deemed new matter.
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.
Claim 7 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 7, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 102
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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) 1-4 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by WO 2008/141176 A1 by Wilensky et al.
Wilensky et al. teach the following general method on page 120:
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The prior art further teaches the following embodiment regarding the agent being used:
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The prior art discloses in paragraph [0500] that the agent recited in claim 8 above is also known as darapladib. The instant claims encompass both the treatment and prevention of “a skin disease caused by radiation irradiation” such that any particular subject would either already have such a disease or be at some risk of developing such a disease by having their skin irradiated by solar radiation. Accordingly, the administration taught by the prior art is deemed to anticipate instant claim 1 since it meets the active step of merely administering darapladib. Regarding instant claims 2 and 3, these claims only appear to recite inherent properties of darapladib or a manner in which it would function in vivo. Regarding instant claim 4, the same rationale above applies where either a subject would already have these conditions or be susceptible to developing fibrosis due to sun exposure.
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.
Claim(s) 1-4 and 7-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2008/141176 A1 by Wilensky et al.
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Wilensky et al. teach the following general method on page 120:
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The prior art further teaches the following embodiment regarding the agent being used:
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The prior art discloses in paragraph [0500] that the agent recited in claim 8 above is also known as darapladib. The instant claims encompass both the treatment and prevention of “a skin disease caused by radiation irradiation” such that any particular subject would either already have such a disease or be at some risk of developing such a disease by having their skin irradiated by solar radiation. Accordingly, the administration taught by the prior art is deemed to anticipate instant claim 1 since it meets the active step of merely administering darapladib. Regarding instant claims 2 and 3, these claims only appear to recite inherent properties of darapladib or a manner in which it would function in vivo. Regarding instant claim 4, the same rationale above applies where either a subject would already have these conditions or be susceptible to developing fibrosis due to sun exposure.
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
The prior art anticipates instant claims 1-4 where anticipation is the epitome of obviousness. Instant claims 7-10 recite particular forms of administration or types of compositions.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2141.02)
Regarding instant claims 7, 9 and 10, the prior art teaches on page 109 that the compositions may be applied topically as follows:
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At least in the interest of determining which particular mode of administration would be optimal, a person having ordinary skill in the art would have been motivated to test the types of administration taught in the prior art. The use of a lotion would be embraced by instant claims 7, 9 and 10 (at least based on skin lotion recited in instant claim 10). The same general rationale applies to instant claim 8 that recites the use of a “health functional food composition” but where this term would only appear to require that the composition be edible. The prior art teaches the following carriers on page 106:
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At least the use of a syrup or dextrose containing composition would be embraced by instant claim 8 since they would be edible.
Claim(s) 1-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2008/141176 A1 by Wilensky et al., as applied to claims 1-4 and 7-10 above, and in further view of Yang et al. Aging, 2020, 12, 23379-23393 and in further view of Office of Environment, Health, Safety and Security, The DOE Ionizing Radiation Dose Ranges Chart, AU-22 001-2018, December 2017.
The obviousness rejection above does not address high-dose radiation, however, Wilensky et al. teach a method (page 120) of treating and/or preventing skin ulcers. Wilensky et al. further teach on page 94 that skin ulcers can result from various conditions including (paragraph [0590]) “traumatic (for example, pressure ulcer, radiation damage)…”. Furthermore, a person having ordinary skill in the art would have been familiar with the occurrence of skin ulcers due to radiation therapy. Yang et al. review (title) “Radiation-induced skin injury” and state on page 23379: “On the whole, RSIs consist of two types, i.e., acute and chronic. Acute RSIs involve dry and wet desquamation, skin necrosis, ulcers, as well as bleeding [3]. Chronic RSIs cover chronic ulcers, radiation-induced keratosis, telangiectasias, fibrosis, as well as skin cancer [4].” Therefore, a person having ordinary skill in the art would have reasonably expected subjects in need of skin ulcer treatment caused by radiation damage would include subjects exposed to radiation therapy. Furthermore, a person having ordinary skill in the art would have been familiar with doses encountered for radiation therapy. The Office of Environment, Health, Safety and Security teaches a chart on page 5 of the document where doses range from 2000 rem and up including 4000 rem. This range overlaps with instant claim 6 corresponding to a range overlapping with 20 Gy to 40 Gy. Accordingly, a person having ordinary skill in the art would have been motivated to administer darapladib to patients being exposed to cancer radiotherapy including with radiation levels embraced by the instant claims to either prevent skin ulcer occurrence or treat skin ulcers that occur as a result.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW P COUGHLIN whose telephone number is (571)270-1311. The examiner can normally be reached Monday - Friday, 10 am - 6 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor can be reached at 571-272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW P COUGHLIN/Primary Examiner, Art Unit 1626
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