DETAILED ACTION
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 .
Response to Amendment and Arguments
The rejection of claims 1-4, 6-8, 10, 11, 14-15 and 18 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph under the written description proviso, is withdrawn in view of the amendment to claim 1 no longer requiring the reduction of skin inflammation as was broadly claimed in a subject in need thereof and in view of the cancelation of claim 11.
The rejection of claim 11 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph as lacking enablement, is withdrawn in view of the cancelation of claim 11.
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, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 365(c) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. EP18306263.7, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. There is no disclosure of the relationship of TAFA4 to induction of IL-10 production. Therefore, the earliest effective filing date of the instant application is 09/26/2019.
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.
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.
Claim(s) 1, 14 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2016/0113996 A1 (‘996) as evidenced by Hoeffel et al. (Nature, 594:94-99, 3 June 2021, cited in the PTO-892 mailed 8/20/2024).
US 20160113996 teaches in paragraph [0126] topical application of an effective amount of TAFA4 to a subject, wherein TAFA4 is applied to target areas, e.g., skin surfaces. It is noted that the invention is for treatment of pain which is acute or chronic and may be caused by burns, bumps, bruises, injections, and that inflammatory pain occurs in the presence of tissue damage or inflammation ([0095]). Also taught (paragraph [0128)]) is a kit comprising “(i) a TAFA4 compound or composition ...and (ii) at least one additional distinct active compound efficient against pain, and optionally (iii) written instructions for using the kit.” Administration with another active agent is also taught in [0113].
The inflammation encompassed by the conditions recited in ‘996, e.g., burns, bumps, bruises, wounds and injections, includes skin inflammation. Further, while ‘996 is silent with respect to increase of IL-10 production by TAFA4, this is an inherent property of TAFA4 as evidenced by Hoeffel et al. (Nature, 594:94-99, 3 June 2021, cited in the PTO-892 mailed 8/20/2024) showing that TAFA4 stimulates TIM4+ dermal macrophages to produce IL-10 (see, e.g., Fig. 3g and pp. 97-99). Hoeffel et al. is not required for anticipation but cited only to show the inherent connection between TAFA4 and IL-10 production.
Applicant’s argument that pertains to the instant rejection is addressed here:
Applicant argues (bottom of p. 5 of REMARKS) that independent claim 1 has been amended to recite a method of increasing IL-10 production in a subject having skin inflammation. ‘996 is completely silent regarding increasing IL-10 production. Therefore, the subject matter is novel and the rejection should be withdrawn. The argument has been fully considered but is not persuasive. The method of ‘996 uses the identical product for treatment of a patient population that overlaps with that of the instant claims. Induction of IL-10 production by TAFA4, particularly by topical administration, is an inherent property of TAFA4 (see Hoeffel et al., supra). As stated in MPEP § 2112(I) “"[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).” Also, in In re Omeprazole Patent Litigation, 483 F.3d 1364, 1373, 82 USPQ2d 1643, 1650 (Fed. Cir. 2007) the court noted that although the inventors may not have recognized that a characteristic of the ingredients in the prior art method resulted in an in situ formation of a separating layer, the in situ formation was nevertheless inherent. "The record shows formation of the in situ separating layer in the prior art even though that process was not recognized at the time. The new realization alone does not render that necessary [sic] prior art patentable." (MPEP § 2112.01(I)). As stated in MPEP § 2112.01(II), “"Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.”
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.
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.
Claim(s) 1-8, 10, 14, 15, 18 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0113996 A1 (‘996) as applied to claim(s) 1, 14 and 15 above, and further in view of GenBank Database Accession AAP92409 (https://www.ncbi.nlm.nih.gov/protein/AAP92409.1, 09 Jul. 2004) and Eichenfield et al. (J. Am. Acad. Dermatol. 71(1):116-132, 2014, cited in the PTO-892 mailed 8/20/2024) as evidenced by Hoeffel et al. (Nature, 594:94-99, 3 June 2021, cited in the PTO-892 mailed 8/20/2024).
US 20160113996 teaches in paragraph [0126] topical application of an effective amount of TAFA4 to a subject, wherein TAFA4 is applied to target areas, e.g., skin surfaces. Paragraph [0121] and claim 22 teach administration may be cutaneous, dermic or transdermic. It is noted that the invention for treatment of pain which is acute or chronic and may be caused by burns, bumps, bruises, injections, and that inflammatory pain occurs in the presence of tissue damage or inflammation ([0095]). Also taught (paragraph [0128)]) is a kit comprising “(i) a TAFA4 compound or composition ...and (ii) at least one additional distinct active compound efficient against pain, and optionally (iii) written instructions for using the kit.” “Inflammation is responsible for the sensitization of peripheral sensory neurons.” [0095]) Paragraph [0013] teaches a kit comprising a TAFA4 protein and at least one additional distinct active compound against pain. Administration with another active agent is also taught in [0113]. Human and mouse TAFA4 are 90% identical and TAFA4 has a 35 amino acid signal sequence and 105 amino acid-long mature chain ([0082]). Using an inflammatory pain model of subcutaneous carrageenan injection in a mouse, TAFA4-KO (-knock out) mice treated with a subcutaneous injection of TAFA4 led to a dose-dependent analgesic effect ([0227]-[0231]). A model of neuropathic pain of SNI (spared nerve injury, [0207]) showed TAFA4 had substantial analgesic effects ([0221]-[0225]). US ‘996 does not teach a TAFA4 protein having the sequence 90% identical to instant SEQ ID NO:1 or administration by a transdermal device. “996 does not teach treatment additionally with a glucocorticoid.
GenBank Database Accession AAP92409 teaches the sequence of human TAFA4, which is identical to instant SEQ ID NO:1.
Eichenfield et al. teach atopic dermatitis (AD) is a chronic, pruritic inflammatory skin disease, with which eczema is considered synonymous (p. 118, col. 1, last two paragraphs). It taught that (p. 121, end of col. 1) the use of topical corticosteroids (TCS) “in the management of AD in both adults and children ... are the mainstay of anti-inflammatory therapy.” “[TCS] are generally the standard to which other topical anti-inflammatory therapies are compared... TCS are used for both active inflammatory disease and for prevention of relapses.” (p. 121, col. 2, middle) Further, TCS may be used in combination with another AD medication, e.g., a topical calcineurin inhibitor (e.g., p. 126, col. 1, third paragraph).
The prior art references are silent with respect to increase of IL-10 production by TAFA4; however, this is an inherent property of TAFA4 as evidenced by Hoeffel et al. (Nature, 594:94-99, 3 June 2021, cited in the PTO-892 mailed 8/20/2024), which shows that TAFA4 stimulates TIM4+ dermal macrophages to produce IL-10 (see, e.g., Fig. 3g and pp. 97-99).
It would have been obvious before the effective filing date of the instant invention to treat inflammation from a skin burn or skin wound by topical application of TAFA4 as taught by ‘996, or any other pain caused by an inflammatory skin condition, such as by atopic dermatitis. Because ‘996 showed TAFA4 treated inflammatory pain from a subcutaneous-originating source as well as deeper sources, and that TAFA4 administration may be transdermal, dermal or cutaneous, one of ordinary skill in the art would have been motivated to treat an inflammatory skin condition accompanied by discomfort, e.g., photodermatitis or diabetic foot ulcers, with topically applied TAFA4 and would have had a reasonable expectation of success. As a result of such treatment, there would have been a reasonable expectation of increase in IL-10 production, which is an inherent property of TAFA4 as evidenced by Hoeffel et al. It would have been obvious wherein the TAFA4 was a full-length or mature human protein as taught by GenBank Accession AAP92409 for treatment of a human subject in order to reduce the chance of an undesirable immune response that may occur against proteins from different species. Note that SEQ ID NO:2 of ‘996 is at least 90% identical to the mature form, i.e., without the signal sequence, of instant SEQ ID NO:1. It further would have been obvious to have applied the TAFA4 to the skin using a transdermal device since ‘996 taught that it could be administered transdermally. It would have been obvious to also treat the subject having skin inflammation with a glucocorticoid if they were in need thereof, for example, a subject who had atopic dermatitis as taught by Eichenfield et al. because glucocorticoids were recognized as anti-inflammatory therapies.
Applicant argues (p. 6) that Moqrich (‘996) does not teach or suggest reduced skin inflammation or a method of increasing IL-10 production in a subject. The GenBank database and Eichenfield do not compensate for the deficiencies of Moqrich. Also, new claim 20 specifies the skin inflammation is not caused by a wound or burn, which is not obvious. The arguments have been fully considered but are not persuasive. As discussed for the rejection under 35 USC 102 above, “The method of ‘996 uses the identical product for treatment of a patient population that overlaps with that of the instant claims. Induction of IL-10 production by TAFA4, particularly by topical administration, is an inherent property of TAFA4 (see Hoeffel et al., supra). As stated in MPEP § 2112(I) “"[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).” As stated in the rejection immediately above, “Because ‘996 showed TAFA4 treated inflammatory pain from a subcutaneous-originating source as well as deeper sources, and that TAFA4 administration may be transdermal, dermal or cutaneous, one of ordinary skill in the art would have been motivated to treat an inflammatory skin condition accompanied by discomfort, e.g., photodermatitis or diabetic foot ulcers, with topically applied TAFA4 and would have had a reasonable expectation of success.” Eichenfield et al. taught that atopic dermatitis is an inflammatory skin condition. For the reasons discussed in the rejection, it would have been obvious to have administered human TAFA4, i.e., having the sequence of SEQ ID NO:1. For these reasons and as set forth in the rejection above, the invention was prima facie obvious.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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Claire Kaufman
/CLAIRE KAUFMAN/Primary Examiner, Art Unit 1674 January 9, 2026