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, filed 05/16/2023 is a National Stage entry of PCT/JP2021/042112, International Filing Date: 11/16/2021. PCT/JP2021/042112 claims foreign priority to 2020-189986, filed 11/16/2020. A certified copy of the foreign priority application is of record.
Status of Claims
Claims 1-3 are currently pending.
Claims 1-3 were examined and are rejected.
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) 1-3 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Westphal et. al., WO 2017062665 A1, publ. 4/13/2017.
Westphal discloses compositions having activity for treating muscle cramps, muscle spasms, spasticity, dystonias, and fasciculations (title & abstract). In particular, Westphal discloses the combination of the TRPV1 activator capsaicin and the TRPA1 activator, cinnamaldehyde (Ex. 1, bridging para pp. 88-89; pp. 90-91, Table 1, see treatment F).
Regarding the recitation in the preamble of claim 1, “for enhancing adrenomedullin gene expression”, this statement is drawn to intended use of the composition. If the preamble limitations don’t impart structural limitations to the claim, and the body of the claim fully sets forth the structural limitations, the statement of intended use doesn’t further limit the claim. See MPEP 2111.02(II): If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020) (The court found that the preamble in one patent’s claim is limiting but is not in a related patent); Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) ("where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation"); Kropa v. Robie, 187 F.2d at 152, 88 USPQ2d at 480-81 (preamble is not a limitation where claim is directed to a product and the preamble merely recites a property inherent in an old product defined by the remainder of the claim); STX LLC. v. Brine, 211 F.3d 588, 591, 54 USPQ2d 1347, 1350 (Fed. Cir. 2000) (holding that the preamble phrase "which provides improved playing and handling characteristics" in a claim drawn to a head for a lacrosse stick was not a claim limitation). As Westphal discloses a composition comprising the same combination of TRPV1 agonist and TRPA1 agonist as claimed, and the preamble of claim 1 doesn’t further limit the claim, Westphal anticipates the claims.
Claim(s) 1-3 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang et. al., CN 111296841 A, publ. 6/19/2020. An English translation of Wang is provided and is referred to for discussion.
Wang discloses a composition for preventing and controlling cold damage comprising 6-gingerol, piperine, and cinnamaldehyde (abstract; para [0010-0012]; p. 35 of 38, claim 1). Wang discloses the composition increases the body’s heat production effect, exhibits a synergistic effect, and has no toxic side effects (para [0008]). Therefore, Wang discloses a composition comprising the combination of the TRPV1 agonists 6-gingerol and piperine, and the TRPA1 agonist, cinnamaldehyde.
Regarding the recitation in the preamble of claim 1, “for enhancing adrenomedullin gene expression”, this statement is drawn to intended use of the composition. If the preamble limitations don’t impart structural limitations to the claim, and the body of the claim fully sets forth the structural limitations, the statement of intended use doesn’t further limit the claim. See MPEP 2111.02(II): If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020) (The court found that the preamble in one patent’s claim is limiting but is not in a related patent); Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) ("where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation"); Kropa v. Robie, 187 F.2d at 152, 88 USPQ2d at 480-81 (preamble is not a limitation where claim is directed to a product and the preamble merely recites a property inherent in an old product defined by the remainder of the claim); STX LLC. v. Brine, 211 F.3d 588, 591, 54 USPQ2d 1347, 1350 (Fed. Cir. 2000) (holding that the preamble phrase "which provides improved playing and handling characteristics" in a claim drawn to a head for a lacrosse stick was not a claim limitation). As Wang discloses a composition comprising the same combination of TRPV1 agonist and TRPA1 agonist as claimed, and the preamble of claim 1 doesn’t further limit the claim, Wang anticipates the claims.
Information Disclosure Statements
The IDS filed on 5/16/23, 7/10/23, 7/26/23, 7/24/25, and 7/28/25 have been considered.
Conclusion
Claims 1-3 are rejected.
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SARAH . PIHONAK
Primary Examiner
Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627