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 .
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.
Claim Status
Claims 1-2 are pending and are examined on the merits in this prosecution.
CLAIM REJECTIONS
Indefiniteness Rejection
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.
Claims 1 and 2 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 1 is drawn to two statutory classes, a product and process for preparing that product in the same claim. As set forth in 2173.05, a single claim which claims both an apparatus and method steps is indefinite under 35 U.S.C. 112(b). Put another way, a claim must not mix elements of a system with actions performed by users, as it creates ambiguity about when infringement occurs.
Claim 1 recites the term “heat sensitizer.” It is unclear what are the metes and bounds of this term. In the instant case, the Examiner performed an internet search of the term “heat sensitizer Weihai Medicinal Oil Factory” to arrive at capsicum oleoresin, the element considered in this action as the heat sensitizer.
Obviousness Rejection
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.
1) Claims 1 and 2 are rejected under 35 U.S.C. 103 as being unpatentable over Liu (CN 11536407 A; citations herein refer to the translation provided by EPO), in view of Zhu (“Chinese herbal medicine for primary dysmenorrhea,” Cochrane Database of Systematic Reviews 2008, Issue 2. Art. No.: CD005288), Min (“Clinical Study on Treatment of Primary Dysmenorrhea with Qihuang Herbal Warm Bag,” Journal of Acupuncture and Tuina Science, Volume 5, Number 5, 2007 October, 304-306), and Lockett (“How to treat severe lower back pain during your period,” downloaded from the Wayback Machine, dated 7/25/2021, at https://web.archive.org/web/20210725143551/https:/www.healthline.com/health/womens-health/severe-lower-back-pain-during-period).
Liu teaches a graphene far-infrared anti-inflammatory analgesic patch and a preparation method thereof. The paste is prepared from the following components in parts by mass: 1 to 3 parts of graphene, 3 to 20 parts of nanoscale far infrared ceramic powder, 74 to 95 parts of hot melt adhesive, 1 to 3 parts of penetration enhancer, 1 to 2 parts of menthol, 1 to 3 parts of borneol, 1 to 3 parts of camphor, 1 to 5 parts of wintergreen oil and 1 to 5 parts of cinnamon oil (reading on “Ramulus cinnamomic”).
Liu does not teach the presence of the following ingredients: heat sensitizer; Rhizoma cyperi; Flos caryophylli, Rhizoma corydalis, Resina olibani, Myrrha, Radix angelicae sinensis, Radix angelicae dahuricae, Herba leonuri, Flos carthami, Fructus foeniculi, Ramulus cinnamomi, Rhizoma zingiberis, and Radix paeoniae alba.
Zhu, Min, and Lockett teach the missing elements of Liu.
Zhu teaches traditional Chinese herbs most frequently evaluated in clinical trials for the treatment of primary dysmenorrhea included: Danggui (Angelicae sinensis Radix, Chinese angelica root); Baishao (Paeoniae Radix alba; white peony root); Yimucao (Leonuri Herba; Chinese motherwort); Xiangfu (Cyperi Rhizoma); Yanhusuo (Corydalis Rhizoma; corydalis rhizome); Huixiang (Foeniculi Fructus; fennel fruit), and Rougui (Cinnamomi Cortex; cinnamon bark) (pg 7, paragraph spanning left and right columns). Zhu further teaches Myrrha as an externally administered treatment for dysmenorrhea (pg 42, “Interventions”), as well as olibani (pg 75, “Interventions”), Radix angelicae dahuricae (“Bai Zhi”, pg 75, “Interventions”), and Flos Carthami (“Interventions” on pgs 25, 28, 63, 65, and 79). It is noted that “Rhizoma zingiberis” is taken to mean both “Shen Jiang” and “Pao Jiang”.
Min teaches a topical treatment for primary dysmenorrhea comprising Radix Angelicae Sinensis, Flos Caryophylli, Cortex Cinnamomi, and Rhizoma Zingiberis (pg 305, left column, “1. Treatment methods).
Lockett teaches that severe lower back pain occurring during a period may be treated with a pain relief cream comprising capsaicin (pg 7, “OTC medications”), taken to be a heat sensitizer.
For the method recited in claim 1, Min teaches crushing the herbs (pg 305, “Treatment methods”) prior to application, and Liu teaches the method of assembling the composition into a graphene patch.
The amounts of each of graphene, far-infrared ceramic powder, hot melt adhesive, and traditional Chinese medicine elements are not specifically taught by Liu, Zhu, Min, and Lockett. However, as set forth in MPEP 2144.05(II), “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." Liu, Zhu, Min, and Lockett each teach claimed elements are effective for treating symptoms of dysmenorrhea, including pain. Routine optimization of amounts of constituents of a formulation is a skill possessed by a practitioner of the art, even when there are a number of elements to be optimized. Furthermore, the instant Specification does not provide evidence of the criticality of the amounts of each of the claimed elements. See MPEP 2144.05(III).
For claim 2, each of Liu, Zhu, Min, and Lockett teach a method for treating dysmenorrhea, as discussed above.
The skilled artisan would have expected success in modifying the composition of Liu with the herbs Zhu and Min, and the capsaicin of Lockett because each Zhu, Min, and Lockett teach a method for treating dysmenorrhea pain. The skilled artisan could have combined each of the compositions of Zhu, Min, and Lockett with that of Liu since it is “prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." See MPEP 2144.06(I) and (II), and MPEP 2144.07.
CONCLUSION
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL P COHEN whose telephone number is (571)270-7402. The examiner can normally be reached on M-Th 8:30-5:30; F 9-4.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana S. Kaup, can be reached on (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL P COHEN/Primary Examiner, Art Unit 1612
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