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 .
Election/Restrictions
Applicant's election without traverse of Group I, claims 1-9, drawn to a method for shortening sleep latency and/or improving sleep quality, enhancing vitality of daytime activities, resisting depression, or protecting brain comprising administering to a subject in need thereof of a composition comprising a Nepeta cataria L. extract in the reply filed on 01/09/2026 is acknowledged. Applicant’s election of species without traverse of sleep/latency and/or quality drawn to claims 1-3 in the reply filed on 1/09/2026 is acknowledged. Claims 4-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention elected without traverse, there being no allowable generic or linking claim. The requirement is still deemed proper and therefore made FINAL.
Pending claims 1-3 have been examined on the merits.
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. The priority date is February 6, 2023.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on November 14, 2024 is being considered by the examiner. The signed IDS form is attached with the instant office action.
Drawings
The drawings were received on 01/25/2024. These drawings are accepted.
Claim Rejections - 35 USC § 112
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 2 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.
The term “improves” in claim 2 is a relative term which renders the claim indefinite. The level of melatonin is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Is the melatonin increased or decreased? It is unclear what the end result of melatonin level occurs in the subject. Clarification is requested.
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)(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.
Claims 1-3 are rejected under 35 U.S.C 102 (A)(1) as being anticipated by Rinaldi (US 2020138783A1).
The claims are as of record, drawn to administering Nepeta Cataria L to a subject to reduce a light sleep ratio and/or increase a deep sleep ratio. The claims are drawn to administering a composition comprising a Nepeta cataria L. extract.
This reference (Rinaldi US ‘783, see entire document) anticipates the claims by teaching a method of administrating a sleep promoting active agent, sleep quality active agent and sleep recovery active agent wherein the composition of the agent is made up from catnip extract (see ‘783 e.g. at claims 1-3). The composition administered includes Nepeta Cataria (catnip) (see claim 7). Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir.1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. The intended uses of the Nepeta cataria extract will necessarily result from the administration of the composition to the subject as currently claimed.
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 (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 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 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.
Claims 1-3 are rejected under 35 U.S.C 103 as being unpatentable over by Rinaldi (US 2020138783A1).
The instant claims are drawn to a method for shortening sleep latency and/or improving sleep quality comprising of administering a composition comprising Nepeta Cataria L Extract to the subject, wherein the extract is obtained by extracting the flower spikes and wherein the extract reduces a light sleep ratio and/or increases a deep sleep ratio in the subject (see instant claims 1-3).
The reference (Rinaldi US ‘783, see entire document) anticipates or makes obvious the claims by teaching a method of administrating a sleep promoting active agent, sleep quality active agent and sleep recovery active agent wherein the composition of the agent is made up from catnip extract (see ‘783 e.g. at claims 1-3). The composition administered includes Nepeta Cataria (catnip) (see claim 7). Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir.1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. The intended uses of the Nepeta cataria extract will necessarily result from the administration of the composition to the subject as currently claimed.
This reference teaches the methods of treating sleep by modifying or improving the sleep-wake cycle that when administered provides an immediate burst release of the sleep promoting active agent within about 30 minutes of administration administering a sleep quality active agent in the form of a delayed burst to supply the sleep quality active agent within 6 hours and administering a sleep recovery and administering a sleep recovery active agent after about 3 hours. Although the reference does not expressly recite a method that reduces a light sleep and/or increases a deep sleep ratio of the subject, they would have been intrinsically present as part of the administration of the sleep promoting agent, sleep quality agent and sleep recovery agent. (e.g. See MPEP 2112.02(1) at Ex parte Novitski regarding reference-silent properties being anticipated).
Claims 1-3 are rejected under 35 U.S.C 103 as being unpatentable over by Rinaldi (US 2020138783A1) in view of Shan (US20220110997A1).
As discussed above in Rinaldi ‘783, the references teach a method of administering a sleep promoting active agent, sleep quality active agent and sleep recovery active agent wherein the composition of the agent is made up from catnip extract. The composition administered includes Nepeta Cataria (catnip) (see claim 7). Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir.1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. The intended uses of the Nepeta cataria extract will necessarily result from the administration of the composition to the subject as currently claimed.
Shan ‘997 teaches a method wherein the Nepeta Cataria may be at least one of stems, leaves, and flowers of Nepeta Cataria. The method of preparing the extract includes crushing the plants into granules, mixing the ration and adding an ethanol solution, transferring to a water bath and extracting for 2-4 hours (para [0015]).
It would have been obvious to the person having ordinary skill in the art to prepare an extract with water as currently claimed, because Shan ‘997 discloses extracting biologically active components from Nepeta Cataria using a water extraction process.
Therefore, it would have been obvious to the person having ordinary skill in the art to administer Nepeta cataria extract for treatment of sleep quality, because Rinaldi ‘783 discloses using Nepeta cataria as a treatment for sleep quality.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARNITIA T WALKER whose telephone number is (571)272-2550. The examiner can normally be reached Monday-Friday 8:00am-5:00pm.
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/Marnitia T Walker/
Examiner, Art unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655