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 .
Priority
The instant application, filed 10/25/2023, is a 371 filing of PCT/US2022/026482, filed 04/27/2022, which claims domestic priority to provisional App no. 63/181,927, filed 04/29/2021.
Amendments and Claim Status
The amendment filed on 04/16/2026 is acknowledged and entered.
Claims 14-16, 22-25, and 27- 53 are cancelled;
Claims 54 are added.
Claims 1-13, 17-21, 26, and 54 are pending and are under prosecution.
Information Disclosure Statement
The Information Disclosure Statement filed on 01/18/2024 is acknowledged and found to be in compliance with the provisions of 37 CFR § 1.97. Accordingly, the information disclosure statement is considered.
Restriction/Election
Applicant’s election without traverse of Group I in the reply filed on 04/16/2026 is acknowledged. Furthermore, the election of a specific species of anesthetic as a terpenoid, elected to be L-Carvone is also acknowledged.
In accordance with the MPEP § 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be reexamined. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. In the event prior art is found during reexamination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final.
As per MPEP § 803.02, the Examiner will determine whether the entire scope of the claims is patentable. Applicants' elected species does not make a contribution over the prior art of record.
Status of Claims
Claims 1-13, 17-21, 26, and 54 are pending in the instant application. Claims 2-4, 6, and 9-12 are withdrawn from further consideration pursuant to 37 CFR § 1.142(b), as being drawn to a non-elected invention and species. Therefore, claims 1, 5, 7, 8, 13, 17-21, 26, and 54 read on an elected invention and species and are therefore under consideration in the instant application.
Drawings
The drawings filed on 10/25/2023 are found to be in compliance with 37 CFR 1.121 § 1.84, and are hereby accepted.
Claim Interpretation
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The instant claims are subject to the following interpretation:
The claims recite the use of terpenoids, elected to be L-Carvone and terpenoids containing 1-3 isoprene units. The claims are subject to the broadest reasonable interpretation, according to MPEP § 2111, and L-Carvone is interpreted as having two isoprene units. Therefore, claim 7 reads on the elected species, while claims 6 and 9 do not. Furthermore, L-carvone is equivalent to (-)-carvone, or (R)-carvone.
Claim Rejections - 35 U.S.C. § 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)(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.
Claims 1, 5, 7, 8, 18, 20, and 26 are rejected under 35 U.S.C. § 102(a)(2) as being anticipated by Danner (US 20110212196 A1, published September 1, 2011, cited on applicant IDS filed 01/18/2024).
The instant claims are drawn to a method of inducing anesthesia comprising the administration of a terpenoid, elected to be L-carvone.
Danner teaches a composition for inducing anesthesia in a subject (see instant claim 1, Abstract, paragraph [0014]). Danner discloses the administration of 400-600 mg/L carvone alone or 75-225 mg/L carvone and 11-32 mg/L methyl salicylate oil-in-water emulsion (see instant claim 26) in a method to anesthetize cold, cool, and warm water teleost fish (see instant claims 1, 5, 7, 8, and 18, paragraph [0010]). This emulsion has the ability to anesthetize fish and amphibians by contact with skin and/or gills (see claims 18 and 20, paragraph [0010])). The method comprises the administration of 400-600 mg/L carvone alone or 75-225 mg/L carvone and 11-32 mg/L methyl salicylate oil-in-water emulsion in order to anesthetize cold, cool, and warm water teleost fish), wherein the amount is effective for inducing anesthesia in the subject (paragraph [0014]), Fish were anesthetized to handleable condition within 2 minutes (see instant claim 18), anesthetized to surgical plane within 5 minutes (see instant claim 20, paragraph [0014). Oil emulsion is an example of a delivery vehicle; see instant claim 26, claim 9, paragraph [0014]).
According to the teachings above, the instant claims are anticipated by the teachings of Danner, and are applied individually to each claim. As such, the claims stand rejected.
Claim Rejections - 35 U.S.C. § 103
The following is a quotation of pre-AIA 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.
Claims 13, 17, 19, 21, and 54 are rejected under 35 U.S.C. § 103 as being unpatentable over Danner (US 20110212196 A1, published September 1, 2011, cited on applicant IDS filed 01/18/2024), as applied to claims 1, 5, 7, 8, 18, 20, and 26 above, in view of Gonçalves et al. (Biol. Pharm. Bull. Volume 31, Issue 5, pages 1017-1020, published February 13, 2008), hereinafter Gonçalves.
The instant claims are further drawn to the administration of L-carvone by way of injection. The instant claims are further drawn to dosing regimens using units of mg/kg. Finally, the claims are further drawn to the method comprising the administration of L-carvone to a mammal .
The teachings of Danner are as set forth above.
Danner fails to teach wherein L-carvone is administered by way of injection. Danner fails to teach dosing regimens using units of mg/kg. Danner fails to disclose a method comprising the administration of L-carvone to a mammal.
The deficiencies of Danner are remedied by Gonçalves, who teaches injection of (-)-carvone (i.e. L-carvone) (page 1018, see instant claim 13). Gonçalves discloses dosages of L-carvone at 50, 100, and 200 mg/kg (page 1018, see instant claim 21). Finally, Gonçalves teaches the anesthetic mechanism was used in Swiss mice (page 1018, see instant claim 54).
Prior to the effective filing date of the instant claims, a person having ordinary skill in the art would be motivated to combine the teachings of Danner in the use of the anesthetic compound L-carvone in a method of inducing anesthesia with the teachings of Gonçalves, in order to adapt the pharmacological method for use in a mammalian subjects. Gonçalves teaches a clinically applicable dose and regimen, and demonstrates the feasibility of the method for use in mammalian subjects. Therefore, a person having ordinary skill in the art would have reasonable expectation of success in extending the method taught in non-mammalian subjects to mammals.
Regarding claim 21, wherein the instant claims recite a dosage greater than or equal to 4mg/kg, the teachings of the prior art (50, 100, and 200 mg/kg) overlap with the instantly claimed range, and are considered prima facie obvious, as such. The courts have stated,
where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985) (see MPEP 2144.05.01).
Because the prior art ranges overlap with the instantly claimed range, the instantly claimed range is considered to be an obvious choice in view of the prior art.
Regarding claims 17 and 19, wherein effective amounts comprising dosage less than or equal to 2mg/kg (instant claim 17) and between 2 to 4mg/kg (instant claim 19), this is considered a routine optimization to find a workable range by way of routine experimentation. The courts have determined that,
“where 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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05 II.
Therefore, the claimed ranges merely represent a routine optimization of the values of the cited prior art, and are determined to be prima facie obvious.
Correspondence
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sophia P. Hirakis whose telephone number is +1 (571) 272-0118. The examiner can normally be reached within the hours of 5:00 am to 5:00pm EST, Monday through Friday.
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/SOPHIA P HIRAKIS/Examiner, Art Unit 1623
/VALERIE RODRIGUEZ-GARCIA/Primary Examiner, Art Unit 1621
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