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 .
DETAILED ACTION
Status of 17/632,437
Claims 1-28 are currently pending.
Priority
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Instant application 17/632,437, filed 2/2/2022, claims priority as follows:
The effective filing date of a claimed invention is determined on a claim-by-claim basis. See MPEP § 2152.01.
The priority document U.S. Provisional Application No. 62/882,253 contains support for claims 1-3, 7-24, and 27-28, but fails to provide support under 35 U.S.C. 112 for limitations present in claims 4-6 and 25-26. Therefore, claims 1-3, 7-24, and 27-28 are entitled to the effective filing date of 8/2/2019, but claims 4-6 and 25-26 are not.
The priority document PCT/US2020/70348 contains support for the limitations of claims 4-6 and 25-26. Specifically, the PCT document contains support for the limitation of “anti-tremor drugs” of claim 4, and the narrower limitations of the anti-tremor drugs recited in claims 5 and 6. Additionally, the PCT document contains support for the essential tremors of claim 25 and the group of tremors recited in claim 26. Therefore, claims 4-6 and 25-26 are entitled to the effective filing date of 7/31/2020.
Information Disclosure Statement
All references from the IDS submitted on 2/2/2022 have been considered unless marked with a strikethrough.
Objection to the Abstract
The abstract of the disclosure is objected to because it reads, “anti-tremor dmgs”, but should state, “anti-tremor drugs”. Appropriate correction is required.
Election/Restriction
Applicant’s election of Group I, claims 1-3, 7-16, and 28, drawn to compositions comprising cannabinoids, anti-epileptic drugs, and a gum base, in the reply filed 8/19/2025 is acknowledged. Applicant’s election of the composition comprising cannabidiol as the single disclosed species of cannabinoid, gabapentin as the single disclosed species of anti-epileptic drug, and couma macrocarpa as the single disclosed species of gum base, in the reply filed 8/19/2025, is also acknowledged. Because Applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse. See MPEP § 818.01(a).
Examination will begin with the elected species. In accordance with 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 examined again. 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 further examination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final.
The elected species was searched and prior art was identified. See the 103 rejection below. Additionally, during the search, an expanded species was identified in the same reference with a different gum base. See the 102 below. The full scope of the claims has not yet been searched in accordance with Markush search practice. Claims 1-3, 7-16, and 28 read on the elected and expanded species. Claims 4-6 and 17-27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species and/or group, there being no allowable generic or linking claim.
Claim interpretation
Claim 10 recites the limitation, “couma macrocarpa”. After a search for prior art, the Examiner notes “couma macrocarpa” is also known in the art as “lechi caspi”, “leche caspi", and “sorva”. Thus, the limitation “couma macrocarpa” is also currently being interpreted as the above terms.
Claim 28 is drafted using “product-by-process” type limitations. See MPEP § 2113 in this regard. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself.” In the instant case, claim 28 is drawn to a composition having the required ingredients of claim 1, and does not necessarily require the recited process limitations for producing the composition. The Examiner construes these claims as encompassing any product having the structure designated in the claim, regardless of what method was used to obtain that product, since the product necessarily has all the required structural features. Thus, the patentability of claim 28 rests on the composition and not the process recited in the claim.
Claim Rejections - 35 USC § 112(b)
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 28 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.
Claim 28 recites the limitation, “about”, in reference to the time duration in which to control temperature. The term “about” is a relative term which renders the claim indefinite. The term “about” 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. Thus, the scope of time durations is rendered indefinite by the term “about”. In the interest of compact prosecution, the term “about” is currently being interpreted mean ±10% of the subsequent value modified by the term.
Claim Rejections - 35 USC § 103 – Elected Species
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, 7-16, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Axim Biotechnologies, Inc. (US 2018/0147141, cited in the IDS of 2/2/2022, herein after “Axim”) and further in view of WM Wrigley Jr. Company (US 2018/0325139, cited in the IDS of 2/2/2022, herein after “Wrigley”). This rejection applies to the elected species.
Determining the scope and contents of the prior art 1-3, 7-16, and 28
The reference Axim teaches chewing gum compositions comprising cannabinoids and the anti-epileptic drug gabapentin to treat neurological disorders (abstract). Specifically, with respect to claims 1-3, 7-8, and 28, Axim teaches the following composition comprising cannabidiol and gabapentin (pages 4 and 5, Table 2):
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Axim further teaches that the gum base may be Gum powder PG 11 TA, Gum powder PG 11 TA New, Gum powder PG 5 TA, Gum powder PG 5 TA New, and Gum powder PG N12 TA (pages 3 and 4, para [0069]).
Regarding claims 11-12, Axim teaches xylitol in the composition as a sugar alcohol.
With respect to claims 13-14, Axim teaches saccharine in the composition as the additional sweetener and sugar substitute.
Regarding claim 15, Axim teaches peppermint oil and peppermint powder as the flavoring agents in the composition, and silicon dioxide and magnesium stearate as additional ingredients to assist with powder flow (page 4, para [0074]). Though silicon dioxide or magnesium stearate are not explicitly defined in Table 2, a skilled artisan could at once envisage the addition of silicon dioxide or magnesium stearate to the chewing gum composition given the small number of powder flow assistance compounds provided.
With respect to claim 16, Axim teaches each ingredient in particular embodiments (page 4, paras [0072]-[0074]) and in composition Tables 1 and 2. Thus, similar to above, one skilled in the art could envisage the combination of ingredients from the teachings of Axim to arrive at the limitations of the instant claim.
The reference Wrigley teaches chewing gum and bases thereof having at least one natural elastomer (abstract), and with respect to claims 1 and 9-10, specifically teaches couma macrocarpa as a natural elastomer or natural elastomer system that is a constituent of the insoluble gum base portion of the chewing gum (page 2, para [0027] and page 9, claim 3) and may be used as the sole elastomer (page 3, para [0051]).
Ascertaining the differences between the prior art and the claims at issue
Axim fails to teach couma macroarpa as the gum base, whereas Wrigley fails to teach cannabidiol and gabapentin in the chewing gum.
Resolving the level of ordinary skill in the pertinent art
The level of ordinary skill in the art is represented by an artisan who has sufficient background in the development of compositions comprising cannabinoids such as cannabidiol, anti-epileptic drugs such as gabapentin, and a gum base such as couma macrocarpa. An artisan possess the technical knowledge necessary to make adjustments to the compositions to enhance their effectiveness. Said artisan has also reviewed the problems in the art as regards to use of said compositions comprising cannabinoids such as cannabidiol, anti-epileptic drugs such as gabapentin, and a gum base such as couma macrocarpa and understands the solutions that are widely known in the art.
Considering objective evidence present in the application indicating obviousness or nonobviousness
Applying KSR prong (B), it would have been prima facie obvious to one of ordinary skill in the art to substitute the gum base of Axim with the gum base couma macrocarpa of Wrigley because couma macrocarpa is known in the art to be an effective gum base and is expected to have similar properties. Thus, one of ordinary skill in the art would have been motivated before the effective filing date to substitute the gum base of Axim with the couma macrocarpa gum base of Wrigley to expand the chewing gum composition options. A skilled artisan would have reasonably predicted that such a substitution would result in successful chewing gum compositions in light of the teachings of Axim and Wrigley.
Claim Rejections - 35 USC § 102 – Expanded Species
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.
(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 1-3, 7-8, and 11-16 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Axim Biotechnologies, Inc. (US 2018/0147141, cited in the IDS of 2/2/2022, herein after “Axim”). This rejection applies to the expanded species.
The reference Axim teaches as disclosed above and at least those teachings are incorporated herein. The Examiner highlights again that the gum base disclosed by Axim in Table 2 is not explicitly defined in the table; however, Axim discloses that the gum bases may be Gum powder PG 11 TA, Gum powder PG 11 TA New, Gum powder PG 5 TA, Gum powder PG 5 TA New, and Gum powder PG N12 TA (pages 3 and 4, para [0069]). Thus, Axim anticipates claims 1-3, 7-8, and 11-16.
Conclusion
Claims 1-3, 7-16, and 28 are rejected. Claims 4-6 and 17-27 are withdrawn.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kendall Heitmeier whose telephone number is (703)756-1555. The examiner can normally be reached Monday-Friday 8:30AM-5:00PM ET.
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/K.N.H./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621