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
Claims 68-87 are currently pending and a preliminary amendment to the claims filed on 11/27/2023 is acknowledged.
Election/Restriction
Applicant's election without traverse of Group I, claims 68-81 and 84 in the Reply filed on 01/20/2026 is acknowledged. By way of applicant’s election, claims 82, 83 and 85-87 have been withdrawn from further consideration. Since the election was made without traverse, the requirement is still deemed proper and is therefore made FINAL.
Therefore, claims 68-81 and 84 are examined on the merits to which the following grounds of rejections are applicable.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Objections
Claims 68 and 72-74 are objected to a minor informality.
Each of claims 68 and 72-74 recites “(by weight)”, which would be better to recite “by weight” without parentheses.
Appropriate correction is requested.
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 81 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 81 recites the term “suitable” in line 1, but this term is relative or subjective that lacks clear or objective boundaries. The term could vary depending on context, adhesive type, environmental conditions, thickness, flexibility, intended purpose or personal judgment, etc. The specification does not provide guidance or criteria by which a person of ordinary skill in the art could determine which backing layer are considered “suitable”. Thus, claim 81 is indefinite.
In addition, claim 81 contains the trademark/trade name “KinesioTM tape”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe tape and, accordingly, the identification/description is indefinite.
Appropriate correction is requested.
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 68-81 and 84 are rejected under 35 U.S.C. 103 as being unpatentable over LaRosa et al. (US2021/0015836A1) in view of Weimann (US2018/0078512A1).
Applicant claims the below claims 68 and 84 filed on 11/27/2023:
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351
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For examination purpose, claim 84 recites product-by-process limitation. However, such limitation is not structurally limiting the claimed patch because the “patentability of a product does not depend on its method of production.” In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985). See also MPEP 2113 reads “Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps.” Thus, the patch of claim 84 is seen as the patch of claim 68 because claim 84 indirectly depends from claim 68.
Determination of the scope and content of the prior art (MPEP 2141.01); Ascertainment of the difference between the prior art and the claims (MPEP 2141.02) and Finding of prima facie obviousness Rational and Motivation (MPEP 2142-2143)
Prior Art
LaRosa discloses topical analgesic composition comprising external analgesic agent, one or more pharmaceutically acceptable excipients, and at least one of a cannabinoid, terpene, and flavonoid (abstract) wherein the topical composition can include one or more transdermal delivery agents and topical formulations can be used for both topical and transdermal administration of substance (e.g., [0036] and [0049]); the at least one of the cannabinoid includes CBD, CBG, CBN, etc. (e.g., [0027] and [0064]) which reads on the claimed cannabinoids; the external analgesic agent includes camphor (e.g., [0020]), menthol (e.g., [0125]); the composition comprises e.g., 2.5±0.5 wt. % menthol which is within the claimed ranges of 0.2-6%, 0.5-5% or 1.0-3%, 0.32±0.1 wt. % cannabidiol (CBD) which is within the claimed ranges of 0.1-20%, 0.1-10% or 0.2-5% (e.g., [0005] and [0222]) and 0.1-3% or 3.1±0.7 camphor (e.g., Table A and [0129]) which is within the claimed range of 0.2-5%, 0.5-5% or 1.0-3%; the composition further comprises arnica extract as inactive ingredient ([0300]-[0318]); the composition can be further in the form of patch ([0047], [0114], [0516]) (instant claims 68 and 84, in part); CBD extract or isolate is a white crystalline powder (instant claim 70). Please note that in instant claim 71, “not provided by critical CO2 extraction”, “provided by extraction with a C3-4 alcohol and one or more crystallization steps with C6-C8 or any combinations thereof” are product-by-process limitations that are not structurally limit the claimed patch because the “patentability of a product does not depend on its method of production.” In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985). See also MPEP 2113 reads “Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps.” Thus, claim 71 is seen as claiming CBD crystal (instant claim 71); the composition has a total THC content of less than 0.1mg/ml (=0.01%) which overlaps the instant range of less than 1.0%, 0.5%, 0.2% or 0.1% (instant claim 72); CBG, CBN or its combination can be present in an amount of no more than 0.1mg/ml (=1%) (e.g., [0240]) which is within the instant range of 0.5-4% (instant claim 74); embodiments do not contain glycosaminoglycan, C8-22 fatty acid, sulfoxide or any combination (e.g., claims 1 and 20 of prior art)(instant claim 75).
However, LaRosa does not expressly teach the adhesive layer contains acrylate copolymer in an amount of at least 60% of instant claim 68; CBD: CBN ratio of instant claim 69; embodiment of instant claim 73; the amounts of CBD, CBG and/or CBN in the patch of instant claims 76-77; the amounts of camphor and menthol of instant claim 78; patch size of instant claim 79; the amount of adhesive layer of instant claim 80; and the backing layer of instant claim 81. The deficiencies are cured by Weimann.
Weimann discloses transdermal delivery of cannabidiol with other active moieties including cannabinoids (title); the delivery is made via patch and for example, monolithic-style transdermal drug delivery patch device has a drug-in-adhesive matrix structure wherein the patch contains a release liner, an adhesive layer mixed with CBD which reads on the claimed adhesive layer containing CBD and the adhesive layer is coated on one side of the backing layer, and a backing layer (e.g., [0018], Fig. 2 and [0080]). Please note that the claimed limitation of “the backing layer is suitable for functioning as a tape having the characteristics of KinesioTM tape” is functional language/intended use which is not structurally limiting the backing layer and thus the backing layer itself reads on the claimed backing layer because it is capable of performing the recited function and see MPEP 2111.02 (instant claim 81); the CBD is pure crystalline powder (e.g., [0030]), and the adhesive layer is acrylate pressure sensitive adhesive in an amount of 60-90% (e.g., [0030] and [0081]) that overlaps the instant range of at least 60, 70, 80 or 90%, and the CBD can be present in an amount of at least about 1 to 50% CBD ([0013]) which overlaps the instant range of 4-12% (instant claim 73 – the amounts of CBD and acrylate); when the CBN is present, its molar quantity should be less than 0.01-20% of CBD (e.g., [0101]) which would be within the ratio of CBD:CBN being 10:1-1.01:1 (instant claim 69); and the patch size is no more than about 30cm2, preferably no more than about 25cm2 or 22cm2 (e.g., [0078]) or about 5 cm2-about 30cm2-[0079]) which overlaps the instant range of 5-10, 10-20, 20-4 or 40-100cm2 (instant claim 79).
Weimann does not expressly teach the amounts of CBD and/or CBN per cm2 of the patch of instant claims 76-77; and the weight of adhesive layer/cm2 of instant claim 80. However, Weismann teaches amounts of CBD (1-50%) and CBN (less than 0.01-20 mol% of CBD), acrylate adhesive layer (60-90%) and patch size (5-100cm2) as noted above. Therefore, the ordinary artisan would optimize the amounts of CBD/CBN per patch cm2 depending on the intended purpose, patch size, etc.,; and also the weight of adhesive per unit area in a patch is result-effective variables because it affects CBD delivery rate, adhesive strength, patch size and thus, the ordinary artisan skill in the art would routinely adjust the amounts of CBD, CBN and adhesive applied to a given patch area to achieve desired adhesion and drug delivery properties, in the absence of criticality evidence. In this context, please see case law stating that [W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable rages by routine experimentation. In re Aller, 220 F.2d454 (CCPA 1955) (instant claims 76, 77 and 80).
Although LaRosa/Weimann do not expressly teach amounts (mg) per patch cm2 of instant claim 78, LaRosa teaches e.g., 0.75-16% menthol and 2-11% of camphor ([0128]-[0129] of LaRosa), and Weimann teaches patch size 5-30cm2 ([0079] of Weimann). The amount (mg) of menthol per patch unit area (cm2) is a result-effective variable that affects the cooling and skin penetration properties of the patch. Thus, it would have been obvious to a person of ordinary skill in the art to adjust the menthol/camphor concentrations in the adhesive layer through routine experimentation to achieve a desired effect including an amount corresponding to 0.1-10mg/cm2 as claimed (instant claim 78).
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the combined references, especially in the absence of evidence to the contrary.
Conclusion
All examined claims are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYUNG S CHANG whose telephone number is (571)270-1392. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Yong (Brian-Yong) S Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYUNG S CHANG/Primary Examiner, Art Unit 1613