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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/10/2026 has been entered.
Status of the Claims
Claims 47, 48, 53, 64-66, 69, 70 and 76-78 are pending in a Response of 06/10/2026.
Withdrawn objection/ rejections:
Applicant's amendments and arguments of 06/10/2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below are herein withdrawn.
The following rejection and/or objection are either reiterated or newly applied. They constitute the complete set of rejection and/or objection presently being applied to the instant application.
Claim Objections
Claim 47 is objected to a minor informality.
Claim 47 recites “the pharmaceutical composition comprises at least one active agent consisting of”, in which “consisting of” means the active agent is limited to CBD and the composition is open to inclusion of other ingredients such as fillers, binders, etc. Thus, it appears that the term “at least one” is not necessary. Appropriate correction is requested.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 77-78 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Each of claims 77-78 depends from base claim 47 reciting “at least one active agent consists of CBD”. That is, the active agent of system base claim 47 is limited to CBD only. However, each of claims 77-78 recites additional active agent which is outside scope of claim 47 because the claimed system should have CBD only as the active agent. Therefore, it may not be said that each of claims 77-78 further defines claim 47 in a proper manner.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 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 of this title, 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 47, 48, 53, 64-66, 69, 70 and 76-78 are rejected under 35 U.S.C. 103 as being unpatentable over Plakogiannis et al. (US2022/0175718A1, IDS of 08/12/2024, hereinafter US ‘2022).
Level of Ordinary Skill in the Art
(MPEP 2141.03)
MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The level of skill is that of a medical/pharmaceutical research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from medicine, pharmacy, physiology and chemistry— without being told to do so.
In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Applicant claims the below claim 47 filed on 06/10/2026:
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Prior Art
US ‘2022 discloses a pharmaceutical formulation comprising an active agent selected from the group consisting of cannabidiol (CBD), tetrahydrocannabinol (THC) or combinations thereof for the treatment of chronical pain with reduced side effects in the patient (e.g., abstract and [0118]) which reads on the claimed active agent consisting of CBD, wherein the formulation is continuous and sustained released and delivered through intact skin to achieve systemic effect in an ambulatory subcutaneous infusion pump (e.g., [0008], [0010], [0017], [0023], and claims 1, 7 & 8-12 of prior art), which may read on the claimed ambulatory continuous subcutaneous delivery infusion pump system, and the formulation contains about 0.01%-about 2% or about 5% of CBD (e.g., [0029], [0063] and claim 1 of prior art) which is identical to or overlaps the instant CBD range of about 0.01% to abut 2%, and/or about 3 to about 15% of THC (e.g., [0029], [0063], and claim 1 of prior art) which overlaps the instant THC range of about 0.5 to about 9%, about 1%, 3%, … about 20% of at least one solvent such as ethanol, propylene glycol, isopropyl alcohol, N-methyl-2-pyrrolidone (e.g., [0136] and claim 1 of prior art) in which the amount overlaps the instant solvent range of about 1% to about 20%, about 1%, 3% … about 10% of at least one non-ionic surfactant polymer such as PVP K30, poloxamer (e.g., [0137], [0141] and claim 1 of prior art) in which the prior art amount is identical to or overlaps the claimed polymer range of about 1% to about 10%, and the composition further contains buffering agent in an amount of about 1-75% which overlaps the instant range of about 50 to about 90% (e.g., [0143]), and optionally, about 0% to about 97% of at least one permeation enhancer, optionally, about 0% to about 97% of an adhesive and/or polymer (e.g., Examples 1-2 and claim 1 of prior art). Please see MPEP 2144.05 “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976),” wherein each CBD or THC is selected from the group comprising of free base thereof, salts thereof, isomers thereof, amorphous forms thereof, crystalline forms thereof, co-crystalline forms thereof, prodrugs thereof, analogs thereof, derivatives thereof, synthetic forms thereof, biosynthetic forms thereof, active metabolites thereof, polymorph thereof, solid solution thereof, coated form thereof, stereoisomers thereof, solid solution thereof, ion-pair thereof, solution thereof, powder form thereof, liquid form thereof, alone or combinations thereof (e.g., claim 4 of prior art) via subcutaneous infusion (e.g., claim 10 of prior art), and the formulation is liquid formulation (e.g., claims 4, 5, 7, and 49 of prior art) which reads on the claimed liquid formulation, and when the liquid formulation is within the infusion pump, it will be contained in the reservoir of the pump (e.g., [0027] and claim 22 of prior art) which reads on the claimed liquid formulation within the reservoir of the pump. US ‘2022 does not expressly disclose the claimed properties of dose rate of infusion pump system comparing oral daily dose system, and however, US ‘2022 teaches the same ambulatory infusion pump system containing active ingredient of CBD and/or THC, additional ingredients of solvent/polymer and their overlapping amounts as well as overlapping blood serum level, for the continuous subcutaneous delivery (see e.g., the Examples, and claims 1, 7-12, 16, 32 and 73 of prior art). Therefore the claimed properties limitation would be implicit from the prior art formulation using the same ambulatory infusion pump system. In this context, please see case law stating that the product and its properties are not separable. See In re Spada 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) and Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008). (inherency is limited when applied to obviousness and is present only when the limitation at issue is the “natural result” of the combination of prior art elements; quoting In re Oelrich, 666 F.2d 578, 581 (CCPA 1981)). See also MPEP 2112.01 (instant claim 47); the formulation also provides an ambulatory continuous, sustained delivery to mitigate peak and valley pharmacokinetic behavior of the active agent (e.g., [0017], [0030] and claim 8 of prior art)(instant claim 48); the pharmaceutical formulation provides a continuous, sustained delivery of the pharmaceutical composition via an ambulatory/portable infusion pump that is worn by the patient and may use replaceable cartridges (e.g., claim 13 of prior art) (instant claim 53); the formulation is delivered via patch pump or micro pump (e.g., claim 14 of prior art); the composition further comprises carriers and/or excipients including gelling agents, polymers, pressure sensitive adhesive polymers, adhesive polymers biodegradable polymers, penetration enhancers, emollients, skin irritation reducing agents, buffering agents, pH stabilizers, solubilizers, suspending agents, dispersing agents, stabilizers, plasticizers, tackifiers, surfactants, volatile chemicals, antioxidants, oxidants, etc., in an amount of 0.1 to 99.5% (e.g., [0027]) which is identical to the instant range. See MPEP 2144.05 above (instant claims 64-65); the formulation can be administered in a dosage regimen selected from the group consisting of once daily, twice daily, once in four to six days, once in a week, once in a 8 to about 13 days, once in two weeks, and once in 15 days to about 30 days ([0027] and claim 27 of prior art) which is identical to the claimed range. See MPEP 2144.05 above (instant claim 66); the formulation or composition provides a blood serum level of active agent is about 0.01 to 500ng/ml (claim 73 of prior art) which is identical to the claimed range (instant claim 69); the active agent is provided in an amount of about 0.1%, about 1% or about 1.5% (e.g., [0027], [0063] and claim 3 of prior art) which is itentical to or overlaps the claimed ranges (instant claim 70). See MPEP 2144.05 above; the active agent is present as a highly purified extract of active agent which is at least 90% or 99.75% ([0060]) in which the purity is identical to the claimed range. See MPEP 2144.05 above (instant claim 76); and the formulation further comprises dopaminergic agonist agent ([0090]) which may embrace the claimed species of cabergoline, levodopa, apomorphine (instant claims 77-78).
In light of the foregoing, instant claims 47, 48, 53, 54, 64-66, 69-71 and 76-78 are obvious over the teachings of US’2022.
Response to Arguments
Applicant’s arguments have been fully considered, but are not persuasive.
Applicant argues that the claimed amendment overcome the prior art rejection because US ‘2022 discloses CBD active ingredient present in the range of about 0.01% to about 2% and Tables 1, 4, 7, 13, 15, 17, and 19 of US ‘2022 show the range from 3.69% to 9.95% and all 19 Examples of US ‘2022 focus on the transdermal delivery, not subcutaneous delivery, and thus, the ordinary artisan would have no motivation to try to lower the concentration of below 3% with subcutaneous infusion pump.
The Examiner responds that it is well-established that consideration of a reference is not limited to the preferred embodiments or working examples, but extends to the entire disclosure for what it fairly teaches, when viewed in light of the submitted knowledge in the art, to a person of ordinary skill in the art. Merck & Co. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989), and here, US’2022 discloses identical or overlapping amounts of active ingredient (see e.g., [0063]), and see also MPEP2144.05 III. “[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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Further, the applied art US ‘2022 discloses the claimed continuous subcutaneous delivery using infusion pump system (e.g., claim 10 of prior art). Unless there is unexpected results of the claimed ranges via subcutaneous delivery, the claimed invention would be obvious from the teachings of the prior art.
Further, as noted in the advisory action of 4/23/2026, US ‘2022 is valid prior art and discloses all the limitations of the claimed invention.
In light of the foregoing, applicant’s arguments are not persuasive.
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
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