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
This Office Action is in response to Applicant’s Arguments filed, 09/03/2026.
Claims 10-29 are pending and examined on the merits herein.
Priority
This application claims the following priority:
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REJECTIONS MAINTAINED
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, 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.
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 10-29 are rejected under 35 U.S.C. 103 as being unpatentable over CN 108236608 (published 07/03/2018, IDS of 03/31/2026) in view of US 2016/166543 to Joshi (published 2016, IDS of 03/31/2026).
CN ‘608 teaches a composition comprising cannabinol and aminohexenoic acid, which is vigabatrin, in the form of a solution, emulsion, suspension, or syrup (claims 1 and 5), and specifically teaches liquid dosage forms (pg. 4). CN ‘608 teaches that these composition can be formulated as isolated dosage forms, wherein one dosage form comprises cannabinol and another dosage form comprises aminohexenoic acid (vigabatrin) (pg. 6).
CN ‘608 teaches a process for preparation comprising mixing the active ingredient(s) with a pharmaceutically acceptable carrier, and additives such as coloring agents, flavoring agents and antisepsis (preservatives) (pg. 4; pg. 5, 1st paragraph) and adjusting the solution to the desired volume (pg. 4).
CN ‘608 teaches that in the preparation of unit dosage forms, the amount of the active compound per unit dose may vary depending on the nature of the of the active compound and the intended dosage regimen, wherein the active compound generally ranges in dose from 0.1-5000mg per unit dose (pg. 5).
Regarding claims 10 and 20, while CN ‘608 teaches a method of making a liquid composition by mixing vigabatrin and a pharmaceutically acceptable carrier, and excipients, it differs from that of instant claim 10 in that it does not teach the pH of the composition or stability of the composition for up to three months at room temperature.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to select a pH of 5-8 for the composition of ‘608, to arrive at instant claims 10 and 20. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-CN ‘608 and Joshi are both directed toward liquid, oral composition for pediatric administration (see [0048] of Joshi),
-Joshi teaches such compositions as having a pH of 4 to 7.5 ([0098]; pg. 9, claim 6), and
- "[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," MPEP 2144.05(II).
As such an ordinary skilled artisan would have been motivated to make such a selection, to predictably arrive at a method of making a liquid, oral formulation that is safe for ingestion and stable in formulation.
Further regarding claims 10 and 20, Joshi teaches its compositions as stable for 3 months at 5º, 25º and 40º C ([0093]-[0095]). As such, an ordinary skilled artisan would predictably expect the liquid, oral composition of CN ‘608, to be stable for up to three months at room temperature with less than 0.06% total impurities, since it is known in the art to produce liquid, oral compositions with such stability, for storage purposes and therapeutic effect.
See also MPEP 2112.01, 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).
Regarding claim 20, CN ‘608 teaches its composition for infants and children (pg. 2).
Regarding claims 11 and 21, ‘608 teaches 0.1-5000mg vigabatrin per unit dose (pg. 5), which is 0.001mg/mL to 50mg/mL of vigabatrin; in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists, wee MPEP 2144.05.
The optimization of known amounts for known active agents is considered well within the competence level of an artisan of ordinary skill in the pharmaceutical sciences; it has been held that the selection of optimal parameters, such as amounts of active agents, to achieve a beneficial effect, is within the skill in the art of an ordinary artisan. See In re Boesch, 205 USPT 215 (CCPA 1980) and MPEP 2144.05.
Regarding claims 12-14, 16-19, 22-24, and 26-29, the combined method of CN ‘608 Joshi does not specifically teach the addition of preservatives, sweetening agents, flavoring agents, and/or buffering agents.
Joshi exemplifies a composition comprising 0.15 w/v% sodium benzoate (preservative), 28 w/v %sugar (sweetener), 10 w/v% glycerin (sweetener/taste masking agent, a synonym for glycerol), sodium chloride (buffering agent), sodium citrate (buffering agent), citric acid (buffering agent) and 0.125 w/v% grape flavor (flavoring agent) ([0075]).
The above wt.% were calculated as follows:
Since final volume of the composition is 100mL, the %(w/v)=Mass of solute in grams (per 100mL). Thus, %(w/v)=(Mass of solute(g)/Total volume of solution(mL) x 100.
For example, 150 mg of sodium benzoate is 0.15g of sodium benzoate. (0.15g/100mL)x100 is 0.15 w/v%.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to select 0.15w/v% sodium benzoate (preservative), and/or 28w/v% sugar (sweetener), and/or 10w/v% glycerin (sweetener/taste masking agent, a synonym for glycerol), and/or sodium chloride (buffering agent), sodium citrate (buffering agent), citric acid (buffering agent) and/or 0.125w/v% grape flavor (flavoring agent), as the excipients in the isolated vigabatrin dosage form of CN ‘608, to arrive at instant claims 12-19 and 22-29. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-CN ‘608 and Joshi are both directed toward liquid, oral composition for pediatric administration (see [0048] of Joshi),
-CN ‘608 specifically teaches its compositions as comprising excipients, and specifically names flavoring agents, and preservatives, and
-Joshi teaches preservatives, sweetening agents, flavoring agents, and buffering agents as known in the art as excipients in stable, liquid, oral formulations, and specifically exemplifies such formulations ([0075], [0096]).
As such, an ordinary skilled artisan would have been motivated to make such selections, to predictably arrive at a method of making a stable, liquid oral formulation that smells goods, is palatable, has a pH acceptable for oral ingestion and composition stability, and is free of microbes.
Regarding claims 15 and 25, while the combined method of CN ‘608 and Joshi teaches 10% glycerin, which is glycerol, and 28% sugar which is sucrose as the sweetening agents, it differs from that of instant claim 15 and 25 in that it does not teach 0.05-10 wt. % of the sweetening agent.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the amount of glycerin and sugar to 0.05-10wt%, i.e., the sweetener, in the combined method of CN ‘608 and Joshi, to arrive at instant claims 15 and 25. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
-Josh teaches sweeteners as providing a sweet taste to the formulation, and
- "[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," MPEP 2144.05(II).
As such, an ordinary skilled artisan would have been motivated to make such a modification to predictably arrive at a method that produces a composition that is optimized for sweetness and/or palatability.
The optimization of known amounts for known active agents is considered well within the competence level of an artisan of ordinary skill in the pharmaceutical sciences; it has been held that the selection of optimal parameters, such as amounts of active agents, to achieve a beneficial effect, is within the skill in the art of an ordinary artisan. See In re Boesch, 205 USPT 215 (CCPA 1980) and MPEP 2144.05.
Response to Arguments
On pg. 6, Remarks, Applicant states that the CN ‘608 translation is not specified. It is respectfully pointed out that CN 108236608 is cited on the 03/31/2026 IDS. The translation is found in parent Patent Application No. 17/299,844; see the 8-page NPL dated 02/06/2023 in ‘844. For clarity of the record and ease of finding the reference, a copy of the CN 108236608 translation is provided in a PTO-892 with this Office Action.
On pg. 6, Remarks, Applicant states that the examiner has not supported the statement that aminohexenoic acid is vigabatrin.
This argument has been fully considered, but is not found persuasive. It is respectfully pointed out that the aminohexenoic acid taught in CN 108236608 was established as vigabatrin in the parent Application 17/299,844. See the first full paragraph of page 5 of the 02/06/2023 Non-Final Office Action: “As evidenced by SciFinder, the aminohexenoic acid referred to in the translation is vigabatrin.”
On pg. 7, Remarks, Applicant argues that “CN ‘608 provides no guidance for preparing compositions comprising aminohexenoic acid alone,” that CN ‘608 fails to disclose the form of the isolated dosage forms, and that nothing in CN ‘608 identifies suitable dosage forms for vigabatrin monotherapy.
These arguments have been fully considered, but are not found persuasive.
It is respectfully pointed out that on pg. 6, 1st paragraph CN ‘608 states “Cannabidiol and aminohexenoic acid may also be included in. . .’isolated dosage form’. . .The term ‘isolated dosage form’ as used herein means that the cannabidiol is contained in one dosage form and the aminohexenoic acid is contained in another dosage form.” As such, CN ‘608 does teach isolated dosage forms of vigabatrin, i.e., compositions wherein the active pharmaceutical ingredient consists of vigabatrin. Moreover, it is respectfully pointed out that the instant claims do not recite “dosage form for vigabatrin monotherapy” as argued; although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Additionally, it is pointed out that independent claims 10 and 20 recite the liquid pharmaceutical composition as optionally comprising water, vigabatrin as the only API, and one or more excipients such as preservatives. It is further respectfully pointed out that cannabidiol is known in the pharmaceutical arts as a natural preservative due to its antioxidant and antimicrobial properties. As such, a composition comprising vigabatrin and cannabidiol meet the composition limitations of instant claims 10 and 20 since cannabidiol can be categorized as a preservative.
On pg. 8, Remarks, Applicant argues that CN ‘608 does not disclose that the isolated aminohexenoic acid dosage form is a liquid formulation, and provides no details whatsoever regarding excipients in a liquid formulation containing aminohexenoic acid.”
This argument has been fully considered, but is not found persuasive.
It is respectfully pointed out that that as discussed on pgs. 3-4 of the previous Office Action, ‘CN ‘608 specifically teaches “Composition for oral administration include liquid dosage forms such as emulsions, suspensions, syrups and elixirs” and teaches a process for preparation comprising mixing the active ingredient(s) with a pharmaceutically acceptable carrier, and additives such as coloring agents, flavoring agents and antisepsis (preservatives) (pg. 4; pg. 5, 1st paragraph), and adjusting the solution to the desired volume (pg. 4).
On pg. 8, Remarks, Applicant argues that the examiner fails to point to anything in CN ‘608 other than a generic “process for preparation” and that no mention is made of a process to prepare a liquid pharmaceutical composition.
This argument has been fully considered, but is not found persuasive. It is respectfully pointed out that as discussed on pg. 4 of the previous Office Action, CN ‘608 specifically teaches the instantly claimed method on pgs. 4 and pg. 5, 1st paragraph: “sterile aqueous solutions of one or more active ingredients. . .may be employed. . .the aqueous solution should be properly buffered and the liquid diluent. . .The preparation can be prepared by dissolving one or more active ingredients and possible additives in a portion of the injectable solvent (preferably sterile water), adjusting the solution to the desired volume. . .Any suitable additives commonly used in the art, such as tonicity agents, preservatives, antioxidants, and the like, may be added. Suitable pharmaceutical carriers include. . .steroid aqueous solutions, and various organic solvents. . .Any other excipients or additives. . .may be used. . .Examples of liquid carriers are. . .The composition formed by mixing the active ingredient of the present invention with a pharmaceutically acceptable carrier can then be conveniently administered in a variety of dosage forms.”
It is respectfully pointed out that independent claims 10 and 20 merely require a step of mixing the active ingredient with one or more excipients. As such, CN ‘608 clearly teaches this claimed limitation.
On pg. 9, Remarks, Applicant argues that Joshi’s disclosed stability results concern melatonin and antihistamine formulations and there would be no way to predict the stability of the materially different composition disclosed by CN ‘608.
This argument has been fully considered, but is not found persuasive.
Joshi is merely relied upon to teach general properties known in the art for pediatric, liquid, oral formulations. Like CN ‘608, Joshi teaches liquid, oral compositions for pediatric composition, wherein Joshi teaches such compositions as having a pH of 4 to 7.5 and as being stable for 3 months at 5º, 25º and 40º C.
Thus, it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to select a pH of 5-8 for the composition of ‘608, to arrive at instant claims 10 and 20. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-CN ‘608 and Joshi are both directed toward liquid, oral composition for pediatric administration (see [0048] of Joshi),
-Joshi teaches such compositions as having a pH of 4 to 7.5 ([0098]; pg. 9, claim 6), and
- "[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," MPEP 2144.05(II).
As such an ordinary skilled artisan would have been motivated to make such a selection, to predictably arrive at a method of making a liquid, oral formulation that is safe for ingestion and stable in formulation.
Further regarding claims 10 and 20, Joshi teaches its compositions as stable for 3 months at 5º, 25º and 40º C ([0093]-[0095]). As such, an ordinary skilled artisan would predictably expect the liquid, oral composition of CN ‘608, to be stable for up to three months at room temperature with less than 0.06% total impurities, since it is known in the art to produce liquid, oral compositions with such stability, for storage purposes and therapeutic effect.
See also MPEP 2112.01, 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).
On pg. 10, Remarks, Applicant argues that the examiner has not identified where Joshi established less than 0.06% total impurities.”
This argument has been fully considered, but is not found persuasive. As discussed above and in the previous Office Action, CN ‘608 does not explicitly teach the percent weight of impurities in its compositions. However, CN ‘608 teaches the instant composition made by the instantly claimed method. As such, an ordinary skilled artisan would reasonably expect the composition of CN ‘608 to have the same or a similar total impurities percent weights; 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).
On pgs. 10-11, Remarks, Applicant argues that a reasonable expectation of success is absent because one of ordinary skill in the art would not have expected Joshi’s formulations to cause the aminohexenoic acid and cannabidiol containing composition of CN ‘608 to exhibit the claimed pH and stability.”
This argument has been fully considered, but is not found persuasive. Applicant is respectfully reminded that obviousness does not require absolute predictability, but a reasonable expectation of success. See MPEP 2143.02. For the reasons stated above there is a reasonable expectation of success that the composition of CN ‘608 would exhibit or would be modified to exhibit the instantly claimed pH and stability.
For these reasons, Applicant’s arguments are not persuasive to overcome the instant rejection.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN WELLS whose telephone number is (571)272-7316. The examiner can normally be reached M-F 7:00-4:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James (Jim) Alstrum-Acevedo can be reached on 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAUREN WELLS/Primary Examiner, Art Unit 1622
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