Detailed Action
The present office action is in response to the reply filed 19 Sep 2025.
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 .
Status
Claims 1, 3-8, 10, 12, 18, 22, and 24-26 of the pending application have been examined on the merits. Claims 9, 11, 13-17, and 23 of the pending application remain withdrawn. Acknowledgement is made of the cancelation of claims 2 and 19-21. Acknowledgement is made of the amendments filed 19 Sep 2025.
Priority
Applicants identify the instant application, Serial #: 17/610,886 filed November 12, 2021, as a National Stage Entry of International Patent Application #: PCT/GB2020/000051, filed May 15, 2020, which claims foreign priority from Foreign Application #: GB1906865.9, filed May 15, 2019.
Reply to Applicant Arguments
Acknowledgement is made of the remarks filed 19 Sep 2025.
The rejection of claims 2-4 under 35 U.S.C. § 112(a) and 35 U.S.C. § 112(b) are rendered moot following applicant amendments.
The rejection of claims 1, 5-8, 10, 12, 18, and 22 under 35 U.S.C. § 103 over WO 2010/098906 (provided in the office action mailed 19 Mar 2025), hereinafter '906, Froehner et al. (US 2016/008320; provided in IDS 11/12/21), hereinafter Froehner, WO 2018/064654 (provided in IDS 11/12/21), hereinafter '654, Green (https://www.foodingredientsfirst.com/news/natural-and-authentic-taste-solutions-part-1-citrus-flavors-dominate-beverage-space.html, 2017, accessed 02/26/2025; provided in the office action mailed 19 Mar 2025), hereinafter Green, has been rendered moot following applicant amendments.
Regarding the rejections of claims 1-2, 5-8, 10, 12, 18, and 22 under 35 U.S.C. § 103 over '906, Froehner, '654, Green, and WO 2016/128707 (provided in IDS 11/12/21), hereinafter '707, applicant arguments have been fully considered but are not persuasive.
Applicant argues that the alkaline water produced by the method of the present application produces stable alkaline water and that the alkaline water, as claimed, does not lose its alkaline pH for extended periods of time and that it is more stable in that it remains alkaline even after the addition of other ingredients. Applicant argues that an advantage of the use of stable alkaline water as described above is that it can sustainably hold active ingredients while maintaining its alkalinity.
This is not considered persuasive. Applicant has not defined "stable alkaline water" in the specification more than that the water does "not lose its alkaline pH for extended periods of time." There is no indication to the person having skill in the art what is meant by "extended periods of time." Further, the references teach all the same steps of making the alkaline water as the claimed method does and so necessarily have the same outcome of "stable alkaline water." It is noted that arguing the stable alkaline water can sustainably hold active ingredients while maintaining alkalinity is arguing limitations that are not present in the claims. See MPEP § 2145(VI).
Applicant argues that the mere fact that individual elements may separately exist in the cited art is no sufficient to render the invention obvious and that there is there is nothing to suggest that a person having skill in the art would combine '707 with '906 and Froehner, that '906 and Froehner do not teach the improved stability of the water and statin mixture, and that '707 teaches only a method of making alkaline water and provides no suggestion that it could be used to improve the stability of a beverage.
This is not persuasive. MPEP § 2145(IV) states, "One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references." The rejection is based on the combination of '906, Froehner, '654, Green, and '707 as stated in the office action mailed 19 Mar 2025 and restated below.
Applicant argues that the problems addressed by '707 and Froehner/'906 are unrelated and the artisan would not be motivated to combine the references. Applicant argues:
‘906 relates to methods of treating neuromuscular diseases with statins, and relates to methods and compositions for liquid statin products suitable for administration to humans or animals. In contrast, '707 relates to methods and apparatus for treating water, particularly drinking or potable water. These references are not analogous and the Office fails provided justification to combine the references.
This is not persuasive. '906 teaches the preparation of simvastatin drinks (see the office action mailed 19 Mar 2025). Froehner teaches that alkaline water solubilizes the active form of simvastatin (see the office action mailed 19 Mar 2025). '707 teaches a method of creating alkaline water (see the office action mailed 19 Mar 2025). Thus the references relate to each other by the teaching of alkaline water solubilizing simvastatin.
Applicant argues that the motivation comes from the present application and it is not reasonable to conclude the artisan would arrive at the present invention at the time of filing.
This is not persuasive. The motivation to combine the references is detailed in the rejections found in the office action mailed 19 Mar 2025 and restated below. See MPEP § 2145(X)(A)
Applicant argues that because Froehner discloses that HCl was added to the alkaline drink before giving it to mice, the reference does not disclose an alkaline drink.
This is not persuasive. Froehner is relied on to teach that alkaline water helps dissolve the simvastatin. There is nothing in Froehner suggesting that the HCl needs to be added, only that it was added before giving it to mice.
In light of the discussion above, the rejection of claims 1, 5-8, 10, 12, 18, and 22 under 35 U.S.C. § 103, as obvious over ‘906, Froehner, ‘654, Green, and ‘707 is maintained for the reasons of record and restated below. The amended claims 3-4 and newly added claims 24-26 have been added to the rejection. These rejections are necessitated by applicant amendment.
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.
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.
Claim(s) 1, 3-8, 10, 12, 18, 22, and 24-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over ‘906 further in view of Froehner, ‘654, Green, and ‘707.
'906 teaches solubilizing simvastatin at 0.2% w/w (Table 10) in a vehicle with mixing followed by checking the pH (paragraph [0094]). '906 teaches transferring methylparaben and propylparaben to the solution with mixing followed by dissolving sorbitol in water before adding to the original solution with mixing (paragraph [0094]). Furthermore, '906 teaches formulating batches of simvastatin solution with and without sodium benzoate and by combining propylene glycol and PEG 400 in a 1:1 ratio as the vehicle to solubilize the simvastatin (paragraph [0098]). '906 teaches that formulations can also incorporate anti-oxidants such as BHA and flavorings (paragraph [0103] and Table 16a). '906 also teaches that simvastatin in not soluble in pure water (paragraph [0089]). '906 additionally teaches the addition of flavor decreases the pH in simvastatin formulations (paragraph [0101]). However, '906 does not teach dissolving simvastatin in water that has a pH of 8-10.5, adding CBD, or adding lemon-lime flavor.
Froehner teaches a method of mixing simvastatin in 1 mL of ethanol and then mixing for several minutes into 1 L of alkaline water (pH 10) to hydrolyze the lactone group on simvastatin and enable the active form to be solubilized in water (paragraph [0196]).
'654 teaches a pharmaceutical composition comprising a statin and a cannabinoid to treat subjects with elevated cholesterol levels (paragraphs [2], [13], and [84]). '654 teaches the pharmaceutically composition comprises a pharmaceutically-acceptable excipient, carrier, or diluent and that drinks are considered an excipient, carrier, or diluent (paragraph [106]). '654 additionally teaches the statin may be simvastatin (paragraph [88] and claim 2) and the cannabinoid may be cannabidiol (paragraph [89] and claim 4).
Green teaches that citrus is a perennial top flavor choice for beverages and no other taste enjoys greater acceptance in the beverage industry (pg. 1, paragraph 1). Green teaches that citrus taste is a favorite in nearly all countries around the globe (pg. 2, paragraph 1). Furthermore, Green teaches that orange, lemon, and lemon-lime are all time citrus favorites in the beverage world (pg. 3, paragraph 5).
‘707 teaches a method of treating water comprising contacting the water with a solid material comprising an elementary metal and effecting sufficient relative flow between the material and the water to raise the pH to lie between the range 7 to 11 (pg. 2, lines 5-9). ’707 teaches the water is passed along a flow path within a vessel and extending between an inlet and outlet of the vessel where the elementary metal material is located within the flow path (pg. 2, lines 23-27). ‘707 teaches an embodiment of the vessel where an inlet pipe has a profiled interior to create a vortex prior to entering a first chamber, this vortex created by a venturi effect based on the schematic of the vessel (pg. 8, lines 22-27; Fig. 6). ‘707 also teaches that water and drinks made in this way have a light, crisp normal spring water taste and no strange aftertastes due to the presence of other ‘ionizers’ (pg. 4, lines 29-31).
It would be obvious to a person having ordinary skill in the art to combine the method of solubilizing simvastatin in a vehicle with mixing taught by '906 with the method of solubilizing simvastatin in 1 mL of ethanol and then mixing into 1 L of pH 10 alkaline water as taught by Froehner. The artisan would be motivated to make this change to hydrolyze the lactone group on simvastatin and enable the active form to be solubilized in water. Furthermore, the artisan would be motivated to use alkaline water to mitigate any decreases in pH that would occur upon addition of flavorings.
It would further be obvious to the artisan to add cannabidiol to the solution taught by '906 and create the pharmaceutical composition drink taught in '654. One having ordinary skill in the art would be motivated to add cannabidiol to the drink solution in order to treat elevated cholesterol in subjects that ingest the drink.
Finally, it would be obvious to a person having skill in the art to use lemon-lime flavoring as the flavoring of drink described in '906. The artisan would be motivated to use lemon-lime flavoring to increase patient compliance by ingesting the drink since citrus flavors are favored in nearly all countries and among the citrus flavors, lemon-lime is one of the favorites in the beverage world.
Taken together, '906, Froehner, '654, and Green teach a method of mixing simvastatin with alkaline water having a pH of 10 and adding in PEG 400, methylparaben, propylparaben, BHA, lemon-lime flavor, and cannabidiol.
It would be prima facie obvious to one having ordinary skill in the art to create the alkaline water for the method of making a statin beverage as taught by ‘906, Froehner, ‘654, and Green by passing the water through vessel taught in ‘707. The artisan would be motivated to make alkaline water in this way so the drink has a light, crisp normal spring water taste with no strange aftertastes.
A reference is good not only for what it teaches by direct anticipation but also for what one of ordinary skill in the art might reasonably infer from the teachings. (In re Opprecht 12 USPQ 2d 1235, 1236 (Fed Cir. 1989); In re Bode 193 USPQ 12 (CCPA) 1976). In light of the foregoing 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 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 references, especially in the absence of evidence to the contrary.
Conclusion
No claim is allowed. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan D. Mahlum whose telephone number is (703)756-4691. The examiner can normally be reached 8:30 AM - 5:00 PM ET, M-F.
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/J.D.M./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625