DETAILED ACTION
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 .
Information Disclosure Statement
The Information Disclosure Statement (IDS) filed on 28 November 2023 has been considered.
Claim Status
Claim(s) 1-16 are examined on the merits herein.
Claim Interpretation
Claim interpretation, herein, is based upon MPEP 2111.02, pertaining to the effect of the preamble of a claim, namely Section I:
Any terminology in the preamble that limits the structure of the claimed invention must be treated as a claim limitation. See, e.g., Corning Glass Works v. Sumitomo Elec. U.S.A., Inc., 868 F.2d 1251, 1257, 9 USPQ2d 1962, 1966 (Fed. Cir. 1989) (The determination of whether preamble recitations are structural limitations can be resolved only on review of the entirety of the application "to gain an understanding of what the inventors actually invented and intended to encompass by the claim" as drafted without importing "‘extraneous’ limitations from the specification."); Pac-Tec Inc. v. Amerace Corp., 903 F.2d 796, 801, 14 USPQ2d 1871, 1876 (Fed. Cir. 1990) (determining that preamble language that constitutes a structural limitation is actually part of the claimed invention). See also In re Stencel, 828 F.2d 751, 4 USPQ2d 1071 (Fed. Cir. 1987) (The claim at issue was directed to a driver for setting a joint of a threaded collar; however, the body of the claim did not directly include the structure of the collar as part of the claimed article. The examiner did not consider the preamble, which did set forth the structure of the collar, as limiting the claim. The court found that the collar structure could not be ignored. While the claim was not directly limited to the collar, the collar structure recited in the preamble did limit the structure of the driver. "[T]he framework - the teachings of the prior art - against which patentability is measured is not all drivers broadly, but drivers suitable for use in combination with this collar, for the claims are so limited." Id. at 1073, 828 F.2d at 754.).
Claim(s) 1-9, citing reference to a “cosmetic sachet for reducing age-related symptoms in human skin”, are interpreted inasmuch as they relate to a sachet, structurally, affording no patentable weight to “cosmetic” and “for reducing age-related symptoms in human skin” as a result of their intended use providing no structural limitations to the Instant invention.
The sachet, as cited by Claim(s) 1-9, is further interpreted as a container made from water-dispersible paper, which envelopes a composition containing the disclosed constituents.
The hot water, as cited by Claim(s) 10, is interpreted inasmuch as it is liquid water that is not in the form of ice or vapor, and no patentable weight is applied to “hot” as it is a subjective quality depending on the user and there is no temperature range provided in the Instant disclosure.
Claim Rejections - 35 USC § 103
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 1-16 are rejected under 35 U.S.C. 103 as being unpatentable over Miller et al (US 20230240978 A1; Filed: 26 January 2023; henceforth Miller) in view of Frabotta et al (US 20230257178 A1; Filed 24 June 2021; henceforth Frabotta) and Khan et al (; Published: 13 January 2022; “Review on Methylene Blue: Its Properties, Uses, Toxicity and Photodegradation”, Water, 2022, 14(2); henceforth Khan).
In regards to Claim(s) 1-3, 6-10, and 12-16, Miller teaches effervescent compositions (powders that may be pressed into tablets) for the delivery of medicaments (e.g. nitric oxide) in foot baths, by means of effervescence that arises from the combination of a first nitrite solution and a second acidic solution (pg. 1; [0014]; lines 03-06). The invention disclosed by Miller meets several limitations of the Instant invention as defined by the claims.
Miller addresses the product be a sachet comprising a bag made from water-dispersing paper by teaching, according to some embodiments, a pod or a pouch being preferably utilized to provide the reagents and/or compounds needed to initiate nitric oxide therapy in a bath. For example, and not by way of limitation, according to some embodiments, a pod or a pouch is preferably comprised of polyvinyl alcohol (pg. 8; [0090]; lines 1-6), as required by Claim 1, line(s) 01-02. Furthermore, Miller also addresses the reversible retention of the components by teaching, according to some embodiments, the single product be configured so as to dissolve and release the first and second mediums into the water bath (pg. 5; [0068]; lines 7-9) as required by Claim 1, line(s) 02-03.
Miller also addresses the comprisal of sodium bicarbonate by teaching a tableted embodiment of the composition to be comprised of any desired reactants, sodium bicarbonate, fragrance materials, or other desired tablet components (pg. 4; [0043]; lines 05-08), as required by Claim 1, line 03; also Claim 12, line 02.
Miller also addresses the comprisal of citric acid by teaching, in one certain embodiment, two solutions or two separate mediums being used to initiate the production of nitric oxide (NO), whereby the first solution may be a nitrite solution and the second solution may be an acidic solution (pg. 1; [0014]; lines 03-06), wherein the latter comprises one or more of hydrochloric acid, ascorbic acid, salicylic, and citric acid (pg. 2; [0021]; lines 07-09), as required by Claim 1, line 04; also Claim 12, line 03.
Miller also addresses the comprisal of magnesium sulfate heptahydrate by teaching, according to some embodiments, Epsom salt (magnesium sulfate heptahydrate) being preferably used to increase the osmolality of the water bath to possibly reduce swelling in the body part being immersed (pg. 6; [0078]; lines 01-04), as required by Claim 1, line 04; also Claim 12, line 03.
Miller also addresses the comprisal of starch, specifically corn starch, by teaching, according to some embodiments, fillers like corn starch and/or oil being preferably included in view of a desired configuration and/or other physical properties (pg. 8; [0091]; lines 01-08), as required by Claim 1, line 04; also Claim 3, line(s) 01-02; also Claim 6, line(s) 01-02; also Claim 9, line 01; also Claim 12, line 03; also Claim 13, line(s) 01-02; also Claim 16, line 03.
Miller also addresses the comprisal of highly saturated plant oil, specifically coconut oil, by teaching, according to some embodiments, coconut oil, and/or another oil, being used as a binder, or binding agent, to help moisturize the skin (pg. 7; [0081]; lines 1-3), as required by Claim 1, line 04; also Claim 2, line(s) 01-02; also Claim 7, line(s) 01-02; also Claim 8, line 01; also Claim 12, line 03; also Claim 14, line(s) 01-02; also Claim 15, line 01.
Miller also addresses the delivery of the sachet to a volume of hot water by teaching, according to some embodiments, the present disclosure relating generally to a system for using one or more mediums to produce nitric oxide in a bath, and more specifically, a system for producing nitric oxide in a water bath for promoting transdermal absorption of nitric oxide to provide nitric oxide therapy (pg. 1; [0009]; lines 01-06), as required by Claim 10, line 07. Furthermore, Miller addresses the final product of the method being a produced topical formulation by teaching certain embodiments of a product, compound, and method in accordance with their invention providing a topical product that can be applied or used by a person (pg. 1; [0006]; lines 01-04), as required by Claim 10 line(s) 07-08.
In regards to Claim(s) 4, 5, 11, and 16, the effervescent compositions disclosed by Miller also meet the ranges for the compositional constituents disclosed in the Instant application.
Namely, that of the sodium bicarbonate, addressing such by teaching its use in the composition at about 30 wt% (pg. 12; [0125]; lines 03-04), as required by Claim 4, line(s) 01-02; also Claim 5, line 01-02; also Claim 11, line 01-02; also Claim 16, line 01-02.
Also, that of the citric acid, addressing such by teaching its use in the composition at about 19.0 wt% (pg. 12; [0125]; line 4), as required by Claim 4, line 02; also Claim 5, line 02; also Claim 11, line 02; also Claim 16, line 02.
Also, that of the magnesium sulfate heptahydrate, addressing such by teaching its use in the composition at 19 wt% (pg. 12; [0125]; lines 04-05), as required by Claim 4, line(s) 02-03; also Claim 5, line 02; also Claim 11, line 02; also Claim 16, line 02-03.
Also, that of starch, especially corn starch, addressing such by teaching its use in the composition at about 11 wt% (pg. 12; [0125]; lines 05-06), as required by Claim 4, line 03; also Claim 5, line 02; also Claim 11, line 02; also Claim 16, line ; also Claim 16, line 03.
Finally, that of 80% saturated plant oil, addressing such by teaching the use of olive oil in the composition at about 8 wt% (pg. 12; [0125]; line 5), in which case can be substituted by coconut oil, as required by Claim 4, line(s) 03; also Claim 5, line 03; also Claim 11, line 02-03; also Claim 16, line 03.
While some of these ranges are outside the bounds of the disclosed ranges, a prima facie case of obviousness can be made when considering proximity of the Instant ranges with those of Miller (see MPEP 2144.05(I)) in the case of sodium bicarbonate, citric acid, magnesium sulfate heptahydrate, starch, and coconut oil. Furthermore, it is noted 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 ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Miller, though, does not teach the use of methylene blue in their compositions.
Frabotta, however, teaches similar effervescent compositions to Miller, preferentially taking the form of a film-enclosed bath article (pg. 1; Abstract; line 1) that is constructed from a weak acid and a carbonate or bicarbonate base (pg. 2; [0020]; lines 12-13) and can include dyes.
The effervescent compositions disclosed by Frabotta analogously meet several structural, compositional, and range limitations set forth in the Instant invention, alongside Miller.
One limitation being that of the bag/container comprising water dispersing paper, addressing such by teaching a bath article and the method of enclosing the formed bath article in a water-soluble film (pg. 1; Abstract; lines 02-04) that is composed of one or more polyvinyl alcohol resins (pg. 3; [0027]; lines 01-02) - highly crystalline polymers which dissolve only in hot water greater than about 140° F (pg. 3; [0028]; lines 01-07); see above for Claim citation.
A further limitation being that of the composition being releasably retained in the bag, addressing such by teaching, in some examples, the film-enclosed bath article to include an effervescing component contained within that is released when the object is placed in a water-filled bath tub (pg. 2; [0018]; lines 04-07); see above for Claim citation.
A further limitation being that of sodium bicarbonate, especially in the range of 32 – 41.5 wt%, addressing such by teaching the carbonate component can include sodium bicarbonate (pg. 2; [0021]; lines 10-12) and its use in the composition within the range of 40-75 wt% (pg. 2-3; [0023]; lines 01-21); see above for Claim citation.
A further limitation being that of citric acid, especially in the range of 17 – 18.6 wt%, addressing such by teaching the weak acid component to be one or more of citric acid, fumaric acid, and tartaric acid (pg. 2; [0021]; lines 03-05) and its use in the composition within the range of 24 - 40 wt% (pg. 2-3; [0023]; lines 01-21); see above for Claim citation.
A further limitation being that of magnesium sulfate (possibly heptahydrate) , addressing such by teaching the use of solid carriers (water-soluble components in powdered form) selected from one or more of salt, sugar, sorbitol, cream of tartar, magnesium carbonate, magnesium sulfate (pg. 2; [0022]; lines 25-29); see above for Claim citation.
A further limitation being that of corn starch, addressing such by teaching its use contacting the composition as an additional polymer in the water-soluble film (pg. 4; [0033]; lines 31-36), but not necessarily in the composition; see above for Claim citation.
And another limitation being that of a highly saturated plant oil, especially coconut oil in the range of 6 – 13 wt%, addressing such by teaching the composition to include a vegetable oil selected from one or more of almond oil, argan oil, castor oil, coconut oil (pg. 2; [0022]; 22-24) and its use in the composition within the range of 0.001% - 12 wt% (pg. 2-3; [0023]; lines 01-21); see above for Claim citation.
In regards to Claim(s) 1-16, Frabotta potentially meets the limitation of methylene blue comprisal, especially in the range of 0.036 to 0.04 wt%, by teaching their compositions to contain dyes or pigments, preferably water-soluble dyes, to release a desired color, for example, to the bathwater (pg. 2; [0022]; lines 11-13) and its use in the composition within the range of 0.001 - 4 wt% (pg. 2-3; [0023]; lines 01-21), as required by Claim 1, line 05; also Claim 4, line 04; also Claim 5, line 03; also Claim 11, line 03; also Claim 16, line 03-04.
Furthermore, it is noted 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 ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). While Frabotta does not specify the use of methylene blue as the dye/coloring agent, Frabotta does cite preference for a water-soluble dye.
Khan teaches the industrial scale usage of methylene blue as a common, water-soluble dye, textile dye, lending support towards methylene blue being a water soluble dye used by Frabotta, given its industrially-abundant usage (Khan; pg. 5; Sect. 3; par. 3; line 02-03 ), high water solubility (Khan; pg. 2; par. 3; lines 02-03), and permissible contact with human skin due to its common use for coloring silk, wool, and cotton (Khan; pg. 2; Sect. 1; par. 1; line 14).
Provided that methylene blue is a common and abundantly used water-soluble dye, and that water-soluble dyes may be added to topical formulations, a prima facie case of obviousness can be made for one of ordinary skill in the art to use the teachings of Miller as a compositional foundation for a water-dispersible bag housing an effervescent composition of sodium bicarbonate, citric acid, magnesium sulfate heptahydrate, coconut oil, and corn starch, and building upon it with the teachings of Frabotta and Khan, to include like methylene blue into therein topical compositions. One of ordinary skill in the art would have a reasonable expectation of success by adding a single additional ingredient, methylene blue, into the composition taught by Miller, at least with the ranges taught by Frabotta, and encasing the composition in polyvinyl alcohol films taught similarly by both Miller and Frabotta, before the effective filing date of the Instant invention, as a means of preparing a topical formulation after adding said sachet/composition to a volume of hot water to achieve the target 1 µM methylene blue concentration.
Conclusion
No claims are allowed in this action.
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/STANLEY BRAM/Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691
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