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 .
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.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-11 and 16-17, in the response dated 7/16/2026, is acknowledged. The applicant also elected the species of specific salt of a mixture of sodium bicarbonate and magnesium chloride without traverse.
Upon further consideration, the Examiner withdraws the species election.
Claims 12-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Status
Claims 1-17 are pending.
Claims 12-15 are withdrawn.
Claims 1-11 and 16-17 are examined on the merits in this prosecution.
CLAIM REJECTIONS
Indefiniteness Rejection
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.
Claim 3 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 pre-AIA the applicant regards as the invention.
Claim 3 recites the limitation of an “aqueous solution” in the preamble. Since the specification lacks a definition of the term “solution,” the Examiner cites the definition provided by Brittanica online: “solution, in chemistry, a homogenous mixture of two or more substances in relative amounts that can be varied continuously up to what is called the limit of solubility” (available at https://www.britannica.com/science/
solution-chemistry). Claim 3 recites the species of sodium hydride, potassium hydride, and magnesium hydride. These species are insoluble and cannot form an aqueous solution. Furthermore, these species are highly reactive upon contact with water and are not considered salts, but rather ionic solids.
Obviousness Rejection
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 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.
1) Claims 1-9, 11, and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Kawano (JP 2018-035130 A; citations herein from the English translation by Google Patents).
Kawano teaches hydrogen containing compositions comprising ascorbic acid and, for example:
calcium carbonate (pg 9, Table 1);
potassium carbonate (pg 10, Table 2);
magnesium carbonate (pg 11, Table 3);
sodium carbonate (pg 11, Table 4);
sodium bicarbonate (pg 12, Table 5);
calcium oxide (pg 13, Table 8);
calcium hydroxide (pg 14, Table 10)
It is noted that these citations are from the Japanese language patent; translation from Google Translate.
For claims 2 and 11, in each of Tables 1-5, 8, and 10, Kawano teaches that at pH of 7.8-8.0 the concentration of molecular hydrogen is within the claimed range.
For claims 3-6, the examples cited above read on the claimed salt species.
Claims 1 and 9 recite limitation of range of ionic strength and claims 7, 8, and 17 recite a concentration range of the salt or of ascorbic acid. Kawano teaches the pH range to obtain the claimed range of hydrogen concentration but does not teach the specific amounts of the salt and ascorbic acid, nor the ionic strength of the solution. However, "It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions."). “In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416, 82 USPQ2d 1385, 1395 (2007) (identifying "the need for caution in granting a patent based on the combination of elements found in the prior art."). As such, it is prima facie obvious to optimize the amounts of ascorbic acid and the salt within the teachings of the prior art of Kawano through routine experimentation to obtain the claimed amounts of ascorbic acid and the salt. See MPEP 2144(II)(A).
For claim 16, Kawano teaches a combination of ascorbic acid and calcium oxide at pH 8 that comprises 0.8 ppm of molecular hydrogen, within the claimed range (see Table 8, entry 46 of the Japanese patent, below
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The examiner acknowledges that some picking and choosing was used to arrive at the instantly claimed composition in view of Kawano. However, the claimed combination of components, including the salt and ascorbic acid, is taught as known and used in solutions containing the claimed amount of molecular hydrogen. It would have therefore been prima facie obvious to a person having ordinary skill in the art to prepare the claimed combination of ingredients, including the salt and ascorbic acid to obtain a composition comprising the claimed amounts of ascorbic acid and the salt, as well as the claimed range(s) of ionic strength, with a reasonable expectation of success, as taught by Kawano.
2) Claims 1-9, 11, and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Kawano (cited above), in view of Safonov (US 2020/0345992 A1).
Safonov teaches a hydrogen-enhanced, drug-releasing transdermal system comprising a therapeutic composition (e.g., one or more drugs) and components capable of generating molecular hydrogen (H2) that facilitates transdermal delivery of the therapeutic composition (pg 2, [0031]). Safonov teaches examples of the aqueous composition include calcium hydroxide, a suitable acid, and a suitable base (pg 6, [0073]). Safonov teaches the therapeutic agents can be natural healing agents such as essential oils (pg 4, [0043]). Safonov also teaches the H2 can also enhance the therapeutic effect of the therapeutic agent (Abstract).
The skilled artisan would have expected success in adding the composition comprising molecular hydrogen, as taught by Kawano, to the drug-releasing, therapeutic transdermal system of Safonov, comprising essential oil as the active agent, since Safonov teaches the molecular hydrogen diffuses to a target surface of a subject's body and facilitates delivery of the therapeutic agent to the subject's body, providing additional therapeutic effect and prevent side effects of the therapeutic agent (pg 1, [0006]).
CONCLUSION
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL P COHEN whose telephone number is (571)270-7402. The examiner can normally be reached on M-Th 8:30-5:30; F 9-4.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana S. Kaup, can be reached on (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL P COHEN/Primary Examiner, Art Unit 1612
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