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 submitted information disclosure statements (IDSs) were filed on 09/12/2024 and 05/15/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 non-obviousness.
Claim(s) 1-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Agarwal et al. (Agarwal et al., Effect of Oxidative Stress on Male Reproduction. World J Mens Health 2014 April 32(1): 1-17), in view of Begum et al. (Begum et al., Molecular hydrogen may enhance the production of testosterone hormone in male infertility through hormone signal modulation and redox balance. Medical Hypotheses 121 (2018) 6–9), and Kobayashi et al. (WO 2017130709 A1).
Claims 1 and 4-5,
Agarwal et al. teach effect of oxidative stress on male reproduction, (Title), and antioxidant supplementation work by halting the oxidative chain reaction-eliminating, taking up, or reducing the formation of reactive oxygen species. (pg. 12, right col. last par.).
Agarwal et al. do not teach administering a silicon fine particle, an aggregate of silicon
fine particles or a crystal grain of silicon to a subject suffering from the reproductive disorder,
wherein the silicon fine particle, the aggregate of silicon fine particles or the crystal grain of silicon has a hydrogen-generating ability.
Begum et al. teach molecular hydrogen may enhance the production of testosterone hormone in male infertility through hormone signal modulation and redox balance. (Title).
Begum et al. do not teach administering a silicon fine particle, an aggregate of silicon
fine particles or a crystal grain of silicon to a subject suffering from the reproductive disorder,
wherein the silicon fine particle, the aggregate of silicon fine particles or the crystal grain of silicon has a hydrogen-generating ability.
Kobayashi et al. (WO 2017130709 A1) teach one solid preparation of the present invention has fine silicon particles as a principal component thereof, and exhibits a hydrogen generation capacity. In addition, one embodiment of this solid preparation has fine silicon particles which for the most part have a crystallite size of 1-100nm, inclusive, as a principal component thereof, and exhibits a hydrogen generation capacity of 3ml/g or higher upon contact with a water-containing solution having a pH value of 7 or higher. According to this solid preparation, hydrogen is generated when fine silicon particles contact a water-containing solution having a pH value of 7 or higher. Consequently, by taking advantage of these properties, it is possible, for example, to promote hydrogen generation in a region of the digestive tract where the pH value is 7 or higher as a result of pancreatic fluid secretion following oral administration of said preparation and passage thereof through the stomach. (Abs). When the silicon nanoparticles were observed using an SEM (scanning electron microscope), some of the silicon nanoparticles were aggregated to form slightly larger, irregular aggregates of about 0.5 µm or less. (pg. 3, 5th par.).
With regard to claims 2-3, and 9-10
Kobayashi et al. (WO 2017130709 A1) teach the coating layer that can be applied to the tablet is a known gastric insoluble enteric material that is a coating agent that covers the outermost layer of the tablet. Moreover, the example of the coating layer which can be applied to a capsule is the capsule itself manufactured from the well-known poorly enteric material which encloses
Silicon fine particles (mainly the aggregate of silicon fine particles). (pg. 5, par. 6th). A glass bottle (with a borosilicate glass thickness of about 1 mm) having a capacity of 100 ml in a powdered state (ie, without mixing or kneading sodium bicarbonate powder) with 10 mg of
Silicon nanoparticles described in the first embodiment. (pg. 6, par. 4th). Moreover, a well-known material can be employ | adopted about a disintegrating agent. In addition, a preferred example of a more suitable disintegrant is an organic acid, and the most preferred example is citric acid. (pg. 5, last par.). Here, the organic acid can also function as a binder that agglomerates the silicon nanoparticles. By adding 50 mg of citric acid (manufactured by Wako Pure Chemical Industries, Ltd., purity 99.5%) and kneading to 5 mg of silicon nanoparticles and 495 mg of sodium bicarbonate powder used in the first embodiment. (pg. 3, par. 7th). The pH value of the water-containing liquid was 8.3 due to the release of sodium bicarbonate and citric acid as the tablet disintegrated. (pg. 7, 1st par.). Sodium bicarbonate is an enteric coating to be released at pH 8.3.
With regard to claim 6,
Kobayashi et al. (WO 2017130709 A1) teach the silicon nanoparticles described in the first embodiment are immersed in a hydrofluoric acid aqueous solution having a concentration of 5% by mass for 10 minutes.(pg. 3, last par.).
With regard to claims 7 and 8,
Kobayashi et al. (WO 2017130709 A1) teach the same high-purity silicon particle powder as used in the first embodiment (typically, silicon particles having a crystal grain size of more than 1 µm. (pg. 4, 4th par.), which includes particle size between 1 and 5 µm.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to learn the Effect of Oxidative Stress on Male Reproduction taught by Agarwal et al., molecular hydrogen may enhance the production of testosterone hormone in male infertility through hormone signal modulation and redox balance, taught by Begum et al.; and fine silicon particles have hydrogen generation capacity, to be able to apply hydrogen generated by silicon particle to treat oxidative stress in treating reproductive disorder, wherein the particles having bicarbonate enteric coating, generating hydrogen in a region of the digestive tract, for oral delivery, the preparation comprising a hydrofluoric acid aqueous solution, and the particles size between 1 and 5 µm, taught by Kobayashi et al., since they have clearly taught these ideas.
Conclusion
No Claim is allowed.
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/NGOC-ANH THI NGUYEN/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615