DETAILED ACTION
Status of the Application
Receipt is acknowledged of Applicants’ Preliminary Amendments and Remarks, filed 6 December 2023, in the matter of Application N° 18/567,479. Said documents have been entered on the record. The Examiner further acknowledges the following:
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 12-15 have been canceled. Claims 16 and 17 are newly added and supported by the originally-filed disclosure.
Claims 1-11 have been amended. Specifically, the statutory category of the claimed invention has been changed from a composition to a method of preventing or treating a disease comprising the administration of silicon particles.
Thus, claims 1-11, 16, and 17 now represent all claims currently under consideration.
Information Disclosure Statement
Two Information Disclosure Statements (IDS) filed 6 December 2023 and 29 October 2024 are acknowledged and have been considered.
Claim Rejections - 35 USC §102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 9, 10, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Garcimartin et al. (J. Nutr.; 2017).
As amended, the claimed invention is directed to a method of preventing or treating a disease, comprising administering to a subject in need thereof, a composition comprising silicon small particles, wherein the disease is at least one disease selected from the group consisting of: non-alcoholic fatty liver disease (e.g., NASH), pain associated with inactivity, and acute pancreatitis, wherein the small silicon particles are the sole active agent.
Garcimartin published a study that was undertaken to study the what effects silicon has on preventing or treating nonalcoholic steatohepatitis (NASH) (see e.g., Title; Abstract). The study found that the inclusion of silicon in meat significantly alleviated and prevented the development of NASH (see e.g., Discussion; pp. 1108, 1112).
The Methods of the experiment disclose adding colloidal (nanoparticular) silicon dioxide to the restructured pork (RP) group (see pg. 1105; left col.), thereby meeting the limitations of claim 10.
The limitations of claim 9 are considered to be met since the compositional limitations of the claim are met (i.e., small particles of silicon) and they are administered as recited by claim 1.
Lastly, the limitations of claim 16 are considered to be met as the limitations of the claim are considered to carry the same scope as independent claim 1, despite the composition being recited as “consisting essentially of” silicon. See MPEP §2111.03(III). Therein it is stated that “[t]he transitional phrase ‘consisting essentially of’ limits the scope of a claim to the specified materials or steps ‘and those that do not materially affect the basic and novel characteristic(s)’ of the claimed invention.” Applicants’ originally-filed disclosure provides no discussion with relating this transitional phrase to the aforementioned characteristics. As such, “[f] or the purposes of searching for and applying prior art under 35 U.S.C. 102 and 103, absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, ‘consisting essentially of’ will be construed as equivalent to ‘comprising.’”
Therefore, the limitations of the instantly claimed method are considered to be met by the reference.
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 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.
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. Applicants are 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 1-11, 16, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Shimada et al. (WO 2019/235577 A1; IDS/ISR reference) in view of Garcimartin et al. (J Nutr; 2017), Powers et al. (J Appl Physiol; 2007), and Robles et al. (Pancreat Disord Ther; 2014).
The limitations of the claimed invention are discussed above.
Shimada discloses administering an agent that can prevent or treat a disease induced by oxidative stress (see e.g., Abstract; claim 1). Claim 1 further discloses that the administered agent contains silicon microparticles. The silicone microparticles are further defined as being capable of generating hydrogen upon contact with water (see e.g., claim 29) and as being either particles or aggregates of silicon microparticles (see e.g., claim 30). Claim 33 discloses that the particle diameter of the aggregates of silicon fine particles is 10 nm or more and 500 µm or less (or 10 nm to 500 µm). Claim 35 discloses that the silicon microparticles are porous silicon particles. Administration of the agent is disclosed as being silicon fine particles alone (aka consisting of). See e.g., ¶[0035] and ¶[0045].
The foregoing is considered to teach the positively recited limitations of the instantly claimed method and the administered composition of said method.
Where Shimada is deficient is with respect to the conditions being treated.
Overall, the reference is directed to preventing and treating diseases and conditions that are induced by oxidative stress. Though the reference does disclose preventing or treating generic hepatitis for instance (see e.g., claims 1, 2, and 7), it does not disclose preventing or treating nonalcoholic steatohepatitis. The reference is additionally deficient insomuch as it does not disclose preventing or treating sever acute pancreatitis or conditions such as pain associated with disuse atrophy.
Regarding the claims directed to preventing or treating NASH, the teachings of Garcimartin disclosed studying the effects of on preventing or treating nonalcoholic steatohepatitis (NASH) (see e.g., Title; Abstract). The study found that the inclusion of silicon in meat significantly alleviated and prevented the development of NASH (see e.g., Discussion; pp. 1108, 1112). The study also highlighted that NASH, the progressive form of nonalcoholic fatty liver disease, is characterized by steatosis that occurs with inflammation and oxidative stress with oxidative stress being involved in the development (see e.g., Introduction; and Discussion pg. 1109, right col., first full paragraph).
The Methods of the experiment disclose adding colloidal (nanoparticular) silicon dioxide to the restructured pork (RP) group (see pg. 1105; left col.), thereby meeting the limitations of claim 10.
Regarding the limitations pertaining to the treatable conditions recited by claims 4-6, Shimada, again, does not expressly teach or suggest treating or preventing pain associated with either muscle atrophy or joint contracture.
However, state-of-the-art disclosures such as Powers, discloses that there is evidence that conditions such as disuse muscle atrophy is caused by oxidative stress. Therein, the study concludes that inactivity-induced skeletal muscle atrophy can occur due to a variety of conditions, such as prolonged bed rest, and that there are several lines of evidence directly linking reactive oxygen species (ROS) to disuse muscle atrophy. One observation that is disclosed is that “evidence reveals that oxidative stress can inhibit protein synthesis in several cell types.” Coupled with the disclosure that oxidative stress being a key regulator of cell signaling pathways, leading to increased proteolysis and muscle atrophy during prolonged periods of disuse, the Examiner submits that there is clear correlation in the state-of-the-art between cause and effect (see e.g., Abstract; Conclusions and Unanswered Questions sections).
Thus, as Shimada discloses the use of compositions of silicon to prevent or treat conditions whose root cause is oxidative stress, the Examiner submits that in view of the added contributions of Powers that the ordinarily skilled artisan would also reasonably expect to be able to treat or prevent disuse muscle atrophy as instantly claimed.
Lastly, regarding the limitations of claims 7 and 8, Shimada, again, does not list acute or severe acute pancreatitis as conditions that are treated or prevented through the administration of its practiced silicon compositions. However, it does provide overall disclosure that conditions, at large, that are treated and prevented have ‘oxidative stress’ as their root cause.
Robles, like Garcimartin and Powers, is relied upon to demonstrate that there is a direct correlation between acute pancreatitis and severe acute pancreatitis (or severe AP). The reference discloses that “[o]xidative stress and its constant companion inflammation play critical roles in the pathogenesis of pancreatitis and its numerous complications” and that “[o]xidative stress is caused by a combination of increased production of reactive oxygen species (ROS) and impaired antioxidant capacity” (see pg. 2; first paragraph).
Thus, what each of Garcimartin, Powers, and Robles establish is that the instantly claimed conditions find direct cause from oxidative stress and that therapy can occur through the use of an antioxidant treatment or agent.
Though Shimada does not expressly disclose treating these conditions, it does lay the groundwork for doing so. Paragraph [0072], for instance states that:
“[o]ne of the mechanisms by which diseases caused by oxidative stress are prevented and/or treated is thought to be that the silicon microparticles of the present invention continue to generate hydrogen over a long period of time, and the generated hydrogen is transported into the blood and various organs, where it selectively reacts with hydroxyl radicals. Furthermore, the antioxidant capacity in the blood was improved, which is thought to be due to antioxidant substances produced in the blood.”
Thus, what is presented by the combination of the foregoing teachings is two-fold. One, the teachings of Shimada importantly establish that conditions in general (e.g., inflammatory conditions) that are caused by oxidative stress are preventable or treatable through the administration of the practiced silicon particle composition that is disclosed, owing to the antioxidative functionality of the composition. Secondly, by extension of this disclosure, other conditions that are known in the art and firmly established as being caused by oxidative stress will have a reasonable expectation of being minimally treatable (if not prevented) through the administration of an antioxidant composition. Garcimartin, Powers, and Robles each disclose these correlations.
Based on the combined teachings of the references, the Examiner submits that a person of ordinary skill in the art would have had a reasonable expectation of success at achieving the instantly recited methods of treatment. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, and absent a clear showing of evidence to the contrary.
All claims have been rejected; no claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Jeffrey T. Palenik whose telephone number is (571) 270-1966. The Examiner can normally be reached on 9:30 am - 7:00 pm; M-F (EST).
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Robert A. Wax can be reached on (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jeffrey T. Palenik/
Primary Examiner, Art Unit 1615