DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This is the first Office action on the merits of the claims.
All citations to the Manual of Patent Examining Procedure (MPEP) refer to Revision 01.2024, which was released in November 2024.
Status of the Claims
In the Preliminary Amendment filed 18 July 2024, Applicant amended claims 1-5 and added eleven new claims, i.e., claims 6-16. Accordingly, claims 1-16 are pending.
Claim Objections
Claims 1-16 are objected to because of the following informalities:
Regarding claims 1-16, under binomial nomenclature, the following scientific name must be italicized: Akkermansia muciniphila.
Regarding claim 5, the period is missing at the end of the claim. MPEP § 608.01(m) (“Each claim begins with a capital letter and ends with a period.”).
Regarding claims 12 and 13, the abbreviation “LPS” is not defined in either of those claims. As a courtesy, Applicant is referred to page 3 of the specification, which defines LPS as “lipopolysaccharide.”
Regarding claim 16, the word dementia in the following phrase is redundant and must be deleted: “Alzheimer’s disease dementia.”
Appropriate corrections are required.
Claim Rejections - 35 U.S.C. 112(a)
The following is a quotation of 35 U.S.C. 112(a):
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 1-16 are rejected under 35 U.S.C. 112(a) for lack of enablement.
The test of enablement is whether one skilled in the art could make and use the claimed invention from the disclosures in the specification coupled with information known in the art without undue experimentation (United States v. Telectronics, 8 USPQ2d 1217 (Fed. Cir. 1988)). MPEP § 2164.01. Whether undue experimentation is needed is not based upon a single factor but rather is a conclusion reached by weighing many factors. MPEP § 2164.01(a). These factors were outlined in In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988) and include the following: (1) the breadth of the claims; (2) the nature of the invention; (3) the state of the prior art; (4) the level of one of ordinary skill; (5) the level of predictability in the art; (6) the amount of direction provided by the inventor; (7) the existence of any working examples; and (8) the quantity of experimentation necessary needed to practice the claimed invention based on the content of the disclosure. MPEP § 2164.01(a).
There is no requirement in any of claims 1-16 that an effective amount of the platinum nanoparticles is administered. Applicant’s specification does not reasonably provide enablement for either (i) promoting growth of Akkermansia muciniphila or (ii) treating/preventing any of diseases, disorders, or conditions recited in claims 12, 14 and 16, respectively, by administering a negligible or otherwise ineffective amount of the platinum nanoparticles.
Furthermore, Applicant’s specification does not reasonably provide enablement for promoting growth of Akkermansia muciniphila in a living organism (e.g., human or other mammal) by administering the platinum nanoparticles by any route of administration other than oral administration. The specification refers oral administration only. No non-oral route of administration is exemplified or even discussed therein. Lengthy and substantial experimentation would have to be undertaken by persons having ordinary skill in the art to formulate, for example, a platinum nanoparticle composition that — following parenteral administration — would significantly interact with Akkermansia muciniphila in the digestive tract. This observation is especially relevant to claims 9-11.
In sum, a person having ordinary skill in the art could not practice the full scope of Applicant’s invention, as recited in claims 1-16, without first engaging in undue experimentation.
Claim Rejections - 35 U.S.C. 112(b)
The following is a quotation of 35 U.S.C. 112(b):
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.
Claims 1-16 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter that the inventor regards as the invention.
Regarding claim 1, the claim fails to identify to whom or to what the platinum nanoparticles are administered. For example, is the claim directed to a laboratory procedure that involves culturing Akkermansia muciniphila? If so, the claim must recite that the platinum nanoparticles are administered to the Akkermansia muciniphila. Alternatively, is the Akkermansia muciniphila present in the gastrointestinal system of a living organism, such as a human? If so, then the claim must recite that the platinum nanoparticles are administered to the human (or other living organism) and must specify a route of administration (e.g., oral) that results in the platinum nanoparticles entering the gastrointestinal system. The foregoing ambiguity renders claim 1, as well as claims 2-9 depending thereon, indefinite. MPEP § 2173.04 (“But a genus claim that could be interpreted in such a way that it is not clear which species are covered would be indefinite (e.g., because there is more than one reasonable interpretation of what species are included in the claim).”).
Regarding claim 9, it is unclear whether (and if so how) the following phrase further limits the method of claim 1: “wherein the method for growth of Akkermansia muciniphila is a method to grow Akkermansia muciniphila in an intestine.” Emphasis added. Does that phrase somehow further define the active (manipulative) step of “administering platinum nanoparticles” recited in claim 1? In the alternative, does it merely implicate the mental state of the person practicing the claimed invention, which is a non-limiting intended result? This ambiguity renders claim 9 indefinite.
Regarding claims 10, 13 and 15, the following phrase is unclear: “a person with low levels of Akkermansia muciniphila in an intestine microflora” (emphasis added). Persons having ordinary skill in the art can reasonably disagree over where the boundary lies between (i) low levels of Akkermansia muciniphila and (ii) levels of Akkermansia muciniphila that are not low. The examiner notes that the adjective <low> is not defined in the specification. Consequently, claims 10, 13, and 15 are indefinite. MPEP § 2173.05(b) (relative terminology). The examiner recommends that Applicant clarify the claims by incorporating the range recited in claim 11, which is “less than 1% of an amount of Akkermansia muciniphila in feces as a percentage of bacteria in the feces.”
Regarding claims 12-16, all these claims fail to identify to whom or to what the platinum nanoparticles are administered and, consequently, are unclear. Applicant is referred above to the §112(b) rejection of claim 1. Furthermore, the patient population is too poorly defined. Under these claims, is any patient a candidate for platinum nanoparticle therapy, regardless of medical status? For example, persons having ordinary skill in the art can reasonably disagree over who is in need of prevention of LPS leakage (claim 12) or neurodegenerative disease (claim 14) and, conversely, who is not. MPEP § 2173.04 (“a genus claim that could be interpreted in such a way that it is not clear which species are covered would be indefinite (e.g., because there is more than one reasonable interpretation of what species are included in the claim)”). This is due primarily to the fact that even relatively healthy people could potentially benefit from such acts of prevention. After all, isn’t everyone potentially in need of prevention of neurodegenerative disease, et cetera? If not, then what is the threshold or patient risk level required to trigger the administration of platinum nanoparticles pursuant to claims 12-16? This ambiguity renders claims 12-16 indefinite.
Claims directed to the treatment of a disease or other disorder are typically drafted in the following format, where [D] is the disease/disorder to be treated, [S] is the subject (e.g., human or other mammal), and [M] is the medication: “A method of treating [D] in a [S] in need thereof comprising administering to the [S] an effective amount of [M].” Applicant is advised that if a particular locus of the living organism is targeted for delivery of the medication, this is accomplished by including claim language defining the route of administration.
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Claim Rejections - 35 U.S.C. 102 / 103
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.
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(a) 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.
Claims 1, 9, 12, 14, and 16 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as unpatentable over Miyamoto (US 2007/0141173 A1), as evidenced by Iwaza (“Akkermansia muciniphila: The state of the art, 18 years after its first discovery.” Frontiers in Gastroenterology 1 (2022): 1024393).
Miyamoto is directed to “a medicament comprising noble metal fine particles for prophylactic and/or therapeutic treatment of a neurodegenerative disease such as amyotrophic lateral sclerosis, rheumatic disease, ischemic heart disease, stress ulcer, dermatitis, arteriosclerosis and hyperlipidemia.” (Emphasis added) Para. [0001].
Miyamoto discloses that, most preferably, “the fine particles of a noble metal consist of platinum colloid having a mean particle size of 10 nm or smaller.” (Emphasis added) Para. [0014]; see also para. [0020] (“platinum is particularly preferred”); para. [0021] (“a mean particle size of, preferably 20 nm or smaller, further preferably 10 nm or smaller, most preferably about 1 to 6 nm, can be used”); and page 8 at claims 13-14 (requiring that platinum is the noble metal).
Miyamoto discloses that the platinum colloid is orally administered to humans or other mammals in the form of an aqueous suspension, such as a soft drink. Paras. [0015], [0033].
Miyamoto discloses that the platinum colloid can be administered to treat/prevent Alzheimer’s disease, Parkinson’s disease, and rheumatoid arthritis. Paras. [0013], [0058]; see also page 8 at claims 3 and 5.
Therefore, claims 14 and 16 are anticipated by Miyamoto.
Regarding claim 12, Miyamoto discloses that the platinum colloid can be orally administered to treat/prevent stress ulcers, including peptic ulcers, such as gastric stress ulcer or duodenal stress ulcers. Paras. [0013], [0029], [0058]; see also page 8 at claims 8-9. Treating a duodenal ulcer, which is a disruption to the surface of the mucosa of the duodenum (the first part of the small intestine), assists in restoring normal intestinal permeability at (and proximate to) the ulcer. This provides a sound basis for the examiner’s position that the method of Miyamoto inherently “improves an intestinal environment” (claim 12). MPEP § 2112.02(I) (“Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device.”). Additionally, Applicant is alerted that “[m]ere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention.” MPEP § 2145(II). In sum, claim 12 is anticipated or rendered prima facie obvious by Miyamoto. MPEP § 2112(III) (“Where applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, the examiner may make a rejection under both 35 U.S.C. 102 and 103.”).
Regarding claims 1 and 9, Iwaza evidences: “A. muciniphila is a common bacterial component of the human intestinal tract. A study by Collado et al. found that the presence of A. muciniphila presence increases from 16% of the samples of one-month-old infants to 90% at 12 months, while it is present in all the adult samples. Similarly, levels also increase in early life to reach levels similar to that observed in adults within a year. On the other hand, this level decreases significantly in the elderly.” Page 03, left column. Thus, Iwaza establishes that Akkermansia muciniphila is omnipresent in the digestive tract of humans. Accordingly, the method of Miyamoto, which involves orally administering platinum nanoparticles to treat ulcers in the digestive tract, inherently promotes the growth of the Akkermansia muciniphila “in an intestine” (claim 9). Applicant is referred to MPEP § 2112.02(I) (quoted above). Additionally, Applicant is alerted that recognizing another advantage that flows naturally from following the suggestion of the prior art (Miyamoto) cannot be the basis for patentability when the differences would otherwise be obvious. MPEP § 2145(II), citing Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). In sum, claim 9 is anticipated or rendered prima facie obvious by Miyamoto. MPEP § 2112(III) (quoted above).
Claim Rejections - 35 U.S.C. 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(a) 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.
Claims 2-8 are rejected under 35 U.S.C. 103 as being unpatentable over Miyamoto (US 2007/0141173 A1), as applied above in the §102/§103 rejection of claims 1, 9, 12, 14 and 16, in view of Kato (“Colloidal platinum in hydrogen-rich water exhibits radical-scavenging activity and improves blood fluidity.” J. of Nanoscience and Nanotechnology 12.5 (2012): 4019-4027).
Miyamoto is discussed above in the §102/§103 rejection of claims 1, 9, 12, 14 and 16. That discussion is incorporated by reference into this §103 rejection.
Although Miyamoto discloses that the colloidal platinum is in an aqueous suspension (para. [0033]), Miyamoto is silent as to whether the water can be electrolyzed. For this reason, Miyamoto does not satisfy claims 2-8. As explained below, Kato compensates for this deficiency.
Kato is directed to colloidal platinum in hydrogen-rich water.
Kato teaches that the hydrogen-rich water (HW) “was prepared by electrolyzing reversed-osmosis ultrapure water of 1.0 L containing 0.5 mM NaHCO3.” Page 4020 at Section 2.1 (emphasis added).
Kato teaches: “Many studies have reported that hydrogen-rich water (HW), which is saturated with approximately 0.8 mM of molecular hydrogen, can exert beneficial effects in reducing of dopaminergic neuronal loss in mice of Parkinson’s disease model or treating of metabolic syndrome. Drinking of HW raises the concentration of hydrogen in blood, which results in antioxidant effect in brain, myocardium or small intestine, etc. However, hydrogen in HW could not be dissolved in an aqueous media so stably but easily lost in the atmosphere with timelapse. Therefore, it has been a subject to hold dissolved-hydrogen in the media and extend the duration of antioxidant effect of HW.” Page 4020, left column (emphasis added).
Kato teaches that adding colloidal platinum to the HW mitigates the hydrogen stability problem, thereby prolonging the advantageous antioxidant effect of the HW. Page 4024 at Section 3.2 (“The enhanced antioxidant activity of Pt/PVP-colloid in HW has mainly been attributed to the ability of platinum to form adducts with hydrogen, which is a remediation of the drawback of HW that is dissolved-hydrogen is easy to be lost gradually (Fig. 1).”); see also Abstract (“The results could be mainly attributed to the enhanced antioxidant activity of Pt/PVP in HW, which may be due to captured-hydrogen on platinum.”).
Before the effective filing date of the claimed invention, the teachings of Kato would have motivated a person having ordinary skill in the art to modify Miyamoto by substituting hydrogen-rich water (HW) for conventional water, in an effort to yield a colloidal platinum formulation that is even more effective in treating Parkinson’s disease and/or disorders of the small intestine. The foregoing modification would have been made with a reasonable expectation of success, especially considering Kato teaches that (i) administration of HW reduces neuronal loss in mice afflicted with Parkinson’s disease and (ii) colloidal platinum stabilizes HW. Therefore, claim 2 is prima facie obvious.
Regarding claims 3-8, Miyamoto teaches “a mean particle size of, preferably 20 nm or smaller, further preferably 10 nm or smaller, most preferably about 1 to 6 nm, can be used.” Para. [0021]. Additionally, Miyamoto teaches colloidal platinum concentrations of 6.6 nM, 0.066 µM, 0.5 µM, and 0.66 µM. Paras. [0038]-[0039] at Examples 2-3. The examiner refers Applicant to MPEP § 2144.05(I) (obviousness of similar and overlapping ranges, amounts, and proportions). Furthermore, the composition recited in the body of claim 5 is defined by its method of manufacture and does not result in a structural difference over the applied prior art (Miyamoto in view of Kato). MPEP § 2113(I) (“product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps”).
Additional Remarks
A search of the relevant art revealed no prior art reference, or combination of prior art references, that would have adequately supported a rejection of claims 10-11, 13, or 15 under either 35 U.S.C. 102 or 35 U.S.C. 103. References considered for this purpose include those listed on the PTO-892 that accompanies this Office action. There is no recognition in the prior art that the administration of platinum nanoparticles either (i) encourages colonization by Akkermansia muciniphila or (ii) modulates the growth of Akkermansia muciniphila.
* * *
Conclusion
Claims 1-16 are rejected.
Claims 1-16 are also objected to.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER ANTHOPOLOS whose telephone number is 571-270-5989. The examiner can normally be reached on Monday – Friday (9:00 am – 5:00 pm). If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany P. Barham, can be reached on Monday – Friday (9:00 am – 5:00 pm) at 571-272-6175. The fax number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P.A./
25 June 2026
/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
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