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 .
Claims Status
Applicant’s election of oral administration without traverse in the reply filed on 01/30/2026 is acknowledged. Examiner notes that although applicants did not elect type of silver particles and administration and blood cell type (species A-C), these species are currently withdrawn.
Claims 1-20 are under current examination directed to oral (i.e. ingestion) of silver particles.
Information Disclosure Statement
No information Disclosure has been filed. Applicants are reminded of their duty to disclose.
Claim Rejections 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is not supported by either a specific and substantial asserted utility or a well-established utility.
The claims are directed to a method which comprises facilitating daily ingestion of silver particles to a subject to protect blood cells in the subject.
The claims do not provide for the utility. A "specific utility" is specific to the subject matter claimed and can "provide a well-defined and particular benefit to the public." In re Fisher, 421 F.3d 1365, 1371, 76 USPQ2d 1225, 1230 (Fed. Cir. 2005). This contrasts with a general utility that would be applicable to the broad class of the invention. Office personnel should distinguish between situations where an applicant has disclosed a specific use for or application of the invention and situations where the applicant merely indicates that the invention may prove useful without identifying with specificity why it is considered useful. For example, indicating that a compound may be useful in treating unspecified disorders, or that the compound has "useful biological" properties, would not be sufficient to define a specific utility for the compound. See, e.g., In re Kirk, 376 F.2d 936, 153 USPQ 48 (CCPA 1967); In re Joly, 376 F.2d 906, 153 USPQ 45 (CCPA 1967). Here, a claim to ingestion a naturally occurring compound to silver particles for protection of blood cells would not be considered specific. Indicating that the silver particles ingestion is performed to protect blood cells is a situation where applicant merely indicates the useful properties of applying the composition. The claimed ingestion of silver particles is not treating any particular condition rather, the claimed silver particles is merely ingested and upon ingestion happens to have protection of blood cells.
Applicant has only disclosed general use for the silver particles not specific ones that satisfy 101. See In re Fisher, 421 F.3d at 1374, 76 USPQ2d at 1232 and Knapp v. Anderson, 477 F.2d 588, 177 USPQ 688 (CCPA 1973). With regards to substantial utility, "[A]n application must show that an invention is useful to the public as disclosed in its current form, not that it may prove useful at some future date after further research. Simply put, to satisfy the ‘substantial’ utility requirement, an asserted use must show that the claimed invention has a significant and presently available benefit to the public." Fisher, 421 F.3d at 1371, 76 USPQ2d at 1230.
The claims require ingestion of silver particles however the claims do not meet the three-pronged requirement of 35 U.S.C. § 101 regarding utility, namely, that the asserted utility be credible, specific and substantial. Silver particles are a naturally occurring product. As evidenced by Public Health Statement for Silver, silver is naturally found in the environment including which includes soils. Merely ingesting naturally occurring substances where they protect blood cells after ingestion is not a specific or substantial utility.
See Brenner v. Manson, 148 U.S.P.Q. 689 (Sus. Ct, 1966), wherein the court held that:
''The basic quid pro quo contemplated by the Constitution and the
Congress for granting a patent monopoly is the benefit derived by
the public from an invention with substantial utility'', ''[u]nless and
until a process is refined and developed to this point-where specific
benefit exists in currently available form-there is insufficient
justification for permitting an applicant to engross what may prove
to be a broad field'', and ''a patent is not a hunting Iicense'', ''[I]t is
not a reward for the search, but compensation for its successful
conclusion.''
Thus, the generic application of silver particles by ingestion and characterizing the biological property of protecting blood cells is not considered a credible specific and substantial utility for the method. As the claims encompass application of a natural product without specific utility, the claimed invention is not supported by either a specific and substantial asserted utility or a well-established utility.
Claim Rejections - 35 USC § 112- Enablement
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. The instant claims recite protection of blood cells and raising or maintaining both white and red blood cells with the silver particles claimed. The specification, does not provide enablement for ingestion of silver particles to a subject daily for protection of blood cells before or after chemo and wherein red or white cells are maintained. The specification does not enable a person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention without undue experimentation. MPEP 2164.01(a), citing In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), sets out the factors to consider whether experimentation is undue, which include:
The nature of the invention
Claim 1 is drawn to a method, comprising: providing a compound comprising silver (Ag) particles to a subject; and facilitating daily ingestion of the compound by the subject, wherein providing the compound to the subject and facilitating daily ingestion of the compound by the subject is performed to protect blood cells in the subject. Ingestion is the elected oral administration.
Claim 10 recites wherein providing the compound to the subject and facilitating ingestion of the compound by the subject is performed in response to the subject preparing for chemotherapy.
Claim 11 recites wherein providing the compound to the subject and facilitating ingestion of the compound by the subject is further performed in response to the subject currently receiving chemotherapy.
Claim 12 recites the method of claim 1, wherein providing the compound to the subject and facilitating ingestion of the compound by the subject is performed in response to the subject currently receiving chemotherapy.
Claim 13 recites the method of claim 1, wherein protecting the blood cells in the subject comprises at least one of raising and maintaining a count of blood cells in the subject.
Claim 14 recites the method of claim 13, wherein the count of blood cells in the subject comprises a count of white blood cells.
Claim 15 recites the method of claim 13, wherein the count of blood cells in the subject comprises a count of red blood cells.
Claim 16 recites the method of claim 13, wherein the count of blood cells in the subject comprises a first count of white blood cells and a second count of red blood cells.
Thus, the nature of the invention is drawn to protection of both red and white blood cells before and during chemo. The red or white blood cells are maintained or raised after administration of silver particles.
The breadth of the claims and amount of direction provided by the inventor.
The nature of the invention is drawn to protection of both red and white blood cells before and during chemo. The red or white blood cells are maintained or raised after administration of silver. The specification states that the silver compound includes silver which may be ingested by any suitable method including ones that are developed in the future (paragraphs 0413 and 0171). The specification does not provide any examples wherein a subject has maintained or increased both white and red blood cells after ingestion of silver particles before or undergoing chemotherapy, nor does the instant specification provide any examples wherein all blood cells are maintained, increased or protected by ingestion of silver particles.
The level of predictability in the art.
Chen et al. (Nanotoxicity of Silver nanoparticles to Red Blood Cells: Size Dependent Absorption, Update and Hemolytic Activity) teaches small sized AgNPs15 displayed a greater ability to induce hemolysis and membrane damage than AgNPs50 and AgNPs100. The cytotoxicity induced by AgNPs is attributed to the direct interaction of the nanoparticle with the RBCs, resulting in the production of oxidative stress, membrane injury, and subsequently hemolysis. Particle size is also a critical factor in influencing interaction with red blood cells, see abstract. Silver nanoparticles induces hemolysis, see discussion.
Ferdous et al. (Health Impact of Silver Nanoparticles: A review of the Biodistribution and Toxicity following Various Routes of Exposure) teach that oral exposure to AgNPs may lead to liver, intestinal and neuronal damage. Cases of argyria (a condition characterized by an irreversible gray or bluish gray pigmentation of the skin), irreversible neurologic toxicity, and death have been reported upon the long-term ingestion of colloidal silver, see in vitro toxicity section. The liver appears to be a major accumulation site of circulatory AgNPs. PVP-AgNPs (20–30 nm) have been shown to increase oxidative stress, enhance autophagy, and deplete insulin signaling pathways following oral exposure for 90 days in the liver of male rats. Changes in blood parameters indicated by a significant elevation of ALT, AST, and hepatoxicity, shown by histological damages (necrosis, hepatocytic inflammation, and the resultant aggregation of lymphocytes in liver tissue) were also observed in a study that evaluated the toxic effect of 14 days of oral exposure to AgNPs (40 nm) at doses 20 and 50 ppm in BALB/C mice, see in vitro toxicity section. Thus, Ferdous also teaches that silver nanoparticles are toxic after being ingested and can turn the skin blue.
Mayo Clinic (Consumer health) teaches that little research has been done to study the health claims of ingesting colloidal silver with the FDA even acting against some manufacturers and that it is not entirely clear how much colloidal silver you can take before it becomes harmful as it can build up in the body tissue over months. Taking too much can cause argyria, kidney damage or even seizures.
Mayo Clinic (Low Blood Cells counts: side effects of cancer treatment) teaches that chemotherapy kills many of the cells in the bone marrow and that radiation therapy can cause low levels of red and white blood cells.
Kassie et al. (Differences in the count of blood cells pre and post chemotherapy in patients with cancer: a retrospective study 2022) teach that both white and red blood cells are reduced after chemotherapy, see section 3.4.
There is no evidence in the art that silver protects blood cells from destruction.
Synder et al. teach that despite anecdotal claims there is no scientific evidence that colloidal silver can support cancer treatment, see page 1. The risk of using silver products exceeds any unsubstantiated benefit with no approved oral drugs containing colloidal silver.
The quantity of experimentation needed to make or use the invention
Because of the known unpredictability in the art, and the absence of experimental evidence, the instantly claimed method of protecting cells one skilled in the art
could not practice the invention with the full scope of the claims without undue experimentation. Overall, the status of the art is such that silver nanoparticles and colloidal silver may not be safe to consume and causes cytotoxicity to blood cells. There is very little research on the health benefits of silver coupled with the absence of experimental research, it appears that silver may actually be toxic to blood cells rather than protective. Furthermore, chemotherapy is known to destroy both red and white blood cells and there is no indication that ingesting silver will in fact protect cells during chemotherapy. The art further specifics that there is no scientific evidence that supports silver for treatment of cancers, thus the art does not support treating with or before chemotherapy. Furthermore, the increase in blood cells cannot reliably be attributed to silver as there is very little research to support the effects of silver. Accordingly, the ingestion of silver particles to protect blood cells lacks enablement.
Conclusion
No claims are allowed and claims 1-20 are rejected.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH ALAWADI whose telephone number is (571)270-7678. The examiner can normally be reached Monday-Friday 10:00am-6:30pm EST.
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/SARAH ALAWADI/Primary Examiner, Art Unit 1619
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