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
Claims 1-20, as originally filed on 11 September 2023, are pending and under consideration.
Claim Objections
Claims 4, 8-9, and 15 are objected to because of the following informality: The use of fractions in connection with pharmaceutical dosages in unconventional in patent claims. Applicant is required to convert the fractions to decimals. For example, “about 1/300,000 mg” should be converted to “about 0.0033 µg” or “about 3.3 nanograms.”
Claim Rejections – “Use” Claims
Claims 17-20 are respectively directed to either (i) “Use of a treatment composition in a drug or other treatment composition, for treatment of Long Covid, other post-viral, or other post-infection conditions” (claims 17-18) or (ii) “Use of a treatment composition to interfere with the metabolism of COVID-19 or other viruses” (claims 19-20). Emphasis added. However, the claims do not set forth any steps involved in the method/process. It is unclear what method/process Applicant is intending to encompass. Consequently, claims 17-20 are indefinite under 35 U.S.C. 112(b) because they merely recite a use without any active, positive steps delimiting how this use is actually practiced. MPEP § 2173.05(q).
Claims 17-20 are additionally rejected under 35 U.S.C. 101 because the claimed recitation of a use, without setting forth any steps involved in the process, result in an improper definition of a process, i.e., result in claims that are not proper process claims under 35 U.S.C. 101. MPEP § 2173.05(q), citing Ex parte Dunki, 153 USPQ 678 (Bd.App. 1967) and Clinical Products, Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966).
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 1-20 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).
First, the scientific literature discloses no compound having either the following empirical or molecular formula: C9H2N2. The extremely low carbon-to-hydrogen ratio indicates an unusually high degree of unsaturation, perhaps due to multiple rings. The presence of two nitrogen atoms suggests a unique, possibly reactive, structure. Combining these two features (low hydrogen count and two nitrogen atoms) makes it difficult to form a stable, neutral molecule. While a theoretical or highly reactive intermediate (or other transient chemical species) might exist with that formula, there is no compound of that formula stable enough to formulate, let alone administer to a patient to treat a disease or other condition. The specification of the present application provides no guidance whatsoever on how to synthesize a compound having formula C9H2N2. The specification — like the scientific literature — does not include a relevant working example. Based on the scientific literature and the content of Applicant’s disclosure, a high quantity of experimentation is necessary to practice the claimed invention involving C9H2N2. On the basis of the foregoing observations, undue experimentation would be required to practice any claim reciting the formula C9H2N2. For this reason, claims 1-20 are rejected under 35 U.S.C. 112(a).
Second, there is no requirement in any of claims 5-16 that an effective amount of the treatment composition is administered to the subject. Applicant’s specification does not reasonably provide enablement for treating Long Covid (or other post-infection condition) by administering a negligible or otherwise ineffective amount of the treatment composition. Additionally, the examiner notes that the ranges recited in claims 8-9 and 15 collectively encompass the simultaneous selection of negligible amounts of each of the recited active agents. In sum, a person having ordinary skill in the art could not practice the full scope of Applicant’s invention, as recited in claims 5-16, 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 1-20 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 inventors regard as the invention.
Regarding claims 1, 4-5, 8-9, 12, 15, 17 and 19, the following three limitations are unclear: “C29H40N2O4”, “C9H2N2”, and “C28H38N2O4”. Are these empirical formulas or molecular formulas? Furthermore, what are the bond types and spatial arrangement of the various elements in these compounds? This lack of clarity renders the foregoing claims and all claims depending thereon indefinite. A structural formula corresponding to each of those three compounds is required to overcome this rejection. The examiner additionally notes that the second formula (C9H2N2) conflicts with the structural formula set forth on page 11 (para. [0048]) of the specification, which has only one nitrogen atom, thereby causing additional confusion.
Regarding claims 1, 5, and 17, the following phrase is unclear: “or other post-viral or other post-infection conditions that result in a toxin induced thickened blood pulp condition.” What is a toxin-induced thickened blood pulp condition? This is an unconventional phrase, and no protocol for reliably diagnosing a toxin-induced thickened blood pulp condition is included in the specification. Accordingly, persons having ordinary skill in the art can reasonably differ over which patients qualify as having a toxin-induced thickened blood pulp condition and, conversely, which patients do not. 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).”). In the interest of compact prosecution, the examiner notes that the phrase “post-viral or other post-infection condition,” even when taken alone, is unclear. Id.
Regarding claims 5 and 12, does the patient actually have to have Long Covid or other post-infection condition to satisfy these claims? Alternatively, is it sufficient to merely exhibit symptoms of Long Covid or other post-infection condition? The examiner recommends clarifying claims 5 and 12 by amending the preamble to read in the following format: “A method of treating [insert disease or condition here] in a patient in need thereof.” For example, the preamble of a claim directed to the treatment of Long Covid would read as follows: “A method of treating Long Covid in a patient in need thereof.”
Regarding claim 10, the verb “used” is unclear in this context. Does this mean that the patient has Long Covid?
Regarding claim 11, the verb “used” is unclear in this context. Does this mean that the patient has a post-viral infection condition associated with influenza, zika, herpes, or epstein-barr viruses? Moreover, persons having ordinary skill in the art can reasonably differ over which conditions qualify as “a post-viral infection condition associated with influenza, zika, herpes, or epstein-barr viruses” and, conversely, which conditions do not. MPEP § 2173.04 (quoted above).
Regarding claim 16, the following functional limitation is unclear: “the components thereof have a molecular or particle size sufficiently small so as to not induce vomiting.” There is no consensus among persons having ordinary skill in the art regarding the foregoing molecular or particle size range, and the specification does not provide any relevant guidance. Consequently, claim 16 is indefinite. MPEP § 2173.05(g) (“the use of functional language in a claim may fail ‘to provide a clear-cut indication of the scope of the subject matter embraced by the claim’ and thus be indefinite”).
Regarding claim 19, COVID-19 is the disease caused by the coronavirus SARS-CoV-2. COVID-19 does not have a metabolism. Does Applicant mean the metabolism of SARS-CoV-2?
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 5, 10, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Schelling (WO 2021/195521 A1) in view of Davis (“Long COVID: major findings, mechanisms and recommendations.” Nature Reviews Microbiology 21.3 (2023): 133-146).
Schelling is directed to “methods for treating a viral infection caused by a coronavirus (such as SARS-Co V-2) and coronavirus diseases, such as COVID-19.” Abstract.
Schelling discloses “methods of treating COVID-19 in a subject in need thereof, comprising administering a therapeutically effective amount of emetine, or a pharmaceutically acceptable salt thereof.” Para. [0009]. As evidenced by page 10 (para. [0044]) of the specification of the present application, emetine is a species of “C29H40N2O4” compound. The examiner notes that the chemical structure of emetine set forth on page 7 (para. [0034]) of Schelling matches the corresponding chemical structure set forth on page 10 of the present specification.
Although Schelling discloses that emetine can be administered to treat COVID-19, it is silent regarding Long Covid and, consequently, fails to satisfy claim 5 of the present application. As explained below, Davis compensates for this deficiency.
Davis is directed to “Long COVID: major findings, mechanisms and recommendations.” Title.
Davis teaches: “Long COVID (sometimes referred to as ‘post-acute sequelae of COVID-19’) is a multisystemic condition comprising often severe symptoms that follow a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.” Page 134, left column.
Davis teaches: “There are likely multiple, potentially overlapping, causes of long COVID. Several hypotheses for its pathogenesis have been suggested, including persisting reservoirs of SARS-CoV-2 in tissues; immune dysregulation with or without reactivation of underlying pathogens, including herpesviruses such as Epstein–Barr virus (EBV) and human herpesvirus 6 (HHV-6) among others; impacts of SARS-CoV-2 on the microbiota, including the virome; autoimmunity and priming of the immune system from molecular mimicry; microvascular blood clotting with endothelial dysfunction; and dysfunctional signalling in the brainstem and/or vagus nerve17,32 (Fig. 3).” (Emphasis added) Page 134, left column.
Davis teaches: “Several reports have pointed towards possible viral persistence as a driver of long COVID symptoms; viral proteins and/or RNA has been found in the reproductive system, cardiovascular system, brain, muscles, eyes, lymph nodes, appendix, breast tissue, hepatic tissue, lung tissue, plasma, stool and urine. In one study, circulating SARS-CoV-2 spike antigen was found in 60% of a cohort of 37 patients with long COVID up to 12 months after diagnosis compared with 0% of 26 SARS-CoV-2-infected individuals, likely implying a reservoir of active virus or components of the virus. Indeed, multiple reports following gastrointestinal biopsies have indicated the presence of virus, suggestive of a persistent reservoir in some patients.” (Emphasis added) Page 135, left column.
Before the effective filing date of the claimed invention, the foregoing teachings of Davis would have motivated a person having ordinary skill in the art to modify Schelling by administering an effective amount of emetine to a patient suffering from Long COVID. The foregoing modification would have been made in view of (i) the fact that Davis identifies persisting reservoirs of SARS-CoV-2 as a potential cause of Long COVID, while (ii) Schelling discloses that emetine is effective against SARS-CoV-2 (para. [0008]). Therefore, claims 5 and 10 are prima facie obvious.
Regarding claim 11, Davis discloses: “Reactivated viruses, including EBV [Epstein–Barr virus] and HHV-6 [human herpesvirus 6], have been found in patients with long COVID (and have been identified in ME/CFS), and lead to mitochondrial fragmentation and severely affect energy metabolism. A recent preprint has reported that EBV reactivation is associated with fatigue and neurocognitive dysfunction in patients with long COVID.” Page 134, right column; see also page 137 at Figure 3. Accordingly, Long COVID qualifies as a post-viral infection condition associated with herpes or Epstein-Barr. MPEP § 2111 (“During patent examination, the pending claims must be ‘given their broadest reasonable interpretation consistent with the specification.’”).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Schelling in view of Davis, as applied above to claims 5 and 10-11, and further in view of Islam (“Dietary supplements, vitamins and minerals as potential interventions against viruses: Perspectives for COVID-19.” Int’l Journal for Vitamin and Nutrition Research, vol. 92, no. 1, Jan. 2022, pp. 49-66) and Straub (“Calcium supplementation in clinical practice: a review of forms, doses, and indications.” Nutrition in clinical practice 22.3 (2007): 286-296).
Schelling and Davis are silent regarding calcium, such as calcium carbonate (CaCO3). Consequently, they do not satisfy claim 6. As explained below, the following two references compensate for this deficiency: Islam and Straub.
Islam is directed to: “Dietary supplements, vitamins and minerals as potential interventions against viruses: Perspectives for COVID-19.” Title.
Islam teaches that minerals inhibit viral replication and/or exert a positive immunomodulatory effect. Page 51 at Figure 1. Thereafter, Islam identifies calcium as an exemplary mineral. Page 57.
Straub is directed to calcium supplementation in clinical practice. Title.
Straub teaches that “[c]alcium carbonate is the most common and least expensive form of calcium.” Page 290, right column.
Straub teaches: “In summary, calcium carbonate is well-absorbed and tolerated in most individuals when taken with a meal. Calcium carbonate supplements provide greater amounts of elemental calcium and consequently require fewer tablets than other forms of calcium.” Page 290, right column.
Before the effective filing date of the claimed invention, a person having ordinary skill in the art would have been motivated to co-formulate (i) emetine and (ii) calcium carbonate, as part of an effort to develop a treatment for Long COVID that is especially effective. MPEP § 2144.06(I) (“‘It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.’”), quoting In re Kerkhoven, 626 F.2d 846, 850 (CCPA 1980).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Schelling in view of Davis, as applied above to claims 5 and 10-11, and further in view of Tosato (“Nutraceuticals and dietary supplements for older adults with long COVID-19.” Clinics in geriatric medicine 38.3 (2022): 565-591) and Baumgartner (“Iron from nanostructured ferric phosphate: absorption and biodistribution in mice and bioavailability in iron deficient anemic women.” Scientific Reports 12.1 (2022): 2792).
Schelling and Davis are silent regarding iron, such as ferric phosphate (FePO4). Consequently, they do not satisfy claim 7. As explained below, the following two references compensate for this deficiency: Tosato and Baumgartner.
Tosato is directed to: “Nutraceuticals and Dietary Supplements for Older Adults with Long COVID-19.” Title.
Tosato teaches: “[L]ow-iron levels could theoretically impair the efficacy of COVID-19 vaccination, underlining the importance of monitoring iron levels, especially in older adults with long COVID.” Page 569.
Tosato teaches: “Based on the available evidence, iron supplementation, especially in older adults with low iron and hemoglobin levels, could be particularly useful for reducing the level of inflammation, mitigating persistent symptoms (such as fatigue and dyspnea), and improving immune response to vaccination. Page 569.
Baumgartner is directed to iron from nanostructured ferric phosphate. Title.
Baumgartner teaches that “absorption of iron from FePO4-NP [nanoparticles] appears to be largely DMT1 dependent and that its biodistribution after absorption is similar to that from FeSO4, without abnormal deposition of iron in the reticuloendothelial system.” Abstract.
Baumgartner teaches FePO4 nanoparticles demonstrate high bioavailability and may be useful for nutritional applications. Abstract.
Before the effective filing date of the claimed invention, a person having ordinary skill in the art would have been motivated to co-formulate (i) emetine and (ii) FePO4 nanoparticles, as part of an effort to develop a treatment for Long COVID that is especially effective. MPEP § 2144.06(I) (“‘It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.’”), quoting In re Kerkhoven, 626 F.2d 846, 850 (CCPA 1980).
Conclusion
Claims 1-20 are rejected.
Claims 4, 8-9, and 15 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./
13 November 2025
/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611