The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Claims 1-8, 17 and 23-24 are presented for examination.
Acknowledgement is made of the instant application as a National Stage (371) entry of PCT Application No. PCT/US2021/038706, filed June 23, 2021, which claims benefit under 35 U.S.C. §119(e) to U.S. Provisional Patent Application No. 63/046,846, filed July 1, 2020.
Requirement for Restriction/Election
Applicant’s election with traverse of the invention of Group II (claims 1-8), directed to a method for preventing, inhibiting or treating viral infections or their physiological immune-related sequelae caused by single-stranded RNA viruses in a subject in need thereof comprising administering parenterally to the subject an amount of a chelate of zinc and L-carnosine effective to treat or to prevent infections associated with said single-stranded viruses in cells in said subject, and the election of L-anserine as the single disclosed species of second zinc ionophore, to which examination on the merits will be confined, as stated in the reply filed November 18, 2025, is acknowledged by the Examiner.
Applicant traverses the requirement for restriction/election on the grounds that “the combinations of carnosine and zinc (e.g., the zinc L-carnosine chelate of Applicant) exhibit synergistic antiviral activity through multiple independent mechanisms of viral inactivation” (Remarks, p.5). Applicant alleges that “[t]he common feature of the species cited in claim 8 is the ability of each named compound to form stable chelates with zinc ion, said chelates having significantly enhanced cell interaction and penetration” (Remarks, p.5).
Applicant’s traversal has been fully and carefully considered, and is considered persuasive.
As a result, the required election of a single disclosed species of second zinc ionophore is hereby withdrawn.
All other required elections remain in effect.
Therefore, for the reasons above and those made of record at p.2-8 of the Office Action dated September 23, 2025, the requirement remains proper and is hereby made FINAL.
Claims 17 and 23-24 are withdrawn from consideration pursuant to 37 C.F.R. §1.142(b) as being directed to non-elected subject matter.
The claims that are drawn to the elected invention are claims 1-8 and such claims are herein acted on the merits infra.
Listing of References in the Specification
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by Applicant on the Information Disclosure Statement filed April 5, 2024 or by the examiner on the attached form PTO-892, they have not been considered.
Information Disclosure Statement
Applicant’s Information Disclosure Statement filed April 5, 2024 (five pages total) has been received and entered into the present application. As reflected by the attached, completed copy of form PTO-1449, the Examiner has considered the cited references.
Priority
Acknowledgement is made of the instant application as a National Stage (371) entry of PCT Application No. PCT/US2021/038706, filed June 23, 2021, which claims benefit under 35 U.S.C. §119(e) to U.S. Provisional Patent Application No. 63/046,846, filed July 1, 2020. The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original non-provisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. §112(a) or the first paragraph of pre-AIA 35 U.S.C. §112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the ‘846 provisional application appears to provide adequate written support and/or enabling guidance in the manner set forth under 35 U.S.C. §112(a) or the first paragraph of pre-AIA 35 U.S.C. §112 for the claimed subject matter under examination. As such, Applicant’s claims 1-8 are entitled to the benefit of the effective filing date of this earlier-filed ‘846 provisional application.
Accordingly, the effective filing date of claims 1-8 is July 1, 2020 (the filing date of the ‘846 provisional application).
The Examiner will revisit the issue of priority as necessary each time the claims are amended.
Objections to the Claims
Claim 1 is objected to for misspelling the term “sequelae”.
Appropriate correction is required.
Claim 1 is also objected to for reciting “an amount of chelate of zinc and L-carnosine”, which is grammatically awkward.
Appropriate correction is required.
Applicant may wish to consider amending the claim to recite ---an amount of zinc L-carnosine chelate--- to remedy the instant objection, but is reminded that the adoption of such suggestion does not necessarily equate to the obviation of any other objection and/or rejection set forth infra.
Claim 7 is objected to for failing to conclude with a period.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b) (Pre-AIA Second Paragraph)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
(1) Claims 1-8 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Applicant’s claim 1 recites “[a] method for preventing, inhibiting or treating viral infections or their physiological immune-related sequellae [sic] caused by single-stranded RNA viruses”.
It is unclear what “sequelae” of single-stranded RNA viruses are considered “physiological” and “immune-related” as claimed. Applicant fails to set forth whether the claim circumscribes any “sequelae” of single-stranded RNA viruses, or only specific “sequelae” of single-stranded RNA viruses that are considered “immune-related” (in which case the claim is additionally indefinite for failing to clearly identify the specific viral effects that are included within, or excluded from, the metes and bounds of this limitation).
Clarification is required.
Applicant’s claim 1 recites a step of “administering parenterally to the subject an amount of chelate of zinc and L-carnosine effective to treat or to prevent infections associated with said single-stranded viruses in cells in said subject”.
There is insufficient antecedent basis for the term “said single-stranded viruses” at l.5 of the claim, as the preceding text of the claim references only “single-stranded RNA viruses” – not broadly “single-stranded viruses” per se.
Clarification is required.
The therapeutic objective of Applicant’s method of claim 1 is “preventing, inhibiting or treating viral infections”, but the recited amount of zinc L-carnosine chelate is “effective to treat or to prevent infections associated with said single-stranded viruses”. It is unclear if such amount must also be effective for “inhibiting” viral infections as claimed (and, if not, how such objective is achieved using the recited effective amount).
Clarification is required.
It is additionally unclear if the amount “effective to treat or to prevent infections associated with said single-stranded viruses” is (i) effective to treat or prevent any type of primary or secondary infection (e.g., viral, bacterial) associated with the single-stranded virus, or (ii) effective to treat or prevent viral infection with the single-stranded virus per se. It is unclear if the “infections” referenced at l.4 of the claim are the “viral infections” of l.1 of the claim, or any type of “infections”.
Clarification is required.
Applicant requires a specific amount of the zinc L-carnosine chelate that provides a specific function, but it is unclear what amounts of zinc L-carnosine chelate are, in fact, effective “to treat or to prevent infections associated with said single-stranded viruses in cells in said subject”. Applicant fails to define the amounts of zinc L-carnosine chelate that yield this specifically recited function either in the claims or the accompanying specification such that the ordinarily skilled artisan would have been reasonably apprised of those amounts of zinc L-carnosine chelate that would be included (or excluded) from the objective boundaries of the claim1.
Clarification is required.
Applicant’s claim 6 recites “[t]he method of claim 5, wherein the SARS-CoV virus is SARS-CoV-19”.
It is unclear whether Applicant intends to reference SARS-CoV-2 (also known as COVID-19), or something else. The art does not explicitly recognize a SARS-CoV-19 virus, but it does recognize SARS-CoV-2 (also known as COVID-19). See U.S. Patent No. 10,729,735 B1 at col.7, l.47-51, which acknowledges the interchangeability of “COVID-19” with “SARS-CoV-2”2.
Clarification is required.
Applicant’s claim 7 recites “[t]he method of claim 1, wherein the chelate of zinc and L-carnitine further comprises a second zinc ionophore”.
There is insufficient antecedent basis for the term “the chelate of zinc and L-carnitine”, as the subject matter of claim 1 (from which claim 7 depends) is directed to a chelate of zinc and L-carnosine – not zinc and L-carnitine. As a result, it is unclear if Applicant intends to reference the chelate of zinc and L-carnosine of claim 1, or the further administration of a zinc L-carnitine chelate.
Clarification is required.
Applicant’s claim 8 recites “[t]he method of claim 7, wherein the second zinc ionophore is selected from the group consisting of L-histidine, L-anserine, L-cysteine, penicillamine, and 2-picolinic acid”.
It is unclear if Applicant intends to claim (i) the further administration of a second chelate of zinc with one of the recited second ionophores, or (ii) the zinc L-carnitine chelate also contains another zinc ionophore within the chelate itself. If Applicant intends for the latter interpretation, then the claim is additionally indefinite for failing to clearly identify the manner in which the two distinct ionophores are complexed to zinc to form a single chelate.
Clarification is required.
As claims 3-5 do not remedy these points of ambiguity in claim 1, they must also be rejected on the same grounds applied thereto.
For these reasons, the claims fail to meet the tenor and express requirements of 35 U.S.C. §112(b) (pre-AIA second paragraph) and are, thus, properly rejected.
Claim Rejections - 35 USC § 112(d) (Pre-AIA Fourth Paragraph)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
(2) Claim 2 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Applicant’s claim 2 recites “[t]he method of claim 1, wherein said chelate of zinc and L-carnosine is first admixed with a carrier in the amount of 1 mg to 41 mg zinc L-carnosine chelate per milliliter or per gram of carrier”.
It is unclear in what manner claim 2 is intended to further limit the subject matter of the method defined by claim 1. Applicant’s claim 2 appears to define the manner in which the zinc L-carnosine chelate is prepared, but this limitation fails to explicitly further limit the physical or structural form of the zinc L-carnosine chelate administered (aside from implying the presence of a carrier) or the amount effective to yield the function recited in the active step of administration in claim 1. As such, it is unclear what limiting effect claim 2 places on the subject matter of instant claim 1.
Clarification is required.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
For the purposes of examination, Applicant’s claim 2 will be interpreted to require only that the zinc L-carnosine chelate further contains a carrier.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(3) Claims 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Matsuoka et al. (“Zinc Supplementation Improves the Outcome of Chronic Hepatitis C and Liver Cirrhosis”, J Clin Biochem Nutr, 2009 November; 45:292-303) in view of Mori et al. (WO 96/41643 A1, 1996; citing to English machine translation thereof),
citing to Kim et al. (“Hepatitis C Virus: Virology and Life Cycle”, Clinical and Molecular Hepatology, 2013; 18:17-25) as factual evidence.
Matsuoka et al. teaches an experimental study of 62 patients with chronic viral hepatitis C or liver cirrhosis, with 32 patients administered study therapy and the remainder serving as controls (abstract; col.2, para.2, p.293-col.2, para.1, p.294). Matsuoka et al. teaches that all study patients were positive for serum HCV (hepatitis C virus) RNA3 (col.1, para,2, p.293). Matsuoka et al. teaches that 1.0 g PROMAC (which contains 150 mg polaprezinc4) was administered orally twice daily to the patients of the polaprezinc study group after breakfast and after dinner (col.2, para.2, p.294-col.1, para.1, p.295). Matsuoka et al. teaches that study patients administered polaprezinc increased average serum zinc concentrations by 9.8% three years after treatment was started relative to baseline zinc concentration and also showed a clear reduction in ALT (alanine aminotransferase) and AST (aspartate aminotransferase) liver enzyme levels compared to the untreated group (col.1, para.1, p.299-col.1, para.1, p.300; col.2, para.2, p.300). Matsuoka et al. teaches that study patients administered polaprezinc were divided into a high zinc group (baseline zinc of >64 mg/dl) or low zinc group (baseline zinc of <64 mg/dl), and further noted that the reduction of AST/ALT levels was significantly greater in the low zinc group than the high zinc group (col.2, para.3, p.300-col.1, para.1, p.301). Matsuoka et al. teaches that maintaining a high serum zinc concentration in hepatitis C viral disease slows the progression of liver fibrosis and development of liver cancer, which was further evidenced by the fact that cumulative incidence of hepatocellular carcinoma was significantly lower in the high zinc (“zinc responders”) group (col.2, para.3, p.300-col.1, para.1, p.301; col.2, para.3, p.301-col.1, para.1, p.302). Matsuoka et al. concludes that zinc supplementation for patients with chronic HCV or liver cirrhosis improves the degree of liver damage and long-term outcome (abstract; col.2, para.3, p.301-col.1, para.1, p.302).
Kim et al. provides the factual extrinsic evidence necessary to establish that HCV is a known single-stranded RNA virus (abstract).
Matsuoka et al. differs from the instant claims only insofar as it does not explicitly teach parenteral administration of polaprezinc (zinc L-carnosine chelate) (claim 1), or the specific effects of preventing “viral infections” or their sequelae caused by coronavirus (claim 4), particularly a SARS-CoV virus (claim 5), more particularly SARS-CoV-2 (claim 6).
Mori et al. teaches an antiviral agent for the treatment of HCV infection comprising interferon together with at least one of a zinc salt or a zinc complex (abstract; p.2, para.[6]-[8]). Mori et al. teaches that the zinc salt or zinc complex is, e.g., polaprezinc (p.2, para.[11]). Mori et al. teaches that the antiviral agent is formulated into a pharmaceutical preparation with diluents or excipients, and may be formulated into oral forms, injections, etc. (p.2, para.[12]). Mori et al. teaches that injections are formulated to be sterile and isotonic, and employ carriers such as water, ethyl alcohol, etc. (p.2, para.[13]). Mori et al. teaches that the interferon and the at least one zinc salt or zinc complex may be formulated into a single pharmaceutical preparation or separate pharmaceutical preparations (p.3, para.[2]).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in administering the polaprezinc therapy of Matsuoka et al. to a subject with HCV infection parenterally because Mori et al. teaches that zinc salts or zinc complexes administered for treatment of HCV infection may be administered by injection with a suitable diluent or carrier. The skilled artisan would have found it prima facie obvious to do so because Mori et al. teaches oral or injectable forms of zinc salts or zinc complexes (including polaprezinc) for administration in the treatment of HCV infection – thus, establishing the interchangeability of oral and parenteral routes for administering zinc salts or zinc complexes for this purpose. Though Mori’s antiviral HCV therapy combines interferon with at least one zinc salt or zinc complex (such as polaprezinc), Mori et al. expressly describes the formulation of such therapy as either a single or separate oral or injectable formulations, thereby establishing that the zinc salt or zinc complex was suitable for administration orally or parenterally as a single, separate formulation from the interferon. Such teachings also further suggest that the administration of the same zinc complex (in this case, polaprezinc) as a single therapy for the treatment of HCV infection (as described by Matsuoka et al.) would have also been effectively administered for this purpose as an oral or, alternatively, an injectable form thereof.
Here, the combined teachings of Matsuoka et al. with Mori et al. provide for the treatment of a subject with chronic HCV infection – wherein HCV was a well-known single-stranded RNA virus, as established by Kim et al. – to treat the HCV infection by slowing progression of liver fibrosis and the development of liver cancer by administering polaprezinc (zinc L-carnosine chelate) parenterally as an injection with a suitable carrier to the HCV subject.
Such teachings as combined meet the limitations of claims 1-3 (see above, under the heading “Claim Rejections – 35 USC §112(b) (Pre-AIA Second Paragraph)” regarding interpretations of the claims for examination).
Applicant’s claim 1 recites “[a] method for preventing” viral infections “or their physiological immune-related sequellae [sic] by single-stranded RNA viruses in a subject in need thereof” via parenterally administering zinc L-carnosine chelate in an amount “effective to treat or to prevent infections associated with said single-stranded viruses in cells in said subject”.
Claim 4 defines the single-stranded RNA virus as a coronavirus.
Claim 5 defines the coronavirus as a SARS-CoV virus.
Claim 6 defines the SARS-CoV virus as SARS-CoV-2.
The chronic HCV subject of Matsuoka et al. also constitutes “a subject in need of” prevention of a viral infection – or its “physiological immune-related sequellae [sic]” – as instantly claimed because any subject is reasonably in need of prevention of infection with a single-stranded RNA virus, particularly coronavirus (claim 4), more particularly SARS-CoV (claim 5), or most particularly SARS-CoV-2 (claim 6).
As the combined teachings of Matsuoka et al. as modified by Mori et al. provide for execution of an identical active step to that instantly claimed, the intended result of “preventing” viral infection with a single-stranded RNA virus or its sequelae – particularly wherein the viral infection is coronavirus (claim 4), SARS-CoV (claim 5) or SARS-CoV-2 (claim 6) – must necessarily yield from the practice of the method of these teachings as combined above.
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.
Conclusion
Rejection of claims 1-8 is proper.
Claims 17 and 23-24 are withdrawn from consideration pursuant to 37 C.F.R. 1.142(b).
No claims of the present application are allowed.
Applicant is requested to specifically point out the support for any amendments made to the disclosure in response to this Office action, including the claims (M.P.E.P. §§ 714.02 and 2163.06). In doing so, applicant is requested to refer to pages and line (or paragraph) numbers (if available) in the as-filed specification, not the published application. Due to the procedure outlined in M.P.E.P. § 2163.06 for interpreting claims, other art may be applicable under 35 U.S.C. § 102 or 35 U.S.C. § 103(a) once the aforementioned issue(s) is/are addressed.
Applicant is reminded that MPEP §2001.06(b) clearly states that “[t]he individuals covered by 37 C.F.R. 1.56 have a duty to bring to the attention of the examiner, or other Office official involved with the examination of a particular application, information within their knowledge as to other copending United States applications which are "material to patentability" of the application in question." See Armour & Co. v. Swift & Co., 466 F.2d 767, 779, 175 USPQ 70, 79 (7th Cir. 1972). MPEP §2001.06(b) clearly indicates that “if a particular inventor has different applications pending in which similar subject matter but patentably indistinct claims are present that fact must be disclosed to the examiner of each of the involved applications.” See Dayco Prod. Inc. v. Total Containment, Inc., 329 F.3d 1358, 1365-69, 66 USPQ2d 1801, 1806-08 (Fed. Cir. 2003).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Leslie A. Royds Draper whose telephone number is (571)272-6096. The examiner can normally be reached Tuesday to Thursday (08:30 AM to 05:00 PM).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey S. Lundgren can be reached at (571)-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Leslie A. Royds Draper/Primary Examiner, Art Unit 1629
January 29, 2026
1 Absent any explicit identification in the claims or the originally filed specification of the amounts of zinc L-carnosine chelate that yield the specific function instantly claimed, any amount of zinc L-carnosine chelate will be understood to function in the manner claimed for the purposes of examination.
2 For the purposes of examination, Applicant’s claim 6 will be interpreted as referring to COVID-19, or SARS-CoV-2.
3 The presence of serum HCV RNA in all study patients demonstrates that the liver cirrhosis patients also exhibited underlying chronic hepatitis C viral infection leading to the development of liver cirrhosis.
4 Applicant defines polaprezinc as a commercially available form of zinc L-carnosine chelate as instantly claimed (“Zinc L-carnosine is commercially available as a compound named polaprezinc”; Specification, p.7, l.12-13).