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 .
The previous claim rejection made under 35 USC 112 (b) on claims 15-17, which was indicated in the Office action dated October 21, 2025, have been withdrawn in view of the claim amendments made to the rejected claims. However, new rejections have been made in view of further consideration as explained below.
The previous claim rejection made under 35 USC 102 (a)(1) or under 35 U.S.C. 103 in view of Cao et al. (CN 111777684 A) has been modified to address the new claim limitation, “wherein the lignosulfonate exhibits anti-viral properties.”
A new rejection under 35 U.S.C. 102 has been made in view of further search and consideration.
The previous claim rejection on claim 13, which was made under 35 U.S.C. 103 over Cao, has been maintained for reasons of record.
Allowable Subject Matter
The indication of allowability of claims 12 and 14 is withdrawn in view of further consideration under 35 U.S.C. 112 (a) and (b) as explained below.
Claim Rejections - 35 USC § 112
§ 112(a)
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 10-19, 31, 33 and 34 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 written description requirement.
The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The amended claim 10 is directed to a method of preventing or treating COVID-19 in a human or animal subject comprising administering to said subject an effective amount of a composition comprising lignosulfonate, wherein the lignosulfonate exhibits anti-viral properties.
The specification does not suggest applicant had possession of the claimed method of preventing or treating a human subject or the “effective amount” of a composition comprising lignosulfonate to do so.
The specification discloses an in vivo study which shows that administering 42.5 mg/kg low dose of lignosulfonate activates the production of IL-12, the body’s immune response against the virus. See Example 2. However, there are no studies, clinical trials or examples regarding human use or dose. Example 1 is limited to an in in vitro study which shows the effective concentration of lignosulfonate composition to stop SARs-CoV-2 from replicating at a cellular level is 0.89 mg/ml (EC50) and cycotoxic concentration of 12.4 mg /ml (CC50). The examiner views that the disclosure might provide a concept on human use according to the claim, but person of ordinary skill in the art could not recognize that the inventor was in possession of the claimed method.
Claims 33 and 34 are rejected on the same grounds.
Claims 11-19 and 31 are rejected for depending on the base claim, claim 10, which fails to meet the written description requirement.
§ 112 (b)
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.
Claims 10-19, 31, 33 and 34 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.
Claims 10, 33 and 34 require “an effective amount of a composition comprising lignosulfonate” to prevent or treat COVID-19 in a human or animal subject. It is not clear what this amount is, as the specification does not define or explain it, and one of ordinary skill in the art would not readily comprehend what amount of such composition would meet the limitation. The remaining claims are rejected for depending on the definite base claim, claim 1.
Claim 15-17 recite that the composition to be administered “in a concentration of specified ranges (e.g., between 0.0125 and 2 mg/ml”). Unless the amount of the composition administered to the animal or human subjects is known, the mere concentration ranges does not define “the effective amount” to prevent or treat the viral infection.
Regarding claim 34, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 34 recites the broad recitation of preventing of treating COVID-19 in a human or animal subject, and the claim also recites using a composition “formulated for administration as an animal feed additives” which is the narrower statement of the scope of the subject group. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim Rejections - 35 USC § 102
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 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.
Claims 10, 11, 18, 19 and 31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by, or in alternative, under 35 U.S.C. 103 as unpatentable over, Cao et al. (CN 111777684 A, published October 16, 2020) (“Cao” hereunder).
The amended claim 10 is directed to a method of preventing or treating COVID-19 in a human or animal subject comprising administering to said subject an effective amount of a composition comprising lignosulfonate, wherein the lignosulfonate exhibits anti-viral properties.
Cao discloses a method of using an antibody against SARS-CoV-2 coronavirus produced from a tandem-epitope coronavirus protein. See translation, abstract. The reference discloses a nasal spray formulation comprising the coronavirus polyvalent antibody powder and sulfonated lignin. See translation, p. 2, step 3. The reference teaches a method of spraying the formulation (0.5 mL) through nasal or oral cavities to reduce the probability of viruses for adsorbing respiratory epithelial cells, See translation, p. 5, Experimental Example 5.
Regarding the new limitation “wherein the lignosulfonate exhibits anti-viral properties”, it is well settled in patent law that where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. See In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "Products of identical chemical composition cannot have mutually exclusive properties." See In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. In this case, the Cao method requires administration of a composition comprising lignosulfonate; lignosulfonate in the prior art and the present invention is chemically same and must have the same anti-viral properties.
Regarding claim 11, the formulation is free of elemental sulphur.
Regarding claim 19, since the composition of the prior art method meets all the limitation of the present claim 1, the same antiviral activity and cytotoxicity should occur when the two methods are practiced.
Regarding claim 31, since the same composition comprising the same lignosulfonate is administered to a subject for the same purposes, “activating one or more of IL-12 and IL-1B” inherently occurs when the prior art method is practiced.
Claims 10, 11, 13, 14, 18, 19 and 31 and 34 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Chery et al. (US 20130344167 A1, published on December 26, 2013) (“Cherry” hereunder).
Cherry discloses method of feeding non-human animals a galenic composition comprising lignosulfonates as a disintegration accelerating agent in the amount of 3-25 wt %, 3-16 % or 3-8 wt % based on the total weight of the composition. See [0029].
It is well settled in patent law that the discovery of a new use for an old structure based on unknown properties of the structure might be patentable to the discoverer as a process of using. In re Hack, 245 F.2d 246, 248, 114 USPQ 161, 163 (CCPA 1957). However, when the claim recites using an old composition or structure and the "use" is directed to a result or property of that composition or structure, then the claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978); MPEP 2112.02, II. In this case, Cherry discloses the same process of administering a composition comprising lignosulfonate to an animal subject, and any prevention effect of COVID-19 infection must be inherently practiced each and every time the prior art composition is used on the subject. Lignosulfonate in the prior art and the present invention is chemically same and must have the same anti-viral properties. Example 1 contains 8 wt % of lignosulfonate with pharmaceutically acceptable excipients. Example 1; the present claims 1,14, 18 and 34.
Regarding claim 11, the formulation is free of elemental sulphur. See Example 1.
Regarding claim 13, the reference teaches that lignosulfonate based on calcium, ammonium, or mixture thereof, or on sodium or potassium are preferred. See [0024].
Regarding claim 19, since the composition of the prior art method meets all the limitation of the present claim 1, the same antiviral activity and cytotoxicity should occur when the two methods are practiced.
Regarding claim 31, since the same composition comprising the same lignosulfonate is administered to a subject, “activating one or more of IL-12 and IL-1B” inherently occurs when the prior art method is practiced.
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.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Cao as applied to claims 10, 11, 18, 19 and 31 as above, and further in view of the same reference.
Regarding claim 13, although Cao does not specifically disclose the salt form of lignin sulfonate, since the compound used in the water-based formulation is viewed in the form of a pharmaceutically acceptable salt.
Response to Arguments
Applicant’s arguments with respect to claim(s) 10-19, 31, 33 and 34 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Claims 10-19, 31, 33 and 34 are rejected.
Claims 20-26 and 32 remain withdrawn from consideration.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GINA JUSTICE whose telephone number is (571)272-8605. The examiner can normally be reached M-F 9:00 AM - 5 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, BETHANY BARHAM can be reached at 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GINA C JUSTICE/Primary Examiner, Art Unit 1617
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