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 .
Claim Status
The amendment of 10/28/2025 has been entered. Claims 41-57 and 60-65 are pending in this US patent application. Claims 52-56 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, and claims 43-44 and 50-51 remain withdrawn as being drawn to nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/25/2025.
Claims 41-42, 45-49, 57, and 60-65 are currently under examination and were examined on their merits.
Withdrawn Rejections
All rejections of claims 58-59 set forth in the previous Office action are withdrawn in light of the amendment of 10/28/2025, which canceled these claims.
The rejection of the claims under 35 U.S.C. 103 as being unpatentable over Westinghouse in view of Gross as set forth in the previous Office action is withdrawn in light of the amendment of 10/28/2025, which brought the limitations of previous claims 58-59 into claim 41.
Claim Rejections - 35 USC § 112
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.
Claim 57 is newly rejected as necessitated by amendment 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.
Claim 41 has been amended to recite a highly specific list of particular coronaviruses that the instantly recited method is intended to treat. Claim 57, however, depends from claim 41 but recites that the coronavirus is significantly broader than the list recited in amended claim 41. As such, claim 57 fails to further limit the claim from which it depends and is rejected under 35 U.S.C. 112(d).
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.
Claim Rejections - 35 USC § 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 for establishing a background for determining obviousness under 35 U.S.C. 103 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 41-42, 45-49, 57, and 60-65 remain rejected under 35 U.S.C. 103 as being unpatentable over international patent application WO 01/87229 filed by Westinghouse et al., published 11/22/2001, in view of Shi, “Authoritative release: Bromelain, phentolamine, and anisodamine are expected to prevent and treat severe new coronavirus pneumonia,” Feb. 2020 (cited on the IDS filed 06/20/2025), as evidenced by Gross et al., J. Phar. Biomed. Anal. 181: 113075 (published 01/08/2020; cited on the IDS filed 05/25/2023).
Westinghouse teaches the treatment of viral infections, which may be coronavirus infection, and of their symptoms, including fever, pain, and fatigue, with a formulation comprising a proteolytic enzyme (see entire document, including page 1, lines 2-5, and page 14, lines 21-24 and 32-33; cf. claims 41 and 60). The proteolytic enzyme is preferably bromelain, which has antiviral activity (page 8, lines 1-18). Bromelain is a mixture of various moieties derived from the stem of Ananas comosus that contains at least two proteolytic enzymes (page 2, lines 21-24; cf. claims 41-42 and 45-46). The composition may be administered orally, intravenously, subcutaneously, intramuscularly, nasally, or rectally (page 10, lines 1-10; cf. claim 64). The composition may be formulated as a hard or soft gelatin capsule, a pill, tablet, powder, solution, or emulsion (page 11, lines 3-9; cf. claim 63). With regard to dosage and duration of treatment, it is recognized that the ability of an artisan skilled in pharmaceutical administration of drugs to determine suitable dosages depending on many interrelated factors is well known, and skilled artisans are readily able to monitor patients to determine whether treatment should be started, continued, discontinued, or resumed at any time (page 12, lines 22-26; cf. claim 65).
Gross teaches that bromelain is a heterogeneous protein mixture extracted from pineapple stem that contains a jacalin-like lectin (see entire document, including page 1, abstract). The jacalin-like lectin is present in a glycated form (page 8, right column, paragraph 2). As such, the stem bromelain of Westinghouse intrinsically contains a glycated jacalin-like lectin in addition to the bromelain protease, as recited in instant claim 47.
However, Westinghouse does not explicitly teach the administration of compositions comprising bromelain to patients for the treatment of coronavirus infections. Westinghouse also does not teach the dose schedule of claim 65 or the relative amounts of bromelain protease and glycated jacalin-like lectin recited in instant claims 48-49 and 61-62. Westinghouse also does not teach that the coronavirus is one of the coronaviruses recited in instant claim 41.
Shi teaches that bromelain has been suggested for the treatment of 2019-nCoV infection (see entire document, including page 1, paragraph 2; cf. claims 41 and 57; the Examiner notes that 2019-nCoV is a synonym for SARS-CoV-2).
While Westinghouse does not explicitly teach the administration of compositions comprising bromelain to patients for the treatment of coronavirus infections, it would have been obvious to one of ordinary skill in the art to do so because Westinghouse teaches that coronaviruses are some of the viruses that can be treated with the recited compositions. One of ordinary skill in the art would have a reasonable expectation that using the bromelain-containing composition to treat coronavirus infection in a patient would successfully result in the amelioration of at least one symptom of the infection to at least some degree.
Westinghouse does not teach the relative amounts of the bromelain protease and glycated jacalin-like lectin intrinsically present within the bromelain composition taught by Westinghouse as recited in instant claims 48-49 and 61-61. However, the instantly recited amounts would be within the realm of routine experimentation. Generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP § 2144.05 part II A. It would have been obvious to one of ordinary skill in the art at the time Applicants' invention was made to determine all operable and optimal concentrations of all substances administered to the patient for the treatment of coronavirus infection because the concentrations of drugs administered for the treatment of illness are art-recognized, result-effective variables known to affect the treatment of the illness, which would have been optimized in the pharmaceutical art to provide the desired effect on the patient. Similarly, while Westinghouse does not teach the dose schedule recited in instant claim 65, Westinghouse does state that, with regard to dosage and duration of treatment, it is recognized that the ability of an artisan skilled in pharmaceutical administration of drugs to determine suitable dosages depending on many interrelated factors is well known, and skilled artisans are readily able to monitor patients to determine whether treatment should be started, continued, discontinued, or resumed at any time. As such, any dose schedule appropriate to the particular patient would be within the level of ordinary skill in the art according to Westinghouse, including the dose schedule recited in instant claim 65.
While Westinghouse does not teach that the coronavirus treated with the bromelain-containing composition is SARS-CoV-2, it would have been obvious to one of ordinary skill in the art based on Westinghouse’s teachings to administer the composition of Westinghouse for the treatment of any coronavirus, including SARS-CoV-2, which Shi suggests can be treated with bromelain. One of ordinary skill in the art would have a reasonable expectation that administering the composition of Westinghouse to a patient with SARS-CoV-2 infection as taught by Shi in the manner described by Westinghouse would successfully result in the amelioration of at least one symptom of the infection to at least some degree.
Therefore, claims 41-42, 45-49, 57, and 60-65 are rendered obvious by Westinghouse in view of Shi, as evidenced by Gross.
The Supreme Court has acknowledged:
When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation…103 likely bars its patentability…if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person’s skill. A court must ask whether the improvement is more than the predictable use of prior-art elements according to their established functions……the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results (see KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 U.S. 2007) (emphasis added).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant has traversed the above rejection of the claims under 35 U.S.C. 103 as being unpatentable over Westinghouse in view of Shi, as evidenced by Gross. Applicant states that Westinghouse does not teach SARS-CoV-2 and that Shi teaches only bromelain monotherapy, not the administration of a crude bromelain extract for the treatment of SARS-CoV-2 (remarks, page 8). This argument has been fully considered but has not been found persuasive.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The Examiner notes that the above-presented rejection is predicated not upon Westinghouse alone or Shi alone but, rather, upon the combination of the teachings of Westinghouse and Shi. Given that Westinghouse teaches the use of a crude bromelain extract for the treatment of coronaviruses and that Shi teaches that SARS-CoV-2 is a coronavirus that can be treated with bromelain, the Examiner does not concur with Applicant’s assertion that Shi cannot be combined with Westinghouse or that such a combination would apply only to bromelain monotherapy.
Applicant states that the cited references provide no suggestion or motivation to combine bromelain with a lectin and that the claimed invention introduces a new and non-obvious dual-mechanism antiviral strategy (remarks, pages 9-10). This argument has been fully considered but has not been found persuasive.
The Examiner notes that the instant claims do not recite a dual-mechanism antiviral strategy but, rather, recite the administration of a composition comprising two ingredients to a particular patient population. The cited references render obvious the administration of a composition comprising those two ingredients to the recited patient population, which is all that is required to render the instant claims obvious. The fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Therefore, the Examiner has maintained the rejections presented above.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Erin M. Bowers, whose telephone number is (571)272-2897. The examiner can normally be reached Monday-Friday, 7:30-5:00.
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/Erin M. Bowers/Primary Examiner, Art Unit 1653 01/09/2026