FINAL REJECTION
Receipt is acknowledged of Applicants' Amendments and Remarks, filed Dec. 8, 2025.
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The rejections and/or objections set forth below are either maintained or newly applied, and constitute the complete set presently applied to the instant claims.
STATUS OF THE CLAIMS
Claim 3 has been amended and incorporates no new matter.
No new claims have been added.
Claims 4-21 stand withdrawn as drawn to nonelected inventions and/or species.
Thus, claims 1-3 now represent all claims currently pending and under consideration.
INFORMATION DISCLOSURE STATEMENT
The information disclosure statements (IDS) submitted on Dec. 8, 2025 and Jan. 21, 2026 were filed after the mailing date of the non-final action on Sep. 18, 2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
MAINTAINED REJECTIONS
The following rejection is maintained from the previous Office Action dated Sep. 18, 2015, on the ground that the references cited therein continue to read on the limitations of the amended claims.
Rejections under 35 USC §102(a)(1)
Claims 1-3 stand rejected under 35 U.S.C. 102(a)(1) as being anticipated by Beović et al. (J Antimicrob Chemother (75) 3386-3390), as evidenced by European Medicines Agency, CHMP assessment report for Tazocin, Feb. 2011 ("EMA report").
Beović et al. disclose the treatment of COVID-19 infection in human patients, caused by the SARS-CoV-2 virus and resembling bacterial pneumonia, by administering various antibiotics (abstract). In particular, Beović et al. found that the most commonly prescribed antibiotic to patients in the ICU (intensive care unit) in April 2020 was piperacillin in combination with tazobactam (abstract; Methods; Fig. 2), which was also reported as the most commonly used antibiotic overall (p. 3387, right col.).
Thus, Beović et al. disclose methods of treating SARS-CoV-2 virus infection in a subject in need thereof comprising administering an effective amount of a pharmaceutical composition comprising piperacillin or a salt thereof, as recited by claim 1.
As evidenced by the EMA report, the combination of piperacillin and tazobactam is marketed in Europe as Tazocin, with each vial containing 2 g piperacillin / 0.25 g tazobactam powder for solution for infusion, or 4 g piperacillin / 0.5 g tazobactam powder for solution for infusion (Annex III, package leaflet, p. 38). These two formulations and are authorized for one or both of these strengths in most EU member states (EMA report, sec. 2.1, p. 3).
Thus, Beović et al. implicitly disclose that the piperacillin or salt thereof is administered in an amount from about 2 g to about 40 g powder per injection, as recited by claim 2.
As further evidenced by the EMA report, the clinical role of piperacillin is strengthened by the addition of tazobactam, an irreversible β-lactamase-inhibitor, which protects piperacillin against enzymatic degradation from β-lactamase-producing bacteria and therefore expanding the antimicrobial spectrum (EMA report, sec. 2.1, p. 3).
Because it strengthens, enhances, and/or potentiates the antibacterial activity of piperacillin, tazobactam can be considered an antibacterial therapeutic.
Thus, Beović et al. implicitly disclose methods of treating SARS-CoV-2 virus infection comprising administering piperacillin or a salt thereof, and further comprising administering tazobactam, an antibacterial therapeutic, as recited by claim 3.
While Beović et al. do not explicitly disclose that piperacillin is a SARS-CoV-2 main protease (Mpro) inhibitor, as recited by claim 1, this activity is an inherent property of piperacillin, even if it is not explicitly recognized by the reference.
As recognized by MPEP § 2112, "the discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function, or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). If the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
For the foregoing reasons, Beović et al. explicitly, implicitly, and/or inherently discloses and anticipates each and every limitation of claims 1-3.
RESPONSE TO ARGUMENTS
Applicant's arguments filed Dec. 8, 2025 have been fully considered but they are not persuasive.
Specifically, Applicant argues that Beović et al. disclose the administration of antibiotics to patients with COVID-19 to treat suspected or confirmed bacterial infection secondary to COVID-19 infection, which does not anticipate the finding that the claimed compounds are SARS-CoV-2 Main Protease (Mpro) inhibitors.
While Beović et al. report that certain antibiotics, including piperacillin/tazobactam, are prescribed to treat secondary infection in COVID-19 patients, the reference provides no evidence, teaching, or suggestion that the claimed antibiotics directly act on COVID-19 enzymes or demonstrate any effect on treating the SARS-CoV-2 virus (Remarks, p. 10).
This is in contrast to the claimed invention, which is the unexpected finding that certain antibiotics have strong binding activity with Mpro (Fig. 2), which inhibits Mpro activity at a high level of over 90% (Fig. 1) (Remarks, p. 10).
Thus, Applicant argues that Beović et al. does not clearly and unequivocally disclose the claimed method or direct those skilled in the art to the method, and thus cannot anticipate the claimed invention.
However, Beović et al. exemplifies the active steps of the claimed method: an effective amount of a pharmaceutical composition comprising piperacillin was administered to subjects with COVID-19, i.e., patients infected with the SARS-CoV-2 virus.
It is acknowledged that Beović et al. does not explicitly disclose that piperacillin is an inhibitor of SARS-CoV-2 Mpro. However, in addition to its antibiotic properties, Mpro inhibition is an inherent property of piperacillin, and thus inherently occurs each and every time piperacillin is administered to a patient infected with the SARS-CoV-2 virus, regardless of the intent or reason for its administration.
By disclosing the administration of an effective amount of piperacillin to a patient infected with SARS-CoV-2, the concomitant result – inhibition of SARS-CoV-2 Mpro by piperacillin – is inherent in the methods of Beović et al., even if this mechanism of action is not recognized by the prior art reference.
All the molecular mechanisms by which a compound exerts its therapeutic effects are intrinsic properties of the compound itself, and occur each time piperacillin is administered to a COVID-19 patient, i.e., a patient infected with SARS-CoV-2, regardless of whether anyone was aware of those mechanisms.
A novel use of a known compound can be patentable. However, claims 1-3 do not recite a novel use of a known compound, but rather a previously unknown property of a compound known to be administered to the same patient population.
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 the use of a known compound in a known method and the “use” is directed to a result or property of that compound, then the claim is anticipated.
For example, In re May, 574 F.2d 1082, 1090, 197 USPQ 601 (CCPA 1978) affirmed the rejection of claims 1 and 6, directed to methods of effecting nonaddictive analgesia, which were anticipated by the applied prior art which disclosed the same compounds for effecting analgesia, but which was silent as to addiction. The court affirmed the rejection on the grounds that the applicants had merely found a new property of the compound and such a discovery did not constitute a new use. Id. at 607. See MPEP § 2131.01.
Claims 1-3 recite the result of administering piperacillin to treat a SARS-CoV-2 virus infection in a subject: inhibition of the SARS-CoV-2 main protease (Mpro). While the references do not show a specific recognition of those results, their discovery is tantamount only to finding a new property intrinsic in carrying out a known method. See MPEP § 2112.
Because the reference discloses a method of treating a SARS-CoV-2 virus infection by administering the same compound in the same dosages to the same patient population, all the biological effects of the claimed method are inherent in the methods of Beović et al.
For the foregoing reasons, the rejection of claims 1-3 under 35 U.S.C. §102 over Beović et al. is maintained.
CONCLUSION
No claims are allowed.
THIS ACTION IS MADE FINAL. 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.
CORRESPONDENCE
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARA E. TOWNSLEY whose telephone number is 571-270-7672. The examiner can normally be reached on Mon-Fri from 9:00 am to 6:00 pm (EST). If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Jeff 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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/SARA ELIZABETH TOWNSLEY/Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629