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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on submitted on 12/01/2025 and 12/29/2025, were in compliance with the provisions of 37 CFR 1.97 and 37 CFR 1.98. The IDS documents were considered. A signed copy of Form PTO-1449 is enclosed herewith.
Withdrawn Rejections:
The rejection of claims 5-10 under 35 U.S.C. 102(a)(1) as being anticipated by Thalmann of record (J. AOAC International, 2004), is withdrawn because of the cancellation of claims 5-10.
Status of the Claims
Claims 1-4 are pending.
Applicants’ arguments filed on 12/29/2025, have been fully considered. Rejections and/or objections not reiterated from previous Office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Applicants’ amendments filed on 12/29/2025, have been fully considered. Applicants have cancelled claims 5-10. Therefore, claims 1-4 are subject of the Office action below.
Maintained Rejections:
Claim Rejections - 35 USC § 103-Maintained
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.
The rejection of claims 1-4 under 35 U.S.C. 103 as being unpatentable over Kim of record (J. Clinical Virology, 2008) in view of: i) Kevin II of record (Expert Opinion on Drug Discovery, 2009); and ii) Gale of record (U.S. Patent No. 3,995,027) as evidenced by Spires of record (U.S. Patent No. 4,394,377), is maintained for the reasons of record set forth in previous Office action, of which said reasons are herein reiterated.
By way of a background, Applicants’ invention (see, e.g., page 1, lines 3-6 of the specification), is drawn to a method for treating porcine epidemic diarrhea virus (PEDV), with narasin. PEDV is a coronavirus (see page 1, line 6 of the specification).
A treatment may be applied prophylactically or therapeutically (see page 4, lines 21-22 of the specification). The specification (see Example 1, pages 5-11 and Tables 1-4), provides a prophylactic working example of feeding piglets free of PEDV infection with feed composition comprising narasin, exposing the piglets to PEDV, continue feeding, while monitoring for signs of diarrhea.
Under the broadest reasonable interpretation (BRI), consistent with the specification, the claimed invention is being interpretated as a method for treating PEDV infection in a nursery pig with a composition comprising from about 30 mg/kg, about 40 mg/kg, about 50 mg/kg, and about 60 mg/kg of narasin and an orally acceptable carrier (e.g., an animal feed).
Similar to the Applicants’ invention, Kim relates to a method for treating coronavirus infections with anti-coronaviral drugs (see abstract). Specifically, Kim teaches a method for inhibiting the replication of MHV (a prototype of coronavirus and a model for human disease). Coronavirus specific inhibition was also demonstrated using PEDV. Please see abstract, Figures 1-4 and Tables 1-2). Coronavirus is a family of enveloped, single-stranded, positive-strand RNA virus with a helical nucleocapsid (see page 122). Among the coronaviral pathogens that are of veterinary importance, Kim discloses PEDV, porcine transmissible gastroenteritis virus (TGEV), bovine coronavirus, and avian infectious bronchitis virus (see page 122). PEDV has more recently been identified as the causative agent of severe entero-pathogenic diarrhea in swine (see page 122). Swine necessarily encompasses pigs of all ages, including nursery pigs.
Accordingly, at the time of the instant invention, a person skilled in the art would have readily envisaged a method of inhibiting a coronavirus (e.g., PEDV) replication with an anti-coronaviral drug, in the Kim disclosures.
Kim differs from the claimed invention only insofar as Kim is not explicit in disclosing narasin as anti-coronaviral drug and a feed composition comprising narasin.
However, the claimed invention would have been obvious over Kim, because at the time of the instant invention, narasin was known in the art as an anti-coronaviral drug and a feed composition comprising narasin was known in the art. For example:
1) Similar to Kim (see discussions above), Kevin II (see § 2.4.2), discloses that narasin has been reported to be active against TGEV (a coronavirus, see discussions above).
2) Gale (see abstract and column 1), discloses a method for moderating the effects of viral infections with compound A-28086 (narasin, as evidenced by Spires1). Narasin has a broad-spectrum antiviral activity against viruses including but not limited to TGEV, infectious canine hepatitis and bovine virus diarrhea (see column 23, lines 43-60 and Table 1). Narasin is useful against viral infections in: i) swine (i.e. pigs in general; see, for example, column 23 lines 37-42); and baby pigs (i.e. nursery pigs; see, for example, Table 2 and column 27, lines 64-68). The disclosed antibiotics were effective in the in feed at a rate of about 2.5 to about 10 g per 100 lb. of feed (which is equivalent to about 55 to about 220 mg/kg of feed, see, for example, column 28, lines 1-4).
The claimed narasin composition of from about 30 mg/kg, about 40 mg/kg, about 50 mg/kg, and about 60 mg/kg (claims 3-4), overlap or lie inside ranges disclosed by Gale because Gale discloses from about 55 to about 220 mg/kg (see discussions above).
A prima facie case of obviousness exists in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" (see MPEP § 2144.05).
In the instant case, because the claimed mg/kg narasin, overlaps or lies inside ranges disclosed by the prior art (see discussions above), a prima facie case of obviousness exists.
Therefore, at the time of the instant invention, one skilled in the art would have found it obvious to administer a composition (e.g., a feed) comprising an anti-coronaviral drug (e.g., narasin) to swine (e.g., nursery pigs) suffering from a coronaviral (e.g., PEDV) infection. A person skilled in the art would have had a reasonable expectation that the administration of the anti-coronaviral drug (e.g., narasin), would treat the coronaviral (e.g., PEDV) infection.
Obviousness requires only a reasonable expectation of success, not complete confidence in a given outcome; "at least some degree of predictability" is all that is required. M.P.E.P. § 2143.02.
The prior art can be modified or combined to reject claims as prima facie obvious as long as there is a reasonable expectation of success. See In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986) (see MPEP § 2143.02).
Therefore, claims 1-4 are obvious over Kim, Kevin II and Gale as evidenced by Spires.
Response to Applicants’ Arguments/Remarks
Applicants raised several arguments (see pages 3-6 of Remarks), alleging that the rejection is improper on the grounds that:
1) Applicants merely cite MPEP § 2141 and a list of case law citations therein (see pages 3-4 of Remarks).
Response:
Applicants’ response fails to link the MPEP § 2141 and the legal concepts to the facts of the application under examination.
2) a person skilled in the art would not have had a reasonable expectation that narasin would be active against PEDV, because the coronavirus that causes TGEV is different from the coronavirus that causes PEDV. Applicants cite Lin et al (J. Virology, 2015), for allegedly providing evidence that TGEV antibody could not neutralize PEDV and vice versa. Please see pages 5-6 of Remarks.
Response
Applicants’ arguments have been fully considered but they are not found to be persuasive. This is because Kim teaches a method for inhibiting coronaviruses MHV, PEDV and VSV, with an antiviral drug. Kim also discloses that PEDV, TGEV, bovine coronavirus, and avian infectious bronchitis virus are of veterinary importance. PEDV has more recently been identified as the causative agent of severe entero-pathogenic diarrhea in swine. Please see discussions above. Swine necessarily encompasses pigs of all ages, including nursery pigs.
Kevin II and Gale as evidence by Spires combine to disclose that narasin has a broad-spectrum antiviral activity against viruses including but not limited to TGEV. Narasin is useful against viral infections in: i) swine (i.e. pigs in general); and baby pigs (i.e. nursery pigs). Please see discussions above.
Therefore, at the time of the instant invention, one skilled in the art would have found it obvious to administer a composition (e.g., a feed) comprising an anti-coronaviral drug (e.g., narasin) to swine (e.g., nursery pigs) suffering from a coronaviral (e.g., PEDV) infection. A person skilled in the art would have had a reasonable expectation that the administration of the anti-coronaviral drug (e.g., narasin), would treat the coronaviral (e.g., PEDV) infection.
Obviousness requires only a reasonable expectation of success, not complete confidence in a given outcome; "at least some degree of predictability" is all that is required. M.P.E.P. § 2143.02.
The prior art can be modified or combined to reject claims as prima facie obvious as long as there is a reasonable expectation of success. See In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986) (see MPEP § 2143.02).
The Examiner notes that Applicants (see discussions above), discloses a treatment as referring to prophylactically or therapeutically. Since The cited references combine to disclose administering narasin to nursery pigs (see discussions above), it would have been obvious to one skilled in the art that the cited references also combine to disclose treating PEDV, to the extent that treatment reads on prevention, because a nursery pig in need of prevention from PEDV, would not have PEDV.
Furthermore, Choi et al (Antiviral Research, 2009, 81, 77-81, cited in response to the Applicants’ allegation), discloses that anti-coronaviral drugs (Ribavirin and Q7R) that inhibit PEDV, can also inhibit coronaviruses TGEV and PRCV, albeit, not at the same level of efficacy. Please see Tables 2-3.
Therefore, the rejection of claims 1-4 over Kim, Kevin II and Gale as evidenced by Spires, is proper.
For the reasons above and those made of record in the previous Office action, the rejections are maintained.
Conclusion
No claim is allowable.
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.
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
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IBRAHIM D BORI whose telephone number is (571)270-7020. The examiner can normally be reached on Monday through Friday 8:00AM-5:00PM(EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JEFFREY S LUNDGREN can be reached on 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/IBRAHIM D BORI/
Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
1 Narasin is a given name for an antibiotic complex also designated A-28086. This is made up of several structurally related factors designated A, B and D produced by submerged aerobic fermentation of Streptomyces aureofaciens NRRL 5758 (see Spires at column 7, lines 3-7).