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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/15/2026, has been entered.
Status of the Claims
Claims 1-4 and 11 are pending.
Applicants’ arguments filed on 05/15/2026, 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 Rejections and/or objections not reiterated from previous Office actions are hereby withdrawn.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 05/15/2026, have been fully considered. Applicants have newly added claim 11.
Election/Restrictions
Newly submitted claim 11 is withdrawn from further consideration as being directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
The inventions of the originally filed claims 1-4 and newly submitted claim 11 are directed to patently distinct, yet related processes. The inventions can be shown to be distinct if either or both of the following can be shown: The related inventions are distinct if the (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case the invention of the originally filed claims 1-4 requires treating porcine epidemic diarrhea virus (PEDV) infection, whereas, the invention of the newly added 11 requires treating porcine circovirus (PCV) infection.
PEDV is a coronaviral pathogen, which belongs to a family of enveloped, single-stranded, positive-strand RNA virus with a helical nucleocapsid (see page 122 of Kim of record), whereas, PCV is a circoviral pathogen, which belongs to a small nonenveloped DNA virus containing a unique single-stranded circular genome (see abstract of Allan et al, 2000).
Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
MPEP § 821.03 Claims for Different Invention Added After An Office Action
Claims added by amendment following action by the examiner, as explained in MPEP § 818.02(a), and drawn to an invention other than the one previously claimed, should be treated as indicated in 37 CFR 1.145.
37 C.F.R. 1.145 Subsequent presentation of claims for different invention.
If, after an office action on an application, the applicant presents claims directed to an invention distinct from and independent of the invention previously claimed, the applicant will be required to restrict the claims to the invention previously claimed if the amendment is entered, subject to reconsideration and review as provided in §§ 1.143 and 1.144.
Since the Applicants have received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, newly added claim 11 is withdrawn from further consideration by the Examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Therefore, claims 1-4 are subject of the Office action below.
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: 1) Kevin II of record (Expert Opinion on Drug Discovery, 2009); and 2) 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 non-infected piglets 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 (see discussions above), 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 (a coronavirus, see discussions above), 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’ arguments are reiterations of previous 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) None of the cited references teach treating PEDV in a nursery pig (see pages 4-5 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.
3) a person skilled in the art would not have had a reasonable expectation that an anti-coronaviral drug (e.g., narasin) that is active against TEGV (a coronavirus, see discussions above) would be active against PEDV (a coronavirus, see discussions above). Applicants cite: 1) Lin et al (J. Virology, 2015); and 2) the declaration of Dr. Christopher Leigh Puls, which cites to a white paper from Iowa State University (filed on 09/30/2021, in the parent Application No. 15/513,735), for allegedly providing support for the Applicants’ allegations. 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 at the time instant invention, it was known in the art that anti-coronaviral drug that inhibit PEDV, can also inhibit TEGV. For example, Choi of record (Antiviral Research, 2009), 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 (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.
Claim Rejections - 35 USC § 103
New Grounds of Rejection
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.
Claims 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Kim of record (J. Clinical Virology, 2008) in view of: 1) Kevin II of record (Expert Opinion on Drug Discovery, 2009); 2) Gale of record (U.S. Patent No. 3,995,027) as evidenced by Spires of record (U.S. Patent No. 4,394,377); and 3) Choi of record (Antiviral Research, 2009).
Similar to the Applicants’ invention (see discussions above), 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 it was known in the art that:
a) narasin is an anti-coronaviral drug;
b) a feed composition comprising narasin can be formulated; and
c) anti-coronaviral drugs that inhibit PEDV, can also inhibit TGEV.
For example:
a) 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).
b) Gale (see abstract and column 1), discloses a method for moderating the effects of viral infections with compound A-28086 (narasin, as evidenced by Spires2). Narasin has a broad-spectrum antiviral activity against viruses including but not limited to TGEV (a coronavirus, see discussions above), 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).
c) Choi of record (Antiviral Research, 2009), 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 (see Tables 2-3).
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, Gale as evidenced by Spires and Choi.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ren et al (PLoS One, 2011, 6(5), e18669, 1-9), discloses that anti-coronaviral drug (LiCl) that inhibit TEGV, can also inhibit coronaviruses PEDV and BRV (see, e.g., abstract, Figures 2-6 and pages 2-9).
No claim is allowable.
If Applicants should amend the claims, a complete and responsive reply will clearly identify where support can be found in the disclosure for each amendment. Applicants should point to the page and line numbers of the application corresponding to each amendment, and provide any statements that might help to identify support for the claimed invention (e.g., if the amendment is not supported in ipsis verbis, clarification on the record may be helpful). Should the Applicants present new claims, Applicants should clearly identify where support can be found in the disclosure.
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.
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/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).
2 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).
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