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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 8 October 2025 has been entered.
Claim Status
Applicant’s remarks and amendments, filed 19 September 2025 in response to the final rejection mailed 28 July 2025, are acknowledged and have been fully considered. Applicant’s amendments to the claims are acknowledged. The listing of claims filed 19 September 2025 replaces all prior versions and listings of the claims.
Claims 1-21 and 26-27 are pending. Claims 9-21 remain withdrawn. Claims 1, 9, 10, and 18-21 are amended. Claims 1-8 and 26-27 are being examined on the merits.
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.
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, 7, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (Food Microbiol, 2018, 346-353) in view of Lu (CN 1042656 A).
The instant claims are as of record, drawn to a method for inhibiting or reducing symptoms of viral gastroenteritis in a human comprising administering a composition comprising Fagopyrum dibotrys extract and a pharmaceutically acceptable excipient to the human.
Liu et al. teach a method for inhibiting viral gastroenteritis comprising administering a composition comprising dimeric procyanidin B2 (Fagopyrum dibotrys extract; 5, 7, 3', 4'-tetrahydroxyflavan-3-ol C4-C8 dimers; instant specification, Formula I, page 9; Liu et al., Figure 1B, page 347; as required for instant Claims 1 and 4), and 10% ethanol and 90% distilled deionized water or phosphate buffered saline (pharmaceutically acceptable excipient; Liu et al., section 2.2., page 347; as required for instant Claim 1). The composition is administered to feline kidney cells infected with feline calicivirus or murine norovirus (norovirus) in an amount effective to inhibit viral gastroenteritis in the subject (Liu et al., Tables 1 and 2, page 348; as required for instant Claim 1). Feline calicivirus and murine norovirus were used as cultivable human norovirus surrogates (broadly, the human subject of instant Claim 1 using the same model as the instant specification, see Examples pages 19-23). The final concentration of dimeric procyanidin B2 was 0.5-1 mg/mL, or 0.05-0.1% (Fagopyrum dibotrys extract; Liu et al., section 2.2, page 347; as required for instant Claim 2).
Liu et al. do not teach wherein the extract is in the claimed amounts of instant Claims 1, 3, or 26, administration to a human, or wherein the composition is administered orally.
Lu teaches a composition comprising 0.1-6% of dimeric procyanidin (Lu, [0050], page 7; as required for instant Claims 3 and 26), a dimer of 5, 7, 3', 4'- tetrahydroxyflavan-3-ol with C4-C8 linkage, and extracted from rhizoma Fagopyti dibotryis (Fagopyrum dibotrys; Lu, Abstract; as required for instant Claims 1 and 4). The composition is mixed with feed and fed (administered; oral administration) at a dose of 0.1-0.2 g/day (Lu, [0039], page 7; as required for instant Claim 7).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instant application to combine the teachings of Liu et al. with those of Lu to arrive at the claimed invention. A skilled artisan would be able to combine the knowledge of efficacy against viruses in the in vitro study of Liu et al. with the in vivo data in chickens from Lu to arrive at the instantly claimed dosages and apply those to humans, based upon the knowledge that an ordinary skilled artisan would be able to consider therapeutic context, age, general health of the recipient, desired therapeutic effect, route of administration, and treatment duration to ascertain appropriate dosages (see e.g., instant specification at page 13, lines 28-31 and page 14, lines 1-4). A skilled artisan would have a reasonable expectation of success of administering the composition to humans due to the known low-toxicity in chickens when provided for a period of 15 days or less at a concentration of 0.1-1% (Lu, [0003], page 1), which could then be extrapolated to administration to humans indicated by the teachings of Liu et al., and as indicated by the instant specification.
Claims 1-7 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (Food Microbiol, 2018, 346-353) in view of Lu (CN 1042656 A) as applied to Claims 1-4, 7, and 26 above, and further in view of Seabrook, Jr., et al. (US 5,906,825).
The instant claims and teachings of Liu et al. and Lu are as of record.
Liu et al. and Lu do not teach wherein the composition further comprises other herbal compounds, extracts, or molecules.
Seabrook, Jr., et al. teach polymeric compositions that can destroy and inhibit the growth of microorganisms, including viruses (Seabrook, Jr., et al., Abstract, page 1). The compositions can comprise biocidal agents (herbal compounds, extracts, or molecules) from various plants, including Forsythia intermedia (forsythia), Prunella vulgaris (Spica prunellae), and Artemisia capillaris (Seabrook, Jr., et al., col. 13-15, pages 12-13; as required for instant Claims 5 and 6).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instant application to combine the teachings of Liu et al. and Lu with those of Seabrook, Jr., et al. because phytochemicals naturally occurring in plants can inhibit the growth of microorganisms, including viruses, bacteria, and fungi (Seabrook, Jr., et al., Abstract, page 1). A skilled artisan could therefore include these herbal compounds, extracts, or molecules in the instantly claimed composition not only to increase antiviral activity, but also to prevent fungal and bacterial growth with a reasonable expectation of success.
Claims 1-4, 7, 8, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (Food Microbiol, 2018, 346-353) in view of Lu (CN 1042656 A) as applied to Claims 1-4, 7, and 26 above, and further in view of Hua (Front Pharmacol, 2019, 16 pages).
The instant claims and teachings of Liu et al. and Lu are as of record.
Liu et al. and Lu do not teach wherein the composition is formulated for rectal administration.
Hua teaches that rectal drug administration is a practical alternative for both local and systemic actions (Hua, Abstract, page 1; as required for instant Claim 8).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instant application to combine the teachings of Liu et al. and Lu with those of Hua because rectal drug administration is a practical alternative when oral administration is not possible (Hua, Abstract, page 1), such as inability to hold down solids or liquids due to vomiting caused by viral gastroenteritis. A skilled artisan would therefore be motivated to provide the composition as taught by Liu et al. as a composition that could be administered rectally with a reasonable expectation of success.
Claims 1-4, 7, 26, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (Food Microbiol, 2018, 346-353) in view of Lu (CN 1042656 A) as applied to Claims 1-4, 7, and 26 above, and further in view of Seo et al. (Food Control, 2016, 25-30).
The instant claims and teachings of Liu et al. and Lu are as of record.
Liu et al. and Lu do not teach wherein the composition comprises quercetin.
Seo et al. teach that quercetin is an antiviral flavonoid capable of inhibiting feline calicivirus and murine norovirus (Seo et al., Table 2, page 28; as required for instant Claim 27).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instant application to combine the teachings of Liu et al. and Lu with those of Seo et al. to arrive at the instant invention. The knowledge of ability of quercetin to inhibit viruses that cause viral gastroenteritis in a subject would allow a skilled artisan to incorporate it in the claimed method with a reasonable expectation of success.
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's arguments filed 19 September 2025 have been fully considered but they are not persuasive.
Applicant argues that the amendment of Claim 1 to recite that the composition is administered to a human subject overcomes the prior art of Liu et al. and Lu because it is not possible to conclude that administration of a composition comprising dimeric procyanidin B2 to a human would successfully inhibit viral gastroenteritis caused by norovirus or sapovirus in a human. Applicant indicates that because the composition was administered to feline kidney cells (Liu et al.) and chickens (Lu), there is no reasonable expectation that a skilled artisan could identify an amount of the composition to administer to a human subject, nor would they be motivated to do so.
This argument is not persuasive because Liu et al. use the same method as presented in the instant specification of administering a composition comprising procyanidin B2 to feline kidney cells infected with feline calicivirus or murine norovirus using overlapping concentrations of 0.1-1.0% (instant specification, page 20, line 14) and 0.05-0.1% (Liu et al., section 2.2, page 347). Additionally, the instant specification indicates that a skilled artisan “considering the therapeutic context, age, and general health of the recipient, will be able to ascertain proper dosing (specification, page 13, lines 30-31).” Based upon the information presented in the instant specification and its similarity to that of Liu et al., a skilled artisan could therefor reasonably ascertain the dosages necessary for administration to a human subject.
Additionally, a skilled artisan would be motivated to refer to Lu as a reference for safe in vivo dosages in an animal (Lu, [0003], page 1) and further extrapolate that information to a human subject, in combination with the knowledge presented in Liu et al. regarding a composition comprising procyanidin B2 dimers and its efficacy against noroviruses, to reach the instantly claimed dosages with a reasonable expectation of success. This is particularly reinforced by the overlapping ranges of procyanidin B2 dimer concentration in the instant claims (0.1-1.0%, page 20, line 14), Liu et al. (0.05-0.1%, section 2.2, page 347), and Lu (0.1-6%, [0050], page 7). Varying the concentration of ingredients within a pharmaceutical composition (e.g., for administration to different species) is not considered to be inventive unless the concentration is demonstrated as critical. In this particular case, there is no evidence that the claimed concentration of the ingredients produces an unexpected result, particularly since the instant specification lacks data indicating criticality of specific amounts and/or concentrations of procyanidin B2 dimers to humans. Thus, absent some demonstration of unexpected results from the claimed parameter, this optimization of ingredient concentration would have been obvious before the effective filing date of applicant’s claimed invention. See MPEP § 2144.05(II)(A).
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Conclusion
No claims are allowed.
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/J.L.C./Examiner, Art Unit 1655
/AARON J KOSAR/Primary Examiner, Art Unit 1655