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 .
This office action is in response to the application filed on April 25, 2024.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d) with filing dates of March 28, 2017 and August 15, 2017. The certified copies of AU2 017901105 and AU 2017903261 have been filed in the parent application, US Application 16/499,155, received on September 27, 2019.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
The present application is a divisional application of US Patent Application 16/499,155 that has currently been abandoned.
Status of Application
Claims 1-22 are pending. Claims 1-22 are presented for examination.
Information Disclosure Statement
The information disclosure statement filed February 12, 2025 fails to comply with the provisions of 37 CFR 1.98(a)(4) because it lacks the appropriate size fee assertion. It has been placed in the application file, but the information referred to therein has not been considered as to the merits.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it is less than 50 words. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 1, 17, 19, and 20 objected to because of the following informalities:
Claim 1 recites “E. coli, Eimeria, Clostridium and Salmonella,” these names should all be italicized.
Claims 17 and 19 recite “Eimeria” and “C. perfringens,” respectively, these names should also be italicized.
Claim 20 recites “wherein animal is a chicken,” should read “wherein the animal is a chicken.”
Appropriate correction is required.
Claim Interpretation
The preamble of claim 1 recites “a method for reducing the feed conversion ratio in a food-producing animal, which is infected or may become infected with an antibiotic-resistant strain of a disease-causing microorganism selected from the group consisting of E. coli, Eimeria, Clostridium and Salmonella.” The recitation of “for reducing the feed conversion ratio in a food-producing animal” is considered to be a mere statement of purpose or use and is therefore not considered to limit the structure of the claimed invention and will not be treated as a claim limitation.
The recitation of “a food-producing animal, which is infected or may become infected with…Salmonella,” will be interpreted as any animal, as any animal may indeed become infected with any bacteria, disease, microorganism, or otherwise.
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.
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 1-9 and 11-22 are rejected under 35 U.S.C. 103 as being unpatentable over Jin et al. (US PG Pub. 2007/0027176) in view of Wang et al. (US PG Pub. 2010/0239603), herein after referred to as Jin and Wang respectively.
Regarding claims 1, 11, 12, 15, 16, 19, and 20, Jin discloses a method comprising administering to a chicken (i.e., a food-producing animal) an animal feed comprising an animal feedstuff [0059] and a composition in granular form [0047] consisting essentially of berberine chloride (i.e., an antimicrobial active ingredient), wherein the berberine chloride is in a concentration of 10-50 ppm in the animal feed [0059], which is equivalent to 0.001-0.005 wt. %. Jin also discloses that berberine inhibits Clostridium perfingens bacteria [0034], which in turn may cause an infection of an antibiotic-resistant strain of a disease-causing microorganism, since Clostridium perfingens bacteria is a disease-causing microorganism.
Jin does not teach that the granular composition also comprises cornstarch or polyvinylpyrrolidone.
Wang, in the same field of invention, teaches administering to an animal an animal feed comprising both berberine chloride and corn starch (Table 1; [0051). Wang offers the motivation that the starch may act as either a binder or a disintegrant for the berberine administration [0027]. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the granular composition of Jin by incorporating the corn starch of Wang, thereby arriving at the claimed invention. One would have been motivated to make this modification for the benefit of adding a binder to the granular composition for easier administration.
Regarding claims 2 and 4, Jin teaches that after the treatment period, no berberine chloride (i.e., antimicrobial active ingredient) residue was found in the meat (i.e., muscle tissue) of the chickens [0061], which meets the claimed limitations of below about 13, or 2 ng per g of muscle tissue.
Regarding claim 3, Jin is silent as to that the residue level is about 10 ng per g of muscle tissue. However, where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). Since the method of the prior art is substantially identical to that of the claimed method, the prior art method and composition must necessarily possess the same properties and characteristics as the method and composition claimed. Therefore, the method and composition taught by Jin is considered to possess the residue level as claimed because the method and composition is substantially the same and thus must necessarily exhibit the same properties.
Regarding claim 5, Jin teaches that the berberine chloride (i.e., antimicrobial active ingredient) is administered to the chicken (i.e., food-producing animal) at a dose of 10-50 ppm [0059]. This is equivalent to 0.01-0.05 g/kg, which overlaps with the claimed range of about 0.03 to about 0.3 g/kg, and where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). See MPEP 2144.05.I.
Regarding claim 6, Jin teaches that the berberine chloride (i.e., antimicrobial active ingredient) is administered to the chicken (i.e., food-producing animal) at a dose of 10-50 ppm [0059]. This is equivalent to 0.01-0.05 g/kg, which does not overlap or lie within the claimed range of about 0.1 to about 0.3 g/kg, but is close. Per MPEP 2144.05.I., a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). The difference between the claimed range and that taught by the prior art is virtually negligible absent any showing of unexpected results or criticality.
Regarding claim 7, Jin teaches that the berberine chloride (i.e., antimicrobial active ingredient) is administered to the chicken (i.e., food-producing animal) at a dose of 10-50 ppm [0059]. This is equivalent to 0.01-0.05 g/kg, which does not overlap or lie within the claimed amount of about 0.3 g/kg.
However, differences in concentration or temperature will generally not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. Where 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.II.A. Concentration/dose of an antimicrobial active ingredient in a method for treating an animal is a result effective variable, as the concentration/dose of the active ingredient is known to affect the outcome and treatment of the animal. Thus, it would have been well within the skill set of one of ordinary skill in the art to have performed a routine optimization on the result effective variable, the dosage of the active ingredient, until achieving the desired output.
Regarding claims 8 and 9, Jin teaches that the animal feed is administered for a treatment period of 36 days (i.e., a little over 5 weeks) ([0059]-[0060]) and is for prevention of infection in the chicken [0034]. The treatment period taught by Jin is one day longer than that of claim 9, however, the treatment period length is close, and a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). The difference between the claimed range and that taught by the prior art is virtually negligible absent any showing of unexpected results or criticality.
Regarding claim 13, Jin teaches that the chickens are normal chickens [0059] and thus are considered to be free of disease.
Regarding claim 14, Jin teaches that piglets (i.e., food-producing animal) were sick (i.e., diseased) and then treated.
Regarding claims 17 and 18, Jin is silent as to that the disease-causing microorganism is Eimeria, but does teach that the animal is a chicken [0059]. However, since independent claim 1 recites that the animal “may become infected with…Eimeria,” any animal is considered to be an animal that may become infected by Eimeria.
Regarding claims 21 and 22, Jin teaches that the berberine chloride is in a concentration of 10-50 ppm in the animal feed [0059], which is equivalent to 0.001-0.005 wt. %, which lies within the claimed ranges of 0.0001-0.2 wt.% and 0.001-0.2 wt.%.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Jin et al. (US PG Pub. 2007/0027176) in view of Wang et al. (US PG Pub. 2010/0239603), as applied to claim 1 above, and further in view of Chae et al. (“Growth-Inhibiting Effects of Coptis japonica Root-Derived Isoquinoline Alkaloids on Human Intestinal Bacteria,” Journal of Agricultural and Food Chemistry, vol. 47, p. 934-938, 1999), herein after referred to as Chae.
Modified Jin teaches the method as claimed as set forth above with regard to claim 1.
Modified Jin is silent as to that the antimicrobial active ingredient is berberine hemisulfate.
Chae, in the same field of invention, teaches berberine sulfate (an equivalent name for berberine hemisulfate) as a growth-inhibiting alkaloid for various intestinal bacteria (Abstract). Chae offers the motivation that berberine sulfate is effective at inhibiting Clostridium perfringens bacteria (Abstract; Table 4). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have used the berberine sulfate of Chae in place of the berberine chloride of modified Jin. One would have been motivated to make this modification because berberine chloride and berberine sulfate are both known alkaloids that inhibit bacterial growth and are suitable equivalents that can be substituted for the same purpose.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAURA E SWEENEY whose telephone number is (571)272-0244. The examiner can normally be reached M-F 8:00-5:00 EST.
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/M.E.S./Examiner, Art Unit 1791
/Nikki H. Dees/Supervisory Patent Examiner, Art Unit 1791