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 .
Status of Claims
Claims 1-3, 6, 8, 10-12, 14-19, and 21 are pending.
Claim 21 is withdrawn.
Claims 4-5, 7, 9, 13, 20 and 22 are cancelled.
Priority
Applicant’s claim for benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. This application is a national stage entry of and claims priority to Application Serial No. PCT/US2020/013637, filed 01/15/2020, and further claims priority to provisional application 62/792,976, filed 01/16/2019.
Information Disclosure Statement
All references from IDS(s) received 11/21/2021, 02/22/2024, 09/20/2024, and 03/17/2025 have been considered unless marked with a strikethrough.
Response to Arguments
Applicant's arguments filed 10/20/2025 have been fully considered but they are not persuasive.
In a non-final dated 8/01/2025, Claims 1-3, 6, 8, 10-12, and 14-19 were examined upon their merits.
In a non-final dated 8/01/2025, Claims 1-3, 6, 8, 10-12, and 14-19 were rejected under 35 U.S.C. 103.
With respect to the 103 rejection for claims 1-3, 6, 8, 10-12, and 14-19, the applicant argues that the art provided by the Examiner (“Supamahitorn”, “Thor” and “Klem”) does not teach the use of the claimed dispersion in a calf and references the argument made in the prior office action. The applicant also argues that the prior art provided by the Examiner fails to teach administration of the compositions between 4-12 hours after birth of the calf. The applicant points out data in the Specification (Ex. 3, Table 6) where it shows this method lead to an “unexpected result” in improving illness and mortality in the calves. The Examiner maintains their original argument as no new argument has been presented for this point. The Examiner argues that the prior art does teach the limitatation of 4-12 hours, as previously stated in the rejection:
“Thor teaches the administration can be done as “as-needed dosing,” also known as “pro re nata,” “pm dosing,” and “on demand dosing or administration” which includes the administration of a therapeutically effective dose prior to commencement of an activity wherein suppression of a disorder would be desirable. For example, administration can be immediately prior to such an activity, including about 0 minutes, about 10 minutes, about 20 minutes, about 30 minutes, about 1 hour, about 2 hours, about 3 hours, about 4 hours, about 5 hours, about 6 hours, about 7 hours, about 8 hours, about 9 hours, or about 10 hours prior to such an activity, depending on the formulation (Page 33, p.0344). Although Thor suggests dosing from 0 to 10 hours which is an overlapping range with instant claim 1, the combination of references fail to teach dosing new born animals at overlapping times.”
Therefore, the prior art does teach overlapping time ranges with the instant claims. The unexpected result provided by the Applicant would be reconsidered by the Examiner if the Applicant could provide data that the 4-12 hour time period for administration show significant improvement from other time periods of administration, not just a placebo, as currently shown in Table 6.
The Applicant also briefly argues that “Supamahitorn provides no teaching that the recited compositions would function to treat or prevent enteritis in a newborn calf. Thor relates to a quaternary ammonium compositions and is silent as to combining the quaternary ammonium compound- clay dispersion or preventing enteritis and/or diarrhea in a newborn calf. Likewise, Klem as evidenced by Berchtold is completely silent as to using ammonium compound- clay dispersions to treat enteritis in a newborn calf” but does not provide an argument for why they believe this is true. The Examiner maintains her argument that it would have been prima facie obvious to use the composition taught by Supamahitorn and apply it to methods of treating bacterial enteritis/diarrhea, as taught by Thor and Klem. Further, it would have been prima facie obvious to extract the dispersion composition taught by Supamahitorn and use it to prevent or treat enteritis and/or diarrhea in an animal, such as young calves, as taught by Thor and Berchtold.
Therefore, the 103 rejection is maintained, see below.
MAINTAINED REJECTIONS
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.
Claim(s) 1-3, 6, 8, 10-12, and 14-19 are rejected under 35 U.S.C. 103 as being unpatentable over Supamahitorn et al (US8858970B2; cited in IDS filed 2/22/2024; “Supamahitorn”) in view of Thor et al (US20060293309A1; cited in IDS filed 2/22/2024; “Thor”) and in view of Klem, F. et al. (Gastroenterology 2017; 152:1042-1054; “Klem”) as evidenced by Berchtold et al. (Food Animal Practice. 2009, 520–525; “Berchtold”).
Supamahitorn teaches a composition comprising a dispersion, said dispersion comprising a dispersed phase within an aqueous phase, said composition comprising: a hydrophilic clay having binding sites in said dispersed phase and a quaternary ammonium compound in said dispersed phase (Claim 1), as required by instant claim 1. The hydrophilic clay can comprise one or more of smectite, LAPONITE® and bentonite (Col. 4, Lines 8-10), and the quaternary ammonium compound is benzethonium chloride (Claim 2) as required by instant claims 2-3.
Supamahitorn also teaches the composition to comprise an antimicrobial agent, an analgesic, an anti-fungal agent, or an anti-inflammatory agent (Claim 10), as required by instant claim 12, as well as emollient, detackifier, moisturizer, thickener, or chelating agent (Claim 9), as required by instant claim 14.
Supamahitorn also teaches the composition to be made by a method of dry mixing the hydrophilic clay and quaternary ammonium compound to produce a mixture, followed by adding water to said mixture to form a suspension, and incubating said suspension in said water to form an antimicrobial composition (Claim 1), as required by instant claim 15.
Supamahitorn teaches in some embodiments, the invention provides for the use of any of the compounds for the preparation of a medicament for treating a disease or condition (e.g., a disease or condition caused by a bacteria, virus, or fungi) (Col. 5, Lines 50-54).
Supamahitorn fails to teach a method of using the composition to treat or prevent enteritis in an animal; however, it does teach that the composition can be used for treating an infection (Col 5, line 55-58).
As evidenced by Klem, enteritis can be caused by bacterial infection (Results paragraph). Furthermore, Klem teaches a study in which patients with infectious enteritis often later developed irritable bowel syndrome.
Along this line, Thor teaches a method for treating disorders, such as functional bowel disorders (Claim 40), diarrhea and enteritis (page 13, p. 0161), as well as irritable bowel syndrome (page 1, p. 003) with a quaternary ammonium compound (Claim 1). As evidenced by Klem, irritable bowel syndrome and enteritis are likely caused by bacterial infections, in which the composition of Supamahitorn is taught, rendering the following teachings by Thor relevant, with respect to instant claims 16 and 17.
Thor teaches a method of treating enteritis, which can be done through intravenous administration (Page 24, p. 0263), as required by instant claim 11, as well as used in animals including bovine (page 7, p. 0068), as required by instant claims 1. As evidenced by Berchtold, diarrhea in preweaned (a period within the first few weeks of life) calves is by far the leading cause of mortality in dairy heifer calves (Clinical Importance paragraph). Therefore, with respect to instant claim 1, it would be obvious to one skilled in the art at the time to extract the genus term of “bovine” taught by Thor, which includes cattle and calves, and specifically apply it to cases in which the calf is less than 1 month old. This logic is also applied to the proceeding examination of instant claims 6, 8, and 18-19.
Thor teaches that the continuous dosing of the dispersion can be dosed from about 0.001 mg to about 1000 mg (Page 34, p.0349) and administered every day, every other day, every two days, etc. (Page 34, p.0350), as required by instant claims 19 and 6, respectively. Thor teaches the administration can be done as “as-needed dosing,” also known as “pro re nata,” “pm dosing,” and “on demand dosing or administration” which includes the administration of a therapeutically effective dose prior to commencement of an activity wherein suppression of a disorder would be desirable. For example, administration can be immediately prior to such an activity, including about 0 minutes, about 10 minutes, about 20 minutes, about 30 minutes, about 1 hour, about 2 hours, about 3 hours, about 4 hours, about 5 hours, about 6 hours, about 7 hours, about 8 hours, about 9 hours, or about 10 hours prior to such an activity, depending on the formulation (Page 33, p.0344). Although Thor suggests dosing from 0 to 10 hours which is an overlapping range with instant claim 1, the combination of references fail to teach dosing new born animals at overlapping times.
However, it would have been prima facie obvious to use an antibiotic on pre-weened calves in order to reduce diarrhea as suggested by Berchtold.. “[e]vidence-based recommendations for the administration of antimicrobial agents in diarrheic calves..” (Clinical Importance paragraph), so one skilled in the art would dose the calf population in order to minimize mortality in the population. Therefore, the concept of “as-needed dosing” for the specific purpose of administration prior the commencement of an activity where suppression of the illness is desirable, as taught by Thor, in combination with the suggestions of Berchtold inherently teaches the requirements of instant claims 1, 8, and 18. It would be obvious to a person skilled in the art to administer the dispersion to a subject in need thereof during time periods in where it would best achieve the desired effect.
Along the same line, Thor teaches that oral administration of the dispersion can be done in a solid or liquid state. Thor does not directly teach administration in milk replacers or water, however, Berchtold teaches that the route of administration can include being dissolved in milk, oral electrolyte solutions, water, or milk replacers (Page 3, “Success of antimicrobial therapy” p. 2) which teaches the requirements of instant claim 10. Furthermore, adjusting the dosing periods and administration methods would be considered routine optimization of variables. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955): "[W]here 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."
The Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham.
Examples of rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) "Obvious to try" – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Applying KSR example rationale (A) it would have been prima facie obvious to use the composition taught by Supamahitorn and apply it to methods of treating bacterial enteritis/diarrhea, as taught by Thor and Klem. Further, it would have been prima facie obvious to extract the dispersion composition taught by Supamahitorn and use it to prevent or treat enteritis and/or diarrhea in an animal, such as young calves, as taught by Thor and Berchtold. Finally, it would have been obvious from the teachings of Thor and Berchtold to administer the dispersion composition taught by Supamahitorn in administration timing, method, and dosing to best achieve the desired effect. Therefore, claims 1-3, 6, 8, 10-12, and 14-19 would have been obvious to a person who is skilled in the art prior to the effective filing date.
Conclusion
Claims 1-3, 6, 8, 10-12, and 14-19 are rejected.
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.
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/N.M.B./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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