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 .
Claim Objections
Claim 1 is objected to because of the following informalities: immediately after “composition of” in line 4 there should be recited --- : ---. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: immediately after “volume” in line 5 there should be recited --- ; ---. Appropriate correction is required.
Claim 8 is objected to because of the following informalities: immediately after “composition of” in line 4 there should be recited --- : ---. Appropriate correction is required.
Claim 8 is objected to because of the following informalities: immediately after “volume” in line 5 there should be recited --- ; ---. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: immediately after “composition of” in line 4 there should be recited --- : ---. Appropriate correction is required.
Claim 20 is objected to as it does not contain any text. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 12 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 12 recites the limitation “the palatable substance" in the last line. There is insufficient antecedent basis for this limitation in the claim. Claim 8, from which it depends, recites a palatant. To obviate this issue, it is suggested for claim 12 to recite --- the palatant ---.
Claim Rejections - 35 USC § 103
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 8-19 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over The Chronicle of the Horse (“Gas and discomfort under saddle,” 07/17/2019) (hereinafter Chronicle).
Chronicle discloses treating gassy horses by administering finely grounded simethicone mixed into feed, or mixed with water in an oral syringe, to treat or prevent gas colic as needed. The composition may also be given up to three times a day to prevent gas colic (p. 2, § 1). The simethicone may be peppermint flavored (p. 3, bottom §, line 4). Exemplary dosage includes 125mg per 100 lbs. of body weight.
Accordingly, Chronicle discloses a method to prevent the onset of horse colic by administering to a horse a composition comprising simethicone, either as a powder mixed into animal feed, or as a liquid in an oral syringe, comprising peppermint flavor. Together these would provide a method as instantly claimed. The prior art is not anticipatory insofar as this combination must be selected from various lists/locations in the reference. It would have been obvious, however, to make the combination since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. See MPEP § 2143 (I)(A).
Regarding claims 8 and 15 reciting a volume of administration, although Chronicle does not explicitly disclose a volume per 400 pounds of body weight, it would have taken no more than the relative skills of one of ordinary skill in the art to have arrived at the claimed amounts (i.e. 1 ml to 1.2 ml per 400 body weight) through routine experimentation based on the amount of water and final volume desired. "[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." See MPEP § 2144.05(II)(A).
Regarding claims 8 and 12 reciting a mixing ratio, although Chronicle does not explicitly disclose a part per one hundred by volume of the simethicone or flavoring, it would have taken no more than the relative skills of one of ordinary skill in the art to have arrived at the claimed amounts (i.e. 50 to 99 parts, or 99 parts per one hundred simethicone by volume, respectively, and 1 to 50 parts, or 1 part per one hundred palatant by volume, respectively) through routine experimentation based on the level of flavoring desired. "[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." See MPEP § 2144.05(II)(A).
Regarding claims 9 and 16, Chronicle discloses administering as needed up to three times a day. Accordingly, instantly claimed administration and repeating the step of administering twice a day would have been obvious.
Regarding claims 10 and 17 , Chronicle discloses wherein the simethicone may be mixed with animal feed.
Regarding claims 11 and 18, Chronicle discloses wherein the simethicone may be delivered in an oral syringe.
Regarding claim 19, Chronicle discloses wherein simethicone may be mixed with water (i.e. a liquid).
Regarding claims 13 and 21, Chronicle discloses wherein simethicone tablets may be crushed and finely grounded (i.e. powder).
Regarding claim 14, Chronicle discloses wherein the simethicone may contain peppermint flavor (p. 3, bottom §, line 4).
Claims 8-12 and 14-19 are rejected under 35 U.S.C. 103 as being unpatentable over Wedgewood Pharmacy (“Simethicone,” 11/10/2020) (hereinafter Wedgewood).
Wedgewood discloses simethicone for horses for treating gas and bloating (p. 1). The simethicone is available in dosage forms including oral paste, suspension, and solutions, and may be administered orally using a dosing syringe or mixed with a small amount of food (i.e. feed). The simethicone dose may be flexibly adjusted, and may be optionally flavored (p. 2, § About). Exemplary flavors include apple or peppermint (p. 2, § Available).
Accordingly, Wedgewood discloses treating gas in horse by administering simethicone, which may be optionally flavored with peppermint (i.e. instantly claimed palatant), which would provide veterinary supplement compositions as instantly claimed. The prior art is not anticipatory insofar as this combination must be selected from various lists/locations in the reference. It would have been obvious, however, to make the combination since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. See MPEP § 2143 (I)(A).
Regarding claims 8 and 15 reciting preventing the onset of horse colic, as noted by para. [0020] of the instant Specification, horses with colic have an overaccumulation of gas in their intestines (“gas colic”). Thus the simethicone of Wedgewood for treating gas would be reasonably expected to prevent an overaccumulation of gas, thus preventing horse colic as instantly claimed.
Regarding claims 8 and 15 reciting a volume of administration, although Wedgewood does not explicitly disclose a volume per 400 pounds of body weight, it would have taken no more than the relative skills of one of ordinary skill in the art to have arrived at the claimed amounts (i.e. 1 ml to 1.2 ml per 400 body weight) through routine experimentation based on the dose desired. "[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." See MPEP § 2144.05(II)(A).
Regarding claims 8 and 12 reciting a mixing ratio, although Wedgewood does not explicitly disclose a part per one hundred by volume of the simethicone or flavoring, it would have taken no more than the relative skills of one of ordinary skill in the art to have arrived at the claimed amounts (i.e. 50 to 99 parts, or 99 parts per one hundred simethicone by volume, respectively, and 1 to 50 parts, or 1 part per one hundred palatant by volume, respectively) through routine experimentation based on the level of flavoring desired. "[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." See MPEP § 2144.05(II)(A).
Regarding claims 9 and 16 reciting a frequency of administration, although Wedgewood does not explicitly disclose a frequency of administration, it would have taken no more than the relative skills of one of ordinary skill in the art to have arrived at the claimed frequency (i.e. repeating the administration two times a day) through routine experimentation based on the level of gas/bloating relief desired. "[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." See MPEP § 2144.05(II)(A).
Regarding claims 10 and 17 , Wedgewood discloses wherein the simethicone may be mixed with a small amount of food (i.e. feed.
Regarding claims 11 and 18, Wedgewood discloses wherein the simethicone is contained in an oral syringe.
Regarding claim 19, Wedgewood discloses wherein the simethicone may be an oral suspension (i.e. liquid).
Regarding claim 14, Chronicle discloses wherein the flavors available for simethicone includes peppermint.
Claims 8-19 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over The Chronicle of the Horse (“Gas and discomfort under saddle,” 07/17/2019) (hereinafter Chronicle) in view of Wedgewood Pharmacy (“Simethicone,” 11/10/2020) (hereinafter Wedgewood).
The disclosure of Chronicle is discussed in detail in the rejection above. While Chronicle is believed to support a finding of obviousness, purely arguendo, for the purposes of complete prosecution, and for the purposes of this ground of rejection only, Chronicle will be interpreted as though it does not explicitly disclose a veterinary supplement composition of 100 parts per one hundred simethicone by volume.
However, Wedgewood discloses simethicone for horses for treating gas and bloating (p. 1). The simethicone is available in dosage forms including oral paste, suspension, and solutions, and may be administered orally using a dosing syringe or mixed with a small amount of food (i.e. feed). The simethicone dose may be flexibly adjusted, and may be optionally flavored (p. 2, § About). Exemplary flavors include apple or peppermint (p. 2, § Available).
Accordingly, it would have been obvious to one of ordinary skill in the art to have administered the simethicone without the optional flavoring since it is a known and effective way to deliver simethicone as taught by Wedgewood.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-19 and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11,986,492 in view of The Chronicle of the Horse (“Gas and discomfort under saddle,” 07/17/2019) (hereinafter Chronicle) and Wedgewood Pharmacy (“Simethicone,” 11/10/2020) (hereinafter Wedgewood).
Regarding claims 1-14, although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims recite a more specific embodiment of the pending claims and thus read on the pending claims.
In regard to claims 15-19 and 21, the patented claims differ from the pending claims insofar as not explicitly teaching all the features of the claimed invention, such as an 100 parts simethicone by volume.
However, these features are known in the art. As noted in the current rejections, the teachings of Chronicle render obvious claims 8-19 and 21, and the teachings of Wedgewood render obvious claims 8-12 and 14-19. Furthermore, the combined teachings of Chronicle and Wedgewood render obvious claims 8-19 and 21.
Therefore, as claims 1-10 of U.S. Patent No. 11,986,492, Chronicle and Wedgewood all disclose veterinary compositions comprising simethicone, it would have been prima facie obvious to one of ordinary skill in the art to have modified the copending application and to include the teachings of Chronicle and Wedgewood as discussed in the rejections above, because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as instantly claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." See MPEP 2144.06(I).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter:
Claims 1-7 are free of prior art. The closest prior art includes Sox, disclosing simethicone use in a level sufficient to treat ulcerative colitis; Chronicle, disclosing mixing simethicone tablets, available in peppermint flavor, in water, and administering to a horse to treat gassy horse and prevent colic; and Wedgewood, disclosing simethicone with optional flavoring for horse to treat gas. As explained by the Applicant’s Remarks filed 10/30/2023 in the parent Application, 17/949,576, horse colic is a specific disorder, not an inflammatory disorder, and Sox would not direct one to treat that particular disorder, let alone by administering prior to, or during, specific (stressful) situations preceding the onset of horse colic. In regard to Chronicle and Wedgewood, although Chronicle discloses mixing simethicone with water to administer to a horse to avoid gas colic, and Wedgewood discloses simethicone with optional flavoring, neither Chronicle or Wedgewood teach the specific combination of simethicone and sorbitol, in specific amounts per body weight of the horse.
It is noted that claim 1 is still objected to as containing minor informalities. Once the necessary corrections are made, however, claims 1-7 are allowable.
Conclusion
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/LUCY M TIEN/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612