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 .
Detailed Action
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12 June 2024 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner. See attached copy of PTO-1449.
Status of Application
2. The instant application is a Divisional of Application 16/770996 (now U.S. Patent 12,041,950) filed 9 June 2020, which is a national stage entry of PCT/EP2018/085191 filed 17 December 2018. Claims 1-21 are currently pending and examined on the merits within.
Claim Rejections – 35 U.S.C. 112(b) Rejections
3. 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.
4. Claims 6 and 15 are 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.
5. Claim 6 recites “wherein the uniform mixture comprises at least 5 wt.% based on the total weight of the uniform mixture, of (i) the powderous formulation and (ii) the silica”. This depends from claim 1 wherein (i) describes the powderous formulation comprising the compound according to formula (I) and silica and (ii) describes at least one inorganic carbonate. Thus it is unclear if component (ii) in claim 6 is directed to the at least one inorganic carbonate or silica. Clarification is requested.
6. Claim 15 recites the limitation "the edible oil" in line 1. There is insufficient antecedent basis for this limitation in the claim. It is believed the claim should instead depend from claim 12 or 13.
Claim Rejections – 35 U.S.C. 103
7. 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.
8. Claim(s) 1-13 and 15-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Guyader et al. (Front Microbiol. 2017).
Guyader et al. teach a composition comprising 0.05% 3-nitrooxypropanol (NOP), 0.38% carrier comprising 60% SiO2 and 40% propylene glycol, and 4.5% calcium carbonate. See Table 1. This equates to a premix comprising 5.64% nitrooxypropanol and silica and 91.28 % inorganic carbonate. Calculation of NOP and silica: 0.6 x 0.38 = 0.228 + 0.05 = 0.278/4.93 = 0.056 x 100 = 5.64%. Calculation of inorganic carbonate: 4.5/4.93 = .91 x 100 = 91.28%. The ratio of inorganic carbonate to powderous formulation is about 10.5:1 (4.5/(0.05+0.38)). See Table 1. NOP is present in 11.63% (0.05/0.43 x 100), silica is present in 53.02% (0.6 x 0.38 = 0.228/0.43 x 100), and propylene glycol (edible oil) is present in 35.35% (0.4 x 0.38 = 0.152/0.43 x 100) of the powderous formulation. See Table 1. The composition additionally comprises corn silage, barley grain and dicalcium phosphate (mineral). See Table 1. The active compound and carrier of NOP were added to the vessels comprising substrates that had been premixed. See page 3.
It would have been well within the purview of the skilled artisan as of the effective filing date of the invention to combine the ingredients to form a uniform mixture in order to achieve homogeneity to allow for a more consistent release of active ingredient. Since Guyader et al. teach the same combination of ingredients, the composition should function in the same manner, i.e., retain the compound of Formula 1 by at least 95% after 4 weeks. 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).
9. Claim(s) 14 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Guyader et al. (Front Microbiol. 2017) as applied to claims 1-13 and 15-20 and further in view of Varner et al. (U.S. Patent Application Publication No. 2015/0272167).
Guyader et al. do not teach the addition of either xanthan gum, karaya gum or ethylcellulose.
Varner et al. teach ruminant feed compositions including food safe viscosifiers such as xanthan gum, karaya gum and various types of celluloses. See paragraph [0048]. Viscosifiers are required at different levels depending on efficacy in the particular combination targeted and desired consistency. See paragraph [0049]. The composition additionally comprises barley grains, vitamins, minerals, etc. See paragraphs [0015] and [0027].
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to add thickeners such as xanthan gum, karaya gum or ethyl cellulose to the formulation of Guyader et al. to achieve a desired consistency of the composition. One would have been motivated, with a reasonable expectation of success, because Varner et al. teach that xanthan gum, karaya gum and cellulose derivatives are effective and safe in ruminant feed compositions.
Double Patenting
10. 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
11. Claims 1-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 26-31 of copending Application No. 16/771004.
Both the instant application and Application No. 16/771004 are directed to methods of improving retention of compound of formula (I) comprising forming a uniform mixture of the compound of Formula 1, silica and an additional component. In the instant application the additional component is an inorganic carbonate. Application No. 16/771004 is directed to an inorganic phosphate. However the instant specification teaches the addition of inorganic phosphate. See Table 2. Thus the two are not patentably distinct. The dependent claims of both applications are directed to similar functional parameters upon storage and are included in this rejection.
This is a provisional nonstatutory double patenting rejection.
12. Claims 1-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15-21 of U.S. Patent No. 12,472,161.
Both the instant application and U.S. Patent No. 12,472,161 are directed to methods of improving retention of compound of formula (I) comprising forming a uniform mixture of the compound of Formula 1 and an additional agent. The additional agent of the instant application is an inorganic carbonate. The additional agent of U.S. Patent No. 12,472,161 is directed to rice hull or rice bran. However, the instant application states that rice bran is a known component of roughage. See paragraph [0110]. Thus the two are not patentably distinct. The dependent claims of both applications are directed to similar amounts of each ingredient and functional parameters upon storage conditions and thus are included in the rejection.
13. Claims 1-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of copending Application No. 18/827625.
Both the instant application and Application No. 18/827625 are directed to improving the retention of the compound of Formula 1 by creating a uniform mixture comprising a compound of Formula 1, silica and an additional agent. The additional agent of the instant application is an inorganic carbonate. The additional agent of Application No. 18/827625 is directed to starch. However, the instant application states that starch is a known component of roughage. See paragraph [0110].Thus the two are not patentably distinct. The dependent claims of both applications are directed to functional parameters upon storage conditions and are included in the rejection.
This is a provisional nonstatutory double patenting rejection.
Conclusion
14. No claims are allowed at this time.
15. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA WORSHAM whose telephone number is (571)270-7434. The examiner can normally be reached Monday-Friday (8-5).
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/JESSICA WORSHAM/Primary Examiner, Art Unit 1615
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