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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1/02/2026 has been entered.
Status of claims
Claims 1, 6, 11-19, 21-25 as amended and new claims 26-29 as filed on 1/02/2026 are currently pending.
Claims 13-15 are/remain withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected invention (method of using).
{Notes: Claims 11-15, as originally filed, were withdrawn from consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions (method of making and method of using). Applicant timely traversed the restriction requirement in the reply filed on 4/03/2024. However, Claims 11 and 12 were amended to be drawn to a composition; thereby, were rejoined with the composition claims in the previous office action}.
Claims 1, 6, 11, 12, 16-19, 21-25 as amended and new claims 26-29 as filed on 1/02/2026 are under examination in the instant office action.
Claim Objections
Claim 29 is objected to because of the following informalities:
Claim 29 contains a typing error in the name of bacteria Bacillus amyloliquefaciens.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
Indefinite
Claims 1, 6, 11, 12, 16-19, 21-25 as amended and new claims 26-29 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.
Claim 1 as amended is rendered indefinite by insertion of 3 phrases “further” (claim 1, lines 9, 11 and 13) because in the first independent claim the use of phrase “further” creates uncertainty with regard whether the “further” limitation is mandatory or optional.
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.
Claims 1, 6, 16, 19, 23 and 24 as amended are rejected under 35 U.S.C. 103 as being unpatentable over CN 104171682 (Wang Kui et al), CN 101791070 (Xiaojie Wang et al) and US 11,197,902 (Grant et al).
Notes: As applied to limitation drawn to incorporation of carbonate, bicarbonate and acid: the presence of these components in the claim 1 is optional by the virtue of the language “further”.
The cited document CN 104171682 discloses an animal feed composition comprising: 1) 5-25% of betaine salt; and 2) 10-60% of probiotic bacteria (see English abstract). The cited composition also contains additional ingredients including “polyfunctional” acid gamma-aminobutyric acid (abstract) and antioxidants (par. 0039, last line). The bacterial probiotics include Bacillus subtills and Bacillus licheniformis (translation par. 0018, 0032). The CFU amount of probiotics are 108 - 1012 CFU/g (par. 0019). The cited CN 104171682 clearly recognizes that all probiotics including various representatives of the Bacillus genus improve animal digestive health and inhibit harmful pathogens (par. 0033-0034). The cited CN 104171682 clearly recognizes that the composition with betaine and bacterial probiotics as a whole accelerate animal growth. The form of the composition is generic.
In particular, in the composition of the cited CN 104171682 the amount of betaine is lower than it is recited in the pending claims. However, the prior art, for example: CN 101791070, recognizes the importance of betaine in a form of betaine hydrochloride as an effective feed additive (0013) and it teaches incorporation of betaine in a form of betaine hydrochloride in amount 30% and up to 98% (0011).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the claimed invention was filed to increase amounts of betaine in an animal feed additive composition of CN 104171682 as taught/suggested by CN 101791070 with a reasonable expectation of success in providing a proper animal feed because prior art recognizes the importance of betaine or betaine hydrochloride as an effective feed additive and teaches incorporation of betaine in amount above 30% and up to 98%.
Thus, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.
The claimed subject matter fails to patentably distinguish over the state art as represented be the cited references. Therefore, the claims are properly rejected under 35 USC § 103.
As applied to limitation drawn to a tablet as a form of the composition: The composition of the cited CN 104171682 with betaine and probiotics appears to be a packaged mixture (0039). The specific form of the feed composition with betaine of the cited CN 104171682 is generic. The feed composition with betaine of the cited CN 101791070 provided as granules (0048). However, the prior art clearly teaches and suggests that compositions for feeding animals comprising probiotics including bacteria from the Bacillus subtilis group in amount about 1010 CFU/g are provided in forms such as compressed tablets, dissolve tablets, effervescent tablets (see US 11,197,902 (Grant et al) at abstract, at col. 5, lines 23-24; col. 8, line 1 and lines 55 and 63; col. 8, line 66).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the claimed invention was filed to provide a feed composition with probiotics as a tablet because tablet is a common form for feed nutritional or feed composition as evidenced by the cited US 11,197,902 (Grant et al).
Thus, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.
The claimed subject matter fails to patentably distinguish over the state art as represented be the cited references. Therefore, the claims are properly rejected under 35 USC § 103.
As applied to claim 24: a feed composition with probiotics in a form of a tablet is conventional; and the tablet can dissolve as evidenced by the cited US 11,197,902 (Grant et al); for example: see at col. 5, line 23).
The claimed subject matter fails to patentably distinguish over the state art as represented be the cited references. Therefore, the claims are properly rejected under 35 USC § 103.
As applied to limitation drawn to incorporation of carbonate, bicarbonate and acid: the presence of these components in the claim 1 is optional by the virtue of the language “further”.
Claims 1, 6, 16-19, 21-24 as amended and new claims 26-28 are rejected under 35 U.S.C. 103 as being unpatentable over CN 104171682 (Wang Kui et al), CN 101791070 (Xiaojie Wang et al) and US 11,197,902 (Grant et al) as applied to claims 1, 6, 16, 19, 23 and 24 above, and further in view of CN 105961886 (Wu Hongmei) and RU 2 652 824.
The cited documents CN 104171682 (Wang Kui et al), CN 101791070 (Xiaojie Wang et al) and US 11,197,902 (Grant et al) as above.
The disclosure by the cited documents is silent about incorporation of carbonate and/or bicarbonates into animal feed compositions. The disclosure by the cited documents is silent about incorporation of citric acid.
However, CN 105961886 (Wu Hongmei) discloses a composition intended for providing an animal feed, wherein the composition comprises betaine and baking soda or sodium bicarbonate in amount 5-20% (see English abstract), wherein the baking soda provides for maintaining normal osmotic pressure and acid-base balance (translation par. 0030).
The cited document RU 2 652 824 teaches incorporation of citric acid into animal feed compositions together with betaine, carbonate/bicarbonate salts and probiotics bacteria (see English abstract). In a particular embodiment of the cited RU 2 652 824 the citric acid is in amount 5% (table on page 4).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the claimed invention was filed to add sodium carbonate and bicarbonate salts to the animal feed compositions of CN 104171682 (Wang Kui et al) and CN 101791070 with a reasonable expectation of success in providing a proper animal feed because sodium bicarbonate and carbonate provide for normal acid-base balance and they are effective as buffering or pH modifying agents. It would be obvious to one of skill in the art to optimize amounts of sodium bicarbonate and sodium carbonate as to provide for normal pH or normal acid-base balance depending on specific conditions of feed or water required by animals.
It would have been obvious to one having ordinary skill in the art at the time the claimed invention was filed to add incorporate citric acid into animal feed compositions with a reasonable expectation of success in providing a proper animal feed because prior art teaches incorporation of citric acid into animal feed compositions together with betaine, carbonate/bicarbonate salts and probiotics bacteria as adequately demonstrated by the cited document RU 2 652 824.
Thus, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.
The claimed subject matter fails to patentably distinguish over the state art as represented be the cited references. Therefore, the claims are properly rejected under 35 USC § 103.
Claims 1, 6, 16-19, 21-28 are rejected under 35 U.S.C. 103 as being unpatentable over CN 104171682 (Wang Kui et al), CN 101791070 (Xiaojie Wang et al), US 11,197,902 (Grant et al), CN 105961886 (Wu Hongmei) and RU 2 652 824 as applied to claims 1, 6, 16-19, 21-24 and 26-28, and further in view of US 8,394,288 (Nurmi et al).
The cited CN 104171682 (Wang Kui et al), CN 101791070 (Xiaojie Wang et al), US 11,197,902 (Grant et al), CN 105961886 (Wu Hongmei) and RU 2 652 824 as above. These cited references are silent about incorporation of silica into compositions comprising betaine.
But US 8,394,288 (Nurmi et al) teaches that betaine is used in animal feed, that betaine is highly hydroscopic and poorly flowable in humid conditions and that hydrophobic silica is added to improve hydroscopic amd fluidity of solid hydroscopic material such as betaine in animal feed, pharmaceuticals and food (see col. 2, lines 21-23 and 35-45).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the claimed invention was filed to incorporate silica into betaine-containing compositions including animal feed compositions with a reasonable expectation of success in providing a proper animal feed with improved properties of hydroscopic betaine as adequately taught/suggested by US 8,394,288 (Nurmi et al).
Thus, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.
The claimed subject matter fails to patentably distinguish over the state art as represented be the cited references. Therefore, the claims are properly rejected under 35 USC § 103.
Claims 1, 6, 11,12, 16-19, 21-28 are rejected under 35 U.S.C. 103 as being unpatentable over CN 104171682 (Wang Kui et al), CN 101791070 (Xiaojie Wang et al), US 11,197,902 (Grant et al), CN 105961886 (Wu Hongmei), RU 2 652 824 and US 8,394,288 (Nurmi et al) as applied to claims 1, 6, 16-19, 21-28 above, and further in view of Grymonpre et al (International Journal of Pharmaceutics. 2018, 548, pages 54-61).
The cited CN 104171682 (Wang Kui et al), CN 101791070 (Xiaojie Wang et al), US 11,197,902 (Grant et al), CN 105961886 (Wu Hongmei), RU 2 652 824 and US 8,394,288 (Nurmi et al) as above. These cited references are silent about products made by compacting powders into tablets.
But the cited reference by Grymonpre et al teaches that powder compression is common and widespread in various industries including pharmaceuticals, that powder compression into tablets is the most popular manufacturing practice for its ease, high economic efficiency, convenience in use, critical accuracy in desired dosages (see page 54 at introduction) and that common compression force is about 15 kN (page 55, col.2, lines 4) which is within the claimed range of claim 12 as amended.
Therefore, it would have been obvious to one having ordinary skill in the art at the time the claimed invention was filed to provide betaine-containing compositions including animal feed compositions as “compressed” tablet with a reasonable expectation of success in providing convenient animal feed and/or pharmaceuticals with accurate dosage because it is widespread, common, routine and convenient practice as adequately taught/suggested and evidenced by Grymonpre.
Thus, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.
The claimed subject matter fails to patentably distinguish over the state art as represented be the cited references. Therefore, the claims are properly rejected under 35 USC § 103.
Claims 1, 6, 11,12, 16-19, 21-28 as amended and new claim 29 are rejected under 35 U.S.C. 103 as being unpatentable over CN 104171682 (Wang Kui et al), CN 101791070 (Xiaojie Wang et al), US 11,197,902 (Grant et al), CN 105961886 (Wu Hongmei), RU 2 652 824, US 8,394,288 (Nurmi et al) and Grymonpre et al (International Journal of Pharmaceutics. 2018, 548, pages 54-61) as applied to claims 1, 6, 11,12, 16-19, 21-28 above, and further in view of US 10,959,447 (Hargis et al).
The cited CN 104171682 (Wang Kui et al), CN 101791070 (Xiaojie Wang et al), US 11,197,902 (Grant et al), CN 105961886 (Wu Hongmei), RU 2 652 824, US 8,394,288 (Nurmi et al) and Grymonpre et al (International Journal of Pharmaceutics. 2018, 548, pages 54-61) as above.
The cited CN 104171682 (Wang Kui et al) discloses an animal feed composition comprising: 1) 5-25% of betaine salt; and 2) 10-60% of probiotic bacteria (see English abstract). The bacterial probiotics belong Bacillus including Bacillus subtills and Bacillus licheniformis (translation par. 0018, 0032) in amounts 108 - 1012 CFU/g (par. 0019).
The cited CN 104171682 is silent incorporation Bacillus amiloliquefaciens into animal feed composition.
However, probiotic formulations in animal feed comprise bacterial probiotics belonging to Bacillus amiloliquefaciens in amounts about 1010 CFU/g (par. 0019) that are provided in pelleted forms or as tablets for the benefits in improving animal digestion and improving nutrition. For example: see US 10,959,447 (Hargis et al) at col.19-20.
Therefore, it would have been obvious to one having ordinary skill in the art at the time the claimed invention was filed to incorporation a species of Bacillus amiloliquefaciens into the Bacillus probiotic-containing composition of the cited CN 104171682 (Wang Kui et al) with a reasonable expectation of success in providing animal feed with beneficial effects in improving animal digestion and improving animal nutrition because probiotic formulations in animal feed comprise bacterial probiotics belonging to Bacillus amiloliquefaciens for the benefits in improving animal digestion and improving nutrition as adequately demonstrated by US 10,959,447 (Hargis et al).
Thus, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.
The claimed subject matter fails to patentably distinguish over the state art as represented be the cited references. Therefore, the claims are properly rejected under 35 USC § 103.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 24 as amended remains/is rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more.
The claim recites an aqueous solution, wherein tablet is dissolved, and, thus, is reverted to a simple mixture of natural ingredients comprising betaine salt and a microorganism belonging to Bacillus. All Bacillus bacterial species are naturally occurring bacteria that would be found in gut or fecal samples. Betaine is a natural compound found in various organisms including plants (sugar beets; for example), animals and microorganisms. Bacteria including Bacillus are present on plants. Thus a combination of betaine and microorganisms including Bacillus is found/present in natural environment.
This judicial exception is not integrated into a practical application because claimed elements in combination do not add a meaningful limitation or extra-solution to the claimed product, and the claimed product as a whole is nothing more than an attempt to generally link the product of nature to a particular technological environment.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because when considered separately and in combination, they do not add significantly more (also known as an “inventive concept”) to the exception.
Response to Arguments
Applicant's arguments filed on 1/02/2026 have been fully considered but they are not found persuasive.
With regard to claim rejection under 35 USC § 103 Applicants’ main argument (response page 9) is that the cited prior art does not teach or suggest incorporation of betaine salt in amount 40-75% or prior art does not teach and suggests increase in betaine amount in the composition of the primary reference CN 104171682 (Wang Kui et al).
This argument is not found persuasive because the secondary reference CN 101791070 teaches incorporation of betaine in amount 30% and up to 98% into an animal feed composition and it recognizes the importance of betaine in a form of betaine hydrochloride as an effective feed additive (0013).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the claimed invention was filed to increase amounts of betaine in an animal feed additive composition of CN 104171682 as taught/suggested by CN 101791070 with a reasonable expectation of success in providing a proper animal feed because prior art recognizes the importance of betaine or betaine hydrochloride as an effective feed additive and teaches incorporation of betaine in amount above 30% and up to 98%.
Applicants further argue (response pages 10-11) that the cited references do not teach or suggest a tablet with all claimed ingredients in the claimed ranges.
This argument is not found convincing because the cited references describe all claimed ingredients in the animal feed compositions in various combinations. It would be obvious to one of skill in the art to optimize amounts of claimed components, in particular, sodium bicarbonate and sodium carbonate as to provide for normal pH or normal acid-base balance depending on specific conditions of feed or water required by animals.
With regard to claim rejection under 35 U.S.C. 101 Applicants argue that the re no evidence that all claim-recited ingredients are found in nature together (response page 11).
This argument sis not persuasive because claimed elements is a simple mixture and their combination does not add a meaningful limitation or extra-solution to the claimed product to be markedly different from a simple mixture of natural products.
No claims are allowed.
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Vera Afremova
February 2, 2026
/VERA AFREMOVA/ Primary Examiner, Art Unit 1653