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 1-21 are original, pending, and under examination.
Priority
This application is not a divisional, continuation, continuation-in-part, or a 35 U.S.C 371 PCT, nor does it claim priority to a foreign application or a U.S. provisional application. It is an original U.S. non-provisional application, with an effective filing date of 03/13/2025.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/10/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 1, 7, 9-10, 14, and 16 are objected to because of the following informalities:
Claim 1 states “wax free coating”. Proper syntax is “wax-free coating”.
Claim 7 states “about 64 to 64 wt.%”, which is an improper range.
Claims 9-10 recite “or such as rapeseed (canola) oil”. Proper syntax is “such as rapeseed (canola) oil”.
Claim 14 recites “…or about 33 to about 35, about 33 to about 34…”. Proper syntax is “…or about 33 to about 35, or about 33 to about 34…”.
Claim 16 recites “choline to the lower digestive tract to a ruminant animal”. Proper syntax is “choline to the lower digestive tract of a ruminant animal”.
Appropriate correction is required.
Claim Rejections – 35 USC § 112 (b)
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.
Claims 1-21 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 recites “(b) a substantially wax free coating comprising about 26 to about 32 wt.% of the coated granule of a hydrogenated seed oil, palm oil, or a combination thereof”. It is unclear whether: (1) the coating itself comprises about 26 to about 32 wt.% of the coated granule, and the coating comprises hydrogenated seed oil, palm oil, or a combination thereof; or (2) the hydrogenated seed oil, palm oil, or a combination thereof constitutes about 26 to about 32 wt.% of the coated granule, while the total coating could contain additional material and therefore exceed 26-32 wt.%.
Claims 2-21 are also indefinite for being dependent on indefinite claim 1.
The term “beyond a naturally occurring amount” in claim 2 is a relative term which renders the claim indefinite. The term “naturally occurring amount” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For compact prosecution, it will be assumed 1 wt.% meets this threshold.
Claim 3 recites the limitation "the coating" in dependence to claim 1, which provides both “a coated microgranule” and “(b) a substantially wax free coating”. As the coated microgranule could have other coatings, it is unclear if applicant means to refer to coating (b) or if applicant may be referring to a different coating on the coated microgranule. There is insufficient antecedent basis for this limitation in the claim.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05©. In the present instance, claim 6 recites the broad recitation “wherein the choline salt is choline chloride, choline bitartrate…”, and the claim also recites “preferably choline chloride” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claims 9-10 recite the phrase “rapeseed (canola) oil”. It is unclear as to whether the “canola” within the parenthesis is merely an optional example, or if it is a required component, thus rendering the claim indefinite.
Regarding claims 9-12, the phrase “such as” renders the claims indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 12 recites the term “paraffin max”, which does not have a conventional definition, nor is its meaning defined in the claim or specification, which renders the claim indefinite. For prosecution, it will be assumed that the intended phrase is “paraffin wax”.
Claim Rejections – 35 USC § 112 (d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection ©, a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 14 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 14 recites that the coated microgranule comprises a range from about 25 wt.% to about 36 wt.% of the coating (b). This recited range, and variations within this recited range, broadens/does not further limit the preceding limitation of its independent claim 1, which recites that the coating comprises “about 26 to about 32 wt.%” of the coated granule.
Applicant may cancel the above claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 1-21 are rejected under 35 U.S.C. 103 as being unpatentable over Gaspari (US20200000733A1) in view of Klose (US5190775A).
Gaspari discloses a rumen-resistant composition in the form of microgranules, and a process for its production and a feedstuff containing such composition [¶abstract].
Regarding Claim 1:
Gaspari teaches coated microgranules comprising a core, choline/choline salts, matrix/excipients, and extrusion of cores [¶¶32-40, 90-97, 122-132, 149]. Gaspari teaches embodiments wherein the product contains 60 wt.% choline chloride as an active [¶132]. Gaspari further teaches embodiments wherein hydrogenated palm oil is present within the core of such compositions (as a hydrophobic additive) at an amount calculating to about 4.12 wt.% of the finished coated product [¶¶73-74, 189-199]. Gaspari teaches that additional excipients such as a variety of disintegrants can be included in the composition [¶¶42-45].
However, Gaspari fails to teach the requirement of claim 1, wherein the hydrogenated seed oil as a coating comprises about 26 to about 32 wt.% of the coated granule.
Klose discloses a composition of matter and method for administering a bioactive substance to the post-rumen portion of the digestive system of a ruminant [¶abstract]. Klose teaches that the composition may be in the form of a coated granule encapsulated in a hydrophobic coating [col. 4, lines 5-7]. Klose teaches that chlorine chloride may be included as an active substance [col. 1, lines 5-10].
Regarding Claim 1:
Klose teaches hydrogenated vegetable oil coatings, including hydrogenated soybean oil [col. 4, lines 25-40]. Example 16 teaches an embodiment wherein the composition contains 30 wt.% partially hydrogenated soybean oil coating [col. 8, line 34-46].
Neither of the references requires a wax, thus obviating the exclusion of waxes.
Regarding Claims 2 & 3:
Klose example 16 teaches a coating consisting of a partially hydrogenated soybean oil, with no separately added palmitic acid [col. 8, line 34-46], and further does not teach palmitic acid in any embodiment. Gaspari also teaches palmitic acid to be optional [¶49]. Both references thus obviate the exclusion of palmitic acid.
Regarding Claim 4:
Neither reference requires the presence of wax as a coating component, thus obviating the exclusion of a wax.
Regarding Claim 5:
Neither reference requires the presence of wax as a core component.
Regarding Claim 6:
Gaspari teaches that the core may comprise choline chloride, choline bitartrate, citrate dehydrogenated choline, choline bicarbonate, choline sulfate and choline hydroxide [¶34].
Regarding Claim 7:
Gaspari teaches finished microgranules containing 60 wt.% choline chloride [¶¶132,146, 159], falling within the claimed subranges.
Regarding Claim 8:
Gaspari non-limiting Example 3.1 teaches 25 kg hydrogenated palm oil in a 500 kg extruded core and subsequently coats 400 kg of that core with 85 kg coating, yielding about 4.12 wt.% hydrogenated palm oil in the unfinished microgranule [¶¶189-199].
Regarding Claim 9:
Gaspari teaches hydrogenated palm oil in the extruded core [¶¶ 73, 189].
Regarding Claim 10:
Gaspari teaches hydrogenated soybean oil, hydrogenated rapeseed oil, hydrogenated cotton oil, hydrogenated palm oil, hydrogenated linseed oil as coating materials [¶71-74].
Regarding Claim 11 & 12:
Gaspari teaches that carnauba wax, rice wax, microcrystalline waxes, fats and their derivatives, are optional components and further teaches alternatives (e.g., rubber and cellulose), thus obviating its exclusion [¶37-38].
Regarding Claim 13:
Gaspari’s non-limiting example 1.1 uses 400 kg core +160 kg coating, resulting in about 71.4 wt.% core, which is within the claimed 65-75 wt.% range [¶¶122-131].
Regarding Claim 14:
Klose example 16 expressly teaches 30 wt.% coating, which falls within the claimed 25-35% range [col. 8, line 34-46].
Regarding Claim 15:
Gaspari teaches administering active substances of the composition through premixtures/complimentary feedstuff and expressly describes feedstuff composition comprising the rumen-resistant composition [¶¶5, 23].
Regarding Claim 16:
Gaspari teaches controlled release of the composition from the abomasum to the small intestine/post-ruminal region [¶¶22-26].
Klose teaches oral administration of rumen-protected bioactive martials to a ruminant for release posterior to omasum [col. 3, lines 1-24; col. 4, lines 5-24].
Regarding Claim 17:
Gaspari teaches controlled post-ruminal release producing improved total bioavailability of the physiologically active substances [¶¶24, 27-29].
Regarding Claim 18:
Klose teaches material leaving the rumen passes into the omasum [col. 1, lines 28-40] and that the protected material is intended to pass to the rumen for post-ruminal delivery [col. 4, lines 5-24].
Regarding Claim 19:
Klose expressly teaches that the coating becomes permeable/dissolves in the abomasum or subsequent intestinal tract [col. 4, lines 5-24].
Regarding Claim 20:
Gaspari reports choline microgranule bioavailability of 71.7% and 71.9%, exceeding the claimed about 70% [¶¶133-134, Table 1; ¶¶147-148, table 2].
Regarding Claim 21:
Gaspari expressly identifies and describes use of the Boisen test/method for post-ruminal digestibility and bioavailability [¶¶118-121, 133, 147].
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the coated, extruded choline-containing microgranules of Gaspari by employing the partially hydrogenated vegetable oil-coating of Klose, including a coating of about 30% by weight. This is because Klose teaches that such hydrogenated oil coatings provide hydrophobic barrier that protects choline-containing particles from degradation in the rumen while permitting release of active material in the post-ruminal digestive tract. A person of ordinary skill in the art would have been motivated to make this modification in order to provide Gaspari’s choline-containing microgranules with a known and effective rumen-resistant coating system, thereby maintaining the active ingredient during ruminal passage and promoting delivery and bioavailability in the lower gastrointestinal tract. This modification would have involved the use of a known coating material and coating proportion for their established purpose in the same field of rumen-protected nutrient delivery. An ordinary skilled artisan would have had a reasonable expectation of success because both Gaspari and Klose address protection and controlled post-ruminal release of physiologically active substances, including choline, and Klose expressly demonstrates that partially hydrogenated vegetable oil coatings at the recited levels are suitable for protecting choline-containing particles while allowing subsequent post-ruminal release.
Conclusions
No claim is found to be allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARYA AHMADI BAZARGANI whose telephone number is (571)272-0211. The examiner can normally be reached Monday - Friday 11:30AM - 6:00 PM ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian-Yong Kwon can be reached at (571) 272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Arya A. Bazargani, Ph.D.
Patent Examiner
Art Unit 1613
/MARK V STEVENS/Primary Examiner, Art Unit 1613
