Prosecution Insights
Last updated: April 19, 2026
Application No. 18/251,343

COATED COMPOSITIONS OF BIOLOGICALLY ACTIVE INGREDIENTS FOR ORAL ADMINISTRATION TO RUMINANTS

Non-Final OA §103§112
Filed
May 01, 2023
Examiner
PALLAY, MICHAEL B
Art Unit
1617
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Evonik Operations GmbH
OA Round
1 (Non-Final)
56%
Grant Probability
Moderate
1-2
OA Rounds
3y 3m
To Grant
91%
With Interview

Examiner Intelligence

Grants 56% of resolved cases
56%
Career Allow Rate
396 granted / 707 resolved
-4.0% vs TC avg
Strong +35% interview lift
Without
With
+35.0%
Interview Lift
resolved cases with interview
Typical timeline
3y 3m
Avg Prosecution
59 currently pending
Career history
766
Total Applications
across all art units

Statute-Specific Performance

§101
1.5%
-38.5% vs TC avg
§103
46.2%
+6.2% vs TC avg
§102
13.2%
-26.8% vs TC avg
§112
23.4%
-16.6% vs TC avg
Black line = Tech Center average estimate • Based on career data from 707 resolved cases

Office Action

§103 §112
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 . Election/Restrictions Applicant's election with traverse of Group I (claims 1-7, 14, and 16) in the reply filed on 31 July 2025 is acknowledged. The traversal is on the ground(s) that there is a special technical feature between Groups I-III and a search of all claims would not impose a serious burden and Groups I-III have a relationship/combination per 37 CFR 1.465(b). This is not found persuasive because applicant fails to indicate what the special technical feature is, burden is irrelevant for showing a lack of unity of invention, and a relationship/combination per 37 CFR 1.465(b) cannot cure a lack of a special technical feature. The requirement is still deemed proper and is therefore made FINAL. Claims 8-13, 15, and 17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 31 July 2025. Claims 1-7, 14, and 16 are under current consideration. Claim Objections Claim 1 is objected to because of the following informalities: the second component of (B) is mislabeled as (A-ii) rather than (B-ii). Appropriate correction is required. Claim 16 is objected to because of the following informalities: the claim incorrectly ends in a comma rather than a period. Appropriate correction is required. Claim Rejections - 35 USC § 112 The following is a quotation of 35 U.S.C. 112(d): (d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), 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 4 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 4 fails to include all the limitations of claim 1 upon which it depends in that claim 1 requires triethyl citrate acetate whereas claim 4 recites the broader triethyl citrate. Applicant may cancel the 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. 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) 1-6, 14, and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wei et al. (CN 111513198 A; published 11 August 2020; of record; citations herein to English machine translation made 02 June 2025; of record) in view of Henrique Enrique (WO 2011/116445 A2; published 29 September 2011; of record; citations herein to English machine translation made 02 June 2025; of record). Regarding claim 1, Wei et al. discloses coated urea ruminant feed (abstract), reading on the claimed coated composition suitable for feeding a ruminant comprising a biologically active ingredient, wherein urea particles core material is coated with wall material comprising ethyl cellulose (claim 1), reading on the claimed ethyl cellulose coating encapsulating the core, wherein the coated urea comprises 10-30% by mass wall material (claim 2), reading on the claimed 1-15 wt% coating, wherein the wall material further comprises a plasticizer (claim 3), reading on the claimed additive, wherein the plasticizer is 10-30% of the wall material (claim 6), reading on the claimed 5-15 wt% additive, wherein the wall material comprises 65-100% of ethyl cellulose (Examples 1-5), reading on the claimed 85-95 wt% ethyl cellulose, wherein urea is a non-protein nitrogen source to synthesize microbial protein and provide degradable protein for ruminants (Background page 3), reading on the claimed (A-vii) prebiotic food as the biologically active ingredient. Further regarding claim 1, although Wei et al. does not disclose monoglyceride acetate or triethyl citrate acetate as plasticizer, Henrique Enrique discloses coated urea ruminant feed (title; abstract) wherein coating commonly uses plasticizers which greatly improve the efficiency of the coating on the core (page 5 second full paragraph) wherein plasticizers include acetyltriethylcitrate (i.e., triethyl citrate acetate) (page 5 twelfth full paragraph and last paragraph). Further regarding claim 1, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Wei et al. and Henrique Enrique by using the triethyl citrate acetate of Henrique Enrique as a plasticizer in the coating of the urea ruminant feed of Wei et al. as discussed above, with a reasonable expectation of success. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do so to greatly improve the efficiency of the coating on the core as suggested by Henrique Enrique and because Wei et al. suggests including a plasticizer therein. Further regarding claim 1, the concentration ranges disclosed by Wei et al. of 10-30% by mass coating, 65-100% ethyl cellulose, and 10-30% plasticizer, as discussed above, overlap the claimed ranges of 1-15 wt%, 85-95 wt%, and 5-15 wt%, respectively, and a prima facie case of obviousness exists where prior art an claimed ranges overlap per MPEP 2144.05(I). Regarding claim 2, the concentration range disclosed by Wei et al. of 10-30% by mass coating, as discussed above regarding claim 1, is so close to the claimed range of 2-8 wt% that a prima facie case of obviousness exists per MPEP 2144.05(I) because “one skilled in the art would have expected them to have the same properties”. See also In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%). Regarding claim 3, the concentration ranges disclosed by Wei et al. of 65-100% ethyl cellulose and 10-30% plasticizer, as discussed above regarding claim 1, overlap the claimed ranges of 86-93 wt% and 7-14 wt%, respectively, and a prima facie case of obviousness exists where prior art an claimed ranges overlap per MPEP 2144.05(I). Regarding claim 4, Henrique Enrique discloses triethyl citrate acetate as discussed above regarding claim 1, which reads on the claimed triethyl citrate. Regarding claim 5, Wei et al. discloses that the wall material is one or more layers (claim 7), which reads on the claimed one-layer coating. It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to follow the suggestions of Wei et al. as discussed above and to make the urea ruminant feed of Wei et al. in view of Henrique Enrique as discussed above with one layer of wall material, with a reasonable expectation of success. Regarding claim 6, Wei et al. discloses that the wall material is one or more layers (claim 7), which reads on the claimed coating comprising a first layer and a second layer, wherein the wall material comprises two layers having different compositions (Examples 4-5), which reads on the claimed first layer and second layer having different composition. It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to follow the suggestions of Wei et al. as discussed above and to make the urea ruminant feed of Wei et al. in view of Henrique Enrique as discussed above with two layers of coating having different compositions, with a reasonable expectation of success. Regarding claim 14, Wei et al. discloses coated urea ruminant feed (abstract) as discussed above regarding claim 1, reading on the claimed feed suitable for feeding a ruminant comprising the coated composition. Regarding claim 16, although the claim further limits the vitamin (A-v) to one specifically listed, the biologically active ingredient is nevertheless not limited to the vitamin (A-v), and may be a prebiotic food (A-vii) as discussed above regarding claim 1. Claim(s) 1-7, 14, and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wei et al. in view of Henrique Enrique as applied to claims 1-6, 14, and 16 above, and further in view of Haussner et al. (CA 3 011 756 A1; published 27 July 2017). Wei et al. and Henrique Enrique are relied upon as discussed above. Wei et al. and Henrique Enrique do not disclose a 1-6 mm particle size as in claim 7. Regarding claim 7, Haussner et al. discloses a composition suitable for ingestion by a ruminant comprising a non-protein nitrogen compound such as urea surrounded by a coating (claim 1) having an average particle size of about 1 mm to about 6 mm (claim 4), reading on the claimed 1-6 mm particle size. Further regarding claim 7, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Wei et al., Henrique Enrique, and Haussner et al. by making the urea ruminant feed of Wei et al. in view of Henrique Enrique as discussed above with a particle size of 1-6 mm as suggested by Haussner et al., with a reasonable expectation of success. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do so to make such urea ruminant feed in a size that was known to be a suitable particle size for ruminant feed as suggested by Haussner et al. Conclusion No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL B. PALLAY whose telephone number is (571)270-3473. The examiner can normally be reached Monday through Friday from 8:30 AM to 5:00 PM Eastern Time. 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, Sue Liu can be reached at (571)272-5539. 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. /MICHAEL B. PALLAY/Primary Examiner, Art Unit 1617
Read full office action

Prosecution Timeline

May 01, 2023
Application Filed
Oct 16, 2025
Non-Final Rejection — §103, §112 (current)

Precedent Cases

Applications granted by this same examiner with similar technology

Patent 12582603
OPHTHALMIC PHARMACEUTICAL COMPOSITION CONTAINING A COMBINATION OF BRINZOLAMIDE AND BRIMONIDINE AND METHOD OF PREPARATION THEREOF
2y 5m to grant Granted Mar 24, 2026
Patent 12577244
HETEROCYCLIC COMPOUND AND HARMFUL ARTHROPOD-CONTROLLING COMPOSITION CONTAINING SAME
2y 5m to grant Granted Mar 17, 2026
Patent 12532883
Powder Compositions Comprising Salts of C4 to C10 Oxocarboxylic Acids and of Unsaturated or Aromatic C6 to C10 Carboxylic Acids
2y 5m to grant Granted Jan 27, 2026
Patent 12533377
PREVENTIVE AND CURATIVE PEROXOMETALLATE BASED COMPOSITION, NOTABLY PHARMACEUTICAL COMPOSITION
2y 5m to grant Granted Jan 27, 2026
Patent 12527752
COMPOSITION BASED ON GELLAN GUM AND PHENYLEPHRINE, PRODUCTION METHOD AND USE AS AN OPHTHALMIC PRODUCT
2y 5m to grant Granted Jan 20, 2026
Study what changed to get past this examiner. Based on 5 most recent grants.

AI Strategy Recommendation

Get an AI-powered prosecution strategy using examiner precedents, rejection analysis, and claim mapping.
Powered by AI — typically takes 5-10 seconds

Prosecution Projections

1-2
Expected OA Rounds
56%
Grant Probability
91%
With Interview (+35.0%)
3y 3m
Median Time to Grant
Low
PTA Risk
Based on 707 resolved cases by this examiner. Grant probability derived from career allow rate.

Sign in with your work email

Enter your email to receive a magic link. No password needed.

Personal email addresses (Gmail, Yahoo, etc.) are not accepted.

Free tier: 3 strategy analyses per month