Prosecution Insights
Last updated: April 19, 2026
Application No. 18/266,064

Formulations for Delivery of Bioactive Agents

Non-Final OA §102§103§112
Filed
Jun 08, 2023
Examiner
WASHVILLE, JEFFREY D
Art Unit
1766
Tech Center
1700 — Chemical & Materials Engineering
Assignee
Royal Melbourne Institute Of Technology
OA Round
1 (Non-Final)
80%
Grant Probability
Favorable
1-2
OA Rounds
2y 10m
To Grant
75%
With Interview

Examiner Intelligence

Grants 80% — above average
80%
Career Allow Rate
988 granted / 1236 resolved
+14.9% vs TC avg
Minimal -5% lift
Without
With
+-4.9%
Interview Lift
resolved cases with interview
Typical timeline
2y 10m
Avg Prosecution
36 currently pending
Career history
1272
Total Applications
across all art units

Statute-Specific Performance

§101
0.1%
-39.9% vs TC avg
§103
50.6%
+10.6% vs TC avg
§102
32.8%
-7.2% vs TC avg
§112
12.3%
-27.7% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1236 resolved cases

Office Action

§102 §103 §112
DETAILED ACTION Notice of Pre-AIA or AIA Status 1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Information Disclosure Statement 2. The information disclosure statement (IDS) submitted on 6/8/2023 and 1/20/2026 w ere filed timely . The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. Claim Rejections - 35 USC § 112 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. 4. Claim 6 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. The use of the term preferably renders the claim indefinite. Claim Rejections - 35 USC § 102 5. 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. 6. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale , or otherwise available to the public before the effective filing date of the claimed invention. (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. 7. Claims 1- 3 and 11 are rejected under 35 U.S.C. 102 (a)(1) and rejected under 35 U.S.C. 102 (a)( 2 ) as being anticipated by (US 2002/0034486 A1) to Midha et al. (hereinafter Midha ) . Midha is directed toward hydrogels. Midha discloses at paragraph [0022] that the gel is in the form of a microparticle that is crosslinked. Midha discloses at paragraph [00 36 ] that the monomers include acrylic acids. Midha discloses at paragraph [00 84 ] that cellulose is used as a thickening agent. Midha discloses at paragraph [0 1 2 3 ] that the polymer may be crosslinked with a methylenebisacrylamide . Midha discloses at paragraph [0 165 ] that viscosity modifiers include a hydroxypropyl methyl cellulose. Midha discloses at paragraph [0 164 ] that the viscosity modifier may be present up to 5% of the composition. Midha discloses at paragraph [02 71 ] that the acrylic acid is 0.5% , which is within the range of 1:3 to 1:10. Midha discloses at paragraph [00 55 ] that vitamins may be present. Midha discloses each and every element of claims 1-3 and 11. 7. Claims 1- 16, 18-19, 21 and 23 are rejected under 35 U.S.C. 102 (a)(1) and rejected under 35 U.S.C. 102 (a)(2) as being anticipated by Yao et al; "Phase Transition Behavior of HPMC-AA and Preparation of HPMC-PAA Nanogels", Journal of Nanomaterials, 2011, 6 pages, 1:10.1155/2011/507542. See Section 2.2 & 2.3, Page 2, Column 2; "Conclusion"- Page 5; Figure 1(a) & 1(b), Page 2 (hereinafter Yao). Yao is directed toward acrylic acid hydrogels. Yao discloses at page 1 that a gel is formed between polyacrylic acid (PAA) and methylcellulose such as hydroxypropyl methylcellulose (HPMC). Yao discloses at page 2 that the PAA and HPCM polymers are crosslinked using N,N ’- methylenebisacrylamide . Yao discloses at page 3 that the LCST of the composition is 38C, which is less than 40C. Yao discloses at page 4 that the ratio of AA/HPCM is 1: 6 that reads on Applicants range of 1:3 to 1:10 . Yao discloses at page 2 that the crosslinker was 1% based on the weight of AA, which falls within the range of 0.01 and 0.10. Yao discloses at page 5 that the phase transition temperature Tg is 38C at 14 and would be expected to be the same at 1:7 as it is the same material and thus would have the same properties. Yao discloses each and every element of claims 1-16, 18-19, 21 and 23 . Claim Rejections - 35 USC § 103 8. 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. 9. 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. 10. Claims 1-16, 18-19, 21 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Yao et al; "Phase Transition Behavior of HPMC-AA and Preparation of HPMC-PAA Nanogels", Journal of Nanomaterials, 2011, 6 pages, 1:10.1155/2011/507542. See Section 2.2 & 2.3, Page 2, Column 2; "Conclusion"- Page 5; Figure 1(a) & 1(b), Page 2 (hereinafter Yao). Yao is directed toward acrylic acid hydrogels. Yao discloses at page 1 that a gel is formed between polyacrylic acid (PAA) and methylcellulose such as hydroxypropyl methylcellulose (HPMC). Yao discloses at page 2 that the PAA and HPCM polymers are crosslinked using N,N ’- methylenebisacrylamide . Yao discloses at page 3 that the LCST of the composition is 38C, which is less than 40C. Yao discloses at page 4 that the ratio of AA/HPCM is 1:6 that reads on Applicants range of 1:3 to 1:10 . Yao discloses at page 2 that the crosslinker was 1% based on the weight of AA, which falls within the range of 0.01 and 0.10. Yao discloses at page 5 that the phase transition temperature Tg is 38C at 14 and would be expected to be the same at 1:7 as it is the same material and thus would have the same properties. It would be obvious to one skilled in the art at the time of the filing of the disclosure of Yao to select each and every element of claims to form a prima facie case of obviousness for claims 1-16, 18-19, 21 and 23. 1 1 . Claims 1-16, 18-19, 21 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Yao et al; "Phase Transition Behavior of HPMC-AA and Preparation of HPMC-PAA Nanogels", Journal of Nanomaterials, 2011, 6 pages, 1:10.1155/2011/507542. See Section 2.2 & 2.3, Page 2, Column 2; "Conclusion"- Page 5; Figure 1(a) & 1(b), Page 2 (hereinafter Yao) in view of the teachings of the (US 2002/0034486 A1) to Midha et al. (hereinafter Midha ) . Yao is directed toward acrylic acid hydrogels. Yao discloses at page 1 that a gel is formed between polyacrylic acid (PAA) and methylcellulose such as hydroxypropyl methylcellulose (HPMC). Yao discloses at page 2 that the PAA and HPCM polymers are crosslinked using N,N ’- methylenebisacrylamide . Yao discloses at page 3 that the LCST of the composition is 38C, which is less than 40C. Yao discloses at page 4 that the ratio of AA/HPCM is 1:6 that reads on Applicants range of 1:3 to 1:10 . Yao discloses at page 2 that the crosslinker was 1% based on the weight of AA, which falls within the range of 0.01 and 0.10. Yao discloses at page 5 that the phase transition temperature Tg is 38C at 14 and would be expected to be the same at 1:7 as it is the same material and thus would have the same properties. Midra is directed toward acrylic acid hydrogels. Yao and Midra are both directed toward acrylic acid hydrogels and therefore are analogous art . Midra teaches uses of the claimed gel that provide commercial benefits and therefore one would be motivated to use the gel of Yao for commercial uses such as hair care. Midha discloses at paragraph [0022] that the gel is in the form of a microparticle that is crosslinked. Midha discloses at paragraph [0036] that the monomers include acrylic acids. Midha discloses at paragraph [0084] that cellulose is used as a thickening agent. Midha discloses at paragraph [0123] that the polymer may be crosslinked with a methylenebisacrylamide . Midha discloses at paragraph [0165] that viscosity modifiers include a hydroxypropyl methyl cellulose. Midha discloses at paragraph [0164] that the viscosity modifier may be present up to 5% of the composition. Midha discloses at paragraph [0271] that the acrylic acid is 0.5%, which is within the range of 1:3 to 1:10. Midha discloses at paragraph [0055] that vitamins may be present. It would be obvious to one skilled in the art at the time of the filing of the disclosure of Yao in view of the teachings of Midra to modify the gel to provide enhanced benefits delivered by the gels to form a prima facie case of obviousness for claims 1-16, 18-19, 21 and 23. Conclusion 12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT JEFFREY D WASHVILLE whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-3262 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F 9-5 . 13. 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. 14. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, FILLIN "SPE Name?" \* MERGEFORMAT Randy Gulakowski can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571-272-1302 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. 15. 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. /JEFFREY D WASHVILLE/ Primary Examiner, Art Unit 1766
Read full office action

Prosecution Timeline

Jun 08, 2023
Application Filed
Feb 23, 2026
Non-Final Rejection — §102, §103, §112 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
80%
Grant Probability
75%
With Interview (-4.9%)
2y 10m
Median Time to Grant
Low
PTA Risk
Based on 1236 resolved cases by this examiner. Grant probability derived from career allow rate.

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