Prosecution Insights
Last updated: July 17, 2026
Application No. 18/639,693

STABLE PHARMACEUTICAL COMPOSITION OF METHYLNALTREXONE FOR AN ORAL ADMINISTRATION

Non-Final OA §102§112
Filed
Apr 18, 2024
Priority
Apr 18, 2023 — IN 202321028283
Examiner
SEAMAN, D MARGARET M
Art Unit
1625
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Lupin Limited
OA Round
1 (Non-Final)
77%
Grant Probability
Favorable
1-2
OA Rounds
0m
Est. Remaining
85%
With Interview

Examiner Intelligence

Grants 77% — above average
77%
Career Allowance Rate
1068 granted / 1394 resolved
+16.6% vs TC avg
Moderate +8% lift
Without
With
+8.0%
Interview Lift
resolved cases with interview
Fast prosecutor
2y 2m
Avg Prosecution
39 currently pending
Career history
1418
Total Applications
across all art units

Statute-Specific Performance

§101
1.6%
-38.4% vs TC avg
§103
20.2%
-19.8% vs TC avg
§102
17.1%
-22.9% vs TC avg
§112
30.7%
-9.3% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1394 resolved cases

Office Action

§102 §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 . Priority This application was filed 04/18/2024 and claims foreign priority to India 20231028283 (04/1882023). Claims 1-21 are before the Examiner. Claim Rejections - 35 USC § 112 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. Claim 8 is 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. Specifically, claim 8 has claim language with parenthesis to fully explain the words within the claim. Correction is required. 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. Claims 4 and 5 are 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. Both claims depend from claim 1 but fail to further limit the scope of claim 1 because a use is not limiting for a composition claim. 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 § 102 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 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)(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. Claims 1-21 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US Pat 11690840. ‘840 teaches pharmaceutical resinate compositions for oral administration to treat pain (C2l13) with a compound which has been complexed to an exchange resin, a binder, a matrix material (C2l24). Methylnatrexone (C13l12) in a composition (C13l24) with an ion exchange resin (C13L56). Stearic acid, glucose, bentonites, carnauba wax stearyl and other lubricants and excipients (C14 l4-33). Suitable disintegrants are taught C14 l65 – C15 l13). Suitable bulking agents are taught (C15 l14-44). Magnesium stearate is taught (C16 l23). The full composition is discussed C18 l6-21. Further support can be seen in the claims of the ‘840 patent. This anticipates the instant claims. Any inquiry concerning this communication or earlier communications from the examiner should be directed to D MARGARET M SEAMAN whose telephone number is (571)272-0694. The examiner can normally be reached M-F 8am-4pm Eastern. 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, Andrew Kosar can be reached at 571-272-0913. 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. /D MARGARET M SEAMAN/Primary Examiner, Art Unit 1625
Read full office action

Prosecution Timeline

Apr 18, 2024
Application Filed
Jun 26, 2026
Non-Final Rejection mailed — §102, §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
77%
Grant Probability
85%
With Interview (+8.0%)
2y 2m (~0m remaining)
Median Time to Grant
Low
PTA Risk
Based on 1394 resolved cases by this examiner. Grant probability derived from career allowance rate.

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