Prosecution Insights
Last updated: July 17, 2026
Application No. 16/882,804

THERAPEUTIC COMPOUNDS

Non-Final OA §102§112
Filed
May 26, 2020
Priority
Mar 01, 2013 — provisional 61/771,655 +4 more
Examiner
COUGHLIN, MATTHEW P
Art Unit
1626
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Gilead Sciences Inc.
OA Round
1 (Non-Final)
71%
Grant Probability
Favorable
1-2
OA Rounds
0m
Est. Remaining
83%
With Interview

Examiner Intelligence

Grants 71% — above average
71%
Career Allowance Rate
708 granted / 992 resolved
+11.4% vs TC avg
Moderate +12% lift
Without
With
+11.9%
Interview Lift
resolved cases with interview
Typical timeline
2y 5m
Avg Prosecution
45 currently pending
Career history
1038
Total Applications
across all art units

Statute-Specific Performance

§101
0.6%
-39.4% vs TC avg
§103
35.7%
-4.3% vs TC avg
§102
18.0%
-22.0% vs TC avg
§112
14.8%
-25.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 992 resolved cases

Office Action

§102 §112
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 . DETAILED ACTION Claims 55-63 are pending in the application. Claims 55-63 are rejected. Information Disclosure Statement The Examiner has considered the Information Disclosure Statement(s) filed on October 5th, 2020. Priority It is noted that claims 58-63 are rejected under 35 USC 112(a) for containing new matter. For this reason, the earliest effective filing date of these claims would be the date on which the claims containing new matter were first introduced, which is October 5th, 2020. Claim Rejections - 35 USC § 112 The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. Claims 58-63 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection. It is noted that claims 58-63 were added as new claims on October 5th, 2020 and are therefore not considered part of the originally filed disclosure. Regarding support for these claims, Applicant stated the following on page 8 of the response filed June 18th, 2018: PNG media_image1.png 137 639 media_image1.png Greyscale The instant specification discloses “General Synthetic Procedures” beginning on page 112. As first general method, the specification discloses a procedure on page 113 (Scheme 1) where the following steps are used: PNG media_image2.png 302 710 media_image2.png Greyscale PNG media_image3.png 316 686 media_image3.png Greyscale . The instantly claimed method (of claim 55) is directed to the conversion of compound A7 to compound A9 in the scheme above. The scheme on page 113 starts from compound A1 and proceeds through compound A11 as an overall scheme. A person having ordinary skill in the art could understand each step alone and that Applicant was in possession of each individual step; however, dependent claims 58-63 embrace methods where intermediate steps are skipped. For instance, claim 58 is dependent upon claim 55 and claim 58 recites reacting a compound of formula A4 to form a compound of formula A5; however, the claim does not require the step of converting a compound of formula A5 to form a compound of formula A7 according to the originally disclosed scheme. A person having ordinary skill in the art of organic synthesis would recognize that working backwards from the final step and sequentially adding each previous step to an overall synthetic approach would be supported by the original disclosure; however, the originally filed disclosure would not appear to support performing an initial step, omitting a disclosed intermediate step and performing the final steps. MPEP 2163.05(I)(A) states the following: A claim that omits an element which applicant describes as an essential or critical feature of the invention originally disclosed does not comply with the written description requirement. See Gentry Gallery, 134 F.3d at 1480, 45 USPQ2d at 1503; In re Sus, 306 F.2d 494, 504, 134 USPQ 301, 309 (CCPA 1962) See also MPEP 706.03(o): […] New matter includes not only the addition of wholly unsupported subject matter, but may also include adding specific percentages or compounds after a broader original disclosure, or even the omission of a step from a method. […] In the situation of claims 58-63, Applicant has omitted intermediate steps of an overall process that were originally disclosed together. This rejection could be overcome by amending claim 58 to depend from claim 57, amending claim 59 to depend from claim 58, amending claim 61 to dependent from claim 59 and amending claim 62 to depend from claim 61. 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 55-63 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. 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(c). In the present instance, claim 55 is replete with instances of a broad recitation of “one or more”, and the claim also recites parenthetical ranges of, for instance, “(e.g., 1 or 2)” or “(e.g., 1, 2, 3, 4 or 5)” which are 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 56-63 are rejected as indefinite for the same reason since they do not correct the issue. Claim 58 is further rejected as indefinite since it refers to “a compound of formula A5” but where neither claim 58 nor its parent claim 55 defines the formula. Accordingly, the scope of claim 58 is unclear. Claim 59 is further rejected as indefinite since it refers to “a compound of formula A4” but where neither claim 58 nor its parent claim 55 defines the formula. Accordingly, the scope of claim 59 is unclear. Dependent claim 59 is rejected as indefinite for the same reason. Claim 61 is further rejected as indefinite since it refers to “a compound of formula A3” but where neither claim 61 nor its parent claim 55 defines the formula. Accordingly, the scope of claim 61 is unclear. Claim 62 is further rejected as indefinite since it refers to “a compound of formula A2” but where neither claim 62 nor its parent claim 55 defines the formula. Accordingly, the scope of claim 62 is unclear. Dependent claim 63 is rejected as indefinite for the same reason. Claim Rejections - 35 USC § 102 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. Claim(s) 58-63 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by International Application Publication No. WO 2014/134566 A2 by Zhang et al. As noted above, the earliest effective filing date of the instant claims (since they contain new matter) is October 5th, 2020. Since the cited WIPO document was published September 4th, 2014, it is available as prior art. The instant rejection under 35 USC 102(a)(1) stands and falls with the issue of new matter presented above. The prior art teaches a scheme containing each instantly recited step on page 113 as part of Scheme 1. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW P COUGHLIN whose telephone number is (571)270-1311. The examiner can normally be reached Monday - Friday, 10 am - 6 pm EST. 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, Joseph McKane can be reached on 571-272-0699. 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. /MATTHEW P COUGHLIN/Primary Examiner, Art Unit 1626
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Prosecution Timeline

Show 22 earlier events
May 13, 2025
Request for Continued Examination
May 15, 2025
Response after Non-Final Action
Aug 28, 2025
Request for Continued Examination
Sep 03, 2025
Response after Non-Final Action
Dec 15, 2025
Request for Continued Examination
Dec 16, 2025
Response after Non-Final Action
Apr 06, 2026
Request for Continued Examination
Apr 07, 2026
Response after Non-Final Action

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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
71%
Grant Probability
83%
With Interview (+11.9%)
2y 5m (~0m remaining)
Median Time to Grant
Low
PTA Risk
Based on 992 resolved cases by this examiner. Grant probability derived from career allowance rate.

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