Prosecution Insights
Last updated: April 19, 2026
Application No. 18/966,720

NEEDLE BREAST BIOPSY SYSTEM AND METHOD OF USE

Non-Final OA §DP
Filed
Dec 03, 2024
Examiner
CWERN, JONATHAN
Art Unit
3797
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Hologic Inc.
OA Round
1 (Non-Final)
50%
Grant Probability
Moderate
1-2
OA Rounds
4y 2m
To Grant
87%
With Interview

Examiner Intelligence

Grants 50% of resolved cases
50%
Career Allow Rate
402 granted / 797 resolved
-19.6% vs TC avg
Strong +36% interview lift
Without
With
+36.3%
Interview Lift
resolved cases with interview
Typical timeline
4y 2m
Avg Prosecution
51 currently pending
Career history
848
Total Applications
across all art units

Statute-Specific Performance

§101
4.0%
-36.0% vs TC avg
§103
48.9%
+8.9% vs TC avg
§102
14.0%
-26.0% vs TC avg
§112
26.5%
-13.5% vs TC avg
Black line = Tech Center average estimate • Based on career data from 797 resolved cases

Office Action

§DP
DETAILED ACTION Notice of Pre-AIA or AIA Status The present application is being examined under the pre-AIA first to invent provisions. Double Patenting The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp. Claims 2-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 10595954. Although the claims at issue are not identical, they are not patentably distinct from each other because comparing claim 1 of the patent with claim 2 of the instant application, the claims are directed to similar needle biopsy assemblies including support arms for attachment to an imaging system and structural mechanisms for providing an angled biopsy in relation to the imaging system. The differences include minor changes in wording of the structural features, which does not change the scope of the claims. Furthermore, the inclusion or omission of a needle support coupled to the angular support arm for stabilizing an end of the needle would be an obvious design choice to one of ordinary skill in the art. Furthermore, it would be within the level of one of ordinary skill in the art to apply the system in the method of a medical procedure, in order to carry out the intended use of the system. Claims 2-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11701199. Although the claims at issue are not identical, they are not patentably distinct from each other because comparing claim 1 of the patent with claim 2 of the instant application, the claims are directed to similar needle biopsy assemblies including support arms for attachment to an imaging system and structural mechanisms for providing an angled biopsy in relation to the imaging system. The differences include minor changes in wording of the structural features, which does not change the scope of the claims. Furthermore, it would be within the level of one of ordinary skill in the art to apply the system in the method of a medical procedure, in order to carry out the intended use of the system. Furthermore, it would have been obvious to one of ordinary skill in the art to include/omit the imaging system and provide the biopsy assembly separately or in combination as an obvious design choice to one of ordinary skill in the art. Claims 2-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12193886. Although the claims at issue are not identical, they are not patentably distinct from each other because comparing claim 1 of the patent with claim 2 of the instant application, the claims are directed to similar needle biopsy assemblies including support arms for attachment to an imaging system and structural mechanisms for providing an angled biopsy in relation to the imaging system. The differences include minor changes in wording of the structural features, which does not change the scope of the claims. Furthermore, it would be within the level of one of ordinary skill in the art to apply the system in the method of a medical procedure, in order to carry out the intended use of the system. Furthermore, it would have been obvious to one of ordinary skill in the art to include/omit the imaging system and provide the biopsy assembly separately or in combination as an obvious design choice to one of ordinary skill in the art. Allowable Subject Matter Claims 2-21 would be allowable if rewritten or amended, or by filing terminal disclaimer to overcome the double patenting rejection(s). The following is a statement of reasons for the indication of allowable subject matter: The parent application (US 10595954) was found allowable based upon applicant’s arguments in the appeal brief filed on 7/24/19. Notably, the prior art add-on biopsy apparatus failed to teach a biopsy apparatus having handles to releasably couple the biopsy apparatus to the gantry of the imaging system. On pages 22-23 of the appeal brief on 7/24/19 in the parent application, applicant notes: “That is, the needle biopsy assembly is a separable component from the x-ray imaging assembly so that with the claimed needle biopsy assembly, all of the existing components of the x-ray system, including the compression device and the x-ray detector, can still be utilized. The component that enables this feature is a coupling mechanism on at least one of the handles.” The examiner has updated the search, and the prior art of record fails to teach such a biopsy assembly, with handles and a coupling mechanism for attachment to the x-ray imaging system. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN CWERN whose telephone number is (571)270-1560. The examiner can normally be reached Monday - Friday, 8:00 am - 5:00 pm. 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, Christopher Koharski can be reached at (571) 272-7230. 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. /JONATHAN CWERN/Primary Examiner, Art Unit 3797
Read full office action

Prosecution Timeline

Dec 03, 2024
Application Filed
Feb 09, 2026
Non-Final Rejection — §DP (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
50%
Grant Probability
87%
With Interview (+36.3%)
4y 2m
Median Time to Grant
Low
PTA Risk
Based on 797 resolved cases by this examiner. Grant probability derived from career allow rate.

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