Prosecution Insights
Last updated: October 02, 2026
Application No. 19/010,686

SYSTEMS, DEVICES, APPS, AND METHODS FOR CAPSULE ENDOSCOPY PROCEDURES

Non-Final OA §112§DOUBLEPATENT
Filed
Jan 06, 2025
Priority
May 17, 2019 — provisional 62/849,508 +4 more
Examiner
ALAM, FAYYAZ
Art Unit
Tech Center
Assignee
Given Imaging Ltd.
OA Round
1 (Non-Final)
83%
Grant Probability
Favorable
1-2
OA Rounds
9m
Est. Remaining
95%
With Interview

Examiner Intelligence

Grants 83% — above average
83%
Career Allowance Rate
857 granted / 1028 resolved
+23.4% vs TC avg
Moderate +11% lift
Without
With
+11.2%
Interview Lift
resolved cases with interview
Typical timeline
2y 6m
Avg Prosecution
20 currently pending
Career history
1035
Total Applications
across all art units

Statute-Specific Performance

§101
5.0%
-35.0% vs TC avg
§103
52.0%
+12.0% vs TC avg
§102
12.5%
-27.5% vs TC avg
§112
13.9%
-26.1% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1028 resolved cases

Office Action

§112 §DOUBLEPATENT
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 Applicant’s claim for domestic benefit under 35 U.S.C. 119(e) is acknowledged. Information Disclosure Statement The information disclosure statement submitted has been considered by the Examiner and made of record in the application file. Claim Objections Claim 17 is objected to because of the following informality: the phrase "by one or more hardware processors" is recited twice (first in the "displaying ... a subset of images" limitation and again in the "displaying ... one or more additional images" limitation), so that it is unclear whether the second recitation refers to the same processors as the first. It is suggested that the second instance be amended to "by the one or more hardware processors." 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer. Claims 1-18 and 80-81 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 12185906. Although the claims at issue are not identical, they are not patentably distinct from each other because it would have been obvious to one of ordinary skill in the art at a time before the effective filing date of the claimed subject matter to arrive the broader instant invention. See comparison table below. Examined claim '906 patent claim(s) Analysis 1 1 Patented claim 1 recites every element of examined claim 1 — a capsule device capturing in-vivo images; a wearable device secured to the person that receives the images and communicates them to a communication device at the same location; and a storage medium storing instructions executing on a remote computing system that receives the images, processes them, and communicates with a healthcare provider device — and additionally requires that the wearable device store the received images, that the images be received and processed "during the capsule endoscopy procedure" by "online processing," and that "a result of the online processing" be communicated during the procedure. Examined claim 1 omits those narrowing limitations and is therefore a genus that wholly encompasses the species of patented claim 1; a generic claim is anticipated by a claim to a species within it (MPEP § 804(II)(B)(1); In re Goodman). 2 2 Same limitation (the computing system is a cloud system comprising the storage medium). 3 3 Patented claim 3 recites the mobile device carried by the person and a patient app installed in the mobile device that interoperates with the wearable device and with the computing system. 4 3 Patented claim 3 further recites that the patient app sets up communication of data from the wearable device to the computing system through the mobile device. 5 4 Same limitation (the computing system coordinates communications between the patient app and the healthcare provider device). 9 5 Patented claim 5 recites each step of examined claim 9 with the additional "storing," "during the capsule endoscopy procedure," "online processing" and "result of the online processing" limitations; examined claim 9 is the encompassing genus and is anticipated for the reasons given for claim 1. 10 5 in view of 2 Patented claim 5 does not name a cloud system. It would have been obvious to practice the method of patented claim 5 using the cloud computing system recited in patented claim 2 (the system that performs the same receiving, processing and communicating), and, in any event, cloud implementation of the remote processing was known. 11, 12 5 in view of 3 It would have been obvious to practice the method of patented claim 5 with the mobile device and patient app of patented claim 3, which set up the communication of data from the wearable device to the computing system through the mobile device (see also Lu, above). 13 5 in view of 4 It would have been obvious to practice the method of patented claim 5 with the computing system of patented claim 4 coordinating communications between the patient app and the healthcare provider device. 80 1, 6 and 7 Patented claim 6 recites applying machine learning to the images received from the wearable device to estimate whether they include a transition from images of a segment of the GIT to images beyond the segment, and patented claim 7 recites that, in that case, the computing system communicates a message indicating that the procedure has completed and the wearable device can be removed, to a device carried by the person or to the wearable device. Examined claim 80 recites the same limitations (without "online" processing) and is anticipated by patented claims 1, 6 and 7. 81 5 in view of 6 and 7 It would have been obvious to practice the method of patented claim 5 with the machine-learning transition estimation and completion message recited in patented claims 6 and 7, which are recited for the system used to perform that method. Claims 6-8 and 14-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 12,185,906 B2. 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. Claims 1-18 and 80-81 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. The omitted elements/steps are: see e.g. fig. 4 step 455; fig. 30, step 3030. In the interest of breadth, applicant has omitted essential elements amounting to a gap. Therefore, it is unclear given the scope of the claim body, as to what is being communicated to the HCP device or even why the final limitation is there. However, such is not the case as clearly shown by at least figs. 4 and 30. Claims 5-6, 13-14, 17, and 81 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. Claim 5 depends from claim 1 and recites "the patient app," but no patient app is introduced in claim 1; a patient app is first introduced in claim 3. There is therefore insufficient antecedent basis for "the patient app" in claims 5 and 13 (MPEP § 2173.05(e)). Claim 13 likewise depends from claim 9 and recites "the patient app," which is first introduced in claim 11. There is therefore insufficient antecedent basis for "the patient app" in claims 5 and 13 (MPEP § 2173.05(e)). Claims 6 and 14 inherit the deficiency through their dependency. For purposes of examination, claim 5 is treated as depending from claim 3 and claim 13 as depending from claim 11. Claim 17 is rejected under 35 U.S.C. 112(b) as being indefinite. The final limitation recites "generating a report, the report comprising images from the displayed images selected by the user." The claim earlier recites "the displayed subset of images" and "one or more additional images"; "the displayed images" has no single antecedent, and it is unclear whether the user-selected images may be drawn from the subset, from the additional images, or from both. For examination, the phrase is interpreted as encompassing images selected from either the displayed subset or the displayed additional images. Claim 81 is rejected under 35 U.S.C. 112(b) as being indefinite. Claim 81 depends from method claim 9 but recites "wherein the computing system is configured to, in case the communicated images include the transition, communicate a message indicating that the capsule endoscopy procedure has completed and the wearable device can be removed." It is unclear whether the claim requires that the message actually be communicated as a step of the claimed method, or merely requires that the computing system used in the method be capable of communicating such a message. Because a method claim is infringed by performing its steps, reciting a capability of an apparatus rather than a step renders the metes and bounds of the claim unclear (cf. MPEP §§ 2173.02, 2173.05(p)(II)). For purposes of examination, the limitation is interpreted as requiring the step of communicating the recited message when the transition is estimated to be present. Allowable Subject Matter Claims 1-18 and 80-81would be allowable over prior art once the remaining outstanding issues have been overcome. Conclusion Any response to this Office Action should be faxed to (571) 273-8300 or mailed to: Commissioner for Patents P.O. Box 1450 Alexandria, VA 22313-1450 Hand-delivered responses should be brought to Customer Service Window Randolph Building 401 Dulany Street Alexandria, VA 22314 Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Fayyaz Alam whose telephone number is (571) 270-1102. The Examiner can normally be reached on Monday-Friday from 9:30am to 7:00pm. If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Jeanette Parker can be reached on (571) 270-3647. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free) or 703-305-3028. Any inquiry of a general nature or relating to the status of this application or proceeding should be directed to the receptionist/customer service whose telephone number is (571) 272-2600. Fayyaz Alam September 5, 2026 /FAYYAZ ALAM/ Primary Examiner, Art Unit 2646
Read full office action

Prosecution Timeline

Jan 06, 2025
Application Filed
Sep 10, 2026
Non-Final Rejection mailed — §112, §DOUBLEPATENT (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
83%
Grant Probability
95%
With Interview (+11.2%)
2y 6m (~9m remaining)
Median Time to Grant
Low
PTA Risk
Based on 1028 resolved cases by this examiner. Grant probability derived from career allowance rate.

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