Prosecution Insights
Last updated: April 19, 2026
Application No. 18/515,079

HEMOSTASIS VALVES AND METHODS OF USE

Non-Final OA §112§DP
Filed
Nov 20, 2023
Examiner
VU, QUYNH-NHU HOANG
Art Unit
3783
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Inari Medical Inc.
OA Round
1 (Non-Final)
68%
Grant Probability
Favorable
1-2
OA Rounds
3y 5m
To Grant
96%
With Interview

Examiner Intelligence

Grants 68% — above average
68%
Career Allow Rate
660 granted / 971 resolved
-2.0% vs TC avg
Strong +28% interview lift
Without
With
+28.1%
Interview Lift
resolved cases with interview
Typical timeline
3y 5m
Avg Prosecution
58 currently pending
Career history
1029
Total Applications
across all art units

Statute-Specific Performance

§101
0.8%
-39.2% vs TC avg
§103
41.4%
+1.4% vs TC avg
§102
21.6%
-18.4% vs TC avg
§112
27.8%
-12.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 971 resolved cases

Office Action

§112 §DP
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 . Election/Restrictions Applicant’s election without traverse of Group I (claims 52-65), species 1 (Figs. 1-4) & sub-species B (Fig. 7) in the reply filed on 01/07/26 is acknowledged. Claims 66-79 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Groups II-III and species 2-3 & A-D (Figs. 5-6, 8-9 & 12), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/07/26. Information Disclosure Statement Applicant should note that the large number of references in the attached IDS have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.05(b). Applicant is requested to point out any particular references in the IDS which they believe may be of particular relevance to the instant claimed invention in response to this office action. It is desirable to avoid the submission of long lists of documents if it can be avoided. Clearly irrelevant and marginally pertinent cumulative information should be eliminated. If a long list is submitted, those documents which have been specifically brought to applicant's attention and/or are known to be of most significance should be highlighted. See Penn Yan Boats, Inc. v. Sea Lark Boats, Inc., 359 F. Supp. 948, 175 USPQ 260 (S.D. Fla. 1972), affd, 479 F.2d 1338, 178 USPQ 577 (5th Cir. 1973), cert. denied, 414 U.S. 874 (1974). But cf. Molins PLC v. Textron Inc., 48 F.3d 1172, 33 USPQ2d 1823 (Fed. Cir. 1995). See MPEP 2004. Applicant's duty of disclosure of material and information is not satisfied by presenting a patent examiner with "a mountain of largely irrelevant [material] from which he is presumed to have been able, with his expertise and with adequate time, to have found the critical [material]. It ignores the real world conditions under which examiners work. Applicant has a duty not just to disclose pertinent prior art references but to make a disclosure in such way as not to "bury" it within other disclosures of less relevant prior art; See Golden Valley Microwave Foods Inc. v. Weaver Popcorn Co. Inc., 24 USPQ2d 1801 (N.D. Ind. 1992); Molins PLC v. Textron Inc., 26 USPQ2d 1889, at 1899 (D.Del 1992); Penn Yan Boats, Inc. v. Sea Lark Boats, Inc. et al., 175 USPQ 260, at 272 (S.D. F1. 1972). The examiner is not afforded the time to thoroughly review each reference of the IDS of 03/06/24, 03/12/24, 10/11/24, 10/26/24, 01/16/25, 03/17/25, 06/22/25, 01/08/25, given the number of references cited. By initialing each of the cited references on the accompanying 1449 form(s), the examiner is merely acknowledging the submission of the cited references and indicating that only a cursory review was made of the cited references. 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 52-65 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. The limitation “the tubular member” in claim 52 is vague. It is unclear to Examiner that the “tubular member” in lines 3-4 of the claim 52 is referring back to the “compliant tube” in line 2 or referring to a different element with respect to claimed “complaint tube”. Claims 53-65 are being rejected due to their dependency. Claim 52 recites the limitation "the tubular member" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim. Claims 53-65 are being rejected due to their dependency. 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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp. Prior art US 12,109,384: Claims 52-65 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12,109,384 in view of Hartley (US 2003/0116731). Regarding claim 52, US’384 discloses a valve assembly, line 1 in claim 1, comprising: a compliant tube defining a passageway, (e.g., a tubular member defining a lumen, see lines 2-3 in claim 1); with aspect to the limitation “compliant” (as modified by Hartley, see the modification below). a first flexible thread (a first filament is flexible) extending in a first loop around the tubular member, (see lines 3-4 in claim 1); Note: the claim 52 involves 112, 2nd paragraph issue, as mentioned the above. For examining purpose, examiner interprets that the compliant tube is equivalent to a tubular member or vice versa. a second flexible thread (a second filament is flexible) extending in a second loop around the tubular member, see lines 5-7 in claim 1; a pair of buttons movable from a first position to a second position, (e.g., a pair of actuator movable from a first position to a second position, in lines 8-9 in claims 1; wherein: the first flexible thread (filament) includes a first portion operably acted upon by a first one of the buttons and a second portion operably acted upon by a second one of the buttons, lines 10-13 in claim 1; the second flexible thread includes a first portion operably acted upon by the first one of the buttons and a second portion operably acted upon by the second one of the buttons, lines 14-17 in claim 1; in the first position, the buttons are positioned to tension the first flexible thread and the second flexible thread thereby decreasing a diameter of the first loop and a diameter of the second loop to constrict the passageway of the compliant tube, lines 18-22 in claim 1; in the second position, the buttons are positioned to loosen the first flexible thread and the second flexible thread thereby permitting the compliant tube to expand against the first loop and the second loop to increase the diameter of the first loop and the diameter of the second loop to at least partially open the passageway of the tubular member, lines 23-29 in claim 1; and the buttons are biased to the first position, line 30 in claim 1. US’384 does not disclose that the tubular member is formed of compliant material. Hartley discloses a valve assembly 2 comprising: a tubular member 8 formed of compliant materiel, or the tubular member 8 is equivalent to the claimed “complaint tube” defining a passageway 3. It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the valve device of US’384 with providing a tubular member formed of complaint tube, as taught by Hartley, in order to constrict the valve or sealing the instrument device when inserting into the valve assembly. Regarding claim 53, see claim 2 in US’384 Regarding claim 54, see claim 3 in US’384 Regarding claim 55, see claim 4 in US’384 Regarding claim 56, see claim 5 in US’384 Regarding claim 57, see claim 6 in US’384 Regarding claim 58, see claim 7 in US’384 Regarding claim 59, see claim 8 in US’384 Regarding claim 60, see claim 9 in US’384 Regarding claim 61, see claim 10 in US’384 Regarding claims 62-65, see claims 11-14 in US’384 Prior art US 11,697,011: Claims 52-65 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12,109,384. Regarding claims 52-55 & 60, US’011 discloses a valve assembly, comprising, see line 1 in claim 1 in US’011: a compliant tube defining a passageway, see line 2 in claim 1; a first flexible thread (filament) extending in a first loop around the tubular member (e.g., the filament comprising a first portion extending around at least a portion of the tubular member, see lines 5-7 in claim 1); a pair of buttons (first member and second member of an actuator, see lines 10-12 in claim 1) movable from a first position to a second position, wherein the first flexible thread includes a first portion operably acted upon by a first one of the buttons and a second portion operably acted upon by a second one of the buttons (e.g. first member, i.e., first button of the actuator coupled to the first end/portion of the filament, and second member, i.e. second button, coupled to the second end/portion of the filament, lines 14-16 in claim 1); in the first position, the buttons are positioned to tension the first flexible thread thereby decreasing a diameter of the first loop to constrict the passageway of the compliant tube, see lines 14-16 in claim 1; and in the second position, the buttons are positioned to loosen the first flexible thread thereby permitting the compliant tube to expand against the first loop and to increase the diameter of the first loop to at least partially open the passageway of the tubular member, see lines 16-18 in claim 1; the buttons are biased to the first position, see lines 19-20 in claim 1. US’011 does not disclose a second flexible thread, as required in the claimed invention. In other words, US’011 does not disclose the limitation: a second flexible thread extending in a second loop around the tubular member; the second flexible thread includes a first portion operably acted upon by the first one of the buttons and a second portion operably acted upon by the second one of the buttons; in the first position, the buttons are positioned to tension the second flexible thread thereby decreasing a diameter of the second loop to constrict the passageway of the compliant tube; in the second position, the buttons are positioned to loosen the second flexible thread thereby permitting the compliant tube to expand against the second loop to increase the diameter of the second loop to at least partially open the passageway of the tubular member. It would have been obvious to one having ordinary skill in the art at the time the invention was made to obtain a second flexible thread being provided structure and functions that similar to the first flexible thread (as discussed in the above), since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. Regarding claim 56, see claim 7 in US’011. Regarding claim 57, US’011 discloses the claimed invention except for the limitation that plurality of strands/filaments woven together. It would have been obvious to one having ordinary skill in the art at the time the invention was made to obtain plurality of strands woven together, since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. Regarding claim 58, the claims 6 & 9 in US’011 discloses that the tubular member (compliant tube) is configured to constricted and sealed. Therefore, a person skilled in the art recognizes that the compliant tube of elastically deformable, also see claim 2. Regarding claim 59, the claim 1 in US’011 states that: a second position wherein the filament is moved to at least partially open the lumen. In other words, the complaint tube is configured to resilient expand. Regarding claim 61, see claim 4 in US’011. Regarding claims 62-66, the US’011 discloses the claimed invention except for the limitations as required in claims 62-66. It would have been obvious to one having ordinary skill in the art at the time of the invention was made to obtain the compliant tube in second position with diameter of at least 14 French, or 16 French, or 20 French or 24 French, since it has been held that discovering these values of result effective variable involves only routine skill in the art. For example: the diameter of the compliant tube in second position that depends on the size of the instrument being inserted through the passage of the compliant tube so that allowing the instrument pass through the passage of the compliant tube easily. Examiner Notes Examiner cites particular columns and line numbers in the references as applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUYNH-NHU HOANG VU whose telephone number is (571)272-3228. The examiner can normally be reached on M-F 7:30 am-4:00 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, Michael Tsai can be reached on 571-270-5246. 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). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /QUYNH-NHU H. VU/Primary Examiner, Art Unit 3783
Read full office action

Prosecution Timeline

Nov 20, 2023
Application Filed
Feb 10, 2026
Non-Final Rejection — §112, §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
68%
Grant Probability
96%
With Interview (+28.1%)
3y 5m
Median Time to Grant
Low
PTA Risk
Based on 971 resolved cases by this examiner. Grant probability derived from career allow rate.

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