Prosecution Insights
Last updated: April 19, 2026
Application No. 18/575,638

ENDOVASCULAR IMPLANT POSITIONING APPARATUS WITH FUNCTIONALLY MODIFIED WIRE

Non-Final OA §103
Filed
Dec 29, 2023
Examiner
LYNCH, ROBERT A
Art Unit
3771
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
BARD PERIPHERAL VASCULAR, INC.
OA Round
1 (Non-Final)
80%
Grant Probability
Favorable
1-2
OA Rounds
3y 2m
To Grant
93%
With Interview

Examiner Intelligence

Grants 80% — above average
80%
Career Allow Rate
673 granted / 844 resolved
+9.7% vs TC avg
Moderate +14% lift
Without
With
+13.6%
Interview Lift
resolved cases with interview
Typical timeline
3y 2m
Avg Prosecution
40 currently pending
Career history
884
Total Applications
across all art units

Statute-Specific Performance

§101
1.4%
-38.6% vs TC avg
§103
39.1%
-0.9% vs TC avg
§102
27.1%
-12.9% vs TC avg
§112
21.6%
-18.4% vs TC avg
Black line = Tech Center average estimate • Based on career data from 844 resolved cases

Office Action

§103
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. Information Disclosure Statement The information disclosure statement(s) (IDS) submitted on 12/29/2023 has been received and made of record. Note the acknowledged form PTO-1449 enclosed herewith. Drawings The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "24" and "25" have both been used to designate a guidewire in Figs. 3 and 3A; reference characters "14c" and "W" have both been used to designate a wall in Fig. 6; and reference characters "14c" and "W" have both been used to designate an extension in Figs. 8 and 10. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance. Claim Interpretation The following is a quotation of 35 U.S.C. 112(f): (f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specific ation and equivalents thereof. The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph: An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked. As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph: (A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function; (B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as "configured to" or "so that"; and (C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function. Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function. Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function. Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Currently no claims are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph . Claim Rejections - 35 USC § 103 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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. Claim (s) 1- 2, 4-11, 13-19 and 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over Crittenden et al. ( EP 0282143 ) in view of Inoue (US 2015/0141855) . Crittenden discloses (see Figs. 1-10) a balloon catheter surgical system comprising the following claim limitations: (claim 1) An apparatus for positioning an endovascular implant adjacent a junction including a branch from a vessel (as shown in Fig. 1, a balloon catheter system capable of delivery an endovascular implant is expressly disclosed), comprising: a sheath (12, Fig. 1) including a first lumen (46, Figs. 3 and 7) and a second lumen (42, Fig. 7), the first lumen (46) adapted for (i.e., capable of) receiving a catheter (10 , Figs 1, 3 and 9 ) adapted for positioning the endovascular implant within the branch (as shown in Fig. 1, balloon catheter 10 expressly disclosed); and a wire (14, Fig. 1) located in the second lumen (42) (as shown in Figs. 1, 3 and 9 ) , the wire (14) including a pre-shaped portion (16, Fig. 1) for positioning at the junction for use in guiding the endovascular implant into position within the branch (as shown in Fig. 1, pre-shaped bent guidewire 14 distal end 16 is fully capable of guiding balloon catheter thereon through vasculature for implant delivery) ; (claim s 2 and 11 ) wherein the first lumen (46) has a larger diameter than the second lumen (42) (as expressly shown in Figs. 3 and 7) ; (claim s 6 and 15 ) wherein an opening (i.e., adjacent 36, as shown in Fig. 7) of the second lumen (42) is at a distal end (36) of the sheath (12) (bore 42 extends into passage 44 with the guidewire 14 exiting at the distal end 36 of the sheath 12) ; (claim s 7 and 16 ) wherein an opening (i.e., proximal opening of bore 42 adjacent 38, as shown in Figs. 1 and 7) of the second lumen (42) is proximal of a distal end (36) of the sheath (12) (as expressly shown in Figs. 1 and 7) ; (claim 10) An apparatus for positioning an endovascular implant adjacent a junction including a branch from a vessel (as shown in Fig. 1, a balloon catheter system capable of delivery an endovascular implant is expressly disclosed) , comprising: a sheath (12, Fig. 1) including a first lumen (46, Figs. 3 and 7) and a second lumen (42, Fig. 7) ; a catheter (10, Figs 1, 3 and 9) at least partially positioned in the first lumen (46) (as shown in Figs. 1, 3 and 9) , the catheter (10) adapted for positioning the endovascular implant within the branch (as shown in Fig. 1, balloon catheter 10 expressly disclosed) ; and a wire (14, Fig. 1) located in the second lumen (42) (as shown in Figs. 1, 3 and 9) , the wire (14) including a pre-shaped portion (16, Fig. 1) for positioning at the junction for use in guiding the endovascular implant into position within the branch (as shown in Fig. 1, pre-shaped bent guidewire 14 distal end 16 is fully capable of guiding balloon catheter thereon through vasculature for implant delivery) ; and (claim 19) An apparatus for positioning an endovascular implant adjacent a junction including a branch from a vessel (as shown in Fig. 1, a balloon catheter system capable of delivery an endovascular implant is expressly disclosed) using a (12, Fig. 1) including a first lumen (46, Figs. 3 and 7) and a second lumen (42, Fig. 7) , the first lumen (46) adapted for (i.e., capable of) receiving a catheter (10) adapted for positioning the endovascular implant within the branch (as shown in Fig. 1, balloon catheter 10 expressly disclosed) , comprising: a wire (14, Fig. 1) adapted to be located in the second lumen (42) (as shown in Figs. 1, 3 and 9) , the wire including a pre-shaped portion (16, Fig. 1) adapted for positioning at the junction for use in guiding the endovascular implant into position within the branch (as shown in Fig. 1, pre-shaped bent guidewire 14 distal end 16 is fully capable of guiding balloon catheter thereon through vasculature for implant delivery) . Crittenden, as applied above, discloses a balloon catheter surgical system comprising all the limitations of the claim except for the wire being a radiopaque shape memory material, wherein an extension or bend of the at least partially radiopaque wire is adapted for engaging a wall adjacent the branch and/or an end of a vascular implant, and wherein the pre-shaped portion comprises a bend, such as a U-shaped bend, and in particular one with two curved portions having a depth and a width, in the at least partially radiopaque wire proximal of a distal end of the at least partially radiopaque wire . However, Inoue teaches (see Figs. 1-2) a similar a balloon catheter surgical system comprising a wire (1, Figs. 1-2; and/or 2, Figs. 1-2) being a radiopaque shape memory material ([0065]; Nitinol and stainless steel are both expressly disclosed) , wherein an extension or bend of the at least partially radiopaque wire (1/2) is adapted for (i.e., capable of) engaging a wall adjacent the branch and/or an end of a vascular implant (as expressly shown in annotated Fig. 2 below, wherein the deflectable shape memory extension of the wire is fully capable of engaging a wall or implant if one so desires ) , and wherein the pre-shaped portion comprises a bend, such as a U-shaped bend, and in particular one with two curved portions having a depth and a width, in the at least partially radiopaque wire proximal of a distal end of the at least partially radiopaque wire (1/2) ( as expressly shown in annotated Fig. 2 below ) in order to beneficially allow for a catheter tube to be curved into one or more desired curved positions so that the catheter tube can be can be looped in order to make the catheter tube pass through desired vasculature wherein operability is significantly improved and enables a surgical procedure to be easily and surely performed ( [0005]-[0009; [0014]-[0016]; [0024]-[0025]; [0028]-[0029] ) . Therefore, i t would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system of Crittenden to have a wire being a radiopaque shape memory material, wherein an extension or bend of the at least partially radiopaque wire is adapted for engaging a wall adjacent the branch and/or an end of a vascular implant, and wherein the pre-shaped portion comprises a bend, such as a U-shaped bend, and in particular one with two curved portions having a depth and a width, in the at least partially radiopaque wire proximal of a distal end of the at least partially radiopaque wire in order to beneficially allow for a catheter tube to be curved into one or more desired curved positions so that the catheter tube can be can be looped in order to make the catheter tube pass through desired vasculature wherein operability is significantly improved and enables a surgical procedure to be easily and surely performed , as taught by Inoue . Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert Lynch whose telephone number is (571)270-3952 . The examiner can normally be reached on Monday-Friday (9:00AM-6:00PM, with alternate Fridays off). If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Elizabeth Houston , at (571) 272- 7134 . 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. /ROBERT A LYNCH/ Primary Examiner, Art Unit 3771
Read full office action

Prosecution Timeline

Dec 29, 2023
Application Filed
Mar 19, 2026
Non-Final Rejection — §103 (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
80%
Grant Probability
93%
With Interview (+13.6%)
3y 2m
Median Time to Grant
Low
PTA Risk
Based on 844 resolved cases by this examiner. Grant probability derived from career allow rate.

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