Prosecution Insights
Last updated: May 04, 2026
Application No. 18/557,416

A DEVICE FOR INSERTING A GUIDE WIRE INTO BLOOD VESSEL

Non-Final OA §103
Filed
Oct 26, 2023
Priority
Sep 20, 2021 — IT 102021000024047 +1 more
Examiner
FLORES, ADRIAN
Art Unit
3774
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Vivheart S R L
OA Round
1 (Non-Final)
Grant Probability
Favorable
1-2
OA Rounds

Examiner Intelligence

Grants only 0% of cases
0%
Career Allowance Rate
0 granted / 0 resolved
-70.0% vs TC avg
Minimal +0% lift
Without
With
+0.0%
Interview Lift
resolved cases with interview
Typical timeline
Avg Prosecution
18 currently pending
Career history
18
Total Applications
across all art units

Statute-Specific Performance

§101
5.0%
-35.0% vs TC avg
§103
65.0%
+25.0% vs TC avg
§102
27.5%
-12.5% vs TC avg
§112
2.5%
-37.5% vs TC avg
Black line = Tech Center average estimate • Based on career data from 0 resolved cases

Office Action

§103
DEATILED 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 Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. FILLIN "Insert series code and serial no. of parent." 102021000024047 , filed on FILLIN "Enter the date filing of the parent application." 20 Sep 2021 (20.09.2021) . Claim Rejections - 35 USC § 103 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. Claim(s) FILLIN "Insert the claim numbers which are under rejection." \d "[ 1 ]" 1-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bulman et al. US 20180207395 A1, herein referred to as Bulman. Regarding claim 1, Bulman discloses a device for inserting a guide wire (Fig 1, guide catheter 214) suitable for heart valve prostheses into a blood vessel [0005], comprising: an external catheter (Fig 1, sheath 1) having a wall defining a longitudinal axis (Fig 1) and a circumferential direction (Fig 1, [0052]), an internal catheter inserted (Fig 1, 218 nose catheter) into said external catheter [0052], having a handle portion (Annotated Fig 1 below) configured to allow a user to advance or retract said internal catheter along said longitudinal axis ([0009], teaches expanding ballon catheter and movement to advance), wherein said external catheter defines an anchoring element to the internal walls of a blood vessel (Fig 2A, layer 50 is capable of anchoring system in place as described), said anchoring element comprising: - a distal annular portion (Fig 2A, annular member 10; Bulman teaches a distal portion of the sheath see [0052], therefore composite annular portion would also have a distal portion ) of said wall of the external catheter, fixed to said internal catheter so as to move integrally with said internal catheter when it is advanced or retracted [0072], - a proximal annular portion of said wall of the external catheter, sliding on said internal catheter (Bulman teaches a distal portion of the sheath see [0052], therefore composite annular portion would also have distal and proximal portions) , wherein the wall of the external catheter (does not have continuity solutions in correspondence with said distal annular portion and with said proximal annular portion [0052], - a median annular portion of said wall of the external catheter ( Bulman teaches a distal portion of the sheath see [0052], therefore composite a nnular portion would also have a medial median portion as claimed ), sliding on said internal catheter [0052], comprising at least a first plurality of notches ( notch as defined my Merriam-Webster an indentation or incision on an edge or surface. Fig 2A, curved ends 26 meet claim limitation ) directed according to said longitudinal axis and having a first length [0064], a second plurality of direct notches according to said longitudinal axis and having a second length (Fig 2A, contact surface 22), in which all said notches divide the wall of the median annular portion of the external catheter [0069] . wherein said notches of the first plurality of notches have respective ends misaligned along said circumferential direction to respective ends of the notches of the second plurality of notches (Fig 2A, not uniformly spaced), so that the notches of the first plurality of notches are offset along the circumferential direction with respect to the notches of the second plurality of notches (capable of being aligned as claimed). But fails to discloses an external catheter and define between them a plurality of threadlike elements suspended above said internal catheter ; - folding away radially with respect to said internal catheter when said handle portion is pulled , causing the internal catheter to retract along said longitudinal axis with respect to the external catheter , abutting against said internal walls of the blood vessel in opposite points], counteracting displacements of the internal catheter transversely to said longitudinal axis - extending along the longitudinal axis when said handle portion is pushed by advancing the internal catheter along said longitudinal axis with respect to the external catheter . However, Bulman in another embodiment discloses a similar device for inserting a guide wire into blood vessels. Bulaman also teaches of the external catheter [0069] and define between them a plurality of threadlike elements suspended above said internal catheter (Fig 4B, members 30 can define an S-shape in cross-section [0070]); - folding away radially with respect to said internal catheter when said handle portion is pulled (capable of functioning as described), causing the internal catheter to retract along said longitudinal axis with respect to the external catheter [0062-0065], abutting against said internal walls of the blood vessel in opposite points [0084], counteracting displacements of the internal catheter transversely to said longitudinal axis ( functions as described ) , - extending along the longitudinal axis when said handle portion is pushed by advancing the internal catheter along said longitudinal axis with respect to the external catheter ([0066] extend along entire sheath); Therefore, 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 base medical device of Bulman to incorporate an external catheter and define between them a plurality of threadlike elements suspended above said internal catheter ; - folding away radially with respect to said internal catheter when said handle portion is pulled , causing the internal catheter to retract along said longitudinal axis with respect to the external catheter , abutting against said internal walls of the blood vessel in opposite points], counteracting displacements of the internal catheter transversely to said longitudinal axis taught and suggested by Bulman in order to lower the coefficient of friction in the device [0069]. Regarding claim 2, the combination of Bulman ’s embodiments discloses the invention substantially as claimed and as discussed above with respect to claim 1 teaches wherein said second length is equal to said first length ( [0064] “radii of curvature, can be constant across all base members 20” therefore lengths are capable of being equal) . Regarding claim 3, the combination of Bulman’s embodiments discloses the invention substantially as claimed and as discussed above with respect to claim 1 teaches wherein the notches of said first plurality of notches are orderly alternated ([0064] can be “linear” arranged, capable of orderly placement])with the notches of said second plurality of notches along said circumferential direction of the median portion of the wall of the external catheter (capable of claimed configuration), so that each threadlike element of said threadlike elements is defined by a notch of the first plurality of notches and by a notch of the second plurality of notches (capable of claimed configuration). Regarding claim 4, the combination of Bulman’s embodiments discloses the invention substantially as claimed and as discussed above with respect to claim 1 teaches in which the notches of said first plurality of notches have their respective ends aligned with each other along said circumferential direction of the median portion of the wall of the external catheter (capable of this configuration), and the notches of said second plurality of notches have their respective ends aligned with each other along said circumferential direction of the median portion of the wall of the external catheter (capable of this configuration). Regarding claim 5, the combination of Bulman’s embodiments discloses the invention substantially as claimed and as discussed above with respect to claim 1 teaches comprising a guide wire for heart valve prostheses (Fig 1, valve 212) inserted in said internal catheter (Fig 1, [0086]). Regarding claim 6, the combination of Bulman’s embodiments discloses the invention substantially as claimed and as discussed above with respect to claim 1 teaches comprising a preformed guiding catheter slidably inserted in said internal catheter [0052]. Regarding claim 7, the combination of Bulman’s embodiments discloses the invention substantially as claimed and as discussed above with respect to claim 1 teaches in which said threadlike elements are made of a biocompatible material [0065]. Regarding claim 8, the combination of Bulman’s embodiments discloses the invention substantially as claimed and as discussed above with respect to claim 1 teaches further comprising a hemostatic valve fixed to said external catheter [0052], configured so that said internal catheter slides tightly therethrough along said longitudinal axis [0052]. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT Adrian Flores whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-1450 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F, 9-5 . 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, FILLIN "SPE Name?" \* MERGEFORMAT Melanie Tyson can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (571) 272-9062 . 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. /A.F./ Patent Examiner, Art Unit 3774 /THOMAS C BARRETT/ SPE, Art Unit 3799
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Prosecution Timeline

Oct 26, 2023
Application Filed
Feb 20, 2026
Non-Final Rejection — §103 (current)

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Prosecution Projections

1-2
Expected OA Rounds
Grant Probability
Low
PTA Risk
Based on 0 resolved cases by this examiner. Grant probability derived from career allowance rate.

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