Prosecution Insights
Last updated: April 19, 2026
Application No. 18/542,664

DELIVERY SYSTEMS FOR PROSTHETIC HEART VALVE

Non-Final OA §102§103
Filed
Dec 16, 2023
Examiner
LOUIS, RICHARD G
Art Unit
3771
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Edwards Lifesciences Corporation
OA Round
1 (Non-Final)
74%
Grant Probability
Favorable
1-2
OA Rounds
3y 5m
To Grant
92%
With Interview

Examiner Intelligence

Grants 74% — above average
74%
Career Allow Rate
699 granted / 939 resolved
+4.4% vs TC avg
Strong +17% interview lift
Without
With
+17.3%
Interview Lift
resolved cases with interview
Typical timeline
3y 5m
Avg Prosecution
49 currently pending
Career history
988
Total Applications
across all art units

Statute-Specific Performance

§101
0.4%
-39.6% vs TC avg
§103
49.7%
+9.7% vs TC avg
§102
24.1%
-15.9% vs TC avg
§112
15.6%
-24.4% vs TC avg
Black line = Tech Center average estimate • Based on career data from 939 resolved cases

Office Action

§102 §103
Notice of Pre-AIA or AIA Status The present application is being examined under the pre-AIA first to invent provisions. Detailed Action This is in response to the non-provisional application filed 12/16/2023 . Claim Rejections - 35 USC § 102 The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States. Claim(s) 1 , 2, 4 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by U.S. Patent Publication Number 2004/0102791 (Murray, III) Regarding claim s 1, 2, 4 Murray, II I discloses as shown in Figures 1, 4, a prosthetic implant delivery assembly comprising: a prosthetic implant expandable (stent 22, see paragraph [0019]) from a radially compressed state to a radially expanded state; and a delivery apparatus, wherein the delivery apparatus comprises: an inflatable balloon (balloon 34, see paragraph [0020]) configured for expanding the prosthetic implant from the radially compressed state to the radially expanded state; and a proximal stop (band 32, see paragraph [0028]) and a distal stop (band 30, see paragraph [0028]) capable of limit ing longitudinal movement of the prosthetic implant relative to the balloon while the prosthetic implant is mounted over the inflatable balloon in the radially compressed state between the proximal stop and the distal stop, wherein the proximal stop and the distal stop each comprise an end portion configured to be positioned adjacent a respective end of the prosthetic implant when the prosthetic implant is radially compressed between the proximal and distal stops, and wherein each of the end portions is cone shaped (see Figure 4 and paragraph [0028]) , wherein the end portion of the distal stop comprises a plurality of longitudinally extending slots that allow the end portion of the distal stop to be radially compressed to a smaller diameter ; see Figures 7, 8; wherein a distal end of the balloon is attached to the distal stop . Claim(s) 1, 5 - 9 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by U.S. Patent Number 8,795,346 ( Alkhatib ) As to claim 1, Alkhatib teaches a prosthetic implant delivery device as shown in Figure 7 comprising a prosthetic implant expandable (Stent 4, see col. 3, lines 16-26) from a radially compressed state to a radially expanded state, the delivery apparatus comprising a catheter ( catheter shaft 3 , see col. 3, lines 16-26 ) ; an inflatable balloon ( balloon 6 , see col. 3, lines 27-50 ) position at a distal portion of the catheter for expanding the prosthetic implant from a radially compressed state to a radially expanded state ; and a proximal stop (see attached fig. 7 below ) and a distal stop (see attached fig. 7 below ) coupled to the catheter and configured to limit longitudinal movement of the prosthetic heart valve relative to the balloon while the prosthetic heart valve is mounted over the balloon in the radially compressed state between the proximal stop and the distal stop (prosthetic heart valve not positivel y claimed, however note stent 4 would indicate where the heart valve would be positioned) ; wherein the proximal stop and the distal stop are at least partially positioned within the balloon ( fig. 7 ) and configured to be positioned adjacent a respective end of the prosthetic heart valve when the prosthetic heart valve is radially compressed between the proximal and distal stops (fig. 7) ; and wherein the proximal and distal stops each comprise at least one passageway (18 in the proximal stop, col. 6, lines 62-65 indicate that 18 is present at both stops) that allows balloon inflation fluid to flow radially inwardly or radially outwardly through the proximal and distal stops ( col. 2, lines 13-17; col. 6, lines 29-40 ) , where each of the proximal and distal stops are cone shaped . As to claim 5 , Alkhatib teaches wherein the delivery apparatus further comprises an outer shaft (34) having a lumen and an inner shaft (14) extending through the lumen of the outer shaft, wherein the proximal stop is attached to a distal end of the outer shaft (fig. 7) and/or attached to an outer surface of the inner shaft, and wherein the distal stop is attached to an outer surface of the inner shaft (fig. 7) . Regarding claim 6, Alkhatib discloses wherein the proximal stop further comprises: a proximal portion attached to the distal end of the outer shaft and to a proximal end of the balloon; and an intermediate portion between the proximal portion and the end portion, the intermediate portion having an outer diameter that is less than an outer diameter of the proximal portion. See Figure 7. Alkhatib fails to disclose intermediate portion having an outer diameter less than the diameter of the end portion. It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the outer diameter of the end portion such that it was more than the diameter of the intermediate portion as matter of engineering design choice. Applicant has not disclosed that diameter of the end portion apart provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Alkhatib ’s end portion , and applicant’s invention, to perform equally well with either size because both spacing dimensions would perform the same function of creating space within the balloon equally well given the relative dimensions disclsoed . Regarding claim 7 , Alkhatib discloses the delivery assembly of claim 5 , wherein the proximal stop is attached to the distal end of the outer shaft (fig. 7) and further comprises at least one fluid passageway (18) that allows an inflation fluid to flow through the at least one passageway and into the balloon. Regarding claim 8, Alkhatib discloses wherein the distal stop further comprises: a proximal portion attached to the distal end of the outer shaft and to a proximal end of the balloon; and an intermediate portion between the proximal portion and the end portion, the intermediate portion having an outer diameter that is less than an outer diameter of the proximal portion. See Figure 7. Alkhatib fails to disclose intermediate portion having an outer diameter less than the diameter of the end portion. It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the outer diameter of the end portion such that it was more than the diameter of the intermediate portion as matter of engineering design choice. Applicant has not disclosed that diameter of the end portion apart provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Alkhatib ’s end portion , and applicant’s invention, to perform equally well with either size because both spacing dimensions would perform the same function of creating space within the balloon equally well given the relative dimensions disclosed . As to claim 9 , Alkhatib discloses the delivery assembly of claim 1, wherein the end portion of each stop decreases in diameter in a direction extending away from the prosthetic device ( fig. 7) . Claim Rejections - 35 USC § 103 The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action: (a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 3 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent Publication Number 2004/0102791 (Murray, III) in view of U.S. Patent Publication Number 2002/0032481 ( Gabbay ) Regarding claim 3 , Murray, III fails to disclose wherein the prosthetic implant is a prosthetic heart valve. Gabbay , from the same field of endeavor teaches a similar delivery assembly as shown in Figure 1 where the prosthetic implant is a prosthetic heart valve. See paragraph [0047]. It would have been obvious to one of ordinary skill in the art, at the time the invention was made to modify the delivery assembly disclosed by Murray, III by substituting the prosthetic implant for the one disclosed by Gabbay such that the prosthetic implant is a prosthetic heart valve because it would only require the simple substitution of one known alternative for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007). Claim 10 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Murray as applied to claim a above, and further in view of Lee et al. US 2011/0077731 A1 (Lee). Regarding claim 10, Murray teaches the delivery apparatus of claim 1. It should be noted that Murray fails wherein the delivery device further comprises a nosecone attached to a distal end of the distal stop . Murray does teach that the device is inserted into a body lumen (artery, [0002]). Lee teaches a device inserted into a body lumen with a common nosecone (25, fig. 14). The nosecone is configured to reduce trauma to the patient’s body lumens as the device is advanced [0043]. It would have been obvious to one having ordinary skill in the art before the invention was made to apply the known improvement in the device of Murray and the results would have been predictable to one of ordinary skill in the art. One skilled in the art would have readily recognized that including a nosecone with the stop of Murray would positively prevent/reduce trauma to the patient’s boy lumens as the device is advanced [0043]. Claim 11 -14, 19 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent Publication Number 2004/0093060 ( Seguin et al. ) in view of U.S. Patent Publication Number 2002/0032481 ( Murray, II I ) Regarding claim s 11 -14 , 19 Senguin discloses a method of implanting a prosthetic heart valve within the heart, the method comprising: introducing a distal end portion of a delivery apparatus into the native aortic valve of the heart, a distal end portion of the delivery apparatus comprising an inflatable balloon, see paragraph [0006]; and a radially expandable prosthetic heart valve mounted over the balloon in a radially compressed state, inflating the balloon to radially expand the prosthetic heart valve within the native aortic valve; deflating the balloon; and retracting the delivery apparatus from the heart. See paragraph [0075]. Senguin fails to disclose a proximal stop and a distal stop positioned at least partially within the balloon, wherein the proximal stop and the distal stop each comprise a cone-shaped end portion. Murray, II I, from the same field of endeavor teaches a similar method as shown shown in Figures 1, 4, a prosthetic implant delivery assembly comprising: a prosthetic implant expandable (stent 22, see paragraph [0019]) from a radially compressed state to a radially expanded state; and a delivery apparatus, wherein the delivery apparatus comprises: an inflatable balloon (balloon 34, see paragraph [0020]) configured for expanding the prosthetic implant from the radially compressed state to the radially expanded state; and a proximal stop (band 32, see paragraph [0028]) and a distal stop (band 30, see paragraph [0028]) capable of limiting longitudinal movement of the prosthetic implant relative to the balloon while the prosthetic implant is mounted over the inflatable balloon in the radially compressed state between the proximal stop and the distal stop, wherein the proximal stop and the distal stop each comprise an end portion configured to be positioned adjacent a respective end of the prosthetic implant when the prosthetic implant is radially compressed between the proximal and distal stops, and wherein each of the end portions is cone shaped (see Figure 4 and paragraph [0028]), wherein the end portion of the distal stop comprises a plurality of longitudinally extending slots that allow the end portion of the distal stop to be radially compressed to a smaller diameter ; see Figures 7, 8; wherein a distal end of the balloon is attached to the distal stop , wherein the balloon is inflated with an inflation fluid that flows radially through the proximal and distal stops, wherein the proximal stop is positioned adjacent to a proximal end of the prosthetic heart valve and the distal stop is positioned adjacent to a distal end of the prosthetic heart valve, such that the prosthetic device is longitudinally contained between the proximal and distal stops during introduction of the delivery heart valve into the heart, wherein inflating the balloon comprises causing the inflation fluid to flow: through a first passageway in the proximal stop and into a proximal portion of the balloon; from the proximal portion of the balloon, through a second passageway in the proximal stop, and into an intermediate portion of the balloon within the prosthetic device; and from the intermediate portion of the balloon, through a passageway in the distal stop, and into a distal portion of the balloon , the purpose of the proximal and distal stops for the purpose of supporting portions of the balloon , wherein the end portion of the distal stop comprises a plurality of longitudinally extending slots that allow the end portion of the distal stop to be radially compressed to a smaller diameter. See paragraph [0024]. It would have been obvious to one of ordinary skill in the art, at the time the invention was made to modify the method disclosed by Senguin to include the proximal and distal stops taught by Murray, II I, in the manne r recited in claim 11 in order to support portions of the balloon. Claim 20 rejected under pre-AIA 35 U.S.C. 103( a) as being unpatentable over U.S. Patent Publication Number 2004/0093060 ( Seguin et al. ) in view of U.S. Patent Publication Number 2002/0032481 ( Murray, II I ) as applied to claim 11 above, and further in view of Lee et al. US 2011/0077731 A1 (Lee) Regarding claim 20, Sengun in view of Murray teach the delivery apparatus of claim 1 1. It should be noted that Murray fails wherein the delivery device further comprises a nosecone attached to a distal end of the distal stop . Murray does teach that the device is inserted into a body lumen (artery, [0002]). Lee teaches a device inserted into a body lumen with a common nosecone (25, fig. 14). The nosecone is configured to reduce trauma to the patient’s body lumens as the device is advanced [0043]. It would have been obvious to one having ordinary skill in the art before the invention was made to apply the known improvement in the device of Sengun in view of Murray and the results would have been predictable to one of ordinary skill in the art. One skilled in the art would have readily recognized that including a nosecone with the stop of Murray would positively prevent/reduce trauma to the patient’s boy lumens as the device is advanced [0043]. Claims 15- 18 are rejected under pre-AIA 35 U.S.C. 103( a) as being unpatentable over U.S. Patent - Publication Number 2004/0093060 ( Seguin et al. ) in view of U.S. Patent Publication Number 2002/0032481 ( Murray, II I ) as applied to claim 11 above, and further in view US Patent Publication Number 2005/0203605 (Dolan) Regarding claims 15 - 18 , Seguin in view of Muarry , III fail to disclose crimping the prosthetic heart valve to the radially compressed state onto a balloon of the delivery apparatus. Dolan, from the same field of endeavor teaches a similar method as shown in Figure 1, which includes the step of crimping the prosthetic heart valve to the radially compressed state onto a balloon of the delivery apparatus for the purpose of ensuring the prosthetic valve has the appropriate diameter for delivery . See paragraph [0062]. It would have been obvious to one of ordinary skill in the art, at the time the invention was to modify the method disclo sed by Seguin in view of Muarry , III to include the step of crimping the prosthetic heart valve to the radially compressed state onto a balloon of the delivery apparatus as taught by Dolan in order to ensure th.e prosthetic valve has the appropriate diameter for delivery Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT RICHARD G LOUIS whose telephone number is 571-270-1965 . The examiner can normally be reached on Monday – Friday, 9:30 – 6:00 pm. If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jackie Ho at 571-272-4696 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. If there are any inquiries that are not being addressed by first contacting the Examiner or the Supervisor, you may send an email inquiry to TC3700_Workgroup_D_Inquiries@uspto.gov . 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. /RICHARD G LOUIS/ Primary Examiner, Art Unit 3771
Read full office action

Prosecution Timeline

Dec 16, 2023
Application Filed
Mar 13, 2026
Non-Final Rejection — §102, §103 (current)

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Prosecution Projections

1-2
Expected OA Rounds
74%
Grant Probability
92%
With Interview (+17.3%)
3y 5m
Median Time to Grant
Low
PTA Risk
Based on 939 resolved cases by this examiner. Grant probability derived from career allow rate.

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