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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/27/2026 has been entered.
Priority
This application claims priority from a plurality of provisional applications, the earliest being 62/911,861 filed 10/07/2019.
Status of Claims
Claims 1-7 and 9-23 are pending.
Claims 2 and 13-23 have been withdrawn from consideration.
Claim 8 has been cancelled.
Election/Restrictions
Applicant elected Invention I (Apparatus) and Species 2 (Figures 6-7) without traverse on 05/19/2025.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "184" and "185" have both been used to designate the first radial fold. Reference numbers 184/185 are pointing at different portions of the same fold in Figures 6-7. At best these are two outer curved portions of a single fold, but the balloon is folded once at this point and the second fold is made within the pocket closer to reference number 185. The applicant is advised to amend the drawings to move one reference number deeper into the pocket at the second fold.
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 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.
Claim(s) 1, 3-7, and 9-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rupp et al (Rupp) US 2017/0065415 A1 in view of Tilson (Tilson) WO 2012/009486 A2 and Pederson Jr et al (Pederson) and.
Rupp discloses the invention substantially as claimed:
1. A balloon assembly (Figure 4), comprising: an inflatable balloon 28 having an inflated state and a deflated state (all balloon delivery catheters used in the art move between inflated and deflated states),
wherein the inflatable balloon in the deflated state comprises:
a valve retaining portion (middle section adjacent 32 in Figure 4) having a generally cylindrical shape (Figures 1-4);
a distal tapered portion (bottom of Figure 4) connected to a distal end of the valve retaining portion (Figure 4), a proximal end of the distal tapered portion having a larger diameter than a distal end of the distal tapered portion and the valve retaining portion (Figure 4 shows the diameter of the proximal end near reference number 44 is larger than the diameter of the distal end closer to reference number 43 and the valve retaining portion near reference number 32);
a proximal tapered portion (Top of Figure 4) connected to a proximal end of the valve retaining portion (Figure 4), a distal end of the proximal tapered portion having a larger diameter than a proximal end of the proximal tapered portion and the valve retaining portion (Figure 4 shows the diameter of the distal end near reference number 42 is larger than the diameter of the proximal end closer to reference number 26 and the valve retaining portion near reference number 32);
a distal leg (flatter portion at the bottom of Figure 4) connected to the distal end of the distal tapered portion (Figure 4); and
a proximal leg (flatter portion near reference number 7 in Figure 4) connected to the proximal end of the proximal tapered portion (Figure 4);
However, Rupp does not disclose if the balloon, when deflated, comprises axial folds in any of the distal tapered portion, valve retaining portion, and proximal tapered portion or distal tapered portion that folds to form a pocket extending as claimed.
Tilson teaches the use of axial pleats or folds extending in each of the distal tapered portion, valve retaining portion, and proximal tapered portion (Figure 9A [0191]) in the same field of endeavor for the purpose of providing a more controlled deflation of the balloon and reinforcement during expansion.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to combine the axial pleats of Tilson to each of the distal tapered portion, valve retaining portion, and proximal tapered portion of the balloon of Rupp in order to provide a more controlled deflation of the balloon and reinforcement during expansion.
In regards to the last paragraph of claim 1, Rup as modified by Tilson discloses the distal tapered portion of the inflatable balloon (bottom of figure 4) comprises a tapered distal end portion (adjacent reference number 43), wherein the one or more axial folds of the distal tapered portion do not extend into the tapered distal end portion of the distal tapered portion such that the tapered distal end portion is free of any folds (because the applicant used the term portion, it can be interpreted to be any section or subsection of the distal tapered portion, keeping in mind the folds are circumferentially offset there are portions in between the folds that are not folded, the examiner is identifying a limited portion between the folds of the tapered distal section as being free of any folds).
Pederson teaches the use of a balloon assembly (Figures 1-4) wherein the proximal end (36b) of the distal tapered portion (right side of figures 2-3) comprises a first radial fold (left fold of 36b) connected to a second radial fold (right fold of 36b), wherein an intersection of the second radial fold and the valve retaining portion forms a pocket extending distally at the proximal end of the distal tapered portion (Figures 2-3 show the stent extending into the pocket at the intersection of the second fold and the valve retaining portion) in the same field of endeavor for the purpose of providing more control over the implant prior to expansion.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the distal tapered portion of Rupp to include the two elongated folds and pocket of Pederson to extend/overlap the heart valve 12 in order to provide a pocket for retaining and controlling the ends of the implant prior to expansion.
3. Rupp discloses a cover (58 Figures 13-16) that encloses the inflatable balloon (Figure 14), wherein the cover comprises a proximal end portion 94, a distal end portion 95, and an intermediate portion 96 between the proximal end portion and the distal end portion, wherein the proximal end portion defines a proximal recess that is shaped to substantially match a shape of the proximal tapered portion of the inflatable balloon (Figures 13-14), the distal end portion defines a distal recess that is shaped to substantially match a shape of the distal tapered portion of the inflatable balloon (Figures 13-14), and the intermediate portion defines an intermediate recess that is shaped to substantially match a shape of the valve retaining portion of the inflatable balloon (Figures 13-14).
4. Rupp discloses the cover comprises a first cover piece and a second cover piece that are complimentarily structured such that they can be matingly assembled together for enclosing the inflatable balloon in the deflated state ([0062] discloses the clam shell shape of the cover comprising the two pieces that mate to enclose the balloon).
5. Rupp discloses an outer sleeve 97 extending over the cover so as to prevent the first and second cover pieces from separating from each other (Figure 15).
6. Rupp discloses the inflatable balloon comprises an internal lumen extending through the tapered proximal portion, the valve retaining portion, and the tapered distal portion (Figure 4).
7. Rupp discloses the proximal tapered portion of the inflatable balloon comprises a proximal end portion, wherein the one or more axial folds of the proximal tapered portion do not extend into the proximal end portion of the proximal tapered portion (as explained above there are portion between the folds at both the proximal and distal tapered end portions, the examiner is identifying a limited portion between the folds of the tapered proximal section as being free of any folds).
9. Rupp discloses the distal end of the proximal tapered portion comprises a radial fold (adjacent 42 in Figure 4) that forms an obtuse or right angle relative to the valve retaining portion (Figure 4 shows the right angle adjacent 42).
10. Rupp as modified discloses the first and second radial folds at the proximal end of the distal tapered portion extends proximally and radially inward (Radially inner/outer folds near 32a extend distally/proximally and inward/outward as shown in Figure 4).
11. Rupp (R) as modified above discloses a balloon assembly (R Figure 4), comprising: an inflatable balloon (R 28) having an inflated state and a deflated state (all balloons inherently have this),
wherein the inflatable balloon in the deflated state comprises:
a valve retaining portion (R middle section adjacent 32 Figure 4) having a generally cylindrical shape (R Figures 1-4) and one or more axial folds (See modification in view of Tilson above);
a distal tapered portion (R bottom of Figure 4) connected to a distal end of the valve retaining portion (R Figure 4), a proximal end of the distal tapered portion having a larger diameter than a distal end of the distal tapered portion and the valve retaining portion (R Figure 4 shows the diameter of the proximal end near reference number 44 is larger than the diameter of the distal end closer to reference number 43 and the valve retaining portion near reference number 32);
a proximal tapered portion (R top of Figure 4) connected to a proximal end of the valve retaining portion (R Figure 4), a distal end of the proximal tapered portion having a larger diameter than a proximal end of the proximal tapered portion and the valve retaining portion (Figure 4 shows the diameter of the distal end near reference number 42 is larger than the diameter of the proximal end closer to reference number 26 and the valve retaining portion near reference number 32);
a distal leg connected to the distal end of the distal tapered portion (R flatter portion at the bottom of Figure 4); and
a proximal leg connected to the proximal end of the proximal tapered portion (R flatter portion near reference number 7 in Figure 4);
wherein the proximal end of the distal tapered portion comprises a first radial fold connected to a second radial fold, wherein an intersection of the second radial fold and the valve retaining portion forms a pocket extending distally at the proximal end of the distal tapered portion (see modification above in view of Pederson with respect to claim 1),
wherein the proximal tapered portion comprises one or more axial folds (See modification in view of Tilson above) and a tapered proximal end portion, wherein the one or more axial folds of the proximal tapered portion do not extend into the tapered proximal end portion of the proximal tapered portion such that the tapered proximal end portion is free of any folds (as explained above there are portion between the folds at both the proximal and distal tapered end portions, the examiner is identifying a limited portion between the folds of the tapered proximal section as being free of any folds).
12. Rupp discloses the inflatable balloon in the deflated state further comprises one or more axially extending folds along at least sections of the distal tapered portion and the proximal tapered portion (See modification in view of Tilson above).
Response to Arguments
Applicant's arguments filed 02/27/2026 have been fully considered but they are not persuasive.
With respect to the prior art rejection the applicant argues that the current amendments foreclose the proposed broad interpretation of the tapered distal end portion. This is not persuasive because the claims still only require a tapered distal end “portion” free from any folds. The folds of the prior art combination are axially extending and offset from each other. The folds do not continuously extend about the entire circumference and the claims do not require the tapered distal end portion to continuously extend about the entire circumference. Therefore there are numerous portions of the tapered distal end that are tapered and free from folds.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER D PRONE whose telephone number is (571)272-6085. The examiner can normally be reached Monday-Friday 10 am - 6 pm (HST).
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, Melanie R Tyson can be reached at (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Christopher D. Prone/Primary Examiner, Art Unit 3774
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