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 .
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 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.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 June 26, 2026 has been entered. Claims 27 and 29-48 are pending in the application. Response to applicant's arguments can be found at the end of this office action.
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.
Claims 27 and 29-33 are rejected under 35 U.S.C. 103 as being unpatentable over Gianotti (U.S. Patent No. 6068635) in view of Weaver et al. (U.S. Patent No. 5536248; hereinafter “Weaver”).
Regarding claim 27, Gianotti discloses a delivery system (150; Fig. 6), comprising a funnel (combination of nose section (165) and body (180); Fig. 6) having a proximal end (183’) and a distal end (170’), said funnel comprising a handle (combination of grip element (187) and grip element (187’); Fig. 6) integrated into a combined funnel and handle (grip elements (187, 187’) are integrally formed with body (180; col. 6, ll. 63-65) and body (180) is connected with nose section (165) via bolt (147; col. 7, ll. 4-16)), a first portion (187) of said integrated handle extending beyond the diameter of the proximal end of the funnel (Fig. 6) and a second portion (187’) of said integrated handle extending beyond the diameter of the proximal end of said funnel (Fig. 6), each of said first and second portions configured to engage an operator’s finger or thumb (e.g., as “grip elements;” col. 6, ll. 63-65), a funnel cap (157) positioned at and in contact with the proximal end of said funnel, and a scaffold (101) positioned in said funnel, said system further comprising an outer delivery sheath (115), wherein said funnel cap has an opening (Fig. 10) configured to accept an elongate member inserted through said funnel cap, said elongate member when inserted extending beyond said distal end of said funnel (element (157) is capable of performing the function of accepting an elongate member inserted through said funnel cap, said elongate member when inserted extending beyond said distal end of said funnel, as claimed because element (157) has an opening/lumen extending therethrough sized and shaped to allow passage of catheter tip (135) and inner shaft (125) past the distal end (170’) of the funnel (Fig. 6; col. 8, ll. 30-39)).
The device of Gianotti is not explicitly disclosed with the first and second portions having a loop or curve with an aperture.
Weaver, a reference in the scaffold delivery field of endeavor, teaches providing a handle with first and second portions each comprising a loop or curve (224) with an aperture to engage an operator’s finger or thumb (col. ) to facilitate advancing and retracting a sliding member (222; col. 17, ll. 51-65).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to provide the grip elements (187, 187’) of Gianotti to each include a loop or curve with an aperture to engage an operator's finger or thumb, in view of Weaver, in order to facilitate a user gripping the grip elements to slidably advance and retract the loading piston during use.
Regarding claim 29, Gianotti discloses wherein said scaffold (101) is a radially self-expandable scaffold (col. 5, ll. 43-46; see also col. 6, ll. 38-40).
Regarding claim 30, Gianotti discloses wherein said funnel cap (157) allows for the scaffold (101) to be properly positioned in the system when it is desired to load said scaffold (e.g., pushing element (157) pushes endoprosthesis (101) until it is properly positioned; col. 8, ll. 11-18).
Regarding claim 31, Gianotti discloses wherein said scaffold (101) is tubular having an as-manufactured diameter and as-manufactured length (Fig. 6).
Regarding claim 32, the modified device is not explicitly disclosed with the as-manufacture diameter being between 5 mm and 40 mm.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the invention of Gianotti to have an as-manufactured diameter is between 5 mm and 40 mm since it has been held that "where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device" Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the invention of Gianotti operates in the same manner as the claimed invention, and an invention having the claimed relative dimensions would not perform differently than the invention of Gianotti. Further, Applicant places no criticality on the dimensions claimed, indicating simply that "the as-manufactured (or unconstrained) diameter of the scaffold may range from 5 mm or less to 40 mm or more, for example, ranging from 5 mm to 10 mm to 15 mm to 20 mm to 25 mm to 30 mm to 35 mm to 40 mm (i.e., ranging between any two of the preceding numerical values), commonly ranging from 5 to 12 mm or from 15 to 30 mm" (Spec. para. [00209]).
Regarding claim 33, the modified device is not explicitly disclosed with the as-manufactured length being between 5 mm and 30 mm.
However, It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the invention of Gianotti to have an as manufactured length is between 5 mm and 30 mm since it has been held that "where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device" Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the invention of Gianotti operates in the same manner as the claimed invention, and an invention having the claimed relative dimensions would not perform differently than the invention of Gianotti. Further, applicant places no criticality on the dimensions claimed, indicating simply that "the as-manufactured (or unconstrained) length may range from 5 mm or less to 30 mm or more, for example, ranging from 5 mm to 10 mm to 15 mm to 20 mm to 25 mm or 30 mm (i.e., ranging between any two of the preceding numerical values), commonly ranging from 8 to 12 mm or from 15 mm to 30" (Spec. para. [00209]).
Claims 34-37 are rejected under 35 U.S.C. 103 as being unpatentable over Gianotti in view of Weaver, as applied to claim 27 above, and further in view of Pinchuk (U.S. Patent Application Publication No. 20070118210).
Regarding claims 34-37, the modified device is not explicitly disclosed with the scaffold being formed of polymeric materials, comprising one or more strands, being braided, or comprising a therapeutic agent.
Pinchuk, a reference in the scaffold field of endeavor, teaches a heart valve (Fig. 11) formed of polymeric materials (pp. [0047]), comprising one or more strands (pp. [0047]), being braided (pp. [0047]), and comprising a therapeutic agent (pp. [0065]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the scaffold of Gianotti to incorporate the teachings of Pinchuk by providing a scaffold formed of polymeric materials comprising one or more braided strands. Doing so would be a simple substitution of one known scaffold composition and structure for another to obtain predictable results of providing a heart valve with a reasonable expectation of success. Further, applying a therapeutic agent to the scaffold would provide the added benefit of delivering a drug to the implant site without needing to insert another device.
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over Hacker et al. (U.S. Patent Application Publication No. 20160346106; hereinafter “Hacker”) in view of Inoue (U.S. Patent Application Publication No. 20030014103).
Regarding claim 38, Hacker discloses a delivery system (Fig. 15), comprising a funnel (308; Fig. 14A) having a proximal end (left side; Fig. 14A) and a distal end (324; Fig. 14A), a funnel cap (202; Fig. 17) positioned at the proximal end (see Fig. 17) of said funnel (308), an elongate pulling member (20; Fig. 16), and a scaffold (102; Fig. 4), said scaffold (102) comprising apertures (118; Fig. 4), said system further comprising an outer delivery sheath (302; Fig. 7) having a lumen (304; Fig. 7) and a distal end (the non-funnel end, see Fig. 14a), wherein said scaffold (102) is positioned in said sheath lumen (302, see Fig. 17), at least a portion of said pulling member (20) extending outside said distal end of said sheath (302, see Fig. 14A).
The device of Hacker is not explicitly disclosed with one or more filaments looped through the apertures of the scaffold such that first and second ends of the filament are secured to the elongate pulling member.
Inoue, a reference in the scaffold delivery field of endeavor, teaches a scaffold ("A," Fig. 14) with apertures (13; Fig. 14), wherein one or more filaments with first and second ends are looped through the apertures (13) of the scaffold (Figs. 12-14; para. [0122]), such that first and second ends of the filament (4) are secured to an elongate pulling member (2; Fig. 14) to facilitate collapsing the scaffold (para. [0121]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the connecting configuration between the scaffold and elongate pulling member of Hacker, such that the system includes one or more filaments having first and second ends looped through one of said apertures of the scaffold and such that first and second ends of the filament are secured to the elongate pulling member, in view of Inoue, in order to facilitate collapsing the scaffold for placement into a deployment configuration. Additionally, doing so would be combining prior art elements according to known methods to yield predictable results of connecting the scaffold to the elongate pulling member.
Claims 39-41 are rejected under 35 U.S.C. 103 as being unpatentable over Hacker in view of Inoue, as applied to claim 38 above, and further in view of Pinchuk.
Regarding claims 39-41, the modified device is not explicitly disclosed with the scaffold comprising one or more strands, being braided, or comprising a therapeutic agent.
Pinchuk, a reference in the scaffold field of endeavor, teaches a heart valve (Fig. 11) comprising one or more strands (pp. [0047]), being braided (pp. [0047]), and comprising a therapeutic agent (pp. [0065]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the scaffold of Gianotti to incorporate the teachings of Pinchuk by providing a scaffold comprising one or more braided strands. Doing so would be a simple substitution of one known scaffold composition and structure for another to obtain predictable results of providing a heart valve with a reasonable expectation of success. Further, applying a therapeutic agent to the scaffold would provide the added benefit of delivering a drug to the implant site without needing to insert another device.
Claims 42 is rejected under 35 U.S.C. 103 as being unpatentable over Gianotti in view of Weaver.
Regarding claim 42, Gianotti discloses a delivery system (150; Fig. 6), comprising a handle (combination of grip element (187) and grip element (187’); Fig. 6) and a funnel (combination of nose section (165) and body (180); Fig. 6) having a proximal end (183’; Fig. 6) and a distal end (170’; Fig. 6), a funnel cap (157; Fig. 6) positioned at and in contact with the proximal end of said funnel, said funnel cap comprising an opening (Fig. 10), a scaffold (101; Fig. 6) positioned in said funnel, an outer delivery sheath (115; Fig. 6), and an elongate member (combination of tip (135) and shaft (125); Fig. 6) inserted into said opening in said funnel cap (Fig. 6), said elongate member extending beyond said distal end of said funnel (Fig. 6), wherein said handle and funnel are integrated into a single article (grip elements (187, 187’) are integrally formed with body (180; col. 6, ll. 63-65) and body (180) is connected with nose section (165) via bolt (147; col. 7, ll. 4-16)), a first portion (187; Fig. 6) of said handle extending above the funnel and a second portion (187’; Fig. 6) of said integrated handle extending below said funnel, each first and second portion configured to engage an operator’s finger or thumb (e.g., as “grip elements,” col. 6, ll. 63-65).
The device of Gianotti is not explicitly disclosed with the first and second portions having a loop with an aperture.
Weaver, a reference in the scaffold delivery field of endeavor, teaches providing a handle with first and second portions each comprising a loop (224) with an aperture to engage an operator’s finger or thumb to facilitate advancing and retracting a sliding member (222; col. 17, ll. 51-65).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to provide the grip elements (187, 187’) of Gianotti to each include a loop with an aperture to engage an operator's finger or thumb, in view of Weaver, in order to facilitate a user gripping the grip elements to slidably advance and retract the loading piston during use.
Claims 43-45 are rejected under 35 U.S.C. 103 as being unpatentable over Gianotti in view of Weaver, as applied to claim 42 above, and further in view of Pinchuk.
Regarding claims 43-45, the modified device is not explicitly disclosed with the scaffold being formed of polymeric materials, comprising one or more strands, or being braided.
Pinchuk, a reference in the scaffold field of endeavor, teaches a heart valve (Fig. 11) formed of polymeric materials (pp. [0047]), comprising one or more strands (pp. [0047]), and being braided (pp. [0047]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the scaffold of Gianotti to incorporate the teachings of Pinchuk by providing a scaffold formed of polymeric materials comprising one or more braided strands. Doing so would be a simple substitution of one known scaffold composition and structure for another to obtain predictable results of providing a heart valve with a reasonable expectation of success.
Claims 46 is rejected under 35 U.S.C. 103 as being unpatentable over Gianotti in view of Weaver.
Regarding claim 46, Gianotti discloses a delivery system (150; Fig. 6), comprising a funnel (combination of nose section (165) and body (180); Fig. 6) having a proximal end (183’) and a distal end (187’), said funnel comprising a handle (combination of grip element (187) and grip element (187’); Fig. 6), said handle comprising two portions (187, 187’; Fig. 6) extending laterally from the funnel in opposite directions and configured to engage an operator’s finger or thumb (e.g., as “grip elements;” col. 6, ll. 63-65), a funnel cap (157) positioned at and in contact with the proximal end of said funnel (Fig. 6), and a scaffold (101) positioned in said funnel, said system further comprising an outer delivery sheath (115), wherein said funnel cap has an opening (Fig. 10) configured to accept an elongate member inserted through said funnel cap, said elongate member when inserted extending beyond said distal end of said funnel (element (157) is capable of performing the function of accepting an elongate member inserted through said funnel cap, said elongate member when inserted extending beyond said distal end of said funnel, as claimed because element (157) has an opening/lumen extending therethrough sized and shaped to allow passage of catheter tip (135) and inner shaft (125) past the distal end (170’) of the funnel (Fig. 6; col. 8, ll. 30-39)).
The device of Gianotti is not explicitly disclosed with each of the two portions having a curve or a loop with an aperture.
Weaver, a reference in the scaffold delivery field of endeavor, teaches providing a handle with first and second portions each comprising a curved loop (224) with an aperture to engage an operator’s finger or thumb to facilitate advancing and retracting a sliding member (222; col. 17, ll. 51-65).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to provide the grip elements (187, 187’) of Gianotti to each include a curve or a loop with an aperture to engage an operator's finger or thumb, in view of Weaver, in order to facilitate a user gripping the grip elements to slidably advance and retract the loading piston during use.
Claims 47-48 are rejected under 35 U.S.C. 103 as being unpatentable over Gianotti in view of Weaver, as applied to claim 46 above, and further in view of Pinchuk.
Regarding claims 47-48, the modified device is not explicitly disclosed with the scaffold being formed of polymeric materials or comprising one or more strands.
Pinchuk, a reference in the scaffold field of endeavor, teaches a heart valve (Fig. 11) formed of polymeric materials (pp. [0047]) and comprising one or more strands (pp. [0047]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the scaffold of Gianotti to incorporate the teachings of Pinchuk by providing a scaffold formed of polymeric materials comprising one or more strands. Doing so would be a simple substitution of one known scaffold composition and structure for another to obtain predictable results of providing a heart valve with a reasonable expectation of success.
Response to Arguments
Applicant's arguments filed June 26, 2026 have been fully considered but they are not persuasive.
On pages 5-7 of the Response, Applicant argues that Gianotti does not disclose a funnel with a handle, as recited in claims 27 and 42. This argument is not persuasive.
The combination of nose section (165’) and receiving body (180) is properly construed as a “funnel” because the nose section includes a funnel-shaped recess (165’; Fig. 6; col. 8, ln. 65 – col. 9, ln. 10) and the nose section and the receiving body are combined to form a unit via bolt (147; col. 7, ll. 4-16).
Furthermore, the combination of grip elements (187, 187’) is properly construed as a “handle” because Gianotti disclose that grip elements “permit better handling” of a device (col. 4, ll. 11-17). Moreover, grip elements (187, 187’) are integrally formed on receiving body (180; Fig. 6; col. 6, ll. 56-65).
Therefore, because the grip elements are integrally formed on part of the unit interpreted as the claimed funnel, these features constitute a “handle integrated into a combined funnel and handle,” as recited in claim 27 or a “handle and funnel [] integrated into a single article,” as recited in claim 42.
On page 7 of the Response, Applicant argues that Gianotti does not disclose a funnel cap, as recited in claims 27, 42, and 46. This argument is not persuasive.
As can readily be understood from Figs. 6, 9, and 10 of Gianotti, handle element (157) is a structure that overlays or covers nose section (165’) and receiving body (180), interpreted as the claimed “funnel,” when viewed in cross-section (Figs. 9-10).
Thus, the handle element constitutes a cap of the funnel or “funnel cap,” as recited in claims 27, 42, and 46.
Applicant’s further argument relying on a “word search of Gianotti for ‘funnel cap’” (Response pg. 7) as evidence of Gianotti failing to disclose the claimed funnel cap is not persuasive. The test for patentability is not whether the claim uses different terminology from the prior art. Rather, the disclosure of the prior art is compared to the broadest reasonable interpretation of claim language in a patentability determination.
On page 8 of the Response, Applicant argues that Hacker does not disclose a funnel cap, as recited in claim 38. This argument is not persuasive.
As can readily be understood from Fig. 17 of Hacker, compression member (202) is a structure that overlays or covers enlarged head (308), interpreted as the claimed “funnel,” when viewed in cross-section.
Thus, compression member (202) constitutes a cap of the funnel or “funnel cap,” as recited in claim 38.
Applicant’s further argument relying on a “word search of Hacker for ‘funnel cap’” (Response pg. 8) as evidence of Hacker failing to disclose the claimed funnel cap is not persuasive for reasons explained above addressing a similar argument presented regarding claims 27, 42, and 46.
On page 8 of the Response, Applicant argues that Inoue does not disclose filaments looped through apertures in a scaffold to link the scaffold to a pulling member, as recited in claim 38. This argument is not persuasive.
Inoue discloses loop-shaped hooking means (13) are part of artificial blood vessel (A) and form an opening as an attached loop or as a hole directly formed therein (para. [0113]). Strings (4) pass through these openings to form a loop secured to wire (3; Fig. 14; para. [0122]). As can be readily understood from Figs. 13-15, the wire pulls on the strings to hold them taught for insertion into a cartridge (para. [0122]).
Therefore, Inoue teaches filaments looped through apertures of a scaffold with ends secured to a pulling member as claimed.
Applicant's further arguments concerning the merits of the invention of the instant application (Response pg. 8) are not commensurate with the scope of the claims. As such, these arguments concerning merits of the instant application are not given patentable weight until they are commensurate with the scope of the claims.
For all the reasons above, Examiner maintains that the claimed invention is not allowable over the prior art of record.
Conclusion
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/JONATHAN A HOLLM/Examiner, Art Unit 3771
