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 .
Response to Amendment and Arguments
In view of the amendment filed April 9, 2026 claims 11 and 20 have been amended and claims 3 and 19 have been canceled. Claims 1-2, 4-18 and 20 are pending. Claims 1-2, 4-6, 11-12, 14-16 and 20 are under examination and claims 7-10, 13 and 17-18 have been withdrawn from consideration.
As to the rejection of claims 1 and 11 under 35 U.S.C. 103 as being unpatentable over Mialhe (US 2007/0078504, hereinafter “Mialhe”) in view of Chen et al. (US 2020/0170647, hereinafter “Chen”), applicant’s arguments have been fully considered but they are not persuasive. Applicant argues that Mialhe fails to disclose the limitation of “an occlusive implant releasably coupled to the core member” as required in claim 1 and claim 11.
Applicant argues that proximal end 25 of implant 10 is abutting with distal end of plunger 4 and there is no joint, no latch, no mechanical interface, and no release connection of any kind between these two component, therefore, Mialhe fails to disclose the limitation of “an occlusive implant releasably coupled to the core member” (pages 6-7 of the Remarks). Examiner respectfully traverses applicant’s remarks. Attention is directed to paragraph [0048] of the publication of the application. Applicant discloses “In some embodiments, the proximal end of the expandable framework 28 may include a proximal hub coupled and/or non-releasably attached thereto. In some embodiments, the proximal hub may be configured to and/or adapted to releasably couple with, join to, mate with, or otherwise engage a distal end of the core wire 24.” (emphasis added). The hub or a structure, which is an additional component, to allow the implant to releasably couple/join/attach to the core member is not claimed anywhere in the claims.
Attention is directed to FIGS. 11 and 16, FIG. 11 is reproduced below, and paragraph [0084] of Mialhe reference. In paragraph [0084] Mialhe discloses “In this case, the implant (10) is positioned within the outer envelope (2) before the start of the operation. More precisely, the expandable distal element (24) is maintained by the inner wall of the outer envelope (2). Behind it is the other expandable element (25), maintained in position against the inner wall of the inner sheath (3). Advantageously, the rear end piece of the expandable element (24) is pressed against the front end piece of the inner sheath (3). At the same time, the rear end piece of the expandable element (25) is pressed against the distal end piece of the plunger (4). This configuration is well illustrated in FIG. 11.” (emphasis added). Similar to applicant’s disclosure the inner sheath 3 is an additional element to allow the implant 10 releasably couple/join/attach to the plunger 4. Thus, Mialhe discloses the limitation of “an occlusive implant releasably coupled to the core member”
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Referring again to Mialhe reference, examiner notes that one of ordinary skill in the art will appreciate that the distal end of inner sheath 3 is mating with implant 10 (“Behind it is the other expandable element (25), maintained in position against the inner wall of the inner sheath (3).” (para. [0084])), thus, in alternative the inner sheath 3, which is a component of the same embodiment cited in the most recent Office action, and the implant 10 read on the limitation of “an occlusive implant releasably coupled to the core member.”
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.
Claim(s) 1-2, 4-6, 11-12, 14-16 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mialhe (US 2007/0078504, hereinafter “Mialhe”) in view of Chen et al. (US 2020/0170647, hereinafter “Chen”).
Referring to claim 1, Mialhe discloses a delivery device for an occlusive implant (Figs. 1-18, Figs. 4 and 11-12 are reproduced below), the delivery device comprising:
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a delivery sheath 2 (Figs. 1-2, 5 and 11-14) having a proximal region and a laser cut distal tip region (nose 14 includes four slots/cuts 15a, 15b, 15c, and 15d as shown in Figs. 4-5, 11 and 14; paras. [0071]-[0073]). Examiner notes that the limitation of “laser cut” has been interpreted as product by process limitation. Here it is noted that a comparison of the recited process with the prior art processes does NOT serve to resolve the issue concerning patentability of the product. In re Fessman, 489 F2d 742, 180 U.S. P.Q. 324 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an nonobvious difference between the claimed product and the prior art product (MPEP chapter 2113 Product-by-Process Claims);
wherein the laser cut distal tip region has one or more laser cuts formed therein that form a patterned distal section (Fig. 4), the patterned distal section being configured to shift between a delivery configuration and an expanded configuration (Fig. 14);
a core member 4 (Figs. 10-11; para. [0077]) slidably disposed within the delivery sheath; and
an occlusive implant 10 releasably coupled to the core member 4 (Fig. 11; paras. [0075] and [0084]. Please see examiner’s position in Response to Amendment and Arguments section above).
Mialhe discloses the invention substantially as claimed except for disclosing a reinforcing member extending along the proximal region of the delivery sheath.
However, in the same field of endeavor, which is a delivery device for an occlusive implant (Figs. 1-2), Chen discloses delivery sheath 12 includes a distal portion 26 is more flexible than proximal portion 24 to facilitate navigation in tortuous vasculature (para. [0038]). Chen further discloses that the proximal portion 24 includes a reinforcing layer in the form of a braid layer to enhance the pushability of the delivery sheath (para. [0038]). In view of Chen’s teaching, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the application, to have made the delivery sheath of Mialhe according to Chen’s teaching so that it too would have the same advantage.
Referring to claim 2, Mialhe/Chen discloses the delivery device of claim 1, wherein at least some of the one or more laser cuts 15a-15d go completely through a wall surface of the laser cut distal tip region 14 (Fig. 14 is reproduced below).
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Referring to claim 4, Mialhe/Chen discloses the delivery device of claim 1, wherein the one or more laser cuts 15a-15d all extend the same distance proximally along the laser cut distal tip region.
Referring to claim 5, Mialhe/Chen discloses the delivery device of claim 1, wherein at least some of the one or more laser cuts extend a different distance proximally along the laser cut distal tip region. (in paragraph [0072] Mialhe discloses “The number of slots (16a, 16b, 16c and 16d) on device (1) and their longitudinal length are not restricted to the example illustrated here.” Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the application, to have made one pair of slots with a distance proximal to the distal tip region different from another pair of slots. Since Mialhe discloses the longitudinal length are not restricted to the example, examiner contends that variation in the length of the slots does not require a leap of inventiveness).
Referring to claim 6, Mialhe/Chen discloses the delivery device of claim 1, wherein the patterned distal section includes a plurality of rounded projections (attention is directed to Figs. 4 and 11, which are reproduced above. The figures show that the distal region 14 has a cone shape, thus, the distal end of each segment 16a-16d, which created by slots 15a-15d, has a rounded projection).
Referring to claim 11, Mialhe/Chen discloses a delivery device for an occlusive implant, the delivery device comprising (see rejection of claim 1 above):
a delivery sheath 2 (see rejection of claim 1 above) having a proximal region and a distal tip region 14 (see rejection of claim 1 above); wherein the distal tip region includes a patterned distal section (see Fig. 4, which is reproduce above); wherein the patterned distal section is configured to allow the distal tip region to shift between a delivery configuration (Fig. 11, which is reproduced above) and an expanded configuration (Fig. 14, which is reproduced above); and
a proximal reinforcing member disposed along the proximal region (see rejection of claim 1 above).
a core member (plunger 4 as shown Figs. 10-11; paras. [0077] and [0084]) slidably disposed within the delivery sheath; and
an occlusive implant 10 releasably coupled to the core member 4 (Fig. 11; paras. [0075] and [0084]. Please see examiner’s position in Response to Amendment and Arguments section above).
Referring to claim 12, Mialhe/Chen discloses the delivery device of claim 11, wherein the patterned distal section includes laser cuts 15a-15d that go completely through a wall surface of the distal tip region 14 (Fig. 14). Examiner notes that the limitation of “laser cut” has been interpreted as product by process limitation. Here it is noted that a comparison of the recited process with the prior art processes does NOT serve to resolve the issue concerning patentability of the product. In re Fessman, 489 F2d 742, 180 U.S. P.Q. 324 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an nonobvious difference between the claimed product and the prior art product (MPEP chapter 2113 Product-by-Process Claims).
Referring to claim 14, Mialhe/Chen discloses the delivery device of claim 11, wherein the patterned distal section includes laser cuts that all extend the same distance proximally along the distal tip region (Figs. 13-14). Examiner notes that the limitation of “laser cut” has been interpreted as product by process limitation. Here it is noted that a comparison of the recited process with the prior art processes does NOT serve to resolve the issue concerning patentability of the product. In re Fessman, 489 F2d 742, 180 U.S. P.Q. 324 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an nonobvious difference between the claimed product and the prior art product (MPEP chapter 2113 Product-by-Process Claims).
Referring to claim 15, Mialhe/Chen discloses the delivery device of claim 11, wherein the patterned distal section includes laser cuts that extend a differing distance proximally along the distal tip region. (in paragraph [0072] Mialhe discloses “The number of slots (16a, 16b, 16c and 16d) on device (1) and their longitudinal length are not restricted to the example illustrated here.” Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the application, to have made one pair of slots with a distance proximal to the distal tip region different from another pair of slots. Since Mialhe discloses the longitudinal length are not restricted to the example, examiner contends that variation in the length of the slots does not require a leap of inventiveness).
Referring to claim 16, Mialhe/Chen discloses the delivery device of claim 11, wherein the patterned distal section includes a plurality of rounded projections. (attention is directed to Figs. 4 and 11, which are reproduced above. The figures show that the distal region 14 has a cone shape, thus, the distal end of each segment 16a-16d, which created by slots 15a-15d, has a rounded projection).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mialhe (US 2007/0078504, hereinafter “Mialhe”) in view of Chen et al. (US 2020/0170647, hereinafter “Chen”) and further in view of Zaver et al. (US 2007/0135826, hereinafter “Zaver”).
Referring to claim 20, Mialhe discloses a method for implanting an occlusive implant into a location in a blood vessel (para. [0065]), the method comprising:
advancing a delivery device (Figs. 1-2, paras. [0075]-[0089]) to a position adjacent to the location in the blood vessel, the delivery device comprising:
a delivery sheath 2 (Figs. 1-2, 5 and 11-14) having a proximal region and a laser cut 15a-15d distal tip region 14, wherein the laser cut distal tip region has one or more laser cuts formed therein that form a patterned distal section (nose 14 includes four slots/cuts 15a, 15b, 15c, and 15d as shown in Figs. 4-5, 11 and 14; paras. [0071]-[0073]) (Examiner notes that the limitation of “laser cut” has been interpreted as product by process limitation. Here it is noted that a comparison of the recited process with the prior art processes does NOT serve to resolve the issue concerning patentability of the product. In re Fessman, 489 F2d 742, 180 U.S. P.Q. 324 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an nonobvious difference between the claimed product and the prior art product (MPEP chapter 2113 Product-by-Process Claims)), the patterned distal section being configured to shift between a delivery configuration (Fig. 11) and an expanded configuration (Fig. 14),
a core member (inner sheath 3 or plunger 4 as shown in Figs. 10-11; paras. [0075]-[0089]) slidably disposed within the delivery sheath, and
an occlusive implant 10 releasably coupled to the core member (Fig. 11; paras. [0075]-[0089]) such that distal advancement of the core member 3 moves the occlusive implant 10 distally relative to the delivery sheath 2 and proximal advancement of the core member 3 moves the occlusive implant proximally relative to the delivery sheath 2 (Claim 3 recites “the implant (10) includes a second, hollow expandable element (25) and a hollow intermediate section (26) that is deformable by twisting; the second expandable element (25) presses against the internal wall of the inner sheath (3); the inner sheath (3) is mounted so as to slide and rotate in the outer envelope (2).” Examiner notes that without spacer 9, the inner sheath 3 can move proximally and then distally with respect to out sheath 2); and
advancing the core member (inner sheath 3 or plunger 4) such that the occlusive implant 10 advances out from the laser cut distal tip region 14 (Figs. 13-18, paras. [0075]-[0089]).
Mialhe discloses the invention substantially as claimed except for disclosing (1) a reinforcing member extending along the proximal region of the delivery sheath and (2) the occlusive implant is implanted into a left atrial appendage.
As to (1), however, in the same field of endeavor, which is a delivery device for an occlusive implant (Figs. 1-2), Chen discloses delivery sheath 12 includes a distal portion 26 is more flexible than proximal portion 24 to facilitate navigation in tortuous vasculature (para. [0038]). Chen further discloses that the proximal portion 24 includes a reinforcing layer in the form of a braid layer to enhance the pushability of the delivery sheath (para. [0038]). In view of Chen’s teaching, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the application, to have made the delivery sheath of Mialhe according to Chen’s teaching so that it too would have the same advantage.
As to (2), Mialhe discloses the device may be used to place other types of implant (para. [0065]: “The following description details the use of the device according to the invention when placing the vaso-occlusive device indicated in said document. However, this is merely one example of a possible use and should not be considered as a limitation on the application of the present invention. In particular, the device may be used to place other types of implant, especially with a single element expandable across its width.”). In the same field of endeavor, which is a delivery device for delivering an occlusive implant, Zaver discloses “Approximately 80,000 strokes per year are attributable to atrial fibrillation. Atrial fibrillation is an arrhythmia of the heart that results in a rapid and chaotic heartbeat that produces lower cardiac output and irregular and turbulent blood flow in the vascular system. There are over five million people worldwide with atrial fibrillation, with about four hundred thousand new cases reported each year. Atrial fibrillation is associated with a 500 percent greater risk of stroke due to the condition.” (paras. [0002]-[0003]). To solve this problem, a catheter system is used to deliver an expandable occlusive device into the left atrial appendage of the heart using a minimally invasive approach (para. [0008]).
Referring again to item 2), in view of the disclosures above, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the application, to have utilized the catheter system of Mialhe to deliver the implant to left atrial appendage (LAA) to treat atrial fibrillation to improve market share of the device of Mialhe because it has been held that known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art (KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007)).
Referring to claim 21, Mialhe/Chen discloses the delivery device of claim 11, wherein distal advancement of the core member moves the occlusive implant 10 distally relative to the delivery sheath 2 and proximal advancement of the core member moves the occlusive implant proximally relative to the delivery sheath (paras. [0083]-[0089]. Examiner notes that without spacer 9, the inner sheath 3 and plunger 4 can move proximally and then distally with respect to out sheath 2).
Referring to claim 22, Mialhe/Chen discloses the delivery device of claim 1, wherein distal advancement of the core member moves the occlusive implant distally relative to the delivery sheath 2 and proximal advancement of the core member moves the occlusive implant proximally relative to the delivery sheath 2 (paras. [0083]-[0089]. Examiner notes that without spacer 9, the inner sheath 3 and plunger 4 can move proximally and then distally with respect to out sheath 2).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 TUAN V NGUYEN whose telephone number is (571)272-5962. The examiner can normally be reached Monday - Friday 8:30 AM - 5:30 PM.
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/TUAN V NGUYEN/Primary Examiner, Art Unit 3771
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