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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/22/2026 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on 04/22/2026. As directed by the amendment: claims 1 and 10 have been amended, claim 3 has been cancelled, and claims 15-20 remain withdrawn. Thus, claims 1-2 and 4-20 are presently pending in this application.
Response to Arguments
Applicant's arguments, see pages 7-9, filed 04/22/2026, with regards to the rejections of claims 1 and 10 under 35 U.S.C. 103 as being unpatentable over Shibata et al (US 20230145301 A1), herein referenced to as “Shibata” and Sykes et al (US 20190183468 A1), herein referenced to as “Sykes” have been fully considered but they are not persuasive.
The applicant has amended claims 1 and 10 to further include “and wherein the delivery sheath remains within the garage section while the occlusive implant is urged through the tapered portion and into the distal portion of the working lumen”.
The applicant argues that the combination of Shibata and Sykes does not explicitly teach this. The examiner respectfully disagrees. Sykes which teaches the tapered portion shows that a delivery sheath 130 remains within the garage section 102 and that an occlusive implant 200 is urged through the tapered portion (see Figs. 12-14).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-2 and 4-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shibata et al (US 20230145301 A1), herein referenced to as “Shibata” and Sykes et al (US 20190183468 A1), herein referenced to as “Sykes”.
Claim 1
Shibata discloses: An occlusive implant system 100 + 200 + 300 (see Figs. 1-3B and 5-7G, [0043]), comprising: an access device 40 (see Figs. 1-3B and 5-7G, [0042]) including a handle 43 (see Figs. 1-3B and 5-7G, [0059], meets the definition of a handle as an element that can be held by a user) and an access sheath 41 (see Figs. 1-3B and 5-7G, the sheath extends distally from the handle 43, [0061]) extending distally from the handle 43, wherein the access device 40 includes a working lumen 42 + 43a (see Figs. 3A-5, [0057]) extending longitudinally (42 + 43a extend longitudinally through the sheath 41 and through the handle, 43 as shown in Figs 3A-5) through the access sheath 41 and the handle 43; wherein a proximal portion 43a (see Figs. 3A-5, [0091]) of the working lumen 42 + 43a defines a garage section 43c + 43d + 43b (see Figs. 3A-5, [0074]) connected to a proximal port 47 (47 is a proximal port attached to handle which is included in 40, see Figs. 3A-5, [0059]) of the handle 43, and a distal portion the distal portion of 42 (see Figs. 3A-5, [0057]) of the working lumen 42 + 43a extends distally of the garage section 43c + 43d + 43b (see Figs. 3A-5) to a distal end 41a (see Figs. 1-3B and 5-7G, [0079], 42 extends to 41a) of the access sheath 41; and an occlusive implant device 20 + 30 (see Figs. 1-3B and 5-7G, [0048]) including: a delivery system 20 (see Figs. 1-3B and 5-7G, [0048]) including a delivery sheath 21 (see Figs. 1-3B and 5-7G, [0055]) configured to be slidably received (see Figs. 1-3B and 5-7G, 21 is received into 43c, see Figs. 3A-5, [0070]) within the garage section 43c + 43d + 43b, the delivery sheath 21 having a delivery lumen 22 (see Figs. 3A-5, [0055]) extending proximally 22 extends proximally from 27b (see Fig. 3A) from a distal end 27b (see Fig. 3A, [0073]) of the delivery sheath 21; a core wire 31 (see Figs. 1 and 5-6B, [0073]) slidably disposed (see [0073], 31 can be inserted in the lumen of 22 and then into the lumen of 42) within the delivery lumen 22; and an occlusive implant 10 (see Figs. 5 and 7F, [0048]) releasably attached to a distal end distal end of 31 (see Fig. 5, [0048], 10 is pushed out by the delivery pusher 30, which includes 31) of the core wire 31, the occlusive implant 10 being configured to shift between a delivery configuration (see Fig. 5, [0048], 10 is compressed while within delivery device) and a deployed configuration (see [0048], the device expands when deployed); wherein the occlusive implant 10 is disposed within a distal portion the lumen of 27a (see Figs. 3A and 5, [0074]) of the delivery lumen 22 in the delivery configuration (see Fig. 5); wherein the garage section 43c + 43d + 43b has a first inner diameter the inner diameter of 43c (see Fig. 3A, [[0074]) and the distal portion 42 of the working lumen 42 + 43a has a second inner diameter the inner diameter of the lumen of 42 (see Fig. 3A) less than the first inner diameter the inner diameter of 43c (see Fig. 3A, the inner diameter of 43c is greater than the inner diameter of 42); wherein the delivery sheath 21 has an outer diameter outer diameter of 21 (see Fig. 3A) less than the first inner diameter the inner diameter of 43c (see Figs. 3A-3B, the outer diameter of 21 is less than the inner diameter of 43c, so that 21 can fit within 43c) and greater than the second inner diameter the inner diameter of the lumen of 42 (see Figs. 3A-3B, the inner diameter of the lumen of 42 is less than the outer diameter of 21).
Shibata does not explicitly teach: the working lumen including a tapered portion disposed between the garage section and the distal portion of the working lumen; wherein the occlusive implant directly engages the tapered portion when the occlusive implant is urged through the tapered portion and into the distal portion of the working lumen, and wherein the delivery sheath remains within the garage section while the occlusive implant is urged through the tapered portion and into the distal portion of the working lumen.
However, Sykes teaches in a similar field of invention an occlusive implant system (see Figs. 12-14) with an occlusive implant 200 (see Figs. 12-14) with an access device 100 + 400 (see Figs. 12-14), a delivery sheath 130 (see Figs. 12-14, 130 is a delivery sheath as it is a tubular member that is used for delivery covering another device, in this case the occlusive implant 200), a handle 300 (see Figs. 12-14), the access device 100 + 400 has a working lumen 102 + 410 (see Figs. 12-14) with a garage section 102 (see Figs. 12-14) and a distal portion 410 (see Figs. 12-14). Sykes further teaches: the working lumen 102 + 410 including a tapered portion (see annotated Fig. 12 and Fig. 13 below) disposed between the garage section 102 and the distal portion 410 of the working lumen 102 + 410; wherein the occlusive implant 200 directly engages the tapered portion (see annotated Fig. 12 and Fig. 13 below) when the occlusive implant 200 is urged through the tapered portion (see annotated Fig. 12 and Fig. 13 below) and into the distal portion 410 of the working lumen 102 + 410; wherein the delivery sheath 130 remains within the garage section 102 while the occlusive implant 200 is urged through the tapered portion (see annotated Fig. 12 and 13 below) and into the distal portion 410 of the working lumen 102 + 410.
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It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Shibata to incorporate the teachings of Sykes and teach an occlusive implant system with the working lumen including a tapered portion disposed between the garage section and the distal portion of the working lumen; wherein the occlusive implant directly engages the tapered portion when the occlusive implant is urged through the tapered portion and into the distal portion of the working lumen and wherein the delivery sheath remains within the garage section while the occlusive implant is urged through the tapered portion and into the distal portion of the working lumen. Motivation for such can be found in Sykes as this allows for a frictional engagement between the implant and the lumen which prevents the implant from being inadvertently distally pushed until the frictional engagement force is exceeded deliberately by a user (see [0054]).
Claim 2
The combination of Shibata and Sykes teaches: The occlusive implant system of claim 1, see 103 rejection above. Shibata further discloses: wherein the distal portion the lumen of 27a (see Figs. 3A-3B) of the delivery lumen 22 has a third inner diameter the inner diameter of the lumen of 27a (see Figs. 3A-3B) and the third inner diameter the inner diameter of the lumen of 27a is substantially equal to or less than the second inner diameter the inner diameter of the lumen of 42 (see Figs. 3A-3B, the inner lumens of 27a and 42 are substantially the same, meeting at 43b, [0073]).
Claim 4
The combination of Shibata and Sykes teaches: The occlusive implant system of claim 1, see 103 rejection above. Sykes further teaches: wherein the tapered portion (see annotated Fig. 12 below) tapers from the first inner diameter (see annotated Fig. 12 below) proximate a proximal end the proximal end of the tapered portion (see the annotated Fig. 12 below) of the tapered portion (see annotated Fig. 12 below) to the second inner diameter (see annotated Fig. 12 below) proximate a distal end the distal end of the tapered portion adjacent to 410 (see annotated Fig. 12 below) of the tapered portion (see annotated Fig. 12 below).
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Claim 5
The combination of Shibata and Sykes teaches: The occlusive implant system of claim 1, see 103 rejection above. Shibata further discloses: wherein the delivery system 20 includes: a proximal hub 23 (see Figs. 1-5, [0055]); a mid-hub 28 (see Figs. 1-5, [0068], meets the definition of a mid-hub as it is between the two ends of delivery sheath 21); and a mid-shaft the portion of 21 that extends between 23 and 28 (see Figs. 1-2) extending from the proximal hub 23 to the mid-hub 28; wherein the delivery sheath 21, especially 27, extends distally beyond 28 (see Figs. 2-5) extends distally from the mid-hub 28.
Claim 6
The combination of Shibata and Sykes teaches: The occlusive implant system of claim 5, see 103 rejection above. Shibata further discloses: wherein the delivery sheath 21 has a first length the length of 27 (see Figs. 3A-3B) from the mid-hub 28 to the distal end 27b of the delivery sheath 21; wherein the garage section 43a has a second length the length of 43a (see Figs. 3A-3B) from the proximal port 47 to a distal end the distal end of 43c adjacent to 43d of the garage section 43c.
Shibata does not explicitly disclose: wherein the second length is less than 10% greater than the first length.
As noted in Shibata it is necessary for the garage section, or the communicating enlarged-diameter portion to protect the embolic device from being damaged on an inner wall of the 43 (see [0075]). This correlates to the second length, the length of the 43c, and the first length, the length of 27 and as such “wherein the second length is less than 10% greater than the first length” is considered to be a result effective variable since that the relative lengths of 43c and 27 effects if the embolic device is damaged on an inner wall of 43 when it pushed through. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Shibata by causing the second length is less than 10% greater than the first length as a matter of routine optimization since it has been held that ‘where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235, (CCPA 1955).
Claim 7
The combination of Shibata and Sykes teaches: The occlusive implant system of claim 5, see 103 rejection above.
Shibata does not explicitly disclose: wherein the second length is less than 5% greater than the first length.
As noted in Shibata it is necessary for the garage section, or the communicating enlarged-diameter portion to protect the embolic device from being damaged on an inner wall of the 43 (see [0075]). This correlates to the second length, the length of the 43c, and the first length, the length of 27 and as such “wherein the second length is less than 5% greater than the first length” is considered to be a result effective variable since that the relative lengths of 43c and 27 effects if the embolic device is damaged on an inner wall of 43 when it pushed through. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Shibata by causing the second length is less than 5% greater than the first length as a matter of routine optimization since it has been held that ‘where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235, (CCPA 1955).
Claim 8
The combination of Shibata and Sykes teaches: The occlusive implant system of claim 5, see 103 rejection above. Shibata further discloses: wherein the distal end 27b of the delivery sheath 21 is disposed proximate a distal end the distal end of 43c (see Figs. 3A-3B, as shown in Fig. 3B, 27b is placed near the distal end of 43c, which is adjacent to 43d) of the garage section 43c when the delivery sheath 21 is disposed within the garage section 43c (see Fig. 3B) and the mid-hub 28 is positioned adjacent (see Fig. 3B) the proximal port 47 of the handle the handle.
Claim 9
The combination of Shibata and Sykes teaches: The occlusive implant system of claim 1, see 103 rejection above. Shibata further discloses: wherein the core wire 31 has a length the length of 31 (see [0102]) greater than a combined length of the delivery system 20 and the access sheath 41 when the distal end 27b of the delivery sheath 21 is disposed within the garage section 43c (se Fig. 7F, the length of 31 extends through both 20 and 41 to push 10 out, see further, [0102], the ideal lengths of 21 is 42 cm and 41 is 47 cm, and 31 is 96 cm, hence 96 cm is greater than 89 cm, furthermore, the length of 31 can be longer, up to 205 cm).
Claims 10-12 and 14 are rejected with a variant interpretation of the garage section
Claim 10
Shibata discloses: An occlusive implant system 100 + 200 + 300 (see Figs. 1-3B and 5-7G, [0043]), comprising: a steerable access device 40 (see Figs. 1-3B and 5-7G, [0042]) including a handle 43 (see Figs. 1-3B and 5-7G, [0059], meets the definition of a handle as an element that can be held by a user) and an access sheath 41 (see Figs. 1-3B and 5-7G, the sheath extends distally from the handle, [0061]) extending distally from the handle 43, wherein the steerable access device 40 includes a working lumen 42 + 43a (see Figs. 3A-5, [0057]) extending longitudinally (42 + 43a extend longitudinally through the sheath 41 and through the handle as shown in Figs 3A-5) through the access sheath 41 and the handle 43; wherein a proximal portion 43a (see Figs. 3A-5, [0091]) of the working lumen 42 + 43a defines a garage section 43c + 43d (see Figs. 3A-5, [0074]) connected to a proximal port 47 (47 is a proximal port attached to handle which is included in 40, see Figs. 3A-5, [0059]) of the handle 43, and a distal portion 42 (see Figs. 3A-5, [0057]) of the working lumen 42 + 43a extends distally of the garage section 43c + 43d (see Figs. 3A-5) to a distal end 41a (see Figs. 1-3B and 5-7G, [0079], 42 extends to 41a) of the access sheath 41; and an occlusive implant device 20 + 30 (see Figs. 1-3B and 5-7G, [0048]) including: a delivery system 20 (see Figs. 1-3B and 5-7G, [0048]) including a delivery sheath 21 (see Figs. 1-3B and 5-7G, [0055]) configured to be slidably received (see Figs. 1-3B and 5-7G, 21 is received into 43c + 43d, see Figs. 3A-5, [0070]) within the garage section 43c + 43d, the delivery sheath 21 having a delivery lumen 22 (see Figs. 3A-5, [0055]) extending proximally 22 extends proximally from 27b (see Fig. 3A) from a distal end 27b (see Fig. 3A, [0073]) of the delivery sheath 21; a core wire 31 (see Figs. 1 and 5-6B, [0073]) slidably disposed (see [0073], 31 can be inserted in the lumen of 22 and then into the lumen of 42) within the delivery lumen 22; and an occlusive implant 10 (see Figs. 5 and 7F, [0048]) releasably attached to a distal end distal end of 31 (see Fig. 5, [0048], 10 is pushed out by the delivery pusher 30, which includes 31) of the core wire 31, the occlusive implant 10 being configured to shift between a delivery configuration (see Fig. 5, [0048], 10 is compressed while within delivery device) and a deployed configuration (see [0048], the device expands when deployed); wherein the occlusive implant 10 is disposed within a distal portion the lumen of 27a (see Figs. 3A and 5, [0074]) of the delivery lumen 22 in the delivery configuration (see Fig. 5); wherein the garage section 43c + 43d has a first inner diameter the inner diameter of 43c (see Fig. 3A, [[0074]) and the distal portion 42 of the working lumen 42 + 43a has a second inner diameter the inner diameter of the lumen of 42 (see Fig. 3A) less than the first inner diameter the inner diameter of 43c (see Fig. 3A, the inner diameter of 43c is greater than the inner diameter of 42); wherein the delivery sheath 21 has an outer diameter outer diameter of 21 (see Fig. 3A) less than the first inner diameter the inner diameter of 43c (see Figs. 3A-3B, the outer diameter of 21 is less than the inner diameter of 43c, so that 21 can fit within 43c) and greater than the second inner diameter the inner diameter of the lumen of 42 (see Figs. 3A-3B, the inner diameter of the lumen of 42 is less than the outer diameter of 21).
The language, "steerable access device," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Shibata meets the structural limitations of the claim, and is capable of the access device being steered as it is advanced over a guide wire to navigate to a proper placement in the body (see Figs. 7A-7B).
Shibata does not explicitly teach: the working lumen including a tapered portion disposed between the garage section and the distal portion of the working lumen; wherein the occlusive implant directly engages the tapered portion when the occlusive implant is urged through the tapered portion and into the distal portion of the working lumen, and wherein the delivery sheath remains within the garage section while the occlusive implant is urged through the tapered portion and into the distal portion of the working lumen.
However, Sykes teaches in a similar field of invention an occlusive implant system (see Figs. 12-14) with an occlusive implant 200 (see Figs. 12-14) with an access device 100 + 400 (see Figs. 12-14), a delivery sheath 130 (see Figs. 12-14, 130 is a delivery sheath as it is a tubular member that is used for delivery covering another device, in this case the occlusive implant 200), a handle 300 (see Figs. 12-14), the access device 100 + 400 has a working lumen 102 + 410 (see Figs. 12-14) with a garage section 102 (see Figs. 12-14) and a distal portion 410 (see Figs. 12-14). Sykes further teaches: the working lumen 102 + 410 including a tapered portion (see annotated Fig. 12 and Fig. 13 below) disposed between the garage section 102 and the distal portion 410 of the working lumen 102 + 410; wherein the occlusive implant 200 directly engages the tapered portion (see annotated Fig. 12 and Fig. 13 below) when the occlusive implant 200 is urged through the tapered portion (see annotated Fig. 12 and Fig. 13 below) and into the distal portion 410 of the working lumen 102 + 410; wherein the delivery sheath 130 remains within the garage section 102 while the occlusive implant 200 is urged through the tapered portion (see annotated Fig. 12 and 13 below) and into the distal portion 410 of the working lumen 102 + 410.
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It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Shibata to incorporate the teachings of Sykes and teach an occlusive implant system with the working lumen including a tapered portion disposed between the garage section and the distal portion of the working lumen; wherein the occlusive implant directly engages the tapered portion when the occlusive implant is urged through the tapered portion and into the distal portion of the working lumen and wherein the delivery sheath remains within the garage section while the occlusive implant is urged through the tapered portion and into the distal portion of the working lumen. Motivation for such can be found in Sykes as this allows for a frictional engagement between the implant and the lumen which prevents the implant from being inadvertently distally pushed until the frictional engagement force is exceeded deliberately by a user (see [0054]).
Claim 11
The combination of Shibata and Sykes teaches: The occlusive implant system of claim 10, see 103 rejection above. Shibata further discloses: wherein the working lumen 42 + 43a changes from the first inner diameter the inner diameter of 43c to the second inner diameter the inner diameter of the lumen of 42 within the handle 43 (see Fig. 3A).
Claim 12
The combination of Shibata and Sykes teaches: The occlusive implant system of claim 10, see 103 rejection above. Shibata further discloses: wherein the garage section 43c is disposed proximal of a distal end the distal end of 43 (see Fig. 3A, 43c is proximal of the distal end of 43, which is distally past 43c + 43d) of the handle 43.
Claim 13
The combination of Shibata and Sykes teaches: The occlusive implant system of claim 10, see 103 rejection above. Shibata does not explicitly disclose: wherein the garage section is less than 10 inches in length from the proximal port to a distal end of the garage section.
As noted in Shibata it is necessary for the garage section, or the communicating enlarged-diameter portion to protect the embolic device from being damaged on an inner wall of the 43 (see [0075]). This correlates to the length of the garage section from the proximal port to the distal end of the garage section and as such “wherein the garage section is less than 10 inches in length from the proximal port to a distal end of the garage section” is considered to be a result effective variable since that the lengths of 43c effects if the embolic device is damaged on an inner wall of 43 when it pushed through. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Shibata by causing the garage section is less than 10 inches in length from the proximal port to a distal end of the garage section as a matter of routine optimization since it has been held that ‘where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235, (CCPA 1955).
Claim 14
The combination of Shibata and Sykes teaches: The occlusive implant system of claim 10, see 103 rejection above. Shibata further discloses: wherein the distal end 27b of the delivery sheath 21 is prevented from extending distal of the garage section 43c + 43d (see Fig. 3B, 27b can’t extend distally past 43d by contacting 43b).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Lenker et al (US 20100114017 A1) teaches a delivery system with a tapered system (see Figs. 27A-27B and 35A-35B)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAIHAN R KHANDKER whose telephone number is (571)272-6174. The examiner can normally be reached Monday - Friday 8:00 AM - 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 571-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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RAIHAN R. KHANDKER
Examiner
Art Unit 3771
/RAIHAN R KHANDKER/Examiner, Art Unit 3771
Prosecution Insights