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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/02/2025 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on 12/05/2025. As directed by the amendment: claim 1 has been amended and claim 5 has been cancelled. Thus, claims 1-4 and 6-12 are presently pending in this application.
Response to Arguments
Applicant's arguments, see pages 5-7, filed 12/05/2025, with regards to the rejection of claim 1 under 35 U.S.C. 103 as being unpatentable over Huang et al (US 20180318114 A1), herein referenced to as “Huang” in view of Sachar et al (US 20190133616 A1), herein referenced to as “Sachar” and Kilemnik (US 20180028222 A1), herein referenced to as “Kilemnik” have been fully considered but they are not persuasive.
The applicant amended claim 1 to further recite “or crimped in a releasable manner on the tightening means in order to keep the distance between the distal connecting body and the proximal connecting body constant during a therapeutic period, thereby enabling individual adaptation of the expansion of the pressure means for efficient treatment and subsequent gentle contraction for retrieval of the implant.
The applicant argues that the combination of references does not teach the amended claim language. The examiner respectfully disagrees.
Kilemnik teaches that the proximal connecting body can be latched in releasable manner on the tightening means (see Figs. 5C-5D, 266 can be pushed distally to cause 264 to move back radially inward and then withdrawn to release the proximal connecting body from the tightening means).
Additionally, the language, "constant during a therapeutic period, thereby enabling individual adaptation of the expansion of the pressure means for efficient treatment and subsequent gentle contraction for retrieval of the implant," 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 Huang, Sachar, and Kilemnik meets the structural limitations of the claim, and is capable of the device maintaining a constant expanded state during a therapeutic period as the device of Huang is designed to be deployed and then later retrieved, being expanded during deployment and then contracted for retrieval (see [0023]).
The applicant further argues that Sachar is non-analogous prior art as it does not explicitly mention applying ischemic pressure.
However, Sachar teaches that the device can apply outward pressure, and a sufficient outward pressure within tissue would be ischemic pressure. Hence, the applicant’s argument that Sachar is non-analogous is not found persuasive.
The applicant argues that there is no motivation for one of ordinary skill in the art to modify Huang with Sachar. They argue that variable expansion of Sachar that applies to grip in Sachar would not be applicable as motivation to Huang. The examiner respectfully disagrees.
Having differing levels of expansion would allow the implant of Huang to better adapt to different morphologies of the target site of implantation depending on patient anatomy.
The applicant additionally argues that Kilemnik is non-analogous art because it is applied to insertion and positioning of a medical device and not enabling individual adaption of the expansion of pressure means for efficient treatment. The examiner respectfully disagrees.
Efficient treatment requires a device to be properly inserted and positioned, hence Kilemnik is in analogous field of art to Huang and Sachar.
The applicant additionally argues that there is no motivation to modify Huang and Sachar with Kilemnik. The applicant argues that since Kilemnik is focused on the phase prior to the final release of the implant and since the pending application is concerned with the phase after release with adjustable, stable, and reversible therapy in the body. The examiner respectfully disagrees. For there to be efficient therapy in the body, secure coupling to a delivery system is necessary to properly delivery the device and to remove the device from the body and minimizing trauma to neighboring tissue during that process.
As such the rejection of the claims will be maintained.
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.
Claim(s) 1-4, 8-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huang et al (US 20180318114 A1), herein referenced to as “Huang” in view of Sachar et al (US 20190133616 A1), herein referenced to as “Sachar” and Kilemnik (US 20180028222 A1), herein referenced to as “Kilemnik”.
Claim 1
Huang discloses: An implant 30 (see Figs. 3A-3D, [0067]) for widening a urethra (see [0023]-[0026], widening the lumen of the urethra) of a person by applying a local ischemic pressure (see [0026], expansion or tissue retraction force) to the tissue of the urethra (see [0023]-[0026]), the implant 30 having a pressure means structure 38a-d (see Figs. 3A-3D, [0067]), which has at least two pressure means 38a-d (see Figs. 3A-3D, [0067], meets the 112f interpretation of wires/rods), wherein the implant 30 can be introduced into the urethra with a distal end 31b (see Fig. 3A, and 1, the distal end of the device is introduced into the urethra) leading, wherein the pressure means 38a-d are secured with their distal ends distal ends of 38a-d converge on 31b (see Fig. 3A, [0067]) on a common distal connecting body 31b (see Fig. 3A, [0067]) and with their proximal ends proximal ends of 38a-d converge on 31a (see Fig. 3A, [0067]) on a common proximal connecting body 31a (see Fig. 3A, [0067]).
Huang does not explicitly disclose: wherein the distal connection body is secured in a fixed manner to a tightening means and the proximal connecting body is movably mounted on the tightening means; wherein the proximal connecting body can be fixed, latched, clamped, screwed, twisted, crimped in a releasable manner or the like on the tightening means in order to keep the distance between the distal connecting body and the proximal connecting body constant during a therapeutic period, thereby enabling individual adaptation of the expansion of the pressure means for efficient treatment and subsequent gentle contraction for retrieval of the implant.
However, Sachar in a similar field of invention teaches an implant 19 (see Figs. 3A-3B) that radially expands within a body lumen with a pressure means structure 111 (see Figs. 3A-3B) with at least two pressure means the wires that comprise 111 (see Figs. 3A-3B), a distal connection body 23 (see Fig. 3B) and a proximal connecting body 27 (see Fig. 3B). Sachar further teaches: wherein the distal connection body 23 is secured in a fixed manner (see Fig. 3B, [0068], the slidable collars (23 in this case) can be positioned proximally to the fixed attachment point, hence, 27 which is fixed is normally proximal is instead distal to 23) to a tightening means 132 (see Fig. 3A-3C, 132 meets the 112f interpretation of a rod, [0068]-[0069]) and the proximal connecting body 27 is movably mounted (see Fig. 3B, [0068], the slidable collars (23 in this case) can be positioned proximally to the fixed attachment point, hence, 23 which is fixed is normally distal is instead proximal to 27) on the tightening means 132.
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 Huang to incorporate the teachings of Sachar and have an implant with the distal connection body is secured in a fixed manner to a tightening means and the proximal connecting body is movably mounted on the tightening means. Motivation for such can be found in Sachar as tensioning of the activation wire/rod enables multiple levels of expansion of the implant (see [0069]).
The combination of Huang and Sachar does not explicitly teach: wherein the proximal connecting body can be fixed, latched, clamped, screwed, twisted, crimped in a releasable manner or the like on the tightening means in order to keep the distance between the distal connecting body and the proximal connecting body constant during a therapeutic period, thereby enabling individual adaptation of the expansion of the pressure means for efficient treatment and subsequent gentle contraction for retrieval of the implant.
However, Kilemnik in a similar field of invention teaches an implant 200 (see Figs. 4A-4C and 5C-5D) with a distal connecting body the distal connection point of the wires 212 (see Fig. 4C), a proximal connecting body 270 (see Fig. 5D), and a tightening means 262 (see Figs. 5C-5D, meets 112f interpretation of a wire). Kilemnik further teaches: wherein the proximal connecting body 270 can be fixed (see Fig. 5D, [0057]-[0058], fixed within), latched (see Fig. 5D, 272 + 264 operate as a latch together), clamped (see Fig. 5D, 272 clamps down onto 262), screwed (will not be examined due to being an optional claim limitation), twisted (will not be examined due to being an optional claim limitation), crimped (will not be examined due to being an optional claim limitation) in a releasable manner (see Figs. 5C-5D, 266 can be pushed distally to cause 264 to move back radially inward and then withdrawn to release the proximal connecting body from the tightening means) on the tightening means 262.
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 the combination of Huang and Sachar to incorporate the teachings of Kilemnik and have the proximal connecting body be capable of being fixed or clamped on the tightening means. Motivation for such can be found in Kilemnik as this allows for secure coupling to a delivery system (see [0054]).
The language, " in order to keep the distance between the distal connecting body and the proximal connecting body constant," 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 combination device of Huang, Sachar, and Kilemnik meets the structural limitations of the claim, and is capable of once the proximal connecting body is locked via a clamp, preventing a change in distance between the normally slidable proximal connecting body and the fixed distal connecting body.
The language, "constant during a therapeutic period, thereby enabling individual adaptation of the expansion of the pressure means for efficient treatment and subsequent gentle contraction for retrieval of the implant," 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 Huang, Sachar, and Kilemnik meets the structural limitations of the claim, and is capable of the device maintaining a constant expanded state during a therapeutic period as the device of Huang is designed to be deployed and then later retrieved, being expanded during deployment and then contracted for retrieval (see [0023]).
Claim 2
The combination of Huang, Sachar, and Kilemnik teaches: The implant as claimed in claim 1, see 103 rejection above. Huang further discloses: wherein the at least two pressure means 38a-d in the pressure means structure 38a-d has three pressure means 38a-d (there are at least 3 wires).
Claim 3
The combination of Huang, Sachar, and Kilemnik teaches: The implant as claimed in claim 1, see 103 rejection above. Huang further discloses: wherein the pressure means 38a-d are wires (see Figs. 3A-3C, 38a-d are wires), wires made from a spring steel (see [0053], spring steels), stainless steel wires (see [0053], stainless steels), plastic rods (see [0053], PEEK which his polymer/plastic), rods made from a biodegradable material (see [0053], bio-absorbable polymers and metals), or rods made from a material having a shape memory (see [0053], shape memory, Nitinol).
Claim 4
The combination of Huang, Sachar, and Kilemnik teaches: The implant as claimed in claim 1, see 103 rejection above. Sachar further teaches: wherein the tightening means 132 is a thread 132 is a elongate thin member, hence a thread, a wire 132 is an activation wire hence a wire (see [0068], a stainless steel wire (see [0079], stainless steel, 132 falls under corresponding components), a plastic rod (see [0079], polymers), a thread or a rod made from a biodegradable material (will not be examined due to being an optional claim limitation), a rod or a wire having a screw thread (will not be examined due to being an optional claim limitation) or a rod or a wire having latching projections or notches (will not be examined due to being an optional claim limitation).
Claim 6
The combination of Huang, Sachar, and Kilemnik teaches: The implant as claimed in claim 1, see 103 rejection above. The combination of Huang and Sachar does not explicitly teach: wherein the proximal connecting body has a latching means, a latching projection, a latching nose, a wedge, a closure or the like, in order to enter into a connection with the tightening means.
However, Kilemnik in a similar field of invention teaches an implant 200 (see Figs. 4A-4C and 5C-5D) with a distal connecting body the distal connection point of the wires 212 (see Fig. 4C), a proximal connecting body 270 (see Fig. 5D), and a tightening means 262 (see Figs. 5C-5D, meets 112f interpretation of a wire). Kilemnik further teaches: wherein the proximal connecting body 270 has a latching means 272 (see Fig. 5D, [0058], meets the 112f interpretation of a latching projection), a latching projection 272 (see Fig. 5D, [0058]), a latching nose 272 (see Fig. 5D, [0058], appears to be a nose-like protrusion), a wedge 272 (see Fig. 5D, [0058], appears to be a wedge like protrusion), or a closure 272 (see Fig. 5D, [0058]) in order to enter into a connection (see Fig. 5D) with the tightening means 262.
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 the combination of Huang and Sachar to incorporate the teachings of Kilemnik and have the proximal connecting body have a latching means to connect to the tightening means. Motivation for such can be found in Kilemnik as this allows for secure coupling to a delivery system (see [0054]).
Claim 7
The combination of Huang, Sachar, and Kilemnik teaches: The implant as claimed in claim 6, see 103 rejection above. Kilemnik further teaches: wherein the latching means 272, the latching projection 272, the latching nose 272, the wedge 272, or the closure 272 is produced from a biodegradable material (see [0063], the implant, which includes the latching means, is made of biodegradable materials).
Claim 8
The combination of Huang, Sachar, and Kilemnik teaches: The implant as claimed in claim 1, see 103 rejection above. Sachar further teaches: wherein the proximal connecting body 27 has a bore 27 is a collar hence it has a bore (see [0068]), a bore having an internal thread (will not be examined due to being an optional claim limitation), a notch (see [0068]-[0069], 132 passes through the attachment point to reach the distal part of the device, hence 27 is a notch), a guide or a gap (see [0068]-[0069], 132 passes through the attachment point to reach the distal part of the device, hence 27 is a guide or gap), through which the tightening means 132 can be passed.
Claim 9
The combination of Huang, Sachar, and Kilemnik teaches: The implant as claimed in claim 1, see 103 rejection above. Sachar further teaches: wherein the pressure means structure 111 can be expanded by shortening the distance (see [0068]-[0069], the activation wire shortens the distance between the sliding collar and the fixed attachment point, reducing the distance between the wires, and causing the structure 111 to expand) between the distal connecting body 23 and the proximal connecting body 27 on the tightening means 132, with the distance between the pressure means the wires that make up 111 increasing.
Claim 10
The combination of Huang, Sachar, and Kilemnik teaches: The implant as claimed in claim 1, see 103 rejection above. Huang further discloses: wherein the pressure means 38a-d (see Figs. 3A-3C) each have one (see Fig. 3A, the midpoint of the wires has one inflection point), two (see Fig. 3B, each of the wires 38a-38d, have two inflection points), or more (will not be examined due to being an optional claim limitation) inflection points about which the pressure means 38a-d can be bent.
Claim 11
The combination of Huang, Sachar, and Kilemnik teaches: The implant as claimed in claim 1, see 103 rejection above. Huang does not explicitly disclose: wherein the pressure means structure comprises two pressure means structures, namely a distal pressure means structure and a proximal pressure means structure, which are arranged one behind the other on the tightening means, wherein the two pressure means structures have at least two pressure means each and wherein the respective at least two pressure means of the two pressure means structures are secured in a common central connecting body, whereby the distal pressure means structure has the distal connecting body and the proximal means structure has the proximal connecting body.
However, Sachar in a similar field of invention teaches an implant 19 (see Figs. 3A-3B) that radially expands within a body lumen. Sachar further teaches: wherein the pressure means structure comprises two pressure means structures 111 + 112 (see 112b rejection above, interpreted as the pressure means structure comprises two pressure means structures, see Figs. 3A-3C, [0068]), namely a distal pressure means structure 112 and a proximal pressure means structure 111, which are arranged one behind the other on the tightening means 132 (see Figs. 3B-3C, [0068]-[0069]), wherein the two pressure means structures the wires that make up 111 and 112 have at least two pressure means both 111 and 112 have at least 2 wires each (see Figs. 3B-3C) each and wherein the respective at least two pressure means 112 + 112 of the two pressure means the wires that make up 111 and 112 of the two pressure means structures 111 + 112 are secured in a common central connecting body 29 (see Figs. 3A-3C, [0068], 111 + 112 are joined together at 29), and the distal pressure means structure 112 has the distal connecting body 23 and the proximal means structure 111 has the proximal connecting body 27.
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 the combination of Huang and Sachar to incorporate the teachings of Sachar and have the implant comprise two pressure means structures arranged one behind the other, instead of one pressure mean structure. Motivation for such can be found in Sachar as this allows for application of the implant over longer ranges (see [0068]).
Claim 12
The combination of Huang, Sachar, and Kilemnik teaches: The implant as claimed in claim 11, see 103 rejection above. Sachar (Figs. 3A-3D) further teaches: wherein the distal pressure means structure 112 has a first distal connecting body 25 (see Fig. 3B, [0068]) and a first proximal connecting body 23 (see Fig. 3B, [0068]) and the proximal pressure means structure 111 has a second distal connecting body 29 (see Fig. 3B, [0068]) and a proximal connecting body 27 (see Fig. 3B, [0068]).
Sachar (Figs. 3A-3D) does not explicitly teach: wherein both the distal pressure means structure and the proximal pressure means structure have a tightening means, thus enabling the pressure means structures to be tightened independently of one another with regard to proximal and distal directions.
However, a variant embodiment of Sachar (see Fig. 4) in a similar field of invention teaches an implant with a distal pressure means structure 114 and a proximal pressure means structure 113 and tightening means activation wire (see [0070]). Sachar (Fig. 4) further teaches: wherein both the distal and proximal means structures 114/113 have a tightening means (see [0070], each assembly 113 + 114 has its individual activation wire), thus enabling the pressure means structures 113 + 114 to be tightened independently of one another with regard to proximal and distal directions (see Fig. 4, [0070]-[0071], the separate activation wires allow each of the structures to be shortened or lengthened independently, which is done by movement in proximal/distal directions).
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 the combination of Huang and Sachar to incorporate the teachings of a variant embodiment (Fig. 4) of Sachar and have the pressure means structures have their own tightening means. Motivation for such can be found in Sachar as this allows for partial deployment of one structure and full deployment of another (see [0071]).
Conclusion
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 7:00 PM - 3:00 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