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
This office action is responsive to the amendment filed on 04/10/2026. As directed by the amendment: claims 1 and 11 have been amended and claims 5 and 9 have been cancelled. Thus, claims 1-4, 6-8, and 10-12 are presently pending in this application.
Response to Arguments
Applicant's arguments, see pages 6-9, filed 04/10/2026, with respect 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 additionally recite “such that the proximal connecting body is configured to maintain a distance between the distal connecting body and the proximal connecting body during a therapeutic period, and the proximal connecting body is configured to vary a distance between the distal connecting body and the proximal connecting body during the therapeutic period or during a different therapeutic period, wherein, in varying the distance the pressure means structure is configured to be expanded to shorten the distance between the distal connecting body and the proximal connecting body on the tightening means, and the pressure means structure configured to be contracted to increase the distance between the connecting bodies, thus varying a state of a mechanical stress of the pressure means”.
The applicant asserts that the combined references of Huang in view of Sachar and Kilemnik do not teach the limitations as recited in claim 1.
The applicant argues that the Office must assert a prima facie case that any alleged functional limitations are inherent. The examiner agrees, and will provide reasoning in the 103 rejection below.
In response to applicant's argument that Sachar is non-analogous art as Sachar makes no mention of applying ischemic pressure, because the purpose of the procedure is to remove thrombi. They further argue that one of ordinary skill in the art would be apply “a brush to sweep a vessel” instead of arriving at the claimed implant with a pressure means.
It has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case:
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. Specifically, in [0047], Sachar teaches “The thrombectomy devices disclosed herein remove a thrombus using a braided assembly that can be expanded to a diameter of the practitioner's choosing, enabling the practitioner to custom fit the device to the particular vessel and thrombus and during the procedure. Unlike conventional thrombectomy devices, the diameter of the disclosed braided assembly can be changed mid-procedure as needed. For example, the braided assembly can be opened to a wider diameter to apply more outward force against the thrombus should additional grip be needed for its removal. In some embodiments, multiple braided assemblies can be used to address longer thrombi. Each braided assembly can be separately expanded, such that the individual assemblies have different diameters during the procedure”.
This expansion which is a diameter of the practitioner’s choosing, is shown to contact the vessel wall, hence putting pressure on the vessel wall. Furthermore, Sachar refers to testing of their device’s radial force to the inner surface of a tubing that simulates a vein, hence showing that their device’s expansion force results in radial outward force within vasculature (see [0055]-[0057], Table 1 for venous applications, and Table 2 for arterial applications).
The applicant argues that Sachar does not teach an implant as it is not designed to be in a patient’s body long-term. However, the claims have no such language of the implant remaining in the body long-term, and furthermore— Sachar is not relied upon for such.
Additionally, the benefit as noted by Sachar, is independent control of expansion of parts of an implant, which is not narrowly benefiting thrombus retrieval (see [0069] of Sachar).
The applicant additionally argues that Kilemnik is non-analogous art as Kilemnik is related to the problem of insertion and position and argues that is a different field of endeavor compared to the pending application. They further argue that the implant of Kilemnik must be covered with a sheath to restrain the pressure means from self-expanding during insertion into the urethra.
In response to applicant's argument that Kilemnik is non-analogous art as Kilemnik is related to the problem of insertion and position and argues that is a different field of endeavor compared to the pending application. They further argue that the implant of Kilemnik must be covered with a sheath to restrain the pressure means from self-expanding during insertion into the urethra.
It has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case:
Efficient treatment requires a device to be properly inserted and positioned, hence Kilemnik is in analogous field of art to Huang and Sachar. Furthermore, the use of a sheath does not separate the field of invention, as Huang utilizes a sheath as well (see Fig. 10, 108).
As such the 103 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, 6-8, and 10-12 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, such that the proximal connecting body is configured to maintain a distance between the distal connecting body and the proximal connecting body during a therapeutic period, and the proximal connecting body is configured to vary a distance between the distal connecting body and the proximal connecting body during the therapeutic period or during a different therapeutic period, wherein, in varying the distance the pressure means structure is configured to be expanded to shorten the distance between the distal connecting body and the proximal connecting body on the tightening means, and the pressure means structure configured to be contracted to increase the distance between the connecting bodies, thus varying a state of a mechanical stress of the pressure means.
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: such that the proximal connecting body is configured to maintain a distance between the distal connecting body and the proximal connecting body during a therapeutic period, and the proximal connecting body is configured to vary a distance between the distal connecting body and the proximal connecting body during the therapeutic period or during a different therapeutic period, wherein, in varying the distance the pressure means structure is configured to be expanded to shorten the distance between the distal connecting body and the proximal connecting body on the tightening means, and the pressure means structure configured to be contracted to increase the distance between the connecting bodies, thus varying a state of a mechanical stress of the pressure 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: such that the proximal connecting body 270 is configured to maintain a distance (see Fig. 5D, [0057]-[0058], fixed within, 272 + 264 operate as a latch together, 272 clamps down onto 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 configured to maintain a distance. Motivation for such can be found in Kilemnik as this allows for secure coupling to a delivery system (see [0054]).
The language, " configured to maintain a distance between the distal connecting body and the proximal connecting body during a therapeutic period," 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, "and the proximal connecting body is configured to vary a distance between the distal connecting body and the proximal connecting body during the therapeutic period or during a different therapeutic period, wherein, in varying the distance the pressure means structure is configured to be expanded to shorten the distance between the distal connecting body and the proximal connecting body on the tightening means, the pressure means structure configured to be contracted to increase the distance between the connecting bodies, thus varying a state of a mechanical stress of the pressure means " 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 to vary its distance by moving the proximal connecting body in relation to the distal connecting body as taught by Huang as modified by Sachar while the device is in operation as shown by Sachar. This is done by sliding the individually controlled collars of that connecting bodies, thus changing the diameter of the pressure means, specifically by shortening the distance by applying tension (see [0063]). This expands the device and thus causes the pressure means to be contracted versus relaxed and lengthened in order to change the amount of mechanical stress. This can be done based on anatomy as by choice of the practitioner (see [0047] of Sachar) thus capable of changing between different therapeutic periods.
Furthermore, wherein in product and apparatus claims, when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See MPEP 2112.01 I.
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 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: a distal pressure means structure and a proximal pressure means structure, and the two pressure means structures are arranged one behind the other on the tightening means, 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 Figs. 3A-3C, [0068]), namely a distal pressure means structure 112 and a proximal pressure means structure 111, the two pressure means structures 111 + 112 are arranged one behind the other on the tightening means 132 (see Figs. 3B-3C, [0068]-[0069]), the two pressure means structures the wires that make up 111 and 112 have at least two pressure means each both 111 and 112 have at least 2 wires each (see Figs. 3B-3C) 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
THIS ACTION IS MADE FINAL. 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 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
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