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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11 December 2025 has been entered.
Response to Amendment
This Office Action is in response to the Applicant’s amendment dated 11 December 2025 wherein Claims 1 and 12 are amended, Claim 11 is cancelled, and no new claims are added. Therefore Claims 1 – 10 and 12 – 20 are currently pending within the Application.
The Applicant’s amendment to the Claims dated 11 December 2025 has overcome each Claim Rejection under 35 U.S.C. 112(a) and 35 U.S.C. 112(b) set forth within the Final Rejection dated 23 September 2025 (hereinafter referred to as the “Final Rejection”). Therefore, the 35 U.S.C. 112(a) and 35 U.S.C. 112(b) rejections set forth in the Final Rejection are withdrawn.
Response to Arguments
Applicant’s arguments, see pages 5 – 6, filed 11 December 2025, with respect to the rejection(s) of independent claim(s) 1 and 16 and their respective dependent claims have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Melsheimer (US 2012/0277729 A1) and Miyata et al. (US 2002/0151823 A1).
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 – 10 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Melsheimer (US 2012/0277729 A1) and Miyata et al. (US 2002/0151823 A1; hereinafter referred to as “Miyata”).
Melsheimer is cited in the Notice of References Cited form dated June 3, 2025.
With regards to claim 1, Melsheimer discloses (Figs. 1 – 3) a variable stiffness catheter (100; see [0015] “catheter 100”) comprising:
an inner layer (106; see [0015] “an elongate tubular inner member 106”) forming an inner lumen (116; see [0015] “The tubular inner portion 106 may comprise a central lumen 116”);
a middle layer (108, 110; see [0015] “An annular cavity 108 may be disposed in between the outer member 14 and the inner member 106. A tubular braid of filaments 110 may be disposed in the annular cavity 108.”) forming an annular lumen (108) and surrounding the inner layer (see Fig. 2A), the annular lumen of the middle layer being fluidly connected to a vacuum source (302; see [0019] The vacuum source 302 of the medical system 300 may be operably connected to the annular cavity 108.”), the annular lumen comprising a plurality of strings (110; see [0015] “A tubular braid of filaments 110 may be disposed in the annular cavity 108”) at least over a portion of a length of the inner layer (see Fig. 2A); and
an outer layer (104; see [0015] “an elongate tubular outer member 104”) surrounding the middle layer (see Fig. 2A),
wherein applying the vacuum and evacuating the annular lumen of the middle layer alters a frictional resistance or adhesion between the inner layer and the outer layer and thereby increases the catheter's flexural rigidity (see Figs. 2A – 2B, [0017] “The outer member 104 and the inner member 106 may bias or clamp the tubular braid of filaments 110 in the fixed position relative to the outer and inner members 104, 106. Clamping the tubular braid of filaments may prevent the filaments from moving across one another, which may immobilize or lock the catheter 100 in the position or configuration in which the catheter 100 is disposed when the tubular braid 110 is clamped,” [0022], [0036] “The vacuum may be applied through operation of the vacuum source 302 that is in fluid communication with and/or operably connected to the cavity 108. When the tubular braid of filaments 110 are clamped between the outer member 104 and the inner member 106, the position of the catheter 100 within the patient may have a flexibility that is less than the flexibility of the catheter 100 when the tubular braid of filaments 110 is not clamped between the outer and inner members 104, 106.”), and wherein releasing the vacuum decreases the catheter’s flexural rigidity (see [0037] “When the vacuum is removed, the catheter 100 may retain a flexibility that is suitable for retraction of the catheter 100 from the treatment site.).
However, Melsheimer is silent with regards to the plurality of strings being in a single sheet along at least a portion of a length of the inner layer.
Nonetheless Miyata, which is within the analogous art of wire-stranded hollow tubes (see abstract), teaches the plurality of strings (8) (see [0059]) being in a single sheet (see Fig. 2) along at least a portion of a length of the inner layer (22) (see [0089] and Fig. 16).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the plurality of strings of the variable stiffness catheter of Melsheimer in view of a teaching of Miyata such that the plurality of strings are in a single sheet along at least a portion of a length of the inner layer. One of ordinary skill in the art would have been motivated to make this modification because this configuration provides for quick torque response and a good torque transmissibility thereby leading to a good manipulability of the catheter as a whole (see abstract of Miyata).
The variable stiffness catheter of Melsheimer modified in view of Miyata will hereinafter be referred to as the catheter of Melsheimer and Miyata.
With regards to claim 2, the catheter of Melsheimer and Miyata teaches the claimed invention of claim 1 and Melsheimer further teaches (Figs. 1 – 3) wherein the middle layer (108, 110; see [0015] “An annular cavity 108 may be disposed in between the outer member 14 and the inner member 106. A tubular braid of filaments 110 may be disposed in the annular cavity 108.”) has a low flexural rigidity or shear resistance when the vacuum is not applied and a high flexural rigidity or shear resistance when the vacuum is applied (see Figs. 2A – 2B, [0016], and [0036] “The vacuum may be applied through operation of the vacuum source 302 that is in fluid communication with and/or operably connected to the cavity 108. When the tubular braid of filaments 110 are clamped between the outer member 104 and the inner member 106, the position of the catheter 100 within the patient may have a flexibility that is less than the flexibility of the catheter 100 when the tubular braid of filaments 110 is not clamped between the outer and inner members 104, 106.”).
With regards to claim 3, the catheter of Melsheimer and Miyata teaches the claimed invention of claim 2 and Melsheimer further teaches (Figs. 1 – 3) wherein the low flexural rigidity or shear resistance of the catheter (100) is from continuous full microfluidic patency of the annular lumen (108) connecting to the vacuum source (302) and the high flexural rigidity or shear resistance of the catheter is from the frictional resistance or adhesion arising when the vacuum source is applied (see Figs. 2A – 2B, [0017] “The outer member 104 and the inner member 106 may bias or clamp the tubular braid of filaments 110 in the fixed position relative to the outer and inner members 104, 106. Clamping the tubular braid of filaments may prevent the filaments from moving across one another, which may immobilize or lock the catheter 100 in the position or configuration in which the catheter 100 is disposed when the tubular braid 110 is clamped” [0022], and [0036] “The vacuum may be applied through operation of the vacuum source 302 that is in fluid communication with and/or operably connected to the cavity 108. When the tubular braid of filaments 110 are clamped between the outer member 104 and the inner member 106, the position of the catheter 100 within the patient may have a flexibility that is less than the flexibility of the catheter 100 when the tubular braid of filaments 110 is not clamped between the outer and inner members 104, 106.”).
With regards to claim 4, the catheter of Melsheimer and Miyata teaches the claimed invention of claim 1 and Melsheimer further teaches (Figs. 1 – 3) wherein evacuation of the annular lumen (108) of the middle layer (108, 110) changes the flexural rigidity or adhesion of the middle layer (see Figs. 2A – 2B, [0017], [0022], and [0036] “The vacuum may be applied through operation of the vacuum source 302 that is in fluid communication with and/or operably connected to the cavity 108. When the tubular braid of filaments 110 are clamped between the outer member 104 and the inner member 106, the position of the catheter 100 within the patient may have a flexibility that is less than the flexibility of the catheter 100 when the tubular braid of filaments 110 is not clamped between the outer and inner members 104, 106.”).
With regards to claim 5, the catheter of Melsheimer and Miyata teaches the claimed invention of claim 4, and Melsheimer further teaches (Figs. 1 – 3) wherein evacuation of the annular lumen (108) of the middle layer (108, 110) causes an increase in the frictional resistance or adhesion that enables the inner layer (106), the middle layer (108, 110), and the outer layer (104) to flex as if they were a single layer, thereby increasing the flexural rigidity of the inner layer, the middle layer, and the outer layer beyond a sum of their flexural rigidities (see Figs. 2A – 2B, [0017], [0022], and [0036] “The vacuum may be applied through operation of the vacuum source 302 that is in fluid communication with and/or operably connected to the cavity 108. When the tubular braid of filaments 110 are clamped between the outer member 104 and the inner member 106, the position of the catheter 100 within the patient may have a flexibility that is less than the flexibility of the catheter 100 when the tubular braid of filaments 110 is not clamped between the outer and inner members 104, 106.”).
With regards to claim 6, the catheter of Melsheimer and Miyata teaches the claimed invention of claim 1, and Melsheimer further teaches (Figs. 1 – 3) wherein there is variable frictional resistance or adhesion between contacting surfaces of the inner layer (106) and the outer layer (104) on the middle layer (108, 110) (see Figs. 2A – 2B, [0017], [0022], and [0036] “The vacuum may be applied through operation of the vacuum source 302 that is in fluid communication with and/or operably connected to the cavity 108. When the tubular braid of filaments 110 are clamped between the outer member 104 and the inner member 106, the position of the catheter 100 within the patient may have a flexibility that is less than the flexibility of the catheter 100 when the tubular braid of filaments 110 is not clamped between the outer and inner members 104, 106.”).
With regards to claim 7, the catheter of Melsheimer and Miyata teaches the claimed invention of claim 1, and Melsheimer further teaches (Figs. 1 – 3) wherein the catheter (100) has a variable stiffness along a length of the catheter between a proximal end (see Fig. 3 near 124) and a distal end (see Fig. 3 near 136) of the catheter (see Figs. 2A – 2B, [0017], [0022], and [0036] “The vacuum may be applied through operation of the vacuum source 302 that is in fluid communication with and/or operably connected to the cavity 108. When the tubular braid of filaments 110 are clamped between the outer member 104 and the inner member 106, the position of the catheter 100 within the patient may have a flexibility that is less than the flexibility of the catheter 100 when the tubular braid of filaments 110 is not clamped between the outer and inner members 104, 106.” Wherein the “length” of the catheter is the portion in which the tubular braid of filament 110 extends along).
With regards to claim 8, the catheter of Melsheimer and Miyata teaches the claimed invention of claim 7 and Melsheimer further teaches (Figs. 1 – 3) wherein the catheter (100) has a variable stiffness along a portion (see [0023] “the tubular braid of filaments 110 longitudinally extends in the cavity 108 over a portion of the inner member 106 that is less than the entire length of the cavity 108”) or more than one portion of the length of the catheter (see Figs. 2A – 2B, [0017], [0022], [0023] “the tubular braid of filaments 110 extends in the cavity 108 over the entire length of the cavity 108,” and [0036] “The vacuum may be applied through operation of the vacuum source 302 that is in fluid communication with and/or operably connected to the cavity 108. When the tubular braid of filaments 110 are clamped between the outer member 104 and the inner member 106, the position of the catheter 100 within the patient may have a flexibility that is less than the flexibility of the catheter 100 when the tubular braid of filaments 110 is not clamped between the outer and inner members 104, 106.” Wherein the “length” of the catheter is the portion in which the tubular braid of filament 110 extends along).
With regards to claim 9, the catheter of Melsheimer and Miyata teaches the claimed invention of claim 8, and Melsheimer further teaches (Figs. 1 – 3) wherein a location of the portion of the catheter (100) having variable stiffness is optimized for a specific surgical procedure (see Abstract “A catheter having a selectively variable degree of flexibility…,” [0002], [0003] “For a given procedure, the type of catheter may be selected based on the catheter’s profile, steerability, lubricity, tip characteristics, length, rigidity, and/or flexibility…,” [0006], [0011], [0016] and [0036]).
With regards to claim 10, the catheter of Melsheimer and Miyata teaches the claimed invention of claim 7, and Melsheimer further teaches (Figs. 1 – 3) wherein the variable stiffness is along an asymmetric side of one portion or more than one portion of the length of the catheter (see Figs. 2A – 2B, [0017], [0022], and [0036] “The vacuum may be applied through operation of the vacuum source 302 that is in fluid communication with and/or operably connected to the cavity 108. When the tubular braid of filaments 110 are clamped between the outer member 104 and the inner member 106, the position of the catheter 100 within the patient may have a flexibility that is less than the flexibility of the catheter 100 when the tubular braid of filaments 110 is not clamped between the outer and inner members 104, 106.” Wherein the “more than one portion of the length of the catheter” is the portions of the catheter in which the tubular braid of filament 110 extends along).
With regards to claim 12, the catheter of Melsheimer and Miyata teaches the claimed invention of claim 1, however, Melsheimer is silent with regards to wherein the plurality of strings are in a spiral formation or linear formation along a length of the inner layer.
Nonetheless Miyata, which is within the analogous art of wire-stranded hollow tubes (see abstract), teaches the plurality of strings (8) (see [0059]) are in a spiral formation (see Fig. 2) or linear formation along a length of the inner layer (22)(see [0089] and see Fig. 16 which shows a spiral formation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the formation of the plurality of strings of the catheter of Melsheimer and Miyata in view of a further teaching of Miyata such that the plurality of strings are in a spiral formation along a length of the inner layer. One of ordinary skill in the art would have been motivated to make this modification because this configuration provides for quick torque response and a good torque transmissibility thereby leading to a good manipulability of the catheter as a whole (see abstract of Miyata).
Claim(s) 13 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Melsheimer and Miyata as applied to claim 1 above and in further view of Gregorich et al. (US 2007/0060880 A1; hereinafter referred to as “Gregorich”).
Gregorich is cited in the Notice of References Cited form dated June 3, 2025.
With regards to claim 13, the catheter of Melsheimer and Miyata the claimed invention of claim 1 however, Melsheimer is silent with regards to wherein the inner layer is relatively non-compliant and the outer layer of the catheter is relatively compliant.
Nonetheless Gregorich, which is within the analogous art of adjustable stiffness catheters (see abstract and title), teaches wherein the inner layer ([0044] “the elongate shaft 12 includes an inner liner, the inner liner can include or be formed from a coating of a material having a suitably low coefficient of friction. Examples of suitable materials include perfluoro polymers such as polytetrafluoroethylene (PTFE)”) is relatively non-compliant (see [0024] and [0026] of the current Specification of the Application wherein the material of PTFE is described as being non-compliant) and the outer layer (see [0045] “The elongate shaft 12 can include, as an outer layer or layers, any suitable polymer that will provide the desired strength, flexibility or other desired characteristics…In some embodiments, the polymer material used is a thermoplastic polymer material. Some examples of suitable materials include block polyamide/ethers (such as Pebax®), silicones”) of the catheter is relatively compliant (see [0026] of the current Specification of the Application wherein the materials of Pebax® and silicone are described as being compliant).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the material of the inner layer and the outer layer of the variable stiffness catheter of Melsheimer and Miyata in view of a teaching of Gregorich such that the inner layer is relatively non-compliant and the outer layer of the catheter is relatively compliant. One of ordinary skill in the art would have been motivated to make this modification because the selection of a known material based on its suitability for its intended use is a matter of obvious design choice. See In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960); MPEP 2144.07. Additionally, Gregorich teaches that the material of the inner layer provides a suitably low coefficient of friction while the material of the outer layer provides the desired strength and flexibility (see [0044] – [0045] of Gregorich).
With regards to claim 15, the catheter of Melsheimer and Miyata teaches the claimed invention of claim 1, however Melsheimer is silent with regards to the variable stiffness catheter further comprising a casing surrounding the outer layer.
Nonetheless Gregorich, which is within the analogous art of adjustable stiffness catheters (see abstract and title), teaches (Fig. 4) the variable stiffness catheter (see [0050] “as seen for example in FIGS. 4 – 6, a catheter”) further comprising a casing (46; see [0050] “a polymeric layer 46”) surrounding the outer layer (44; see [0050] “outer hypotube 44”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the variable stiffness catheter of Melsheimer and Miyata in view of a teaching of Gregorich such that the variable stiffness catheter further comprising a casing surrounding the outer layer. One of ordinary skill in the art would have been motivated to make this modification because Gregorich teaches that the catheter shaft can include any suitable number of layers that will provide the desired strength, flexibility, or other desired characteristic (see [0045] of Gregorich).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Melsheimer and Miyata as applied to claim 1 above and in further view of Hoste (US 6,508,806).
With regards to claim 14, the catheter of Melsheimer and Miyata teaches the claimed invention of claim 1, however Melsheimer is silent with regards to wherein the inner layer further comprises a braid on its outer surface.
Nonetheless Hoste, which is within the analogous art of catheters with multi-layer wire reinforced wall constructions (see abstract and title), teaches wherein the inner layer (22) further comprises a braid (17) on its outer surface (see Fig. 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the catheter of Melsheimer and Miyata in view of Hoste such that the inner layer further comprises a braid on its outer surface. One of ordinary skill in the art would have been motivated to make this modification because including the combination of multiple layers provides the catheter shaft with desired structural properties such as torsional stiffness, torsional collapse load, bending stiffness, and bend kink. The structural properties of this wall construction can also be easily modified by varying one or more of the design parameters, such as wire material, wire size, wire volume fraction, braid lay angle, coil pitch or matrix polymer (see Col. 2, lines 38 – 59 of Hoste).
Claim(s) 16 – 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Melsheimer and Miyata as applied to Claim 1 above and in further view of Takemura et al. (US 2017/0151417 A1; hereinafter referred to as “Takemura”).
Takemura is cited in the Notice of References Cited form dated June 3, 2025.
With regards to claim 16, the catheter of Melsheimer and Miyata teaches a method, the method comprising:
inserting the variable stiffness catheter of claim 1 through a patient (see the rejection of claim 1 above and [0015] “configured to deliver one or more medical devices to a treatment site within a patient” of Melsheimer); and
navigating the variable stiffness catheter through the patient's vasculature, wherein the variable stiffness catheter has a low flexural rigidity (see Figs. 2A – 2B, [0011], [0017], [0022], and [0036] of Melsheimer).
However Melsheimer is silent with regards to the method providing transradial interventions; and
inserting the variable stiffness catheter through a radial artery of a patient.
Nonetheless Takemura, which is within the analogous art of catheters (see abstract), teaches a method providing transradial interventions (see [0004] “a technique of inserting a catheter into an artery of a wrist and treating a coronary artery via transradial intervention (TRI) has been widely performed,” [0028], and [0038]); and
inserting the variable stiffness catheter through a radial artery of a patient (see [0028] and [0038] “the catheter shaft 2 is inserted into and moved inside a blood vessel such as a radial artery”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the method of Melsheimer and Miyata in view of a teaching of Takemura such that the method is used for providing transradial interventions and the variable stiffness catheter is inserted through a radial artery of the patient. One of ordinary skill in the art would have been motivated to make this modification because treating a coronary artery via a technique of inserting a catheter into a radial artery of a wrist of a patient is well known and widely performed (see [0004] of Takemura).
The method of Melsheimer and Miyata modified in view of Takemura will hereinafter be referred to as the method of Melsheimer, Miyata, and Takemura.
With regards to claim 17, the method of Melsheimer, Miyata, and Takemura teaches the claimed invention of claim 16, and Melsheimer further teaches (Figs. 1 – 3) the method further comprising:
fluidly connecting a vacuum source to the annular lumen (108) (see [0019] “FIG. 3 shows the vacuum source 302 connected to a proximal portion 118 of the catheter 100. The vacuum source 302 of the medical system 300 may be operably connected to the annular cavity 108”); and
applying the vacuum to the annular lumen (108; see [0015]) to compress together the inner layer (106; see [0015]), and the outer layer (104; see [0015]), creating high flexural rigidity (see Figs. 2A – 2B, [0011], [0017], [0022], and [0036]).
With regards to claim 18, the method of Melsheimer, Miyata, and Takemura teaches the claimed invention of claim 17, and Melsheimer further teaches (Figs. 1 – 3) the method further comprising:
inserting a medical device (see [0015] “The central lumen 116 may be configured to deliver one or more medical devices to a treatment site within a patient”) through the inner lumen (116; see [0015] “”) of the variable stiffness catheter (100; see [0015]).
With regards to claim 19, the method of Melsheimer, Miyata, and Takemura teaches the claimed invention of claim 18, and Melsheimer further teaches (Figs. 1 – 3) wherein the medical device is a neurovascular, body vascular, or pulmonary vascular medical device (see [0036] “a percutaneous intervention procedure to deliver one or more medical device to a treatment site within a patient” wherein percutaneous intervention procedures provide body vascular medical devices).
With regards to claim 20, the method of Melsheimer, Miyata, and Takemura teaches the claimed invention of claim 16, and the method of Melsheimer, Miyata, and Takemura further teaches (Figs. 1 – 3 of Melsheimer) wherein the variable stiffness catheter (100; see [0015] of Melsheimer) is operable to reduce herniation and buckling in the vasculature (see [0011] “a catheter that has a selectively variable degree of flexibility. The flexibility may be selective among two degrees of flexibility, a first degree of flexibility that is suitable for navigation through bodily passages of a patient, such as vessels, ducts, and/or cavities, and a second degree of flexibility that is suitable for delivery and/or removal of a medical device through the catheter.” Here, the flexibility of the variable stiffness catheter of Melsheimer reduces the herniation and buckling of the vasculature.) when inserted radially (see the rejection of claim 16 above and the teaching of Takemura wherein the catheter 100 of Melsheimer is inserted through the radial artery).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim(s) 1 – 8 and 16 – 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 6 and 16 – 20 of copending Application No. 18/968,552 in view of Melsheimer and Miyata.
This is a provisional nonstatutory double patenting rejection.
With regards to claim 1, claim 1 of copending Application No. 18/968,552 recites a variable stiffness catheter (see Claim 1 “A variable stiffness catheter”) comprising:
an inner layer forming an inner lumen (see Claim 1 “an inner layer forming an inner lumen”);
a middle layer forming an annular lumen and surrounding the inner layer (see Claim 1 “a middle layer forming a lumen and surrounding the inner layer”, the annular lumen of the middle layer being fluidly connected to a vacuum source (see Claim 1 “the lumen of the middle layer being fluidly connected to a vacuum source”), the annular lumen comprising a plurality of strings (see Claim 1 “the middle layer comprising a plurality of strings”); and
an outer layer surrounding the middle layer (see Claim 1 “an outer layer surrounding the middle layer”).
However, Claim 1 of the copending Application No. 18/968,552 is silent with regards to
wherein applying the vacuum and evacuating the annular lumen of the middle layer alters a frictional resistance or adhesion between the inner layer and the outer layer and thereby dynamically increases the catheter's flexural rigidity, and wherein releasing the vacuum dynamically decreases the catheter’s flexural rigidity;
and wherein the plurality of strings are in a single sheet along at least a portion of a length of the inner layer.
Nonetheless Melsheimer, which is within the analogous art of catheters with a selectively variable degree of flexibility (see abstract), teaches wherein applying the vacuum and evacuating the annular lumen of the middle layer alters a frictional resistance or adhesion between the inner layer and the outer layer and thereby dynamically increases the catheter's flexural rigidity (see Figs. 2A – 2B, [0017] “The outer member 104 and the inner member 106 may bias or clamp the tubular braid of filaments 110 in the fixed position relative to the outer and inner members 104, 106. Clamping the tubular braid of filaments may prevent the filaments from moving across one another, which may immobilize or lock the catheter 100 in the position or configuration in which the catheter 100 is disposed when the tubular braid 110 is clamped,” [0022], [0036] “The vacuum may be applied through operation of the vacuum source 302 that is in fluid communication with and/or operably connected to the cavity 108. When the tubular braid of filaments 110 are clamped between the outer member 104 and the inner member 106, the position of the catheter 100 within the patient may have a flexibility that is less than the flexibility of the catheter 100 when the tubular braid of filaments 110 is not clamped between the outer and inner members 104, 106.”), and wherein releasing the vacuum dynamically decreases the catheter’s flexural rigidity (see [0037] “When the vacuum is removed, the catheter 100 may retain a flexibility that is suitable for retraction of the catheter 100 from the treatment site.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the variable stiffness catheter of Claim 1 of the copending Application No. 18/968,552 in view of a teaching of Melsheimer such that wherein applying the vacuum and evacuating the annular lumen of the middle layer alters a frictional resistance or adhesion between the inner layer and the outer layer and thereby dynamically increases the catheter's flexural rigidity, and wherein releasing the vacuum dynamically decreases the catheter’s flexural rigidity. One of ordinary skill in the art would have been motivated to make this modification because Melsheimer teaches that it is desirable to adjust a catheter’s flexibility such that it is rigid or stiff enough to delivery a medical device through the catheter while also being able to revert the flexibility of the catheter such that the catheter is able to navigate through the vasculature of the patient to the treatment site (see [0003] and [0006] of Melsheimer).
The variable stiffness catheter of Claim 1 of the copending Application No. 18/968,552 modified in view of a teaching of Melsheimer will hereinafter be referred to as the variable stiffness catheter of copending Application No. 18/968,552 and Melsheimer.
However, neither the claims of copending Application No. 18/968,552 nor Melsheimer teaches the plurality of strings being in a single sheet along at least a portion of a length of the inner layer.
Nonetheless Miyata, which is within the analogous art of wire-stranded hollow tubes (see abstract), teaches the plurality of strings (8) (see [0059]) being in a single sheet (see Fig. 2) along at least a portion of a length of the inner layer (220) (see [0089]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the plurality of strings of the variable stiffness catheter of copending Application No. 18/968,552 and Melsheimer in view of a teaching of Miyata such that the plurality of strings being in a single sheet along at least a portion of a length of the inner layer. One of ordinary skill in the art would have been motivated to make this modification because this configuration provides for quick torque response and a good torque transmissibility thereby leading to a good manipulability of the catheter as a whole (see abstract of Miyata).
The variable stiffness catheter of copending Application No. 18/968,552 and Melsheimer modified in view of Miyata will hereinafter be referred toas the catheter of copending Application No. 18/968,552, Melsheimer, and Miyata.
With regards to claim 2, the variable stiffness catheter of copending Application No. 18/968,552, Melsheimer, and Miyata teaches the invention of Claim 1 of the current application, and Claim 2 of copending Application No. 18/968,552 further recites wherein the middle layer has a low flexural rigidity or shear resistance when the vacuum is not applied and a high flexural rigidity or shear resistance when the vacuum is applied (see Claim 2 “wherein the middle layer has a low flexural rigidity or shear resistance when the vacuum or actuation is not applied and a high flexural rigidity or shear resistance when the vacuum is applied.”).
With regards to claim 3, the variable stiffness catheter of copending Application No. 18/968,552, Melsheimer, and Miyata teaches the invention of Claim 2 of the current application, and Claim 3 of copending Application No. 18/968,552 further recites wherein the low flexural rigidity or shear resistance of the catheter is from continuous full microfluidic patency of the annular lumen connecting to the vacuum source and the high flexural rigidity or shear resistance of the catheter is from the frictional resistance or adhesion arising when the vacuum source is applied (see Claim 3 “wherein the low flexural rigidity or shear resistance of the catheter is from continuous full microfluidic patency of the lumen connecting to the vacuum source or actuation source and the high flexural rigidity or shear resistance of the catheter is from the friction or adhesion arising when the vacuum or actuation source is applied.”).
With regards to claim 4, the variable stiffness catheter of copending Application No. 18/968,552, Melsheimer, Miyata teaches the invention of Claim 1 of the current application, and Claim 4 of copending Application No. 18/968,552 further recites wherein evacuation of the annular lumen of the middle layer changes the flexural rigidity or adhesion of the middle layer (see Claim 4 “wherein evacuation or actuation of the lumen of the middle layer changes the flexural rigidity or adhesion of the middle layer.”).
With regards to claim 5, the variable stiffness catheter of copending Application No. 18/968,552, Melsheimer, and Miyata teaches the invention of Claim 4 of the current application, and Claim 5 of copending Application No. 18/968,552 further recites wherein evacuation of the annular lumen of the middle layer causes an increase in the frictional resistance or adhesion that enables the inner layer, the middle layer, and the outer layer to flex as if they were a single layer, thereby increasing the flexural rigidity of the inner layer, the middle layer, and the outer layer beyond a sum of their flexural rigidities (see Claim 5 “wherein evacuation or actuation of the lumen of the middle layer causes an increase in the frictional resistance or adhesion that enables the inner layer, the middle layer, and the outer layer to flex as if they were a single layer, thereby increasing the flexural rigidity of the inner layer, the middle layer, and the outer layer beyond a sum of their flexural rigidities.”).
With regards to claim 6, the variable stiffness catheter of copending Application No. 18/968,552, Melsheimer, and Miyata teaches the invention of Claim 1 of the current application, and Claim 6 of copending Application No. 18/968,552 further recites wherein there is variable frictional resistance or adhesion between contacting surfaces of the inner layer and the outer layer on the middle layer (see Claim 6 “wherein there is variable frictional resistance or adhesion between contacting surfaces of the inner layer and the outer layer on the middle layer.”).
With regards to claim 7, the variable stiffness catheter of copending Application No. 18/968,552, Melsheimer, and Miyata teaches the invention of Claim 1 of the current application, and Claim 1 of copending Application No. 18/968,552 further recites wherein the catheter has a variable stiffness along a length of the catheter between a proximal end and a distal end of the catheter (see Claim 1 “thereby changes a flexural rigidity of the variable stiffness catheter over a defined region” wherein the defined region is between a proximal end and a distal end of the catheter).
With regards to claim 8, the variable stiffness catheter of copending Application No. 18/968,552, Melsheimer, and Miyata teaches the invention of Claim 7 of the current application, and Claim 1 of copending Application No. 18/968,552 further recites wherein the catheter has a variable stiffness along a portion or more than one portion of the length of the catheter (see Claim 1 “thereby changes a flexural rigidity of the variable stiffness catheter over a defined region” wherein the defined region is the “portion” that has a variable stiffness).
With regards to claim 16, Claim 16 of the copending Application No. 18/968,552 recites a method of providing transradial interventions (see Claim 16 “ A method of providing transradial interventions”), the method comprising:
inserting the variable stiffness catheter of claim 1 through a radial artery of a patient (see Claim 16 “inserting the variable stiffness catheter of claim 1 through a radial artery of a patient” and see the rejection of Claim 1 above in view of the variable stiffness catheter of copending Application No. 18/968,552, Melsheimer, and Miyata); and
navigating the variable stiffness catheter through the patient's vasculature, wherein the variable stiffness catheter has a low flexural rigidity (see Claim 16 “navigating the variable stiffness catheter through a vasculature of the patient, wherein the variable stiffness catheter has a low flexural rigidity”).
The method of Claim 16 of copending Application No. 18/968,552 incorporating the variable stiffness catheter of Claim 1 will hereinafter be referred to as the method of copending Application No. 18/968,552, Melsheimer, and Miyata.
With regards to claim 17, the method of copending Application No. 18/968,552, Melsheimer, and Miyata teaches claim 16 of the current application, and Claim 17 of copending Application No. 18/968,552 further recites fluidly connecting a vacuum source to the annular lumen (see Claim 17 “fluidly connecting a vacuum source or an actuation source to the lumen”); and
applying the vacuum to the annular lumen to compress together the inner layer, and the outer layer, creating high flexural rigidity (see Claim 17 “applying the vacuum or actuation to the lumen to remove fluid from the lumen and compress together the inner layer and the outer layer, creating high flexural rigidity”).
With regards to claim 18, the method of copending Application No. 18/968,552, Melsheimer, and Miyata teaches claim 17 of the current application, and Claim 18 of copending Application No. 18/968,552 further recites inserting a medical device through the inner lumen of the variable stiffness catheter (see Claim 18 “inserting a medical device through the inner lumen of the variable stiffness catheter”).
With regards to claim 19, the method of copending Application No. 18/968,552, Melsheimer, and Miyata teaches claim 18 of the current application, and Claim 19 of copending Application No. 18/968,552 further recites wherein the medical device is a neurovascular, body vascular, or pulmonary vascular medical device (see Claim 19 “wherein the medical device is a neurovascular, body vascular, or pulmonary vascular medical device”).
With regards to claim 20, the method of copending Application No. 18/968,552, Melsheimer, and Miyata teaches claim 16 of the current application, and Claim 20 of copending Application No. 18/968,552 further recites wherein the variable stiffness catheter is operable to reduce herniation and buckling in the vasculature when inserted radially (see Claim 20 “wherein the variable stiffness catheter is operable to reduce herniation and buckling in the vasculature when inserted radially”).
Conclusion
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/ROBERT F ALLEN/Examiner, Art Unit 3783
/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783
01/20/206