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 .
Information Disclosure Statement
The information disclosure statement filed October 31, 2024 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered. No copy has been provided for Foreign Patent Document Cite No. 001 – AU-2016209354-A1.
Claim Objections
Claim 115 is objected to because there is a lack of antecedent basis for “the catheter” as opposed to “the catheter shaft” in line 2-3 of the claim. Appropriate correction is required.
Claim 117 is objected to because there is a lack of antecedent basis for “the catheter” as opposed to “the catheter shaft” in line 1 of the claim. Appropriate correction is required.
Claim 117 is further objected to because there appears to be a typo regarding “in relaxed configuration and in collapsed configuration” as opposed to “in the relaxed configuration and in the collapsed configuration”. Appropriate correction is required.
Claim 121 is objected to because there appears to be a typo regarding “…over entire length of the structural support” as opposed to “…over an entire length of the structural support”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 111 and 116 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 111, the limitation “the elastomer comprise thermoplastic polyurethane” is a recitation of new matter. The disclosures as originally filed on 07/16/24 does not provide support for this limitation. Paragraph [0070] states that “The outer tubular element 200 in the present examples is formed from polyurethane”, but does not disclose that the polyurethane is specifically thermoplastic polyurethane.
Regarding claim 116, the limitation “the increase in stiffness results in increase in resistance to bending by at least 10%” is a recitation of new matter. The disclosures as originally filed on 07/16/24 does not provide support for this limitation. The disclosure as originally filed states that the catheter has an increased stiffness and an increased resistance to bending in the collapsed configuration (see at least “move relative to each other or relative to the adjacent surfaces without a significant amount of force. In the constrained or supportive configuration, the structural support resists bending of the catheter, reducing its flexibility and increasing its stiffness.” [0106]). The originally filed disclosure also states “the variable shaped portion of the catheter in going from the tracking or flexible mode to the support or fixed mode applies little if any force on the adjacent lumen wall. Such results can be illustrated with a three-point bending flexural test with the variable shaped portion of the catheter arranged in a second shape configuration, and the force measured before and after fixing or pressing the structural support member would not be very different. For example, the force difference could be approximately 20%-25%, and could be in the range of 15-25%, and with the configuration of the structural support member 300 illustrated in FIGS. 10-13, can be less than 10%” [0108], but does not provide support for “the increase in stiffness results in increase in resistance to bending by at least 10%” as required by claim 116.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 103-108 and 114-122 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Melsheimer (US 20120277729).
Regarding claim 103, Melsheimer discloses a catheter assembly (medical system 300 having catheter 100) comprising:
a catheter shaft (inner member 106) having one or more apertures through a wall of a distal portion of the catheter shaft (at distal-most end of catheter 100; Figure 3);
a structural support (tubular braid 110) extending over the distal portion of the catheter shaft (Figures 1-3), wherein at least a portion of the structural support is in contact with a portion of an outer surface of the distal portion of the catheter shaft (Figure 2B); and
a flexible outer layer (outer member 104; “the outer member 104 may comprise an elastic material” [0026]) extending over at least a portion of the structural support (Figures 1-3), wherein a distal end and a proximal end of the flexible outer layer is circumferentially secured to an outer surface of the catheter shaft (Figure 3: via cap 126 and at annual termination 136; “The annular termination 136 may comprise a connection of the distal end of the outer member 104 and the distal end of the inner member 106. In order to form the termination 136, the distal portion 120 may comprise a taper portion, at which the outer member 104 and the inner member 106 distally converge to form the termination 136.” [0030]).
Regarding claim 104, Melsheimer discloses the catheter assembly of claim 103, wherein the structural support comprises a tubular mesh (tubular braid of filaments 110; Figures 1-2B).
Regarding claim 105, Melsheimer discloses the catheter assembly of claim 104, wherein the tubular mesh comprises one or more longitudinally extending struts (individual filaments of tubular braid of filaments 110; Figures 1-2B).
Regarding claim 106, Melsheimer discloses the catheter assembly of claim 105, wherein the one or more longitudinally extending struts comprises a serpentine strut (individual filament serpentine through the tubular braid of filaments 110; Figures 1-2B).
Regarding claim 107, Melsheimer discloses the catheter assembly of claim 105, wherein the one or more longitudinally extending struts are joined at a node (locations at which individual filaments of tubular braid of filaments 110 overlap; Figures 1-2B).
Regarding claim 108, Melsheimer discloses the catheter assembly of claim 103, wherein the structural support comprises a metal (“The filaments that comprise the tubular braid of filaments 110 may comprise a…metallic alloys, stainless steel” [0032]).
Regarding claim 114, Melsheimer discloses the catheter assembly of claim 103, wherein the flexible outer layer is configured to have a relaxed configuration (Figure 2A) and a collapsed configuration (Figure 2B).
Regarding claim 115, Melsheimer discloses the catheter assembly of claim 114, wherein in the collapsed configuration of the flexible outer layer compresses the structural support onto the distal portion of the catheter (Figure 2B), thereby increasing the stiffness of the catheter assembly at the distal portion (“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.” [0017]; “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.” [0036]).
Regarding claim 116, Melsheimer discloses the catheter assembly of claim 115, wherein the increase in stiffness results in increase in resistance to bending by at least 10% (“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.” [0017]; “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.” [0036], wherein the catheter is disclosed as being immobilized in the position in which it is disposed when clamped as opposed to having flexibility, thereby increasing its bending resistance at least 10%).
Regarding claim 117, Melsheimer discloses the catheter assembly of claim 115, wherein the catheter substantially maintains its shape in relaxed configuration and in collapsed configuration (Figures 2A-2B).
Regarding claim 118, Melsheimer discloses the catheter assembly of claim 114, wherein the flexible outer layer is configured to move from the relaxed configuration to the collapsed configuration by removal of a fluid through the one or more apertures (“The vacuum source 302 may be configured to apply the vacuum to and/or remove the vacuum from the annular cavity 108. For example, the vacuum source 302 may be configured to apply the vacuum to the cavity 108 by removing the gas from the cavity 108” [0019]; “The vacuum may be applied to and/or removed from the cavity 108 through a port of the catheter 100. The port may be in fluid communication with and/or operably connected to the cavity 108 and may be configured to allow the gas to pass therethrough and into and/or out of the cavity 108. An example port is shown in FIG. 3. The example port shown in FIG. 3 comprises a side arm 114 of a hub 112. The hub 112 may be connected to a proximal end of the outer member 104 and/or the inner member 106” [0020]; “The tubular braid of filaments 110 may be clamped by applying a vacuum to the cavity 108, which configures the outer and inner members 104, 106 in the second configuration. 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.” [0036]).
Regarding claim 119, Melsheimer discloses the catheter assembly of claim 118, wherein the fluid comprises saline, air, or a combination thereof (“The vacuum may be applied to the cavity by removing all or less than all of the gaseous particles, such as air molecules, from the cavity.” [0013]).
Regarding claim 120, Melsheimer discloses the catheter assembly of claim 103, wherein the catheter assembly comprises an introducer sheath (hub 112).
Regarding claim 121, Melsheimer discloses a catheter assembly (medical system 300) comprising:
an introducer sheath;
a catheter shaft (inner member 106);
a structural support comprising a tubular mesh (tubular braid of filaments 110) extending over a distal portion of the catheter shaft (Figure 3), wherein at least a portion of the structural support is in contact with a portion of an outer surface of the distal portion of the catheter shaft (Figure 2B);
a flexible outer layer (outer member 104; “the outer member 104 may comprise an elastic material” [0026]) extending over entire length of the structural support (Figure 3), wherein a distal end and a proximal end of the flexible outer layer is circumferentially secured to an outer surface of the catheter shaft (Figure 3: via cap 126 and at annual termination 136; “The annular termination 136 may comprise a connection of the distal end of the outer member 104 and the distal end of the inner member 106. In order to form the termination 136, the distal portion 120 may comprise a taper portion, at which the outer member 104 and the inner member 106 distally converge to form the termination 136.” [0030]).
Regarding claim 122, Melsheimer discloses a method of changing the stiffness of a catheter assembly (medical system 300; “A method of selectively varying flexibility of a catheter” [0006]) comprising:
(a) introducing a catheter assembly (medical system 300) into a vasculature (“when the outer member 104 and the inner member 106 are in the first configuration, the catheter 100 may comprise a degree of flexibility that is suitable for navigation of the catheter 100 through a bodily path, such as a body cavity, duct, or vessel, inside a patient and toward a treatment site within the patient.” [0016]), wherein the catheter assembly comprises a catheter shaft (inner member 106), a structural support (tubular braid of filaments 110) extending over a distal portion of the catheter shaft (Figure 3); and a flexible outer layer (outer member 104; “the outer member 104 may comprise an elastic material” [0026]) extending over at least a portion of structural support (Figures 1-3), and;
(b) advancing the catheter assembly to a desired location (“The hub 112 may be used to navigate a distal end of the catheter 100 to the treatment site within the patient,” [0020]);
(c) transitioning the flexible outer layer (outer member 104) from an relaxed configuration (Figure 2A) to a collapsed configuration (Figure 2B), wherein the flexible outer layer compresses the structural support onto the distal portion of the catheter shaft in the collapsed configuration, thereby increasing the stiffness of the catheter assembly at the distal portion (“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.” [0017]; “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.” [0036]);
(d) transitioning the flexible outer layer from the collapsed configuration to the relaxed configuration (“When the vacuum is removed, the outer and inner members 104, 106 are configured in the first configuration and remove the clamp on the tubular braid of filaments 110.”) [0037]; and
(e) removing the catheter assembly from the desired location (“After the clamp on the tubular braid of filaments 110 is removed, the catheter 100 may be retracted from the treatment site and removed from within the patient.” [0037]).
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.
Claim 109 is rejected under 35 U.S.C. 103 as being unpatentable over Melsheimer (US 20120277729) in view of Berry et al. (USPN 6231598).
Regarding claim 109, Melsheimer discloses the assembly of claim 108.
Melsheimer fails to explicitly disclose the metal comprises nitinol.
Berry teaches a catheter assembly (Figure 10) comprising a catheter shaft (catheter 46) extending longitudinally (Figure 10) and a structural support (stent 10) comprised of nitinol (“other materials can be used for the stent including…nitinol” [Col 8, lines 61-62]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the structural support of Melsheimer to comprise nitinol based on the teachings of Berry to provide the structural support with structural resiliency that allows for both contraction and enlargement to a predetermined shape without plastic deformation (Berry [Col 18, line 54 – Col 19, line 10]).
Claims 110-111 are rejected under 35 U.S.C. 103 as being unpatentable over Melsheimer (US 20120277729) in view of Sagae (USPN 5176637).
Regarding claims 110-111, Melsheimer discloses the catheter assembly of claim 103.
Melsheimer fails to explicitly disclose the flexible outer layer comprises an elastomer, as required by claim 110, and wherein the elastomer comprises thermoplastic polyurethane, as required by claim 111.
Sagae discloses a catheter assembly (Figures 1-3) comprising a catheter shaft ( inner tube 1); a structural support (reinforcing member 14), and a flexible outer layer (dilation element 3) comprised of thermoplastic polyurethane (“Materials usable for the dilatation element 3 include thermoplastic resins such as…polyurethane” [Col 5, lines 29-35]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the flexible outer layer of Melsheimer to comprise thermoplastic polyurethane based on the teachings of Sagae to provide the flexible outer layer with the necessary flexibility (Sagae [Col 5, lines 28-35]).
Claims 112-113 are rejected under 35 U.S.C. 103 as being unpatentable over Melsheimer (US 20120277729) in view of Lodin et al. (USPN 5460608).
Regarding claims 112-113, Melsheimer discloses the catheter assembly of claim 103.
Melsheimer fails to explicitly discloses the catheter shaft comprises a reinforcement, as required by claim 112; and wherein the reinforcement comprises a metal coil or a braid, as required by claims 113.
Lodin teaches a catheter assembly (peripheral catheter 10) comprising a catheter shaft (inner shaft 204) and a flexible outer layer (balloon 50); wherein the catheter shaft comprises a reinforcement (reinforcement member 100; Figure 4) that comprises a metal coil or a braid (“Reinforcement member 100 is in the form of a helical coil formed from a material such as stainless steel.” [Col 6, lines 64-65]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the catheter shaft of Melsheimer to include a reinforcement comprising a metal coil based on the teachings of Lodin to improve the mechanical integrity of the catheter shaft (Lodin [Col 6, lines 20-22]).
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.
Claim 122 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 135 of copending Application No. 18774776 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 135 of the copending Application discloses all of the limitations of claim 122 of the present application, and therefor claim 122 is anticipated by claim 135 of the copending application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/LEAH J SWANSON/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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