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 10/31/24 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 127 is objected to because there appears to be a typo regarding “wherein in a contraction…” in line 1 as opposed to “wherein
Claim 130 is objected to because there appears to be a typo regarding “wherein in an enlargement…” in line 1 as opposed to “wherein
Claim 131 is objected to because there is a lack of antecedent basis for “the stiffness of the lumenal member” in line 1. Appropriate correction is required.
Claim 135 is objected to because there is a lack of antecedent basis for “the stiffness of a catheter assembly” in line 1. Appropriate correction is required.
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 116-123, 125-131, and 134-135 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Melsheimer (US 20120277729).
Regarding claim 116, Melsheimer discloses a catheter assembly (medical system 300 having catheter 100) for transiting a body lumen, the assembly comprising:
a lumenal member (inner member 106) extending longitudinally;
a structural support member (tubular braid of filaments 110) configured to have a facing surface that is non-smooth (outer surface of tubular braid of filaments 110, shown non-smooth in at least Figures 2A-2B); and
an outer member (outer member 104),
wherein the structural support member extends outside a distal portion of the lumenal member and inside the outer member (“An annular cavity 108 may be disposed in between the outer member 104 and the inner member 106. A tubular braid of filaments 110 may be disposed in the annular cavity 108.” [0015]; Figures 1-3), and
wherein the outer member is configured to selectively apply pressure to the structural support member by enlargement and contraction of the outer member (Figures 2A-2B; see all of [0016-0017]).
Regarding claim 117, Melsheimer discloses the assembly of claim 116, wherein the non-smooth facing surface of the structural support member comprises one or more of discontinuities, non-uniformities, raised structures, and cavities (outer surface of tubular braid of filaments 110, wherein the overlapping filaments cause at least raised structures and cavities between each other as shown in at least Figures 2A-2B).
Regarding claim 118, Melsheimer discloses the assembly of claim 117, wherein the raised structures are distributed substantially uniformly (see Figures 1-3).
Regarding claim 119, Melsheimer discloses the assembly of claim 116, wherein the structural support member comprises a tubular mesh (tubular braid of filaments 110; Figures 1-2B).
Regarding claim 120, Melsheimer discloses the assembly of claim 116, wherein the structural support member comprises one or more longitudinally extending struts (individual filaments of tubular braid of filaments 110; Figures 1-2B).
Regarding claim 121, Melsheimer discloses the assembly of claim 120, 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 122, Melsheimer discloses the catheter assembly of claim 120, 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 123, Melsheimer discloses the assembly of claim 116, wherein the structural support member comprises a metal (“The filaments that comprise the tubular braid of filaments 110 may comprise a…metallic alloys, stainless steel” [0032]).
Regarding claim 125, Melsheimer discloses the assembly of claim 116, wherein the outer member is resiliently flexible (“the outer member 104 may comprise an elastic material such that when a radially outward bias is applied to an inner wall of the outer member 104, an inner diameter of the proximal end outer member 104 may expand from a first diameter to a second diameter.” [0026]).
Regarding claim 126, Melsheimer discloses the assembly of claim 116, wherein when the outer member (outer member 104) is contracted (Figure 2B), the structural support member (tubular braid of filaments 110) is configured to resist rearrangement (“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]).
Regarding claim 127, Melsheimer discloses the assembly of claim 116, wherein in a contraction of the outer member (Figure 2B) compresses the structural support member onto the distal portion of the lumenal member (“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.” [0017]).
Regarding claim 128, Melsheimer discloses the assembly of claim 127, wherein a stiffness of the lumenal member is increased 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 129, Melsheimer discloses the assembly of claim 116, wherein when the outer member is enlarged (Figure 2A), the structural support member is configured to be rearrangeable (“When the outer member 104 and the inner member 106 are in the first configuration, the tubular braid of filaments 110 may be movably disposed within the cavity 108.” [0016]).
Regarding claim 130, Melsheimer discloses the assembly of claim 116, wherein in an enlargement of the outer member (Figure 2A) allows the structural support member to move over the distal portion of the lumenal member (“When the outer member 104 and the inner member 106 are in the first configuration, the tubular braid of filaments 110 may be movably disposed within the cavity 108.” [0016]).
Regarding claim 131, Melsheimer discloses the assembly of claim 130, wherein the stiffness of the lumenal member is decreased at the distal portion of the lumenal member (“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” [0016]; “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 134, Melsheimer discloses the assembly of claim 116, wherein the assembly further comprises an introducer sheath (hub 112, shown as an introducer sheath in Figure 3).
Regarding claim 135, 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 lumenal member (inner member 106) extending longitudinally (Figures 1-3), a structural support member (tubular braid of filaments 110) configured to have a facing surface that is non-smooth (outer surface of tubular braid of filaments 110, shown non-smooth in at least Figures 2A-2B); and an outer member (outer member 104), wherein the structural support member extends outside a distal portion of the lumenal member and inside the outer member (“An annular cavity 108 may be disposed in between the outer member 104 and the inner member 106. A tubular braid of filaments 110 may be disposed in the annular cavity 108.” [0015]; 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 outer member (outer member 104) from an enlarged configuration (Figure 2A) to a contracted configuration (Figure 2B), wherein the outer member compresses the structural support member onto the distal portion of the lumenal member in the contracted 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 outer member from the contracted configuration to the enlarged 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 124 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 124, Melsheimer discloses the assembly of claim 123.
Melsheimer fails to explicitly disclose the metal comprises nitinol.
Berry teaches a catheter assembly (Figure 10) comprising a lumenal member (catheter 46) extending longitudinally (Figure 10) and a structural support member (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 member of Melsheimer to comprise nitinol based on the teachings of Berry to provide the structural support member 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 132-133 are rejected under 35 U.S.C. 103 as being unpatentable over Melsheimer (US 20120277729) in view of Schafersman et al. (US 20080243222).
Regarding claims 132-133, Melsheimer discloses the assembly of claim 116.
Melsheimer fails to explicitly disclose the assembly comprises a dilator shaft having a central lumen and a dilator tip, wherein the dilator shaft is configured to extend through a distal end of the lumenal member, as required by claim 132; and wherein the dilator tip is tapered, as required by claim 133.
Schafersman teaches a catheter assembly (introducer assembly 10) comprising a lumenal member (introducer sheath 20); and a dilator shaft (dilator 50) having a central lumen (“Dilator 50 comprises an elongated tubular structure” [0033]) and a dilator tip (distal tip portion 56), wherein the dilator shaft is configured to extend through a distal end of the lumenal member (Figure 1); and wherein the dilator tip is tapered (“The distal tip portion 56 of dilator 50 is tapered for accessing and dilating a vascular access site over wire guide 18” [0033]).
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 assembly of Melsheimer to include a dilator shaft having a central lumen and a tapered dilator tip, wherein the dilator shaft is configured to extend through a distal end of the lumenal member based on the teachings of Schafersman to provide a means for enlarging an opening in the vasculature in a controlled manner to minimize trauma to the patient (Schafersman [0005]).
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.
Claims 116-120 and 125-131 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 8, 10, 16, 18, 21-22, 24, 34, and 58-59 of U.S. Patent No. 12076503. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-2, 8, 10, 16, 18, 21-22, 24, 34, and 58-59 of USPN 12076503 disclose all of the limitations of claims 116-120 and 125-131 of the present application (see table below), and therefor claims 116-120 and 125-131 of the present application are anticipated by claims 1-2, 8, 10, 16, 18, 21-22, 24, 34 and 58-59 of USPN 12076503.
Claims 122-124 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 58-59 of U.S. Patent No. 12076503 in view of Berry et al. (USPN 6231598).
Regarding claim 122, the patented claims disclose substantially the same invention as claim 122, except for the struts comprising a serpentine strut. Berry teaches a catheter assembly (Figure 10) comprising a lumenal member (46) extending longitudinally (Figure 10) and a structural support member (10) comprising longitudinally extending struts comprising a serpentine strut (81). Before the effective filing date of the claimed invention, it would have been obvious to modify the longitudinal extending structures of the structural support member of the catheter assembly of USPN 12076503 to comprise serpentine struts based on the teachings of Berry to permit both radial and circumferential expansion of the structural support member (Berry [Col 10, lines 61-67]).
Regarding claims 123-124, the patented claims disclose substantially the same invention as claim 123-124 except for the structural support member comprising nitinol. Berry teaches a catheter assembly (Figure 10) comprising a lumenal member (46) extending longitudinally (Figure 10) and a structural support member (10) comprised of 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 member of the catheter assembly of USPN 12076503 to comprise nitinol based on the teachings of Berry to provide the structural support member 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 132-134 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12076503 in view of Schafersman et al. (US 20080243222). Regarding claims 132-134, the patented claims disclose substantially the same invention as claims 132-134, except for a dilator shaft having a central lumen and a tapered dilator tip, wherein the dilator shaft is configured to extend through a distal end of the lumenal member and an introducer sheath. Schafersman teaches a catheter assembly (10) comprising a lumenal member (20); and a dilator shaft and/or introducer sheath (50) having a central lumen ([0033]) and a dilator tip (56), wherein the dilator shaft is configured to extend through a distal end of the lumenal member (Figure 1); and wherein the dilator tip is tapered ([0033]). 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 assembly of USPN 12076503 to include a dilator shaft having a central lumen and a tapered dilator tip, wherein the dilator shaft is configured to extend through a distal end of the lumenal member and/or an introducer sheath based on the teachings of Schafersman to provide a means for enlarging an opening in the vasculature in a controlled manner to minimize trauma to the patient (Schafersman [0005]).
Claim 135 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12076503 in view of Melsheimer et al. (US 20080243222). Regarding claim 135, the patented claim discloses substantially the same invention as claim 135, except for the method steps of introducing and advancing the catheter assembly, transitioning the outer member from an enlarged to a contracted configuration, transitioning the outer member from the contracted to the configuration, and removing the catheter assembly. Melsheimer teaches a method of changing the stiffness of a catheter assembly ([0006]) comprising: (a) introducing a catheter assembly (300) into a vasculature ([0016]); (b) advancing the catheter assembly to a desired location ([0020]); (c) transitioning the outer member from an enlarged configuration to a contracted configuration ([0017]; [0036]); (d) transitioning the outer member from the contracted configuration to the enlarged configuration and (e) removing the catheter assembly from the desired location ([0037]). 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 assembly of USPN 12076503 to be used in a method comprising the steps of introducing and advancing the catheter assembly, transitioning the outer member from an enlarged to a contracted configuration, transitioning the outer member from the contracted to the configuration, and removing the catheter assembly based on the teachings of Melsheimer to allow for accurate delivery of a medical device through the catheter assembly to a treatment site (Melsheimer [0006]).
Nonstatutory Double Patenting
Present Application
USPN 12076503
116
1
117
2
118
2
119
10
120
1, 58-59
121
1, 24, 34
122
In view of Berry
123
In view of Berry
124
In view of Berry
125
16
126
1, 8
127
1, 8
128
1
129
1, 18, 21-22
130
1, 18, 21-22
131
1, 18, 21-22
132
In view of Schafersman
133
In view of Schafersman
134
In view of Schafersman
135
In view of Melsheimer
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEAH J SWANSON whose telephone number is (571)270-0394. The examiner can normally be reached M-F 9 AM- 5 PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LEAH J SWANSON/ Examiner, Art Unit 3783
/KEVIN C SIRMONS/ Supervisory Patent Examiner, Art Unit 3783
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