DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Specification
The disclosure is objected to because of the following informalities: on paragraph [0001], the corresponding patent number for the parent application must be added.
Appropriate correction is required.
Claim Objections
Claim 22 is objected to because of the following informalities:
On line 1, “a proximal portion” should be –the proximal portion--.
On line 2, “a distal portion” should be –the distal portion--.
Appropriate correction is required.
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 21, 22, 24, 25, 28, 29, 31, 32, and 34-47 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, and 5-23 of U.S. Patent No. 12,233,258. Although the conflicting claims are not identical, they are not patentably distinct from each other because each of the structural limitation recited in claims 1-3 and 5-23 of U.S. Patent No. 12,233,258. The difference in the terminology used would be obvious to one of ordinary skill in the art.
Specifically, the claimed limitations of claims 21, 22, 24, and 25 are found in claims 1, 19, 14, and 6 of U.S. Patent No. 12,233,258, respectively. The claimed limitations of claims 28, 29, and 31 are found in claims 2, 3, and 17 of U.S. Patent No. 12,233,258, respectively. The claimed limitations of claim 32 are found in the combinations of claims 18 and 19 of U.S. Patent No. 12,233,258. The claimed limitations of claims 34-37 are found in claims 20-23 of U.S. Patent No. 12,233,258. The claimed limitations of claims 38-47 are found in claims 5, 8, 7, and 9-16 of U.S. Patent No. 12,233,258.
Claim Rejections - 35 USC § 103
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 21-30 and 32-47 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Chambers (2004/0015151) in view of Kurth (6,887,229).
Chamber discloses a catheter system (Fig. 1) comprising: a catheter ([0022] and [0024]) comprising: a catheter body (20) (Fig. 1-1a, [0012], and [0029]) defining a first lumen (32) (Fig. 1a and [0026]), the catheter body having a proximal end of the catheter body (Fig. 1) and a distal end of the catheter body (Fig. 1), wherein the catheter body has at least a first stiffness along a proximal portion (24) ([0024]) and transitions at a transition point (Fig. 1a, [0024], and [0029]) to a single second stiffness (55) (Fig. 1a, [0024], and [0029]) characterizing a distal portion from the transition point to the distal end of the catheter body (Fig. 1a, [0024], and [0029]), the single second stiffness being less than the first stiffness (Fig. 1a, [0024], and [0029]).
Chambers further discloses wherein a first center line of a proximal portion of the catheter body and a second center line of a distal portion of the catheter body define an angle of 90-130 degrees in a relaxed state, wherein the second center line of the distal portion extends to the distal end ([0012], [0022], and claim 1); wherein the proximal end of the catheter body is configured to couple to a hemostasis valve system (where it is capable of being coupled to the valve system) ([0040-41]); wherein the catheter body comprises a braided material disposed around a circumference of the catheter body ([0011]); wherein the catheter body comprises three stiffness transition points ([0024] and [0026] where it can be divided along its length in different sections such as a third section 23 and a second section 22 which would be at different distances along the length as seen in Fig. 1); wherein the catheter body has no more than three stiffness transition points ([0024] and [0026] where it can be divided along its length into only three different sections such as a third section 23 and a second section 22 which would be at different distances along the length as seen in Fig. 1); wherein a portion (portion that is straight at the distal end) of the catheter body that is approximately one sixth of a total length of the catheter body (Fig. 1a) and that includes the distal end of the catheter body includes no more than one stiffness transition point (Fig. 1a); wherein the catheter comprises a curved portion (22) at the distal end of the catheter body (Fig. 1 and 1a), the curved portion being configured such that the distal end of the catheter body is angled relative to a portion of the catheter body nearest the curved portion ([0012], [0022], and claim 1); wherein the curved portion is entirely within the distal portion of the catheter body (Fig. 1a); wherein the transition point is within the curved portion of the catheter body (Fig. 1); wherein the catheter body is constructed of a first material and the curved portion is constructed of a second material that is less stiff than the first material to define the transition point ([0024]); wherein the distal end of the catheter body is angled relative to the portion of the catheter body nearest the curved portion by at least 80 degrees in a relaxed state ([0012], [0022], and claim 1) ; further comprising a second stiffness transition point ([0024] and [0026] where it can be divided along its length in different sections such as a third section 23 and a second section 22 which would be at different distances along the length as seen in Fig. 1); wherein the transition point is a material transition point ([0024]).
Chambers discloses all the limitations discussed above including the use of a variable stiffness guidewire (42) used to help shape and guide the catheter through the body by straightening the pre-formed hook section of the catheter as described in [0034].
Chambers discloses that the guidewire (42) configured to slidably move within the lumen of the catheter (Fig. 3a and [0034]; wherein the guidewire has a proximal end and a distal end (Fig. 2), wherein the guidewire has a first body stiffness along a proximate the distal end of the guidewire ([0033]) and a second body stiffness proximate the distal end of the guidewire ([0033]), wherein the second body stiffness is less that the first body stiffness ([0033]); wherein the guidewire comprises a tapered tip (52) at the distal end of the guidewire (Fig. 2); wherein the tapered tip comprises a material that is more flexible than the guidewire body ([0033]); and wherein the catheter body has a catheter tip (45) (Fig. 1a) at the distal end of the catheter (Fig. 1a), and wherein the tapered tip is configured to pass through the catheter tip (Fig. 3a-d); wherein the tapered tip is configured to push through vasculature (Fig. 5a-f).
Chambers discloses all the limitations above however Chambers does not call the guidewire which is being used to shape the catheter as a catheter dilator.
Kurth discloses another well-known catheter having a pre-formed bend which can be shaped by means of a guiding or shaping tool such as the dilator, stylet and or guide wire during placement within the body cavity (Abstract). Thus, Kurth discloses that these devices can be used interchangeably for purposes of shaping a catheter such as the one disclosed by Chambers. Furthermore, the guidewire of Chambers is being used to shape the catheter, therefore, it would have been obvious to one of ordinary skill in the art to use the guidewire of Chambers as a dilator, since it has been held that a simple substitution of one known element for another will yield predictable results. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Claims 28 and 29:
Chambers discloses all the limitations discussed above, however Chambers is silent to having a plurality of preformed bends.
Kurth discloses a catheter body that can have a plurality of preformed bends as seen in Fig. 1c-d (Col. 6 Lines 34-37 and Fig. 1c-d and 6).
It would have been obvious to a person having ordinary skill in the art at the time the invention was made to provide Chambers with a plurality of bends in view of the teachings of Kurth, in order to accommodate the different anatomies of individual patients (Col. 6 Lines 34-37).
With respect to the functional language, it has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987).
Claim 36:
Chambers discloses all the limitations discussed above, however Chambers is silent the catheter body having different thickness to define the transition point .
Kurth discloses a catheter body that can be made of the same material and have varying thickness which allow for transition points with different stiffness (Col. 2 Lines 34-45).
It would have been obvious to a person having ordinary skill in the art at the time the invention was made to use one material with varying thickness for the catheter body of Chambers in view of the teachings of Kurth, in order to change the stiffness throughout the length of the catheter body.
Furthermore, Kurth states that any means known in the art such as varying thickness can be used to change the stiffness (Col. 2 Lines 44-48). Therefore, it would have been obvious to one of ordinary skill in the art to use one material with varying thickness, as taught by Kurth, since it has been held that a simple substitution of one known element for another will yield predictable results. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Claim 39:
Chambers discloses the claimed invention except for the second stiffness transition point is 6 cm from the distal end. It would have been obvious to one having ordinary skill in the art at the time the invention was made to have the second stiffness transition point is 6 cm from the distal end, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Claim 40:
Chambers discloses the claimed invention except for the third stiffness transition point is 10 cm from the distal end. It would have been obvious to one having ordinary skill in the art at the time the invention was made to have the third stiffness transition point is 10 cm from the distal end, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Claim 46:
Chambers discloses the claimed invention except for the first lumen has an inner diameter sized to accept a 4 Fr lead. It would have been obvious to one having ordinary skill in the art at the time the invention was made to have the first lumen has an inner diameter sized to accept a 4 Fr lead, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Claim 47:
Chambers discloses the claimed invention except for the catheter body has an outer diameter of up to about 5 Fr to 6 Fr with a taper at the distal end to less than 5 Fr. It would have been obvious to one having ordinary skill in the art at the time the invention was made to have the catheter body has an outer diameter of up to about 5 Fr to 6 Fr with a taper at the distal end to less than 5 Fr, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claims 31 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Chambers (2004/0015151) in view of Kurth (6,887,229) and further in view of Trask et al. (2009/0312786).
The combination of Chambers in view of Kurth would have a catheter with a shaping device that is a dilator; therefore Chambers in view of Kurth teaches all the claimed limitations discussed above, however, Kurth does not specify that the dilator has a lumen.
Trask discloses a well known dilator (30) (Fig. 1) which has a second lumen ([0033]) configured to accept insertion of a guide wire (20) (Fig. 4), wherein the catheter dilator has a proximal end (34) (Fig. 1 and [0034]) of the catheter dilator and a distal end (33) (Fig. 1 and [0034]) of the catheter dilator (Fig. 1), wherein the catheter dilator comprises a catheter dilator body (32) (Fig. 1) having a first catheter dilator body stiffness (32a) proximate the proximal end of the catheter dilator (Fig. 1 and [0034]) and a second catheter dilator body stiffness (32b) proximate the distal end of the catheter dilator (Fig. 1 and [0034]), and wherein the second catheter dilator body stiffness is less that the first catheter dilator body stiffness ([0034]); wherein the catheter dilator comprises a tapered tip at the distal end of the catheter dilator (Fig. 1 and [0035]); wherein the tapered tip comprises a material that is more flexible than the catheter dilator body ([0014]); wherein the tapered tip is configured to push through vasculature ([0034]).
It would have been obvious to one of ordinary skill in the art to modify the dilator of Kurth with the dilator of Trask, since it has been held that a simple substitution of one known element for another will yield predictable results. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Furthermore, it would have been obvious to a person having ordinary skill in the art at the time the invention was made to provide Chambers in view of Kurth with the dilator of Trask, in order to reduce trauma to the vessel due to the varying stiffnesses of the dilator because the stiffnesses allow the dilator to move easier through the vasculature ([0021]).
Additionally, Chambers in view of Kurth and Trask discloses the claimed invention except for the second lumen with an inner diameter sized to accept a 0.038-inch (approximately 0.096 cm) guidewire. It would have been obvious to one having ordinary skill in the art at the time the invention was made to have the second lumen with an inner diameter sized to accept a 0.038-inch (approximately 0.096 cm) guidewire, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DIANNE DORNBUSCH whose telephone number is (571)270-3515. The examiner can normally be reached Monday-Wednesday 9 am-3 pm.
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/DIANNE DORNBUSCH/ Primary Examiner, Art Unit 3771
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