DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
As of the reply filed 5/22/2026, claims 1-12 and 14-20 are pending. Claim 13 is cancelled. Claims 1, 5, 15, and 20 have been amended.
Response to Arguments
Applicant’s amendments to the claims have overcome the previously filed claim objections, therefore these objections are withdrawn.
With respect to Applicant’s argument that “Davies discloses only that the dilator tip itself tapers, not that the distal tip outer diameter is dimensioned in relation to the crossing device so as to define the claimed distal-tip/crossing device relationship” (see pages 7-8 of reply), the Examiner respectfully disagrees. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). In the present case, the claims do not explicitly require a specific dimensional relationship between the dilator and a crossing device (which is claimed as an object of functional language and is not positively recited by the claims), but simply states “the distal tip having an outer diameter which tapers to an outer diameter of the crossing device”, which the Examiner argues is patentably indistinct from the taper of the Davies reference. The Davies dilator tapers to a reduced diameter that is radially aligned to the outer diameter of a crossing device (see Fig. 5, where the end taper of 108 matches the outer diameter of crossing device 500), reading on the claim language.
Applicant’s arguments with respect to the amended claim limitations have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 1-12 and 14-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,426,565 B2, hereinafter known as the ‘565 patent, in view of Martin et al. (US PGPub 2012/0296275 A1) and Davies et al. (US PGPub 2014/0039315 A1). Claims 2, 6, 9-12, and 16-19 each depend from independent claims 1 and 15, inheriting the obviousness-type nonstatutory double patenting rejections of those independent claims, but the limitations of claims 2, 6, 9-12, and 16-19 are further disclosed by the ‘565 patent as mapped out below.
Claims
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With respect to claim 1, the ‘565 patent discloses most of the limitations of claim 1, yet fails to explicitly disclose a hub coupled to the dilator shaft defining a lumen therethrough wherein the hub has a side arm, or wherein the distal tip comprises a secondary surface modification, the secondary surface modification comprising a divot formed on the tapered outer surface.
In the same field of endeavor, namely dilators for enlarging apertures in a patient’s vasculature (PP [0004]), Martin et al. teaches a dilator (503 in Fig. 5) comprising a dilator shaft (see shaft of 503) and a hub (509) coupled to the dilator shaft (shaft of 503) defining a lumen therethrough (see lumen of 510 through 509 and connected to 505), wherein the hub (509) has a side arm (501 with connector 511).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified claim 1 of the ‘565 patent to further include a hub comprising a side arm as taught by the Martin et al. reference. One of ordinary skill in the art would have been motivated to perform this modification because doing so would have constituted the use of a known technique (the incorporation of a hub with a side arm on the proximal end of a dilator) to improve a similar device (the dilator of the ‘565 patent) ready for improvement to yield predictable results, since adding a hub comprising a side arm would not change the operation of the device of the ‘565 patent and would simply enable a releasable connection to a syringe to inject fluid and flush the dilator lumen or to extract blood from the target vasculature as necessary (PP [0074] of Martin et al.).
However, the ‘565 patent as modified by Martin et al. further fails to disclose wherein the distal tip comprises a secondary surface modification, the secondary surface modification comprising a divot formed on the tapered outer surface.
In the same field of dilators (abstract), Davies et al. teaches a medical device (30 in Fig. 1) comprising a distal end (PP [0011]: “FIG. 1 is a side view of the distal end of an embodiment of a medical device having cut out rings”), wherein the distal end comprises a secondary surface modification (22 and 24), the secondary surface modification (22 and 24) comprising divots formed on the outer surface (PP [0034]: “cut-out rings 22 proximal of aperture 20 and cut-out rings 24 distal of aperture 20”, see divots in Fig. 1).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have further modified the combination of the ‘565 patent and Martin et al. to include divots along the distal end as taught by the Davies et al. reference. One of ordinary skill in the art would have been motivated to perform this modification in order to “increase the echogenicity” of the dilator (PP [0034]), enhancing its visibility in all directions when imaging the procedure with ultrasound. Placing the divots as taught by Davies et al. onto the distal taper of the ‘565 patent additionally would have been obvious to one of ordinary skill in the art since Davies et al. explicitly states that the divots are located on the distal-most end of the device (30). Such a modification would not have altered the main operating principle of the ‘565 patent, which contemplates alternative avenues for facilitating imaging (see col. 11, lines 4-24), but would have yielded predictable results since Davies et al. already contemplates placing divots in such a way as to maintain the structural integrity of a device where higher stresses are expected (such as on a tapered distal tip of a dilator, PP [0028]: “in areas where higher stresses are expected in use, smaller features are used. Embodiments of the present invention provide enhanced visibility of medical devices while maintaining the structural integrity of the devices to a greater extent relative to other devices with similar visibility enhancing features”).
Regarding claim 3, the ‘565 patent as modified by Martin et al. and Davies et al. further discloses wherein the side arm (501 with connector 511 in Fig. 5 of Martin et al.) provides an indication of the direction of the distal end of curvature (the combination as proposed would yield a sideport as shown in Fig. 5 of Martin et al. placed onto the dilator described by the ‘565 patent in claim 1 such that the sideport would have a directionality which is comparable to the directionality of the dilator’s curvature to indicate the direction of the curvature).
Regarding claim 4, the ‘565 patent as modified by Martin et al. and Davies et al. further discloses wherein the side arm is a pseudo side-port (501 with connector 511 in Fig. 5 of Martin et al., the sideport is a pseudo side-port when it is not being actively used to transport fluids through the inner lumen, see MPEP 2112.01).
Regarding claim 5, the ‘565 patent as modified by Martin et al. and Davies et al. further discloses wherein the side arm is a side-port (501 with connector 511 in Fig. 5 of Martin et al., see syringe 502 connected to 511 and 501).
Regarding claim 8, the ‘565 patent as modified by Martin et al. and Davies et al. fails to explicitly disclose wherein the side arm has an endpoint and the distance between the side arm endpoint and an opposing point on the hub is 28.39 mm.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the ‘565 and Martin et al. combination such that the side arm has an endpoint and the distance between the side arm endpoint and an opposing point on the hub is 28.39 mm because the hub 209 and side arm 211 of Martin et al. would not operate differently with the claimed distance between them, as the device of Martin et al. is intended for use in similar applications (Martin et al. PP [0003]: “in endovascular surgery, the dilator and the introducer sheath have radiopaque characteristics to aid in visualization of these items within the body”) and would be capable of accommodating the hub/side arm length as claimed. Furthermore, it has been held that a change in size is generally recognized as being within the level of ordinary skill in the art (In re Rose, 105 USPQ 237 (CCPA 1955), In Gardnerv.TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), see MPEP 2144.04), particularly since the applicant has placed no criticality on the claimed dimension, only stating the distance of 28.39 mm with no additional reasoning (see PP [0070] of present application).
With respect to claim 15, the ‘565 patent discloses most of the limitations of claim 15 via claim 13, yet fails to explicitly disclose a hub coupled to the dilator shaft defining a lumen therethrough wherein the hub has a side arm, or wherein the distal tip comprises a secondary surface modification, the secondary surface modification comprising a divot formed on the tapered outer surface.
In the same field of endeavor, namely dilators for enlarging apertures in a patient’s vasculature (PP [0004]), Martin et al. teaches a dilator (503 in Fig. 5) comprising a dilator shaft (see shaft of 503) and a hub (509) coupled to the dilator shaft (shaft of 503) defining a lumen therethrough (see lumen of 510 through 509 and connected to 505), wherein the hub (509) has a side arm (501 with connector 511).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified claim 1 of the ‘565 patent to further include a hub comprising a side arm as taught by the Martin et al. reference. One of ordinary skill in the art would have been motivated to perform this modification because doing so would have constituted the use of a known technique (the incorporation of a hub with a side arm on the proximal end of a dilator) to improve a similar device (the dilator of the ‘565 patent) ready for improvement to yield predictable results, since adding a hub comprising a side arm would not change the operation of the device of the ‘565 patent and would simply enable a releasable connection to a syringe to inject fluid and flush the dilator lumen or to extract blood from the target vasculature as necessary (PP [0074] of Martin et al.).
However, the ‘565 patent as modified by Martin et al. further fails to disclose wherein the distal tip comprises a secondary surface modification, the secondary surface modification comprising a divot formed on the tapered outer surface.
In the same field of dilators (abstract), Davies et al. teaches a medical device (30 in Fig. 1) comprising a distal end (PP [0011]: “FIG. 1 is a side view of the distal end of an embodiment of a medical device having cut out rings”), wherein the distal end comprises a secondary surface modification (22 and 24), the secondary surface modification (22 and 24) comprising divots formed on the outer surface (PP [0034]: “cut-out rings 22 proximal of aperture 20 and cut-out rings 24 distal of aperture 20”, see divots in Fig. 1).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have further modified the combination of the ‘565 patent and Martin et al. to include divots along the distal end as taught by the Davies et al. reference. One of ordinary skill in the art would have been motivated to perform this modification in order to “increase the echogenicity” of the dilator (PP [0034]), enhancing its visibility in all directions when imaging the procedure with ultrasound. Placing the divots as taught by Davies et al. onto the distal taper of the ‘565 patent additionally would have been obvious to one of ordinary skill in the art since Davies et al. explicitly states that the divots are located on the distal-most end of the device (30). Such a modification would not have altered the main operating principle of the ‘565 patent, which contemplates alternative avenues for facilitating imaging (see col. 11, lines 4-24), but would have yielded predictable results since Davies et al. already contemplates placing divots in such a way as to maintain the structural integrity of a device where higher stresses are expected (such as on a tapered distal tip of a dilator, PP [0028]: “in areas where higher stresses are expected in use, smaller features are used. Embodiments of the present invention provide enhanced visibility of medical devices while maintaining the structural integrity of the devices to a greater extent relative to other devices with similar visibility enhancing features”).
With respect to claim 20, the ‘565 patent discloses most of the limitations of claim 20 via claim 18, yet fails to explicitly disclose a hub coupled to the dilator shaft defining a lumen therethrough wherein the hub has a side arm, or wherein the distal tip comprises a secondary surface modification, the secondary surface modification comprising a divot formed on the tapered outer surface.
In the same field of endeavor, namely dilators for enlarging apertures in a patient’s vasculature (PP [0004]), Martin et al. teaches a dilator (503 in Fig. 5) comprising a dilator shaft (see shaft of 503) and a hub (509) coupled to the dilator shaft (shaft of 503) defining a lumen therethrough (see lumen of 510 through 509 and connected to 505), wherein the hub (509) has a side arm (501 with connector 511).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified claim 1 of the ‘565 patent to further include a hub comprising a side arm as taught by the Martin et al. reference. One of ordinary skill in the art would have been motivated to perform this modification because doing so would have constituted the use of a known technique (the incorporation of a hub with a side arm on the proximal end of a dilator) to improve a similar device (the dilator of the ‘565 patent) ready for improvement to yield predictable results, since adding a hub comprising a side arm would not change the operation of the device of the ‘565 patent and would simply enable a releasable connection to a syringe to inject fluid and flush the dilator lumen or to extract blood from the target vasculature as necessary (PP [0074] of Martin et al.).
However, the ‘565 patent as modified by Martin et al. further fails to disclose wherein the distal tip comprises a secondary surface modification, the secondary surface modification comprising a divot formed on the tapered outer surface.
In the same field of dilators (abstract), Davies et al. teaches a medical device (30 in Fig. 1) comprising a distal end (PP [0011]: “FIG. 1 is a side view of the distal end of an embodiment of a medical device having cut out rings”), wherein the distal end comprises a secondary surface modification (22 and 24), the secondary surface modification (22 and 24) comprising divots formed on the outer surface (PP [0034]: “cut-out rings 22 proximal of aperture 20 and cut-out rings 24 distal of aperture 20”, see divots in Fig. 1).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have further modified the combination of the ‘565 patent and Martin et al. to include divots along the distal end as taught by the Davies et al. reference. One of ordinary skill in the art would have been motivated to perform this modification in order to “increase the echogenicity” of the dilator (PP [0034]), enhancing its visibility in all directions when imaging the procedure with ultrasound. Placing the divots as taught by Davies et al. onto the distal taper of the ‘565 patent additionally would have been obvious to one of ordinary skill in the art since Davies et al. explicitly states that the divots are located on the distal-most end of the device (30). Such a modification would not have altered the main operating principle of the ‘565 patent, which contemplates alternative avenues for facilitating imaging (see col. 11, lines 4-24), but would have yielded predictable results since Davies et al. already contemplates placing divots in such a way as to maintain the structural integrity of a device where higher stresses are expected (such as on a tapered distal tip of a dilator, PP [0028]: “in areas where higher stresses are expected in use, smaller features are used. Embodiments of the present invention provide enhanced visibility of medical devices while maintaining the structural integrity of the devices to a greater extent relative to other devices with similar visibility enhancing features”).
Claim 7 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,426,565 B2, hereinafter known as the ‘565 patent, in view of Martin et al. (US PGPub 2012/0296275 A1) and Davies et al. (US PGPub 2014/0039315 A1), as applied to claim 1 above, and further in view of Davies et al. (US PGPub 2007/0185522 A1).
Regarding claim 7, the ‘565 patent as modified by Martin et al. and Davies et al. fails to disclose wherein the hybrid dilator further comprises a coupling for providing strain relief between the hub and the dilator shaft.
In the same field of dilators (abstract), Davies et al. teaches a dilator (102 in Fig. 1) comprising a hub (110), and further comprising a coupling (PP [0033]: “Hub 110 may be attached to elongated member 102 via a number of methods, such as the use of adhesives, friction fitting, crimping or by a screw-mechanism, for example. Furthermore, hub 110 may be detachable from elongated member 102, for example by un-screwing or by pressing or releasing a button and/or switch”) for providing strain relief between the hub (110) and the dilator shaft (116, the screw-mechanism provides a greater degree of connective security thus reducing strain between the hub and the dilator shaft, see MPEP 2112.01).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the combination of the ‘565 patent, Martin et al., and Davies et al. according to the teachings of Davies et al. to include a coupling for providing strain relief between the hub and the dilator shaft. One of ordinary skill in the art would have been motivated to perform this modification because doing so constitutes the use of a known technique (a fitting such as a screw mechanism to connect a hub to an elongated member/dilator) to improve a similar device (the combination as proposed which is a dilator comprising a hub) in the same way. Modifying the combination to include the screw mechanism fitting of Davies et al. would not change the primary operating principle of the proposed combination and would only provide a specific fitting to enable the structures already discussed in the prior art, which contemplate the attachment between the hub and the dilator shaft (Martin et al. PP [0074]: “hub 509 attached to the proximal end of dilator 503”) but fail to provide a specific avenue for achieving that attachment, which the proposed modification remedies.
Claim 14 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,426,565 B2, hereinafter known as the ‘565 patent, in view of Martin et al. (US PGPub 2012/0296275 A1) and Davies et al. (US PGPub 2014/0039315 A1), as applied to claim 1 above, and further in view of Kashkarov et al. (US PGPub 2009/0318951 A1).
Regarding claim 14, the ‘565 patent as modified by Martin et al. and Davies et al. fails to disclose wherein the distal tip is comprised of high density polyethylene, and wherein from about 20 percent to 50 percent of the distal tip is comprised of BaSO4 to facilitate imaging.
In the relevant field of blood filter delivery systems (abstract), which is pertinent to one of ordinary skill in the art because the reference also concerns itself with the use of a dilator (18 in Fig. 5) to enable access of a patient’s vasculature (PP [0084]: “Other components that may be used with the system include a catheter introducer 16, shown in FIG. 22, and a catheter dilator 18, shown in FIG. 25”), Kashkarov et al. teaches a dilator (18 in Fig. 25) wherein the entire dilator is comprised of high density polyethylene, and wherein from about 20 percent to 50 percent of the distal tip is comprised of BaSO4 to facilitate imaging (PP [0096]: “The dilator tube 18d may be formed from a variety of biocompatible flexible materials, such as polyurethane, polyethylene, polyamide, polyether block amide (PEBA), nylon, and combinations thereof, preferably from a HDPE/LLDPE blend of polymer and 18-20% of barium sulfate by weight, with the barium sulfate providing the radio-opaque functionality”, emphasis added).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have further modified the combination of the ‘565 patent, Martin et al., and Davies et al. to incorporate the teachings of Kashkarov et al. and include wherein the distal tip is comprised of high density polyethylene, and wherein from about 20 percent to 50 percent of the distal tip is comprised of BaSO4 to facilitate imaging. One of ordinary skill in the art would have been motivated to perform this modification since it has been held that that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists” (In re Wertheim , 541 F.2d 257, 191 USPQ 90 (CCPA1976); In re Woodruff , 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)). Furthermore, the applicant has placed no criticality on this range, stating only that the embodiment “typically” comprises about 20-50% BaSO4 (PP [0063]).
Claims 1-12 and 14-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 and 14-20 of U.S. Patent No. 12,128,199 B2, hereinafter known as the ‘199 patent, in view of Davies et al. (US PGPub 2014/0039315 A1). Claims 2-14 and 16-19 each depend from independent claims 1 and 15, inheriting the obviousness-type nonstatutory double patenting rejections of those independent claims, but the limitations of claims 2, 6, 9-13, and 16-19 are further disclosed by the ‘199 patent as mapped out below.
Claims
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With respect to claims 1, 15, and 20, the ‘199 patent discloses each of the limitations as claimed, yet fails to disclose wherein the distal tip comprises a secondary surface modification, the secondary surface modification comprising a divot formed on the tapered outer surface.
In the same field of dilators (abstract), Davies et al. teaches a medical device (30 in Fig. 1) comprising a distal end (PP [0011]: “FIG. 1 is a side view of the distal end of an embodiment of a medical device having cut out rings”), wherein the distal end comprises a secondary surface modification (22 and 24), the secondary surface modification (22 and 24) comprising divots formed on the outer surface (PP [0034]: “cut-out rings 22 proximal of aperture 20 and cut-out rings 24 distal of aperture 20”, see divots in Fig. 1).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the ‘199 patent to include divots along the distal end as taught by the Davies et al. reference. One of ordinary skill in the art would have been motivated to perform this modification in order to “increase the echogenicity” of the dilator (PP [0034]), enhancing its visibility in all directions when imaging the procedure with ultrasound. Placing the divots as taught by Davies et al. onto the distal taper of the ‘565 patent additionally would have been obvious to one of ordinary skill in the art since Davies et al. explicitly states that the divots are located on the distal-most end of the device (30). Such a modification would not have altered the main operating principle of the ‘199 patent, which contemplates alternative avenues for facilitating imaging (see col. 11, lines 4-24), but would have yielded predictable results since Davies et al. already contemplates placing divots in such a way as to maintain the structural integrity of a device where higher stresses are expected (such as on a tapered distal tip of a dilator, PP [0028]: “in areas where higher stresses are expected in use, smaller features are used. Embodiments of the present invention provide enhanced visibility of medical devices while maintaining the structural integrity of the devices to a greater extent relative to other devices with similar visibility enhancing features”).
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-8, 10, 15, and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Davies et al. (US PGPub 2007/0185522 A1) in view of Martin et al. (US PGPub 2012/0296275 A1) and Davies (US PGPub 2014/0039315 A1).
With respect to claim 1, Davies et al. discloses a hybrid dilator (102 in Fig. 5) for use with a crossing device (500) in tissue puncturing procedures (abstract), the hybrid dilator (102) comprising:
a dilator shaft (116 in Fig. 4) extending between a proximal end (end near 106) and a distal end (end near 107), the dilator shaft (116) having a lumen for receiving a crossing device (500) therethrough (PP [0025]: “the elongated member lumen comprises the tube lumen, plus the lumens defined by member proximal end section 103 and member distal end section 107”);
a distal tip (107) associated with the distal end (end near 107), the distal tip (107) having an outer diameter which tapers to an outer diameter of the crossing device (500 in Fig. 5, PP [0028]: “the distal end section 107 of the elongated member 102 tapers in a direction leading away from the middle section 105 of the elongated member 102”) for providing a smooth transition between the crossing device (500) and the distal tip (107) when the crossing device (500) is inserted through the lumen and protrudes beyond the distal tip (107); and
a hub (110) coupled to the dilator shaft (102) defining a lumen therethrough (see 500 with second hub 506 extending through 110 and 102 in Fig. 5).
However, Davies et al. fails to disclose wherein the hub has a side arm, or wherein the distal tip comprises a secondary surface modification, the secondary surface modification comprising a divot formed on the tapered outer surface.
In the same field of endeavor, namely dilators for enlarging apertures in a patient’s vasculature (PP [0004]), Martin et al. teaches a dilator (503 in Fig. 5) comprising a dilator shaft (see shaft of 503) and a hub (509) coupled to the dilator shaft (shaft of 503) defining a lumen therethrough (see lumen of 510 through 509 and connected to 505), wherein the hub (509) has a side arm (501 with connector 511).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Davies et al. device to further include a hub comprising a side arm as taught by the Martin et al. reference. One of ordinary skill in the art would have been motivated to perform this modification because doing so would have constituted the use of a known technique (the incorporation of a hub with a side arm on the proximal end of a dilator) to improve a similar device (the dilator of Davies et al.) ready for improvement to yield predictable results, since adding a hub comprising a side arm would not change the operation of the Davies et al. dilator and would simply enable a releasable connection to a syringe to inject fluid and flush the dilator lumen or to extract blood from the target vasculature as necessary (PP [0074] of Martin et al.), which would be desirable for the Davies et al. dilator which is configured to be “advanced… into and through the patient’s vasculature” (PP [0047] of Davies et al.).
However, Davies et al. as modified by Martin et al. further fails to disclose wherein the distal tip comprises a secondary surface modification, the secondary surface modification comprising a divot formed on the tapered outer surface.
In the same field of dilators (abstract), Davies et al. teaches a medical device (30 in Fig. 1) comprising a distal end (PP [0011]: “FIG. 1 is a side view of the distal end of an embodiment of a medical device having cut out rings”), wherein the distal end comprises a secondary surface modification (22 and 24), the secondary surface modification (22 and 24) comprising divots formed on the outer surface (PP [0034]: “cut-out rings 22 proximal of aperture 20 and cut-out rings 24 distal of aperture 20”, see divots in Fig. 1).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have further modified the combination of the ‘565 patent and Martin et al. to include divots along the distal end as taught by the Davies et al. reference. One of ordinary skill in the art would have been motivated to perform this modification in order to “increase the echogenicity” of the dilator (PP [0034]), enhancing its visibility in all directions when imaging the procedure with ultrasound. Placing the divots as taught by Davies et al. onto the distal taper of the ‘565 patent additionally would have been obvious to one of ordinary skill in the art since Davies et al. explicitly states that the divots are located on the distal-most end of the device (30). Such a modification would not have altered the main operating principle of the ‘565 patent, which contemplates alternative avenues for facilitating imaging (see col. 11, lines 4-24), but would have yielded predictable results since Davies et al. already contemplates placing divots in such a way as to maintain the structural integrity of a device where higher stresses are expected (such as on a tapered distal tip of a dilator, PP [0028]: “in areas where higher stresses are expected in use, smaller features are used. Embodiments of the present invention provide enhanced visibility of medical devices while maintaining the structural integrity of the devices to a greater extent relative to other devices with similar visibility enhancing features”).
Regarding claim 2, Davies et al. as modified by Martin et al. and Davies et al. further discloses wherein the dilator shaft (116 in Fig. 4) further comprises a distal end curvature (108).
Regarding claim 3, Davies et al. as modified by Martin et al. and Davies et al. further discloses wherein the side arm (501 with connector 511 in Fig. 5 of Martin et al.) provides an indication of the direction of the distal end curvature (108 in Fig. 5 of Davies et al., the combination as proposed would yield a side arm on the hub of Davies et al. which has a directionality relative to the distal end curvature which one of skill in the art could use to detect the direction of the distal end curvature).
Regarding claim 4, Davies et al. as modified by Martin et al. and Davies et al. further discloses wherein the side arm (501 with connector 511 in Fig. 5 of Martin et al.) is a pseudo side-port (when 501 with connector 511 is not being used to actively transport fluid, it is a pseudo side-port).
Regarding claim 5, Davies et al. as modified by Martin et al. and Davies et al. further discloses wherein the side arm (501 with connector 511 in Fig. 5 of Martin et al.) is a side-port (PP [0074]: “a tube 501 that includes a connector 511, such as a luer connector. Connection 511 may releasably connect to a device such as syringe 502, which may be used to inject fluid 507”).
Regarding claim 6, Davies et al. as modified by Martin et al. and Davies et al. further discloses wherein the dilator shaft (116 in Fig. 5 of Davies et al.) is structured to provide support for the crossing device (500) when the crossing device (500) is used to create a puncture in tissue (PP [0041]: “elongated member 102 may be structured to allow a device, for example an electrosurgical device 500, to be disposed therethrough”, the dilator shaft 116 supports the crossing device 500 as it travels through the lumen of the dilator 102).
Regarding claim 7, Davies et al. as modified by Martin et al. and Davies et al. further discloses wherein the hybrid dilator (102 in Fig. 4) further comprises a coupling (PP [0033]: “Hub 110 may be attached to elongated member 102 via a number of methods, such as the use of adhesives, friction fitting, crimping or by a screw-mechanism, for example. Furthermore, hub 110 may be detachable from elongated member 102, for example by un-screwing or by pressing or releasing a button and/or switch”) for providing strain relief between the hub (110) and dilator shaft (116).
Regarding claim 8, Davies et al. as modified by Martin et al. and Davies et al. fails to disclose wherein the side arm has an endpoint and the distance between the side arm endpoint and an opposing point on the hub is 28.39 mm.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Davies et al., Martin et al., and Davies et al. combination such that the side arm has an endpoint and the distance between the side arm endpoint and an opposing point on the hub is 28.39 mm because the hub 209 and side arm 211 of Martin et al. would not operate differently with the claimed distance between them, as the device of Martin et al. is intended for use in similar applications (Martin et al. PP [0003]: “in endovascular surgery, the dilator and the introducer sheath have radiopaque characteristics to aid in visualization of these items within the body”) and would be capable of accommodating the hub/side arm length as claimed. Furthermore, it has been held that a change in size is generally recognized as being within the level of ordinary skill in the art (In re Rose, 105 USPQ 237 (CCPA 1955), In Gardnerv.TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), see MPEP 2144.04), particularly since the applicant has placed no criticality on the claimed dimension, only stating the distance of 28.39 mm with no additional reasoning (see PP [0070] of present application).
Regarding claim 10, Davies et al. as modified by Martin et al. and Davies et al. further discloses wherein a distal portion of the distal tip (107 in Fig. 4) defines a distal internal diameter which is restricted to thereby control a distance by which a crossing device (500 in Fig. 5) with a narrow distal portion protrudes from the hybrid dilator (102, the restricted tapering internal diameter of 107 seen in Fig. 4 is configured to control a distance by which 500 extends from the dilator 102 because the narrowed taper is configured to abut a wider proximal end of a crossing device with a narrower distal portion).
With respect to claim 15, Davies et al. discloses a kit for puncturing a tissue (see Fig. 5, abstract: “positioning the member distal end section substantially adjacent the aperture while allowing for the transmission of substantially longitudinal forces from the member proximal end section to the member distal end section to enlarge the aperture by pushing, at least in part, the member distal end section through the aperture”) comprising:
a crossing device (500) having a puncturing feature (502, PP [0041]: “a wire or catheter structured to deliver energy, for example radiofrequency current, from its distal tip 502”); and
a hybrid dilator (102) having:
a dilator shaft (116 in Fig. 4) extending between a proximal end (end near 106) and a distal end (end near 107), the dilator shaft (116) having a lumen for receiving a crossing device (500) therethrough (PP [0025]: “the elongated member lumen comprises the tube lumen, plus the lumens defined by member proximal end section 103 and member distal end section 107”, see 500 extend through 102 in Fig. 5);
a distal tip (107) associated with the distal end (end near 107), the distal tip (107) having an outer diameter which tapers to an outer diameter of the crossing device (500 in Fig. 5, PP [0028]: “the distal end section 107 of the elongated member 102 tapers in a direction leading away from the middle section 105 of the elongated member 102”) for providing a smooth transition between the crossing device (500) and the distal tip (107) when the crossing device (500) is inserted through the lumen and protrudes beyond the distal tip (107); and
a hub (110) coupled to the dilator shaft (102) defining a lumen therethrough (see 500 with second hub 506 extending through 110 and 102 in Fig. 5).
However, Davies et al. fails to disclose wherein the hub has a side arm, or wherein the distal tip comprises a secondary surface modification, the secondary surface modification comprising a divot formed on the tapered outer surface.
In the same field of endeavor, namely dilators for enlarging apertures in a patient’s vasculature (PP [0004]), Martin et al. teaches a dilator (503 in Fig. 5) comprising a dilator shaft (see shaft of 503) and a hub (509) coupled to the dilator shaft (shaft of 503) defining a lumen therethrough (see lumen of 510 through 509 and connected to 505), wherein the hub (509) has a side arm (501 with connector 511).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Davies et al. device to further include a hub comprising a side arm as taught by the Martin et al. reference. One of ordinary skill in the art would have been motivated to perform this modification because doing so would have constituted the use of a known technique (the incorporation of a hub with a side arm on the proximal end of a dilator) to improve a similar device (the dilator of Davies et al.) ready for improvement to yield predictable results, since adding a hub comprising a side arm would not change the operation of the Davies et al. dilator and would simply enable a releasable connection to a syringe to inject fluid and flush the dilator lumen or to extract blood from the target vasculature as necessary (PP [0074] of Martin et al.), which would be desirable for the Davies et al. dilator which is configured to be “advanced… into and through the patient’s vasculature” (PP [0047] of Davies et al.).
However, Davies et al. as modified by Martin et al. further fails to disclose wherein the distal tip comprises a secondary surface modification, the secondary surface modification comprising a divot formed on the tapered outer surface.
In the same field of dilators (abstract), Davies et al. teaches a medical device (30 in Fig. 1) comprising a distal end (PP [0011]: “FIG. 1 is a side view of the distal end of an embodiment of a medical device having cut out rings”), wherein the distal end comprises a secondary surface modification (22 and 24), the secondary surface modification (22 and 24) comprising divots formed on the outer surface (PP [0034]: “cut-out rings 22 proximal of aperture 20 and cut-out rings 24 distal of aperture 20”, see divots in Fig. 1).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have further modified the combination of the ‘565 patent and Martin et al. to include divots along the distal end as taught by the Davies et al. reference. One of ordinary skill in the art would have been motivated to perform this modification in order to “increase the echogenicity” of the dilator (PP [0034]), enhancing its visibility in all directions when imaging the procedure with ultrasound. Placing the divots as taught by Davies et al. onto the distal taper of the ‘565 patent additionally would have been obvious to one of ordinary skill in the art since Davies et al. explicitly states that the divots are located on the distal-most end of the device (30). Such a modification would not have altered the main operating principle of the ‘565 patent, which contemplates alternative avenues for facilitating imaging (see col. 11, lines 4-24), but would have yielded predictable results since Davies et al. already contemplates placing divots in such a way as to maintain the structural integrity of a device where higher stresses are expected (such as on a tapered distal tip of a dilator, PP [0028]: “in areas where higher stresses are expected in use, smaller features are used. Embodiments of the present invention provide enhanced visibility of medical devices while maintaining the structural integrity of the devices to a greater extent relative to other devices with similar visibility enhancing features”).
Regarding claim 17, Davies et al. as modified by Martin et al. and Davies et al. further discloses wherein the crossing device (500 in Fig. 5 of Davies et al.) comprises an energy delivery device that is configured for delivering energy to the tissue to create a puncture in the tissue (PP [0041]: “a wire or catheter structured to deliver energy, for example radiofrequency current, from its distal tip 502”).
Regarding claim 18, Davies et al. as modified by Martin et al. and Davies et al. further discloses wherein the energy delivery device (500 in Fig. 5 of Davies et al.) comprises a radiofrequency needle (PP [0041]: “a wire or catheter structured to deliver energy, for example radiofrequency current, from its distal tip 502”).
Regarding claim 19, Davies et al. as modified by Martin et al. and Davies et al. further discloses wherein the energy delivery device (500 in Fig. 5 of Davies et al.) comprises a radiofrequency guidewire (PP [0041]: “a wire or catheter structured to deliver energy, for example radiofrequency current, from its distal tip 502”).
Regarding claim 20, Davies et al. discloses a system for puncturing a tissue (see Fig. 5, abstract: “positioning the member distal end section substantially adjacent the aperture while allowing for the transmission of substantially longitudinal forces from the member proximal end section to the member distal end section to enlarge the aperture by pushing, at least in part, the member distal end section through the aperture”) comprising:
a crossing device (500) having a puncturing feature (502) which is operable to deliver energy to a tissue (PP [0041]: “a wire or catheter structured to deliver energy, for example radiofrequency current, from its distal tip 502”);
an electrosurgical generator (510) which is operable to provide energy to the puncturing feature (PP [0041]: “one connector cable 508 may operatively connect electrosurgical probe 500 to a source of energy, such as generator 510”); and
a hybrid dilator (102) having:
a dilator shaft (116 in Fig. 4) extending between a proximal end (end near 106) and a distal end (end near 107), the dilator shaft (116) having a lumen for receiving a crossing device (500) therethrough (PP [0025]: “the elongated member lumen comprises the tube lumen, plus the lumens defined by member proximal end section 103 and member distal end section 107”, see 500 extend through 102 in Fig. 5);
a distal tip (107) associated with the distal end (end near 107), the distal tip (107) having an outer diameter which tapers to an outer diameter of the crossing device (500 in Fig. 5, PP [0028]: “the distal end section 107 of the elongated member 102 tapers in a direction leading away from the middle section 105 of the elongated member 102”) for providing a smooth transition between the crossing device (500) and the distal tip (107) when the crossing device (500) is inserted through the lumen and protrudes beyond the distal tip (107); and
a hub (110) coupled to the dilator shaft (102) defining a lumen therethrough (see 500 with second hub 506 extending through 110 and 102 in Fig. 5).
However, Davies et al. fails to disclose wherein the hub has a side arm, or wherein the distal tip comprises a secondary surface modification, the secondary surface modification comprising a divot formed on the tapered outer surface.
In the same field of endeavor, namely dilators for enlarging apertures in a patient’s vasculature (PP [0004]), Martin et al. teaches a dilator (503 in Fig. 5) comprising a dilator shaft (see shaft of 503) and a hub (509) coupled to the dilator shaft (shaft of 503) defining a lumen therethrough (see lumen of 510 through 509 and connected to 505), wherein the hub (509) has a side arm (501 with connector 511).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Davies et al. device to further include a hub comprising a side arm as taught by the Martin et al. reference. One of ordinary skill in the art would have been motivated to perform this modification because doing so would have constituted the use of a known technique (the incorporation of a hub with a side arm on the proximal end of a dilator) to improve a similar device (the dilator of Davies et al.) ready for improvement to yield predictable results, since adding a hub comprising a side arm would not change the operation of the Davies et al. dilator and would simply enable a releasable connection to a syringe to inject fluid and flush the dilator lumen or to extract blood from the target vasculature as necessary (PP [0074] of Martin et al.), which would be desirable for the Davies et al. dilator which is configured to be “advanced… into and through the patient’s vasculature” (PP [0047] of Davies et al.).
However, Davies et al. as modified by Martin et al. further fails to disclose wherein the distal tip comprises a secondary surface modification, the secondary surface modification comprising a divot formed on the tapered outer surface.
In the same field of dilators (abstract), Davies et al. teaches a medical device (30 in Fig. 1) comprising a distal end (PP [0011]: “FIG. 1 is a side view of the distal end of an embodiment of a medical device having cut out rings”), wherein the distal end comprises a secondary surface modification (22 and 24), the secondary surface modification (22 and 24) comprising divots formed on the outer surface (PP [0034]: “cut-out rings 22 proximal of aperture 20 and cut-out rings 24 distal of aperture 20”, see divots in Fig. 1).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have further modified the combination of the ‘565 patent and Martin et al. to include divots along the distal end as taught by the Davies et al. reference. One of ordinary skill in the art would have been motivated to perform this modification in order to “increase the echogenicity” of the dilator (PP [0034]), enhancing its visibility in all directions when imaging the procedure with ultrasound. Placing the divots as taught by Davies et al. onto the distal taper of the ‘565 patent additionally would have been obvious to one of ordinary skill in the art since Davies et al. explicitly states that the divots are located on the distal-most end of the device (30). Such a modification would not have altered the main operating principle of the ‘565 patent, which contemplates alternative avenues for facilitating imaging (see col. 11, lines 4-24), but would have yielded predictable results since Davies et al. already contemplates placing divots in such a way as to maintain the structural integrity of a device where higher stresses are expected (such as on a tapered distal tip of a dilator, PP [0028]: “in areas where higher stresses are expected in use, smaller features are used. Embodiments of the present invention provide enhanced visibility of medical devices while maintaining the structural integrity of the devices to a greater extent relative to other devices with similar visibility enhancing features”).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Davies et al. (US PGPub 2007/0185522 A1) in view of Martin et al. (US PGPub 2012/0296275 A1) and Davies et al. (US PGPub 2014/0039315 A1), as applied to claim 1 above, and further in view of Fischer et al. (US PGPub 2014/0343512 A1).
Regarding claim 9, Davies et al. as modified by Martin et al. and Davies et al. fails to disclose wherein the dilator shaft has an outer diameter from about 12 French to about 20 French.
In the same field of endovascular procedures involving dilators (see abstract and PP [0040]), Fischer et al. teaches that a common size for dilators deployed in such endovascular procedures ranges from 10 Fr to 20 Fr (PP [0040]: “It is common to have a range in size for such implements and medical devices from various small guidewires (0.01 inch diameter) to relatively large dilators and other implements (e.g., 10 French (F) to 20 F)”, emphasis added).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified combination as proposed according to the teachings of Fischer et al. to include wherein the dilator shaft has an outer diameter from about 12 French to about 20 French. One of ordinary skill in the art would have been motivated to perform this modification since it has been held that that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists” (In re Wertheim , 541 F.2d 257, 191 USPQ 90 (CCPA1976); In re Woodruff , 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)). Furthermore, the dilator of Davies et al. would not operate differently with the taught range of outer diameters since the dilator of Davies et al. is intended for use within the vasculature (PP [0047]: “In one embodiment, the target site, for example the atrial septum of the heart”) and since the present disclosure places no criticality on the range of outer diameters, stating only that “In some embodiments, the size of hybrid dilator 100 is from about 12 French to about 20 French” (PP [0037]).
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Davies et al. (US PGPub 2007/0185522 A1) in view of Martin et al. (US PGPub 2012/0296275 A1) and Davies et al. (US PGPub 2014/0039315 A1), as applied to claim 1 above, and further in view of Shimogami et al. (US PGPub 2010/0094258 A1).
Regarding claim 11, Davies et al. as modified by Martin et al. fails to disclose wherein the dilator shaft comprises an inner layer, an outer layer, and a torque layer therebetween.
In the same field of dilators for vascular procedures (PP [0005]: “the catheter has been preferably used for an operation of dilating a stenosis”), Shimogami et al. teaches a dilator shaft (11 in Fig. 1), wherein the dilator shaft (11) comprises an inner layer (32 in Fig. 3), an outer layer (28), and a torque layer (24 and 30) therebetween (PP [0034]: “the catheter body 11 includes a hollow coil 24, an inner resin layer 26 with which an inner peripheral surface of the coil 24 is coated, an outer resin layer 28 with which an outer peripheral surface of the coil 24 is coated, and a braid 30 embedded in the inner resin layer 26”, PP [0035]: “The inner resin layer 26 further includes an innermost layer 32 and a middle layer 34 arranged on the outer side of the innermost layer 32”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the combination as proposed to incorporate the teachings of Shimogami et al. and include the layers as claimed. One of ordinary skill in the art would have been motivated to perform this modification in order to improve torque transmission performance (Shimogami et al. PP [0010]) of the dilator in a variety of procedures (Shimogami et al. PP [0008]: “for advantageously carrying out various operations other than the CART approach”), which would be desirable for the Davies et al. device in improving rotatability and maneuverability while navigating torturous vasculature. Additionally, modifying the Davies et al. in this manner would not change the primary operating principle of the device, as the Shimogami et al. dilator is also contemplated to be used in the vasculature (PP [0064]: “The catheter 10 of this embodiment with the above-mentioned structure is used for dilation of a cardiac vessel”).
Regarding claim 12, Davies et al. as modified by Martin et al., Davies et al., and Shimogami et al. further discloses wherein the torque layer (24 and 30 in Fig. 2 of Shimogami et al.) is comprised of a braided material (PP [0039]: “the braid 30 axially extends from the distal end of the catheter body 11”).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Davies et al. (US PGPub 2007/0185522 A1) in view of Martin et al. (US PGPub 2012/0296275 A1) and Davies et al. (US PGPub 2014/0039315 A1), as applied to claim 1 above, and further in view of Kashkarov et al. (US PGPub 2009/0318951 A1).
Regarding claim 14, Davies et al. as modified by Martin et al. and Davies et al. fails to disclose wherein the distal tip is comprised of high density polyethylene, and wherein from about 20 percent to 50 percent of the distal tip is comprised of BaSO4 to facilitate imaging.
In the relevant field of blood filter delivery systems (abstract), which is pertinent to one of ordinary skill in the art because the reference also concerns itself with the use of a dilator (18 in Fig. 5) to enable access of a patient’s vasculature (PP [0084]: “Other components that may be used with the system include a catheter introducer 16, shown in FIG. 22, and a catheter dilator 18, shown in FIG. 25”), Kashkarov et al. teaches a dilator (18 in Fig. 25) wherein the entire dilator is comprised of high density polyethylene, and wherein from about 20 percent to 50 percent of the distal tip is comprised of BaSO4 to facilitate imaging (PP [0096]: “The dilator tube 18d may be formed from a variety of biocompatible flexible materials, such as polyurethane, polyethylene, polyamide, polyether block amide (PEBA), nylon, and combinations thereof, preferably from a HDPE/LLDPE blend of polymer and 18-20% of barium sulfate by weight, with the barium sulfate providing the radio-opaque functionality”, emphasis added).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have further modified the combination as proposed to incorporate the teachings of Kashkarov et al. and include wherein the distal tip is comprised of high density polyethylene, and wherein from about 20 percent to 50 percent of the distal tip is comprised of BaSO4 to facilitate imaging. One of ordinary skill in the art would have been motivated to perform this modification since doing so would not change the main operating principle of the Davies et al. device and further since it has been held that that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists” (In re Wertheim , 541 F.2d 257, 191 USPQ 90 (CCPA1976); In re Woodruff , 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)). Furthermore, the applicant has placed no criticality on this range, stating only that the embodiment “typically” comprises about 20-50% BaSO4 (PP [0063]).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Davies et al. (US PGPub 2007/0185522 A1) in view of Martin et al. (US PGPub 2012/0296275 A1) and Davies et al. (US PGPub 2014/0039315 A1), as applied to claim 15 above, and further in view of Bednarek et al. (US PGPub 2009/0171276 A1).
Regarding claim 16, Davies et al. as modified by Martin et al. and Davies et al. fails to disclose wherein the crossing device is a mechanical needle, since the crossing device of Davies et al. is an RF needle/wire (see PP [0041]).
In the same field of transseptal puncture devices comprising dilators (abstract), Bednarek et al. teaches a dilator (28 in Fig. 1) and a crossing device (26), wherein the crossing device is a mechanical needle (see needle tip 96 in Fig. 4, PP [0064]: “The distal end 92 of the inner needle tube 26 includes a needle tip 96 having the puncture tip leading edge 90 and a puncture tip trailing edge 98”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the combination as proposed to incorporate the teachings of Bednarek et al. and include wherein the crossing device is a mechanical needle. One of ordinary skill in the art would have been motivated to perform this modification because it is a simple substitution of crossing devices that would have yielded predictable results, as Davies et al. already contemplates the use of alternative crossing devices and other auxiliary devices (PP [0041]: “In other embodiments, further auxiliary devices may be included. For example, systems of the present invention may comprise visualization devices such as endoscopes, devices for measurement of blood pressure, or cooling devices. Any of the aforementioned devices may be packaged together in a kit”). Replacing the RF needle/wire shown in Fig. 5 of Davies et al. with the mechanical needle of Bednarek et al. would not have changed the operating principle of the device, particularly since the modification as proposed would constitute the use of a known technique (a mechanical needle in combination with a dilator for puncturing a target tissue) to improve a similar device (the combination of Davies et al. and Martin et al.) in the same way to yield predictable results.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/BRIDGET E. RABAGLIA/Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771
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