DETAILED ACTION
Note: The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s arguments filed in the reply on February 9, 2026 were received and fully considered. Claims 17-20, 24, 25, 27, and 29 were amended. Claim 26 was cancelled. The current action is FINAL. Please see correspond rejection headings and response to arguments section below for more detail.
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 17, 19-28, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Yassinzadeh et al. (US PG Pub. No. 2005/0267522 A1) (hereinafter “Yassinzadeh”).
Yassinzadeh was applied in the previous office action.
With respect to claim 17, Yassinzadeh teaches a method for producing sealed access to an interior of a vessel of an animal or human body using a sheath assembly, the method comprising: inserting a base sheath of the sheath assembly into a vessel aperture of the vessel, the base sheath having a tubular body with a distal end and a proximal end (abstract “percutaneous access and closure of vascular puncture sites”; flexible tubular body 25 is inserted into a vessel aperture, as depicted in Figs. 1-8), the tubular body defining a pass-through channel that is open from the distal end to the proximal end of the tubular body, wherein the pass-through channel has an inner diameter configured to receive a catheter such that the catheter extends through the pass-through channel and into the interior of the vessel when the base sheath is within the vessel (flexible tubular member 25 has a pass-through channel that allows catheter 11 to extend through so as to access vessel 43; see Figs. 1-8); and increasing an outer diameter of the sheath assembly in a region of the vessel aperture by actuating an expansion device of the sheath assembly such that a portion of the sheath assembly contacts the vessel aperture to close and seal the vessel aperture thereby providing sealed access to the interior of the vessel (par.0043 “expansible occlusion member 14 is disposed on the distal end 12 of the tubular member 11”; par.0045 “When deployed, the expansible member 14 in an expanded state has a diameter in a range from about 3 mm to about 15 mm, preferably from about 4 mm to about 7 mm, as shown in FIGS. 3B and 4B”; par.0050 “expansible member 14 can exert against a vessel wall at the puncture site primarily depends on the diameter”; see also Figs. 3B and 4B, which depict increasing an outer diameter of the sheath assembly via member 14).
Although Yassinzadeh does not explicitly teach wherein the outer diameter of the sheath assembly is increased while the base sheath disposed through the vessel aperture and in a stationary position in the vessel, such a modification would have been prima facie obvious to person having ordinary skill in the art (“PHOSITA”) when the invention was filed for several reasons. Mainly, Yassinzadeh suggests that base sheath 11 can be manipulated with respect to the puncture site in ways that would include for stationary placement in the vessel, as depicted in other embodiments (see Fig. 8). Additionally, Yassinzadeh suggests, in other embodiments, utilizing locking features in order to maintain the assembly in a desired state. (see par.0048 “locking mechanism may be beneficial to greatly reduce the chances of parts 19 and 20 slipping relative to each other causing unintended retraction”). Therefore, further modifying Yassinzadeh such that the base sheath remains in place and/or locked while the outer diameter of the sheath assembly is increased (via expansible occlusion member 14) would only involve routine skill in the art.
With respect to claim 19, Yassinzadeh teaches fixing the sheath assembly to the animal or human body after inserting the base sheath of the sheath assembly into the vessel aperture (Figs. 1-8; par.0060).
With respect to claim 20, Yassinzadeh teaches wherein the fixing comprises stitching a fixation element of the sheath assembly to the animal or human body (par.0060 “Clip 50… to secure”).
With respect to claim 21, Yassinzadeh teaches wherein the sheath assembly includes a sleeve that encases the base sheath and the expansion device such that the sleeve contacts the vessel aperture when the outer diameter is increased and the sheath assembly is in the stationary position (par.0064 “preferably be fully covered… sufficient to cover the expansible member”).
With respect to claim 22, Yassinzadeh teaches wherein the expansion device is an expansion sheath that is disposed over an exterior of the tubular body of the base sheath and the expansion sheath is configured to be displaceable over the exterior of the tubular body and along a length of the tubular body and to increase the outer diameter of the sheath assembly (par.0043 “expansible member id disposed on the distal end 12 of tubular member 11”; see Figs. 1-8).
With respect to claim 23, Yassinzadeh does not explicitly teach wherein the expansion device is an inflation tube that is spirally wound around the base sheath, wherein the inflation tube is inflatable to increase the outer diameter of the sheath assembly. However, Yassinzadeh, in other embodiments, suggests utilizing tension coil springs 26 in concert with expansible member 14 (see par.0049-50). Therefore, PHOSITA would have had predictable success when the invention was filed utilizing an inflation tube that is spirally wound as this would be a simple substitution that would achieve the same end result, i.e. allow for sealing an occlusion device at a puncture site in an alternative manner. Examiner also takes official notice that utilizing inflation tubes that is spirally wound around a base sheath is widely known in the art.
With respect to claim 24, Yassinzadeh teaches wherein the expansion device includes a flexible portion that forms a part of the tubular body of the base sheath between the proximal end and the distal end, the flexible portion is configured to radially expand to increase the outer diameter of the sheath assembly when the distal end of the tubular body is pulled in a direction of the proximal end by a pulling means (par.0046 “expansible member 14 comprises a pull type”; see also par.0061).
With respect to claim 25, Yassinzadeh teaches wherein the expansion device includes a stretchable portion that forms a part of the tubular body of the base sheath between the proximal end and the distal end, the stretchable portion is configured to attain a first thickness in a stretched condition and a second thickness, which is larger than the first thickness, in an unstretched condition when the proximal end of the tubular body is released in a direction of the vessel aperture from the stretched condition to the unstretched condition to increase the outer diameter of the sheath assembly (par.0044, 0053, 0057-59).
With respect to claim 27, Yassinzadeh teaches wherein the pass-through channel of the base sheath is configured such that the catheter is axially displaceable through the pass-through channel of the base sheath independently of the base sheath and expansion device when the sheath assembly is within the vessel (par.0020 “may be displaced at a predetermined distance to effect a predetermined transitional tension onto the expansible member”; see also Figs. 1-8).
With respect to claim 28, Yassinzadeh teaches wherein a wall of the tubular body of the base sheath has a second channel extending in the wall from the distal end toward the proximal end (par.0049).
With respect to claim 30, Yassinzadeh does not explicitly teach wherein the expansion device is configured to increase the outer diameter of the sheath assembly by 0.33 mm to 1.00 mm. However, such a modification would have been prima facie obvious to PHOSITA when the invention was filed since it has been held that where the general conditions of a claim are disclosed in the prior art (see Yassinzadeh, par.0045 “expansible member 13… diameter… preferably less than about 1.5 mm”), discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claims 18 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Yassinzadeh in view of Lewinsky et. al. (WO 2004/062526 A2) (hereinafter “Lewinsky”).
Lewinsky was applied in the previous office action.
With respect to claims 18 and 29, Yassinzadeh teaches a method for producing sealed access to the interior of a vessel of an animal or human body by means of a sheath assembly, as established above. Yassinzadeh also suggests providing hemostasis at vascular puncture sites by sealing the puncture site (par.0003+).
However, Yassinzadeh does not explicitly teach the limitations further recited in claims 18 and 29.
Regarding claim 18, Lewinsky teaches determining a pressure that is applied to the vessel aperture to determine an increase of the outer diameter of the sheath assembly to provide hemostasis (pg. 4 line 26 – pg. 5 line 12).
Regarding claim 29, Lewinsky teaches wherein the second channel is configured to conduct blood from the vessel to the proximal end of the tubular body when the base sheath is inserted into the vessel (pg. 4 line 26 – pg. 5 line 12).
Therefore, it would have been prima facie obvious to PHOSITA when the invention was filed to modify Yassinzadeh to further incorporate a pressure sensor and allowing for conducting of blood at the puncture site in order to distinguish between standard plaque and vulnerable plaque in a blood vessel, as evidence by Lewinsky (pg. 4 line 26 – pg. 5 line 12).
Response to Arguments
Applicant’s arguments filed with respect to the 35 USC 112B rejections raised in the previous office action were persuasive in view of amendment. Therefore, these rejections are withdrawn from consideration.
Applicant's arguments filed with respect to the prior art rejections raised in the previous office action have been fully considered, but they are not persuasive. Upon further consideration, and as necessitated by amendment, Examiner maintains that Yassinzadeh renders obvious the claimed invention. Specifically, Examiner now interprets that Yassinzadeh’s flexible tubular member 25 which allows for catheter to advance therethrough so as to access a vessel equates to the claimed “base sheath having a tubular body… to receive a catheter such that the catheter extends through… and into the interior of the vessel”, as set forth in amended claim 17. Please see prior art section above for updated citations.
Applicant’s arguments filed with respect to the double patenting rejections raised in the previous office action were persuasive. Therefore, the double patenting rejections are withdrawn.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PUYA AGAHI whose telephone number is (571)270-1906. The examiner can normally be reached M-F 8 AM - 5 PM.
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/PUYA AGAHI/Primary Examiner, Art Unit 3791
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