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
This Office Action is a response to applicant’s arguments and amendment filed 08/28/2025. Claims 17, 30 and 34 are amended. Claims 1-16 and 33 are cancelled. Claim 37 is new. Claims 17-32 and 34-37 are currently pending.
Response to Arguments
Applicant’s arguments, see Remarks, filed 08/28/2025, with respect to the rejection(s) of claim(s) 17-21 and 24-36 under 35 U.S.C. 103 as being unpatentable over Wu in view of Thielen; and claims 22-23 under 35 U.S.C. 103 as being unpatentable over Wu in view of Thielen and Muni, have been fully considered but are not persuasive. The rejection has been modified, necessitated by applicant’s amendment to the claims.
Applicant argues Thielen discloses a perfusion balloon that explicitly requires length reduction during expansion and teaches away from non-foreshortening configurations; the proposed combination of Wu and Thielen is improper because Thielen teaches away from the proposed combination; the combination renders Thielen unsatisfactory for its intended purpose; and the combination does not teach the new claim limitations (Remarks, pgs. 6-10).
In response to applicant’s argument, it is respectfully submitted one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references (MPEP 2145(IV)). As discussed in the rejection below, Wu discloses the inflatable balloon including proximal and distal attachment points, but is silent to the specific spacing of the balloon during expansion. Applicant argues that Thielen explicitly requires length reduction, however this is inaccurate, as para. [0047] of Thielen explicitly states the length of the balloon may be constant or change during inflation. Therefore, the arguments are narrower than the claim limitations, because Thielen does not teach away from the balloon maintaining its length during inflation, and instead teaches multiple configurations of the balloon in which its length may remain constant or change. Further, applicant argues the combination renders Thielen unsatisfactory for its intended purpose, however, Thielen is not the base reference. Wu is the base reference, to which Thielen is initially relied upon to teach the benefit of a pass-through lumen in the balloon of Wu, and is further relied upon to teach the length of the balloon remaining constant during inflation, as discussed below. Since applicant has not described how the modification of Wu would not be obvious, the claims remain rejected.
Applicant’s arguments with respect to claim 37 have been fully considered, and new claim 37 has been rejected as discussed below.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 37 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 37, the claim recites “wherein the inflatable balloon includes a self-regulating pressure mechanism, the method further comprising automatically adjusting an inflation pressure of the balloon via the self-regulating pressure mechanism to maintain contact with the stenotic region without exceeding a predetermined threshold to prevent tissue damage”. Para. [0035] of the published application describes the physician inflating balloon 30 to a desired pressure, and the balloon being inflated and deflated multiple times to sufficiently dilate the stenotic region. Para. [0046] further describes repeated inflation/deflation steps performed at the same or different pressures, and the balloon possibly being left in an inflated state. However, the instant spec. fails to specifically describe a self-regulating pressure mechanism which automatically adjusts an inflation pressure of the balloon. In contrast, the instant spec. states the physician inflates the balloon to a desired pressure, and is silent to any automatic adjustment of the inflation pressure. The instant spec. does describe repeated inflation and deflation, but this is not equivalent to automatic adjustment via a self-regulating pressure mechanism as claimed.
Therefore, claim 37 contains new matter, because the written description fails to provide adequate support for the balloon including a self-regulating pressure mechanism as claimed.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claim(s) 17-21, 24-32 and 34-37 are rejected under 35 U.S.C. 103 as being unpatentable over Wu (US 2014/0277058 A1) in view of Thielen (US 2011/0264039 A1) (all references previously of record).
Regarding claim 17, Wu discloses (see abstract; paras. [0027]-[0057]; figs. 1-16) a method for dilating a stenotic region in an airway of a patient (paras. [0041]-[0044]), the method comprising:
(a) advancing a distal portion of a catheter shaft (12, para. [0030]) of a dilation catheter (10) through the mouth of the patient and into the airway of the patient (para. [0042]), the dilation catheter including an inflatable balloon (18) operatively coupled with the distal portion of the catheter shaft (fig. 1) at proximal and distal attachment points of the catheter shaft (depicted in fig. 1, Wu also describes balloon attached to distal end of shaft, para. [0030]), the inflatable balloon being configured to transition between non-expanded and expanded configurations (collapsed and expanded states, para. [0028]), the inflatable balloon reaching the stenotic region in the non-expanded configuration (unexpanded during placement and advancement, para. [0042]);
(b) inflating the inflatable balloon from the non-expanded configuration to the expanded configuration so that an outer perimeter of the inflatable balloon contacts the stenotic region of the airway (inflated to dilate stenotic region, para. [0042]), and a shaft lumen (inner lumen of shaft 12, para. [0030]) defined by the catheter shaft (fig. 1);
(c) deflating the inflatable balloon so that the outer perimeter of the inflatable balloon does not contact the stenotic region of the airway (balloon deflated to enable removal from airway, see fig. 3a depicting collapsed configuration of balloon, which balloon is considered to enter upon deflation, para. [0042]); and
(d) withdrawing the dilation catheter from the stenotic region of the airway (removal from airway, paras. [0042]-[0043]).
However, Wu fails to disclose the inflatable balloon being configured to transition between non-expanded and expanded configurations while maintaining a constant spacing between the proximal and distal attachment points of the catheter shaft, the inflatable balloon including a pass-through lumen that allows air to pass therethrough while the inflatable balloon is in the expanded configuration, the pass-through lumen being disposed completely within the outer perimeter of the inflatable balloon and being not concentric with the shaft lumen defined by the catheter shaft.
Thielen teaches (para. [0047]), in the same field of endeavor, a method for dilating a stenotic region in an airway (abstract, para. [0003]) comprising an inflatable balloon (10, para. [0037]) which has a length that can remain constant during expansion, in place of the length of the balloon changing or reducing in length (para. [0047]).
The substitution of one known element (the length of the balloon remaining constant) for another (the length of the balloon changing, para. [0047] of Thielen) would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, since the substitution of the length of the balloon remaining constant as taught by Thielen, such that the balloon maintains constant spacing between proximal and distal attachment points to the catheter shaft, would have yielded predictable results, specifically, providing an inflatable balloon which can maintain its position within an airway when inflated.
Wu (as modified) still fails to teach the inflatable balloon including a pass-through lumen that allows air to pass therethrough while the inflatable balloon is in the expanded configuration, the pass-through lumen being disposed completely within the outer perimeter of the inflatable balloon and being not concentric with the shaft lumen defined by the catheter shaft.
Thielen teaches (paras. [0006], [0012], [0037] and [0042]-[0046]; figs. 1a-b), in the same field of endeavor, a method for dilating a stenotic region in an airway (abstract, para. [0003]), comprising an inflatable balloon (10, para. [0037]) including a pass-through lumen (25) that allows air to pass therethrough while the inflatable balloon is in an expanded configuration (paras. [0006] and [0046]; figs. 1a-b), the pass-through lumen being disposed completely within the outer perimeter of the inflatable balloon (figs. 1a-b) and being not concentric (figs. 1a-b) with a shaft lumen (90, para. [0043]) defined by a catheter shaft (92, fig. 1a), for the purpose of providing the necessary oxygen delivery to the body tissues during use, minimizing damage to tissue during prolonged dilating procedures (paras. [0006] and [0012]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the balloon of Wu (as modified) to include a pass-through lumen as arranged in Thielen, in order to provide the necessary oxygen delivery to body tissues during use, minimizing damage to tissue during prolonged dilating procedures, based on the teachings of Thielen (paras. [0006] and [0012]).
Regarding claim 18, Wu (as modified) teaches the method of claim 17. Wu (as modified) further teaches the inflatable balloon including inner (inner wall of balloon, fig. 1a of Thielen) and outer walls (outer wall of balloon, fig. 1a of Thielen), the outer wall defining the outer perimeter (considered to define outer perimeter of balloon), and the inner wall defining the pass-through lumen (figs. 1a-b of Thielen) that allows air to pass therethrough while the inflatable balloon is in the expanded configuration (paras. [0006] and [0046] of Thielen).
Regarding claim 19, Wu (as modified) teaches the method of claim 17. Wu further discloses steps (b) and (c) being performed at least twice (inflation and deflation may be repeated, encompasses performing steps at least twice, paras. [0028], [0033] and [0044]).
Regarding claim 20, Wu (as modified) teaches the method of claim 17. Wu further discloses advancing the distal portion of the catheter shaft of the dilation catheter further including advancing the distal portion of the catheter shaft of the dilation catheter with a stylet (22, para. [0028]) disposed at least partially within the shaft lumen (fig. 1), and withdrawing the dilation catheter further comprising withdrawing the dilation catheter and the stylet from the stenotic region of the airway together or separately (para. [0043]).
Regarding claim 21, Wu (as modified) teaches the method of claim 20. Wu further discloses the stylet having a first column strength (column strength of stylet 22), the catheter shaft having a second column strength less than the first column strength of the stylet (shaft 12 considered to have less column strength, since stylet 22 provides added column strength to the balloon catheter, paras. [0028] and [0043]).
Regarding claim 24, Wu (as modified) teaches the method of claim 20. Wu further discloses a distal portion of the stylet including a preformed bend (34, para. [0036]; fig. 2) or a malleable bend, the preformed bend or the malleable bend being configured to be sufficiently rigid to bend the dilation catheter during the act of advancing the distal portion of the catheter shaft of the dilation catheter (para. [0036]).
Regarding claim 25, Wu (as modified) teaches the method of claim 17. Wu further discloses the airway including a larynx (paras. [0001]-[0003]).
Regarding claim 26, Wu (as modified) teaches the method of claim 25. Wu further discloses the patient including an adult patient (paras. [0002] and [0031]).
Regarding claim 27, Wu (as modified) teaches the method of claim 17. Wu further discloses the airway including a trachea (paras. [0002]-[0003]).
Regarding claim 28, Wu (as modified) teaches the method of claim 27. Wu further discloses the patient including an adult patient (paras. [0002] and [0031]).
Regarding claim 29, Wu (as modified) teaches the method of claim 17. Wu further discloses inflating the inflatable balloon including dilating the stenotic region of the airway (para. [0042]).
Regarding claim 37, Wu (as modified) teaches the method of claim 17.
However, Wu (as modified) fails to teach wherein the inflatable balloon includes a self- regulating pressure mechanism, the method further comprising automatically adjusting an inflation pressure of the balloon via the self-regulating pressure mechanism to maintain contact with the stenotic region without exceeding a predetermined threshold to prevent tissue damage.
Thielen teaches (para. [0078]), in the same field of endeavor, a method for dilating a stenotic region in an airway of a patient (abstract, para. [0003]) comprising a self- regulating pressure mechanism (240), the method further comprising automatically adjusting an inflation pressure of the balloon via the self-regulating pressure mechanism (automatically adjusted via cycle frequency) to maintain contact with the stenotic region without exceeding a predetermined threshold to prevent tissue damage (creates fractures in material, para. [0018]), for the purpose of providing improved expansion to calcified or fibrotic tissue by providing pressure pulses in rapid succession (paras. [0018] and [0078]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Wu (as modified) to further include a self-regulating pressure mechanism of the balloon, and automatically adjusting the inflation pressure of the balloon, in order to provide improved expansion to calcified or fibrotic tissue by providing pressure pulses in rapid succession, based on the teachings of Thielen (paras. [0018] and [0078]).
Regarding claim 30, Wu discloses (see abstract; paras. [0027]-[0057]; figs. 1-16) a method for dilating a stenotic region in an airway of a patient (paras. [0041]-[0044]), the method comprising:
(a) advancing a distal portion of a catheter shaft (12, para. [0030]) of a dilation catheter (10) into the airway of the patient (para. [0042]) while an inflatable balloon (18) of the dilation catheter is in a non-expanded configuration (unexpanded during placement and advancement, para. [0042]), the catheter shaft extending along a first longitudinal axis (fig. 1), the dilation catheter including the inflatable balloon operatively coupled with the distal portion of the catheter shaft at proximal and distal attachment points of the catheter shaft (depicted in fig. 1, Wu also describes balloon attached to distal end of shaft, para. [0030]);
(b) arresting advancement of the distal portion of the catheter shaft when the inflatable balloon of the dilation catheter reaches the stenotic region of the airway (considered to be arrested when positioned, para. [0042]);
(c) inflating the inflatable balloon from the non-expanded configuration to an expanded configuration so that an outer perimeter of the inflatable balloon engages the stenotic region of the airway and thereby dilates the stenotic region of the airway (inflated to dilate stenotic region, para. [0042]);
(e) deflating the inflatable balloon so that the outer perimeter of the inflatable balloon disengages the stenotic region of the airway (balloon deflated to enable removal from airway, see fig. 3a depicting collapsed configuration of balloon, which balloon is considered to enter upon deflation, para. [0042]); and
(f) withdrawing the dilation catheter from the stenotic region of the airway (removal from airway, paras. [0042]-[0043]).
However, Wu fails to disclose the inflatable balloon being configured to transition between non-expanded and expanded configurations while maintaining a constant spacing between the proximal and distal attachment points of the catheter shaft; and (d) allowing air within the airway to pass through a pass-through lumen of the inflatable balloon while the inflatable balloon is in the expanded configuration, the pass-through lumen being disposed completely within the outer perimeter of the inflatable balloon and extending along a second longitudinal axis that is laterally offset from the first longitudinal axis.
Thielen teaches (para. [0047]), in the same field of endeavor, a method for dilating a stenotic region in an airway (abstract, para. [0003]) comprising an inflatable balloon (10, para. [0037]) which has a length that can remain constant during expansion, in place of the length of the balloon changing or reducing in length (para. [0047]).
The substitution of one known element (the length of the balloon remaining constant) for another (the length of the balloon changing, para. [0047] of Thielen) would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, since the substitution of the length of the balloon remaining constant as taught by Thielen, such that the balloon maintains constant spacing between proximal and distal attachment points to the catheter shaft, would have yielded predictable results, specifically, providing an inflatable balloon which can maintain its position within an airway when inflated.
Wu (as modified) still fails to teach (d) allowing air within the airway to pass through a pass-through lumen of the inflatable balloon while the inflatable balloon is in the expanded configuration, the pass-through lumen being disposed completely within the outer perimeter of the inflatable balloon and extending along a second longitudinal axis that is laterally offset from the first longitudinal axis.
Thielen teaches (paras. [0006], [0012], [0037] and [0042]-[0046]; figs. 1a-b), in the same field of endeavor, a method for dilating a stenotic region in an airway (abstract, para. [0003]), comprising an inflatable balloon (10, para. [0037]) including a pass-through lumen (25), and a catheter shaft (92) extending along a first longitudinal axis (fig. 1a), and allowing air within the airway to pass through the pass-through lumen of the inflatable balloon while the inflatable balloon is in an expanded configuration (paras. [0006] and [0046]; figs. 1a-b), the pass-through lumen being disposed completely within the outer perimeter of the inflatable balloon (figs. 1a-b) and extending along a second longitudinal axis that is laterally offset from the first longitudinal axis (figs. 1a-b), for the purpose of providing the necessary oxygen delivery to the body tissues during use, minimizing damage to tissue during prolonged dilating procedures (paras. [0006] and [0012]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the balloon of Wu (as modified) to include a pass-through lumen as arranged in Thielen, in order to provide the necessary oxygen delivery to body tissues during use, minimizing damage to tissue during prolonged dilating procedures, based on the teachings of Thielen (paras. [0006] and [0012]).
Regarding claim 31, Wu (as modified) teaches the method of claim 30. Wu further discloses advancing the distal portion of the catheter shaft including advancing the distal portion of the catheter shaft through the mouth of the patient (para. [0042]).
Regarding claim 32, Wu (as modified) teaches the method of claim 30. Wu further discloses the airway including at least one of a larynx or a trachea (paras. [0001]-[0003]).
Regarding claim 34, Wu discloses (see abstract; paras. [0027]-[0057]; figs. 1-16) a method for dilating a stenotic region in an airway of a patient (paras. [0041]-[0044]), the method comprising:
(a) advancing a distal portion of a catheter shaft (12, para. [0030]) of a dilation catheter (10) into the airway of the patient (para. [0042]) while an inflatable balloon (18) of the dilation catheter is in a non-expanded configuration (unexpanded during placement and advancement, para. [0042]), the catheter shaft extending along a first longitudinal axis (fig. 1), the dilation catheter including the inflatable balloon operatively coupled with the distal portion of the catheter shaft at proximal and distal attachment points of the catheter shaft (depicted in fig. 1, Wu also describes balloon attached to distal end of shaft, para. [0030]);
(b) arresting advancement of the distal portion of the catheter shaft when the inflatable balloon of the dilation catheter reaches the stenotic region of the airway (considered to be arrested when positioned, para. [0042]);
(c) communicating an inflation fluid (para. [0030]) through an inflation lumen (37) of the catheter shaft (para. [0030]) to an inflation volume of the inflatable balloon to inflate the inflatable balloon from the non-expanded configuration to an expanded configuration (paras. [0030] and [0042]) so that an outer perimeter of the inflatable balloon engages the stenotic region of the airway and thereby dilates the stenotic region of the airway (inflated to dilate stenotic region, para. [0042]);
(e) deflating the inflatable balloon so that the outer perimeter of the inflatable balloon disengages the stenotic region of the airway (balloon deflated to enable removal from airway, see fig. 3a depicting collapsed configuration of balloon, which balloon is considered to enter upon deflation, para. [0042]); and
(f) withdrawing the dilation catheter from the stenotic region of the airway (removal from airway, paras. [0042]-[0043]).
However, Wu fails to disclose the inflatable balloon being configured to transition between non-expanded and expanded configurations while maintaining a constant spacing between the proximal and distal attachment points of the catheter shaft; and (d) allowing air within the airway to pass through a pass-through lumen of the inflatable balloon while the inflatable balloon is in the expanded configuration, the pass-through lumen being in fluid isolation relative to the inflation volume and extending along a second longitudinal axis that is laterally offset from the first longitudinal axis.
Thielen teaches (para. [0047]), in the same field of endeavor, a method for dilating a stenotic region in an airway (abstract, para. [0003]) comprising an inflatable balloon (10, para. [0037]) which has a length that can remain constant during expansion, in place of the length of the balloon changing or reducing in length (para. [0047]).
The substitution of one known element (the length of the balloon remaining constant) for another (the length of the balloon changing, para. [0047] of Thielen) would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, since the substitution of the length of the balloon remaining constant as taught by Thielen, such that the balloon maintains constant spacing between proximal and distal attachment points to the catheter shaft, would have yielded predictable results, specifically, providing an inflatable balloon which can maintain its position within an airway when inflated.
Wu (as modified) still fails to teach (d) allowing air within the airway to pass through a pass-through lumen of the inflatable balloon while the inflatable balloon is in the expanded configuration, the pass-through lumen being in fluid isolation relative to the inflation volume and extending along a second longitudinal axis that is laterally offset from the first longitudinal axis.
Thielen teaches (paras. [0006], [0012], [0037] and [0042]-[0046]; figs. 1a-b), in the same field of endeavor, a method for dilating a stenotic region in an airway (abstract, para. [0003]), comprising an inflatable balloon (10, para. [0037]) including a pass-through lumen (25), and a catheter shaft (92) extending along a first longitudinal axis (fig. 1a), and allowing air within the airway to pass through the pass-through lumen of the inflatable balloon while the inflatable balloon is in an expanded configuration (paras. [0006] and [0046]; figs. 1a-b), the pass-through lumen being in fluid isolation relative to an inflation volume of the balloon (para. [0043]; fig. 1a) and extending along a second longitudinal axis that is laterally offset from the first longitudinal axis (figs. 1a-b), for the purpose of providing the necessary oxygen delivery to the body tissues during use, minimizing damage to tissue during prolonged dilating procedures (paras. [0006] and [0012]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the balloon of Wu (as modified) to include a pass-through lumen as arranged in Thielen, in order to provide the necessary oxygen delivery to body tissues during use, minimizing damage to tissue during prolonged dilating procedures, based on the teachings of Thielen (paras. [0006] and [0012]).
Regarding claim 35, Wu (as modified) teaches the method of claim 34. Wu further discloses the airway including at least one of a larynx or a trachea (paras. [0001]-[0003]).
Regarding claim 36, Wu (as modified) teaches the method of claim 35. Wu further discloses the patient including an adult patient (paras. [0002] and [0031]).
Claim(s) 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Wu in view of Thielen as applied to claim 20 above, and further in view of Muni (US 2010/0168511 A1).
Regarding claim 22, Wu (as modified) teaches the method of claim 20.
However, Wu (as modified) fails to teach the catheter shaft defining a stop element configured to prevent the stylet from extending distally beyond the stop element.
Muni teaches (paras. [0061]-[0062]; figs. 7a-b), in the same field of endeavor, a method for dilating a stenotic region in an airway of a patient (abstract) comprising a catheter shaft (84) defining a stop element (sealed distal end) configured to prevent the stylet from extending distally beyond the stop element (para. [0062]), for the purpose of preventing the stylet from extending beyond the distal end and allowing direct visualization of the stenotic region (para. [0062]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter shaft of Wu (as modified) to define a stop element, in order to prevent the stylet from extending beyond the distal end of the catheter shaft, allowing direct visualization or unhindered visualization of the stenotic region when desired, based on the suggestions and teachings of Muni (para. [0062]).
Regarding claim 23, Wu (as modified) teaches the method of claim 22. Wu (as modified) further teaches the stop element including a completely enclosed atraumatic distal tip (considered to be completely enclosed due to seal and atraumatic due to distal end of stylet and catheter shaft disclosed as atraumatic, para. [0037] of Wu, paras. [0042], [0044], [0059] and [0064] of Muni).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIGID K BYRD whose telephone number is (571)272-7698. The examiner can normally be reached Mon-Fri 8:00-5:00.
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/BRIGID K BYRD/Examiner, Art Unit 3771