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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “dilator” as recited in claims 3 and 14 (in addition to the “tubular device” or “device” where the guidewire control device is on a handle of the dilator and on the tubular device or device) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 7-11, 16, 17 and 19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claims 7, 16 and 19 recite the limitation "the handle". There is insufficient antecedent basis for this limitation in the claim. Claims 8-11 are rejected due to their dependence from claim 7. Claim 17 is rejected due to its dependence from claim 16.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-6, 12-15, 18 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schaeffer (US 2005/0245847).
Regarding claim 1, Schaeffer discloses a system (Figures 1 and 2) for deployment of a pre-loaded guidewire (17) for access to a heart (Abstract - capable of providing access to a heart), the system comprising: a tubular device (20/11 or 11 - noting that in view of claims 3 and 4, a handle can be considered as part of the tubular device or a separate device) comprising an elongated body (13 or 12/13) having a body length, a proximal end and a distal end portion terminating in a distal tip, a lumen extending through the elongated body and being dimensioned to slidingly receive the pre-loaded guidewire (evident from ¶[0021] and [0028]); and a guidewire control device (32 or 32/62) positioned on the device (it is positioned on member 20 which can be considered as part of the tubular device, or alternatively, it is positioned “on” member 13 or 12/13 inasmuch as Applicant’s guidewire control device 270, 372 or 474 is positioned on member 220, 320 or 420 - noting that in view of claim 3, the handle is not claimed as part of the tubular device but is claimed as part of the device in claim 4), physically communicating with the pre-loaded guidewire and controlling the lateral movement of the pre-loaded guidewire within the lumen; wherein the pre-loaded guidewire includes an untriggered state and a triggered state, and wherein in the triggered state the pre-loaded guidewire extends longitudinally within the lumen towards the distal tip of the device (¶[0028]; in view of ¶[0058] of Applicant’s spec., a proximal position of the guidewire within the lumen can be considered as untriggered and a more distal position of the guidewire within the lumen can be considered as triggered).
Regarding claim 2, the device is a puncture wire (“needle” - ¶[0021]), and wherein the pre-loaded guidewire cannulates the puncture wire through the lumen of the puncture wire (¶[0028]).
Regarding claim 3, the system further comprises a dilator (12; it is capable of being inserted into and dilating some type of opening) defining a dilator lumen and having a handle (20) at a proximal end portion of the dilator, wherein the guidewire control device is positioned on the dilator handle (Figure 2), and wherein the puncture wire is advanced through the dilator lumen (¶[0028]).
Regarding claim 4, the device is a dilator having a handle (20) at the proximal end of the elongated body, and wherein the guidewire control device is positioned on the dilator handle (Figure 2).
Regarding claim 5, the guidewire control device includes a trigger feature, and wherein when the trigger feature is actuated the pre-loaded guidewire is in the triggered state (32 can be considered as a trigger inasmuch as Applicant’s wheel 372 can; alternatively, button 62 can be actuated when the guidewire is in the triggered state - see explanation of “triggered” in regard to claim 1).
Regarding claim 6, the trigger feature is a button on the handle (member 62 can be considered as a button).
Regarding claim 12, the guidewire control device allows the advancement of the pre-loaded guidewire through the device with minimal hand movement (wheel 32 would only require the use of 1 finger which can be regarded as requiring minimal hand movement).
Regarding claim 13, Schaeffer discloses a device for deployment of a pre-loaded guidewire (17) for access to a heart (capable of this function - Abstract), the device comprising: a device (20/11 or 11) comprising an elongated body (13 or 12/13) having a body length, a proximal end and a distal end portion terminating in a distal tip and a lumen extending through the elongated body (“needle” - ¶[0021]) and being dimensioned to slidingly receive the pre-loaded guidewire (¶[0028]); and a guidewire control device (32 or 32/62) positioned on the device, (it is positioned on member 20 which can be considered as part of the device, or alternatively, it is positioned “on” member 13 or 12/13 inasmuch as Applicant’s guidewire control device 270, 372 or 474 is positioned on member 220, 320 or 420 - noting that in view of claim 14, the handle is not claimed as part of the tubular device but it is in claim 4 above) configured to physically communicate with the pre-loaded guidewire and advance the pre-loaded guidewire longitudinally within the lumen (¶[0028]); wherein the pre-loaded guidewire includes an untriggered state and a triggered state, and wherein in the triggered state the pre-loaded guidewire extends longitudinally within the lumen towards the distal tip of the device (¶[0028]); and wherein the device is a puncture wire (“needle” - ¶[0021]), and wherein the pre-loaded guidewire cannulates the puncture wire through the lumen of the puncture wire (¶[0028]).
Regarding claim 14, the device further comprises a dilator (12; it is capable of being inserted into and dilating some type of opening) defining a dilator lumen and having a handle (20) at a proximal end portion of the dilator, wherein the guidewire control device is positioned on the dilator handle (Figure 2), and wherein the puncture wire is advanced through the dilator lumen (¶[0028]).
Regarding claim 15, the guidewire control device includes a trigger feature, and wherein when the trigger feature is actuated the pre-loaded guidewire is in the triggered state (32 can be considered as a trigger inasmuch as Applicant’s wheel 372 can; alternatively, button 62 can be actuated when the guidewire is in the triggered state - see explanation of “triggered” in regard to claim 1).
Regarding claim 18, the guidewire control device can be regarded as an accessory feature combined with, e.g., member 11.
Regarding claim 20, Schaeffer discloses a method for deployment of a pre-loaded guidewire (17), the method comprising: providing a device (20/11 or 11; Figures 1 and 2) comprising an elongated body (13 or 12/13) having a body length, a proximal end and a distal end portion terminating in a distal tip and a lumen extending through the elongated body (“needle” - ¶[0021]) and being dimensioned to slidingly receive the pre-loaded guidewire (¶[0028]); and providing a guidewire control device (32 or 32/62) positioned on the device (it is positioned on member 20 which can be considered as part of the device, or alternatively, it is positioned “on” member 13 or 12/13 inasmuch as Applicant’s guidewire control device 270, 372 or 474 is positioned on member 220, 320 or 420 - noting that in view of claim 14, the handle is not claimed as part of the device but it is in claim 4 above), configured to physically communicate with the pre-loaded guidewire and advance the pre-loaded guidewire longitudinally within the lumen (¶[0028]); wherein the pre-loaded guidewire includes an untriggered state and a triggered state, and wherein in the triggered state the guidewire control device is in physical communication with the pre-loaded guidewire and the pre-loaded guidewire extends longitudinally within the lumen towards the distal tip of the device (¶[0028]; in view of ¶[0058] of Applicant’s spec., a proximal position of the guidewire within the lumen can be considered as untriggered and a more distal position of the guidewire within the lumen can be considered as triggered).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Thomas McEvoy whose telephone number is (571) 270-5034 and direct fax number is (571) 270-6034. The examiner can normally be reached on Monday-Friday, 9:00 am – 6:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Elizabeth Houston at (571) 272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THOMAS MCEVOY/Primary Examiner, Art Unit 3771
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