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 .
This office action is in response to the amendment filed 11/21/25. As directed by the amendment, claims 1-2, 8, and 11-14 have been amended and no claims have been added nor cancelled. As such, claims 1-9 and 11-14 are pending in the instant application.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 5-6, 11, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Griffith et al. (2010/0300451) in view of Lester (5,055,107) and Jacobs (3,788,326).
Regarding claim 1, Griffith discloses a device for percutaneous dilational tracheostomy (see Fig. 1-6 and abstract for example) which includes a puncture needle including a ground tip at a distal end and a connector at a proximal end (see Fig. 1, puncture needle 3, ground tip 14 at distal end, connector 5 at proximal end, see para. 0017-0019); a guide catheter (see Fig. 1, guide catheter 2); and a guidewire (see Fig. 5, guidewire 15 para. 0017 and 0023), wherein the maximum outer diameter of the puncture needle is smaller than the minimum inner diameter of the guide catheter (see Fig. 1-2, 4-5 showing puncture needle 2 located within the guide catheter 2, thus having the diameters as claimed, see also para. 0017-0019), wherein the puncture needle can be inserted so far into the guide catheter that the ground tip of the puncture needle projects beyond the distal end of the guide catheter (see Fig. 2 and 4 which shows this feature), wherein the maximum diameter of the guidewire is smaller than the minimum inner diameter of the puncture needle so that the guidewire can pass through the puncture needle (see para. 0017 which discloses that the puncture needle is desirably hollow for insertion of a guidewire therethrough, thus having the inner and outer diameter limitations as claimed). Griffith is silent as to the guidewire end projecting beyond the ground tip of the puncture needle and the connector having a first lumen which narrows in a first funnel shape having a first taper toward a lumen of the puncture needle; however, Lester teaches a similar device which includes this feature (see Lester Fig. 1 showing puncture needle with proximal end opposite ground tip having a connector that narrows/tapers in funnel shape in the direction of the puncture needle at the proximal end, 27 being funnel shaped proximal end/connector as claimed; see Fig. 6-7 showing guidewire 45 sized such that it extends out of distal end of the needle, see also col. 1 ln. 16-36). Thus 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 Griffith device’s connector of the puncture needle to have a tapered connector lumen and for the needle to extend beyond the needle, as taught by Lester, in order to provide a well-known type of connector (luer connector) and for the guidewire to positively extend from the needle in order to perform the emergency airway tracheostomy (see Lester col. 1 ln. 9-36 and col. 3 ln. 6-18). The now modified Griffith device is silent as to including an adapter insertable into the connector at the proximal end of the puncture needle, the adapter having a second lumen that narrows in a funnel shape having a second taper toward the lumen of the puncture needle with the second taper being different from the first taper; however, Jacobs teaches a similar device which includes this feature (see Jacobs Fig. 1: puncture needle 4 with tapered lumen connector 12 and adapter 13 with different tapered lumen as shown; Fig. 5: puncture needle 252 with proximal tapered connector 257 and adapter 258 with different second tapered lumen 259, col. 5 ln. 16-42). 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 modified Griffith device to include the adapter with second, different tapered lumen, as taught by Jacobs, in order to provide the ability to determine proper positioning of the device in the patient’s trachea (see Jacobs col. 5 ln. 16-42).
Regarding claim 5, the modified Griffith device’s puncture needle is made of steel (see Griffith para. 0030, “Stainless Steel”).
Regarding claim 6, the modified Griffith device’s guide catheter is made of plastic (see Griffith para. 0030).
Regarding claim 11, the modified Griffith device is a kit for percutaneous dilational tracheostomy (see Griffith Fig. 1-6 and abstract for example, including additional elements such as dilator 1 such that it is a kit) which includes the device according to claim 1 (see rejection of claim 1 addressed above); and a dilator for expanding a tracheostoma, wherein the dilator comprises a dilatation region having a diameter which increases continuously in longitudinal direction and wherein a guide channel is provided in longitudinal direction in the dilator, the minimum inner diameter of which is larger than the maximum diameter of the guidewire, so that the guidewire can be passed through the guide channel (see Griffith Fig. 1, dilator 1, see para. 0017-0019, Fig. 2-6 which shows the dilator having a guide channel sized to receive the guide catheter, puncture needle, and guidewire thus having the diameter limitations as claimed).
Regarding claim 14, the modified Griffith kit further includes a scalpel, a predilator, a set of compresses, a reinforcement catheter, a tracheostomy tube, one or more insertion aids for a tracheostomy tube, and/or a syringe (see Lester col. 1 ln. 9-36 which discloses scalpel as part of tracheostomy kit, Fig. 4-5 showing syringe 30, col. 3 ln. 14-18).
Claim(s) 2-4 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Griffith, Lester, and Jacobs as applied to claims 1 and 11 above, and further in view of Schnell (2018/0280647).
Regarding claim 2, the modified Griffith device is silent as to the maximum diameter of the guidewire being in a range of 1.0 to 1.5 mm; however, Schnell teaches a similar device which teaches this feature (see Schnell para. 0019). Thus 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 modified Griffith device’s guidewire to be sized in the range of 1.0 to 1.5 mm, as taught by Schnell, as this is a well-known size for such a device and would have been obvious to try.
Regarding claim 3, the modified Griffith device is silent as to the minimum inner diameter of the puncture needle being 0.1 to 0.4 mm larger than the maximum diameter of the guidewire; however, Schnell teaches this feature (see Schnell para. 0019 and 0023). Thus 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 modified Griffith device’s puncture needle to be 0.1 to 0.4 mm larger than the maximum diameter of the guidewire, as taught by Schnell, as this is a well-known size for such a device and would have been obvious to try.
Regarding claim 4, the modified Griffith device is silent as to the inner diameter of the guide catheter being 0.05 to 0.3 mm larger than the maximum outer diameter of the puncture needle; however, Schnell teaches a similar device with similar inner/outer diameter clearances (see Schnell para. 0019 and 0023). Thus 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 modified Griffith device’s guide catheter to be 0.05 to 0.3 mm larger than the maximum outer diameter of the puncture needle, as taught by Schnell, as this is a well-known size for such a device and would have been obvious to try.
Regarding claim 13, the modified Griffith kit is silent as to the end of the guidewire that projects beyond the puncture needle including an insertion aid including a guide channel in longitudinal direction, the minimum inner diameter of which is larger than the maximum diameter of the guidewire, so that the guidewire can be passed through the guide channel of the insertion aid, wherein one end of the guide channel of the insertion aid opens into a conically tapering section of the insertion aid; however, Schnell teaches a similar device which includes this feature (see Schnell Fig. 1-5 insertion aid 1, see also para. 0065). Thus 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 modified Griffith kit to include an insertion aid on the guidewire, as taught by Schnell, in order to provide additional structural elements to help insert and dilate the stoma (see Schnell para. 0018 and 0065).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Griffith, Lester, and Jacobs as applied to claim 1 above, and further in view of Watanabe et al. (2011/0028904).
Regarding claim 7, the modified Griffith device is silent as to the guidewire being made of metal or plastic; however, Watanabe teaches a similar device which includes a guidewire made of steel (see Watanabe para. 0046). Thus 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 modified Griffith device’s guidewire to be made of metal or plastic, as taught by Watanabe, as this is a well-known material type for such a device and this would have been obvious substitution of one known element for another and one would expect the modified Griffith device to perform equally as well.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Griffith, Lester, and Jacobs as applied to claim 1 above, and further in view of Kraus et al. (2004/0092879).
Regarding claim 8, the modified Griffith device teaches connectors on the puncture needle and guide catheter disposed at proximal ends (see Griffith Fig. 1-2, connectors 10 and 5; connector 10 being connector of the guide catheter 2, see Lester Fig. 1, 27; Jacobs Fig. 1 and 5, 12 and 257, respectively), but is silent as to the puncture needle being in a first stable insertion position projecting beyond distal end of the guide catheter by 1-10 mm and via turning or pulling on the connector, brough into a second stable insertion position in which the ground tip does not project beyond the guide catheter; however, Kraus teaches a similar device which includes such a puncture needle which is movable between first and second stable insertion positions as claimed (see Kraus Fig. 3A and 3B, Fig. 18 and 20, see para. 0039-0046, actuation of actuator button 362, it being obvious to modify the button to be a pull or twist/turn type button as this would be obvious substitution). Thus 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 modified Griffith device’s puncture needle to be disposed in first and second stable insertion positions, as taught by Kraus, in order to provide the ability to retract the puncture needle when not in use for safety reasons. The needle extending 1-10 mm would have been an obvious distance to choose and furthermore, it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involve only routine skill in the art. In re Aller, 200 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Griffith, Lester, and Jacobs as applied to claim 1 above, and further in view of Schnell (DE 102005006276).
Regarding claim 9, the modified Griffith device is silent as to the guidewire end that projects beyond the puncture needle being curved in a quarter to three-quarter circle; however, Schnell teaches a similar device with a guidewire curved as claimed (see Schnell Fig. 1, guidewire 1 with curved distal end 2, see translation provided by Applicant para. 0010). Thus 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 modified Griffith device’s guidewire to have the curved distal end, as taught by Schnell, in order to avoid injuries to the patient (see Schnell translation provided by Applicant para. 0010).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Griffith, Lester, and Jacobs as applied to claim 11 above, and further in view of Turnbull (2003/0114871).
Regarding claim 12, the modified Griffith kit is silent as to further including a predilator as claimed; however, Turnbull teaches a similar tracheostomy kit which includes a predilator as claimed (see Turnbull para. 0002 and 0018). Thus 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 modified Griffith kit to further include a predilator, as taught by Turnbull, in order to provide for initial dilation of the stoma. The minimum inner diameter of the guide channel of the predilator being 0.1 to 1.0 mm larger than the guidewire would have been an obvious value to choose and furthermore, it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involve only routine skill in the art. In re Aller, 200 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on the same combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 COLIN W STUART whose telephone number is (571)270-7490. The examiner can normally be reached M-F: 9-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Timothy Stanis can be reached at 571-272-5139. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/COLIN W STUART/Primary Examiner, Art Unit 3785