DETAILED ACTION
This Office Action is in response to the filing of an amendment to the claims on 6/25/2025. As per the amendments, claims 1, and 3-20 have been amended, claim 21 has been added, and claim 2 has been cancelled. Thus, claims 1, and 3-21 are pending in the application.
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 .
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.
Claims 1, 3-4, and 18-21 rejected under 35 U.S.C. 103 as being unpatentable over Christopher (US Pub. 2005/0139220) in view of Esnouf (US Pat. 7,383,736) in view of Long (US Pat. 5,207,220).
Regarding claim 1, Christopher discloses a kit comprising (see [0118] where the invention and its components can come packaged as a kit): a syringe (see Figs. 5, 21, and 35) having a tip defining a female Luer taper fitting (see Figs. 19-21 and [0134], [0153] where the syringe tip connects to a luer connector 92, the luer connector 92 being a male end of a luer connection and thus the syringe end luer connection point must be female; as seen in Fig. 21 where luer connector 92 fits within the tip of syringe 55); and an adaptor (guide cap 91 and luer connector 92 in Figs. 19-21) defining a first end portion shaped to couple with the female Luer taper fitting (see Figs. 19-21 where a top end of guide cap luer connector 92 couples to the bottom of the syringe via a luer connection; see also [0134] and [0153]) and a second end portion shaped to cooperatively couple with an opening of an endotracheal tube (see Figs. 5, 21, and 35 where the guide cap 91 has a bottom end that couples to and interacts with an endotracheal tube of guide 25), wherein the first end portion of the adaptor comprises a male Luer taper fitting configured to cooperatively couple with the female Luer taper fitting (see Figs. 19-21 and [0134], [0153] where the shown luer connector 92 is a male end of a luer connection and connects to the female end of the syringe, as seen in Fig. 21 where luer connector 92 fits within the tip of syringe 55), and wherein the second end portion comprises a barrel portion shaped to couple to an outer surface of the endotracheal tube (sees Fig. 21 and annotated Fig. 20 below, where the guide cap 91 has a barrel portion, which engages with an outer surface of guide 25); and a tube portion positioned coaxially within the barrel portion (see annotated Fig. 20 below), and wherein the tube portion is configured to removably couple with an inner surface of the endotracheal tube (see annotated Fig. 20 below where the second end of the adaptor has a tube portion that engages with an inner surface of the guide 25 at annular ring 26 and the tube portion is coaxially located within the barrel portion (and where guide cap 91 is able to be removed from guide 25 as seen in [0135])).
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Christopher lacks a detailed description of a barrel portion shaped to couple to an outer surface of an endotracheal injection tube line, the tube portion positioned coaxially within the barrel portion, wherein the tube portion comprises an integrated male Luer taper fitting.
However, Esnouf teaches a syringe connected to a tube with an adaptor, where a barrel portion shaped to couple to an outer surface of a tube line (see Fig. 4 where an intermediate connector has male luer fitting 26 to connect to the female luer fitting of inflation valve 61 of inflation tube 64, the male luer fitting 26 having an outer barrel portion about its male tip member), the tube portion positioned coaxially within the barrel portion (see Fig. 4 where the tip of male luer fitting 26 is a tube portion, that fits within the barrel portion that surrounds it), wherein the tube portion comprises an integrated male Luer taper fitting (see Fig. 4 where the male luer fitting 26 has the tip portion that is the tube, which is integrated with the male luer fitting 26).
Therefore 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 luer connection between the adaptor and tube of Christopher to be a male luer fitting on the tube end within the barrel to connect to a female luer connection on the tubing line as taught by Esnouf, as it would be a simple substitution of one luer configuration between an adaptor and a tube for another, to yield the predictable result of providing a removable luer connection between an adaptor and tube.
The modified Christopher device lacks a detailed description of the syringe tip being a male Luer fitting, interacting with a female Luer taper fitting of the adaptor, and the tube the adaptor connects to being an endotracheal tube injection line.
However, Long teaches a syringe device connecting to an endotracheal tubing system, where the syringe tip is a male Luer fitting (see Fig. 1 where nipple 21 of the syringe is inserted into female portion of luer lock fitting 12), interacting with a female Luer taper fitting (see Fig. 1 where nipple 21 of the syringe is inserted into female portion of luer lock fitting 12), and connecting to an endotracheal tube injection line (see Fig. 1 where passageway 13 is an injection line that connects to endotracheal tube 1).
Therefore 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 luer connection between the adaptor and the endotracheal tube of the modified Christopher device to be a male end of the adaptor connected to a female end of an endotracheal tube injection line as taught by Long, as it would be a simple substitution of one configuration of a luer connection for another, to yield the predictable result of providing a luer connection between the adaptor and the tube, as well as allowing the syringe to connect to an injection line for different use in an endotracheal system.
Regarding claim 3, the modified Christopher device has wherein the second end portion is shaped to couple to an inner surface of the endotracheal tube injection line or cuff (Christopher; see annotated Fig. 20 above, where the tube portion of the adaptor couples to the inner surface of the injection line as modified in light of Esnouf and Long).
Regarding claim 4, the modified Christopher device has wherein the adaptor is configured to transfer liquid between the syringe coupled to the first end portion and an endotracheal tube coupled to the second end portion (Christopher; see Figs. 5, 21, and 35 and [0098] where anesthetic from the syringe is sent through the connector 92/ guide cap 91 into the guide 25).
Regarding claim 18, the modified Christopher device has a pharmaceutical composition for delivery to a subject in need thereof with the syringe (Christopher; see [0084] and [0107] where the syringe delivers an anesthetic).
Regarding claim 19, the modified Christopher device has wherein the pharmaceutical composition is lidocaine (Christopher; see [0107] where the syringe can carry lidocaine).
Regarding claim 20, the modified Christopher device has wherein pharmaceutical composition is disposed within the syringe (Christopher; see [0107] where the anesthetic is carried within the syringe).
Regarding claim 21, the modified Christopher device has wherein the integrated male Luer taper is configured to removable couple to the another Luer-compatible device (where it is understood that the modified Christopher device, as modified by Esnouf, has an integrated male Luer taper end on the tube portion, which is capable of being removably connected to any other Luer-compatible device).
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Christopher in view of Esnouf in view of Long as applied to claim 1 above, and further in view of Peters (US Pat. 11,305,055).
Regarding claim 5, the modified Christopher device has the syringe is a first syringe, with a male Luer taper fitting.
The modified Christopher device lacks a detailed description of the kit further comprising a second syringe having a tip defining a male Luer taper fitting
However, Peters teaches a syringe kit that includes a plurality of syringes of different sizes (see Col. 1 lines 53-65).
Therefore 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 kit of the modified Christopher device to include a plurality of different sizes syringes as taught by Peters, as it would provide a plurality of syringes that can be used for different purposes, improving the flexibility of the kit on different patients/ to administer different dosages. It is understood that the modified plurality of syringes have the same luer connection system as Christopher, and thus the syringes have a male end of a luer connection.
Regarding claim 6, the modified Christopher device has wherein a barrel size of the first syringe is different than a barrel size of the second syringe (Peters; see Col. 1 lines 53-65).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Christopher in view of Esnouf in view of Long in view of Peters as applied to claim 5 above, and further in view of Stubbs (GB 2,285,926).
Regarding claim 7, the modified Christopher device has wherein the first syringe and the second syringe.
The modified Christopher device lacks a detailed description of wherein the first syringe has a first color and the second syringe has a second color different than the first color.
However, Stubbs teaches wherein the first syringe has a first color and the second syringe has a second color different than the first color (see abstract, and page 4 the last paragraph, where syringes are made to be different color from one another for easy differentiation).
Therefore 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 syringes of the modified Christopher device to be different colors as taught by Stubbs, as it would allow for different syringes to be easily differentiated from one another, preventing accidental misuse.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Christopher in view of Esnouf in view of Long in view of Peters as applied to claim 5 above, and further in view of Fraas (US Pat. 10,814,075).
Regarding claim 8, the modified Christopher device has the first syringe is for use with an endotracheal tube.
The modified Christopher device lacks a detailed description of wherein the first syringe includes written indicia including markings indicating that the syringe is for use with an endotracheal tube.
However, Fraas teaches wherein the syringe includes written indicia including markings indicating that the syringe is for oral use (see Col. 5 lines 7-24).
Therefore 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 syringes of the modified Christopher device to include marking elements on the syringe which indicate oral use of the syringe as taught by Fraas, as it would provide additional labelling to the syringes, ensuring proper use between different syringes.
Claims 9-15 are rejected under 35 U.S.C. 103 as being unpatentable over Christopher in view of Esnouf in view of Long in view of Peters in view of Fraas as applied to claim 8 above, and further in view of Creaturo (US Pat. 9,302,050).
Regarding claim 9, the modified Christopher device has a dosage of a pharmaceutical composition for use with the endotracheal tube.
The modified Christopher device lacks a detailed description of wherein the written indicia further includes markings indicating a dosage of a pharmaceutical composition when used with the endotracheal tube.
However, Creaturo teaches a similar syringe system, where indicia can be provided to show the requisite dosage (see Col. 5 lines 29-55).
Therefore 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 syringes of the modified Christopher device to have dosage indicia as taught by Creaturo, as it would label the syringes based on dosage, allowing for accurate selection of medication based on patient parameters.
Regarding claim 10, the modified Christopher device has wherein the markings indicating a dosage include markings indicating a range of weights of a subject to receive the pharmaceutical composition corresponding to the dosage of the pharmaceutical composition (Creaturo; see Col. 5 lines 29-55 where the graduation markings for dosage are based on patient weight).
Regarding claim 11, the modified Christopher device has wherein the dosage is a neonatal dosage (Creaturo; see Col. 9 lines 7-22).
Regarding claim 12, the modified Christopher device has wherein the second syringe includes second written indicia including second markings indicating that the second syringe is for use with an intravenous delivery line (Fraas; see Col. 5 lines 7-24 for dermal use. Further, it would be a simple matter of design choice for a person of ordinary skill in the art, to label the syringe for its intended use as taught by Fraas, including intravenous use, which is very nearly dermal use).
Regarding claim 13, the modified Christopher device has wherein the second written indicia further includes second markings indicating a dosage of the pharmaceutical composition when used with the intravenous or intraosseous delivery line (Creaturo; see Col. 5 lines 29-55).
Regarding claim 14, the modified Christopher device has wherein the second markings indicating a dosage include markings indicating a range of weights of a subject to receive the pharmaceutical composition corresponding to the dosage of the pharmaceutical composition (Creaturo; see Col. 5 lines 29-55 where the graduation markings for dosage are based on patient weight).
Regarding claim 15, the modified Christopher device has wherein the markings indicating a dosage are different than the second markings indicating a dosage (Creaturo; see Col. 5 lines 29-55 where dosage markings are provided, which differ from one another based on patient and medicine parameters. See above 35 U.S.C. 112(b) rejection for interpretation of this claim).
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Christopher in view of Esnouf in view of Long as applied to claim 1 above, and further in view of Creaturo.
Regarding claim 16, the modified Christopher device has administering a dose of a pharmaceutical composition to a subject in need thereof.
The modified Christopher device lacks a detailed description of written instructions for administering a dose of a pharmaceutical composition to a subject in need thereof.
However, Creaturo teaches a similar syringe system, with written instructions for administering a dose of a pharmaceutical composition to a subject in need thereof (see Col. 5 lines 24-55 and Col. 7 lines 14-20 where the dosage indicia constitute instructions about the amount and concentration of the applied medicament).
Therefore 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 syringe of the modified Christopher device to include indicia that give dosage instructions as taught by Creaturo, as it would ensure that the proper procedures are followed to deliver a medically appropriate amount of the medicament.
Regarding claim 17, the modified Christopher device has wherein the method of administering the pharmaceutical composition can include administering the pharmaceutical composition through an endotracheal tube (Christopher; see Figs. 5, 21, and 35 where the syringe applied the medicament into an endotracheal tube).
Response to Arguments
Applicant’s arguments with respect to claims 1 and 3-21 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. Specifically, the newly applied Esnouf and Long references of the rejection of claim 1.
For these reasons, the above rejections hold.
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 MATTHEW D ZIEGLER whose telephone number is (571)272-3349. The examiner can normally be reached Mon-Thurs 9:00-6:00.
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/MATTHEW D ZIEGLER/Examiner, Art Unit 3785
/JUSTINE R YU/Supervisory Patent Examiner, Art Unit 3785