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 .
Information Disclosure Statement
The information disclosure statement(s) filed on the record are in compliance with the content requirements of 37 CFR 1.97 and 37 CFR 1.98 and have been considered.
Claim Objections
Claims 6, 11, 12, 17, and 19 are objected to because of the following informalities:
Claim 6 recites "the first and second tubing connector body portion"; the recitation should refer to "body portions".
Claim 12 recites "the first and second deflectable body portion"; the recitation should refer to "body portions".
Claims 11 and 17 recite "the flow hub," although the respective base claims recite only "a hub".
Claim 19 recites "the first and second body portion"; the recitation should refer to "body portions".
Appropriate correction is required.
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 1-4, 8-10, 14-16 and all claims depending therefrom 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.
Claim 1 is directed to "A tubing connector for fluidically coupling a flow lumen of a run of infusion tubing to a cannula of an infusion set comprising", thereby establishing the invention as a tubing connector functionally associated with a flow lumen of a run of infusion tubing. However, the body of the claim further recites "the run of infusion tubing coupled to a first end of the channel and a sharp coupled into a second opposing end of the channel, a sharp lumen of the sharp being in fluid communication with the flow lumen." Claims 8 and 14 recite a similar set of limitations.
In view of this language, it is unclear whether the "run of infusion tubing" is an element external to the tubing connector or is, instead, a part of the claimed tubing connector itself. Accordingly, it is unclear what constitutes the claimed invention. See In re Packard, 751 F.3d 1311, 110 USPQ2d 1787.
Further, claim 1 recites "a sharp coupled into a second opposing end of the channel". It is not clear what "coupled into" means. For the purpose of examination, the latter interpretation will be applied, i.e., that the “flanking projections” are defined in relation to the “sharp” coupled to the channel rather than having a sharp shape.
Further, claims 1-4, 10 and 16 recite "sharp flanking projection[s]". It is unclear whether the term “sharp” modifies “flanking projection[s],” such that the projections themselves are sharp, or whether the term instead refers to projections that flank “the sharp” coupled to the channel. For the purpose of examination, the latter interpretation will be applied.
Claims 2, 9 and 15 recite "extend within a plane". But since a plane is a completely flat, two dimensional surface, is not clear how a structure can extend "within" a plane.
For the purpose of examination, the limitation will be interpreted to mean "extend along a plane".
Claim Rejections - 35 USC § 102
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 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 1-4, 6-17, 19 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Morrissey (U.S. Pat. 8,172,803 B2, hereinafter "Morrissey").
Regarding claim 1, Morrissey discloses a tubing connector for fluidically coupling a flow lumen of a run of infusion tubing to a cannula of an infusion set comprising:
a flow hub 21 (see Fig. 23) having a channel therethrough, the run of infusion tubing coupled to a first end of the channel (at port 183; see Fig. 23) and a sharp 182 (see Fig. 23) coupled into a second opposing end of the channel, a sharp lumen of the sharp being in fluid communication with the flow lumen (see col. 12, lines 66-67);
a pair of cantilevered connector fingers (a portion of the first arm 164 that extends from crossbar 170 to barbed head 178; and a portion of the second arm 165 that extends from crossbar 170 to barbed head 179; see Fig. 23a), a first connector finger of the pair of connector fingers coupled to a first side of the flow hub via a first tubing connector body portion and a second connector finger of the pair of connector fingers coupled to a second opposing side of the flow hub via a second tubing connector body portion (each finger is connected to the flow hub via a respective portion of fingers 164/165 and crosspiece 170), each of the connector fingers including a latch projection 178 (see Fig. 23); and
a set of sharp flanking projections 187, 188 and 185 (see Fig. 23a) extending from the flow hub parallel to an axis of the sharp, the set of sharp flanking projections including a pair of sharp flanking projections 187 and 188 (see Fig. 23a) disposed lateral to the sharp and a centrally disposed projection 185 (see Fig. 23a) which extends from a top face of the flow hub over at least a segment of the sharp.
Regarding claim 2, Morrissey discloses the tubing connector of claim 1, wherein the pair of sharp flanking projections 187 and 188 disposed lateral to the sharp extend within a plane along which the connector fingers extend (see Fig. 23a, showing the pair of sharp flanking projections 187 and 188 extending along the same plane as the connector fingers).
Regarding claim 3, Morrissey discloses the tubing connector of claim 1, wherein the pair of sharp flanking projections includes a first sharp flanking projection 187 which extends from the first side of the flow hub and a second sharp flanking projection 188 which extends from the second opposing side of the flow hub (see Fig. 23a, showing two flanking projections 187 and 188 on either side of the flow hub).
Regarding claim 4, Morrissey discloses the tubing connector of claim 1, wherein the pair of sharp flanking projections each have a projection tip (i.e., the end of each projection 187 and 188 that is opposite the crossbar 170), and the projection tips are more distal to the flow hub than a terminal portion of each connector finger (the connector fingers 177 and 178 have a first terminal portion at barbed head 178 and 179 and a second terminal portion that connect to the crosspiece 170; Fig. 23a shows that the projection tips extend more distally to the flow hub than the second terminal portion of each connector finger).
Regarding claim 6, Morrissey discloses the tubing connector of claim 1, wherein the lateral face of each of the first and second tubing connector body portion include a set of ridges (first connector body portion includes ridges 176 and second connector body portion includes ridges 177; see Fig. 23a).
Regarding claim 7, Morrissey discloses the tubing connector of claim 1, wherein the first and second connector body portions are configured to deflect and engender (interpreted to mean cause) displacement of the cantilevered connector fingers toward the axis of the sharp upon application of force against the first and second connector body portions in a direction toward the axis of the sharp (see col. 12, lines 50-55; the first and second connector body portions are gripped between the finger and thumb and deflect inwardly when pressed together, causing displacement of the cantilevered connector fingers toward the axis of the sharp).
Regarding claim 9, Morrissey discloses the tubing connector of claim 8, wherein the projections disposed lateral to the sharp extend within a plane along which the connector fingers extend (see Fig. 23 and 23a, showing the projections extending in the same plane as the connector fingers).
Regarding claim 10, Morrissey discloses the tubing connector of claim 8, wherein the projections disposed lateral to the sharp includes a first sharp flanking projection 187 which extends from the first side of the hub and a second sharp flanking projection 188 which extends from the second opposing side of the hub (see Fig. 23a).
Regarding claim 11, Morrissey discloses the tubing connector of claim 8, wherein the pair of projections each have a projection tip (i.e., the end of each projection 187 and 188 that is opposite the crossbar 170), and the projection tips are more distal to the flow hub than a terminal portion of each connector finger (the connector fingers 177 and 178 have a first terminal portion at barbed head 178 and 179 and a second terminal portion that connect to the crosspiece 170; Fig. 23a shows that the projection tips extend more distally to the flow hub than the second terminal portion of each connector finger).
Regarding claim 12, Morrissey discloses the tubing connector of claim 8, wherein the first and second deflectable body portion are each continuous with the top face of the hub (see col. 12, lines 37-38, disclosing the tube connector 21 as being formed from a plastic material; each body portion is continuous with the top face of the hub by being connected and made from the same material).
Regarding claim 13, Morrissey discloses the tubing connector of claim 8, wherein the first and second deflectable body portions are configured to deflect and engender (interpreted to mean cause) displacement of the cantilevered connector fingers toward the axis of the sharp upon application of force against the first and second connector body portions in a direction toward the axis of the sharp (see col. 12, lines 50-55; the first and second connector body portions are gripped between the finger and thumb and deflect inwardly when pressed together, causing displacement of the cantilevered connector fingers toward the axis of the sharp).
Regarding claim 14, Morrissey discloses a tubing connector for establishing a fluidic connection to an infusion set comprising:
a hub 21 (see Fig. 23) coupled to a run of infusion tubing (attached to proximal end of port 183; see Fig. 23) and a sharp 182 (see Fig. 23) having a sharp lumen, the sharp lumen being in fluid communication with a flow lumen of the infusion tubing (see col. 12, lines 66-67);
a pair of latching fingers (a portion of the first arm 164 that extends from crossbar 170 to barbed head 178; and a portion of the second arm 165 that extends from crossbar 170 to barbed head 179; see Fig. 23a), a finger of the pair coupled to a first side of the hub via a first body portion and a second finger of the pair coupled to a second opposing side of the hub via a second body portion (each finger is connected to the flow hub via a respective portion of fingers 164/165 and crosspiece 170); and
a set of projections 187, 188 and 185 (see Fig. 23a) extending from the hub parallel to an axis of the sharp, the set of projections including two (187 and 188; see Fig. 23a) disposed lateral to the sharp as well as a centrally disposed projection 185 (see Fig. 23a) which extends from a top face of the hub over at least a segment of the sharp.
Regarding claim 15, Morrissey discloses the tubing connector of claim 14, wherein the projections disposed lateral to the sharp extend within a plane along which the connector fingers extend (see Fig. 23a, showing the pair of sharp flanking projections 187 and 188 extending along the same plane as the connector fingers).
Regarding claim 16, Morrissey discloses the tubing connector of claim 14, wherein the projections disposed lateral to the sharp includes a first sharp flanking projection 187 which extends from the first side of the hub and a second sharp flanking projection 188 which extends from the second opposing side of the hub (see Fig. 23a, showing two flanking projections 187 and 188 on either side of the flow hub).
Regarding claim 17, Morrissey discloses the tubing connector of claim 14, wherein the pair of projections each have a projection tip (i.e., the end of each projection 187 and 188 that is opposite the crossbar 170), and the projection tips are more distal to the flow hub than a terminal portion of each connector finger (the connector fingers 177 and 178 have a first terminal portion at barbed head 178 and 179 and a second terminal portion that connect to the crosspiece 170; Fig. 23a shows that the projection tips extend more distally to the flow hub than the second terminal portion of each connector finger).
Regarding claim 19, Morrissey discloses the tubing connector of claim 14, wherein the first and second body portion are each continuous with the top face of the hub (see col. 12, lines 37-38, disclosing the tube connector 21 as being formed from a plastic material; each body portion is continuous with the top face of the hub by being connected and made from the same material).
Regarding claim 20, Morrissey discloses the tubing connector of claim 14, wherein the first and second body portions are configured to deflect and engender (interpreted to mean cause) displacement of the latching fingers toward the axis of the sharp upon application of force against the first and second body portions in a direction toward the axis of the sharp (see col. 12, lines 50-55; the first and second connector body portions are gripped between the finger and thumb and deflect inwardly when pressed together, causing displacement of the cantilevered connector fingers toward the axis of the sharp).
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 5 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Morrissey, in view of Williams et al (U.S. Pub. 2009/0188575 A1, hereinafter "Williams").
Regarding claims 5 and 18, Morrissey teaches the tubing connector of respective claims 4 and 17, but does not appear to disclose that the projection tips include a chamfered face.
Williams discloses a tubing connector, comprising a projection tip including a chamfered face (see front surface 320 defined by chamfered lead-in surface 315).
A skilled artisan would have found it obvious to modify the projection tips to have a chamfered face in order to improve the guiding of a complementary coupling feature for the projection tips, with a reasonable expectation of success (see Williams at para [033]). Further, choosing a chamfered surface would also have been a matter of obvious design choice to a skilled artisan at the time of the invention, requiring no more than a change in shape that would not have meaningfully modified the operation of the device.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See Notice of References Cited.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SCOTT J MEDWAY whose telephone number is (571)270-3656. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783 06/18/2026
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