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 .
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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 5/13/26 has been entered.
Notice of Amendment
In response to the amendment(s) filed on 5/13/26, amended claim(s) 1 is/are acknowledged. The following new and/or reiterated ground(s) of rejection is/are set forth:
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.
Claim(s) 1-5, 7, and 13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Application Publication No. 2017/0319118 to Pizzi et al. (hereinafter “Pizzi”).
For claim 1, Pizzi discloses a blood collection assembly couplable to a vascular access device (Abstract), the blood collection assembly comprising:
a blood collection device comprising a first branch (10a) (Fig. 1) (para [0039]), a second branch (5a) (Fig. 1) (para [0034]), a third branch (11) (Fig. 1) (para [0043]), and a channel configured for fluid communication between the first branch, the second branch, and the third branch (unlabeled, but as can be seen in Fig. 3 where all the lumens connect with one another);
a syringe (3) (Fig. 1) (para [0055]) comprising a syringe body (3b) (Fig. 1) (para [0055]), a plunger (3c) (Fig. 1) (para [0055]), and a stopper (3d) (Fig. 3) (para [0055]), wherein the plunger and the stopper are compressible and retractable within the syringe body (para [0055]), and wherein the syringe is coupled to the first branch of the blood collection device (as can be seen in Fig. 3);
a testing sample collection device (5) (Fig. 1) (para [0039]) coupled to the second branch of the blood collection device (as can be seen in Fig. 3); and
an access portion (12) (Fig. 1) (para [0043]) coupled to the third branch of the blood collection device (as can be seen in Fig. 3) and the vascular access device (2 and K1/K2) (Figs. 1 and 3) (para [0032]-[0033]) (Examiner’s Note: the coupling being via 10a and 14), wherein the access portion is in fluid communication with the vascular access device (as can be seen in Fig. 1) (also see para [0044]) and the blood collection device (as can be seen in Fig. 3).
For claim 2, Pizzi further discloses wherein the blood collection device further comprises a valve member (7), wherein rotation of the valve member switches fluid communication of the channel from communication between the first branch and the third branch to communication between the second branch and the third branch (para [0054]).
For claim 3, Pizzi further discloses wherein the channel is a T-shaped channel (as can be seen in Fig. 3).
For claim 4, Pizzi further discloses wherein the valve member is selectively rotatable via a rotatable knob (7a) (para [0037] and [0054]).
For claim 5, Pizzi further discloses wherein the testing sample collection device comprises a luer lock access device (para [0034]).
For claim 7, Pizzi further discloses wherein the access portion comprises flexible tubing (para [0034]) and a luer access connector positioned on a distal end of the flexible tubing (para [0034]).
For claim 13, Pizzi further disclose wherein the syringe comprises an air trap portion (Examiner’s Note: this limitation being construed in view of Fig. 6 of Applicant’s specification) (see the angled portion of 3d in Fig. 3 and how it will trap air when it comes into contact with the flat surface of the inner wall of 3b).
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.
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) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pizzi in view of U.S. Patent Application Publication No. 2004/0162540 to Walenciak et al. (hereinafter “Walenciak”).
For claim 6, Pizzi further discloses wherein the testing sample collection device comprises a luer connector (para [0034]).
Pizzi does not expressly disclose that the luer connector is a male-male luer connector.
However, Walenciak teaches a male-male luer connector (para [0046]).
It would have been obvious to a skilled artisan to modify Pizzi such that the luer connector is a male-male luer connector, in view of the teachings of Walenciak, because such a modification would be the simple substitution of one type of luer connector for another type of luer connector that would lead to the predictable result of being able to connector devices together.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pizzi in view of U.S. Patent Application Publication No. 2005/0188985 to Sullivan et al. (hereinafter “Sullivan”).
For claim 8, Pizzi further discloses wherein the syringe is positioned proximate the third branch and in fluid communication with the channel (as can be seen in Fig. 1).
Pizzi does not expressly disclose wherein the syringe is a compressible bulb.
However, Sullivan teaches wherein a compressible bulb can be used alternatively to a syringe (para [0011]).
It would have been obvious to a skilled artisan to modify Pizzi wherein the syringe is a compressible bulb, in view of the teachings of Sullivan, because such a modification would be the simple substitution of one fluid delivery device for another fluid delivery device that would lead to the predictable result of delivering fluid.
Claim(s) 9-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pizzi in view of U.S. Patent Application Publication No. 2011/0130740 to Levy.
For claim 9, Pizzi further discloses wherein the testing sample collection device is removably coupled to the second branch of the blood collection device (para [0053]).
Pizzi does not expressly disclose that the testing sample collection device is a compressible bulb device.
However, Levy teaches wherein a testing sample collection device is a compressible bulb device (para [0067]).
It would have been obvious to a skilled artisan to modify Pizzi such that the testing sample collection device is a compressible bulb device, in view of the teachings of Levy, because such a modification would be the simple substitution of one testing sample collection device for another testing sample collection device that would lead to the predictable result of collecting a test sample.
For claim 10, Pizzi, as modified, further discloses wherein the compressible bulb device comprises a nozzle (see where reference numeral 5a points to in Fig. 5) (also see, for reference, how Levy shows its compressible blub device to have a nozzle in Fig. 1) and a connection interface (see where reference numeral 7c points to in Fig. 5) (Examiner’s Note: Levy’s nozzle can be inserted into 7c the same way Pizzi shows 5a being inserted into 7c), wherein the connection interface is configured to couple the compressible bulb device to an exterior surface of the second branch (as can be seen in Fig. 5) and the nozzle is configured to extend into the second branch so as to be in fluid communication with the channel (as can be seen in Fig. 5).
For claim 11, Pizzi further discloses wherein the blood collection device further comprises a one-way valve positioned within the second branch (para [0044] and [0048]), wherein the one-way valve is configured to (Examiner’s Note: functional language, i.e., capable of) close when the compressible bulb device is detached from the blood collection device and to open when the compressible bulb device is attached to the blood collection device (para [0044] and [0048]) (also see Fig. 3 of Levy, which shows the nozzle of the bulb penetrating element 18 to open a pathway through element 18).
For claim 12, Pizzi further discloses wherein the nozzle of the compressible bulb device is configured to (Examiner’s Note: functional language, i.e., capable of) penetrate the one-way valve (para [0044] and [0048]) (also see Fig. 3 of Levy, which shows the nozzle of the bulb penetrating element 18 to open a pathway through element 18).
Response to Arguments
Applicant's arguments filed 5/13/26 have been fully considered. In response, Applicant’s arguments are rendered moot in view of the new grounds of rejection. The Pizzi reference has been reconsidered in view of the amendments.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL LEE CERIONI whose telephone number is (313) 446-4818. The examiner can normally be reached M - F 8:00 AM - 5:00 PM PT.
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/DANIEL L CERIONI/Primary Examiner, Art Unit 3791
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