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.
Notice of Amendment
In response to the amendment(s) filed on 9/1/26, 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 § 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) 1, 3-7, 9-10, 12-14, and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2014/0309551 to Burkholz et al. (hereinafter “Burkholz’551”) in view of U.S. Patent Application Publication No. 2019/0021640 to Burkholz (hereinafter “Burkholz’640”).
For claim 1, Burholz’551 discloses a blood sample collection system (Abstract) comprising:
a blood access device (12, which includes 14) (Fig. 1) (para [0033]) having a fluid flow path (20) (Fig. 1) (para [0033]); and
a diagnostic device (110, optionally including 138) (Figs. 1-4) (para [0033]) comprising a septum (156) (Fig. 6) (para [0049]), the diagnostic device configured to (Examiner’s Note: functional language, i.e., capable of) receive a sample of blood (para [0038]),
wherein the diagnostic device is in fluid communication with the fluid flow path (as can be seen in Fig. 1), and wherein the diagnostic device is configured to be detached from the blood access device (Figs. 3-4) (para [0019]-[0020]).
Burkholz’551 does not expressly disclose the blood access device comprising: a housing; an instrument disposed within the housing; and an instrument advancement element comprising a cannula, wherein in response to movement of the instrument advancement element with respect to the housing, the instrument is configured to advance beyond the distal end of the housing, wherein cannula is configured to extend through the septum to place the fluid flow path of the blood access device in fluid communication with the diagnostic device.
However, Burkholz’640 teaches the blood access device comprising: a housing (28) (Fig. 2) (para [0048]); an instrument (12) (Fig. 2) (para [0040]) disposed within the housing(as can be seen in Fig. 2); and an instrument advancement element (36, 46) (Fig. 2) (para [0053] and [0060]) comprising a cannula (38) (Fig. 2) (para [0054]), wherein in response to movement of the instrument advancement element with respect to the housing, the instrument is configured to advance beyond the distal end of the housing (as can be seen in Fig. 2D), wherein cannula is configured to extend through the septum (para [0054]) to place the fluid flow path of the blood access device in fluid communication with the diagnostic device (para [0053]-[0054], [0061], and [0066]).
It would have been obvious to a skilled artisan to modify Burkholz’551 to include the blood access device comprising: a housing; an instrument disposed within the housing; and an instrument advancement element comprising a cannula, wherein in response to movement of the instrument advancement element with respect to the housing, the instrument is configured to advance beyond the distal end of the housing, wherein cannula is configured to extend through the septum to place the fluid flow path of the blood access device in fluid communication with the diagnostic device, in view of the teachings of Burkholz’640, for the obvious advantage of sealing the diagnostic device until the time/position when the patient’s vasculature is accessed by the blood collection device.
For claim 3, Burkholz’551 further discloses wherein the diagnostic device is configured to receive a sample volume of 0.3 to 500 microliters (para [0038]).
For claim 4, Burkholz’551 further discloses wherein the diagnostic device is configured to receive a sample volume of 0.3 to 100 microliters (para [0038]).
For claim 5, Burkholz’551 further discloses wherein the blood access device comprises a peripheral intravenous catheter (para [0034]).
For claim 6, Burkholz’551 further discloses wherein the blood access device comprises extension tubing (20).
For claim 7, Burkholz’551 further discloses wherein the diagnostic device comprises a diagnostic test cartridge (138).
For claim 9, Burkholz’551 further discloses wherein a body of the diagnostic test cartridge is cylindrical (as can be seen in Fig. 1).
For claim 10, Burkholz’551 further discloses wherein a body of the diagnostic test cartridge is planar (as can be seen in Fig. 14).
For claim 12, Burkholz’551, as modified, further discloses wherein the housing of the blood access device comprises a distal opening (opening is distal of the proximal end of element 28 shown in Fig. 2D of Burkholz’640) configured to receive at least a portion of the diagnostic device (as can be seen in Fig. 2D of Burkholz’640).
For claim 13, Burkholz’551, as modified, further discloses wherein the instrument comprises a flow tube or a helical coil (para [0041] of Burkholz’640) (also see para [0042] of Burkholz’640).
For claim 14, Burkholz’551 further discloses wherein the diagnostic device comprises a diagnostic test strip (para [0037]).
For claim 16, Burkholz’551 further discloses wherein the diagnostic device comprises a visual indicator (para [0011]).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz’551 in view of Burkholz’640, and further in view of U.S. Patent Application Publication No. 2007/0031283 to Davis et al. (hereinafter “Davis”).
For claim 15, Burkholz’551, Ehrenreich, and Burkholz’640 do not expressly disclose wherein the diagnostic device comprises a lateral flow assay.
However, Davis teaches wherein the diagnostic device comprises a lateral flow assay (para [0137] and [0149]).
It would have been obvious to a skilled artisan to modify Burkholz’551 wherein the diagnostic device comprises a lateral flow assay, in view of the teachings of Davis, for the obvious advantage of determining the presence of absence of a particular analyte in the sample.
Response to Arguments
Applicant’s arguments filed 9/1/26 have been fully considered.
With respect to the claim objection, Applicant’s amendments and arguments are persuasive and thus the objection is withdrawn.
With respect to the 103 rejections, Applicant’s arguments will be treated in the order they were presented. With respect to the first argument, claim 1 explicitly recites that “the diagnostic device configured to receive a sample of blood.” The “blood sampling device 110” also receives a sample of blood (see para [0033] of Burkholz’551). Therefore, the citation meets the claim language in how the diagnostic device is defined in the claim. Additionally, the “blood sampling device 110” and the “diagnostic device” are both devices and the difference is the “blood sampling” versus “diagnostic.” However, blood sampling is part of the diagnostic process itself as evidenced by para [0033] of Burkholz’551, which states “a blood sampling device 100, used to collect a blood sample for use in point-of-care testing and analysis” (emphasis added). Additionally, para [0036] of Burkholz’551 discloses that “[t]he blood sampling device 100 can … draw a diagnostic blood sample from the patient” (emphasis added). So if the device 100 draws a “diagnostic” blood sample, how is it not a “diagnostic” device? With respect to the next argument, Burkholz’640 is not relied upon for teaching the diagnostic device being configured to be detached from the blood access device. With respect to the next argument, Burkholz’551 is not deficient for the reason(s) above and therefore Davis does not need to be relied upon for teaching those aspects of the claim language.
Conclusion
THIS ACTION IS MADE FINAL. 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 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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