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 3/23/26, amended claim(s) 1 and 12-13, canceled claim(s) 2, 8, and 11, and new claims 21-22 is/are acknowledged. The following new and/or reiterated ground(s) of rejection is/are set forth:
Election/Restrictions
Newly submitted claim(s) 21-22 is/are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
The invention of claims 1, 3-7, 9-10, and 12-16 and the invention of claim 21 are directed to related apparatuses. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed can have a materially different design, mode of operation, function, or effect as evidenced by “an instrument advancement element comprising a cannula,” “a diagnostic device comprising a septum,” and “wherein the cannula is configured to extend through the septum to place the fluid path of the blood access device in fluid communication with the diagnostic device,” as recited in claim 1 and “a housing comprising a distal opening,” and “the distal opening is configured to receive at least a portion of the diagnostic device,” as recited in claim 21. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
The invention of claims 1, 3-7, 9-10, and 12-16 and the invention of claim 22 are directed to related apparatuses. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed can have a materially different design, mode of operation, function, or effect as evidenced by “an instrument advancement element comprising a cannula,” and “a diagnostic device comprising a septum,” as recited in claim 1 and “an instrument advancement element comprising a septum,” and “a diagnostic device comprising a cannula,” as recited in claim 22. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim(s) 21-22 is/are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim Objections
Claim 1 objected to because of the following informalities: “the fluid path” (line 10) appears that it should be “the fluid flow path.”
Appropriate correction is required.
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 3/23/26 have been fully considered.
With respect to the 112 rejections, Applicant’s amendments and arguments are persuasive and thus the rejections are withdrawn.
With respect to the 102/103 rejections, Applicant’s arguments have been considered but are moot because the arguments do not address the new grounds of rejection.
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