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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 21 August 2026 has been entered.
The Examiner acknowledges the amendments to claims 11-12. Claims 1-20 and 22 are pending, with claims 1-6 and 14-17 standing as previously withdrawn.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters “102” and “152” are both used to designate the “instrument” in Fig. 1F.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
Examiner Notes: currently, NO limitation invokes interpretation under § 112(f).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim(s) 18, 20, and 22 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 2 of U.S. Patent No. 11,969,247, hereinafter Burkholz ‘247 in view of Burkholz (US-20140309551-A1), hereinafter Burkholz ‘551.
Conflicting claim 2 of Burkholz ‘247 is considered to anticipate almost each and every limitation of claim 18 of the instant application [see comparison below], except wherein the blood sample collection device is operatively connected to the advancement element “to collect a small volume blood sample of 0.3 to 500 microliters, wherein the blood sample collection device is configured to be removed from operative connection with the advancement element after the small volume blood sample has been received in the blood sample collection device for analysis by a point-of-care device”.
Burkholz ‘551 discloses a blood sample collection system, wherein Burkholz ‘551 discloses a vascular access device comprising a proximal end that is fluidically coupled to an extension tube [A clinician establishes a vascular access site on a patient using any known means for establishing such access such as a needle 14, catheter 16, or blood collection set as is known in the art. The needle 14 and/or catheter 16 may include a shielding structure 18 for shielding a user from the needle 14 as well as other safety structures as are known in the art. Extension tubing 20 is connected to the vascular access device 12 and extends from the vascular access site to an open end of the tube having a port or luer access adapter 22 (Burkholz ‘551 ¶0056, Fig. 13)], wherein a proximal end of the extension tube is fluidically coupled and operatively connected to a blood sample collection device that is configured to collect a small volume blood sample of 0.1 microliters [With reference now to FIGS. 8-10, a further embodiment of an extravascular system 10 including the vascular access device 12 having a through-portion 210 and a side port 212 is depicted. The through portion 210 includes a main outflow port 214 in addition to the side port 212. The main outflow port 214 and/or the side port 212 may include female luer lock connections configured to receive a corresponding narrow tubular portion 120 of a blood sampling device 110, as is depicted in FIG. 8 (Burkholz ‘551 ¶0051, Fig. 8); The housing body 114 of the biological sampling device 110 includes a narrow tubular portion 120 having an access lumen 122 configured to establish fluid communication with the separate vascular access device 12… The reservoir 118 is enclosed within the housing body 114 and includes an internal volume sufficient to contain enough blood for use in a diagnostic test, for example, an internal volume of between about 0.1 mL and about 10 mL (Burkholz ‘551 ¶0038, Figs. 2-4)], wherein the blood sample collection device is configured to be removed from operative connection to the extension tube after the small volume blood sample has been received in the blood sample collection device for analysis by a point-of-care device [Once a sufficient portion of blood is retained within the reservoir 118, the sampling device 110 and connected collection device 112 can be removed from the extravascular system 10. Blood can be ejected through the access lumen 122 of the sampling device 110 for testing and analysis according to the process described above (Burkholz ‘551 ¶0050); Once the blood sampling device 110 is removed from the extravascular system 10, blood may be expelled from the sampling device 110, as described in greater detail below, to a point-of-care testing device 30 (shown in FIG. 14) such as a test strip, glass slide, diagnostic cartridge, or other testing device for testing and analysis (Burkholz ‘551 ¶0037, Fig. 14)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of conflicting Burkholz ‘247 to employ wherein the blood sample collection device is configured to collect a small volume blood sample of 0.3 to 500 microliters, wherein the blood sample collection device is configured to be removed from operative connection with the advancement element after the small volume blood sample has been received in the blood sample collection device for analysis by a point-of-care device, so as to reduce the number of processing steps and amount of time between sampling and obtaining blood test results [Burkholz ‘551 ¶0060], and as the modification to employ wherein the blood sample collection device is configured to collect a small volume blood sample of 0.3 to 500 microliters is considered to amount to mere simple substitution of one known element for another with similar expected results [blood sample collection device of Burkholz ‘247 for the blood sample collection device of Burkholz ‘551 (¶0038), each configured to collect a blood sample] [MPEP § 2143(I)(B)].
Conflicting claim 2 of Burkholz ‘247 in view of Burkholz ‘551 is further considered to render obvious instant claims 20 and 22.
Claim 18 of the Instant Application
Claim 2 of Conflicting Patent No. 11,969,247, hereinafter Burkholz ‘247 [wherein conflicting claim 2 is considered to incorporate the subject matter of conflicting claim 1 therein]
An instrument advancement device, comprising:
A vascular access device [Col 13:32]
the proximal end of the another catheter, including the blood collection adapter, being configured to move along the slot from a proximal position distal to the proximal end of the slot to a distal position [Col 13:54-58]
[wherein as the another catheter is configured to be moved along the slot from a proximal position to a distal position (advanced), the vascular access device is considered to be an instrument (the another catheter) advancement device]
a housing comprising a distal end and a proximal end;
an extension comprising: a housing having a proximal end, a distal end [Col 13:43-44]
an instrument disposed within the housing;
another catheter disposed within the housing [Col 13:49]
an advancement element, wherein in response to movement of the advancement element with respect to the housing, the instrument is configured to advance distal to the distal end of the housing, and
wherein the proximal end of the another catheter extends out through the slot to form a blood collection adapter, the proximal end of the another catheter, including the blood collection adapter, being configured to move along the slot from a proximal position distal to the proximal end of the slot to a distal position [Col 13:52-58]
wherein in response to movement of the proximal end of the another catheter from the proximal position to the distal position and withdrawal of the introducer needle, the blunt distal tip of the another catheter is configured to advance out through the catheter to thereby enable blood to be collected directly from a patient's vasculature via the blood collection adapter [Col 13:63-14:3]
[wherein the blood collection adapter is considered to read on the claimed “advancement element” due to the broad instant claim language, and as the blood collection adapter is physically coupled to the another catheter to function similar to the instant advancement element; and wherein as the blunt distal tip of the another catheter is configured to advance into the vasculature through the catheter, the another catheter is considered to be configured to advance distal to the distal end of the housing]
a blood sample collection device operatively connected to the advancement element to collect a small volume blood sample of 0.3 to 500 microliters, wherein the blood sample collection device is configured to be removed from operative connection with the advancement element after the small volume blood sample has been received in the blood sample collection device for analysis by a point-of-care device.
wherein the proximal end of the another catheter extends out through the slot to form a blood collection adapter [Col 13:52-54]
wherein the blood collection adapter comprises a cavity configured to receive a syringe or a blood collection tube [Col 14:6-8]
[wherein the proximal end of the another catheter forming the blood collection adapter that is configured to receive a blood collection is considered to read on a blood sample collection device being “operatively connected” to the advancement element]
Claim(s) 7-10 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 6 of U.S. Patent No. 12,636,479, hereinafter Harding in view of Burkholz ‘551.
Conflicting claim 6 is considered to anticipate almost each and every limitation of claim 7 of the instant application [see comparison below], except for “a blood sample collection device integrated into the distal end of the housing, wherein the blood sample collection device is configured to receive and hold a blood sample and is detachable from the housing to dispense the blood sample to a point-of-care instrument or device for testing and analysis”.
Burkholz ‘551 discloses a blood sample collection system, wherein Burkholz discloses a vascular access device that is fluidically coupled to a distal end of an extension tube [Burkholz ‘551 ¶0056, Fig. 13], wherein a proximal end of the extension tube is fluidically coupled and operatively connected to a blood sample collection device [Burkholz ‘551 ¶¶0038, 0051, Figs. 2-4, 8], wherein the blood sample collection device is detachable from the extension tube to dispense the blood sample to a point-of-care instrument or device for testing and analysis [Burkholz ‘551 ¶¶0037, 0050, Fig. 14].
As Harding already claims an extension tube extending from the housing at a distal position of the housing [Harding Col 14:56-60], it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the conflicting device of Harding to employ a blood sample collection device integrated into the distal end of the housing, wherein the blood sample collection device is configured to receive and hold a blood sample, so as to reduce the number of processing steps and amount of time between sampling and obtaining blood test results [Burkholz ‘551 ¶0060].
Conflicting claim 6 of Harding in view of Burkholz ‘551 is further considered to render obvious instant claims 8-10.
Claim 7 of the Instant Application
Claim 6 of Conflicting Patent No. 12,636,479, hereinafter Harding [wherein conflicting claim 6 is considered to incorporate the subject matter of conflicting claim 1 therein]
An instrument advancement device, comprising:
A vascular access device [Col 14:15]
wherein in response to movement of the advancement tab from the retracted position to the advanced position, the distal tip of the instrument is advanced beyond the distal end of the housing [Col 14:30-33]
[wherein the conflicting vascular access device being configured to advance an instrument is considered to define an instrument advancement device]
a housing comprising a distal end and a proximal end;
a housing, comprising a proximal end, a distal end [Col 14:16]
an instrument disposed within the housing;
an instrument disposed within the housing [Col 14:27]
an advancement element, wherein in response to movement of the advancement element with respect to the housing, the instrument is configured to advance distal to the distal end of the housing, and
an advancement tab configured to move linearly along the slot between a retracted position and an advanced position [Col 14:17-19]
wherein in response to movement of the advancement tab from the retracted position to the advanced position, the distal tip of the instrument is advanced beyond the distal end of the housing [Col 14:30-33]
a blood sample collection device integrated into the distal end of the housing, wherein the blood sample collection device is configured to receive and hold a blood sample and is detachable from the housing to dispense the blood sample to a point-of-care instrument or device for testing and analysis.
further comprising an extension tube extending from the housing between the distal end of the housing and a distal end of the slot, wherein a blood collection pathway extends through the extension tube [Col 14:56-60]
Claim(s) 18 and 22 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 3 of U.S. Patent No. 12,343,145, hereinafter Burkholz ‘145 in view of Burkholz ‘551.
Conflicting claim 3 of Burkholz ‘145 is considered to anticipate almost each and every limitation of claim 18 of the instant application [see comparison below], except wherein the blood sample collection device is operatively connected to the advancement element “to collect a small volume blood sample of 0.3 to 500 microliters, wherein the blood sample collection device is configured to be removed from operative connection with the advancement element after the small volume blood sample has been received in the blood sample collection device for analysis by a point-of-care device”.
Burkholz ‘551 discloses a blood sample collection system, wherein Burkholz ‘551 discloses a vascular access device comprising a proximal end that is fluidically coupled to an extension tube [Burkholz ‘551 ¶0056, Fig. 13], wherein a proximal end of the extension tube is fluidically coupled and operatively connected to a blood sample collection device that is configured to collect a small volume blood sample of 0.1 microliters [Burkholz ‘551 ¶¶0038, 0051, Figs. 2-4, 8], wherein the blood sample collection device is configured to be removed from operative connection to the extension tube after the small volume blood sample has been received in the blood sample collection device for analysis by a point-of-care device [Burkholz ‘551 ¶¶0037, 0050, Fig. 14].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of conflicting Burkholz ‘145 to employ wherein the blood sample collection device is configured to collect a small volume blood sample of 0.3 to 500 microliters, wherein the blood sample collection device is configured to be removed from operative connection with the advancement element after the small volume blood sample has been received in the blood sample collection device for analysis by a point-of-care device, so as to reduce the number of processing steps and amount of time between sampling and obtaining blood test results [Burkholz ‘551 ¶0060], and as the modification to employ wherein the blood sample collection device is configured to collect a small volume blood sample of 0.3 to 500 microliters is considered to amount to mere simple substitution of one known element for another with similar expected results [blood sample collection device of Burkholz ‘145 for the blood sample collection device of Burkholz ‘551 (¶0038), each configured to collect a blood sample] [MPEP § 2143(I)(B)].
Conflicting claim 3 of Burkholz ‘145 in view of Burkholz ‘551 is further considered to render obvious instant claim 22.
Claim 18 of the Instant Application
Claim 3 of Conflicting Patent No. 12,343,145, hereinafter Burkholz ‘145 [wherein conflicting claim 3 is considered to incorporate the subject matter of conflicting claim 1 therein]
An instrument advancement device, comprising:
An extension set to provide access to a patient's vascular system [Col 11:62-63]
wherein the translation handle is configured to move along the outer surface of the tube between a proximal position and a distal position to translate the distal end of the instrument between a retracted position and an advanced position [Col 12:2-6]
[wherein the conflicting extension set being configured to advance an instrument is considered to define an instrument advancement device]
a housing comprising a distal end and a proximal end;
a tube, comprising a proximal end, a distal end, and an outer surface [Col 11:64-65]
an instrument disposed within the housing;
an instrument disposed within the tube [Col 11:66-67]
an advancement element, wherein in response to movement of the advancement element with respect to the housing, the instrument is configured to advance distal to the distal end of the housing, and
a translation handle coupled to the outer surface of the tube, wherein the translation handle is configured to move along the outer surface of the tube between a proximal position and a distal position to translate the distal end of the instrument between a retracted position and an advanced position, wherein in response to the distal end of the instrument being in the advanced position, the distal end of the instrument extends beyond the distal end of the tube [Col 12:1-9]
a blood sample collection device operatively connected to the advancement element to collect a small volume blood sample of 0.3 to 500 microliters, wherein the blood sample collection device is configured to be removed from operative connection with the advancement element after the small volume blood sample has been received in the blood sample collection device for analysis by a point-of-care device.
further comprising a fluid path assembly comprising the instrument, a proximal end, and a distal end, wherein an extension tube is coupled to the proximal end of the instrument and wherein the proximal end of the fluid path assembly comprises a proximal connector configured to connect to a blood collection device [Col 12:26-31]
[wherein the extension tube being physically coupled to the proximal end of the instrument, which is physically coupled to translation handle, is considered to define “operative connection” between the blood sample collection device (blood collection device) and the advancement element (translation handle)
Claim(s) 7, 10, 12-13, 18-20, and 22 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 11, 15, and 19-20 of copending Application No. 18/646,142, hereinafter Govindaraj in view of Burkholz ‘551.
Conflicting claim 11 of Govindaraj is considered to anticipate almost each and every limitation of claim 7 of the instant application [see comparison below], except the limitation “wherein the blood sample collection device… is detachable from the housing to dispense the blood sample to a point-of-care instrument or device for testing and analysis”.
Burkholz ‘551 discloses a blood sample collection system, wherein Burkholz discloses a vascular access device that is fluidically coupled to a distal end of an extension tube [Burkholz ‘551 ¶0056, Fig. 13], wherein a proximal end of the extension tube is fluidically coupled and operatively connected to a blood sample collection device [Burkholz ‘551 ¶¶0038, 0051, Figs. 2-4, 8], wherein the blood sample collection device is detachable from the extension tube to dispense the blood sample to a point-of-care instrument or device for testing and analysis [Burkholz ‘551 ¶¶0037, 0050, Fig. 14].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Govindaraj to employ wherein the blood sample collection device is detachable from the housing to dispense the blood sample to a point-of-care instrument or device for testing and analysis, so as to reduce the number of processing steps and amount of time between sampling and obtaining blood test results [Burkholz ‘551 ¶0060].
Conflicting claim 11 of Govindaraj in view of Burkholz ‘551 further render obvious instant claims 10 and 12-13.
Claim 7 of the Instant Application
Claim 11 of Conflicting Patent Application 18/646,142, hereinafter Govindaraj [which is considered to incorporate the subject matter of claim 1]
An instrument advancement device, comprising:
A blood draw device for use with a catheter assembly, the blood draw comprising:… an advancement member movably coupled to the housing and configured to move relative to the housing to move the catheter tube between a first position, in which the catheter tube is disposed within the housing, and a second position, in which a distal end of the catheter tube is disposed beyond the distal end of the housing [Govindaraj claim 1, lines 1-2, 11-16]
a housing comprising a distal end and a proximal end;
a housing having a proximal end and a distal end, the housing defining a housing lumen at the distal end and defining an inner volume that is proximal to the housing lumen [Govindaraj claim 1, lines 3-6]
an instrument disposed within the housing;
a catheter tube movably received within the housing [Govindaraj claim 1, line 10]
an advancement element, wherein in response to movement of the advancement element with respect to the housing, the instrument is configured to advance distal to the distal end of the housing, and
an advancement member movably coupled to the housing and configured to move relative to the housing to move the catheter tube between a first position, in which the catheter tube is disposed within the housing, and a second position, in which a distal end of the catheter tube is disposed beyond the distal end of the housing [Govindaraj claim 1, lines 11-16]
a blood sample collection device integrated into the distal end of the housing, wherein the blood sample collection device is configured to receive and hold a blood sample and is detachable from the housing to dispense the blood sample to a point-of-care instrument or device for testing and analysis.
a first port provided on the housing at the distal end, the first port in fluid communication with the housing lumen [Govindaraj claim 1, lines 17-19]
wherein each of the first port and the second port comprises a vacutainer port including: an outer collar; and a needle positioned within a circumference of the outer collar and secured to the housing, the needle comprising: a needle lumen therein in fluid communication with the housing lumen; and a needle tip positioned to pierce a seal of a vacutainer connected to the vacutainer port, thereby placing an inner chamber of the vacutainer in fluid communication with the needle lumen [Govindaraj claim 11, lines 1-13]
Conflicting claim 15 of Govindaraj is considered to anticipate each and every limitation of claim 18 of the instant application [see comparison below], except the limitation wherein the small volume sample is “of 0.3 to 500 microliters”, as Govindaraj is non-specific regarding the particular volume, and “wherein the blood sample collection device is configured to be removed from operative connection with the advancement element after the small volume blood sample has been received in the blood sample collection device for analysis by a point-of-care device”.
Burkholz ‘551 discloses a blood sample collection system, wherein Burkholz ‘551 discloses a vascular access device comprising a proximal end that is fluidically coupled to an extension tube [Burkholz ‘551 ¶0056, Fig. 13], wherein a proximal end of the extension tube is fluidically coupled and operatively connected to a blood sample collection device that is configured to collect a small volume blood sample of 0.1 microliters [Burkholz ‘551 ¶¶0038, 0051, Figs. 2-4, 8], wherein the blood sample collection device is configured to be removed from operative connection to the extension tube after the small volume blood sample has been received in the blood sample collection device for analysis by a point-of-care device [Burkholz ‘551 ¶¶0037, 0050, Fig. 14].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Govindaraj to employ wherein the blood sample collection device is configured to collect a small volume blood sample of 0.3 to 500 microliters, wherein the blood sample collection device is configured to be removed from operative connection with the advancement element after the small volume blood sample has been received in the blood sample collection device for analysis by a point-of-care device, so as to reduce the number of processing steps and amount of time between sampling and obtaining blood test results [Burkholz ‘551 ¶0060], and as the modification to employ wherein the blood sample collection device is configured to collect a small volume blood sample of 0.3 to 500 microliters is considered to amount to mere simple substitution of one known element for another with similar expected results [blood sample collection device of Govindaraj for the blood sample collection device of Burkholz ‘551 (¶0038), each configured to collect a blood sample] [MPEP § 2143(I)(B)].
Conflicting claims 15 and 19-20 of Govindaraj as modified by Burkholz ‘551 are further considered to render obvious instant claims 19-20 and 22.
Claim 18 of the Instant Application
Claim 15 of Conflicting Patent Application 18/646,142 (Govindaraj)
An instrument advancement device, comprising:
a blood draw device… the blood draw device comprising:… a catheter tube movably received within the housing; an advancement member movably coupled to the housing and configured to move relative to the housing to move the catheter tube between a first position, in which the catheter tube is disposed within the housing, and a second position, in which a distal end of the catheter tube is disposed beyond the distal end of the housing and beyond a distal end of the indwelling catheter [Govindaraj claim 15, lines 3, 4-5, 10, 11-18]
a housing comprising a distal end and a proximal end;
a housing having a proximal end and a distal end [Govindaraj claim 15, line 6]
an instrument disposed within the housing;
a catheter tube movably received within the housing [Govindaraj claim 15, line 10]
an advancement element, wherein in response to movement of the advancement element with respect to the housing, the instrument is configured to advance distal to the distal end of the housing, and
an advancement member movably coupled to the housing and configured to move relative to the housing to move the catheter tube between a first position, in which the catheter tube is disposed within the housing, and a second position, in which a distal end of the catheter tube is disposed beyond the distal end of the housing and beyond a distal end of the indwelling catheter [Govindaraj claim 15, lines 11-18]
a blood sample collection device operatively connected to the advancement element to collect a small volume blood sample of 0.3 to 500 microliters, wherein the blood sample collection device is configured to be removed from operative connection with the advancement element after the small volume blood sample has been received in the blood sample collection device for analysis by a point-of-care device.
a first port provided on the housing at the distal end, the first port in fluid communication with the housing lumen… connecting a first vacutainer to the first port with the catheter tube in the first position, with a first blood sample being drawn into the first vacutainer upon connection thereof to the first port [Govindaraj claim 15, lines 19-21, 31-34]
[In Innova/Pure Water Inc. v. Safari Water Filtration Sys. Inc., 381 F.3d 1111, 1117-20, 72 USPQ2d 1001, 1006-08 (Fed. Cir. 2004), the court noted that the claim term "operatively connected" is "a general descriptive claim term frequently used in patent drafting to reflect a functional relationship between claimed components," that is, the term "means the claimed components must be connected in a way to perform a designated function." (see MPEP § 2173.05(g)), wherein the Examiner notes that the position of the catheter tube as positioned by the advancement element affects the operation of the first vacutainer (blood sample collection device), such that the first vacutainer is considered to be operatively connected to the advancement element]
This is a provisional nonstatutory double patenting rejection.
Claim(s) 7 and 12 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of copending Application No. 17/752,312, hereinafter Burkholz ‘312 in view of Burkholz ‘551.
Conflicting claim 6 of Burkholz ‘312 is considered to anticipate almost each and every limitation of claim 7 of the instant application [see comparison below], except the limitation “wherein the blood sample collection device… is detachable from the housing to dispense the blood sample to a point-of-care instrument or device for testing and analysis”.
Burkholz ‘551 discloses a blood sample collection system, wherein Burkholz discloses a vascular access device that is fluidically coupled to a distal end of an extension tube [Burkholz ‘551 ¶0056, Fig. 13], wherein a proximal end of the extension tube is fluidically coupled and operatively connected to a blood sample collection device [Burkholz ‘551 ¶¶0038, 0051, Figs. 2-4, 8], wherein the blood sample collection device is detachable from the extension tube to dispense the blood sample to a point-of-care instrument or device for testing and analysis [Burkholz ‘551 ¶¶0037, 0050, Fig. 14].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Burkholz ‘312 to employ wherein the blood sample collection device is detachable from the housing and is configured to dispense the blood sample to a point-of-care instrument or device for testing and analysis, so as to reduce the number of processing steps and amount of time between sampling and obtaining blood test results [Burkholz ‘551 ¶0060].
Conflicting claim 6 of Burkholz ‘312 in view of Burkholz ‘551 further render obvious instant claim 12.
Claim 7 of the Instant Application
Claim 6 of Conflicting Patent Application 17/752,312, hereinafter Burkholz ‘312 [which is considered to incorporate the subject matter of claims 1 and 4]
An instrument advancement device, comprising:
A catheter extension set, comprising:… an advancement element… an instrument [Burkholz claim 1, lines 1, 7, 10]
a housing comprising a distal end and a proximal end;
a housing, comprising a distal end, a proximal end [Burkholz claim 1, line 2]
an instrument disposed within the housing;
an instrument extending through the U-shaped channel, wherein the instrument comprises a fixed first end and a second end [claim 1, lines 9-12]
an advancement element, wherein in response to movement of the advancement element with respect to the housing, the instrument is configured to advance distal to the distal end of the housing, and
a handle; an advancement element comprising a U-shaped channel and a pocket, wherein the advancement element is disposed within the lumen;… wherein in response to distal movement of the handle a first distance, the second end is configured to advance distally a second distance, wherein the second distance is at least twice the first distance; and a translation feature disposed between the handle and an outer surface of the housing and within the pocket such that in response to distal movement of the handle the first distance, the translation feature moves distally outside of the lumen in response to distal movement of the handle the first distance, the advancement element moves distally within the lumen the first distance and the second end of the instrument advances distally the second distance [claim 1, lines 6-8, 13-17, wherein the Examiner notes that any “distal” portion of the housing may define a “distal” end of the housing, such that the advancement of the instrument may be considered to advance distal to the “distal” end]
a blood sample collection device integrated into the distal end of the housing, wherein the blood sample collection device is configured to receive and hold a blood sample and is detachable from the housing to dispense the blood sample to a point-of-care instrument or device for testing and analysis.
wherein the housing further comprises another lumen, wherein the other lumen extends through the distal end of the housing and the proximal end of the housing and is configured for fluid flow therethrough [claim 4, lines 1-4]
further comprising a blood collection device in fluid communication with the distal connector and the other lumen [claim 6, lines 1-2]
This is a provisional nonstatutory double patenting rejection.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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) 7-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz (US-20200016374-A1, previously presented), hereinafter Burkholz ‘374, in view of Burkholz (US-20140309551-A1), hereinafter Burkholz ‘551.
Regarding claim 7, Burkholz ‘374 teaches
An instrument advancement device, comprising:
a housing comprising a distal end and a proximal end [a housing 14. In some embodiments, the housing may include a distal end 16, a proximal end 18 (Burkholz ‘374 ¶0033, Fig. 1A-C)];
an instrument disposed within the housing [the delivery device 10 may facilitate delivery of an instrument, such as, for example, a catheter 12, into an intravenous catheter assembly and/or a vein of a patient. In some embodiments, the delivery device 10 may facilitate placement of the catheter 12 into a second catheter, which may include an indwelling peripheral intravenous catheter (“PIVC”) (Burkholz ‘374 ¶0032); the housing 14 may encase or enclose the instrument when the instrument is in a retracted position (Burkholz ‘374 ¶0033, Figs. 1A-C)];
an advancement element, wherein in response to movement of the advancement element with respect to the housing, the instrument is configured to advance distal to the distal end of the housing [the guide feature 22 may include an advancement tab 26, which may be configured to be moved by a hand of a user. In some embodiments, the guide feature 22 may be moveable along the slot 20 to advance the instrument in a distal direction 23 and/or retract the instrument in a proximal direction 25 (Burkholz ‘374 ¶0034, Figs. 1A-C); in response to movement of the guide feature 22 along the slot 20 in the distal direction 23, a first end 28 of the instrument may be advanced distally (Burkholz ‘374 ¶0037)], and
a blood sample collection device integrated into the distal end of the housing, wherein the blood sample collection device is configured to receive and hold a blood sample [the second end 30 of the instrument may be coupled to extension tubing 32. In some embodiments, the extension tubing 32 may be coupled to a blood collection device. In some embodiments, the blood collection device may include any suitable type of blood collection device. In some embodiments, the blood collection device may include a reservoir. In some embodiments, the blood collection device may include a vacuum tube, test tube, or syringe. In some embodiments, the blood collection device may include an adapter, which may be configured to hold a test tube or syringe. In some embodiments, a fluid pathway of the delivery device 10 may include the catheter 12 and the extension tubing 32 (Burkholz ‘374 ¶0039, Figs. 1A-C), wherein as depicted in Burkholz ‘374 Figs. 1A-C, the second end 30 is positioned at the distal end 16 of the housing 14].
However, Burkholz ‘374 fails to explicitly disclose wherein the blood sample collection device is detachable from the housing to dispense the blood sample to a point-of-care instrument or device for testing and analysis.
Burkholz ‘551 discloses a blood sample collection system, wherein Burkholz discloses a vascular access device that is fluidically coupled to a distal end of an extension tube [A clinician establishes a vascular access site on a patient using any known means for establishing such access such as a needle 14, catheter 16, or blood collection set as is known in the art. The needle 14 and/or catheter 16 may include a shielding structure 18 for shielding a user from the needle 14 as well as other safety structures as are known in the art. Extension tubing 20 is connected to the vascular access device 12 and extends from the vascular access site to an open end of the tube having a port or luer access adapter 22 (Burkholz ‘551 ¶0056, Fig. 13)], wherein a proximal end of the extension tube is fluidically coupled and operatively connected to a blood sample collection device [With reference now to FIGS. 8-10, a further embodiment of an extravascular system 10 including the vascular access device 12 having a through-portion 210 and a side port 212 is depicted. The through portion 210 includes a main outflow port 214 in addition to the side port 212. The main outflow port 214 and/or the side port 212 may include female luer lock connections configured to receive a corresponding narrow tubular portion 120 of a blood sampling device 110, as is depicted in FIG. 8 (Burkholz ‘551 ¶0051, Fig. 8); The housing body 114 of the biological sampling device 110 includes a narrow tubular portion 120 having an access lumen 122 configured to establish fluid communication with the separate vascular access device 12… The reservoir 118 is enclosed within the housing body 114 and includes an internal volume sufficient to contain enough blood for use in a diagnostic test, for example, an internal volume of between about 0.1 mL and about 10 mL (Burkholz ‘551 ¶0038, Figs. 2-4)], wherein the blood sample collection device is detachable from the extension tube to dispense the blood sample to a point-of-care instrument or device for testing and analysis [Once a sufficient portion of blood is retained within the reservoir 118, the sampling device 110 and connected collection device 112 can be removed from the extravascular system 10. Blood can be ejected through the access lumen 122 of the sampling device 110 for testing and analysis according to the process described above (Burkholz ‘551 ¶0050); Once the blood sampling device 110 is removed from the extravascular system 10, blood may be expelled from the sampling device 110, as described in greater detail below, to a point-of-care testing device 30 (shown in FIG. 14) such as a test strip, glass slide, diagnostic cartridge, or other testing device for testing and analysis (Burkholz ‘551 ¶0037, Fig. 14)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Devgon to employ wherein the blood sample collection device is detachable from the housing to dispense the blood sample to a point-of-care instrument or device for testing and analysis, so as to reduce the number of processing steps and amount of time between sampling and obtaining blood test results [Burkholz ‘551 ¶0060].
Regarding claim 8, Burkholz ‘374 in view of Burkholz ‘551
The instrument advancement device of claim 7, wherein an opening of the blood sample collection device is in fluid communication with a fluid path defined by the instrument [Burkholz ‘374 ¶0039].
Regarding claim 9, Burkholz ‘374 in view of Burkholz ‘551
The instrument advancement device of claim 7, wherein the blood sample collection device is configured for removal from the housing once a small volume blood sample has been received in the blood sample collection device for point-of-care testing, and wherein the small volume blood sample is 0.3 to 500 microliters [See § 103 modification of claim 7; Burkholz ‘551 ¶¶0037-0038, 0050].
Regarding claim 10, Burkholz ‘374 in view of Burkholz ‘551
The instrument advancement device of claim 7, further comprising a fluid chamber access port defined in the distal end of the housing to receive the blood sample collection device [Burkholz ‘374 ¶0039, Figs. 1A-C].
Claim(s) 11 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz ‘374 in view of Burkholz ‘551, as applied to claims 7 and 10 above, in further view of McNamara (US-6042567-A, previously presented).
Regarding claim 11, Burkholz ‘374 in view of Burkholz ‘551
The instrument advancement device of claim 10.
However, Burkholz ‘374 in view of Burkholz ‘551 fails to explicitly disclose wherein the fluid chamber access port includes a seal that prevents blood from exiting the housing after the blood sample collection device has been removed from the housing.
McNamara discloses systems for fluid withdrawal from a patient, wherein McNamara discloses a housing comprising a fluid chamber access port, wherein the fluid chamber access port includes a seal that prevents fluid from exiting the housing after a blood sample collection device has been removed from the housing [Preferably, the controlling means includes a valve such as a two-way stopcock 44 in fluidic connection with each side port 24 for closing or opening the side port 20 so fluid based material can continually flow into or out of the body. Essentially, any device that serves to control or limit the flow as desired can also perform the same function as the stopcock (McNamara Col 3:33-39, Fig. 1); The stopcock 44 is in the open position to allow blood to flow through the side port 24 to be collected at a hook-up site 46 at the end of the side port 24. If, for instance, glucose or other fluid based drugs are desired to be introduced into the patient, the stopcock 44 is first repositioned to a closed position, preventing any flow through the side port 38. The instrument that collects the blood at the hook-up site 46 is withdrawn and replaced with an IV connected to the drug (McNamara Col 3:61-4:3, Fig. 1), wherein the Examiner notes that as depicted in at least McNamara Fig. 1, the stopcock 44 is coupled to side port 24].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Burkholz ‘374 in view of Burkholz ‘551 to employ wherein the fluid chamber access port includes a seal that prevents blood from exiting the housing after the blood sample collection device has been removed from the housing, so as to allow for user control of blood flow into the blood sample collection device and prevent blood from escaping the housing when the blood sample collection device is not coupled to the housing.
Regarding claim 13, Burkholz ‘374 in view of Burkholz ‘551
The instrument advancement device of claim 7.
However, Burkholz ‘374 in view of Burkholz ‘551 fails to explicitly disclose wherein a fluid chamber access port provided on the housing includes a valve member that moves between an open position in which blood is free to flow into the blood sample collection device and a closed position in which the blood is prevented from entering the blood sample collection device.
McNamara discloses systems for fluid withdrawal from a patient, wherein McNamara discloses a housing comprising a fluid chamber access port, wherein the fluid chamber access port provided on the housing includes a valve member that moves between an open position in which blood is free to flow into the blood sample collection device and a closed position in which the blood is prevented from entering the blood sample collection device [McNamara Col 3:33-39, Col 3:61-4:3, Fig. 1, wherein the Examiner notes that as depicted in at least McNamara Fig. 1, the stopcock 44 is coupled to side port 24].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Burkholz ‘374 in view of Burkholz ‘551 to employ wherein a fluid chamber access port provided on the housing includes a valve member that moves between an open position in which blood is free to flow into the blood sample collection device and a closed position in which the blood is prevented from entering the blood sample collection device, so as to allow for user control of blood flow into the blood sample collection device and prevent blood from escaping the housing when the blood sample collection device is not coupled to the housing.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz ‘374 in view of Burkholz ‘551, as applied to claim 7 above, in further view of Devgon (US-20200100716-A1, previously presented), hereinafter Devgon ‘716.
Regarding claim 12, Burkholz ‘374 in view of Burkholz ‘551
The instrument advancement device of claim 7.
However, Burkholz ‘374 in view of Burkholz ‘551 fails to explicitly disclose wherein the blood sample collection device is pre-attached to a fluid chamber access port.
Devgon discloses a fluid transfer device configured to withdraw a volume of blood from a patient [a fluid transfer device can be used with the closed system access device 200 to, for example, transfer a bodily fluid from the patient to a fluid collection device, container, reservoir, etc. (Devgon ¶0067) By way of example, FIG. 5 is a perspective view of a fluid transfer device 210 according to an embodiment. As described in further detail herein, the fluid transfer device 210 can be used with the closed system access device 200 to transfer bodily fluid from the patient to one or more fluid collection devices, containers, reservoirs, etc. More particularly, in some instances, the access device 270 can be inserted into a patient such that the catheter 272 is at least partially disposed within a vein. In such instances, the fluid transfer device 210 can be used with (e.g., coupled to) the access device 270 and manipulated to withdraw a volume of blood from the vein of the patient into one or more fluid collection devices, reservoirs, containers, etc. (Devgon ¶0068)], wherein Devgon discloses pre-assembling and sterilizing elements of the fluid transfer device prior to use [the access device 270 and the insertion device 290 can be pre-assembled and sterilized during one or more manufacturing processes and provided to an end user as an integrated closed system (i.e., the closed system access device 200) (Devgon ¶0057)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Burkholz ‘374 in view of Burkholz ‘551 to employ wherein the blood sample collection device is pre-attached to a fluid chamber access port, so as to provide a pre-assembled and sterilized closed system to a user.
Claim(s) 18-20 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Devgon (US-20170216564-A1), hereinafter Devgon ‘564, in view of Burkholz (US-20140309551-A1), hereinafter Burkholz ‘551.
Regarding claim 18, Devgon ‘564 teaches
An instrument advancement device, comprising:
a housing comprising a distal end and a proximal end [introducer 210 (Devgon ‘564 Figs. 4-5); The first member 220 and the second member 230 collectively form a proximal end portion 211 and a distal end portion 212 of the introducer 210 and collectively define an inner volume 213 of the introducer 210 (Devgon ‘564 ¶0067)];
an instrument disposed within the housing [catheter 260 (Devgon ‘564 Fig. 5); the second portion 215 of the inner volume 213 can movably receive, for example, a portion of the actuator 270 and a portion of the catheter 260 (Devgon ‘564 ¶0072)];
an advancement element, wherein in response to movement of the advancement element with respect to the housing, the instrument is configured to advance distal to the distal end of the housing [actuator 270 (Devgon ‘564 Figs. 4-5); Thus, the actuator 270 can be moved relative to the introducer 210 to move the catheter 260 between a first position, in which the catheter 260 is entirely disposed within the second portion 215 of the inner volume 213, and a second position, in which at least a portion of the catheter 260 extends outside of the second portion 215 of the inner volume 213 and distal to the introducer 210, as described in further detail herein (Devgon ‘564 ¶0072)], and
a blood sample collection device operatively connected to the advancement element to collect a small volume blood sample [the proximal end portion 266 of the secondary catheter 265 is coupled to and/or otherwise includes a coupler 269. The coupler 269 is configured to physically and fluidically couple the secondary catheter 265 to any suitable device such as, for example, a fluid reservoir, fluid source, syringe, evacuated container holder (e.g., having a sheathed needle or configured to be coupled to a sheathed needle), pump, and/or the like (Devgon ‘564 ¶0085, Figs. 5, 16, 21-22, 28-29)].
However, Devgon ‘564 fails to explicitly disclose wherein the blood sample collection device [Devgon ‘564 ¶0085] is configured to collect a small volume blood sample of 0.3 to 500 microliters, wherein the blood sample collection device is configured to be removed from operative connection with the advancement element after the small volume blood sample has been received in the blood sample collection device for analysis by a point-of-care device.
Burkholz ‘551 discloses a blood sample collection system, wherein Burkholz ‘551 discloses a vascular access device comprising a proximal end that is fluidically coupled to an extension tube [A clinician establishes a vascular access site on a patient using any known means for establishing such access such as a needle 14, catheter 16, or blood collection set as is known in the art. The needle 14 and/or catheter 16 may include a shielding structure 18 for shielding a user from the needle 14 as well as other safety structures as are known in the art. Extension tubing 20 is connected to the vascular access device 12 and extends from the vascular access site to an open end of the tube having a port or luer access adapter 22 (Burkholz ‘551 ¶0056, Fig. 13)], wherein a proximal end of the extension tube is fluidically coupled and operatively connected to a blood sample collection device that is configured to collect a small volume blood sample of 0.1 microliters [With reference now to FIGS. 8-10, a further embodiment of an extravascular system 10 including the vascular access device 12 having a through-portion 210 and a side port 212 is depicted. The through portion 210 includes a main outflow port 214 in addition to the side port 212. The main outflow port 214 and/or the side port 212 may include female luer lock connections configured to receive a corresponding narrow tubular portion 120 of a blood sampling device 110, as is depicted in FIG. 8 (Burkholz ‘551 ¶0051, Fig. 8); The housing body 114 of the biological sampling device 110 includes a narrow tubular portion 120 having an access lumen 122 configured to establish fluid communication with the separate vascular access device 12… The reservoir 118 is enclosed within the housing body 114 and includes an internal volume sufficient to contain enough blood for use in a diagnostic test, for example, an internal volume of between about 0.1 mL and about 10 mL (Burkholz ‘551 ¶0038, Figs. 2-4)], wherein the blood sample collection device is configured to be removed from operative connection to the extension tube after the small volume blood sample has been received in the blood sample collection device for analysis by a point-of-care device [Once a sufficient portion of blood is retained within the reservoir 118, the sampling device 110 and connected collection device 112 can be removed from the extravascular system 10. Blood can be ejected through the access lumen 122 of the sampling device 110 for testing and analysis according to the process described above (Burkholz ‘551 ¶0050); Once the blood sampling device 110 is removed from the extravascular system 10, blood may be expelled from the sampling device 110, as described in greater detail below, to a point-of-care testing device 30 (shown in FIG. 14) such as a test strip, glass slide, diagnostic cartridge, or other testing device for testing and analysis (Burkholz ‘551 ¶0037, Fig. 14)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Devgon ‘564 to employ wherein the blood sample collection device is configured to collect a small volume blood sample of 0.3 to 500 microliters, wherein the blood sample collection device is configured to be removed from operative connection with the advancement element after the small volume blood sample has been received in the blood sample collection device for analysis by a point-of-care device, so as to reduce the number of processing steps and amount of time between sampling and obtaining blood test results [Burkholz ‘551 ¶0060], and as the modification to employ wherein the blood sample collection device is configured to collect a small volume blood sample of 0.3 to 500 microliters is considered to amount to mere simple substitution of one known element for another with similar expected results [blood sample collection device of Devgon ‘564 (¶0085) for the blood sample collection device of Burkholz ‘551 (¶0038), each configured to collect a blood sample] [MPEP § 2143(I)(B)].
Regarding claim 19, Devgon ‘564 in view of Burkholz ‘551 teaches
The instrument advancement device of claim 18, wherein the blood sample collection device is operatively connected to a proximal end of the advancement element [Devgon ‘564 ¶0085, Figs. 5, 16, 21-22, 28-29].
Regarding claim 20, Devgon ‘564 in view of Burkholz ‘551 teaches
The instrument advancement device of claim 18, wherein the advancement element defines a fluid path to fluidly connect the blood sample collection device to a fluid path defined by the instrument [The distal end portion 267 of the secondary catheter 265 is at least partially disposed within the second portion 215 of the inner volume 213 defined by the introducer 210 and is coupled to the second portion 275 of the actuator 270 (Devgon ‘564 ¶0085, Figs. 5, 16, 21-22, 28-29)].
Regarding claim 22, Devgon ‘564 in view of Burkholz ‘551 teaches
The instrument advancement device of claim 18, wherein the small volume blood sample is 0.3 to 100 microliters [See § 103 modification of claim 18 above; Burkholz ‘551 ¶0038].
Response to Arguments
Applicant’s arguments, see Applicant’s Remarks p. 7, filed 21 August 2026, with respect to the previously presented claim objections have been fully considered and are persuasive. The objection(s) to claim 11 has been withdrawn.
Applicant's arguments, see Applicant’s Remarks p. 7, with respect to the previously applied Double Patenting rejections have been fully considered but they are not persuasive.
The Applicant requests that the non-provisional and provisional non-statutory double patenting rejections be held in abeyance until patentable subject matter is identified in the present application. However, the Examiner notes that the non-provisional and provisional non-statutory double patenting rejections will be maintained until patentable subject matter is identified in either the instant or co-pending applications.
Applicant’s arguments, see Applicant’s Remarks p. 7-10, with respect to the rejection(s) of claim(s) 7, 18, and those dependent therefrom under § 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Burkholz (US-20200016374-A1, previously presented), hereinafter Burkholz ‘374, in view of Burkholz (US-20140309551-A1), hereinafter Burkholz ‘551, with respect to claim 7, and Devgon (US-20170216564-A1), hereinafter Devgon ‘564, in view of Burkholz (US-20140309551-A1), hereinafter Burkholz ‘551, with respect to claim 18.
The Applicant asserts that Burkholz, Beat, and Stocking, either individually or in combination, fail to disclose or suggest a blood sample collection device configured to receive and hold a blood sample and that is detachable from the housing to dispense the blood sample to a point-of-care instrument or device for testing and analysis, as recited in claim 7. The Applicant further asserts that Burkholz, Beat, and Stocking, either individually or in combination, fail to disclose or suggest a blood sample collection device configured to be removed from operative connection with the advancement element after the small volume blood sample has been received in the blood sample collection device for analysis by a point-of-care device, as recited in claim 18. The Applicant notes that while the Office Action relies on the disclosure of Beat to correct the deficiencies of Burkholz and Stocking each failing to disclose a blood sample collection device as claimed in each of claims 7 and 18 [see p. 15 and 23 of the Final Rejection dated 21 May 2026], the Applicant asserts that one of ordinary skill in the art would not have considered incorporating the capillary tube 12 of Beat into the assembly 10 of Stocking or the delivery device 10 of Burkholz, and that Beat does not teach or suggest the capillary tube 12 can be removably attached to a housing [such as the housing 14 of Burkholz or a body, such as the tubular body 20 of Stocking] and instead only discloses the capillary tube 12 being removably connected to the needle assembly 16. The Applicant further notes that Beat does not disclose any type of catheter placement device, which forms the basis of the instant invention, and that one of ordinary skill in the art would not have considered the teachings of Beat since the teachings of Beat are directed to blood sample collection, while the teachings of Stocking are directed to catheter placement in a patient. The Applicant also notes that Beat does not disclose any new features that are not already disclosed in Burkholz, as Burkholz discloses the use of an extension tubing 32 inserted into the housing 14, while Beat discloses the use of a capillary tubing 12 inserted into a needle assembly 16. Furthermore, the Applicant notes that neither Burkholz nor beat discloses or suggests a blood sample collection device that is directly received in a housing to collect a blood sample. However, the Examiner notes that Applicant’s arguments with respect to claim(s) 7 and 18 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. The Examiner notes that claim 7 is presently rejected under § 103 as being obvious over Burkholz (US-20200016374-A1, previously presented), hereinafter Burkholz ‘374, in view of Burkholz (US-20140309551-A1), hereinafter Burkholz ‘551, and claim 18 is presently rejected under § 103 as being obvious over Devgon (US-20170216564-A1), hereinafter Devgon ‘564, in view of Burkholz ‘551. With respect to the Applicant’s arguments that one of ordinary skill in the art would not have considered incorporating the capillary tube of Beat into either of Burkholz ‘374 or Stocking and that Beat is directed to blood sample collection, while Burkholz ‘374 and Stocking are directed towards catheter placement, the Examiner notes that each of Burkholz ‘374, Devgon ‘564, and Burkholz ‘551 are directed towards blood sample collection through a vascular access device [Burkholz ‘374 ¶¶0032, 0039; Devgon ‘564 ¶¶0044, 0085; Burkholz ‘551 ¶0033], and that each of Burkholz ‘374 and Devgon ‘564 disclose systems that are configured to couple to any suitable fluid collection device [Burkholz ‘374 ¶0039; Devgon ‘564 ¶0085]. Furthermore, Burkholz ‘551 is considered to disclose a blood sample collection device that is configured to be detached from a housing or removed from operative connection to an extension tube to dispense blood to a point-of-care device [Once a sufficient portion of blood is retained within the reservoir 118, the sampling device 110 and connected collection device 112 can be removed from the extravascular system 10. Blood can be ejected through the access lumen 122 of the sampling device 110 for testing and analysis according to the process described above (Burkholz ‘551 ¶¶0037, 0050, Fig. 13].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEVERO ANTONIO P LOPEZ whose telephone number is (571)272-7378. The examiner can normally be reached M-F 9-6 EST.
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/SEVERO ANTONIO P LOPEZ/Examiner, Art Unit 3791
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