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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1 and 10, as well as the cancelation of claim 6. Claims 1-5 and 7-19 are pending.
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 [the line of the upper instance of reference character “152” appears to be directed towards instrument 102 in Fig. 1F instead of the upper instance of the bottom between the upper instances of support wall 148 and the other support wall 150].
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: “extension tube 132” [Applicant’s Specification ¶0043].
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: “202” [Fig. 3]; “206” [Fig. 3]; “207” [Fig. 3]; “307” [Fig. 5].
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) 1 and 5-7 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 [which the Examiner notes incorporates the subject matter of claim 1 therein], hereinafter Burkholz ‘145, in view of Burkholz (US-20140309551-A, previously presented), hereinafter Burkholz ‘551, hereinafter Burkholz ‘551 in the Double Patenting section.
Conflicting claim 3 of Burkholz ‘145 is considered to anticipate almost each and every limitation of claim 1 of the instant application [see comparison below], except for the limitations “a small sample dispense device connected to the proximal end of the housing”, wherein the blood collection device is “connected to a proximal end of the small sample dispense device”, wherein the blood collection container is an “evacuated” blood collection container, “wherein the small sample dispense device is detachable from the housing and configured to dispense a blood sample”, and “wherein the small sample dispense device comprises a needle-free connector configured to be connected to the blood sample collection device and to prevent fluid from leaving the small sample dispense device when detached from the blood sample collection device”.
Burkholz ‘551 teaches a blood sample collection system comprising: a vascular access device [vascular access device 12 (Burkholz ‘551 Fig. 1)]; a small sample dispense device connected to the proximal end of the housing [blood sampling device 110 (Burkholz ‘551 Fig. 1); The blood sampling device 110 is configured as part of a larger extravascular system 10, and is configured to receive the fluid sample from a separate vascular access device 12 (Burkholz ‘551 ¶0033, Fig. 1), wherein as depicted in Burkholz Fig. 1, the blood sampling device is connected to the proximal end of the vascular access device 12 (housing) via the extension tubing 20; the sampling device 110 may be directly connected to an intravenous catheter hub, without additional components such as extension tubing 20, to reduce the number of components and simplify the collection and sampling process (Burkholz ‘551 ¶0034)]; and a blood collection device connected to a proximal end of the small sample dispense device, the blood collection device is configured to receive an evacuated blood collection container, wherein the small sample dispense device is detachable from the housing and configured to dispense a blood sample [body 140 (Burkholz ‘551 Fig. 5); the sampling device 110 is instead connected to the sample container collection device 112 through the threaded port 128 and outflow lumen 126. The sample container collection device 112 may be a vacuum tube collection system (e.g., a Vacutainer). A sample container 138 may be a vacuum evacuated test tube having a pierceable closure or other suitable medical container, as is known in the art (Burkholz ‘551 ¶0046); The sample container collection device 112 includes a generally cylindrical body 140 having a fastener 142 for connecting the collection device 112 to the body of the sampling device 110. For example, the collection device 112 may be configured to attach to the threaded port 128 of the sampling device 110 through a corresponding threaded cap 144. The cylindrical body 140 defines an interior region 146 having an open end 148 which receives the sample container 138 (Burkholz ¶0047, Fig. 5); 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); In certain configurations, the sampling device 110 is configured to retain blood when uncompressed and to eject an amount of blood when compressed. As such, once removed from the extravascular system 10, blood is naturally retained within the reservoir 118 of the blood sampling device 110 until the compressible portion 134 is compressed by a clinician (Burkholz ‘551 ¶0043)]. Burkholz further discloses wherein the small sample dispense device comprises a needle-free connector configured to be connected to the blood sample collection device and to prevent fluid from leaving the small sample dispense device when detached from the blood sample collection device [For example, the collection device 112 may be configured to attach to the threaded port 128 of the sampling device 110 through a corresponding threaded cap 144 (Burkholz ¶0047, Fig. 5); The removable cap 116 is configured to be attached to the threaded port 128 and includes an inner channel 130 extending through a portion of the end cap 116 which is in fluid communication with the outflow lumen 126 and reservoir 118. The inner channel 130 is provided with a gas permeable vent 132 which permits gas to pass therethrough but which prevents passage of a fluid such as blood. The vent 132 may include various structures capable of providing these properties, such as porous plugs, permeable membranes, and/or structures containing a plurality of small venting holes (Burkholz ¶0040, Fig. 4); With reference to FIGS. 5-7, in certain configurations, the removable end cap 116 of the blood sampling device 110 is removed and the sampling device 110 is instead connected to the sample container collection device 112 through the threaded port 128 and outflow lumen 126 (Burkholz ¶0046), wherein the blood sampling device 110 (small sample dispense device) comprising a removable end cap 116 for use when the blood sampling device 110 is not connected to the blood sample collection device (Burkholz ¶0046), wherein the end cap is configured to prevent fluid from leaving the blood sampling device 110 by providing a fluid impermeable vent (gas permeable vent 132) is considered to read on the claimed limitation of the small sample dispense device comprising a needle-free connector configured to prevent fluid from leaving the small sample dispense device when detached from the blood sample collection device].
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 ‘145 to employ a small sample dispense device connected to the proximal end of the housing, wherein the blood collection device is connected to a proximal end of the small sample dispense device, wherein the small sample dispense device is detachable from the housing and configured to dispense a blood sample, and wherein the small sample dispense device comprises a needle-free connector configured to be connected to the blood sample collection device and to prevent fluid from leaving the small sample dispense device when detached from the blood sample collection device, so as to facilitate point-of-care testing of collected blood samples, while also maintaining sterility and control of the collected blood samples [Burkholz ‘551 ¶0037]; and it would have been further obvious to employ an evacuated blood collection container, as this modification would amount to mere simple substitution of one known element for another with similar expected results [MPEP § 2143(I)(B)].
Conflicting claim 3 of the modified Burkholz ‘145 in view of Burkholz ‘551 is further considered to render obvious instant dependent claims 5-7 [See Burkholz ‘551 ¶¶0036, 0042-0043, 0047].
Claim 1 of the Instant Application
Claim 3 of Conflicting Burkholz Patent 12,343,145 (hereinafter Burkholz ‘145) [which the Examiner notes incorporates the subject matter of claim 1 therein]
An instrument advancement device comprising:
An extension set to provide access to a patient’s vascular system, comprising:… an instrument… a translation handle… wherein the translation handle is configured to… translate the distal end of the instrument between a retracted position and an advanced position [Burkholz ‘145 Col 11:62-63, 66; Col 12:1, 2, 4-6, wherein the Examiner notes that the extension set of Burkholz ‘145 being configured to advance an instrument is considered to define an “instrument advancement device”]
a housing comprising a fluid path, a distal end, and a proximal end;
a tube, comprising a proximal end, a distal end, and an outer surface [Burkholz ‘145 Col 11:64-65]
an instrument disposed within the housing;
an instrument disposed within the tube, the instrument comprising a proximal end and a distal end [Burkholz ‘145 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;
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 [Burkholz ‘145 Col 12:1-9]
a small sample dispense device connected to the proximal end of the housing; and
a blood collection device connected to a proximal end of the small sample dispense device, wherein the blood collection device is configured to receive an evacuated blood collection container, wherein the small sample dispense device is detachable from the housing and configured to dispense a blood sample,
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 [Burkholz ‘145 Col 12:27-30, wherein the proximal connector is considered to read on the broadest reasonable interpretation of a blood collection device, as the proximal connector is similarly configured to receive an evacuated blood collection container/device (blood collection device of Burkholz ‘145)]
wherein the small sample dispense device comprises a needle-free connector configured to be connected to the blood sample collection device and to prevent fluid from leaving the small sample dispense device when detached from the blood sample collection device.
Claim(s) 1 and 5-7 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 3 of U.S. Patent No. 12,201,800 [which the Examiner notes incorporates the subject matter of claim 1 therein], hereinafter Scherich, in view of Burkholz ‘551.
Conflicting claim 3 of Scherich is considered to anticipate almost each and every limitation of claim 1 of the instant application [see comparison below], except for the limitations “a small sample dispense device connected to the proximal end of the housing” and wherein the blood collection device is “connected to a proximal end of the small sample dispense device”, wherein the blood collection container is an “evacuated” blood collection container, “wherein the small sample dispense device is detachable from the housing and configured to dispense a blood sample”, and “wherein the small sample dispense device comprises a needle-free connector configured to be connected to the blood sample collection device and to prevent fluid from leaving the small sample dispense device when detached from the blood sample collection device”.
Burkholz ‘551 teaches a blood sample collection system comprising: a vascular access device [vascular access device 12 (Burkholz ‘551 Fig. 1)]; a small sample dispense device connected to the proximal end of the housing [blood sampling device 110 (Burkholz ‘551 ¶¶0033-0034, Fig. 1)]; and a blood collection device connected to a proximal end of the small sample dispense device, the blood collection device is configured to receive an evacuated blood collection container, wherein the small sample dispense device is detachable from the housing and configured to dispense a blood sample [body 140 (Burkholz ‘551 ¶¶0037, 0043, 0046-0047, Fig. 5)]. Burkholz further discloses wherein the small sample dispense device comprises a needle-free connector configured to be connected to the blood sample collection device and to prevent fluid from leaving the small sample dispense device when detached from the blood sample collection device [Burkholz ¶¶0040, 0046-0047, Figs. 4-5), wherein the blood sampling device 110 (small sample dispense device) comprising a removable end cap 116 for use when the blood sampling device 110 is not connected to the blood sample collection device (Burkholz ¶0046), wherein the end cap is configured to prevent fluid from leaving the blood sampling device 110 by providing a fluid impermeable vent (gas permeable vent 132) is considered to read on the claimed limitation of the small sample dispense device comprising a needle-free connector configured to prevent fluid from leaving the small sample dispense device when detached from the blood sample collection device].
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 Scherich to employ a small sample dispense device connected to the proximal end of the housing, wherein the blood collection device is connected to a proximal end of the small sample dispense device, and wherein the small sample dispense device is detachable from the housing and configured to dispense a blood sample, and wherein the small sample dispense device comprises a needle-free connector configured to be connected to the blood sample collection device and to prevent fluid from leaving the small sample dispense device when detached from the blood sample collection device, so as to facilitate point-of-care testing of collected blood samples, while also maintaining sterility and control of the collected blood samples [Burkholz ‘551 ¶0037]; and it would have been further obvious to employ an evacuated blood collection container, as this modification would amount to mere simple substitution of one known element for another with similar expected results [MPEP § 2143(I)(B)].
Conflicting claim 3 of the modified Scherich in view of Burkholz ‘551 is further considered to render obvious instant dependent claims 5-7 [See Burkholz ‘551 ¶¶0036, 0042-0043, 0047].
Claim 1 of the Instant Application
Claim 3 of Conflicting Scherich Patent 12,201,800 [which the Examiner notes incorporates the subject matter of claim 1 therein]
An instrument advancement device comprising:
An extension set to provide access to a patient’s vascular system, comprising:… an instrument… a translation handle… wherein the translation handle is configured to… translate the distal end of the instrument [Scherich Col 16:27-28, 31, 35, 36, 38-40, wherein the Examiner notes that the extension set of Scherich being configured to advance an instrument is considered to define an “instrument advancement device”]
a housing comprising a fluid path, a distal end, and a proximal end;
a tube, comprising a proximal end, a distal end, and an outer surface [Scherich Col 16:29-30]
an instrument disposed within the housing;
an instrument disposed within the tube, the instrument comprising a proximal end and a distal end [Scherich Col 16:31-32]
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;
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 the distal end of the instrument is configured to extend beyond the distal end of the tube when the instrument is in the advanced position [Scherich Col 16:35-43]
a small sample dispense device connected to the proximal end of the housing; and
a blood collection device connected to a proximal end of the small sample dispense device, wherein the blood collection device is configured to receive an evacuated blood collection container, wherein the small sample dispense device is detachable from the housing and configured to dispense a blood sample,
an extension tube is coupled to the proximal end of the instrument, and wherein the fluid path assembly comprises a proximal end and a distal end, the proximal end of the fluid path assembly comprising a proximal connector configured to connect to a blood collection device [Scherich Col 16:55-60, wherein the proximal connector is considered to read on the broadest reasonable interpretation of a blood collection device, as the proximal connector is similarly configured to receive an evacuated blood collection container (blood collection device of Scherich)]
wherein the small sample dispense device comprises a needle-free connector configured to be connected to the blood sample collection device and to prevent fluid from leaving the small sample dispense device when detached from the blood sample collection device.
Claim(s) 1 and 5-7 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of copending Application No. 18/603,324 [which the Examiner notes incorporates the subject matter of claim 1 therein], hereinafter Burkholz ‘324, in view of Burkholz ‘551.
Conflicting claim 3 of Burkholz ‘324 is considered to anticipate almost each and every limitation of claim 1 of the instant application [see comparison below], except for the limitations “a small sample dispense device connected to the proximal end of the housing”, wherein the blood collection device is “connected to a proximal end of the small sample dispense device”, “wherein the small sample dispense device is detachable from the housing and configured to dispense a blood sample”, and “wherein the small sample dispense device comprises a needle-free connector configured to be connected to the blood sample collection device and to prevent fluid from leaving the small sample dispense device when detached from the blood sample collection device”.
Burkholz ‘551 teaches a blood sample collection system comprising: a vascular access device [vascular access device 12 (Burkholz ‘551 Fig. 1)]; a small sample dispense device connected to the proximal end of the housing [blood sampling device 110 (Burkholz ‘551 ¶¶0033-0034, Fig. 1)]; and a blood collection device connected to a proximal end of the small sample dispense device, the blood collection device is configured to receive an evacuated blood collection container, wherein the small sample dispense device is detachable from the housing and configured to dispense a blood sample [body 140 (Burkholz ‘551 ¶¶0037, 0043, 0046-0047, Fig. 5)]. Burkholz further discloses wherein the small sample dispense device comprises a needle-free connector configured to be connected to the blood sample collection device and to prevent fluid from leaving the small sample dispense device when detached from the blood sample collection device [Burkholz ¶¶0040, 0046-0047, Figs. 4-5), wherein the blood sampling device 110 (small sample dispense device) comprising a removable end cap 116 for use when the blood sampling device 110 is not connected to the blood sample collection device (Burkholz ¶0046), wherein the end cap is configured to prevent fluid from leaving the blood sampling device 110 by providing a fluid impermeable vent (gas permeable vent 132) is considered to read on the claimed limitation of the small sample dispense device comprising a needle-free connector configured to prevent fluid from leaving the small sample dispense device when detached from the blood sample collection device].
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 ‘324 to employ a small sample dispense device connected to the proximal end of the housing, wherein the blood collection device is connected to a proximal end of the small sample dispense device, and wherein the small sample dispense device is detachable from the housing and configured to dispense a blood sample, and wherein the small sample dispense device comprises a needle-free connector configured to be connected to the blood sample collection device and to prevent fluid from leaving the small sample dispense device when detached from the blood sample collection device, so as to facilitate point-of-care testing of collected blood samples, while also maintaining sterility and control of the collected blood samples [Burkholz ‘551 ¶0037]; and it would have been further obvious to employ an evacuated blood collection container, as this modification would amount to mere simple substitution of one known element for another with similar expected results [MPEP § 2143(I)(B)].
Conflicting claim 3 of the modified Burkholz’324 in view of Burkholz ‘551 is further considered to render obvious instant dependent claims 5-7 [See Burkholz ‘551 ¶¶0036, 0042-0043, 0047].
Claim 1 of the Instant Application
Claim 3 of Conflicting Burkholz Patent Application 18/603,324 (hereinafter Burkholz ‘324) [which the Examiner notes incorporates the subject matter of claim 1 therein]
An instrument advancement device comprising:
the blood draw device comprising: a catheter tube… an advancement member movably coupled to the housing and configured to move relative to the housing to move the catheter tube [Burkholz ‘324 claim 1, lines 2-4, 8-10, wherein the Examiner notes that the device of Burkholz ‘324 being configured to advance an instrument is considered to define an “instrument advancement device”]
a housing comprising a fluid path, a distal end, and a proximal end;
the blood draw device comprising: a catheter tube; a housing having a proximal end portion and a distal end portion and defining an inner volume configured to movably receive the catheter tube [Burkholz ‘324 claim 1, lines 2-7]
an instrument disposed within the housing;
a catheter tube [Burkholz ‘324 claim 1, line 4]
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;
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 portion of the housing and past a distal tip of the indwelling arterial catheter [Burkholz ‘324 claim 1, lines 8-15]
a small sample dispense device connected to the proximal end of the housing; and
a blood collection device connected to a proximal end of the small sample dispense device, wherein the blood collection device is configured to receive an evacuated blood collection container, wherein the small sample dispense device is detachable from the housing and configured to dispense a blood sample,
a secondary catheter coupled to the advancement member and extending out proximally therefrom and out through the proximal end portion of the housing, the secondary catheter in fluid communication with the catheter tube; and a collection device coupled to the proximal end of the secondary catheter, so as to be in fluid communication with the secondary catheter and the catheter tube [Burkholz ‘324 claim 1, lines 16-23]
wherein the blood draw device comprises a coupler connected to a proximal end of the secondary catheter, and wherein the collection device is connected to the coupler [Burkholz ‘324 claim 2, lines 1-4]
wherein the collection device comprises a vacuum-assisted collection device [Burkholz ‘324 claim 3, lines 1-2]
wherein the small sample dispense device comprises a needle-free connector configured to be connected to the blood sample collection device and to prevent fluid from leaving the small sample dispense device when detached from the blood sample collection device.
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) 1-3, 5, and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz (US-20140309551-A, previously presented), hereinafter “Burkholz” in § 103 section, in view of Devgon (US-20200100716-A1, previously presented).
Regarding claim 1, Burkholz teaches
An instrument advancement device comprising:
a housing comprising a fluid path, a distal end, and a proximal end [vascular access device 12 (Burkholz Fig. 1); drawing blood from the vascular access device 12 through extension tubing 20 to the sampling device 110 (Burkholz ¶0036), wherein the Examiner notes that the extension tubing 20 is considered to be coupled to a proximal end of the vascular access device 12 and the needle 14 is considered to be positioned at a distal end of the vascular access device 12 (see Burkholz Fig. 1)];
a small sample dispense device connected to the proximal end of the housing [blood sampling device 110 (Burkholz Fig. 1); The blood sampling device 110 is configured as part of a larger extravascular system 10, and is configured to receive the fluid sample from a separate vascular access device 12 (Burkholz ¶0033, Fig. 1), wherein as depicted in Burkholz Fig. 1, the blood sampling device is connected to the proximal end of the vascular access device 12 (housing) via the extension tubing 20; the sampling device 110 may be directly connected to an intravenous catheter hub, without additional components such as extension tubing 20, to reduce the number of components and simplify the collection and sampling process (Burkholz ¶0034)]; and
a blood collection device connected to a proximal end of the small sample dispense device, wherein the blood collection device is configured to receive an evacuated blood collection container, wherein the small sample dispense device is detachable from the housing and configured to dispense a blood sample [body 140 (Burkholz Fig. 5); the sampling device 110 is instead connected to the sample container collection device 112 through the threaded port 128 and outflow lumen 126. The sample container collection device 112 may be a vacuum tube collection system (e.g., a Vacutainer). A sample container 138 may be a vacuum evacuated test tube having a pierceable closure or other suitable medical container, as is known in the art (Burkholz ¶0046); The sample container collection device 112 includes a generally cylindrical body 140 having a fastener 142 for connecting the collection device 112 to the body of the sampling device 110. For example, the collection device 112 may be configured to attach to the threaded port 128 of the sampling device 110 through a corresponding threaded cap 144. The cylindrical body 140 defines an interior region 146 having an open end 148 which receives the sample container 138 (Burkholz ¶0047, Fig. 5); 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 ¶0037); In certain configurations, the sampling device 110 is configured to retain blood when uncompressed and to eject an amount of blood when compressed. As such, once removed from the extravascular system 10, blood is naturally retained within the reservoir 118 of the blood sampling device 110 until the compressible portion 134 is compressed by a clinician (Burkholz ¶0043)],
wherein the small sample dispense device comprises a needle-free connector configured to be connected to the blood sample collection device and to prevent fluid from leaving the small sample dispense device when detached from the blood sample collection device [For example, the collection device 112 may be configured to attach to the threaded port 128 of the sampling device 110 through a corresponding threaded cap 144 (Burkholz ¶0047, Fig. 5); The removable cap 116 is configured to be attached to the threaded port 128 and includes an inner channel 130 extending through a portion of the end cap 116 which is in fluid communication with the outflow lumen 126 and reservoir 118. The inner channel 130 is provided with a gas permeable vent 132 which permits gas to pass therethrough but which prevents passage of a fluid such as blood. The vent 132 may include various structures capable of providing these properties, such as porous plugs, permeable membranes, and/or structures containing a plurality of small venting holes (Burkholz ¶0040, Fig. 4); With reference to FIGS. 5-7, in certain configurations, the removable end cap 116 of the blood sampling device 110 is removed and the sampling device 110 is instead connected to the sample container collection device 112 through the threaded port 128 and outflow lumen 126 (Burkholz ¶0046), wherein the blood sampling device 110 (small sample dispense device) comprising a removable end cap 116 for use when the blood sampling device 110 is not connected to the blood sample collection device (Burkholz ¶0046), wherein the end cap is configured to prevent fluid from leaving the blood sampling device 110 by providing a fluid impermeable vent (gas permeable vent 132) is considered to read on the claimed limitation of the small sample dispense device comprising a needle-free connector configured to prevent fluid from leaving the small sample dispense device when detached from the blood sample collection device].
However, Burkholz fails to explicitly disclose wherein the device further comprises: an instrument disposed within the housing; 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.
Devgon discloses an instrument advancement device comprising a housing [fluid transfer device 210 (Devgon Figs. 5-7); the fluid transfer device 210 includes at least an introducer 215, an actuator 220, and a catheter 230 (Devgon ¶0069)], an instrument disposed within the housing [catheter 230 (Devgon Fig. 7); Although not shown, the introducer 215 defines an inner volume within which at least a portion of the catheter 230 and at least a portion of the actuator 220 are movably disposed (Devgon ¶0070)]; 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 a distal end of the housing [actuator 220 (Devgon Figs. 5-7); As described in further detail herein, prior to use, the catheter 230 can be in a first position, configuration, and/or state in which the catheter 230 is disposed or substantially disposed within the inner volume of the introducer 215… In use, the catheter 230 can be transitioned to a second position, configuration, and/or state in which at least a portion of the catheter 230 is distal to and outside of the introducer 215 (Devgon ¶0070); The catheter 230 of the transfer device 210 is movably disposed within the inner volume defined by the introducer 215 and is coupled to the actuator 220. In some embodiments, the catheter 230 can be moved (e.g., via movement of the actuator 220) between a first position and a second position to transition the transfer device 210 between the first configuration and the second configuration, respectively (Devgon ¶0072)]; and a blood collection device coupled to a proximal end of the housing [a proximal end portion of the catheter 230 and/or the outlet or secondary catheter 245 can be coupled to a fluid reservoir, fluid source, syringe, and/or the like via a coupler 246, which in turn, places the catheter 230 in fluid communication therewith (Devgon ¶0074, Figs. 5-7)].
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 to define an instrument advancement device and employ an instrument disposed within the housing; 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, as this modification would amount to mere simple substitution of one known element [elements of the housing of Burkholz to fluidically couple the blood collection device with a fluid source] for another [instrument and advancement element of Devgon] with similar expected results [MPEP § 2143(I)(B)].
Regarding claim 2, Burkholz in view of Devgon teaches
The instrument advancement device of claim 1, wherein the small sample dispense device is configured to receive a volume of 0.3 to 500 microliters [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. Because different blood tests require different quantities of blood, in some embodiments, the reservoir 118 is sized to retain a quantity of blood needed for a specific test or a specific number of tests (Burkholz ¶0038)].
Regarding claim 3, Burkholz in view of Devgon teaches
The instrument advancement device of claim 2, wherein the small sample dispense device is configured to receive a volume of 0.3 to 100 microliters [Burkholz ¶0038, wherein the Examiner notes that it is understood that the reservoir 118 being configured to receive 0.1 mL (100 microliters) is considered to read on the reservoir 118 being configured to receive any amount of fluid between 0 μL and 100 μL, as blood is considered to flow into the reservoir 118 at a rate].
Regarding claim 5, Burkholz in view of Devgon teaches
The instrument advancement device of claim 1, wherein the small sample dispense device is removably attached to the blood collection device [Burkholz ¶0047].
Regarding claim 7, Burkholz in view of Devgon teaches
The instrument advancement device of claim 1, wherein the small sample dispense device is configured to be squeezed to dispense fluid from the small sample dispense device [Burkholz ¶0047, wherein the body 140 having a fastener 142 configured to couple to threaded cap 144 of the sampling device 110 is considered to define a needle-free connector].
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz in view of Devgon, as applied to claim 1 above, in further view of Bischof (US-6126618-A, previously presented).
Regarding claim 4, Burkholz in view of Devgon teaches
The instrument advancement device of claim 1.
However, while Burkholz discloses integrally forming portions of the blood sample collection system [It is also intended herein, that an integrated unit of both the luer access adapter 22 and the sampling device 110 may be provided within the scope of the present invention (Burkholz ¶0035)], Burkholz in view of Devgon fails to explicitly disclose wherein the small sample dispense device is formed integrally with the blood collection device.
Bischof discloses systems for obtaining liquid samples comprising a blood collection device configured to receive a blood collection container, wherein the blood collection device is integrally formed with a housing defining a fluid flow path from tubing to the blood collection device [In fact, in order to reduce the number of external components required for obtaining a liquid sample, it is preferred that housing 18 include the sleeve 32, piercing member 34 and receptacle 40 as a pre-assembled or otherwise integral unit (Bischof Col 5:15-19, Figs. 2-5)].
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 instrument advancement device of Burkholz in view of Devgon to integrally form the small sample dispense device and the blood collection device, in order to reduce the number of external components required and as this modification is considered to merely be a matter of obvious engineering choice [In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965) (MPEP § 2144.04(V)(B)].
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz in view of Devgon, as applied to claim 1 above, in further view of Nishio (US-20160100786-A1, previously presented).
Regarding claim 8, Burkholz in view of Devgon teaches
The instrument advancement device of claim 1.
However, while Burkholz is considered to disclose the use of external sources for drawing blood into the sampling device 110 [External power sources such as motorized pumps, as are known in the art, may also be used to push blood through the extravascular system 10 to the sampling device 11 (Burkholz ¶0036)], Burkholz in view of Devgon fails to explicitly disclose wherein the small sample dispense device is configured to be attached to a syringe barrel to dispense fluid from the small sample dispense device.
Nishio discloses a blood sample collection system comprising a vascular access device [needle 69 (Nishio Fig. 18C)], a small sample dispense device [adapter 1 for blood sample dispensing (Nishio Figs. 2-3); an adapter 1 for blood sample dispensing according to the present embodiment has a piping structure, of which one end is a fitting portion 3 fitted to a distal portion 20a of a syringe 7 (that is, a syringe main body 20) and the other end is a nozzle portion 2, and a flange portion 4 on an outer circumference surface of the piping structure (Nishio ¶0046)], wherein the small sample dispense device is configured to be attached to a syringe barrel to dispense fluid from the small sample dispense device [Nishio ¶0046].
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 instrument advancement device of Burkholz in view of Devgon to employ wherein the small sample dispense device is configured to be attached to a syringe barrel to dispense fluid from the small sample dispense device, so as to facilitate dispensing of the sample.
Claim(s) 9-14 and 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz (US-20140309551-A1, previously presented), in view of Teoh (US-20160361519-A1).
Regarding claim 9, Burkholz teaches
A blood sample collection system comprising:
a vascular access device [vascular access device 12 (Burkholz Fig. 1)];
a small sample dispense device connected to the vascular access device [blood sampling device 110 (Burkholz Fig. 1); The blood sampling device 110 is configured as part of a larger extravascular system 10, and is configured to receive the fluid sample from a separate vascular access device 12 (Burkholz ¶0033, Fig. 1), wherein as depicted in Burkholz Fig. 1, the blood sampling device is connected to the proximal end of the vascular access device 12 (housing) via the extension tubing 20; the sampling device 110 may be directly connected to an intravenous catheter hub, without additional components such as extension tubing 20, to reduce the number of components and simplify the collection and sampling process (Burkholz ¶0034)]; and
a blood collection device connected to a proximal end of the small sample dispense device, wherein the blood collection device is configured to receive an evacuated blood collection container, wherein the small sample dispense device is detachable from the vascular access device and is configured to dispense a blood sample [body 140 (Burkholz Fig. 5); the sampling device 110 is instead connected to the sample container collection device 112 through the threaded port 128 and outflow lumen 126. The sample container collection device 112 may be a vacuum tube collection system (e.g., a Vacutainer). A sample container 138 may be a vacuum evacuated test tube having a pierceable closure or other suitable medical container, as is known in the art (Burkholz ¶0046); The sample container collection device 112 includes a generally cylindrical body 140 having a fastener 142 for connecting the collection device 112 to the body of the sampling device 110. For example, the collection device 112 may be configured to attach to the threaded port 128 of the sampling device 110 through a corresponding threaded cap 144. The cylindrical body 140 defines an interior region 146 having an open end 148 which receives the sample container 138 (Burkholz ¶0047, Fig. 5); 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 ¶0037); In certain configurations, the sampling device 110 is configured to retain blood when uncompressed and to eject an amount of blood when compressed. As such, once removed from the extravascular system 10, blood is naturally retained within the reservoir 118 of the blood sampling device 110 until the compressible portion 134 is compressed by a clinician (Burkholz ¶0043)],
wherein the small sample dispense device is configured to be vented [This is because the blood sampling device 110 combines the ability to perform the processes of venting the extravascular system and obtaining a blood sample into a single device. More specifically, the blood sampling device 110 is configured to vent air from the extravascular system 10, thereby drawing blood from the vascular access device 12 through extension tubing 20 to the sampling device 110 (Burkholz ¶0036)].
However, while the small sample dispense device is configured to be vented [Burkholz ¶0036], Burkholz fails to explicitly disclose wherein the small sample dispense device is vented to provide a blood flashback during use of the vascular access device.
Teoh discloses needle assemblies, wherein Teoh discloses a vascular access device [needle assembly 100 (Teoh Fig. 3)] and a small sample dispense device connected to the vascular access device [The proximal end of the needle hub 108 preferably carries or supports a flashback plug 118… a nose section 172 may project into the proximal chamber 166 and around the proximal end of the needle 106… the flashback plug 118 can be removed from the needle hub 108 and subsequently used as a blood sampling source, such as for use to dispense blood samples (Teoh ¶0060, Fig. 3)]; wherein Teoh further discloses that the small sample dispense device is vented to provide a blood flashback during use of the vascular access device [the flashback plug 118 has a wall surface defining a flashback chamber 130 in fluid communication with the hollow needle 106… Upon successful venipuncture, flashback of blood flows through the needle and into the flashback chamber 130, which is viewable to the healthcare worker. A vent filter, such as a hydrophobic filter, is typically placed at a proximal end of the flashback plug 118 to permit venting. In this way, the flashback chamber 130 provides a visual indicator that the healthcare worker has properly and successfully inserted the needle into the patient's vein (Teoh ¶0060, Fig. 3), wherein providing a vent filter for the flashback plug 118 (small sample dispense device) for the purposes of enabling flashback of blood in the flashback chamber 130 of the flashback plug 118 is considered to read on the claimed limitation wherein the small sample dispense device is vented to provide a blood flashback during use of the vascular access device].
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 system of Burkholz to employ wherein the small sample dispense device is vented to provide a blood flashback during use of the vascular access device, so as to provide a visual indicator to a user of the blood sample collection system of proper and successful insertion of the vascular access device for blood collection.
Regarding claim 10, Burkholz in view of Teoh teaches
The blood sample collection system of claim 9, wherein the vascular access device comprises a catheter adapter including a catheter [The vascular access device 12 may include numerous components such as an intravascular needle 14, an over-the-needle catheter 16 (Burkholz ¶0033), wherein the Examiner notes that the structure depicted in Fig. 1 and defined by the vascular access device as coupled to the catheter 16 is considered to read on a “catheter adapter”] and a patient connector [The vascular access device 12 may include numerous components such as… luer access adapter 22 (Burkholz ¶0033, Fig. 1)], wherein the small sample dispense device is connected to the patient connector [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. For example, the narrow tubular portion 120 may be a male luer lock connection 124 adapted for insertion into the female luer access adapter 22 of the vascular access device 12 (Burkholz ¶0038, Fig. 2)].
Regarding claim 11, Burkholz in view of Teoh teaches
The blood sample collection system of claim 10, wherein the patient connector is connected to the catheter adapter via tubing [extension tubing 20 (Burkholz Fig. 1); thereby drawing blood from the vascular access device 12 through extension tubing 20 to the sampling device 110 (Burkholz ¶0036)].
Regarding claim 12, Burkholz in view of Teoh teaches
The blood sample collection system of claim 10, wherein the vascular access device comprises extension tubing [extension tubing 20 (Burkholz ¶0036, Fig. 1)].
Regarding claim 13, Burkholz in view of Teoh teaches
The blood sample collection system of claim 9, wherein the small sample dispense device is configured to receive a volume of 0.3 to 500 microliters [Burkholz ¶0038].
Regarding claim 14, Burkholz in view of Teoh teaches
The blood sample collection system of claim 9, wherein the small sample dispense device is configured to receive a volume of 0.3 to 100 microliters [Burkholz ¶0038, wherein the Examiner notes that it is understood that the reservoir 118 being configured to receive 0.1 mL (100 microliters) is considered to read on the reservoir 118 being configured to receive any amount of fluid between 0 μL and 100 μL, as blood is considered to flow into the reservoir 118 at a rate].
Regarding claim 16, Burkholz in view of Teoh teaches
The blood sample collection system of claim 9, wherein the small sample dispense device is removably attached to the blood collection device [Burkholz ¶0047].
Regarding claim 17, Burkholz in view of Teoh teaches
The blood sample collection system of claim 16, wherein the small sample dispense device comprises a needle-free connector configured to be connected to the blood sample collection device [Burkholz ¶0047, wherein the body 140 having a fastener 142 configured to couple to threaded cap 144 of the sampling device 110 is considered to define a needle-free connector].
Regarding claim 18, Burkholz in view of Teoh teaches
The blood sample collection system of claim 9, wherein the small sample dispense device is configured to be squeezed to dispense fluid from the small sample dispense device [the blood sampling device 110 includes a compressible portion 134 (Burkholz ¶0042); the sampling device 110 is configured to retain blood when uncompressed and to eject an amount of blood when compressed. As such, once removed from the extravascular system 10, blood is naturally retained within the reservoir 118 of the blood sampling device 110 until the compressible portion 134 is compressed by a clinician (Burkholz ¶0043, Fig. 14)].
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz in view of Teoh, as applied to claim 9 above, in further view of Bischof (US-6126618-A, previously presented).
Regarding claim 15, Burkholz in view of Teoh teaches
The blood sample collection system of claim 9.
However, while Burkholz discloses integrally forming portions of the blood sample collection system [It is also intended herein, that an integrated unit of both the luer access adapter 22 and the sampling device 110 may be provided within the scope of the present invention (Burkholz ¶0035)], Burkholz in view of Teoh fails to explicitly disclose wherein the small sample dispense device is formed integrally with the blood collection device.
Bischof discloses systems for obtaining liquid samples comprising a blood collection device configured to receive a blood collection container, wherein the blood collection device is integrally formed with a housing defining a fluid flow path from tubing to the blood collection device [In fact, in order to reduce the number of external components required for obtaining a liquid sample, it is preferred that housing 18 include the sleeve 32, piercing member 34 and receptacle 40 as a pre-assembled or otherwise integral unit (Bischof Col 5:15-19, Figs. 2-5)].
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 blood sample collection system of Burkholz in view of Teoh to integrally form the small sample dispense device and the blood collection device, in order to reduce the number of external components required and as this modification is considered to merely be a matter of obvious engineering choice [In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965) (MPEP § 2144.04(V)(B)].
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz in view of Teoh, as applied to claim 9 above, in further view of Nishio (US-20160100786-A1, previously presented).
Regarding claim 19, Burkholz in view of Teoh teaches
The blood sample collection system of claim 9.
However, while Burkholz is considered to disclose the use of external sources for drawing blood into the sampling device 110 [External power sources such as motorized pumps, as are known in the art, may also be used to push blood through the extravascular system 10 to the sampling device 11 (Burkholz ¶0036)], Burkholz in view of Teoh fails to explicitly disclose wherein the small sample dispense device is configured to be attached to a syringe barrel to dispense fluid from the small sample dispense device.
Nishio discloses a blood sample collection system comprising a vascular access device [needle 69 (Nishio Fig. 18C)], a small sample dispense device [adapter 1 for blood sample dispensing (Nishio Figs. 2-3); an adapter 1 for blood sample dispensing according to the present embodiment has a piping structure, of which one end is a fitting portion 3 fitted to a distal portion 20a of a syringe 7 (that is, a syringe main body 20) and the other end is a nozzle portion 2, and a flange portion 4 on an outer circumference surface of the piping structure (Nishio ¶0046)], wherein the small sample dispense device is configured to be attached to a syringe barrel to dispense fluid from the small sample dispense device [Nishio ¶0046].
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 blood sample collection system of Burkholz in view of Teoh to employ wherein the small sample dispense device is configured to be attached to a syringe barrel to dispense fluid from the small sample dispense device, so as to facilitate dispensing of the sample.
Response to Arguments
Applicant’s arguments, see Applicant’s Remarks p. 5, filed 21 August 2026, with respect to the previously presented claim objections have been fully considered and are persuasive. The objection to claim 10 has been withdrawn.
Applicant's arguments, see Applicant’s Remarks p. 5, with respect to the previously applied Non-Statutory Double Patenting Rejections of claim 1 have been fully considered but they are not persuasive.
The Applicant requests that the double patenting rejections be held in abeyance until patentable subject matter is identified in the pending claims. However, the Examiner notes that filing a terminal disclaimer, or filing a showing that the claims subject to the rejection are patentably distinct from the reference application’s claims, is necessary for further consideration of the rejection of the claims, such a filing should not be held in abeyance [MPEP § 804(I)(B)(1)].
Applicant’s arguments, see Applicant’s Remarks p. 5, with respect to the previously applied Non-Statutory Double Patenting Rejections of claim 9 and corresponding amendments to claim 9 have been fully considered and are persuasive. The Non-Statutory Double Patenting rejection(s) to claim 9 and those dependent therefrom have been withdrawn.
Applicant's arguments, see Applicant’s Remarks p. 5-9, with respect to the previously applied rejection(s) of claims 1 and those dependent therefrom under § 103 have been fully considered but they are not persuasive.
Regarding claim 1, the Applicant asserts that the previously applied Burkholz and Devgon, either individually or in combination, fail to teach or suggest a small sample dispense device comprising a needle-free connector configured to be connected to a blood sample collection device and to prevent fluid from leaving the small sample dispense device when detached from the blood sample collection device, as recited in amended independent claim 1, as the Applicant notes that neither the threaded fastener 142 nor the threaded cap 144 of the sampling device 110 of Burkholz are configured to prevent fluid from leaving the sampling device 110 when detached from the collection device 112, and as Devgon fails to disclose a small sample dispense device, and furthermore, fails to disclose a needle-free connector on the small sample dispense device. However, the Examiner disagrees with the Applicant’s argument, as the Examiner notes that Burkholz explicitly discloses the argued needle-free connector configured to be connected to a blood sample collection device and to prevent fluid from leaving the small sample dispense device when detached from the blood sample collection device [For example, the collection device 112 may be configured to attach to the threaded port 128 of the sampling device 110 through a corresponding threaded cap 144 (Burkholz ¶0047, Fig. 5); The removable cap 116 is configured to be attached to the threaded port 128 and includes an inner channel 130 extending through a portion of the end cap 116 which is in fluid communication with the outflow lumen 126 and reservoir 118. The inner channel 130 is provided with a gas permeable vent 132 which permits gas to pass therethrough but which prevents passage of a fluid such as blood. The vent 132 may include various structures capable of providing these properties, such as porous plugs, permeable membranes, and/or structures containing a plurality of small venting holes (Burkholz ¶0040, Fig. 4); With reference to FIGS. 5-7, in certain configurations, the removable end cap 116 of the blood sampling device 110 is removed and the sampling device 110 is instead connected to the sample container collection device 112 through the threaded port 128 and outflow lumen 126 (Burkholz ¶0046)], wherein the blood sampling device 110 [small sample dispense device] comprising a removable end cap 116 for use when the blood sampling device 110 is not connected to the blood sample collection device [Burkholz ¶0046], wherein the end cap is configured to prevent fluid from leaving the blood sampling device 110 by providing a fluid impermeable vent (gas permeable vent 132) is considered to read on the claimed limitation of the small sample dispense device comprising a needle-free connector configured to prevent fluid from leaving the small sample dispense device when detached from the blood sample collection device.
Applicant’s arguments, see Applicant’s Remarks p. 5-9, with respect to the rejection(s) of claim(s) 9 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-20140309551-A1, previously presented) in view of Teoh (US-20160361519-A1).
Regarding claim 9, the Applicant asserts that Burkholz fails to teach or suggest a small sample dispense device that is vented to provide a blood flashback during use of the vascular access device, as recited in amended claim 9 [wherein the Examiner notes that the Applicant states that claim 9 is amended, however no amendments are provided in claim 9 in the claims as amended on 21 August 2026], as the Applicant notes that the cited portion of ¶0036 of Burkholz regarding air being vented from blood sampling device 110 to draw blood from the vascular access device 112 is improperly applied to read on the “flashback” language of claim 9, as the Applicant asserts that “flashback” is a commonly used term in the art that refers to a condition in which the appearance of blood flowing through a device is identified by a user/physician due to the transparent nature of the device, which the Applicant notes is not disclosed in Burkholz. However, the Examiner notes that Applicant’s arguments with respect to claim(s) 9 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. Claim 9 is presently rejected as being obvious over Burkholz (US-20140309551-A1, previously presented) in view of Teoh (US-20160361519-A1), wherein the Examiner notes that Burkholz already discloses that the small sample dispense device is configured to be vented [This is because the blood sampling device 110 combines the ability to perform the processes of venting the extravascular system and obtaining a blood sample into a single device. More specifically, the blood sampling device 110 is configured to vent air from the extravascular system 10, thereby drawing blood from the vascular access device 12 through extension tubing 20 to the sampling device 110 (Burkholz ¶0036)], and wherein Teoh discloses venting a small sample dispense device coupled to a vascular access device to enable a blood flashback during use of the vascular access device [the flashback plug 118 has a wall surface defining a flashback chamber 130 in fluid communication with the hollow needle 106… Upon successful venipuncture, flashback of blood flows through the needle and into the flashback chamber 130, which is viewable to the healthcare worker. A vent filter, such as a hydrophobic filter, is typically placed at a proximal end of the flashback plug 118 to permit venting. In this way, the flashback chamber 130 provides a visual indicator that the healthcare worker has properly and successfully inserted the needle into the patient's vein… the flashback plug 118 can be removed from the needle hub 108 and subsequently used as a blood sampling source, such as for use to dispense blood samples (Teoh ¶0060, Fig. 3), wherein providing a vent filter for the flashback plug 118 (small sample dispense device) for the purposes of enabling flashback of blood in the flashback chamber 130 of the flashback plug 118 is considered to read on the claimed limitation wherein the small sample dispense device is vented to provide a blood flashback during use of the vascular access device].
Conclusion
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/SEVERO ANTONIO P LOPEZ/Examiner, Art Unit 3791
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