DETAILED ACTION
This action is responsive to the claim amendments and Applicant’s Remarks 22 January 2026. The Examiner acknowledges the amendments to claims 7, 12-13, and 18, and the cancelation of claim 21. Claims 1-20 and 22 are pending, with claims 1-6 and 14-17 standing as previously withdrawn.
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 .
Claim Objections
Claim(s) 11 is/are objected to because of the following informalities:
Claim 11 should read “wherein [[the]] a fluid chamber access port” [lines 1-2].
Appropriate correction is required.
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) 7, 10, 12-13, 18-20 and 22 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11 and 15 of copending Application No. 18/646,142 (Govindaraj) [which is considered to incorporate the subject matter of claim 1] in view of Beat (US-6155991-A, previously presented).
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”.
Beat discloses a blood collection system, wherein a blood collection device is coupled through a luer connection to a housing for collecting blood [As noted above, needle assembly 16 can be conventional in construction and includes hollow needle 32 and hub 34 made of a synthetic resin or the like. Hub 34 defines an inner Luer surface that compliments the Luer surface defined on base portion 18 to allow base portion 18 to fit snugly in hub 34, as illustrated in FIGS. 3 and 5, to couple capillary tube 12 to needle assembly 1 (Beat Col 4:15-21, Figs. 1-3); Once blood supply B is accessed by needle 32, capillary tube 12 will begin to fill by drawing blood into passage 13 formed therethrough through capillary action (i.e. the movement of liquid due to the forces of adhesion, cohesion, and surface tension) (Beat Col 4:51-56)], wherein the blood sample collection device is configured to receive and hold a blood sample of 0.3 to 500 microliters [When passage 13 of capillary tube 12 is filled with blood, i.e. a sample of approximately 100 microliters has been collected in passage 13, needle 32 is withdrawn from blood supply B and plug 20 of end cap 14 on the distal end of capillary tube 12 is immediately placed in opening 26 to seal the distal end of capillary tube 12. Needle assembly 16 is then removed from end cap 14 of the proximal end of capillary tube 12 and plug 20 of end cap 14 of the proximal end is immediately placed in opening 26 to seal the proximal end of capillary tube 12. A 100 microliter sample is now sealed in passage 13 of capillary tube 12 as illustrated in FIG. 4 (Beat Col 4:57-5:1, Fig. 4)] and is detachable from the housing to dispense the blood sample to a point-of-care instrument or device for testing and analysis [Beat Col 4:57-5:1; the invention facilitates other handling procedures of the blood sample contained in sealed capillary tube 12, such as introducing the blood sample into a blood gas analyzer, or other test instrument (Beat Col 5:30-34)].
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 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 allow for controlled sample dispensing for sample analysis.
Conflicting claim 11 of Govindaraj in view of Beat further render obvious instant claims 10 and 12-13.
Claim 7 of the Instant Application
Claim 11 of Conflicting Patent Application 18/646,142 (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.
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”.
Beat discloses a blood collection system, wherein a blood collection device is coupled through a luer connection to a housing for collecting blood [As noted above, needle assembly 16 can be conventional in construction and includes hollow needle 32 and hub 34 made of a synthetic resin or the like. Hub 34 defines an inner Luer surface that compliments the Luer surface defined on base portion 18 to allow base portion 18 to fit snugly in hub 34, as illustrated in FIGS. 3 and 5, to couple capillary tube 12 to needle assembly 1 (Beat Col 4:15-21, Figs. 1-3); Once blood supply B is accessed by needle 32, capillary tube 12 will begin to fill by drawing blood into passage 13 formed therethrough through capillary action (i.e. the movement of liquid due to the forces of adhesion, cohesion, and surface tension) (Beat Col 4:51-56)], wherein the blood sample collection device is configured to receive and hold a blood sample of 0.3 to 500 microliters [When passage 13 of capillary tube 12 is filled with blood, i.e. a sample of approximately 100 microliters has been collected in passage 13, needle 32 is withdrawn from blood supply B and plug 20 of end cap 14 on the distal end of capillary tube 12 is immediately placed in opening 26 to seal the distal end of capillary tube 12. Needle assembly 16 is then removed from end cap 14 of the proximal end of capillary tube 12 and plug 20 of end cap 14 of the proximal end is immediately placed in opening 26 to seal the proximal end of capillary tube 12. A 100 microliter sample is now sealed in passage 13 of capillary tube 12 as illustrated in FIG. 4 (Beat Col 4:57-5:1, Fig. 4)] and is detachable from the housing to dispense the blood sample to a point-of-care instrument or device for testing and analysis [Beat Col 4:57-5:1; the invention facilitates other handling procedures of the blood sample contained in sealed capillary tube 12, such as introducing the blood sample into a blood gas analyzer, or other test instrument (Beat Col 5:30-34)].
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 small volume blood sample is 0.3 to 500 microliters, as the amount of blood volume required for certain tests is known to be in the range of microliters to reduce the amount of blood volume required to be withdrawn [Recently, analyzers have been developed that are capable of accurately analyzing blood samples ranging in volume from 90-250 microliters (Beat Col 1:20-22); In many procedures, such as performing blood gas analyses in neonates, it is desirable to minimize the volume of collected blood samples. Of course, neonates have a very small blood volume. Also, blood gas analysis requires that blood be drawn at frequent intervals. Therefore, it is important to draw samples that are as small as possible to reduce or eliminate blood waste and the potential need for blood transfusions (Beat Col 1:26-33)].
Conflicting claims 15 and 19-20 of Govindaraj as modified by Beat 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.
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, 10, 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 (Burkholz) [which is considered to incorporate the subject matter of claims 1 and 4] in view of Beat (US-6155991-A, previously presented).
Conflicting claim 6 of Burkholz 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”.
Beat discloses a blood collection system, wherein a blood collection device is coupled through a luer connection to a housing for collecting blood [As noted above, needle assembly 16 can be conventional in construction and includes hollow needle 32 and hub 34 made of a synthetic resin or the like. Hub 34 defines an inner Luer surface that compliments the Luer surface defined on base portion 18 to allow base portion 18 to fit snugly in hub 34, as illustrated in FIGS. 3 and 5, to couple capillary tube 12 to needle assembly 1 (Beat Col 4:15-21, Figs. 1-3); Once blood supply B is accessed by needle 32, capillary tube 12 will begin to fill by drawing blood into passage 13 formed therethrough through capillary action (i.e. the movement of liquid due to the forces of adhesion, cohesion, and surface tension) (Beat Col 4:51-56)], wherein the blood sample collection device is configured to receive and hold a blood sample of 0.3 to 500 microliters [When passage 13 of capillary tube 12 is filled with blood, i.e. a sample of approximately 100 microliters has been collected in passage 13, needle 32 is withdrawn from blood supply B and plug 20 of end cap 14 on the distal end of capillary tube 12 is immediately placed in opening 26 to seal the distal end of capillary tube 12. Needle assembly 16 is then removed from end cap 14 of the proximal end of capillary tube 12 and plug 20 of end cap 14 of the proximal end is immediately placed in opening 26 to seal the proximal end of capillary tube 12. A 100 microliter sample is now sealed in passage 13 of capillary tube 12 as illustrated in FIG. 4 (Beat Col 4:57-5:1, Fig. 4)] and is detachable from the housing to dispense the blood sample to a point-of-care instrument or device for testing and analysis [Beat Col 4:57-5:1; the invention facilitates other handling procedures of the blood sample contained in sealed capillary tube 12, such as introducing the blood sample into a blood gas analyzer, or other test instrument (Beat Col 5:30-34)].
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 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 allow for controlled sample dispensing for sample analysis.
Conflicting claim 6 of Burkholz in view of Beat further render obvious instant claims 10 and 12.
Claim 7 of the Instant Application
Claim 6 of Conflicting Patent Application 17/752,312 (Burkholz) [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.
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) in view of Beat (US-6155991-A, previously presented).
Regarding claim 7, Burkholz teaches
An instrument advancement device, comprising:
a housing comprising a distal end and a proximal end [the delivery device 10 may include a housing 14. In some embodiments, the housing may include a distal end 16, a proximal end 18 (Burkholz ¶0033)];
an instrument disposed within the housing [the delivery device 10 may facilitate delivery of an instrument, such as, for example, a catheter 12 (Burkholz ¶0032); the housing 14 may encase or enclose the instrument when the instrument is in a retracted position (Burkholz ¶0033];
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 (Burkholz ¶0034); 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 ¶0037, Figs. 1-4)], 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 instrument may include the catheter 12, and 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 ¶0039), wherein as depicted in Burkholz Figs. 1-4, the position of extension tubing 32 is at the distal end of the device].
However, Burkholz fails to explicitly disclose 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.
Beat discloses a blood collection system, wherein a blood collection device is coupled through a luer connection to a housing for collecting blood [As noted above, needle assembly 16 can be conventional in construction and includes hollow needle 32 and hub 34 made of a synthetic resin or the like. Hub 34 defines an inner Luer surface that compliments the Luer surface defined on base portion 18 to allow base portion 18 to fit snugly in hub 34, as illustrated in FIGS. 3 and 5, to couple capillary tube 12 to needle assembly 1 (Beat Col 4:15-21, Figs. 1-3); Once blood supply B is accessed by needle 32, capillary tube 12 will begin to fill by drawing blood into passage 13 formed therethrough through capillary action (i.e. the movement of liquid due to the forces of adhesion, cohesion, and surface tension) (Beat Col 4:51-56)], wherein the blood sample collection device is configured to receive and hold a blood sample of 0.3 to 500 microliters [When passage 13 of capillary tube 12 is filled with blood, i.e. a sample of approximately 100 microliters has been collected in passage 13, needle 32 is withdrawn from blood supply B and plug 20 of end cap 14 on the distal end of capillary tube 12 is immediately placed in opening 26 to seal the distal end of capillary tube 12. Needle assembly 16 is then removed from end cap 14 of the proximal end of capillary tube 12 and plug 20 of end cap 14 of the proximal end is immediately placed in opening 26 to seal the proximal end of capillary tube 12. A 100 microliter sample is now sealed in passage 13 of capillary tube 12 as illustrated in FIG. 4 (Beat Col 4:57-5:1, Fig. 4)] and is detachable from the housing to dispense the blood sample to a point-of-care instrument or device for testing and analysis [Beat Col 4:57-5:1; the invention facilitates other handling procedures of the blood sample contained in sealed capillary tube 12, such as introducing the blood sample into a blood gas analyzer, or other test instrument (Beat Col 5:30-34)].
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 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 allow for controlled sample dispensing for sample analysis.
Regarding claim 8, Burkholz in view of Beat teaches
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 ¶0039].
Regarding claim 9, Burkholz in view of Beat teaches
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 [Beat Col 4:57-5:1, 5:30-34].
Regarding claim 10, Burkholz in view of Beat teaches
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 [wherein the extension tubing 32, as depicted in at least Burkholz Figs. 1-4, is considered to be coupled to a port defined in the distal end of the housing].
Claim(s) 11 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz in view of Beat, as applied to claims 7-8 above, in further view of McNamara (US-6042567-A).
Regarding claim 11, Burkholz in view of Beat teaches
The instrument advancement device of claim 8.
However, Burkholz in view of Beat 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 in view of Beat 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 in view of Beat teaches
The instrument advancement device of claim 7.
However, Burkholz in view of Beat 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 in view of Beat 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 in view of Beat, as applied to claim 7 above, in further view of Devgon (US-20200100716-A1).
Regarding claim 12, Burkholz in view of Beat teaches
The instrument advancement device of claim 7.
However, while Burkholz in view of Beat 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 in view of Beat 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 Stocking (US-5704914-A, previously presented) in view of Beat (US-6155991-A, previously presented).
Regarding claim 18, Stocking teaches
An instrument advancement device, comprising:
a housing comprising a distal end and a proximal end [assembly 10 (Figs. 1-4); The assembly 10 includes two removably connected portions, a first of these being a flexible catheter 12 and hub 14 of the type through which a hypodermic needle, such as a catheter introducer needle, can be passed in close fitting relationship. While the catheter 12 and hub 14 can be removably connected together if desired, we prefer that they be permanently connected together in any suitable manner. A proximal end of the hub 14 is exteriorly threaded, as at 16, so as to threadably join an interiorly threaded open end portion of a thickened distal end portion 18 (See FIGS. 3-4) of the second of the aforementioned portions, namely, an elongate hollow sheath or tubular body 20 of uniform outside diameter throughout its length (Stocking Col 3:43-55); wherein as depicted in Figs. 1-4, the assembly 10 (housing) may be defined by a distal end (catheter 12 and hub 14) and a proximal end (tubular body 20)];
an instrument disposed within the housing [Similarly, a flexible, longitudinally movable guide wire 32 is disposed entirely within the hollow interior 31 of the body 20 when in a fully retracted position as also shown in FIG. 4 and, in addition, is inserted through the cannula of the needle 27 when the latter is in its fully retracted position. The guide wire 32 is sufficiently longer than the needle 27 so as to be capable of extension forwardly beyond the tip 28 of the needle 27, when both the guide wire and needle are in their extended or advanced positions and after the needle is inserted into a blood vessel lumen, to provide a track over which to slide the catheter 12 when the latter is being inserted into the blood vessel lumen (Stocking Col 4:11-23, Figs. 1-4)];
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 [A similarly constructed sleeve 44 operates along the slot 42 and is connected to a proximal end of the guide wire 32. The guide wire sleeve 44 is located behind the needle sleeve 37 so that, as the sleeve 37 and needle 27 are withdrawn toward the retracted position, the sleeve 44 and, hence, the guide wire 32 are also retracted (Stocking Col 4:66-5:4, Figs. 1-4); Next, with the needle tip 28 penetrating the blood vessel lumen, the guide wire sleeve 44 is advanced along the body 20 until it is positioned against the needle sleeve 37 as shown in FIG. 3 wherein the guide wire 32 advances beyond the tip 28 of the needle 27 along the lumen of the blood vessel, assuming no substantial resistance to its advancement is encountered (Stocking Col 6:12-18, Figs. 1-4)], and
a blood sample collection device operatively connected to the advancement element to collect a small volume blood sample [The hub 14 also contains a liquid outlet port or side access port 54 which communicates with the hub lumen 24… When the handle 60 is rotated so as to point toward the port 54, the port 54 is sealed relative to the hub lumen 24 so that blood can not continue to flow through the port 54 into the line 58. The line 58 is connected to a second stop cock 62 which leads to an in-line outlet port 64… The port 64 may be connected to the transducer of a conventional blood pressure monitor to monitor the blood pressure of a patient with which the catheter 12 is used (Stocking Col 5:17-18, 40-45, 51-54, Figs. 1-5); A stop cock handle 60, when positioned as shown in FIGS. 1 and 5, permits blood flow from a blood vessel into the needle tip 28, thence through the needle 27 to the fenestration 30, thence through one or more of the fenestrations into the enlarged hub lumen 24 and, thereafter, through the port 54 into the line 58 when the guide wire 32 is at least partially retracted through the needle 27 rearwardly of the particular fenestration which communicates with the port 54 (Stocking Col 5:26-34, Fig. 5); Optionally, a side port is provided on a catheter hub to provide means for sampling a biological liquid introduced into the catheter, for monitoring blood pressure for sampling blood and for observing the flow of such a liquid in a line attached to the side port (Stocking Col 8:26-30), wherein the Examiner notes that the line 58 may be considered to read on the broadest reasonable interpretation of a “blood collection device”, as line 58 is configured to allow blood to flow in, as noted 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 line 58 (blood sample collection device) is “operatively connected” to guide wire sleeve 44 (advancement element) to collect a small volume blood sample, as movement of the guide wire sleeve 44 positions the guide wire 32 (instrument) such that blood may flow through the needle 27 to line 58].
However, Stocking fails to explicitly disclose wherein the small volume blood sample is 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.
Beat discloses a blood collection system, wherein a blood collection device is coupled to a housing for collecting blood [Once blood supply B is accessed by needle 32, capillary tube 12 will begin to fill by drawing blood into passage 13 formed therethrough through capillary action (i.e. the movement of liquid due to the forces of adhesion, cohesion, and surface tension) (Beat Col 4:51-56)], wherein the blood sample collection device is configured to collect a sample of 0.3 to 500 microliters [When passage 13 of capillary tube 12 is filled with blood, i.e. a sample of approximately 100 microliters has been collected in passage 13, needle 32 is withdrawn from blood supply B and plug 20 of end cap 14 on the distal end of capillary tube 12 is immediately placed in opening 26 to seal the distal end of capillary tube 12. Needle assembly 16 is then removed from end cap 14 of the proximal end of capillary tube 12 and plug 20 of end cap 14 of the proximal end is immediately placed in opening 26 to seal the proximal end of capillary tube 12. A 100 microliter sample is now sealed in passage 13 of capillary tube 12 as illustrated in FIG. 4 (Beat Col 4:57-5:1, Fig. 4); the invention facilitates other handling procedures of the blood sample contained in sealed capillary tube 12, such as introducing the blood sample into a blood gas analyzer, or other test instrument (Beat Col 5:30-34)]; 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 [Beat Col 4:57-5:1, Col 5:30-34, Fig. 4]
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 Stocking to employ wherein the small volume blood sample is 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, as the amount of blood volume required for certain tests is known to be in the range of microliters to reduce the amount of blood volume required to be withdrawn [Recently, analyzers have been developed that are capable of accurately analyzing blood samples ranging in volume from 90-250 microliters (Beat Col 1:20-22); In many procedures, such as performing blood gas analyses in neonates, it is desirable to minimize the volume of collected blood samples. Of course, neonates have a very small blood volume. Also, blood gas analysis requires that blood be drawn at frequent intervals. Therefore, it is important to draw samples that are as small as possible to reduce or eliminate blood waste and the potential need for blood transfusions (Beat Col 1:26-33)] and to facilitate testing of the collected blood sample [Beat Col 5:30-34].
Regarding claim 19, Stocking in view of Beat 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 [wherein a proximal end of the guide wire sleeve 44 (advancement element) being connected to the guide wire 32 (instrument) is considered to be in operative communication with the blood sample collection device (as modified) as the position of guide wire 32 allows for the blood sample collection device (as modified) to collect a small volume blood sample (see Stocking Col 5:26-34)].
Regarding claim 20, Stocking in view of Beat 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 [wherein the guide wire sleeve 44 (advancement element) being connected to the guide wire 32 (instrument) is considered to define a fluid path to fluidly connect the blood sample collection device (as modified) to a fluid path defined by the needle 27 and guide wire 32, as the position of guide wire 32 allows for fluid flow to the blood sample collection device (as modified) (see Stocking Col 5:26-34)].
Regarding claim 22, Stocking in view of Beat 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; Beat Col 4:57-5:1, Fig. 4].
Response to Arguments
Applicant's arguments, see Applicant’s Remarks p. 8, filed 22 January 2026, with respect to the previously presented drawing objections have been fully considered and are persuasive. The drawing objection for reference characters not depicted in the drawings has been withdrawn.
Applicant’s arguments, see Applicant’s Remarks p. 8, with respect to the previously presented claim objection(s) have been fully considered and are persuasive. The objection to claim 21 has been withdrawn.
Applicant’s arguments, see Applicant’s Remarks p. 8, with respect to the previously applied rejections under § 112(b) have been fully considered and are persuasive. The rejections to claims 12-13 have been withdrawn.
Applicant's arguments, see Applicant’s Remarks p. 8, with respect to the previously applied Non-Statutory Double Patenting provisional rejections have been fully considered but they are not persuasive.
The Applicant requests that the 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 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. 9-11, with respect to the previously applied rejection(s) of claim(s) 7 and those dependent therefrom under § 102 and § 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) in view of Beat (US-6155991-A, previously presented).
Regarding claim 7, the Applicant asserts that Stocking fails to disclose or suggest the amended subject matter of claim 7 of a blood sample collection device 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. Applicant’s arguments with respect to claim(s) 7 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 as being obvious over Burkholz (US-20200016374-A1) in view of Beat (US-6155991-A, previously presented), wherein the Examiner notes that Burkholz discloses 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 [Burkholz ¶0039, wherein as depicted in Burkholz Figs. 1-4, the position of extension tubing 32 is at the distal end of the device] and Beat discloses a blood sample collection device that 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 [Beat Col 4:15-21, 4:51-5:1, 5:30-34, Figs. 1-3].
Applicant's arguments, see Applicant’s Remarks p. 9-11, with respect to the respect to the previously applied rejections of claim(s) 18 and those dependent therefrom under § 103 have been fully considered but they are not persuasive.
Regarding claim 18, the Applicant asserts that each of the functionality and intended purpose of the devices of Stocking and Beat are distinct from one another such that one of ordinary skill in the art would not have found it obvious to simply substitute these two devices with one another, wherein the Applicant notes that Stocking discloses a catheter placement assembly, while Beat discloses a blood sample collection apparatus. However, the Examiner disagrees with the Applicant’s argument, as the Examiner notes that Stocking is not only directed towards a catheter placement assembly, but further discloses sampling of a biological liquid [The hub 14 also contains a liquid outlet port or side access port 54 which communicates with the hub lumen 24 (Stocking Col 5:17-18, Fig. 5); Optionally, a side port is provided on a catheter hub to provide means for sampling a biological liquid introduced into the catheter, for monitoring blood pressure for sampling blood and for observing the flow of such a liquid in a line attached to the side port (Stocking Col 8:26-30)], such that Stocking and Beat are considered to be in the same field of endeavor.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to 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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