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 .
Drawings
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: “first end 28” and “second end 30” [Applicant’s Specification ¶0028]. 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.
Specification
The disclosure is objected to because of the following informalities:
The Examiner notes that the Specification recites “U.S. Patent Application Publication No. 2021/10186394” [¶0032], which is considered to be improperly written/cited, and has been interpreted to read “U.S. Patent Application Publication No. 2021/0186394”.
Appropriate correction is required.
Claim Interpretation
Examiner Notes: currently, NO limitation invokes interpretation under § 112(f).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 13-15 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 13 recites the limitation “further comprising a vascular access device” [line 1], which is considered indefinite, as it is not clear whether the recited vascular access device of claim 13 is meant to positively recite the vascular access device of claim 1 [line 7] as being part of the system and further define the vascular access device, or define a new/separate vascular access device from the vascular access device of claim 1. For examination purposes, the Examiner has interpreted the vascular access device of claim 13 to positively recite the vascular access device of claim 1 as being part of the claimed system and further define the vascular access device. The Examiner notes that each of claims 14-15 recite similarly indefinite subject matter [“further comprising a vascular access device” (line 1 in each of claims 14 and 15)] to the indefinite subject matter of claim 13 as noted above, wherein the Examiner has interpreted claims 14-15 similar to claim 13 as noted above mutatis mutandis.
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) 1-2, 5, 10-11, and 13-18 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1 and 8 of copending Application No. 18/881,785 (hereinafter Steel) in view of Bullington (US-20190175087-A1), hereinafter Bullington ‘087.
Conflicting claim 1 of Steel is considered to anticipate almost each and every limitation of claim 1 of the instant application [see comparison below], except for the instant preamble defining the sample collection system as a “blood culture sample collection system” and the instant limitation “the access connector configured to be connected to a vascular access device”.
Bullington ‘087 discloses vascular access systems, wherein Bullington ‘087 discloses a vascular access device for collecting a blood sample [The inlet device 310 can be any suitable device(s) such as, for example, an IV catheter, a sharpened catheter or sharpened needle, and/or any other suitable lumen-containing device (Bullington ‘087 ¶0102); a user such as a doctor, physician, nurse, phlebotomist, technician, etc. can manipulate the device 300 by inserting at least a portion of the needle 314 into a patient's vein (e.g., a venipuncture event) and/or can otherwise establish fluid communication between the needle 314 and the patient. Once in fluid communication with the patient, bodily fluid can flow from the bodily fluid source (e.g., the vein of the patient), through the inlet device 310, and into the housing 330 (Bullington ‘087 ¶0108, Figs. 5, 7)] including a passive diversion portion, the vascular access device in fluid communication with a fluid collection device [The inlet 332 of the housing 330 is coupled to the flexible tubing 320 (e.g., the flexible tubing 320 is a flexible inlet tubing for the housing 330), which defines a lumen configured to place the inlet 332 in fluid communication with the inlet device 310. The first outlet 336 is coupled to a first flexible outlet tubing 338 (also referred to herein as “first outlet tubing”), which defines a lumen 339 configured to receive a first or initial volume of bodily fluid flowing through the housing 330. The first outlet tubing 338 is also coupled to a vent 335 having a vent material 342 that can selectively vent the lumen 339 of the first outlet tubing 338. As such, at least a portion of the lumen 339 can form, for example, a sequestration portion 334 (also referred to herein as “sequestration portion”) and/or the like, as described in further detail herein. The second outlet 337 is in fluid communication with a second flexible outlet tubing 347 (also referred to herein as “second outlet tubing”), which defines a lumen 348 configured to place the second outlet tubing 347 in fluid communication with one or more fluid collection devices (not shown) (Bullington ‘087 ¶0105, Figs. 5, 7); the actuator 350 can be switched by a manual or mechanical action (e.g. engaging and/or exerting a force on a button, a stopcock, a switch, a toggle, a slider, etc.), by one or more internal or external forces and/or changes in the magnitude of such forces (e.g., a change in magnitude of a negative pressure differential and/or the like), by the passage of a predetermined time, or through any suitable combination of active and/or passive mechanisms (Bullington ‘087 ¶0107)].
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 Steel to employ the sample collection system as a blood culture sample collection system, as this modification would amount to merely applying a known technique to a known device (method, or product) ready for improvement to yield predictable results [MPEP § 2143(I)(D)]; as well as be obvious to employ configuring the access connector to be connected to a vascular access device, such as the vascular access device as disclosed by Bullington ‘087, so as to vent and sequester an initial volume of blood prior to collecting a subsequent volume of blood to maintain sterility of the subsequent volume of blood [The arrangement of the first outlet tubing 338 (e.g., the sequestration portion 334) can be such that the lumen retains and/or sequesters the initial volume or amount of bodily fluid therein. As described in detail above, contaminants such as, for example, dermally residing microbes or the like dislodged during the venipuncture event, can be entrained and/or included in the initial volume of the bodily fluid and thus, can also be sequestered in the first outlet tubing 338 (Bullington ‘087 ¶0113)].
Conflicting claims 1 and 8 of Steel in view of Bullington ‘087 are further considered to render obvious claims 2, 5, 10-11, and 13-18 of the instant application.
Claim 1 of the Instant Application
Claim 1 of Conflicting Patent Application 18/881,785 (Steel)
A sample collection system comprising:
A sample collection system comprising: [claim 1 line 1]
a container holder having a first end and a second end positioned opposite the first end, the container holder defining an opening, the container holder comprising a needle positioned within the opening;
an adaptor comprising a distal end, a proximal end, a needle, and an interior, the adaptor configured to receive a sample through a connector at the distal end, the needle extending from the connector into the interior of the adaptor, and the proximal end including an opening to receive a first end of the container into the interior of the adaptor; [claim 1 lines 3-9]
an adapter engaged with the container holder;
a securing mechanism configured to releasably secure the container at a first position, wherein, at the first position, the first end of the container is held in a spaced relationship with the needle in the interior of the adaptor, [claim 1 lines 10-14]
an access connector in fluid communication with the needle of the container holder; and
a connector at the distal end, the needle extending from the connector into the interior of the adaptor [claim 1 lines 3-7]
a collection container having a first end and a second end positioned opposite the first end, the collection container including:
a container for collecting a sample; [claim 1 line 2, wherein the Examiner notes that any structure may be considered to have a first end and a second end positioned opposite the first end]
a pre-advancement position where the first end of the collection container is spaced from the needle, the first end of the collection container is received within the opening of the container holder, and the collection container is engaged with the adapter;
a securing mechanism configured to releasably secure the container at a first position, wherein, at the first position, the first end of the container is held in a spaced relationship with the needle in the interior of the adaptor, [claim 1 lines 10-14]
an advanced position where the first end of the collection container is received within the opening of the container holder, the needle is in fluid communication with the collection container, and the collection container is engaged with the adapter; and
wherein the securing mechanism is operated to allow the container to be advanced distally within the interior of the adaptor from the first position to a second position and thereby engage the needle to receive the sample into the container, [claim 1 lines 15-19]
a post-collection position where the collection container is positioned outside of the opening of the container holder.
wherein the securing mechanism is further configured to enable the container to be withdrawn proximally to remove the container from the interior of the adaptor [claim 1 lines 20-22]
This is a provisional nonstatutory double patenting rejection.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-2, 5-6, and 10-11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vandenbrink (US-20210196167-A1, cited by Applicant in IDS dated 24 August 2023 and not presently cited in Notice of References cited).
Regarding claim 1, Vandenbrink teaches
A blood culture sample collection system comprising:
a container holder [fluid access assembly 220 (Vandenbrink Fig. 2B)] having a first end and a second end positioned opposite the first end, the container holder defining an opening, the container holder comprising a needle positioned within the opening [The fluid access assembly 220 can have a first end 223 and a second end 225. The fluid access component 224 can be disposed within the interior 221 of the housing 228 and can extend from the first end 223 of the housing 228 into the interior 221 of the housing 228… The fluid access component 224 can include a needle defining a lumen (Vandenbrink ¶0054, Fig. 2B)];
an adapter [adapter 230 (Vandenbrink Fig. 2B)] engaged with the container holder [The second engagement feature 232 of the adapter 230 can be configured to releasably engage with the engagement feature 222 of the fluid access assembly 220 (Vandenbrink ¶0058, Fig. 2E)];
an access connector [fluid connector component 226 (Vandenbrink Fig. 2B)] in fluid communication with the needle of the container holder, the access connector configured to be connected to a vascular access device [when the fluid connector component 226 is fluidically coupled to a patient's vasculature system, fluid (e.g., blood) can be drawn through the fluid connector component 226, through the fluid access component 224, and into the reservoir 211 of the container assembly 210 (e.g., due to the pressure differential between the reservoir 211 of the container assembly 210 and the patient's vasculature system) (Vandenbrink ¶0061, Fig. 2G), wherein the Examiner notes that claim 1 does not physically require a vascular access device, and wherein the fluid connector component 226 (access connector) is considered to be configurable to be connected to a vascular access device as noted in Vandenbrink ¶0061]; and
a collection container [container assembly 210 (Vandenbrink Fig. 2B)] having a first end and a second end positioned opposite the first end [As shown in FIG. 2B, the container assembly 210 can include a cap 212 and a tube 214. The tube 214 can have a first end coupled to the cap 212 and a second closed end 216 (Vandenbrink ¶0052, Fig. 2B)], the collection container including:
a pre-advancement position where the first end of the collection container is spaced from the needle, the first end of the collection container is received within the opening of the container holder, and the collection container is engaged with the adapter [As shown in FIG. 2F, the system 200 has a first configuration (e.g., an initial configuration) in which the first engagement feature 231 of the adapter 230 is engaged with the cap 212 and the second engagement feature 232 is engaged with the engagement feature 222 of the fluid access assembly 220 (Vandenbrink ¶0060, Fig. 2F)];
an advanced position where the first end of the collection container is received within the opening of the container holder, the needle is in fluid communication with the collection container, and the collection container is engaged with the adapter [As shown in FIG. 2G, the system 200 can be transitioned to a second configuration in which the lumen of the fluid access component 224 is in fluidic communication with the reservoir 211. To transition the system 200 from the first configuration to the second configuration, the container assembly 210 can be translated in the direction of arrow A toward the first end 223 of the fluid access assembly 220 such that the cap 212 is engaged with the fluid access component 224 (e.g., the fluid access component 224 pierces the cap 212) and a portion of the fluid access component 224 is disposed within the reservoir 211 (Vandenbrink ¶0061, Fig. 2G)]; and
a post-collection position where the collection container is positioned outside of the opening of the container holder [As shown in FIG. 2I, after the second engagement feature 232 of the adapter 230 is disengaged from the engagement feature 222 of the fluid access assembly 220, the container assembly 210 and the adapter 230 can be separated from the fluid access assembly 220 (Vandenbrink ¶0063, Fig. 2I)].
Regarding claim 2, Vandenbrink teaches
The system of claim 1, wherein the adapter is engaged with the collection container and separated from the container holder when the collection container is in the post-collection position [Vandenbrink ¶0063, Fig. 2I].
Regarding claim 5, Vandenbrink teaches
The system of claim 1, wherein the collection container comprises a blood culture sample collection container, wherein the collection container comprises a septum positioned at the first end of the collection container, and wherein the needle pierces the septum when the collection container moves from the pre-advancement position to the advanced position [As shown in FIG. 2B, the container assembly 210 can include a cap 212 and a tube 214 (Vandenbrink ¶0052), wherein tube 214 is considered to define a blood culture sample collection container as Vandenbrink ¶0061 discloses that the fluid collected in the tube 214 is blood; The cap 212 can include a resealable membrane such that a fluid access component, such as fluid access component 224, can pierce the resealable membrane to achieve fluidic communication with the reservoir 211. The resealable membrane of the cap 212 can be configured to reseal upon decoupling the fluid access component 224 from the cap 212 such that the reservoir 211 is fluidically isolated from an area external to the container assembly 210 (Vandenbrink ¶0053, Figs. 2F-I), wherein the resealable membrane of the cap 212 is considered to define a septum at the first end of the collection container].
Regarding claim 6, Vandenbrink teaches
The system of claim 1, wherein the access connector comprises a luer connector [the fluid connector component 226 can be a Luer connector (Vandenbrink ¶0055)].
Regarding claim 10, Vandenbrink teaches
The system of claim 1, wherein the adapter is annular, the adapter including a first portion configured to be received within the opening of the container holder [see Annotated Figure 1] and a second portion configured to engage the second end of the container holder [second engagement feature 232 (Vandenbrink Fig. 2D);the second engagement feature 232 can include two oppositely disposed tabs 233. A latch 234 can be disposed on the end of each tab 233. As shown, for example, in FIG. 2E, which is a side view of the system 200 in a first configuration, each latch 234 can be shaped and sized to receive a portion of the flange of the engagement feature 222 of the fluid access assembly 220 (Vandenbrink ¶0058, Fig. 2D)].
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Annotated Fig. 1. The Examiner notes that the adapter 230 is considered to be defined by a first portion [see annotation; As shown in FIG. 2D, which is a perspective view of the adapter 230 and a portion of the container assembly 210, the inner surface of the adapter 230 can have a diameter sufficiently small relative to an outermost diameter of the annular flange 219 of the cap 212 such that the inner surface and the cap 212 can be engaged via a friction fit (Vandenbrink ¶0057, Fig. 2D)] and a second portion [second engagement feature 232], wherein Vandenbrink Figs. 2E-H depict the first portion as identified as being received within the opening of the container holder.
Regarding claim 11, Vandenbrink teaches
The system of claim 10, wherein the second portion of the adapter is larger in diameter than the first portion of the adapter [see Annotated Fig. 1, Vandenbrink Fig. 2D, wherein the second engagement feature 232 (second portion) is considered to be larger in diameter than the identified first portion].
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.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vandenbrink, as applied to claim 1 above, in view of Swenson (US-20080319345-A1).
Regarding claim 3, Vandenbrink teaches
The system of claim 1.
However, Vandenbrink fails to explicitly disclose wherein the container holder comprises an elastomeric sleeve enclosing the needle.
Swenson discloses a blood collection system, wherein the system comprises a container holder [holder housing 22 (Swenson Fig. 2)] having a first end and a second end positioned opposite the first end, the container holder defining an opening, the container holder comprising a needle positioned within the opening [The blood collection assembly 10 also includes a holder housing 22, which defines a receiving chamber 24. The holder housing has a rearward end 26 for receiving a sample collection tube (not shown) within the chamber 24, and a forward end 28 with a receiving port 30 extending therethrough, establishing a pathway through the holder housing 22 into the receiving chamber 24. The receiving port 30 is sized and shaped so as to receive at least a portion of the proximal end 16 of the hub 12 of the needle assembly 11 therein (Swenson ¶0043, Figs. 1, 6, 13), wherein the needle assembly 11 as coupled to holder housing 22 is considered to read on the holder housing 22 (container holder) comprising puncturing element 32 (needle)], wherein the container holder comprises an elastomeric sleeve enclosing the needle [As shown in FIG. 6, the hub 12 may also include an elastomeric sleeve 82 extending from the proximal end 16 about the non-patient end 46 of the needle cannula 38. This elastomeric sleeve 82 acts as a valve for maintaining fluid within needle cannula during use of the blood collection assembly 10, and is adapted to be pierced by the non-patient end 46 of the needle cannula 38 during use, as is known in the art (Swenson ¶0042, Fig. 6)].
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 Vandenbrink to employ wherein the container holder comprises an elastomeric sleeve enclosing the needle, so as to maintain fluid within the needle and prevent leakage.
Claim(s) 4 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vandenbrink, as applied to claim 1 above, in view of Bullington (US-20150246352-A1), herein after Bullington ‘352.
Regarding claim 4, Vandenbrink teaches
The system of claim 1.
However, Vandenbrink fails to explicitly disclose wherein the collection container comprises a neck portion and a main body, the neck portion increasing in diameter in a direction extending from the first end of the collection container to the second end of the collection container.
Bullington ‘352 discloses a blood culture sample collection system, wherein Bullington ‘352 discloses a container holder [transfer adapter 220 (Bullington ‘352 Figs. 2-3); As shown in FIGS. 2 and 3, the transfer adapter 220 has a proximal end portion 221 and a distal end portion 223, and defines an inner volume 236 therebetween. The transfer adapter 220 can be any suitable shape, size, or configuration… the puncture member 250 are each at least partially disposed within the inner volume 236 defined by the transfer adapter 220 (Bullington ‘352 ¶0072, Figs. 2-3)]; and a collection container configured to be received within an opening of the container holder [fluid reservoir 210 (Bullington ‘352 Fig. 2); at least a portion of the fluid reservoir 210 can be selectively disposed within the inner volume 236, as described in further detail herein (Bullington ‘352 ¶0072, Figs. 2, 6, 8)] and wherein the collection container comprises a neck portion and a main body, the neck portion increasing in diameter in a direction extending from the first end of the collection container to the second end of the collection container [see Annotated Fig. 2].
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Annotated Fig. 2. The Examiner notes that the fluid reservoir 210 [collection container] as depicted in Bullington ‘352 Fig. 6 is considered to define a neck portion and a main body, the neck portion increasing in diameter in a direction extending from a first end of the collection container [distal surface 212 (Bullington ‘352 Figs. 2, 6; Annotated Fig. 2)] to a second end of the collection container [see annotation].
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 Vandenbrink to employ wherein the collection container comprises a neck portion and a main body, the neck portion increasing in diameter in a direction extending from the first end of the collection container to the second end of the collection container, as this modification would amount to mere simple substitution of one known element [container assembly 210 (Vandenbrink Fig. 2B)] for another [fluid reservoir 210 (Bullington ‘352 Fig. 2)] with similar expected results [MPEP § 2143(I)(B)].
Regarding claim 12, Vandenbrink in view of Bullington ‘352 teaches
The system of claim 4.
However, Vandenbrink in view of Bullington ‘352 as presently modified fails to explicitly disclose wherein more than half of the neck portion of the collection container is received within the container holder when the collection container is in the advanced position.
Bullington ‘352 discloses that the shape of the container holder may be of any suitable shape, size, or configuration and depicts more than half of the neck portion of the collection container is received within the container holder when the collection container is in an advanced position [The transfer adapter 220 can be any suitable shape, size, or configuration. For example, the transfer adapter 220 can have a set of annular walls 225 that define at least a portion of the inner volume 236 (Bullington ‘352, Fig. 8); As shown in FIG. 8, arrangement of the annular walls 225 of the transfer adapter 220 is associated with the general shape of the fluid reservoir 210. For example, the first portion 226, the second portion 228, and the tapered portion 227 of the annular walls 225 are arranged to substantially correspond to a shape of the fluid reservoir 210 when the fluid reservoir 210 is in the second position (Bullington ‘352 ¶0091, Fig. 8].
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 Vandenbrink in view of Bullington to employ wherein more than half of the neck portion of the collection container is received within the container holder when the collection container is in the advanced position, so as to securely accommodate any shape of collection container.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vandenbrink, as applied to claim 1 above, in view of Breindel (US-20190374145-A1).
Regarding claim 7, Vandenbrink teaches
The system of claim 6.
However, Vandenbrink fails to explicitly disclose wherein the access connector is connected to the container holder via flexible tubing.
Breindel discloses a blood collection system comprising a blood collection device coupled to an access connector via flexible tubing, wherein the access connector is further coupled to a vascular access device [For example, in one embodiment, the outlet port 132 can define a Luer connector configured to accept a portion of the blood collection device 134 (Breindel ¶0046, Fig. 1A); In some embodiments, the blood collection device 134 can be a vial or syringe 136 fluidly coupled to the outlet port 132 by an extension tube 138 (Breindel ¶0047, Fig. 1A)].
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 Vandenbrink to employ wherein the access connector is connected to the container holder via flexible tubing, as this modification would amount to mere simple substitution of one known element [direct connection between access connector and container holder (Vandenbrink Fig. 2B)] for another [connection via flexible tubing (Breindel Fig. 1A)] with similar expected results [fluid communication between the access connector and the container holder] [MPEP § 2143(I)(B)].
Claim(s) 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vandenbrink, as applied to claim 1 above, in view of Burkholz (US-20210228127-A1).
Regarding claim 8, Vandenbrink teaches
The system of claim 1.
However, Vandenbrink fails to explicitly disclose wherein the access connector comprises a compact connector with a fluid path configured to reduce a risk of hemolysis.
Burkholz discloses a blood collection system, wherein the blood collection system comprises a container holder [blood collection device 34 (Burkholz Figs. 2A-B)] configured to receive a collection container [the blood collection device 34 may include a needle assembly 36, which may include a needle 38 configured to receive a blood collection container. In these and other embodiments, the blood collection container may include an evacuated blood collection tube (Burkholz ¶0046)], wherein the container holder is coupled to an access connector [adapter 10 (Burkholz Figs. 1-2)] in fluid communication with a needle of the container holder, the access connector configured to be connected to a vascular access device [the fluid pathway of the vascular access system, which may include one or more of the needle assembly 36, the adapter 10, and the catheter assembly 37 (which may include an extension tube) (Burkholz ¶0049, Figs. 1-2)], wherein the access connector comprises a compact connector with a fluid path configured to reduce a risk of hemolysis [the adapter 10 may be configured to reduce a likelihood of hemolysis during blood collection using a vascular access device (Burkholz ¶0029); the non-linear portion 22 may increase a length of the fluid pathway 20 through the adapter 10 and thereby may increase flow resistance and decrease blood flow within the adapter 10. In these embodiments, a risk of hemolysis during blood collection may be reduced (Burkholz ¶0035)].
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 Vandenbrink to employ wherein the access connector comprises a compact connector with a fluid path configured to reduce a risk of hemolysis, so as to reduce the likelihood of hemolysis occurring during sample collection in order to collect an acceptable sample of blood [Burkholz ¶0007].
Regarding claim 9, Vandenbrink in view of Burkholz teaches
The system of claim 8, wherein the access connector is directly connected to the container holder [Burkholz, Figs. 2A-B].
Claim(s) 13-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vandenbrink, as applied to claim 1 above, in view of Bullington (US-20190175087-A1), hereinafter Bullington ‘087.
Regarding claim 13, Vandenbrink teaches
The system of claim 1.
However, while Vandenbrink discloses that the system may be couplable to a vascular access device [Vandenbrink ¶0061], Vandenbrink fails to explicitly disclose further comprising a vascular access device including a passive diversion portion, the vascular access device in fluid communication with the needle.
Bullington ‘087 discloses vascular access systems, wherein Bullington ‘087 discloses a vascular access device [The inlet device 310 can be any suitable device(s) such as, for example, an IV catheter, a sharpened catheter or sharpened needle, and/or any other suitable lumen-containing device (Bullington ‘087 ¶0102); a user such as a doctor, physician, nurse, phlebotomist, technician, etc. can manipulate the device 300 by inserting at least a portion of the needle 314 into a patient's vein (e.g., a venipuncture event) and/or can otherwise establish fluid communication between the needle 314 and the patient. Once in fluid communication with the patient, bodily fluid can flow from the bodily fluid source (e.g., the vein of the patient), through the inlet device 310, and into the housing 330 (Bullington ‘087 ¶0108, Figs. 5, 7)] including a passive diversion portion, the vascular access device in fluid communication with a fluid collection device [The inlet 332 of the housing 330 is coupled to the flexible tubing 320 (e.g., the flexible tubing 320 is a flexible inlet tubing for the housing 330), which defines a lumen configured to place the inlet 332 in fluid communication with the inlet device 310. The first outlet 336 is coupled to a first flexible outlet tubing 338 (also referred to herein as “first outlet tubing”), which defines a lumen 339 configured to receive a first or initial volume of bodily fluid flowing through the housing 330. The first outlet tubing 338 is also coupled to a vent 335 having a vent material 342 that can selectively vent the lumen 339 of the first outlet tubing 338. As such, at least a portion of the lumen 339 can form, for example, a sequestration portion 334 (also referred to herein as “sequestration portion”) and/or the like, as described in further detail herein. The second outlet 337 is in fluid communication with a second flexible outlet tubing 347 (also referred to herein as “second outlet tubing”), which defines a lumen 348 configured to place the second outlet tubing 347 in fluid communication with one or more fluid collection devices (not shown) (Bullington ‘087 ¶0105, Figs. 5, 7); the actuator 350 can be switched by a manual or mechanical action (e.g. engaging and/or exerting a force on a button, a stopcock, a switch, a toggle, a slider, etc.), by one or more internal or external forces and/or changes in the magnitude of such forces (e.g., a change in magnitude of a negative pressure differential and/or the like), by the passage of a predetermined time, or through any suitable combination of active and/or passive mechanisms (Bullington ‘087 ¶0107)].
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 Vandenbrink to employ further comprising a vascular access device including a passive diversion portion, the vascular access device in fluid communication with the needle, so as to vent and sequester an initial volume of blood prior to collecting a subsequent volume of blood to maintain sterility of the subsequent volume of blood [The arrangement of the first outlet tubing 338 (e.g., the sequestration portion 334) can be such that the lumen retains and/or sequesters the initial volume or amount of bodily fluid therein. As described in detail above, contaminants such as, for example, dermally residing microbes or the like dislodged during the venipuncture event, can be entrained and/or included in the initial volume of the bodily fluid and thus, can also be sequestered in the first outlet tubing 338 (Bullington ‘087 ¶0113)].
Regarding claim 14, Vandenbrink teaches
The system of claim 1.
However, while Vandenbrink discloses that the system may be couplable to a vascular access device [Vandenbrink ¶0061], Vandenbrink fails to explicitly disclose further comprising a vascular access device including an integrated catheter and a vented diversion chamber, the vascular access device in fluid communication with the needle.
Bullington ‘087 discloses vascular access systems, wherein Bullington ‘087 discloses a vascular access device including an integrated catheter and a vented diversion chamber, the vascular access device in fluid communication with a fluid collection device [Bullington ‘087 ¶¶0102, 0105, 0107-0108, 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 system of Vandenbrink to employ further comprising a vascular access device including an integrated catheter and a vented diversion chamber, the vascular access device in fluid communication with the needle, so as to vent and sequester an initial volume of blood prior to collecting a subsequent volume of blood to maintain sterility of the subsequent volume of blood [Bullington ‘087 ¶0113].
Regarding claim 15, Vandenbrink teaches
The system of claim 1.
However, while Vandenbrink discloses that the system may be couplable to a vascular access device [Vandenbrink ¶0061], Vandenbrink fails to explicitly disclose further comprising a vascular access device including an extension set and a vented diversion chamber, the vascular access device in fluid communication with the needle.
Bullington ‘087 discloses vascular access systems, wherein Bullington ‘087 discloses a vascular access device including an extension set and a vented diversion chamber, the vascular access device in fluid communication with a fluid collection device [Bullington ‘087 ¶¶0102, 0105, 0107-0108, 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 system of Vandenbrink to employ further comprising a vascular access device including an extension set and a vented diversion chamber, the vascular access device in fluid communication with the needle, so as to vent and sequester an initial volume of blood prior to collecting a subsequent volume of blood to maintain sterility of the subsequent volume of blood [Bullington ‘087 ¶0113].
Regarding claim 16, Vandenbrink teaches
The system of claim 1.
However, while Vandenbrink discloses that the system may be couplable to a vascular access device [Vandenbrink ¶0061], Vandenbrink fails to explicitly disclose further comprising a user-controlled active diversion mechanism.
Bullington ‘087 discloses vascular access systems, wherein Bullington ‘087 discloses a vascular access device comprising a user-controlled active diversion mechanism [Bullington ‘087 ¶¶0102, 0105, 0107-0108, 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 system of Vandenbrink to employ further comprising a user-controlled active diversion mechanism, so as to vent and sequester an initial volume of blood prior to collecting a subsequent volume of blood to maintain sterility of the subsequent volume of blood [Bullington ‘087 ¶0113].
Regarding claims 17-18 [rejected as claim 18 in longhand format to incorporate the subject matter of claim 17 therein], Vandenbrink teaches
The system of claim 17.
However, while Vandenbrink discloses that the system may be couplable to a vascular access device [Vandenbrink ¶0061], Vandenbrink fails to explicitly disclose further comprising a blood draw device in fluid communication with the needle and further comprising a vented diversion chamber.
Bullington ‘087 discloses vascular access systems, wherein Bullington ‘087 discloses a blood draw device in fluid communication with a fluid collection device and a vented diversion chamber [Bullington ‘087 ¶¶0102, 0105, 0107-0108, 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 system of Vandenbrink to employ further comprising a blood draw device in fluid communication with the needle and further comprising a vented diversion chamber, so as to vent and sequester an initial volume of blood prior to collecting a subsequent volume of blood to maintain sterility of the subsequent volume of blood [Bullington ‘087 ¶0113].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Ebara (US-5360012-A) discloses a blood sample collection system comprising: a container holder comprising a needle positioned within an opening of the container holder [tube holder 1 comprising hollow needle body 11 (see Ebara Col 4:11-18, Figs. 1-2)]; an adapter engaged with the container holder [adapter 4 (see Ebara Col 4:39-41, Figs. 1-2)]; a collection container engaged with the adapter and positionable between a pre-advancement position, an advanced position, and a post-collection position [evacuated tube 3 (see Ebara Col 5:22-32, Figs. 1-2)]
Wendelborn (US-5181523-A) discloses a blood sample collection system comprising: a container holder comprising a needle positioned within an opening [holder 6 comprising needle 3 (see Wendelborn Col 4:1-3, Fig. 1)]; an adapter engaged with the container holder [transparent protective sleeve 12 (see Wendelborn Col 4:19-26, Fig. 1)]; a collection container engaged with the adapter and positionable between a pre-advancement position, an advanced position, and a post-collection position [blood sample container 1 (see Miller Col 4:28-35, 48-56, Fig. 1)]
Noble (US-20090156963-A1) discloses collection containers that comprises a neck portion and a main body, the neck portion increasing in diameter in a direction extending from a first end of the collection container to a second end of the collection container [pierceable septum 32 of blood collection tube 30 (Noble Figs. 4-5, 7, 10, 12)]
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/SEVERO ANTONIO P LOPEZ/Examiner, Art Unit 3791
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