DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 17 February 2026 has been entered.
The Examiner acknowledges the amendments to claims 1 and 16, and the cancelation of claim 5. Claims 1-4 and 6-20 are pending.
Claim Interpretation
Examiner Notes: currently, NO limitation invokes interpretation under § 112(f).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim(s) 1-2, 6-9, 11-15, and 17-20 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-2, 6-8, 11-12, and 16-18 of U.S. Patent No. 11,213,232 in view of Braig (US-20070179436-A1).
Conflicting claims 1 and 16 of Ivosevic is/are considered to anticipate almost each and every limitation of instant claims 1 and 16 [see comparison below], respectively, except for the limitation of claim 1 “wherein the second chamber is constructed of a hydrophobic material” and the limitation of claim 16 wherein the second chamber comprises “a hydrophobic portion”.
Braig discloses systems for sampling blood, wherein Braig discloses constructing tubing through which blood flows through with a hydrophobic material [For purposes of minimizing sequential blood sample cross contamination, transfer tube 9301 comprises as nearly as possible a single uninterrupted length of extruded elastomeric tubing, as silicone plastic for example, the surfaces of which are essentially hydrophobic and otherwise nonadherent to blood or liquid-blood-born medications or transformed blood components. Inlet ports 9312 and 9313 and catheter 9304 attachment to transfer tube 9301 are so constructed as to minimize the production of areas of fluid stagnation that might transfer residues between blood samples, as will be explained (Braig ¶0472)].
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 diversion device of Ivosevic to employ wherein the second chamber is constructed of a hydrophobic material, so as to prevent adherence and stagnation of blood within the second chamber. It would have been similarly obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the diversion device used in the method of Ivosevic to employ wherein the second chamber comprises a hydrophobic portion, so as to prevent adherence and stagnation of blood within the second chamber.
Instant claims 2, 6-9, 11-15, and 17-20 are further considered to be rendered obvious by conflicting claims 1-2, 6-8, 11-12, and 16-18 of Ivosevic as modified by Braig.
Claim 1 of the Instant Application
Claim 1 of Conflicting Patent 11,213,232 (hereinafter referred to as Ivosevic)
A diversion device comprising:
A diversion device comprising: [Ivosevic Col 9, line 34]
a housing having:
a housing having [Ivosevic Col 9, line 35]
an inlet conduit,
an inlet conduit [Ivosevic Col 9, line 35]
an outlet conduit,
an outlet conduit [Ivosevic Col 9, line 35]
a first chamber, and
a diversion chamber [Ivosevic Col 9, line 44]
a second chamber,
a tube [Ivosevic Col 9, line 49]
wherein the housing is configured to sequester an initial flow of blood into the first chamber and, upon at least partially filling the first chamber, direct a subsequent flow of blood into the second chamber, and
wherein the diversion chamber is configured to receive and retain the initial flow of blood [Ivosevic Col 9, lines 45-46, wherein to receive and retain is considered to define “sequestering”]
wherein the internal conduit is configured to permit the subsequent flow of fluid to exit the diversion device [Ivosevic Col 9, lines 51-53, wherein the diversion chamber (first chamber) being configured to retain the initial flow of blood is considered to be equivalent to the subsequent flow of blood being directed to the tube (second chamber) upon “at least partially filling the first chamber”]
wherein the housing is configured to allow the subsequent flow of blood to exit the diversion device through the second chamber through the outlet conduit; and
wherein the internal conduit is configured to permit the subsequent flow of fluid to exit the diversion device [Ivosevic Col 9, lines 51-53]
wherein the housing is configured to allow the subsequent flow of blood to exit the diversion device through the outlet conduit [Ivosevic Col 9, lines 38-40]
a filter positioned within the housing adjacent to the outlet conduit, wherein the filter comprises a material that allows air, but not blood, to pass through it.
a filter positioned within the housing adjacent to the outlet conduit, wherein the filter comprises a material that allows air, but not blood, to pass through it [Ivosevic Col 9, lines 41-43]
Claim 16 of the Instant Application
Claim 16 of Conflicting Patent 11,213,232 (hereinafter referred to as Ivosevic)
A blood collection method comprising:
A blood collection method comprising: [Ivosevic Col 10, line 45]
assembling a blood collection pathway from a patient to a collection vessel,
assembling a blood collection pathway from a patient to a collection vessel, [Ivosevic Col 10, lines 46-47]
wherein the blood collection pathway comprises a first needle piercing a skin of the patient and a diversion device, and
wherein the blood collection pathway comprises a first needle piercing the skin of the patient and a diversion device, [Ivosevic Col 10, lines 48-50]
wherein the diversion device comprises:
wherein the diversion device comprises: [Ivosevic Col 10, line 57]
a housing having an inlet conduit, an outlet conduit, a first chamber, and a second chamber, wherein the housing is configured to sequester an initial flow of blood into the first chamber and, upon at least partially filling the first chamber, direct a subsequent flow of blood into the second chamber that is at least partially surrounded by the first chamber, and wherein the housing is configured to allow the subsequent flow of blood to exit the diversion device through the second chamber through the outlet conduit; and
a housing having an inlet conduit and an outlet conduit, [Ivosevic Col 10, line 58]
a diversion chamber [Ivosevic Col 11, line 1, wherein the diversion chamber is considered to be equivalent to the instant first chamber]
a tube [Ivosevic Col 11, line 6, wherein the tube is considered to be equivalent to the instant second chamber]
wherein the diversion chamber is configured to receive and retain the initial flow of blood [Col 11, lines 2-4, wherein to receive and retain is considered to define “sequestering”]
wherein the internal conduit is configured to permit the subsequent flow of fluid to exit the diversion device [Ivosevic Col 11, lines 8-10, wherein the diversion chamber (first chamber) being configured to retain the initial flow of blood is considered to be equivalent to the subsequent flow of blood being directed to the tube (second chamber) upon “at least partially filling the first chamber”]
a tube having a first end forming a conduit through the filter and a second end extending into the diversion chamber [Ivosevic Col 11, lines 6-8, wherein the tube (second chamber) extending into the diversion chamber (first chamber) is considered to be equivalent to the first chamber at least partially surrounding the second chamber]
wherein the housing is configured to allow the subsequent flow of blood to exit the diversion device through the outlet conduit [Ivosevic Col 10, lines 61-63]
wherein the internal conduit is configured to permit the subsequent flow of fluid to exit the diversion device [Ivosevic Col 11, lines 8-10]
a filter positioned within the housing adjacent to the outlet conduit, wherein the filter comprises a material that allows air, but not blood, to pass through it.
a filter positioned within the housing adjacent to the outlet conduit, wherein the filter comprises a material that allows air, but not blood, to pass through it [Ivosevic Col 10, lines 64-66]
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) 16-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rogers (US-20180177445-A1, effective filing date of 27 December 2016).
Regarding claim 16, Rogers teaches
A blood collection method comprising:
assembling a blood collection pathway from a patient to a collection vessel [an inlet port 2302 to connect with a patient needle, an outlet port 2304 to connect with a blood sample collection device (Rogers ¶0135, Fig. 23A)],
wherein the blood collection pathway comprises a first needle piercing a skin of the patient and a diversion device [Rogers ¶0135, Fig. 23A], and
wherein the diversion device comprises:
a housing having an inlet conduit [inlet port 2302 (Rogers Fig. 23A)], an outlet conduit [outlet port 2304 (Rogers Fig. 23A)], a first chamber [sequestration chamber 2306 (Rogers Fig. 23A)], and a second chamber comprising a hydrophobic portion [sampling channel 2308 (Rogers Fig. 23A); wherein as depicted in Rogers 23A, a wall of the sampling channel 2308 is defined by the hydrophobic plug 2312], wherein the housing is configured to sequester an initial flow of blood into the first chamber and, upon at least partially filling the first chamber, direct a subsequent flow of blood into the second chamber that is at least partially surrounded by the first chamber [a sampling channel 2308 that bypasses the sequestration chamber 2306 once the sequestration chamber is filled to an initial aliquot of potentially contaminated blood to be sequestered (Rogers ¶0135, Figs. 23A-B); Valve 2308 can be a clip or other enclosing device to pinch, shunt, bend or otherwise close off the sampling channel 2308 before the initial aliquot of blood is sequestered in the sequestration chamber 2306. For instance, valve 2308 can also be formed as a flap, door or closable window or barrier within the sampling channel 2308 (Rogers ¶0136), wherein as depicted in Rogers Figs. 23A-B, the sequestration chamber 2306 being positioned to the side and including portions that contact the sampling channel 2308 is considered to read on the broadest reasonable interpretation to “at least partially surround the second chamber”], and wherein the housing is configured to allow the subsequent flow of blood to exit the diversion device through the second chamber through the outlet conduit [Rogers ¶¶0135-0136, Figs. 23A-B, wherein as depicted in Rogers Figs. 23A-B, the flow path as defined allows blood to exit the device through the second chamber through the outlet conduit]; and
a filter positioned within the housing adjacent to the outlet conduit, wherein the filter comprises a material that allows air, but not blood, to pass through it [The sequestration chamber 2306 includes a hydrophobic plug 2312 at a distal end of the sequestration chamber 2306 (Rogers ¶0135, Fig. 23A); As used herein the term “air permeable blood barrier” means an air permeable but substantially blood impermeable substance, material, or structure. Examples may include hydrophobic membranes and coatings, a hydrophilic membrane or coating combined with a hydrophobic membrane or coating, mesh, a filter, a mechanical valve, antimicrobial material, or any other means of allowing air to be displaced from the sequestration chamber 55 as it is filled with blood (Rogers ¶0060); an air-permeable, blood impermeable blood barrier 2324, such as a hydrophobic plug of material, or a filter formed of one or more layers, for example (Rogers ¶0137), wherein the Examiner notes that a hydrophobic plug as defined by Rogers is considered to refer to an air-permeable, blood impermeable barrier (filter)].
Regarding claim 17, Rogers teaches
The method of claim 16, wherein the diversion device is configured to allow an initial flow of air to pass through the outlet conduit [Rogers ¶¶0135-0137, Figs. 23A-B].
Regarding claim 18, Rogers teaches
The method of claim 17, wherein the blood collection pathway is a closed system that prevents the initial flow of air through the diversion device from being vented into the atmosphere [wherein the direction of flow as depicted in Rogers 23B depicts flow of fluid (air) as being towards the vacuum].
Regarding claim 19, Rogers teaches
The method of claim 16, wherein the collection vessel has a sub-atmospheric internal pressure that draws (a) the initial flow of blood from the patient through the first needle and into the diversion device and (b) the subsequent flow of blood through the first needle and the diversion device, respectively, and into the collection vessel [Rogers ¶¶0135-0136, Figs. 23A-B].
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) 1-4 and 6-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rogers (US-20180177445-A1, effective filing date of 27 December 2016) in view of Braig (US-20070179436-A1).
Regarding claim 1, Rogers teaches
A diversion device comprising: a housing having:
an inlet conduit [inlet port 2302 (Rogers Fig. 23A)],
an outlet conduit [outlet port 2304 (Rogers Fig. 23A)],
a first chamber [sequestration chamber 2306 (Rogers Fig. 23A)], and
a second chamber [sampling channel 2308 (Rogers Fig. 23A)],
wherein the housing is configured to sequester an initial flow of blood in the first chamber and, upon at least partially filling the first chamber, direct a subsequent flow of blood into the second chamber [a sampling channel 2308 that bypasses the sequestration chamber 2306 once the sequestration chamber is filled to an initial aliquot of potentially contaminated blood to be sequestered (Rogers ¶0135, Figs. 23A-B); Valve 2308 can be a clip or other enclosing device to pinch, shunt, bend or otherwise close off the sampling channel 2308 before the initial aliquot of blood is sequestered in the sequestration chamber 2306. For instance, valve 2308 can also be formed as a flap, door or closable window or barrier within the sampling channel 2308 (Rogers ¶0136)],
wherein the housing is configured to allow the subsequent flow of blood to exit the diversion device through the second chamber through the outlet conduit [Rogers ¶¶0135-0136, Figs. 23A-B, wherein as depicted in Rogers Figs. 23A-B, the flow path as defined allows blood to exit the device through the second chamber through the outlet conduit]; and
a filter positioned within the housing adjacent to the outlet conduit, wherein the filter comprises a material that allows air, but not blood, to pass through it [The sequestration chamber 2306 includes a hydrophobic plug 2312 at a distal end of the sequestration chamber 2306 (Rogers ¶0135, Fig. 23A); As used herein the term “air permeable blood barrier” means an air permeable but substantially blood impermeable substance, material, or structure. Examples may include hydrophobic membranes and coatings, a hydrophilic membrane or coating combined with a hydrophobic membrane or coating, mesh, a filter, a mechanical valve, antimicrobial material, or any other means of allowing air to be displaced from the sequestration chamber 55 as it is filled with blood (Rogers ¶0060); an air-permeable, blood impermeable blood barrier 2324, such as a hydrophobic plug of material, or a filter formed of one or more layers, for example (Rogers ¶0137), wherein the Examiner notes that a hydrophobic plug as defined by Rogers is considered to refer to an air-permeable, blood impermeable barrier (filter)].
However, while Rogers does disclose that the second chamber is constructed of a plastic [The sampling channel 2308 can have any suitable geometry and can be formed of plastic tubing or any other suitable material (Rogers ¶0136)], Rogers fails to explicitly disclose wherein the second chamber is constructed of a hydrophobic material.
Braig discloses systems for sampling blood, wherein Braig discloses constructing tubing through which blood flows through with a hydrophobic material [For purposes of minimizing sequential blood sample cross contamination, transfer tube 9301 comprises as nearly as possible a single uninterrupted length of extruded elastomeric tubing, as silicone plastic for example, the surfaces of which are essentially hydrophobic and otherwise nonadherent to blood or liquid-blood-born medications or transformed blood components. Inlet ports 9312 and 9313 and catheter 9304 attachment to transfer tube 9301 are so constructed as to minimize the production of areas of fluid stagnation that might transfer residues between blood samples, as will be explained (Braig ¶0472)].
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 Rogers to employ wherein the second chamber is constructed of a hydrophobic material, so as to prevent adherence and stagnation of blood within the second chamber.
Regarding claim 2, Rogers in view of Braig teaches
The diversion device of claim 1.
However, while Rogers in view of Braig as presently modified above teaches a hydrophobic plug [wherein the Examiner notes that the plug is disposed within the first chamber and is considered to define a wall of the first chamber], such that the instant embodiment of Rogers fails to explicitly disclose wherein a portion of the housing comprises a hydrophilic material, Rogers does disclose alternative embodiments wherein the air-permeable, liquid impermeable filter may comprise a hydrophilic material [Rogers ¶0060].
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 Rogers in view of Braig to employ wherein a portion of the housing comprises a hydrophilic material, as this modification would amount to mere simple substitution of one known element [hydrophobic plug 2312] for another [filter comprising a hydrophilic material] with similar expected results [providing an air-permeable, liquid impermeable barrier] [MPEP § 2143(I)(B)].
Regarding claim 3, Rogers in view of Braig teaches
The diversion device of claim 2, wherein the portion of the housing comprising the hydrophilic material first receives the initial flow of blood [see § 103 modification of claim 2 above].
Regarding claim 4, Rogers in view of Braig teaches
The diversion device of claim 2, wherein the portion of the housing comprising the hydrophilic material includes part of the first chamber [see § 103 modification of claim 2 above].
Regarding claim 6, Rogers in view of Braig teaches
The diversion device of claim 1, wherein the first chamber at least partially surrounds the second chamber [wherein as depicted in Rogers Figs. 23A-B, the sequestration chamber 2306 being positioned to the side and including portions that contact the sampling channel 2308 is considered to read on the broadest reasonable interpretation to “at least partially surround the second chamber”].
Regarding claim 7, Rogers in view of Braig teaches
The diversion device of claim 1, wherein the housing includes a filter receptacle, and the filter is positioned within the filter receptacle [Rogers ¶0135, Fig. 23A, wherein the hydrophobic plug 2312 being positioned as disclosed/depicted within the sequestration chamber 2306 is considered to define a receptable for the filter].
Regarding claim 8, Rogers in view of Braig teaches
The diversion device of claim 7.
However, while Rogers in view of Braig as presently modified above teaches a hydrophobic plug, such that the instant embodiment of Rogers fails to explicitly disclose wherein the filter comprises a hydrophilic material, Rogers does disclose alternative embodiments wherein the air-permeable, liquid impermeable filter may comprise a hydrophilic material [Rogers ¶0060].
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 Rogers in view of Braig to employ wherein the filter comprises a hydrophilic material, as this modification would amount to mere simple substitution of one known element [hydrophobic plug 2312] for another [filter comprising a hydrophilic material] with similar expected results [providing an air-permeable, liquid impermeable barrier] [MPEP § 2143(I)(B)].
Regarding claim 9, Rogers in view of Braig teaches
The diversion device of claim 8.
However, while Rogers in view of Braig as presently modified above fails to explicitly disclose wherein the hydrophilic material is carboxymethylcellulose ("CMC"), Rogers does disclose in a separate embodiment that carboxymethylcellulose is a known type of hydrophilic air-permeable and blood-impermeable filter [As shown in FIGS. 22A and B, an air permeable blood barrier 2202 of a blood sequestration device 2200 can include a polymer bead matrix 2204, in which at least some beads are treated to make them hydrophilic. The air permeable blood barrier 2202 further includes a self-sealing material 2206, such as carboxymethyl cellulose (CMC) or cellulose gum, or other sealing material (Rogers ¶0134)].
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 Rogers to employ carboxymethylcellulose ("CMC") as the hydrophilic material to comprise the filter, as this modification would amount to mere simple substitution of one known element [non-specific hydrophilic material of Rogers as presently modified] for another [carboxymethylcellulose filter of separate embodiment of Rogers] to produce similar expected results [allow air to pass through the filter, but prevent blood from passing through the filter (Rogers ¶¶0060, 0134, 0137] [MPEP § 2143(I)(B)].
Regarding claim 10, Rogers in view of Braig teaches
The diversion device of claim 1, wherein the housing is configured to allow an initial flow of air to pass through the outlet conduit [Rogers ¶¶0135-0137, Figs. 23A-B].
Regarding claim 11, Rogers in view of Braig teaches
A blood collection kit comprising the diversion device of claim 1 [see § 102 rejection of claim 1, wherein the entire diversion device as taught by Rogers is considered to read on a “kit” comprising the diversion device of Rogers].
Regarding claim 12, Rogers in view of Braig teaches
The blood collection kit of claim 11, further comprising:
instructions to assemble a blood collection pathway from a patient to a collection vessel [wherein Rogers ¶¶0135-0136 and Figs. 23A-B are considered provide operation instructions for the kit; a blood sequestration device 2300, having an inlet port 2302 to connect with a patient needle… A vacuum or other drawing force applied from the outlet port 2304, such as from a Vacutainer or the like, draws in blood into the inlet port 2302 (Rogers ¶0135)],
wherein the blood collection pathway comprises a first needle piercing a skin of the patient and the diversion device of claim 1 [Rogers ¶¶0135-0136, Figs. 23A-B].
Regarding claim 13, Rogers in view of Braig teaches
The blood collection kit of claim 12, wherein the blood collection pathway is a closed system that prevents an initial flow of air through the diversion device of claim 1 from being vented into the atmosphere [wherein the direction of flow as depicted in Rogers 23B depicts flow of fluid (air) as being towards the vacuum].
Regarding claim 14, Rogers in view of Braig teaches
The blood collection kit of claim 12, wherein the collection vessel has a sub-atmospheric internal pressure that draws (a) the initial flow of blood from the patient through the first needle and into the diversion device and (b) the subsequent flow of blood through the first needle and the diversion device, respectively, and into the collection vessel [Rogers ¶¶0135-0136, Figs. 23A-B].
Regarding claim 15, Rogers in view of Braig teaches
The blood collection kit of claim 12.
However, while Rogers in view of Braig as presently modified above fails to explicitly disclose wherein the blood collection pathway further comprises a holder having a second needle piercing a cap of the collection vessel, another embodiment of Rogers discloses a diversion device wherein a blood collection pathway further comprises a holder having a second needle piercing a cap of the collection vessel [the blood sample collection device 2404 includes a protective shield that includes a sealed collection needle on which a sealed vacuum-loaded container is placed, which, once pierced by the collection needle, draws in a blood sample under vacuum pressure or force through the conduit 2006 from the patient needle 2402 (Rogers ¶0138, Fig. 24A)].
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 kit of Rogers in view of Braig to employ wherein the blood collection pathway further comprises a holder having a second needle piercing a cap of the collection vessel, as this modification would amount to mere simple substitution of one known element [non-specific coupling to vacuum/Vacutainer] for another [holder having a second needle piercing a cap of the collection vessel] with similar expected results [allow for coupling between the blood collection pathway and the collection vessel] [MPEP § 2143(I)(B)].
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rogers, as applied to claim 16 above.
Regarding claim 20, Rogers teaches
The method of claim 16.
However, while the instant embodiment of Rogers fails to explicitly disclose wherein the blood collection pathway further comprises a holder having a second needle piercing a cap of the collection vessel, another embodiment of Rogers discloses a diversion device wherein a blood collection pathway further comprises a holder having a second needle piercing a cap of the collection vessel [the blood sample collection device 2404 includes a protective shield that includes a sealed collection needle on which a sealed vacuum-loaded container is placed, which, once pierced by the collection needle, draws in a blood sample under vacuum pressure or force through the conduit 2006 from the patient needle 2402 (Rogers ¶0138, Fig. 24A)].
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 method of Rogers to employ wherein the blood collection pathway further comprises a holder having a second needle piercing a cap of the collection vessel, as this modification would amount to mere simple substitution of one known element [non-specific coupling to vacuum/Vacutainer] for another [holder having a second needle piercing a cap of the collection vessel] with similar expected results [allow for coupling between the blood collection pathway and the collection vessel] [MPEP § 2143(I)(B)].
Response to Arguments
Applicant’s arguments, see Applicant’s Remarks p. 8, filed 17 February 2026, with respect to the previously presented drawing objection(s) have been fully considered and are persuasive. The drawing objection(s) for failing to show the “second chamber” of claims 1, 16, and those dependent therefrom has been withdrawn.
Applicant’s arguments, see Applicant’s Remarks p. 9-15, with respect to the rejection(s) of claim(s) 1-4, 6-8, and 10-20 under § 102, and claim(s) 5 and 9 under § 103 have been fully considered and are persuasive. Therefore, the rejection(s) has/have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Rogers (US-20180177445-A1, effective filing date of 27 December 2016) in view of Braig (US-20070179436-A1) with respect to claim 1; and Rogers (US-20180177445-A1, effective filing date of 27 December 2016) with respect to claim 16.
The Applicant asserts that the amendment to claim 1 “a second chamber, wherein the second chamber is constructed of a hydrophobic material, wherein the housing is configured to sequester an initial flow of blood into the first chamber” fails to be anticipated by Tan, as the Applicant notes that Tan is silent on sequestering an initial blood sample and that Tan does not disclose “wherein at least a part of the second chamber comprises a hydrophobic material” [from previously presented/presently canceled claim 5]. The Applicant submits that claim 16 is novel and nonobvious for the same reasons as discussed for claim 1. The Applicant further asserts against Tan in view of Kratzer, which was previously applied to teach the subject matter of previously presented/presently canceled claim 5, wherein the Applicant notes that the amendments to claim 1 to recite that the second chamber is constructed of a hydrophobic material and claim 16 to recite that at least a portion of the second chamber is constructed of a hydrophobic material fail to taught by Kratzer, as the Applicant argues that a chamber with a hydrophobic coating as taught by Kratzer is not the same as a chamber that is constructed of a hydrophobic material. However, the Examiner notes that the Applicant’s arguments with respect to claim(s) 1 and 16 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. With respect to claim 1, Rogers is modified by Braig to employ a chamber constructed of a hydrophobic material [For purposes of minimizing sequential blood sample cross contamination, transfer tube 9301 comprises as nearly as possible a single uninterrupted length of extruded elastomeric tubing, as silicone plastic for example, the surfaces of which are essentially hydrophobic and otherwise nonadherent to blood or liquid-blood-born medications or transformed blood components. Inlet ports 9312 and 9313 and catheter 9304 attachment to transfer tube 9301 are so constructed as to minimize the production of areas of fluid stagnation that might transfer residues between blood samples, as will be explained (Braig ¶0472)]. With respect to claim 16, the Examiner notes that the language “a second chamber comprising a hydrophobic portion” is broader than the language of claim 1, such that Rogers anticipates the amended limitation [sampling channel 2308 (Rogers Fig. 23A); wherein as depicted in Rogers 23A, a wall of the sampling channel 2308 is defined by the hydrophobic plug 2312]. Regarding both claims 1 and 16, Rogers discloses sequestering an initial flow of blood in a first chamber [a sampling channel 2308 that bypasses the sequestration chamber 2306 once the sequestration chamber is filled to an initial aliquot of potentially contaminated blood to be sequestered (Rogers ¶0135, Figs. 23A-B); Valve 2308 can be a clip or other enclosing device to pinch, shunt, bend or otherwise close off the sampling channel 2308 before the initial aliquot of blood is sequestered in the sequestration chamber 2306. For instance, valve 2308 can also be formed as a flap, door or closable window or barrier within the sampling channel 2308 (Rogers ¶0136)].
Applicant’s arguments, see Applicant’s Remarks p. 8-9, with respect to the rejection(s) of claim(s) 1-2, 5-9, and 11-20 under Non-Statutory Double Patenting 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 U.S. Patent No. 11,213,232 [hereinafter Ivosevic] in view of Braig (US-20070179436-A1).
The Applicant asserts that the amendments to claim 1 and 16 render the claims patentably distinct from the conflicting Ivosevic patent for reasons as outlined in the Applicant’s Remarks regarding the prior art rejections. However, the Examiner notes that the Applicant’s arguments with respect to claim(s) 1 and 16 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 in the present non-statutory double patenting rejection, Ivosevic is modified by Braig to teach the argued subject matter of claim 1 regarding the second chamber being constructed of a hydrophobic material and of claim 16 regarding the second chamber comprising a hydrophobic portion [Braig ¶0472].
Conclusion
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/SEVERO ANTONIO P LOPEZ/Examiner, Art Unit 3791
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