DETAILED ACTION
This action is responsive to the claim amendments and Applicant’s Remarks filed 29 June 2026. The Examiner acknowledges the amendments to claim 16. Claims 1-4 and 6-20 are pending.
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 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, previously presented).
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 similar limitation of claim 16 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 each of the diversion device and method 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
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 § 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 6-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rogers (US-20180177445-A1, effective filing date of 27 December 2016, previously presented) in view of Braig (US-20070179436-A1, previously presented).
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)].
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 [sampling channel 2308 (Rogers Fig. 23A)], 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)].
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 method 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 17, Rogers in view of Braig 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 in view of Braig 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 in view of Braig 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].
Regarding claim 20, Rogers in view of Braig teaches
The method of claim 16.
However, while the instant embodiment of Rogers, as applied in the modification of Rogers in view of Braig, 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 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)].
Response to Arguments
Applicant's arguments, see Applicant’s Remarks p. 10-17, filed 29 June 2026, with respect to the rejections of claims 1 and those dependent therefrom under § 103 have been fully considered but they are not persuasive.
The Applicant asserts that there is nothing in Rogers alone or in combination with Braig that teaches the features and limitations of independent claim 1; wherein the Applicant notes that Braig merely describes a hydrophobic transfer tube that is used in the input of a blood analyzer [Braig ¶0470], wherein a person skilled in the art would not be motivated to combine the hydrophobic transfer tube of Braig with the blood collection device of Rogers; and wherein the Applicant notes that Braig does not contemplate a structure in which a first chamber surrounds a second chamber, and that the second chamber is constructed of a hydrophobic material as recited in claim 1, such that the Office Action uses impermissible hindsight to support the rejection of claim 1 by relying on information gleaned solely from the Applicant’s claims and using them as a template to guide the combination of references rather than relying on the references themselves. However, the Examiner disagrees with the Applicant’s arguments, as the Examiner notes that as both Rogers and Braig are directed towards the use of a chamber for allowing blood therethrough for the purposes of sampling [Rogers ¶¶0135-0136; Braig ¶0472], the modification of Rogers in view of Braig is considered to be applicable. In response to applicant’s argument that the examiner’s conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant’s disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In response to applicant’s arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The Examiner further notes that Braig is not specifically required to contemplate a structure in which a first chamber surrounds a second chamber, and that the second chamber is constructed of a hydrophobic material as specifically argued by the Applicant, as Rogers is applied to teach the argued arrangement of the first chamber and the second chamber, which based on the instant claim language [of claim 1] does not specifically require the first chamber to “surround” the second chamber. For the sake of compact prosecution, the Examiner notes that claim 6 does positively recite wherein the first chamber at least partially surrounds the second chamber, wherein based on the plain definition of “surround”, the positioning as previously indicated in the § 103 rejection of claim 6 is considered applicable; and wherein the Examiner notes that for the reasonings as provided above in the Examiner’s response to argument regarding the modification of Rogers in view of Braig, the modified construction is still considered applicable and does not use impermissible hindsight.
The Applicant further asserts that Braig merely teaches a single elongated transfer tube comprising hydrophobic material to minimize blood adherence during multiple blood collections [Braig ¶0472] and further describes the using a one-way valve to keep blood contained within the transfer tube and prevent the blood from entering the fluid delivery tube; wherein the Applicant notes that combining an input tube composed of hydrophobic material as described in Braig with the device of Rogers would defeat the purpose of the Present Application, because the hydrophobic transfer tube would repel blood into the bypass chamber; and wherein the Applicant notes that the skilled person would not modify Rogers to include a hydrophobic “transfer tube” since it is not clear from Braig, what tube in Rogers should be hydrophobic (if any). In response to applicant’s arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The Examiner disagrees with Applicant’s argument and notes that Braig is not specifically cited regarding the use of a one-way valve to keep blood contained within the transfer tube and prevent blood from entering the fluid delivery tube, or the use of bypass elements as disclosed in Braig, and that Rogers is not being modified to specifically incorporate the entire transfer tube of Braig. The Examiner notes that Braig is merely cited as providing evidence regarding the use of hydrophobic materials in the formation of fluid chambers and conduits, such that the modification is not considered to teach away or defeat the purpose of the instant invention as presently claimed.
Applicant’s arguments, see Applicant’s Remarks p. 6-9, with respect to the rejection(s) of claim(s) 16 and those dependent therefrom under § 102(a)(1) 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 under § 103 as being obvious in view of Rogers (US-20180177445-A1, effective filing date of 27 December 2016, previously presented) in view of Braig (US-20070179436-A1, previously presented).
The Applicant asserts that the amendments to claim 16 regarding “… a housing having an inlet conduit, an outlet conduit, a first chamber, and a second chamber comprising constructed of a hydrophobic material portion…” are not considered to be anticipated by Rogers. The Applicant further asserts that Rogers does not disclose “direct[ing] a subsequent flow of blood into the second chamber that is at least partially surrounded by the first chamber” as recited in claim 16. Applicant’s arguments with respect to claim(s) 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 Rogers in view of Braig as previously applied to claim 1 is considered to be similarly applicable to claim 16 as amended mutatis mutandis and is further considered to be an applicable modification in light of the Examiner’s responses to the Applicant’s Remarks as presented above. Furthermore, the Examiner disagrees with the Applicant’s argument regarding the interpretation of Rogers regarding the limitation “direct[ing] a subsequent flow of blood into the second chamber that is at least partially surrounded by the first chamber”, as the Examiner notes that the plain definition of “surround” merely refers to “to extend around the margin or edge of” [https://www.merriam-webster.com/dictionary/surround], such that as the sampling channel 2308 [second chamber] is positioned relative to the sequestration chamber 2306 [first chamber], the sampling channel 2308 is considered to at least partially surround the sequestration chamber 2306. In response to applicant’s argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the particularity of the “surrounding” of the first chamber relative to the second chamber as depicted in Applicant’s Figs. 5A-C as referred to by the Applicant in the Applicant’s Remarks p. 9) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The Examiner further notes that the present modification of Rogers in view of Braig is still considered to be applicable with respect to the rejection of claim 20, as Rogers in view of Braig is not considered to be deficient in teaching the subject matter of claim 16 as argued above.
Applicant's arguments, see Applicant’s Remarks p. 6, with respect to the rejections of claims 1, 16, and those dependent therefrom under non-statutory double patenting have been fully considered but they are not persuasive.
The Applicant submits that claims 1-4 and 6-20 are patentably distinct from the claims of U.S. Patent No. 11,213,232 in view of Braig (US-20070179436-A1) for the reasons outlined in the Applicant’s Remarks regarding the § 102 and § 103 rejections. The Applicant further requests that the double patenting rejection be held in abeyance until all other rejections are withdrawn in the present application. However, the Examiner notes that the double patenting rejection will not be held in abeyance and will be maintained until a terminal disclaimer is timely filed or the instant claims are amended to render the previously applied double patenting rejections moot. The Examiner notes that for the reasons as presented above in the Examiner’s responses to the Applicant’s arguments, the Non-Statutory Double Patenting rejection is maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/SEVERO ANTONIO P LOPEZ/Examiner, Art Unit 3791
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