DETAILED ACTION
This action is responsive to response to election/restriction filed 30 October 2025. The Examiner acknowledges that no claims were amended, canceled, or added. Claims 1-20 are pending, with claims 8-20 standing as presently withdrawn.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Claim(s) 8-20 is/are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention(s), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 30 October 2025.
Applicant’s election without traverse of the invention of group 1, directed towards claims 1-7, in the reply filed on 30 October 2025 is acknowledged.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters “1130” and “1330” are both used to designate the proximal connector of the embodiment depicted in Figs. 12A-C.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “50” is used to designate the catheter assembly [Figs. 1A-C, 9A-C] and flow paths in Figs. 14D and 19B; “1570” is used to designate two separate elements of the flow restriction device in Figs. 14A and 14B.
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: “larger diameter internal flowpath 445” in ¶0131 [the Examiner notes that “445” as referred to in the Specification may be considered a typo and should read “455” due to at least ¶0130 reciting “internal flowpath 455”, wherein at least Fig. 5C depicts internal flowpath 455]; “connector 1505” in ¶0190; “lumen 1518” in ¶0191.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: “42” in Fig. 1A; “45” in Figs. 1A-B; “90” in Figs. 1A-C; “132” in Fig. 2B; “136” in Fig. 2B; “138” in Fig. 2B; “144” in Fig. 2C; “168” in Fig. 2C; “232” in Fig. 3B; “233” in Fig. 3B; “332” in Fig. 4B; “344” in Fig. 4C; “440” in Figs. 5B-C; “460” in Fig. 5B; “Fd” in Fig. 5C; “517” in Fig. 6B; “518” in Fig. 6B; “532” in Fig. 6B; “613” in Fig. 7B; “1234” in Fig. 11B; “1356” in Fig. 12B; “1358” in Fig. 12B; “1368” in Fig. 12B; “1370 in Figs. 12B-C; “1432” in Figs. 13A and 13C; “1436” in Fig. 13C; “1438” in Figs. 13A and 13C; “1501” in Fig. 14D; “1514” in Figs. 14C-D; “1524” in Figs. 14C-D; “1528” in Fig. 14A; “1536” in Figs. 14C-D; “1570” in Figs. 14A-B; “1629” in Fig. 15D; “1654” in Figs. 15D-E; “2118” in Fig. 19B; “2136” in Fig. 19B; “2145” in Fig. 19B.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or corresponding amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
Examiner Notes: currently, NO limitation invokes interpretation under § 112(f).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim(s) 1-7 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-3 and 8-10 of copending Application No. 17/900,844, hereinafter Burkholz, in view of Penagondla (US-20210196867-A1).
Conflicting claim 1 of Burkholz is considered to anticipate almost each and every limitation of instant claim 1 [see comparison below], except for the limitation “a distal connector configured to couple to a catheter assembly, the distal connector comprising a first connection portion at a proximal end thereof and a second connection portion at a distal end thereof, the first connection portion comprising an inner surface defining a lumen” to define the first connection portion and wherein the proximal connector is “coupled to the distal connector”.
Conflicting claim 1 of Burkholz does disclose a mating luer, wherein the body [equivalent to the instant insertion portion] is coupled within the mating luer [claim 1, lines 8-9].
Penagondla discloses a flow restriction device, comprising: a distal connector [housing 150 (Penagondla Fig. 2)], the distal connector comprising a first connection portion at a proximal end thereof [Housing 150 also includes outer side wall 180 that is configured to engage main body 110 (Penagondla ¶0051, Figs. 2, 9)] and a second connection portion at a distal end thereof [Housing 150 includes connector 160 defining inlet port 162 and configured to connect with tube 161 (Penagondla ¶0049, Figs. 2, 9)], the first connection portion comprising an inner surface defining a lumen [Penagondla Fig. 9]; a proximal connector coupled to the distal connector [main body 110 (Penagondla Fig. 2); Filter adaptor 100 includes main body 110 configured for engagement with housing 150 (Penagondla ¶0041)], the proximal connector comprising an insert portion for inserting into the lumen of the first connection portion [shaft 130 (Penagondla Figs. 3-4); Housing 150 also includes intermediate side wall 170 that defines an intermediate chamber within housing 150 for receiving shaft 130 of main body 110 when housing 150 and main body 110 are connected with one another (Penagondla ¶0049)], the insert portion including an outer surface having a continuous non-linear channel recessed therein [While grooves 135 are shown in this embodiment as being oriented circumferentially around shaft 130, this disclosure contemplates other orientations for grooves 135 such as, for example, spiral or helical grooves, longitudinal grooves and mesh-cut grooves (Penagondla ¶0047)], wherein the inner surface of the first connection portion encases the outer surface of the insert portion such that the continuous non-linear channel and the inner surface of the first connection portion define a non-linear fluid pathway along which a fluid flows from the distal connector to the proximal connector [Penagondla ¶¶0047, 0049, Fig. 2; Within the intermediate cavity and the fluid collection space, the fluid flow path is again redirected toward passageway 131, and travels into passageway 131 by passing through filter 190 into grooves 135, then through holes 136 into passageway 131, where it is again redirected toward outlet port 126 (Penagondla ¶0052)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Burkholz to employ “a distal connector configured to couple to a catheter assembly, the distal connector comprising a first connection portion at a proximal end thereof and a second connection portion at a distal end thereof, the first connection portion comprising an inner surface defining a lumen” to define the first connection portion and wherein the proximal connector is “coupled to the distal connector”, so as to allow for coupling between the fluid collection device and a fluid source.
Conflicting claims 1-3 and 8-10 of Burkholz as modified by Penagondla are further considered to render obvious instant claims 2-7.
Claim 1 of the Instant Application
Claim 1 of Conflicting Patent Application 17/900,844, hereinafter Burkholz
A flow restriction device, comprising:
A flow restriction device, comprising: [line 1]
a proximal connector configured to couple to a fluid collection device, the proximal connector comprising an insert portion for inserting into a lumen of a first connection portion, the insert portion including an outer surface having a continuous non-linear channel recessed therein,
a distal end configured to couple to a catheter assembly [line 2]
a proximal end including a proximal connector configured to couple to a fluid collection device [lines 3-4]
a body extending from the proximal connector to the distal end, the body comprising an outer surface and an inner surface, the inner surface defining a lumen of the body [lines 5-7]
a fluid pathway disposed between the distal end and the proximal end when the outer surface is coupled within a mating luer, the fluid pathway comprising a non-linear portion on at least a portion of the outer surface along which a fluid flows from the distal end into the fluid collection device [lines 8-11]
wherein an inner surface of the first connection portion encases the outer surface of the insert portion such that the continuous non-linear channel and the inner surface of the first connection portion define a non-linear fluid pathway along which a fluid flows from the distal connector into the fluid collection device.
a fluid pathway disposed between the distal end and the proximal end when the outer surface is coupled within a mating luer, the fluid pathway comprising a non-linear portion on at least a portion of the outer surface along which a fluid flows from the distal end into the fluid collection device [lines 8-11]
[wherein the fluid pathway disposed along the outer surface is considered to be encased by the mating luer, as the outer surface is disposed within the mating luer]
This is a provisional nonstatutory double patenting rejection.
Claim(s) 1-2 and 4 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of copending Application No. 18/185,876, hereinafter Salehi, in view of Mijers (US-20160129181-A1).
Conflicting claim 5 of Salehi is considered to anticipate almost each and every limitation of instant claim 1 [see comparison below], except wherein the proximal connector is configured to couple to a fluid collection device and wherein the non-linear fluid pathway allows for fluid to flow from the distal connector into the fluid collection device.
Mijers discloses a flow restriction device for controlling flow between a catheter assembly coupled to a distal end of the flow restriction device [Referring now to FIG. 1, a bidirectional valve 10 per the present invention may be attached at a lower end 12 to a flexible catheter 14 communicating with a patient 15 (not shown) to provide for vascular access, for example, through a needle or the like placed in the patient 15. The lower end 12 of the bidirectional valve 10 may provide for a standard needle-free tubing connector 17, as known in the art, providing, for example, a tube of the flexible catheter 14 with a frustoconical outer surface receiving the IV line and expanding it into a barbed collar around the tube (Mijers ¶0043, Fig. 1)] and a fluid collection device coupled to a proximal end of the flow restriction device [FIG. 1 is a fragmentary perspective view of a bidirectional valve of the present invention providing, in one application, a needle-free connection to a syringe for drawing a blood sample (Mijers ¶0030); An upper end 16 of the bidirectional valve 10 may provide for a needle-free luer connector 18 such as a female luer lock or luer slip connector that may receive a corresponding connector 20 of a syringe 22, for example, for flushing, sampling or aspiration. Alternatively, the upper end 16 may receive a corresponding connector of an IV bag, infusion pump, or the like (not shown) (Mijers ¶0044, Fig. 1)].
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 Salehi to employ wherein the proximal connector is configured to couple to fluid collection device, and wherein fluid flow along the non-linear fluid pathway from the distal connector into the fluid collection device, as this modification would amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [provide a flow restriction device between a catheter assembly and fluid collection device/IV bag to allow for control of fluid flow between the catheter assembly and the fluid collection device/IV bag] [MPEP § 2143(I)(D)].
Conflicting claim 5 of Salehi as modified by Mijers is further considered to render obvious instant claims 2 and 4.
Claim 1 of the Instant Application
Claim 5 of Conflicting Patent Application 18/185,876, hereinafter Salehi [wherein claim 5 is considered to incorporate the subject matter of claim 1 therein]
A flow restriction device, comprising:
A flow restriction device, comprising: [claim 1, line 1]
a distal connector configured to couple to a catheter assembly, the distal connector comprising a first connection portion at a proximal end thereof and a second connection portion at a distal end thereof, the first connection portion comprising an inner surface defining a lumen;
a male luer connector portion comprising an inner surface defining a first cavity and a first lumen in fluid flow continuity with the first cavity [claim 1, lines 2-3]
wherein the first lumen is configured to be coupled to a catheter hub [claim 5, lines 1-2]
a proximal connector coupled to the distal connector, the proximal connector comprising an insert portion for inserting into the lumen of the first connection portion, the insert portion including an outer surface having a continuous non-linear channel recessed therein,
a female luer connector portion comprising a body, an extension, and an inner surface, the extension having a proximal end, a distal end, and an outer surface, wherein the proximal end of the extension is proximate to the body [claim 1, lines 4-6]
a channel defined on the outer surface of the extension, wherein the channel is helically disposed around the outer surface of the extension between the proximal end of the extension and the distal end of the extension, wherein the extension is configured to be at least partially disposed within the first cavity [claim 1, lines 12-15]
wherein the inner surface of the first connection portion encases the outer surface of the insert portion such that the continuous non-linear channel and the inner surface of the first connection portion define a non-linear fluid pathway along which a fluid flows from the distal connector.
wherein the extension is configured to be at least partially disposed within the first cavity, and the channel and an inner surface of the male luer connector portion define a fluid passage in fluid flow continuity with the first lumen, the second cavity, and the second lumen [claim 1, lines 14-17]
This is a provisional nonstatutory double patenting rejection.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-2, 4, and 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Penagondla (US-20210196867-A1) in view of Mijers (US-20160129181-A1).
Regarding claim 1, Penagondla teaches
A flow restriction device, comprising:
a distal connector [housing 150 (Penagondla Fig. 2)], the distal connector comprising a first connection portion at a proximal end thereof [Housing 150 also includes outer side wall 180 that is configured to engage main body 110 (Penagondla ¶0051, Figs. 2, 9)] and a second connection portion at a distal end thereof [Housing 150 includes connector 160 defining inlet port 162 and configured to connect with tube 161 (Penagondla ¶0049, Figs. 2, 9)], the first connection portion comprising an inner surface defining a lumen [Penagondla Fig. 9];
a proximal connector coupled to the distal connector [main body 110 (Penagondla Fig. 2); Filter adaptor 100 includes main body 110 configured for engagement with housing 150 (Penagondla ¶0041)], the proximal connector comprising an insert portion for inserting into the lumen of the first connection portion [shaft 130 (Penagondla Figs. 3-4); Housing 150 also includes intermediate side wall 170 that defines an intermediate chamber within housing 150 for receiving shaft 130 of main body 110 when housing 150 and main body 110 are connected with one another (Penagondla ¶0049)], the insert portion including an outer surface having a continuous non-linear channel recessed therein [While grooves 135 are shown in this embodiment as being oriented circumferentially around shaft 130, this disclosure contemplates other orientations for grooves 135 such as, for example, spiral or helical grooves, longitudinal grooves and mesh-cut grooves (Penagondla ¶0047)],
wherein the inner surface of the first connection portion encases the outer surface of the insert portion such that the continuous non-linear channel and the inner surface of the first connection portion define a non-linear fluid pathway along which a fluid flows from the distal connector to the proximal connector [Penagondla ¶¶0047, 0049, Fig. 2; Within the intermediate cavity and the fluid collection space, the fluid flow path is again redirected toward passageway 131, and travels into passageway 131 by passing through filter 190 into grooves 135, then through holes 136 into passageway 131, where it is again redirected toward outlet port 126 (Penagondla ¶0052)].
However, while Penagondla discloses application of the device with medical equipment and with liquids [Described herein are compact filter devices for use with medical equipment, including wound dressings and other negative pressure wound therapy equipment, which are capable of filtering large volumes of fluid (Penagondla ¶0033); In some embodiments, the filter comprises material that is gas permeable and liquid permeable (¶0045)], Penagondla fails to explicitly disclose wherein the distal connector is configured to couple to a catheter assembly, wherein the proximal connector is configured to couple to fluid collection device, and wherein fluid flow along the non-linear fluid pathway from the distal connector into the fluid collection device.
Mijers discloses a flow restriction device for controlling flow between a catheter assembly coupled to a distal end of the flow restriction device [Referring now to FIG. 1, a bidirectional valve 10 per the present invention may be attached at a lower end 12 to a flexible catheter 14 communicating with a patient 15 (not shown) to provide for vascular access, for example, through a needle or the like placed in the patient 15. The lower end 12 of the bidirectional valve 10 may provide for a standard needle-free tubing connector 17, as known in the art, providing, for example, a tube of the flexible catheter 14 with a frustoconical outer surface receiving the IV line and expanding it into a barbed collar around the tube (Mijers ¶0043, Fig. 1)] and a fluid collection device coupled to a proximal end of the flow restriction device [FIG. 1 is a fragmentary perspective view of a bidirectional valve of the present invention providing, in one application, a needle-free connection to a syringe for drawing a blood sample (Mijers ¶0030); An upper end 16 of the bidirectional valve 10 may provide for a needle-free luer connector 18 such as a female luer lock or luer slip connector that may receive a corresponding connector 20 of a syringe 22, for example, for flushing, sampling or aspiration. Alternatively, the upper end 16 may receive a corresponding connector of an IV bag, infusion pump, or the like (not shown) (Mijers ¶0044, Fig. 1)].
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 Penagondla to employ wherein the distal connector is configured to couple to a catheter assembly, wherein the proximal connector is configured to couple to fluid collection device, and wherein fluid flow along the non-linear fluid pathway from the distal connector into the fluid collection device, as this modification would amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [provide a flow restriction device between a catheter assembly and fluid collection device/IV bag to allow for control of fluid flow between the catheter assembly and the fluid collection device/IV bag] [MPEP § 2143(I)(D)].
Regarding claim 2, Penagondla in view of Mijers teaches
The flow restriction device of claim 1, wherein the continuous non-linear channel comprises a continuous groove having a coil shape recessed in the outer surface [Penagondla ¶0047].
Regarding claim 4, Penagondla in view of Mijers teaches
The flow restriction device of claim 1, wherein the insert portion further comprises an inner surface defining a lumen of the insert portion, the lumen forming an internal flowpath along which a fluid flows from the proximal connector into the catheter assembly via the distal connector [Shaft 130 defines passageway 131 that extends from end wall 132, through shaft 130, and extends through connector 120 to outlet port 126 (Penagondla ¶0047, Fig. 2); Within the intermediate cavity and the fluid collection space, the fluid flow path is again redirected toward passageway 131, and travels into passageway 131 by passing through filter 190 into grooves 135, then through holes 136 into passageway 131, where it is again redirected toward outlet port 126 (Penagondla ¶0052); Moreover, due to the construction of filter adaptor 100, it can be operated equally well with a fluid flow in the opposite direction of that described above, in which case outlet port 126 operates as an inlet port and inlet port 162 operates as an outlet port (Penagondla ¶0053)].
Regarding claim 6, Penagondla in view of Mijers teaches
The flow restriction device of claim 4, wherein the internal flowpath in which the fluid flows from the proximal connector into the catheter assembly via the distal connector comprises a linear flowpath [wherein the passageway 131 is depicted as a linear passageway in Penagondla Fig. 2].
Regarding claim 7, Penagondla in view of Mijers teaches
The flow restriction device of claim 4, wherein the continuous non-linear channel comprises a first diameter, the internal flowpath comprises a second diameter, and the first diameter is smaller than the second diameter [wherein as depicted in at least Penagondla Figs. 2-4, the grooves 135 have a smaller diameter than the diameter of passageway 131].
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Penagondla in view of Mijers, as applied to claim 1 above, in further view of Schinazi (US-10376633-B2).
Regarding claim 3, Penagondla in view of Mijers teaches
The flow restriction device of claim 1.
However, Penagondla in view of Mijers fails to explicitly disclose wherein the continuous non-linear channel comprises a continuous groove having an S-shape recessed in the outer surface.
Schinazi discloses a flow restriction device comprising a body with an outer surface configured to define a fluid pathway comprising a non-linear portion along the outer surface of the body, wherein the non-linear portion comprises a continuous groove having an S-shape recessed in the outer surface [As best shown in FIG. 11, exterior surface 66 of mandrel 20 is positioned proximate to interior surface 86 of cavity 80 of housing 22 (Schinazi Col 7:49-51); As shown in FIG. 13A, protrusion 90 is positioned on mandrel 20 so that two sealed fluid channels 100 are created when wedge-shaped mandrel 20 is engaged with housing 22. One, two, or more sealed fluid channels 100 may be included in microflow assembly 10. Sealed fluid channel 100 may encircle mandrel 20 or be positioned on a single side of mandrel 20. FIGS. 13A-13D depict mandrels 20 having at least one planar surface upon which protrusion 90 is formed. Protrusion 90 of FIG. 13A forms two sealed fluid channels 100 which move the fluid back and forth across a single surface of mandrel 20 (Schinazi Col 9:28-38, Figs. 11, 13A), wherein the Examiner notes that the protrusion 90 defines an S-shape on the exterior surface 66].
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 Penagondla in view of Mijers to employ wherein the continuous non-linear channel comprises a continuous groove having an S-shape recessed in the outer surface, as this modification is considered to amount to mere simple substitution of one known element for another with similar expected results [non-linear continuous groove defining a fluid pathway configured to allow fluid flow across] [MPEP § 2143(I)(B)].
Examiner’s Note Regarding Subject Matter Not Taught By Prior Art
The closest prior art of record for the subject matter of claim 5 regarding “a check valve disposed in the lumen of the insert portion, the check valve configured to (i) prevent fluid flowing from the distal connector into the proximal connector via the lumen of the insert portion, and (ii) allow fluid to flow from the proximal connector into the distal connector via the lumen of the insert portion” is Penagondla (US-20210196867-A1) and Mijers (US-20160129181-A1).
Regarding Penagondla, the Examiner notes that Penagondla does not disclose any valve disposed within the lumen of the insert portion [passageway 131], wherein positioning a valve as claimed within the lumen of the insert portion of Penagondla would render the flow restriction device of Penagondla unfit for its intended purpose of restricting flow in either direction, the valve would not prevent fluid flow from the distal connector and into the proximal connector via the lumen of the insert portion, but further prevent fluid flow from the distal connector and into the proximal connector entirely if positioned toward a proximal end of the proximal connector [main body 110] or fail to prevent fluid flow from the distal connector and into the proximal connector via the lumen of the insert portion due to the fluid flow path defined by the grooves 135, holes 136, and passageway 131 [Penagondla Fig. 2].
Regarding Mijers, the Examiner notes that Mijers discloses a bidirectional valve configured to allow fluid flow in a first direction along a first flowpath and allow fluid flow in a second direction opposite to the first direction along a second flowpath [Mijers ¶¶0043-0044, Figs. 5-6], and fails to teach wherein fluid flows in either direction along both the first flowpath and the second flowpath.
As such, without the benefit of hindsight, it would not have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified any of Penagondla or Mijers, alone or in combination, to employ the subject matter of claim 5.
Claim 5 is objected to as being dependent upon a rejected base claim, but would be allowable over the prior art if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEVERO ANTONIO P LOPEZ whose telephone number is (571)272-7378. The examiner can normally be reached M-F 9-6 EST.
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/SEVERO ANTONIO P LOPEZ/Examiner, Art Unit 3791
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