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 .
Election/Restrictions
Applicant's election with traverse of Species 1, directed towards claims 1-7 and 16-20, in the reply filed on 19 February 2026 is acknowledged. The traversal is on the ground(s) that the structure of the scrubbing cap, connector portion, and lock of the coupling device of each species share similar structures, such that when searching and examining one of Species 1-6, the Examiner will encounter subject matter of the other species and a series search burden does not exist. This is not found persuasive because the Examiner notes that while the species may share certain structural compositions and/or configurations, the mutually exclusive structural compositions and configurations between the coupling device, lock, and connector portion of the scrubbing cap of each species would still require different search strategies or search queries unique to the respective structure and/or configuration of each species, wherein the mutually exclusive structural compositions and configurations as noted are not considered to be obvious variants of each other.
The requirement is still deemed proper and is therefore made FINAL.
Claim(s) 8-15 is/are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Species, there being no allowable generic or linking claim.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters “140” [slits (Applicant’s Specification ¶0078)] and 142 [fingers (¶0078)] are both used to refer the fingers in Fig. 6A.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim(s) 1 and 3 is/are objected to because of the following informalities:
Claim 1 should read “the instrument delivery device;” [line 17].
Claim 3 should read “engageable”
Appropriate correction is required.
Claim Interpretation
Examiner Notes: currently, NO limitation invokes interpretation under § 112(f).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 4 and those dependent therefrom is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 4 recites the limitations “the protrusion of the connector portion” [lines 1-2], “the opening” [lines 5-6], “the pair of locking arms” [line 10], and “elongated member” [line 10], which are each considered to lack antecedent basis, as claims 1 and 4 fail to previously define each of “a protrusion of the connector portion”, “an opening”, “a pair of locking arms”, and “elongated member”; and wherein the recited limitations are further considered to render claim 4 indefinite, as it is not clear whether claim 4 is meant to define new elements of “a protrusion of the connector portion”, “an opening”, “a pair of locking arms”, and “elongated member” or whether claim 4 is meant to be dependent from either of claims 2 or 3, which are each considered to define at least some or all of the identified recited limitations of claim 4, which would provide antecedent basis to the corresponding limitations as recited in claim 4. For examination purposes, the Examiner has interpreted any of the identified interpretations to be applicable in light of any prior art applied under § 102 or § 103.
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) 1-4 and 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Devgon (US-20200100716-A1, cited by Applicant) in view of Burkholz (US-20160325089-A1).
Regarding claim 1, Devgon teaches
An instrument delivery device coupleable to a catheter assembly including a catheter positionable intravenously in a patient [In this example, the access device 270 can be any suitable device configured to be at least partially inserted or disposed within a portion of the body. For example, the access device 270 can be a known peripheral intravenous line (PIV) or the like configured to be percutaneously inserted into a portion of the body. In some instances, the access device 270 (e.g., PIV) can be at least partially disposed within a vein of a patient via a venipuncture event or the like, as described in further detail herein (Devgon ¶0058, Figs. 6-7); the fluid transfer device 210 can be used with (e.g., coupled to) the access device 270 and manipulated to withdraw a volume of blood from the vein of the patient into one or more fluid collection devices, reservoirs, containers, etc. (Devgon ¶0068, Figs. 6-7)], the instrument delivery device comprising:
an instrument configured to be inserted within the catheter [catheter 230 (Devgon Fig. 7); at least a portion of the catheter 230 is disposed within the inner volume and/or the lock 240 when the catheter 230 is in the first position (FIGS. 5 and 6) and at least a portion of the catheter 230 extends beyond the introducer 215 and lock 240 to place a distal end of the catheter 230 in a position within the access device 270 or a position distal to the access device 270 when the catheter 230 is in the second position (FIG. 7), as described in further detail herein (Devgon ¶0072, Fig. 7)];
a housing having a proximal end and a distal end and defining an inner volume configured to movably receive the instrument [The introducer 215 includes a proximal end portion 216 and a distal end portion 217 (Devgon ¶0071); The catheter 230 of the transfer device 210 is movably disposed within the inner volume defined by the introducer 215 (Devgon ¶0072)];
a coupling device positioned at the distal end of the housing, the coupling device comprising a lock configured to couple the housing to a proximal connector of the catheter assembly [a lock 240 configured to physically and fluidically couple the introducer 215 to, for example, the access device 270 (e.g., a PIV or the like), as described in further detail herein (Devgon ¶0071, Figs. 6-7)];
an advancement member configured to move relative to the housing to move the instrument between a first position, in which a distal end of the instrument is disposed within the housing or within the lock, and a second position, in which the distal end of the instrument is disposed within the catheter or past a distal tip of the catheter [actuator 220 (Devgon Figs. 5-7); the catheter 230 can be moved (e.g., via movement of the actuator 220) between a first position and a second position to transition the transfer device 210 between the first configuration and the second configuration, respectively. More specifically, at least a portion of the catheter 230 is disposed within the inner volume and/or the lock 240 when the catheter 230 is in the first position (FIGS. 5 and 6) and at least a portion of the catheter 230 extends beyond the introducer 215 and lock 240 to place a distal end of the catheter 230 in a position within the access device 270 or a position distal to the access device 270 when the catheter 230 is in the second position (FIG. 7), as described in further detail herein (Devgon ¶0072, Figs. 6-7)].
However, while Devgon discloses that the lock allows for selective coupling between the coupling device additional devices [In the embodiment shown in FIGS. 5-7, the lock 240 includes a set of arms 241 and a proboscis 242. The set of arms 241 can be configured to engage an outer surface of the proximal port 273 of the access device 270 when the lock 240 is coupled thereto. Although described as including the set of arms 241 that are used to couple to the proximal port 273 of the access device 270, in other embodiments, the lock 240 can include and/or can form any suitable coupler or the like configured to couple or attach the transfer device 210 to the access device 270 (Devgon ¶0076, Figs. 6-7); As described above, the set of arms 341 of the lock 340 can selectively engage an outer surface of the adapter 395 to at least temporarily secure or attach the adapter 395 to the transfer device 310 (Devgon ¶0090, Fig. 8)], Devgon fails to explicitly disclose a scrubbing cap engaged with the lock, the scrubbing cap comprising: a scrubbing insert; a housing including: a connector portion configured to engage with the lock to secure the scrubbing cap to the instrument delivery device a holder portion distal from the connector portion and including a cavity configured to retain the scrubbing insert therein; and a seal attached to the holder portion to seal the scrubbing insert within the cavity; wherein the scrubbing cap is engaged with the lock in a manner that provides for removal of the scrubbing cap from the instrument delivery device.
Burkholz discloses a fluid delivery devices, wherein Burkholz discloses a syringe [syringe 100 (Burkholz Figs. 4A-B)] and a scrubbing cap comprising: a scrubbing insert [The first and second caps each contain an antimicrobial composition that is configured to clean a needleless connector and/or an access port of an infusion system, such as an intravenous catheter assembly or intravenous tubing (Burkholz ¶0007); a first pad 130. First pad 130 may comprises an antimicrobial composition that is configured to clean an access port (not shown) intended to receive nozzle 104 of syringe 100 (Burkholz ¶0037, Fig. 4B); First pad 130 is then used to clean an access port of an infusion system. The access port is clean by inserting the access portion within second opening 128 to contact first pad 130 (Burkholz ¶0040)]; a housing [first cap 120 (Burkholz Fig. 4A-B)] including: a connector portion configured to engage with a coupling device of the syringe to secure the scrubbing cap to the syringe [a first cap 120 is provided having a receptacle 122 for receiving nozzle 104 of syringe 100 (Burkholz ¶0036, Fig. 4B)]; a holder portion distal from the connector portion and including a cavity configured to retain the scrubbing insert therein [First cap 120 further comprises a first opening 128 in which is seated a first pad 130 (Burkholz ¶0037, Fig. 4B)]; and a seal attached to the holder portion to seal the scrubbing insert within the cavity [First cap 120 may further include a lid 150 to protect first pad 130 and prevent evaporation of the antimicrobial composition prior to use (Burkholz ¶0037, Figs. 4A-B)]; wherein the scrubbing cap is engaged with the coupling device in a manner that provides for removal of the scrubbing cap from the syringe [First cap 120 is then removed from nozzle 104 (Burkholz ¶0040)].
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 Devgon to employ a scrubbing cap engaged with the lock, the scrubbing cap comprising: a scrubbing insert; a housing including: a connector portion configured to engage with the lock to secure the scrubbing cap to the instrument delivery device; a holder portion distal from the connector portion and including a cavity configured to retain the scrubbing insert therein; and a seal attached to the holder portion to seal the scrubbing insert within the cavity; wherein the scrubbing cap is engaged with the lock in a manner that provides for removal of the scrubbing cap from the instrument delivery device, so as to facilitate cleaning of the proximal connector of the catheter assembly prior to coupling between the instrument delivery device and the proximal connector.
Regarding claim 2, Devgon in view of Burkholz teaches
The instrument delivery device of claim 1.
However, Devgon in view of Burkholz as presently modified fails to explicitly disclose wherein the connector portion comprises a protrusion having a distal end joined with the connector portion and a proximal end having an opening formed therein, the opening providing access to a channel formed within the protrusion.
Devgon discloses and depicts adapters configured to be coupled to the coupling device via the lock, wherein Devgon discloses wherein the adapters comprise a connector portion that comprises a protrusion having a distal end joined with the connector portion and a proximal end having an opening formed therein, the opening providing access to a channel formed within the protrusion [For example, FIG. 8 illustrates an access device 370, a fluid transfer device 310 (referred to herein as “transfer device”), and an adapter 395, according to an embodiment (Devgon ¶0083, Fig. 8); The adapter 395 can be any suitable shape, size, and/or configuration. In some embodiments, the adapter 395 can be similar to some commercially available adapters, connectors, couplers, extension sets, and/or the like. For example, in some embodiments, the adapter 395 can be substantially similar in at least form and/or function to some commercially available adapters suitable for use with needle-free connectors. In other embodiments, the adapter 395 need not be similar to known or commercially available adapters, connectors, couplers, extension sets, etc. (Devgon ¶0084); As shown in FIG. 8, the adapter 395 has a proximal end portion 396 and a distal end portion 397. The proximal end portion 396 is configured to be coupled to a lock 340 of the transfer device 310. For example, in some embodiments, the lock 340 of the transfer device 310 can include a set of arms 341 (similar to the set of arms 241) configured to selectively engage an outer surface of the proximal end portion 396 of the adapter 395 to couple the adapter 395 thereto. In addition, a proboscis 342 of the lock 340 (similar to the proboscis 242) can be inserted into the proximal end portion 396 of the adapter 395, as described in further detail herein (Devgon ¶0085)].
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 Devgon in view of Burkholz to employ wherein the connector portion comprises a protrusion having a distal end joined with the connector portion and a proximal end having an opening formed therein, the opening providing access to a channel formed within the protrusion, 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 known configuration/structure for coupling the coupling device and lock of the instrument delivery device to an attachment] [MPEP § 2143(I)(D)].
Regarding claim 3, Devgon in view of Burkholz teaches
The instrument delivery device of claim 2, wherein the lock comprises:
an elongated member insertable within the channel of the protrusion [Devgon ¶0085, wherein Devgon ¶0083 notes that the transfer device 310 is substantially similar to the transfer device 210 as referenced in the above § 103 rejection of claim 1]; and
a pair of locking arms positioned on opposing sides of the elongated member and enagageable with the protrusion [Devgon ¶0085].
Regarding claim 4, Devgon in view of Burkholz teaches
The instrument delivery device of claim 1 [considered to be dependent from claim 3 based on the § 112(b) rejection above].
However, Devgon in view of Burkholz as presently applied fails to explicitly disclose wherein a protrusion of the connector portion includes: a first portion having a first outer diameter; a second portion positioned proximally from the first portion and having a second outer diameter less than the first outer diameter, the second portion including the opening; and an annular flange disposed between the first portion and the second portion and forming a lip; wherein the annular flange is positioned such that a hooked end portion of each of the pair of locking arms engages the lip of the annular flange when the elongated member is inserted into the channel.
Devgon discloses and depicts adapters configured to be coupled to the coupling device via the lock, wherein Devgon discloses wherein a protrusion of an adapter includes: a first portion having a first outer diameter; a second portion positioned proximally from the first portion and having a second outer diameter less than the first outer diameter, the second portion including the opening; and an annular flange disposed between the first portion and the second portion and forming a lip; wherein the annular flange is positioned such that a hooked end portion of each of the pair of locking arms engages the lip of the annular flange when the elongated member is inserted into the channel [Devgon ¶¶0084-0085, Fig. 8, wherein the Examiner further notes that at least Devgon Figs. 21-22 and 24 are considered to depict the pair of locking arms engaging the lip of the annular flange when the elongated member is inserted into the channel as claimed; See Annotated Fig. 1 below].
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Annotated Fig. 1. Fig. 8 of Devgon has been annotated to identify each of the first portion, second portion, annular flange, and lip formed by the annular flange.
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 Devgon in view of Burkholz to employ wherein a protrusion of the connector portion includes: a first portion having a first outer diameter; a second portion positioned proximally from the first portion and having a second outer diameter less than the first outer diameter, the second portion including the opening; and an annular flange disposed between the first portion and the second portion and forming a lip; wherein the annular flange is positioned such that a hooked end portion of each of the pair of locking arms engages the lip of the annular flange when the elongated member is inserted into the channel, 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 known configuration/structure for coupling the coupling device and lock of the instrument delivery device to an attachment] [MPEP § 2143(I)(D)].
Regarding claim 18, Devgon teaches
A method of manufacturing an instrument delivery device coupleable to a catheter assembly including a catheter positionable intravenously in a patient [In this example, the access device 270 can be any suitable device configured to be at least partially inserted or disposed within a portion of the body. For example, the access device 270 can be a known peripheral intravenous line (PIV) or the like configured to be percutaneously inserted into a portion of the body. In some instances, the access device 270 (e.g., PIV) can be at least partially disposed within a vein of a patient via a venipuncture event or the like, as described in further detail herein (Devgon ¶0058, Figs. 6-7); the fluid transfer device 210 can be used with (e.g., coupled to) the access device 270 and manipulated to withdraw a volume of blood from the vein of the patient into one or more fluid collection devices, reservoirs, containers, etc. (Devgon ¶0068, Figs. 6-7)], the method comprising:
providing an instrument delivery device comprising:
an instrument configured to be inserted within the catheter [catheter 230 (Devgon Fig. 7); at least a portion of the catheter 230 is disposed within the inner volume and/or the lock 240 when the catheter 230 is in the first position (FIGS. 5 and 6) and at least a portion of the catheter 230 extends beyond the introducer 215 and lock 240 to place a distal end of the catheter 230 in a position within the access device 270 or a position distal to the access device 270 when the catheter 230 is in the second position (FIG. 7), as described in further detail herein (Devgon ¶0072, Fig. 7)];
a housing having a proximal end and a distal end and defining an inner volume configured to movably receive the instrument [The introducer 215 includes a proximal end portion 216 and a distal end portion 217 (Devgon ¶0071); The catheter 230 of the transfer device 210 is movably disposed within the inner volume defined by the introducer 215 (Devgon ¶0072)];
a coupling device positioned at the distal end of the housing, the coupling device comprising a lock configured to couple the housing to a proximal connector of the catheter assembly [a lock 240 configured to physically and fluidically couple the introducer 215 to, for example, the access device 270 (e.g., a PIV or the like), as described in further detail herein (Devgon ¶0071, Figs. 6-7)]; and
an advancement member configured to move relative to the housing to move the instrument between a first position, in which a distal end of the instrument is disposed within the housing or within the lock, and a second position, in which the distal end of the instrument is disposed within the catheter or past a distal tip of the catheter [actuator 220 (Devgon Figs. 5-7); the catheter 230 can be moved (e.g., via movement of the actuator 220) between a first position and a second position to transition the transfer device 210 between the first configuration and the second configuration, respectively. More specifically, at least a portion of the catheter 230 is disposed within the inner volume and/or the lock 240 when the catheter 230 is in the first position (FIGS. 5 and 6) and at least a portion of the catheter 230 extends beyond the introducer 215 and lock 240 to place a distal end of the catheter 230 in a position within the access device 270 or a position distal to the access device 270 when the catheter 230 is in the second position (FIG. 7), as described in further detail herein (Devgon ¶0072, Figs. 6-7)].
However, while Devgon discloses that the lock allows for selective coupling between the coupling device additional devices [In the embodiment shown in FIGS. 5-7, the lock 240 includes a set of arms 241 and a proboscis 242. The set of arms 241 can be configured to engage an outer surface of the proximal port 273 of the access device 270 when the lock 240 is coupled thereto. Although described as including the set of arms 241 that are used to couple to the proximal port 273 of the access device 270, in other embodiments, the lock 240 can include and/or can form any suitable coupler or the like configured to couple or attach the transfer device 210 to the access device 270 (Devgon ¶0076, Figs. 6-7); As described above, the set of arms 341 of the lock 340 can selectively engage an outer surface of the adapter 395 to at least temporarily secure or attach the adapter 395 to the transfer device 310 (Devgon ¶0090, Fig. 8)], Devgon fails to explicitly disclose engaging a scrubbing cap with the lock, the scrubbing cap comprising: a scrubbing insert; a housing including: a connector portion configured to engage with the lock to secure the scrubbing cap to the instrument delivery device; and a holder portion distal from the connector portion and including a cavity configured to retain the scrubbing insert therein; and a seal attached to the holder portion to seal the scrubbing insert within the cavity; wherein the scrubbing cap is engaged with the lock in a manner that provides for removal of the scrubbing cap from the instrument delivery device.
Burkholz discloses a methods of assembling fluid delivery devices, wherein Burkholz discloses engaging a syringe [syringe 100 (Burkholz Figs. 4A-B)] and with a scrubbing cap, the scrubbing cap comprising: a scrubbing insert [The first and second caps each contain an antimicrobial composition that is configured to clean a needleless connector and/or an access port of an infusion system, such as an intravenous catheter assembly or intravenous tubing (Burkholz ¶0007); a first pad 130. First pad 130 may comprises an antimicrobial composition that is configured to clean an access port (not shown) intended to receive nozzle 104 of syringe 100 (Burkholz ¶0037, Fig. 4B); First pad 130 is then used to clean an access port of an infusion system. The access port is clean by inserting the access portion within second opening 128 to contact first pad 130 (Burkholz ¶0040)]; a housing [first cap 120 (Burkholz Fig. 4A-B)] including: a connector portion configured to engage with a coupling device of the syringe to secure the scrubbing cap to the syringe [a first cap 120 is provided having a receptacle 122 for receiving nozzle 104 of syringe 100 (Burkholz ¶0036, Fig. 4B)]; a holder portion distal from the connector portion and including a cavity configured to retain the scrubbing insert therein [First cap 120 further comprises a first opening 128 in which is seated a first pad 130 (Burkholz ¶0037, Fig. 4B)]; and a seal attached to the holder portion to seal the scrubbing insert within the cavity [First cap 120 may further include a lid 150 to protect first pad 130 and prevent evaporation of the antimicrobial composition prior to use (Burkholz ¶0037, Figs. 4A-B)]; wherein the scrubbing cap is engaged with the coupling device in a manner that provides for removal of the scrubbing cap from the syringe [First cap 120 is then removed from nozzle 104 (Burkholz ¶0040)].
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 Devgon to employ engaging a scrubbing cap with the lock, the scrubbing cap comprising: a scrubbing insert; a housing including: a connector portion configured to engage with the lock to secure the scrubbing cap to the instrument delivery device; and a holder portion distal from the connector portion and including a cavity configured to retain the scrubbing insert therein; and a seal attached to the holder portion to seal the scrubbing insert within the cavity; wherein the scrubbing cap is engaged with the lock in a manner that provides for removal of the scrubbing cap from the instrument delivery device, so as to facilitate cleaning of the proximal connector of the catheter assembly prior to coupling between the instrument delivery device and the proximal connector.
Regarding claim 19, Devgon in view of Burkholz teaches
The method of claim 18, wherein engaging the scrubbing cap with the lock comprises:
inserting an elongated member of the lock into a channel formed in the connector portion of the scrubbing cap [See § 103 modification of claim 18 above; Devon ¶0076, Figs. 6-7; Burkholz ¶¶0036-0037, Fig. 4B].
However, Devgon in view of Burkholz as presently modified fails to explicitly disclose wherein engaging the scrubbing cap with the lock further comprises: pinching a pair of locking arms of the lock onto an annular flange formed about a protrusion of the connector portion.
Devgon discloses engagement methods for coupling the lock to an adapter by pinching a pair of locking arms of the lock onto an annular flange formed about a protrusion of a connector portion of the adapter [the adapter 395 has a proximal end portion 396 and a distal end portion 397. The proximal end portion 396 is configured to be coupled to a lock 340 of the transfer device 310. For example, in some embodiments, the lock 340 of the transfer device 310 can include a set of arms 341 (similar to the set of arms 241) configured to selectively engage an outer surface of the proximal end portion 396 of the adapter 395 to couple the adapter 395 thereto (Devgon ¶0085, Fig. 8)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Devgon in view of Burkholz to employ wherein engaging the scrubbing cap with the lock further comprises: pinching a pair of locking arms of the lock onto an annular flange formed about a protrusion of the connector portion, so as to allow for user control of selective coupling between the lock and the connector portion of the scrubbing cap, and 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 [allow for user-controlled selective coupling between devices] [MPEP § 2143(I)(D)].
Claim(s) 5 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Devgon in view of Burkholz, as applied to claims 4 and 19 above, in further view of Wyatt (US-5632735-A).
Regarding claim 5, Devgon in view of Burkholz teaches
The instrument delivery device of claim 4.
However, Devgon in view of Bullington fails to explicitly disclose wherein the first portion includes a pair of retaining stops formed on an outer surface thereof and adjacent the annular flange, the pair of retaining stops arranged to form a retaining seat that receives the hooked end portion of a respective locking arm of the pair of locking arms, with the retaining seat preventing circumferential displacement of the locking arm.
Wyatt discloses systems and devices for coupling fluid pathways, wherein Wyatt discloses a coupling device comprising a lock [medical connector “M” (Wyatt Figs. 8B-F)] configured to couple the coupling device to a protrusion of a connector portion [port 58 (Wyatt Figs. 8B-C)] [As best seen in FIG. 8C, wall 58b, which defines port 58a, is provided with generally "L" shaped bayonet type grooves L which receive protuberances "P" formed on wings "W" provided on the mating medical connector "M". (See also FIGS. 8B and 8D) (Wyatt Col 7:28-32, Figs. 8B-F)]; wherein the lock comprises an elongated member insertable within a channel of the protrusion, and a pair of locking arms positioned on opposing sides of the elongated member and engageable with the protrusion [Wyatt Col 7:28-32, Figs. 8B-F]; wherein the protrusion includes a pair of retaining stops formed on an outer surface thereof, the pair of retaining stops arranged to form a retaining seat that receives a hooked end portion of a respective locking arm of the pair of locking arms, with the retaining seat preventing circumferential displacement of the locking arm [see Annotated Fig. 2].
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Annotated Fig. 2. Fig. 8C of Wyatt is annotated to identify the structural elements of the L shaped grooves of Wyatt that are considered to define retaining stops, wherein as depicted in at least Wyatt Figs. 8B-F, the identified retaining stops are considered to maintain the circumferential position of the medical connector “M”, such that without manual intervention, the identified retaining stops prevent circumferential displacement of the medical connector “M” [After the cannula penetrates the septum, the connector is rotated in the manner shown in FIGS. 8E and 8F to urge protuberances "P" into portion "L-2" of the L shaped grooves. Once connected fluids flowing through passageway "FP" can be sampled, or alternatively, fluids can be added to passageway "FP" (Wyatt Col 7:43-48)].
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 Devgon in view of Burkholz to employ wherein the first portion includes a pair of retaining stops formed on an outer surface thereof and adjacent the annular flange, the pair of retaining stops arranged to form a retaining seat that receives the hooked end portion of a respective locking arm of the pair of locking arms, with the retaining seat preventing circumferential displacement of the locking arm, so as to provide additional security for the coupling of the locking arms to the connector portion for user control of coupling.
Regarding claim 20, Devgon in view of Burkholz teaches
The method of claim 19.
However, Devgon in view of Bullington fails to explicitly disclose wherein a locking arm of the pair of locking arms is secured between a pair of retaining stops formed on the protrusion of the connector portion, thereby preventing circumferential displacement of the pair of locking arms relative to the connector portion.
Wyatt discloses systems and devices for coupling fluid pathways, wherein Wyatt discloses a coupling device comprising a lock [medical connector “M” (Wyatt Figs. 8B-F)] configured to couple the coupling device to a protrusion of a connector portion [port 58 (Wyatt Figs. 8B-C)] [As best seen in FIG. 8C, wall 58b, which defines port 58a, is provided with generally "L" shaped bayonet type grooves L which receive protuberances "P" formed on wings "W" provided on the mating medical connector "M". (See also FIGS. 8B and 8D) (Wyatt Col 7:28-32, Figs. 8B-F)]; wherein the lock comprises an elongated member insertable within a channel of the protrusion, and a pair of locking arms positioned on opposing sides of the elongated member and engageable with the protrusion [Wyatt Col 7:28-32, Figs. 8B-F]; wherein a locking arm of the pair of locking arms is secured between a pair of retaining stops formed on the protrusion of the connector portion, thereby preventing circumferential displacement of the pair of locking arms relative to the connector portion [see Annotated Fig. 2].
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 Devgon in view of Burkholz to employ wherein a locking arm of the pair of locking arms is secured between a pair of retaining stops formed on the protrusion of the connector portion, thereby preventing circumferential displacement of the pair of locking arms relative to the connector portion, so as to provide additional security for the coupling of the locking arms to the connector portion for user control of coupling.
Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Devgon in view of Burkholz and Wyatt, as applied to claim 5 above, in further view of Utterberg (US-5071413-A).
Regarding claim 7 [written in longhand format to incorporate the subject matter of claim 6 therein], Devgon in view of Burkholz and Wyatt teaches
The instrument delivery device of claim 5.
However, Devgon is not particular regarding the channel or structure of the proboscis [considered to read on the claimed elongated member], such that Devgon in view of Burkholz and Wyatt fails to explicitly disclose wherein the channel comprises: a first channel portion formed in the first portion of the protrusion; and a second channel portion formed in the second portion of the protrusion; wherein the first channel portion has a first channel diameter and the second channel portion has a second channel diameter greater than the first channel diameter; and wherein the elongated member comprises a male luer portion and a blunted cannula portion extending out distally from the male luer portion, with the blunted cannula portion sized to fit in the first channel portion and the male luer portion sized to fit in the second channel portion.
Utterberg discloses medical connectors for coupling fluid pathways [universal connector 10 may be carried on the end of any type of medical fluid flow set, for example arterial or venous sets for hemodialysis, peritoneal dialysis sets, parenteral solution administration sets, blood administration sets, or the like (Utterberg Col 6:1-6)], wherein Utterberg discloses a channel of a connector comprising a first channel portion formed in a first portion of the connector; and a second channel portion formed in a second portion of the connector; wherein the first channel portion has a first channel diameter and the second channel portion has a second channel diameter greater than the first channel diameter [In the circumstance of FIG. 5a, female luer 42a, as shown, is made to the 6% frustoconical minimum permitted length by the ANSI specifications of 7.5 millimeters. No maximum length is defined by the ANSI specifications, as long as it tapers at 6 percent. In that circumstance, the tip 16 of first tubular section 14 penetrates beyond the tapered portion of luer 42a. However, because of the reduced diameter of about 3 millimeters of first tubular section 14, tip 16 can adequately penetrate into the tubular portion 43a of the connector portion 45 that is distal to luer 42a with at least a slight spacing from the walls of portion 45 (Utterberg Col 6:52-63); See Annotated Fig. 3]. Utterberg further discloses a coupling device comprising an elongated member insertable within the channel of the connector, wherein the elongated member comprises a male luer portion [universal connector 10 further defines a frustoconical male luer section 24 (Utterberg Col 5:32-33, Fig. 2)] and a blunted cannula portion extending out distally from the male luer portion [As particularly shown in FIG. 3, distal end 16 of first tubular section 14 is relatively blunt… A pair of opposed apertures 22 are also provided adjacent pointed tip 16 of the first tubular section 14, for communication of lumen 23 with the exterior (Utterberg Col 5:16-18, 29-31, Figs. 2-3)], with the blunted cannula portion sized to fit in the first channel portion and the male luer portion sized to fit in the second channel portion [See Annotated Fig. 3].
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Annotated Fig. 3. Fig. 5A of Utterberg is annotated to identify the first channel portion formed in a first portion of the connector and the second channel portion formed in a second portion of the connector, wherein the first channel portion has a first channel diameter and the second channel portion has a second channel diameter greater than the first channel diameter as depicted; wherein Fig. 5A of Utterberg is further considered to depict the blunted cannula portion sized to fit in the first channel portion and the male luer portion sized to fit in the second channel portion.
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 Devgon in view of Burkholz and Wyatt to employ wherein the channel comprises: a first channel portion formed in the first portion of the protrusion; and a second channel portion formed in the second portion of the protrusion; wherein the first channel portion has a first channel diameter and the second channel portion has a second channel diameter greater than the first channel diameter; and wherein the elongated member comprises a male luer portion and a blunted cannula portion extending out distally from the male luer portion, with the blunted cannula portion sized to fit in the first channel portion and the male luer portion sized to fit in the second channel portion, as this modification would amount to mere simple substitution of known elements for another with similar expected results [providing a male luer to female luer connection between a male connector and a female connector] [MPEP § 2143(I)(B)].
Claim(s) 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Devgon in view of Burkholz, as applied to claim 1 above, in further view of Okman (US-20210008237-A1).
Regarding claim 16, Devgon in view of Burkholz teaches
A method of using the instrument delivery device of claim 1, the method comprising:
removing the seal from the holder portion [Burkholz ¶¶0037, 0040];
positioning the proximal connector of the catheter assembly into the holder portion, such that the proximal connector contacts the scrubbing insert [Burkholz ¶¶0037, 0040].
However, Burkholz does not specifically describe the steps for using the scrubbing insert to clean a proximal connector, such that Devgon in view of Burkholz fails to explicitly disclose cleaning the proximal connector with the scrubbing insert via application of a twisting motion to the instrument delivery device.
Okman discloses methods of using a scrubbing element to disinfect a medical connector, wherein Okman discloses applying a twisting motion to the medical connector relative to the scrubbing element [Use of the disinfection device 100 requires only one single mounting movement by a user. Upon insertion of the medical connector 400 into disinfection device 100, the user may twist or compress the medical connector 400 to promote disinfection of the medical connector 400 (Okman ¶0049)].
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 Devgon in view of Burkholz to employ wherein cleaning the proximal connector with the scrubbing insert via application of a twisting motion to the instrument delivery device, as twisting a scrubbing element relative to a medical connector, while contacting the scrubbing element with the medical connector, is considered to promote disinfection of the medical connector, and 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 [contacting a medical connector with a scrubbing element and twisting the medical connector relative to the scrubbing element to disinfect the medical connector] [MPEP § 2143(I)(D)].
Regarding claim 17, Devgon in view of Burkholz and Okman teaches
The method of claim 16, comprising:
detaching the scrubbing cap from the lock subsequent to cleaning of the proximal connector [Burkholz ¶0040]; and
coupling the lock to the proximal connector [Devgon ¶0071, Figs. 6-7];
wherein, upon coupling of the lock to the proximal connector, the instrument delivery device is operable to move the instrument between from the first position to the second position [Devgon ¶0072, Figs. 6-7].
Conclusion
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/SEVERO ANTONIO P LOPEZ/Examiner, Art Unit 3791
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