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 .
Response to Amendment
This office action is responsive to the amendment filed on 11/18/2025. As directed by the amendment: claims 1, 18, and 24 have been amended, and claim 4 is cancelled. Thus, claims 1-3 and 6-24 are presently pending in this application.
Response to Arguments
Applicant's arguments filed 11/18/2025 have been fully considered but they are not fully persuasive.
Regarding applicant’s argument regarding the independent claims on page 8-10:
Applicant argues that the prior art relied upon in the preceding office action does not teach the following limitations of the presently amended claims:
"a retaining space [between a first valve connector retaining feature of the locking piece and a second valve connector retaining feature of the base] … when the locking piece and the base are in the locking engagement with the locking piece in the locked connection with the base about the valve connector with the retaining space enclosed therebetween, the retaining space comprises additional vertical space relative to the retaining element of the valve connector to enable rotation and vertical movement of the retaining element and the valve connector relative to the anchor such that the conduit of the valve connector maintains fluid connection with the gastrostomy feeding tube during rotation"
Applicant arguments seem to regard a particular interpretation of the prior art of record wherein the claimed "locking engagement" or "locked configuration" occurs only when the prior art of Utterberg's lock 5's lug 15, have traveled their full extent through threads 326 such that ridge 333 abuts ridge 308 and is in the configuration immediately prior to Utterberg's figure 8 where its luer lock 5 has been removed.
Examiner notes that this interpretation of the art is inconsistent with the broadest reasonable interpretation of the claim terms as presented in the preceding and present office action.
The claimed locking piece, ring 320, can be considered to be in locking engagement with the claimed base, luer lock 5, such that ring 320 and lock 5 are connected/locked together when Utterberg's invention is in the configuration immediately following the configuration illustrated in fig 7 of Utterberg. Figure 7 of Utterberg illustrates its invention after a user has performed a relative translation and rotation between nozzle 300 and luer lock 5 when nozzle tip 310 has entered the tapered surface 11 of luer lock 5 far enough to penetrate luer lock 5's sealing membrane, thereby permitting a fluid connection from nozzle 300 through luer lock 5, and the ring 320 is positioned relative to luer lock 5 and nozzle 300 such that threads 326 do not yet engage lugs 15 of luer lock 5. As discussed in col 6 line 32-49, when completing this connection, ring 320 is translated along the flow axis toward luer lock 5 and rotate such that threads 326 are screwed onto lugs 15, and tip 310 is permitted to slide within taper 11 of luer lock 5. Thus, immediately following the configuration of Utterberg illustrated in fig 7, upon the threads 326 first engaging lugs 15, the claimed locking piece, ring 320, can be considered to be in a locking engagement with the claimed base, luer lock 5, with the ring 320 locked to luer 5 such that the elements cannot be disconnected from one another without reversing the rotation of ring 320 relative to luer 5.
Examiner provides a rudimentary illustration of the process for connecting/assembling Utterberg's invention as written in its col 6 line 3-49 but not fully illustrated in its figures.
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Notably, during such a locking engagement of the prior art, the claimed valve connector, nozzle 300, and its retaining element, ridge 308, are permitted to move vertically, or as it's shown in the prior art as sliding axially with the direction of flow, relative to the claimed anchor, luer lock 5 and ring 320, in the manner by which nozzle 300's tip 310, which ridge 308 is fixed relative to, can slide within tapered surface 11 as ring 320 's threads 326 are rotated over luer lock 5's lugs 15 during this locking engagement. During such translation and locking engagement, the nozzle tip 310 is still disposed in a position penetrating the membrane of luer lock 5 such that fluid connection is maintained. Similarly, nozzle 300 and ridge 308 can be considered enabled to rotate relative to ring 320 and luer lock 5 because as ring 320 can freely rotate relative to nozzle 300 during this locking engagement, see col 6 line 44-49, and further nozzle 300 can rotate/twist while its tip 310 is pressed into/translates within tapered surface 11 of luer lock 5, see col 6 line 36-38, which it nozzle 300 is permitted to do during the cited locking engagement, the claimed valve connector and claimed retaining element, nozzle 300 and ridge 308 respectively, can rotate relative to both ring 320 and luer lock 5 while maintaining the claimed fluid connection.
Accordingly, examiner's rejection as necessitated by the amendment below in view of the prior art of record, stands and is proper.
Examiner notes for applicant that amendments to the claim incorporate newly amended features of "a second valve connector retaining feature" to define the boundaries of the claimed retaining space, which based on the interview held 11/12/2025 is intended to represent the horizontal ledge 165, however the language of the claims are not so specific as to limit the interpretation of the claims to such structure alone. If applicant desires to distinguish from the prior art of record in this regard and better define what they consider to be the novel and inventive feature of a retaining space which enables rotation and vertical movement of a valve connector relative to an anchor while maintaining fluid connection therebetween, then incorporating further aspects of the disclosure, particularly the subject matter of paragraph 65 and fig 8, defining the boundaries of the retaining space and the second valve connector retaining feature, or ledge, relative to both the different diameter portions of the base, as well as describing the disposition of the retaining element radially within the first diameter of the base and axially between an end of the thread on the base and the second valve connector retaining feature, would likely distinguish such amended claims from the prior art of record so as to require a new rejection of record or to constitute allowable subject matter, after adequate search and consideration of such amended claims are filed for the record.
Regarding applicant’s argument regarding dependent claims on page 10-11:
Applicant argues that their preceding arguments render the independent claims allowable, and consequently likewise the dependent claims are allowable.
See examiner's rejection as necessitated by the amendment, below, detailing the prior art which discloses/teaches the limitations of the dependent claims.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 6, 8, 10-14, and 16-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 5047021 A, henceforth written as Utterberg.
Regarding claim 1, Utterberg discloses:
An assembly for attachment to a gastrostomy feeding tube, the assembly comprising:
(invention (not enumerated) of fig 4-8)
a valve connector comprising:
(nozzle 300; fig 4)
a valve connector housing;
(housing (not enumerated) of nozzle 300; fig 4)
a conduit traversing the valve connector housing from an inlet to an outlet;
(lumen (not enumerated) of nozzle 300 extends along axis 315 from a rear opening (not enumerated) through lumen (not enumerated) of luer lock 5 and its forward opening (not enumerated); fig 4; fig 3 best illustrates the lumen and forward opening of luer lock 5 as the inner diameter of portions 202 and 201, and inner circumference of portion 201, respectively )
and a retaining element extending outwardly from the valve connector housing;
(ridge 308 extending radially outward from nozzle 300; fig 4)
and an anchor configured for attachment to the gastrostomy feeding tube,
(luer lock 5 and ring 320 constitutes the claimed anchor; fig 7)
the anchor comprising: an anchor housing configured to receive a portion of the valve connector,
(fig 7 illustrates housings (not enumerated) of luer lock 5 and ring 32 as receiving a portion of nozzle 300)
the anchor housing comprising: a gastrostomy feeding tube attachment feature for attaching the anchor to the gastrostomy feeding tube;
(Examiner claim language of “configured to” implies a functional language and the prior art must at least be capable of performing the recited function of receiving a tube to attachment of the anchor and a tube; col 7 line 14-22; end portion 201's of luer lock 5 inner diameter is 5.1 mm and accordingly is functionally capable of mating with appropriately sized tubes for gastrostomy feeding; fig 3+4)
a locking piece defining a first valve connector retaining feature;
( twist ring 320, the claimed locking piece, radially extending about ridge 332, the claimed first valve connector retaining feature ; fig 6-7)
and a base
(luer lock 5; fig 6-7)
defining a second valve connector retaining feature,
(the outer surface of lugs 15 and luer lock 5, illustrated on the right side of lock 5 in fig 1 and on the left side of lock 5 of fig 6-7, is considered the claimed second valve connector retaining feature in that it defines the boundary which ring 320 must overlap with to arrive at a locked configuration of the invention)
wherein when the base is in locking engagement with the locking piece in locked connection with the base about the valve connector, the locking piece and the base define a retaining space for the retaining element between the first valve connector retaining feature of the locking piece and the second valve connector retaining feature of the base,
(the claimed retaining space is considered the 3-dimensional space bounded by the right side of ridge 332 of ring 320, as illustrated in fig 6-7, and the outer surface of lugs 15 and luer lock 5, illustrated on the right side of lock 5 in fig 1, which ridge 308 is disposed in between as illustrated in fig 6-7; see examiner's illustration of Utterberg's col 6 line 3-49, in the response to arguments section above, which details the assembly procedure connecting its nozzle 300, ring 32, and luer 5, and provides an illustration of the locking engagement and locked connection of the claimed base, luer 5, and the claimed locking piece, ring 320, occurring when threads 326 of ring 320 first engage with lugs 15 of luer 5)
wherein, when the locking piece and the base are in the locking engagement with the locking piece in the locked connection with the base about the valve connector with the retaining space enclosed therebetween, the retaining space comprises additional vertical space relative to the retaining element of the valve connector to enable rotation and vertical movement of the retaining element and the valve connector relative to the anchor such that the conduit of the valve connector maintains fluid connection with the gastrostomy feeding tube during rotation.
(the claimed locking piece, ring 320, can be considered to be in locking engagement with the claimed base, luer lock 5, such that ring 320 and lock 5 are connected/locked together when Utterberg's invention is in the configuration immediately following the configuration illustrated in fig 7 of Utterberg. Figure 7 of Utterberg illustrates its invention after a user has performed a relative translation and rotation between nozzle 300 and luer lock 5 when nozzle tip 310 has entered the tapered surface 11 of luer lock 5 far enough to penetrate luer lock 5's sealing membrane, thereby permitting a fluid connection from nozzle 300 through luer lock 5, and the ring 320 is positioned relative to luer lock 5 and nozzle 300 such that threads 326 do not yet engage lugs 15 of luer lock 5. As discussed in col 6 line 32-49, when completing this connection, ring 320 is translated along the flow axis toward luer lock 5 and rotate such that threads 326 are screwed onto lugs 15, and tip 310 is permitted to slide within taper 11 of luer lock 5. Thus, immediately following the configuration of Utterberg illustrated in fig 7, upon the threads 326 first engaging lugs 15, the claimed locking piece, ring 320, can be considered to be in a locking engagement with the claimed base, luer lock 5, with the ring 320 locked to luer 5 such that the elements cannot be disconnected from one another without reversing the rotation of ring 320 relative to luer 5; see examiner's illustration of Utterberg's col 6 line 3-49, in the response to arguments section above, which demonstrates that the locking engagement and locked connection of the claimed base, luer 5, and the claimed locking piece, ring 320, occurs when threads 326 of ring 320 first engage with lugs 15 of luer 5, and further over the course of this locking engagement the nozzle 300, and therein also its ridge 308 the claimed retaining element, are permitted to translate axially and rotate relative to luer 5 and ring 320)
Regarding claim 2, Utterberg discloses:
The assembly of claim 1, wherein the valve connector housing further defines an upper portion having an upper diameter,
(ridge 312 has the greatest outer diameter on nozzle 300; fig 4)
and a lower portion having a lower diameter, wherein the upper diameter is larger than the lower diameter.
(col 5 line 48-57; section C+G of nozzle 300, the claimed lower portion, has a smaller diameter than the ridge 312; fig 4)
Regarding claim 3, Utterberg discloses:
The assembly of claim 2, wherein the retaining element extends radially outward from the lower portion of the valve connector housing.
(fig 4 demonstrates that ridge 308 radially extends from a rearward most portion of section C of nozzle 300)
Regarding claim 6, Utterberg discloses:
The assembly of claim 1, wherein the base comprises at least one thread protruding from and extending partially about an outer circumference of the base;
(lugs 15 extending from outer circumference of luer lock 5; fig 6-7)
and wherein the locking piece comprises at least one channel configured to receive the at least one thread, wherein the at least one channel extends at least partially about the outer circumference of an inner surface of the locking piece.
(twist ring 320 has threads 326, therein a channel, extending about the circumference of ring 320's inner surface and receives lugs 15; fig 6-7)
Regarding claim 8, Utterberg discloses:
The assembly of claim 6, wherein the at least one channel angularly descends about the circumference of the locking piece.
(fig 5 demonstrates that threads 36 angularly descends along the flow axis 315 about the circumference of ring 320)
Regarding claim 10, Utterberg discloses:
The assembly of claim 6, wherein the locking piece is rotatable by 90 degrees in a first direction to secure the locking piece to the base, and rotatable 90 degrees in a second direction opposite the first direction to release the locking piece from securement with the base.
Examiner notes that claim language of “rotatable” implies a functional language and the prior art must at least be capable of performing the recited function of being rotated by 90 degrees in one direction to secure the locking piece and base, and rotated 90 degrees in an opposing direction to disconnect the locking piece from the base.
(luer lock 5 mates to ring 320 by a number of rotations, such that when the lugs 15 are first disposed at a quarter rotation into threads 326, a clockwise quarter rotation, therein 90 degrees, of ring 320 would act to secure the claimed locking piece and claimed base together, however a subsequent quarter rotation of ring 320 in a counter-clockwise direction would work to decouple lugs 15 of the claimed base from the threads 326 of the claimed locking piece)
Regarding claim 11, Utterberg discloses:
The assembly of claim 1, wherein the inlet comprises an engagement member
(inner diameter (not enumerated) of nozzle 300 at its opening (not enumerated), constitutes the claimed engagement member; fig 4)
configured to receive a feeding tube to enable fluid communication between the feeding tube and the conduit.
Examiner claim language of “configured to” implies a functional language and the prior art must at least be capable of performing the recited function of receiving a tube to enable fluid communication between the conduit and the tube.
(col 7 line 23-28; the male luer lock, aka the nozzle 300, is functionally capable of securing to a medical instrument, therein its inner diameter may mate with a medical instrument, such as a feeding tube, for conveying media therethrough)
Regarding claim 12, Utterberg discloses:
The assembly of claim 1, wherein the valve connector is 360 degree rotatable within the anchor.
(col 4 line 44-46 + col 6 line 17-31 notes that nozzle 300 is feely rotatable, therein 360 degree rotatable, about ring 320, a constituent component of the claimed anchor; col 2 line 15-16 and col 6 line 43-44 note that the tapered tip 310 of nozzle 300 may slide/rotate relative to the taper 11 of luer lock 5, such that nozzle 300 is likewise functionally capable of rotating 360 degrees relative to luer lock 5, the other constituent component of the claimed anchor)
Regarding claim 13, Utterberg discloses:
The assembly of claim 1, wherein the valve connector is a reflux valve.
(membrane of luer lock 5 maintains fluid on one side thereof until acted upon by nozzle 300, such that nozzle 300 and the membrane of luer lock 5 act as a reflux valve since fluid may not exit lock 5 until engaged with nozzle 300; fig 3)
Regarding claim 14, Utterberg discloses:
The assembly of claim 1, wherein the assembly is made from a thermoplastic.
(col 7 line 14-16; the invention is molded from polyvinyl chloride, a thermoplastic polymer)
Regarding claim 16, Utterberg discloses:
The assembly of claim 1, wherein the valve connector is configured to enable administration of a bolus feed.
(claim language of “configured to” implies a functional language and the prior art must at least be capable of performing the recited function of allowing a bolus media to be transmitted through the valve connector; accordingly the fluid connection of a mated nozzle 300 and luer lock 5 enables the conveyance of media therethrough, therein being functionally capable of administering a bolus feed therethrough)
Regarding claim 17, Utterberg discloses:
The assembly of claim 1, wherein the valve connector is configured to enable administration of a continuous feed.
(claim language of “configured to” implies a functional language and the prior art must at least be capable of performing the recited function of allowing a continuous media to be transmitted through the valve connector; accordingly the fluid connection of a mated nozzle 300 and luer lock 5 enables the conveyance of media therethrough, therein being functionally capable of administering a continuous feed therethrough)
Regarding claim 18, Utterberg discloses:
A device enabling rotation of a supply tube of a medical device, the device comprising:
(invention (not enumerated) of fig 4-8; col 7 line 23-28, the invention is mated to a tube of a medical instrument at its rear opening (not enumerated) of its nozzle 300 )
a connector comprising:
(nozzle 300; fig 4)
a connector housing;
(housing (not enumerated) of nozzle 300; fig 4)
a conduit traversing the connector housing from an inlet to an outlet;
(lumen (not enumerated) of nozzle 300 extends along axis 315 from a rear opening (not enumerated) through lumen (not enumerated) of luer lock 5 and its forward opening (not enumerated); fig 4; fig 3 best illustrates the lumen and forward opening of luer lock 5 as the inner diameter of portions 202 and 201, and inner circumference of portion 201, respectively )
and a retaining element extending outwardly from the connector housing;
(ridge 308 extending radially outward from nozzle 300; fig 4)
and an anchor configured for attachment to the medical device,
(luer lock 5 and ring 320 constitutes the claimed anchor; fig 7)
the anchor comprising: an anchor housing configured to receive a portion of the connector housing,
(fig 7 illustrates housings (not enumerated) of luer lock 5 and ring 320 as receiving a portion of nozzle 300)
the anchor housing comprising: a locking piece defining a first connector retaining feature; and
( twist ring 320, the claimed locking piece, radially extending about ridge 332, the claimed first valve connector retaining feature ; fig 6-7)
a base
(luer lock 5; fig 6-7)
defining a second connector retaining feature,
(the outer surface of lugs 15 and luer lock 5, illustrated on the right side of lock 5 in fig 1 and on the left side of lock 5 of fig 6-7, is considered the claimed second valve connector retaining feature in that it defines the boundary which ring 320 must overlap with to arrive at a locked configuration of the invention)
wherein when the base is in locking engagement with the locking piece, the first connector retaining feature and the second connector retaining feature define a retaining space
(the claimed retaining space is considered the 3-dimensional space bounded by the right side of ridge 332 of ring 320, as illustrated in fig 6-7, and the outer surface of lugs 15 and luer lock 5, illustrated on the right side of lock 5 in fig 1, which ridge 308 is disposed in between as illustrated in fig 6-7; see examiner's illustration of Utterberg's col 6 line 3-49, in the response to arguments section above, which details the assembly procedure connecting its nozzle 300, ring 32, and luer 5, and provides an illustration of the locking engagement and locked connection of the claimed base, luer 5, and the claimed locking piece, ring 320, occurring when threads 326 of ring 320 first engage with lugs 15 of luer 5)
wherein, when the anchor housing receives the portion of the connector housing and the base is in the locking engagement with the locking piece in locked connection with the base about the valve connector, and the retaining element of the connector is disposed in the retaining space, the retaining space comprises additional vertical space relative to the retaining element of the valve connector to enable rotation and vertical movement of the retaining element and the valve connector relative to the anchor such that the conduit of the valve connector maintains fluid connection with the gastrostomy feeding tube during rotation.
(the claimed locking piece, ring 320, can be considered to be in locking engagement with the claimed base, luer lock 5, such that ring 320 and lock 5 are connected/locked together when Utterberg's invention is in the configuration immediately following the configuration illustrated in fig 7 of Utterberg. Figure 7 of Utterberg illustrates its invention after a user has performed a relative translation and rotation between nozzle 300 and luer lock 5 when nozzle tip 310 has entered the tapered surface 11 of luer lock 5 far enough to penetrate luer lock 5's sealing membrane, thereby permitting a fluid connection from nozzle 300 through luer lock 5, and the ring 320 is positioned relative to luer lock 5 and nozzle 300 such that threads 326 do not yet engage lugs 15 of luer lock 5. As discussed in col 6 line 32-49, when completing this connection, ring 320 is translated along the flow axis toward luer lock 5 and rotate such that threads 326 are screwed onto lugs 15, and tip 310 is permitted to slide within taper 11 of luer lock 5. Thus, immediately following the configuration of Utterberg illustrated in fig 7, upon the threads 326 first engaging lugs 15, the claimed locking piece, ring 320, can be considered to be in a locking engagement with the claimed base, luer lock 5, with the ring 320 locked to luer 5 such that the elements cannot be disconnected from one another without reversing the rotation of ring 320 relative to luer 5; see examiner's illustration of Utterberg's col 6 line 3-49, in the response to arguments section above, which demonstrates that the locking engagement and locked connection of the claimed base, luer 5, and the claimed locking piece, ring 320, occurs when threads 326 of ring 320 first engage with lugs 15 of luer 5, and further over the course of this locking engagement the nozzle 300, and therein also its ridge 308 the claimed retaining element, are permitted to translate axially and rotate relative to luer 5 and ring 320)
Regarding claim 19, Utterberg discloses:
The device of claim 18, wherein the medical device is an interventional or invasive device.
Examiner notes that the claimed medical device is associated to the rest of the invention only with functional language of "enabling rotation of", "configured for", "for attaching", "configuration with", and "maintain connection with". Accordingly the aforementioned claim language implies a functional language and the prior art must at least be capable of performing the recited functions of enabling rotation of/connection to a medical device of the designated type.
(col 7 line 23-28, nozzle 300 is mated to a medical instrument such as a tubular catheter, therein the invention is functionally capable of enabling the rotation of and attachment thereto of another tubular catheter such as the claimed medical device type)
Regarding claim 20, Utterberg discloses:
The device of claim 18, wherein the medical device is a gastrostomy feeding tube.
Examiner notes that the claimed medical device is associated to the rest of the invention only with functional language of "enabling rotation of", "configured for", "for attaching", "configuration with", and "maintain connection with". Accordingly the aforementioned claim language implies a functional language and the prior art must at least be capable of performing the recited functions of enabling rotation of/connection to a medical device of the designated type.
(col 7 line 23-28, nozzle 300 is mated to a medical instrument such as a tubular catheter, therein the invention is functionally capable of enabling the rotation of and attachment thereto of another tubular catheter such as the claimed medical device type)
Regarding claim 21, Utterberg discloses:
The device of claim 18, wherein the medical device is a ventricular assist device.
Examiner notes that the claimed medical device is associated to the rest of the invention only with functional language of "enabling rotation of", "configured for", "for attaching", "configuration with", and "maintain connection with". Accordingly the aforementioned claim language implies a functional language and the prior art must at least be capable of performing the recited functions of enabling rotation of/connection to a medical device of the designated type.
(col 7 line 23-28, nozzle 300 is mated to a medical instrument such as a tubular catheter, therein the invention is functionally capable of enabling the rotation of and attachment thereto of another tubular catheter such as the claimed medical device type)
Regarding claim 22, Utterberg discloses:
The device of claim 18, wherein the medical device is a catheter.
(col 7 line 23-28, nozzle 300 is mated to a medical instrument such as a tubular catheter)
Regarding claim 23, Utterberg discloses:
The device of claim 18, wherein the medical device is a venous access port.
Examiner notes that the claimed medical device is associated to the rest of the invention only with functional language of "enabling rotation of", "configured for", "for attaching", "configuration with", and "maintain connection with". Accordingly the aforementioned claim language implies a functional language and the prior art must at least be capable of performing the recited functions of enabling rotation of/connection to a medical device of the designated type.
(col 7 line 23-28, nozzle 300 is mated to a medical instrument such as a tubular catheter, therein the invention is functionally capable of enabling the rotation of and attachment thereto of another tubular catheter such as the claimed medical device type)
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 7 is rejected under 35 U.S.C. 103 as being unpatentable over Utterberg as applied to claim 6 above, and further in view of US 20160325087 A1, henceforth written as Lapp.
Regarding Claim 7,
Utterberg discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However, Utterberg is silent regarding:
The assembly of claim 6, wherein the at least one thread comprises a protrusion and the at least one channel comprises a divot to receive the protrusion.
However, Lapp teaches a screw lock connector
wherein the at least one thread comprises a protrusion
(paragraph 69; outside thread 120 has first formation 140; fig 3)
and the at least one channel comprises a divot to receive the protrusion.
(paragraph 69; union nut 230 has second formation 240; fig 3)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to incorporate the protrusion mating with divot teachings of Lapp to the threaded engagement in Utterberg’s assembly in order to arrive at an invention which can advantageously inform the user, through the user's senses, of threaded engagement of the connector by the interaction of the claimed protrusion and claimed divot, see paragraph 50+69 of Lapp.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Utterberg as applied to claim 6 above, and further in view of US 20130046287 A1, henceforth written as Davis.
Regarding Claim 9,
Utterberg discloses all of the elements of the current invention which the present claim is dependent upon, as described above, including the follow limitations of the present claim:
The assembly of claim 6, wherein the at least one thread is a first thread and a second thread, wherein the second thread is disposed opposite the first thread;
(lugs 15 on luer lock 5, illustrated in fig 6-7 as being disposed on opposite sides thereof)
and wherein the at least one channel is a first channel --
(threads 326; fig 5-7)
However, Utterberg is silent regarding:
wherein the at least one channel is a first channel and a second channel, wherein the second channel is disposed opposite the first channel.
However, Davis teaches a screw lock connector
wherein the at least one thread is a first thread and a second thread, wherein the second thread is disposed opposite the first thread;
(fig 1 demonstrating projections 120 are disposed opposite each other)
and wherein the at least one channel is a first channel and a second channel, wherein the second channel is disposed opposite the first channel.
(paragraph 27; threads 158 160 are disposed in a double helix pattern opposite of each other)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to duplicate the claimed channel of Utterberg and arranging the duplicate channel in the manner taught by Davis, therein arriving at the claimed invention, as such a modification involving duplication of parts only involves routine skill in the art, see MPEP 2144.04 (VI), and further would advantageously arrive at an invention with redundant threading means for engaging two components together, improving the security of the engagement process.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Utterberg as applied to claim 1 above, and further in view of US 4338933 A, henceforth written as Bayard.
Regarding Claim 15,
Utterberg discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However, Utterberg is silent regarding:
The assembly of claim 1, wherein the assembly is made from polycarbonate.
Notably Utterberg does recite in col 7 line 15 that the invention is formed of plastic.
However, Bayard teaches a coupling and cutoff valve
wherein the assembly is made from polycarbonate.
(col 7 line 46-54; in order to sterilize and maintain sterility of the coupling mechanism 18, it is made of polycarbonate)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to incorporate the material teachings of Bayard to the invention of Davis as it is a suitable and preferred material for constructing a medical device, see col 7 line 46-54 of Bayard and MPEP 2144.07.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Utterberg, and further in view of US 20170112721 A1, henceforth written as Munnich.
Regarding Claim 24,
Davis discloses the following limitations of the present claim:
A method of installing an assembly for a medical device, the method comprising: --
(assembly invention of fig 4-8)
--wherein the medical device comprises an opening;
(col 7 line 23-28; medical instrument (not enumerated/illustrated) has an opening (not enumerated/illustrated) for mating with a rear opening (not enumerated) of nozzle 300; fig 4)
attaching an outlet of a connector to the opening of the medical device,
(rear opening (not enumerated) of nozzle 300 mates to the medical instrument (not enumerated/illustrated) ; fig 4)
the connector comprising: a connector housing;
(housing (not enumerated) of nozzle 300; fig 4)
a conduit traversing the connector housing from an inlet to an outlet;
(lumen (not enumerated) of nozzle 300 extends along axis 315 from a rear opening (not enumerated) through lumen (not enumerated) of luer lock 5 and its forward opening (not enumerated); fig 4; fig 3 best illustrates the lumen and forward opening of luer lock 5 as the inner diameter of portions 202 and 201, and inner circumference of portion 201, respectively )
and a retaining element extending outwardly from the connector housing;
(ridge 308 extending radially outward from nozzle 300; fig 4)
and attaching an anchor to the medical device about the connector,
(luer lock 5 and ring 320 constitutes the claimed anchor; fig 7; lock 5 and ring 320 are indirectly attached to the medical instrument (not enumerated/illustrated) via their interaction(s) with nozzle 300)
wherein the anchor comprises: an anchor housing configured to receive a portion of the connector housing,
(fig 7 illustrates housings (not enumerated) of luer lock 5 and ring 320 as receiving a portion of nozzle 300)
the anchor housing comprising: a locking piece defining a first connector retaining feature; and
( twist ring 320, the claimed locking piece, radially extending about ridge 332, the claimed first valve connector retaining feature ; fig 6-7)
a base
(luer lock 5; fig 6-7)
defining a second connector retaining feature,
(the outer surface of lugs 15 and luer lock 5, illustrated on the right side of lock 5 in fig 1 and on the left side of lock 5 of fig 6-7, is considered the claimed second valve connector retaining feature in that it defines the boundary which ring 320 must overlap with to arrive at a locked configuration of the invention)
wherein, when the base is in locking engagement with the locking piece, the first connector retaining feature and the second connector retaining feature define a retaining space,
(the claimed retaining space is considered the 3-dimensional space bounded by the right side of ridge 332 of ring 320, as illustrated in fig 6-7, and the outer surface of lugs 15 and luer lock 5, illustrated on the right side of lock 5 in fig 1, which ridge 308 is disposed in between as illustrated in fig 6-7; see examiner's illustration of Utterberg's col 6 line 3-49, in the response to arguments section above, which details the assembly procedure connecting its nozzle 300, ring 32, and luer 5, and provides an illustration of the locking engagement and locked connection of the claimed base, luer 5, and the claimed locking piece, ring 320, occurring when threads 326 of ring 320 first engage with lugs 15 of luer 5)
wherein, when the anchor housing receives the portion of the connector housing and the base is in the locking engagement with the locking piece in locked connection with the base about the connector, and the retaining element is disposed in the retaining space, the retaining space comprises additional vertical space relative to the retaining element of the connector to enable rotation and vertical movement of the retaining element and the connector relative to the anchor such that the conduit of the connector maintains fluid connection with the medical device during rotation.
(the claimed locking piece, ring 320, can be considered to be in locking engagement with the claimed base, luer lock 5, such that ring 320 and lock 5 are connected/locked together when Utterberg's invention is in the configuration immediately following the configuration illustrated in fig 7 of Utterberg. Figure 7 of Utterberg illustrates its invention after a user has performed a relative translation and rotation between nozzle 300 and luer lock 5 when nozzle tip 310 has entered the tapered surface 11 of luer lock 5 far enough to penetrate luer lock 5's sealing membrane, thereby permitting a fluid connection from nozzle 300 through luer lock 5, and the ring 320 is positioned relative to luer lock 5 and nozzle 300 such that threads 326 do not yet engage lugs 15 of luer lock 5. As discussed in col 6 line 32-49, when completing this connection, ring 320 is translated along the flow axis toward luer lock 5 and rotate such that threads 326 are screwed onto lugs 15, and tip 310 is permitted to slide within taper 11 of luer lock 5. Thus, immediately following the configuration of Utterberg illustrated in fig 7, upon the threads 326 first engaging lugs 15, the claimed locking piece, ring 320, can be considered to be in a locking engagement with the claimed base, luer lock 5, with the ring 320 locked to luer 5 such that the elements cannot be disconnected from one another without reversing the rotation of ring 320 relative to luer 5; see examiner's illustration of Utterberg's col 6 line 3-49, in the response to arguments section above, which demonstrates that the locking engagement and locked connection of the claimed base, luer 5, and the claimed locking piece, ring 320, occurs when threads 326 of ring 320 first engage with lugs 15 of luer 5, and further over the course of this locking engagement the nozzle 300, and therein also its ridge 308 the claimed retaining element, are permitted to translate axially and rotate relative to luer 5 and ring 320)
However, Utterberg is silent regarding:
inserting the medical device through an incision, wherein a first portion of the medical device is on an internal side of the incision and a second portion of the medical device is on an external side of the incision,
However, Munnich teaches a method of using gastrostomy tube comprising
inserting the medical device through an incision, wherein a first portion of the medical device is on an internal side of the incision and a second portion of the medical device is on an external side of the incision,
(paragraph 3; gastrostomy feeding tubes "is inserted through a small incision in the abdomen of the patient such that the head of the gastrostomy tube is placed outside of the patient and the tube section extends into the stomach of the patient"; fig 1)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, apply the feeding tube insertion method and feeding tube use case teachings of Munnich to the assembly and surgical instrument of Davis in order to arrive at an invention which can be secured to a patient for long-term and chronic enteral feeding use, see paragraph 3-4 of Munnich.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FORREST DIPERT whose telephone number is (703)756-1704. The examiner can normally be reached M-F 8:30am-5pm eastern.
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/FORREST B DIPERT/Examiner, Art Unit 3783 /MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783