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 .
Status of Claims
This application is responsive to the amendment filed 7 January 2026.
Claims 1-20 are presently pending in this application.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 8-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In the instant case, claim 8 recites the limitation “wherein a first internal lobe of the three internal lobes contacts an outer surface of the nose and a second internal lobe of the three internal lobes contacts an outer surface of the strain relief element rib when the needle cover is coupled to the nose” is not a limitation that was present in any form in the application prior to the amendment filed 23 January 2026. Neither the drawings nor the specifications describe the added limitation of claim 8. Therefore, the recited limitation of claim 8 is new matter and does not allow one of ordinary skill in the art to make use of the invention as recited. For the purposes of examination, lines 8-12 of claim 8 will be examined as it was written in lines 6-8 of claim 8 in the application filed 8 February 2023.
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.
Claims 1-7 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 1 recites the limitation “the needle cover experiences a flexing beam effect when fitted over the strain relief rib”. The term implicitly requires the structure of a beam to be flexed. There is no clear indication in the drawings nor the specification that there is a beam that is part of the cover that experiences flexing. Therefore, it is unclear how the needle cover experiences a flexing beam effect.
Claims 2-7 are rejected as they depend from independent claim 1.
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.
Claims 1, 5-7, 15, 16, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz et al. (US Patent Publication No. 20170120010 A1), hereinafter Burkholz, in view of Shaw et al. (US Patent Publication No. 20140012206 A1), hereinafter Shaw.
Regarding claim 1, Burkholz discloses a catheter assembly (Burkholz: Fig. 1, catheter system 100) comprising: a catheter adapter (Fig. 1, catheter adapter 102) comprising a nose (Fig. 1, distal end 122), wherein a distal end of the nose (Fig. 1, distal end 122) comprises a strain relief element (Fig. 1, strain relief coupling 138) constructed of a flexible material (coupling 138 can be configured as a soft compliant material; para. 0041), wherein a proximal end of the strain relief element (Fig. 1, strain relief coupling 138) comprises an outer circumference (Fig. 1, strain relief connecting tab 140); a catheter (Fig. 1, catheter 115) secured within the catheter adapter (Fig. 2, catheter 115 is secured within adapter 102) and extending distally beyond the distal end of the catheter adapter (Fig. 1, catheter 115 extends beyond distal end 122 of catheter adapter 102); a needle (Fig. 2, needle 172) extending through the catheter (Fig. 2, needle 172 extends through catheter 115) and distally beyond the distal end of the catheter adapter (Fig. 2, needle 172 extends beyond distal end 116 of catheter 115); wherein the strain relief element (Fig. 1, strain relief coupling 138) surrounds the needle and the catheter (Fig. 2, coupling 138 surrounds catheter 115 and needle 172).
Burkholz does not expressly disclose a strain relief rib extending proximally from the outer circumference of the nose and having a longitudinal axis aligned with a longitudinal axis of the catheter adapter, wherein the strain relief rib is constructed of the flexible material or another flexible material; and a needle cover removably coupled to the catheter adapter, wherein an inner surface of the needle cover is in contact with the strain relief rib, wherein the needle cover experiences a flexing beam effect when fitted over the strain relief rib.
Shaw teaches a strain relief rib (Shaw: Fig. 4, tapered ribs 88) extending laterally from an outer circumference of a nose (Fig. 4, ribs 88 extend laterally from tubular shaft portion 74 of needle support 84) and having a longitudinal axis aligned with a longitudinal axis of the catheter adapter (Fig. 4 and 14, axis of ribs 88 are aligned with longitudinal axis of the syringe 104 when fully constructed), wherein the strain relief rib (Fig. 4, ribs 88) is constructed of the flexible material or another flexible material (device 30 can be constructed of a moldable polymeric material; para. 0085); and a needle cover (Fig. 2, needle cover 36) removably coupled to an adapter (Fig. 2 and 4, needle cover 36 is removable coupled to device 30), wherein an inner surface of the needle cover (Fig. 2, needle cover 36) is in contact with the strain relief rib (ribs 88 provide releasably frictional engagement with the inside of needle cover 36; para. 0075).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Burkholz such that a strain relief rib is extending proximally from the outer circumference of the nose and having a longitudinal axis aligned with a longitudinal axis of the catheter adapter, wherein the strain relief rib is constructed of the flexible material or another flexible material; and a needle cover removably coupled to the catheter adapter, wherein an inner surface of the needle cover is in contact with the strain relief rib, as taught by Shaw, in order to provide an improved releasably securing needle cover (Shaw: para. 0075).
Regarding claim 5, Burkholz in view of Shaw discloses the catheter assembly above, wherein the strain relief element (Burkholz: Fig. 1, strain relief coupling 138) is disposed on a distalmost surface of the nose (Fig. 1, coupling 138 is disposed on the distalmost surface of the distal end 122).
Regarding claim 6, Burkholz in view of Shaw discloses the catheter assembly above, wherein the catheter adapter (Burkholz: Fig. 1, adapter 102) includes a securement platform (Fig. 1, stabilization platform 118).
Regarding claim 7, Burkholz in view of Shaw discloses the catheter assembly above, wherein the securement platform (Burkholz: Fig. 1, stabilization platform 118) comprises a first wing (Fig. 1, first wing 146) and a second wing (Fig. 1, second wing 148).
Claims 2 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz, in view of Shaw, in further view of Jalgaonkar al. (US Patent Publication No. 20190269491 A1), hereinafter Jalgaonkar.
Regarding claim 2, Burkholz in view of Shaw discloses the catheter assembly above.
Burkholz in view of Shaw does not expressly disclose that the flexible material comprises an elastomer.
Jalgaonkar teaches a flexible material (Jalgaonkar: Fig. 1, outer jacket 24 is made of an elastic material; para. 0109) that comprises an elastomer (outer jacket 24 is made of a thermoplastic elastomer; para. 0109).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the flexible material of Burkholz in view of Shaw such that it comprises an elastomer as taught by Jalgaonkar in order to allow for the material to be elastic and permit expansion (Jalgaonkar: para. 0109).
Regarding claim 3, Burkholz in view of Shaw discloses the catheter assembly above.
Burkholz in view of Shaw does not expressly disclose that the flexible material comprises a thermoplastic elastomer.
Jalgaonkar teaches a flexible material (Jalgaonkar: Fig. 1, outer jacket 24 is made of an elastic material; para. 0109) that comprises a thermoplastic elastomer (outer jacket 24 is made of a thermoplastic elastomer; para. 0109).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the flexible material of Burkholz in view of Shaw such that it comprises an elastomer as taught by Jalgaonkar in order to allow for the material to be elastic and permit expansion (Jalgaonkar: para. 0109).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Burkholz, in view of Shaw, in further view of Carlyon et al. (US Patent Publication No. 20080082053 A1), hereinafter Carlyon.
Regarding claim 4, Burkholz in view of Shaw disclose the catheter assembly above.
Burkholz in view of Shaw does not expressly disclose that the nose is constructed of a rigid or semi-rigid material.
Carlyon teaches a nose (Carlyon: Fig. 3L, needle hub 40) that is constructed of a rigid or semi-rigid material (needle hub is fabricated from semi-rigid or rigid polymers; para. 0071).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the nose of Burkholz in view of Shaw to be constructed of a rigid or semi-rigid material as taught by Carlyon in order to allow the needle hub be a sufficiently resilient, moldable, and biocompatible material (Carlyon: para. 0071).
Claims 8, 9, and 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz, in view of Shaw, in further view of applicant's admitted prior art.
Regarding claim 8, Burkholz discloses a catheter assembly (Burkholz: Fig. 1, catheter system 100), comprising: a catheter adapter (Fig. 1, catheter adapter 102) comprising a body (Fig. 1, catheter hub body 120) and a nose (Fig. 1, distal end 122) extending distally from the body (Fig. 1, distal end 122 extends distally from hub body 120), wherein the nose (Fig. 1, distal end 122) is generally cylindrical (Fig. 1, distal end 122 is cylindrical), wherein a distal end of the nose (Fig. 1, distal end 122) comprises a strain relief element (Fig. 1, strain relief coupling 138) constructed of a flexible material (coupling 138 can be configured as a soft compliant material; para. 0041); a needle (Fig. 2, needle 172) secured within the catheter adapter (Fig. 2, needle 172 adapter 102) and extending distally beyond the nose (Fig. 2, needle 172 extends beyond distal end 122).
Burkholz does not expressly disclose a strain relief element extending laterally from an outer circumference of the nose and having a longitudinal axis aligned with a longitudinal axis of the catheter adapter; and a needle cover configured to be removably coupled to the nose of the catheter adapter.
Shaw teaches a strain relief element (Shaw: Fig. 4, tapered ribs 88) extending laterally from an outer circumference of the nose (Fig. 4, ribs 88 extend laterally from tubular shaft portion 74 of needle support 84) and having a longitudinal axis aligned with a longitudinal axis of the catheter adapter (Fig. 4 and 14, axis of ribs 88 are aligned with longitudinal axis of the syringe 104 when fully constructed); and a needle cover (Shaw: Fig. 2, needle cover 36) configured to be removably coupled to a nose of a catheter adapter (Fig. 2 and 4, needle cover 36 is removable; para. 0075).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the assembly of Burkholz such that a strain relief element extending laterally from an outer circumference of the nose and having a longitudinal axis aligned with a longitudinal axis of the catheter adapter; and a needle cover configured to be removably coupled to the nose of the catheter adapter as taught by Shaw in order to provide a releasably securing needle cover (Shaw: para. 0075).
Burkholz in view of Shaw does not expressly disclose an inner surface of the needle cover comprises three internal lobes contacting the strain relief element.
Applicant admitted prior art teaches an inner surface (Applicant admitted prior art: Fig. 1A, inner surface 14) of a needle cover (Fig. 1A, needle cover 10) comprising three internal lobes (Fig. 1A, internal lobes 12) contacting the strain relief element (needle cover 10 is meant to be coupled onto catheter adapter 16, press fitted onto its outer surface. Examiner interprets the needle cover 10 would contact the strain relief element of Burkholz in view of Shaw if combined).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the needle cover of Burkholz in view of Shaw such that an inner surface of a needle cover comprising three internal lobes contacting the strain relief element as taught by the applicant admitted prior art in order to allow for a press fit of the needle cover onto a catheter adapter (Applicant admitted prior art: para. 0028).
Regarding claim 9, Burkholz in view of Shaw and applicant admitted prior art discloses the catheter assembly above.
Burkholz in view of Shaw and applicant admitted prior art does not expressly disclose the three internal lobes are evenly spaced around the inner surface of the needle cover.
The applicant admitted prior art teaches three internal lobes (Applicant admitted prior art: Fig. 1A, internal lobes 12) are evenly spaced around the inner surface (Fig. 1A, internal lobes 12 are evenly spaces around inner surface 14) of the needle cover (Fig. 1A, needle cover 10).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the needle cover of Burkholz and Shaw such that the three internal lobes are evenly spaced around the inner surface of the needle cover as taught by the applicant admitted prior art in order to allow for a press fit of the needle cover onto a catheter adapter (Applicant admitted prior art: para. 0028).
Regarding claim 12, Burkholz in view of Shaw and applicant admitted prior art discloses the catheter assembly above, wherein the strain relief element (Fig. 1, strain relief coupling 138) surrounds the needle (Fig. 2, coupling 138 surrounds catheter 115 and needle 172).
Regarding claim 13, Burkholz in view of Shaw and applicant admitted prior art discloses the catheter assembly above.
Burkholz does not expressly disclose a needle cover that is removably coupled to the distal end of the catheter adapter via a friction fit.
Shaw teaches a needle cover (Shaw: Fig. 2, needle cover 36) that is removably coupled to the distal end of the catheter adapter (Fig. 2 and 4, needle cover 36 is removable coupled to device 30) via a friction fit (ribs 88 provide releasably frictional engagement with the inside of needle cover 36; para. 0075).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the catheter assembly of Burkholz such that it comprises a needle cover that is removably coupled to the distal end of the catheter adapter via a friction fit as taught by Shaw in order to provide a releasably securing needle cover (Shaw: para. 0075).
Regarding claim 14, Burkholz in view of Shaw and applicant admitted prior art discloses the catheter assembly above.
Burkholz does not expressly disclose a needle cover is generally cylindrical having an open proximal end.
Shaw teaches a needle cover (Shaw: Fig. 2, needle cover 36) that is generally cylindrical (Fig. 2, needle cover 36 is generally cylindrical) having an open proximal end (Fig. 5, open end 96).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the catheter assembly of Burkholz such that a needle cover is generally cylindrical having an open proximal end as taught by Shaw in order to provide a releasably securing needle cover (Shaw: para. 0075).
Claims 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz, in view of Shaw and applicant admitted prior art, in further view of Jalgaonkar.
Regarding claim 10, Burkholz in view of Shaw and applicant admitted prior art discloses the catheter assembly above.
Burkholz in view of Shaw and applicant admitted prior art does not expressly disclose that the flexible material comprises an elastomer.
Jalgaonkar teaches a flexible material (Jalgaonkar: Fig. 1, outer jacket 24 is made of an elastic material; para. 0109) that comprises an elastomer (outer jacket 24 is made of a thermoplastic elastomer; para. 0109).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the flexible material of Burkholz in view of Shaw and applicant admitted prior art such that it comprises an elastomer as taught by Jalgaonkar in order to allow for the material to be elastic and permit expansion (Jalgaonkar: para. 0109).
Regarding claim 11, Burkholz in view of Shaw and applicant admitted prior art discloses the catheter assembly above.
Burkholz in view of Shaw and applicant admitted prior art does not expressly disclose that the flexible material comprises a thermoplastic elastomer.
Jalgaonkar teaches a flexible material (Jalgaonkar: Fig. 1, outer jacket 24 is made of an elastic material; para. 0109) that comprises a thermoplastic elastomer (outer jacket 24 is made of a thermoplastic elastomer; para. 0109).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the flexible material of Burkholz in view of Shaw and applicant admitted prior art such that it comprises an elastomer as taught by Jalgaonkar in order to allow for the material to be elastic and permit expansion (Jalgaonkar: para. 0109).
Claims 15, 16, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz, in view of Shaw, in further view of Kennedy et al. (US Patent Publication No. 20070208221 A1), hereinafter Kennedy.
Regarding claim 15, Burkholz discloses a catheter assembly (Burkholz: Fig. 1, catheter system 100) comprising: catheter adapter (Fig. 1, catheter adapter 102) comprising a body (Fig. 1, catheter hub body 120) and a nose (Fig. 1, distal end 122) extending distally from the body (Fig. 1, distal end 122 extends distally from body 120), wherein the nose (Fig. 1, distal end 122) is generally cylindrical (Fig. 1, distal end 122 is cylindrical); a needle (Fig. 2, needle 172) secured within the catheter adapter (Fig. 2, needle 172 is inside catheter adapter 102) and extending distally beyond the nose (Fig. 2, needle 172 extends distally beyond distal end 122), wherein the needle (Fig. 2, needle 172) comprises a bevel (Fig. 3A, beveled opening 178) pointing upward opposite the bottom (Fig. 3A, beveled opening 178 points upward).
Burkholz does not expressly disclose a strain relief rib disposed on a bottom of the nose, wherein the strain relief rib is constructed of a flexible material; and a needle cover configured to be removably coupled to the nose of the catheter adapter, wherein an inner surface of the needle cover is smooth and is configured to contact the strain relief rib, wherein an inner surface of the needle cover is configured to contact an outer surface of the nose and the outer surface of the strain relief element.
Shaw teaches a strain relief rib (Shaw: Fig. 4, tapered ribs 88) disposed on a bottom of the nose (Fig. 7, ribs 88 are disposed all around needle support 84, including on the bottom circumferentially), wherein the strain relief rib (Fig. 4, tapered ribs 88) is constructed of a flexible material (device 30 can be constructed of a moldable polymeric material; para. 0085); and a needle cover (Fig. 2, needle cover 36) configured to be removably coupled to the nose of the catheter adapter (Fig. 2 and 4, needle cover 36 is removable coupled to device 30), wherein an inner surface of the needle cover (Fig. 2, needle cover 36) is smooth (Fig. 11, inner surface of needle cover 36 is shown without bumps) and is configured to contact the strain relief rib (ribs 88 provide releasably frictional engagement with the inside of needle cover 36; para. 0075).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the catheter assembly of Burkholz such that a strain relief rib disposed on a bottom of the nose, wherein the strain relief rib is constructed of a flexible material; and a needle cover configured to be removably coupled to the nose of the catheter adapter, wherein an inner surface of the needle cover is smooth and is configured to contact the strain relief rib as taught by Shaw in order to provide a releasably securing needle cover (Shaw: para. 0075).
Burkholz in view of Shaw does not expressly disclose an inner surface of the needle cover is configured to contact an outer surface of the nose and an outer surface of the strain relief rib.
Kennedy teaches an inner surface of a cover (Kennedy: Fig. 12, sheath 414) is configured to contact an outer surface of a nose (Fig. 12, sheath 414 is shown to be in contact with catheter 412) and an outer surface of the strain relief rib (Fig. 12, ribs 412).
It would have been an obvious matter of design choice to make nose and strain relief of whatever form or shape was desired or expedient and, therefore, any shape that would allow for different contact with the needle cover as taught by Kennedy. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47. Furthermore, applicant has not disclosed that this limitation solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Absent a teaching as to criticality that an inner surface of the needle cover is configured to contact an outer surface of the nose and an outer surface of the strain relief rib, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement.
Regarding claim 16, Burkholz in view of Shaw and Kennedy discloses the catheter assembly above, wherein a distal end of the nose (Fig. 1, distal end 122) comprises a strain relief element (Fig. 1, strain relief coupling 138) constructed of the flexible material (coupling 138 can be configured as a soft compliant material; para. 0041), wherein a proximal end of the strain relief element (Fig. 1, strain relief coupling 138) comprises an outer circumference (Fig. 1, strain relief connecting tab 140).
Burkholz in view of Kennedy does not expressly disclose a strain relief rib that extends proximally from the outer circumference of the strain relief element and has a longitudinal axis aligned with a longitudinal axis of the catheter adapter.
Shaw teaches a strain relief rib (Shaw: Fig. 4, tapered ribs 88) extending proximally from an outer circumference of a strain relief element (Fig. 4, ribs 88 extend proximally from tubular shaft portion 74 of needle support 84) and having a longitudinal axis aligned with a longitudinal axis of the catheter adapter (Fig. 4 and 14, axis of ribs 88 are aligned with longitudinal axis of the syringe 104 when fully constructed).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the catheter assembly of Burkholz in view of Kennedy such that a strain relief rib extends proximally from the outer circumference of the strain relief element and has a longitudinal axis aligned with a longitudinal axis of the catheter adapter as taught by Shaw in order to provide a releasably securing needle cover (Shaw: para. 0075).
Regarding claim 19, Burkholz in view of Shaw and Kennedy discloses the catheter assembly above,
Burkholz in view of Kennedy does not expressly disclose the strain relief rib is generally aligned with a longitudinal axis of the catheter adapter.
Shaw teaches a strain relief rib (Shaw: Fig. 4, tapered ribs 88) is generally aligned with a longitudinal axis of the catheter adapter (Fig. 4 and 14, axis of ribs 88 are aligned with longitudinal axis of the syringe 104 when fully constructed).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the catheter assembly of Burkholz in view of Kennedy such that the strain relief rib is generally aligned with a longitudinal axis of the catheter adapter as taught by Shaw in order to provide a releasably securing needle cover (Shaw: para. 0075).
Regarding claim 20, Burkholz in view of Shaw and Kennedy discloses the catheter assembly above,
Burkholz in view of Kennedy does not expressly disclose a stop configured to prevent proximal movement of the needle cover beyond the stop, wherein the stop is disposed proximate and proximal to the nose, wherein the strain relief rib extends to the stop.
Shaw teaches a stop (Shaw: Fig. 4, base 82) configured to prevent proximal movement of the needle cover (Fig. 2, needle cover 36) beyond the stop (Fig. 4 and 11, base 82 prevents further movement of the needle cover 36 proximally), wherein the stop (Fig. 4, base 82) is disposed proximate and proximal to the nose (Fig. 4, base 82 is proximal of needle support 84), wherein the strain relief rib (Fig. 4, ribs 88) extends to the stop (Fig. 4, ribs 88 terminate at base 82).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the catheter assembly of Burkholz in view of Kennedy such that it comprises a stop configured to prevent proximal movement of the needle cover beyond the stop, wherein the stop is disposed proximate and proximal to the nose, wherein the strain relief rib extends to the stop as taught by Shaw in order to provide a releasably securing needle cover (Shaw: para. 0075).
Claims 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz, in view of Shaw and Kennedy, in further view of Jalgoankar.
Regarding claim 17, Burkholz in view of Shaw and Kennedy discloses the catheter assembly above.
Burkholz in view of Shaw and Kennedy does not expressly disclose that the flexible material comprises an elastomer.
Jalgaonkar teaches a flexible material (Jalgaonkar: Fig. 1, outer jacket 24 is made of an elastic material; para. 0109) that comprises an elastomer (outer jacket 24 is made of a thermoplastic elastomer; para. 0109).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the flexible material of Burkholz in view of Shaw and Kennedy such that it comprises an elastomer as taught by Jalgaonkar in order to allow for the material to be elastic and permit expansion (Jalgaonkar: para. 0109).
Regarding claim 18, Burkholz in view of Shaw, and Kennedy discloses the catheter assembly above.
Burkholz in view of Shaw and Kennedy does not expressly disclose that the flexible material comprises a thermoplastic elastomer.
Jalgaonkar teaches a flexible material (Jalgaonkar: Fig. 1, outer jacket 24 is made of an elastic material; para. 0109) that comprises a thermoplastic elastomer (outer jacket 24 is made of a thermoplastic elastomer; para. 0109).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the flexible material of Burkholz in view of Shaw and Kennedy such that it comprises an elastomer as taught by Jalgaonkar in order to allow for the material to be elastic and permit expansion (Jalgaonkar: para. 0109).
Response to Arguments
Applicant’s arguments, see page 1, filed 23 January 2026, with respect to objection to the drawings have been fully considered and are persuasive. The objection of the drawings has been withdrawn.
Applicant’s arguments, see page 1 and 2, filed 23 January 2026, with respect to the rejections of claims 15-20 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of Burkholz in view of Shaw, in further view of Kennedy.
Applicant’s arguments, see page 1 and 2, filed 23 January 2026, with respect to the rejections of claims 1-14 under 35 USC 103 have been fully considered but they are not persuasive.
Applicant argues that none of the cited references appear to teach or suggest the elements of the amended claims 1 and 8.
Claim 1 recites the “flexing beam effect”, which is rejected under 35 USC 112(b), as noted above. A prior art rejection has also been applied.
Claim 8 is rejected under 35 USC 112(a) as incorporating new matter limitations. Additionally, the art rejection has also been applied.
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.
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/LEI GONZALEZ/Examiner, Art Unit 3783
/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783
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