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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/19/2024 has been entered.
Claims Pending
Applicant's cancellation of claim 20, addition of claim 21, and withdrawal of claims 6-9 in the response filed 12/19/2024, and previous withdrawal of claims 10-19 is acknowledged.
Claims 1-5 and 21 are the current claims hereby under examination.
Claim Interpretation - Withdrawn
Applicant’s amendments filed 12/19/2024, have been fully considered, and the previous interpretation withdrawn.
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 1-5 and 21 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.
Claim 1 recites the limitation “an extension extending through the slot, wherein the extension is coupled to the septum such that in response to translation of the extension proximally along the slot, the septum slides from the distal position to the proximal position”, which is considered to be new matter as the applicant made no previous indication as to the extension being coupled to the septum. The specification does state “the puller element 116 may include an extension 126 extending through the slot 124…” “…In some embodiments, the stop 128 may contact the extension 126 when the septum 114 is moved from the distal position to the proximal position.” (Par. 57-58 of applicant’s spec.). However, the applicant makes no indication as to the extension itself being coupled to the septum. As such, the claim is rejected.
Claim 2 recites the limitation “wherein the extension is coupled to a blood collection set such that in response to translation of the extension proximally along the slot, the blood collection set is moved proximally”, which is considered to be new matter as the applicant made no previous indication as to the extension being coupled to a blood collection set. The specification does state “the puller element 116 may include an extension 126 extending through the slot 124…” “…In some embodiments, the stop 128 may contact the extension 126 when the septum 114 is moved from the distal position to the proximal position.” (Par. 57-58 of applicant’s spec.). However, the applicant makes no indication as to a specific manner in which the extension itself interacts or couples to the blood collection set. As such, the claim is rejected.
Claim 21 recites the limitation “wherein the extension is coupled to the septum by a press fit or an interference fit”, which is considered to be new matter as the applicant made no previous indication as to the extension being coupled to the septum by a press fit or an interference fit. The specification does state “the puller element 116 may include an extension 126 extending through the slot 124…” “…In some embodiments, the stop 128 may contact the extension 126 when the septum 114 is moved from the distal position to the proximal position.” (Par. 57-58 of applicant’s spec.). However, the applicant makes no indication as to the specific manner in which the extension itself couples to the septum. As such, the claim is rejected.
Claims 2-5 and 21 are dependent on claim 1, and as such are also rejected.
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 claims are generally directed towards a catheter assembly that comprises catheter adapter with a distal end, proximal end, a side port, and a slot. The catheter assembly further comprises a catheter extending from the distal end of the adapter and a septum configured to slide from a distal position that aligns with the side port to a proximal position in which the side port is in fluid communication with the catheter.
Claim(s) 1,3, and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shevgoor (US Pub. No. 20180256885) hereinafter Shevgoor, and further in view of Hu (US Pub. No. 20180353729) hereinafter Hu, Hyer (US Pub. No. 20130218082) hereinafter Hyer, and Bornhoft (US Pub. No. 20140074032) hereinafter Bornhoft.
Regarding claim 1, Shevgoor discloses A catheter assembly (Abstract (catheter assembly – 10)), comprising:
a catheter adapter (Fig. 5 (Catheter hub – 28)), comprising a distal end (Fig. 5 (the very tip of the side of the catheter hub -28 with side port – 36)) , a proximal end (Fig. 5, (the end of catheter hub 28 with structure 22)), a lumen extending through the distal end and the proximal end (Fig. 5 (observable space of catheter hub -28 in which septum -20 resides)), and a side port between the distal end of the catheter adapter and the proximal end of the catheter adapter (Fig. 5, side port – 36 (observable that the side port is between the indicated proximal and distal ends));
a catheter extending from the distal end of the catheter adapter (Fig. 7, catheter -18 (observable that the catheter is on the distal end)); and
a septum (septum – 20) disposed within the lumen at a distal position aligned with the side port (Fig. 6, (observable that the septum 20 is covering the side port)) , wherein in response to the septum being in the distal position, the septum provides a seal between the side port and the catheter (Fig. 6, 15, mounting surface – 26) (Par. 68, “a septum 50 having a mounting surface 26 is used to seal the side port 36”).
Shevgoor fails to explicitly disclose wherein the catheter adapter further comprises a slot disposed between the distal end of the catheter adapter and the proximal end of the catheter adapter.
However, Hu teaches wherein the catheter adapter (catheter adapter – 14) further comprises a slot (Fig. 4C, Par. 64, “groove or opening 72 in the wall 28”) disposed between the distal end of the catheter adapter and the proximal end of the catheter adapter (Par. 65, Fig. 4C, (observable that opening 72 is located between the distal end and proximal end of the unlabeled catheter adapter 14)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Shevgoor with that of Hu to include wherein the catheter adapter further comprises a slot disposed between the distal end of the catheter adapter and the proximal end of the catheter adapter through the combination of references as it would have yielded the predictable result of ensuring that the septum does not get dislodged (Hu (Par. 67)).
Modified, Shevgoor fails to explicitly disclose wherein the septum is configured to slide from the distal position to a proximal position proximal to the side port, wherein in response to the septum being in the proximal position, the side port is in fluid communication with the catheter.
However, Hyer teaches wherein the septum (septum – 10) is configured to slide from the distal position (position of the septum in Fig. 7) to a proximal position proximal to the side port (Fig. 7, 8, (observable that top of the septum has moved proximally in Fig. 8)), wherein in response to the septum being in the proximal position (Fig. 8 (position of the septum)), the side port is in fluid communication with the catheter (Fig. 7, 8 (observable that side hole 86 is exposed in Fig. 8)) (Par. 43, “multiple holes 86 are disposed along each location along the longitudinal axis 12 of the catheter assembly 18, such that as fluid is ejected from the holes 86, the lateral forces generated from the escaping fluid are counteracted”).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the apparatus of Shevgoor and Hu with that of Hyer to include wherein the septum is configured to slide from the distal position to a proximal position proximal to the side port, wherein in response to the septum being in the proximal position, the side port is in fluid communication with the catheter through the combination of references as it would have yielded the predictable result of counteracting the lateral forces of fluid and prevent unwanted movement of the catheter adapter (Hyer (Par. 43)).
Modified Shevgoor fails to explicitly disclose wherein when the septum slides from the distal position to the proximal position, an entirety of the septum slides proximally.
However, Bornhoft teaches wherein when the septum (Fig. 5-6 (distal end – 44 of septum activator 40)) slides from the distal position (Fig. 5 (the location of the distal end -44 of septum activator 40 in Fig. 5)) to the proximal position (Par. 36, “Window 24 generally comprises a length that permits movement of septum activator 40 and other components in proximal and distal directions 12 and 14, respectively.”)(Fig. 6 (the location of the distal end -44 of septum activator 40 in Fig. 6)), an entirety of the septum slides proximally (Par. 36, “Window 24 generally comprises a length that permits movement of septum activator 40 and other components in proximal and distal directions 12 and 14, respectively.”)(Fig. 6 (the location of the distal end -44 of septum activator 40 in Fig. 6))(Fig. 5-6 (observable that the entirety of the distal end -44 of septum activator 40 slides)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Shevgoor, Hu, and Hyer with that of Bornhoft to include wherein when the septum slides from the distal position to the proximal position, an entirety of the septum slides proximally through the combination of references as it would have yielded the predictable result of eliminating frictional resistance (Bornhoft (Par. 28)).
Modified Shevgoor fails to explicitly disclose an extension extending through the slot, wherein the extension is coupled to the septum such that in response to translation of the extension proximally along the slot, the septum slides from the distal position to the proximal position.
However, Bornhoft further teaches an extension (Par. 36, handle portion – 46) extending through the slot (Par. 36, window – 24) (Fig. 2 (handle portion – 46 through the window - 24)), wherein the extension is coupled to the septum (Fig. 5-6 (distal end – 44 of septum activator 40)) such that in response to translation of the extension proximally along the slot (Fig. 5-6 (observable that the handle portion has moved to the right (proximally)), the septum slides from the distal position (Fig. 5 (the location of the distal end -44 of septum activator 40 in Fig. 5)) to the proximal position (Par. 36, “Window 24 generally comprises a length that permits movement of septum activator 40 and other components in proximal and distal directions 12 and 14, respectively.”)(Fig. 6 (the location of the distal end -44 of septum activator 40 in Fig. 6)).
Shevgoor, Hu, Hyer, and Bornhoft are considered to be analogous art to the claimed invention as they are involved with catheter devices.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Shevgoor, Hu, Hyer, and Bornhoft with that of Bornhoft to include an extension extending through the slot, wherein the extension is coupled to the septum such that in response to translation of the extension proximally along the slot, the septum slides from the distal position to the proximal position through the combination of references as it would have yielded the predictable result of eliminating frictional resistance (Bornhoft (Par. 28)).
Regarding claim 3, modified Shevgoor fails to explicitly disclose the limitations of the claim.
However, Hu further teaches wherein a proximal end of the slot comprises a stop (Fig. 4C, Par. 64, “which may be sized and configured to snap into or interfere with a corresponding groove or opening 72 in the wall 28.” (the stop is the observable end of the groove furthest away from the number 70)), wherein the extension (Fig. 4C, wings – 70, groove – 72, retention disc - 62)(Par. 64) is configured to contact the stop in response to the septum sliding from the distal position to the proximal position (Par. 64, “the retention disc 62 may include one or more wings 70, which may be sized and configured to snap into or interfere with a corresponding groove or opening 72 in the wall 28. In some embodiments, the retention disc 62 may include a first wing 70a and a second wing 70b.” (the snap fit of the wings into the groove)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Shevgoor, Hu, Hyer, and Bornhoft with that of Hu to include wherein a proximal end of the slot comprises a stop, wherein the extension is configured to contact the stop in response to the septum sliding from the distal position to the proximal position through the combination of references as it would have yielded the predictable result of ensuring that the septum does not get dislodged (Hu (Par. 67)).
Regarding claims 5, Modified Shevgoor fails to explicitly disclose wherein the catheter adapter comprises an air vent, wherein an outer surface of the septum comprises an annular groove,
However, Hu further teaches wherein the catheter adapter comprises an air vent (Par. 41, “holes 26 that extend through a wall 28 of the catheter adapter 14.”) (Fig. 1C), wherein an outer surface of the septum comprises an annular groove (grooves – 24) (Par. 41-43).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Shevgoor, Hu, Hyer, and Bornhoft with that of Hu to include wherein the catheter adapter comprises an air vent, wherein an outer surface of the septum comprises an annular groove through the combination of references as it would have yielded the predictable result of providing the user with the capability to secure the septum at a particular position (Hu (Par. 45)).
Modified Shevgoor fails to explicitly disclose wherein in response to the septum being in the distal position, the side port is in fluid communication with the annular groove and the air vent.
However, Hu further teaches wherein in response to the septum of Hyer being in the distal position, the side port of Hyer is in fluid communication with the annular groove (grooves – 24) (Par. 41-43) and the air vent (Par. 41, “holes 26 that extend through a wall 28 of the catheter adapter 14.”) (Fig. 1C).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Shevgoor, Hu, Hyer, and Bornhoft with that of Hu to include wherein in response to the septum of Hyer being in the distal position, the side port of Hyer is in fluid communication with the annular groove of Hu and the air vent of Hu through substitution of the septum wall and catheter adapter inner surface -82 of Hyer at the area with the recess - 84 proximal to the hole -86 with the annular groove and air vent of Hu as it would have yielded the predictable result of ensuring that the septum is secured in a particular position (Hu (Par. 45)) and ensure that fluid does not escape from the side port.
Claim(s) 2 and 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shevgoor in view of Hu, Hyer, and Bornhoft as applied to claims 1 and 3 above, and further in view of Burkholz (US Pub. No. 20190021640) hereinafter Burkholz 2.
Shevgoor, Hu, Hyer, and Bornhoft teach the device of claim 1 above.
Regarding claim 2, modified Shevgoor fails to explicitly disclose the limitations of the claim.
However, Burkholz 2 teaches wherein the extension (Fig. 2D, adapter – 36) is coupled to a blood collection (Fig. 2D, blood collection tube – 48) set such that in response to translation of the extension proximally along the slot (Par. 58, “extend through the slot 34 and/or may be coupled to the adapter 36…” “…the proximal end of the instrument 12 may extend through the slot 34 via either the instrument hub extending through the slot 34 or another portion of the instrument 12 extending through the slot 34.”), the blood collection set is moved proximally (Fig. 60, “in FIGS. 2A-2E, which may facilitate easy movement of the instrument 12 and/or the adapter 36 with respect to the slot 34. In some embodiments, the advancement tab 46 may be aligned with the slot 34. In addition or as an alternative to the advancement tab 46, the extension 10 may include one or more other gripping surfaces. For example, the adapter 36 may include one or more gripping surfaces”)(Par. 60, “the extension may include an advancement tab 46, which may be coupled to the proximal end of the instrument 12 and/or the adapter 36. In some embodiments, the clinician may pinch or grasp the advancement tab 46 to move the instrument 12 to the proximal position and/or the distal position.”).
Shevgoor, Hu, Hyer, Bornhoft, and Burkholz 2 are considered to be analogous art to the claimed invention as they are involved with catheter devices.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Shevgoor, Hu, Hyer, and Bornhoft with that of Burkholz 2 to include wherein the extension is coupled to a blood collection set such that in response to translation of the extension proximally along the slot, the blood collection set is moved proximally through the combination of references as it would have yielded the predictable result of enabling the movement of the instrument inside of the slot (Burkholz 2 (Par. 60)) and providing a tube for blood collection (Burkholz 2 (Par. 60)).
Shevgoor, Hu, Hyer, and Bornhoft teach the device of claim 3 above.
Regarding claim 4, modified Shevgoor fails to explicitly disclose the limitations of the claim.
However, Burkholz 2 teaches wherein the extension is coupled to a push tab (Fig. 2E, advancement tab – 46) (Par. 60, “the extension may include an advancement tab 46, which may be coupled to the proximal end of the instrument 12 and/or the adapter 36. In some embodiments, the clinician may pinch or grasp the advancement tab 46 to move the instrument 12 to the proximal position and/or the distal position.”).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Shevgoor, Hu, Hyer, and Bornhoft with that of Burkholz 2 to include wherein the extension is coupled to a push tab through the substitution of the securing mechanism of Hu for the advancement tab and slot of Burkholz 2 as it would have yielded the predictable result of enabling the movement of the instrument inside of the slot (Burkholz 2 (Par. 60)).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shevgoor in view of Hu, Hyer, and Bornhoft as applied to claim 1 above, and further in view of Burkholz (US Pub. No. 20190022367) hereinafter Burkholz,
Shevgoor, Hu, Hyer, and Bornhoft teach the device of claim 1 above.
Regarding claim 21, modified Shevgoor fails to explicitly disclose wherein the extension is coupled to the septum by a press fit or an interference fit.
However, Burkholz teaches wherein the extension is coupled to the septum by a press fit or an interference fit (Par. 70, “Referring now to FIG. 5, as explained previously, in some embodiments, the introducer element 44 may be coupled with the proximal end of the catheter adapter 14 via any number of coupling mechanisms. For example, the introducer element 44 may be coupled with the proximal end of the catheter adapter via a snap-fit, threads, a press-fit, an interference-fit, etc. In some embodiments, the introducer 44 may include a connector 62, which may include the one or more coupling mechanisms, such as, for example, threads, as illustrated in FIG. 5.” (introducer element -44 and connector – 62)).
Shevgoor, Hu, Hyer, Bornhoft, and Burkholz are considered to be analogous art to the claimed invention as they are involved with catheter devices.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Shevgoor, Hu, Hyer, and Bornhoft with that of Burkholz to include wherein the extension is coupled to the septum by a press fit or an interference fit through the combination of references as differing coupling mechanisms are known in the art (Burkholz (Par. 70)) and it would have yielded the same or similar results.
Response to Arguments
Applicant's arguments filed 12/19/2024, regarding the 103 rejection, have been fully considered but they are not persuasive
The applicant’s arguments, that the prior art does not teach the indicated amendments to the claim have been fully considered and deemed as not persuasive. As the limitations were not previously presented, the limitations have been addressed in the 103 rejection as indicated above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARI SINGH KANE PADDA whose telephone number is (571)272-7228. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm.
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/ARI SINGH KANE PADDA/Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791