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 in response to the Applicant’s amendment filed 1 May 2026 wherein Claims 1, 5 – 7, 9, 12, and 13 are amended, Claim 16 is cancelled, and no claims are newly added. Therefore, Claims 1 – 15 and 17 – 19 are currently pending.
The Applicant’s amendments to the Drawings, Abstract, and Specification dated 1 May 2026 have been fully considered. These amendments have overcome each Drawing and Specification Objection set forth in the Non-Final Rejection dated 9 February 2026 (hereinafter referred to as the “Non-Final Rejection”). Therefore, each Drawing and Specification Objection set forth in the Non-Final Rejection are withdrawn.
The Applicant’s amendments to the Claims dated 1 May 2026 have been fully considered. These amendments have overcome each Claim Objection and Claim Rejection under 35 U.S.C. § 112(b) set forth within the Non-Final Rejection. Therefore, each Claim Objection and Claim Rejection under 35 U.S.C. § 112(b) set forth in the Non-Final Rejection are withdrawn.
Response to Arguments
Applicant’s arguments, see pages 9 – 15, filed 1 May 2026, with respect to the 35 U.S.C. § 103 rejection of independent Claim 1 and its dependent claims have been fully considered and are persuasive. The 35 U.S.C. § 103 rejection of claim 1 and its dependent claims has been withdrawn.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.
Claim(s) 17 – 19 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.
Claims 17 – 19 recite the following:
Claim 17:
The catheter insertion apparatus of claim 1, wherein the proximal connector of the catheter comprises a female luer taper and a proximal portion of the housing comprises male luer threads, wherein the female luer taper and the male luer threads are joined to form a complete luer fitting when the catheter is fully advanced through the housing.
Claim 18:
The catheter insertion apparatus of claim 1, further comprising a valve in the proximal connector configured to open in response to engagement with an external connector when the external connector is attached to the proximal connector.
Claim 19:
The catheter insertion apparatus of claim 18, wherein the valve in the proximal connector comprises a split valve that opens when advanced distally against a male fitting in an axial passage in the proximal connector.
Claim(s) 17 – 19 are rejected under 35 U.S.C. § 112(a) as failing to comply with the written description requirement. The claims contain 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 at the time the application was filed, had possession of the claimed invention. The subject matter of Claims 17 – 19 are shown in Figs. 22A – 22C. The Applicant’s amendment to the Claims dated 1 May 2026 has narrowed Claim 1 to the embodiment shown in Figures 23 – 24B. The subject matter recited in Claims 17 – 19 fails the written description requirement because the Applicant has not described in such a way as to reasonably convey to one skilled in the relevant art about how the subject matter of Claims 17 – 19 is incorporated into the embodiment shown in Figures 23 – 24B.
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 6 – 9 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 6 recites:
The catheter insertion apparatus of claim, wherein the releasable latch comprises at least one spring-loaded latch disposed in a proximal hub of the needle, wherein the at least one spring-loaded latch is configured to engage a locking feature on an inside surface of the longitudinal passage in the housing to hold the needle in place, and wherein the catheter comprises at least one latch release feature which engages and releases the at least one spring-loaded latch as the catheter is advanced.
Claim 6 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention because Claim 6 has been amended to remove its dependency upon any other claim. It is unclear if Claim 6 is intended to an independent claim or if it was an inadvertent deletion of the claim upon which Claim 6 depends. Claim 6 is rejected as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention because the dependency of Claim 6 is unknown.
Claims 7 – 9 are rejected under 35 U.S.C. § 112(b) as well because of their dependency on Claim 6.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 6 – 9 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 6 recites:
The catheter insertion apparatus of claim, wherein the releasable latch comprises at least one spring-loaded latch disposed in a proximal hub of the needle, wherein the at least one spring-loaded latch is configured to engage a locking feature on an inside surface of the longitudinal passage in the housing to hold the needle in place, and wherein the catheter comprises at least one latch release feature which engages and releases the at least one spring-loaded latch as the catheter is advanced.
Claim 6 is rejected under 35 U.S.C. § 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends or for failing to include all the limitations of the claim upon which it depends. Here, Claim 6 has been amended to remove its dependency upon any other claim. It is unclear if this was an intentional amendment or an inadvertent typographical error. The claim language of “The catheter insertion apparatus of claim,” suggests the later. Nonetheless Claim 6 is rejected as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends and for failing to include all the limitations of the claim upon which it depends because the dependency of Claim 6 cannot be determined.
Claims 7 – 9 are rejected under 35 U.S.C. § 112(d) as well because of their dependency on Claim 6.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim(s) 1 – 7, 10 – 15, and 17 – 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 13 of U.S. Patent No. 11,197,980 B2 (hereinafter referred to as “USPAT ‘980”) in view of Harper (US 7,070,579 B1).
With regards to claim 1, Claim 1 of USPAT ‘980 recites an integrated catheter insertion apparatus, comprising:
a housing having a longitudinal passage;
a needle slidably mounted within the longitudinal passage of the housing and having an axial lumen extending from a proximal end of the needle to a tissue-penetrating distal tip of the needle, wherein the needle extends distally from a distal end of the housing in an initial configuration of the catheter insertion apparatus, wherein the needle is configured to be fully retractable within the longitudinal passage of the housing in a subsequent needle configuration; and
a catheter slidably mounted within the axial lumen and having a distal port and a proximal connector, wherein the catheter is proximally retracted within the needle in the initial configuration, wherein the catheter is configured to be distally advanceable from the needle to position the distal port of the catheter distally beyond the distal tip of the needle in the subsequent needle configuration (see Col. 17, line 43 – Col. 18, line 3 of USPAT ‘980).
However Claim 1 of USPAT ‘980 is silent with regards to wherein the proximal connector of the catheter comprises a side port oriented and connected at an angle relative to an axis of the catheter, wherein the proximal connector and the side port are integrated with the catheter, and wherein the proximal connector and the side port are configured to be pushed distally to distally advance to a proximal end of the housing to extend the distal port of the catheter distally from the distal tip of the needle.
Nonetheless Harper, which is within the analogous art of devices used to connect an external ventricular drainage catheter (see abstract and title), teaches (Figs. 4 – 9) the proximal connector (20) (see Col. 2, lines 60 – 67) of the catheter (2) (see Col. 2, lines 47 – 59) comprises a side port (40) (see Col. 3, lines 4 – 13) oriented and connected at an angle relative to an axis of the catheter (see Fig. 6 and Col. 3, lines 20 – 26), wherein the proximal connector and the side port are integrated with the catheter (see Col. 3, lines 53 – 62).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the catheter insertion apparatus of Claim 1 of USPAT ‘980 in view of a teaching of Harper such that the proximal connector of the catheter comprises a side port oriented and connected at an angle relative to an axis of the catheter, wherein the proximal connector and the side port are integrated with the catheter. One of ordinary skill in the art would have been motivated to make this modification because Harper teaches that adjusting the angle of the proximal connector makes it easier for a physician to connect a tubing connector to the proximal connector (see Col. 3, line 27 – 37 of Harper).
The integrated catheter insertion apparatus of Claim 1 of USPAT ‘980 modified in view of a teaching of Harper will hereinafter be referred to as the catheter insertion apparatus of USPAT ‘980 and Harper.
The catheter insertion apparatus of USPAT ‘980 and Harper teaches wherein the proximal connector and the side port are configured to be pushed distally to distally advance to a proximal end of the housing to extend the distal port of the catheter distally from the distal tip of the needle (see Col. 17, line 58 – Col. 18, line 2 of USPAT ‘980).
With regards to claim 2, the catheter insertion apparatus of USPAT ‘980 and Harper teaches the claimed invention of Claim 1, and Claim 10 of USPAT ‘980 wherein the proximal connector comprises a luer fitting (see Col. 18, lines 42 – 44 of USPAT ‘980)..
With regards to claim 3, the catheter insertion apparatus of USPAT ‘980 and Harper teaches the claimed invention of Claim 1, however USPAT ‘980 is silent with regards to wherein the angle is in a range from 30º to 60º.
Nonetheless Harper, which is within the analogous art of devices used to connect an external ventricular drainage catheter (see abstract and title), teaches (Figs. 4 – 9) wherein the angle is in a range from 30º to 60º (see Col. 3, lines 20 – 26 “the preferred angle between central axis 42 and axis 26 is about 30º”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the angle of the catheter insertion apparatus of USPAT ‘980 and Harper in view of a further teaching of Harper such that the angle is in a range from 30º to 60º. One of ordinary skill in the art would have been motivated to make this modification because Harper teaches that adjusting the angle of the proximal connector makes it easier for a physician to connect a tubing connector to the proximal connector (see Col. 3, line 27 – 37 of Harper).
With regards to claim 4, the catheter insertion apparatus of USPAT ‘980 and Harper teaches the claimed invention of Claim 1, and Claim 1 of USPAT ‘980 further recites wherein the needle is held in place by a releasable latch (see Col. 17, lines 48 – 51 of USPAT ‘980).
With regards to claim 5, the catheter insertion apparatus of USPAT ‘980 and Harper teaches the claimed invention of Claim 4, and Claim 1 of USPAT ‘980 further recites wherein the catheter is configured to release the releasable latch to allow the needle to retract when the catheter is fully advanced within the axial lumen (see Col. 17, lines 56 – 58 of USPAT ‘980).
With regards to claim 6, the catheter insertion apparatus of USPAT ‘980 and Harper teaches the claimed invention of claim 4 (see the 35 U.S.C. § 112(b) and (d) above wherein Claim 6 is interpreted to be dependent upon Claim 4), and Claim 2 of USPAT ‘980 further recites wherein the releasable latch comprises at least one spring-loaded latch disposed in a proximal hub of the needle, wherein the at least one spring-loaded latch is configured to engage a locking feature on an inside surface of the longitudinal passage in the housing to hold the needle in place, and wherein the catheter comprises at least one latch release feature which engages and releases the at least one spring-loaded latch as the catheter is advanced (see Col. 18, lines 4 – 11 of USPAT ‘980).
With regards to claim 7, the catheter insertion apparatus of USPAT ‘980 and Harper teaches the claimed invention of claim 6, and Claim 3 of USPAT ‘980 further recites wherein the at least one spring-loaded latch comprises a cantilevered hook on the proximal hub and the locking feature comprises an undercut on the inside surface of the longitudinal passage in the housing (see Col. 18, lines 12 – 16 of USPAT ‘980).
With regards to claim 10, the catheter insertion apparatus of USPAT ‘980 and Harper teaches the claimed invention of claim 1, and Claim 4 of USPAT ‘980 further recites further comprising a spring assembly within the longitudinal passage of the housing configured to retract the needle after the catheter has been distally advanced from the needle (see Col. 18, lines 17 – 20 of USPAT ‘980).
With regards to claim 11, the catheter insertion apparatus of USPAT ‘980 and Harper teaches the claimed invention of claim 10, and Claim 5 of USPAT ‘980 further recites wherein the spring assembly is configured to automatically retract the needle after the catheter has been distally advanced from the needle (see Col. 18, lines 21 – 24 of USPAT ‘980).
With regards to claim 12, the catheter insertion apparatus of USPAT ‘980 and Harper teaches the claimed invention of claim 11, and Claim 6 of USPAT ‘980 further recites wherein the spring assembly comprises a coil disposed coaxially over the needle and a locking mechanism that holds the needle in its distally advanced position with the spring assembly in an axially compressed configuration, wherein release of the locking mechanism allows the spring assembly to axially expand to cause the needle to retract (see Col. 18, lines 25 – 32 of USPAT ‘980).
With regards to claim 13, the catheter insertion apparatus of USPAT ‘980 and Harper teaches the claimed invention of claim 12, and Claim 7 of USPAT ‘980 further recites wherein the locking mechanism is configured to automatically release the spring assembly when the catheter is fully advanced (see Col. 18, lines 33 – 35 of USPAT ‘980).
With regards to claim 14, the catheter insertion apparatus of USPAT ‘980 and Harper teaches the claimed invention of claim 1, and Claim 8 of USPAT ‘980 further recites wherein the catheter locks to the housing after the catheter has been fully advanced (see Col. 18, lines 36 – 38 of USPAT ‘980).
With regards to claim 15, the catheter insertion apparatus of USPAT ‘980 and Harper teaches the claimed invention of claim 1, and Claim 9 of USPAT ‘980 further recites wherein the housing is configured to be taped to a patient after the needle has been retracted (see Col. 18, lines 39 – 41 of USPAT ‘980).
With regards to claim 17, the catheter insertion apparatus of USPAT ‘980 and Harper teaches the claimed invention of claim 1, and Claim 11 of USPAT ‘980 further recites wherein the proximal connector of the catheter comprises a female luer taper and a proximal portion of the housing comprises male luer threads, wherein the female luer taper and the male luer threads are joined to form a complete luer fitting when the catheter is fully advanced through the housing (see Col. 18, lines 45 – 50 of USPAT ‘980).
With regards to claim 18, the catheter insertion apparatus of USPAT ‘980 and Harper teaches the claimed invention of claim 1, and Claim 12 of USPAT ‘980 further recites further comprising a valve in the proximal connector configured to open in response to engagement with an external connector when the external connector is attached to the proximal connector (see Col. 18, lines 51 – 55 of USPAT ‘980).
With regards to claim 19, the catheter insertion apparatus of USPAT ‘980 and Harper teaches the claimed invention of claim 18, and Claim 13 of USPAT ‘980 further recites wherein the valve in the proximal connector comprises a split valve that opens when advanced distally against a male fitting in an axial passage in the proximal connector (see Col. 18, lines 56 – 59 of USPAT ‘980).
Claim(s) 8 and 9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 3 of USPAT ‘980 and Harper in further view of Cameron et al. (US 4,994,040 A) (hereinafter referred to as “Cameron”).
With regards to claim 8, the catheter insertion apparatus of USPAT ‘980 and Harper teaches the claimed invention of claim 7, however, USPAT ‘980 is silent with regards to further comprising a slider coupled to the proximal end of the needle, wherein the slider is mounted on an outer surface of the housing so that a user may manually retract the needle in a proximal direction after the catheter has been advanced through the needle in a distal direction.
Nonetheless Cameron, which is within the analogous art of through the needle catheter insertion devices and techniques (see abstract and title), teaches the catheter insertion apparatus further comprising a slider (172; see Col. 7, lines 10 – 24 “As the needle assembly is moved rearward by sliding the grip 172”) coupled to the proximal end of the needle (160; see Col. 6, lines 10 – 12 and see Figs 8 – 12b and the movement of the slider 172 causing the needle 160 to be retracted), wherein the slider is mounted on an outer surface of the housing (110, 110’, 112; see Col. 5, lines 65 – 68 and see Figs. 8 – 12b) so that a user may manually retract the needle in a proximal direction after the catheter (140; see Col. 6, lines 45 – 50) has been advanced through the needle in a distal direction (see Figs. 8 – 12b, Abstract, Col. 5, line 65 – Col. 6, line 24, and Col. 7, lines 25 – 40).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the catheter insertion apparatus of USPAT ‘980 and Harper in view of a teaching of Cameron such that a slider coupled to the proximal end of the needle, wherein the slider is mounted on an outer surface of the housing so that a user may manually retract the needle in a proximal direction after the catheter has been advanced through the needle in a distal direction. One of ordinary skill in the art would have been motivated to make this modification because Cameron teaches this structure prevents any inadvertent forward motion of the needle relative to the catheter which could perforate or shear the catheter (see Col. 7, lines 10 – 24 of Cameron).
The catheter insertion apparatus of USPAT ‘980 and Harper modified in view of a teaching of Cameron will hereinafter be referred to as the catheter insertion apparatus of USPAT ‘980, Harper, and Cameron.
With regards to claim 9, the catheter insertion apparatus of USPAT ‘980, Harper, and Cameron teaches the claimed invention of claim 8, however USPAT ‘980 is silent with regards to wherein the slider is configured to be retracted in an axial slot in the housing.
Nonetheless Cameron, which is within the analogous art of through the needle catheter insertion devices and techniques (see abstract and title), further teaches wherein the slider (172; see Col. 7, lines 10 – 24 and Col. 5, line 65 – Col. 6, line 24) is configured to be retracted in in an axial slot (see at 186 in Fig. 11a) in the housing (110, 110’, 112; see Col. 5, lines 65 – 68 and see Figs. 8 – 12b).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the catheter insertion apparatus of USPAT ‘980, Harper, and Cameron in view of a further teaching of Cameron such that the slider is configured to be retracted in an axial slot in the housing. One of ordinary skill in the art would have been motivated to make this modification because Cameron teaches this structure prevents any inadvertent forward motion of the needle relative to the catheter which could perforate or shear the catheter (see Col. 7, lines 10 – 24 of Cameron).
Claim(s) 1 – 7, 10 – 15, and 17 – 19 rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1 – 8 and 10 – 13 of U.S. Patent No. 12,496,434 (hereinafter referred to as “USPAT ‘434”) in view of Harper.
With regards to claim 1, Claim 1 of USPAT ‘434 recites an integrated catheter insertion apparatus, comprising:
a housing having a longitudinal passage;
a needle slidably mounted within the longitudinal passage of the housing and having an axial lumen extending from a proximal end of the needle to a tissue-penetrating distal tip of the needle, wherein the needle extends distally from a distal end of the housing in an initial configuration of the catheter insertion apparatus, wherein the needle is configured to be fully retractable within the longitudinal passage of the housing in a subsequent needle configuration; and
a catheter slidably mounted within the axial lumen and having a distal port and a proximal connector, wherein the catheter is proximally retracted within the needle in the initial configuration, wherein the catheter is configured to be distally advanceable from the needle to position the distal port of the catheter distally beyond the distal tip of the needle in the subsequent needle configuration (see Col.17, line 47 – Col. 18, line 9 of USPAT ‘434).
However Claim 1 of USPAT ‘434 is silent with regards to wherein the proximal connector of the catheter comprises a side port oriented and connected at an angle relative to an axis of the catheter, wherein the proximal connector and the side port are integrated with the catheter, and wherein the proximal connector and the side port are configured to be pushed distally to distally advance to a proximal end of the housing to extend the distal port of the catheter distally from the distal tip of the needle.
Nonetheless Harper, which is within the analogous art of devices used to connect an external ventricular drainage catheter (see abstract and title), teaches (Figs. 4 – 9) the proximal connector (20) (see Col. 2, lines 60 – 67) of the catheter (2) (see Col. 2, lines 47 – 59) comprises a side port (40) (see Col. 3, lines 4 – 13) oriented and connected at an angle relative to an axis of the catheter (see Fig. 6 and Col. 3, lines 20 – 26), wherein the proximal connector and the side port are integrated with the catheter (see Col. 3, lines 53 – 62).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the catheter insertion apparatus of Claim 1 of USPAT ‘434 in view of a teaching of Harper such that the proximal connector of the catheter comprises a side port oriented and connected at an angle relative to an axis of the catheter, wherein the proximal connector and the side port are integrated with the catheter. One of ordinary skill in the art would have been motivated to make this modification because Harper teaches that adjusting the angle of the proximal connector makes it easier for a physician to connect a tubing connector to the proximal connector (see Col. 3, line 27 – 37 of Harper).
The integrated catheter insertion apparatus of Claim 1 of USPAT ‘434 modified in view of a teaching of Harper will hereinafter be referred to as the catheter insertion apparatus of USPAT ‘434 and Harper.
The catheter insertion apparatus of USPAT ‘434 and Harper teaches wherein the proximal connector and the side port are configured to be pushed distally to distally advance to a proximal end of the housing to extend the distal port of the catheter distally from the distal tip of the needle (see Col. 17, line 58 – Col. 18, line 2 of USPAT ‘980).
With regards to claim 2, the catheter insertion apparatus of USPAT ‘434 and Harper teaches the claimed invention of claim 1, and Claim 1 of USPAT ‘434 further recites wherein the proximal connector comprises a luer fitting (see Col. 18, lines 4 – 5 of USPAT ‘434).
With regards to claim 3, the catheter insertion apparatus of USPAT ‘434 and Harper teaches the claimed invention of Claim 1, however USPAT ‘434 is silent with regards to wherein the angle is in a range from 30º to 60º.
Nonetheless Harper, which is within the analogous art of devices used to connect an external ventricular drainage catheter (see abstract and title), teaches (Figs. 4 – 9) wherein the angle is in a range from 30º to 60º (see Col. 3, lines 20 – 26 “the preferred angle between central axis 42 and axis 26 is about 30º”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the angle of the catheter insertion apparatus of USPAT ‘434 and Harper in view of a further teaching of Harper such that the angle is in a range from 30º to 60º. One of ordinary skill in the art would have been motivated to make this modification because Harper teaches that adjusting the angle of the proximal connector makes it easier for a physician to connect a tubing connector to the proximal connector (see Col. 3, line 27 – 37 of Harper).
With regards to claim 4, the catheter insertion apparatus of USPAT ‘434 and Harper teaches the claimed invention of Claim 1, and Claim 2 of USPAT ‘434 further recites wherein the needle is held in place by a releasable latch (see Col. 18, lines 10 – 13 of USPAT ‘434).
With regards to claim 5, the catheter insertion apparatus of USPAT ‘434 and Harper teaches the claimed invention of Claim 4, and Claim 2 of USPAT ‘434 further recites wherein the catheter is configured to release the releasable latch to allow the needle to retract when the catheter is fully advanced within the axial lumen (see Col. 18, lines 10 – 13 of USPAT ‘434).
With regards to claim 6, the catheter insertion apparatus of USPAT ‘434 and Harper teaches the claimed invention of Claim 4 (see the 35 U.S.C. § 112(b) and (d) above wherein Claim 6 is interpreted to be dependent upon Claim 4), and Claim 6 of USPAT ‘434 further recites wherein the releasable latch comprises at least one spring-loaded latch disposed in a proximal hub of the needle, wherein the at least one spring-loaded latch is configured to engage a locking feature on an inside surface of the longitudinal passage in the housing to hold the needle in place, and wherein the catheter comprises at least one latch release feature which engages and releases the at least one spring-loaded latch as the catheter is advanced (see Col. 18, lines 28 – 34 of USPAT ‘434).
With regards to claim 7, the catheter insertion apparatus of USPAT ‘434 and Harper teaches the claimed invention of Claim 6, and Claim 7 of USPAT ‘434 further recites wherein the at least one spring-loaded latch comprises a cantilevered hook on the proximal hub and the locking feature comprises an undercut on the inside surface of the longitudinal passage in the housing (see Col. 18, lines 35 – 39 of USPAT ‘434).
With regards to claim 10, the catheter insertion apparatus of USPAT ‘434 and Harper teaches the claimed invention of Claim 1, and Claims 2 – 3 of USPAT ‘434 further recites further comprising a spring assembly within the longitudinal passage of the housing configured to retract the needle after the catheter has been distally advanced from the needle (see Col. 18, liens 10 – 17 of USPAT ‘434).
With regards to claim 11, the catheter insertion apparatus of USPAT ‘434 and Harper teaches the claimed invention of Claim 10, and Claim 3 of USPAT ‘434 further recites wherein the spring assembly is configured to automatically retract the needle after the catheter has been distally advanced from the needle (see Col. 18, lines 14 – 17 of USPAT ‘434).
With regards to claim 12, the catheter insertion apparatus of USPAT ‘434 and Harper teaches the claimed invention of Claim 11, and Claims 4 – 5 of USPAT ‘434 further recites wherein the spring assembly comprises a coil disposed coaxially over the needle and a locking mechanism that holds the needle in its distally advanced position with the spring assembly in an axially compressed configuration, wherein release of the locking mechanism allows the spring assembly to axially expand to cause the needle to retract (see Col. 18, lines 21 – 27 of USPAT ‘434).
With regards to claim 13, the catheter insertion apparatus of USPAT ‘434 and Harper teaches the claimed invention of Claim 12, and Claims 4 – 5 of USPAT ‘434 wherein the locking mechanism is configured to automatically release the spring assembly when the catheter is fully advanced (see Col. 18, liens 18 – 27 of USPAT ‘434).
With regards to claim 14, the catheter insertion apparatus of USPAT ‘434 and Harper teaches the claimed invention of Claim 1, and Claim 8 of USPAT ‘434 wherein the catheter locks to the housing after the catheter has been fully advanced (see Col. 18, lines 40 – 42 of USPAT ‘434)..
With regards to claim 15, the catheter insertion apparatus of USPAT ‘434 and Harper teaches the claimed invention of Claim 1, and Claim 10 of USPAT ‘434 further recites wherein the housing is configured to be taped to a patient after the needle has been retracted (see Col. 18, lines 46 – 48 of USPAT ‘434).
With regards to claim 17, the catheter insertion apparatus of USPAT ‘434 and Harper teaches the claimed invention of Claim 1, and Claim 13 of USPAT ‘434 further recites wherein the proximal connector of the catheter comprises a female luer taper and a proximal portion of the housing comprises male luer threads, wherein the female luer taper and the male luer threads are joined to form a complete luer fitting when the catheter is fully advanced through the housing (see Col. 18, lines 59 – 64 of USPAT ‘434).
With regards to claim 18, the catheter insertion apparatus of USPAT ‘434 and Harper teaches the claimed invention of Claim 1, and Claim 11 of USPAT ‘434 further recites further comprising a valve in the proximal connector configured to open in response to engagement with an external connector when the external connector is attached to the proximal connector (see Col. 18, lines 49 – 56 of USPAT ‘434).
With regards to claim 19, the catheter insertion apparatus of USPAT ‘434 and Harper teaches the claimed invention of Claim 18, and Claims 11 and 12 of USPAT ‘434 further recites wherein the valve in the proximal connector comprises a split valve that opens when advanced distally against a male fitting in an axial passage in the proximal connector (see Col. 18, lines 49 – 58 of USPAT ‘434).
Claim(s) 8 – 9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 6, and 7 of USPAT ‘434 and Harper in further view of Cameron.
With regards to claim 8, the catheter insertion apparatus of USPAT ‘434 and Harper teaches the claimed invention of claim 7, however, USPAT ‘434 is silent with regards to further comprising a slider coupled to the proximal end of the needle, wherein the slider is mounted on an outer surface of the housing so that a user may manually retract the needle in a proximal direction after the catheter has been advanced through the needle in a distal direction.
Nonetheless Cameron, which is within the analogous art of through the needle catheter insertion devices and techniques (see abstract and title), teaches the catheter insertion apparatus further comprising a slider (172; see Col. 7, lines 10 – 24 “As the needle assembly is moved rearward by sliding the grip 172”) coupled to the proximal end of the needle (160; see Col. 6, lines 10 – 12 and see Figs 8 – 12b and the movement of the slider 172 causing the needle 160 to be retracted), wherein the slider is mounted on an outer surface of the housing (110, 110’, 112; see Col. 5, lines 65 – 68 and see Figs. 8 – 12b) so that a user may manually retract the needle in a proximal direction after the catheter (140; see Col. 6, lines 45 – 50) has been advanced through the needle in a distal direction (see Figs. 8 – 12b, Abstract, Col. 5, line 65 – Col. 6, line 24, and Col. 7, lines 25 – 40).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the catheter insertion apparatus of USPAT ‘434 and Harper in view of a teaching of Cameron such that a slider coupled to the proximal end of the needle, wherein the slider is mounted on an outer surface of the housing so that a user may manually retract the needle in a proximal direction after the catheter has been advanced through the needle in a distal direction. One of ordinary skill in the art would have been motivated to make this modification because Cameron teaches this structure prevents any inadvertent forward motion of the needle relative to the catheter which could perforate or shear the catheter (see Col. 7, lines 10 – 24 of Cameron).
The catheter insertion apparatus of USPAT ‘434 and Harper modified in view of a teaching of Cameron will hereinafter be referred to as the catheter insertion apparatus of USPAT ‘434, Harper, and Cameron.
With regards to claim 9, the catheter insertion apparatus of USPAT ‘434, Harper, and Cameron teaches the claimed invention of claim 8, however USPAT ‘434 is silent with regards to wherein the slider is configured to be retracted in an axial slot in the housing.
Nonetheless Cameron, which is within the analogous art of through the needle catheter insertion devices and techniques (see abstract and title), further teaches wherein the slider (172; see Col. 7, lines 10 – 24 and Col. 5, line 65 – Col. 6, line 24) is configured to be retracted in in an axial slot (see at 186 in Fig. 11a) in the housing (110, 110’, 112; see Col. 5, lines 65 – 68 and see Figs. 8 – 12b).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the catheter insertion apparatus of USPAT ‘434, Harper, and Cameron in view of a further teaching of Cameron such that the slider is configured to be retracted in an axial slot in the housing. One of ordinary skill in the art would have been motivated to make this modification because Cameron teaches this structure prevents any inadvertent forward motion of the needle relative to the catheter which could perforate or shear the catheter (see Col. 7, lines 10 – 24 of Cameron).
Claim(s) 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 19/385,137 in view of Harper. This is a provisional nonstatutory double patenting rejection.
With regards to claim 1, Claim 1 of copending Application No. 19/385,137 recites an integrated catheter insertion apparatus, comprising:
a housing having a longitudinal passage;
a needle slidably mounted within the longitudinal passage of the housing and having an axial lumen extending from a proximal end of the needle to a tissue-penetrating distal tip of the needle, wherein the needle extends distally from a distal end of the housing in an initial configuration of the catheter insertion apparatus, wherein the needle is configured to be fully retractable within the longitudinal passage of the housing in a subsequent needle configuration; and
a catheter slidably mounted within the axial lumen and having a distal port and a proximal connector, wherein the catheter is proximally retracted within the needle in the initial configuration, wherein the catheter is configured to be distally advanceable from the needle to position the distal port of the catheter distally beyond the distal tip of the needle in the subsequent needle configuration (see Claim 1 of Copending Application No. 19/385,137).
However Claim 1 of copending Application No. 19/385,137 is silent with regards to wherein the proximal connector of the catheter comprises a side port oriented and connected at an angle relative to an axis of the catheter, wherein the proximal connector and the side port are integrated with the catheter, and wherein the proximal connector and the side port are configured to be pushed distally to distally advance to a proximal end of the housing to extend the distal port of the catheter distally from the distal tip of the needle.
Nonetheless Harper, which is within the analogous art of devices used to connect an external ventricular drainage catheter (see abstract and title), teaches (Figs. 4 – 9) the proximal connector (20) (see Col. 2, lines 60 – 67) of the catheter (2) (see Col. 2, lines 47 – 59) comprises a side port (40) (see Col. 3, lines 4 – 13) oriented and connected at an angle relative to an axis of the catheter (see Fig. 6 and Col. 3, lines 20 – 26), wherein the proximal connector and the side port are integrated with the catheter (see Col. 3, lines 53 – 62).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the catheter insertion apparatus of Claim 1 of copending application 19/385,137 in view of a teaching of Harper such that the proximal connector of the catheter comprises a side port oriented and connected at an angle relative to an axis of the catheter, wherein the proximal connector and the side port are integrated with the catheter. One of ordinary skill in the art would have been motivated to make this modification because Harper teaches that adjusting the angle of the proximal connector makes it easier for a physician to connect a tubing connector to the proximal connector (see Col. 3, line 27 – 37 of Harper).
The integrated catheter insertion apparatus of Claim 1 of copending application 19/385,137 modified in view of a teaching of Harper will hereinafter be referred to as the catheter insertion apparatus of copending application 19/385,137 and Harper.
The catheter insertion apparatus of copending application 19/385,137 and Harper teaches wherein the proximal connector and the side port are configured to be pushed distally to distally advance to a proximal end of the housing to extend the distal port of the catheter distally from the distal tip of the needle (see Claim 1 of copending application 19/385,137).
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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/ROBERT F ALLEN/Examiner, Art Unit 3783
/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783
06/26/2026
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