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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because of the following:
Reference character “424” has been used to designate both “a coil or compression spring” (paragraph [0112]) and “hub” (see paragraph [0112]).
Reference character “α” has been used to designate both “the chamfer will be formed at an angle α in range from 30º to 75º” (see [0081]) and “the side port 420 has a passage 440 which is oriented along a center line 442 line an angle α relative to a longitudinal axis 444” (see [0113]). Note reference character β is already used within [0083] as well.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
[0112] recites “the needle cannula 204.” The Examiner suggests amending this to recite “the needle cannula [[204]] 404” because this paragraph is referring to the embodiment shown in Figs. 23 – 24 which shows the needle cannula 404 rather than the needle cannula 204.
[0112] recites “a coil or other compression spring 424…a hub 424.” The Examiner suggests amending this paragraph to provide separate, distinct reference numerals for these structures. See the Drawing Objection above related to the same issue.
[0113] is suggested to be amended to recite “The side port 420 has a passage 440 which is oriented along a center line 442 line at an angle α relative to a longitudinal axis 444” to improve the grammar of the sentence.
Paragraph [0081] and [0113] use the same reference character “α” to refer to two separate angles. The Examiner suggests amending one of these paragraphs to correct this. Note reference character β is already used within [0083] as well.
Appropriate correction is required.
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
The abstract of the disclosure is objected to because the abstract is not within the range of 50 to 150 words in length. Currently the abstract is 156 words in length. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Applicant is advised that should claims 2 and 16 be found allowable, claim 16 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claims 5 and 9 are objected to because of the following informalities:
Claim 5 recites “with in.” The Examiner suggests amending this to recite “within.”
Claim 9 recites “The catheter insertion apparatus of claim 8, wherein the slider is configured to be retracted in in an axial slot in the housing.” The Examiner suggests amending Claim 9 to remove the duplicated word of “in” from the claim language.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1 – 19 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 lumen.” There is insufficient antecedent basis for this limitation in the claim. Does “the needle lumen” refer to “axial lumen” recited earlier within Claim 1?
Claim 1 recites “an initial configuration of the catheter insertion apparatus” twice. The second iteration of an initial configuration is indefinite because it cannot be interpreted if the second iteration is referring to the first iteration of the “initial configuration of the catheter insertion apparatus.” The Examiner suggests amending the second iteration to recite “[[an]] the initial configuration of the catheter insertion apparatus” to provide the proper antecedent basis for this limitation.
Claims 2 – 19 are dependent upon Claim 1. Therefore Claims 2 – 19 are rejected under 35 U.S.C. 112(b) for the same rationale as Claim 1.
Claim 1 recites “wherein the proximal connector of the catheter is oriented and connected at an angle relative to an axis of the catheter.” The Examiner believes the Applicant is attempting to claim the structure shown in Figs. 23 – 24B of the Drawings. Within this embodiment the proximal connector is the catheter hub 412. This catheter hub is not oriented or connected at an angle relative to an axis of the catheter. Figure 24A shows the catheter hub oriented in alignment (i.e., no angle between the components) with the axis of the catheter when connected. The catheter hub 412 does comprise an angled side port 420 which allows for tubing 436 to be oriented and connected to the proximal connector at an angle relative to an axis of the catheter. However, this is not what the claim language of Claim 1 recites. Therefore, Claim 1 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 (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention because of the discrepancy between what is shown in Figures 23 – 24B and what the claim language recites.
Claims 2 – 19 are dependent upon Claim 1. Therefore Claims 2 – 19 are rejected under 35 U.S.C. 112(b) for the same rationale as Claim 1.
Claim 5 recites the limitation "the releasable latch" and “the needle lumen.” There is insufficient antecedent basis for these limitations in the claim. Is “the releasable latch” intended to refer to the releasable latch of Claim 4? If yes, then the dependency of Claim 5 would need correction. Is the “needle lumen” referring to the “axial lumen” referred to in Claim 1?
Claims 6 - 9 are dependent upon Claim 5. Therefore Claims 6 – 9 are rejected under 35 U.S.C. 112(b) for the same rationale as Claim 5.
Claim 6 recites “at least one spring-loaded latch.” Does this “spring-loaded latch” refer to the “releasable latch” recited in Claim 5? If yes, then Claim 6 is rejected under 35 U.S.C. § 112(b) for a lack of antecedent basis between these claim limitations because the claim uses two nomenclatures to refer to the same structure. This indefiniteness also translates to the other recitations of “the at least one spring-loaded latch” within Claims 6 and 7.
Claim 7 recites the limitation "the needle hub.” There is insufficient antecedent basis for this limitation in the claim. Is “the needle hub” referring to the “proximal hub” recited in Claim 6?
Claims 8 – 9 are dependent upon Claim 7. Therefore Claims 8 – 9 are rejected under 35 U.S.C. 112(b) for the same rationale as Claim 7.
Claim 12 recites the limitation "the spring” three times. There is insufficient antecedent basis for each limitation in the claim.
Claim 13 recites the limitation "the spring.” There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1 – 3, 15, and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cameron et al. (US 4,994,040 A; hereinafter referred to as “Cameron”) and Harper (US 7,070,579 B1).
With regards to claim 1, Cameron discloses (see Figs. 8 – 12b) an integrated catheter insertion apparatus (see Col. 5, lines 65 – 68 “As shown in Figs. 8, 9, and 10, the catheter device of these FIGURES”), comprising:
a housing (110, 110’, 112) (see Col. 5, lines 65 – 68 “As shown in Figs. 8, 9, and 10, the catheter device of these FIGURES has a housing including a distal end 112 which divides into two U-shaped proximal sections 110 and 110’ with an opening 111 therebetween”) having a longitudinal passage (111) (see Col. 5, lines 65 – 68);
a needle (160) (see Col. 6, lines 10 – 12 “A splitable needle 160”) slidably mounted within the longitudinal passage of the housing (see Figs. 8 – 12b) and having an axial lumen (see Col. 6, lines 25 – 40 “A suitable needle for adult applications would have an I.D. of 0.036””) extending from a proximal end (see at 175 in Fig. 11b) to a tissue-penetrating distal tip (see at 160 in Fig. 11b), wherein the needle extends distally from a distal end (112) (see Col. 5, lines 65 – 68) of the housing in an initial configuration of the catheter insertion apparatus (see Figs. 8 – 10); and
a catheter (140) (see Col. 6, lines 45 – 50 “With the needle properly located, the catheter cannula 140 is threaded into the blood vessel by advancing”) slidably mounted within the needle lumen (see Figs. 8 – 12b) and having a distal port (see at 140 in Fig. 11a) (see Col. 5, lines 59 -65 “The reference numerals used in these FIGURES are incremented by 100 as compared with reference numerals used in the previous FIGURES to refer to components which perform substantially the same function in the several embodiments,” Col. 3, line 49 – Col. 4, line 16 “The catheter cannula is connected through a junction 44, molded as ap art of taping wing 42, to microbore extension tubing 46…At the proximal end of the tubing is a female luer 48,” and Col. 5, line 65 – Col. 6, line 24 “An extension set configured as shown in FIGS. 2a – 2c is mounted on the bottom of the device”) and a proximal connector (48) (see Col. 5, lines 50 – 65 and Col. 3, line 49 – Col. 4, line 2), wherein the catheter is proximally retracted within the needle in an initial configuration of the catheter insertion apparatus (see Figs. 8 – 10); and
wherein the proximal connector is distally advanceable to a proximal end (114) (see Col. 5, line 65 – Col. 6, line 24) of the housing to extend the distal port of the catheter distally from the distal tip of the needle (see Figs. 12A – 12B, Col. 6, lines 45 – 50); and wherein the needle is fully retractable within the housing (see Figs. 12A – 12B and Col. 7, lines 10 – 24).
However Cameron is silent with regards to:
wherein the proximal connector of the catheter is oriented and connected at an angle relative to an axis of the catheter.
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) is oriented and connected at an angle (see Fig. 6 and Col. 3, line 20 – 26) relative to an axis (see at 26 in Fig. 6) (see Col. 2, lines 43 – 59) of the catheter.
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 proximal connector of the integrated catheter insertion apparatus of Cameron in view of a teaching of Harper such that wherein the proximal connector of the catheter is oriented and connected at an angle relative to an axis of 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 Cameron modified in view of a teaching of Harper will hereinafter be referred to as the catheter insertion apparatus of Cameron and Harper.
With regards to claim 2, the catheter insertion apparatus of Cameron and Harper teaches the claimed invention of claim 1, and Cameron further teaches (Figs. 8 – 12b) wherein the proximal connector (48) (see Col. 3, line 49 – Col. 4, line 16 and Col. 5, line 65 – Col. 6, line 24) comprises a luer fitting (see Col. 3, line 63 – Col. 4, line 2 “At the proximal end of the tubing 46 is a female luer 48 having luer lugs 47”).
With regards to claim 3, the catheter insertion apparatus of Cameron and Harper teaches the claimed invention of claim 1, however, Cameron 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 Cameron 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 15, the catheter insertion apparatus of Cameron and Harper teaches the claimed invention of claim 1, and Cameron further teaches wherein the housing (110, 110’, 112) (see Col. 5, lines 65 – 68) is configured to be taped to a patient after the needle has been retracted (the language “wherein the housing is configured to be taped to a patient after the needle has been retracted” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. MPEP 2144. Furthermore, the claim is an apparatus claim and is to be limited by the structural limitations. The Office submits that the device of Cameron and Harper meets the structural limitations of the claim and is capable of being taped to a patient after the needle has been retracted in view of Col. 4, lines 3 – 16 “enabling the wings to be taped immediately adjacent to the insertion side when the catheter is fully inserted into the body” and Col. 6, lines 6 – 9 of Cameron).
With regards to claim 16, the catheter insertion apparatus of Cameron and Harper teaches the claimed invention of claim 1, and Cameron further teaches (Figs. 8 – 12b) wherein the proximal connector (48) (see Col. 3, line 49 – Col. 4, line 16 and Col. 5, line 65 – Col. 6, line 24) of the catheter (140) (see Col. 6, lines 45 – 50) comprises a luer fitting (see Col. 3, line 63 – Col. 4, line 2 “At the proximal end of the tubing 46 is a female luer 48 having luer lugs 47”).
Claim(s) 4, 5, and 10 – 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cameron and Harper as applied to claim 1 above, and further in view of Haindl (US 6,537,253 B1).
With regards to claim 4, the catheter insertion apparatus of Cameron and Harper teaches the claimed invention of claim 1, however, Cameron is silent with regards to wherein the needle is held in place by a releasable latch.
Nonetheless Haindl, which is within the analogous art of cannular arrangements (see abstract and title) wherein the needle (3) see Col. 4, lines 32 – 47 “a cannula 3 with a sharp front end 4”)is held in place by a releasable latch (37) see Col. 7, lines 15 – 44 “a hook 37 engaging from behind a front edge 38 of the housing 7…Disengagement of the hook 37 from the edge 38 is implemented in that following sufficient insertion of the cannula 3, the projecting hook 37 is pressed against the skin surface.”).
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 Cameron and Harper in view of a teaching of Haindl such that the needle is held in place by a releasable latch. The housing of the catheter insertion apparatus of Cameron is modified to include the front edge 38 taught by Haindl while the slider of the catheter insertion apparatus of Cameron and Harper is modified to include the hook 37 taught by Haindl. One of ordinary skill in the art would have been motivated to make this modification, as Haindl teaches the automatic withdrawal protects the catheter from damage from the sharp front end of the needle/cannula while also making separate actuation of the withdrawal unnecessary (see Col. 7, lines 15 – 44 of Haindl).
With regards to claim 5, the catheter insertion apparatus of Cameron and Harper teaches the claimed invention of claim 1, however, Cameron is silent with regards to wherein the catheter is configured to release the releasable latch to allow the needle to retract when the catheter is fully advanced with in the needle lumen.
Nonetheless, Haindl which is within the analogous art of cannular arrangements (abstract), teaches (Figs. 15 – 16) the catheter (2; see Col. 4, lines 32 – 47 “a microdialysis catheter 2”) is configured to release the releasable latch (37; see Col. 7, lines 15 – 44 “a hook 37 engaging from behind a front edge 38 of the housing 7…Disengagement of the hook 37 from the edge 38 is implemented in that following sufficient insertion of the cannula 3, the projecting hook 37 is pressed against the skin surface.”) to allow the needle (3; see Col. 4, lines 32 – 47 “a cannula 3 with a sharp front end 4”) to retract when the catheter is fully advanced within the needle lumen (see Fig. 16).
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 housing and the slider coupled with the needle of the catheter insertion apparatus of Cameron and Harper in view of a teaching of Haindl such that the catheter is configured to release a releasable latch to allow the needle to retract when the catheter is fully advanced within the needle lumen. The housing of the catheter insertion apparatus of Cameron is modified to include the front edge 38 taught by Haindl while the slider of the catheter insertion apparatus of Cameron and Harper is modified to include the hook 37 taught by Haindl. One of ordinary skill in the art would have been motivated to make this modification, as Haindl teaches the automatic withdrawal protects the catheter from damage from the sharp front end of the needle/cannula while also making separate actuation of the withdrawal unnecessary (see Col. 7, lines 15 – 44 of Haindl).
The catheter insertion apparatus of Cameron and Harper modified in view of a teaching of Haindl will hereinafter be referred to as the catheter insertion apparatus of Cameron, Harper and Haindl.
With regards to claim 10, the catheter insertion apparatus of Cameron and Harper teaches the claimed invention of claim 1, however Cameron is silent with regards to the catheter insertion apparatus 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.
Nonetheless Haindl, which is within the analogous art of cannular arrangements (abstract), further teaches (Figs. 15 – 16) the catheter insertion apparatus (see Fig. 15) further comprising a spring assembly (6, 34; see Col. 7, lines 15 – 44 “the slider 6…the spring 34”) within the longitudinal passage (see the lumen of the housing 7 in Figs. 15 – 16) of the housing (7; see Col. 7, lines 15 – 44 “housing 7”) configured to retract the needle after the catheter (2; see Col. 4, lines 32 – 47 “a microdialysis catheter 2”) has been distally advanced from the needle (see Col. 7, lines 15 – 44).
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 Cameron and Harper in view of a teaching of Haindl such that the catheter insertion apparatus 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. One of ordinary skill in the art would have been motivated to make this modification because Haindl teaches the automatic withdrawal protects the catheter from damage from the sharp front end of the needle/cannula while also making separate actuation of the withdrawal unnecessary (see Col. 7, lines 15 – 44 of Haindl).
The catheter insertion apparatus of Cameron and Harper modified in view of a teaching of Haindl will hereinafter be referred to as the catheter insertion apparatus of Cameron, Harper and Haindl.
With regards to claim 11, the catheter insertion apparatus of Cameron, Harper and Haindl teaches the claimed invention of claim 10, however, Cameron is silent with regards to wherein the spring assembly is configured to automatically retract the needle after the catheter has been distally advanced from the needle.
Nonetheless, Haindl which is within the analogous art of cannular arrangements (abstract), further teaches (Figs. 15 – 16) the spring assembly (6, 34; see Col. 7, lines 15 – 44 “the slider 6…the spring 34”) is configured to automatically retract the needle (3; see Col. 4, lines 32 – 47) after the catheter (2; see Col. 4, lines 32 – 47 “a microdialysis catheter 2”) has been distally advanced from the needle.
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 spring assembly of the catheter insertion apparatus of Cameron, Harper, and Haindl in view of an additional teaching of Haindl such that the spring assembly is configured to automatically retract the needle after the latch has been released. One of ordinary skill in the art would have been motivated to make this modification, as Haindl teaches the automatic withdrawal protects the catheter from damage from the sharp front end of the needle/cannula while also making separate actuation of the withdrawal unnecessary (see Col. 7, lines 15 – 44 of Haindl).
With regards to claim 12, the catheter insertion apparatus of Cameron, Harper and Haindl teaches the claimed invention of claim 11, however, Cameron is silent with regards to wherein the spring comprises a coil disposed coaxially over the needle and a locking mechanism that holds the needle in its distally advanced position with the spring in an axially compressed configuration, wherein release of the locking mechanism allows the spring to axially expand to cause the needle to retract.
Nonetheless, Haindl which is within the analogous art of cannular arrangements (abstract), further teaches (Figs. 15 – 16) the spring (34; see Col. 7, lines 15 – 44 “the slider 6…the spring 34”) comprises a coil (34; see Col. 7, lines 15 – 44 “the spring 34”) disposed coaxially over the needle (3; see Col. 4, lines 32 – 47 and see Figs. 15 – 16) and a locking mechanism (6, 37; see Col. 7, lines 15 – 44) that holds the needle in its distally advanced position with the spring in an axially compressed configuration (see Fig. 15), wherein release of the locking mechanism allows the spring to axially expand to cause the needle to retract (see Fig. 16 and Col. 7, lines 15 – 44).
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 spring assembly of the catheter insertion apparatus of Cameron, Harper, and Haindl in view of an additional teaching of Haindl such that the spring comprises a coil disposed coaxially over the needle and a locking mechanism that holds the needle in its distally advanced position with the spring in an axially compressed configuration, wherein release of the locking mechanism allows the spring to axially expand to cause the needle to retract. One of ordinary skill in the art would have been motivated to make this modification, as Haindl teaches the automatic withdrawal protects the catheter from damage from the sharp front end of the needle/cannula while also making separate actuation of the withdrawal unnecessary (see Col. 7, lines 15 – 44 of Haindl).
With regards to claim 13, the catheter insertion apparatus of Cameron, Harper and Haindl teaches the claimed invention of claim 12, however, Cameron is silent with regards to wherein the locking mechanism is configured to automatically release the spring when the catheter is fully advanced.
Nonetheless, Haindl which is within the analogous art of cannular arrangements (abstract), further teaches (Figs. 15 – 16) the locking mechanism (6, 37) (see Col. 7, lines 15 – 44) is configured to automatically release the spring (34) (see Col. 7, lines 15 – 44) when the catheter (2; see Col. 4, lines 32 – 47 “a microdialysis catheter 2”) is fully advanced (see Figs. 15 – 16).
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 locking mechanism of the catheter insertion apparatus of Cameron, Harper, and Haindl in view of a further teaching of Haindl such that the locking mechanism is configured to automatically release the spring when the catheter is fully advanced. One of ordinary skill in the art would have been motivated to make this modification because Haindl further teaches the automatic withdrawal protects the catheter from damage from the sharp front end of the needle/cannula while also making separate actuation of the withdrawal unnecessary (see Col. 7, lines 15 – 44 of Haindl).
Claim(s) 6 – 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cameron, Harper, and Haindl as applied to claim 5 above, and further in view of Botich et al. (US 6,547,762 B1; hereinafter referred to as “Botich”)
With regards to claim 6, the catheter insertion apparatus of Cameron, Harper and Haindl teaches the claimed invention of claim 5, however, Cameron is silent with regards to wherein the needle comprises a proximal hub having at least one spring-loaded latch which engages 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.
Nonetheless Botich, which is within the analogous art of retractable needle medical devices (abstract), further teaches (Figs. 5 – 7) the needle (130; see Col. 6, lines 25 – 58 “a retractable needle 130”) comprises a proximal hub (140; see Col. 6, lines 25 – 58 “a needle retainer 140”) having at least one spring-loaded latch (145, 146; see Col. 6, lines 25 – 58 “The forward portion 146 of the needle retainer…a ridge 145…The spring then propels the needle rearwardly”) which engages a locking feature (124; see Col. 6, lines 25 – 58 “so that a ridge 145 on the arm engages a lip 124 formed by the opening…”) on an inside surface of the longitudinal passage (see the lumen of the housing 120) in the housing (120; see Col. 6, lines 25 – 58 “a housing 120”) to hold the needle in place and wherein the catheter comprises at least one latch release feature (see at 172 in Fig. 7; see Col. 6, lines 25 – 58 “the catheter hub 172 wedges the needle retainer arm radially outwardly so that a ridge 145 on the arm engages a lip 124 formed by the opening…”) which engages and releases the at least one spring-loaded latch as the catheter is advanced (see Figs. 5 – 7 and Col. 6, lines 25 – 58).
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 Cameron, Harper, and Haindl in view of a teaching of Botich such that the needle comprises a proximal hub having at least one spring-loaded latch which engages 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. One of ordinary skill in the art would have been motivated to make this modification because Botich teaches the needle automatically retracting after use so that the medical professional does not need to perform any additional steps to ensure that the contaminated needle is safely enclosed (see Col. 6, lines 59 – 65 of Botich).
The catheter insertion apparatus of Cameron, Harper, and Haindl modified in view of a teaching of Botich will hereinafter be referred to as the catheter insertion apparatus of Cameron, Harper, Haindl, and Botich.
With regards to claim 7, the catheter insertion apparatus of Cameron, Harper, Haindl, and Botich teaches the claimed invention of claim 6, however, Cameron is silent with regards to wherein the at least one spring-loaded latch comprises a cantilevered hook on the needle hub and the locking feature comprises an undercut on the inside surface of the longitudinal passage in the housing.
Nonetheless Botich, which is within the analogous art of retractable needle medical devices (abstract), further teaches (Figs. 5 – 7) the at least one spring-loaded latch (145, 146; see Col. 6, lines 25 – 58) comprises a cantilevered hook (see Col. 6, lines 25 – 58) on the needle hub (140; see Col. 6, lines 25 – 58) and the locking feature (124; see Col. 6, lines 25 – 58) comprises an undercut (see at 124 in Fig. 7) on the inside surface of the longitudinal passage (see the lumen of the housing 120) in the housing (120; see Col. 6, lines 25 – 58 “a housing 120”).
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 at least one spring-loaded latch and the locking feature of the catheter insertion apparatus of Cameron, Harper, Haindl and Botich in view of an additional teaching of Botich such that the at least one spring-loaded latch comprises a cantilevered hook on the needle hub and the locking feature comprises an undercut on the inside surface of the longitudinal passage in the housing. One of ordinary skill in the art would have been motivated to make this modification because Botich teaches the needle automatically retracting after use so that the medical professional does not need to perform any additional steps to ensure that the contaminated needle is safely enclosed (see Col. 6, lines 59 – 65 of Botich).
With regards to claim 8, the catheter insertion apparatus of Cameron, Harper, Haindl, and Botich teaches the claimed invention of claim 7, and Cameron further 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).
With regards to claim 9, the catheter insertion apparatus of Cameron, Harper, Haindl, and Botich teaches the claimed invention of claim 8, and Cameron 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).
Claim(s) 14 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cameron and Harper as applied to claim 1 above, and further in view of Hickingbotham et al. (US 2013/0178822 A1; hereinafter referred to as “Hickingbotham”).
With regards to claim 14, the catheter insertion apparatus of Cameron and Harper teaches the claimed invention of claim 1, however, Cameron is silent with regards to wherein the catheter locks to the housing after the catheter has been fully advanced.
Nonetheless Hickingbotham, which is within the analogous art of delivery and extraction devices, teaches (Fig. 4) the catheter (1, 27; see [0238] “The proximal end of the mandrel 1 is fixed to the delivery unit support 4 in a Luer lock 27…The Luer lock 27 is optionally connected to an external device through a Luer housing of the external device (not shown)” wherein the Luer lock is a portion of the catheter) locks to the housing (4; see [0238] “the delivery unit support 4”) after the catheter (1; see [0207] “a mandrel 1 disposed internally of the mandrel guide (2)” and [0209]) has been fully advanced.
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 proximal connector of the catheter of the catheter insertion apparatus Cameron and Harper in view of a teaching of Hickingbotham such that the catheter locks to the housing after the catheter has been fully advanced. One of ordinary skill in the art would have been motivated to make this modification because Hickingbotham teaches that a proximal connector could be connected to an external device via a Luer housing of the external device thereby securing the components with relation to each other (see [0238] of Hickingbotham).
With regards to claim 17, the catheter insertion apparatus of Cameron and Harper teaches the claimed invention of claim 1, however, Cameron is silent with regards to 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.
Nonetheless, Hickingbotham which is within the analogous art of delivery and extraction devices, teaches (Fig. 4) the proximal connector (27; see [0238] “The Luer lock 27 is optionally connected to an external device through a Luer housing of the external device (not shown)”) of the catheter (1; see [0207] “a mandrel 1 disposed internally of the mandrel guide (2)” and [0209]) 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 [0078] “Further, when reference is made to a "male" or "female" Luer fitting, the invention also contemplates an alternative embodiment, wherein the interface is any fluid-pump interface, for example, any type of Luer fitting or tube coupler” and [0238]).
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 proximal connector of Cameron and Harper in view of a teaching of Hickingbotham such that 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. One of ordinary skill in the art would have been motivated to make this modification because Hickingbotham teaches that a proximal connector could be connected to an external device via a Luer housing of the external device thereby securing the components with relation to each other (see [0238] of Hickingbotham).
Claim(s) 18 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cameron and Harper as applied to claim 1 above, and further in view of Fangrow, JR (US 2004/0006330 A1; hereinafter referred to as “Fangrow”).
With regards to claim 18, the catheter insertion apparatus of Cameron and Harper teaches the claimed invention of claim 1, however, Cameron is silent with regards to the catheter insertion apparatus 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.
Nonetheless, Fangrow which is within the analogous art of medical valve with positive flow characteristics (abstract), teaches (Figs. 1 – 4) a valve (20; see [0059] “The valve 20”) in the proximal connector (30; see [0059] “a relatively rigid housing 30”) configured to open in response to engagement with an external connector (28; see [0060] “the syringe Luer 28”) when the external connector is attached to the proximal connector (see [0059 - 0060]).
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 Cameron and Harper in view of a teaching of Fangrow such that the catheter insertion apparatus further comprises 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. One of ordinary skill in the art would have been motivated to make this modification, as the inclusion of a valve creates the selective permitting of a fluid flow between first and second medical implements (see Abstract of Fangrow).
The catheter insertion apparatus of Cameron and Harper modified in view of a teaching of Fangrow will hereinafter be referred toas the catheter insertion apparatus of Cameron, Harper, and Fangrow.
With regards to claim 19, the catheter insertion apparatus of Cameron, Harper, and Fangrow teaches the claimed invention of claim 18, however, Cameron is silent with regards to 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.
Nonetheless, Fangrow which is within the analogous art of medical valve with positive flow characteristics (abstract), further teaches (Figs. 1 – 4) the valve (20; see [0059] “The valve 20”) in the proximal connector (30; see [0059] “a relatively rigid housing 30”) comprises a split valve (36; see [0060] “a slit opening 36”) that opens when advanced distally against a male fitting (28; see [0060] “the Luer 28 of the syringe 24”) in an axial passage in the proximal connector (see Figs. 1 – 4 and [0059 – 0060]).
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 valve of the catheter insertion apparatus of Cameron, Harper, and Fangrow in view of a further teaching of Fangrow such that 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. One of ordinary skill in the art would have been motivated to make this modification, as the inclusion of a valve creates the selective permitting of a fluid flow between first and second medical implements (see Abstract of Fangrow).
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 and 10 – 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1 – 13 of U.S. Patent No. 11,197,980 B2 (hereinafter referred to as “USPAT ‘980”) in view of Harper.
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 to a tissue-penetrating distal tip, wherein the needle extends distally from a distal end of the housing in an initial configuration of the catheter insertion apparatus; and
a catheter slidably mounted within the needle lumen and having a distal port and a proximal connector, wherein the catheter is proximally retracted within the needle in an initial configuration of the catheter insertion apparatus;
wherein the proximal connector of the catheter is distally advanceable to a proximal end of the housing to extend the distal port of the catheter distally from the distal tip of the needle; and wherein the needle is fully retractable within the housing (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 is oriented and connected at an angle relative to an axis of the catheter.
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) is oriented and connected at an angle (see Fig. 6 and Col. 3, line 20 – 26) relative to an axis (see at 26 in Fig. 6) (see Col. 2, lines 43 – 59) of the catheter.
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 is oriented and connected at an angle relative to an axis of 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.
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 further recites 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 1, 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 with in the needle 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 5, and Claim 2 of USPAT ‘980 further recites wherein the needle comprises a proximal hub having at least one spring-loaded latch which engages 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 needle 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 the catheter insertion apparatus 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 comprises a coil disposed coaxially over the needle and a locking mechanism that holds the needle in its distally advanced position with the spring in an axially compressed configuration, wherein release of the locking mechanism allows the spring 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 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 16, the catheter insertion apparatus of USPAT ‘980 and Harper teaches the claimed invention of claim 1, and Claim 10 of USPAT ‘980 further recites wherein the proximal connector of the catheter comprises a luer fitting (see Col. 18, lines 42 – 44 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.
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 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 and 10 – 19 are 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 to a tissue-penetrating distal tip, wherein the needle extends distally from a distal end of the housing in an initial configuration of the catheter insertion apparatus; and
a catheter slidably mounted within the needle lumen and having a distal port and a proximal connector, wherein the catheter is proximally retracted within the needle in an initial configuration of the catheter insertion apparatus;
wherein the proximal connector is distally advanceable to a proximal end of the housing to extend the distal port of the catheter distally from the distal tip of the needle; and wherein the needle is fully retractable within the housing (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 is oriented and connected at an angle relative to an axis of the catheter.
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) is oriented and connected at an angle (see Fig. 6 and Col. 3, line 20 – 26) relative to an axis (see at 26 in Fig. 6) (see Col. 2, lines 43 – 59) of the catheter.
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 is oriented and connected at an angle relative to an axis of 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.
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 1, 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 with in the needle 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 5, and Claim 6 of USPAT ‘434 further recites wherein the needle comprises a proximal hub having at least one spring-loaded latch which engages 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 needle 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 comprises a coil disposed coaxially over the needle and a locking mechanism that holds the needle in its distally advanced position with the spring in an axially compressed configuration, wherein release of the locking mechanism allows the spring 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 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 further recites 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 16, 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 of the catheter comprises a luer fitting (see Col. 18, lines 4 – 5 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 the catheter insertion apparatus 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 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 to a tissue-penetrating distal tip, wherein the needle extends distally from a distal end of the housing in an initial configuration of the catheter insertion apparatus; and
a catheter slidably mounted within the needle lumen and having a distal port and a proximal connector, wherein the catheter is proximally retracted within the needle in an initial configuration of the catheter insertion apparatus;
wherein the proximal connector of the catheter is distally advanceable to a proximal end of the housing to extend the distal port of the catheter distally from the distal tip of the needle; and wherein the needle is fully retractable within the housing (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 is oriented and connected at an angle relative to an axis of the catheter.
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) is oriented and connected at an angle (see Fig. 6 and Col. 3, line 20 – 26) relative to an axis (see at 26 in Fig. 6) (see Col. 2, lines 43 – 59) of the catheter.
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 is oriented and connected at an angle relative to an axis of 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).
Conclusion
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/ROBERT F ALLEN/Examiner, Art Unit 3783
/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783
02/06/2026