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 .
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.
Claim(s) 11 and 15 is/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.
Regarding Claim 11, Applicant recites the limitation “wherein the curved end extends from the tapered portion of the male luer”. However, the instant claim lacks previous, explicit recitation toward any “curved end” and therefore use of the definite article “the” appears improper. It is unclear if Applicant is intending to introduce a new “curved end” or if the “curved end” was intended to further limit a previously introduced element (see e.g. previously presented Claim 15 wherein a “curved portion” was claimed as part of the “instrument advancement feature). Examiner further notes that replacement of the phrase “curved portion” (previously presented Claim 15) with the phrase “curved end” along with eliminating the requirement that the “curved end” is part of the “instrument advancement feature” implies a distinct scope to this limitation.
Regarding Claim 15, Applicant references “the curved portion”. It is unclear if this “the curved portion” is a new structure or is intended to reference “the curved end”, i.e. it is unclear to what extent the “curved end” is or is not distinctive from the “curved portion”.
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) 11 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 6,240,960 (“Fillmore 1”) in view of U.S. Patent No. 6,481,762 (“Fillmore 2”) and U.S. Patent No. 12,005,199 (“Trainer”).
Regarding Claim 11, Fillmore 1 discloses a catheter system, comprising:
A catheter adapter (100) comprising a distal end (24, 16), a proximal end (24, 18), and a lumen (110) extending through the distal end of the catheter adapter and the proximal end of the catheter adapter (see Fig. 4), and a side port (120) disposed between the distal end of the catheter adapter and the proximal end of the catheter adapter (see Fig. 4);
A catheter (not shown) extending from the distal end of the catheter adapter (Col. 4, Ln. 29-33; Col. 8, Ln. 43-55 – re: Fillmore 1 envisages connecting either end 16 or 18 to either a catheter, drainage bag, or tubing such that a configuration wherein end 16 is connected to a catheter so as to define a “distal end” in accordance with the claims is immediately envisaged by the disclosure of Fillmore 1);
An annular valve (108) disposed within the lumen and configured to seal the side port (Col. 9); and
A connector (124, 104) coupled to the side port having an instrument advancement feature (128, 126 – i.e. the valve/seal stem in association with the conduit within which the valve/seal stem reciprocates where the two features, in combination, serve to regulate whether an instrument can or cannot be advanced through the lumen 48 of the connector/instrument advancement feature), wherein when an instrument is inserted through the side port, the instrument advancement feature is configured to direct the instrument in a distal direction within the lumen of the catheter adapter (see generally Fig. 5 – i.e. when an instrument is inserted through the lumen 46 of the instrument advancement feature the angled distal end will redirect the instrument toward the distal end 16 – whereby express discussion by Fillmore 1 of such an instrument is not required to satisfy the metes and bounds of the instant claims); and
Wherein the instrument advancement feature comprises a male feature (see where the male feature is received within 120) configured to extend into the side port and seal the side port (i.e. at 126), wherein a curved end extends (131, 48) from the tapered portion of the male feature (see Fig. 4)
Fillmore 1 discloses the invention substantially as claimed except that instrument advancement male feature (i.e. 126) comprises a “tapered portion” configured to extend into the side port and seal the side port. The male portion does comprise a complemental shape which cooperates with the side port, but as illustrated the shape appears substantially cylindrical and no clear taper is disclosed. However, Fillmore 2 discloses an equivalent arrangement (200) which like that of Fillmore 1 comprises a catheter adapter (inter alia 300) having a side port (308) within which a similar connector (inter alia 702) may be received. In order to fit the two components together Fillmore 2 describes that the side port should have a tapered interior space (310 – see Fig. 7) which receives a correspondingly shaped male portion (704B) of the connector (see Fig. 12) in order to seal the side port and permit receipt of the valve opening feature of the connector.
It would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the male portion and side port of the invention of Fillmore 1 to have a cooperate sealing taper, as disclosed by Fillmore 2, in order provide for the ability for the connector to be selectively connected and removed as needed for assembly, servicing, and replacement, the tapered shape being understood by the ordinary artisan to provide for better seating of the two surfaces together during assembly.
Fillmore 2 fails to characterize the illustrated taper as a “luer taper”. However, Examiner submits that a “luer” taper is merely one well-known standard found in the prior art of medical devices that is recognized specifically for its suitability in creating stable, sealing fluid connections between medical appliances. For example, Trainer discloses a related adapter (32) having a side port (30) wherein this side port can be configured to accommodate an access connector (80), wherein the ports can be configured with corresponding tapers of the “luer” ISO standard. It would have been obvious for one having ordinary skill in the art at the time the invention was made to utilize the luer ISO standard to define the taper of the connector and side port of modified Fillmore 1, as disclosed by Tainer, in order to utilize a well-known and ubiquitous standard that ensures favorable manufacturing conditions and tolerances.
Regarding Claim 15, Fillmore 1, as modified, discloses the connector comprises a needleless access connector (see generally Fig. 5), comprising:
a first end (30) comprising a female luer (see Col. 5); and
a second end (126 – when modified in view of Fillmore 2 and Trainer) comprising the male luer and coupled to the side port (see generally Fig. 5 with considerations as to modifications in view of Fillmore 2 and Trainer), wherein the second end comprises a curved portion (131, 48), wherein the curved portion comprises a trough or enclosed pathway (see Fig. 5).
Claim(s) 1-2, 4-7, 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2017/0120034 (“Kaczorowski”) in view of Applicant’s Admitted Prior Art (“AAPA”) and U.S. Patent No. 6,083,194 (“Lopez”)
Regarding Claim 1, Kaczorowski discloses an instrument delivery device to insert an instrument through a catheter assembly, the instrument delivery device comprising:
An instrument (60) and a connector (30), wherein the instrument is configured to advance beyond the connector (see Fig. 5A), wherein the connector comprises a curved portion (38, 39) configured to change a direction of the instrument when the instrument is advanced through the connector (see Fig. 5A).
Kaczorowski discloses the invention substantially as claimed except that instrument is disposed within a housing coupled to the connector at its distal end as claimed. Rather, Kaczorowski merely recites that the instrument (60) may comprise a suitable “intervention device” selected from “any diagnostic and therapeutic device used in medical procedures” (Par. 50) without any additional exposition concerning the specific structure of the intervention device. However, APAA (see Fig. 1A – Par. 63) describes a suitable intervention device used in association with catheters comprising:
A housing (12), comprising a proximal end (14), a distal end (16), and a slot (18) disposed therebetween;
The housing having a connector (20) at its distal end configured to be attached to a corresponding connector
A slider (22) configured to move along the slot (Par. 64); and
An instrument (11) disposed within the housing and coupled to the slider, wherein the instrument is configured to advance beyond the connection interface and catheter connector and into a catheter in response to movement of the slider along the slot from a proximal position to a distal position (Par. 64). It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the connector of Kaczorowski to have a suitable connection geometry and membrane to permit receipt of the intervention device of AAPA in order to allow the two devices to be paired together such that the blood draw instrument of AAPA can be used in an expected and predictable manner to permit an interventional procedure such as a blood draw as is known in the art.
Kaczorowski discloses the connector comprises a male feature (33a) having a portion which extends toward a longitudinal axis of the male luer and is configured to extend into a side port (5, 6) of the catheter assembly (see Fig. 5A) and contact an inner surface of the side port along a length thereof to seal the side port (see Fig. 5A), where the curved portion extends from the male portion of the fitting (see Fig. 5A). Kaczorowski discloses the invention substantially as claimed except that that the male portion comprises a male, tapered luer portion. Based on the figures it is unclear if the structure is tapered or if the taper is provided as a “luer” standard taper. However, Kaczorowski does disclose that the connector (35, 6) can be a “luer connector” (Par. 54), which does imply the presence of corresponding tapering surfaces in accordance with ISO standards associated with the term “luer”. For example, Lopez discloses a related catheter adapter (Fig. 1) wherein the side port is explicitly provided with a tapered luer shape which is cooperatively provided with a taper to receive a corresponding standard luer taper male fitting (see Col. 3, Ln. 1-12). It would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the side port and corresponding male portion of the invention of Kaczorowski to comprise a luer taper, as disclosed by Lopez, in order to provide a fluid-tight sealed surface in accordance with ISO standards known in the art to be effective and useful for ensuring intraoperative connections between fluid handling components of medical instruments in a standardized and predictable manner.
Regarding Claim 2, Kaczorowski discloses the curved portion is configured to change a direction of the instrument when the instrument is advanced through the connector (see Fig. 3A – Par. 49).
Regarding Claim 4, Kaczorowski discloses the curved portion comprises an enclosed pathway (see Fig. 3A, 5A, 5B).
Regarding Claim 5, Kaczorowski discloses the enclosed pathway is disposed within a straight end of the connector (see e.g. Fig. 5B).
Regarding Claim 6, Kaczorowski discloses the connector comprises a male luer (Par. 54) configured to form a seal within the catheter assembly, wherein the straight end extends from the male luer (see Fig. 5B).
Regarding Claim 7, Kaczorowski discloses the enclosed pathway is disposed within a curved end of the connector (see Fig. 3A).
Regarding Claim 9, Kaczorowski discloses a side arm (37) which is diametrically opposed to the curved portion (see Fig. 3A) such that, in use, it can be used as a directional indicator to indicate to a clinician an orientation of the instrument delivery device with respect to the catheter assembly such that the curved portion is configured to direct the instrument in a distal direction within the catheter assembly (i.e. the user, knowing that the side arm and curved portion are diametrically opposed will be able to position the curved portion in a desired position by positioning the side arm in the opposing direction as shown).
Regarding Claim 10, AAPA discloses the connector (20) – wherein in light of Applicant’s elected embodiment it should be understood that the “connector” comprises a two part construction (see Fig. 2B) - comprises an insertion portion and a plurality of arms, wherein the insertion portion is configured to insert into the catheter assembly, wherein the plurality of arms are configured to snap onto an exterior of the catheter assembly.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2017/0120034 (“Kaczorowski”) in view of Applicant’s Admitted Prior Art (“AAPA”) and U.S. Patent No. 6,083,194 (“Lopez”) as applied above, and further in view of U.S. Publication No. 2021/0023319 (“Brar”).
Regarding Claim 3, Kaczorowski discloses the invention substantially as claimed except that the curved portion comprises a trough, wherein the trough is not annular, wherein the curved portion extends from a proximal side of the tapered portion of the male luer. However, Brar discloses a related instrument advancing connector (12) in the same field of endeavor (i.e. interventional medical appliances) directed toward the same problem to be solved (i.e. providing a guiding surface which is useful to assisting in the insertion of an interventional medical device through a lumen with a roughly 90 degree bend (see Fig. 5) while preventing kinking or buckling of the inserted instrument. Like Kaczorowski, Brar discloses a male portion (54) which can be inserted into the opening of the lumen and advanced inward, with a curved/ramped portion (71) extending from the end thereof in order to deflect or guide the instrument away from the initial insertion axis to a roughly 90 degree bend (see Fig. 5). Brar the curved portion comprising a trough which is not annular (see Fig. 4) having an open face and where the curved portion extends proximally from the male portion (see Fig. 4, 5). The ordinary artisan would reasonably recognize and appreciate that such an open shape to the curved portion/ramp is beneficial by reducing friction and better allowing the inserted device to be received proximally and deflected 90 degrees without kinking or bulking by increasing the size of the exit port. It would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the shape of the male portion of Kaczorowski to include an open, troughed curved portion extending proximally from the male, tapered sealing portion, as disclosed by Brar, whereby it has been held that a mere change in shape is obvious when it affects only predictable and expected results, see In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966), and whereby the ordinary artisan would reasonably recognize and appreciate that such a shape is known to be useful in the guided insertion of interventional medical appliances through lumens which present with a 90 degree bend between the insertion section and the receiving section (sere Fig. 5 – Brar). Kaczorowski already discloses that a variety of shapes can be employed (see Fig. 3A, 5A, 5B) whereby the shape suggested by Brar merely presents as one well-known obvious shape for an insertion guide that the ordinary artisan would be reasonably expected to be familiar with based upon their level of knowledge, training, and expertise in interventional medicine.
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Supplemental Figure: Modified Kaczorowski including a curved, open trough configured to assist in guiding and deflecting an inserted appliance/instrument in a roughly 90-degree arrangement in a known and predictable manner.
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM R CARPENTER whose telephone number is (571)270-3637. The examiner can normally be reached Mon. to Thus. - 7:00AM to 5:00PM (EST/EDT).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, KEVIN SIRMONS can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 09/08/2026
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