DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The Amendment filed 03/18/26 has been entered. Claims 1, 6, 12-14, 27, and 34, have been amended. Claims 1, 3-7, 12-16, 27, and 29-38 are addressed in the following office action.
Claim Objections
Claims 6 and 38 are objected to because of the following informalities:
In claim 6, line 3, “hub ,” should read “hub,”.
In claim 38, line 1, “claim 1” should read “claim 34”.
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.
Claim 27 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 27 recites the limitation "a blunt distal end" in line 16. It is unclear if “a blunt distal end” is the same or different from the “an open blunt distal end”. For examination purposes, the limitation will be interpreted as the same as “an open blunt distal end” and read as “the blunt distal end”. Claims 29-33 are rejected for the same reasons as claim 3 by virtue of dependency on claim 3.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 27 and 31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dubrul et al. (US 5,431,676).
Regarding claim 27, an invention relating to trocar systems, Dubrul discloses (Figs. 1-3)an IV catheter device (10) comprising: a needle component (40) having an elongated needle that extends outwardly from a needle hub (44), the needle hub having a distal end wall (see annotated figure below); a catheter component (30) that is detachably coupled to the needle component, the catheter component having a hollow body through which the elongated needle passes (Col. 9, lines 40-43), the catheter component having a flange (32) at a proximal end (Fig. 1); and an actuatable obturator (48) that is slidingly disposed within the needle component and moves axially between a pre-deployment position and a deployed position, the actuatable obturator having an elongated hollow structure [i.e. axial lumen] that terminates in an open blunt distal end (50 & 52) and a hollow hub portion (54) that is enlarged relative to the elongated hollow structure and defines a flash chamber that moves axially with the obturator, the hollow hub portion defining a proximal end of the actuatable obturator and including a distal end wall (see annotate figure below & Col. 9, lines 48-64); wherein in both the pre-deployment and deployed positions, the entire hollow hub portion of the actuatable obturator is fully contained within the needle hub; wherein in the deployed position, the actuatable obturator is disposed within an inner lumen of the elongated needle and a blunt distal end of the obturator is located distal to the sharp distal tip so as to blunt the elongated needle (Col. 9, lines 48-64); wherein the obturator has an inner lumen [i.e. axial lumen] formed therein with an entrance (52) to the inner lumen of the obturator being open and distal to the sharp distal tip of the elongated needle when the obturator is in the deployed position (Fig. 2; Col. 9, lines 48-64).
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Regarding claim 31, Dubrul discloses the IV catheter device of claim 27. Dubrul discloses further including a spring contained within the needle hub and seating at one end against a proximal end of the hollow hub portion of the actuatable obturator for applying a biasing force against the actuatable obturator (Col. 9, lines 48-64).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 3-7, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Dubrul et al. (US 5,431,676) in view of Robson et al. (EP 0 405 883).
Regarding claim 1, an invention relating to trocar systems, Dubrul discloses (Figs. 1-3) an IV catheter device (10) comprising: a hollow housing (44 & 54) that defines a flash chamber [i.e. lumen between element 54 and the proximal end opening of element 48] (Col. 9, lines 59-61); a needle component (40) having an elongated needle with a sharp distal tip (42; Col. 9, lines 31-37), the needle being coupled to the hollow housing and located distal to the flash chamber (Fig. 1; Col. 9, lines 31-32); a catheter component (30) having a hollow body through which the needle passes (Col. 9, lines 40-43); and an actuatable obturator (48) that is disposed within the needle component and moves between a pre-deployment position and a deployed position, wherein in the deployed position, the actuatable obturator is disposed within an inner lumen of the elongated needle and a blunt distal end of the obturator is located distal to the sharp distal tip so as to blunt the elongated needle; wherein the actuatable obturator is biased by a biasing element [i.e. spring] that stores energy in the pre-deployment position and releases energy as the actuatable obturator moves from the pre-deployment position to the deployed position; wherein the actuatable obturator is hollow and has an inner lumen [i.e. axial lumen] formed therein that is open at proximal and distal ends of the obturator, the inner lumen at the proximal end of the obturator being open to an area of the flash chamber for allowing external fluid to flow through the inner lumen into the flash chamber (Col. 9, lines 48-64). However, Dubrul fails to disclose the biasing element being disposed within the flash chamber defined in the hollow housing; the inner lumen at the proximal end of the obturator being open to an area of the flash chamber that contains the biasing element for allowing external fluid to flow through the inner lumen into the flash chamber.
In the same field of endeavor, which is trocar systems, Robson teaches (Figs. 1-3) a biasing element (7) being disposed within a flash chamber (18) defined in the hollow housing (8); an inner lumen [i.e. hollow of element 4] (Par. 0022) at a proximal end (12) of an obturator (3) being open to an area of the flash chamber that contains the biasing element for allowing external fluid to flow through the inner lumen into the flash chamber (Par. 0007).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Dubrul to have the biasing element being disposed within the flash chamber defined in the hollow housing; the inner lumen at the proximal end of the obturator being open to an area of the flash chamber that contains the biasing element for allowing external fluid to flow through the inner lumen into the flash chamber, as taught by Robson. Dubrul discloses a spring-loaded obturator is desired (Col. 9, lines 48-58), thus Robson spring-loaded obturator that provides the spring within the flash chamber would have provided Dubrul with the specific spring position and structure to extend the blunt end of the obturator distally from the sharpened distal tip of the needle component to act as a protective element.
Regarding claim 3, Dubrul, as modified by Robson, further discloses wherein the biasing element comprises a coil spring and the inner lumen is axially aligned with a center of the coil spring [i.e. helical spring 7 aligned with hollow of element 4, see Robson figure 2 and paragraph 0022].
Regarding claims 4-7, Dubrul, as modified by Robson, further discloses the IV catheter device of claim 1. Dubrul further discloses (Figs. 1-3) wherein the actuatable obturator includes an elongated section that includes the blunt distal end of the actuatable obturator [i.e. section of element 48 distal to element 32]. However, Dubrul fails to further disclose wherein the actuatable obturator includes an elongated section that includes the blunt distal end of the actuatable obturator and an enlarged hub portion that is wider than the elongated section of the actuatable obturator [Claim 4]; wherein the needle component includes an internal stop and in the deployed position, the hub portion of the actuatable obturator seats against the stop [Claim 5]; wherein the hollow housing comprises a hollow needle hub and wherein the stop comprises an inner shoulder formed at one end of the hollow needle hub , the elongated needle extending distal to the hollow needle hub [Claim 6]; wherein a length of the elongated section is selected so that when the hub portion of the actuatable obturator seats against the stop, the blunt distal end of the obturator is located distal to the sharp distal tip [Claim 7].
Robson further teaches (Figs. 2-3) wherein the actuatable obturator includes an elongated section (4) that includes a blunt distal end (30) of the actuatable obturator and an enlarged hub portion (12) that is wider than the elongated section of the actuatable obturator (Par. 0022 & 0027-0028); wherein the needle component includes an internal stop [i.e. the internal shoulder created where the flared end 12 meets the tube 4 of element 2] and in the deployed position, the hub portion of the actuatable obturator seats against the stop (Par. 0022); wherein the hollow housing comprises a hollow needle hub [i.e. flared end 12] and wherein the stop comprises an inner shoulder formed at one end of the hollow needle hub (see annotated figure), the elongated needle extending distal to the hollow needle hub (Fig. 2); wherein a length of the elongated section is selected so that when the hub portion of the actuatable obturator seats against the stop, the blunt distal end of the obturator is located distal to the sharp distal tip (Fig. 2; Par. 0028).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Dubrul, in view of Robson, to have wherein the actuatable obturator includes an elongated section that includes the blunt distal end of the actuatable obturator and an enlarged hub portion that is wider than the elongated section of the actuatable obturator [Claim 4]; wherein the needle component includes an internal stop and in the deployed position, the hub portion of the actuatable obturator seats against the stop [Claim 5]; wherein the hollow housing comprises a hollow needle hub and wherein the stop comprises an inner shoulder formed at one end of the hollow needle hub , the elongated needle extending distal to the hollow needle hub [Claim 6]; wherein a length of the elongated section is selected so that when the hub portion of the actuatable obturator seats against the stop, the blunt distal end of the obturator is located distal to the sharp distal tip [Claim 7]. Doing so would prevent the obturator sliding completely through the hollow needle (Par. 0022), as taught by Robson.
Regarding claim 12, Dubrul, as modified by Robson, further discloses wherein the actuatable obturator includes an actuator disposed along the hollow hub portion of the needle component, the actuator being operatively coupled to the actuatable obturator such that activation of the actuator releases the actuatable obturator allowing the biasing element to advance the actuatable obturator forward toward the sharp distal tip of the needle [i.e. actuator (17) held in the bore against the action of the spring, and the needle penetrates tissue from being advanced in part by the actuator resistance exerted by tissue is removed and the obturator returns to the extended position, see Robson figure 2 and paragraph 0026-0027].
Claims 34-38 are rejected under 35 U.S.C. 103 as being unpatentable over Breznock (US 2007/0021767) in view of Lui (US 2012/0277576).
Regarding claim 34, an invention relating to trocar systems, Breznock discloses an IV catheter device (100) comprising: a needle component (104; Par. 0025) having an elongated needle that extends outwardly from a needle hub (110), wherein the needle hub includes a flash chamber [i.e. inside of element 110]; a catheter component (106) that is detachably coupled to the needle component, the catheter component having a hollow body through which the elongated needle passes (Par. 0025), the catheter component having a flange (112) at a proximal end; and an actuatable obturator (140) that is disposed within the needle component travels through the flash chamber and moves between a pre-deployment position and a deployed position, wherein in the deployed position, the actuatable obturator is disposed within an inner lumen of the elongated needle and a blunt distal end of the actuatable obturator is located distal to a sharp distal tip of the elongated needle so as to blunt the elongated needle; wherein in the deployed position, the actuatable obturator passes completely through the flash chamber, while in the pre-deployment position, the actuatable obturator is located completely external to the flash chamber [i.e. when element 140 is completely pulled out of the device] (Par. 0012 & 0036). However, Breznock fails to disclose an actuatable echogenic obturator; wherein the actuatable echogenic obturator includes at least one echogenic element that provides localized increased echogenicity of the actuatable echogenic obturator and improved visualization of the actuatable echogenic obturator, wherein the actuatable echogenic obturator includes at least one region that is adjacent the at least one echogenic element and does not provide increased echogenicity [Claim 34]; wherein the at least one echogenic element is located at the blunt distal end [Claim 35]; wherein the at least one echogenic element comprises a first band and a second band spaced longitudinally from the first band [Claim 36]; wherein each of the first band and the second band comprises one of an etched region of the actuatable echogenic obturator and a region that is formed of an echodense material [Claim 37]; and wherein in the fully deployed position, an entire width of a least a section of the at least one echogenic element is visible beyond the sharp distal tip of the elongated needle [Claim 38].
In the analogous art of obturators, Lui teaches an actuatable echogenic obturator (24); and wherein the actuatable echogenic obturator includes at least one echogenic element [i.e. discrete echogenic markers] that provides localized increased echogenicity of the actuatable echogenic obturator and improved visualization of the actuatable echogenic obturator, wherein the actuatable echogenic obturator includes at least one region [i.e. space between discrete echogenic markers] that is adjacent the at least one echogenic element and does not provide increased echogenicity; wherein the at least one echogenic element is located at a blunt distal end (44); wherein the at least one echogenic element comprises a first band and a second band spaced longitudinally from the first band [i.e. an echogenic marker is positioned at the distal end of shaft, and additional echogenic markers are positioned at intervals of about 5.0 cm proximally along the length of the shaft]; wherein each of the first band and the second band comprises one of an etched region of the actuatable echogenic obturator and a region that is formed of an echodense material; and wherein in the fully deployed position, an entire width of a least a section of the at least one echogenic element is visible beyond the sharp distal tip of the elongated needle [i.e. given Yoon's disclosure of having the distal end of the obturator extending beyond the sharp distal tip of the elongated needle, the at least one echogenic element on the distal end of the obturator will be visible beyond the sharp distal tip of the elongated needle] (Par. 0026-0027).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Breznock to have an actuatable echogenic obturator; and wherein the actuatable echogenic obturator includes at least one echogenic element that provides localized increased echogenicity of the actuatable echogenic obturator and improved visualization of the actuatable echogenic obturator, wherein the actuatable echogenic obturator includes at least one region that is adjacent the at least one echogenic element and does not provide increased echogenicity [Claim 34]; wherein the at least one echogenic element is located at the blunt distal end [Claim 35]; wherein the at least one echogenic element comprises a first band and a second band spaced longitudinally from the first band [Claim 36]; wherein each of the first band and the second band comprises one of an etched region of the actuatable echogenic obturator and a region that is formed of an echodense material [Claim 37]; and wherein in the fully deployed position, an entire width of a least a section of the at least one echogenic element is visible beyond the sharp distal tip of the elongated needle [Claim 38]. Doing so would allow a physician to know how far the marker(s), and thus obturator and catheter, have traveled within the body (Par. 0026), as taught by Lui.
Allowable Subject Matter
Claim 13 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Prior art references Dubrul, in view of Robson, disclose the claim as substantially detailed. However, the combination fails to disclose wherein in the pre-deployment position, the actuatable obturator is contained completely within the rear section. Prior art reference Breznock teaches wherein in the pre-deployment position, the actuatable obturator is contained completely within the rear section [i.e. sliding the obturator (140) via element 108 until the obturator is only located within elements 110, 116, 128] (Fig. 2; Par. 0034). Modifying the prior art to include the missing limitations wouldn't have been obvious because the modification would only be motivated by hindsight and would possibly render the device inoperable because the spring would have to be removed for the device to function as intended in Breznock.
Claims 14-16 are allowable. The following is a statement of reasons for the indication of allowable subject matter: There is no art of record alone or in combination that teaches of an IV catheter device that includes the combination of recited limitations in claim 14.
Prior art references Dubrul, in view of Robson, disclose the claim as substantially detailed. However, the combination fails to disclose wherein in the pre-deployment position, the actuatable obturator is contained completely within the rear section. Prior art reference Breznock teaches wherein in the pre-deployment position, the actuatable obturator is contained completely within the rear section [i.e. sliding the obturator (140) via element 108 until the obturator is only located within elements 110, 116, 128] (Fig. 2; Par. 0034). Modifying the prior art to include the missing limitations wouldn't have been obvious because the modification would only be motivated by hindsight and would possibly render the device inoperable because the spring would have to be removed for the device to function as intended in Breznock. Claims 15-16 are allowable for the same reasons as claim 14 by virtue of dependency on claim 14.
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 Examiner Chima Igboko whose telephone number is (571)272-8422. The examiner can normally be reached on Monday-Friday 9:00am-6:00pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jackie Ho, at (571) 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.U.I/ Examiner, Art Unit 3771
/ASHLEY L FISHBACK/Primary Examiner, Art Unit 3771 May 30, 2026
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