DETAILED ACTION
Claim Objections
Claim 10 objected to because of the following informalities:
Claim 10 depends from claim 1, yet claim 10 recites multiple limitations, including “the unbiased barriers”, and “the fingers”, which only find antecedent basis in claim 5. Therefore, it seems that claim 10 was intended to depend from claim 5, rather than claim 1.
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 1-20 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 has been amended to recite “a proximal section having a cross dimension larger than the cross dimension of the distal section configured to be proximal to the opened proximal end of the catheter hub” in lines 9-10. Firstly, the wording of “configured to proximal to the opened proximal end…” is unclear if it refers to the proximal section or specifically to the “cross dimension larger than the cross dimension of the distal section”. Secondly, “configured to be proximal to” implies that the proximal section/cross dimension is not currently in a state of being proximal to the opened proximal end of the catheter, but instead is designed to become proximal to the opened proximal end of the catheter. Based on the instant disclosure, it appears that the proximal section remains proximal to opened proximal end of the catheter hub throughout use of the assembly. Thus, the claim language creates a lack of clarity over whether it is intended for the proximal section/cross dimension to start out in a position that is not proximal to the opened proximal end of the catheter hub. The examiner points out a different amendment that was made to claim 1, stating “a guard proximal to the catheter hub” which avoids this issue.
Claim 12, line 17 recites “a ready to use position”. Because the claim already recited “a ready to use position” earlier in the claim, it is unclear if line 17 is referring to the same ready to use position or a different one.
Claims 14, 17, 18 and 20 each recite “the ready to use position” in at least one instance, which is now unclear based on the fact that claim 12 now introduces two different ready to use positions.
Claim 18 recites the limitation "the needle housing" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Dependent claims inherit the deficiencies of the claims from which they depend.
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.
Claim(s) 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cindrich et al. (US 2007/0093778 A1, hereafter “Cindrich”).
As to claim 12, Cindrich discloses a catheter assembly (20; see Figs. 1-11) comprising:
a catheter hub (24) having a body defined by a wall having a distal end (end where catheter 22 protrudes from) and an opened proximal end having a flange (flange seen in Figs. 1, 2, 13, 14, 17, 18), and an internal cavity defined by an inner surface of the wall between the distal end and the opened proximal end (see Figs. 13-15, 17-18 showing cross-section of 24);
a catheter (22) having a distal end extending from the distal end of the catheter hub along a longitudinal axis (12) (see Figs. 1, 2, 13, 14);
a wiper member (10) including a distal section having a cross dimension fit friction fitted into the opened proximal end of the catheter hub (see para 0056), the wiper member having an orifice (70) defined by a circular wall therethrough (see embodiments of Figs. 4-7);
a needle (30) having a diameter and a sharp distal tip (34) extending through the orifice of the wiper member and slidably extending along the catheter with the distal tip extending beyond the distal end of the catheter when the catheter assembly is in a ready to use position (position for inserting into skin; see para 0049);
wherein the orifice has a dimension slightly smaller than the diameter of the needle such that the needle and the circular wall of the orifice are in circumferential contact with each other in a ready to use position (para 0013, Claim 6), the wiper member adapted to wipe off fluid adhered to the needle as the needle is withdrawn from the catheter hub and passes through the orifice (para 0013, Claim 6).
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.
Claim(s) 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cindrich in view of in view of Sonderegger et al. (US 2013/0090609 A1, cited previously and hereafter “Sonderegger”), and further in view of Akcay et al. (US 2016/0220791 A1, cited previously and hereafter “Akcay”).
As to claim 15, Cindrich discloses the catheter assembly of claim 12, wherein the catheter hub includes a sideport hub (see side/lateral port depicted on side of 24 in Figs. 1, 2).
While it is possible that the sideport hub of Cindrich further includes an opened end and an opening into the internal cavity of the catheter hub to establish a through fluid passage between the internal cavity of the catheter hub and a tubing adapted to be connected to the opened end of the sideport hub, Cindrich does not explicitly show these limitations.
Sonderegger however discloses wherein a catheter hub (14) includes a sideport hub (60) having an opened end (opened when cover 52 is opened) and an opening (54) into the internal cavity of the catheter hub to establish a through fluid passage between the internal cavity of the catheter hub (para 0029, 0030). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Cindrich such that the sideport hub has an opened end and an opening into the internal cavity of the catheter hub to establish a through fluid passage between the internal cavity of the catheter hub. One would have been motivated to do so in order to provide infusion of fluids into the catheter hub (see para 0024, 0029, 0030 of Sonderegger).
Cindrich and Sonderegger however are silent to a tubing adapted to be connected to the opened end of the sideport hub.
Akcay ‘791 teaches a tubing (127) adapted to be connected to an opened end of a sideport hub (125) (see Fig. 2b, para 0038, 0130). It would have been further obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, when modifying Cindrich, to include a tubing adapted to be connected to the opened end of the sideport hub. One would have been motivated to do so in order to allow connection of the catheter assembly to an IV fluid supply line (see para 0131 of Akcay).
As to claim 16, Cindrich in view of Sonderegger and Akcay ‘791 teaches the catheter assembly of claim 15 as described above.
Cindrich is silent to a resealable valve mounted to the inner wall of the catheter hub to cover the sideport opening, the sideport opening adapted to be opened when subjected to an input fluid at a given pressure or when push opened by a tube inserted through the opened end of the sideport hub, Sonderegger further discloses a resealable valve (60) mounted to the inner wall of the catheter hub to cover the sideport opening (see Fig. 2-4), the sideport opening adapted to be opened when subjected to an input fluid at a given pressure (see para 0029-0030 of Sonderegger).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention when modifying Cindrich, to further do so by including a resealable valve mounted to the inner wall of the catheter hub to cover the sideport opening, the sideport opening adapted to be opened when subjected to an input fluid at a given pressure. One would have been motivated to do so in order to keep the sideport opening closed until a particular pressure is reached (see para 0029-0030 of Sonderegger).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cindrich in view of Sonderegger.
As to claim 20, Cindrich discloses the catheter assembly of claim 12 as described above, but is silent to a resealable septum positioned in the internal cavity of the catheter hub distal the wiper member, the septum pierced by the needle when the catheter assembly is in the ready to use position, the septum reseals to close off the internal cavity distal of the septum from the proximal end of the catheter hub when the needle is withdrawn from the septum (however, this is only due to the fact that Cindrich’s “septum” is part of the wiper member and not a separate component – see distal portion 60 as depicted in Fig. 3-9).
However, Sonderegger discloses a resealable septum (70) positioned in the internal cavity of the catheter hub (14) in a distal portion, the septum pierced by a needle (86) when the catheter assembly is in the ready to use position (see Fig. 2), the septum reseals to close off the internal cavity distal of the septum from the proximal end of the catheter hub when the needle is withdrawn from the septum (para 0026, 0027). The septum (70) of Sonderegger is a separate component from other parts found within the internal cavity.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Cindrich to include a resealable septum positioned in the internal cavity of the catheter hub distal the wiper member (either as an additional component, or by separating distal portion 60 from the rest of the wiper member), the septum pierced by the needle when the catheter assembly is in the ready to use position, the septum reseals to close off the internal cavity distal of the septum from the proximal end of the catheter hub when the needle is withdrawn from the septum in view of Sonderegger. One would have been motivated to do so to provide a way of fluidically sealing the catheter hub distal the wiper member when the needle is not present (see para 0026, 0027 of Sonderegger).
Allowable Subject Matter
Claims 1-11 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Claims 13, 14, and 17-19 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
As to claim 1, the amendments have overcome the previous rejections using Dombrowski et al. (US 4,978,344) and Ackay et al. (US 2021/0100985 A1). Neither reference teaches the limitations of a wiper member including a distal section having a cross dimension configured to fit into the opened proximal end of the catheter hub into the internal cavity and a proximal section having a cross dimension larger than the cross dimension of the distal section configured to be proximal to the opened proximal end of the catheter hub; a guard proximal to the catheter hub in alignment with a needle hub along a longitudinal axis, in combination with the rest of the limitations of claim 1.
Claims 2-11 depend from claim 1.
As to claim 13, while Cindrich teaches the catheter assembly of claim 12 as described above, Cindrich is silent to a needle tip protector slidable along the needle, the needle tip protector having a base with an opening through which the needle passes, the needle tip protector including barriers biased by the needle and fingers responsive to the barriers being biased by the needle to grasp the catheter hub when the needle passes between the barriers in combination with the limitations of claim 12.
Claims 14 and 17-19 depend from claim 13.
Response to Arguments
Applicant’s Remarks submitted 7/14/26 have been considered.
With regard to the arguments concerning the previous claim objections and rejections under 35 U.S.C. 112(b) (pages 9-10 of Remarks), the amendments have obviated the previous claim objections and rejections, with the exception of an antecedent basis issue in claim 18. Further discussion would be moot.
With regard to the arguments concerning the previous rejections under 35 U.S.C. 102 and 35 U.S.C. 103 (pages 10-13 of Remarks), the amendments to claim 1 have obviated the previous rejections using Dombrowski et al. (US 4,978,344) and Ackay et al. (US 2021/0100985 A1). No prior art rejections are applied to claim 1. With regard to claim 12, the amendments have significantly changed the scope of the claim and have prompted the new rejections above using Cindrich.
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 James D Ponton whose telephone number is (571)272-1001. The examiner can normally be reached M-F 9am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/James D Ponton/ Primary Examiner, Art Unit 3783
Prosecution Insights