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 .
Acknowledgment
Claims 1, 6, 13, 16-17 are amended and filed on 12/10/2025.
Claims 8, 10, 14 are canceled and claims 21-22 are newly added.
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 3, 5 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 3 recites the limitation "a distal end of the septum" in line 1. It is unclear if it is referring to the limitation in claim 1, line 7 of it is referring to new limitation. For the purpose of examination, the examiner will interpret the limitation as it is referring to the limitation in claim 1.
Claim 5 recites the limitation "a distal end of the septum" in line 1. It is unclear if it is referring to the limitation in claim 1, line 7 of it is referring to new limitation. For the purpose of examination, the examiner will interpret the limitation as it is referring to the limitation in claim 1.
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) 6-7, 9, 11-12 is/are rejected under 35 U.S.C. 102(a) (1) as being anticipated by Harding et al. (US. 20200078579A1)( Harding").
Re Claim 6, Harding discloses a catheter assembly (Fig. 1-4), comprising: a catheter adapter (12), comprising a body (19) and a side port (18)extending outwardly from the body (Fig.4), wherein the body comprises a distal end (22, Fig. 2c), a proximal end (right end of 19), and an inner surface extending through the distal end and the proximal end and forming a lumen (inner surface of 19, Fig. 2c, Fig. 4), wherein the side port comprises a side port pathway (34) extending through the side port and in fluid communication with the lumen (Fig. 4); a catheter (14) extending distally from the distal end of the catheter adapter (Fig. 2b, Fig. 4); and a septum (64) disposed within the lumen (Fig. 4), wherein a distal end of the septum is approximately aligned with or distal to a proximal edge of the side port pathway (70, 66 of 64, Fig. 4, is distal or align with top end of 34, Fig. 4, ¶0063, Annotated Fig. 4 of Harding) wherein the distal end of the septum comprises a planar distal face ( face under 70 is planar) and an arm (70) extending distally from the planar distal face (Fig.4), wherein a length of the arm contacts the inner surface of the body (¶0065).
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Annotated Fig. 4 of Harding
Re Claim 7, Harding discloses wherein the side port pathway is generally cylindrical (Fig. 4).
Re Claim 9, Harding discloses wherein the distal end of the septum is distal to the proximal edge of the side port pathway ( Fig. 4).
Re Claim 11, Harding discloses wherein an angle of the side port with respect to a longitudinal axis of the body is less than 45° (FIG. 2C, Fig. 4, angle theta, ¶0061).
Re Claim 12, Harding discloses wherein a distal end of the septum is asymmetric (Fig, 4).
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) 1-7, 9, 11-13, 15-19, 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harding et al. (US. 20200078579A1)(“ Harding”).
Re Claim 1, Harding discloses a catheter assembly (Fig. 1, an admitted prior art, ¶0043), comprising: a catheter adapter (4, ¶0043), comprising a body (body of 4) and a side port (9) extending outwardly from the body (Fig. 1), wherein the body comprises a distal end (top end of 4, Fig. 1), a proximal end ( close to 7, Fig. 7), and an inner surface ( inner surface of 4, Fig. 1) extending through the distal end and the proximal end and forming a lumen (Fig. 1), wherein an angle (angle between the axis of 9 and axis of 8) of the side port with respect to a longitudinal axis (axis of 8) of the body a catheter (14) extending distally from the distal end of the catheter adapter (2, Fig 1); and a septum (6) disposed within the lumen (Fig. 1), wherein a distal end of the septum comprises a protrusion ( in the middle of the distal end, annotated Fig, 1 of Harding) , wherein the protrusion is spaced apart from the inner surface of the body (Fig. 1), but it fails to discloses that the angle of the side port is less than 45 degree and an arm so that the protrusion is spaced apart from an arm, wherein the arm extends more distally than the protrusion, wherein a length of the arm contacts the inner surface of the body.
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Annotated Fig. 1 of Harding
However, Harding discloses in the embodiment (Fig. 2a-2d, 4) and a catheter assembly comprises a catheter adapter (12, Fig. 2c) and wherein the angle between the side port 42 and the axis of the body of the adapter 40) is less than 45 degree (¶0048) and the septum (64, Fig. 4) comprises distal end of comprises an arm (70, annotated Fig, 1 of Harding) extends distally ( annotated Fig, 1 of Harding, the arm extended to fit within the month 44, ¶0065), wherein a length of the arm contacts the inner surface of the body (¶0065).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the angle of the side port and the septum of the embodiment of Fig. 1 of Harding to include the angle of the side port with the axis of the adapter body is less than 45 degree and an arm so that that the angle of the side port is less than 45 degree and an arm so that the protrusion is spaced apart from an arm, wherein the arm extends more distally than the protrusion, wherein a length of the arm contacts the inner surface of the body as taught by embodiment of Fig. 4 of Harding for the purpose of directing the inserted interment in the side port to the catheter (Harding, ¶0052, wherein the arm is added to septum at the opposite side from the side port and it spaced from the protrusion at the central of the distal end and the arm will be extended distally to reach mouth 44 which across of the side port pathway opening at the body, ¶0065, Fig. 1 shows that the protrusion extend less than side port pathway opening at body, so that the arm extend distally more than the protrusion).
Re Claim 2, Harding discloses wherein the septum is disposed proximal to a side port pathway (34) extending through the side port and in fluid communication with the lumen (Fig. 41).
Re Claim 3, Harding discloses wherein a distal end of the septum (annotated Fig. 1 of Harding) is approximately aligned with or distal to a proximal edge of the side port pathway (annotated Fig. 1 of Harding, substantially aligned ).
Re Claim 4, the modified Harding discloses wherein the angle of the side port with respect to the longitudinal axis of the body is about 25 degree (¶0048).
Re Claim 5, the modified Harding discloses wherein a distal end of the septum is asymmetric (Fig. 4).
Re Claim 13, Harding discloses a catheter assembly (Fig. 1, an admitted prior art, ¶0043), comprising: a catheter adapter (4, ¶0043), comprising a body (body of 4) and a side port (9) extending outwardly from the body (Fig. 1), wherein the body comprises a distal end (top end of 4, Fig. 1), a proximal end ( close to 7, Fig. 7), and an inner surface ( inner surface of 4, Fig. 1) extending through the distal end and the proximal end and forming a lumen (Fig. 1), wherein the side port comprises a side port pathway (annotated Fig. 1 of Harding) extending through the side port and in fluid communication with the lumen (Fig. 1); a catheter (annotated Fig. 1 of Harding) extending distally from the distal end of the catheter adapter (Fig. 1); and a septum (6,, ¶0044) disposed within the lumen (Fig. 1), wherein the distal end of the septum comprises a planar distal face (annotated Fig. 1) and a protrusion extending distally from the planar distal face ( Fig. 1), but it fails to discloses
However, Harding discloses in the embodiment (Fig. 2a-2d, 4) and a catheter assembly comprises a catheter adapter (12, Fig. 2c) and wherein the angle between the side port 42 and the axis of the body of the adapter 40) is less than 45 degree (¶0048) and the septum (64, Fig. 4) comprises distal end of comprises an arm (70, annotated Fig, 1 of Harding) extends distally ( annotated Fig, 1 of Harding, the arm extended to fit within the month 44, ¶0065), wherein a distal end of the septum is asymmetric (Fig. 4).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify distal end of septum of the embodiment of Fig. 1 of Harding by including an arm so that the distal end of the septum is asymmetric as taught by embodiment of Fig. 4 of Harding for the purpose of directing the inserted interment in the side port to the catheter (Harding, ¶0052, wherein the arm is added to septum at the opposite side from the side port and it spaced from the protrusion at the central of the distal end and the arm will be extended distally to reach mouth 44 which across of the side port pathway opening at the body, ¶0065).
Re Claim 15, embodiment of Fig. 1 of Harding fails to disclose wherein the distal end comprises an arm extending distally and contacting the inner surface, wherein the arm is on an opposite side of the lumen as the side port.
However, Harding discloses in the embodiment (Fig. 2a-2d, 4) and a catheter assembly comprises a catheter adapter (12, Fig. 2c) and wherein the angle between the side port 42 and the axis of the body of the adapter 40) is less than 45 degree (¶0048) and the septum (64, Fig. 4) comprises distal end of comprises an arm (70, annotated Fig, 1 of Harding) extending distally and contacting the inner surface (Fig. 4), wherein the arm is on an opposite side of the lumen as the side port (Fig. 4).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify distal end of septum of the embodiment of Fig. 1 of Harding by including an arm so that the distal end comprises an arm extending distally and contacting the inner surface, wherein the arm is on an opposite side of the lumen as the side port as taught by embodiment of Fig. 4 of Harding for the purpose of directing the inserted interment in the side port to the catheter (Harding, ¶0052, wherein the arm is added to septum at the opposite side from the side port and it spaced from the protrusion at the central of the distal end and the arm will be extended distally to reach mouth 44 which across of the side port pathway opening at the body, ¶0065).
Re Claim 16, Harding in the embodiment of Fig, 1 fails to disclose wherein a distal end of the arm comprises an extension extending inwardly and across a longitudinal axis of the body.
However, Fig. 3a of Harding discloses wherein a distal end of the arm (59) comprises an extension ( left surface of 59, ¶0057), extending inwardly and across a longitudinal axis of the body (¶0057).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify distal end of septum of the embodiment of Fig. 1 of Harding so that a distal end of the arm comprises an extension extending inwardly and across a longitudinal axis of the body as taught by embodiment of Fig. 3a of Harding for the purpose of directing the fluid from the side port to the catheter (Harding, ¶0052).
Re Claim 17, Harding in the embodiment of Fig, 1 fails to disclose wherein a proximal side of the extension is disposed distal to a proximal edge of the side port pathway wherein the extension extends perpendicular to the extension.
However, Fig. 3a of Harding discloses wherein a distal end of the arm (59) comprises an extension ( left surface of 59, ¶0057), extending inwardly and across a longitudinal axis of the body (¶0057) and wherein a proximal side of the extension is disposed distal to a proximal edge of the side port pathway wherein the extension extends perpendicular to the extension (Fig. 3b).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify distal end of septum of the embodiment of Fig. 1 of Harding so that a proximal side of the extension is disposed distal to a proximal edge of the side port pathway wherein the extension extends perpendicular to the extension as taught by embodiment of Fig. 3a of Harding for the purpose of directing the fluid from the side port to the catheter (Harding, ¶0052).
Re Claim 18, Harding in the embodiment of Fig, 1 fails to disclose wherein an angle of the side port with respect to a longitudinal axis of the body is less than 45 degree.
However, Harding discloses in the embodiment (Fig. 2a-2d, 4) and a catheter assembly comprises a catheter adapter (12, Fig. 2c) and wherein the angle between the side port 42 and the axis of the body of the adapter 40) is less than 45 degree (¶0048) and the septum (64, Fig. 4) comprises distal end of comprises an arm (70, annotated Fig, 1 of Harding) extends distally ( annotated Fig, 1 of Harding, the arm extended to fit within the month 44, ¶0065), wherein a length of the arm contacts the inner surface of the body (¶0065).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the angle of the side port and the septum of the embodiment of Fig. 1 of Harding to include the angle of the side port with the axis of the adapter body is less than 45 degree as taught by embodiment of Fig. 4 of Harding for the purpose of directing the inserted interment in the side port to the catheter (Harding, ¶0052).
Re Claim 19, Harding discloses wherein a side of the septum closest to the side port pathway is aligned with or distal to a proximal edge of the side port pathway (Fig. 1).
Re Claim 21, the modified Harding discloses wherein the arm is spaced apart from the protrusion by the planar distal face of the septum (Harding, ¶0052, wherein the arm of Fig, 4 is added to septum 6 of Fig. 1 at the opposite side from the side port and it spaced from the protrusion at the central of the distal end).
Re Claim 22, Harding discloses wherein a longitudinal axis of the body passes through the protrusion ( Fig. 1).
Response to Arguments
Applicant’s arguments, see remark, filed 12/10/2025 with respect to the rejection(s) of claim(s) 1, 13 under 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made over the admitted prior art in Fig, 1 of Harding in view of embodiment of Fig. 4 of Harding .
The argument with regards to claim 6 has been fully considered and are not persuasive as the tilted distal surface of septum 64 in Fig, 5 is planar distal face
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 HAMZA A. DARB whose telephone number is (571)270-1202. The examiner can normally be reached 8:00-5:00 M-F (EST).
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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.
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/HAMZA A DARB/ Examiner, Art Unit 3783
/CHELSEA E STINSON/ Supervisory Patent Examiner, Art Unit 3783