CTNF 18/238,971 CTNF 77797 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Election/Restrictions 08-25-01 AIA Applicant’s election without traverse of Group I, Species 2 (Fig. 1B) and Sub-Species A (Figs. 2A-2C) in the reply filed on 05/29/26 is acknowledged. Applicant states that the claims 1-3, 6-9 and 11-16 read on the election of the elected Figs. 1B & 2A-2C. However, the claims 8-11 read on the non-elected Fig. 3A-3D (different embodiment with the elected Figs. 1B & 2A-2C). For example : claim 8 requires that a diameter 78 of a first portion of the lumen 62 between the air vent 64 and the first end 56 is greater than a diameter 82 of a second portion 84 of the lumen between the air vent 64 and the second end 58. This feature has been described in the Fig. 3D but not in the elected Figs. 2A-2C. Note : The Figs. 2A-2C describes that the diameter of the first portion 662 is smaller than a diameter 66 in the second portion. The other claims 9-12 read on the non-elected Figs. 3A-3D. Therefore, claims 8-12 withdrawn from further consideration. 08-06 AIA Claim s 4-5, 8-12, 17-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II, Species 1 (Fig. 1A), & Sub-Species B-C (Figs. 2D-3D) , there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/29/26 . Currently, claims 1-3, 6-7 and 13-16 are being examined in the office action . Drawings The drawing in the elected Fig. 1A is objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the features of “ patency indicato r” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. 06-22 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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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. Claim Rejections - 35 USC § 112 07-30-02 AIA 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. 07-34-01 Claims 1-1-3, 6-7 and 13-16 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. The elected Fig. 1B does not show a location of “patency indicator”. In the original specifciaotn (US 2024/0082558) of the current application, the para [0031] states that: ... In some embodiments, a second sampling port 42 may provide an alternate or additional port than an access connector 44 for coupling of the patency indicator 22 . The statement in the para [0031] is confusing. It is unclear to Examiner that where is a patency indicator 22 being located in the arterial line system in Fig. 1B. Does Applicant mean that the claimed “patency indicator 22” is located at the second sampling 42? Applicant is requested to provide the patency indicator feature in the Fig. 1B. Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. 07-20-aia AIA 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. 07-27-aia AIA Claim s 1-3, 6-7 are rejected under 35 U.S.C. 102( a)(1 ) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Conway et al. (US 2009/0043225) . Regarding claims 1 & 3 , Conway discloses a patency indicator 10, in Figs. 27A-27B for use with an arterial line, the patency indicator 10 comprising: a body 328, comprising: a first end 30 comprising a luer adapter, i.e. nose 30; Note : a nose 30 has similar structure of the first end 56, i.e., luer slip adapter 56 in Figs. 2A-2C of the current application. A person skilled in the art would recognize that the nose 30 can be inserted into the Luer-connector. Therefore, the nose 30 is equivalent or fair enough to call as a luer slip adapter. a second end 20 opposite the first end, wherein the second end is closed; (via #64) and a transparent portion 100 (in Fig. 1) between the first end and the second end. Therefore, the transparent portion 100 in Fig. 1 can be provided in/on the body 328 in the device in Fig. 27A. a lumen 22 extending through the first end and towards the second end; and an air vent 349 disposed within the body between the first end and the second end, wherein the air vent is configured to pass air and not blood, para [0064]. Regarding claim 2 , wherein in response to arterial blood entering the lumen at the first end, an air pocket (e.g., a hole where is the valve 349 sits therein, or around or near a porous vent plug 352) is configured to form between the second end 20 and the air vent 349, and the transparent portion 100 is configured to align with a leading edge of the arterial blood for visualization of the leading edge of the arterial blood. Regarding claim 6 , wherein the transparent portion 100 comprises a lens. Regarding claim 7 , Conway states in para [0066]: As will be apparent to one skilled in the art, it is possible to combine one or more vent mechanisms in a single device or put identical vent mechanisms at more than one location in a device . In other words, a person skilled in the art would recognize that the transparent portion 100 can be located anywhere in between the first and second ends of the body of the device as considered as rearrangement part. Therefore, the air vent is disposed closer to the first end than the lens is to the first end and that is considered as rearrangement parts . 07-21-aia AIA Claim s 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Anderson et al. (US 2020/0390340) in view of Conway et al. (US 2009/0043225) . Regarding claim 13 , Anderson discloses in Fig. 2A, an arterial line, comprising: a catheter assembly 14 comprising a catheter 14; a pressure transducer 26; a patency indicator 16 disposed between the catheter assembly 14 and the pressure transducer 26, the patency indicator comprising: a body 16 comprising: a first end (at a distal end of the hub 16 or a nose of the hub 16) comprising a luer adapter. Note : a nose of the hub 16 has similar structure of the first end 56, i.e., luer slip adapter 56 in Figs. 2A-2C of the current application. A person skilled in the art would recognize that the nose can be inserted into the Luer-connector. Therefore, the nose is equivalent or fair enough to call as a luer slip adapter. a second end opposite the first end, wherein the second end is closed (by a sensor overall 20, see Fig. 2A); and a lumen (a passage 19 inside the hub 16) extending through the first end and towards the second end; Anderson does not disclose the limitations that: a transparent portion between the first end and the second end; and an air vent disposed within the body between the first end and the second end, wherein the air vent is configured to pass air and not blood. Conway discloses a patency indicator 10, in Figs. 27A-27B comprising: a body 328; a transparent portion 100 (in Fig. 1) between the first end and the second end. Therefore, the transparent portion 100 in Fig. 1 can be provided in/on the body 328 in the device in Fig. 27A; and an air vent 349 disposed within the body between the first end and the second end, wherein the air vent is configured to pass air and not blood, para [0064]. It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the device of Anderson with including a transparent portion 100 between the first end and the second end; and including an air vent disposed within the hub body, as taught by Conway, for the benefits of visualization by the user to confirm successful vein entry and allowing air escape from hub chamber. Regarding claim 14 , Anderson in view of Conway discloses all claimed subject matter as required. Conway (or Anderson in view of Conway) discloses that wherein in response to arterial blood entering the lumen at the first end, an air pocket (e.g., a hole where is the valve 349 sits therein, or around or near a porous vent plug 352) is configured to form between the second end 20 and the air vent 349, and the transparent portion 100 is configured to align with a leading edge of the arterial blood for visualization of the leading edge of the arterial blood. In addition, a person skilled in the art would recognize that the transparent portion 100 can be located anywhere in between the first and second ends of the body of the device as considered as rearrangement part. Regarding claim 15 , Anderson in view of Conway discloses all claimed subject matter as required. Anderson discloses in Fig. 6 that wherein the catheter assembly 12 comprises a catheter adapter (catheter hub is located at a proximal end of the catheter/tubing), wherein the catheter extends from a distal end of the catheter adapter/hub; wherein the catheter adapter/hub comprises a port, wherein the patency indicator is coupled to the port. A person skilled in the art would recognize that the catheter assembly 12 in Fig. 6 can be replaced to the catheter 14 in Fig. 2A. PNG media_image1.png 408 697 media_image1.png Greyscale Regarding claim 16 , Anderson in view of Conway discloses all claimed subject matter as required. Anderson discloses that a sampling port (an upward-Y branch port, i.e., to/from input/out to/from blood vessel, fluid in/out, see Fig. 2A) disposed between the catheter assembly 14 and the pressure transducer 26, wherein the patency indicator 16 is coupled to the sampling port . 07-21-aia AIA Claim 15 is alternatively rejected under 35 U.S.C. 103 as being unpatentable over Anderson et al. (US 2020/0390340) in view of Conway et al. (US 2009/0043225) in view of Maxwell (US 4,928,694) . Note: in case the Applicant disagrees with the rationale for the rejection of claim 15 above, claim 15 is alternatively being rejected as follows. Anderson in view of Conway discloses all claimed subject matter as required. Anderson (or Anderson in view of Conway) does not disclose that the catheter assembly 14 comprises a catheter adapter, wherein the catheter extends from a distal end of the catheter adapter, wherein the catheter adapter comprises a port, wherein the patency indicator is coupled to the port. Maxwell discloses an arterial line comprising: a catheter assembly 53 (in Figs. 1, 7 & 9) comprises a catheter adapter 67; wherein the catheter 53/59 (Fig. 7) extends from a distal end of the catheter adapter 67, wherein the catheter adapter 67 comprises a port 57, wherein a patency indicator 55 (Y-branch catheter hub 95) is coupled to the port. It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the catheter assembly of Anderson in view of Conway with including a catheter adapter, as taught by Maxwell, in order to attach and release the catheter assembly to the patency indicator . 07-21-aia AIA Claim s 1-3 & 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Quang et al. (US 5,045,096) in view of Conway et al. (US 2009/0043225) . Regarding claim 1 , Quang discloses a device in Figs. 1-2 (can be called as a patency indicator) for use with an arterial line, the device comprising: a body 2, comprising: a first end 5, comprising a luer adapter 5; a second end opposite the first end, wherein the second end is closed (by a cover 7); and a lumen 1 extending through the first end and towards the second end; and an air vent 15 disposed within the body between the first end and the second end, wherein the air vent is configured to pass air and not blood, col. 4, lines 42-45. Quang does not disclose that a transparent portion between the first end and the second end. Conway discloses a patency indicator 10 for use with an arterial line comprising: a body 12 having a first end 30 and second end 20 is closed; a transparent portion 100 between the first end and the second end, see Fig. 1. It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the device of Quang with including a transparent portion 100 between the first end and the second end, as taught by Conway, in order to provide a timely indication of proper vein entry with the help of a venting mechanism. Regarding claim 2 , Quang in view of Conway discloses all claimed subject matter as required. Quang discloses that wherein in response to arterial blood entering the lumen at the first end, an air pocket 3 (about arrow area 12, see Fig. 1-2) is configured to form between the second end and the air vent, and the transparent portion 100 (as modified by Conway) is configured to align with a leading edge of the arterial blood for visualization of the leading edge of the arterial blood, see Fig. 1 in Conway. In addition, a person skilled in the art would recognize that the transparent portion 100 can be located anywhere in between the first and second ends of the body of the device as considered as rearrangement part. Regarding claim 3 , Quang in view of Conway discloses all claimed subject matter as required. Quang discloses that wherein the luer adapter comprises a luer slip adapter. Regarding claim 6 , Quang in view of Conway discloses all claimed subject matter as required. Conway discloses that wherein the transparent portion 100 comprises a lens. Regarding claim 7 , Quang in view of Conway discloses all claimed subject matter as required. The air vent 15 in Quang is disposed closer to the second end. Meanwhile, the claimed invention requires that the air vent is disposed closer to the first end than the lens is to the first end. It would have been obvious to one having ordinary skill in the art, prior to the effective filling date of the claimed invention was made to obtain the air vent being disposed closer to the first end than the lens being to the first end, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70 . Examiner Notes Examiner cites particular columns and line numbers in the references as applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUYNH-NHU HOANG VU whose telephone number is (571)272-3228. The examiner can normally be reached on M-F 7:30 am-4:00 pm. 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, Michael Tsai can be reached on 571-270-5246 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /Quynh-Nhu H. Vu/ Quynh-Nhu H Vu Primary Examiner, Art Unit 3783 Application/Control Number: 18/238,971 Page 2 Art Unit: 3783 Application/Control Number: 18/238,971 Page 3 Art Unit: 3783 Application/Control Number: 18/238,971 Page 4 Art Unit: 3783 Application/Control Number: 18/238,971 Page 5 Art Unit: 3783 Application/Control Number: 18/238,971 Page 6 Art Unit: 3783 Application/Control Number: 18/238,971 Page 7 Art Unit: 3783 Application/Control Number: 18/238,971 Page 8 Art Unit: 3783 Application/Control Number: 18/238,971 Page 9 Art Unit: 3783 Application/Control Number: 18/238,971 Page 10 Art Unit: 3783
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