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 .
Election/Restrictions
Applicant’s election without traverse of Group III, Claims 12-19 in the reply filed on 12/29/25 is acknowledged.
Claims 1-11 and 21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected product and a nonelected method, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/29/25.
Claim Objections
Claim 19 is objected to because of the following informalities: 1) the “with lumen” should be corrected. 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 12-19 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.
1) Regarding Claim 12, the phrase “sensor coupled disposed at the distal end of the flexible, elongate member” is grammatically incorrect and incomplete, to the point where the bounds of the claim are not discernable. What does “coupled disposed at” entail? Is it both coupled at and disposed at the distal end? Is it either coupled or disposed? Is it coupled to be disposed at? Is it disposed via coupling? What state of connection, arrangement or location is “coupled disposed at” meant to cover?
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 12-16, and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2021/0204818 by Akins.
Regarding Claim 12, Akins discloses a system comprising:
a medical device (e.g. abstract: catheter assembly) comprising:
a flexible, elongated member configured for insertion within a body such that a distal end may be positioned near a cavoatrial junction of a patient, the flexible, elongated member having a proximal end, and a lumen extending along a length of the flexible, elongated member (e.g. abstract, ¶¶ 4,14,57-58,61,124, and 133, and Fig. 1, 11, 24-25: vascular access catheter assembly 10 with lumens 14 of a flexible catheter 12, which is advanceable near the CAJ as clearly see in Fig. 25, and monitors said advancement past the junction);
one sensor coupled disposed at the distal end of the flexible, elongated member (e.g. abstract, ¶¶ 18,54,58-59, Fig. 16-18, 24: multiple sensors are both coupled to, indirectly or directly, the catheter 12, as well as disposed at the distal end of the tube 12. As one example, see sensors 32/200/210 at the distal end 13 of the catheter in ¶¶ 18, 91-93, Fig. 16-18. As another example, see ¶¶ 91,116, and Fig. 16-18, and 24: multiple temperature sensors 100a/100b are placed and integrated along the length of the distal end 13 of the catheter 12);
an external device in wireless communication with the medical device and configured to receive data from the sensor (e.g. ¶¶ 48,60,67,77,107,118, and Fig. 11, and 24: wireless communication between the catheter assembly 10 and its sensors, and an external device, such as a smartphone 120/console 2402).
Regarding Claim 13, Akins discloses the system of claim 12, wherein the sensor includes a pressure sensor (e.g. ¶ 91, Fig. 16: any of the sensors disclosed are included in sensor array 200, such as a pressure sensor; ¶92: glucose sensor)
Regarding Claim 14, Akins discloses the system of claim 12, wherein the sensor includes a first temperature sensor and a second temperature sensor disposed a known distance from the first temperature sensor (e.g. ¶ 91 places all sensors 30 at the distal end, which would include the multiple temperature sensors 100a and 100b used to detect temperature at different locations along the length of catheter 12, and ¶ 116 places said multiple temperature sensors at the distal end; Also see ¶¶ 113, and Fig. 16-18, and 24).
Regarding Claim 15, Akins discloses the system of claim 12, wherein the flexible, elongated member is configured as a peripherally inserted central catheter (¶ 57: PICC).
Regarding Claim 16, Akins discloses the system of claim 12, wherein the flexible, elongated member is configured as a central venous catheter (¶ 57: CVC).
Regarding Claim 17, Akins discloses the system of claim 12, wherein the external device provides power to the sensor (¶118: external console 2402 powers the entire catheter assembly 10).
Regarding Claim 19, Akins discloses the system of claim 12, further comprising a volume of fluid in communication with lumen of the elongated, flexible member (See MPEP 2115: Material worked upon does not limit apparatus claims. The device of Akins includes catheter 12 with lumens 14, and such lumens are capable of receiving fluids, see e.g. ¶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 18 is rejected under 35 U.S.C. 103 as being unpatentable over Akins, as applied to Claim 17, in view of US 2009/0131854 by DiCarlo.
Regarding Claims 18, Akins discloses the system of claim 17, yet does not explicitly disclose wherein the external device provides wireless power to the sensor.
However, Akins does teach that the catheter assembly 10 does receive power remotely (¶66). Dekker teaches an analogous intravascular catheter with temperature monitoring, wherein the sensors of the catheter are powered wirelessly by an external device (e.g. abstract, ¶¶ 2,15,21,58,65). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate wirelessly powering the sensors of the catheter with the external device according to the teachings of Akins, as taught by DiCarlo, as this would only amount to an equivalent mechanism of predictably powering the sensors with the external device, and furthermore, this would obviate the need for wires or intermediary powering devices.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 12 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,268,525 in view of Akins.
Regarding Claim 12, Claim 1 of the issued patent teaches a system comprising: a medical device comprising: a flexible, elongated member configured for insertion within a body; the flexible, elongated member having a proximal end, and at least one lumen extending along a length of the flexible, elongated member; at least one sensor coupled disposed at the distal end of the flexible, elongated member (Claim 1: a peripherally inserted central catheter having an elongated tube structure comprising a proximal end, a distal end, and a lumen extending therethrough; a set of sensors coupled to a distal section of the tube structure, the set of sensors comprising at least one pressure sensor and at least one imaging sensor); an external device in wireless communication with the medical device and configured to receive data from the at least one sensor (Claim 1: wherein the power and data coupling device is configured to wirelessly communicate with one or more external devices).
Claim 1 of the issued patent does not explicitly disclose the capability of the elongate member such that a distal end may be positioned at or near a cavoatrial junction of a patient. However, Akins discloses an analogous PICC which can be advanced near the CAJ (e.g. abstract, ¶¶ 4,14,57-58,61,124, and 133, and Fig. 1, 11, 24-25: vascular access catheter assembly 10 with lumens 14 of a flexible catheter 12, which is advanceable near the CAJ as clearly see in Fig. 25, and monitors said advancement past the junction). Therefore, it would have been obvious to a person having ordinary skill in the art to size a catheter according to Claim 1 of the issued patent such that it is advanceable near the CAJ, as taught by Akins, as: a) it has been held that a change in the shape or proportion of a prior art device is a design consideration within the skill of the art (See MPEP 2144.04.IV.A), and b) in order to predictably acquire hemodynamic measurements, such as CVP.
Regarding Claim 13, Claim 1 of the issued patent as modified in Claim 12 teaches the system of claim 12, wherein the at least one sensor includes a pressure sensor (Claim 1: pressure sensor).
Regarding Claims 15-16, Claim 1 of the issued patent as modified in Claim 12 teaches the system of claim 12, wherein the flexible, elongated member is configured as a peripherally inserted central catheter and as a central venous catheter (Claim 1: PICC).
Regarding Claims 17-18, Claim 1 of the issued patent as modified in Claim 12 teaches the system of claim 12, wherein the external device provides wireless power to the at least one sensor (Claim 1: wireless transfer of power).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MANOLIS Y PAHAKIS whose telephone number is (571)272-7179. The examiner can normally be reached M-F 9-5, EST.
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/MANOLIS PAHAKIS/Examiner, Art Unit 3796