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 .
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 17, 18, and 23 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 17 depends from claim 16, which already introduces "a modulator configured to provide the electric field." Claim 17 again recites "a modulator" using the indefinite article "a," which creates ambiguity as to whether this is the same modulator previously recited in claim 16 or a second, distinct modulator. If it is the same modulator, the claim should use the definite article "the modulator." This ambiguity renders the scope of claim 17 unclear.
Claim 18 first introduces "a pumping mechanism" and then refers to "a fluid path of pumping mechanism" (omitting the article before "pumping mechanism"). The phrase "a fluid path of pumping mechanism" is grammatically incomplete and lacks the required article. The intended phrase is presumably "a fluid path of the pumping mechanism," where "the pumping mechanism" refers back to the previously introduced "a pumping mechanism." As written, the phrase is ambiguous and renders the scope of claim 18 indefinite.
Claim 23 uses the phrase "said coupling" to refer to a previously introduced noun. However, "coupling" does not appear as a noun in claim 23 or in any of its parent claims (claims 19 and 13). In the preceding clause of claim 23, the word "coupled" appears only as a verb in the phrase "configured to be coupled to said patient." Because "coupling" was never introduced as a noun, the phrase "said coupling" lacks proper antecedent basis and renders the scope of claim 23 indefinite.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 13, 14, 15, 19, and 23 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Muller (US 2010/0022935A1).
Independent claim 13 recites a medical device, comprising:
at least one electric-field sensor configured to estimate a characteristic of an electric field associated with a patient; and
a measuring component operatively coupled to the at least one electric-field sensor to receive the estimate of the characteristic of the electric field."
In relation to independent claim 13, Muller discloses each limitation of claim 13. Muller
discloses a medical device, specifically a hemodialysis machine system (Abstract; Fig. 1). Muller discloses at least one electric-field sensor configured to estimate a characteristic of an electric field associated with a patient: Muller's non-contact sensor 71 is described as detecting "a value of a quantity corresponding to the electric current" generated in the patient's vascular system and the extracorporeal blood circuit, and the sensor may be "an electromagnetic induction coil, a capacitive sensor, a hall-effect sensor" ([0039]). The detected quantity is a characteristic of the electric field (current, voltage, or flux) associated with the patient. Muller further discloses a measuring component operatively coupled to the at least one electric-field sensor to receive the estimate of the characteristic of the electric field: Muller's signal processing module 72 and microcontroller 78 are operatively connected to the non-contact sensor 71 and receive the detected value of the quantity corresponding to the current ([0039]).
In relation to claim 14, Muller discloses wherein the characteristic of the electric field is a magnitude. Muller's sensor detects the instantaneous current or voltage (a magnitude) in the patient's vascular system and extracorporeal blood circuit ([0039], [0045]). The microcontroller 78 compares
the detected value against expected ranges, confirming that the detected quantity is a magnitude value ([0039]).
In relation to claim 15, Muller discloses wherein the characteristic of the electric field is a flux. Muller's sensor may be an electromagnetic induction coil, which detects electromagnetic flux ([0039]). The detection of a quantity corresponding to the time-varying electric current via an induction coil constitutes detection of electromagnetic flux.
In relation to claim 19, Muller discloses wherein the characteristic is at least one of a magnitude and a flux. As set forth above with respect to claims 14 and 15, Muller's sensor detects a value of a quantity corresponding to the current, which may be a magnitude (voltage or current level) or a flux
(via induction coil), or both depending on the sensor type selected ([0039]).
In relation to claim 23, Muller discloses the electric-field sensor (non-contact sensor) positioned atop the access site of the patient, near the vascular system of the patient, or near the tubing ([0010],
[0039]). Muller's sensor communicates with the hemodialysis machine controller via a radio
transmitter (wireless coupling) or alternatively via a wire harness (wired coupling) ([0040],
[0046]). Muller thus discloses that the sensor is configured to be coupled to the patient via
either a wired or wireless coupling. It would have been obvious to a person of ordinary skill
in the art to provide both wired and wireless coupling options for the sensor, as both
options are explicitly taught by Muller.
Claim Rejections - 35 USC § 103
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.
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 16, 17, 18, 20, 21, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Muller (US 2010/0022935A1) in view of Williams et al. (US 6,754,472; hereinafter “Williams”).
In relation to claim 16, Muller discloses the medical device of claim 13, as set forth above. Muller does not explicitly disclose a modulator configured to provide the electric field, the electric field being modulated. While Muller discloses generating a time-varying electric current (which inherently involves some form of signal generation), Muller does not disclose a dedicated modulator that modulates the electric field to encode information or to provide a specifically modulated waveform.
However, Williams discloses a modulator configured to provide a modulated electrical signal transmitted through the body of a person (Abstract; col. 9, lines 16–21; claim 14). Williams teaches that modulating the signal allows information to be encoded and transmitted through the body as a conductive medium.
Based on the above comments, it would have been obvious to a person of ordinary skill in the art at the time of filing to modify the medical device of Muller to include a modulator as taught by Williams. The motivation to combine would have been to improve the ability to distinguish the intended electric field signal from ambient electrical noise by modulating the signal at a specific frequency or with a specific encoding scheme, thereby increasing the reliability of the access disconnect detection system. A person of ordinary skill in the art would have recognized that modulating the electric field, as taught by Williams, could be straightforwardly applied to the system of Muller to improve signal-to-noise ratio and detection accuracy.
In relation to claim 17, Muller discloses applying the electric field to the extracorporeal blood circuit, which constitutes a fluid path of a pumping mechanism (hemodialysis machine with blood pump 11) ([0008], [0010], [0021]). Muller does not explicitly disclose a modulator applying the modulated electric field to the fluid path. Williams discloses a modulator providing a modulated signal through a conductive medium (Abstract; col. 4, lines 19–21, claims 46 and 47). Based on the above comments, it would have been obvious to combine these teachings to apply the modulated electric field to the fluid path of the pumping mechanism, as the conductive fluid (blood) in the extracorporeal circuit serves as the transmission medium, consistent with the teachings of both Muller and Williams.
In relation to claim 18, Muller discloses a pumping mechanism configured to pump fluid (blood pump 11, [0021]) and applying the electric field to the fluid path of the hemodialysis machine ([0008], [0010]). Muller does not disclose a modulator for providing a modulated electric field to the fluid path. Williams discloses a modulator for providing a modulated electrical signal through a conductive medium (Abstract; col. 2, lines 55–65). Based on the above comments, it would have been obvious to combine these teachings for the reasons stated above with respect to claim 16.
In relation to claim 20, Muller discloses the medical device of claim 18, as set forth above. Muller does not explicitly disclose an authentication circuit to securely give commands to the pumping mechanism, nor a communication unit configured to communicate at least one command to the modulator. Williams discloses a system for transmitting information, including control signals and commands, between devices coupled to the human body (Abstract; col. 4, lines 1–6). Williams further discloses establishing master/slave control relationships between devices communicating through the body (claim 41), and a communication unit receiving signals from the modulator and transmitting commands back (claims 14, 15, 50). Based on the above comments, it would have been obvious to a person of ordinary skill in the art to modify the system of Muller with the authentication and communication teachings of Williams to include an authentication circuit and a communication unit configured to securely communicate commands to the modulator and pumping mechanism. The motivation to combine would have been to ensure the security and integrity of commands given to the medical pump, preventing unauthorized or accidental modification of pumping parameters, which is a recognized safety concern in medical device design.
In relation to claim 21, Muller discloses generating a time-varying electric current in the vascular system of the patient ([0008]), which constitutes injecting a signal into the patient. Williams discloses a modulator generating a signal that is transmitted through the body of a person (Abstract). Accordingly, it would have been obvious to configure the modulator to generate a signal injected into the patient, as this is the fundamental operating principle of both Muller and Williams. Since this enhancement would have been well-known in the art, its implementation in the invention would have been considered an obvious alternative in the design of the medical device.
In relation to claim 22, Williams discloses a communication unit (receiver device) that receives the signal transmitted through the body and communicates information back to the transmitting device (claims 15, 50). Accordingly, it would have been obvious to configure the communication unit to recover the signal injected by the modulator and communicate it back to the modulator, as taught by Williams, to verify that the signal was successfully transmitted through the patient and that the patient is properly connected to the system. This would have enhanced the safety and reliability of the medical device.
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.
Claim 14 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,994,074. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the cited patent discloses all the structural elements disclosed in claim 14 of this application. Claim 1 of the cited patent discloses:
a pumping mechanism [medical device] configured to pump fluid;
a modulator configured to provide a modulated electric field, wherein the modulator is configured to apply the modulated electric field to at least one of a fluid path of the pumping mechanism and a patient;
an electric-field sensor configured to estimate an electric-field magnitude associated with the patient, wherein the electric-field sensor is configured to be operatively coupled to at least one of a fluid path of the pumping mechanism and the patient; and
a measurement component operatively coupled to the electric-field sensor to receive the estimate of the electric-field magnitude.
Since claim 1 of the cited patent discloses all the limitations of claim 14 of this application, it is concluded that claim 14 is not patentably distinct, and therefore, a double patenting rejection is justified.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MANUEL A MENDEZ whose telephone number is (571)272-4962. The examiner can normally be reached Mon-Fri 7:00 AM-5:00 PM.
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Respectfully submitted,
/MANUEL A MENDEZ/ Primary Examiner, Art Unit 3783
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