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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation is: “a noise rejection system” in claim 31. Upon review of the originally filed specifications (e.g. 120 Fig. 1, paragraphs [0075]-[0082]) and claim 32, the noise rejection system is interpreted as comprising a waveform generator and an operational amplifier.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 24-36 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.
In claims 24 and 36, the metes and bounds of the claimed invention are unclear. Claims 24 and 36 recite “…the gain amplifier is configured to amplify biopotential signals having a signal less than about 5 mV…”. The term about renders the claim unclear since the originally filed specifications do not provide any special definition for the term “about” and no tolerances have been provided. Therefore, the upper limit of the claimed range is unclear.
In claim 24 as recited, the surface electrodes are inferentially included and not positively recited and it is unclear if the surface electrodes are part of the claimed invention.
Claim 26 recites a “wireless communication subsystem” that actively drive the patient's body to a varying potential that shunts environmental noise currents flowing in the patient's body” and claim 34 recites “wherein the noise rejection system actively drives the patient's body to a constant potential value so as to shunt environmental noise currents flowing in the patient's body.” It is unclear as how how a “patient’s body” can be “actively driven”.
In claim 27, the metes and bounds of the claimed invention are unclear. Claim 27 recites “…a substantial portion of the varying potential is negative.” The term substantial renders the claim unclear since the originally filed specifications do not provide any special definition for the term “substantial” or any standard for ascertaining the requisite degree. Therefore, it is unclear as to what is meant by a substantial portion of the varying potential is negative. It raises questions such as is 50% or 75% or 25% of the varying potential a substantial portion that is negative.
In claim 31 as recited, the signal carrying conductor in a cable common-mode surface electrode are inferentially included and not positively recited and it is unclear if the conductor in the cable and the common-mode surface electrode are part of the claimed invention. further is the common-mode surface electrode same as the other surface electrodes in claim 27 or an additional surface electrode.
The dependent claims inherit the deficiencies.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 24- 35 are rejected under 35 U.S.C. 101 because it is drawn to non-statutory subject matter. Applicant recites part of a human, i.e. "…one or more surface electrodes placed on a patient to generate a wide-band cardiac phase gradient signal…” (Claim 24, lines 6-8). Thus, these claims include a human within the scope and are non-statutory.
A claim directed to or including within its scope a human is not considered to be patentable subject matter under 35 U.S.C. 101. The grant of a limited, but exclusive property right in a human being is prohibited by the Constitution. In re Wakefield, 422 F.2d 897, 164 USPQ 636 (CCPA 1970). The examiner suggests using the phrase "adapted to be placed" when referring to the placement of the surface electrodes in relation to the patient.
While no prior art rejection has been provided, claims 24-35 cannot be indicated as allowable due to the rejection under 35 U.S.C. 101 discussed above.
Allowable Subject Matter
Claim 36 would be allowable if rewritten or amended to overcome the rejection under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is an examiner’s statement of reasons for allowance:
The closest prior art is Clancy et al (U.S. Patent Application Publication Number: US 2006/0173364 A1, hereinafter “Clancy”) which teaches a biopotential acquisition subsystem and method comprising two or more biosignal acquisition channels ( e.g. 102,102’ Fig.1B) each biosignal acquisition channel comprising a gain amplifier configured to amplify biopotential signals received from one or more a corresponding surface electrodes placed on a patient to generate a wide-band cardiac phase gradient signal (e.g. [0033],[0034], [0059-[0060], [0062], [0069],[0070], [0079], [0096],[0108]); and
a wireless communication subsystem comprising an antenna and a transceiver, the transceiver being configured to transmit, via the antenna, data stream associated with the wide- band cardiac phase gradient signal to a remote computing device (e.g. abstract, [0007],[0037],[0081], [0107]).
McGrath (U.S. Patent Application Publication Number: US 2008/0045832 A1, hereinafter “McGrath”) teaches a biopotential acquisition subsystem and method comprising surface electrodes for obtaining wideband ECG signals (e.g. [0087]).
However no prior art was found teaching individually, or suggesting in combination, all of the features of the applicants' invention, specifically the wireless communication subsystem being configured to disable transmission of electromagnetic radiation over the antenna when the biopotential acquisition subsystem is acquiring the wide-band cardiac phase gradient signal, and being configured to enable transmission of electromagnetic radiation immediately following acquisition of the wide-band cardiac phase gradient signal by the biopotential acquisition subsystem in combination with the recited structural/ steps limitations of the claimed invention.
Applicant’s originally filed specification (e.g. [0004]) discusses that when the signal of interest has an order of magnitude of a few micro-Volts or even smaller, interference from external energy sources such as radiofrequency transmission as well as those from internal circuitries of the measurement instrument itself can affect the acquisition and recording of such information and therefore it is necessary to overcome these associated challenges.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MALLIKA DIPAYAN FAIRCHILD whose telephone number is (571)270-7043. The examiner can normally be reached Monday- Friday 8 am-5pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, BENJAMIN KLEIN can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MALLIKA D FAIRCHILD/Primary Examiner, Art Unit 3792
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