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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 59-62, 64, 65, 70-73, 75, 76, and 80-85 are objected to because of the following informalities:
“preferably” in each instance should be removed in order to avoid a potential indefiniteness issue as it may raise the question as to whether the limitations following the term are merely preferred or are required. See MPEP 2173.05(d).
Claim 68, line 8: “generated by field generator” should read --generated by the field generator--
Appropriate correction is required.
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.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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(s) is/are:
control unit first appearing in claim 58 (corresponding structure disclosed in applicant’s original specification as a computer, [0085] and its equivalents).
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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 78 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 68 requires the field generator to include a coil. Dependent claim 78 recites the field generator “comprises an electrode…or a coil design”. Accordingly, the scope of claim 78 encompasses an interpretation wherein the field generator includes both the coil (of claim 68) and the electrode (of claim 78). Applicant’s original specification only discloses an electrode and a coil provided in separate embodiments of a field generator, with no disclosure of an embodiment wherein the electrode and coil are provided together in a single field generator. Even though claim 78 appears in a preliminary amendment present on the filing date of the application thus is considered part of the original disclosure (MPEP 714.07e), applicant’s specification fails to provide adequate written description of the invention as claimed as there is no disclosure of a field generator comprising both an electrode to produce an electric field as well as a coil to produce an electromagnetic field. See MPEP 2163(I)(A) and 2163(II)(A)(3)(a).
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 65, 76, 78, and 85 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.
Claims 65, 76, and 85 each recite “the pulse temporal width comprises an increasing portion…and/or a decreasing portion…and wherein the increasing portion and the decreasing portion preferably together cover…”. The scope of “an increasing portion…and/or a decreasing portion” is interpreted as “at least one of”, such that one or both of the increasing and decreasing portions is required. Since “at least one of” the increasing and decreasing portions are initially recited, and subsequently “the increasing portion and the decreasing portion…together” is recited, it is unclear whether applicant intends to require at least one of, or both of, the increasing and decreasing portions, as claimed.
Claim 78 recites “a coil design”, yet parent claim 68 recites “a coil design”. It is unclear whether the coil design of claim 78 is intended to be the same as that of claim 68.
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 79-86 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim does not fall within at least one of the four categories of patent eligible subject matter because claim 79 merely recites “a computer program comprising instructions”. In its broadest reasonable interpretation, a computer program encompasses software or transitory signals per se, thus is non-statutory. See MPEP 2106.03(I).
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 58 and 67 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Application Publication No. 2002/0188332 (Lurie et al.).
Regarding claim 58, Lurie teaches a stimulation arrangement comprising
an induction device (200) having a field generator (electrodes of 200) configured to generate a spatial field having a targeted shape ([0119]; Figure 8A), and
a control unit (202) in communication with the induction device and configured to control the induction device to generate the spatial field ([0120]; Figure 8A),
wherein the field generator of the induction device is configured to be positioned at a human or animal patient such that, for activating the patient, a target tissue is stimulable by the spatial field generated by the field generator (phrenic nerve stimulated via electrodes, [0120]; Figure 8A), and
wherein the control unit is configured to operate the induction device such that the field generator generates a sequence of consecutive trains of plural pulses of the spatial field, wherein the trains are intermitted (intermittent pulse trains: [0095], respiratory muscle stimulation coordinated with compressions, [0119], and [0136]; “electrodes may then be coupled to controller 202 to stimulate the phrenic nerve according to any of the techniques described herein”, [0119]-[0120]; Figure 8A).
Regarding claim 67, Lurie teaches the field generator of the induction device (200) comprises an electrode and the spatial field generated by the field generator is an electric field ([0119]).
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 59-66 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2002/0188332 (Lurie et al.).
Regarding claim 59, Lurie teaches all the limitations of claim 58. Lurie teaches the intensity of the plural pulses of the trains may be varied (“electrical signal may have a wide range of currents”, [0026] and [0094]; “asymmetric biphasic waveforms”, [0093]; stimulation delivered at different pulse trains and voltage outputs, [0095]). Lurie does not expressly state the plural pulses of each of the trains comprise a first pulse having a first intensity and a maximum pulse having a maximum intensity, wherein the maximum intensity is higher than the first intensity, wherein the intensities of intermediate pulses between the first pulse and the maximum pulse preferably raise from the first pulse to the maximum pulse.
However, Lurie teaches an alternative embodiment wherein stimulation delivered comprises a pulse train including a first pulse having a first intensity and a maximum pulse having a maximum intensity, wherein the maximum intensity is higher than the first intensity, wherein the intensities of intermediate pulses between the first pulse and the maximum pulse preferably raise from the first pulse to the maximum pulse ([0133]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the stimulation arrangement of Lurie’s Figure 8A such that the plural pulses of each of the trains comprise a first pulse having a first intensity and a maximum pulse having a maximum intensity, wherein the maximum intensity is higher than the first intensity, wherein the intensities of intermediate pulses between the first pulse and the maximum pulse preferably raise from the first pulse to the maximum pulse as taught by Lurie’s stimulation arrangement of Figure 13 in order to meet the treatment needs of an individual patient ([0133]).
Regarding claims 60 and 61, Lurie as modified teaches all the limitations of claims 58 and 59. Lurie teaches the intensity of the plural pulses of the trains may be varied (“electrical signal may have a wide range of currents”, [0026] and [0094]; “asymmetric biphasic waveforms”, [0093]; stimulation delivered at different pulse trains and voltage outputs, [0095]), and teaches “a variety of pulse trains…and pulse waveforms may be used for stimulation” ([0010]). Each train of the stimulation arrangement of Lurie comprises an accumulated intensity calculated by summarizing the intensities of its pulses (The examiner notes the claim merely requires each pulse train has an accumulated intensity, and does not require the control unit performs the calculation to determine the accumulated intensity. Accordingly, by virtue of the pulse trains comprising a plurality of pulses, the pulse trains necessarily have an accumulated intensity value that may be established by summation of the pulse intensities.).
Lurie does not expressly state the plural pulses of each of the trains comprise a last pulse having a last intensity, wherein the last intensity is lower than the maximum intensity, wherein the intensities of intermediate pulses between the maximum pulse and the last pulse preferably lower from the maximum pulse to the last pulse; and wherein the accumulated intensities of the trains differ, wherein the trains preferably comprise a first train having a first accumulated intensity and a maximum train having a maximum accumulated intensity, the maximum accumulated intensity being higher than the first accumulated intensity. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the stimulation arrangement of Lurie such that 1) the plural pulses of each of the trains comprise a last pulse having a last intensity, wherein the last intensity is lower than the maximum intensity, wherein the intensities of intermediate pulses between the maximum pulse and the last pulse preferably lower from the maximum pulse to the last pulse, and 2) modifying the pulse trains such that the accumulated intensities of the trains differ, wherein the trains preferably comprise a first train having a first accumulated intensity and a maximum train having a maximum accumulated intensity, the maximum accumulated intensity being higher than the first accumulated intensity in order to provide stimulation that meets the needs of a particular patient, as Lurie recognizes “a variety of pulse trains…and pulse waveforms may be used for stimulation” ([0010]; “electrical signal may have a wide range of currents”, [0026] and [0094]; “asymmetric biphasic waveforms”, [0093]; stimulation delivered at different pulse trains and voltage outputs, [0095]).
Regarding claim 62, Lurie teaches all the limitations of claim 58. Lurie teaches the train temporal width is in a range from about 0.25 seconds to about 6 seconds ([0027]; [0029]), and discloses repeated stimulation with a plurality of pulse trains (stimulated multiple times per minute, [0029]). Lurie does not expressly state each of the trains comprises an identical number of pulses and/or an essentially identical train temporal width, and does not explicitly disclose the train temporal width is in a range from about 0.5 seconds to about 1.5 seconds. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pulse trains of Lurie to have an identical number or pulses and/or an essentially identical train temporal width in order to provide repeated, regular stimulation to restore or support respiration depending on the needs of the individual patient ([0027]; [0029]). Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the train temporal width of Lurie to be in a range of about 0.5 seconds to about 1.5 seconds as Lurie teaches a train temporal width of 0.25 seconds to about 6 seconds is desirable for sufficiently stimulating the phrenic nerve to cause diaphragm contraction ([0027]; [0029]), wherein optimum duration values are discoverable through routine experimentation. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Additionally, it has been held that “[i]n the case where the claims ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 101 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 63, Lurie teaches all the limitations of claim 58. Lurie teaches the trains comprise about 5 to 30 trains per minute (pulse train stimulation, [0010], [0095]; 5-30 stimulations per minute: [0027], [0090]), but does not explicitly state the trains comprise about 10 to about 20 trains per minute. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pulse trains of Lurie to have about 10-20 trains per minute in order to provide sufficient stimulation to restore or support respiration depending on the needs of the individual patient ([0027]; [0090]), wherein the optimum number of trains per minute is discoverable through routine experimentation. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Additionally, it has been held that “[i]n the case where the claims ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 101 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 64, Lurie teaches all the limitations of claim 58. Lurie teaches the pulse temporal width is in a range from about 1 microsecond to about 5 milliseconds ([0094]). Lurie also discloses an embodiment wherein the pulse temporal width is about 300 microseconds ([0138]). Lurie does not expressly state the pulse temporal width is in a range of about 160 microseconds to about 220 microseconds, and that each of the plural pulses of the trains comprises an essentially identical pulse temporal width. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pulse trains of Lurie such that each of the pulses of the trains comprises an essentially identical pulse width in order to provide repeated, regular stimulation to restore or support respiration depending on the needs of the individual patient ([0094]). Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pulse temporal width of Lurie to be in a range of about 160 microseconds to about 220 microseconds as Lurie teaches a pulse temporal width of 1 microsecond to about 5 milliseconds is desirable for sufficiently stimulating the phrenic nerve to cause diaphragm contraction ([0094]; [0138]), wherein optimum duration values are discoverable through routine experimentation. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Additionally, it has been held that “[i]n the case where the claims ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 101 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 65, Lurie as modified teaches all the limitations of claim 64. Lurie teaches the intensity of the plural pulses of the trains may be varied (“electrical signal may have a wide range of currents”, [0026] and [0094]; “asymmetric biphasic waveforms”, [0093]; stimulation delivered at different pulse trains and voltage outputs, [0095]; varied intensity: [0133], [0138]). Lurie does not expressly state the pulse temporal width comprises an increasing portion, in which the intensity is increased, and/or a decreasing portion, in which the intensity is decreased, and wherein the increasing portion and the decreasing portion preferably together cover at least 60 percent of the pulse temporal width. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pulse intensity such that the pulse temporal width comprises an increasing portion, in which the intensity is increased, and/or a decreasing portion, in which the intensity is decreased, and wherein the increasing portion and the decreasing portion preferably together cover at least 60 percent of the pulse temporal width in order to meet the treatment needs of an individual patient, as Lurie recognizes “a wide range of currents…and a wide range of pulse widths” may be employed “[d]epending on the particular treatment” ([0094]; [0138]).
Regarding claim 66, Lurie teaches all the limitations of claim 58. Lurie teaches the plural pulses of the trains comprise a frequency in a range from about 10 Hz to about 100 Hz ([0094]), and does not explicitly state the frequency range is from about 15 Hz to about 25 Hz. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify pulse frequency of Lurie to be in a range of about 15 Hz to about 25 Hz as Lurie teaches frequency range of about 10 Hz to about 100 Hz is desirable for sufficiently stimulating the phrenic nerve to cause diaphragm contraction ([0094]), wherein optimum duration values are discoverable through routine experimentation. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Additionally, it has been held that “[i]n the case where the claims ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 101 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Claims 68-86 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2002/0188332 (Lurie et al.) in view of U.S. Patent Application Publication No. 2014/0142654 (Simon et al.).
Regarding claim 68, Lurie teaches a method of activating a human or animal patient by stimulating a target tissue of the patient (Figure 7; [0112]), comprising:
obtaining an induction device (18, 20) having a field generator (22) configured to generate a spatial field having a targeted shape and a control unit which is in communication with the induction device and which is configured to control the induction device to generate the spatial field (“control unit” construed as actuation circuitry for electrodes 22, [0095] and [0112]-[0113]; Figure 7);
positioning the field generator of the induction device at the patient such that the target tissue is stimulable by the spatial field generated by field generator (“placed over the ribs”, [0112]); and
operating the induction device such that the field generator generates a sequence of consecutive trains of plural pulses of the spatial field, wherein the trains are intermitted (intermittent pulse trains: [0095], electrodes actuated during every, or during only selected, relaxation and compression phase(s), [0112]; Figure 7A). Lurie teaches “[a]lthough electrodes 22 have been described it as electrodes which provide electrical simulation, it will be appreciated that device 10 can be modified to provide a magnetic field to stimulate the respiratory muscles to contract” through phrenic nerve stimulation ([0096]), but does not expressly state the field generator has a coil design.
However, Simon teaches a method of activating a human or animal patient by stimulating a target tissue (abstract; [0064]; phrenic nerve, [0139]), comprising: obtaining an induction device having a field generator with a coil design configured to generate a spatial field for stimulating the target tissue (coils, [0058]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the field generator of Lurie to have a coil design as taught by Simon, because Simon teaches magnetic coils or electrodes are suitable alternative field generators for producing a spatial field for stimulating a phrenic nerve in target tissue ([0058]; [0139]), as recognized by Lurie ([0096]).
Regarding claim 69, Lurie in view of Simon teaches all the limitations of claim 68. Lurie teaches the target tissue is a phrenic nerve of the patient and activating the patient is activating a diaphragm of the patient ([0011]; [0112]), wherein the method further comprises: connecting a conduit interface to a respiratory system of the patient ([0114]); delivering air through the conduit interface into the respiratory system of the patient ([0114]); controlling the delivery of air into the respiratory system of the patient according to a breathing scheme ([0114]); and activating the diaphragm of the patient in coordination with the breathing scheme ([0112]-[0114]).
Regarding claim 70, Lurie in view of Simon teaches all the limitations of claim 68. Lurie teaches the intensity of the plural pulses of the trains may be varied (“electrical signal may have a wide range of currents”, [0026] and [0094]; “asymmetric biphasic waveforms”, [0093]; stimulation delivered at different pulse trains and voltage outputs, [0095]; trains, [0113]). Lurie does not expressly state the plural pulses of each of the trains comprise a first pulse having a first intensity and a maximum pulse having a maximum intensity, wherein the maximum intensity is higher than the first intensity, wherein the intensities of intermediate pulses between the first pulse and the maximum pulse preferably raise from the first pulse to the maximum pulse.
However, Lurie teaches an alternative embodiment wherein stimulation delivered comprises a pulse train including a first pulse having a first intensity and a maximum pulse having a maximum intensity, wherein the maximum intensity is higher than the first intensity, wherein the intensities of intermediate pulses between the first pulse and the maximum pulse preferably raise from the first pulse to the maximum pulse ([0133]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Lurie’s Figure 7 as modified such that the plural pulses of each of the trains comprise a first pulse having a first intensity and a maximum pulse having a maximum intensity, wherein the maximum intensity is higher than the first intensity, wherein the intensities of intermediate pulses between the first pulse and the maximum pulse preferably raise from the first pulse to the maximum pulse as taught by Lurie’s stimulation arrangement of Figure 13 in order to meet the treatment needs of an individual patient ([0133]).
Regarding claims 71 and 72, Lurie in view of Simon teaches all the limitations of claim 68 and 70. Lurie teaches the intensity of the plural pulses of the trains may be varied (“electrical signal may have a wide range of currents”, [0026] and [0094]; “asymmetric biphasic waveforms”, [0093]; stimulation delivered at different pulse trains and voltage outputs, [0095]; trains, [0113]), and teaches “a variety of pulse trains…and pulse waveforms may be used for stimulation” ([0010]). Each train of the stimulation arrangement of Lurie comprises an accumulated intensity calculated by summarizing the intensities of its pulses (The examiner notes the claim merely requires each pulse train has an accumulated intensity, and does not require the control unit performs the calculation to determine the accumulated intensity. Accordingly, by virtue of the pulse trains comprising a plurality of pulses, the pulse trains necessarily have an accumulated intensity value that may be established by summation of the pulse intensities.).
Lurie does not expressly state the plural pulses of each of the trains comprise a last pulse having a last intensity, wherein the last intensity is lower than the maximum intensity, wherein the intensities of intermediate pulses between the maximum pulse and the last pulse preferably lower from the maximum pulse to the last pulse; and wherein the accumulated intensities of the trains differ, wherein the trains preferably comprise a first train having a first accumulated intensity and a maximum train having a maximum accumulated intensity, the maximum accumulated intensity being higher than the first accumulated intensity. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the stimulation arrangement of Lurie such that 1) the plural pulses of each of the trains comprise a last pulse having a last intensity, wherein the last intensity is lower than the maximum intensity, wherein the intensities of intermediate pulses between the maximum pulse and the last pulse preferably lower from the maximum pulse to the last pulse, and 2) modifying the pulse trains such that the accumulated intensities of the trains differ, wherein the trains preferably comprise a first train having a first accumulated intensity and a maximum train having a maximum accumulated intensity, the maximum accumulated intensity being higher than the first accumulated intensity in order to provide stimulation that meets the needs of a particular patient, as Lurie recognizes “a variety of pulse trains…and pulse waveforms may be used for stimulation” ([0010]; “electrical signal may have a wide range of currents”, [0026] and [0094]; “asymmetric biphasic waveforms”, [0093]; stimulation delivered at different pulse trains and voltage outputs, [0095]).
Regarding claim 73, Lurie in view of Simon teaches all the limitations of claim 68. Lurie teaches the train temporal width is in a range from about 0.25 seconds to about 6 seconds ([0027]; [0029]), and discloses repeated stimulation with a plurality of pulse trains (stimulated multiple times per minute, [0029]). Lurie does not expressly state each of the trains comprises an identical number of pulses and/or an essentially identical train temporal width, and does not explicitly disclose the train temporal width is in a range from about 0.5 seconds to about 1.5 seconds. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pulse trains of Lurie as modified to have an identical number or pulses and/or an essentially identical train temporal width in order to provide repeated, regular stimulation to restore or support respiration depending on the needs of the individual patient ([0027]; [0029]). Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the train temporal width of Lurie as modified to be in a range of about 0.5 seconds to about 1.5 seconds as Lurie teaches a train temporal width of 0.25 seconds to about 6 seconds is desirable for sufficiently stimulating the phrenic nerve to cause diaphragm contraction ([0027]; [0029]), wherein optimum duration values are discoverable through routine experimentation. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Additionally, it has been held that “[i]n the case where the claims ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 101 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 74, Lurie teaches all the limitations of claim 68. Lurie teaches stimulation is supplied “during every relaxation or decompression phase or during only selected relaxation or decompression phases”, [0112]). Lurie further teaches the trains comprise about 5 to 30 trains per minute (pulse train stimulation, [0010], [0095]; 5-30 stimulations per minute: [0027], [0090]). Lurie does not explicitly state the trains comprise about 10 to about 20 trains per minute. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pulse trains of Lurie as modified to have about 10-20 trains per minute in order to provide sufficient stimulation to restore or support respiration depending on the needs of the individual patient ([0027]; [0090]), wherein the optimum number of trains per minute is discoverable through routine experimentation. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Additionally, it has been held that “[i]n the case where the claims ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 101 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 75, Lurie in view of Simon teaches all the limitations of claim 68. Lurie teaches the pulse temporal width is in a range from about 1 microsecond to about 5 milliseconds ([0094]). Lurie also discloses an embodiment wherein the pulse temporal width is about 300 microseconds ([0138]). Lurie does not expressly state the pulse temporal width is in a range of about 160 microseconds to about 220 microseconds, and that each of the plural pulses of the trains comprises an essentially identical pulse temporal width. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pulse trains of Lurie as modified such that each of the pulses of the trains comprises an essentially identical pulse width in order to provide repeated, regular stimulation to restore or support respiration depending on the needs of the individual patient ([0094]). Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pulse temporal width of Lurie as modified to be in a range of about 160 microseconds to about 220 microseconds as Lurie teaches a pulse temporal width of 1 microsecond to about 5 milliseconds is desirable for sufficiently stimulating the phrenic nerve to cause diaphragm contraction ([0094]; [0138]), wherein optimum duration values are discoverable through routine experimentation. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Additionally, it has been held that “[i]n the case where the claims ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 101 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 76, Lurie in view of Simon teaches all the limitations of claim 75. Lurie teaches the intensity of the plural pulses of the trains may be varied (“electrical signal may have a wide range of currents”, [0026] and [0094]; “asymmetric biphasic waveforms”, [0093]; stimulation delivered at different pulse trains and voltage outputs, [0095]; varied intensity: [0133], [0138]). Lurie does not expressly state the pulse temporal width comprises an increasing portion, in which the intensity is increased, and/or a decreasing portion, in which the intensity is decreased, and wherein the increasing portion and the decreasing portion preferably together cover at least 60 percent of the pulse temporal width. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pulse intensity of Lurie as modified such that the pulse temporal width comprises an increasing portion, in which the intensity is increased, and/or a decreasing portion, in which the intensity is decreased, and wherein the increasing portion and the decreasing portion preferably together cover at least 60 percent of the pulse temporal width in order to meet the treatment needs of an individual patient, as Lurie recognizes “a wide range of currents…and a wide range of pulse widths” may be employed “[d]epending on the particular treatment” ([0094]; [0138]).
Regarding claim 77, Lurie in view of Simon teaches all the limitations of claim 58. Lurie teaches the plural pulses of the trains comprise a frequency in a range from about 10 Hz to about 100 Hz ([0094]), and does not explicitly state the frequency range is from about 15 Hz to about 25 Hz. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify pulse frequency of Lurie as modified to be in a range of about 15 Hz to about 25 Hz as Lurie teaches frequency range of about 10 Hz to about 100 Hz is desirable for sufficiently stimulating the phrenic nerve to cause diaphragm contraction ([0094]), wherein optimum duration values are discoverable through routine experimentation. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Additionally, it has been held that “[i]n the case where the claims ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 101 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 78, Lurie as modified teaches all the limitations of claim 68. Lurie as modified teaches the field generator of the induction device comprises a coil design and the spatial field generated by the field generator is an electro-magnetic field (see discussion for claim 68; Simon: [0058]).
Regarding claim 79, Lurie teaches a control unit (202) configured to operate a field generator (electrodes of 200) of an induction device (200) positioned at a human or animal patient such that a target tissue of the patient is stimulable by a spatial field generated by the field generator of the induction device, such that the field generator generates a sequence of consecutive trains of plural pulses of the spatial field, wherein the trains are intermitted (intermittent pulse trains: [0095], respiratory muscle stimulation coordinated with compressions, [0119], and [0136]; “electrodes may then be coupled to controller 202 to stimulate the phrenic nerve according to any of the techniques described herein”, [0119]-[0120]; Figure 8A). Lurie does not expressly state instructions for operating the control unit are provided in instructions in a computer program.
However, Simon teaches a computer program comprising instructions which, when the program is executed by a control unit (330), cause the control unit to operate a field generator (coils or electrodes 340) of an induction device positioned at a human or animal patient such that a target tissue of the patient is stimulable by a spatial field generated by the field generator of the induction device ([0058]; [0062]; [0064]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the control unit of Lurie such that the operating instructions for the control unit are provided in a computer program for execution by the control unit as taught by Simon, because providing such a computer program for execution by a control unit confers additional functionality such as feedback data analysis and automated control of the induction unit via the control unit to improve treatment delivery (Simon: [0062]).
Regarding claim 80, Lurie in view of Simon teaches all the limitations of claim 79. Lurie teaches the intensity of the plural pulses of the trains may be varied (“electrical signal may have a wide range of currents”, [0026] and [0094]; “asymmetric biphasic waveforms”, [0093]; stimulation delivered at different pulse trains and voltage outputs, [0095]). Lurie does not expressly state the plural pulses of each of the trains comprise a first pulse having a first intensity and a maximum pulse having a maximum intensity, wherein the maximum intensity is higher than the first intensity, wherein the intensities of intermediate pulses between the first pulse and the maximum pulse preferably raise from the first pulse to the maximum pulse.
However, Lurie teaches an alternative embodiment wherein stimulation delivered comprises a pulse train including a first pulse having a first intensity and a maximum pulse having a maximum intensity, wherein the maximum intensity is higher than the first intensity, wherein the intensities of intermediate pulses between the first pulse and the maximum pulse preferably raise from the first pulse to the maximum pulse ([0133]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pulses of each train of Lurie as modified such that the plural pulses of each of the trains comprise a first pulse having a first intensity and a maximum pulse having a maximum intensity, wherein the maximum intensity is higher than the first intensity, wherein the intensities of intermediate pulses between the first pulse and the maximum pulse preferably raise from the first pulse to the maximum pulse as taught by Lurie’s stimulation arrangement of Figure 13 in order to meet the treatment needs of an individual patient ([0133]).
Regarding claims 81 and 82, Lurie as modified teaches all the limitations of claims 79 and 80. Lurie teaches the intensity of the plural pulses of the trains may be varied (“electrical signal may have a wide range of currents”, [0026] and [0094]; “asymmetric biphasic waveforms”, [0093]; stimulation delivered at different pulse trains and voltage outputs, [0095]), and teaches “a variety of pulse trains…and pulse waveforms may be used for stimulation” ([0010]). Each train of the stimulation arrangement of Lurie comprises an accumulated intensity calculated by summarizing the intensities of its pulses (The examiner notes the claim merely requires each pulse train has an accumulated intensity, and does not require the control unit performs the calculation to determine the accumulated intensity. Accordingly, by virtue of the pulse trains comprising a plurality of pulses, the pulse trains necessarily have an accumulated intensity value that may be established by summation of the pulse intensities.).
Lurie does not expressly state the plural pulses of each of the trains comprise a last pulse having a last intensity, wherein the last intensity is lower than the maximum intensity, wherein the intensities of intermediate pulses between the maximum pulse and the last pulse preferably lower from the maximum pulse to the last pulse; and wherein the accumulated intensities of the trains differ, wherein the trains preferably comprise a first train having a first accumulated intensity and a maximum train having a maximum accumulated intensity, the maximum accumulated intensity being higher than the first accumulated intensity. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the stimulation arrangement of Lurie as modified such that 1) the plural pulses of each of the trains comprise a last pulse having a last intensity, wherein the last intensity is lower than the maximum intensity, wherein the intensities of intermediate pulses between the maximum pulse and the last pulse preferably lower from the maximum pulse to the last pulse, and 2) modifying the pulse trains such that the accumulated intensities of the trains differ, wherein the trains preferably comprise a first train having a first accumulated intensity and a maximum train having a maximum accumulated intensity, the maximum accumulated intensity being higher than the first accumulated intensity in order to provide stimulation that meets the needs of a particular patient, as Lurie recognizes “a variety of pulse trains…and pulse waveforms may be used for stimulation” ([0010]; “electrical signal may have a wide range of currents”, [0026] and [0094]; “asymmetric biphasic waveforms”, [0093]; stimulation delivered at different pulse trains and voltage outputs, [0095]).
Regarding claim 83, Lurie as modified teaches all the limitations of claim 79. Lurie teaches the train temporal width is in a range from about 0.25 seconds to about 6 seconds ([0027]; [0029]), and discloses repeated stimulation with a plurality of pulse trains (stimulated multiple times per minute, [0029]). Lurie does not expressly state each of the trains comprises an identical number of pulses and/or an essentially identical train temporal width, and does not explicitly disclose the train temporal width is in a range from about 0.5 seconds to about 1.5 seconds. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pulse trains of Lurie as modified to