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/Restriction
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group 1, claims 1-12, 16-18 and 28, drawn to a system of controlling blood pressure.
Group 2, claims 24-27, drawn to a method of controlling blood pressure.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups 1 and 2 lack unity of invention because even though the inventions of these groups require the technical feature of a first OR second stimulation pattern, as recited in claims 1 and 24, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of US 2017/0304048 to Mika, as detailed below in the 102 rejection.
During a telephone conversation with Steve Arnheim on 5/26/26 a provisional election was made without traverse to prosecute the invention of Group 1, claims 1-12, 16-18 and 28. Affirmation of this election must be made by applicant in replying to this Office action. Claims 24-27 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Effective Filing Date
The earliest possible effective filing date of the current application is 6/1/2022. Although the first few paragraphs of the specification list numerous “related” applications with filing dates going back to 2012, these are not considered priority applications, as applicant has failed to claim benefit back to these any of these applications on the ADS. Therefore, the earliest possible effective filing date of the current application is 6/1/2022, based on the provisional application 63/365668.
However, based on the written description rejection below, the current effective filing date is 11/20/24, i.e. the filing date of the current US application, as the original specification does not provide sufficient support for the amendments; see discussion below.
Specification
The disclosure is objected to because of the following informalities: The specification, in Pars 0002-4, lists numerous “related” applications, however there is no indication on the ADS that these are truly related applications, i.e. CON, CIP or DIV. By referring to these applications as “related”, confusion arises as to whether applicant believes these applications provide priority benefit for the claimed subject matter, making the effective filing date of the current application difficult to discern. Clarification is recommended.
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: The first and second configurations are never discussed in the specification, specifically a controller that is configured to operate in one of a first configuration or a second configuration (as detailed in the claims) is never mentioned.
Appropriate correction is required.
Claim Objections
Claim 16 is objected to because of the following informalities: the limitation “based on the determined diastolic blood pressure reduction and/or systolic blood pressure reduction and the systolic and diastolic blood pressure increases at the different heart rates, set the second stimulation pattern to provide a desired heart rate increase” should be “based on the determined diastolic blood pressure reduction and/or systolic blood pressure reduction and the determined systolic and diastolic blood pressure increases at the different heart rates, set the second stimulation pattern to provide a desired heart rate increase”. Appropriate correction is required.
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.
Claims 1-12, 16-18 and 28 are 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 1] While the amendments to claim 1 (“wherein the at least one controller is configured to operate in one of (a) a first configuration with both a first mode of operation and a second mode of operation, or (b) a second configuration with the second mode of operation and not the first mode of operation”) are part of the original claims, they are not sufficiently supported by the disclosure.
Specifically, the claim language relates to a specific controller configuration, i.e. computer implemented functional claim limitations, that describes a first configuration (with both a first mode and a second mode) and a second configuration (with the second mode, but not the first mode). These two configurations for the controller are never described in applicant’s specification (other than the claims themselves). In fact, the terms first and second configurations are never even mentioned in the specification. Based on this lack of discussion/explanation/details, it is unclear exactly how the controller is configured to operate in these two different configurations, specifically when the entire of the originally-filed specification seems to contradict the claimed concept of two different configurations. Specifically, the specification seems to support the idea that the controller is always capable of operating in both modes, as the mere existence of two modes and a controller configured to operate in either/both seems to contradict the claim language, i.e. there is never a “configuration” disclosed that would only allow the second mode (as the first mode is always a possibility). There is also no discussion related to how a user would select, choose or switch between these different configurations, which are seemingly mutually exclusive, and also how a user (in the first configuration) would then select/choose/switch between the first and second modes or how a user (in the second configuration) would only be able to select the second mode (and not the first). Specifically, the claims seem to require/imply (or at least encompass) that the controller can switch between the first configuration (with both a first mode and second mode that can then be further selected) and the second configuration (with a second mode and no ability to select a first mode); This is simply not supported, as there is zero discussion related to these configurations (or switching between them) or modes that are not able to be selected. It is emphasized that these are computer implemented functional limitations with no discussion related to the algorithm or steps/procedure as to how these operations/functions are achieved.
MPEP 2161.01 states “original claims may lack written description when the claims define the invention in functional language specifying a desired result, but the specification does not sufficiently describe how the function is performed or how the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. See MPEP §§ 2163.02 and 2181, subsection IV”
MPEP 2163.03 states “An original claim may lack written description support when (1) the claim defines the invention in functional language specifying a desired result but the disclosure fails to sufficiently identify how the function is performed or the result is achieved or (2) a broad genus claim is presented but the disclosure only describes a narrow species with no evidence that the genus is contemplated. See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349-50 (Fed. Cir. 2010) (en banc). The written description requirement is not necessarily met when the claim language appears in ipsis verbis in the specification. "Even if a claim is supported by the specification, the language of the specification, to the extent possible, must describe the claimed invention so that one skilled in the art can recognize what is claimed. The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement.”
[Claim 28] Similar issues exist with this claim language, as there is no indication in the originally-filed disclosure how a controller is configured to operate in the first configuration and not the second configuration, other than the exact words recited in the current claim. How does this work? Again, the specification provides no guidance related to the two configurations or how to select/choose/switch between them such that the controller is configured to only operate in one of the configurations. Even if applicant has support for the two configurations (which the examiner disagrees with; see above), there is no support/explanation as to how a controller can operate in one configuration and not the other… Why do both configurations exist if one cannot be in operation? There is simply no support/explanation for the claimed controller configuration; see explanation above.
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 1-12, 16-18 and 28 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 1] The limitation “wherein, in a the first mode of operation, a first stimulation pattern of the one or more stimulation patterns reduces both systolic blood pressure and diastolic blood pressure of a patient, and wherein, in a the second mode of operation, a second stimulation pattern of the one or more stimulation patterns reduces systolic blood pressure of a patient while controlling diastolic blood pressure, so as to reduce a difference between the systolic blood pressure and the diastolic blood pressure” is indefinite. Claim 1, as a whole, make it clear that these modes are mutually exclusive, i.e. distinct/different modes, however the claim language that defines the modes, specifically “controlling” in the second mode, is broad enough to encompass the first mode and the second mode being the same mode which creates confusion. Specifically, the breadth/scope of “controlling” includes/encompasses reducing, therefore the second mode can include a stimulation pattern that reduces both the systole and the diastole blood pressure, which is the same as the first stimulation pattern recited in the first mode, so it’s unclear how these are different/distinct modes when the actually overlap, i.e. can be the same. This leads to additional confusion when considering that the claimed configurations relate to different modes, but if the modes can be the same, then how are these different configurations?
Furthermore, based on the lack of explanation/details in the specification related to the first and second configurations, the scope, i.e. metes and bounds, of a controller configured to operate one or the other of these two configurations or one of the two modes, but not the other is unclear. Clearly, the device, as a whole, is programmed to operate in either/both mode, i.e. both modes exists, so how can there ever be a configuration where one of the modes is not operational? Similarly, if both configurations exist, how can there ever be a controller that is not configured to operate in one of the two configurations? Stated differently, it’s unclear what the prior art must teach in order to meet this claim limitation. For examination purposes, if the prior art teaches operating in a second mode, i.e. a stimulation pattern that reduces systolic blood pressure while controlling diastolic blood pressure to reduce the difference between the two blood pressures, then the second configuration is met. Since the claim only requires one of the first or second configurations, by teaching the second mode and therefore the second configuration, the claim language is met.
[Claim 10] The limitation “the resulting pulse pressure” is indefinite, as it lacks antecedent basis.
[Claim 16] It is emphasized that the independent claim (from which this claim depends) has been amended so that the claim encompasses a controller configured to operate in only the second mode of operation, i.e. “configured to operate in one of (a) a first configuration with both a first mode of operation and a second mode of operation, or (b) a second configuration with the second mode of operation and not the first mode of operation”), where the second mode of operation includes the second stimulation pattern. Therefore, the BRI of the independent claim encompasses an interpretation where only the second stimulation pattern is required. However, claim 16 requires both the first and second stimulation pattern, making it unclear if both configurations/modes are required (as seemingly required by claim 16) or if only a second mode is required (as seemingly encompassed by claim 16). If it is applicant’s intention that the first configuration is required, i.e. operation in both the first mode and the second mode is required, then applicant needs to make this clear in the claim by first requiring this configuration and then further limiting, not merely reciting it as an optional limitation.
For claim interpretation, this is considered a limitation that further limits an optional limitation, i.e. a first configuration with both a first mode and a second mode, and is therefore also considered optional and not required. Therefore, any prior art reference that teaches operating in just the second configuration, i.e. just the second mode having a second stimulation pattern, meets the BRI of the claim language and is rejected over the prior art, as both the first and second stimulation pattern are not required by the independent claim. MPEP 2103 “Language that suggests or makes a feature or step optional but does not require that feature or step does not limit the scope of a claim under the broadest reasonable claim interpretation”.
[Claim 28] Based on the lack of discussion and details in the specification, the scope, i.e. metes and bounds, of the current claim language are unclear. Specifically, it’s unclear how a controller that is clearly programmed with a first configuration (first mode and second mode, i.e. first stimulation and second stimulation pattern) and a second configuration (just second mode, i.e. second stimulation pattern), but somehow cannot operate in the second configuration. Clearly both configurations have to exist in order to operate in either one, so it’s confusing how the controller is configured to not operate in one configuration. Specifically, does this mean that the second configuration is NEVER in operation, or does this mean the ability to switch between the two configurations, i.e. when the first configuration is in operation the second configuration is not? For examination purposes, the examiner interprets this as a single moment in time, if/when the controller is operating in the first configuration, then this inherently means that the controller is not operating in the second configuration.
There is even more confusion when considering what the claimed modes of operation are, the first mode requires
Claim Rejections - 35 USC § 102 or 103
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.
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 1-12, 16-18 and 28 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over US 2017/0304048 to Mika et al.
[Claim 1] A system for controlling blood pressure (Figs. 9 or 14), the system comprising:
a stimulation circuit (electrode 702, Fig. 9, Pars 0366-378; electrodes 57 and 561, Fig. 14, Pars 0450-459) configured to deliver a stimulation pulse to at least one cardiac chamber of a heart of a patient (Pars 0366-378 describe the system shown in Fig. 9; Pars 0450-459 describe the system shown in Fig. 14); and
at least one controller (controller 703, Fig. 9; controller(s) 52, Fig. 14) configured to execute delivery of one or more stimulation patterns of stimulation pulses to the at least one cardiac chamber (at least Pars 0374-377, related to controller 703, and Pars 0451-459, related to controller 52),
wherein the at least one controller is configured to operate in one of (a) a first configuration with both a first mode of operation and a second mode of operation, or (b) a second configuration with the second mode of operation and not the first mode of operation (“For example, in some embodiments, a stimulation pattern may be set to cause an initial reduction in blood pressure (systolic and/or diastolic) that will exceed a predetermined threshold or will be within a predetermined range.” Par 0321. The “and/or” is interpreted as different configurations/modes. For example, the first configuration relates to “and”, where both systolic and diastolic blood pressure is reduced. Similarly, the second configuration relates to “or”, where only diastolic blood pressure is reduced),
wherein, in the first mode of operation, a first stimulation pattern of the one or more stimulation patterns reduces both systolic blood pressure and diastolic blood pressure of a patient (see discussion above; Specifically, Mika explicitly teaches reducing both systolic and diastolic blood pressure in Par 0321. Additionally, Mika teaches “for example, the time interval may be adjusted until such time that systolic blood pressure is above 100 mmHg and/or below 140 mmHg and/or diastolic blood pressure is below 90 mmHg and/or above 60 mmHg” Par 0444. The examiner contends that depending on the patient’s original blood pressure, this explicitly teaches reducing both systolic and diastolic blood pressure, e.g. if a patient’s original blood pressure is 180/120, the disclosed range of values is a reduction in both systolic and diastolic), and
wherein, in the second mode of operation, a second stimulation pattern of the one or more stimulation patterns reduces systolic blood pressure of a patient while controlling diastolic blood pressure, so as to reduce a difference between the systolic blood pressure and the diastolic blood pressure (see discussion above; Specifically, Mika explicitly teaches reducing systolic or diastolic blood pressure in Par 0321, i.e. reducing only systolic blood pressure. Therefore, when only systolic blood pressure is reduced, the difference between systolic blood pressure and diastolic is inherently reduced, as diastolic remains the same. Additionally, Fig. 2, specifically the time period a-a’, explicitly shows a reduction in just systolic blood pressure; at least Par 0302. Furthermore, Mika teaches “for example, the time interval may be adjusted until such time that systolic blood pressure is above 100 mmHg and/or below 140 mmHg and/or diastolic blood pressure is below 90 mmHg and/or above 60 mmHg” Par 0444. The examiner contends that depending on the patient’s original blood pressure, this explicitly teaches reducing systolic and controlling diastolic blood pressure to reduce a difference between the two, e.g. if a patient’s original blood pressure is 180/100 (a difference of 80) and the stimulation reduces the systolic to 130 and the diastolic to 80 (a difference of 50), as disclosed by the claimed ranges.)
If applicant disagrees with the examiner interpretation of reducing systolic while controlling diastolic blood pressure, the examiner contends that such a stimulation pattern is obvious based on the disclosure of Mika, specifically “for example, the time interval may be adjusted until such time that systolic blood pressure is above 100 mmHg and/or below 140 mmHg and/or diastolic blood pressure is below 90 mmHg and/or above 60 mmHg” Par 0444. It’s abundantly clear that there is an optimal range for both systolic and diastolic blood pressure, and it’s clear that both or either systolic and diastolic blood pressure can be reduced/controlled. Therefore, the reduction of systolic and control of diastolic to reduce the difference between the two is going to depend solely on the patient’s original blood pressure. For example, if a patient has a blood pressure of 180/85 (difference of 95), it’s clear from Mika that only the systolic would be reduced to be below 140, e.g. 135, which would result in a difference of 50. Therefore, it would be obvious for a POSITA to decide which type of blood pressure to reduce (systole or diastole) and by how much, depending on the patient’s original blood pressure, in order to achieve the desired values for each systole and diastole to be in the desired range (140-100 for systole and 90-60 for diastole). This amounts to choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success or routine optimization of result effective variables.
Regarding the first and second configurations, the examiner interprets the second configuration to be when the second mode is in operation, i.e. delivery of the second stimulation (that reduces systolic while controlling diastolic to reduce a difference between the two). Therefore, when this second stimulation is being delivered, the second mode is the only mode in operation, and this is considered the second configuration, because, at this exact moment in time, it includes only the second mode (not the first). Since the claims only require one of the first or second configuration, the claim language is met when the second mode is in operation, i.e. when the second stimulation is being delivered. Regarding the first configuration, based on the clamed overlap between the first and second modes, i.e. both modes encompassing/including reducing both systole and diastole blood pressure, the first configuration is met when a stimulation pattern is delivered that reduces both systole and diastole, as this reads on both first and second modes. For example, if a patient’s original blood pressure is 180/95 (difference of 85), and the stimulation pattern reduces the blood pressure to 135/89 (difference of 46, by minimally reducing the diastole) this reads on both modes and therefore teaches the first configuration.
[Claims 2, 3 and 5] Based on the explanation provided above, in relation to claim 1, the examiner takes the position that Mika either explicitly/inherently teaches the claimed stimulation patterns or such stimulation patterns are obvious to try or as a matter of routine optimization, specifically depending on the patient’s original blood pressure and the express teaching in Mika to control both or either systolic and diastolic pressure to achieve the desired range of 140-100 mmHg for systole and 90-60 mmHg for diastole. For example, if a patient has an original blood pressure of 160/85, it’s clear from Mika (or extremely obvious) that the stimulation pattern would only reduce the systole to below 140, as the diastole is already in the desired range. This is considered “causing minimal or no effect on diastolic blood pressure” and a “limiting effect on diastolic blood pressure to a level that does not prevent achievement of a therapeutically effective reduced pulse pressure”. Similarly, this is considered a controller configured to “treat isolated systolic hypertension of a patient using the second stimulation pattern”, based on the situation described above, i.e. a patient has only elevated systolic blood pressure, i.e. isolated systolic hypertension, it’s clear (or obvious) that the stimulation of Mika would only reduce the systolic blood pressure to achieve the desired range. MPEP 2112.02 states “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process”.
[Claim 4] Similar to above, the examiner contends that this depends on a patient’s original blood pressure, e.g. if a patient’s original blood pressure is 160/50, based on the desired ranges/values for systolic and diastolic blood pressure (140-100 for systole and 90-60 for diastole; Par 0444) it is either explicitly/inherently taught by Mika or obvious in view of Mika to reduce systolic and increase diastolic. Par 0072 specifically contemplates when “an increase in BP may be a healthy and thus a desired condition” and therefore is either explicitly taught (or made obvious) by Mika. Therefore, it would be obvious for a POSITA to decide which type of blood pressure to adjust (systole or diastole) and by how much, depending on the patient’s original blood pressure, in order to achieve the desired values for each systole and diastole to be in the desired range (140-100 for systole and 90-60 for diastole). This amounts to choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success or routine optimization of result effective variables.
[Claims 6-11] As discussed above, Mika teaches (or makes obvious) a stimulation pattern that reduces systolic blood pressure while “causing minimal or no effect on diastolic blood pressure” (claim 2), “limiting effect on diastolic blood pressure to a level that does not prevent achievement of a therapeutically effective reduced pulse pressure” (claim 3), “effecting an increase in diastolic blood pressure” (claim 4), controlling diastolic blood pressure between a lower allowed value, i.e. above a designated minimum value, (60 mmHg; Par 0444) and a higher allowed value (90 mmHg; Par 0444), such that the resulting pulse pressure, i.e. difference between systole and diastole, is between a lower allowed value and a higher allowed value (the ranges/values disclosed for the desired systole and diastole blood pressures, as discussed in Par 0444, inherently have a resulting pulse pressure between a lower and higher value. For example, the highest allowed value for the resulting pulse pressure is 140 - 60 = 80, and the lowest allowed value for the resulting pulse pressure is 100 – 90 = 10), and/or is lower than an initial pulse pressure by a predetermined amount and/or predetermined percent (this is going to depend on a patient’s original blood pressure measurement). Furthermore, Mika discloses combining these stimulation patterns that reduce/control blood pressure (as noted above) with electrical stimulation patterns that “change heart rate in order to increase cardiac output or implement other methods known in the art for controlling cardiac output. In some embodiments, system 700 may include rate response algorithms to affect changes in heart rate as a response to certain circumstances. For example, system 700 may include rate response algorithms to affect changes in heart rate as a response to changes in level of exercise, ventilation activity, and/or oxygen consumption.” (Par 0402). The examiner contends that an increase in heart rate increases cardiac output, and therefore Mika explicitly teaches increasing heart rate, in combination with the stimulation patterns that affect blood pressure. Specifically, by explicitly disclosing stimulation patterns that change heart rate, especially one that increases cardiac output, a POSITA would at once envisage an increase in heart rate or at the very least it would be obvious to try an increase (as there are only two known options, i.e. increase or decrease). Furthermore, the examiner also contends that it would be obvious to try the stimulation that increase heart rate with any of the stimulation patterns that change/effect/adjust blood pressure (as discussed above), as this is choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success, and Mika explicitly teaches that the electrical stimulation device “system 700 may include additional functions relating to control of heart function and overall cardiovascular system performance.” (Par 0402).
[Claim 12] Mika teaches sensing the natural heart rate or natural excitation (Par 0404; see also sensors 705 described in Par 0394, specifically the electrical activity of the heart which includes heart rate). As discussed above, in relation to claims 6-11, Mika teaches (or makes obvious) a second stimulation pattern that combines blood pressure stimulation with stimulation that increases heart rate.
[Claims 16-18] As noted above, in the 112b rejection, these claim limitations are met by teaching “(b) a second configuration with the second mode of operation and not the first mode of operation”, as the second mode of operation does not require a first stimulation. Since Mika teaches (or makes obvious) the second configuration, the optional claim language is met, as the first mode/stimulation is not required to be taught by the prior art.
[Claim 28] As discussed above, in the 112b rejection, this claim language is met when the controller is operating in the first configuration, i.e. both first and second modes; see explanation for claim 1 above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lynsey C Eiseman whose telephone number is (571)270-7035. The examiner can normally be reached Monday-Thursday and alternating Fridays 7 to 4 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at 571-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
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