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 .
Information Disclosure Statement
The IDS filed 10/16/2024 has been considered by the Examiner.
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 Interpretation
The term “flag” appears to be synonymous with the terms “thresholds”, “values”, “parameters”, and “conditions”, as shown in Par. [0021] of the instant application’s printed publication (US 2025/0281756). Par. [0021] explains that “the data memory saves the above and below mentioned thresholds, values, flags, parameters and conditions.”. Par. [0026] explains that a “motion flag” is either true (i.e., during high activity of the patient) or false (i.e., low/no activity conditions) (Par. [0026]). Therefore, a “motion flag” is interpreted as a data value stored in the data memory as true or false that represents activity levels of the patient.
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 use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: “by means of AV delays” in claim 7.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends 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 remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
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 1-15 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 recites the limitation “this information” in line 7, whereas “a corresponding pacing information” was already introduced in claim 1 (lines 5-6). It is unclear whether the Applicant intended to claim the same or a different information. Consider changing to “the corresponding pacing information”.
Claim 1 recites the limitation "the actual activity" in line 8. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation “the cardiac activity” in line 11, whereas “the actual activity” was already introduced in claim 1 (line 8). It is unclear whether the Applicant intended to claim the same or a different information. Consider changing to “(a/the) actual cardiac activity” for both instances.
The limitation of instant claim 5 renders claim 5 indefinite. It is confusing/unclear how the ventricular pacing time value and ventricular pacing rate can be determined by both the VVI behavior and VVI-R behavior, when preceding claim 4 appears to limit the ventricular pacing time value and ventricular pacing rate to be determined by only one of either VVI behavior or VVI-R behavior. The Examiner notes that claim 5 appears to correspond to claim 12. The Examiner also questions why the phrase “and such” was used in claim 5, while the phrase “and/or” is used in claim 12. Please provide appropriate correction and/or explanation.
Claim 8 recites the limitation “this information” in lines 7-8, whereas “a corresponding pacing information” was already introduced in claim 8 (line 6). It is unclear whether the Applicant intended to claim the same or a different information. Consider changing to “the corresponding pacing information”.
Claim 1 recites the limitation "the actual activity" in line 8. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation “the cardiac activity” in lines 10-11, whereas “the actual activity” was already introduced in claim 8 (line 8). It is unclear whether the Applicant intended to claim the same or a different information. Consider changing to “(a/the) actual cardiac activity” for both instances.
The limitation of instant claim 12 renders claim 12 indefinite. It is confusing/unclear how the ventricular pacing time value and ventricular pacing rate can be determined by both the VVI behavior and VVI-R behavior, when preceding claim 11 appears to limit the ventricular pacing time value and ventricular pacing rate to be determined by only one of either VVI behavior or VVI-R behavior. The Examiner notes that claim 5 appears to correspond to claim 12. The Examiner also questions why the phrase “and such” was used in claim 5, while the phrase “and/or” is used in claim 12. Please provide appropriate correction and/or explanation.
*All other claims are rejected due to their dependency on a rejected claim.
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 14-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claimed computer program product and computer readable data carrier storing a computer program product does not fall within at least one of the four categories of patent eligible subject matter as the courts have found that a computer program per se is merely a series of mathematical calculations or mental steps and does not constitute a patentable process [Gottschalk v. Benson, 409 U.S. at 72.; MPEP 2106.03].
Allowable Subject Matter
Claims 1-15 contain potentially allowable subject matter.
The following is a statement of reasons for the indication of allowable subject matter:
The prior art of record (namely Alt (EP 0580128 – cited on IDS)) does not disclose or fairly suggest either singly or in combination the claimed invention of independent claims 1 and 8 when taken as a whole, comprising, in addition to the other recited claim elements, wherein in a first atrial tracking state the processing unit is configured to continuously determine an estimated cardiac rate based on at least one actual intrinsic atrial event or evidence of such an event from a conducted intrinsic ventricular event detected from the received cardiac activity signals and to compare the estimated cardiac rate with a pre-defined validity check rate, wherein if the estimated cardiac rate is greater than or equal to the validity check rate the processing unit is configured to assess the actual status of the motion flag,
wherein, if the estimated cardiac rate is greater than or equal to the validity check rate and the actual status of the motion flag is true or if the estimated cardiac rate is lower than the validity check rate, the processing unit is configured to stay in the first atrial tracking state in which the ventricular pacing time value and/or the ventricular pacing rate value is determined based on the estimated cardiac rate,
wherein, if the estimated cardiac rate is greater than or equal to the validity check rate and the actual status of the motion flag is false, the processing unit is configured to transition into a supraventricular tachycardia state in which the processing unit is configured to ramp the ventricular pacing time value up and/or the ventricular pacing rate value down until a pre-defined first pacing time threshold value and a pre-defined first pacing rate threshold value, respectively, is reached, and to suspend detecting intrinsic atrial events of the patient's heart from the received cardiac activity signals.
It is noted that the Examiner finds Alt to fail to reasonably teach or suggest the limitations of instant claims 1 and 8 in the same way as the EPO’s written opinion for corresponding International Application No. PCT/EP2023/058805 (cited on IDS).
The Examiner also wishes to comment on prior art reference Ujhelyi, et al. (US 2007/0027394). In Ujhelyi, Figs. 4-5 are flowcharts showing methods for how cardiac conditions are treated when a patient has low or increased physical activity (Pars. [0011-0012]). Ujhelyi teaches that high physical activity is determined by increased activity of a motion sensor (Par. [0034]). Ujhelyi differs from the instant claims because despite mentioning SVT (Par. [0028]), there isn’t a teaching of a supraventricular tachycardia state of the processing unit. For instance, the low physical activity determination (Fig. 5, # 550) simply appears to be associated with a low ventricular rate (Par. [0036]) and therefore Ujhelyi at least does not reasonably teach or suggest the required limitation “wherein, if the estimated cardiac rate is greater than or equal to the validity check rate and the actual status of the motion flag is false, the processing unit is configured to transition into a supraventricular tachycardia state in which the processing unit is configured to ramp the ventricular pacing time value up and/or the ventricular pacing rate value down until a pre-defined first pacing time threshold value and a pre-defined first pacing rate threshold value, respectively, is reached, and to suspend detecting intrinsic atrial events of the patient's heart from the received cardiac activity signals”.
No other prior art reference could be found that teaches or renders obvious the limitations of instant claims 1 and 8. Due to their dependency on independent claims 1 and 8, instant claims 2-7 and 9-15 also considered to contain potentially allowable subject matter.
Therefore, in view of the prior art and its deficiencies, the claimed invention as a whole is rendered novel and non-obvious, and thus, is allowable as claimed.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a). In particular, the 35 U.S.C. 101 and 112 rejections must be overcome.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Garner, et al. (EP 2767222) – Par. [0064] - Activity sensor 72 allows for rate adaptive pacing wherein a pacing rate (the rate of consecutive ventricular stimulation pulses for a duration of consecutive atrial stimulation pulses) depends on a physiological demand of a patient that is sensed by a way of activity sensor 72. While Garner does teach using an activity sensor to help adapt a pacing rate, Garner lacks in reasonably teaching or suggesting the specific requirements of the instant claims.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL TAYLOR HOLTZCLAW whose telephone number is (571)272-6626. The examiner can normally be reached Monday-Friday (7:30 a.m.-5:00 p.m. EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at (571) 270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL T. HOLTZCLAW/Primary Examiner, Art Unit 3796
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