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 information disclosure statement (IDS) submitted on 3/6/24 is being considered by the examiner.
Claim Objections
Claims 1 and 13 are objected to because of the following informalities: step b is missing a “;” before the and in the last line of the step. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: lines 7-8 recite “wherein in that the memory unit” which should recite –wherein the memory unit—for grammatical purposes. 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:
memory unit in claims 1-2 and 15;
first stimulation unit in claims 1, 11, and 13-15;
second stimulation unit in claims 1 and 15;
first detection unit in claims 1 and 13-15; and
second detection unit in claims 1 and 15.
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.
For memory unit in claims 1-2 and 15, the specification states “the memory unit comprises a computer- readable program that causes the processor to perform the steps explained in the following when executed on the processor” (page 2). Therefore, the Examiner is interpreting the memory unit to be a computer- readable program that causes the processor to perform the steps.
For a first stimulation unit in claims 1, 11, and 13-15, claim 13 recites “a first stimulation unit of the implantable medical device.” Therefore, the Examiner is interpreting a first stimulation unit to be a part of the implantable medical device.
For a second stimulation unit in claims 1 and 15, claim 15 recites “wherein the implantable medical device comprises…a second stimulation unit.” Therefore, the Examiner is interpreting a second stimulation unit to be a part of the implantable medical device.
For a first detection unit in claims 1 and 13-15, claim 15 recites “wherein the implantable medical device comprises…a first detection unit.” Therefore, the Examiner is interpreting a first detection unit to be a part of the implantable medical device.
For a second detection unit in claims 1 and 15, claim 15 recites “wherein the implantable medical device comprises…a second detection unit.” Therefore, the Examiner is interpreting a second detection unit to be a part of the implantable medical device.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2 and 12 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 2 recites the limitation "the maxima of the amplitudes" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. Applicant is encouraged to recite –the maximum of the first amplitude and the maximum of the second amplitude—for correct antecedent basis from claim 1. For the purposes of examination, the Examiner is interpreting “the maxima of the amplitudes” to be the same as “the maximum of the first amplitude and the maximum of the second amplitude.”
Claim 12 recites the limitation "the at least one further criterion" in in line 2. There is insufficient antecedent basis for this limitation in the claim. The Examiner thinks this claim was meant to depend from claim 11 instead of claim 1. For the purposes of examination with the current dependency, “the at least one further criterion” will be interpreted as “at least one further criterion.”
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 13 and 15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, specifically an abstract idea.
Step 1
The claimed invention in claims 13 and 15 are directed to statutory subject matter as the claims recite a method for treating a human or animal patient in need of such treatment with an implantable medical device.
Step 2A, Prong One
Regarding claims 13 and 15, the recited steps are directed to a mental process of performing concepts in a human mind or by a human using a pen and paper (see MPEP 2106.04(a)(2) subsection (III)).
Regarding claims 13 and 15, the limitations of “the electric signal comprising at least two consecutive amplitudes correlating with a contraction of the heart to be stimulated; b) determining i) whether a first amplitude of the two consecutive amplitudes and a second amplitude of the two consecutive amplitudes have a maximum lying within a predeterminable intensity range, and/or ii) whether a maximum of the first amplitude and a maximum of the second amplitude do not deviate significantly from each other in terms of intensity” are a process, as drafted, covers performance of the limitation that can be performed by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard. For example, these limitations are nothing more than a medical professional correlating two consecutive amplitudes of an electric signal using pen and paper, and determining whether a first amplitude of the two consecutive amplitudes and a second amplitude of the two consecutive amplitudes have a maximum lying within a predeterminable intensity range, and/or ii) whether a maximum of the first amplitude and a maximum of the second amplitude do not deviate significantly from each other in terms of intensity.
Step 2A, Prong Two
For claims 13 and 15, the judicial exception is not integrated into a practical application. In particular, claim 13 recites “a first detection unit of the implantable medical device” and claim 15 recites “a processor, a memory unit, wherein the implantable medical device comprises… a first stimulation unit…a second stimulation unit…a first detection unit…and a second detection unit.” The implantable medical device amounts to nothing more than pre-solution activity of data gathering. The processor and memory unit are recited at a high-level of generality and amount to nothing more than parts of a generic computer. Merely including instructions to implement an abstract idea on a computer does not integrate a judicial exception into practical application. While claims 13 and 15 recite “otherwise allowing an atrial stimulation with the first stimulation unit,” this step is a contingent limitation, because if atrial stimulation is prevented, then the atrial stimulation step will not occur.
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into
a practical application, the additional element of an implantable medical device amounts to nothing more than mere pre-solution activity of data gathering, which does not amount to an inventive concept. Moreover, the implantable medical device is recited at a high level of generality and are well-understood, routine, and conventional structures as evidenced by US 20090198251 (¶3-conventional pacemakers and ICDs), US 20040230230 (¶82-a conventional implantable ICD), and US 20040230129 (¶77-a conventional implantable ICD). Further, simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d)).
Examiner’s Note
Claims 1-12 and 14 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, and 35 U.S.C. 101 set forth in this Office action.
The following is a statement of reasons for the indication of overcoming the prior art:
The scope of a) detecting, with the first detection unit, an electric signal of a heart to be stimulated, the electric signal comprising at least two consecutive amplitudes correlating with a contraction of the heart to be stimulated; b) determining i) whether a first amplitude of the two consecutive amplitudes and a second amplitude of the two consecutive amplitudes have a maximum lying within a predeterminable intensity range, and/or ii) whether a maximum of the first amplitude and a maximum of the second amplitude do not deviate significantly from each other in terms of intensity and c) preventing an atrial stimulation with the first stimulation unit if at least one of conditions i) and ii) of step b), if tested, is not fulfilled, otherwise allowing an atrial stimulation with the first stimulation unit were not found in the prior art alone or in combination with one another to be obvious over the prior art of record. The closest prior art of record is US 20210170170; however it fails to recite correlating with a contraction of the heart to be stimulated and preventing an atrial stimulation with the first stimulation unit if at least one of conditions i) and ii) of step b), if tested, is not fulfilled, otherwise allowing an atrial stimulation with the first stimulation unit.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA HODGE whose telephone number is (571) 272-7101. The examiner can normally be reached M-F: 8:00 am-5:00 pm.
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/L.N.H./Examiner, Art Unit 3792 /AMANDA L STEINBERG/Examiner, Art Unit 3792