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 .
Response to Amendment
This office action is in response to the amendment filed on 3/20/2026. Currently claims 1-6 and 8-15 are pending.
Response to Arguments
Applicant’s arguments, see pgs. 7-8, filed 3/20/2026, with respect to the previous rejection of the claims 1-15 under 35 USC 112(b) for the use of “in particular” have been fully considered and are persuasive based on applicant’s amendments. The previous rejection of claims 1-15 under 35 USC 112(b) for the use of “in particular” has been withdrawn.
Applicant’s arguments, see pgs. 9-12, filed 3/20/2026, with respect to the previous rejection(s) of:
Claim(s) 1-3, 5-6, 8 and 13-15 rejected under 35 USC 102(a)(1) as being anticipated by Hareland
Claim(s) 4, 7 and 9-12 rejected under 35 USC 103 as being unpatentable over Hareland
have been fully considered and are persuasive. The previous rejections of claims 1-15 has been withdrawn.
Applicant's arguments, see pgs. 7-9 filed 3/20/2026 with respect to the previous rejections of claims 2, 5 and 12 under 35 USC 112(a) and 112(b) have been fully considered but they are not persuasive.
In the previous rejection (non-final rejection mailed on 12/23/2025), the limitations:
“a tachyarrhythmia detection unit configured to detect a tachycardia” in claim 2
“an anti-tachycardia pacing timing unit configured to deliver an anti- tachycardia pacing sequence in response to tachycardia detection” in claim 2
“a fault detection device configured to detect the unavailability of defibrillation in particular due to a battery exhaustion and/or fault conditions of the implantable cardioverter defibrillator” in claim 5
“A communication unit for intrabody communication configured to signal the availability of defibrillation to the implantable pacing device” in claim 12
were deemed to raise 112(f) interpretation. The specification was deemed to fail providing support for the structure recited by the functional language in these limitations the specification failed to provide what the meets and bounds for these structures are. Thus, raising a 35 USC 112(a) and 35 USC 112(b) rejection.
Applicant argues that a tachyarrhythmia detection unit, an anti-tachycardia pacing timing unit, a fault detection device, a communication unit are part of or embodiment by implantable cardioverter defibrillator or an implantable pacing device which are well known and that the functions tied to elements are tied to the defibrillator and/or pacing device. [see pgs. 8-9 of applicant’s arguments received on 3/20/2026].
This is not persuasive. Based on the ways the claims are written it is clear that the claimed generic place holders of anti-tachycardia pacing timing unit, a fault detection device, a communication unit are part of implantable cardioverter defibrillator and/or an implantable pacing device, but what is not clear is what structures within the implantable cardioverter defibrillator and/or an implantable pacing device they represent. For example, is the tachyarrhythmia detection unit a processor within the implantable pacing device? Or is it some other structure within the implantable pacing device? The groups of structures or specific structures that applicant is claiming using generic placeholders with functional language that further define the defibrillator and/or pacing device is what is lacking and unclear. Since the claims are written to raise 112(f) interpretation, the disclosure is reviewed to see what structures applicant is claiming that is within the defibrillator and/or implantation device. Applicant’s arguments fail make it clear on the record what the structures these place holders with functional language are reciting (i.e. are the structures processors, circuitry, something else?). And since applicant’s arguments maintain the limitations in a form that raises 112(f) interpretation, the claims still raise a 112(f) interpretation that appears have a specification devoid of what structures these limitations are effectively claiming. Therefore, for similar reasons as in the previous office action the rejections under 35 USC 112(a) and 35 USC 112(b) rejections for claims 2, 5 and 12 have been maintained.
Claim Objections
Claims 1 and 13 are objected to because of the following informalities:
Claim 1 recites:
“Implantable system for providing anti-tachycardia and/or shock therapy”
This should be changed to:
“ An implantable system for providing anti-tachycardia and/or shock therapy”
Claim 13 recites:
“Computer implemented method for providing anti-tachycardia and/or shock therapy”
This should be changed to:
“ A computer implemented method for providing anti-tachycardia and/or shock therapy”
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:
“a tachyarrhythmia detection unit configured to detect a tachycardia” in claim 2
“an anti-tachycardia pacing timing unit configured to deliver an anti- tachycardia pacing sequence in response to tachycardia detection” in claim 2
“a fault detection device configured to detect the unavailability of defibrillation in particular due to a battery exhaustion and/or fault conditions of the implantable cardioverter defibrillator” in claim 5
“A communication unit for intrabody communication configured to signal the availability of defibrillation to the implantable pacing device” in claim 12
These limitations raise 112 issues, please see the 112 rejection section below for how these means plus functions limitation were interpreted.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2, 5 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’s limitation “a tachyarrhythmia detection unit configured to detect a tachycardia” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The closest support in the specification is described as Fig. 1 element 16 and pg. 11 lines 25-31 of applicant’s specification received on 2/21/2024 (hereafter referred to as applicant’s specification) which states the following:
“Furthermore, the implantable pacing device IPD comprises a configurable tachyarrhythmia detection unit 16 configured to detect a tachycardia and further comprises an anti-tachycardia pacing timing unit 18 configured to deliver an anti-tachycardia pacing ATP sequence in response to tachycardia detection.”
The specification is devoid of adequate structure to perform the claimed function. In particular, the specification merely repeats the placeholder and states the claimed function. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. For this examination any type of hardware, software or combination of hardware and software that can perform the function of detecting a tachycardia.
Claim 2’s limitation “an anti-tachycardia pacing timing unit configured to deliver an anti- tachycardia pacing sequence in response to tachycardia detection” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function.
The closest support in the specification is described as Fig. 1 element 18 and pg. 11 lines 25-31 of applicant’s specification which states the following:
“Furthermore, the implantable pacing device IPD comprises a configurable tachyarrhythmia detection unit 16 configured to detect a tachycardia and further comprises an anti-tachycardia pacing timing unit 18 configured to deliver an anti-tachycardia pacing ATP sequence in response to tachycardia detection.”
The specification is devoid of adequate structure to perform the claimed function. In particular, the specification merely repeats the placeholder and states the claimed function. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. For this examination any type of hardware, software or combination of hardware and software that can perform the function of delivering an anti- tachycardia pacing sequence in response to tachycardia detection will recite this limitation.
Claim 5’s limitation “a fault detection device configured to detect the unavailability of defibrillation in particular due to a battery exhaustion and/or fault conditions of the implantable cardioverter defibrillator” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function.
The closest support in the specification is described as Fig. 1 element 20 and pg. 12 lines 15-20 of applicant’s specification which states the following:
“Moreover, the implantable cardioverter defibrillator ICD comprises a fault detection device 20 configured to detect the unavailability of defibrillation, in particular due to a battery exhaustion and/or fault conditions of the implantable cardioverter defibrillator ICD.”
The specification is devoid of adequate structure to perform the claimed function. In particular, the specification merely repeats the placeholder and states the claimed function. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. For this examination any type of hardware, software or combination of hardware and software that can perform the function of detecting the unavailability of defibrillation in particular due to a battery exhaustion and/or fault conditions of the implantable cardioverter defibrillator will recite this limitation.
Claim 12’s limitation “a communication unit for intrabody communication configured to signal the availability of defibrillation to the implantable pacing device” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function.
The closest support in the specification is described as Fig. 1 element 26 and pg. 13 lines 10-15 of applicant’s specification received on 2/21/2024 which states the following:
“Moreover, the cardioverter defibrillator ICD comprises a communication unit 26 for intrabody communication configured to signal 10 the availability of defibrillation to the implantable pacing device IPD.”
The specification is devoid of adequate structure to perform the claimed function. In particular, the specification merely repeats the placeholder and states the claimed function. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. For this examination any type of hardware, software or combination of hardware and software that can perform the function of signaling the availability of defibrillation to the implantable pacing device will recite this limitation.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claims 2, 5 and 12 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. As outlined above, the disclosure is devoid of structure and does not provide adequate structure to perform the claimed functions for the following means plus function limitations:
“a tachyarrhythmia detection unit configured to detect a tachycardia” in claim 2
“an anti-tachycardia pacing timing unit configured to deliver an anti- tachycardia pacing sequence in response to tachycardia detection” in claim 2
“a fault detection device configured to detect the unavailability of defibrillation in particular due to a battery exhaustion and/or fault conditions of the implantable cardioverter defibrillator” in claim 5
“A communication unit for intrabody communication configured to signal the availability of defibrillation to the implantable pacing device” in claim 12
Thus, the specification does not demonstrate that applicant has made an invention that achieves the claimed function because the invention is not described with sufficient detail that one of ordinary skill in the art can reasonably conclude that the inventor had possession of the claimed invention.
Allowable Subject Matter
Claims 3-4, 6, 8-11 and 14-15 allowed.
Claims 1 and 13 would be allowable if rewritten or amended to overcome the objection, set forth in this Office action.
Claims 2, 5 and 12 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Claim 1 is the broadest independent claim of the allowable subject matter. Claim 1 recites an implantable system for providing anti-tachycardia and/or shock therapy. The closest prior art is Hareland. Hareland discloses the invention substantially as claimed as outlined in the previous non-final rejection mailed on 12/23/2025. However, Hareland fails to fully recite “wherein the implantable pacing device is configured to prompt the cardioverter defibrillator to signal the availability of defibrillation by means of intrabody communication before delivering anti-tachycardia pacing”. Furthermore, nothing in the prior art when viewed with Hareland obviates this limitation. It is important to note that this limitation by itself does not define the invention over the prior. Rather, it is the missing limitation in combination of all the limitations of claim 1 together that defines the invention over the prior art. Therefore, the combination of claimed limitations recited by claim 1 is neither anticipated, nor obviated in view of the prior art.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action. Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEBASTIAN X LUKJAN whose telephone number is (571)270-7305. The examiner can normally be reached Monday - Friday 9:30AM-6PM.
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SEBASTIAN X LUKJAN
/SXL/Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
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