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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/09/2026 has been entered.
Claims 1, 7-13, and 17-18 are the current claims hereby under examination.
All below references to Applicant’s specification are made using the paragraph numbers assigned in the US publication of the present application US 20220354429 A1.
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:
Claim 13: a magnetic field generator configured to generate a magnetic field. This limitation is interpreted as referring to a power source and coil of conductive wire as described in paragraphs 0042-0044 and Fig. 1 of Applicant’s specification and its equivalents.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
It is noted that the limitation “sensor” is being interpreted as referring to both a sensing element and the associated circuitry supporting its function in all claims.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 7-9, 12-13, and 17 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Keilman US Patent Application Publication Number US 2009/0005859 A1 hereinafter Keilman
Regarding claim 1, Keilman discloses a stent (Abstract; Paragraph 0009), comprising:
an expandable tubular scaffold having a proximal end and a distal end (Paragraphs 0057 and 0092: the expandable structure of the stent, stents are cylindrical structures; Paragraph 0007: blood flows through the stent; Fig. 7 reference 106: the stent has a proximal and distal end);
a first wire coupled to the tubular scaffold (Paragraph 0057: RF coupling coil is added to the stent structure; Paragraph 0092: RF coupling coil may comprise a separate RF coupling coil),
wherein the first wire is shaped into a first coil (Paragraph 0057: the coupling coil may comprise a helical coil, Fig. 7 reference 30a: the wire is shaped into a coil);
wherein the tubular scaffold includes a plurality of braided filaments extending from the proximal end to the distal end, and wherein the first wire is included within the plurality of braided filaments (Paragraph 0094: the stent may be a woven mesh of fine helical wires ; Paragraph 0092: The Rf coupling coil may be a separate RF coupling coil that is wound through the structure comprising the wall of the stent; Paragraph 0057: the RF coupling coil may be added to the expandable structure by threading an insulated wire through the expandable wall of a stent); and
a sensor electrically coupled to the first wire (Paragraph 0101: the ends of the RF coupling coil are coupled to ore or more transducers or sensors through implantable circuitry), wherein the sensor is configured to monitor a physiological parameter within the vessel (Paragraphs 0063-0066: flow, temperature, and pressure sensors may be utilized);
wherein the sensor is inductively powered by a magnetic field passing through the first wire (Paragraphs 0057 and 0063-0064: the RF excitation frequency applied to the coil generates power for the sensors).
Regarding claim 7, Keilman discloses the stent of claim 1. Keilman further discloses the stent wherein the sensor is electrically coupled to a battery configured to store energy for powering the sensor (Paragraph 0060: the power supply may include a battery or capacitor for storing energy)
Regarding claim 8, Keilman discloses the stent of claim 1. Keilman further discloses the stent further comprising wireless communication circuitry configured to generate wireless signals responsive to output from the sensor, wherein the wireless signals responsive to output from the sensor are configured to be received by an external receiver located in a remote location from the sensor (Paragraph 0055: the stent transmits data signals from the transducers to locations outside the body; Paragraphs 0068-0072, 0078, and 0080: the transducers may transmit data outside of the patient’s body through the RF coupling coil to an external coil; Fig. 7: the external receiver 90).
Regarding claim 9, Keilman discloses the stent of claim 1. Keilman further discloses the stent wherein the sensor is selected from a group consisting of a temperature sensor, a pH sensor, a flow sensor, a pressure sensor, an oxygen sensor, and a heart rate sensor (Paragraphs 0063-0066 and 0078: flow, temperature, and pressure sensors may be utilized).
Regarding claim 12, Keilman discloses the stent of claim 1. Keilman further discloses the stent wherein the first wire includes an insulated covering (Paragraph 0057: the coil may be an insulated wire).
Regarding claim 13, Keilman discloses a medical device system (Abstract), comprising:
a magnetic field generator configured to generate a magnetic field (Paragraph 0058: the RF coil is excited electromagnetically; Paragraphs 0080-0082 and 0087-0091: the external coil to provide signals to and receive data from the transducers; Fig. 7: the external receiver 90 and magnetic flux lines 112);
a stent (Abstract; Paragraph 0009), comprising:
an expandable tubular scaffold having a proximal end and a distal end, and a lumen extending therethrough (Paragraphs 0057 and 0092: the expandable structure of the stent, stents are cylindrical structures; Paragraph 0007: blood flows through the stent; Fig. 7 reference 106: the stent has a proximal and distal end);
a first wire coupled to the tubular scaffold (Paragraph 0057: RF coupling coil is added to the stent structure; Paragraph 0092: RF coupling coil may comprise a separate RF coupling coil), wherein the first wire is shaped into a coil (Paragraph 0057: the coupling coil may comprise a helical coil, Fig. 7 reference 30a: the wire is shaped into a coil);
wherein the tubular scaffold includes a plurality of braided filaments extending from the proximal end to the distal end (Paragraph 0094: the stent may be a woven mesh of fine helical wires);
wherein the first wire is included within the plurality of braided filaments (Paragraph 0092: The Rf coupling coil may be a separate RF coupling coil that is wound through the structure comprising the wall of the stent; Paragraph 0057: the RF coupling coil may be added to the expandable structure by threading an insulated wire through the expandable wall of a stent); and
a sensor electrically coupled to the first wire (Paragraph 0101: the ends of the RF coupling coil are coupled to ore or more transducers or sensors through implantable circuitry) wherein the sensor is configured to monitor a physiological parameter within the vessel (Paragraphs 0063-0066: flow, temperature, and pressure sensors may be utilized), the sensor being inductively powered by the magnetic field passing through the first wire (Paragraphs 0057 and 0063-0064: the RF excitation frequency applied to the coil generates power for the sensors);
wireless communication circuitry configured to generate wireless signals responsive to output from the sensor (Paragraph 0055: the stent transmits data signals from the transducers to locations outside the body; Paragraphs 0068-0072, 0078, and 0080: the transducers may transmit data outside of the patient’s body through the RF coupling coil to an external coil; Fig. 10: the external receiver 90B); and
an external receiver configured to receive the wireless signals responsive to output from the sensor (Paragraphs 0080-0082 and 0087-0091: the external coil to provide signals to and receive data from the transducers; Fig. 7: the external receiver 90).
Regarding claim 17, Keilman discloses the medical device system of claim 13. Keilman further discloses the system wherein the magnetic field generator includes the receiver (Paragraphs 0080-0082 and 0087-0091: the external coil to provide signals to and receive data from the transducers; Fig. 7: the external receiver 90 and the magnetic flux lines 112; The external coil is the magnetic field generator and the receiver).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Keilman US Patent Application Publication Number US 2009/0005859 A1 hereinafter Keilman as applied to claim 1 above and further in view of Kveen US Patent Application Publication Number US 2007/0150009 A1 hereinafter Kveen
Regarding claim 10, Keilman discloses the stent of claim 1. Keilman fails to further disclose the stent wherein the sensor is attached to only the first wire.
Kveen teaches a pacing apparatus having a stent electrode through which pulses of electrical current can be delivered. Stent electrodes receive energy for generating the electrical current from a variety of sources. Sources include from one or more induction coils that can form at least a portion of the stent. Sources can also include an implantable pulse generator coupled to a lead through which pulses of the electrical current are supplied to the stent electrodes (Abstract). Thus, Kveen falls within the same field of endeavor as Applicant’s invention.
Kveen teaches that induction coils may extend circumferentially along a longitudinal axis of a stent and may form at least a portion of the structural members of the stent, or may lie on and be attached to a stent having structural members separate from the induction coils (Paragraph 0027-0028). Kveen further teaches that control circuitry may be located in a variety of locations including between members of the induction coil, suspended within the lumen of the stent, within the material structure of the stent, or away from the stent (Paragraph 0031).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the stent of Keilman to have a structure where the circuitry components are located between members of the induction coil structure as taught by Kveen and attached only to the induction coil structure because such a configuration would allow the RF coupling coil and associated circuitry of Keilman in view of Kveen to be an entirely separate and independent structure from the stent body and may allow the system to me more readily adapted into different stent configurations. Additionally, the particular method of attachment, anchor points, and positioning of the implanted circuitry is considered to be a matter of routine optimization and experimentation to adapt the system to a desired use case or particular stent structure as the attachment method, members to which the circuitry is attached, and location of attachment do not produce any surprising technical effect.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Keilman US Patent Application Publication Number US 2009/0005859 A1 hereinafter Keilman as applied to claim 1 above and further in view of Tassel US Patent Application Publication Number US 2005/0149170 A1 hereinafter Tassel.
Regarding claim 11, Keilman discloses the stent of claim 1. Keilman fails to further disclose the stent wherein the sensor is attached to a portion of the tubular scaffold, and wherein the tubular scaffold is configured to transfer power from the first wire to the sensor.
Tassel teaches an implantable stent having surface features adapted to promote an organized growth pattern of infiltrating cells when implanted in a tubular organ. The surface features comprise depressions, pores, projections, pleats, channels or grooves in the stent body and are designed to increase turbulence or stagnation in the flow of a liquid, such as blood through the stent, and/or to promote the growth of infiltrating cells in an organized pattern. Alternatively, the stent can be populated with living cells prior to implant and can be heatable from an external source of energy, thereby inducing production of therapeutic bioactive agents from ingrowing cells. The invention also provides an implantable heatable stent for transcutaneously monitoring the flow of fluid through a lumen into which the stent is implanted by measuring the rate at which the heated stent cools in response to blood flow when the source of heat is removed (Abstract). Thus, tassel falls within the same field of endeavor as Applicant’s invention.
Tassel teaches that a stent body may be used to transfer energy to a sensor in order to activate the sensor (Paragraph 0067).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement the conductive stent structure and teachings of Tassel into the stent of Keilman such that the power generated by the coils Keilman would be connected to the stent which in turn would be connected to the sensing circuitry because such a configuration may allow the implanted circuitry to be placed in a more desirable location for a particular use case. Additionally, the particular method of transferring power from the RF coupling coil to the circuitry of Keilman is considered a matter of routine optimization and experimentation as transferring the power directly from the coil to the sensors, from the coil into the stent then to the sensors, or from the coil and through some other intermediate structure or wire then to the sensors produces the same effect of supplying power to the sensors. Thus the particular method of transferring power from the excitation coil to the sensor is considered a matter of routine optimization and experimentation to configure the system to a desired use case or particular stent structure but does not produce a surprising technical effect.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Keilman US Patent Application Publication Number US 2009/0005859 A1 hereinafter Keilman as applied to claim 17 above and further in view of Spillman US Patent Number US 6206835 B1 hereinafter Spillman.
Regarding claim 18, Keilman discloses the system of claim 17. Keilman fails to further disclose the system, wherein the magnetic field generator includes a handheld device.
Spillman teaches an implant device which is responsive to an external interrogation circuit. The implant device includes a structure implantable within a living animal and operatively configured to carry out or assist in carrying out a function within the living animal. The device further includes an electrically passive sensing circuit integral with the structure for sensing a parameter associated with the function. In particular, the sensing circuit includes an inductive element wherein the sensing circuit has a frequency dependent variable impedance loading effect on the interrogation circuit in response to an interrogation signal provided by the exciter/interrogator element, the impedance loading effect varying in relation to the sensed parameter (Abstract). Thus, Spillman falls within the same field of endeavor as Applicant’s invention.
Spillman teaches an exciter or interrogator unit which is a handheld sized device which communicates with an implanted device utilizing magnetic and/or electromagnetic coupling (Fig. 3 references 38 and 52; Col 4 lines 28-40).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the external coil for providing power and receiving signals from the stent of Keilman to be a handheld unit as taught by Spillman because configuring the external coil to be a handheld unit may improve the usability of the system and communication quality since a handheld interrogator unit can typically be brought into closer proximity to the implanted device than a stationary communication unit and may allow for a greater degree of positional adjustment to best align the external coil with the coil of the implanted stent.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 13 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
In particular, Applicant’s arguments are not directed towards the newly cited portions of Keilman including paragraphs 0057 and 0092 which each disclose that the RF coupling coil may be a separate and distinct coil from the structure of the stent that is wound through and thus included within the plurality of braided filaments that comprise the stent structure.
Additionally, Examiner notes that Applicant’s arguments are not commensurate in scope with the claim language. There is no language present in the current claims that differentiates the first wire from the plurality of braided filaments. There is no recitation stating that the first wire is of a different structure or configuration than the braided filaments and thus it would seem that any one of the braided filaments that act as a RF coupling coil may be designated as a “first wire”. While Applicant’s arguments are not found to be persuasive, new portions of Keilman are cited to better align the prior art mapping to Applicants seemingly intended scope.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US Patent Number US 6280385 B1 hereinafter Melzer teaches a stent with a passive magnetic resonance circuit (Abstract). Melzer teaches an inductor coil in a stent wherein the inductor is not formed of the skeleton of the stent itself but rather an additional wire woven into the stent skeleton (Col 10 lines 38-44; Fig. 2 reference 2’).
US Patent Application Publication Number US 2006/0178576 A1 hereinafter Weber teaches a resonator device for medical devices with a helical structure which may be used in conjunction with a stent (Abstract). Weber teaches a resonator coil may be woven at least partially through the openings of a stent structure (Paragraphs 0061 and 0076; Fig. 8)
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/MATTHEW ERIC OGLES/Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791
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