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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/11/2025 has been entered.
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:
an electro-anatomical mapping system configured to transmit an electromagnetic-transmission signal in claims 3 and 22.
any type of medical imaging-system configured to exchange electromagnetic-transmission signals in claim 20.
a sensor interface system configured to transmit a signal to the sensor assembly in claim 21.
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. A review of the specification shows that these structures should be understood to be:
The applicant does not explicitly define the electro-anatomical mapping system, but given numerous examples in [0031] (citing PGPUB US 20210308425 A1, hereafter merely the specification) that may implicitly define the system. As such the electro-anatomical mapping system shall be taken to mean: “The electro-anatomical mapping system 902 may include any type of medical signal-measurement system configured to detect (view) any type of medical procedure, medical signal-analysis system, an electromagnetic medical system, an electro-anatomic nonfluoroscopic mapping system, a dielectric imaging system, and/or any type of medical imaging-system (that is, any type of medical imaging-system configured to exchange electromagnetic-transmission signals as an arrangement for interacting with a medical device, such as a sheath assembly), etc., and any equivalent thereof (whether implemented for three-dimensional (3D) viewing and/or two-dimensional (2D) viewing).” Notably this includes a truly massive scope that means the examiner could equally treat a surface EKG, a computer that analyzed medical signals without transmitting or receiving anything from the body, an inserted OCT probe, a fluoroscopy C-arm, a US probe (internal or external), an MRI apparatus, and an EP mapping catheter etc. as equally reading on this structure which, for compact prosecution purposes, should be brought to the applicant’s attention directly.
Regarding the “medical imaging system” or “any type of medical imaging system” the examiner notes that this appears exclusively in the single statement made in [0031] of the specification which does not in any way describe the structure at issue. As such the system at issue will be presumed to be anything involved in imaging in accordance with the little information on the function that exists in the specification.
Regarding the “sensor interface-system” the examiner notes that the term appears only in two places at [0017] to identify it as 904 in the figures which is itself a featureless box containing no identifiable structure, and at [0031] which does not in any way describe the structure at issue. As such the assembly at issue will be presumed to be anything capable of transmitting any signal in accordance with the little information on the function that exists in the specification.
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 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 3, 5-8, 9-12, 19-22 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.
More specifically, the “electro-anatomical mapping system configured to transmit an electromagnetic-transmission signal”, the “medical imaging system” or “any type of medical imaging system”, and the “sensor interface-system” are not subject to adequate written description. In each instance the structure is a generic term (e.g. system, assembly) paired with a function and with no further structure recited in the claim. As such these have been interpreted under 112(f). However, the specification does not adequately disclose the structure. For each of these terms the structures are never explicitly defined and for the mapping system are only given by way of example and the examples are of other generic terms without clear structure. For the mapping system see [0031] and note that in each instance there is no clear structure and that each term used to describe this system is, itself, a system that is not further structurally described. Additionally and in the same vein, the term “electro-anatomical mapping system” has an ordinary meaning (it’s an electrical system which at is most basic implementation, requires at least a source electrode, a sink electrode, and a measurement electrode, and the electromagnetic transmission signal is an oscillating electrical field measured by electrodes per se) but which is not in line with the claim language (especially new claim 20) and does not appear to be adequately described or even clearly covered by the examples given in [0031]. As such and for compact prosecution purposes the examiner notes that any choice of prior art showing an electro-anatomical mapping system that actually has structure for electrically mapping and the choice of sensor assemblies that correspond to this sort of transmission are not limitations enforced by the claim language but are instead one option provided by the examiner to compact prosecution. Regarding the “medical imaging system” or “any type of medical imaging system” the examiner notes that there is simply no disclosure, even by example, of which this structure should be and therefore it is prima facie the case that the disclosure could not be adequate to allow one to make or use an invention commensurate with the scope of the claims. Regarding the “sensor-interface system” the examiner notes that there is simply no disclosure, even by example, of which this structure should be and therefore it is prima facie the case that the disclosure could not be adequate to allow one to make or use an invention commensurate with the scope of the claims.
Claims 5-8, 9-12, 19-21 are each similarly affected either directly as addressed above, or at least by virtue of dependency.
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 3, 5-8, 10-12, 19-22 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.
Regarding claims 3, 22, and 23, the phrase “electro-anatomical mapping system configured to transmit an electromagnetic-transmission signal” render the claim indefinite and call into question the scope of the claim in the following ways. First, the terms are being treated under 112(f) and the specification does not clarify what sort of structures should be under examination. Regarding in particular the “electro-anatomical mapping system”, the specification states in relevant part “The electro-anatomical mapping system 902 may include any type of medical signal-measurement system configured to detect (view) any type of medical procedure, medical signal-analysis system, an electromagnetic medical system, an electro-anatomic nonfluoroscopic mapping system, a dielectric imaging system, and/or any type of medical imaging-system (that is, any type of medical imaging-system configured to exchange electromagnetic-transmission signals as an arrangement for interacting with a medical device, such as a sheath assembly), etc., and any equivalent thereof (whether implemented for three-dimensional (3D) viewing and/or two-dimensional (2D) viewing).” Without ever describing the structures that comprise any of these “systems”; e.g. it is unclear what the applicant views to be the structure behind “medical signal-analysis system” nor how this would teach the claimed “electro-anatomical mapping” or “electromagnetic-transmission”. This in particular has ramifications for the claim interpretation as a whole and for the interpretation of the components that interact with this “electromagnetic-transmission signal”. As such the examiner will interpret the claim below as best understood including interpreting that the electromagnetic-transmission signal could be an electrical field (e.g. under the ordinary meaning of “electro-anatomical mapping system” or under [0031] of the specification’s “an electro-anatomic nonfluoroscopic mapping system, a dielectric imaging system” as those terms are best understood by the examiner) or a magnetic field (e.g. under [0031] of the specification’s “an electromagnetic medical system” as that term is best understood by the examiner) or as any electromagnetic waves (e.g. under [0031] of the specification’s “and/or any type of medical imaging-system” as that term is best understood by the examiner).
Claims 5, 7-8, 10, 12, and 21 are each similarly affected, at least by virtue of dependency.
Claim limitations “electro-anatomical mapping system”, “medical imaging system”, and “sensor-interface assembly” in claims 3 and 21-23 have been evaluated under the three-prong test set forth in MPEP § 2181, subsection I, but the result is inconclusive. Thus, it is unclear whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the specification does not disclosure or clearly link these generic terms “system” to structures and because the disclosure related to these terms is ambiguous for the reasons set forth in the Claim Interpretation section as set forth above. The boundaries of this claim limitation are ambiguous; 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.
In response to this rejection, applicant must clarify whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Mere assertion regarding applicant’s intent to invoke or not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph is insufficient. Applicant may:
(a) Amend the claim to clearly invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by reciting “means” or a generic placeholder for means, or by reciting “step.” The “means,” generic placeholder, or “step” must be modified by functional language, and must not be modified by sufficient structure, material, or acts for performing the claimed function;
(b) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, should apply because the claim limitation recites a function to be performed and does not recite sufficient structure, material, or acts to perform that function;
(c) Amend the claim to clearly avoid invoking 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by deleting the function or by reciting sufficient structure, material or acts to perform the recited function; or
(d) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, does not apply because the limitation does not recite a function or does recite a function along with sufficient structure, material or acts to perform that function.
Claims 5, 7-8, 10, 12, and 21 are each similarly affected, at least by virtue of dependency.
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)(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.
Claims 3, 5, 7-8, 10, 21, and 23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20130172712 A1 by Koyrakh et al. (hereafter Koyrakh, previously of record).
Regarding claim 3, Koyrakh teaches: 3. An apparatus, comprising:
an electro-anatomical mapping system configured to transmit an electromagnetic-transmission signal; a sensor assembly configured to receive the electromagnetic-transmission signal emanating from the electro-anatomical mapping system, and configured to transmit a detected signal back to the electro-anatomical mapping system, in response to the sensor assembly receiving electromagnetic-transmission signal provided by the electro-anatomical mapping system (regarding the electro-anatomical mapping system (EAMS) and sensor assembly (SA) and functions together; as best understood see Koyrakh’s [0038]-[0042] which establish that the sheath, further addressed below, is configured to introduce a medical device 26 in an internal lumen thereof and that this medical device can be an electrophysiology (either EP or ICE specifically, but also any of the commercially available systems such as those of the Ensite family produced by St. Jude medical and incorporated) mapping catheter per se and is part of a larger electroanatomical mapping system including a control unit 32, display 34, and positioning system 28 as well as external sources of electromagnetic transmission signal such as patch electrodes 30, the catheter including the SA, specifically electrodes 44/46 for measuring the induced voltage responsive to the transmission of current by the patch electrodes and regarding the communication back to the EAMS note that the sensed signal is used by the EAMS to determine the location of 26 relative to the heart within a coordinate system set forth by 28 per se and also note that this is specifically referred to as an “electroanatomical mapping and catheter navigation system” per se in [0042] such that, even given the potential ambiguity in the structure recited by the claims, it appears that Koyrakh teaches the exact same sort of setup using the exact same source (i.e. the EAMS is specifically and “electroanatomical mapping system” of the sort described by the applicant’s specification at [0031]) and receiver (i.e. electrodes, one of the SA options set forth in the applicant’s specification at [0041]) in the claimed communication arrangement as set forth by the applicant),
the apparatus further comprising:
a medical sheath assembly (see Koyrakh’s Fig. 2 noting the introducer 54 comprising at least sheath 62 which IVO the use described above for the EAMS/SE or as depicted in Koyrakh’s Fig. 1, or described below in regards to the mapping/transmission must be introduced into the patient in use), defining a lumen extending therethrough, and the lumen configured to receive the sensor assembly therein, and configured to permit movement of the sensor assembly along a length of the lumen (regarding the lumen of the sheath and movement of the SA together, note that Koyrakh’s [0043]-[0045] which sets forth that the sheath 64 has a lumen 78 and that the catheter 26 that contains the SA has a shaft 38 which is inserted into the sheath and movable therein with the movement controllable by the hub 58 and which describe the longitudinal movement therethrough);
wherein the medical sheath assembly is configured to convey the electromagnetic-transmission signal emanated from the electro-anatomical mapping system through the medical sheath assembly, and toward the sensor assembly positioned within the lumen in such a way that the medical sheath assembly permits the sensor assembly to transmit the detected signal back to the electro-anatomical mapping system; and wherein the medical sheath assembly includes a sheath-support component, the sheath-support component consists of a braid positioned on the medical sheath assembly and made of material that assists in transmission of electromagnetic energy traveling through the sheath-support component, dispatched toward, or dispatched away from, the medical sheath assembly, the braid being segmented into metallic sections and non-metallic sections (see Koyrakh’s Fig. 3 noting the sheath 62 comprises layers 72-26 in light of [0044], wherein layer 74 in particular is a braided wire layer that can be comprised of both metallic and non-metallic sections as per [0044] noting specifically that the wire is “stainless steel … coated with a layer of insulating material”. While the claim does not describe the how the metallic and non-metallic sections are formed and thus the foregoing is a full and complete rejection of the structure, the examiner notes for compact prosecution purposes that other ways in which this could be segmented into metallic and non-metallic sections are addressed below in regards to claim 22 as well as in the conclusion section. As best understood the remaining grouped limitations including are actually inherent in/taught by the foregoing citations already made above. That is, as best understood this only requires that the sheath assembly and its support component(s) not entirely block the signal from the EAMS from reaching the SA and not be entirely made of metal which is already discussed and covered by Koyrakh’s [0038]-[0042] as given above which even goes into detail by teaching that the EAMS receives and processes the signal received by the SA to determine the position/perform mapping. This same reasoning and interpretation also applies to multiple dependents below. For compact purposes, the examiner notes that the sheath and its components set forth in Koyrakh actually explicitly facilitate the transmission of the electromagnetic transmission signal in ways that may compact prosecution to establish up front despite not being required by the claims at the current juncture such as are shown in Figs. 4-17 and described in various and myriad sections of Koyrakh as they are the purpose of the invention of Koyrakh. That is, Koyrakh teaches many ways in which the sheath facilitates the signal transmission including having gaps through the sheath (see 80, 82 in Figs. 4-13) to allow signal transmission, or having gaps in at least one sheath component (see 80 in Fig. 6, where this is different insofar as it does not remove/pierce the wire braiding but instead fits in the pics between braids) or having sheath sections that are not gaps but are meant to actively facilitate signal transmission through the sheath (e.g. the hydrogel of Fig. 7, the conductive metal inserts 94 of Figs. 8-9, conductive strips 98 of Fig. 10, sections 128, 130 that are conductive in Figs. 14, conductive rings 150 or sections 158 in Figs. 15-16) or having sections that are transparent to the signal (e.g. the permeable material choice 172 or pores 174 In Fig. 17); among other options which are described but not depicted. Such additional teachings potentially being relevant to prosecution if-and-when the claims are narrowed to describe what structural arrangement leads to these functional limitations set forth in the claims).
Regarding claim 5, Koyrakh further teaches: 5. The apparatus of claim 3, wherein: the sheath-support component is configured to support, at least in part, an attribute of the medical sheath assembly (the examiner notes that, after consultation with SPE Bui Pho it was agreed that this limitation was so broad as to be inherent; but not indefinite. That is to say, no structure could possibly fail to teach the claimed limitation as all structures have mass or thickness etc. which support (e.g. modify, improve) an attribute (e.g. durability or torque-ability as there is more structure to work with). The converse is also seemingly always true (e.g. removing or not having a structure/thinness/reduced mass) also improves attributes (e.g. makes lightweight, makes more flexible) given the vast breadth of the claim language. In any event, see Koyrakh’s Fig. 3 and note that the sheath support component 74 exist and thus support, in part, myriad attributes of the sheath assembly. For compact prosecution purposes, the examiner notes that certain limitations from the specification that may be related to this feature but are not currently under examination are taught by noting that the sheath support component can provide durability, transfer torque, and resist deformation/bursting).
Regarding claim 7, Koyrakh further teaches: 7. The apparatus of claim 5, wherein: the sheath-support component is configured to convey, at least in part, the electromagnetic-transmission signal being emanated from the electro-anatomical mapping system through, at least in part, the sheath-support component, and toward the sensor assembly positioned within the lumen in such a way that the sheath-support component permits the sensor assembly to transmit the detected signal back to the electro-anatomical mapping system (as addressed above in regards to claim 3, this is taught by Koyrakh’s [0038]-[0042] which shows the signal from the EAMS reaching the SA. While that fully teaches the limitations, the examiner also notes that, as explained above in regards to claim 3, [0038]-[0042] also describe that the signal from the SA is used by the EAMS to determine the position and perform mapping).
Regarding claim 8, Koyrakh further teaches: 8. The apparatus of claim 3, wherein: the medical sheath assembly comprises an intravascular device (as per Koyrakh’s Fig. 1 the sheath can be an intravascular device and moreover, as per Koyrakh’s [0043] the sheath is configured to allow device 26 to pass therein and the device, as per [0038]-[0043] can be a catheter so as to include (contain within) an intravascular device).
Regarding claim 10, Koyrakh further teaches: 10. The apparatus of claim 3, wherein: the sheath-support component is configured to permit spatial tracking of the sensor assembly by the electro-anatomical mapping system (as addressed above in regards to claim 3, this is taught by Koyrakh’s [0038]-[0042] which shows the signal from the EAMS reaching the SA. While that fully teaches the limitations, the examiner also notes that, as explained above in regards to claim 3, [0038]-[0042] also describe that the signal from the SA is used by the EAMS to determine the position and perform mapping).
Regarding claim 21, Koyrakh further teaches: 21. The apparatus of claim 3, wherein: the electro-anatomical mapping system is configured to be electrically connected to a sensor-interface system; and the sensor-interface system is configured to transmit a signal to the sensor assembly positioned in the patient (regarding the electro-anatomical mapping system/medical imaging system (EAMS/MIS) and sensor assembly/sensor interface (SA/SI) and functions together; as best understood see Koyrakh’s [0038]-[0042] which establish that the sheath, further addressed below, is configured to introduce a medical device 26 in an internal lumen thereof and that this medical device can be an electrophysiology (either EP or ICE specifically, but also any of the commercially available systems such as those of the Ensite family produced by St. Jude medical and incorporated) mapping catheter per se and is part of a larger electroanatomical mapping system including a control unit 32, display 34, and positioning system 28 as well as external sources of electromagnetic transmission signal such as patch electrodes 30, the catheter including the SA, specifically electrodes 44/46 for measuring the induced voltage responsive to the transmission of current by the patch electrodes and regarding the communication back to the EAMS note that the sensed signal is used by the EAMS to determine the location of 26 relative to the heart within a coordinate system set forth by 28 per se and also note that this is specifically referred to as an “electroanatomical mapping and catheter navigation system” per se in [0042] such that, even given the potential ambiguity in the structure recited by the claims, it appears that Koyrakh teaches the exact same sort of setup using the exact same source (i.e. the EAMS is specifically and “electroanatomical mapping system” of the sort described by the applicant’s specification at [0031]) and receiver (i.e. electrodes, one of the SA options set forth in the applicant’s specification at [0041]) in the claimed communication arrangement as set forth by the applicant and which, in the cited sections, perform imaging per se; alternatively since the medical imaging system/sensor interface is merely for exchanging signals, the tracking described in [0010] or [0054] also appears to teach this from a second and different perspective).
Regarding claim 23, Koyrakh teaches: 23. An apparatus, comprising:
an electro-anatomical mapping system configured to transmit an electromagnetic-transmission signal from fixed sources; a sensor assembly configured to receive the electromagnetic-transmission signal emanating from the fixed sources, and configured to transmit a detected signal back to the electro-anatomical mapping system, in response to the sensor assembly receiving the electromagnetic-transmission signal provided by the electro anatomical mapping system (regarding the electro-anatomical mapping system (EAMS) and sensor assembly (SA) and functions together; as best understood see Koyrakh’s [0038]-[0042] which establish that the sheath, further addressed below, is configured to introduce a medical device 26 in an internal lumen thereof and that this medical device can be an electrophysiology (either EP or ICE specifically, but also any of the commercially available systems such as those of the Ensite family produced by St. Jude medical and incorporated) mapping catheter per se and is part of a larger electroanatomical mapping system including a control unit 32, display 34, and positioning system 28 as well as external sources of electromagnetic transmission signal such as patch electrodes 30, the catheter including the SA, specifically electrodes 44/46 for measuring the induced voltage responsive to the transmission of current by the patch electrodes and regarding the communication back to the EAMS note that the sensed signal is used by the EAMS to determine the location of 26 relative to the heart within a coordinate system set forth by 28 per se and also note that this is specifically referred to as an “electroanatomical mapping and catheter navigation system” per se in [0042] such that, even given the potential ambiguity in the structure recited by the claims, it appears that Koyrakh teaches the exact same sort of setup using the exact same source (i.e. the EAMS is specifically and “electroanatomical mapping system” of the sort described by the applicant’s specification at [0031]) and receiver (i.e. electrodes, one of the SA options set forth in the applicant’s specification at [0041]) in the claimed communication arrangement as set forth by the applicant; additionally and regarding the limitation that the source be “fixed” this is not limited to being positionally fixed nor is it clear what structural limitations are required to be fixed. As such the examiner notes that the ECU 32 and signal generator 52 which can be interpreted as the source as they drive the electrodes are positionally fixed/static structures by ordinary meaning. Likewise the electrodes which these structures drive are also fixed with respect to the skin of the patient, see Koyrakh’s [0040]-[0041] noting that these are mounted on the skin and used as a frame of reference for the position measurements of the SA);
a medical sheath assembly (see Koyrakh’s Fig. 2 noting the introducer 54 comprising at least sheath 62 which IVO the use described above for the EAMS/SE or as depicted in Koyrakh’s Fig. 1, or described below in regards to the mapping/transmission must be introduced into the patient in use), defining a lumen extending therethrough, the lumen configured to receive the sensor assembly therein, and configured to permit movement of the sensor assembly along a length of the lumen (regarding the lumen of the sheath and movement of the SA together, note that Koyrakh’s [0043]-[0045] which sets forth that the sheath 64 has a lumen 78 and that the catheter 26 that contains the SA has a shaft 38 which is inserted into the sheath and movable therein with the movement controllable by the hub 58 and which describe the longitudinal movement therethrough);
wherein the medical sheath assembly is configured to convey the electromagnetic-transmission signal emanated from the electro-anatomical mapping system through the medical sheath assembly, and toward the sensor assembly positioned within the lumen in such a way that the medical sheath assembly permits the sensor assembly to transmit the detected signal back to the electro-anatomical mapping system; and wherein the medical sheath assembly includes a sheath-support component, the sheath- support component comprising a braid segmented into metallic sections and non- metallic sections (see Koyrakh’s Fig. 3 noting the sheath 62 comprises layers 72-26 in light of [0044], wherein layer 74 in particular is a braided wire layer that can be comprised of both metallic and non-metallic sections as per [0044] noting specifically that the wire is “stainless steel … coated with a layer of insulating material”. While the claim does not describe the how the metallic and non-metallic sections are formed and thus the foregoing is a full and complete rejection of the structure, the examiner notes for compact prosecution purposes that other ways in which this could be segmented into metallic and non-metallic sections are addressed below in regards to claim 22 as well as in the conclusion section. As best understood the remaining grouped limitations including are actually inherent in/taught by the foregoing citations already made above. That is, as best understood this only requires that the sheath assembly and its support component(s) not entirely block the signal from the EAMS from reaching the SA and not be entirely made of metal which is already discussed and covered by Koyrakh’s [0038]-[0042] as given above which even goes into detail by teaching that the EAMS receives and processes the signal received by the SA to determine the position/perform mapping. This same reasoning and interpretation also applies to multiple dependents below. For compact purposes, the examiner notes that the sheath and its components set forth in Koyrakh actually explicitly facilitate the transmission of the electromagnetic transmission signal in ways that may compact prosecution to establish up front despite not being required by the claims at the current juncture such as are shown in Figs. 4-17 and described in various and myriad sections of Koyrakh as they are the purpose of the invention of Koyrakh. That is, Koyrakh teaches many ways in which the sheath facilitates the signal transmission including having gaps through the sheath (see 80, 82 in Figs. 4-13) to allow signal transmission, or having gaps in at least one sheath component (see 80 in Fig. 6, where this is different insofar as it does not remove/pierce the wire braiding but instead fits in the pics between braids) or having sheath sections that are not gaps but are meant to actively facilitate signal transmission through the sheath (e.g. the hydrogel of Fig. 7, the conductive metal inserts 94 of Figs. 8-9, conductive strips 98 of Fig. 10, sections 128, 130 that are conductive in Figs. 14, conductive rings 150 or sections 158 in Figs. 15-16) or having sections that are transparent to the signal (e.g. the permeable material choice 172 or pores 174 In Fig. 17); among other options which are described but not depicted. Such additional teachings potentially being relevant to prosecution if-and-when the claims are narrowed to describe what structural arrangement leads to these functional limitations set forth in the claims).
Claim Rejections - 35 USC § 102 & 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 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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 12 is rejected under 35 U.S.C. 102(a)(1) as anticipated by Koyrakh as evidenced by US 7914515 B2 by Heideman et al. (hereafter Heideman, previously of record) or, in the alternative, under 35 U.S.C. 103 as obvious over Koyrakh in view of Heideman.
Regarding claim 12, Koyrakh as evidenced by Heideman further teaches: 12. The apparatus of claim 3, wherein: the medical sheath assembly includes an exposed distal tip portion that is devoid of the sheath-support component; and the exposed distal tip portion is relatively softer than section of the medical sheath assembly having the sheath-support component (see Kyrakh’s [0044] and note that in describing the structure of the sheath Koyrakh states “Additional details regarding several exemplary sheath constructions may be found in commonly assigned U.S. Pat. No. 7,914,515 titled "Catheter and Introducer Catheter Having Torque Transfer Layer and Method of Manufacture," the entire disclosure of which is incorporated herein by reference” One could not discern the meaning of this statement without further referencing Heideman (as cited) who explains the meaning of this citation (i.e. see MPEP 2131.01(II) then see Heideman’s Figs. 7-9 which depicts the tip that does not have the other sheath layers or see col. 6 lines 1-19 and col. 7 lines 17-54 and col. 8 lines 12-26 which depict that at the distal end the various layers taper off, that describe that an atraumatic tip is bonded to the distal end, and that the durometer (i.e. the inverse of softness) decreases as you progress to the distal tip so as to be atraumatic. Therefore Koyrakh, at least when one understands the additional component that is the tip structure that is incorporated through and evidenced by Heideman, teaches the claimed limitations).
Additionally or alternatively, and in order to compact prosecution to the upmost the examiner notes that the same modification is also set forth by Heideman to be advantageous (see Figs. 7-9 tip that does not have the other sheath layers or see col. 6 lines 1-19 and col. 7 lines 17-54 and col. 8 lines 12-26 which again teach all limitations not explicitly taught by Koyrakh and which also states, in relevant part, “the present invention contemplates the inclusion of a tip assembly for use in medical procedures, such as an atraumatic tip” where having a tip that does not pierce or damage (i.e. is atraumatic) the patient’s vessel walls is a clear and profound advantage).
Therefore and in the alternative, it would have been obvious to one of ordinary skill in the art prior to the date of invention to improve the device of Koyrakh with the use of the atraumatic tip taught by Heideman in order to advantageously prevent harm to the patient as the sheath is introduced into the patient.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Koyrakh further in view of US 20080200874 A1 by Steven Ferry (hereafter Ferry, newly of record).
Regarding claim 22, Koyrakh teaches: 22. An apparatus, comprising:
an electro-anatomical mapping system configured to transmit an electromagnetic- transmission signal; and a sensor assembly configured to receive the electromagnetic-transmission signal emanating from the electro-anatomical mapping system, and configured to transmit a detected signal back to the electro-anatomical mapping system, in response to the sensor assembly receiving the electromagnetic-transmission signal provided by the electro-anatomical mapping system (regarding the electro-anatomical mapping system (EAMS) and sensor assembly (SA) and functions together; as best understood see Koyrakh’s [0038]-[0042] which establish that the sheath, further addressed below, is configured to introduce a medical device 26 in an internal lumen thereof and that this medical device can be an electrophysiology (either EP or ICE specifically, but also any of the commercially available systems such as those of the Ensite family produced by St. Jude medical and incorporated) mapping catheter per se and is part of a larger electroanatomical mapping system including a control unit 32, display 34, and positioning system 28 as well as external sources of electromagnetic transmission signal such as patch electrodes 30, the catheter including the SA, specifically electrodes 44/46 for measuring the induced voltage responsive to the transmission of current by the patch electrodes and regarding the communication back to the EAMS note that the sensed signal is used by the EAMS to determine the location of 26 relative to the heart within a coordinate system set forth by 28 per se and also note that this is specifically referred to as an “electroanatomical mapping and catheter navigation system” per se in [0042] such that, even given the potential ambiguity in the structure recited by the claims, it appears that Koyrakh teaches the exact same sort of setup using the exact same source (i.e. the EAMS is specifically and “electroanatomical mapping system” of the sort described by the applicant’s specification at [0031]) and receiver (i.e. electrodes, one of the SA options set forth in the applicant’s specification at [0041]) in the claimed communication arrangement as set forth by the applicant), the apparatus further comprising:
a medical sheath assembly assembly (see Koyrakh’s Fig. 2 noting the introducer 54 comprising at least sheath 62 which IVO the use described above for the EAMS/SE or as depicted in Koyrakh’s Fig. 1, or described below in regards to the mapping/transmission must be introduced into the patient in use), defining a lumen extending therethrough, the lumen configured to receive the sensor assembly therein, and configured to permit movement of the sensor assembly along a length of the lumen (regarding the lumen of the sheath and movement of the SA together, note that Koyrakh’s [0043]-[0045] which sets forth that the sheath 64 has a lumen 78 and that the catheter 26 that contains the SA has a shaft 38 which is inserted into the sheath and movable therein with the movement controllable by the hub 58 and which describe the longitudinal movement therethrough);
wherein the medical sheath assembly is configured to convey the electromagnetic- transmission signal emanated from the electro-anatomical mapping system through the medical sheath assembly, and toward the sensor assembly positioned within the lumen in such a way that the medical sheath assembly permits the sensor assembly to transmit the detected signal back to the electro-anatomical mapping system; and wherein the medical sheath assembly includes a braid and positioned on the medical sheath assembly and made of a material that assists in transmission of electromagnetic energy traveling through the sheath-support component, dispatched toward, or dispatched away from, the medical sheath assembly, the braid being segmented into metallic sections and non-metallic sections … (see Koyrakh’s Fig. 3 noting the sheath 62 comprises layers 72-26 in light of [0044], wherein layer 74 in particular is a braided wire layer. This at least comprises metallic sections as it is stainless steel wire. Additionally the examiner notes that from a first perspective this can comprise non-metallic sections as well, specifically an insulating layer as addressed in [0044] thought this is not stated to be made of PEEK per se, with the use of PEEK and other modifications to the braid being addressed below in the 103(a) analysis. While the claim does not describe the how the metallic and non-metallic sections are formed and thus the foregoing is a full and complete rejection of the structure, the examiner notes for compact prosecution purposes that other ways in which this could be segmented into metallic and non-metallic sections are addressed below in regards to claim 22 as well as in the conclusion section. As best understood the remaining grouped limitations including are actually inherent in/taught by the foregoing citations already made above. That is, as best understood this only requires that the sheath assembly and its support component(s) not entirely block the signal from the EAMS from reaching the SA and not be entirely made of metal which is already discussed and covered by Koyrakh’s [0038]-[0042] as given above which even goes into detail by teaching that the EAMS receives and processes the signal received by the SA to determine the position/perform mapping. This same reasoning and interpretation also applies to multiple dependents below. For compact purposes, the examiner notes that the sheath and its components set forth in Koyrakh actually explicitly facilitate the transmission of the electromagnetic transmission signal in ways that may compact prosecution to establish up front despite not being required by the claims at the current juncture such as are shown in Figs. 4-17 and described in various and myriad sections of Koyrakh as they are the purpose of the invention of Koyrakh. That is, Koyrakh teaches many ways in which the sheath facilitates the signal transmission including having gaps through the sheath (see 80, 82 in Figs. 4-13) to allow signal transmission, or having gaps in at least one sheath component (see 80 in Fig. 6, where this is different insofar as it does not remove/pierce the wire braiding but instead fits in the pics between braids) or having sheath sections that are not gaps but are meant to actively facilitate signal transmission through the sheath (e.g. the hydrogel of Fig. 7, the conductive metal inserts 94 of Figs. 8-9, conductive strips 98 of Fig. 10, sections 128, 130 that are conductive in Figs. 14, conductive rings 150 or sections 158 in Figs. 15-16) or having sections that are transparent to the signal (e.g. the permeable material choice 172 or pores 174 In Fig. 17); among other options which are described but not depicted. Such additional teachings potentially being relevant to prosecution if-and-when the claims are narrowed to describe what structural arrangement leads to these functional limitations set forth in the claims).
In the foregoing the examiner used ellipsis to omit that the braid comprises non-metallic sections which are made of “polyether ether ketone polymer” because Koyrakh does not specifically teach the use of PEEK as a portion of the braid material. Therefore, Koyrakh alone would fail to fully teach this limitation.
However Ferry in the same or eminently related field of catheter design (see Ferry’s Abstract) teaches that one can use PEEK as a braid material and teaches that one can use alternating braid geometries to achieve better trackability (see Ferry’s [0026]-[0027] which states that the support wires can be PEEK and that such wires “provide strength, resiliency and torque response to the braided or coiled catheter shaft” which is a feature they have in common to the stainless steel reinforcing wire braid, but also that polymer wire braids such as those made of PEEK additionally “provide a surprisingly effective method of reinforcing a catheter shaft main body”; additionally or alternatively, Ferry also teaches in [0033] and [0035] that “A combination of progressively softer durometer polymer segments coupled with alternating support geometries of coils braids or a combination thereof are employed by catheter embodiments described herein to achieve improved trackability and catheter retention” and “Alternately, other reinforcing materials are taken from a family of polymeric filaments used to form the shaft support.--shape memory--Use of these materials results in improved tracking combined with better catheter retention at the site of treatment.” providing additional advantages to this specific feature and options for their implementation).
Therefore it would have been obvious to one of ordinary skill in the art prior to the date of invention to use PEEK as a braid material either for the insulating layer or to replace one or more strands of the braid as Ferry teaches the PEEK is a suitable material and can advantageously improve trackability and retention of the catheter.
Response to Arguments
Applicant’s arguments, see page 11, filed 11/11/2025, with respect to the rejections of claim 5 under 112(b) and of claims 6 and 10 under 112(d) have been fully considered and is persuasive. The associated rejection of the previous office action has therefore been withdrawn.
Applicant's arguments filed 11/11/2025 with respect to all other grounds of rejection have been fully considered but they are not persuasive, with each argument being responded to in the order presented as follows:
On page 7 the applicant opines that the IDS statements previously issue have not been considered. The examiner notes that these IDS statements were considered and annotated copies of the IDS statements were filed in the after final action mailed 11/25/2025, thus this issue should be resolved.
On pages 7-10 the applicant opines that the 112(f) interpretations and 112(a)/(b) rejections of the systems terms are improper. Responding to these arguments in order, the examiner notes that the idea that one of ordinary skill in the art would understand the structure may work well for the applicants cited/argued items "(e.g., "filters", "brakes," "clamp," "screwdriver," and "locks")" this does not realistically apply to the claimed "electro-anatomical mapping system" or the like as the cited examples are all simple physical structures with well-defined meanings and the claimed limitations are complex systems that can be embodied in myriad ways that are vastly different from each other and where no ordinary meaning or common implementation exists. As such this argument is unconvincing. The applicant then opines that the specification does not need to disclose what is well known ergo they do not need to disclose the composition of their means. This is not a viable argument as means are treated differently and must necessarily be disclosed in the specification and as such it is not convincing for legal reasons (e.g. see MPEP 2181) in addition to the logical issue with calling such structures well-known when they are not. The applicant then opines that 112(f) does not apply because steps can be define the structure. This appears to be an argument made in error but for compact prosecution proposes the examiner notes that this is interpreted as a means plus function and not as a step plus function limitation. The applicant then argues that it would be implicit or inherent from the specification what structures correspond to the means plus function limitation and opines that the tens of thousands of references referring to "electro-anatomical mapping system[s]" (EAMS) would serve to clarify as much. Even if, arguendo, we initially limit ourselves to classical EAMS instead of the specified EAMS; this argument decisively proves why the examiner must hold the claimed term to be indefinite as given the EAMS of the prior art would not all share even a single overlapping structure. This is in part because some people regard magnetic sensing as falling under EAMS, but it is also simply something that occurs when a field has so much variation that there are tens of thousands of patents and patent applications which relate thereto as pointed out by the applicant. If instead we regard the actual merits of the arguments (i.e. reintroduce the specification's contents) the argument is even worse for the applicant's position. As previously iterated by the examiner in the rejection, no section of the specification defines the term or gives any clear structure thereto, which alone requires the rejection, moreover the specification at [0031] of the PGPUB gives various examples of what the applicant believes falls under an EAMS which are themselves undefined means terms and which the applicant is using the term to encompass a truly vast swath of technology that is far outside of the regular usage of the term and includes effectively any imaging or detection system without reservation. While the foregoing addressed the EAMS directly because it was singled out in the applicant's arguments for having so many related prior arts, the examiner notes that the sensor interface-system and medical imaging system are similarly affected for the same reasons as addressed in the rejection. As such the arguments for the structures being well known or adequately disclosed is unconvincing.
The applicant then turns to the prior art rejections under 102/103 and opines that the newly recited claim wording is not taught by Koyrakh and thus the claims should be patentable. Initially the examiner notes that the “braid being segmented into metallic sections and non-metallic sections” was not previously under examination and thus the examiner has amended their rejection to cover this new limitation. As such the best rebuttal to the applicant’s position is to simply see the new grounds of rejection given above. That is, Koyrakh teaches that the braid can be encapsulated in an insulating layer. As such Koyrakh’s braid comprises a core metal segment and a cladding non-metal segment and thus the examiner is not convinced by the argument. Additionally, the examiner notes that while the applicant’s specification never provides any details relevant to how this segmentation is formed/structured, the examiner did find other sorts of ways to segment the braid into metallic and non-metallic sections and has included an additional reference in the conclusion section which the applicant may find relevant.
Lastly the applicant opines that new claim 23 is patentable for similar reasons as claim 3. In this instance the examiner was not convinced by the applicant’s arguments regarding claim 3 and additionally notes that Koyrakh teaches the limitations of claim 23 as given above in the new grounds of rejection. As such the examiner was not convinced by the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure is as follows:
Mechanical characteristics of novel polyester/NiTi wires braided composite stent for the medical application by Zou et al. is an interesting reference as it shows how one can simply interleave metallic and non-metallic filaments to get a braid material having rigidity and flexibility between that of the braid materials which may later be relevant if the applicant further narrows or defines how the braid is constructed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael S Kellogg whose telephone number is (571)270-7278. The examiner can normally be reached M-F 9am-1pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pascal Bui Pho can be reached at (571)272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL S KELLOGG/ Examiner, Art Unit 3798
/PASCAL M BUI PHO/ Supervisory Patent Examiner, Art Unit 3798