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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the sheath support component comprising a “braid being segmented along a length of the braid into metallic sections and non-metallic sections” now present in at least claims 3, 22, and 23 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 emanating an electromagnetic-transmission signal in claims 3 and 21 (structurally included, presumably – see 112(b), in claim 21, with the function described in claim 3).
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 “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, 7-8, 10, 12, and 21-23 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.
In this instance claims 3, 22, and 23, and therefore all other claims by dependency, contain the limitation that the sheath support component comprises “a bread segmented along a length of the braid into metallic sections and non-metallic sections”. This is not found in the original disclosure. Indeed this is not found in the original claims, is never subject to depiction in the figures, and there is only one related statement in the speciation, merely a single sentence, which does not adequately support this limitation. For context the examiner has reproduced [0043] in its entirety with the only relevant statement underlined:
“[0043] Referring to the embodiments as depicted in FIG. 1 and FIG. 2, the sheath-support component 106 (preferably) may include a non-metallic material. The sheath-support component 106 may include a metallic material. The sheath-support component 106 may be segmented into metallic sections and non-metallic sections (if desired). It will be appreciated that there may be types of electromagnetic waves that may penetrate a metallic material. Relatively lower frequencies may penetrate a metallic material. Electromagnetic waves (energy) contain oscillating electrical fields and these fields may disturb the electrons in conductors and produce a penetration of an electric field into the conductor. This is called the skin effect. The longer the wavelength of the incident electromagnetic wave, the deeper the penetration in a metallic material. Even at low frequencies, there is a finite depth of penetration of electromagnetic waves in metals because they are not perfect conductors with infinite conductivity.”
Notably this does not contain, nor support, much less adequately describe there being a segmentation “along a length”. No other section of the specification so much as mentions the segments or discusses the braid differing along its length in a way that would support the claim language. Likewise and for compact prosecution purposes the examiner notes that no support cited by the applicant for their amendments, notably as per page 7 of the remarks “Support or the amendments to the claims can be found throughout the application as filed, including [0044] and [0056], for example”, addresses this limitation. Where the applicant’s original disclosure (non-PGPUB format) stops at [034] and thus does not contain a section 44 or a section 56. And where the PGPUB format stops at [0044] with a generic statement that embodiments cited above are combinable and the terms are not intended to be absolute and the embodiments are non-limiting with no reference to segments, braids, or anything relevant to supporting this limitation. And where section [0056] simply does not exist in the PGPUB specification. As such this limitation is not described in the original disclosure in a way that would allow one of ordinary skill in the art to make or use an invention commensurate with the scope of the claim and, given that this was added by amendment, the claims are therefore equally held to contain new matter.
Claims 21 and 23 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” in claims 21 and 23 and ”the “sensor interface-system” in claim 21 are not subject to adequate written description. In each instance the structure is a generic term (e.g. system) 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 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 “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.
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 21 and 23 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 21 and 23, the phrase “electro-anatomical mapping system” 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). Likewise the structure of “the fixed sources” or being “ now included in claim 21 nor being “positioned outside the body” now included in claim 23 does not in any way remedy this issue nor is it clear whether or not this is even sufficient or appropriate structure for being the “electro-anatomical mapping system” as sources alone cannot perform mapping and as a “source” is still generic to any of the various modalities addressed above as this provides no clear structural limitation about what is being emitted or what structure(s) perform “electro-anatomical mapping”.
Regarding claim 21, the claim recites both “The apparatus of claim 3” and “the electro-anatomical mapping system includes the fixed sources” which call into question what if any limitation is required by this claim language. More specifically claim 3 recites, as a preamble limitation not structurally included in the invention (see MPEP 2111), that the apparatus is “for use with an electro-anatomical mapping system”. As such it is unclear whether or not the applicant simply means to provide an optional limitation on what sort of systems the apparatus can be “for use with” or if the applicant means to require that the electro-anatomical mapping system is a portion of the invention; calling into question the scope of the claim. Given the issues with the electro-anatomical mapping system, the examiner recommends cancelling the claim, as there is no clear examinable meaning to any limitation on a structure that is not part of the invention and there is no clear examinable structure associated with the electro-anatomical mapping system given the lack of disclosure of as much. For compact prosecution purposes the examiner will examine the claim below as best understood.
Regarding claim 21, the claim recites both “the electro-anatomical mapping system includes the fixed sources [and, from claim 3 these sources: emanating an electromagnetic-transmission signal]” and “the sensor-interface system configured to transmit a signal”; however as amended these overlap entirely or almost entirely in scope, calling into question whether or not these are different structures and if/how they differ. More specifically things that emanate are transmitting and things that transmit are emanating, thus the only potential difference between these two systems is that one emanates/transmits a “electromagnetic-transmission signal” whereas the other emanates/transmits a generic “signal” which certainly could and by ordinary meaning would be “electromagnetic” since it both have to propagate through the body and be received by the same sensor assembly. As such it is not clear what if any difference exists between the “electro-anatomical mapping system” and the “sensor interface system” as they both appear to perform the same function in the same way targeting the same sensor assembly and both use undisclosed means to do so as addressed above in the 112(f) and 112(a) rejections. For compact prosecution purposes this limitation will be addressed as best understood.
Regarding claim 21, the claim recites both “The apparatus of claim 3” and “wherein the fixed sources are configured to transmit the electromagnetic-transmission signal to the sensor assembly positioned in the patient”; however, claim 3 as amended already recites this same subject matter, see lines 5-6; therefore it is unclear what if scope is covered by this statement which renders this redundant and confusing.
Claim 21 recites the limitation "the patient" in lines 6 and 8. There is insufficient antecedent basis for this limitation in the claim.
Claim limitations “electro-anatomical mapping system” in claims 21 and 23, and claimed limitation “sensor-interface assembly” in claim 21 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.
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.
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), alternatively as evidenced by US 7914515 B2 by Heideman et al. (hereafter Heideman, previously of record), further alternatively as being obvious under 35 U.S.C. 103 as being unpatentable further in view of US 20080200874 A1 by Steven Ferry (hereafter Ferry, previously of record).
Regarding claim 3, Koyrakh teaches: 3. An apparatus for use with an electro-anatomical mapping system (this is now drafted as expressly not required structure, see MPEP 2111, and thus does not require further rejection. To compact prosecution to the upmost, and because Koyrakh teaches this structure anyways, the examiner notes that the structure of the electro-anatomical mapping system EAMS is also included in the rejection of the sensor assembly (SA) below), the apparatus comprising:
a sensor assembly configured to receive an electromagnetic-transmission sisgnal emanating from fixed sources positioned outside the body, 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 (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 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 consisting 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).
Additionally or alternatively the examiner notes that, Koyrakh teaches that the invention is segmented into portions, with each portion differing in stiffness/flexibility, such that the proximal end is the stiffest and the distal end is the most flexible (see Koyrakh’s [0044] noting that in describing the sheath structure, the description is by incorporation noting: “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.”. To that end, see MPEP 2131.01 noting that this feature of Koyrakh is expressly incorporated but one would not understand the meaning of that statement of incorporation the full teachings and disclosure of Koyrakh without turning to the cited reference, then see Heideman and note e.g.: col. 2 lines 44-49 “The torque transfer layer has a braid density of between about 5 PPI and about 100 PPI and may be braided in a one-over, one-under pattern, or a two-over, two-under pattern. The outer sheath comprises a plurality of segments having differing hardness characteristics” Or col. 7 lines 27-29 “The lengths of the various segments may vary, but preferably, the durometer hardness levels will decrease as the outer sheath 306 approaches its distal end.” And lastly col. 5 lines 33-45 which states “Alternatively, the torque transfer layer 204 may utilize a varying braid density construction along the length of the introducer catheter 200. For example, the torque transfer layer may be characterized by a first braid density at the proximal end of the introducer catheter 200 and then transition to one or more braid densities as the torque transfer layer 204 approaches the distal end of the introducer catheter 200; the braid density of the distal end may be greater or less than the braid density at the proximal end. In a specific example, the braid density at the proximal end is about 50 PPI and the braid density at the distal end is about 10 PPI. In another embodiment, the braid density at the distal end is about 20-35% of the braid density at the proximal end.” Which respectively spell out that the length of the sheath is sectioned from a proximal to distal end, that the flexibility increases as one proceeds distally, and that one of the tools Heideman, and thus Koyrakh by incorporation, uses to accomplish this is by changing the structure of the braid, in this instance by reducing the number of wires/PPI).
In the foregoing the examiner omitted, indicated by ellipsis, the limitation that the segmentation of the braid be “along a length of the braid” because it bears additional consideration. In short, the broadest reasonable interpretation of this language is taught either directly by Koyrakh or indirectly by Koyrakh through incorporation of Heideman because the claim wording of the braid does not require that the segments be such that they are comprised of “only metal” at one segment and of “only non-metal” at another segment, rather it requires that there are segmented sections of braid having metal and segments having non-metal. Given that Koyrakh’s [0044] directly states that in one embodiment the wires can be (“stainless steel … coated with a layer of insulating material”) it is clear that, at least when the optional insulating layer is used, each segment will contain both metal and non-metal and thus in any two segments there will be segments containing metal and segments containing non-metal regardless of where and how the segments are chosen. Notably this is additionally, and alternatively, improved upon by Heideman as while it is not strictly required to cite to Heideman, it does show that the various segments are not an arbitrary invention of the examiner but rather that Koyrakh, by incorporation, specifically intended to segment the invention and even to have the segments vary by how the braid was constructed and that this segmentation was to occur with respect to the length as one proceeded proximally and distally (see in the alternate, Heideman’s col. 2 lines 44-49, col. 7 lines 27-29, and col. 5 lines 33-45 as cited above).
The examiner fully admits that the foregoing, while a complete and proper rejection of the broadest reasonable interpretation (BRI), does not address what could arguably be an ordinary meaning (OM). More specifically, while the applicant has not expressly claimed that the sections are only metal in one segment and only non-metal in another segment, that is one reasonable reading of the claim as drafted. As such and given the divergence of the BRI and one potential OM it may compact prosecution to at least separately and alternatively address the potential OM as follows:
The sum total difference between the claim language and Koyrakh, presuming the meaning of the claim to require only metal braid segments and only non-metal braid segments, would be that Koyrakh teaches a metal only braid (see Koyrakh’s [0044] noting that “Braided wire layer 74 is configured to provide appropriate levels of pushability, torqueability, flexibility, and kink resistance to sheath 62. Layer 74 may be formed from stainless steel wire, preferably flat wire (wire having a cross-section that, when taken along the wire's longitudinal axis and measured along two orthogonal axes, is substantially rectangular) arranged in various braid patterns” and that the only reference to a non-metal component of this braid is expressly optional, see again [0044] noting “The wire may be coated with a layer of an insulating material.”). As such in order to obviate the claim there would need to be a teaching that showed that non-metal wires could be employed suitably in this context and (at least in order to adhere to Heideman’s incorporated teachings of the segments getting progressively more flexible) that they had greater flexibility than metal wires.
To that end, 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 segments of PEEK as a braid material to replace one or more strands of the braid as Ferry teaches the PEEK is a suitable material which is more flexible and which and can advantageously improve trackability and retention of the catheter.
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 as best understood, Koyrakh further teaches: 21. The apparatus of claim 3, wherein: the electro-anatomical mapping system includes the fixed sources positioned outside the body and 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; and wherein the fixed sources are configured to transmit the electromagnetic-transmission signal to the sensor assembly positioned in the patient (as best understood the amendment has render this inherent/holding no patentable weight as it now addresses only a desiderata of what sort of structure the applicant wishes the invention to be “for use with” without placing any limitation on any claimed structure. For compact prosecution purposes as presuming, arguendo, that these structures are includes the examiner alternatively notes that: 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 and wherein these sources can be fixed, e.g. attached, relative to the sensor in the patient as per [0038] or, given the breadth of the systems, could be as described in [0046] which is entirely external and disconnected from the patient).
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 positioned outside a body, 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 and wherein these sources can be fixed externally, e.g. attached to the patient’s skin, relative to the sensor in the patient as per [0038] or, given the breadth of the systems, could be as described in [0046] which is entirely external and disconnected from the patient);
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).
Additionally or alternatively the examiner notes that, Koyrakh teaches that the invention is segmented into portions, with each portion differing in stiffness/flexibility, such that the proximal end is the stiffest and the distal end is the most flexible (see Koyrakh’s [0044] noting that in describing the sheath structure, the description is by incorporation noting: “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.”. To that end, see MPEP 2131.01 noting that this feature of Koyrakh is expressly incorporated but one would not understand the meaning of that statement of incorporation the full teachings and disclosure of Koyrakh without turning to the cited reference, then see Heideman and note e.g.: col. 2 lines 44-49 “The torque transfer layer has a braid density of between about 5 PPI and about 100 PPI and may be braided in a one-over, one-under pattern, or a two-over, two-under pattern. The outer sheath comprises a plurality of segments having differing hardness characteristics” Or col. 7 lines 27-29 “The lengths of the various segments may vary, but preferably, the durometer hardness levels will decrease as the outer sheath 306 approaches its distal end.” And lastly col. 5 lines 33-45 which states “the torque transfer layer 204 may utilize a varying braid density construction along the length of the introducer catheter 200. For example, the torque transfer layer may be characterized by a first braid density at the proximal end of the introducer catheter 200 and then transition to one or more braid densities as the torque transfer layer 204 approaches the distal end of the introducer catheter 200; the braid density of the distal end may be greater or less than the braid density at the proximal end. In a specific example, the braid density at the proximal end is about 50 PPI and the braid density at the distal end is about 10 PPI. In another embodiment, the braid density at the distal end is about 20-35% of the braid density at the proximal end.” Which respectively spell out that the length of the sheath is sectioned from a proximal to distal end, that the flexibility increases as one proceeds distally, and that one of the tools Heideman, and thus Koyrakh by incorporation, uses to accomplish this is by changing the structure of the braid, in this instance by reducing the number of wires/PPI).
In the foregoing the examiner omitted, indicated by ellipsis, the limitation that the segmentation of the braid be “along a length of the braid” because it bears additional consideration. In short, the broadest reasonable interpretation of this language is taught either directly by Koyrakh or indirectly by Koyrakh through incorporation of Heideman because the claim wording of the braid does not require that the segments be such that they are comprised of “only metal” at one segment and of “only non-metal” at another segment, rather it requires that there are segmented sections of braid having metal and non-metal. Given that Koyrakh’s [0044] directly states that in one embodiment the wires can be (“stainless steel … coated with a layer of insulating material”) it is clear that, at least when the optional insulating layer is used, each segment will contain both metal and non-metal and thus in any two segments there will be segments containing metal and segments containing non-metal regardless of where and how the segments are chosen. Notably this is additionally, and alternatively, improved upon by Heideman as while it is not strictly required to cite to Heideman, it does show that the various segments are not an arbitrary invention of the examiner but rather that Koyrakh, by incorporation, specifically intended to segment the invention and even to have the segments vary by how the braid was constructed and that this segmentation was to occur with respect to the length as one proceeded proximally and distally (see in the alternate, Heideman’s col. 2 lines 44-49, col. 7 lines 27-29, and col. 5 lines 33-45 as cited above).
The examiner fully admits that the foregoing, while a complete and proper rejection of the broadest reasonable interpretation (BRI), does not address what could arguably be an ordinary meaning (OM). More specifically, while the applicant has not expressly claimed that the sections are only metal in one segment and only non-metal in another segment, that is one reasonable reading of the claim as drafted. As such and given the divergence of the BRI and one potential OM it may compact prosecution to at least separately and alternatively address the potential OM as follows:
The sum total difference between the claim language and Koyrakh, presuming the meaning of the claim to require only metal braid segments and only non-metal braid segments, would be that Koyrakh teaches a metal only braid (see Koyrakh’s [0044] noting that “Braided wire layer 74 is configured to provide appropriate levels of pushability, torqueability, flexibility, and kink resistance to sheath 62. Layer 74 may be formed from stainless steel wire, preferably flat wire (wire having a cross-section that, when taken along the wire's longitudinal axis and measured along two orthogonal axes, is substantially rectangular) arranged in various braid patterns” and that the only reference to a non-metal component of this braid is expressly optional, see again [0044] noting “The wire may be coated with a layer of an insulating material.”). As such in order to obviate the claim there would need to be a teaching that showed that non-metal wires could be employed suitably in this context and (at least in order to adhere to Heideman’s incorporated teachings of the segments getting progressively more flexible) that they had greater flexibility than metal wires.
To that end, 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 segments of PEEK as a braid material to replace one or more strands of the braid as Ferry teaches the PEEK is a suitable material which is more flexible and which and can advantageously improve trackability and retention of the catheter.
Claim 12 is rejected under 35 U.S.C. 102(a)(1) as anticipated by Koyrakh as evidenced Heideman or, in the alternative, under 35 U.S.C. 103 as obvious over Koyrakh in view of Heideman, these rejections further alternatively as being obvious under 35 U.S.C. 103 as being unpatentable further in view Ferry.
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 as evidenced by Heideman, further in view of Ferry.
Regarding claim 22, Koyrakh teaches: 22. An apparatus for use with an electro-anatomical mapping system (this is now drafted as expressly not required structure, see MPEP 2111, and thus does not require further rejection. To compact prosecution to the upmost, and because Koyrakh teaches this structure anyways, the examiner notes that the structure of the electro-anatomical mapping system EAMS is also included in the rejection of the sensor assembly (SA) below), the apparatus comprising:
a sensor assembly including at least one of an electrode, a coil, or an antenna (see Koyrakh’s [0039] noting e.g. electrodes 44), the sensor assembly configured to receive the electromagnetic-transmission signal emanating from fixed sources outside the body, 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 (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, 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 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 a 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).
Additionally the examiner notes that, Koyrakh teaches that the invention is segmented into portions, with each portion differing in stiffness/flexibility, such that the proximal end is the stiffest and the distal end is the most flexible (see Koyrakh’s [0044] noting that in describing the sheath structure, the description is by incorporation noting: “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.”. To that end, see MPEP 2131.01 noting that this feature of Koyrakh is expressly incorporated but one would not understand the meaning of that statement of incorporation the full teachings and disclosure of Koyrakh without turning to the cited reference, then see Heideman and note e.g.: col. 2 lines 44-49 “The torque transfer layer has a braid density of between about 5 PPI and about 100 PPI and may be braided in a one-over, one-under pattern, or a two-over, two-under pattern. The outer sheath comprises a plurality of segments having differing hardness characteristics” Or col. 7 lines 27-29 “The lengths of the various segments may vary, but preferably, the durometer hardness levels will decrease as the outer sheath 306 approaches its distal end.” And lastly col. 5 lines 33-45 which states “the torque transfer layer 204 may utilize a varying braid density construction along the length of the introducer catheter 200. For example, the torque transfer layer may be characterized by a first braid density at the proximal end of the introducer catheter 200 and then transition to one or more braid densities as the torque transfer layer 204 approaches the distal end of the introducer catheter 200; the braid density of the distal end may be greater or less than the braid density at the proximal end. In a specific example, the braid density at the proximal end is about 50 PPI and the braid density at the distal end is about 10 PPI. In another embodiment, the braid density at the distal end is about 20-35% of the braid density at the proximal end.” Which respectively spell out that the length of the sheath is sectioned from a proximal to distal end, that the flexibility increases as one proceeds distally, and that one of the tools Heideman, and thus Koyrakh by incorporation, uses to accomplish this is by changing the structure of the braid, in this instance by reducing the number of wires/PPI).
In the foregoing the examiner omitted, indicated by ellipsis, two limitations, first that the braid’s non-metallic portions be made of “polyether ether ketone polymer” the limitation that the segmentation of the braid be “along a length of the braid”. Regarding the latter of these, this can arguable be seen as taught by Koyrakh directly but it bears additional consideration. In short, the broadest reasonable interpretation of this language is taught either directly by Koyrakh or indirectly by Koyrakh through incorporation of Heideman because the claim wording of the braid does not require that the segments be such that they are comprised of “only metal” at one segment and of “only non-metal” at another segment, rather it requires that there are segmented sections of braid having metal and non-metal. Given that Koyrakh’s [0044] directly states that in one embodiment the wires can be (“stainless steel … coated with a layer of insulating material”) it is clear that, at least when the optional insulating layer is used, each segment will contain both metal and non-metal and thus in any two segments there will be segments containing metal and segments containing non-metal regardless of where and how the segments are chosen. Notably this is additionally, and alternatively, improved upon by Heideman as while it is not strictly required to cite to Heideman, it does show that the various segments are not an arbitrary invention of the examiner but rather that Koyrakh, by incorporation, specifically intended to segment the invention and even to have the segments vary by how the braid was constructed and that this segmentation was to occur with respect to the length as one proceeded proximally and distally (see in the alternate, Heideman’s col. 2 lines 44-49, col. 7 lines 27-29, and col. 5 lines 33-45 as cited above).
The examiner fully admits that the foregoing, while a complete and proper rejection of the broadest reasonable interpretation (BRI) of this segmentation limitation, this does not address what could arguably be an ordinary meaning (OM) and it also does not address the former limitation that the non-metallic braid material be PEEK. More specifically, while the applicant has not expressly claimed that the sections are only metal in one segment and only non-metal in another segment, that is one reasonable reading of the claim as drafted. As such and given the divergence of the BRI and one potential OM it may compact prosecution to at least separately address the potential OM as well as the use of PEEK as follows:
Therefore the difference between the claim language and Koyrakh, presuming the meaning of the claim to require only metal braid segments and only non-metal braid segments, would be that Koyrakh teaches a metal only braid (see Koyrakh’s [0044] noting that “Braided wire layer 74 is configured to provide appropriate levels of pushability, torqueability, flexibility, and kink resistance to sheath 62. Layer 74 may be formed from stainless steel wire, preferably flat wire (wire having a cross-section that, when taken along the wire's longitudinal axis and measured along two orthogonal axes, is substantially rectangular) arranged in various braid patterns” and that the only reference to a non-metal component of this braid is expressly optional, see again [0044] noting “The wire may be coated with a layer of an insulating material.”) and does not teach PEEK as a braid material choice. As such in order to obviate the claim there would need to be a teaching that showed that non-metal wires of PEEK could be employed suitably in this context and (at least in order to adhere to Heideman’s incorporated teachings of the segments getting progressively more flexible) that they had greater flexibility than metal wires.
To that end, 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 segments of PEEK as a braid material to replace one or more strands of the braid as Ferry teaches the PEEK is a suitable material which is more flexible and which and can advantageously improve trackability and retention of the catheter.
Response to Arguments
Applicant’s arguments, see pages 7-9, filed 4/23/2026, with respect to the rejections under 112(a)/(b) have been fully considered but are not persuasive.
More specifically, the applicant’s arguments with respect to claims 3 and 22 and their dependents are persuasive in part (i.e. for claims 3 and 22 directly and for all dependents except claim 21); however, the applicant still attempts to either incorporate or otherwise structurally limited (e.g. as a desiderata on what sort of thing the invention is for use with?) the EAMS even though this is now a preamble limitation. As such, the issue remains intact for at least one claim and thus the argument is not fully convincing even though the majority of claims this affected are no longer rejected.
The applicant further opines with respect to claim 23 that the EAMS being fixed and external, as amended, overcomes the 112(a) and 112(b) rejections. With regards to the 112(a) this is an incredibly simple issue and the examiner notes that, because the specification is not amended, this is fundamentally an argument that cannot be convincing. With regards to the 112(b) issues, the issues reliant on claim interpretation under 112(f) are also not affected in anyway by this amendment for the same reasons. With regards to the remaining 112(b) issues, the examiner notes that being fixed and being external do not in any substantive or meaningful way describe or limit the structures at issue and therefore this argument is also unconvincing for all remaining grounds of rejection, including the new rejections introduced by the amendment to claim 21.
The applicant then opines that the sensor-interface system of claim 21 is definite. No section of the specification is cited, and the argument does not point out, even unsupported, what structures the applicant feels should be understood to comprise the sensor interface system therefore this is both unconvincing on its face and also a rote spurious argument under 37 CFR 1.111(b) since it merely alleges without evidence or substantive information that the structure would be known without evidencing where in the specification this structure can be found or even describing what they believe the structurer is.
Therefore and for the foregoing reasons the examiner is not convinced that the 112(a) and 112(b) rejections are overcome.
Applicant's arguments filed 4/23/2026 with respect to the 102/103 rejections have been fully considered but they are not fully persuasive, with each argument being responded to in the order presented as follows:
On pages 9-10 the applicant addresses the 102(a)(1) rejection featuring Koyrakh alone. In this instance the applicant has seemingly erred in assuming a meaning not actually spelled out in the claim language directly. That is, Koyrakh’s braid containing both metallic and non-metallic elements, and Koyrakh’s invention already being segmented along its length (any arbitrary segment can be enforced without further reference, but at least in the alternative Heideman can be used to show that this is not arbitrary or an invention of the examiner’s mind but instead a known and document portion of Koyrakh’s invention) means that any section can be (i.e. contain) a metal segment and any section can be (i.e. contain) a non-metal segment as the argument appears to presume that the segments are “only metal” or “only non-metal” which is not actually present in the claims.
Likewise the examiner notes that the applicant has cited in support of their amendment [0044] and [0056]. Since originally provided specification ends at [034] and the PGPUB, which renumbers these sections, ends at [0044] with a generic statement that embodiments are combinable but without addressing segments at all, that the applicant’s amendment does not appear supported. If we presume, arguendo, that the applicant intended to cite [0043] which is the sole section where a segment is mentioned and the only section that addresses this new feature, then the examiner notes that there is still no disclosure of segmenting the “along the length” as claimed. Likewise there is no reason to argue about this, see:
“[0043] Referring to the embodiments as depicted in FIG. 1 and FIG. 2, the sheath-support component 106 (preferably) may include a non-metallic material. The sheath-support component 106 may include a metallic material. The sheath-support component 106 may be segmented into metallic sections and non-metallic sections (if desired). It will be appreciated that there may be types of electromagnetic waves that may penetrate a metallic material. Relatively lower frequencies may penetrate a metallic material. Electromagnetic waves (energy) contain oscillating electrical fields and these fields may disturb the electrons in conductors and produce a penetration of an electric field into the conductor. This is called the skin effect. The longer the wavelength of the incident electromagnetic wave, the deeper the penetration in a metallic material. Even at low frequencies, there is a finite depth of penetration of electromagnetic waves in metals because they are not perfect conductors with infinite conductivity.”
And note that the single sentence, underlined for emphasis, is the only relevant disclosure in the entire specification and it does not provide what the applicant is claiming, and even less so provides what the applicant appears to be arguing for. As such the 102 is actually maintained because the claim wording is broader than the argument and the only relevant disclosure does not compel the examiner to presume that this needs to be read as anything narrower than the broadest reasonable interpretation.
However, and for compact prosecution purposes, and despite being rejected under 112(a) and despite not being explicitly claimed, the examiner has nevertheless introduced two alternatives to reject this subject matter being argued as the claim amendment can be read, arguendo, to include this. Specifically Heideman who iterates that Koyrakh has by incorporation segments of varying flexibility where this is accomplished, in part, by changing the structure of the braid. Or further as obvious over Ferry who rather clearly points out that PEEK is suitable for use as a braid material but more flexible than steel wire and thus plays directly into the combination the applicant is arguing (but again, has not explicitly claimed). These new grounds or rejection being responsive to the amendment.
The applicant then argues on pages 10-11 that Ferry does not cure the above identified deficiencies. As an initial note the examiner notes that the claim language is rejectable as rebutted above and thus this argument is not convincing as there is no deficiency for Ferry to cure. Nevertheless, and as documented in the examiner’s alternative rejection of other claims and in the amended claim 23 rejection, Ferry very much cures this deficiency. That is, when provided with a reference that is in every way identical to the applicant’s save that it uses a metal braid instead of a segmented metal and non-metal braid (i.e. Koyrakh alone) where this could (i.e. inherently, e.g. any arbitrary segment) and also actually is specifically intended to be segmented along its length such that the flexibility increases as one proceeds from the proximal end to the distal end and that one mechanism contemplated by the author for doing this is to change the braid structure (i.e. expressly, via Heideman which while alternative/not strictly necessary certainly fleshes out the combination to follow), then simply combining this with a reference that teaches that PEEK/polymer braids are a suitable replacement for metal wires that are more flexible (i.e. Ferry) would in fact remedy the only outstanding claim limitation that the segmentation occur along the length since the base references segmentation already occurs to cause changes in flexibility along the length and already describes that the braid contributes to and can be modified to accomplish this. As such the argument is not convincing for a second reason.
The applicant then opines that all remaining claims are patentable at least by virtue of dependency; however, given that the examiner was not convinced by the foregoing arguments that examiner is similarly not convinced that the dependent claims are ripe for patentability by dependency at this juncture for the foregoing reasons.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure is as follows:
Polyetheretherketone (PEEK): How to select the right grade? By Specialchem.com is a reference containing basic background/scientific information about PEEK. While Ferry states that PEEK and other polymers are suitable and have similar properties and are flexible enough for this context which is enough to form a rejection, this or any of the myriad other similar references can be used to quickly and readily determined that the physical properties of PEEK, e.g. its young’s modulus or flexural modulus, make it vastly more flexible than stainless steel. As such while this sort of reference is not strictly required it is a nice reference to have in support of the examiner’s position above.
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 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, Keith Raymond can be reached at (571)270-1790. 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
/KEITH M RAYMOND/Supervisory Patent Examiner, Art Unit 3798
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