DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement (IDS) submitted was filed on 11/18/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
The amendment filed 12/08/2025 has been entered. Claim 8 has been canceled. Accordingly, claims 1-7 and 9-16 remain pending in the application.
Response to Arguments
Applicant's arguments filed 12/08/2025 have been fully considered but they are not persuasive.
Applicant argues Griffith discloses “…an annular region will be established between this insulating sleeve and the interior of the housing 40, which space may be filled with a suitable electrically insulating epoxy to ensure adequate bonding between these structures and to enhance the mechanical integrity of the same” and therefore does not reasonably teach “the housing comprises a hollow interior defined by a continuous surface” as presently claimed.
Examiner respectfully disagrees. Griffith discloses “It will be observed in FIG. 2 that an annular region will be established between this insulating sleeve 56 and the interior of the housing 40, which space may be filled with a suitable electrically insulating epoxy”. The “space” which may be filled disclosed by Griffith refers to the annular region between the insulating sleeve 56 and interior of the housing 40, not the space of the entire interior of the housing 40. This space is indicated in the annotated figure 2 below for clarity, wherein two circles are drawn to indicate the space and wherein a hollow interior is also indicated.
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As shown in figure 2 and disclosed by Griffith, there exists an annular region between the insulating sleeve 56 and interior of the housing 40. This annular region, or space, may be filled with epoxy “to ensure adequate bonding between these structures and to enhance mechanical integrity of the same”. The epoxy filled within this space or annular region bonds the insulating sleeve 56 to the housing 40; “these structures” clearly refer to the insulating sleeve 56 and housing 40. The interior of the housing 40 is therefore not entirely filled with epoxy; only an annular region between the housing 40 and insulating sleeve 56 is filled with epoxy. Griffith therefore teaches a housing 40 comprising a hollow interior, as shown in annotated figure 2 above; a hollow interior exists on a proximal (right) side of the piezoelectric body (50), allowing for leads (26a, 26b) of a cable (26) to connect to the piezoelectric body (50) of the transducer (44). The hollow interior may also exist around the piezoelectric body (50) as Griffith does not disclose wherein the entire annular region is filled but rather an annular region between the insulating sleeve 56 and interior of the housing 40 is filled.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 9 and 10 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.
Claims 9 and 10 recite the limitation "the first projection". There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, it will be interpreted for the devices of claims 9 and 10 to include a first projection.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 5 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 5 depends upon claim 1. Claim 5 recites a hollow interior defined by a continuous surface, a first portion, and a second portion which are similarly recited in claim 1. Assuming the hollow interior, continuous surface, first portion, and second portion recited in claim 5 are the same as the ones recited to in claim 1, claim 5 fails to further limit the subject matter of claim 1 upon which it depends. Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 4-7, 9, 13, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Griffith (US5115814).
Regarding claim 1, Griffith teaches an intraluminal sensing device (11) (Figs. 1 & 7a-7d, Abstract, Column 5 lines 45-65, Column 10 lines 53-56, Claim 26), comprising:
a flexible elongate member (14) comprising a distal portion (16) and a proximal portion and configured to be positioned within a body lumen of a patient (Fig. 1, Column 12 lines 6-13 and 22-34);
a housing (40) positioned at the distal portion (16) of the flexible elongate member (14), wherein the housing (40) comprises a conductive material (stainless steel) and a non-conductive material (epoxy, 56) (Fig. 2, Column 5 lines 11-14, Column 6 lines 50-63, wherein stainless steel is conductive material, Column 8 lines 28-56, wherein insulating sleeve 56 formed of electrically insulating epoxy material is non-conductive material),
wherein the housing (40) comprises a hollow interior defined by a continuous surface, wherein a first portion (40) of the continuous surface comprises the conductive material (stainless steel) and a different, second portion (epoxy) of the continuous surface comprises the non-conductive material (epoxy) (Fig. 2; figure 2 shows housing 40 to comprise a continuous surface, Column 6 lines 58-63, wherein the housing 40 being fabricated of stainless steel comprises a first portion of the continuous surface being conductive, Column 8 lines 28-41, “It will be observed in FIG. 2 that an annular region will be established between this insulating sleeve 56 and the interior of the housing 40, which space may be filled with a suitable electrically insulating epoxy to ensure adequate bonding between these structures and to enhance the mechanical integrity of the same”, wherein the insulating sleeve 56 which is formed of insulating epoxy and the annular region whose space is filled with insulating epoxy comprises the non-conductive second portion of the continuous surface); and
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a sensor (44) comprising an exposed conductive surface (50) and configured to obtain physiological data while positioned within the body lumen, wherein the sensor (44) is positioned within the housing (40) such that the exposed conductive surface (50) contacts the non-conductive material (epoxy, 56) of the housing (40) and is electrically isolated from the conductive material (stainless steel) (Fig. 2, Abstract, Column 1 lines 14-63, Column 4 lines 25-30, wherein ultrasound images of a blood vessel comprises physiological data, Column 6 lines 21-38 and 65-67, Column 8 lines 28-56, wherein piezoelectric body 50 requiring an insulating sleeve 56 for electrical isolation implies the piezoelectric body 50 having an exposed conductive surface).
Regarding claim 2, Griffith teaches the invention as claimed above in claim 1.
Griffith further teaches wherein the exposed conductive surface comprises a perimeter of the sensor (44) (Fig. 2, Column 8 lines 28-56, “The piezoelectric body 50 is electrically isolated from the housing 40 via an insulating sleeve 56 formed of any suitable electrically insulating epoxy material coated on its exterior circumferential surface”, wherein coating the exterior circumferential surface of the piezoelectric body 50 of the transducer 44 with insulation means that the exterior circumferential surface is conductive and thus wherein the exposed conductive surface comprises a perimeter (circumferential surface); see also figure 2 showing the sleeve 56 covering the sides or perimeter of the body 50).
Regarding claim 4, Griffith teaches the invention as claimed above in claim 1.
Griffith further teaches wherein the non-conductive material (epoxy) comprises a polymer (Column 8 lines 28-41, wherein epoxy is a polymer).
Regarding claim 5, Griffith teaches the invention as claimed above in claim 1.
Griffith further teaches wherein the housing (40) comprises a hollow interior defined by a continuous surface, wherein a first portion of the continuous surface comprises the conductive material (stainless steel) and a different, second portion (epoxy) of the continuous surface comprises the non-conductive material (epoxy) (Fig. 2; figure 2 shows housing 40 to comprise a continuous surface, Column 6 lines 58-63, wherein the housing 40 being fabricated of stainless steel comprises a first portion of the continuous surface being conductive, Column 8 lines 28-41, “It will be observed in FIG. 2 that an annular region will be established between this insulating sleeve 56 and the interior of the housing 40, which space may be filled with a suitable electrically insulating epoxy to ensure adequate bonding between these structures and to enhance the mechanical integrity of the same”, wherein the insulating sleeve 56 and the annular region whose space is filled with insulating epoxy comprises the non-conductive second portion of the continuous surface).
Regarding claim 6, Griffith teaches the invention as claimed above in claim 5.
Griffith further teaches wherein the housing (40) comprises a plurality of layers formed atop one another such that the plurality of layers defines the continuous surface, wherein a first layer (40) of the plurality of layers comprises the conductive material (stainless steel) and is disposed within the first portion of the continuous surface and a different, second layer (56 + annular region between sleeve 56 and interior of the housing 40) of the plurality of layers comprises the non-conductive material (epoxy) and is disposed within the second portion (epoxy) of the continuous surface (Fig. 2, Column 6 lines 58-63, Column 8 lines 28-41, wherein the housing 40 being stainless steel comprises the first layer and the annular region of insulating epoxy between the housing and insulating sleeve 56 + insulating sleeve 56 forms the second layer atop the housing 40; see figure 2).
Regarding claim 7, Griffith teaches the invention as claimed above in claim 5.
Griffith further teaches wherein the sensor (44) is positioned within the hollow interior such that the exposed conductive surface (50) contacts the second portion (epoxy, 56) of the continuous surface and is spaced from the first portion (40) of the continuous surface (Fig. 2, Column 8 lines 28-41, wherein figure 2 shows the sensor 44 positioned within the hollow interior of the housing 40 such that its exposed conductive surface 50 contacts the second portion 56 of the continuous surface and is spaced from the stainless steel first portion 40 of the housing 40, and wherein only an annular region is filled with epoxy rather than the entire annular region, resulting in the sensor 44 being positioned within a hollow interior of the housing).
Regarding claim 9, Griffith teaches the invention as claimed above in claim 1.
Griffith further teaches wherein the first projection (56 + annular region) surrounds a perimeter of the exposed conductive surface (50) (Fig. 2, Column 8 lines 28-41, “…electrically insulating epoxy material coated on its exterior circumferential surface” ; see figure 2).
Regarding claim 13, Griffith teaches the invention as claimed above in claim 1.
Griffith teaches the invention further comprising a wire assembly (26a) electrically coupled to the exposed conductive surface (50) (Fig. 2, Column 8 lines 10-16 and 42-50; the inner lead 26a comprising a wire assembly is electrically connected to the piezoelectric body 50 via the electrically conductive backing layer 54; see figure 2).
Regarding claim 15, Griffith teaches the invention as claimed above in claim 1.
Griffith further teaches wherein the housing (40) comprises a coating of the non-conductive material (Fig. 2, Column 8 lines 28-35, wherein insulating sleeve 56 is a coating of non-conductive material).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Griffith (US5115814) in view of Beckers (US20190192116).
Regarding claim 3, Griffith teaches the invention as claimed above in claim 1.
However, Griffith fails to teach wherein the non-conductive material comprises a ceramic material.
In an analogous intraluminal sensing device field of endeavor, Beckers teaches such a feature. Beckers teaches an intraluminal sensing device comprising an ultrasound catheter (100) configured to measure physiological data comprising blood flow (Fig. 1, [0034], [0063-0064]). Beckers teaches ceramic particles such as metal oxide particles exhibit electrically insulating properties which may advantageously provide electrical insulation to transducer element electronics ([0047]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Griffith to use ceramic material for electrical insulation as taught by Beckers ([0047]). Griffith teaches wherein the insulating sleeve (56) may be formed of any suitable electrically insulating epoxy material (Column 8 lines 28-31) and Beckers teaches ceramic material may exhibit electrically insulating properties for specifically providing electrical insulation to a transducer ([0047]). Therefore, Griffith modified by the teachings of Beckers would predictably result wherein the insulating sleeve (56) may be formed of ceramic material and/or an insulating ceramic epoxy. By using ceramic material, the sensor/transducer may be electrically insulated.
Claims 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Griffith (US5115814) in view of Diederich (US5620479).
Regarding claim 10, Griffith teaches the invention as claimed above in claim 1.
However, Griffith fails to teach wherein: the housing comprises a different, second projection extending within the hollow interior, wherein the second projection comprises the non-conductive material and is in contact with the exposed conductive surface; the first projection is arranged to contact the exposed conductive surface over a first portion of the exposed conductive surface; and the second projection is arranged to contact the exposed conductive surface over a different, second portion of the exposed conductive surface, wherein the second portion is spaced from the first portion.
In an analogous intraluminal sensing device field of endeavor, Diederich teaches such a feature. Diederich teaches a flexible ultrasound catheter (12) (Figs. 1-3, Column 6 lines 43-57). Diederich teaches wherein the catheter (12) includes sensors such as ultrasound transducers (16) (Figs. 1-3, Column 6 lines 58-67). Diederich teaches electrical isolation of the transducers (16) includes the use of rubber spacers (22) between the transducers (16) and the catheter (12) (Fig. 3, Column 7 line 35 – Column 8 line 7). As shown in figure 3 and disclosed in Column 7 lines 40-41, the rubber spacers (22) extend along the catheter (12) of the ultrasound device (10). Moreover, Figure 3 shows a plurality (three) of spacers. Therefore, Diederich teaches first and second projections (wherein the spacers 22 project) and wherein the projections (22) contact different portions of the transducer (16) and/or catheter (12) surfaces, the transducer having exposed conductive surfaces (wherein the transducer requiring electrical isolation implies it having exposed conductive surfaces).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Griffith to include a plurality of non-conductive/rubber projections for electrically isolating the transducer as taught by Diederich (Fig. 3, Column 7 line 35 – Column 8 line 7). The use of the plurality of projections may result in the transducer being “air backed”, and by air backing the transducer, the transducers may produce more energy and have more uniform energy distribution as recognized by Diederich (Fig. 3, Column 7 lines 56-61). The modification of Griffith with the teachings of Diederich would result in a plurality of non-conductive spacers surrounding the transducer, thereby further resulting in first and second projections which extend through the hollow interior and contact the transducer at different portions of its exposed conductive surface.
Regarding claim 11, Griffith teaches the invention as claimed above in claim 1.
However, Griffith fails to teach the invention further comprising an air gap position between the sensor and the housing, wherein the air gap comprises an acoustic backing layer.
In an analogous intraluminal sensing device field of endeavor, Diederich teaches such a feature. Diederich teaches a flexible ultrasound catheter (12) (Figs. 1-3, Column 6 lines 43-57). Diederich teaches wherein the catheter (12) includes sensors such as ultrasound transducers (16) (Figs. 1-3, Column 6 lines 58-67). Diederich teaches electrical isolation of the transducers (16) includes the use of rubber spacers (22) between the transducers (16) and the catheter (12) (Fig. 3, Column 7 line 35 – Column 8 line 7). Diederich teaches the spacers (22) result in air gaps, causing the transducers (16) to be “air backed” (Fig. 3, Column 7 lines 56-61). Moreover, Diederich teaches wherein the air gaps are positioned between the transducer sensor (16) and the catheter (12) (Fig. 3, Column 7 lines 35-61; see figure 3) and wherein the air gap “backs” the acoustic transducer (16) (Fig. 3, Column 7 lines 56-61). Diederich therefore teaches an air gap positioned between a sensor (transducer 16) and a housing (catheter 12) and wherein the air gap comprises an acoustic backing layer (air backing for ultrasound/acoustic transducer 16).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Griffith to apply air backing to the transducer by using an air gap as an acoustic backing layer as taught by Diederich (Fig. 3, Column 7 line 35 – Column 8 line 7). An air gap comprising an acoustic backing layer may allow the transducer to produce more energy and have more uniform energy distribution as recognized by Diederich (Column 7 lines 56-61).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Griffith (US5115814) in view of Stigall (US20140228943).
Regarding claim 12, Griffith teaches the invention as claimed above in claim 1.
Griffith further teaches wherein the sensor is an ultrasound transducer (44) (Column 6 lines 64-67).
However, Griffith fails to explicitly teach wherein the sensor comprises a flow sensor.
In an analogous intraluminal sensing device field of endeavor, Stigall teaches such a feature. Stigall teaches a delivery system (100) including an elongate body (25) and a flow sensor (12) (Fig. 1, [0035-0036]). Stigall teaches wherein the flow sensor can be an ultrasound transducer ([0093]). Stigall teaches wherein the flow sensor can be used to measure blood flow velocity within a blood vessel, which can be used to assess coronary flow reserve (CFR) or similar ([0093]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Griffith to have the ultrasound transducer be a flow sensor as taught by Stigall ([0093]). By having the sensor be a flow sensor, blood velocity may be measured and may be used to assess coronary flow reserve (CFR) and stenosis as recognized by Stigall ([0065], [0093]).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Griffith (US5115814) in view of Belef (US5503154).
Regarding claim 14, Griffith teaches the invention as claimed above in claim 1.
However, Griffith fails to explicitly teach the invention further comprising an adhesive positioned between the sensor and the housing.
In an analogous intraluminal sensing device field of endeavor, Belef teaches such a feature. Belef teaches an intraluminal catheter including an ultrasound transducer (10) (Title, Abstract, Column 1 lines 33-35). Belef teaches wherein the transducer (10) is mounted to a distal housing (24) (Fig. 2, Column 2 lines 53-54). Belef teaches wherein adhesive material (26, 76) is used to mount the transducer (10) to the distal housing (24) (Figs. 2 & 6B, Column 2 lines 53-57, Column 4 lines 12-14). Belef therefore teaches an adhesive positioned between a sensor (transducer 10) and a housing (distal housing 24).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Griffith to include an adhesive positioned between the sensor and the housing as taught by Belef (Figs. 2 & 6B, Column 2 lines 53-57, Column 4 lines 12-14). Using an adhesive positioned between the sensor and housing predictably allows for mounting of the sensor to the housing using said adhesive. The adhesive may ensure the sensor or transducer is rigidly fixed to the housing of the device, allowing for more accurate measurements as the sensor/transducer is fixed in place.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Griffith (US5115814) in view of Millett (US20140276138).
Regarding claim 16, Griffith teaches an intraluminal sensing device (11) (Figs. 1 & 7a-7d, Abstract, Column 5 lines 45-65, Column 10 lines 53-56, Claim 26), comprising:
a guidewire (80) comprising a distal portion and a proximal portion and configured to be positioned within a blood vessel of a patient (Figs. 7a-7d & 8, Column 10 line 65 – Column 11 line 42, “The guide wire 80 is maneuvered beyond the terminal end of the external guide tube until it is positioned at the desired location within the coronary artery to be investigated”);
a housing (40) comprising a hollow interior defined by a continuous surface, wherein a first portion (40) of the continuous surface comprises a conductive material (stainless steel) and a different, second portion (epoxy) of the continuous surface comprises a non-conductive material (epoxy) (Fig. 2; figure 2 shows housing 40 to comprise a continuous surface, Column 6 lines 58-63, wherein housing 40 being fabricated of stainless steel comprises a first portion of the continuous surface being conductive, Column 8 lines 28-41, “It will be observed in FIG. 2 that an annular region will be established between this insulating sleeve 56 and the interior of the housing 40, which space may be filled with a suitable electrically insulating epoxy to ensure adequate bonding between these structures and to enhance the mechanical integrity of the same”, wherein the insulating sleeve 56 and the annular region whose space is filled with insulating epoxy comprises the non-conductive second portion of the continuous surface); and
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a sensor (44) comprising an exposed conductive surface (50) and configured to obtain physiological data while positioned within the blood vessel, wherein the sensor (44) is positioned within the hollow interior of the housing (40) such that the exposed conductive surface (50) contacts the second portion (56 + “annular region”) and is electrically isolated from the first portion (40) (Fig. 2, Abstract, Column 1 lines 14-64, Column 4 lines 25-30, wherein ultrasound images of a blood vessel comprises physiological data, Column 6 lines 21-38 and 65-67, Column 8 lines 28-56, wherein piezoelectric body 50 requiring an insulating sleeve 56 for electrical insolation implies the piezoelectric body 50 having an exposed conductive surface, Column 10 lines 53-56, “…positioning the probe 11 of this invention within a vessel of a patient's vascular system”).
However, Griffith fails to explicitly teach wherein the intraluminal sensing device is an intraluminal flow-sensing device; the housing is positioned at the distal portion of the guidewire; and wherein the sensor comprises a flow sensor configured to obtain intravascular flow data.
In an analogous intraluminal sensing device field of endeavor, Millett teaches such a feature. Millett teaches a sensing guidewire (5) including a distal portion (104) (Fig. 1, Title, abstract, [0030]). Millett teaches wherein a distal tip (110) of the guidewire (5) may include an sensor coupled thereto such as an ultrasound transducer for measuring flow ([0035]). Millett further teaches a sensor housing (120) directly coupled to the distal tip (110) (Figs. 4-7, [0035-0036]). Millett teaches wherein the sensor housing (120) includes a flow sensor (400) and is positioned at the distal portion (104) of the guidewire (5) (Fig. 7, [0051-0052]). Moreover, Millet teaches wherein the sensors may obtain intravascular flow data ([0045], “This allows an operator to better position the sensors 114 within the vessel or vasculature to obtain measurements. Accordingly, by adjusting the distal portion 104 to re-position the sensors 114 within the vessel, one can obtain better intraluminal measurements, such as pressure and flow measurements, than without the adjustment”, [0047]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Griffith to have the sensing device comprise an intraluminal/intravascular flow sensing guidewire and wherein the housing is positioned at the distal portion of the guidewire as taught by Millet (Figs. 1 & 4-7, [0030], [0035-0036], [0045], [0047]). A flow sensor disposed in a housing at the distal tip of a guide wire may be used to measure blood flow velocity within a vessel, which can be used to assess coronary flow reserve (CFR) as recognized by Millett ([0051]), and CFR may reveal information about stenosis severity as further recognized by Millett ([0048]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TOMMY T LY whose telephone number is (571) 272-6404. The examiner can normally be reached M-F 12:00pm-8:00pm eastern time.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan Nguyen can be reached at 571-272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TOMMY T LY/ Examiner, Art Unit 3797
/SERKAN AKAR/ Primary Examiner, Art Unit 3797