DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
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.
Claim(s) 1-2, 8, 11-12 and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 6,106,477 A (Miesel).
Regarding claims 1 and 11, Miesel discloses a system for measuring vital signs of a patient having a blood vessel (e.g., Figs. 20-27), comprising:
a sensor module having a housing, the sensor module being configured to measure a blood vessel blood pressure waveform (Figs. 20-27, pressure sensor capsule, e.g., 202, 221, 231, etc.); and
a sensor module retaining device (Figs. 20-27, fixture 223, 238, 248, etc.), comprising:
a first portion defining an open loop sized and configured to contour around an outer surface of a blood vessel (portion of fixture defining tunnel or passageway (e.g., Fig. 20, 201) with a slit or opening (e.g., Fig. 20, 203) for receiving a blood vessel, as described in col. 11, lines 33-45; see, e.g., annotated Fig. 27C below); and
a second portion and a third portion opposite the second portion, the second and third portions extending distally away from the open loop and defining an open channel therebetween, the second and third portions being contiguous with and converging inwards towards the first portion (portions of fixture extending away from the above-noted "first portion" and defining channel/location for receiving the pressure sensor capsule (e.g., Fig. 27A-C, 263), as described in col. 13, lines 48-59; see, e.g., annotated Fig. 27C below).
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Regarding claim 2, Miesel discloses the first portion has a first end and a second end opposite the first end, the first end being contiguous with the second portion and the second end being contiguous with the third portion (see, e.g., annotated Fig. 27C above).
Regarding claim 8, Miesel discloses the sensor module retaining device is made of at least one substantially rigid material selected from the group consisting of titanium, stainless steel, MP35N alloy, plastic, and ceramic (col. 5, lines 59-65, device may be built of metal, e.g., titanium, or plastic; claim 40, where the fixture is rigid; etc.).
Regarding claim 12, Miesel discloses the sensor module includes a diaphragm coupled to the housing and wherein the sensor module is received within the open channel such that the diaphragm is in contact with the outer surface of the blood vessel (e.g., col. 4, lines 23-30, where the fixture holds the vessel, e.g., artery, against a diaphragm of the sensor or against a pressure transferring medium capable of accurately transferring pressure from the artery side wall to the sensor diaphragm).
Regarding claim 15, Miesel discloses the second and third portions each have a proximal segment and a distal segment contiguous with the proximal segment, the proximal segment of the second and third portions being contiguous with the first portion (see, e.g., annotated Fig. 27C above, where the "proximal segment" of each of the second a third portions is the wider section of said portions nearest the first portion, and the "distal segment" of each of the second and third portions is the narrower section of said portions).
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:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
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) 4, 9, 13 and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miesel in view of US 5,693,088 A (Lazarus).
Regarding claims 4, 9, 13 and 19, Miesel discloses the limitations of claims 1 and 11, as discussed above, but does not disclose the first portion defines a plurality of apertures to promote tissue ingrowth, or at least a portion of the first portion is textured to facilitate adhesion of the sensor module retaining device to the outer surface of the blood vessel. However, Miesel does disclose the system is intended to be chronically implanted (throughout document), and discloses movement and/or slippage of system along the vessel is undesirable (e.g., col. 12, lines 11-19).
Lazarus discloses a means for attaching to a blood vessel surface (e.g., col. 5, lines 31-40, attachment means), wherein said means defines a plurality of apertures (pores) to promote tissue ingrowth and/or at least a portion of said means is textured to facilitate adhesion to the blood vessel surface (col. 5, lines 31-40, the material of the attachment means is formed from material which is, or is otherwise treated to be, porous and/or textured to promote the attachment or ingrowth of tissue into the attachment means).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Miesel with the first portion defining a plurality of apertures to promote tissue ingrowth and/or at least a portion of the first portion being textured to facilitate adhesion of the sensor module retaining device to the outer surface of the blood vessel as taught and/or suggested by Lazarus in order to facilitate better preventing movement/slippage of the system along the vessel (Miesel, col. 12, lines 11-19).
Regarding claim 20, Miesel discloses/suggests a system for measuring vital signs of a patient having a blood vessel (e.g., Figs. 20-27), comprising:
a sensor module having a housing and configured to measure a blood vessel blood pressure waveform (Figs. 20-27, pressure sensor capsule, e.g., 202, 221, 231, etc.), the sensor module having a diaphragm coupled to the housing (e.g., Fig. 23, diaphragm 246); and
a sensor module retaining device (Figs. 20-27, fixture 223, 238, 248, etc.) releasably coupled to the sensor module (e.g., col. 12, lines 50-59; col. 13, lines 21-31; etc.), comprising:
a first portion defining an open loop sized and configured to contour around an outer surface of a blood vessel (portion of fixture defining tunnel or passageway (e.g., Fig. 20, 201) with a slit or opening (e.g., Fig. 20, 203) for receiving a blood vessel, as described in col. 11, lines 33-45; see, e.g., annotated Fig. 27C below); and
a second portion and a third portion opposite the second portion, the second and third portions extending distally away from the open loop and defining an open channel there-between, the second and third portions being contiguous with and converging inwards towards the first portion (portions of fixture extending away from the above-noted "first portion" and defining channel/location for receiving the pressure sensor capsule (e.g., Fig. 27A-C, 263), as described in col. 13, lines 48-59; see, e.g., annotated Fig. 27C above), wherein, when the sensor module is received within the housing the diaphragm is in contact with the outer surface of the blood vessel (e.g., col. 4, lines 23-30, where the fixture holds the vessel, e.g., artery, against a diaphragm of the sensor or against a pressure transferring medium capable of accurately transferring pressure from the artery side wall to the sensor diaphragm).
Miesel does not disclose the first portion defines a plurality of apertures to promote tissue ingrowth. However, Miesel does disclose the system is intended to be chronically implanted (throughout document), and discloses movement and/or slippage of system along the vessel is undesirable (e.g., col. 12, lines 11-19).
Lazarus discloses a means for attaching to a blood vessel surface (e.g., col. 5, lines 31-40, attachment means), wherein said means defines a plurality of apertures (pores) to promote tissue ingrowth and/or at least a portion of said means is textured to facilitate adhesion to the blood vessel surface (col. 5, lines 31-40, the material of the attachment means is formed from material which is, or is otherwise treated to be, porous and/or textured to promote the attachment or ingrowth of tissue into the attachment means).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Miesel with the first portion defining a plurality of apertures to promote tissue ingrowth as taught/suggested by Lazarus in order to facilitate better preventing movement/slippage of the system along the vessel (Miesel, col. 12, lines 11-19).
Claim(s) 7 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miesel in view of Lazarus as applied to claim(s) 4 and 13 above; or alternatively, over Miesel in view of Lazarus as applied to claim(s) 4 and 13 above, and further in view of US 4,760,849 A (Kropf).
Regarding claims 7 and 18, Miesel as modified discloses/suggests the limitations of claims 4 and 13, respectively, as discussed above, but does not expressly disclose the plurality of apertures are uniformly spaced about the first portion. However, at the time the invention was effectively filed, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the system of Miesel with the plurality of apertures being uniformly spaced about the first portion because Applicant has not disclosed that said aperture spacing provides an advantage, is used for a particular purpose, or solves a stated problem. Rather, Applicant expressly discloses uniform spacing or "any other arrangement or pattern" as suitable alternatives for the plurality of apertures (e.g., ¶ [0058]). Accordingly, as no evidence has been provided to the contrary, one of ordinary skill in the art would have expected Applicant's invention to perform equally well with the arrangement disclosed and/or suggested by Miesel as modified because either arrangement sufficiently promotes tissue ingrowth of the system, or sensor module retaining device thereof.
Alternatively/Additionally, Kropf discloses a device (5) configured to contour to a blood vessel surface (col. 2, lines 51-59), wherein the device comprises a plurality of apertures uniformly spaced thereabout to promote tissue ingrowth (through-going apertures 21; col. 4, lines 6-8). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Miesel with the plurality of apertures being uniformly spaced about the first portion as taught/suggested by Kropf as a simple substitution of one suitable aperture arrangement for facilitating tissue ingrowth for another to yield no more than predictable results. See MPEP 2143(I)(B).
Claim(s) 1-3, 5-6, 10-11, 14 and 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2007/0163353 A1 (Lec) in view of US 2022/0090951 A1 (Lilleland); or alternatively, over Lec in view of Lilleland and US 2019/0365249 A1 (Verkaik).
Regarding claims 1-3, 5-6, 10-11, 14 and 16-17, Lec discloses and/or suggests a system for measuring vital signs of a patient having a blood vessel, comprising:
a sensor module having a housing, the sensor module being configured to measure a blood vessel blood pressure waveform (Fig. 2, sensor head 104; Fig. 8, transducer platform; Fig. 12, stainless steel housing 1203, 1206; etc.); and
a sensor module retaining device comprising:
a first portion defining an open loop/lumen sized and configured to contour around an outer surface of a blood vessel (Fig. 2, support structure 101; Fig. 8, U-shaped support structure; Fig. 12, 1207, 1209; etc.), wherein the first portion has a first end and a second end opposite the first end that defines the open loop (e.g., ends of the U-shaped support structure through which a blood vessel is inserted, ¶ [0183]); and
a second portion and a third portion opposite the second portion defining an open channel therebetween, wherein the first portion has a first end and a second end opposite the first end, the first end being contiguous with the second portion and the second end being contiguous with the third portion (Fig. 2, tongues of tongue-and-groove attachment mechanism for inserting into corresponding grooves of the sensor head).
Lec does not disclose the second and third portions extend distally away from the open loop.
Lilleland discloses a system (e.g., Figs. 7-8) comprising: a sensor module having a housing (sensor assembly 200-6); and a sensor module retaining device (clamp assembly 500) comprising a first portion defining an open loop sized and configured to contour around an outer surface of a conduit (mounting elements 502-1, 502-2 and interconnecting member 503 that cooperate to define a partially enclosed opening that the conduit 110 extends through) and a second portion and a third portion opposite the second portion, the second and third portions extending distally away from the open loop and defining an open channel therebetween, the second and third portions being contiguous with a first and opposing second end of the first portion, respectively (opposing attachment ends 505a, 505b), and the second and third portions each define at least one opening (apertures 508) sized and configured to engage at least one corresponding mating member located on the sensor module (mounting elements 250) (e.g., Figs. 7A, 8A, etc.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Lec with the second and third portions extending distally away from the open loop, wherein the second and third portions each define at least one opening sized and configured to engage at least one corresponding mating member located on the sensor module, as taught/suggested by Lilleland as a simple substitution of one suitable sensor module retaining configuration for another to yield no more than predictable results. See MPEP 2143(I)(B).
Lec as modified discloses the open channel is sized to receive a sensor module having a width equal to a width of the blood vessel (e.g., Fig. 2). Accordingly, Lec as modified does not expressly disclose the second and third portions converge inwards towards the first portion, such that the width of the open channel has a width larger than a width of the open lumen and the open channel is sized to receive a sensor module having a width larger than a width of the blood vessel. However, at the time the invention was effectively filed, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the system of Lec with the second and third portions converging inwards towards the first portion, such that the width of the open channel has a width larger than a width of the open lumen and is configured to receive a sensor module having a width larger than a width of the blood vessel because Applicant has not disclosed that the second and third portions converging inwards towards the first portion provides an advantage, is used for a particular purpose, or solves a stated problem. Rather, Applicant discloses the above-noted arrangement as merely exemplary (e.g., ¶ [0056]), discloses the sensor housing, which is received in the open channel, may have a width smaller than the open lumen, or diameter of blood vessel therein, discloses the width of the sensor module may be uniform (e.g., ¶ [0047], ¶ [0062], etc.). Accordingly, as no evidence has been provided to the contrary, one of ordinary skill in the art would have expected Applicant's invention to perform equally well with the second and third portion arrangement disclosed and/or suggested by Lilleland, or Lec as modified thereby, because either arrangement enables securely attaching a sensor module of a desired size and/or proportion to the target blood vessel.
Alternatively/Additionally, Verkaik discloses a system comprising a sensor module (Figs. 1, 17, portion 14) having a housing (housing 20), the sensor module being configured to measure a blood vessel blood pressure waveform (e.g., Fig. 17), wherein the sensor module comprises a first width in a blood vessel securing region (70), and a second, larger width in a proximal region (24). It would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the system of Lec with the second and third portions converging inwards towards the first portion, such that the width of the open channel has a width larger than a width of the open lumen and is configured to receive a sensor module having a width larger than a width of the blood vessel, in order to facilitate accommodating and/or supporting alternately sized/shaped available sensor modules, such as the sensor module disclosed by Verkaik.
Conclusion
The prior art made of record and not relied upon is considered pertinent to Applicant's disclosure: see attached PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Meredith Weare whose telephone number is 571-270-3957. The examiner can normally be reached Monday - Friday, 9 AM - 5 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. Applicant is encouraged to use the USPTO Automated Interview Request at http://www.uspto.gov/interviewpractice to schedule an interview.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Tse Chen, can be reached on 571-272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Meredith Weare/Primary Examiner, Art Unit 3791