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 .
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.
Claim(s) 25, 27, 32, 43, 46, and 49 are rejected under 35 U.S.C. 103 as being unpatentable over in view of US 2007/0282209 Lui, hereinafter “Lui”, in view of CN 206577218 Shi et al., hereinafter “Shi”, further in view of US 2004/0082868 Campbell et al., hereinafter “Campbell” (all cited previously).
Regarding claim 25, Lui discloses a vascular monitoring system (Figure 1, element 10, Abstract, and Para 31) comprising: a strap having a base portion (Figure 1, element 20) and a saddle portion (Figure 1, element 30), wherein the saddle portion is configured to be positioned around a patient's vessel (Figure 1, element 30 and Para 33), wherein the saddle portion includes a contact surface configured to contact a portion of the patient's vessel (Para 33; the inside of element 30); a first band portion and a second band portion (See annotated Figure 4A), wherein the first band portion and the second band portion extend from respective distal ends of the saddle portion (See annotated Figure 4A; the first and second band portions are at the distal ends of the saddle portion, they are the ends of the saddle portion); a clasp configured to engage the first band portion and the second band portion (Figure 4A, the clasp consists of elements 12 and 22; see also Para 34), wherein a distance between the first band portion and the second band portion decreases as the first band portion and the second band portion extend through the clasp (See Figure 4A and Para 34; element 12 wraps around sleeve 30 and tightens it around the blood vessel, thereby brining the first and second band portions closer to one another), and wherein the clasp is configured to maintain a closed configuration (See Figure 4A, the clasp consisting of elements 12 and 22, maintains a closed configuration around saddle portion 30; see also 103 below) and a transducer coupled to the strap (Figure 1, element 34), the transducer configured to emit an ultrasonic signal that is transmitted through the patient's vessel (Para 7 and 33-34); and a probe holder having a receptacle configured to receive the transducer (Figure 1, element 23 receives transducer 34).
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Annotated Figure 4A
Lui does not explicitly disclose the first band portion and the second band portion extend through the clasp, and wherein the clasp is configured to maintain a closed configuration when each of the first band portion and the second band portion extend through the clasp in the same direction.
However, Shi teaches a medical device (Para 2) and teaches the first band portion and the second band portion extend through the clasp (Figure 3a, element 212 and 211 extend through clasp 11; examiner relies on this reference only for the clasping configuration); and wherein the clasp is configured to maintain a closed configuration when each of the first band portion and the second band portion extend through the clasp in the same direction (Examiner believes this is disclosed by Shi, consider Figure 3a and 3b. First, the clasp 11 holds straps 211 and 212 in place, allowing to maintain a closed loop, i.e. a closed configuration as shown in Figure 3b. Examiner also believes that under BRI of the language in the claim, Shi is disclosing “each of the first band portion and the second band portion extend through the clasp in the same direction” as can be seen in Figure 3a, the straps 211 and 212 extend through the clasp from the back side, to the front side, i.e. the side facing us. The straps are both traveling through clasp 11, in the upward direction, see response to arguments below for further argument).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed the first band portion and the second band portion extend through the clasp as taught by Shi, in the invention of Lui, in order to fix the frame to the necessary structure (Shi; Para 32-33).
Lui does not disclose a probe holder having a receptacle having a conical profile, wherein the receptacle is configured to receive the transducer and removably retain the transducer, and wherein the transducer is coupled to the receptacle through a friction fit; and a cylindrical transition region.
However, Campbell discloses a vascular coupling/sensing device (Abstract and Figure 1) and teaches a probe holder (Figure 1, element 4) having a receptacle having a conical profile (Para 43; the receptacle can be any suitable shape that obtains a friction fit, regardless, see design choice rejection below), wherein the receptacle is configured to receive the transducer (Para 41, 43, 50, and 52; the receptacle 4 is configured to receive the sensing device, which can and preferably is a transducer) and removably retain the transducer (Para 52 states that it is removable “e.g., by applying enough force to the percutaneous lead so as to pull the transducer from the receptacle”), and wherein the transducer is coupled to the receptacle through a friction fit (Para 43); and a cylindrical transition region (See Annotated Figure 5).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed a receptacle that allows attachment of a transducer via a friction fit as taught by Campbell, in the invention of Lui, in order to allow the transducer to be removably attachable to the cuff (Campbell; Para 43 and 52).
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Annotated Figure 5
Lui does not disclose a receptable having a conical profile.
At the time the invention was made, it would have been an obvious matter of design choice to a person of ordinary skill in the art to have included any profile shape for the receptable of Campbell because Applicant has not disclosed that the specified shape provides an advantage, is used for a particular purpose, or solves a stated problem over the prior art (see MPEP 2144.04 [R-10.2019], section IVB “Changes in Shape”). Applicant states that the conical profile allows the probe holder to more securely grip the transducer, however, one of ordinary skill in the art, furthermore, would expect Campbell’s device, to perform equally as well as the applicant’s invention in terms of holding the friction fit between the receptable and the transducer as shown in Para 43-44 of Campbell.
Therefore, it would have been prima facie obvious to modify Campbell to obtain the invention as specified in claim 25, because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Lui and Campbell.
Regarding claim 27, Lui discloses all the limitations of claim 25.
Lui does not disclose a diameter of the cylindrical transition region is between 0.015 inches and 0.030 inches.
However, Campbell teaches a diameter of the cylindrical transition (Para 43; the receptacle 4 is configured as a circular shape and Annotated Figure 5).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed a cylindrical transition region as taught by Campbell, in the invention of Lui, in order to allow the transducer to friction fit into the receptable (Campbell; Para 43).
At the time the invention was made, it would have been an obvious matter of design choice to a person of ordinary skill in the art to have included any size diameter of the cylindrical transition region of Campbell because Applicant has not disclosed that the specified size provides an advantage, is used for a particular purpose, or solves a stated problem over the prior art (see MPEP 2144.04 [R-10.2019], section IVA “Changes in Size/Proportion”). One of ordinary skill in the art, furthermore, would expect Campbell’s device, to perform equally as well as the applicant’s invention in terms of holding the friction fit between the receptable and the transducer.
Therefore, it would have been prima facie obvious to modify Campbell to obtain the invention as specified in claim 27, because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Lui and Campbell.
Regarding claim 32, Lui discloses the transducer is coupled to the strap (Para 29 and 33 the transducer is affixed after the cuff is positioned).
Lui does not disclose the transducer is removably coupled to the strap.
However, Campbell discloses the transducer is coupled to the strap (Para 52).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed a receptacle that allows attachment of a transducer via a friction fit as taught by Campbell, in the invention of Lui, in order to allow the transducer to be removably attachable to the cuff (Campbell; Para 43 and 52).
Regarding claim 43, Lui discloses a vascular strap (Abstract and Para 31) comprising: a base portion (Figure 1, element 20); a saddle portion extending from the base portion (Figure 1, element 30), the saddle portion having a proximal end (Figure 4A, element 30 proximal end is the end attached to the transducer 34), a first distal end, and a second distal end (Annotated Figure 4A, the first and second distal ends are the regions proximal to the first and second portions); a first band portion extend from the first distal end of the saddle portion and a second band portion extend from the second distal end of the saddle portion (Annotated Figure 4A), wherein the saddle portion and the first and second band portions are sized and shaped to be positioned about a patient's vessel (Figure 1 and element 30; see also Figure 4a, see Para 33), wherein the saddle portion includes a contact surface configured to contact a portion of the patient's vessel (Para 33; the inside of element 30), and wherein the first and second band portions are configured to extend through a clasp in a closed configuration (See Figure 4A and Para 34; element 12 wraps around sleeve 30 and tightens it around the blood vessel, thereby brining the first and second band portions closer to one another); a clasp (Figure 4A, the clasp consists of elements 12 and 22; see also Para 34) configured to engage the first band portion and the second band portion (See Figure 4A), wherein a distance between the first band portion and the second band portion decreases as the first band portion and the second band portion extend through the clasp (See Figure 4A and Para 34; element 12 wraps around sleeve 30 and tightens it around the blood vessel, thereby brining the first and second band portions closer to one another) and wherein the clasp is configured to maintain a closed configuration (See Figure 4A, the clasp consisting of elements 12 and 22, maintains a closed configuration around saddle portion 30; see also r103 below); and a probe holder formed within the base portion, the probe holder having a receptable configured to receive the transducer (Figure 1, element 34 and 23. See also Figure 2 and Para 33), wherein the transducer configured to emit an ultrasonic signal that is transmitted through the patient's vessel (Para 7 and 33-34).
Lui does not explicitly disclose the first band portion and the second band portion extend through the clasp; and wherein the clasp is configured to maintain a closed configuration when each of the first band portion and the second band portion extend through the clasp in the same direction.
However, Shi a medical device (Para 2) and teaches the first band portion and the second band portion extend through the clasp (Figure 3a, element 212 and 211 extend through clasp 11; examiner relies on this reference only for the clasping configuration); and wherein the clasp is configured to maintain a closed configuration when each of the first band portion and the second band portion extend through the clasp in the same direction (Examiner believes this is disclosed by Shi, consider Figure 3a and 3b. First, the clasp 11 holds straps 211 and 212 in place, allowing to maintain a closed loop, i.e. a closed configuration as shown in Figure 3b. Examiner also believes that under BRI of the language in the claim, Shi is disclosing “each of the first band portion and the second band portion extend through the clasp in the same direction” as can be seen in Figure 3a, the straps 211 and 212 extend through the clasp from the back side, to the front side, i.e. the side facing us. The straps are both traveling through clasp 11, in the upward direction, see response to arguments below for further argument).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed the first band portion and the second band portion extend through the clasp as taught by Shi, in the invention of Lui, in order to fix the frame to the necessary structure (Shi; Para 32-33).
Lui does not disclose a probe holder having a receptacle having a conical profile, wherein the receptacle is configured to receive the transducer and removably retain the transducer, and wherein the transducer is coupled to the receptacle through a friction fit; and a cylindrical transition region.
However, Campbell discloses a vascular coupling/sensing device (Abstract and Figure 1) and teaches a probe holder (Figure 1, element 4) having a receptacle having a conical profile (Para 43; the receptacle can be any suitable shape that obtains a friction fit, regardless, see design choice rejection below), wherein the receptacle is configured to receive the transducer (Para 41, 43, 50, and 52; the receptacle 4 is configured to receive the sensing device, which can and preferably is a transducer) and removably retain the transducer (Para 52 states that it is removable “e.g., by applying enough force to the percutaneous lead so as to pull the transducer from the receptacle”), and wherein the transducer is coupled to the receptacle through a friction fit (Para 43); and a cylindrical transition region (See Annotated Figure 5).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed a receptacle that allows attachment of a transducer via a friction fit as taught by Campbell, in the invention of Lui, in order to allow the transducer to be removably attachable to the cuff (Campbell; Para 43 and 52).
Lui does not disclose a receptable having a conical profile.
At the time the invention was made, it would have been an obvious matter of design choice to a person of ordinary skill in the art to have included any profile shape for the receptable of Campbell because Applicant has not disclosed that the specified shape provides an advantage, is used for a particular purpose, or solves a stated problem over the prior art (see MPEP 2144.04 [R-10.2019], section IVB “Changes in Shape”). Applicant states that the conical profile allows the probe holder to more securely grip the transducer, however, one of ordinary skill in the art, furthermore, would expect Campbell’s device, to perform equally as well as the applicant’s invention in terms of holding the friction fit between the receptable and the transducer as shown in Para 43-44 of Campbell.
Therefore, it would have been prima facie obvious to modify Campbell to obtain the invention as specified in claim 25, because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Lui and Campbell.
Regarding claim 46, Lui discloses all the limitations of claim 43.
Lui does not disclose a diameter of the cylindrical transition region is between 0.015 inches and 0.030 inches.
However, Campbell teaches a diameter of the cylindrical transition (Para 43; the receptacle 4 is configured as a circular shape and Annotated Figure 5).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed a cylindrical transition region as taught by Campbell, in the invention of Lui, in order to allow the transducer to friction fit into the receptable (Campbell; Para 43).
At the time the invention was made, it would have been an obvious matter of design choice to a person of ordinary skill in the art to have included any size diameter of the cylindrical transition region of Campbell because Applicant has not disclosed that the specified size provides an advantage, is used for a particular purpose, or solves a stated problem over the prior art (see MPEP 2144.04 [R-10.2019], section IVA “Changes in Size/Proportion”). One of ordinary skill in the art, furthermore, would expect Campbell’s device, to perform equally as well as the applicant’s invention in terms of holding the friction fit between the receptable and the transducer.
Therefore, it would have been prima facie obvious to modify Campbell to obtain the invention as specified in claim 46, because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Lui and Campbell.
Regarding claim 49, Lui discloses the clasp is configured to maintain the vascular strap in the closed configuration (Figure 1, element 12 and 22; see also Para 31 and 34, see also Figure 4A).
Claim(s) 26, 29, 45, and 47 are rejected under 35 U.S.C. 103 as being unpatentable over US 2007/0282209 Lui, hereinafter “Lui” (previously cited), in view of US 2004/0082868 Campbell et al., hereinafter “Campbell”, further in view of CN 206577218 Shi et al., hereinafter “Shi”, further in view of WO 8906513 Rabinovitz et al., hereinafter “Rabinovitz” (cited previously).
Regarding claim 26, Lui discloses the strap (Figure 1, element 10).
Lui does not disclose the strap includes at least one eyelet that is adapted to be sutured to adjacent tissue to fixedly position the strap about the patient's vessel.
However, Rabinovitz discloses an implantable vessel cuff/probe (Abstract and Figure 1a) and teaches the strap includes at least one eyelet (Figure 2, elements 16a-d and Page 7, lines 6-19, Page 5, lines 26-30) that is adapted to be sutured to adjacent tissue to fixedly position the strap about the patient's vessel (This is a mere statement of intended use, if the reference reads on eyelets, that is enough to read on this limitation).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed an eyelet as taught by Rabinovitz, in the invention of Lui, in order to attach the probe in its place (Rabinovitz; Page 7, lines 6-19).
Regarding claim 29, Lui discloses the strap (Figure 1, element 10).
Lui does not disclose the strap is made of at least one of at least one of implant grade liquid-silicon rubber (LSR), high-consistency silicone rubber (HCR), HDPE, Nusil 4750, Nusil 4840, and a thermoplastic.
However, Rabinovitz teaches the strap is made of at least one of at least one of implant grade liquid-silicon rubber (LSR), high-consistency silicone rubber (HCR), HDPE, Nusil 4750, Nusil 4840, and a thermoplastic (Page 5, lines 4-9).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed silicone rubber as taught by Rabinovitz, in the invention of Lui, in order to have a biocompatible flexible body (Rabinovitz; Page 5, lines 4-12).
Regarding claim 45, Lui discloses the vascular strap (Figure 1, element 10).
Lui does not disclose the vascular strap includes at least one eyelet that is adapted to be sutured to adjacent tissue to fixedly position the strap about the patient's vessel.
However, Rabinovitz discloses an implantable vessel cuff/probe (Abstract and Figure 1a) and teaches the vascular strap includes at least one eyelet (Figure 2, elements 16a-d and Page 7, lines 6-19, Page 5, lines 26-30) that is adapted to be sutured to adjacent tissue to fixedly position the strap about the patient's vessel (This is a mere statement of intended use, if the reference reads on eyelets, that is enough to read on this limitation).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed an eyelet as taught by Rabinovitz, in the invention of Lui, in order to attach the probe in its place (Rabinovitz; Page 7, lines 6-19).
Regarding claim 47, Lui discloses all the limitations of claim 43.
Lui does not disclose the vascular strap is made of at least one of implant grade liquid-silicon rubber (LSR) and high-consistency silicone rubber (HCR) with a durometer between 40 and 80.
Rabinovitz teaches the vascular strap is made of at least one of implant grade liquid-silicon rubber (LSR) and high-consistency silicone rubber (HCR) with a durometer between 40 and 80 (Page 5, lines 4-9; also see https://www.matweb.com/search/datasheet.aspx?matguid=938969be874d4fdab0b526923c6800fe the durometer of medical grade silicone rubber is known 45-55).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed silicone rubber as taught by Rabinovitz, in the invention of Lui, in order to have a biocompatible flexible body (Rabinovitz; Page 5, lines 4-12).
Claim 48 is rejected under 35 U.S.C. 103 as being unpatentable over US 2007/0282209 Lui, hereinafter “Lui” (previously cited), in view of CN 206577218 Shi et al., hereinafter “Shi”, further in view of US 2004/0082868 Campbell et al., hereinafter “Campbell”, further in view of JP 2006/006649 Ezaki et al., hereinafter “Ezaki” (cited previously).
Regarding claim 48, Lui discloses the saddle portion and the first and second band portions are sized (Para 34, see also Figure 1, elements 18 that control sizing, see para 33 and Annotated Figure 4A).
Lui does not disclose the vascular strap is closed to form a collar about a vessel, an inside diameter of the collar is between 1.0mm and 4.0mm.
However, Ezaki discloses a blood vessel device that wraps around a vessel (Abstract and Para 15) and teaches the vascular strap is closed to form a collar about a vessel, an inside diameter of the collar is between 1.0mm and 4.0mm (See Para 40 and Figure 1).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed a specific, as taught by Ezaki, in the invention of Lui, in order to allow the device to fit over the blood vessel to which it is applied to (Ezaki; Para 40).
Response to Arguments
Applicant’s arguments have been fully considered but are moot because the new ground of rejection.
Refer to rejection above for the rejection of the newly amended limitations.
Examiner believes both references Lui and Shi disclose “wherein the clasp is configured to maintain a closed configuration”. Under BRI this strictly means the clasp is connecting to ends to form a closed loop around the vessel. Figure 4A of Lui shows that clearly, the clasp (Figure 4A, elements 12 & 22) holds the strap 12 to maintain a closed configuration around saddle portion 30. Even Shi discloses this limitation. Consider Figure 3b of Shi. The clasp 11 is used to maintain a closed loop using element 21. The clasp itself is what is allowing the device as a whole to maintain a closed configuration around an object.
In terms of the newly amended limitation “when each of the first band portion and the second band portion extend through the clasp in the same direction”, examiner still believes reference Shi discloses this under BRI. Consider Figures 3a and 3b of Shi. In the cited figures, it is clearly showing straps 211 and 212 (I.e. first and second band portions) extending through clasp 11 in the same direction. The straps extend from the back end of the clasp (the end away from us) through the clasp toward us. Therefore, both ends of the band are traveling up the clasp in the same direction. That is all the claim is stating. Applicant argues “To the contrary, and as illustrated by Fig. 1 (excerpted below), the two sides of element 21 each independently engage with clasp 11 from opposite directions.” And while that might be a fact, that is not what is translating in the claims. Yes, the clasp in Shi engages the bands at two end of the clasp, the right side/aperture and the left side/aperture, however, after it is engaged, the bands are both extending through the clasp in the same direction, that being up the clasp. That is what the claim recites. The claims do not recite any limitation that denies two apertures on opposite directions of the clasp. The clasp is not defined as one large aperture that receives both bands in the same entrance. Clasp 11 in Shi engages both straps at either end of clasp 11 and allows the straps to extend through the clasp in the same direction (upward) to maintain a closed loop configuration as shown in Figure 3b. Examiner also warns of design choice rejections if amending further. If claims are amended to include one aperture, a design choice rejection might be applicable, unless there is a clear advantage to having one aperture.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AYA ZIAD BAKKAR whose telephone number is (313)446-6659. The examiner can normally be reached on 7:30 am - 5:00 pm M-Th.
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/AYA ZIAD BAKKAR/
Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796
Prosecution Insights