DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The action is in response to the application filed on 06/27/2024. Claims 2-21 are pending and examined below.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 20200223805 A1 (hereinafter referred to as “Le”).
Regarding claim 1, Le, a two piece sensor assembly, teaches A system for aligning a tissue site of a patient to a sensor (abstract; paragraph [0061]; as shown in Figure 5), the system comprising:
a tissue anchor configured to couple to the tissue site of a patient (510; paragraph [0061]; as shown in Figure 5), wherein the tissue anchor comprises:
a first surface configured to couple to the tissue site (paragraph [0061]; as shown in Figure 5);
a first opening configured to allow at least one non-invasive sensor to perform a physiological measurement of the tissue site (paragraph [0044], [0061]; as shown in Figure 5); and
a sensor attachment, the sensor attachment comprising a second opening, the sensor attachment configured to secure to the tissue anchor by moving a catch of either the tissue anchor or the sensor attachment into a mating slide of the other of the tissue anchor or the sensor attachment via a twisting motion (paragraph [0061]; as shown in Figure 5),
wherein the second opening is configured to align with the first opening when the sensor attachment is secured to the tissue anchor (paragraph [0061]; as shown in Figure 5).
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.
Claim(s) 2-7, 9-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20070123763 A1 (hereinafter referred to as “Al-Ali”) in view of Le.
Regarding claim 2, Al-Ali teaches a system for aligning a tissue site of a patient to a sensor (abstract), the system comprising:
a tissue anchor (206; as shown in Figure 1) configured to couple to the tissue site of a patient (paragraphs [0055]-[0058]; Figures 4-9), wherein the tissue anchor comprises:
a first surface configured to couple to the tissue site (paragraphs [0055]-[0058]; Figures 4-9);
a first opening configured to allow at least one non-invasive sensor to perform a physiological measurement of the tissue site (as shown in Figure 9); and
a sensor attachment (204; as shown in Figure 1), the sensor attachment comprising a second opening, the sensor attachment configured to secure to the tissue anchor (as shown in Figures 1, 4-9),
wherein the second opening is configured to align with the first opening when the sensor attachment is secured to the tissue anchor (as shown in Figures 1, 4-9).
Al-Ali does not explicitly teach the sensor attachment comprising a second opening, the sensor attachment configured to secure to the tissue anchor by moving a catch of either the tissue anchor or the sensor attachment into a mating slide of the other of the tissue anchor or the sensor attachment via a twisting motion.
However, Le teaches the sensor attachment comprising a second opening, the sensor attachment configured to secure to the tissue anchor by moving a catch of either the tissue anchor or the sensor attachment into a mating slide of the other of the tissue anchor or the sensor attachment via a twisting motion (paragraph [0061]; as shown in Figure 5). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Al-Ali, to have a sensor attachment that attaches through a twisting motion, as taught by Le, because it would be a simple substitution of the attachment mechanism of Al-Ali with that of Le in order to achieve a predictable result namely a means to attach the sensor attachment to the tissue anchor.
Regarding claim 3, Al-Ali, in view of Le, teaches wherein the first surface couples to the tissue site using an adhesive (paragraph [0034]; as taught by Al-Ali).
Regarding claim 4, Al-Ali, in view of Le, teaches wherein the adhesive is configured to couple the first surface to the tissue site for a period comprising at least one day (paragraph [0034]; as taught by Al-Ali).
Regarding claim 5, Al-Ali, in view of Le, teaches wherein the first surface comprises a curvature similar to that of the tissue site (as shown in Figures 1, 4-8; as taught by Al-Ali).
Regarding claim 6, Al-Ali, in view of Le, teaches wherein the tissue anchor is configured to couple to a fingernail of the patient (as shown in Figures 1, 4-8; as taught by Al-Ali).
Regarding claim 7, Al-Ali, in view of Le, teaches further comprising the non-invasive sensor (paragraph [0048]; as shown in Figure 2; as taught by Al-Ali).
Regarding claim 9, Al-Ali, in view of Le, teaches wherein the sensor attachment is attached to the non-invasive sensor (as shown in Figure 2; as taught by Al-Ali).
Regarding claim 10, Al-Ali, in view of Le, teaches wherein, when the sensor attachment is secured to the tissue anchor, the system is configured to secure the non-invasive sensor such that a vertical distance is maintained between the tissue site and the non-invasive sensor and is secured to disallow horizontal movement of the non-invasive sensor relative to the tissue site (paragraphs [0055]-[0058]; Figures 4-8).
Regarding claim 11, Al-Ali, in view of Le, teaches wherein the sensor attachment is configured to mate with a sensor interface component (as shown in Figure 2; as taught by Al-Ali).
Regarding claim 12, Al-Ali, in view of Le, teaches wherein the sensor interface component comprises a sensor head of a non-invasive sensor (as shown in Figure 2; as taught by Al-Ali).
Regarding claim 13, Al-Ali, in view of Le, teaches wherein tissue anchor comprises the catch and the sensor attachment comprises the mating slide (as shown in Figure 5, as taught by Le).
Regarding claim 14, Al-Ali, in view of Le, teaches wherein tissue anchor comprises the mating slide and the sensor attachment comprises the catch (as shown in Figure 5, as taught by Le).
Regarding claim 15, Al-Ali teaches A method for aligning a tissue site to a sensor (abstract), comprising:
attaching a tissue anchor to the tissue site (paragraphs [0055]-[0058]; Figures 4-9); and
securing the tissue anchor to a sensor attachment attached to a sensor head, such that the sensor head is aligned with an opening in the tissue anchor (paragraphs [0055]-[0058]; Figures 4-8), and
wherein, once the tissue anchor is secured to the sensor attachment, a distance between the tissue site and the sensor head is maintained (paragraphs [0055]-[0058]; Figures 4-8).
Al-Ali does not teach securing, using a twist lock mechanism, the tissue anchor to a sensor attachment attached to a sensor head.
However, Le teaches securing, using a twist lock mechanism, the tissue anchor to a sensor attachment attached to a sensor head (paragraph [0061]; as shown in Figure 5). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Al-Ali, to have a sensor attachment that attaches through a twisting motion, as taught by Le, because it would be a simple substitution of the attachment mechanism of Al-Ali with that of Le in order to achieve a predictable result namely a means to attach the sensor attachment to the tissue anchor.
Regarding claim 16, Al-Ali in view of Le, teaches sing the twist lock mechanism, the tissue anchor to the sensor attachment comprises moving at least one catch into at least one slide (paragraph [0061]; as shown in Figure 5; as taught by Le).
Regarding claim 17, Al-Ali, in view of Le, teaches wherein attaching the tissue anchor to the tissue site comprises adhering the tissue anchor to the tissue site (paragraph [0034]; as taught by Al-Ali).
Regarding claim 18, Al-Ali, in view of Le, teaches wherein the tissue anchor and the sensor attachment are secured such that horizontal movement is of the sensor attachment relative to the tissue site is restricted (paragraphs [0055]-[0058]; Figures 4-8; as taught by Al-Ali; paragraph [0061]; as shown in Figure 5; as taught by Le).
Regarding claim 19, Al-Ali teaches A method for aligning a tissue site to a sensor (abstract), comprising:
attaching a tissue anchor to the tissue site (paragraphs [0055]-[0058]; Figures 4-8; as taught by Al-Ali);
securing the tissue anchor to a sensor attachment (paragraphs [0055]-[0058]; Figures 4-8; as taught by Al-Ali); and
connecting the sensor attachment to a sensor interface component attached to a sensor head, such that, when the tissue anchor is secured to the sensor attachment, the sensor head is aligned with an opening in the tissue anchor (paragraphs [0055]-[0058]; Figures 4-8; as taught by Al-Ali); and wherein the sensor head maintains a vertical distance away from the tissue site (paragraphs [0055]-[0058]; Figures 4-8; as taught by Al-Ali).
Al-Ali does not explicitly teach securing, using a twist lock mechanism, the tissue anchor to a sensor attachment.
Le teaches securing, using a twist lock mechanism, the tissue anchor to a sensor attachment (paragraph [0061]; as shown in Figure 5). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Al-Ali, to have a sensor attachment that attaches through a twisting motion, as taught by Le, because it would be a simple substitution of the attachment mechanism of Al-Ali with that of Le in order to achieve a predictable result namely a means to attach the sensor attachment to the tissue anchor.
Regarding claim 20, Al-Ali, in view of Le, teaches wherein connecting, using the twist lock mechanism, the tissue anchor to the sensor attachment comprises moving at least one catch into at least one slide (paragraphs [0055]-[0058]; Figures 4-8; as taught by Al-Ali; paragraph [0061]; as shown in Figure 5; as taught by Le).
Regarding claim 21, Al-Ali, in view of Le, teaches wherein attaching the tissue anchor to the tissue site comprises adhering the tissue anchor to the tissue site (paragraph [0034]; as taught by Al-Ali).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Al-Ali, in view of Le, as applied to claim 7 above, and further in view of US 20050187438 A1 (hereinafter referred to as “Xie”).
Regarding claim 8, Al-Ali, in view of Le, does not explicitly teach wherein the non-invasive sensor is a Raman sensor.
Xie teaches wherein the non-invasive sensor is a Raman sensor (paragraph [0027]). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Al-Ali, in view of Le, teaches using a Raman sensor, as taught by Xie, because doing so provides a sensor capable of measuring non-invasively for analytes within the user.
Conclusion
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/ABID A MUSTANSIR/Examiner, Art Unit 3791
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