DETAILED ACTION
Response to Arguments
Applicant's arguments filed 7/15/2026 have been fully considered but they are not persuasive.
Regarding the rejection of the claims as being anticipated by Leonhard, the applicant argues Leonhard has no sensor, light source, or detector and cannot meet the 10-degree limitation. The examiner disagrees and states that this argument is moot in view of the amendment incorporating the 10-degree limitation into claims 1, 16 and 18. The limitation is addressed below under the Adams/Leonhard/Hoarau, previously applied to Claims 4, 5 and 20.
Regarding the rejection of the claims as being obvious over Adams in view of Leonhard, the application argues the two references are non-analogous art. Applicant argues Leonhard is an endoscopic grasper with nothing to do with oximetry, so the artisan would not be motivated to combine the references. The examiner disagrees and submits analogous art is either the same field of endeavor or reasonably pertinent to the problem addressed. Applicant has only addressed the first prong. Both references are medical devices with two jaws that close on and conform to a body appendage/tissue. Adams itself seeks a flexible housing to accommodate the body part ([0040]-[0041]), and Leonhard addresses exactly this problem - conforming a clamp to the object and avoiding point loads ([0003]-[0005]). Applicant’s own claim 15 recites a “fin ray structure”, a term from the gripper art. Furthermore, the applicant has not addressed examiner’s stated motivation for combination.
The applicant argues that neither Adams nor Leonhard disclose the 10-degree angular difference. Examiner agrees, and the rejection never asserted otherwise, the claim limitation is met by Hoarau.
The applicant argues that Hoarau [0040] gives no angular threshold, no deformed vs. non-deformed comparison, and no structure limiting angular movement, and that “optical distance” is not angular orientation. The examiner disagrees and submits that the applicant concedes Hoarau [0040] teaches that deformation causes the emitter and detector to change angle relative to one another and that such change degrades the signal and causes motion artifact. Hoarau therefore identifies relative emitter/detector angular deviation as a result-effective variable to be minimized; selecting a maximum allowed deviation is routine optimization. Further, Hoarau’s teaching to hold the emitter and detector fixed relative to one another corresponds to substantially 0-degree deviation, which is within “does not exceed 10 degrees”. Applicant identifies no criticality, or unexpected result of 10-degrees and the claim does not require that the two elements deviate from each other, rather than they fall somewhere within this range. The rejection relied on Hoarau’s angular teaching, not its optical-distance teaching, so the distinction Applicant draws is immaterial. The comparison between states is supplied by the combination: Adams places the light source and detector at distal ends aimed at one another ([0006], [0035]), Leonhard’s fin-ray element bends toward and conforms to the body part ([0005]) so that distal ends remain facing one another across the tissue in both states and Hoarau provides a boundary of less than 10 degrees of the deviation. Furthermore, the rejection is supplied by ample motivational statements from each reference so that a skilled artisan would have found such combination of references obvious.
The rejections are maintained.
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) 1-3, 6-19 and 21-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20080262328 A1 to Adams in view of US 20110213409 A1 to Leonhard et al. (hereinafter, Leonhard), and further in view of US 20070073128 A1 to Hoarau et al. (hereinafter, Hoarau).
Regarding Claims 1, 6, 16 and 18, Adams discloses a sensor clamping arrangement and process of using a first clamping element comprising a light source and a second clamping element comprising a radiation detector, wherein the arrangement is configured to receive the body part between the clamping elements (first and second bundles configured in the first and second clip housings for the purpose of performing pulse oximetry as described in the Abstract) wherein the light source is arranged at a distal end of the first clamping element, and wherein the radiation detector is arranged at a distal end of the second clamping element ([0035]) (see FIG. 1). Adams also discloses the housing and bundles themselves to be flexible to accommodate a body part. ([0040]-[0041]).
Adams discloses the claimed invention except for expressly disclosing the following:
(Claims 1, 16 and 18) wherein the first clamping element comprising a deformed state and a non-deformed state comprises:
a first deformable side wall;
a second deformable side wall;
a number of first connecting elements, which extend between the first side wall and the second side wall, wherein the first clamping element is configured to be deformable such that the first clamping element bends towards the body part upon the first clamping element being applied to the body part;
wherein the oxygen saturation sensor is configured such that a difference between an orientation of the light source and the radiation detector relative to each other in a deformed state of the first clamping element and an orientation of the light source and the radiation detector relative to each other in a non-deformed state of the first clamping element does not exceed an angular difference of 10 degrees.
(Claim 2) wherein the first clamping element and the second clamping element are pivotably connected to one another or rigidly connected to one another;
(Claims 3 and 19) a third deformable side wall; a fourth deformable side wall, and a number of second connecting elements, which are located between the third side wall and the fourth side wall and extend, wherein the second clamping element is configured to be deformable such that the second clamping element bends towards the body part upon the second clamping element being applied to the body part;
(Claim 7) wherein the first side wall and the second side wall enclose an acute angle in an undeformed state of the first clamping element;
(Claim 8) wherein the first side wall and the second side wall enclose an acute angle in an undeformed state of the first clamping element, and/or wherein the third side wall and the fourth side wall enclose an acute angle in an undeformed state of the second clamping element;
(Claim 9) wherein at least one of the first connecting elements is planar, and wherein a surface normal of the at least one of the first connecting elements is arranged perpendicular to a longitudinal axis of the first clamping element;
(Claim 10) wherein at least one of the first connecting elements is planar and/or at least one of the second connecting elements is planar, and wherein a surface normal of the at least one of the first connecting elements is arranged perpendicular to a longitudinal axis of the first clamping element and/or a surface normal of the at least one of the second connecting elements is arranged perpendicular to a longitudinal axis of the second clamping element;
(Claim 11) wherein the first side wall is provided by side wall segments spaced apart from each other and/or by overlapping side wall segments;
(Claim 12) wherein the first side wall and/or the third side wall is provided by side wall segments spaced apart from each other and/or by overlapping side wall segments;
(Claim 13) wherein the first side wall and/or the second side wall is interrupted transversely to a direction of a longitudinal axis of the first clamping element;
(Claim 14) wherein the first side wall and/or the second side wall and/or the third side wall and/or the fourth side wall is interrupted transversely to a direction of a respective longitudinal axis of the respective clamping element;
(Claims 15 and 17) wherein the first clamping element comprises a fin ray structure;
(Claim 21) wherein the first connecting elements are located at spaced location from each other, the first connecting elements being in contact with the first deformable side wall and the second deformable side wall.
(Claim 22) wherein a distance between the first deformable side wall and the second deformable side wall increases in a longitudinal direction of the first clamping element with respect to a longitudinal axis of the first clamping element.
(Claim 23) wherein the second connecting elements are located at spaced location from each other, the second connecting elements being in contact with the third deformable side wall and the fourth deformable side wall.
However, Leonhard teaches a medical instrument for clamping attachment to the body, including a similar two-jaw medical device with gripping/clamping function where each jaw carries a functional element and the two jaws close on tissue or a body part (see entire document of Leonhard, including [0002]). Leonhard goes on to teach:
(Claims 1, 16 and 18) a first clamping element (top jaw member 4) and a second clamping element (bottom jaw member 4), wherein the clamping elements are configured to receive the body part between the first clamping element and the second clamping element ([0005] “The Fin Ray Effect refers to a double-layered structure that performs a directed deformation through force impact, for example by sidestepping in the force contact point and at its ends turning against the force direction, and thus adapts to the shape of the object that induces the force.”), and
wherein the first clamping element comprising a deformed state and a non-deformed state (see FIGS. 2 & 4) and further comprises:
a first deformable side wall (inner cheek 7 of top jaw member 4 - the wall facing the grasped object/body part);
a second deformable side wall (outer cheek 8 of top jaw member 4 – the wall facing away from the object/body part);
a number of first connecting elements (two connected braces 9 between the first and second deformable side walls, see FIG. 7), which extend between the first side wall and the second side wall ([0056] “In the fourth embodiment, shown in FIG. 7, the solid-state joints 10 in the transition from the connecting brace 9 to the respective cheek 7 or 8 are configured with varying material thickness.”), wherein the first clamping element is configured to be deformable such that the first clamping element bends towards the body part upon the first clamping element being applied to the body part ([0005] “The Fin Ray Effect refers to a double-layered structure that performs a directed deformation through force impact, for example by sidestepping in the force contact point and at its ends turning against the force direction, and thus adapts to the shape of the object that induces the force.”).
One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the first and second clamping elements with respective light source and radiation detectors of Adams with the specific configuration Fin-ray configuration as taught above by Leonhard, as Leonhard teaches this would have avoided point loads which are disadvantageous between jaw members to prevent damage to the grasped object ([0003]-[0004]) and further teaches that the Fin-ray would have adapted to the shape of the object that induces force ([0005]) and would have maintained flexibly and have high stability ([0007]). Applying the clip Fin-ray effect arrangement of Leonhard to the pulse oximeter clip arrangement of Adams, as a skilled artisan would have recognized that this would have avoided point-load pressure on a bodily extremely and would be adaptable to various appendage sizes.
Adams in view of Leonhard teach the claimed invention (Claims 1, 16 and 18) as set forth and cited above except for expressly disclosing wherein the oxygen saturation sensor is configured such that a difference between an orientation of the light source and the radiation detector relative to each other in a deformed state of the first clamping element and an orientation of the light source and the radiation detector relative to each other in a non-deformed state of the first clamping element does not exceed an angular difference of 10 degrees.
First, it is noted that Adams discloses the light source and the radiation detector are arranged at the distal ends of the first and second clamping elements and are aimed at one another ([0006], [0035]). Modifying Adam’s flexible clip housings ([0040]-[0041]) with the fin-ray wall and brace structure of Leonhard alters only the manner in which the clamping elements deform, not the placement or the facing arrangement of the light source and the detector, which remain at the distal ends. Because the fin-ray structure bends towards and conforms to the shape of the appendage that induces force (Leonhard [0005]), each clamping element in the combination conforms to an opposing surface of the received body part, such that the light source and detector remain aimed at one another in both the non-deformed and deformed states. The principle operation of Adams (transmission oximetry) is therefore retained.
However, Hoarau teaches various embodiments of clip oximeter sensors that are flexible (Abstract, see entire document), recognizes that a change in the angle of the emitter and detector with respect to one another may occur ([0040]), that motion artifacts may be caused by such a change in direction and/or angles of the emitter ([0040]), that semi-rigid clip type sensors are prone to such change in angle and motion artifacts ([0010]) and expressly teaches that it is desirable that a sensor’s emitter and detector are held at a substantially fixed optical distance with respect to one another ([0040]). One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify Adams in view of Leonhard to hold the sensor and detector at fixed optical angles/distances as this would have reduced motion artifacts.
Regarding Claim 2, Adams in view of Leonhard and further in view of Hoarau teach wherein the first clamping element and the second clamping element are pivotably connected to one another or rigidly connected to one another (Leonhard [0034] “To convert the jaw members 4 of the tool 5 from an open starting position into a closed position, the handle 3 and the jaw members 4 are in active connection with one another by way of an actuating element 6 mounted in the shaft 2.”) (Leonhard [0036] “The inner cheeks 7 of the two jaw members 4 are connected with one another on their proximal ends as a contact point on the jaw member side for the actuating element 6 that serves to open and close the jaw members 4.”);
Regarding Claims 3 and 19, Adams in view of Leonhard and further in view of Hoarau teach a third deformable side wall (Leonhard: inner cheek 7 of bottom jaw member 4 - the wall facing the grasped object/body part); a fourth deformable side wall (Leonhard: outer cheek 8 of bottom jaw member 4 – the wall facing away from the object/body part), and a number of second connecting elements (Leonhard: two connected braces 9 between the first and second deformable side walls, see FIG. 7), which are located between the third side wall and the fourth side wall and extend (Leonhard [0056] “In the fourth embodiment, shown in FIG. 7, the solid-state joints 10 in the transition from the connecting brace 9 to the respective cheek 7 or 8 are configured with varying material thickness.”), wherein the second clamping element is configured to be deformable such that the second clamping element bends towards the body part upon the second clamping element being applied to the body part (Leonhard [0005] “The Fin Ray Effect refers to a double-layered structure that performs a directed deformation through force impact, for example by sidestepping in the force contact point and at its ends turning against the force direction, and thus adapts to the shape of the object that induces the force.”);
Regarding Claim 7, Adams in view of Leonhard and further in view of Hoarau teach wherein the first side wall and the second side wall enclose an acute angle in an undeformed state of the first clamping element (Leonhard: see FIG. 7, which depicts the inner and outer cheeks converging at the distal end and diverging toward the proximal end, enclosing an acute angle);
Regarding Claim 8, Adams in view of Leonhard and further in view of Hoarau teach wherein the first side wall and the second side wall enclose an acute angle in an undeformed state of the first clamping element (Leonhard: see FIG. 7, which depicts the inner and outer cheeks of the first clamping element converging at the distal end and diverging toward the proximal end, enclosing an acute angle), and/or wherein the third side wall and the fourth side wall enclose an acute angle in an undeformed state of the second clamping element (Leonhard: see FIG. 7, which depicts the inner and outer cheeks of the second clamping element converging at the distal end and diverging toward the proximal end, enclosing an acute angle);
Regarding Claim 9, Adams in view of Leonhard and further in view of Hoarau teach wherein at least one of the first connecting elements is planar, and wherein a surface normal of the at least one of the first connecting elements is arranged perpendicular to a longitudinal axis of the first clamping element (Leonhard: connecting brace 9, shown in FIG. 7, is depicted as a flat transverse plane spanning between inner cheek 7 and outer cheek 8, which is perpendicular to the axis of the top jaw member 4 when FIG. 7 is in the closed position, as evidenced in FIG. 4. While FIG. 4 is a separate embodiment, it differs mainly in the fact that is has a single connecting brace 9) (Leonhard: see [0029]), which is shown in said perpendicular position. A skilled artisan would have recognized that FIG. 7, when closed, provides such claimed arrangement when closed, as similarly show in FIG. 4);
Regarding Claim 10, Adams in view of Leonhard and further in view of Hoarau teach wherein at least one of the first connecting elements is planar and/or at least one of the second connecting elements is planar, and wherein a surface normal of the at least one of the first connecting elements is arranged perpendicular to a longitudinal axis of the first clamping element and/or a surface normal of the at least one of the second connecting elements is arranged perpendicular to a longitudinal axis of the second clamping element (Leonhard: connecting brace 9, shown in FIG. 7, is depicted as a flat transverse plane spanning between inner cheek 7 and outer cheek 8, which is perpendicular to the axis of the top jaw member 4 when FIG. 7 is in the closed position, as evidenced in FIG. 4. While FIG. 4 is a separate embodiment, it differs mainly in the fact that is has a single connecting brace 9) (Leonhard: see [0029]), which is shown in said perpendicular position. A skilled artisan would have recognized that FIG. 7, when closed, provides such claimed arrangement when closed, as similarly show in FIG. 4);
Regarding Claim 11, Adams in view of Leonhard and further in view of Hoarau teach wherein the first side wall is provided by side wall segments spaced apart from each other and/or by overlapping side wall segments (Leonhard: FIG. 7 discloses the first side wall (inner cheek 7) is provided by side wall segments spaced apart from each other via the window-like perforation 14, see [0037]);
Regarding Claim 12, Adams in view of Leonhard and further in view of Hoarau teach wherein the first side wall and/or the third side wall is provided by side wall segments spaced apart from each other and/or by overlapping side wall segments (Leonhard: Both jaw members 4 are configured identically, such that the window-like perforation 14 and the resulting interrupted/spaced-apart side wall segments as shown in FIG. 7 are present on the second clamping element as well, see [0037]);
Regarding Claim 13, Adams in view of Leonhard and further in view of Hoarau teach wherein the first side wall and/or the second side wall is interrupted transversely to a direction of a longitudinal axis of the first clamping element (Leonhard: FIG. 7 discloses the first side wall (inner cheek 7) is provided by side wall segments spaced apart from each other via the window-like perforation 14, see Leonhard [0037]);
Regarding Claim 14, Adams in view of Leonhard and further in view of Hoarau teach wherein the first side wall and/or the second side wall and/or the third side wall and/or the fourth side wall is interrupted transversely to a direction of a respective longitudinal axis of the respective clamping element (Leonhard: Both jaw members 4 are configured identically, such that the window-like perforation 14 and the resulting interrupted/spaced-apart side wall segments as shown in FIG. 7 are present on the second clamping element as well, see Leonhard [0037]);
Regarding Claim 15 and 17, Adams in view of Leonhard and further in view of Hoarau teach wherein the first clamping element comprises a fin ray structure (Leonhard [0005] “The Fin Ray Effect refers to a double-layered structure that performs a directed deformation through force impact, for example by sidestepping in the force contact point and at its ends turning against the force direction, and thus adapts to the shape of the object that induces the force.”).
Regarding Claim 21, Adams in view of Leonhard and further in view of Hoarau wherein the first connecting elements are located at spaced location from each other, the first connecting elements being in contact with the first deformable side wall and the second deformable side wall (Leonhard: two connecting braces 9 positioned between inner cheer 7 and outer cheek 8 of each jaw member 4, see FIG. 7 and [0047], each brace 9 being connected to the respective cheek 7, 8 by solid state joints 10, see [0035] and [0041]).
Regarding Claim 22, Adams in view of Leonhard and further in view of Hoarau wherein a distance between the first deformable side wall and the second deformable side wall increases in a longitudinal direction of the first clamping element with respect to a longitudinal axis of the first clamping element (Leonhard: [0035] “inner cheek 7 and the outer cheek 8, which are connected with one another on the distal end of each jaw member 4… are configured at a distance from one another toward the proximal end of the jaw member 4”, see FIG. 7).
Regarding Claim 23, Adams in view of Leonhard and further in view of Hoarau wherein the second connecting elements are located at spaced location from each other, the second connecting elements being in contact with the third deformable side wall and the fourth deformable side wall (Leonhard: both jaw members 4 are configured identically, such that the two spaced connecting braces 9 joined to inner cheek 7 and outer cheek 8 of the bottom jaw member are present as well, see FIG. 7, [0035], [0041] and [0047]).
Conclusion
THIS ACTION IS MADE FINAL. 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 SEAN PATRICK DOUGHERTY whose telephone number is (571)270-5044. The examiner can normally be reached 8am-5pm (Pacific Time).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jacqueline Cheng can be reached at (571)272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEAN P DOUGHERTY/ Primary Examiner, Art Unit 3791
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