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 .
Response to Amendment
The amendment filed on 09/12/2025 has been entered. Claims 10, 12, 14-15, 17, and 22-26 remain pending.
Response to Arguments
Applicant's arguments filed on 09/12/2025 have been fully considered but they are not persuasive.
With regard to Claims 10 and 12, Applicant argues that the systems of the application “detects various components in the blood non-invasively with high accuracy without noises of tissue and other components of living body because lasers are focused on the blood vessel only and scattered only from the blood vessel”, or “detect strong scattering without noises of tissue and other components of living body non-invasively because the lasers are focused on the blood vessel only”. For the applied art Iddan, Applicant argues that the detecting result shall contain information of skin, tissue and blood vessel because the beam disclosed in Iddan passes through skin, tissue and blood vessel, and that the disclosed system does not focus laser beams.
Examiner respectfully disagrees. In both the application and Iddan, the light beam needs to transmit through the skin, tissue and optional blood vessel to reach a reflector, which is shown in Fig. 2 of the Application and Fig. 4 or Fig. 8 of Iddan. For the issue of focusing light, the Application has a conventional reflector with a concave surface, and Iddan discloses using a retroreflector that has “the optical property of always reflecting an impinging light beam back in the orientation of the incoming light beam” (Iddan, Para 0068), which means that the incoming light that is scattered by a blood vessel can be refocused back to the same vessel by the retroreflector.
With regard to the applied art Van Beek, Applicant argues that the disclosed catheters “are not non-invasive and do not have any suggestion relating to the amended claims”.
Examiner respectfully disagrees. Regarding the issue of non-invasiveness, the two inventions differ in that the system of the application perform measurement for peripheral blood vessel under the skin, while the device of Van Beek performs the same measurement for blood deep in the body, such as the heart (Van Beek, Column 1, Lines 45-58). Note that in Van Beek, the catheterization procedure, which is mostly invasive, is required for a patient’s treatment, but the disclosed measurement of blood property based on the already inserted catheter does not further add any significant degree of invasiveness for the patient. In addition, the implant of the application is not fully non-invasive as its size can be as large as 10 mm. Regarding whether Van Beek has any suggestion related to the claims, the application and Van Beek are common in their purpose and overall mechanism. Both the inventions are for in vivo measurement of blood property such as level of glucose (Van Beek, Column 5, Lines 2-5; “… determine one or more blood properties such as the concentrations of glucose, glycohemoglobin, lactate, bilirubin, cholesterol, triglycerides, hemoglobin and blood gases”). Both the inventions disclose using Raman radiation and scattering (Van Beek, Column 4, Lines 58-62; “… laser beam 112 provided by Raman excitation laser 114 … The Raman scattered radiation is collected by objective lens 108 …”). More details are in section of Claim rejection.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are:
“a contactless detection apparatus that is configured to detect the position of the reflector” in Claim 15.
A review of the Specification discloses that the corresponding structure for the “apparatus” is a search apparatus that may use an electromagnetic field generator apparatus, may include an image processing function such as OCT, and may be an apparatus that scans a region with laser light (Para. 0028).
“an injector that is configured to inject a drug” in Claim 17.
A review of the Specification discloses that the corresponding structure for the “injector” may be microneedles or needleless (Para. 0035).
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have these limitations interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claims 12, 15, 24 and 26 are objected to because of the following informalities:
Claim 12, Lines 10-11 recites “outside the skin”, which should be changed to “outside of the skin”.
Claim 15, Line 4 recites “outside the living body”, which should be changed to “outside of the living body”.
Claim 24, Line 3 recites “outside the living body”, which should be changed to “outside of the living body”.
Claim 16, Line 4 recites “outside the skin”, which should be changed to “outside of the skin”.
Appropriate correction is required.
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.
Claims 10, 12, 22 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Iddan et al (US 20080269575 A1; hereafter Iddan) in view of Van Beek et al (US 7486978 B2; hereafter Van Beek).
With regard to Claim 10, Iddan discloses a living body monitoring system (Iddan, Para 0133; “FIG. 14 schematically depicts some elements of the embodiment 7000 of the wrist-worn analyzer 100. Under command and control of the processing unit 300, the data sampler 200 obtains retroreflected returned beams of imprinted radiation from the twin-level retroreflector R2, which returned beams are processed and the results are forwarded, to the display 400”) comprising an analyzer apparatus that is configured to be attached to a skin of a living body (“the wrist-worn analyzer 100”), and an implant configured to be embedded under the skin of the living body (“the twin-level retroreflector R2”),
wherein the analyzer apparatus comprises:
an irradiating apparatus (“the data sampler 200”) that irradiates a target under the skin of the living body with at least two laser beams (Iddan, Fig. 9 E-9G shows that at least two light beams are transmitted to irritate an under-skin object. Para 0103 discloses “Radiation is emitted as at least one beam having at least one wavelength, ...”); and
a detector that detects scattered light from the target (Iddan, Para 0133; “… the data sampler 200 obtains retroreflected returned beams of imprinted radiation …”), and
the implant comprises a reflector configured to be embedded below the target so as to focus light from the target toward the outside of the skin (Iddan, Para 0068; “retroreflectors RR present the optical property of always reflecting an impinging light beam back in the orientation of the incoming light beam … thus helps to increase the illumination efficiency of the incoming radiation, as well as the reduction of rays of scattered light 6.” Also see Fig. 4. This disclosure does not explicitly disclose that the RR has a reflective concave surface, but the RR is embedded below the target, and focus some of the scattered light from the target toward the outside of the skin. Note that due to the disclosed optical property of retroreflector, retroreflector has the function of focusing light), and
the detector (the data sampler 200) is configured to detect scattered light from the target via the reflector of the implant that has been embedded under the skin of the living body (Iddan, Para 0069; “… most of the light beam 18 is reflected back by the retroreflector RR toward the source of radiation 2 ... The retroreflected returned beam 24 of imprinted radiation enters the data sampler 200 …”).
Iddan does not explicitly and clearly disclose wherein the reflector includes a reflective concave surface, and
the irradiating apparatus includes: a focusing apparatus that is configured to focus the at least two laser beams on a common spot on the target.
Van Beek in the same field of endeavor discloses wherein the reflector includes a reflective concave surface (Van Beek, Column 8, Lines 34-38; “… scattered radiation in part passes through the blood in the cavity to the concave mirror, is reflected by the concave mirror, and passes back through the blood in the cavity to the end of the waveguide …”. Fig. 8 shows the concave mirror 302, which focuses the light from the detection area back to the optical fiber.), and
the irradiating apparatus includes: a focusing apparatus (objective lens 304) that is configured to focus the at least two laser beams on a common spot on the target (Van Beek, Column 5, Lines 28-30; “… laser radiation through catheter 308 which is directed through objective lens 304 towards the confocal detection volume 310.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Iddan, as suggested by Van Beek, in order to use a reflector with concave surface and a focusing apparatus for focusing beams to one common spot. One of ordinary skill in the art would have been motivated to make the modification for the benefit of increased signal to noise ratio for the measured result (Van Beek, Column 6, Lines 17-22; “As a consequence Raman scattering takes place twice, once for the original laser beam and once for the reflected laser beam. Further the Raman scattered radiation is also reflected by spherical mirror 320 and collected by objective lens 304; as a result the sensitivity and the Raman signal to noise ratio are substantially increased”).
With regard to Claim 12, Iddan discloses a living body monitoring system (Iddan, Para 0133; “FIG. 14 schematically depicts some elements of the embodiment 7000 of the wrist-worn analyzer 100. Under command and control of the processing unit 300, the data sampler 200 obtains retroreflected returned beams of imprinted radiation from the twin-level retroreflector R2, which returned beams are processed and the results are forwarded, to the display 400”) comprising an analyzer apparatus that is configured to be attached to a skin of a living body (“the wrist-worn analyzer 100”), and an implant configured to be embedded under the skin of the living body (“the twin-level retroreflector R2”),
wherein the analyzer comprises:
an irradiating apparatus (“the data sampler 200”) that irradiates a target under the skin of the living body with at least two laser beams (Iddan, Fig. 9 E-9G shows that at least two light beams are transmitted to irritate an under-skin object. Para 0103 discloses “Radiation is emitted as at least one beam having at least one wavelength, ...”); and
a detector that is configured to detect scattered light from the target (Iddan, Para 0133; “… the data sampler 200 obtains retroreflected returned beams of imprinted radiation …”), and
the implant comprises a reflector that is configured to be embedded below the target so as to focus the light irradiated from outside the skin toward the target under the skin (Iddan, Para 0068; “retroreflectors RR present the optical property of always reflecting an impinging light beam back in the orientation of the incoming light beam … thus helps to increase the illumination efficiency of the incoming radiation, as well as the reduction of rays of scattered light 6.” Also see Fig. 4. In this disclosure, the light is irradiated from outside of skin, and the part of light that reaches the retroreflector is reflected back along its incoming path to the target.).
Iddan does not clearly and explicitly disclose wherein the reflector includes a reflective concave surface, and
the irradiating apparatus includes a focusing apparatus that is configured to focus the at least two laser beams on a common spot on the target via the reflector of the implant embedded under the skin of the living body.
Van Beek in the same field of endeavor discloses wherein the reflector includes a reflective concave surface (Van Beek, Column 8, Lines 34-38; “… scattered radiation in part passes through the blood in the cavity to the concave mirror, is reflected by the concave mirror, and passes back through the blood in the cavity to the end of the waveguide …”. Fig. 8 shows the concave mirror 302, which focuses the light from the detection area back to the optical fiber.), and
the irradiating apparatus includes a focusing apparatus (objective lens 304) that is configured to focus the at least two laser beams on a common spot on the target (Van Beek, Column 5, Lines 28-30; “… laser radiation through catheter 308 which is directed through objective lens 304 towards the confocal detection volume 310.”) via the reflector of the implant embedded under the skin of the living body.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Iddan, as suggested by Van Beek, in order to use a reflector with concave surface and a focusing apparatus for focusing beams to one common spot. One of ordinary skill in the art would have been motivated to make the modification for the benefit of increased signal to noise ratio for the measured result (Van Beek, Column 6, Lines 17-22; “As a consequence Raman scattering takes place twice, once for the original laser beam and once for the reflected laser beam. Further the Raman scattered radiation is also reflected by spherical mirror 320 and collected by objective lens 304; as a result the sensitivity and the Raman signal to noise ratio are substantially increased”).
With regard to Claim 22, Iddan further discloses the living body monitoring system according to claim 10,
wherein the target is blood flowing through a blood vessel (Iddan, Para 0053; “The retroreflector is possibly implanted in tissue, under a blood vessel …”), and
the implant is configured to be embedded so that the reflector focuses light from the blood inside the blood vessel toward the outside of the skin (Iddan, Fig. 4 shows that the implant, i.e. retroreflector (RR), reflects light from blood inside a blood vessel (BV) toward the outside of the skin (the dashed line). Note that as retroreflector has the property of reflecting a light back in the orientation of the incoming light, all the light scattered from the vessel and received by the retroreflector would re-focus back to the blood vessel, and then transmit outside of the skin).
With regard to Claim 26, Iddan further discloses the living body monitoring system according to 12,
wherein the target is blood flowing through a blood vessel (Iddan, Para 0053; “The retroreflector is possibly implanted in tissue, under a blood vessel …”), and
the implant is configured to be embedded so that the reflector focuses light irradiated from outside the skin toward the blood vessel (Iddan, Fig. 4 shows that the implant, i.e. retroreflector (RR), receives light irradiated from outside of the skin (the solid line, including all the scattered light beams by the vessel and other tissue, which are also irradiated from outside of the skin). All the light scattered from the vessel and received by the retroreflector would re-focus to the blood vessel.).
Claims 14 and 23 is rejected under 35 U.S.C. 103 as being unpatentable over Iddan and Van Beek, further in view of Connor et al (US 20200000345 A1; hereafter Connor).
With regard to Claim 14, Iddan and Van Beek disclose all the limitations of Claim 10 as discussed above, but do not clearly and explicitly disclose wherein the focusing apparatus includes a micromirror array that is configured to control a wave front.
Connor in the same field of endeavor discloses wherein the focusing apparatus includes a micromirror array that is configured to control a wave front (Connor, Para 0065; “the angle and/or vector of light beams … can be automatically changed by a wearable device by one or more mechanisms selected from the group consisting of: … micromirror array …”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Iddan and Van Beek, as suggested by Connor, in order to include a micromirror array in the focusing apparatus. One of ordinary skill in the art would have been motivated to make the modification for the benefit of increased illumination efficiency by maintaining the same angle of incidence of the light with respect to the target and the capability of quickly focusing on the target even if the device moves relative to the subject’s body (Connor, Para 0065; “a device can automatically change the angle and/or vector of light beams in order to maintain the same angle and/or vector of incidence with respect to the surface of a person's body … even if the device shifts and/or rotates with respect to the person's body”).
With regard to Claim 23, Iddan and Van Beek disclose all the limitations of Claim 12 as discussed above, but do not clearly and explicitly disclose wherein the focusing apparatus includes a micromirror array that is configured to control a wave front.
Connor in the same field of endeavor discloses wherein the focusing apparatus includes a micromirror array that is configured to control a wave front (Connor, Para 0065; “the angle and/or vector of light beams … can be automatically changed by a wearable device by one or more mechanisms selected from the group consisting of: … micromirror array …”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Iddan and Van Beek, as suggested by Connor, in order to include a micromirror array in the focusing apparatus. One of ordinary skill in the art would have been motivated to make the modification for the benefit of increased illumination efficiency by maintaining the same angle of incidence of the light with respect to the target and the capability of quickly focusing on the target even if the device moves relative to the subject’s body (Connor, Para 0065; “a device can automatically change the angle and/or vector of light beams in order to maintain the same angle and/or vector of incidence with respect to the surface of a person's body … even if the device shifts and/or rotates with respect to the person's body”).
Claims 15 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Iddan and Van Beek, further in view of Van Gogh et al (US 20080214913 A1; hereafter Van Gogh).
With regard to Claim 15, Iddan and Van Beek disclose all the limitations of Claim 10 as discussed above, but do not clearly and explicitly disclose wherein the implant includes a marker that is configured to enable contactless detection of a position inside the living body of the reflector from outside the living body, and
the analyzer apparatus includes a contactless detection apparatus that is configured to detect the position of the reflector that has been embedded under the skin of the living body.
Van Gogh in the same field of endeavor discloses wherein the implant includes a marker (fluorescent marker) that is configured to enable contactless detection of a position inside the living body of the reflector (biosensing substrates) from outside the living body (Van Gogh, Para 0037; “substrate detection and location determination may be performed by making use of a fluorescent marker on the surface of the biosensing substrates 102, 104”), and
the analyzer apparatus includes a contactless detection apparatus (imaging system) that is configured to detect the position of the reflector that has been embedded under the skin of the living body (Van Gogh, Para 0037; “Based on the derived image, the imaging system 114 is further capable of performing image processing in order to identify or to recognize the implanted biosensing substrates 102, 104.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Iddan and Van Beek, as suggested by Van Gogh, in order to use a marker and a detection apparatus to enable contactless positioning of the implanted object. One of ordinary skill in the art would have been motivated to make the modification for the benefit of better focusing light onto the target by appropriately adjusting the location and orientation of the implant (Van Gogh, Para 0038; “… the location information gathered by the imaging system 114 can be used in order to steer the objective control 120 for appropriately tuning and adjusting of the focusing arrangement …”).
With regard to Claim 24, Iddan and Van Beek disclose all the limitations of Claim 12 as discussed above, but do not clearly and explicitly disclose wherein the implant includes a marker that enables contactless detection of a position inside the living body of the reflector from outside the living body, and
the analyzer apparatus includes a contactless detection apparatus that is configured to detect the position of the reflector that has been embedded under the skin of the living body.
Van Gogh in the same field of endeavor discloses wherein the implant includes a marker (fluorescent marker) that enables contactless detection of a position inside the living body of the reflector (biosensing substrates) from outside the living body (Van Gogh, Para 0037; “substrate detection and location determination may be performed by making use of a fluorescent marker on the surface of the biosensing substrates 102, 104”), and
the analyzer apparatus includes a contactless detection apparatus (imaging system) that is configured to detect the position of the reflector that has been embedded under the skin of the living body (Van Gogh, Para 0037; “Based on the derived image, the imaging system 114 is further capable of performing image processing in order to identify or to recognize the implanted biosensing substrates 102, 104.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Iddan and Van Beek, as suggested by Van Gogh, in order to use a marker and a detection apparatus to enable contactless positioning of the implanted object. One of ordinary skill in the art would have been motivated to make the modification for the benefit of better focusing light onto the target by appropriately adjusting the location and orientation of the implant (Van Gogh, Para 0038; “… the location information gathered by the imaging system 114 can be used in order to steer the objective control 120 for appropriately tuning and adjusting of the focusing arrangement …”).
Claims 17 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Iddan and Van Beek, further in view of Sjolund et al (US 20190175841 A1; hereafter Sjolund).
With regard to Claim 17, Iddan and Van Beek disclose all the limitations of Claim 10 as discussed above, but do not clearly and explicitly disclose an injector that is configured to inject a drug into the living body via the skin, based on a condition of the living body obtained by the analyzer apparatus.
Sjolund in the same field of endeavor discloses an injector that is configured to inject a drug into the living body via the skin (an insulin injection pen), based on a condition of the living body obtained by the analyzer apparatus (Sjolund, Para 0281; “a reusable accessory adapted to be reversibly secured to an insulin injection pen, wherein the reusable accessory comprises an accessory wireless communication interface adapted to be used by a user to interrogate the flash glucose monitor to receive the blood glucose data”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Iddan and Van Beek, as suggested by Sjolund, in order to use an injector to inject drug into the living body based the living body’s condition. One of ordinary skill in the art would have been motivated to make the modification for the benefit of providing constant control of blood analyte, such as blood sugar, within normal limits (Sjolund, Para 0003; “… a permanent therapy is necessary which provides constant glycemic control in order to constantly maintain the level of blood analyte within normal limits. Such glycemic control is achieved by regularly supplying external drugs to the body of the patient to thereby reduce the elevated levels of blood analyte.”).
With regard to Claim 25, Iddan and Van Beek disclose all the limitations of Claim 12 as discussed above, but do not clearly and explicitly disclose an injector that is configured to inject a drug into the living body via the skin, based on a condition of the living body obtained by the analyzer apparatus.
Sjolund in the same field of endeavor discloses an injector that is configured to inject a drug into the living body via the skin (an insulin injection pen), based on a condition of the living body obtained by the analyzer apparatus (Sjolund, Para 0281; “a reusable accessory adapted to be reversibly secured to an insulin injection pen, wherein the reusable accessory comprises an accessory wireless communication interface adapted to be used by a user to interrogate the flash glucose monitor to receive the blood glucose data”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Iddan and Van Beek, as suggested by Sjolund, in order to use an injector to inject drug into the living body based the living body’s condition. One of ordinary skill in the art would have been motivated to make the modification for the benefit of providing constant control of blood analyte, such as blood sugar, within normal limits (Sjolund, Para 0003; “… a permanent therapy is necessary which provides constant glycemic control in order to constantly maintain the level of blood analyte within normal limits. Such glycemic control is achieved by regularly supplying external drugs to the body of the patient to thereby reduce the elevated levels of blood analyte.”).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, 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 LEI ZHANG whose telephone number is (571)272-7172. The examiner can normally be reached Monday-Friday 8am-5pm E.T..
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/L.Z./Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798