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 Objections
Claim 1 is objected to because of the following informalities: “the least one” should be “the at least one”. Appropriate correction is required.
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.
Claims 1-3 and 5-8 are rejected under 35 U.S.C. 103 as being obvious over Kane et al. (US 20190167112 A1 – Cited by Applicant), hereinafter Kane, in view of Kane et al. (US 20190059792 A1 – Cited by Applicant), hereinafter ‘792, further in view of Carpenter et al. (US 20090076353 A1 – Cited by Applicant), hereinafter Carpenter.
The applied reference has common joint inventors with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Regarding claim 1, Kane discloses an implantable optical chemical sensor [The implantable medical device can include a first chemical sensor including an optical excitation assembly, see in ¶ 0004] comprising:
a circuit board [circuit board 830, see in Fig. 9];
at least one optical emitter, wherein the at least one optical emitter are disposed on the circuit board [optical emitters 812 and 822 on circuit board 830, see in Fig. 9 and ¶ 0076 and ¶ 0077];
at least one optical detector, wherein the least one optical detector is disposed on the circuit board [optical detectors 814 and 816 on circuit board 830, see in Fig. 9 and ¶ 0076];
a floor plate [floor plate 614, see in ¶ 0065 Fig. 6]; and
a well plate [opposed sides 608 and 610 to surround an interior volume of sensing element 602, see in ¶ 0063 and Fig. 6];
the well plate defining at least one well [see in Fig. 6];
the well plate comprising
a vertical facet [see in Fig. 6, vertical facet is defined by the well created by 610 and 608];
wherein the well plate is disposed over the floor plate [well plate created by 608 and 610 is disposed over floor plate 614];
and
wherein the at least one optical emitter is configured to emit light through the floor plate and into the well plate [the implantable housing 102 (see FIG. 1) can define an aperture occluded by a transparent member 614… The aperture can be disposed at the bottom of the recessed pan 612. The aperture can provide an interface allowing for optical communication between sensing element 602 and the optical excitation 611, 613, 615 and optical detection 616, 617 assemblies, see in ¶ 0065].
Kane fails to disclose wherein the well plate comprises a beveled facet, wherein the beveled facet and the vertical facet are disposed on at least one perimeter edge of the well plate, a feed-through flange defining a window, wherein the vertical facet of the well plate fits into the window, and wherein the light emitted from the at least one optical emitter is redirected by the beveled facet of the well plate into the at least one well.
However, ‘792 discloses a well plate comprising a beveled facet, wherein the beveled facet and the vertical facet are disposed on at least one perimeter edge of the well plate [masking layer 310 is tapered and disposed on the upper perimeter of the well, having a tapered edge, see in Fig. 9 and ¶ 0052].
Kane and ‘792 are both analogous to the claimed invention because they are in the same field of implantable chemical sensors. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to have modified Kane to incorporate the teachings of ‘792 and include that the well plate also has a beveled facet disposed on at least one perimeter edge of the well plate in order to protect the sensing elements. As Kane modified by ‘792 teaches in the limitation of a beveled facet being disposed on at least one perimeter edge of the well plate, Examiner notes that the beveled facet taught by ‘792 would further assist in redirecting the light emitted by the optical emitter into the at least one well, as the beveled facet prevents emitted light from escaping the top of the well.
Kane, as modified by ‘792, still fails to disclose a feed-through flange defining a window, wherein the vertical facet of the well plate fits into the window.
However, Carpenter discloses a feed-through flange defining a window, wherein the vertical facet of the well plate fits into the window [The assembly including an optical window including edges and a flange surrounding the edges of the optical window forming a hermetic seal between the flange and the optical window, see in ¶ 0005].
Kane and Carpenter are both analogous to the claimed invention because they are in the same field of implantable chemical sensors. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to have modified Kane to incorporate the teachings of Carpenter to include that the well also comprises a feed-through flange defining a window, wherein the vertical facet of the well plate fits into the window, in order to define the opening of the window and allow for the use of a hermetic seal between the flange and window [see in Carpenter ¶ 0005].
Regarding claim 2, Kane, as modified, discloses the implantable optical chemical sensor of claim 1.
Kane fails to disclose wherein the beveled facet is disposed at an angle of 20 to 70 degrees with respect to a surface of the vertical facet.
However, ‘792 discloses wherein the beveled facet is disposed at an angle of 20 to 70 degrees with respect to a surface of the vertical facet [the tapered edge can have a slope of about 10 degrees to about 80 degrees, see in ¶ 0052; Examiner notes that the tapered edge would be at an angle with respect to a side surface of the vertical facet].
Kane and ‘792 are both analogous to the claimed invention because they are in the same field of implantable chemical sensors. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to have modified Kane to incorporate the teachings of ‘792 and include that the beveled facet is disposed at an angle of 20 to 70 degrees with respect to a surface of the vertical facet to ensure that the angle is significant enough to be considered beveled.
Regarding claim 3, Kane, as modified, discloses the implantable optical chemical sensor of claim 1, further comprising a sensor element [sensing element 602, see in ¶ 0064 and Fig. 6], wherein the sensor element is configured to fit into the at least one well [In some embodiments, the top of the recessed pan 612 can be substantially flush with the top of the sensing element 602, see in ¶ 0064].
Regarding claim 5, Kane, as modified, discloses the implantable optical chemical sensor of claim 1, wherein the floor plate includes a low-index glass [The transparent member 614 can be a glass (including but not limited to borosilicate glasses), a polymer or other transparent material, see in ¶ 0065].
Regarding claim 6, Kane, as modified, discloses the implantable optical chemical sensor of claim 1, wherein the at least one optical detector comprises a photo-diode [Optical detection assemblies 616, 617 can include a component selected from the group consisting of a photodiode, a phototransistor, a charge-coupled device (CCD), a junction field effect transistor (JFET) optical sensor, a complementary metal-oxide semiconductor (CMOS) optical sensor, an integrated photo detector integrated circuit, a light to voltage converter, and the like, see in ¶ 0068].
Regarding claim 7, Kane, as modified, discloses the implantable optical chemical sensor of claim 1, the implantable optical chemical sensor further comprising a top housing shell [implantable housing 102 and header 104, see in Fig. 1 and Fig. 4], the top housing shell comprising a sensor window, wherein the feed-through flange fits into the sensor window [Examiner notes that the flange taught in by Carpenter is disclosed to be fitted with a window].
Regarding claim 8, Kane, as modified, discloses the implantable optical chemical sensor of claim 7, wherein a top surface of the feed-through flange fits flush with a top surface of the top housing shell [Examiner notes that the flange taught in by Carpenter is disclosed to be fitted with a window, therefore the window would be aligned so that the top surface of the flange would fit flush with a top surface of the hosing shell components 102 and 104 in Fig. 1 and Fig. 4].
Claim 4 is rejected under 35 U.S.C. 103 as being obvious over Kane (US 20190167112 A1 – Cited by Applicant), in view of ‘792 (US 20190059792 A1 – Cited by Applicant) and Carpenter (US 20090076353 A1 – Cited by Applicant), further in view of DeHennis et al. (US 9693714 B2 – Cited by Applicant).
The applied reference has common joint inventors with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Regarding claim 4, Kane, as modified, discloses the implantable optical chemical sensor of claim 1.
Kane fails to disclose the sensor further comprising a coating, wherein the coating is disposed over the beveled facet and configured to cause internal reflection of light off the beveled facet.
However, DeHennis teaches that reflective coatings used for implantable chemical sensors are known in the art [The face 121 of the reflector 119 may reflect radiation emitted by light source 108. In other words, the reflector 119 may block radiation emitted by light source 108 from entering the axial end of the sensor 100. For example, in one embodiment, face 121 may have a reflective coating disposed thereon, see in Col. 10, lines 10-16].
Kane and DeHennis are both analogous to the claimed invention because they are in the same field of implantable chemical sensors. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to have modified Kane to incorporate the teachings of DeHennis and include that the sensor further comprising a coating, wherein the coating is disposed over the beveled facet and configured to cause internal reflection of light off the beveled facet so that emitted light can be directed towards the targeted wells.
Claims 9-20 are rejected under 35 U.S.C. 103 as being obvious over Kane (US 20190167112 A1 – Cited by Applicant) in view of Carpenter (US 20090076353 A1 – Cited by Applicant), further in view of Matsumoto et al. (JP 2006126715 A – Cited by Applicant), hereinafter Matsumoto.
The applied reference has common joint inventors with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Regarding claim 9, Kane discloses an implantable optical chemical sensor comprising:
a circuit board [circuit board 830, see in Fig. 9];
at least one optical emitter, wherein the at least one optical emitter are disposed on the circuit board [optical emitters 812 and 822 on circuit board 830, see in Fig. 9 and ¶ 0076 and ¶ 0077];
a floor plate [floor plate 614, see in ¶ 0065 Fig. 6]; and
a well plate [opposed sides 608 and 610 to surround an interior volume of sensing element 602, see in ¶ 0063 and Fig. 6];
the well plate defining at least one well [see in Fig. 6];
wherein the well plate is disposed over the floor plate [well plate created by 608 and 610 is disposed over floor plate 614]; and
at least one optical detector, wherein the least one optical detector is disposed on the circuit board [optical detectors 814 and 816 on circuit board 830, see in Fig. 9 and ¶ 0076].
Kane fails to disclose the sensor comprising at least one prism, wherein the at least one prism is arranged to receive light from the at least one optical emitter and direct the same into the well plate and a feed-through flange, the feed-through flange defining a window.
However, Carpenter discloses a feed-through flange defining a window [The assembly including an optical window including edges and a flange surrounding the edges of the optical window forming a hermetic seal between the flange and the optical window, see in ¶ 0005].
Kane and Carpenter are both analogous to the claimed invention because they are in the same field of implantable chemical sensors. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to have modified Kane to incorporate the teachings of Carpenter to include that the well also comprises a feed-through flange defining a window in order to define the opening of the window and allow for the use of a hermetic seal between the flange and window [see in Carpenter ¶ 0005].
Kane, as modified by Carpenter, still fails to disclose the sensor comprising at least one prism, wherein the at least one prism is arranged to receive light from the at least one optical emitter and direct the same into the well plate.
However, Matsumoto discloses that using a prism is common and known in the art of optical sensors [the wavelength width of the excitation light and the wavelength width of the fluorescence to be measured are overlapped by a prism or a diffraction grating. In this way, the excitation light signal is designed not to be added to the fluorescence signal. When excitation light enters a photodetector that detects fluorescence, a signal from the excitation light is added as a bias to fluorescence that changes depending on the analyte, so the change in signal relative to changes in analyte concentration is relatively small, see in ¶ 0003].
Kane and Matsumoto are both analogous to the claimed invention because they are in the same field of optical sensors. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to have modified Kane to incorporate the teachings of Matsumoto and include that the sensor comprises at least one prism wherein the at least one prism is arranged to receive light from the at least one optical emitter and direct the same into the well plate in order to prevent deterioration of the response signal [see in Matsumoto ¶ 0003].
Regarding claim 10, Kane, as modified, discloses the implantable optical chemical sensor of claim 9, further comprising a prism holder, wherein the prism holder is configured to hold a prism and fit over at least one optical emitter thereby aligning the same [Examiner notes that teaching in a prism to receive and direct light from an optical emitter would require the prism to be secured in alignment with the optical emitter].
Regarding claim 11, Kane, as modified, discloses the implantable optical chemical sensor of claim 9, further comprising a sensor element [sensing element 602, see in ¶ 0064 and Fig. 6], wherein the sensor element is configured to fit into the at least one well [In some embodiments, the top of the recessed pan 612 can be substantially flush with the top of the sensing element 602, see in ¶ 0064].
Regarding claim 12, Kane, as modified, discloses the implantable optical chemical sensor of claim 9, wherein the floor plate includes a low-index glass [The transparent member 614 can be a glass (including but not limited to borosilicate glasses), a polymer or other transparent material, see in ¶ 0065].
Regarding claim 13, Kane, as modified, discloses the implantable optical chemical sensor of claim 9, further comprising: a top housing shell [implantable housing 102 and header 104, see in Fig. 1 and Fig. 4], the top housing shell defining a sensor window; and wherein the feed-through flange fits into the sensor window [Examiner notes that the flange taught in by Carpenter is disclosed to be fitted with a window].
Regarding claim 14, Kane, as modified, discloses the implantable optical chemical sensor of claim 13, wherein a top surface of the feed-through flange fits flush with a top surface of the top housing shell [Examiner notes that the flange taught in by Carpenter is disclosed to be fitted with a window, therefore the window would be aligned so that the top surface of the flange would fit flush with a top surface of the hosing shell components 102 and 104 in Fig. 1 and Fig. 4].
Regarding claim 15, Kane discloses an implantable optical chemical sensor comprising:
a circuit board [circuit board 830, see in Fig. 9];
at least one optical emitter, wherein the at least one optical emitter are disposed on the circuit board [optical emitters 812 and 822 on circuit board 830, see in Fig. 9 and ¶ 0076 and ¶ 0077];
at least one optical detector, wherein the least one optical detector is disposed on the circuit board [optical detectors 814 and 816 on circuit board 830, see in Fig. 9 and ¶ 0076];
a well plate [opposed sides 608 and 610 to surround an interior volume of sensing element 602, see in ¶ 0063 and Fig. 6], the well plate comprising
at least one well [see in Fig. 6].
Kane fails to disclose wherein the well plate comprises at least one prism, at least one prism alignment notch, wherein the at least one prism alignment notch is configured to receive at least a portion of the at least one prism or a structure connected thereto thereby aligning the prism with the well plate and wherein the at least one prism is arranged to receive light from the at least one optical emitter and direct the same into the well plate and wherein the sensor comprises a feed-through flange, the feed-through flange defining a window.
However, Carpenter discloses a feed-through flange defining a window [The assembly including an optical window including edges and a flange surrounding the edges of the optical window forming a hermetic seal between the flange and the optical window, see in ¶ 0005].
Kane and Carpenter are both analogous to the claimed invention because they are in the same field of implantable chemical sensors. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to have modified Kane to incorporate the teachings of Carpenter to include that the well also comprises a feed-through flange defining a window in order to define the opening of the window and allow for the use of a hermetic seal between the flange and window [see in Carpenter ¶ 0005].
Kane, as modified by Carpenter, still fails to disclose wherein the well plate comprises at least one prism, at least one prism alignment notch, wherein the at least one prism alignment notch is configured to receive at least a portion of the at least one prism or a structure connected thereto thereby aligning the prism with the well plate and wherein the at least one prism is arranged to receive light from the at least one optical emitter and direct the same into the well plate.
However, Matsumoto discloses that using a prism is common and known in the art of optical sensors [the wavelength width of the excitation light and the wavelength width of the fluorescence to be measured are overlapped by a prism or a diffraction grating. In this way, the excitation light signal is designed not to be added to the fluorescence signal. When excitation light enters a photodetector that detects fluorescence, a signal from the excitation light is added as a bias to fluorescence that changes depending on the analyte, so the change in signal relative to changes in analyte concentration is relatively small, see in ¶ 0003].
Kane and Matsumoto are both analogous to the claimed invention because they are in the same field of optical sensors. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to have modified Kane to incorporate the teachings of Matsumoto and include that the well plate comprises at least one prism, at least one prism alignment notch, wherein the at least one prism alignment notch is configured to receive at least a portion of the at least one prism or a structure connected thereto thereby aligning the prism with the well plate and wherein the at least one prism is arranged to receive light from the at least one optical emitter and direct the same into the well plate, in order to prevent deterioration of the response signal [see in Matsumoto ¶ 0003] as well as secure and orient the prism to the sensor so that it can function as intended.
Regarding claim 16, Kane, as modified, discloses the implantable optical chemical sensor of claim 15, further comprising a prism holder, wherein the prism holder is configured to hold a prism and fit over at least one optical emitter thereby aligning the same [Examiner notes that teaching in a prism to receive and direct light from an optical emitter would require the prism to be secured in alignment with the optical emitter].
Regarding claim 17, Kane, as modified, discloses implantable optical chemical sensor of claim 15, further comprising a sensor element [sensing element 602, see in ¶ 0064 and Fig. 6], wherein the sensor element is configured to fit into the at least one well [In some embodiments, the top of the recessed pan 612 can be substantially flush with the top of the sensing element 602, see in ¶ 0064].
Regarding claim 18, Kane, as modified, discloses the implantable optical chemical sensor of claim 15, further comprising a floor plate [floor plate 614, see in ¶ 0065 Fig. 6], wherein the well plate is disposed over the floor plate [well plate created by 608 and 610 is disposed over floor plate 614].
Regarding claim 19, Kane, as modified, discloses the implantable optical chemical sensor of claim 15, further comprising: a top housing shell [implantable housing 102 and header 104, see in Fig. 1 and Fig. 4], the top housing shell defining a sensor window; and wherein the feed-through flange fits into the sensor window [Examiner notes that the flange taught in by Carpenter is disclosed to be fitted with a window].
Regarding claim 20, Kane, as modified, discloses the implantable optical chemical sensor of claim 19, wherein a top surface of the feed-through flange fits flush with a top surface of the top housing shell [Examiner notes that the flange taught in by Carpenter is disclosed to be fitted with a window, therefore the window would be aligned so that the top surface of the flange would fit flush with a top surface of the hosing shell components 102 and 104 in Fig. 1 and Fig. 4].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HY KHANH DOAN whose telephone number is (703)756-5434. The examiner can normally be reached Monday - Friday 8:00 a.m. - 5 p.m..
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Chen can be reached at (571) 272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/HY KHANH DOAN/Examiner, Art Unit 3791 /TSE CHEN/Supervisory Patent Examiner, Art Unit 3791
Prosecution Insights