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
In response to preliminary amendment filed March 8, 2024, claims 38-44, 46, 51-52, 62, 68, 72-74 are amended. Claims 1-36, 45, 47, 50, 54-61, 63-67, 69-71 and 75-76 are cancelled and new claim 77 is added. Claims 37-44, 46, 48-49, 51-53, 62, 68, 72-74 and 77 are pending.
Specification
The use of the term BLUETOOTH, which is a trade name or a mark used in commerce, has been noted in this application in [0017] and [00149]. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 37, 48-49, 51-53, 62, 68, 72-74 and 77 are rejected under 35 U.S.C. 103 as being unpatentable over Rozakis (US 20120201755 A1; cited by applicant) in view of Colvin (US 7016714 B2; cited by applicant).
With respect to claim 37, Rozakis discloses a multi-analyte monitoring (MAM) system (see Fig.1 and see paragraph 0061-0062: sensor system; see paragraph 0087: sensors for different analytes may be accommodated in a single probe) comprising:
a.) a multi-analyte sensor unit (see paragraph 0061-0062 and Fig. 1: sensor probe #10; and see paragraph 0087: sensors for different analytes may be accommodated in a single probe) comprising:
i.) a support substrate (see paragraph 0086-0087 and 0116-0118: substrate #44);
ii.) a plurality of analyte sensors disposed on the support substrate (see paragraph 0087: sensors for different analytes may be accommodated in a single probe #10 and a variety of sensing elements #40 are associated with a single substrate #44), the plurality of analyte sensors configured to monitor a plurality of analytes (see paragraph 0087: sensors for different analytes may be accommodated in a single probe #10 and a variety of sensing elements #40 are associated with a single substrate #44 where they monitor various analytes), each analyte sensor comprising:
B.) a luminescent sheet (see paragraph 0126 and Fig. 8: sensing element #40 has a gel layer #56 sitting between layers #54 and #50; applicant’s specification in [0080] discloses the term luminescent as an adjective and a sheet in [0085] as general term that can be a film, matrix, coating, covering, layer, topping, surface, substance or substrate) comprising a porous sheet coated with a dye coating (see paragraph 0124-0126: suitable materials for a gel layer can include polyacrylates which is highly porous and a dye can be mixed into layer 50 which is a coating for gel layer #56),; and
b.) a recording unit operatively coupled to the sensor unit (see paragraph 0079: control system #32 controls operation of sensor probe #10 where #32 may be part of #10), wherein the recording unit includes an analyte detector for detecting luminescence from at least one of the analyte sensors (see paragraph 0062: detector #12; and see paragraph 0222: probe #10 uses optically detectable properties such as optical emission like luminescence for detection of analyte; and see paragraph 0079: control system #32 controls operation of sensor probe #10 where #32 may be part of detector #12).
Rozakis does not specifically disclose at least one opto-electronic component disposed on a support substrate and further does not specifically disclose wherein a luminescent sheet is disposed on the at least one opto-electronic component.
Colvin teaches at least one opto-electronic component disposed on a support substrate (see Fig. 1: LED #18 is disposed on ceramic substrate #70) wherein a luminescent sheet is disposed on the at least one opto-electronic component (see Fig. 1: matrix layer #14 is coated over surface of sensor body #12 wherein the LED #18 is disposed within it).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Rozakis with the teachings of Colvin to have included an opto-electronic component that is disposed on a support substrate because it would have resulted in the predictable result of having light be emitted within a sensor and surrounding body (Colvin: see Col 7 lines 27-43) to reduce noise (Colvin: see col 7 lines 54-65).
With respect to claim 48, all limitations of claim 37 apply in which Rozakis further discloses wherein the luminescent sheet comprises one or more catalysts configured to interact with a target during interaction with an analyte (see paragraph 0121-0129: gel layer #56 along with layers #54 and #50 comprises a various types of materials where one is a polymer that supports a detection substance which is specific for an analyte), and a luminescent dye configured to interact with the target and generate a luminescence corresponding to said analyte (see paragraph 0121-0129: an indicator material such as a dye is mixed with layer #50 where responds to an analyte and generates a luminescence response as it is sensitive to light; and see paragraph 0222: probe #10 uses optically detectable properties such as optical emission like luminescence for detection of analyte), wherein changes in said luminescence are related to the concentration of said analyte (see paragraph 0086: the optical properties of sensor probe #10 changes with changing concentration of an analyte).
With respect to claim 49, all limitations of claim 48 apply in which Rozakis further discloses wherein the one or more catalysts consume the target in the presence of the analyte and the luminescent dye (see paragraph 0121-0129: the polymer detects substrate in the presence of analyte and the indicator material), wherein the target binds or reacts to the luminescent dye and at least partially quenches the luminescence of the luminescent dye, thereby resulting in the change in luminescence (see paragraph 0121-0129: the polymer detects substrate in the presence of analyte and the indicator material by binding to dye which changes luminescence).
With respect to claim 51, all limitations of claim 48 apply in which Rozakis further discloses wherein the one or more analytes are lactate, glucose, ketones, or a combination thereof (see paragraph 0087, sensing elements that detect glucose and lactate).
With respect to claim 52, all limitations of claim 48 apply in which Rozakis further discloses wherein the one or more analyte sensors further comprise luminescent probes (see paragraph 0061-0062 and Fig. 1: sensor probe #10; and see paragraph 0087: sensors for different analytes may be accommodated in a single probe; and see paragraph 0086: the optical properties of sensor probe #10 changes with changing concentration of an analyte).
With respect to claim 53, all limitations of claim 52 apply in which Rozakis further discloses wherein each luminescent probe comprises a fluorescent protein pair, wherein each fluorescent protein is conjugated to a macromolecule, wherein a binding event produces an energy transfer between the fluorescent protein pairs that yield luminescent signals (see paragraph 0121-0129: gel layer #56 along with layers #54 and #50 comprises a various types of materials where one is a polymer that supports a detection substance which is specific for an analyte where the combination of the detection substance and the analyte is a protein pair; and see paragraph 0121-0129: an indicator material such as a dye is mixed with layer #50 where responds to an analyte and generates a luminescence response as it is sensitive to light; and see paragraph 0222: probe #10 uses optically detectable properties such as optical emission like luminescence for detection of analyte)).
With respect to claim 62, all limitations of claim 37 apply in which Rozakis further discloses wherein the support substrate further comprises a flexible base layer and electrically conducting wires or traces disposed on the flexible base layer (see paragraph 0086-0087, 0079-0080 and 0116-0118 and Fig. 8: substrate #44 has base layer and wires disposed on it) and operatively coupling the recording unit to the analyte sensors (see paragraph 0079: control system #32 controls operation of sensor probe #10 where #32 may be part of #10).
With respect to claim 68, all limitations of claim 37 apply in which Colvin further teaches wherein the opto-electronic components comprise light sources that can be activated one at a time to limit any optical signal crosstalk (see Fig. 1 and Figs. 3-4 and see Col 7 lines 27-43: LED #18 and light emitted by #16 are activated one by one).
With respect to claim 72, all limitations of claim 37 apply in which Rozakis further discloses wherein the analyte sensors are disposed on both sides of the supporting substrate (Fig. 6: sensing elements #40 are disposed on two sides of substrate #44).
With respect to claim 73, all limitations of claim 37 apply in which Rozakis further discloses wherein the sensor unit is configured to be implanted under skin, in a tissue, or in an organ (see paragraph 0065: sensing probe #10 is preferably implanted beneath a person’s skin).
With respect to claim 74, all limitations of claim 37 apply in which Rozakis further discloses wherein the recording unit is configured to be placed on the skin or implanted under the skin, in the tissue, or in the organ such that the analyte detector is positioned above or directly facing at least one of the analyte sensors of the sensor unit (see paragraph 0065: sensing probe #10 is preferably implanted beneath a person’s skin; and see paragraph 0079: control system #32 controls operation of sensor probe #10 where #32 may be part of #10).
With respect to claim 77, all limitations of claim 52 apply in which Rozakis further discloses wherein the luminescent probes are sensitive to peptides, sugars, lipids, hormones, nucleic acids, calcium, magnesium, zinc, and other ions or electrolytes (see paragraph 0087, sensing elements detect glucose and lactate which are sugars meaning that the sensing probe is sensitive to them).
Claims 38-44 and 46 are rejected under 35 U.S.C. 103 as being unpatentable over Rozakis in view of Colvin as applied to claim 37 above, and further in view of Kauer (US 6649416 B1; cited by applicant).
With respect to claim 38, all limitations of claim 37 apply in which Rozakis further discloses wherein the plurality of analyte sensors includes a pH sensor (see paragraph 0160, probe may have a pH sensing electrode #108 as part of it). Rozakis further discloses a pH sensor sheet comprising a porous sheet coated with a polymer coating comprising particles and pH sensitive dye molecules bound thereto (see paragraph 0086-0087 and 0116-0118 and 0125: substrate #44 has pH indicator on it; see paragraph 0121-0129: the polymer detects substrate in the presence of analyte and the indicator material by binding to dye which changes luminescence), a luminescence that is detectable, wherein changes in the luminescence is related to changes in the pH (see paragraph 0121-0129: the polymer detects substrate in the presence of analyte and the indicator material by binding to dye which changes luminescence)
However Rozakis and Colvin do not specifically teach a.) at least one light source disposed on the support substrate; b.) at least one photodiode disposed on the support substrate, adjacent to the at least one light source.
Kauer teaches at least one light source disposed on a support substrate (see Fig. 8 and col 13 lines 1-8: light sources and photodiode detectors are placed on substrate); at least one photodiode disposed on the support substrate, adjacent to the at least one light source (see Fig. 8 and col 13 lines 1-8: light sources and photodiode detectors are placed on substrate next to each other).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Rozakis and Colvin with the teachings of Kauer to have utilized a light source and photodiode detector on a pH sensor because it would have resulted in the predictable result of enabling independent control and modulation of individual channel optical filtering, current/voltage conversion, signal amplification and temporal filtering (Kauer: see Col 25 lines 55-67 – Col 26 lines 1-6) and lower power requirements, cooler operating temperature and high light output over small area (Kauer: see col 25 lines 10-24).
With respect to claim 39, all limitations of claim 38 apply in which the combination of Rozakis, Colvin and Kauer teach wherein the pH sensor further comprises a second light source disposed on the support substrate, wherein the pH sensor sheet is further disposed on the second light source, wherein the second light source is configured to illuminate the pH sensitive dye molecules (Kauer: see col 12 lines 44-47 and see col 13 lines 1-8: multiple layers of array substrates are employed with multiple LED light sources and photodiode detectors).
With respect to claim 40, all limitations of claim 39 apply in which Kauer further teaches wherein the second light source is positioned such that the at least one photodiode is disposed between the two light sources (see col 13 lines 1-8: LED light sources and photodiode detectors are positioned next to each other sequentially).
With respect to claim 41, all limitations of claim 38 apply in which Kauer further teaches wherein the at least one photodiode is coated with an optical filter to pass a specific band or bands of wavelength (see Col 17 lines 63-67 – col 18 lines 1-8, photodiodes are filters with array of emission filters for specific band of wavelength).
With respect to claim 42, all limitations of claim 38 apply in which he combination of Rozakis, Colvin and Kauer wherein the pH sensor further comprises a second photodiode disposed on the support substrate, wherein the pH sensor sheet is further disposed on the second photodiode, wherein the second photodiode is configured to detect the luminescence of the pH sensitive dye molecules (Kauer: see col 12 lines 44-47 and see col 13 lines 1-8: multiple layers of array substrates are employed with multiple LED light sources and photodiode detectors).
With respect to claim 43, all limitations of claim 42 apply in which Kauer further teaches wherein the second photodiode is positioned such that the at least one light source is disposed between the two photodiodes (see col 13 lines 1-8: LED light sources and photodiode detectors are positioned next to each other sequentially).
With respect to claim 44, all limitations of claim 42 apply in which Kauer further teaches wherein each photodiode is coated with an optical filter to pass a specific band or bands of wavelength (see Col 17 lines 63-67 – col 18 lines 1-8, photodiodes are filters with array of emission filters for specific band of wavelength).
With respect to claim 46, all limitations of claim 38 apply in which Rozakis further discloses wherein the recording unit is configured to receive and record signals that correspond to the luminescence from the pH sensor (see paragraph 0062: detector #12; and see paragraph 0222: probe #10 uses optically detectable properties such as optical emission like luminescence for detection of analyte from the pH sensing; and see paragraph 0079: control system #32 controls operation of sensor probe #10 where #32 may be part of detector #12).
Conclusion
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/N.N.P./Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791