DETAILED ACTION
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 18 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 18 recites a biosensor comprising a “stacked cylindrical design”. It is unclear what form of design that is. It is noted that the original disclosure fails to articulate what is meant by that phrase. In particular, it’s unclear whether the design results in cylinders stacked vertically on top of each other, whether it’s stacked axially, whether it’s just multiple cylinders individually standing next to each other, or some other possible configuration. Where there is a great deal of confusion and uncertainty as to the proper interpretation of the limitations of a claim, it would not be proper to reject such a claim on the basis of prior art. As stated in In re Steele, 305 F.2d 859, 134 USPQ 292 (CCPA 1962), a rejection should not be based on considerable speculation about the meaning of terms employed in a claim or assumptions that must be made as to the scope of the claims. See MPEP 2173.06.
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.
Claim(s) 1-4, 11-17, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huang (“Pd-Porphyrin-Cross-Linked Implantable Hydrogels with Oxygen-Responsive Phosphorescence”) in view of Guery et al. (US 2021/0353184).
As to claims 1, 11, and 19, Huang teaches an analyte detection system (p891 – oxygen detection), the system comprising: a biosensor operable to be implanted into a media, said media being skin (p894 – implanted in the space between skin and the muscle); and a transmitter comprising a light source (p895 – pulsed dye laser source), wherein the transmitter is operable to receive photoluminescence outputs back from the biosensor to determine properties of an analyte (p893 – Figure 3)
Huang does not explicitly teach that the transmitter is operable to be external to the media. However, it is noted that the devices used (p895 – VSL-337 pulsed laser) is certainly unlikely to be implanted into the media. Moreover, Guery teaches a subcutaneous biosensor in which the excitation light source is external to the media (Fig. 4) while the biosensor (402) is implanted into the user (Rig. 4). It would have been obvious to modify Huang with Guery to ensure that the light source remains outside of the media such that the device can be used in a minimally invasive way and reduce potential harms to the user.
As to claims 2 and 12, Guery teaches the biosensor comprises a plurality of discrete compartments (108) that is in a barcode configuration (Fig. 1). It would have been obvious to further modify Huang with Guery to enable the use of a plurality of sensors within the system to make multiple measurements.
As to claims 3 and 13, the combination teaches each discrete compartment comprises at least one of an oxygen sensing assay and a glucose sensing assay. As noted above, Huang teaches oxygen sensing. Guery teaches glucose sensing ([0040]) in which each individual compartment is configured to allow individual sensing ([0041]). Accordingly, the combined teachings would allow for each individual compartment to comprise at least one of an oxygen and a glucose sensing array, as it would be obvious to try.
As to claims 4, 14, and 15, Guery teaches at least one discrete compartment of the plurality of discrete compartments comprises at least one glucose-responsive compartment ([0041] – glucose oxidase).
As to claim 16, Guery teaches biosensor has a barcode configuration (Fig. 1) and the combination teaches functionality through two modalities that relate interstitial analyte level to emitted photoluminescence (via both oxygen and glucose sensing).
As to claim 17, Guery teaches the biosensor comprising at least one sensing chemistry within a domain of the biosensor ([0041]).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huang (“Pd-Porphyrin-Cross-Linked Implantable Hydrogels with Oxygen-Responsive Phosphorescence”) in view of Guery et al. (US 2021/0353184), and further in view of Brown et al. (“Encapsulation of glucose oxidase and an oxygen-quenched fluorophore in polyelectrolyte-coated calcium alginate microspheres as optical glucose sensor systems”).
As to claim 5, the above combination fails to teach that the least one glucose-responsive compartment comprises glucose-responsive microparticles comprising alginate microparticles for detection of glucose and oxygen. However, Brown teaches a system for encapsulating glucose-oxidase within alginate microspheres for optical glucose sensor systems (Abstract, p213). Accordingly, it would have been obvious to modify the above combination further with Brown to enable the use of alginate microspheres to encapsulate the glucose-oxidase and increase the stability of the device.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huang (“Pd-Porphyrin-Cross-Linked Implantable Hydrogels with Oxygen-Responsive Phosphorescence”) in view of Guery et al. (US 2021/0353184), Brown et al. (“Encapsulation of glucose oxidase and an oxygen-quenched fluorophore in polyelectrolyte-coated calcium alginate microspheres as optical glucose sensor systems”), and further in view of Dong et al. (“A Glucose Biosensor Based on Phosphorescence Lifetime Sensing and a Thermoresponsive Membrane”).
As to claim 6, the above combination does not teach that the glucose-responsive microparticles comprise Pd(II) meso-tetra (sulfophenyl) tetrabenzoporphyrin sodium salt (PdBP). However, Dong teaches the use of such a particle in a system designed for an optical-sensing based glucose sensing array to retain desired thermosensitivity, glucose diffusivity, and primary optical properties (p1). Accordingly, it would have been obvious to modify the above combination to utilize PdBP as it would have been an obvious substitution yielding similar and thus predictable results.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huang (“Pd-Porphyrin-Cross-Linked Implantable Hydrogels with Oxygen-Responsive Phosphorescence”) in view of Guery et al. (US 2021/0353184), Brown et al. (“Encapsulation of glucose oxidase and an oxygen-quenched fluorophore in polyelectrolyte-coated calcium alginate microspheres as optical glucose sensor systems”), and further in view of Suri et al. (US 2017/0273610).
As to claim 7, Brown teaches that glucose oxidase is included in the fabrication of the glucose-responsive microparticles (p213) but the combination does not teach the inclusion of catalase. However, Suri teaches the use of antioxidants such as catalase to protect biosensing molecules from reactive oxygen species ([0055]). As such, it would have been obvious to modify the above combination with Suri to utilize catalase and increase the longevity of the device.
Claim(s) 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huang (“Pd-Porphyrin-Cross-Linked Implantable Hydrogels with Oxygen-Responsive Phosphorescence”) in view of Guery et al. (US 2021/0353184), Markle et al. (US 2011/0105866), and further in view of Brown et al. (“Encapsulation of glucose oxidase and an oxygen-quenched fluorophore in polyelectrolyte-coated calcium alginate microspheres as optical glucose sensor systems”).
As to claims 8-9, the above combination fails to teach that the at least one discrete compartment of the plurality of discrete compartments comprises at least one glucose-insensitive compartment, said glucose-insensitive particles comprising alginate microparticles for detection of oxygen.
However, Markle teaches an optical sensor system for detecting glucose in which certain measurement cavities contain a fluorophore system which is sensitive to glucose and another in which the fluorosphore system is glucose insensitive ([0014], [0057], [0072]) and Brown teaches the use of alginate microparticles to encapsulate specific materials (Abstract, p213). Accordingly, it would have been obvious to modify the above combination with Markle and Brown to utilize glucose-insensitive particles comprising alginate microparticles for the sensors meant for the detection of oxygen, such that the presence of glucose does not affect its measurements.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huang (“Pd-Porphyrin-Cross-Linked Implantable Hydrogels with Oxygen-Responsive Phosphorescence”) in view of Guery et al. (US 2021/0353184), Markle et al. (US 2011/0105866), Brown et al. (“Encapsulation of glucose oxidase and an oxygen-quenched fluorophore in polyelectrolyte-coated calcium alginate microspheres as optical glucose sensor systems”), and further in view of Sinaasappel et al. (“Calibration of Pd-porphyrin phosphorescence for oxygen glucose measurements in vivo”).
As to claim 10, the above combination does not teach that the glucose-insensitive particles comprise Pd-meso- tetra(4-carboxyphenyl) porphyrin (PdP). Sinaasappel teaches the use of this very particle (p2298) within a system for measuring oxygen concentration measurements in vivo. Accordingly, it would have been obvious to modify the above combination with Sinaasappel to utilize a known material that is glucose-insensitive in the measurement of oxygen.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Guery et al. (US 2021/0353184), Markle et al. (US 2011/0105866), and further in view of Brown et al. (“Encapsulation of glucose oxidase and an oxygen-quenched fluorophore in polyelectrolyte-coated calcium alginate microspheres as optical glucose sensor systems”).
As to claim 20, Guery teaches a plurality of discrete compartments in a barcode configuration (Fig. 1); wherein a first discrete compartment of the plurality of discrete compartments comprises a glucose-responsive compartment ([0041]). It does not teach that a second discrete compartment of the plurality of discrete compartments comprises a glucose-insensitive compartment; the glucose-responsive compartment comprising glucose-responsive microparticles comprising alginate microparticles for detection of glucose and oxygen; and the glucose-insensitive compartments comprising glucose-insensitive particles comprising alginate microparticles for detection of oxygen.
However, Markle teaches an optical sensor system for detecting glucose in which certain measurement cavities contain a fluorophore system which is sensitive to glucose and another in which the fluorosphore system is glucose insensitive ([0014], [0057], [0072]) and Brown teaches the use of alginate microparticles to encapsulate specific materials (Abstract, p213). Accordingly, it would have been obvious to modify the above combination further with Brown to enable the use of alginate microspheres to encapsulate the glucose-oxidase and increase the stability of the device. Accordingly, it would have been obvious to modify the above combination with Markle and Brown to encapsulate glucose-responsive and glucose-insensitive particles comprising alginate microparticles for detection of oxygen and glucose.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIAN JANG whose telephone number is (571)270-3820. The examiner can normally be reached Monday-Friday (7-3:30 EST).
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CHRISTIAN JANG
Primary Examiner
Art Unit 3791
/CHRISTIAN JANG/Primary Examiner, Art Unit 3791 1/6/26