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 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 17-20 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 17 (18-20 by dependency) recites “wherein the at least one optical filter comprises a third optical property having respective fifth and sixth values in response to the third and fourth values of the second optical property”. It is unclear what this limitation means. It is unclear what the third and fourth values of the second property are and what relationship they have with the fifth and sixth values of the third property. Examiner is unable to understand/interpret what is being claimed here, and thus no prior art rejection is being made for this claim and its dependents. Examiner suggests amending the claim to specify what the properties and associated values are and their relationship between other properties and values.
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) 1-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over McMaster et al. (US 2019/0069785 A1 – cited by Applicant), hereinafter McMaster in view of Schoendorfer (US 5438984 A).
Regarding Claim 1, McMaster teaches: A dressing system for sensing a presence of an analyte (paragraph 0026), the dressing system comprising:
a first layer comprising a first major surface and a second major surface opposite to the first major surface (figure 2), wherein the first layer has a first permeability to the analyte (every material has a permeability; paragraph 0079);
a second layer facing the first major surface of the first layer (figure 2), wherein the second layer has a second permeability to the analyte (every material has a permeability; paragraph 0079);
a first fiber at least partially disposed between the first layer and the second layer, wherein the first fiber is configured to deliver an excitation light (element 26; figure 2; paragraph 0067);
at least one sensor layer comprising a sensor material disposed between the first layer and the second layer (element 64), wherein the at least one sensor layer is configured to receive the excitation light from the first fiber and emit an emitted light in response to the excitation light, wherein the emitted light comprises a first optical property sensitive to the presence of the analyte (paragraph 0069); and
a second fiber separate from the first fiber and disposed between the first layer and the second layer, wherein the second fiber is configured to receive the emitted light from the at least one sensor layer (element 28).
McMaster does not mention that the permeability of the second layer is less than the first permeability of the first layer.
Schoendorfer teaches the use of a dermal patch to collect analytes for analysis containing different levels of permeability (col 7 – col 8). Examiner notes that it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the system to include that the permeability of the second layer is less than the first permeability of the first layer in order to control the movement and collection of analyte molecules for sensing.
Regarding Claim 2, McMaster in view of Schoendorfer teach: The dressing system of claim 1, but do not mention wherein the first permeability is greater than the second permeability by a factor of at least 2. It would have been obvious to one of ordinary skill in the art, before the effective filing date to have modified the system wherein the first permeability is greater than the second permeability by a factor of at least 2 as this would be a matter of routine optimization to arrive at a state that allows for sufficient permeation of the analyte towards to sensing area.
Regarding Claim 3, McMaster in view of Schoendorfer teach: The dressing system of claim 1, further comprising an adhesive layer disposed on the second major surface of the first layer and comprising an adhesive material (McMaster – paragraph 0079; Schoendorfer – col 7 – col 8).
Regarding Claim 4, McMaster in view of Schoendorfer teach: The dressing system of claim 3, wherein the adhesive layer has a third permeability to the analyte greater than or equal to the first permeability of the first layer (Schoendorfer implies that adhesive layer has the same permeability – col 7 – col 8 ).
Regarding Claim 5, McMaster in view of Schoendorfer teach: The dressing system of claim 3, wherein the adhesive layer has a third permeability to the analyte (Schoendorfer implies that adhesive layer has the same permeability – col 7 – col 8), but does not mention explicitly wherein the third permeability is greater than the second permeability by a factor of at least 1.5. It would have been obvious to one of ordinary skill in the art, before the effective filing date to have modified the system wherein the third permeability is greater than the second permeability by a factor of at least 1.5 as this would be a matter of routine optimization to arrive at a state that allows for sufficient permeation of the analyte towards to sensing area.
Regarding Claim 6, McMaster in view of Schoendorfer teach: The dressing system of claim 1, further comprising a light source optically coupled to the first fiber and configured to emit the excitation light (McMaster – paragraph 0012).
Regarding Claim 7, McMaster in view of Schoendorfer teach: The dressing system of claim 1, wherein the first fiber comprises at least one light emitting region disposed between the first layer and the second layer and configured to emit the excitation light (figure 2; McMaster - paragraph 0065).
Regarding Claim 8, McMaster in view of Schoendorfer teach: The dressing system of claim 1, wherein the first fiber comprises a fiber body, at least one electrical conductor disposed within the fiber body and extending at least partially along a length of the fiber body, and at least one light emitting device electrically connected to the at least one electrical conductor and configured to emit the excitation light in response to an electrical current (McMaster – paragraph 0065-0070).
Regarding Claim 9, McMaster in view of Schoendorfer teach: The dressing system of claim 8, further comprising a current source electrically coupled to the at least one electrical conductor and configured to supply the electrical current to the at least one light emitting device via the at least one electrical conductor (McMaster – paragraph 0065, 0080, 0081, 0102).
Regarding Claim 10, McMaster in view of Schoendorfer teach: The dressing system of claim 9, wherein the current source is at least one of a battery, a capacitor, a wearable nanogenerator, and a wireless charging circuit (McMaster - paragraph 0085; official notice is taken that it is well known that a power source for a control unit can be a battery).
Regarding Claim 11, McMaster in view of Schoendorfer teach: The dressing system of claim 1, wherein the second fiber comprises at least one light receiving region disposed between the first layer and the second layer and configured to receive the emitted light from the at least one sensor layer (McMaster - figure 1 and 2).
Regarding Claim 12, McMaster in view of Schoendorfer teach: The dressing system of claim 1, further comprising a light detector optically or electrically coupled to the second fiber and configured to receive an optical signal or an electrical signal corresponding to the emitted light (McMaster – figure 2).
Regarding Claim 13, McMaster in view of Schoendorfer teach: The dressing system of claim 12, wherein the light detector comprises at least one of a photodetector, a camera, a spectrometer, a multimeter, and an oscilloscope (McMaster – figure 2).
Regarding Claim 14, McMaster in view of Schoendorfer teach: The dressing system of claim 1, wherein the first optical property is at least one of an optical intensity of the emitted light, a photoluminescence lifetime of the emitted light, and a wavelength of the emitted light (McMaster - paragraph 0069).
Regarding Claim 15, McMaster in view of Schoendorfer teach: The dressing system of claim 1, wherein the emitted light comprises the first optical property having a first value in an absence of the analyte and the emitted light comprises the first optical property having a second value in the presence of the analyte, and wherein the first value is different from the second value (McMaster - figures 7b, 8 11).
Regarding Claim 16, McMaster in view of Schoendorfer teach: The dressing system of claim 1, wherein the excitation light comprises a second optical property different from the first optical property and having a third value, and wherein the emitted light comprises the second optical property having a fourth value different from the third value (Examiner notes that light inherently comprises multiple optical properties, such as wavelength, frequency, intensity amplitude etc.).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Bremer - CN 110300564 A; Evans et al. WO 2015006015 A1; Schoendorfer - US 5441048 A all discuss permeability of different layers.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAY B SHAH whose telephone number is (571)272-0686. The examiner can normally be reached M-F 8-5.
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JAY SHAH
Primary Examiner
Art Unit 3791
/JAY B SHAH/Primary Examiner, Art Unit 3791
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