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 .
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 20 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.
As to claim 20, “the one or more signals” is recited in the penultimate line of the claim. There is insufficient antecedent basis for this term, rendering the claim indefinite.
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.
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.
Claim(s) 1-4, 6-8, 10, 12-16, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2008/0319287 A1 to Gross et al. (“Gross”) in view of US 2007/0191702 A1 to Yodfat et al. (“Yodfat”).
As to claim 1, Gross discloses a wearable device (“device 10”; [0150]) for use in monitoring physiological changes in the patient (“detecting a concentration of a substance in a subject”; [0150]), comprising:
a housing adapted to being secured to a patient's body (see [0072], [0156], and [0170]),
a chamber situated within the housing (see Fig 1, element 24), the chamber comprising a biological sensing component comprising one or more living cells configured to respond to physiological changes in the bodily fluid by emitting fluorescence;
an electronic component comprising a light source (see Fig 1, element 28) configured to direct light toward the biological sensing component to induce emission of the fluorescence (see [0153] – “For some applications, the FRET protein further comprises a leading peptide that directs the protein to the cell membrane, such as represented by Sequence No. 2”) and [0156] – “For other applications, the FRET protein remains within chamber 24 while FRET measurements are made thereof. For example, cells 26 and the FRET protein may be configured such that the FRET protein remains contained within cells 26 in chamber 24.”; see also [0150]-[0151] showing the changes being glucose); and
a reader for detecting and/or decoding the emitted fluorescence to monitor physiological changes in the patient (see Fig 1, element 30).
Gross, however, fails to explicitly teach that the device is wearable and comprises a housing comprising a needle configured for insertion into the patient subcutaneously or intraveneously and configured for fluid communication with a bodily fluid under a skin surface.
Yodfat teaches a wearable device (“closed loop system 100”; [0050]-[0054]) with a housing (“housing 110”; 0050, FIG. 1) adapted to being secured to a patient's body (“attached to a patient’s skin”; [0050]), wherein the housing comprises a needle (“cannula 108”; [0050]-[0054], FIG. 1 and Fig 2, element 204 and Fig 6, elements 610 and 612) configured for fluid contact with a bodily fluid under a skin surface (“penetrate the skin and allows fluid delivery”; [0050]). Yodfat is considered to be analogous to the claimed invention because it is in the same field, namely a device that monitors physiological changes in a patient (“sensing and detection of the concentration level of the analyte”; Abstract). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have modified the system of Gross to utilize a wearable device and extend the properties of the housing to comprise a needle configured for fluid contact with a bodily fluid under a skin surface because Gross recognizes the use of tubes with fluid contact to a bodily fluid under the skin surface (“tubes 222”; [0184]), Yodfat recognizes that a needle can be multi-functional ( [0090]) and Gross further explicitly states that variations of the invention are not limited to those enclosed ([0186]).
As to claim 2, Gross further discloses wherein the device is capable of substantially continuous monitoring (see [0155]).
As to claim 3, Gross teaches the device as discussed above in claim 1. While Gross successfully anticipates the wearable device (“device 10”; 0150) for use in monitoring physiological changes in the patient (“detecting a concentration of a substance in a subject”; 0150) that comprises a housing that is adapted to being secured to a patient’s body (“first membrane 40”; 0156), Gross fails to explicitly anticipate that the housing is secured to the patient's body with a removable element.
Yodfat teaches a device (“closed loop system 100”; [0050]) with a housing (“housing 110”; [0050]), wherein the housing is secured to the patient's body with a removable element (adherable patch; [0026], FIG. 1). Yodfat is considered to be analogous to the claimed invention because it is in the same field, namely a device that monitors physiological changes in a patient (“sensing and detection of the concentration level of the analyte”; Abstract). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have modified the system of Gross to extend the properties of the housing to secure to the patient’s body with a removable element because Gross teaches alternatives for the housing (“alternatively, the cells are held directly in housing 20…”; [0154]), and Gross further explicitly states that variations of the invention are not limited to those enclosed ([0186]).
For claim 4, Gross teaches the device as discussed above in claim 3. While Gross successfully anticipates the wearable device (“device 10”; [0150]) for use in monitoring physiological changes in the patient (“detecting a concentration of a substance in a subject”; [0150]) that comprises a housing that is adapted to being secured to a patient’s body (“first membrane 40”; [0156]), Gross fails to explicitly anticipate that the housing is secured to the patient's body with a removable element that is an adhesive tape.
Yodfat teaches a device (“closed loop system 100”; [0050]) with a housing (“housing 110”; [0050]), wherein the housing is secured to the patient's body with a removable element that is an adhesive tape (adherable patch; [0026], FIG. 1). Yodfat is considered to be analogous to the claimed invention because it is in the same field, namely a device that monitors physiological changes in a patient (“sensing and detection of the concentration level of the analyte”; Abstract). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have modified the system of Gross to extend the properties of the housing to secure to the patient’s body with a removable element because Gross teaches alternatives for the housing (“alternatively, the cells are held directly in housing 20…”; [0154]), and Gross further explicitly states that variations of the invention are not limited to those enclosed ([0186]).
As to claim 6, Gross further discloses wherein the biological sensing component comprises a plurality of living cells (see [0154]).
As to claim 7, Gross further discloses wherein the chamber further comprises a first membrane (“chamber 24”; [0156]) and a second membrane on either side of the biologic biological sensing component (second membrane 42; [0156]).
As to claim 8, Gross further discloses wherein the first membrane is a non-porous membrane (see [0156]).
As to claim 10, Gross further discloses wherein the second membrane is a porous membrane that allows for select fluid and nutrients to pass to the biological sensing component (see [0156]).
As to claim 12, Gross further discloses wherein the electronic component comprises an excitation source configured to stimulate the biological sensing component (see Fig 1, element 28).
As to claim 13, Gross fails to disclose wherein the chamber further comprises a microfluid pump for pumping fresh fluid over the biological sensing component.
Yodfat teaches a device (“closed loop system 100”; [0050]) with a chamber (“apparatus”; [0026]) wherein the chamber further comprises a microfluid pump (“pump”; [0026]) for pumping fresh fluid over the cells (“e.g., a therapeutic fluid such as insulin, a non-therapeutic fluid such as saline, or a combination thereof”; [0026]). Yodfat is considered to be analogous to the claimed invention because it is in the same field, namely a device that monitors physiological changes in a patient (“sensing and detection of the concentration level of the analyte”; Abstract). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have modified the system of Gross to extend the properties of the chamber to further comprise a pump to pump fresh fluid over to the cells because Gross does mention the use of a pump to drive blood serum ([0164]) and Gross further explicitly states that variations of the invention are not limited to those enclosed ([0186]).
As to claim 14, Gross further discloses wherein the chamber further comprises a waste fluid chamber (see [0156]).
As to claim 15, Gross further discloses wherein the waste fluid chamber receives and stores the fluid after it has passed over the biological sensing component ([0156]).
As to claim 16, Gross fails to disclose wherein the device is capable of engaging in a two-way communication through transmission of one of more signals with a second device.
Yodfat teaches a device (“closed loop system 100”; [0050]), wherein the device is capable of engaging in a two-way communication through transmission of one of more signals with a second device (“user control unit”; [0051]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have modified the system of Gross to extend the capabilities of the device to engage in two-way communication through the transmission of one or more signals with a second device because Gross already engages in one-way communication through the transmission of one or more signals with a second device (raw or processed data transmitted to electronic device; [0167]); Yodfat recognizes that two-way communication allows for simultaneous data processing and device control ([0051]); Yodfat recognizes that receiving input can help refine the actions of the device ([0033]); Yodfat recognizes that communication to a second device can allow for remote or direct programming and/or data programming ([0051]); and Gross further explicitly states that variations of the invention are not limited to those enclosed ([0186]).
Claim 20 is rejected for the reasons laid out in the treatment of claim 1, with method aspects being changed as necessary.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Gross in view of Yodfat as applied to claim 1 above, and further in view of US 2004/0191119 A1 to Zanzucchi et al. (“Zanzucchi”).
For claim 9, Gross fails to explicitly teach that the first membrane is made from glass.
Zanzucchi teaches a device (“assay pad construction 1200”; FIG. 12) wherein the first membrane (“component 1204”; [0074]) is made from glass (“glass fibers”; [0074]). Zanzucchi is considered to be analogous to the claimed invention because it is in the same field, namely a device (“assay pad construction 1200”; FIG. 12) for monitoring physiological changes in a subject (“detection of the presence and/or concentration of an analyte”; Abstract).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have modified the system of Gross to adjust the properties of the device such that the first membrane was composed of glass because glass is a material that can be used for properties as a selectively permeable medium as Zanzucchi recognizes ([0074]); Gross recognizes the properties of a membrane in multiple other sources (low-conductivity, impedance, and semi-permeable; [0013]-[0016], [0023], [0025], [0027], [0028], [0033], [0037], [0038]); Gross specifically teaches that that there are multiple suitable membrane materials ([0073]); and Gross further explicitly states that variations of the invention are not limited to those enclosed ([0186]).
Claims 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Gross in view of Yodfat as applied to claim 1 above, and further in view of US 2006/0217636 A1 to Braig et al. (“Braig”).
As to claims 17-18, Gross fails to disclose wherein the device further comprises a temperature sensor for monitoring temperature changes within the device, wherein the device further comprises a temperature controller for adjusting the temperature within the device to a desired parameter.
Braig teaches a device (“apparatus”; 0005) that comprises a temperature sensor (“one or more temperature sensors”; 0343) for monitoring temperature changes in the cells (0207) and a temperature controller for adjusting the temperature to a desired parameter ([0207]). Braig is considered to be analogous to the claimed invention because it is in the same field, namely a device (“apparatus”; [0005]) for monitoring physiological changes in a subject (temperature, [0207]). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have extended the capabilities of the system of Gross to monitor temperature changes in the cells because Gross already utilizes temperature as a parameter to monitor physiological change (“glucose levels”; [0077]), which inherently requires a temperature sensor; Gross already recognizes how temperature can monitor physiological changes ([0077]) and Braig recognizes that controlling temperature can be advantageous to prevent changing controlled properties ([0207]); and Gross further explicitly states that variations of the invention are not limited to those enclosed ([0186]).
Response to Arguments
Applicants’ arguments filed June 29, 2026 have been fully considered but they are not persuasive.
Applicants argue that the amendments define over the applied art because Gross fails to disclose a biological sensing component comprising one or more living cells configured to respond to physiological changes in the bodily fluid by emitting fluorescence and an electronic component comprising a light source configured to direct light toward the biological sensing component to induce emission of the fluorescence.
Examiner respectfully disagrees. As to the latter point, the laser is explicitly disclosed. As to the former, the cells of Gross are genetically engineered to produce a fluorescence resonance energy transfer (FRET) protein acceptor and donor, which is a fluorescent phenomenon wherein binding of the substance (here, glucose), changes the distance between the donor and acceptor, thereby changing the fluorescence emitted by the protein. Gross further specifies that these proteins may be expressed at the membrane layer. In other words, they appear to be part of the cell and conform to the language of the claim.
Applicant further argues that there is no direction, suggestion, or reasoning provided for making such a drastic change to the Gross or Yodfat references that would allow them to monitor physiological changes in a patient on the cellular level by detecting and/or decoding the emitted fluorescence.
Examiner respectfully disagrees with Applicants’ characterization of the modification of Gross. The sensing device of Yodfat is sufficiently analogous to the sensing device of Gross that any gap between the two is predictably bridged by the knowledge of one of ordinary skill in the art as to amount to the application of a known technique (the use of a cannula/needle connected to a measurement chamber) to a known device (a sensing chamber with cells having fluorescent activity in the presence of glucose) that is ready for improvement to yield the predictable result that is a wearable device that does not require total implantation.
For these reasons, the claims remain rejected.
Conclusion
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 Eric Messersmith whose telephone number is (571)270-7081. The examiner can normally be reached M-Tu, 8:30 am - 5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JACQUELINE CHENG can be reached at 571-272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIC J MESSERSMITH/ Primary Examiner, Art Unit 3791
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