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.
Claims 9, 14, 18, and 23 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 18, the claim now reads, “wherein the signals are transmitted with the signals having a frequency in a range of approximately 1x 10-8 to 1X 10-1Hz.” Examiner assumes that this means 1x10-8 to 1x10-1 Hz. It is not clear what is intended given that light may have a wavelength in this range, but not a frequency. It is understood as applying to a wavelength (1x10-8 to 1x10-1 m) instead of a frequency.
As to claims 9 and 14, there is no longer antecedent basis for the term “the cell layer” in the claims. For purposes of examination, it is understood as “a cell layer of the biological component.”
As to claim 23, “the disease or condition” lacks antecedent basis in the claims. Neither claim 21 nor claim 1 recites a disease condition. For purposes of examination, it will be understood as “a disease or condition.”
Claim Objections
Claim 1 objected to because of the following informalities: It appears that the phrase “the emitted fluorescence from the biological component signals” in lines 13-14 of the claim should be changed to “the emitted fluorescence from the biological component”. Appropriate correction is required.
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) 1-2, 4, 6, 14-15, 21, and 23-25 are rejected under 35 U.S.C. 103 as being unpatentable over US 2010/0202966 A1 to Gross et al. (“Gross”) in view of US 2007/0249007 A1 to Rosero (“Rosero ‘007”).
As to claim 1, Gross discloses an implantable device for use in monitoring physiological changes in the patient (implantable device 10 for detecting a concentration of analyte in a subject, Figure 1, paragraph [0141]), the device comprising:
a vessel adapted to being implanted into any one of an intravascular space, an extravascular space, and a perivascular space, within a patient’s body (implantable device 10 comprises a housing 20, paragraph [0141]; the housing may be implanted inside bone of the patient, and extravascular space, paragraphs [0130], [0132]);
a chamber situated within the vessel, the chamber comprising a biological component comprising one or more cells, and adapted to being secured to the vessel (chamber 24 holds cells 26 within a membrane 42, Figure 1, paragraph [0142]) and capable of being secured to the vessel (see Figure 1, where chamber is secured to housing 20), wherein the one or more cells are pre-positioned on or in the device prior to implantation (cells 26 are in chamber 24 before the apparatus is implanted in the subject, Figure 1, abstract , [0142], [0158]) and wherein the pre-positioned cells are adapted to respond to a physiological signal from the patient by emitting fluorescence (cells 26 produce fluorescent sensor proteins in response to the analyte; see [0138], [0141], [0154]-[0155]);
a light source for shining light onto the biological component, thereby causing one or more of the pre-positioned cells to emit fluorescence (light source 28 illuminates cells 26 in membrane 42, see [0144], [0146], [0149]), wherein the emitted fluorescence is indicative of one or more physiological changes in the patient (see [0141], [0154]-[0155]);
a reader for detecting and/or decoding the emitted fluorescence from the biological component signals to monitor physiological changes in the patient optical detector 30 receives optical signal from cell layer to send to signal processor to determine concentration of analyte in patient, Figure 2, abstract, paragraphs [0141], [0143]) and for transmitting an electromagnetic radiation signal to an external receiver (device 50 comprises a transmitter 90, which wirelessly transmits the collected data to electronic receiving apparatus 132, such as a watch with receiving capabilities, a personal computer, a cellphone or a PDA, paragraph [0159]), wherein the external receiver detects and decodes the transmitted electromagnetic radiation signal and, in response, subsequently triggers an adjustment in drug delivery from a second device implanted within the patient's body, wherein the second device is capable of drug delivery (the receiving apparatus translates the raw data into concentration data and is coupled to a drug-delivery unit 130, such as an insulin pump, which supplies insulin to the body in response to the level of the analyte determined by the device, see [0160]).
Gross fails to explicitly disclose that the second device is implanted within the patient’s body.
However, in a similar invention, Rosero ‘007 discloses an implantable biological chip device in which cells produce a fluorescent protein in response to glucose, which is detected by a photodetector and excitation array (see [0032], [0098]), and in which data is transferred via wireless communication to an implantable or external insulin delivery system (see [0072] and [0099]– “Insulin delivery, for example, may be from an external insulin pump, an implantable insulin pump, or from a second portion of an implanted device that has a biological materials component adapted to produce insulin.”). In this way, Rosero ‘007 identifies implantable and external insulin pumps as being interchangeable alternatives (see above). It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to substitute the external insulin pump of Gross for the implantable one of Rosero ‘007 in order to achieve the predictable result of delivering the drug without requiring the user to wear an external pump.
As to claim 2, Gross further discloses the vessel is tubular, rectangular, square, or any other shape (see Figure 3-4, where device 100 is cylindrical in shape).
As to claim 4, Gross further discloses wherein the chamber comprises a body adapted to being secured to the vessel (see Figure 1, where chamber 24 is secured to housing 20).
As to claim 6, Gross further discloses wherein the biological component comprises a cell layer having one or more cells pre-positioned on or in the device prior to implantation (chamber 24 holds cells 26 within a membrane 42, where cells 26 are in chamber 24 before apparatus is implanted in subject, Figure 1, abstract, paragraph (0142]).
As to claim 14, Gross further discloses wherein the light source shines light onto the cell layer thereby causing one or more cells within the cell layer to emit fluorescence (light source coupled to wall of chamber 24 to emit light in a steady-state mode to cells 26 within membrane 42, paragraphs [0141], [0146], [0149]) thereby causing certain cells within the cell layer to emit light (cells 26 produce sensor proteins, can be fluorescent proteins that are detected by optical detector 30, paragraphs [0141], [0154]-[0155]).
As to claim 15, Gross discloses the device of claim 1. Gross further discloses wherein the device is capable of wireless communication (device 10 can comprise a transmitter 90 to transmit data wirelessly, paragraph ([0159]).
As to claim 21, Gross discloses the device of claim 1. Gross discloses wherein the signals measure blood pressure, ECG, heartrate, body temperature, glucose levels, gene and protein changes, local cellular changes that reflect systemic disease or change in health status or combinations thereof (optical detector 30 sends signal to determine indication concentration of analyte in chamber 24, and thus analyte concentration in subject, such as a glucose level of the subject, Figure 2, abstract, paragraphs (0058]-[0059], [0143]).
As to claim 23, Gross further discloses wherein the receiver compares the signal to a reference signal to diagnose the disease or condition ([0160] – this is inherently done in order to translate the received signal into glucose concentrations).
As to claims 24-25, Gross further discloses wherein the receiver decodes the signal to trigger an event, wherein the event may include adjusting the patient’s medical treatment (see [0160] – in the event of hyperglycemia, the receiver may trigger the release of insulin).
Claims 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gross in view of US 7,163,825 B2 to Gault ("Gault").
As to claim 8, Gross discloses the device of claim 1. Gross further discloses the chamber (chamber 24, paragraph [0141]) and a biologic component (cells 26, paragraph [0141]) but fails to disclose wherein the chamber further comprises a first membrane and a second membrane on either side of the biologic component.
Gault discloses wherein the chamber further comprises a first membrane and a second membrane on either side of the biologic component (culture chamber is defined as between two walls, where there is a cell culture space to hold thin layers of cells, abstract, claim 1 ). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gross to include wherein the chamber further comprises a first membrane and a second membrane on either side of the biologic component, as taught by Gault, because having membranes on either side of the biologic component provides an environment in which can promote cell adhesion, and thus promote its functionality.
As to claim 9, Gross in view of Gault discloses the device of claim 8.
Gross fails to disclose wherein the first membrane is a non-porous membrane on which the cell layer is pre-positioned.
Gault discloses wherein the first membrane is a non-porous membrane on which the cell layer is pre-positioned (culture chamber is defined as between two walls, where wall can be glass, where there is a cell culture space to introduce thin layers of cells, abstract, claims 1, 5). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gross to include wherein the first membrane is a non-porous membrane on which the cell layer is pre-positioned, as taught by Gault, because having a non-porous membrane can prevent the cells from dispersing their biological products through that particular wall, allowing control of where the biological products do travel through.
As to claim 10, Gross in view of Gault discloses the device of claim 8. Gross fails to disclose wherein the first membrane is made from glass.
Gault discloses wherein the first membrane is made from glass (walls of culture chamber can be glass, claim 5). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gross to include wherein the first membrane is made from glass, as taught by Gault, because glass is biocompatible, which will not negatively affect the cell culture.
Claims 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gross in view of Rosero ‘007, and further in view of US 2018/0085038 A1 to Chen et al. (“Chen”).
As to claims 16-20, neither Gross nor Rosero ‘007 discloses wherein the device is capable of engaging in a two-way communication through transmission of one of more signals through at least a portion of the patient’s body, wherein the two-way communication includes transmitting and receiving electromagnetic radiation signals, wherein the signals are transmitted with the signals having a wavelength in a range of approximately 1x 10-8 to 1X 10-1Hz, wherein the electromagnetic radiation signals include infrared, visible light, radio waves, microwaves, ultraviolet, X-rays, gamma rays, ultrasonic signals or combinations thereof, wherein the electromagnetic radiation signals travel through the body with minimal interference from the surrounding tissues or organs.
However, in a similar device, Chen discloses a device capable of engaging in a two-way communication through transmission of one of more signals through at least a portion of the patient's body, wherein the two-way communication includes transmitting and receiving electromagnetic radiation signals, wherein the signals are transmitted with the signals having a wavelength in a range of approximately 1x 10-8 to 1X 10-1 m, wherein the electromagnetic radiation signals include infrared, visible light, radio waves, microwaves, ultraviolet, X-rays, gamma rays, ultrasonic signals or combinations thereof, wherein the electromagnetic radiation signals travel through the body with minimal interference from the surrounding tissues or organs (see [0026]-[0027]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Gross with the transceiver capable of two-way communication as shown by Chen in order to achieve the predictable result of allowing the device to both communicate its analyte values while also updating the device’s firmware if problems arise after implantation.
Claims 11 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Gross in view of Rosero’007 and Gault, and further in view of US 7,892,222 B2 to Vardi et al. (“Vardi”).
As to claim 11, neither Gross, Rosero ‘007, nor Gault discloses wherein the first membrane is adjacent to the light source.
Vardi discloses wherein the first membrane is adjacent to the light source (see Figure 18, where first membrane of inner membrane 110 is adjacent to optical fiber 148, column 4, lines 56-58).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gross to include wherein the first membrane is adjacent to the light source, as taught by Vardi, because having the light adjacent to the first membrane ensures that cells receive the optical light needed to evaluate their status.
As to claim 13, Gross fails to disclose wherein the second membrane is distal to the light source.
Vardi discloses wherein the second membrane is distal to the light source (see Figure 18, where second membrane of inner membrane 110 is distal to the optical fiber 148, where second membrane is closest to functional cells 120).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gross to include wherein the second membrane is distal to the light source, as taught by Vardi, because having the second membrane distal to the light source would ensure that the light is coming from one direction.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Gross in view of Rosero ’007 and Gault, and further in view of US 5,713,888 A to Neuenfeldt et al. (“Neuenfeldt”).
As to claim 12, neither Gross, Rosero ‘007, nor Gault discloses wherein the second membrane is a porous membrane that allows for select fluid and nutrients to pass to the biological component. Neuenfeldt discloses wherein the second membrane is a porous membrane that allows for select fluid and nutrients to pass to the cell layer (second porous wall element 34 associates with the host's biological system closely enough to transfer nutrients and wasted in support of the biological processes of the implanted cells, and allows therapeutic products generated by the implanted cell 12 to the host, column 5, lines 33-38).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gross to include wherein the second membrane is a porous membrane that allows for select fluid and nutrients to pass to the cell layer, as taught by Neuenfeldt, because having a porous membrane allows nutrients to pass through to improve the chance of cell viability.
Response to Arguments
Applicants’ arguments with respect to the pending claim(s) have been considered but are moot because in view of the new grounds of rejection.
Conclusion
Applicants’ amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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, 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
