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 2 - 10 are 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.
In regard to claims 2 - 10, while claims 2 - 10 refer to “the fiber coupled tissue oxygen sensor of claim…”, independent claim 1 refers to the invention as “a fiber coupled tissue oxygen scanner”. It is unclear if claims 2 - 10 are attempting to claim the limitations of the independent claim due to the discrepancy in the named claim elements of a “scanner” and a “sensor”, making the metes and bounds of claims 2 - 10 unclear. Examiner is interpreting the “fiber coupled tissue oxygen sensor” of claims 2 - 10 as the same element as the “fiber coupled tissue oxygen scanner” of claim 1.
In regard to claim 8, claim 8 contains the trademark “Bluetooth”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a method of wireless communication utilized by the device and, accordingly, the identification/description is indefinite. Claim 9 is rejected by virtue of dependence on claim 8.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 9 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
In regard to claim 9, lines 1 - 2 recite “the 2xn optical switch is an mxn optical switch and includes m/2 transmitters and m/2 receivers”. However, claim 1 from which claim 9 depends already specifies that the optical switch is a 2xn optical switch which encompasses an “mxn optical switch that includes m/2 transmitters and m/2 receivers” such that claim 9 is not further limiting.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1 – 10 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 1 recites “wherein light is generated by the transmitter… and received by the other one of the optical fibers of the transmitter-received pair after it is introduced into animal tissue and scattered by that tissue”, which improperly claims “animal tissue” as a part of the fiber coupled tissue oxygen scanner. Examiner recommends amending the claim to -- wherein light generated by the transmitter is configured to be emitted … and configured to be received by the other one of the optical fibers of the transmitter-received pair after it is introduced into animal tissue and scattered by that tissue.--
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1 - 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Moeskops (WO 2009136338 A1).
In regard to claims 1 - 5, Moeskops discloses an optical sensing device for sensing an analyte in the tissue based on the scattering a near infrared (NIR) light (Page 7, lines 9 - 19; Pages 15, line 31 - Page 16, line 5) on a tissue sample (FIG. 8 - 10). The device includes an optical transceiver including a transmitter (FIG. 3, component “Broadband NIR lightsource”) and a receiver (FIG. 3, component “Spectrometer”) in optical communication with a 2xn optical switch (FIG. 3, component “2xn2 fibre switch”) that is in optical communication with a bundle or plurality of optical fibers (Page 12, lines 21 - 26; FIG. 3, see fibers connecting “2xn2 fibre switch” and “nxn matrix”). At a given time, the transmitter is optically connected to one of the optical fibers of the plurality of optical fibers and the receiver is optically connected to another one of the optical fibers of the plurality of optical fibers such that the two optical fibers constitute a transmitter-receiver pair wherein the light generated by the transmitter is emitted from one of the optical fibers of the transmitter-receiver pair and received by the other after the light is introduced into animal tissue and scattered by said tissue (FIGs. 9 & 10; Page 3, lines 4 - 5). The Moeskops further discloses that the two optical fibers of the transmitter-receiver pair are separated by a distance less than 3 cm and more specifically less than or equal to 5 mm (Page 12, lines 31 - 32). While many of the examples given by Moeskops are directed towards glucose measurements in an animal tissue, they additionally disclose that the system is not limited to glucose measurement and is able to measure oxygenated and deoxygenated hemoglobin in tissue where the scattered NIR light is indicative of oxygenated and deoxygenated hemoglobin in tissue (Page 7, lines 9 - 11; FIG. 4 and discussion thereof Page 13, lines 17 - 19). Moeskops further discloses that the system includes a controller (FIG. 3, component “Controller”) that is configured to control the sequential light transmission and reception of light to a plurality of transmitter-receiver pairs of optical fibers, one pair at a time where the pattern includes alternating columns of transmitter and receiver fibers (FIG. 9 & 10; page 3, lines 4 - 5).
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.
Claims 6 - 7 & 10 are rejected under 35 U.S.C. 103 as being unpatentable over Moeskops (WO 2009136338 A1) as applied to claim 5 above, and further in view of Kashyap (US 7884933 B1).
In regard to claims 6 - 7, Moeskops discloses the invention of claim 5. While Moeskops discloses a sensing device that comprises a controller (FIG. 3, component “controller”) that can include a computer system for carrying out measurements and processing signals, including wireless signals (Page 6, line 6 - Page 7, line 4), they do not specify that the scanner comprises communications circuitry for communicating oxy- and deoxy- hemoglobin indications to another system or that the communications occur wirelessly.
However, Kashyap teaches that a sensor system for optically determining analyte concentrations (FIG. 2) can include a controller (FIG. 2, component 28) that can wirelessly communicate with another system (FIG. 2, component 24) to transmit measurement results, including oxy- and deoxy- hemoglobin indications (column 15, lines 7 - 20), processed by the controller (Column 6, lines 17 - 29).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date to have modified the system disclosed by Moeskops with the teachings of Kashyap that a controller can wirelessly communicate with another system because Moeskops discusses the use of a controller that processes signals, including wireless signals, such that modifying the controller disclosed by Moeskops with the teachings of Kashyap would be considered combining prior art elements according to known methods to yield predictable results.
In regard to claim 10, Moeskops as modified discloses the invention of claim 6. Moeskops further discloses that the scanner includes a 2D matrix of illumination and collection optical fibers (FIG. 3, see “nxn matrix”) where the pattern of the applied light and collection is modified by the controller and optical switch (FIG. 3, components “Controller” and “2xn2 fibre switch”) without physically moving the location of the fibers (Page 12, lines 21 - 26).
Claims 8 - 9 are rejected under 35 U.S.C. 103 as being unpatentable over Moeskops (WO 2009136338 A1) in view of Kashyap (US 7884933 B1) as applied to claim 7 above, and further in view of Goldstein (US 20170112671 A1).
In regard to claim 8, Moeskops as modified discloses the invention of claim 7. While Kashyap teaches that a controller of a sensor system for measuring oxy- and deoxy- hemoglobin indications can wirelessly communicate measurement results with another system, they do not specify the use of radio communications such as the use of Bluetooth to communicate the oxy- and deoxy- hemoglobin indications to another system.
However, Goldstein teaches that data from sensors, including optical sensors configured for pulse oximetry measurements, can be transmitted wirelessly using appropriate wireless modules and communication protocols including Bluetooth (paragraph [0064]; FIG. 1A, components 6A).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date to have modified the system disclosed by Moeskops as modified with Kashyap that includes the wireless communication of sensor results to another system with the teaching of Goldstein that the wireless communication can include Bluetooth communications because Moeskops as modified already contemplates wireless communication such that further modification with the teachings of Goldstein would be considered combining prior art elements according to known methods to yield the predictable results of communicating sensor measurements between devices.
In regard to claim 9, Moeskops as modified discloses the invention of claim 8. Moeskops further discloses a 2xn optical switch (FIG. 3, component “2xn2 fibre switch”) which includes 1 transmitter (FIG. 3, component “Broadband NIR lightsource”) and 1 receiver (FIG. 3, component “Spectrometer”).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SIENNA CHRISTINE PYLE whose telephone number is (703)756-5798. The examiner can normally be reached 8 am - 5:30 pm M - T; Off first Fridays; 8 am - 4 pm second Fridays.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor, II can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIC F WINAKUR/Primary Examiner, Art Unit 3791
/S.C.P./Examiner, Art Unit 3791
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