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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 36-55 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 36 recites and “entry point location system”. The claim is broadly written that it encompasses an entry point for any and all objects/things whereas the Specification specifically mentions an entry point for inserting a needle into a bone of a subject.
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 36-55 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.
Claim 36 (rest by dependency) recites and “entry point”. An entry point for what? And into where? The scope of the claim is unclear.
Claim 36 (rest by dependency) recites “reversible attachment”. It is unclear what this means.
Claims 36-55 recite either “the plurality of sensors”, “ the plurality of spaced apart sensors” or “the sensors”. It is unclear if there is a different. Examiner requests the same convention be used throughout the claims.
Claim 38 recites “the skin facing” and “the skin”. There is insufficient antecedent basis for this limitation.
Claim 38 recites “a patient”. Examiner notes that Claim 36 already refers to “a patient”. Is Applicant referring to the same patient? Or another one?
Claim 39 recites “the patella”. There is insufficient antecedent basis for this limitation.
Claim 39 recites “the tibial tuberosity”. There is insufficient antecedent basis for this limitation.
Claim 39 recites “the knee”. There is insufficient antecedent basis for this limitation.
Claim 46 recites “the horizontal lines”. There is insufficient antecedent basis for this limitation.
Claim 46 recites “the determined entry point”. There is insufficient antecedent basis for this limitation.
Claim 47 recites “the same horizontal line as the alignment means”. There is insufficient antecedent basis for this limitation.
Claim 49 recites “the sensor device”. There is insufficient antecedent basis for this limitation.
Claim 51 (52-55 by dependency) recites “the strain”. There is insufficient antecedent basis for this limitation.
Claim 51 (52-55 by dependency) recites “the device”. There is insufficient antecedent basis for this limitation.
Claim 51 (52-55 by dependency) recites “the user”. There is insufficient antecedent basis for this limitation.
Claim 51 (52-55 by dependency) recites “two bending configurations”. It is unclear what this means in the context of the claims.
Claim 51 (52-55 by dependency) recites “approximating to zero”. It is unclear what this means in the context of the claims.
Claim 51 (52-55 by dependency) recites “the at least one sensors”. There is insufficient antecedent basis for this limitation. Examiner notes that Claim 36 recites “the sensors”.
Claim 54 refers to two claims – it is unclear what the scope of the claim is.
Claim 54 refers to claim 16, which has been canceled.
Claim Rejections - 35 USC § 102
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.
Claim(s) 36-45 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Foppen et al. (US 2014/0323856 A1 – cited by Applicant), hereinafter Foppen.
Regarding Claim 36, Foppen teaches: An entry point location system (figure 1) comprising:
a device comprising a plurality of spaced apart sensors for external reversible attachment to a patient at a target site (paragraph 0022-0023; figure 1), wherein the sensors are configured to transmit sensed data (paragraph 0029-0032); and
a computing device (module 15; paragraph 0019-0022; 0029; figure 1);
wherein the sensors are in communication with the computing device (paragraph 0022; 0029) and the computing device is configured to receive the data from the sensors and use the data to calculate the location of an entry point (paragraph 0028-0029).
Regarding Claim 37, Foppen teaches: The location system of claim 36, wherein each of the plurality of sensors comprises a load cell for measuring load or displacement, and/or a bridge resistor for measuring strain (paragraph 0022-0029; 0048).
Regarding Claim 38, Foppen teaches: The location system of claim 36, wherein the plurality of spaced apart sensors are disposed longitudinally on the skin facing side of a patch, and, wherein the patch comprises an adhesive on the skin facing side of the patch for detachable attachment to the skin of a patient (figures 1-3; paragraph 0047).
Regarding Claim 39, Foppen teaches: The location system of claim 38, wherein the patch is sized and shaped to be placed on the knee, such that the plurality of spaced apart sensors are disposed between about the patella to below the tibial tuberosity (paragraph 0017; all areas of body).
Regarding Claim 40, Foppen teaches: The location system of claim 36, wherein the computing device is at least one of a computer, a microcomputer, a smartphone, a tablet and a smartwatch (paragraph 0019-0020).
Regarding Claim 41, Foppen teaches: The location system of claim 36, wherein the plurality of sensors are coupled by wires to the computing device, or wherein the plurality of sensors are coupled wirelessly to the computing device (Examiner is taking Official notice this it is known that sensors need to be wired/wirelessly connected to the computer).
Regarding Claim 42, Foppen teaches: The location system of claim 41, wherein the sensor device comprises an attachment component for coupling to the computing device for facilitating communication from the plurality of sensors to the computing device, optionally wherein the computing device powers the plurality of spaced apart sensors (paragraph 0022).
Regarding Claim 43, Foppen teaches: The location system of claim 36, wherein each sensor of the plurality of sensors comprises an identification means corresponding to the sensor to facilitate a user identifying the sensor, wherein the identification means are optionally disposed on the external facing side of the sensor device (paragraph 0025-0027).
Regarding Claim 44, Foppen teaches: The location system of claim 43, wherein the identification means is a led, optionally an identification number (paragraph 0025-0027).
Regarding Claim 45, Foppen teaches: The location system of claim 36, wherein the system is configured to collect data from the plurality of sensors when the target site is flexed and/or when the target site is extended (paragraph 0019-0029).
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) 46-48 is/are rejected under 35 U.S.C. 103 as being unpatentable over Foppen in view of Long Jr et al. (US 2017/0196591 A1), hereinafter Long.
Regarding Claim 46, Foppen teaches: The location system of claim 36, but does not mention further comprising a guiding tool for guiding a user to an entry point, wherein the guiding tool comprises a section of the sensor device, the section spaced apart from the plurality of sensors, the section comprising one or more openings positioned on the horizontal lines of each of the plurality of sensors, for providing an opening for needle insertion at the determined entry point.
Long teaches a guiding tool for guiding a user to an entry point, wherein the guiding tool comprises a section of the sensor device, the section spaced apart from the plurality of sensors, the section comprising one or more openings positioned on the horizontal lines of each of the plurality of sensors, for providing an opening for needle insertion at the determined entry point (figure 1A; 5B). 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 a guiding tool for guiding a user to an entry point, wherein the guiding tool comprises a section of the sensor device, the section spaced apart from the plurality of sensors, the section comprising one or more openings positioned on the horizontal lines of each of the plurality of sensors, for providing an opening for needle insertion at the determined entry point for accurate insertion of a needle.
Regarding Claim 47, Foppen in view of Long teach: The location system of claim 46, wherein the guiding tool comprises:
a base substrate, the base substrate comprising:
an alignment means for aligning the tool with the sensor determined to be positioned at an entry point;
an access hole spaced apart and in the same horizontal line as the alignment means, the access hole configured for providing access to an instrument to an internal target site; and
attachment means for attaching the guiding tool to the sensor device (Long; figures 5A; 5B).
Regarding Claim 48, Foppen in view of Long teach: The location system of claim 47, wherein the alignment means comprises an opening configured to overlie a marked position of a sensor on the external side of the sensor device (Long – figure 5A).
Allowable Subject Matter
Due to the nature of the 112 rejections, Examiner has not indicated any allowable subject matter. While Claims 49-55 have not been rejected using prior art, Examiner notes that once claims are amended to overcome pending 112 rejections and more clarity regarding the claimed invention is provided, a prior art rejection may be presented.
Conclusion
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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