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 Objections
Claims 3 and 5 are objected to because of the following informalities: “configured to process at least one of correction on measurement data of the implant device and measurement of an operating state of the implant device based on the measured change in the field” should be “configured to process at least one of a correction on measurement data of the implant device or measurement of an operating state of the implant device based on the measured change in the field.”. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are
A non-invasive measurement device
A position adjustment tool
A fixing tool configured to fix the implant device at an insertion position in the body of the subject to be analyzed
a tool configured to measure the tilt of an implant
a tool configured to provide an alarm through an external device or terminal
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
Paragraph [0068] of the published specification defines a non-invasive measurement device as a “charge coupled device (CCD) camera”.
Paragraph [0097] of the published specification defines a “position adjustment tool” as a dial.
Paragraph [0101] of the published specification teaches that the external device provides alarms
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 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.
Claims 9-10 are rejected under 35 U.S.C. 112(a) 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 9 recites “a fixing tool configured to fix the implant device at an insertion position in the body of the subject to be analyzed”. The specification fails to describe how a fixing tool is used for fixing the implant device at an insertion position in the body of the subject to be analyzed. Paragraphs 0015 and 00121 of the specification merely restate the claims without providing a structure that fixes the implant device.
Claim 10 recites “a tool configured to measure a tilt of the implant device based on the skin surface of the subject to be analyzed”. The specification fails to describe how the tilt of the implant device is determined. Paragraphs 0016 and 00123 of the specification merely restate the claims without providing a structure that measures a tilt of the implant device based on the skin surface of the subject to be analyzed.
As claims 9 and 10 are interpreted as invoking 35 USC 112(a), but lack any corresponding structure in the specification to describe what carries out the function, the examiner has determined that the claim limitations lack written description support as they do not provide sufficient evidence to show the applicant had possession of the claimed invention at the time of filing. See MPEP 2163, specifically 2163 II, 3(a) and 2163.03 VI. In addition, see further the 35 USC 112(b) rejection below regarding claims 9 and 10.
Claims 3-4 and 9-10 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 claim 3 it is unclear what is meant by “operating state”. The specification does not provide a definition for “an operating state” within the context of the claim. For purposes of examination the “operating state” is being interpreted as a position of the device.
Claim 4 teaches determining abnormality according to “the operating state”, however claim 3 states that the device is configured to “to process at least one of correction on measurement data of the implant device and measurement of an operating state of the implant device based on the measured change in the field”. Claim 3 could just process a correction on measurement data of the implant device and not an operating state, which makes the term “the operating state” in claim 4 lacking antecedent basis.
Claim limitation “a fixing tool configured to fix the implant device at an insertion position in the body of the subject to be analyzed” in claim 9 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Paragraphs 0015 and 00121 of the specification merely restate the claims without providing a structure that fixes the implant device. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Claim limitation “a tool configured to measure a tilt of the implant device based on the skin surface of the subject to be analyzed” in claim 10 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Paragraphs 0016 and 00123 of the specification merely restate the claims without providing a structure that measures a tilt of the implant device based on the skin surface of the subject to be analyzed. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3 and 5 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Bien (US 20230092592 A1).
In regards to In regards to claim 1 Bien teaches a sensor information measurement device comprising:
an implant device configured to insert into a body of a subject to be analyzed, to emit an electromagnetic wave of a specific frequency, and to measure a signal reflected from a surrounding analyte ([0061]);
and a non-invasive measurement device configured to measure a change in a field formed by the electromagnetic wave of the specific frequency outside the body of the subject to be analyzed ([0064] external reader module 400 is a non-invasive measurement device).
In regards to claim 2 Bien teaches the sensor information measurement device of claim 1, wherein the non- invasive measurement device is configured to measure a change in intensity of the field that changes according to a change in permittivity in the body of the subject to be analyzed ([0061] [0064] [0074]).
In regards to claim 3 Bien teaches the sensor information measurement device of claim 1, wherein the non- invasive measurement device is configured to process at least one of correction on measurement data of the implant device or measurement of an operating state of the implant device based on the measured change in the field ([0098-0101] Location is operating state).
In regards to claim 5 Bien teaches the sensor information measurement device of claim 1, further comprising: an external device configured to supply power to the implant device ([0058] external device 200), to receive first measurement data of the implant device ([0060]), to receive the change in the field measured by the non-invasive measurement device ([0064] [0075]), and to process at least one of correction on measurement data of the implant device and measurement of an operating state of the implant device based on the received change in the field ([0098-0101] location is operating state).
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.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bien (US 20230092592 A1) as applied to claim 1, in view of Visweswara (US 20210145304 A1).
In regards to claim 4 Bien teaches the sensor information measurement device of claim 3. Bien fails to teach a device wherein the non- invasive measurement device is configured to determine an abnormality status of the implant device according to the operating state of the implant device and to provide an alarm to a user through the sensor information measurement device or a terminal that communicates with the sensor information measurement device depending on the determined abnormality status.
Visweswara teaches a device wherein a non- invasive measurement device is configured to determine an abnormality status of an implant device according to the operating state of the implant device and to provide an alarm to a user through the sensor information measurement device or a terminal that communicates with the sensor information measurement device depending on the determined abnormality status ([0015] “Thus, if the implanted device has moved from its initial position by more than a threshold amount, an alarm may be created. This may provide an alert before the subject is aware of a potential issue”).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to modify the device of Bien to alert the user if the implant device has moved from its initial location like the device of Visweswara. Doing so would alert the reader to implant migration before they are aware of the issue themselves.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bien (US 20230092592 A1) as applied to claim 5, in view of Lee (US 20180175677 A1).
In regards to claim 6 Bien teaches the sensor information measurement device of claim 5, wherein the external device includes: a communication unit configured to communicate with the implant device ([0063] Resonator 300). Bien fails to teach and a position adjustment tool configured to adjust a position of the communication unit in the external device based on position state information with the implant device.
Lee teaches and a position adjustment tool configured to adjust a position of the communication unit in the external device based on position state information with the implant device ([0074] [0084-0085] User is the position adjustment tool that adjusts based on location information).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to modify the device of Bien to make the external device adjustable by the user like the device of Lee in order to position the device for optimal power transmission ([0003] Lee).
Claim(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bien (US 20230092592 A1) in view of Lee (US 20180175677 A1) as applied to claim 6, in view of Visweswara (US 20210145304 A1).
In regards to claim 7 modified Bien teaches sensor information measurement device of claim 6. Modified Bien fails to teach a device wherein the position state information includes information on a degree of alignment between the external device and the implant device, and information on the degree of alignment is generated based on position detection results of a first position detection sensor included in the implant device and position detection results of a second position detection sensor included in the external device.
Visweswara teaches position state information including information on a degree of alignment between the external device and the implant device ([0041] proximity of the probe to the implanted device), and information on the degree of alignment is generated based on position detection results of a first position detection sensor ([0041] [0106] reference signal) included in the implant device and position detection results of a second position detection sensor included in the external device ([0041] [0106] received signal) and alert the user when the proximity is over a threshold ([0080]).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to modify the device of modified Bien to use the position detection method of Visweswara to determine sensor the proximity of the implant to the external device and alert the user in order to accurately and conveniently measure the position of the implant (Visweswara [0006]).
In regards to claim 8 modified Bien teaches the sensor information measurement device of claim 7 wherein the external device is configured to generate an alarm message if a position state value between a first position of the external device and a second position of the implant device according to the position detection results of the first position detection sensor and the position detection results of the second position detection sensor included in the external device is greater than or equal to a threshold (Visweswara [0080]). Modified Bien fails to teach an alarm for requesting a user to relocate the external device.
Lee teaches an adjustment request signal to alert the user to make wither a fine or large adjustment ([0084-0085]).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to modify the alarm of modified Bien to include a position adjustment alert request like the device of Lee in order to indicate to the user if the external device must be moved a large or small distance.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bien (US 20230092592 A1) as applied to claim 1, in view of Najafi (US 20210059527 A1).
In regards to claim 9 Bien teaches the sensor information measurement device of claim 1. Bien a fixing tool configured to fix the implant device at an insertion position in the body of the subject to be analyzed.
Najafi teaches a fixing tool configured to fix an implant device at an insertion position in the body of a subject to be analyzed ([0005-0006] anchor).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to modify the implantable device of modified Bien to include the anchors of Najafi in order to secure the sensor within the body.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bien (US 20230092592 A1) as applied to claim 1, in view of Papadimitrakopoulos (US 20170027608 A1).
In regards to claim 10 Bien teaches the sensor information measurement device of claim 1, wherein the implant device measures a position of the implant device based on the skin surface of the subject to be analyzed ([0100]). Bien fails to teach measuring tilt angle.
Papadimitrakopoulos teaches using magnets and a magnetic field detecting sensor array to detect position and tilt angle of an implanted sensor ([0029]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to modify the external device of Bien to include a magnetic field detecting sensor array and the implant to include magnetic markers like the device of Papadimitrakopoulos in order to detect the tilt angle of the implanted sensor.
Bien/Papadimitrakopoulos fails to teach a tool configured to provide an alarm through an external device or a terminal when the measured tilt is tilted by a predetermined tilt or more.
Visweswara teaches a device that provides an alarm through an external device or a terminal when the implanted device has moved from its initial position by more than a threshold amount ([0015]).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to modify the device of Bien/Papadimitrakopoulos to alert the user if the implant device has moved from its initial location like the device of Visweswara by comparing the position/tilt to a threshold. Doing so would alert the reader to implant migration before they are aware of the issue themselves.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUCY EPPERT whose telephone number is (571)270-0818. The examiner can normally be reached M-F 7:30-5:00 EST.
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, Jennifer Robertson can be reached at (571) 272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LUCY EPPERT/Examiner, Art Unit 3791
/ADAM J EISEMAN/Primary Examiner, Art Unit 3791