DETAILED ACTION
The amendment, received on June 30, 2026, has been entered into the record.
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 1-7 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.
As for claim 1, on line 17 ‘the optical fiber’ is indefinite, for it is unclear as to which optical fiber is being referred to since lines 3, 4, 6, 12, 13, and 15 all refer to a plurality of optical fibers.
In addition, ‘even when a concentration of the antigens in the sample is less than a limit of detection concentration of the optical fiber’ of lines 15-17 is indefinite, for it is unclear how the digital LSPR sensor can detect antigens less than the limit of detection concentration of its own optical fiber and therefore its own limit of detection concentration.
The examiner notes that the applicant’s specification appears to describe a limit of detection of concentration for an optical fiber of an analog LSPR sensor. Please see page 12, line 24 to page 13, line 3 with FIG. 3 and page 17, lines 15-22 with FIG. 6.
Claims 2-3 are rejected by virtue of their dependency from claim 1.
As for claim 4, on line 19 ‘the optical fiber’ is indefinite, for it is unclear as to which optical fiber is being referred to since lines 3, 4, 6, 14, 15, and 17 all refer to a plurality of optical fibers.
In addition, ‘even when a concentration of the antigens in the sample is less than a limit of detection concentration of the optical fiber’ of lines 17-19 is indefinite, for it is unclear how the digital LSPR sensor can detect antigens less than the limit of detection concentration of its own optical fiber and therefore its own limit of detection concentration.
The examiner notes that the applicant’s specification appears to describe a limit of detection of concentration for an optical fiber of an analog LSPR sensor. Please see page 17, lines 15-22 with FIG. 6.
Claims 5-6 are rejected by virtue of their dependency from claim 4.
As for claim 7, on line 19 ‘the optical fiber’ is indefinite, for it is unclear as to which optical fiber is being referred to since lines 3, 5, 9, 13, 14, and 17 all refer to a plurality of optical fibers.
In addition, ‘even when a concentration of the antigens in the sample is less than a limit of detection concentration of the optical fiber’ of lines 17-19 is indefinite, for it is unclear how the digital LSPR sensor can detect antigens less than the limit of detection concentration of its own optical fiber and therefore its own limit of detection concentration.
The examiner notes that the applicant’s specification appears to describe a limit of detection of concentration for an optical fiber of an analog LSPR sensor. Please see page 12, line 24 to page 13, line 3 with FIG. 3 and page 17, lines 15-22 with FIG. 6.
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 1-7 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.
As for claim 1, ‘wherein the digital LSPR sensor is configured to determine, as an output value of the digital LSPR sensor, a number of optical fibers, among the plurality of optical fibers, that output the signal of the predetermined magnitude or more (lines 11-13)’ appears to be new matter. There appears to be only ‘configuring’ with regards to the digital LSPR sensor being a signal optical fiber bundle from a plurality of optical fibers (see page 2, lines 25-26 and 31-32; page 5, line 32 to page 6, line 1; page 7, lines 26-27; page 8, lines 21-22; page 11, lines 2-3 and lines 30-31; page 15, lines 18-19; and page 18, lines 28-29). In addition, there does not appear to be any description of how to perform or accomplish the determination by the digital LSPR sensor such as describing a component or structure of the digital LSPR to perform the function. Applicant’s disclosure appears to only describe the optical fibers and antigens without any description of other components of the digital LSPR sensor (see FIGS. 2, 3, 5, and 6: (b) and (d)). It is noted that software products are mentioned, but the specification does not refer to any type of hardware to perform determinations or operations (see page 20, line 31 to page 21, line 7).
Claims 2-3 are rejected by virtue of their dependency from claim 1.
As for claim 3, ‘wherein the digital LSPR sensor is configured to digital value of 1 when the number of antigens bound the plurality of antibodies is equal to or greater than the preset number, and output a digital value of 0 when the number of antigens bound to the plurality of antibodies is less than the preset number (lines 1-9)’ appears to be new matter. There appears to be only ‘configuring’ with regards to the digital LSPR sensor being a signal optical fiber bundle from a plurality of optical fibers (see page 2, lines 25-26 and 31-32; page 5, line 32 to page 6, line 1; page 7, lines 26-27; page 8, lines 21-22; page 11, lines 2-3 and lines 30-31; page 15, lines 18-19; and page 18, lines 28-29). In addition, there does not appear to be any description of how to perform or accomplish the outputting a digital value of 1 or 0 such as describing a component or structure of the digital LSPR to perform the function. Applicant’s disclosure appears to only describe the optical fibers and antigens without any description of other components of the digital LSPR sensor (see FIGS. 2, 3, 5, and 6: (b) and (d)). It is noted that software products are mentioned, but the specification does not refer to any type of hardware to perform determinations or operations (see page 20, line 31 to page 21, line 7).
As for claim 4, ‘wherein the digital LSPR sensor is configured to determine, as an output value of the digital LSPR sensor, a number of optical fibers, among the plurality of optical fibers, that output the signal of the predetermined magnitude or more (lines 13-15)’ appears to be new matter. There appears to be only ‘configuring’ with regards to the digital LSPR sensor being a signal optical fiber bundle from a plurality of optical fibers (see page 2, lines 25-26 and 31-32; page 5, line 32 to page 6, line 1; page 7, lines 26-27; page 8, lines 21-22; page 11, lines 2-3 and lines 30-31; page 15, lines 18-19; and page 18, lines 28-29). In addition, there does not appear to be any description of how to perform or accomplish the determination by the digital LSPR sensor such as describing a component or structure of the digital LSPR to perform the function. Applicant’s disclosure appears to only describe the optical fibers and antigens without any description of other components of the digital LSPR sensor (see FIGS. 2, 3, 5, and 6: (b) and (d)). It is noted that software products are mentioned, but the specification does not refer to any type of hardware to perform determinations or operations (see page 20, line 31 to page 21, line 7).
Claims 5-6 are rejected by virtue of their dependency from claim 4.
As for claim 6, ‘wherein the digital LSPR sensor is configured to digital value of 1 when the number of antigens bound the plurality of antibodies is equal to or greater than the preset number, and output a digital value of 0 when the number of antigens bound to the plurality of antibodies is less than the preset number (lines 1-9)’ appears to be new matter. There appears to be only ‘configuring’ with regards to the digital LSPR sensor being a signal optical fiber bundle from a plurality of optical fibers (see page 2, lines 25-26 and 31-32; page 5, line 32 to page 6, line 1; page 7, lines 26-27; page 8, lines 21-22; page 11, lines 2-3 and lines 30-31; page 15, lines 18-19; and page 18, lines 28-29). In addition, there does not appear to be any description of how to perform or accomplish the outputting a digital value of 1 or 0 such as describing a component or structure of the digital LSPR to perform the function. Applicant’s disclosure appears to only describe the optical fibers and antigens without any description of other components of the digital LSPR sensor (see FIGS. 2, 3, 5, and 6: (b) and (d)). It is noted that software products are mentioned, but the specification does not refer to any type of hardware to perform determinations or operations (see page 20, line 31 to page 21, line 7).
As for claim 7, ‘wherein the digital LSPR sensor fabricated by the method is configured to determine, as an output value of the digital LSPR sensor, a number of optical fibers, among the plurality of optical fibers, that output the signal of the predetermined magnitude or more (lines 12-15)’ appears to be new matter. There appears to be only ‘configuring’ with regards to the digital LSPR sensor being a signal optical fiber bundle from a plurality of optical fibers (see page 2, lines 25-26 and 31-32; page 5, line 32 to page 6, line 1; page 7, lines 26-27; page 8, lines 21-22; page 11, lines 2-3 and lines 30-31; page 15, lines 18-19; and page 18, lines 28-29). In addition, there does not appear to be any description of how to perform or accomplish the determination by the digital LSPR sensor such as describing a component or structure of the digital LSPR to perform the function. Applicant’s disclosure appears to only describe the optical fibers and antigens without any description of other components of the digital LSPR sensor (see FIGS. 2, 3, 5, and 6: (b) and (d)). It is noted that software products are mentioned, but the specification does not refer to any type of hardware to perform determinations or operations (see page 20, line 31 to page 21, line 7).
Allowable Subject Matter
Claims 1-7 appear to be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and if the rejection(s) under 35 U.S.C. 112(a) are overcome.
Response to Arguments
Applicant’s arguments with respect to claims 1-7 (see Remarks of June 30, 2026, pages 6-9) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US 11,680,900 to Groves (see col. 2, line 39 to col. 3, line 34).
Applicant's 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.
Fax/Telephone Numbers
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Gordon J. Stock, Jr. whose telephone number is (571) 272-2431.
The examiner can normally be reached on Monday-Friday, 10:00 a.m. - 6:30 p.m.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner's
supervisor, Kara Geisel, can be reached at 571-272-2416. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GORDON J STOCK JR/
Primary Examiner, Art Unit 2877
Prosecution Insights