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 .
Response to Arguments
The examiner notes that while the amendment to claim 25 in the amendment filed January 29, 2026 addresses the objections made to the claim in the previous Office action, this amendment raises new issues under 35 USC 112(b) and 35 USC 112(d). This new rejection can be found below.
While a terminal disclaimer was timely filed on January 29, 2026, this disclaimer was disapproved. Please see the following section for reasons why and how to overcome the issue.
Terminal Disclaimer
The terminal disclaimer filed on January 29, 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of United States Patent 12,044,606 has been reviewed and is NOT accepted.
The terminal disclaimer was not accepted because the applicant cited on the terminal disclaimer must be cited exactly as it is cited on the ADS and/or filing receipt and also in its entirety. If needed, please submit an attachment page to a newly filed terminal disclaimer to ensure that the applicant is cited in full.
No fee is required for resubmission of a terminal disclaimer to correct the issue at hand.
Claim Interpretation
For the reasons given in the previous Office action mailed January 7, 2026, the following limitation remains interpreted under 35 USC 112(f):
“A focusing optical system” in claims 1, 3, 5-6, 8-9, 11, 19, 21, 24-26, 28-30, and 33.
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 25, 26, and 28-31 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 25 recites the limitation "said device" in line 2 of the claim. There is insufficient antecedent basis for this limitation in the claim. What device is being referred to here? The amendment of the preamble of the claim from “A device” to “A method” is what has created the antecedent basis issue here. To overcome the rejection, the examiner recommends amending the claim to recites that the method being claimed is performed on a device comprising a laser emitter, a focusing optical system, and so on.
Further regarding claim 25, while the claim recites method steps after setting forth the limitations of the device performing the method, the claim, in line 13, also recites “wherein the electronic data processor is further arranged to” and then recites functionality that the processor performs. This makes it unclear whether or not applicant intends to set forth a method in claim 25 or a device and its function. To overcome the rejection, the examiner recommends amending the claim to positively recite method steps for the function electronic data processor is currently claimed as being further arranged to perform in order to use the pre-trained machine learning classifier as to classify the calculated sample coefficients as claimed. The examiner also is available to review suggested claim language via a scheduled interview to ensure that this rejection is overcome.
Claims 26 and 28-31 are rejected by virtue of their dependence on claim 25, thereby containing all the limitations of the claim on which they depend.
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.
Claims 26 and 28-31 are 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.
Claims 26 and 28-31 all recite “the device according to claim 25”. While these claims recite further limitations of the device that is used to perform the method of claim 25, claim 25 recites a method; as a result, claims 26 and 28-31, by reciting “the device according to claim 25”, fail to further limit the method of claim 25.
To overcome this rejection, the examiner recommends making sure that claims 26 and 28-31 are in the same statutory class of invention as claim 25.
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.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3, 5-6, 8-9, 11-14, 19, 21, 24-26, 28-31, and 33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,044,606. Although the claims at issue are not identical, they are not patentably distinct from each other because while the ‘606 patent discloses detecting extracellular vesicles and the instant application discloses detecting nanoparticles, extracellular vesicle are nanoparticles and thus anticipate the instant application for the reasons given below.
Regarding claim 1, claim 1 of the ‘606 patent discloses a method for detecting nanoparticles dispersed in a liquid dispersion sample, using an electronic data processor for classifying the sample as having, or not having, nanoparticles present, and using the electronic data processor for pre-training a machine learning classifier with a plurality of nanoparticles liquid dispersion specimens, while dispersed, the method comprising the steps of (see lines 1-8 of the ‘606 claim): emitting a laser modulated by a modulation frequency onto each specimen (see lines 9-10 of the ‘606 claim); capturing a temporal signal from laser light backscattered by each specimen for a plurality of temporal periods of a predetermined duration for each specimen (see lines 11-14 of the ‘606 claim); calculating specimen DCT or Wavelet transform coefficients from the captured signal for each of the temporal periods (see lines 15-17 of the ‘606 claim); using the calculated coefficients to pre-train the machine learning classifier (see lines 18-19 of the ’6060 claim); emitting, by using a laser emitter having a focusing optical system coupled to the emitter, to emit a laser modulated by a modulation frequency onto the sample (see lines 20-22 of the ‘606 claim); using a light receiver to capture a signal from laser light backscattered by the sample for a plurality of temporal periods of a predetermined duration (see lines 23-25 of the ‘606 claim); calculating sample DCT or Wavelet transform coefficients from the captured signal for each of the temporal periods; (see lines 26-28 of the ‘606 claim) and using the pre-trained machine learning classifier to classify the calculated sample coefficients as having, or not having, nanoparticles present (see lines 29-31 of the ‘606 claim), wherein the extracellular vesicles have a particle size, in any particle direction, below 1 µm (see lines 32-33 of the ‘606 claim), and further wherein the focusing optical system is a focusing optical system configured to provide a field gradient pattern (see lines 34-36 of the ‘606 claim).
Further claim correspondence is as follows:
Claim 3 of the instant application with claim 2 of the ‘606 patent.
Claim 5 of the instant application with claim 3 of the ‘606 patent.
Claim 6 of the instant application with claim 4 of the ‘606 patent.
Claim 8 of the instant application with claim 5 of the ‘606 patent.
Claim 9 of the instant application with claim 6 of the ‘606 patent.
Claim 11 of the instant application with claim 7 of the ‘606 patent.
Claim 12 of the instant application with claim 8 of the ‘606 patent.
Claim 13 of the instant application with claim 9 of the ‘606 patent.
Claim 14 of the instant application with claim 10 of the ‘606 patent.
Claim 19 of the instant application with claim 11 of the ‘606 patent.
Claim 21 of the instant application with claim 12 of the ‘606 patent.
Claim 24 of the instant application with claim 13 of the ‘606 patent (for the details of the claimed process the non-transitory storage media stores, see the rejection of claim 1 above).
Regarding claim 25, claim 14 of the ‘606 patent discloses a method for detecting dispersed nanoparticles while dispersed in a liquid dispersion sample using a device comprising (see lines 1-3 of the ‘606 claim) a laser emitter (see line 4 of the ‘606 claim); a focusing optical system coupled to the emitter (see line 5 of the ‘606 claim); an infrared light receiver (see line 6 of the ‘606 claim); and an electronic data processor arranged to classify the sample as having, or not having, nanoparticles present using a machine learning classifier which has been pre-trained using a plurality of nanoparticles liquid dispersion specimens, while dispersed, (see lines 7-12 of the ‘606 claim) comprising: emitting a laser modulated by a modulation frequency onto each specimen (see lines 13-14 of the ‘606 claim); capturing a temporal signal from laser light backscattered by each specimen for a plurality of temporal periods of a predetermined duration for each specimen (see lines 15-17 of the ‘606 claim); calculating specimen DCT or Wavelet transform coefficients from the captured signal for each of the temporal periods (see lines 18-20 of the ‘606 claim); using the calculated coefficients to pre-train the machine learning classifier (see lines 21-22 of the ’606 claim); wherein the electronic data processor is further arranged to (see lines 23-24 of the ‘606 claim): use the laser emitter to emit a laser modulated by a modulation frequency onto the sample (see lines 25-26 of the ‘606 claim); use the light receiver to capture a signal from laser light backscattered by the sample for a plurality of temporal periods of a predetermined duration (see lines 27-29 of the ‘606 claim); calculating sample DCT or Wavelet transform coefficients from the captured signal for each of the temporal periods (see lines 30-32 of the ‘606 claim); and using the pre-trained machine learning classifier to classify the calculated sample coefficients as having, or not having, nanoparticles present (see lines 33-35 of the ‘606 claim); wherein the nanoparticles have a particle size, in any particle direction, below 1 µm (see lines 36-37 of the ‘606 claim); wherein the focusing optical system is a focusing optical system suitable to provide a field gradient pattern (see lines 38-39 of the ’606 claim).
Further claim correspondence is as follows:
Claim 26 of the instant application with claim 15 of the ‘606 patent.
Claim 28 of the instant application with claim 16 of the ‘606 patent.
Claim 29 of the instant application with claim 17 of the ‘606 patent.
Claim 30 of the instant application with claim 18 of the ‘606 patent.
Claim 31 of the instant application with claim 19 of the ‘606 patent.
As for claim 33, while the claims of the ‘606 patent fail to disclose that the nanoparticles are selected to show distinctive time-dependent fluctuations in scattering intensity, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to choose the nanoparticles to have distinctive time-dependent fluctuations in scattering intensity, as it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of design choice. In re Leshin, 125 USPQ 416. In the instant case, a nanoparticle like the extracellular vesicle claimed by the ‘606 patent is known in the art to be measured via light scattering techniques.
Allowable Subject Matter
Claims 1, 3, 5-6, 8-9, 11-14, 19, 21, 24, and 33 would be allowed in view of the prior art should the double patenting rejection set forth above be properly overcome.
Claims 25, 26, and 28-31 would 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, in addition to the double patenting rejection, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter:
As to claims 1, 24, and 25, the claims remain allowable in view of the prior art for the reasons given in the previous Office action of record mailed January 7, 2026.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael A. Lyons whose telephone number is (571)272-2420. The examiner can normally be reached Monday - Friday.
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, Michelle Iacoletti can be reached at 571-270-5789. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Michael A Lyons/Primary Examiner, Art Unit 2877 February 12, 2026