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/Amendments
Applicant’s amendments overcome the previous rejections. However, upon further search and consideration, new rejections have been made (double patenting and prior art rejections). See below for more details.
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 91-92 and 96-106 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-8, 11-13, 16, and 18-19 of U.S. Patent No. 10324019 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because all the subject matter of the instant claims 91-92 and 96-106 are also claimed in 2-8, 11-13, 16, and 18-19 of U.S. Patent No. 10324019 B2, as shown below:
Regarding claim 91, U.S. Patent No. 10324019 B2 also claims
instructions for the processor (implied by processing) to receive a temporal data signal (claim 2) generated from light detected from a sample (claim 2) comprising particles (cells); and
instructions for the processor to generate a sort decision (claim 2) without forming an image for sorting one or more particles of the sample based on the temporal data signal (claim 6).
Claim of instant application
Claim of US 10324019 B2
92
2
96
8
97
3
98
2
99
5
100
7
101
11
102
12
103
13
104
16
105
18
106
19
Claims 91-93 and 97-106 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13, 16, and 18-19 of U.S. Patent No. 10620111 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because all the subject matter of the instant claims 91-93 and 97-106 are also claimed in 1-13, 16, and 18-19 of U.S. Patent No. 10620111 B2, as shown below:
Claim of instant application
Claim of US 10620111 B2
91
1, 2
92
1
93
1
96
5
97
6
98
7
99
8
100
9
101
11-12
102
11-12
103
13
104
16
105
18
106
19
Claims 91-94 and 96-106 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11105728 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because all the subject matter of the instant claims 91-93 and 97-106 are also claimed in 1-19 of U.S. Patent No. 11105728 B2.
Claims 91-94 and 96-105 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11774343 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because all the subject matter of the instant claims 91-93 and 97-105 are also claimed in 1-20 of U.S. Patent No. 11774343 B2.
Claims 91-94 and 96-105 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 12078587 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because all the subject matter of the instant claims 91-94and 96-105 are also claimed in 1-25 of U.S. Patent No. 12078587 B2.
Claims 91-94 and 96-100 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 12313521 B1. Although the claims at issue are not identical, they are not patentably distinct from each other because all the subject matter of the instant claims 91-94 and 96-100 are also claimed in 1-22 of U.S. Patent No. 12313521 B1.
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.
(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.
Claims 91-94 and 96-98 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Hansen (US 20020176069 A1).
Regarding claim 91, Hansen teaches:
instructions for the processor (paragraphs 69-71) to receive a temporal data signal generated from light detected from a sample comprising particles (organisms; paragraph 71); and
instructions for the processor to generate a sort decision without forming an image (paragraph 76) for sorting one or more particles of the sample based on the temporal data signal (paragraphs 77 and 71).
Regarding claim 92, Hansen teaches the temporal data signal is generated from light detected from an irradiated sample in a flow stream (paragraphs 66-67 and 77).
Regarding claim 93, Hansen teaches light detected from the irradiated sample is fluorescence (paragraphs 71-76).
Regarding claim 94, Hansen teaches light detected from the irradiated sample is scattered light (paragraphs 71-73).
Regarding claim 96, Hansen teaches instructions for generating the sort decision based on the temporal signal with a latency equal to or less than about 100 microseconds (paragraph 76).
Regarding claim 97, Hansen teaches the memory further comprises instructions for determining a characteristic of the one or more particles in the sample based on the temporal data signal (paragraphs 74 and 81).
Regarding claim 98, Hansen teaches the particles are cells in a biological sample (paragraphs 71-77).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 91-92, 94, and 97 are rejected under 35 U.S.C. 103 as being unpatentable over Batchelder (US 5192870 A; cited by Applicant).
Regarding claim 91, Batchelder teaches
instructions for the processor to receive a temporal data signal generated from light detected from a sample comprising particles (column 7, lines 30-35); and
instructions for the processor to generate a sort decision for sorting one or more particles of the sample based on the temporal data signal (column 7, lines 30-50).
Batchelder suggests and implies but doesn’t explicitly teach without forming an image (this is suggested and implied in column 7, lines 30-50, since a single photocell produces a pulse whose amplitude is a measure of size; it uses pulse height analysis to sort the particles based on the amplitude of the pulse, not based on any image). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the generating of the sort decision without forming an image (as suggested and implied by Batchelder) in order to provide a simple and cost-effective implementation of the system that doesn’t rely on extra steps (and the optical elements they require) such as forming images, which aren’t necessary for the sorting described by Batchelder.
Regarding claim 92, Batchelder teaches the temporal data signal is generated from light detected from an irradiated sample in a flow stream (suggested /implied by velocity of particle as it passes through in column 3, lines 55-60).
Regarding claim 94, Batchelder teaches light detected from the irradiated sample is scattered light (column 7, lines 30-50).
Regarding claim 97, Batchelder teaches determining a characteristic of the one or more particles in the sample based on the temporal data signal (size in column 7, lines 30-50).
Claims 93 and 98-100 are rejected under 35 U.S.C. 103 as being unpatentable over Batchelder as applied to claims 91 and 97 above, and further in view of Kornyei (Cell sorting in a Petri dish controlled by computer vision) and Njoh (Screening far red probes for use on optical biochip devices).
Regarding claim 93, Batchelder doesn’t explicitly teach light detected from the irradiated sample is fluorescence.
However, it is conventional to use fluorescence in addition to (or as an alternative to) scattering to sort particles and further it is known to do fluorescence with or without imaging. For example, Kornyei and Njoh are both directed to particle sorting based on irradiating the sample and teach the light detected from the irradiated sample is fluorescence and further teach doing it without forming an image (Njoh, abstract and last page; Kornyei, first paragraph) and that it is conventional (for example, see “Since the invention of the fluorescence-activated cell sorter (FACS)1 in the 1960s the method gained widespread application both in research and medical diagnosis… the fluorescent or scattered light of cells is normally detected without imaging the cells” in Kornyei, first paragraph).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the above combination such that the light detected from the irradiated sample is fluorescence in order to extend the combination to allow the sorting of particles based on additional characteristics besides size (e.g. see Njoh, Kornyei, and the prior art of record), while using conventional and well understood means.
Regarding claim 98, in the above combination the particles are cells in a biological sample (Njoh and Kornyei, first and last pages).
Regarding claim 99, in the above combination the characteristic is associated with an internal organelle (Njoh, abstract).
Regarding claim 100, in the above combination the characteristic of the cells in the biological sample comprises any of a dimensional size of the cell, a ratio of sizes of the cell in along two different dimensions, co-localization of fluorescence radiation emitted by two or more markers associated with the cell, a ratio of sizes of the cell's cytoplasm and nucleus, a degree of punctateness of fluorescent radiation emitted from the cell, a measure of the spatial distribution of the fluorescent radiation, a measure of location or orientation of the cell, a measure of the eccentricity of the cell, a measure of the cell's similarity to a reference cell, a combination of one or more spatial Fourier components of the cell, a measure of the degree to which the cell lies in a focal point of the illuminating radiation (e.g., dimensional size as mentioned in the above citations, including Batchelder, column 7).
Claim 96 is rejected under 35 U.S.C. 103 as being unpatentable over Batchelder as applied to claim 91 above, and further in view of Rocca (Real-time fluorescence lifetime actuation).
Regarding claim 96, Batchelder doesn’t explicitly teach the memory comprises instructions for generating the sort decision based on the temporal signal with a latency equal to or less than about 100 microseconds.
Like Batchelder (and like the instant application), Rocca is directed to particle sorting and provides a general teaching of a latency equal to or less than about 100 microseconds (abstract). It also teaches that this provides the benefit of increased throughput (abstract and last page).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the above combination such that the memory comprises instructions for generating the sort decision based on the temporal signal with a latency equal to or less than about 100 microseconds in order to achieve increased throughput.
Claims 99-104 are rejected under 35 U.S.C. 103 as being unpatentable over Hansen as applied to claim 98 above, and further in view of Njoh.
Regarding claim 99, Hansen doesn’t explicitly teach the characteristic is associated with an internal organelle.
Njoh is directed to particle sorting based on irradiating the sample and teaches the characteristic is associated with an internal organelle (abstract).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the above combination such that the characteristic is associated with an internal organelle in order to gain additional information about the sample.
Regarding claim 100, in the above combination the characteristic of the cells in the biological sample comprises any of a dimensional size of the cell, a ratio of sizes of the cell in along two different dimensions, co-localization of fluorescence radiation emitted by two or more markers associated with the cell, a ratio of sizes of the cell's cytoplasm and nucleus, a degree of punctateness of fluorescent radiation emitted from the cell, a measure of the spatial distribution of the fluorescent radiation, a measure of location or orientation of the cell, a measure of the eccentricity of the cell, a measure of the cell's similarity to a reference cell, a combination of one or more spatial Fourier components of the cell, a measure of the degree to which the cell lies in a focal point of the illuminating radiation (Hansen, paragraphs 13, 70-77, and 81).
Regarding claim 101, Hansen teaches the cells in the biological sample are stained with two or more fluorescent markers (paragraph 81).
Regarding claim 102, Hansen teaches the memory comprises instructions for generating temporal fluorescence waveforms for each of the fluorescent markers (paragraph 81).
Regarding claim 103, Hansen teaches instructions for measuring co-localization of fluorescence signals corresponding to the fluorescent markers; and instructions for generating the sort decision based on the measure of co-localization (paragraph 81).
Regarding claim 104, Hansen teaches the memory comprises: instructions for obtaining an estimate of a size of cells in the biological sample; and instructions for generating the sort decision based on the estimated cell size (paragraph 49).
Claim 101-102 is rejected under 35 U.S.C. 103 as being unpatentable over Batchelder, Kornyei, and Njoh, as applied to claim 100 above, and further in view of Hansen (US 20020176069 A1).
Regarding claim 101, in the above combination the cells in the biological sample are stained with a fluorescent marker (Kornyei, pages 6-7).
The above combination doesn’t explicitly teach the marker is two or more markers.
Like the above combination (and like the instant application), Hansen is also directed to fluorescence analysis of biological samples as well as sorting particles of a sample and teaches the cells in the biological sample are stained with two or more fluorescent markers (paragraph 81). Additionally, Hansen teaches this provides the benefit of resolving multiple features of the biological sample (paragraph 81).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the above combination such that the cells in the biological sample are stained with two or more fluorescent markers in order to resolve multiple features of the biological sample.
Regarding claim 102, in the above combination the memory comprises instructions for generating temporal fluorescence waveforms for each of the fluorescent markers (since there is a waveform for each detected fluorescence signal from each marker; see the above citations)
Claim 105 is rejected under 35 U.S.C. 103 as being unpatentable over Hansen and Njoh as applied to claim 98 above, and further in view of Hoffman (Pulse Width for Particle Sizing; cited by Applicant).
Regarding claim 105, the above combination doesn’t explicitly teach instructions for estimating the cell size based on a temporal duration of a pulse of fluorescence from the cell.
Like the above combination (and like the instant application), Hoffman is directed to characterizing particles using fluorescence and teaches estimating the cell size based on a temporal duration of a pulse of fluorescence from the cell (abstract and pages 1-2). Additionally, Hoffman teaches that this is one of the most basic results of measurements and has a broad application, including allowing one to discriminate cells based on their size, discriminate between single cells and multiple cells, and discriminate cells based on their sub-cellular components (pages 1-3).
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It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the above combination such that it comprises instructions for estimating the cell size based on a temporal duration of a pulse of fluorescence from the cell in order to allow one to discriminate cells based on their size, discriminate between single cells and multiple cells, and discriminate cells based on their sub-cellular components, using one of the most basic results of measurements.
Allowable Subject Matter
Claim 106 would be allowable if rewritten to overcome the double patenting rejection set forth in this Office action and to include all of the limitations of the base claim and any intervening claims. The following is a statement of reasons for the indication of allowable subject matter: The prior art of record (taken alone or in combination) fails to anticipate or render obvious, “instructions for the processor to generate a sort decision without forming an image for sorting one or more particles of the sample based on the temporal data signal, the memory further comprises instructions for determining a characteristic of the one or more particles in the sample based on the temporal data signal, the particles are cells in a biological sample, the characteristic is associated with an internal organelle, wherein the characteristic of the cells in the biological sample comprises any of a dimensional size of the cell, a ratio of sizes of the cell in along two different dimensions, co-localization of fluorescence radiation emitted by two or more markers associated with the cell, a ratio of sizes of the cell's cytoplasm and nucleus, a degree of punctateness of fluorescent radiation emitted from the cell, a measure of the spatial distribution of the fluorescent radiation, a measure of location or orientation of the cell, a measure of the eccentricity of the cell, a measure of the cell's similarity to a reference cell, a combination of one or more spatial Fourier components of the cell, a measure of the degree to which the cell lies in a focal point of the illuminating radiation, wherein the cells in the biological sample are stained with two or more fluorescent markers, wherein the memory comprises instructions for generating temporal fluorescence waveforms for each of the fluorescent markers, , wherein the memory comprises: instructions for squaring the detected temporal fluorescence data; instructions for applying a bandpass filter to the squared fluorescence data; instructions for integrating the filtered data; and instructions for comparing the filtered data with a predefined threshold,” in combination with the other claimed limitations.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUFUS L PHILLIPS whose telephone number is (571)270-7021. The examiner can normally be reached M-Th, 2 -10 pm.
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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.
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/RUFUS L PHILLIPS/ Examiner, Art Unit 2877
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