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 Applicant’s first point (page 1 of remarks), the Examiner agrees with the Applicant’s statement regarding the objection to the Abstract and correctly amends claims 6 and 39, therefore the objections have been withdrawn.
Applicant’s arguments, see page 2 of Remarks, filed 08/19/2025, with respect to the rejection(s) of claim(s) 1 and 35 under USC § 103 in light of the amendments have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of paragraphs, [0023] and [0060] of Shigaki.
In response to Applicant’s arguments, see page 3-4 of Remarks, with respect to claim(s) 9, 26-28, 33 under USC § 103 in light of the amendments have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of US-20100079762-A1 (Kusuzawa) as explained below.
Specification
The amendment filed 08/19/2025 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: The claim language “wherein the optical system includes an optical energy from operating the flow cytometer” in claims 1, 26.
Applicant is required to cancel the new matter in the reply to this Office Action.
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.
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, 9, 16, 23, 26-28, and 33 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. The claim language “wherein the optical system includes an optical energy from operating the flow cytometer” in claims 1 and 26 is not specifically disclosed in the Specification, the remarks appear to state the language is generally supported throughout the Specification, however the Examiner was unable to find this. The claim language could cover examples of light emanating from the flow cell that is not envisioned by the Specification.
Claims 2-7, 9, 16, 23 are rejected for their dependency on base claim 1.
Claims 27-28, 33 are rejected for their dependency on base claim 26.
Claims 1-7, 9, 16, 23, 26-28, and 33 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.
In regards to claims 1 and 26, it is unclear what is meant by “wherein the optical system includes an optical energy from operating the flow cytometer”. The Examiner is interpreting it to mean there is some light source within the flow cytometer (inherent with any flow cytometer), which emits some optical energy, which is then being used in the optical system for imaging.
Claims 2-7, 9, 16, 23 are rejected for their dependency on base claim 1.
Claims 27-28, 33 are rejected for their dependency on base claim 26.
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.
Claims 1-7, 35-40 are rejected under 35 U.S.C. 103 as being unpatentable over US-20160125615-A1 (Shigaki) in light of US-20170315122-A1 (Li).
As to claim 1, Shigaki teaches a monitoring device (flow analyzer 10, Fig. 1), for a flow cytometer (20), the monitoring device (10)
configured to attach to a portion of the flow cytometer (20)([0024] teaches the flow analyzer is attachable to flow cytometer) such that an optical system is substantially aligned with a monitoring region within a flowcell (21) of the flow cytometer (20) (Fig. 1),
wherein the optical system includes an optical energy from operating the flow cytometer ([0060] teaches flow analyzer is used during particle analysis with scattered light or fluorescence i.e. optical energy from operating the flow cytometer, some optical energy would inherently be detected, [0023] teaches scattered light or fluorescence as result of laser irradiation), and
wherein the optical system is configured to continuously capture and monitor at least a portion of the optical energy received from the monitoring region of the flowcell (21) ([0026] teaches imaging, [0060]), and
wherein the optical system comprises at least one sensor (imaging section 12, [0026]) configured to:
detect the at least a portion of the optical energy captured by the optical system ([0026] teaches imaging), and generate, based on the detected optical energy, an image of the monitoring region [0026]; and
at least one processor configured to continuously provide the image to an electronic device ([0026-27] teaches imaging section 12 sends images to A/D converter 13 with memory 14, [0029] teaches the evaluator 15 reads out images from memory 14).
Shigaki is silent to: the external monitoring device comprising a housing configured to attach to a portion of the flow cytometer such that an optical system coupled to the housing is substantially aligned with a monitoring region within a flowcell of the flow cytometer.
Li teaches an optical detection system for a flow cytometer with a housing unit for the optical components [0024] (Fig.1 shows the optical engine 100 attached to the flow cytometer 10).
It would have been obvious to one of ordinary skill in the art to implement the housing of Li in the device of Shigaki to prevent accidental damage and misalignment of components, as well as for easier and quicker coupling to the flow cytometer.
As to claim 35, Shigaki teaches a monitoring device (flow analyzer 10, Fig. 1), for a flow cytometer (20) the external monitoring device configured to reversibly attach to a portion of the flow cytometer (20) ([0024] teaches the flow analyzer is attachable to flow cytometer) such that an optical system is substantially aligned with a monitoring region (Fig. 1) within a flowcell (21) of the flow cytometer (20), wherein the optical system is configured to continuously monitor a sample core stream flowing through the monitoring region of the flowcell [0026], the monitoring comprising one or more of:
monitoring flow stability of the sample core stream, monitoring dimensions of the sample core stream [0033], and monitoring alignment of the sample core stream [0033] with at least one light beam from at least one excitation laser light source ([0023] teaches laser light, [0060]), wherein
the at least one light beam from the at least one excitation laser light source interacts with the sample core stream [0023] as the sample core stream flows through the monitoring region during operation of the flow cytometer and generates optical energy [0025], and
wherein at least a portion of the optical energy is captured by the optical system [0026];
wherein the optical system comprises at least one sensor (imaging section 12) configured to:
detect the at least a portion of the optical energy captured by the optical system, and generate, based on the detected optical energy, an image of the monitoring region [0026]; and
at least one processor configured to continuously provide the image to an electronic device ([0026-27] teach imaging section 12 sends images to A/D converter 13 with memory 14, [0029] teaches the evaluator 15 reads out images from memory 14).
Shigaki is silent to: the external monitoring device comprising a housing configured to reversibly attach to a portion of the flow cytometer such that an optical system supported by or attached coupled to the housing is substantially aligned with a monitoring region within a flowcell of the flow cytometer.
Li teaches an optical detection system for a flow cytometer with a housing unit for the optical components [0024] (Fig.1 shows the optical engine 100 attached to the flow cytometer 10).
It would have been obvious to one of ordinary skill in the art to implement the housing of Li in the device of Shigaki to prevent accidental damage and misalignment of components, as well as for easier and quicker coupling to the flow cytometer.
As to claim 2, the combination teaches the monitoring device of claim 1.
As to claim 36, the combination teaches the monitoring device of claim 35.
As to claims 2, 36, the combination teaches wherein the image comprises a series of images [0008].
As to claim 3, the combination teaches the monitoring device of claim 1.
The combination teaches wherein the at least a portion of optical energy emanates from an interaction between at least one light beam from at least one excitation light source ([0023][0060]) and a sample core stream as the sample core stream flows through the flowcell (21) during operation of the flow cytometer (20) ([0025-26] of Shigaki teach imaging section 12 takes optical images, [0020][0023] teach laser irradiates sample flow in flow cell 21).
As to claim 4, the combination teaches the monitoring device of claim 1,
wherein the optical system is configured to detect interactions between at least one beam from at least one excitation light source ([0023] of Shigaki) and one or more of: one or more structures in the monitoring region, a particle in in the monitoring region [0023], a sample core stream in the monitoring region, a sheath fluid in the monitoring region [0022], a dye solution in the monitoring region ([0054] teaches staining solution 24), an air bubble in the monitoring region, a cleaning fluid in the monitoring region, and a sample in the monitoring region [0023], Fig. 2.
As to claim 5, the combination teaches the monitoring device of claim 1.
As to claim 38, the combination teaches the monitoring device of claim 1.
As to claims 5, 38, the combination teaches wherein the optical energy comprises one or more of: reflection, scatter, fluorescence, phosphorescence, and luminescence ([0023] of Shigaki teaches scatter or fluorescence as result of laser irradiation).
As to claim 6, the combination teaches the monitoring device of claim 1.
As to claim 39, the combination teaches the monitoring device of claim 35.
As to claim 6, the combination teaches the monitoring device of claim 1.
As to claim 39, the combination teaches the monitoring device of claim 1.
As to claims 6, 39, the combination teaches wherein the at least one sensor is further configured to: detect an occurrence of one or more anomalies in the optical energy emanating from the monitoring region [0026]; and cause the at least one processor to generate indications about the one or more anomalies([0029] evaluator 15 analyzes images); and
wherein the at least one processor is further configured to send the indications to the electronic device ([0036] evaluator 15 analyzer and output section 16 outputs result).
As to claim 7, the combination teaches the monitoring device of claim 6,
wherein the one or more anomalies comprises one or more of: a misalignment of a sample core stream [0033] and at least one light beam from at least one excitation laser light source [0023][0060], debris in the monitoring region, an air bubble in the monitoring region, clogging in the flowcell, and an unstable sample core stream (Fig. 4A, 4B)[0030-34].
As to claim 37, the combination teaches the monitoring device of claim 35,
wherein the optical system is configured to detect interactions between at least one beam from at least one excitation laser light source ([0023] of Shigaki) and one or more of: one or more structures in the monitoring region, a particle in in the monitoring region [0023], a sample core stream in the monitoring region, a sheath fluid in the monitoring region [0022], a dye solution in the monitoring region ([0054] teaches staining solution 24), an air bubble in the monitoring region, a cleaning fluid in the monitoring region, and a sample in the monitoring region [0023], Fig. 2.
As to claim 40, the combination teaches the monitoring device of claim 39,
wherein the one or more anomalies comprises one or more of: a misalignment of a sample core stream [0033] and at least one light beam from at least one excitation laser light source [0023][0060], debris in the monitoring region, an air bubble in the monitoring region, clogging in the flowcell, and an unstable sample core stream (Fig. 4A, 4B)[0030-34].
Claims 9, 16, 23, 26-28, 33 are rejected under 35 U.S.C. 103 as being unpatentable over US-20160125615-A1 (Shigaki) in light of US-20170315122-A1 (Li) and US-20100079762-A1 (Kusuzawa).
As to Claim 9, the combination teaches the monitoring device of claim 1.
Shigaki teaches the imaging section (12) includes a lens and a circuit system [0026].
The combination is silent to: wherein the optical system comprises:
a first lens within a first distance of an object plane of the monitoring region; and
a second lens within a second distance of the at least one sensor; and
wherein the optical energy captured by the optical system is substantially collimated between the first lens and the second lens and is substantially focused by the second lens to form the image of the monitoring region on the at least one sensor.
Kusuzawa teaches: a first lens within a first distance of an object plane of the monitoring region (45, Fig. 4, [0026] teaches collimator lens); and
a second lens within a second distance of the at least one sensor (69, Fig. 4, [0036] teaches imaging lens 69 converges light to form image on receiving surface of camera 64) ; and
wherein the optical energy captured by the optical system is substantially collimated between the first lens and the second lens and is substantially focused by the second lens to form the image of the monitoring region on the at least one sensor (See Fig. 4 showing light being substantially collimated by collimating lens 45 and substantially focused by imaging lens 69, [0026] teaches collimating, [0036] teaches imaging lens converging light onto monitoring region of sensor).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the combination to include the collimating lens and imaging lens of Kusuzawa in order to efficiently focus the light for imaging, in hand reducing the size of the optical set up.
As to claim 16, the combination teaches the monitoring device of claim 9.
The combination is silent to: wherein the optical system further comprises an aperture between the first lens and the second lens.
Kusuzawa teaches an aperture (iris 67, Fig. 4, [0034].
Kusuzawa is silent to: between the first lens and the second lens.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the combination to include the aperture of Kusuzawa and position it between the first lens and the second lens in order to remove any unnecessary light before focusing it on the detector.
As to claim 23, the combination teaches the monitoring device of claim 1.
The combination is silent to: wherein the optical system further comprises at least one removable filter positioned between the monitoring region and the at least one sensor,
wherein the at least one removable filter receives the at least a portion of the optical energy emanating from the monitoring region of the flowcell, selectively blocks a first spectral portion of the received optical energy, and selectively transmits a second spectral portion of the received optical energy toward the at least one sensor.
Kusuzawa teaches: wherein the optical system further comprises at least one removable filter positioned between the monitoring region and the at least one sensor (71 Fig. 4, [0037] teaches band-pass filter between camera 64 and sheath flow cell 30 i.e. monitoring region), wherein the at least one removable filter receives the at least a portion of the optical energy emanating from the monitoring region of the flowcell (see Fig. 4 showing filter 71 receiving at least a portion of the optical energy emanating from the monitoring region of the flowcell (30)), selectively blocks a first spectral portion of the received optical energy ([0037] teaches selective blocking), and selectively transmits a second spectral portion of the received optical energy toward the at least one sensor [0037].
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the combination to include the filter of Kusuzawa in order to allow for selective filtering for noise reduction or examination of specific ranges.
As to claim 26, Shigaki teaches a continuous flowcell monitoring device (flow analyzer 10, Fig. 1) comprising:
to enable attachment of the flowcell monitoring device to a flowcell ([0024] teaches the flow analyzer is attachable to flow cytometer)
a monitoring region of a flow cytometer and an opening positioned for access to the monitoring region,
an optical system comprising:
at least one image sensor (imaging section 12, [0026]),
wherein the optical energy emanates from the monitoring region of the flowcell by operating the flow cytometer ([0060] teaches flow analyzer is used during particle analysis with scattered light or fluorescence i.e. optical energy from operating the flow cytometer, some optical energy would inherently be detected, [0023] teaches scattered light or fluorescence as result of laser irradiation).
Shigaki is silent to: a housing with a connector to enable attachment of the flowcell monitoring device to a flowcell defining: a monitoring region of a flow cytometer and an opening positioned for access to the monitoring region, wherein the housing is configured to couple to an optical system
And: a first lens positioned to: receive optical energy from the monitoring region of the flowcell and substantially collimate the optical energy.
However, Li teaches a housing [0024] with a connector ([0024] teaches fasteners, screws, snaps) to enable attachment of the flowcell monitoring device to a flowcell (Fig.1 shows the optical engine 100 attached to the flow cytometer 10) defining:
a monitoring region of a flow cytometer (Fig. 1 where 100 is attached to 130) and an opening positioned for access to the monitoring region (Fig. 1 shows 100 coupled to the flow cytometer 10 around flow cell 130, Fig. 3 shows light sources 110abc to the left of flowcell 130 and photodiode 186 to the right, the opening would be the area where the housing is mounted around the flowcell 130)
and: a first lens (154) positioned to: receive optical energy from the monitoring region (Fig. 6A) of the flowcell (130) and substantially collimate the optical energy (154, Fig. 6A).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the combination to include the attachable housing of Li in order to be able to remove the optical setup to allow for adjustments, repairs, and cleaning, while ensuring the optical components do not get damaged or displaced. It would have further been obvious to include the collimating lens of Li in order to increase precision.
The combination is further silent to: a second lens positioned to: receive the substantially collimated optical energy from the first lens and substantially focus the substantially collimated optical energy to form the image of the monitoring region on the at least one image sensor.
However, Kusuzawa teaches: a first lens positioned to: receive optical energy from the monitoring region of the flowcell and substantially collimate the optical energy (45, Fig. 4, [0026] teaches collimator lens); and
a second lens positioned to: receive the substantially collimated optical energy from the first lens and substantially focus the substantially collimated optical energy to form the image of the monitoring region on the at least one image sensor (69, Fig. 4, [0036] teaches imaging lens 69 converges light to form image on receiving surface of camera 64, See Fig. 4 showing light being substantially collimated by collimating lens 45 and substantially focused by imaging lens 69, [0026] teaches collimating, [0036] teaches imaging lens converging light onto monitoring region of sensor).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the combination to include the collimating lens and imaging lens of Kusuzawa in order to efficiently focus the light for imaging, in hand reducing the size of the optical set up.
As to claim 27, the combination teaches the continuous flowcell monitoring device of claim 26.
The combination is silent to: wherein the attachment comprises reversible physical attachment.
However, [0024] of Li teaches interchangeability and fasteners, (i.e. detachment is possible).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the combination to include the fasteners and interchangeability of Li in order to be able to remove the housing with the components for cleaning or repair purposes.
As to claim 28, the combination teaches the flowcell monitoring device of claim 26.
The combination is silent to: wherein the optical system further comprises an aperture between the first lens and the second lens.
Kusuzawa teaches an aperture (iris 67, Fig. 4, [0034].
Kusuzawa is silent to: between the first lens and the second lens.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the combination to include the aperture of Kusuzawa and position it between the first lens and the second lens in order to remove any unnecessary light before focusing it on the detector.
As to claim 33, the combination teaches the monitoring device of claim 26.
The combination is silent to: wherein the optical system further comprises at least one removable filter positioned between the monitoring region and the at least one image sensor, wherein the at least one removable filter receives the optical energy emanating from the monitoring region of the flowcell, selectively blocks a first spectral portion of the optical energy, and selectively transmits a second spectral portion of the optical energy toward the at least one image sensor.
Kusuzawa teaches: wherein the optical system further comprises at least one removable filter positioned between the monitoring region and the at least one image sensor (71 Fig. 4, [0037] teaches band-pass filter between camera 64 and sheath flow cell 30 i.e. monitoring region),
wherein the at least one removable filter receives the at least a portion of the optical energy emanating from the monitoring region of the flowcell (see Fig. 4 showing filter 71 receiving at least a portion of the optical energy emanating from the monitoring region of the flowcell (30)), selectively blocks a first spectral portion of the received optical energy ([0037] teaches selective blocking), and s
electively transmits a second spectral portion of the received optical energy toward the at least one sensor [0037].
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the combination to include the filter of Kusuzawa in order to allow for selective filtering for noise reduction or examination of specific ranges.
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 Maya Hendija whose telephone number is (571)272-0269. The examiner can normally be reached M-F 08:00-16:00 (PST).
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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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/MAYA HENDIJA/Examiner, Art Unit 2877
/Kara E. Geisel/Supervisory Patent Examiner, Art Unit 2877