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 .
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Drawings
The drawings are objected to because:
-The drawings are objected to because: Figs. 1, 6, 8A-B and 14 possess labels that are blurry.
-Fig. 9A-B label should possibly read Fig. 9A-D.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description:
-Fig. 5 contains elements 64 and 66. Should possibly read 52 and 54, respectively.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description:
-[0052] references elements 38 and 40 which are not found within the drawings.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The abstract of the disclosure is objected to because:
-Line 3 recites “a one or more”. Examiner recommends amending to –one or more—
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because of the following informalities:
-[0070] recites “Sigma Adrich”, should possibly read –Sigma Aldrich—
Appropriate correction is required.
Claim Objections
Claims 1, 2, 3, 5, 10, 11, 14, 15, 17, 19, 23, 24, 33, 34, 39 are objected to because of the following informalities:
-Claim 1 recites “the device” in line 2. Examiner recommends amending to –the microfluidic device—
-Claim 1 recites “a one or more” in line 5. Examiner recommends amending to –one or more—
-Claims 1, 2, 3, 5, 10, 11, 14, 15, 17, 19, 23, 24, 33, 34, 39 recites “the channel.” Examiner recommends amending to –the first channel—
-Claim 34 recites “valve such the” in line 6. Examiner recommends amending to –valve such that the—
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 following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
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:
-Claim 30 recites “controller” which is a generic placeholder. There is no sufficient structure for this limitation provided in the claims. The function of this limitation is to alternately open and close the first and second valve. According to the specification the controller includes microcontroller and model number LHDA2431115H [0059] and equivalents thereof.
-Claim 33 recites “optical imaging device” which is a generic placeholder. There is no sufficient structure for this limitation provided in the claims. The function of this limitation is to image a portion of the channel. According to the specification the optical imaging device includes CCD or CMOS [0067] and equivalents thereof.
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.
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 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, 2, 3, 5, 9, 10, 11, 12, 13, 14, 15, 17, 19, 23, 24, 26, 30, 33, 34, 39 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 1 recites “a width of about 200µm to about 1 mm” in line 4. It is unclear whether the claim limitation requires a range of 200µm to about 1 mm, or a separate embodiment. Further clarification should be provided.
-Claim 2 recites “as oriented” in line 2. It is unclear what this entails in reference to the limitations set forth by the claim. Further clarification should be provided to define whether this means that the ridge elements are oriented on a top surface of the channel, the ridge elements are oriented in a particular way in reference to another structure or the other ridge elements within the microfluidic device or a separate embodiment.
-Claim 13 recites “one of rectangular, …offset chevron” in line 2. It is unclear whether these limitations are referring to the shape of the ridge elements or a separate embodiment. Further clarification should be provided.
-Claim 14 recites “a length of about 1 cm to about 10 cm” in lines 1-2. It is unclear whether the claim limitation requires a range of 1 cm to about 10 cm, or a separate embodiment. Further clarification should be provided.
-Claim 15 recites “the surface of the substrate” in line 2. There is insufficient antecedent basis for this limitation in the claim.
-Claim 19 recites “elements per mm” in line 2. It is unclear whether this is referring to per mm of the channel or a separate embodiment. Should possibly read –per mm of the channel—
-Claim 33 recites “a cumulus oocyte complex” in line 5. It is unclear whether this is the same or different from the cumulus oocyte complex originally referenced in claim 1, line 1.
-Claim 34 recites “a cumulus oocyte complex” in line 5. It is unclear whether this is the same or different from the cumulus oocyte complex originally referenced in claim 1, line 1.
-Claim 39 recites “a cumulus oocyte complex” in line 5. It is unclear whether this is the same or different from the cumulus oocyte complex originally referenced in claim 1, line 1.
-Claim 39 recites “the optical imaging device” in lines 9-10. There is insufficient antecedent basis for this limitation in the claim.
-Claim 39 recites “the position and/or state” in line 9. There is insufficient antecedent basis for this limitation in the claim.
-Claim 39 recites “the computing device” in line 11. There is insufficient antecedent basis for this limitation in the claim.
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.
Claim(s) 1, 2, 5, 9, 13, 14, 19, 24, 26 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Weng (U.S. Pub. No. 20210161635).
Regarding Claim 1, Weng teaches a microfluidic device for denudation of a cumulus oocyte complex [Abstract]—reference to microfluidic systems that process cumulus-oocyte complexes “denuded” from surrounding cells, the device comprising: a substrate [0060]—reference to substrate of the microfluidic system; a first channel having a width of about 200 µm to about 1 mm located within the substrate and extending from a first end to a second end [0005; “The systems include a substrate and a channel or two or more sub-channels”], [0016]—reference to the channel width of 240-260 µm and reference to the first and second end shown in annotated Fig. 2A-C below, the first channel having a one or more ridge elements located along a surface thereof [0053]—discloses expansion units (element 140) and constriction units (141) interpreted to be the one or more ridge elements; a first port located in the substrate and in fluid communication with the first end of the channel; and a second port located in the substrate and in fluid communication with the second end of the channel [Fig. 2A-B, elements 101 (inlet), 102 (outlet)], [0052]—description of inlet receiving COCs, and [0090]—description of COCs collected at the outlet.
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Regarding Claim 2, Weng teaches wherein the one or more ridge elements are located along a top surface of the channel as oriented during use of the microfluidic device [0087]—where the top surface of the channel is interpreted to be the portion of the channel walls in contact with the COCs based on the recited claim.
Regarding Claim 5, Weng teaches wherein the one or more ridge elements are positioned in an oblique orientation with respect to a longitudinal axis of the channel [0071; “the rows of posts are arranged across the channel, e.g., perpendicular to a longitudinal axis of the channel, or at an angle, e.g., a slight angle, to the longitudinal axis of the channel.”]—where the posts are representative of the one or more ridge elements.
Regarding Claim 9, Weng teaches wherein each of the one or more ridge elements are positioned in a parallel orientation with respect to each of the other one or more ridge elements [0023; “The posts can be ovals…that run in parallel to each other.”] —where the posts are representative of the one or more ridge elements.
Regarding Claim 13, Weng teaches wherein the one or more ridge elements are one of rectangular, chevron, offset chevron, or combinations thereof [0063; “In this embodiment, the expansion units 140 of the first stage 110 are rectangular shaped”].
Regarding Claim 14, Weng teaches wherein the channel comprises a length of about 1 cm to about 10 cm [0072; “the length of the first and second stages 610, 620 are about 10 to 50 mm”].
Regarding Claim 19, Weng teaches wherein the channel comprises 1 to 10 of the one or more ridge elements per mm [Fig. 4A-B, elements 640 (ridges)]—showing approximately 5-6 ridges per row considering [0072]—which describes the 1st stage being 1-50mm in length showing approximately 50 rows of posts/ridges. This would constitute 5-6 ridges per 1 mm given the provided dimensions.
Regarding Claim 24, Weng teaches further comprising at least one secondary channel in fluid communication with the channel [Fig. 3A-C, elements 110 (first channel), 120 (second channel) and 130 (third channel)].
Regarding Claim 26, Weng teaches wherein the substrate comprises a base layer, a control layer, and a flow layer [0060]—describes a PDMS layer (control layer) formed on a glass slide (base layer), and [0087]—description of the microchannels and COCs flowing through the expansion and constriction units to contact inner walls of the constriction channels (flow layer).
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.
Claim(s) 3, 12, 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weng (U.S. 20210161635) in view of Kapur (U.S. 20160123858).
Regarding Claim 3, Weng is silent on wherein the one or more ridge elements are configured to generate a secondary flow of fluid within the channel when a first flow of fluid is applied from the first end of the channel to the second end of the channel. Kapur teaches wherein the one or more ridge elements are configured to generate a secondary flow of fluid within the channel when a first flow of fluid is applied from the first end of the channel to the second end of the channel [0078]—includes disclosure of fluidic resistance flow occurring in the particle sorting region with that region including elements 110 interpreted as the one or more ridge elements.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to cause a change in flow characteristics as taught by Kapur to cause effects to the cells such as denudation as suggested by Weng, as Weng discusses including multiple channels to ensure continuous COC flow should channels become defective or clogged [0067] with Kapur because Kapur teaches utilizing different dimensions across the device to maintain optimal particle shifting [0124].
Regarding Claim 12, Weng is silent on wherein the one or more ridge elements are curvilinear. Kapur teaches wherein the one or more ridge elements are curvilinear [0104]—reference to the islands, interpreted to be the ridge elements, having curved contour.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to design the ridge elements to be curved as taught by Kapur to allow for structural transitioning as suggested by Weng, as Weng discusses using curves to transition the cells between channels [0057] with Kapur because Kapur teaches this curvilinear configuration to create a flow region having undulating longitudinal pathway for fluid samples to propagate [0104].
Regarding Claim 15, Weng is silent on wherein the one or more ridge elements have a depth in the surface of the substrate of less than half of a height of the channel. Kapur teaches wherein the one or more ridge elements have a depth in the surface of the substrate of less than half of a height of the channel [0156]—describes the island structures having a height (interpreted to be depth) of 100nm and the channel height having a height of 500 nm which would be 1/5 of the height of the channel.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to design the ridge elements to a depth less than ½ of the channel height as taught by Kapur to accommodate COC sizes as suggested by Weng, as Weng discusses accommodate the size of the COCs within causing clogging [0056] with Kapur because Kapur teaches these dimensions to control flow characteristics without having to use moving parts within the device [0185].
Claim(s) 10, 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weng (20210161635) in view of Sulchek (WO 2018089512).
Regarding Claim 10, Weng is silent on wherein the one or more ridge elements are equally spaced along the channel. Sulchek teaches wherein the one or more ridge elements are equally spaced along the channel [0080]—describes the ridges equally spaced along the channel length.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to space the ridges equally along the channel as taught by Sulchek to facilitate controlled denudation as suggested by Weng, as Weng discusses ridge and teeth spacing considerations to facilitate denudation without causing excessive damage to the oocyte [0077] with Sulchek because Sulchek teaches the equal spacing to cause a cellular strain of ~15% on each cell type [0080].
Regarding Claim 17, Weng is silent on wherein the one or more ridge elements have a thickness of less than half a width of the channel. Sulchek teaches wherein the one or more ridge elements have a thickness of less than half a width of the channel [0080; “The channel width was 560 μm … The ridges were 20 μm wide”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to design the dimensions of the ridges in reference to the channels as taught by Sulchek to facilitate controlled denudation as suggested by Weng, as Weng discusses the units having different widths to cause the COCs to tumble and contact the inner walls of the units [0056] with Sulchek because Sulchek teaches these dimensions to cause a cellular strain of ~15% on each cell type [0080].
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weng (20210161635) in view of Han (U.S. 9445840).
Regarding Claim 11, Weng is silent on wherein the one or more ridge elements extend an entire width of the channel. Han teaches wherein the one or more ridge elements extend an entire width of the channel [Col 10, lines 35-37]—describes the array, interpreted to be the ridges, coverings the entire width of the micro-channel.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to dimension the widths of the ridges to cover the width of the channel as taught by Han to cause a useful distance considering the size of an oocyte as suggested by Weng, as Weng discusses the constriction units spanning no less than the approximate width of the oocyte to avoid damage to the oocyte [0093] with Han because Han teaches repositioning and allowing for entrance of the oocytes into the micro-well through the use of these dimensions [Col 10, lines 39-43]
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weng (20210161635) in view of Palermo (U.S. 20150031012).
Regarding Claim 23, Weng is silent on further comprising one or more sieve valves located along the channel. Palermo teaches further comprising one or more sieve valves located along the channel [0085]—including description of the funnel shapes exit chamber and cumulus removal channel with further reference to piezoelectric gates (interpreted to be a valve type mechanism).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a gate like isolation structure as taught by Palermo to cause complete removal of cumulus cells as suggested by Weng, as Weng discusses mechanisms for removal of bulky loosely attached cumulus cells [0055] with Palermo because Palermo teaches using this chamber to apply suction to the cumulus cells to remove them [0085].
Claim(s) 30, 33, 34, 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weng (20210161635) in view of Saadat (U.S. 20210121880).
Regarding Claim 30, Weng is silent on further comprising: a first valve coupled to the first port [0036]—with reference to first valve between a first inlet (first port); a second valve coupled to the second port [0038]—reference to a third valve coupled to a third outlet (second port); a pump in fluid communication with the first valve and the second valve [0021-0022]; and a controller coupled to the pump and configured to alternately open and close the first valve and the second valve [0023] and [0041-0042]—describes alternatingly closing the first and second valve and opening the third valve.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include valves, pumps and control means as taught by Saadat to trap materials as suggested by Weng, as Weng discusses selectively trapping unwanted debris [0047] with Saadat because Saadat teaches using this chamber to trap sperm for collection [0042].
Regarding Claim 33, Weng is silent on an optical imaging device configured to image a portion of the channel including a cumulus oocyte complex of the microfluidic device; and a computing device coupled to the optical imaging device, the computing device comprising a processor coupled to a memory and configured to execute programmed instructions stored in the memory comprising: determining, based on one or more images received from the optical imaging device, a state of denudation of the cumulus oocyte complex located in the portion of the channel; and provide one or more instructions to the controller to alternately open and close the first valve and the second valve. Saadat teaches an optical imaging device configured to image a portion of the channel including a cumulus oocyte complex of the microfluidic device [0130]—reference to using microscope cameras and [0140]—reference to use of algorithm and microscopes to detect oocytes;
and a computing device coupled to the optical imaging device, the computing device comprising a processor coupled to a memory and configured to execute programmed instructions stored in the memory [0088]—reference to non-transitory medium and memory and a computer to execute a program
comprising: determining, based on one or more images received from the optical imaging device, a state of denudation of the cumulus oocyte complex located in the portion of the channel [0152; “Polar body position and orientation are recognized (step 803) and the locational information of the polar body and oocyte is provided to the controller of the manipulator, as described in further detail above in relation to FIG. 1.”] ;
and provide one or more instructions to the controller to alternately open and close the first valve and the second valve [0088]—reference to instructions for performing the method with the method defined in [0039-0042].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include visualization and computing capabilities as taught by Saadat to view conditions in the channels of the system as suggested by Weng, as Weng discusses using magnified images to view debris captured in the sub-channels of the system [0041] with Saadat because Saadat which defines the current state of viewing microfluidic systems from a microscope and the user making determinations on the state of the oocyte with no feedback given [0004-0005].
Regarding Claim 34, Weng teaches introducing a fluid into the channel of the microfluidic device through the first port [0046]—reference to COC injected into inlet and traveling through the channel, the fluid comprising a cumulus oocyte complex [0046]; along the one or more ridge elements [0053]—discloses expansion units (element 140) and constriction units (141) interpreted to be the one or more ridge elements.
Weng is silent on and activating the first valve and the second valve such the cumulus oocyte complex is translated along the channel in a first direction toward the second end from the first end. Saadat teaches and activating the first valve and the second valve such the cumulus oocyte complex is translated along the channel in a first direction toward the second end from the first end [0186-0187]—reference to use of oocytes in the system [0042]—reference to sperm traveling to the third outlet for collection.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include injecting sperm and oocyte fluid into the system as taught by Saadat to travel through the system as suggested by Weng, as Weng discusses the COCs traversing through the channels of the system [0046] with Saadat because Saadat discusses the use of the laminar flow aspects of the device to promote collection of samples after traveling through the system [0042].
Regarding Claim 39, Weng teaches introducing a fluid into the channel of the microfluidic device through the first port [0046]—reference to COC injected into inlet and traveling through the channel, the fluid comprising a cumulus oocyte complex [0046]; along the one or more ridge elements [0053]—discloses expansion units (element 140) and constriction units (141) interpreted to be the one or more ridge elements.
Weng is silent on activating the first valve and the second valve using the pump such that the cumulus oocyte complex is translated along the channel in a first direction toward the second end from the first end; monitoring the position and/or state of the cumulus oocyte complex using the optical imaging device; and adjusting, by the computing device, the activation of the first valve and the second valve based on the position and/or state of the cumulus oocyte complex. Saadat teaches activating the first valve and the second valve using the pump such that the cumulus oocyte complex is translated along the channel in a first direction toward the second end from the first end [0186-0187]—reference to use of oocytes in the system [0042]—reference to sperm traveling to the third outlet for collection; monitoring the position and/or state of the cumulus oocyte complex using the optical imaging device; and adjusting, by the computing device, the activation of the first valve and the second valve based on the position and/or state of the cumulus oocyte complex [0152; “Polar body position and orientation are recognized (step 803) and the locational information of the polar body and oocyte is provided to the controller of the manipulator, as described in further detail above in relation to FIG. 1.”] [0104]—reference to adjusting pressure differentials to cause injection of the sperm into the oocyte and [0042]—reference to the valve system;
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to allow for adjustments in the system to change outcome of cellular movement and positioning as taught by Saadat to impact travel through the system as suggested by Weng, as Weng discusses the COCs traversing through the channels of the system [0046] with Saadat because Saadat discusses the use of this adjustment mechanisms to balance injection and holding the cells as needed [0168].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
-Abbaspourrad (U.S. 20190308192)-includes a similar microfluidic system for separation of sperm
-Stewart (U.S. 20190275520)-references perturbation zone in microfluidic system to maintain cell viability
-Nguyen, Darien, Developing Microfluidic Devices for Assisted Reproductive Technologies, CNF REU, NNCI iREU, Paradim, Pgs, 20-21, 2019—discloses an identical type of microfluidic system
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE NICOLE KOHUTKA whose telephone number is (571)272-5583. The examiner can normally be reached Monday-Friday 7:30am-5:00pm EST.
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/B.N.K./Examiner, Art Unit 3791
/CHRISTINE H MATTHEWS/Primary Examiner, Art Unit 3791