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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/17/2026 has been entered.
Response to Amendment
The Amendment filed on 2/17/2026 has been entered. Claims 14-21 remain pending in the application.
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.
Claims 14-20 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. Claim 14 recites “the channel tapers immediately prior to at an entry point into the first intersection” does not appear to have support in the specification as filed. The applicant points to figure 5A as providing support for this limitation; however, the examiner does not see the support for this limitation in this figure. When looking at item 164 (the main channel) the examiner might see that the channel could be tapering as it approaches item 161, however, there are several lines which are shown and it is unclear how these lines show a taper to the intersection. Further one of the lines on item 164 looks to be tapering inwards, but just before it ends there is a flat point to the line which would seem to indicate that it stops tapering just before getting to the intersection. Therefore, the examiner does not see where the written description is for this limitation.
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 14-20 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 14 recites “the channel tapers immediately prior to at an entry point into the first intersection,” however, it is unclear what is meant by “immediately prior.” As described above, there doesn’t appear to be support for the channel to taper until right before the intersection, which appears to be what applicant is trying to claim. However, the specification as filed appears to also show (for example in figure 5b) that the channel tapers and then there is a straight section right before the first intersection. As the specification does not help to clarify what is meant by “immediately prior,” the examiner interprets that there cannot be any other structure besides the channel between the taper and the first intersection. Claims 15-19 are rejected by virtue of their dependence on a rejected base claim.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claim(s) 14, 15, 17 and 19-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over United States Application Publication No. 2005/0123450, hereinafter Gilbert in view of United States Application Publication No. 2009/0201504, hereinafter Ho and United States Application Publication No. 2004/0089798, hereinafter Gruber.
Regarding claim 14, Gilbert teaches a method of sorting particles in a fluid mixture (paragraph [0033]), the method comprising: flowing the fluid sample (item 160) comprising a plurality of the components into a channel of a microfluidic chip (paragraph [0050]); flowing a first sheath fluid flow (item 120) and a second sheath fluid flow (item 130) into the microfluidic chip (figures 4a-4d); intersecting the fluid sample with the first sheath fluid flow at a first intersection such that the plurality of components in the fluid mixture is compressed on all sides by the sheath fluid from the first sheath fluid flow (paragraph [0042]), thereby focusing the fluid sample while maintaining laminar flow in the channel (paragraph [0050]); intersecting the fluid sample and the first sheath fluid flow with the second sheath fluid flow at a second intersection of the microfluidic chip (figure 4c), thereby further focusing the fluid sample and causing the plurality of components to flow in approximately single file formation and uniform orientation (paragraph [0003]), while maintaining laminar flow in the channel (paragraph [0050]).
Gilbert fails to teach wherein the channel tapers immediately prior to at an entry point into the first intersection.
Ho teaches a hydrodynamic focusing method where the channel tapers (item 64) and then a straight stability section prior to at an entry point into the first intersection (between items 65 and 66) so that multiple beads are forced to align one by one when they reach the narrower channel section and to decrease any rotational force (Ho, paragraphs [0059]-[0060]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have added a taper and a straight section to the channel (thereby the taper is immediately before the first intersection (see 112b rejection above)) before the first intersection of the sheath fluid because it would allow for multiple beads to align one by one when they reach the narrower channel section and to decrease any rotational force (Ho, paragraphs [0059]-[0060]).
Gilbert and Ho fail to teach interrogating components of the plurality of components at an interrogation location in the microfluidic chip by emitted light induced by a light source; distinguishing selected components of the plurality of components based on the interrogating; and damaging or killing the selected components in the sample fluid mixture with a focused energy device which emits a focused energy beam.
Gruber teaches a method of sorting materials in which interrogates components of the plurality of components at an interrogation location in the microfluidic chip by emitted light induced by a light source (Gruber, paragraph [0040]); distinguishing selected components of the plurality of components based on the interrogating (Gruber, paragraph [0041]); and damaging or killing the selected components in the sample fluid mixture with a focused energy device which emits a focused energy beam (Gruber, paragraph [0178]) so that the cells can be interrogated, distinguished and one or more groups of cells can be killed and the dead cells removed from the fluid in an output channel (Gruber, paragraphs [0160] and [0178]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to interrogated components of the fluid mixture using emitted light from a light source, distinguished selected components and then killed the selected components with a focused energy device because it would allow for one or more groups of cells can be killed and the dead cells removed from the fluid (Gruber, paragraph [0178]).
Regarding claim 15, modified Gilbert teaches further comprising collecting the selected components and the unselected components through at least one output channel (see supra).
Regarding claim 17, Gilbert teaches wherein at the first intersection, the plurality of components in the fluid mixture are compressed by sheath fluid to form a relatively smaller, narrower stream (figure 4b).
Regarding claims 19 and 20, modified Gilbert, as described above, teaches all limitations of claim 14; however, modified Gilbert, as described above, fails to teach the plurality of the components are sperm cells and the interrogating the sperm cells in the fluid sample selects cells based on viability, motility, gender, label, desirable trait, DNA content, surface marker, membrane integrity, predicted reproductive status, health, or survival characteristics.
Gruber further teaches sperm sorting in which the sperm is sorted by and whether the sperm is X or Y (Gruber, paragraph [0047]) which would allow for an efficient way to select the gender of offspring in farm animals (Gruber, paragraph [0005]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have utilized sperm as the components and to have select the sperm based upon the gender because it would allow for an efficient way to select the gender of offspring in farm animals (Gruber, paragraph [0005]).
Regarding claim 21, Gilbert teaches a method of sorting particles in a fluid mixture (paragraph [0033]), the method comprising: flowing the fluid sample (item 160) comprising a plurality of the components into a channel of a microfluidic chip (paragraph [0050]); flowing a first sheath fluid flow (item 120) and a second sheath fluid flow (item 130) into the microfluidic chip (figures 4a-4d); intersecting the fluid sample with the first sheath fluid flow at a first intersection such that the plurality of components in the fluid mixture is compressed on all sides by the sheath fluid from the first sheath fluid flow (paragraph [0042]), thereby focusing the fluid sample while maintaining laminar flow in the channel (paragraph [0050]); intersecting the fluid sample and the first sheath fluid flow with the second sheath fluid flow at a second intersection of the microfluidic chip (figure 4c), thereby further focusing the fluid sample and causing the plurality of components to flow in approximately single file formation and uniform orientation (paragraph [0003]), while maintaining laminar flow in the channel (paragraph [0050]).
Gilbert fails to teach wherein the channel tapers immediately prior to at an entry point into the first intersection.
Ho teaches a hydrodynamic focusing method where the channel tapers (item 64) and then a straight stability section prior to at an entry point into the first intersection (between items 65 and 66) so that multiple beads are forced to align one by one when they reach the narrower channel section and to decrease any rotational force (Ho, paragraphs [0059]-[0060]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have added a taper and a straight section to the channel (thereby the taper is immediately before the first intersection (see 112b rejection above)) before the first intersection of the sheath fluid because it would allow for multiple beads to align one by one when they reach the narrower channel section and to decrease any rotational force (Ho, paragraphs [0059]-[0060]).
Gilbert and Ho fail to teach interrogating components of the plurality of components at an interrogation location in the microfluidic chip by emitted light induced by a light source; distinguishing selected components of the plurality of components based on the interrogating; damaging or killing the selected components in the sample fluid mixture with a focused energy device which emits a focused energy beam and flowing the fluid sample and sheath fluid through a plurality of output channels to remove the fluid sample and sheath fluids from the microfluidic chip.
Gruber teaches a method of sorting materials in which interrogates components of the plurality of components at an interrogation location in the microfluidic chip by emitted light induced by a light source (Gruber, paragraph [0040]); distinguishing selected components of the plurality of components based on the interrogating (Gruber, paragraph [0041]); damaging or killing the selected components in the sample fluid mixture with a focused energy device which emits a focused energy beam (Gruber, paragraph [0178]) and two output channels so that the cells can be interrogated, distinguished and one or more groups of cells can be killed and the dead cells sorted and removed from the fluid in an output channel (Gruber, paragraphs [0156], [0160] and [0178]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to interrogated components of the fluid mixture using emitted light from a light source, distinguished selected components and then killed the selected components with a focused energy device and utilized two output channels because it would allow for one or more groups of cells can be killed and the dead cells sorted and removed from the fluid (Gruber, paragraph [0178]).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gilbert, Ho and Gruber as applied to claim 14 above, and further in view of United States Patent No. 6,159,739, hereinafter Weigl.
Regarding claim 16, Gilbert, Ho and Gruber teach all limitations of claim 14; however, they fail to teach the channel tapers into the interrogation location.
Weigl teaches a sheath fluid device in which the diameter of the flow channel can taper from a wider to a narrower downstream portion which leads to horizontal hydrodynamic focusing (Weigl, column 5, lines 54-57).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have tapered the sample input channel tapers into said interrogation apparatus because it would lead to horizontal hydrodynamic focusing (Weigl, column 5, lines 54-57).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gilbert, Ho and Gruber as applied to claim 14 above, and further in view of United States Application Publication No. 2013/0164773, hereinafter Bardell.
Regarding claim 18, Gilbert, Ho and Gruber teach all limitations of claim 14; however, they fail to teach wherein the second sheath fluid flow intersects from above and below said channel at the second intersection.
Bardell teaches disposable cartridges for analyzing blood samples with light measuring instrument with sample fluid positioned by fluid from a first sheath fluid sub channel and a second sheath fluid sub channel located downstream from the first sheath fluid sub channel which deliver sheath fluid from above and below the channel which provides an improved and three-dimensional hydrodynamic focusing of sample flow (Bardell, abstract, [0047]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to have made the two sets of sheath fluid channels intersect the sample input channel on different planes and made the second plurality of sheath channels intersect from above and below the channel because it would provide an improved and three-dimensional hydrodynamic focusing of sample flow (Bardell, abstract, [0047]).
Response to Arguments
Applicant's arguments filed 2/17/2026 have been fully considered but they are not persuasive.
Regarding applicant’s argument regarding feature 1 and that Ho does not teach the channel tapers immediately prior to at an entry point into the first intersection is not found persuasive. As discussed above the examiner interprets that there cannot be any other structure besides the channel between the taper and the first intersection. Therefore, the straight section of channel in Ho would still allow the modified Gilbert to render the claims as obvious.
Regarding applicant’s argument that flowing the fluid and sheath fluid through a plurality of output channels to remove the fluid sample and sheath fluid from the microfluidic chip is not found persuasive. As detailed above in the rejection of claim 21, Gruber teaches having a plurality of output channels in which the all of the fluid flow out of and the output channels allow for the sorting of the cells within the fluid.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW D KRCHA whose telephone number is (571)270-0386. The examiner can normally be reached M-Th 7am-5pm.
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, Maris Kessel can be reached at (571)270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW D KRCHA/ Primary Examiner, Art Unit 1796
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