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 Amendment
The Amendment filed 09/18/2025 has been entered. Claims 1-12, 14-20 and 23 are currently pending. Claims 14-20 and 23 were previously withdrawn, and claims 21-22 were previously cancelled. Claims 4-5 have been canceled and imported to claim 1. Claims 7-9, 12 have been amended to include an extension of recited limitations to the first, second, or third objects of the invention. Claims 1-3, 6-12 are examined herein.
Status of Objections and Rejections
The objections to the claims and drawings have been withdrawn in view of Applicant's amendment.
The rejections under 35 U.S.C. 112(b) are withdrawn in view of Applicant's amendment.
The rejection of claim 9 under 35 U.S.C. 103 has been withdrawn in view of Applicant’s amendment.
The rejection of claims 1-3, 6-8, 10-12, from the previous office action under 35 U.S.C. 103 are maintained.
A new ground of objection to claim 2 as being a substantial duplicate of claim 1 is necessitated by the amendments.
A new ground of rejection to claim 9 under 35 U.S.C. 103 in view of Jurgensen (US 20020090741 A1) is necessitated by the amendments.
Response to Arguments
Applicant's arguments, see pages 8-17, filed 09/18/2025, with respect to the rejection of claims 1-12, under 35 U.S.C. 103, have been fully considered but they are not persuasive.
Applicant (p. 9) disagrees with the Examiner’s claim interpretation that the italicized texts of the office action dated 06/18/2025 indicate intended uses of the invention and will not be given patentable weight. “Applicant submits that the features recited in the claims define the steps of the claimed methods, which are novel and non-obvious. Accordingly, all of the features recited in the claims should be accorded patentable weight in evaluating patentability of the claimed methods over the cited art”.
Applicant’s arguments, see p. 9, filed 09/18/2025, with respect to the Examiner’s claim
interpretations have been fully considered and are persuasive. All claim limitations are therefore accorded patentable weight in evaluating patentability of the claimed methods over the cited art.
Applicant argues (p. 11) “Blainey merely discloses general sieve valves without recognition of the claimed dimensional relationship. The Office's position that a "rectangle is structurally defined to have a short dimension and a long dimension" does not establish that Blainey inherently meets the specific dimensional relationships recited in claim 1. Such a combination of structural relationships is not taught, suggested, or rendered obvious by Blainey”.
The Examiner respectfully disagrees.
Blainey expressly teaches “The channel can have a substantially-rectangular profile…The channel can have an aspect ratio of height to width selected from the group consisting of: less than about 1:2, less than about 1:5, less than about 1:10, and less than about 1:15” ([0030]). Paragraph [0170] and Figs. 2A-2B show that a sieve valve formed by a deflected membrane (206 and 256) matches the shape of the channel and further narrows this width while the length remains constant. This partial seal allows fluid flow while preventing passage of particles larger than the remaining opening, resulting in capture beads accumulating at the valve. Blainey also that states that these rectangular profiles have protrusions of the same shape (See paragraph [0031]). This action thereby demonstrates that particle accumulation and filter formation naturally results from the disclosed non-circular channel geometry and size exclusion.
Applicant argues (p. 11) that Blainey does not disclose microparticles having a hydrodynamic diameter between 1µm and 1000 µm and contends that this range is not the result of routine optimization, but rather was deliberately selected to achieve functional advantages such as stable filter formation and predictable porosity under fluidic shear, which Applicant asserts are neither taught nor suggested by Blainey or Rolland.
The Examiner respectfully disagrees.
Blainey explicitly mentions that the diameter of the capture beads can be varied between 1000 µm and 750 µm “and so on until a desired porosity is achieved” (See paragraph [0171]). Accordingly, the rejection of claim 1 over Blainey and Rolland is maintained.
Applicant asserts (p. 11) that claim 3 requires a processing system coupled to the conduit and argues that Blainey’s disclosure of a mixing circuit merely describes bead and cell mixing, not a downstream analytical or processing system as specifically recited in the claim.
The Examiner respectfully disagrees.
Paragraph [0003] of the instant publication (US 20220291097 A1) teaches that “the processing system comprises a polymerase chain reaction system”. Likewise, Blainey discloses amplification of nucleic acid fragments within the mixing circuit, explicitly stating that amplification may involve, without limitation, polymerase chain reaction (See paragraph [0059]). Thus Blainey’s mixing circuit constitutes a processing system coupled to the conduit as broadly recited in claim 3, and the claim does not require a processing system distinct from or downstream of the mixing circuit. Accordingly, Blainey reasonably teaches the claimed processing system limitation.
Applicant argues (pp. 11-12) that Blainey’s disclosure of flow reversal does not teach the claimed dispersal and reformation of filter elements because Blainey allegedly uses flow reversal to destroy particle aggregation for rinsing, exposure, or lysis, rather than to enable repeatable formation of distinct filter elements with defined porosity. Applicant further contends that Blainey teaches away from maintaining a filter structure during sample withdrawal and that applying Blainey’s mechanism would render the claimed invention inoperable for its intended purpose.
The Examiner respectfully disagrees.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., repeatable dispersion/reformation steps producing sequential and distinct filter elements with defined porosity) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Claims 4-6 do not require maintenance of a permanent or structurally preserved filter element, nor do they recite a specific temporal sequence beyond dispersing a filter element and subsequently forming another. Blainey expressly teaches reversing fluid flow to remove trapped particles from a sieve valve and further teaches that such reversal may be performed a plurality of times, which reasonably corresponds to dispersing a particle aggregation and permitting subsequent re-accumulation when forward flow is resumed (See paragraph [0205]). The claims do not exclude disruption of the aggregation, nor do they require that the filter remain intact during any particular processing step. Accordingly, Blainey’s disclosure of repeated flow reversal and particle trapping teaches or suggests the claimed dispersal and reformation steps. Applicant’s arguments rely on unclaimed distinctions regarding filter integrity, duration, and intended function, which are not afforded patentable weight. Therefore, Blainey does not teach away from the claimed invention, and the rejection is maintained.
Applicant argues (p. 13) that Blainey’s disclosure of binding reagents is generic and does not satisfy the limitations of claims 7-8 for the first microparticles comprising a surface that does not bind nucleic acids.
The Examiner respectfully disagrees.
Blainey teaches that a “”capture substrate” is meant a reagent that specifically binds an analyte to select or isolate the analyte…in the form of a bead, microbead, or surface of a microfluidic circuit” ([0142]). Blainey then lists a number of different analytes that are not nucleic acids (See paragraph [0050]). Isolation naturally requires that only the desired analyte is captured, and that other species pass through without binding. Paragraph [0158] states that nucleic acid binding occurs only when such substrates are in an activated state and therefore would not bind when not functionalized or activated for nucleic acid capture. In the same paragraph, Blainey states that “the capture substrate can be configured to capture…any other cellular component that can be collected from a cell”. The desired reagent is meant to be isolated from other analytes by specific configuration, selection or use of microparticles in a non-binding state for the undesired analyte (e.g. nucleic acid). Doing so represents a routine design choice and does not patentably distinguish the claimed invention. Accordingly, the rejection of claims 7-8 is maintained.
Applicant argues (p. 13) that the teachings of Yang are directed to fluorescence assays and not directed to hydrodynamic capture and filter formation in non-circular openings. Applicant additionally argues that Yang does not satisfy the limitation of microparticles with a fluorinated surface, but rather only teaches a microparticles with a fluorescent surface. Applicant argues therefore that there is no motivation to combine Yang’s teachings with the teachings of Blainey in the manner required by claim 9. Even if combined, the references do not yield the claimed invention without impermissible hindsight reconstruction.
Applicant’s arguments with respect to claim(s) 9 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant’s amendment introduces fluorination of the second microparticles. Reference Jurgensen (US 20020090741 A1) is applied to teach this newly added feature.
Applicant argues (p. 13) that Rolland’s PFPE materials of claim 10 are unrelated to microparticle trapping and filter element formation and therefore “the cited advantages of PFPE (solvent resistance, curing speed) are unrelated to the Applicant's recognition of filter element formation and do not provide motivation to make the claimed modification”.
The Examiner respectfully disagrees.
In response to applicant's argument that Rolland is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992).
Blainey expressly incorporates Rolland by reference, thereby making Rolland’s teachings part of Blainey’s disclosure for purposes of obviousness analysis (See paragraphs [0168] and [0451] of Blainey). As a result, the use of fluorinated PFPE materials for forming microfluidic conduit surfaces is already contemplated within Blainey’s disclosure, and reliance on Rolland does not constitute an improper combination of unrelated references but rather an application of incorporated teachings expressly identified by Blainey. Accordingly, the rejection of claim 10 is maintained.
Applicant argues (p. 13) “claim 11 recites a polymerase chain reaction system, which is not taught or suggested in the cited art. Claim 12 recites specific geometric relationships (spherical microparticles and rectangular openings) that confer the functional ability to form controlled filter elements. Blainey's generalized disclosure of bead trapping does not rise to the level of the claimed structural definitions.
The Examiner respectfully disagrees.
Blainey discloses amplification of nucleic acid fragments within the mixing circuit, explicitly stating that amplification may involve, without limitation, polymerase chain reaction (See paragraph [0059]). Thus Blainey’s mixing circuit constitutes a processing system coupled to the conduit as broadly recited in claim 3, and the claim does not require a processing system distinct from or downstream of the mixing circuit. Accordingly, Blainey reasonably teaches the claimed processing system limitation. Blainey also discloses spherical microparticles and rectangular profiles with protrusions of the same shape (See paragraph [0031] of Blainey and the arguments of for claim 1 above). Accordingly, the rejection of claims 11-12 is maintained.
The rejection of claims 1-3, 6-12 under 35 U.S.C. 103 is maintained.
Drawings
The drawings were received on 09/18/2025. These drawings are acceptable.
Claim Objections
Claims 2 and 12 objected to because of the following informalities:
Claim 2 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 1. Claim 2 is a duplicate of lines 10-11 of claim 1. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Application may correct this by cancelling claim 2.
Claim 12, line 3 states “the opening”. Applicant may correct this to read “the non-circular opening” as consistent with independent claim 1.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
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.
Claims 1-3, 5-8, 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Blainey (US 20160215332 A1) and Rolland (Solvent-Resistant Photocurable “Liquid Teflon” for Microfluidic Device Fabrication, 2004), incorporated by reference.
Regarding claim 1, teaches a method for providing a first filter element (microfluidic device generally disclosed herein can be used to capture or separate an analyte using any suitable capture or separation means; [200]) comprising
(i) providing a first suspension (capture substrate; [0050]) comprising a plurality of first microparticles (“the capture substrate may comprise more than one capture bead,” where the “Capture substrates may be in the form of a…microbead”; [0050][0159]) in a first liquid (The capture substrate can include one or more capture reagents; [0050]) wherein the first microparticles have a first diameter of between 1 µm and 1000 µm (“1 mm diameter capture beads can be introduced upstream of the deployed sieve valve,” wherein 1 mm corresponds to 1000 µm; [0171]); and
(ii) applying the first suspension (the capture substrate may comprise more than one capture bead loaded into the microfluidic channel 100; [0159]) to at least one non-circular opening (“The channel can have a substantially-rectangular profile,” and “The deflected membrane may have a different profile shape than the microfluidic channel” wherein the at least one non-circular opening is the gap between the inner walls of the channel 202 or 252 of sieve valves 200 or 250 and “the partial seal of the membrane 206 or 256” as shown in Figs. 2A-B below, which could never achieve a circular opening between a rectangle and any other shape; [0170][0172])(The sieve valves are located within the microfluidic channel 100) with a short dimension and a long dimension (a rectangle is structurally defined to have a short dimension and a long dimension), wherein the short dimension is less than the hydrodynamic diameter of the first microparticles ( the capture substrate has a dimension that is…larger than the height of the microfluidic channel 100 at a closed sieve valve, such as any of sieve valves 108a-108i; [0159]; Fig. 2B), and the long dimension is at least 2x the hydrodynamic diameter of the first particles (“The channel can have an aspect ratio of height to width selected from the group consisting of: less than about 1:2, less than about 1:5, less than about 1:10, and less than about 1:15; [0030]), so that the first microparticles accumulate (The cells and capture substrate can be concentrated at a sieve valve in the holding chamber; [0175]) and form a first filter element comprising the first microparticles at the non-circular opening (As more and more capture beads 260 are trapped at the sieve valve, the capture beads 260 form a column that traps cells 262; [0170]).
Wherein the applying comprises flowing the first liquid into and through the non-circular opening (When the sieve valve 250 is activated, fluid may still continue to flow, for example in direction 258, through the valve. Capture beads 260 are trapped at the membrane 256 because they are too large to fit past the partial seal of the membrane 256; [0170]).
(iii) dispersing the first filter element formed in step (ii) by (a) flowing a second liquid out of and through the opening to disperse the first microparticles at the non-circular opening, or (b) reversing flow of the first liquid out of and through the non-circular opening to disperse the first microparticles at the non-circular opening (The fluid flow direction can then be reversed as depicted in FIG. 53B to flow fluid over the trapped objects of interest; [0205])(See dispersion or change of fluid flow and shift of microbeads from Fig. 53A to Fig. 54B below)(Since “The flow direction can be reversed a plurality of times,” the second liquid can be formed after the wash or reverse in fluid flow of the first liquid; [0205]).
PNG
media_image1.png
720
581
media_image1.png
Greyscale
PNG
media_image2.png
745
537
media_image2.png
Greyscale
Figs. 53A-B of Blainey
(iv) forming a second filter element (in a first interpretation, the second filter element occurs within one of the individual chambers 103a-103c that is different than the individual chamber wherein the first filter element is formed. In this first interpretation, the limitations of the claim are met by duplicating the steps of independent claim 1, since the inlet channel splits within all three individual chambers each containing adjustable sieve valves and the capture substrate can also be split)(In a second interpretation, the second filter element is formed within the same individual chamber as the first filter element and the steps are outlined below) by applying a second suspension of a plurality of second microparticles in a third liquid to the at least one non-circular opening (“A capture substrate can be loaded into the mixing circuit again,” wherein adding another capture substrate comprises a second plurality of microparticles or microbeads and a third liquid or a capture reagent, wherein the capture substrate must also be applied to the holding chamber before reaching the mixing chamber; [0188][0050])(Paragraph [0171] states that if the diameter of the first capture beads are insufficient to retain a sample then small diameter of capture beads can be supplied and so on until a desired porosity is achieved), wherein the second microparticles have a second diameter of between 1 µm and 1000 µm (“capture beads of 0.75 mm,” wherein 0.75 mm converts to 750 µm, and the second microparticles atop or between the first microparticles are still located at the at least one opening; [0071]), wherein the short dimension of the non-circular opening is less than the hydrodynamic diameter of the second microparticles (the capture substrate has a dimension that is…larger than the height of the microfluidic channel 100 at a closed sieve valve, such as any of sieve valves 108a-108i; [0159]; Fig. 2B), and the long dimension is at least 2x the hydrodynamic diameter of the first particles (“The channel can have an aspect ratio of height to width selected from the group consisting of: less than about 1:2, less than about 1:5, less than about 1:10, and less than about 1:15; [0030]), thereby forming the second filter element comprising the second microparticles at the non-circular opening (The cells and capture substrate can be concentrated at a sieve valve in the holding chamber; [0175])(As more and more capture beads 260 are trapped at the sieve valve, the capture beads 260 form a column that traps cells 262; [0170])(The second filter element can also be formed by applying the capture substrate to a different opening within the sieve channels of chambers 103a-103c of Fig. 1).
Blainey is silent to teaching the second microparticles have a first and second hydrodynamic diameter between 1 µm and 1000 µm (emphasis added). However, the selected physical diameter of the second microparticles or microbeads and the selected first and second liquid or capture reagent can be routinely optimized to create a hydrodynamic diameter (diameter when immersed in the first liquid or capture reagent due to the coating of the microparticles or microbeads) to be within the range of 1 µm and 1000 µm. The height of the channels 202 and 252 of the sieve valves 200 and 250 of Fig. 2A-B is selected between about 5 µm-55 µm ([0030]) so that the “capture beads 260 are trapped at the membrane 256 because they are too large to fit past the partial seal of the membrane 256” ([0170]). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Blainey to specify the first and second microparticles have a second hydrodynamic diameter between 1 µm and 1000 µm, so as to account for the appropriate true diameter of the microbead while in the capture reagent or any other liquid that would produce the desired result of trapping the microbead within the sieve valve in order to block passage of “capture beads 260 and cells 262” ([0170]) and thereby filter analytes of interest by the microbeads as shown in Fig. 2B. It is also advantageous to select such a diameter so as to achieve the desired porosity to retain a sample component ([0171]).
Regarding claim 2, Modified Blainey teaches the method of claim 1, wherein the first suspension is applied to the at least one non-circular opening by flowing the first liquid into and through the non-circular opening (When the sieve valve 250 is activated, fluid may still continue to flow, for example in direction 258, through the valve. Capture beads 260 are trapped at the membrane 256 because they are too large to fit past the partial seal of the membrane 256; [0170])( Claim 2 is a duplicate limitation of claim 1)(See objection above).
Regarding claim 3, Modified Blainey teaches the method of claim 1, wherein the non-circular opening comprises an opening to a conduit (input port 106; [0157]; Fig. 1 below) leading to a processing system (mixing circuit 104, see Fig. 1)(“Using this column of beads, cells can be concentrated inside holding chamber 102 before passing the cells to further processing steps inside the mixing circuit 104; [0159])( The holding chamber 102 includes individual chambers 103a-103c that are connected to an input port 106 of the mixing circuit 104; [0157]).
PNG
media_image3.png
791
567
media_image3.png
Greyscale
Fig. 1 of Blainey
PNG
media_image4.png
698
619
media_image4.png
Greyscale
Fig. 2B of Blainey
Regarding claim 6, Modified Blainey teaches the method of claim 5, further comprising dispersing the second filter element by a)flowing a fourth liquid out of and through the non-circular opening to disperse the second microparticles at the non-circular opening or( b) reversing flow of the third liquid out of and through the non-circular opening to disperse the second microparticles at the non-circular opening (The fluid flow direction can then be reversed as depicted in FIG. 53B to flow fluid over the trapped objects of interest; [0250])(See dispersion or change of fluid flow and shift of microbeads from Fig. 53A to Fig. 54B)(Since “The flow direction can be reversed a plurality of times,” the fourth liquid can be formed after the wash or reverse in fluid flow of the capture substrate containing the third liquid and a second suspension of microparticles).
Regarding claim 7, Modified Blainey teaches the method of claim 1, wherein:
the first microparticles comprise a surface that adsorbs at least one component of the first liquid (the capture substrate can be configured to capture a protein, such as hemoglobin, antibodies, carbohydrates, small molecules, or any other cellular component that can be collected from a cell; [0158]); or
the second microparticles comprise a surface that adsorbs at least one component of the third liquid;
both (a) and (b).
Regarding claim 8, Modified Blainey teaches the method of claim 1, wherein:
the first microparticles comprise a surface that does not bind nucleic acids (paragraph [0158] explains that the microbeads can be treated with an activation chemical that can selectively bind to a cellular component of interest. The cellular component of interest can be chosen to be a component that is not a nucleic acid.)
the second microparticles comprise a surface that does not bind nucleic acids;
or both (a) and (b).
Regarding claim 10, Modified Blainey teaches the method of claim 3.
Modified Blainey fails to teach the conduit comprises an inner fluorinated surface. However, Blainey does teach that “functionalized photocurable perfluoropolyether (PFPE) is particularly useful as a material for fabricating solvent-resistant microfluidic devices” ([0168])). Figures 2 and 3 of Rolland (incorporated by reference) show inner channels made of a PFPE (page 2323). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Blainey to specify the conduit to comprise an inner fluorinated surface. Doing so will allow the capture reagents and other fluids to travel easily through the conduit with little to no swelling (page 2323, column 1, paragraphs 3, 5) which proves resistance to organic solvents (page 2323, column 2, paragraph 2). Also, photocuring of the inner conduit surface decreases fabrication from several hours to a matter of minutes as compared to PDMS (page 2323, column 2, paragraph 2).
Regarding claim 11, Modified Blainey teaches the method of claim 3, wherein the first liquid, the third liquid, or both the first liquid and the third liquid comprise nucleic acid (one or more capture reagents, including…nucleic acid; [0050]) and the processing system (mixing circuit 104, see Fig. 4) comprises a polymerase chain reaction system (amplifying the nucleic acid fragments inside the mixing circuit. Amplifying can involve, for example without limitation, polymerase chain reaction (PCR); [0059]).
Regarding claim 12, Modified Blainey teaches the method of claim 1, wherein the first microparticles, the second microparticles, or both first and second microparticles are spherical (a bead with a diameter is a sphere, see spherical shape of microbead in Fig. 2B) and wherein the opening has a rectangular shape (“The channel can have a substantially-rectangular profile,” and “the one or more protrusions can each have a substantially rectangular profile,” ; [0030])(See rectangular shape of opening between 256 and 252 blocked by microbeads 260 in Fig. 2B).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Blainey (US 20160215332 A1) and Rolland (Solvent-Resistant Photocurable “Liquid Teflon” for Microfluidic Device Fabrication, 2004), incorporated by reference, in view of Jurgensen (US 20020090741 A1 ).
Regarding claim 9, Modified Blainey teaches the method of claim 1, and first and second microparticles.
Modified Blainey fails to teach the first, second, or both microparticles have a fluorinated surface.
Jurgensen teaches microparticles having a fluorinated surface (The microbeads are
made of a suitable material that is non-reactive with the target component…Suitable materials include…fluorinated…resins ; [0045]).
Jurgensen is considered to be analogous to the claimed invention because it is in the
same field of endeavor for microparticle separation using microbeads. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the second microparticles taught by Blainey with microbeads made of a fluorinated resin taught by Jurgensen. Doing so would provide an additional layer of separation for unwanted target analytes. Blainey describes the use of multiple microparticle populations within a microfluidic device to achieve controlled retention of cellular components under flow. In order to facilitate the separation, Blainey employs a capture microbead that “selectively binds a cellular component of interest” ([0158]). The addition of the second fluorinated microbeads of Jurgensen would provide the benefit of allowing the undesired cellular components of the same or subsequent fluid to continue to flow downstream and therefore isolate the components of interest. These undesired cellular components can then become the desired components in another separation process. Combining the binding microbeads of Blainey with Jurgensen’s fluorinated microbeads represents a routine materials optimization that is well-known in the art and would have yielded the predictable result of further separation between cellular components (See MPEP 2143(I)(B)).
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 VALERIE SIMMONS whose telephone number is (703)756-1361. The examiner can normally be reached M-F 7:30-4:00.
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 on 571-270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/V.S./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758