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 10/29/2025 has been entered. Claims 16-34 remain pending in the application. Claims 32-34 are withdrawn. Claims 16-31 are being examined herein.
Status of Objections and Rejections
The objection to the claims 16 and 26 has been withdrawn in view of Applicant's amendment.
The objections to claims 27 and 28 are maintained.
The rejection of claims 16-31 under 35 U.S.C 112(b) are maintained.
New grounds for rejection under 35 U.S.C. 112(b) are necessitated by Applicant’s amendments.
The rejection of claims under 35 U.S.C 102 and 35 U.S.C 103 are being withdrawn in view of Applicant’s amendment.
New grounds of rejection under 35 U.S.C. 102 and 35 U.S.C 103 are necessitated by the amendments
Claim Objections
Claim 24, 27 and 28 are objected to because of the following informalities:
claim 24, line 2, “connecting channels” should read “connection channels” to be consistent;
claim 27, line 3 and claim 28, line 3, “cross section(s)” should read “cross sectional area(s)”.
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 claim limitations that uses the word “means”. Such claim limitations are:
“blocking means configured to block selectively the at least one input and at least one output harvest channels” in claim 17, lines 1-2;
“blocking means configured to block selectively the at least one plurality of input seeding channels and at least one plurality of output seeding channels” in line 18, lines 1-2
“blocking means configured to block selectively each connection channel” in claim 19, line 1;
In this instant case, the corresponding structure for:
the “blocking means configured to block selectively the at least one input and at least output harvest channels” is a “deformable gas permeable membrane” (p. 21, lines 11-12 and p. 32, lines 3-6 and Fig. 4a ) and equivalents thereof;
the “blocking means configured to block selectively the at least one plurality of input seeding channels and at least one plurality of output seeding channels” is a “deformable gas permeable membrane” (p. 21, lines 11-12 and p. 32, lines 3-6 and Fig. 4a) and equivalents thereof.
“blocking means configured to block selectively each connection channel” is a “deformable gas permeable membrane disposed on the seeding channels” (p. 21, lines 11-12 and p. 32, lines 3-6 and Fig. 4a) and equivalents thereof.
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 16-31 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 16 is amended to recite “two distinct elongated segments” in line 20; however it is still unclear whether they are the same, different or inclusive as the “as least two elongated segments” in line 3. For the purpose of examiner, it is being interpreted as the same segments. The limitation is being read as “two of the at least two elongated segments.”
Claims 17-31 are indefinite because of their dependency on claim 16.
Claim 25 newly recites the limitation “the microfluidic device comprises a plurality of connecting channels” in lines 1-2. It is first noted that “connecting channel” and “connection channel” are used interchangeably in the specification (e.g. p. 7, lns. 15-28), and thus It is unclear whether the “connecting channels” in this claim is part of the “one connection channel or a plurality of connection channel” of claim 16, or they are a different set of channels. Clarification is requested. For the purpose of examination, it is being interpreted that they are referring to the same set of channels with claim 25 narrowing the limitation from the options of one connection channel or a plurality connection channels, to now claim 25 requires the option of a plurality of connection channels.
Claim 26 has been amended to recite the limitation “in each seeding tree, the cross sectional areas of the at least one plurality of input seeding channels and the cross sectional areas at least one plurality of output seeding channels respectively decreases with increasing channel path distance from the input seeding tree root and the output seeding tree root” in lines 1-4. This limitation requires each seeding tree includes both input and output seeding channels and both input and output seeding tree roots, which is inconsistent with the recitation of claim 16 where the input seeding tree comprises only the input seeding channels and the input seeding tree root, and the output seeding tree comprises only the output seeding channels and the output seeding tree root. “The examiner suggests the limitation to be amended to “in each seeding tree, the cross sectional areas of the at least one plurality of input seeding channels or the cross sectional areas at least one plurality of output seeding channels decreases with increasing channel path distance from the input seeding tree root or the output seeding tree root, respectively" to overcome the rejection.
Claim Rejections - 35 USC § 102
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.
Claims 16-19, 23-25 and 31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Levhenko et al. (US 20100035292 A1).
Regarding claim 16, Levhenko teaches a microfluidic device (Fig. 2) for processing particles comprising:
a processing chamber (51, 51’ and the top test chamber 45)(p. 3 of the specification, “Within the meaning of the invention a processing chamber is a volume of the microfluidic device in which a bioprocess may be implemented … the chamber may be defined as the volume in which bioprocess parameters may be kept the same, regardless segmentation,” which describes the processing chamber has an intended use of “in which bioprocess may be implemented” following by examples what features or functions the processing chamber may or may not have. Flow through channels 51, 51’ and the top test chamber 45 meets the structural limitation of the intended use) including at least two elongated segments (51, 51’) aligned along a longitudinal direction (X)(Fig. 2);
at least one plurality of input seeding channels (two branched channels connecting between 55 to 51)(see annotated Fig. A below) and one plurality of output seeding channels (two of the branched channels connecting 51’ to 47) (see annotated Fig. A below)(“seeding” is interpreted as an intended use. The channels meet the structural limitation of the intended use) configured to define a seeding flow in a transverse direction (Y) (side to side of Fig. 2) to the longitudinal direction (X) (top to bottom of Fig. 2) of all segments of the processing chamber (Fig. 2 and paras. 0039 and 0053); and
at least one input harvest channel (53) and one output harvest channel (49) configured to define a harvest flow in the longitudinal direction (X) of all segments of the processing chamber (Fig. 2 and para. 0053),
for a first segment S1 (51) of the processing chamber, the at least one plurality of input seeding channels (see annotated figure below) whose junctions with S1 are distributed along S1 (annotated figure), the at least one plurality of input seeding channels (two branched channels connecting between 55 to 51) being defined by a single input seeding tree, said single input seeding tree being a seeding tree having a single input (port 55)(“seeding” is interpreted as an intended use. Port 55 and the branched channels meet the structural limitation of the intended use. Fig. 2 and para. 0053, the “single input seeding tree” has a single input port 55, which branches into two branched channels).
for a second segment S2 (51’) of the processing chamber different from S1, the at least one plurality of output seeding channels (see annotated figure) whose junctions with S2 are distributed along S2 (Fig. 2), the at least one plurality of output seeding channels being defined by a single output seeding tree, said seeding tree with a single output being a seeding tree with a single output (Fig. 2, a single outlet through port 47 includes branched channels, see annotated Fig. A); and
one connection channel (one of the test chambers 45 that is not the top test chamber 45, see annotated figure)
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Figure A. Annotated Fig. 2 with legend of Fig. 1A of Levhenko
Regarding claim 17, , Levhenko teaches all of the elements of the current invention as stated above with respect to claim 16. Levhenko teaches further teaches the microfluidic device comprising blocking means configured to block selectively the at least one input and at least one output harvest channels (valve 54 and valve 7 by outlet 49; paras. 0024 and 0059, the valves made of a deformable, gas permeable elastomeric membrane)(Fig. 2 and paras. 0009 and 0053) when a seeding flow is applied to the processing chamber through the input seeding channels, connection channels and at least one plurality of output seeding channels (interpreted as an intended use. Valve 54 and the valve 7 by outlet 49 meet the structural limitation of the intended use).
Regarding claim 18, Levhenko teaches all of the elements of the current invention as stated above with respect to claim 16. Levhenko teaches the microfluidic device comprising blocking means (valves 7 by the inlet)(paras. 0024 and 0059, the valves made of a deformable, gas permeable elastomeric membrane) configured to block selectively the at least one plurality of input seeding channels and at least one plurality of output seeding channels (Fig. 2 and paras. 0021, 0043 and 0053) when a harvest flow is applied to the processing chamber through the input and output harvest channels (interpreted as an intended use. Valves 7 on the input seeding channels and valves 7 on the output seeding channels meet the structural limitation of the intended use).
Regarding claim 19, Levhenko teaches all of the elements of the current invention as stated above with respect to claim 16. With regard to the limitation “the microfluidic device comprising blocking means configured to block selectively each connection channel when a harvest flow is applied to the processing chamber through the at least one input and at least one output harvest channels,” the invention is being interpreted with the alternative of one connection channel, and thus, this limitation involving multiple connection channels does not apply since there is only one connection channel, and “selectively” requires a plurality of connection channels.
Regarding claim 23, Levhenko teaches all of the elements of the current invention as stated above with respect to claim 16. Levhenko teaches wherein, a pitch (p) between adjacent junctions of the at least one plurality of input seeding channels with the first segment of the processing chamber and the pitch (p) between adjacent junctions of the at least one plurality of output seeding channels with the second segment (21) of the processing chamber is the same (pitch is the distance between successive corresponding points. See annotated Fig. A above).
Regarding claim 24, Levhenko teaches all of the elements of the current invention as stated above with respect to claim 16. With regard to the limitation “wherein a pitch (p) between adjacent junctions of each connecting channel with the segments and the pitch (p) between adjacent junctions of the input seeding channels with the first segment of the processing chamber is the same,” the invention is being interpreted with the alternative of one connection channel. This limitation recites “pitch (p) between adjacent junctions of each connecting channel with the segments” requires a plurality of connection channels, and thus does not apply.
Regarding claim 25, Levhenko teaches all of the elements of the current invention as stated above with respect to claim 16. Levhenko teaches wherein the microfluidic device comprising a plurality of connecting channels (two of the chambers 45, that is not the top chamber 45) and all connecting channels have all the same length (Fig. 2).
Regarding claim 31, Levhenko teaches all of the elements of the current invention as stated above with respect to claim 16. Levhenko teaches the microfluidic device comprising fluidic connectors (two of the chambers 45, that is not the top chamber 45) between segments of the processing chamber (51 and 51’), said fluidic connectors being configured to allow the harvest flow through all the segments of the processing chamber serially (interpreted as a functional limitation. Chambers 45 is structural capable of allowing the harvest flow through 51 and 51’. Para. 0027 and Fig. 2).
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.
Claims 20-22 and 27-30 are rejected under 35 U.S.C. 103 as being unpatentable over Levhenko et al. (US 20100035292 A1).
Regarding claim 20, Levhenko teaches all of the elements of the current invention as stated above with respect to claim 16.
Levhenko fails to teach wherein the surface of the processing chamber (51, 51’ and the top test chamber 45), extending within a plane, perpendicular to the height direction (Z), is greater than 4 cm2.
However, Levhenko teaches the width of the flow-through channels and the length of the test chamber are the result-effective variables (paras. 0017-0018, 0031). Specifically, Levhenko teaches the width of channels need to be sufficiently wide to not inhibit the flow of fluid through the channel, and not excessively wide to inhibit the function of valves (para. 0017). Additionally, Levhenko teaches the length of test chambers 45 is determined based on the type of the cells (paras. 0018 and 0031). Since the particular parameters (the width of the flow-through channels 51 and 51’ and the length of test chamber 45) are recognized as a result-effective variable (i.e. a variable which achieves a recognized result), the determination of the optimum or workable ranges of said variables can be characterized as routine experimentation. See MPEP 2144.05 (II)(A). The area of the surface of processing chamber perpendicular to the height direction is dependent on the width of flow-through channels 51 and 51’ and the length of test chamber 45.
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the width of flow-through channel 51 and 51’ and the length of test chamber 45 of Levhenko such that the surface of the processing chamber (51, 51’ and the top test chamber 45), extending within a plane, perpendicular to the height direction (Z), is greater than 4 cm2 because it would have been within the ambit of one of ordinary skill in the art to arrive at through routine experimentation
Regarding claim 21, Levhenko teaches all of the elements of the current invention as stated above with respect to claim 16.
Levhenko fails to teach wherein the surface of the processing chamber (51, 51’ and the top test chamber 45), extending within a plane, perpendicular to the height direction (Z), is greater than 10 cm2.
However, Levhenko teaches the width of the flow-through channels and the length of the test chamber are the result-effective variables (paras. 0017-0018, 0031). Specifically, Levhenko teaches the width of channels need to be sufficiently wide to not inhibit the flow of fluid through the channel, and not excessively wide to inhibit the function of valves (para. 0017). Additionally, Levhenko teaches the length of test chambers 45 is determined based on the type of the cells (paras. 0018 and 0031). Since the particular parameters (the width of the flow-through channels 51 and 51’ and the length of test chamber 45) are recognized as a result-effective variable (i.e. a variable which achieves a recognized result), the determination of the optimum or workable ranges of said variables can be characterized as routine experimentation. See MPEP 2144.05 (II)(A). The area of the surface of processing chamber perpendicular to the height direction is dependent on the width of flow-through channels 51 and 51’ and the length of test chamber 45.
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the width of flow-through channel 51 and 51’ and the length of test chamber 45 of Levhenko such that the surface of the processing chamber (51, 51’ and the top test chamber 45), extending within a plane, perpendicular to the height direction (Z), is greater than 10 cm2 because it would have been within the ambit of one of ordinary skill in the art to arrive at through routine experimentation.
Regarding claim 22, Levhenko teaches all of the elements of the current invention as stated above with respect to claim 16.
Levhenko fails to teach wherein the surface of the processing chamber (51, 51’ and the top test chamber 45), extending within a plane, perpendicular to the height direction (Z), is greater than 16 cm2.
However, Levhenko teaches the width of the flow-through channels and the length of the test chamber are the result-effective variables (paras. 0017-0018, 0031). Specifically, Levhenko teaches the width of channels need to be sufficiently wide to not inhibit the flow of fluid through the channel, and not excessively wide to inhibit the function of valves (para. 0017). Additionally, Levhenko teaches the length of test chambers 45 is determined based on the type of the cells (paras. 0018 and 0031). Since the particular parameters (the width of the flow-through channels 51 and 51’ and the length of test chamber 45) are recognized as a result-effective variable (i.e. a variable which achieves a recognized result), the determination of the optimum or workable ranges of said variables can be characterized as routine experimentation. See MPEP 2144.05 (II)(A). The area of the surface of processing chamber perpendicular to the height direction is dependent on the width of flow-through channels 51 and 51’ and the length of test chamber 45.
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the width of flow-through channel 51 and 51’ and the length of test chamber 45 of Levhenko such that the surface of the processing chamber (51, 51’ and the top test chamber 45), extending within a plane, perpendicular to the height direction (Z), is greater than 16 cm2 because it would have been within the ambit of one of ordinary skill in the art to arrive at through routine experimentation.
Regarding claim 27, Levhenko teaches all of the elements of the current invention as stated above with respect to claim 16.
Levhenko fails to explicitly teach wherein the ratio of the cross sectional areas(s) (S21) perpendicular to the transverse direction (Y) of the first segment of the processing chamber (flow-through channel 51) to the sum of the average cross sectional area (S31) of the input seeding channels perfusing the first segment (connection channels between port 55 and 51, see annotated figure A and para. 0019) is higher than 5.
However, Levhenko teaches the size (cross sectional area and length) of the connection channels is a result-effective variable (para. 0047). Specifically, Levhenko teaches connection channels must be sufficiently large to delivery sufficient fluids to flow-through channels without inhibiting flow. However, connection channels must be small enough to be fabricated and effectively closed by valves. (0047). Since the particular parameter is recognized as a result-effective variable (i.e. a variable which achieves a recognized result), the determination of the optimum or workable ranges of said variable can be characterized as routine experimentation. See MPEP 2144.05 (II)(A).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the cross sectional area of the connection channels of Levhenko such that the ratio of the cross sectional areas perpendicular to the transverse direction (Y) of the first segment of the processing chamber to the sum of the average cross sections of the input seeding channels perfusing the first segment is higher than 5 because it would have been within the ambit of one of ordinary skill in the art to arrive at through routine experimentation.
Regarding claim 28, Levhenko teaches all of the elements of the current invention as stated above with respect to claim 16.
Levhenko fails to explicitly teach wherein the ratio of the cross sectional area(s) (S21) perpendicular to the transverse direction (Y) of the first segment of the processing chamber (flow-through channel 51) to the sum of the average cross sections (S31) of the at least one plurality of input seeding channels perfusing the first segment (connection channels between port 55 and 51, see annotated figure A and para. 0019) is higher than 10.
However, Levhenko teaches the size (cross sectional area and length) of connection channels is a result-effective variable (para. 0047). Specifically, Levhenko teaches connection channels must be sufficiently large to delivery sufficient fluids to flow-through channels without inhibiting flow. However, connection channels must be small enough to be fabricated and effectively closed by valves. (0047). Since the particular parameter is recognized as a result-effective variable (i.e. a variable which achieves a recognized result), the determination of the optimum or workable ranges of said variable can be characterized as routine experimentation. See MPEP 2144.05 (II)(A).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the cross sectional area of the connection channels of Levhenko such that the ratio of the cross section perpendicular to the transverse direction (Y) of the first segment of the processing chamber to the sum of the average cross sections of the at least one plurality of input seeding channels perfusing the first segment is higher than 10 because it would have been within the ambit of one of ordinary skill in the art to arrive at through routine experimentation.
Regarding claim 29, Levhenko teaches all of the elements of the current invention as stated above with respect to claim 16.
Levhenko fails to explicitly disclose wherein the total volume of the seeding trees (interpreted as the inlet port 55 and its two branched channels and the outlet port 47 and its two branched channels. See annotated Fig. A above) is less than the total volume of the processing chamber (51, 51’ and the top test chamber 45).
However, Levhenko teaches flow-through channel 51 and 51’ are low resistance flow channels, and the width of the channels is a result-effective variable (para. 17). Specifically, Levhenko teaches the width of channels need to sufficiently wide to not inhibit the flow of fluid through the channel, and not excessively wide to inhibit the function of valves. Additionally, Levhenko teaches the size of test chambers 45 is also a result-effective variable (para. 0018) that the size of the test chambers is determined based on the type of the cells. Since the particular parameters (the width of the flow-through channels 51 and 51’ and the size of test chamber 45) are recognized as a result-effective variable (i.e. a variable which achieves a recognized result), the determination of the optimum or workable ranges of said variables can be characterized as routine experimentation. See MPEP 2144.05 (II)(A).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the width of flow-through channel 51 and 51’ and consequently the volume of test chamber 45 of Levhenko such that total volume of the seeding trees is less than the total volume of the processing chamber because it would have been within the ambit of one of ordinary skill in the art to arrive at through routine experimentation.
Regarding claim 30, Levhenko teaches all of the elements of the current invention as stated above with respect to claim 16.
Levhenko fails to explicitly disclose wherein the total volume of the seeding trees (interpreted as the inlet port 55 and its two branched channels and the outlet port 47 and its two branched channels. See annotated Fig. A above) is less than 33% of the total volume of the processing chamber (51, 51’ and the top test chamber 45).
However, Levhenko teaches flow-through channel 51 and 51’ are low resistance flow channels, and the width of the channels is a result-effective variable (para. 00 17). Specifically, Levhenko teaches the width of channels need to sufficiently wide to not inhibit the flow of fluid through the channel, and not excessively wide to inhibit the function of valves. Additionally, Levhenko teaches the size of test chambers 45 is also a result-effective variable (para. 0018) that the size of the test chambers is determined based on the type of the cells. Since the particular parameters (the width of the flow-through channels 51 and 51’ and the size of test chamber 45) are recognized as a result-effective variable (i.e. a variable which achieves a recognized result), the determination of the optimum or workable ranges of said variables can be characterized as routine experimentation. See MPEP 2144.05 (II)(A).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the width of flow-through channel 51 and 51’ and consequently the volume of test chamber 45 of Levhenko such that total volume of the seeding trees is less than 33% of the total volume of the processing chamber because it would have been within the ambit of one of ordinary skill in the art to arrive at through routine experimentation.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Levhenko et al. (US 20100035292 A1) in view of Cao et al. (US 20110296903 A1).
Regarding claim 26, Levhenko teaches all of the elements of the current invention as stated above with respect to claim 16.
Levhenko teaches a single input seeding tree and a single output seeding tree, and each seeding tree has a port opening that leads to a main channel which splits into branch channels. The single input seeing tree has inlet port 55 where buffer is introduced through its opening that leads to a main channel (the flow path between the opening of 55 and where the channel is split into two branches) that splits into two channels (Fig. 2 and paras. 0039 and 0053). The single outlet port has an outlet port 46 that collects fluid a main channel which is connected branch channels from test chambers 45 and the flow through channels (Fig. 2 and annotated Fig. A, and paras. 0039 and 0053).
Levhenko fails to explicitly teach wherein, in each seeding tree, the cross sectional areas of the at least one plurality of input seeding channels and the cross sectional areas of the at least one plurality of output seeding channels respectively decreases with increasing channel path distance from the input seeding tree root and the output seeding tree root (inlet and outlet, which are interpreted as the opening of the ports).
However, Cao teaches a microfluidic device with primary channels, and each primary channel that forks into two branched channels (Fig. 7 and para. 0207). Cao further teaches that the branched channels that emerge from each fork are each about half the size of the original channel at each branch, so that the total cross-sectional area available to a fluid contained within the branch channels is approximately equal to the cross-sectional area of the primary channel. Cao further teaches by maintaining along the length of a branched channel device an essentially constant cross-sectional area available for fluid flow, the disclosed devices minimize the changes and disruptions in flow fields that can result from channels of narrowing or broadening cross-sectional area (para. 0207).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cross sectional area of the branch channels of each seeding tree taught by Levhenko to have a reduced cross sectional area in portion to the number of channels branched from the main channel as taught by Cao in order to essentially constant cross-sectional area available for fluid flow, so that changes and disruptions of the flow field are minimized with a reasonable expectation of success (Cao, para. 0207) (MPEP 2143)(I)(G).
The teachings of Levhenko as modified by Cao would yield in each seeding tree, the cross sectional areas of the at least one plurality of input seeding channels and the cross sectional areas at least one plurality of output seeding channels decreases with increasing channel path distance from the input seeding tree root and the output seeding tree root " (the main channel which are closer to the tree root have a large cross sectional area than that of each of its branch channels. The examiner notes that each seeding tree only has either input or output seeding channels and seeing tree root. See 35 U.S.C. 112(b) above).
Response to Arguments
Applicant’s arguments, see p. 8, filed 10/29/2025, with respect to the claim objections of claims 16 and 28 have been fully considered and are persuasive. The objections of claims 16 and 28 have been withdrawn. However, Applicant’s arguments with respect to the claim objections of claims 27 and 28 have been fully considered and are not fully persuasive. The objections of claims 27 and 28 are maintained. See the objection section above.
Applicant’s arguments, see p. 8, filed 10/29/2025, with respect to the rejections under 35 U.S.C. 112(b) have been fully considered and are not persuasive. While a number of issues pertaining indefiniteness have been cured by the amendments, there are still remaining indefiniteness in claim 16 and a number of dependent claims. For this reason, the rejections of claims 16-31 of 07/29/2025 are maintained. Please see above.
Applicant’s arguments, see pages 9-14, filed 10/29/2025, with respect to the claim rejections under 35 U.S.C. 102 have been fully considered and are not persuasive.
The Applicant argues that claim 16 and all its dependent claims requiring the device of claim 16 are patentably distinguishable over Levhenko because Levhenko fails to teach or suggest every feature recited in claim 16. More specifically, the Applicant argues the rejection in the previous Office Action “does not fully consider the functional aspects of the claimed elements, which shall be considered in interpretation of prior art.” In particular, the Applicant asserts that the technical equivalent of the “processing chamber” in the instant invention is the “test chambers” of Levhenko, and that “flow-through channels” of Levhenko are not functionally equivalent to the processing chamber of claim 16 and thus cannot be considered to be part of the processing chamber. Consequentially, the Applicant alleges, that the processing chamber has only one segment, which is the test chamber of Levhenko. As a result, the Applicant argues that all the features related to the processing chambers, (1), (2), (3), (6), (7), listed on pp. 12 -13 are not taught by Levhenko. Furthermore, the Applicant argues that there are no “single input/output seeding tree” can been seen in Fig. 2 of Levhenko’s teaching. Regarding the “connection channel” (feature 8 on p. 13), the Applicant mentions that the “flow-through channel” may potentially be considered to be the “connection channel;” however, the Applicant states that there appears to be no seeds flow through the “flow-through channel.”
The examiner respectfully disagrees. With respect to the Applicant's argument regarding to “the rejection does not fully consider the functional aspects of the claimed elements”, the interpretation the one of the test chambers 45 along with flow-through channels 51 and 51’ taught by Levhenko as the claimed “processing chamber” does take into consideration of the functional aspects of the processing chamber. As states in the Office Action of 07/29/2025, the examiner did consider page 3, first paragraph of the specification (which is also referred to by the Applicant in p. 10 of Remarks of 10/29/2025) where it states “[w]ithin the meaning of the invention a processing chamber is a volume of the microfluidic device in which a bioprocess may be implemented… ” This statement indicates the processing chamber has an intended use of structurally supporting a bioprocess to be implemented. One of the test chambers 45 along with flow-through channels 51 and 51’ of Levhenko can structurally support a bioprocess, and thus meets the structural limitation of the intended use. The rest of the paragraph describes the structural features and functions the processing chamber “may” possess, and does not further limit the structure of the process chamber. Therefore, it is proper to interpret one of the test chambers 45 along with flow-through channels 51 and 51’ taught Levhenko as the processing chamber of claim 16.
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). Furthermore, “a claim containing a ‘recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus’ if the prior art apparatus teaches all the structural limitations of the claim” (MPEP 2114 II). Since Levhenko teaches the structural limitations of the processing chamber as discussed above and in 35 U.S.C. the 102 section, the claimed processing chamber is not patentably differentiable from the teachings of Levhenko.
On the basis that it is proper to interpret one of the test chambers 45 along with flow-through channels 51 and 51’ taught Levhenko as the processing chamber of claim 16, the Applicant’s arguments relating to (1), (2), (3), (6), (7) are not persuasive. In fact, Levhenko does teach (1), (2), (3), (6), (7) as discussed above in the 35 U.S.C 102 and 103 sections.
In regard to (4) and (5), the argument that there are no “single input/output seeding tree” can been seen in Fig. 2 of Levhenko’s teaching.
The examiner respectful disagrees. Fig. 2 shows input 55 branches to two channels, which meets the structural limitation of a single input seeding tree as recites in claim 16, “the at least one plurality of input seeding channels (two branched channels) being defined by a single output seeding tree, said seeding tree with a single input being a seeding tree with a single input (55). Fig. 2 further shows output 47 that branches to channels, which meets the structural limitation of a single output seeding tree as recites in claim 16, “the at least one plurality of output seeding channels (two of the branched channels) being defined by a single output seeding tree, said seeding tree with a single input being a seeding tree with a single output (47).
Regarding Applicant’s argument (8), since we have established above that it is proper to interpret one of the test chambers 45 along with flow-through channels 51 and 51’ as the processing chamber, “one of the test chambers 45 that is not the top test chamber 45” can be interpreted as the “connection channel” as discussed in the 35 U.S.C. 102 section above.
In view of the above, Levhenko does teach every feature recited in claim 16. Therefore, the arguments are not persuasive.
Applicant’s arguments, see p. 14, filed 10/29/2025, with respect to the claim rejections under 35 U.S.C. 103 have been fully considered and are not persuasive.
The Applicant argues that claims 20-22, 26 and 27-30 (as well as all the dependent claims, claims 17-31, p. 15 of Remarks) are patentable over Levhenko or the combination of Levhenko and Cao on the basis that Levhenko does not teach every features of claim 16. However, Levhenko does teach every features of claim 16 as discussed above. Furthermore, the argument does not provide any specific supposed errors in the examiner’s action. Therefore, this argument is unpersuasive.
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.
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/M.L.C./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758