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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-14 in the reply filed on 11/18/2025 is acknowledged.
Applicant's election with traverse of species A. 1. Fig. 1 (claims 1-5, 11 and 14-17) in the reply filed on 11/18/2025 is acknowledged. The traversal is on the ground(s) that Fig. 1 “is generic and encompasses the remainder of figures. In addition, Fig. 2 reads on features additionally recited in at least Claims 7-10, Fig. 3 reads on features additionally recited in at least Claim 6 and Fig. 9 reads on features additionally recited in at least Claims 12 and 13.” This is not found persuasive because they are directed to more than one species of the generic invention, and the species are deemed to lack unity of invention because they are not so linked as to form a single general inventive concept as noted in the 09/18/2025 Restriction Requirement.
The requirement is still deemed proper and is therefore made FINAL.
Newly amended claim 15 and its dependent claims 16-17 are eligible for rejoinder, since the claims are drawn only to a product and a process of use of said product.
Claims 1-5, 11 and 14-17 are being examined.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-5, 11 and 14-17 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.
Claims 1, 2, 16 are not clear with respect to what applicant is claiming. The claims do not clearly set forth the metes and bounds of the patent protection desired. The claimed “configured” is unclear what structural configurations are being claimed.
The term “oversized portion of microfluidic channel” in claim 11 is a relative term which renders the claim indefinite. The term “oversized portion of microfluidic channel” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim limitation “configured [...]” has been evaluated under the three-prong test set forth in MPEP § 2181, subsection I, but the result is inconclusive. Thus, it is unclear whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation uses the word “means” or a generic placeholder coupled with functional language, but it is modified by some structure or material that is ambiguous regarding whether that structure or material is sufficient for performing the claimed function. The boundaries of this claim limitation are ambiguous; therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
In response to this rejection, applicant must clarify whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Mere assertion regarding applicant’s intent to invoke or not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph is insufficient. Applicant may:
(a) Amend the claim to clearly invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by reciting “means” or a generic placeholder for means, or by reciting “step.” The “means,” generic placeholder, or “step” must be modified by functional language, and must not be modified by sufficient structure, material, or acts for performing the claimed function;
(b) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, should apply because the claim limitation recites a function to be performed and does not recite sufficient structure, material, or acts to perform that function;
(c) Amend the claim to clearly avoid invoking 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by deleting the function or by reciting sufficient structure, material or acts to perform the recited function; or
(d) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, does not apply because the limitation does not recite a function or does recite a function along with sufficient structure, material or acts to perform that function.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-5, 11 and 14-17 is/are rejected under 35 U.S.C. 102a1/a2 as being anticipated by Stone et al. (WO 2017/034868 A1).
Regarding claim 1, Stone et al. teach:
1. A microfluidic device (e.g., 100, 150) comprising:
a microfluidic channel (e.g., channels/fluidic lines 116-118, ¶ 0003, 0075+);
a positive displacement pump (e.g., 152) comprising a chamber (e.g., 186) fluidically connected to the microfluidic channel (see Fig. 2 for example), wherein the positive displacement pump is configured such that when the positive displacement pump is actuated, fluid within the chamber is displaced into the microfluidic channel (see ¶ 0073-0074, 0097-0101 & Figs. 1-6 for example); and
a fluid reservoir (e.g., 154) fluidically connected to the chamber of the positive displacement pump (see Fig. 2 for example) capable of providing a source of fluid (e.g., 156) to re-fill the chamber after the positive displacement pump has been actuated (see ¶ 0096-0101 & Figs. 2-6 for example), wherein the fluid reservoir is configured such that fluid within the reservoir is sealed within the microfluidic device (see Figs. 1-6 for example).
Regarding claim 15, Stone et al. teach:
15. A method of moving fluid through the microfluidic channel of the microfluidic device of claim 1, the method comprising:
actuating the positive displacement pump of the microfluidic device such that fluid within the chamber of the positive displacement pump is displaced into the microfluidic channel thereby causing fluid to move through the microfluidic channel (see ¶ 0073-0074, 0096-0101 & Figs. 2-6 for example); and
re-filling the chamber of the positive displacement pump from the source of fluid provided by the fluid reservoir of the microfluidic device (see ¶ 0096-0101 & Figs. 2-6 for example).
Regarding claims 2-5, 11, 14, 16, 17, Stone et al. teach:
2. The microfluidic device as claimed in claim 1, wherein the microfluidic device further comprises a first valve (e.g., 160) capable of selectively controlling a flow of fluid between the chamber of the positive displacement pump and the microfluidic channel (see ¶ 0081, 0096-0098 for example), and a second valve (e.g., 162) capable of selectively controlling a flow of fluid between the chamber of the positive displacement pump and the fluid reservoir (see ¶ 0081, 0096-0098 for example).
3. The microfluidic device as claimed in claim 2, wherein at least one of the first and second valves are externally actuatable (see i.e., As described with respect to Figures 3-6, the actuator 168, the first and second valves 160, 162, the system valve 164 and or the system pump 158 may be selectively controlled [...] ¶ 0096).
4. The microfluidic device as claimed in claim 1, wherein the fluid reservoir comprises a fluid storage chamber of the microfluidic device (see Fig. 1 for example).
5. The microfluidic device as claimed in claim 4, wherein the fluid storage chamber is capable of being pre-pressurized to above atmospheric pressure prior to use (see ¶ 0004 & Figs. 2-6 for example).
11. The microfluidic device as claimed in claim 1, wherein the fluid reservoir comprises a portion (e.g., 188) of microfluidic channel adjacent to a port of the positive displacement pump (see Figs. 1-6 for example).
14. The microfluidic device as claimed in claim 1, wherein the microfluidic device is a microfluidic cassette (e.g., 300, Fig. 14 & ¶ 0118-0119).
16. The method as claimed in claim 15, the microfluidic device further comprising a first valve (e.g., 160) capable of selectively controlling the flow of fluid between the chamber of the positive displacement pump and the microfluidic channel (see ¶ 0081, 0096-0098 for example), and a second valve (e.g., 162) capable of selectively controlling the flow of fluid between the chamber of the positive displacement pump and the fluid reservoir (see ¶ 0081, 0096-0098 for example).
17. The method as claimed in claim 16, wherein the method further comprises: closing the second valve and opening the first valve prior to actuating the positive displacement pump; and closing the first valve and opening the second valve prior to re-filling the chamber (see ¶ 0081, 0096-0098 for example).
Claim(s) 1-5, 11 and 14-17 is/are rejected under 35 U.S.C. 102a1/a2 as being anticipated by Battrell et al. (US 2012/0177543 A1).
Regarding claim 1, Battrell et al. teach:
1. A microfluidic device (Abstract+) comprising:
a microfluidic channel (e.g., 152-154, 158-160+);
a positive displacement pump (e.g., 161 ¶ 0157) comprising a chamber fluidically connected to the microfluidic channel (see Fig. 10 for example), wherein the positive displacement pump is configured such that when the positive displacement pump is actuated, fluid within the chamber is displaced into the microfluidic channel (see ¶ 0145-0147, 0157, 0167-0173, 0207-0211 for example); and
a fluid reservoir (e.g., 151) fluidically connected to the chamber of the positive displacement pump (see Fig. 10 for example) capable of providing a source of fluid to re-fill the chamber after the positive displacement pump has been actuated, wherein the fluid reservoir is configured such that fluid within the reservoir is sealed within the microfluidic device (see ¶ 0145-0147, 0157, 0167-0173, 0207-0211 & Figs. 10, 23-24 for example).
Regarding claim 15, Battrell et al. teach:
15. A method of moving fluid through the microfluidic channel of the microfluidic device of claim 1, the method comprising:
actuating the positive displacement pump of the microfluidic device such that fluid within the chamber of the positive displacement pump is displaced into the microfluidic channel thereby causing fluid to move through the microfluidic channel (see ¶ 0145-0147, 0157, 0167-0173, 0207-0211 for example); and
re-filling the chamber of the positive displacement pump from the source of fluid provided by the fluid reservoir of the microfluidic device (see ¶ 0145-0147, 0157, 0167-0173, 0207-0211 for example).
Regarding claims 2-5, 11, 14, 16, 17, Battrell et al. teach:
2. The microfluidic device as claimed in claim 1, wherein the microfluidic device further comprises a first valve capable of selectively controlling a flow of fluid between the chamber of the positive displacement pump and the microfluidic channel, and a second valve capable of selectively controlling a flow of fluid between the chamber of the positive displacement pump and the fluid reservoir (see e.g., 46, 47, 70+ & ¶ 0146+).
3. The microfluidic device as claimed in claim 2, wherein at least one of the first and second valves are externally actuatable (see ¶ 0145-0147 for example).
4. The microfluidic device as claimed in claim 1, wherein the fluid reservoir comprises a fluid storage chamber of the microfluidic device (see ¶ 0145, 0210 & Figs. 3-5, 23-24 for example).
5. The microfluidic device as claimed in claim 4, wherein the fluid storage chamber is capable of being pre-pressurized to above atmospheric pressure prior to use (see ¶ 0079, 0145-0147 for example).
11. The microfluidic device as claimed in claim 1, wherein the fluid reservoir comprises a portion (e.g., 78) of microfluidic channel adjacent to a port of the positive displacement pump (see Figs. 5A-5B for example).
14. The microfluidic device as claimed in claim 1, wherein the microfluidic device is a microfluidic cassette (see ¶ 0207-0210 & Figs. 23-24 for example).
16. The method as claimed in claim 15, the microfluidic device further comprising a first valve capable of selectively controlling the flow of fluid between the chamber of the positive displacement pump and the microfluidic channel, and a second valve capable of selectively controlling the flow of fluid between the chamber of the positive displacement pump and the fluid reservoir (see e.g., 46, 47, 70+ & ¶ 0146+).
17. The method as claimed in claim 16, wherein the method further comprises: closing the second valve and opening the first valve prior to actuating the positive displacement pump; and closing the first valve and opening the second valve prior to re-filling the chamber (see ¶ 0146 for example).
Claim(s) 1, 2, 4, 5, 11 and 15-17 is/are rejected under 35 U.S.C. 102a1/a2 as being anticipated by Nelson et al. (US 2018/0106798 A1).
Regarding claim 1, Nelson et al. teach:
1. A microfluidic device (e.g., 100/200) comprising:
a microfluidic channel (e.g., 20; 120, 150, 160);
a positive displacement pump comprising a chamber (e.g., 130) fluidically connected to the microfluidic channel (see Figs. 5-8 for example), wherein the positive displacement pump is configured such that when the positive displacement pump is actuated, fluid within the chamber is displaced into the microfluidic channel (see ¶ 0032-0036 for example); and
a fluid reservoir (e.g., 110) fluidically connected to the chamber of the positive displacement pump (see Figs. 5-8 for example) capable of providing a source of fluid to re-fill the chamber after the positive displacement pump has been actuated (see ¶ 0032-0036 for example), wherein the fluid reservoir is configured such that fluid within the reservoir is sealed within the microfluidic device (unambiguously derivable from the passages and figures cited).
Regarding claim 15, Nelson et al. teach:
15. A method of moving fluid through the microfluidic channel of the microfluidic device of claim 1, the method comprising:
actuating the positive displacement pump of the microfluidic device such that fluid within the chamber of the positive displacement pump is displaced into the microfluidic channel thereby causing fluid to move through the microfluidic channel (see ¶ 0032-0036 for example); and
re-filling the chamber of the positive displacement pump from the source of fluid provided by the fluid reservoir of the microfluidic device (see ¶ 0032-0036 for example).
Regarding claims 2, 4, 5, 11, 16, 17, Nelson et al. teach:
2. The microfluidic device as claimed in claim 1, wherein the microfluidic device further comprises a first valve capable of selectively controlling a flow of fluid between the chamber of the positive displacement pump and the microfluidic channel, and a second valve capable of selectively controlling a flow of fluid between the chamber of the positive displacement pump and the fluid reservoir (see ¶ 0034 for example).
4. The microfluidic device as claimed in claim 1, wherein the fluid reservoir comprises a fluid storage chamber of the microfluidic device (see Figs. 5-8 for example).
5. The microfluidic device as claimed in claim 4, wherein the fluid storage chamber is capable of being pre-pressurized to above atmospheric pressure prior to use (see ¶ 0034-0036 & Figs. 5-8 for example).
11. The microfluidic device as claimed in claim 1, wherein the fluid reservoir comprises a portion of microfluidic channel adjacent to a port of the positive displacement pump (i.e., upstream portion of 130).
16. The method as claimed in claim 15, the microfluidic device further comprising a first valve capable of selectively controlling the flow of fluid between the chamber of the positive displacement pump and the microfluidic channel, and a second valve capable of selectively controlling the flow of fluid between the chamber of the positive displacement pump and the fluid reservoir (see ¶ 0034 for example).
17. The method as claimed in claim 16, wherein the method further comprises: closing the second valve and opening the first valve prior to actuating the positive displacement pump; and closing the first valve and opening the second valve prior to re-filling the chamber (see ¶ 0032-0036 for example).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEAN KWAK whose telephone number is (571)270-7072. The examiner can normally be reached M-TH, 4:30 am - 2:30 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CHARLES CAPOZZI can be reached at (571)270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DEAN KWAK/Primary Examiner, Art Unit 1798
DEAN KWAK
Primary Examiner
Art Unit 1798