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 .
Status of Claims
The claims set submitted on 28 AUGUST 2026 is acknowledged and considered. In the claim set, Claims 1, 2 and 7 are ‘Currently Amended’; Claims 3-6, 8, 14, 15, and 16 are ‘Previously presented’; Claims 9-13 are ‘Cancelled’; and Claims 17-19 are ‘New’.
Current pending claims are Claims 1-8 and 14-19 and are considered on the merits below.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 20 JULY 2026 was filed after the mailing date of the Non-Final Office Action on 02 JUNE 2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
The information disclosure statement (IDS) submitted on 27 AUGUST 2026 was filed after the mailing date of the Non-Final Office Action on 02 JUNE 2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment/Arguments
Applicant’s arguments, see REMARKS, filed 28 AUGUST 2026, with respect to the objection the drawing and specification have been fully considered and are persuasive. The objection the drawings and specification has been withdrawn.
Applicant's arguments filed 28 AUGUST 2026 have been fully considered but they are not persuasive.
In the REMARKS, Applicant asserts that the amendment to the claim including “maintaining the lysate on the carrier substrate for a sufficient time to obtain a cell sediment in wells of the carrier substrate separate from a cell suspension of the lysate” clarifies claim language.
However, this claim language does not obviate the 101 rejection. The newly added language merely adds a clarifying step which is considered to be an extra presolution activity which would added to a mere data gathering step. See MPEP 2106.05(g).
The claim still includes an ‘identifying step’, which is considered to a mental step and/or a step which can be used done with a pen and paper. See MPEP 2106.04(a).
Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Applicant's arguments do not comply with 37 CFR 1.111(c) because they do not clearly point out the patentable novelty which he or she thinks the claims present in view of the state of the art disclosed by the references cited or the objections made. Further, they do not show how the amendments avoid such references or objections.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
The claim(s) recite(s) process for detecting nucleus-containing cells in a sample liquid of a patient using a microfluidic device, comprising: providing a mixing signal to an interface with a mixing device, wherein the mixing signal causes mixing of the sample liquid with a lysis buffer in a mixing chamber of the microfluidic device to obtain a lysate; outputting an application signal which causes application of the lysate onto a carrier substrate of the microfluidic device to obtain a cell sediment and cell suspension of the lysate; and identifying the nucleus-containing cells from the cell sediment in Claim 1.
In Claim 1, in the last step, the claim recites ‘identifying the nucleus-containing cells…”; this is an abstract idea that falls within the mathematical concept and mental process groupings in the 2019 PEG, and a law of nature). This claim identifies the recited exception as an abstract idea. The identifying can also be done with the human mind/eye or can be done with pen and paper.
The claim is for detecting, by using the identifying step, which describes a correlation or relationship between what is seen or determined in the identifying step then using this for determination. This judicial exception is not integrated into a practical application because the first two steps are well-understood routine and convention and represent term "extra-solution activity" can be understood as activities incidental to the primary process or product that are merely a nominal or tangential addition to the claim. Extra-solution activity includes both pre-solution and post-solution activity. MPEP 2106.05(g).
The claim as a whole integrates the recited judicial exception into a practical application of the exception; No. After the step of identifying nothing else is done. There does not appear to have any additional steps which are significantly more than the abstract idea.
The claim does not recite any elements that are ‘significantly’ more; all steps in the method are WURC. The steps do not appear to have ‘significantly’ more as all steps are WURC (well understood routine and conventional) and taught in a reference MAASKANT, US Publication No. 2017/0080422 A1, submitted on the Information Disclosure Statement on 13 OCTOBER 2023, US Patent Application Publications Cite No. 1.
The providing step is recited at a high level of generality such that it amount to insignificant presolution activity, e.g. mere data gathering is necessary to use to analyze (compare). Since it is claimed at a high level of generality, there is no meaningful limitation claimed, such as a particular or unconventional machine or transformation of a particular article.
The claim is ineligible.
Similarly, Claim 7 would follow the same analysis as it includes a mixing, and identifying step. The applying and maintaining steps are "extra-solution activities" can be understood as activities incidental to the primary process or product that are merely a nominal or tangential addition to the claim. Extra-solution activity includes both pre-solution and post-solution activity. MPEP 2106.05(g).
In addition, Claims 2-6 and 16, only include steps which are WURC and do not any meaningful limitation to the abstract idea or practical ones.
Claims 8, 14 and 15 recites a preamble directed to a control device, computer program and machine readable storage medium this does not distinguish it from it not being patent eligible. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea. This judicial exception is not integrated into a practical application. The control device, computer program and machine readable storage medium is recited at a high-level of generality (i.e., as a generic processor performing a generic computer function obtaining information about the slugs) such that it amounts no more than mere instructions to apply the exception using a generic computer component. These claims are also not patent eligible.
Claims 17 and 19 merely further define the wash buffer and does not any meaningful limitation to the abstract idea or practical ones. In addition, PBS as a wash buffer is known in the art.
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.
Claims 1-8, 14-16 and 18 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by MAASKANT, US Publication No. 2017/0080422 A1, submitted on the Information Disclosure Statement on 13 OCTOBER 2023, US Patent Application Publications Cite No. 1.
Applicant’s invention is directed towards a process.
Regarding Claim 1, the reference MAASKANT discloses a process for detecting nucleus-containing cells in a sample liquid of a patient using a microfluidic device, abstract, [0096], comprising:
providing a mixing signal to an interface with a mixing device, wherein the mixing signal causes mixing of the sample liquid with a lysis buffer in a mixing chamber of the microfluidic device to obtain a lysate, [0099, 0163, 0190];
outputting an application signal which causes application of the lysate onto a carrier substrate of the microfluidic device, [0099, 0190];
maintaining the lysate on the carrier substrate for a sufficient time to obtain a cell sediment in wells of the carrier substrate separate from a cell suspension of the lysate, [0192-0200]; and
identifying the nucleus-containing cells from the cell sediment, [0190, 0221], MALDI.
Additional Disclosures Included are: Claim 2: wherein the process according to claim 1, further comprising washing the lysate prior to the step of identifying using a wash buffer to cause an optical transparency of the lysate, wherein in the step of washing, the lysate is washed using the wash buffer which is isotonic and/or pH neutral, [0090, 0099, 0100, 0145].; Claim 3: wherein the process according to claim 1, wherein in the step of providing, the mixing signal is provided which causes mixing of an amount of the lysis buffer dependent on an amount of the sample liquid, [0108, 0124, 0198].; Claim 4: wherein the process according to claim 1, wherein in the step of identifying, the nucleus-containing cells are optically detected and/or quantified from the cell sediment, [0190].; Claim 5: wherein the process according to claim 1, wherein: in the step of providing, the mixing signal is provided to mix the sample liquid with the lysis buffer, and the lysis buffer comprises a fluorescent dye for determining a cell type of the nucleus- containing cells, [0108, 0124, 0189].; Claim 6: wherein the process according to claim 1, further comprising introducing the sample liquid into the microfluidic device, [0121]. ; and Claim 16: wherein the process according to claim 5, further comprising supplying the fluorescent dye in the lysis buffer prior to the step of providing, [0189].
Applicant’s invention is directed towards a process.
Regarding Claim 7, reference MAASKANT discloses a process for detecting nucleus-containing cells in a sample liquid of a patient using a microfluidic device, abstract, [0096], comprising:
mixing the sample liquid with a lysis buffer in a mixing chamber of the microfluidic device to obtain a lysate, [0099, 0163, 0190];
applying the lysate onto a carrier substrate of the microfluidic device, [0099, 0190]; [0099, 0190];
maintaining the lysate on the carrier substrate for a sufficient time to obtain a cell sediment in wells of the carrier substrate separate from a cell suspension of the lysate, [0192-0200]; and then
identifying the nucleus-containing cells from the cell sediment, [0099, 0190].
Additional Disclosures Included are: Claim 18: wherein the process according to claim 7, further comprising washing the lysate, prior to the step of identifying, using a wash buffer configured to cause an optical transparency of the lysate to facilitate identification of the nucleus-containing cells, wherein the wash buffer is isotonic and/or pH neutral, [0090, 0099, 0100, 0145]
Applicant’s invention is directed towards a control device.
Regarding Claim 8, the reference MAASKANT discloses a control device configured to carry out and/or control the steps of a process according to claim 1 in corresponding units, [0130], control and processing unit 140, Figure 1.
Applicant’s invention is directed towards a computer program.
Regarding Claim 14, the reference MAASKANT discloses a computer program configured to carry out and/or control the steps, of the process according to claim 1, [0129-0135], control and processing unit 140 may be programmed.
Applicant’s invention is directed towards a machine-readable storage medium.
Regarding Claim 15, the reference MAASKANT discloses machine-readable storage medium on which the computer program according to claim 14 is stored, [0133], Figure 1, computer readable medium, See Rejection to Claim 14 above.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over MAASKANT, US Publication No. 2017/0080422 A1, submitted on the Information Disclosure Statement on 13 OCTOBER 2023, US Patent Application Publications Cite No. 1, and further in view of HANDIQUE, US Publication No. 2019/0060902 A1, submitted on the Information Disclosure Statement.
Regarding Claims 17 and 19, the reference MAASKANT discloses the claimed invention, but is silent in regards to wherein the wash buffer is phosphate buffered saline (PBS).
HANDIQUE discloses a method for isolating and analyzing cells, abstract. HANDIQUE discloses it is well known in the art to use a phosphate buffered saline (PBS) as a wash buffer, [0106].
It would be obvious to one having ordinary skill in the art before the effective filing date to modify the invention of MAASKANT such that the wash buffer is phosphate buffered saline (PBS) since it known to provide an isotonic, pH-stable, and non-toxic environment that removes residual media and prepares cells for further manipulation without causing osmotic stress or damage.
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 CHRISTINE T MUI whose telephone number is (571)270-3243. The examiner can normally be reached M-Th 5:30 -15:30 EST.
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CTM
/CHRISTINE T MUI/Primary Examiner, Art Unit 1797
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