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
Applicant amendments filed 12/09/2025 have been entered. Applicant amendments overcomes the previous claim objection and 112(b) rejection set forth in the Office Action mailed 07/10/2025, the previous claim objection and 112(b) rejection are withdrawn. Applicant amendments overcomes the previous provisional double patenting rejections set forth in the Office Action mailed 07/10/2025, the previous provisional double patenting rejections are withdrawn.
Status of Claims
Claims 1-3, 8-16, 19-23, 26-27, 37-44, 46-53 remain pending in the application, with claims 1-3, 8-16, 19-20, 22-23, 26-27, 37-44, and 46-53 being examined and claim 21 being withdrawn pursuant to the election filed 01/05/2024.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-3, 8-16, 19-20, 22-23, 26-27, 37-44, and 46-53 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites “wherein the control unit is configured to control the valve to:
(a) identify the presence of a tumor cell in the biological fluid when the one or more characteristics of the healthy cell are not recognized in the scanned data” on lines 16-18, where it is not seen in the instant specification where there is support for this limitation. On page 21 lines 13-22 does describe that the control unit is in communication with the scanner and valve, where the control unit is configured to receive scanned data from the scanner and to control the valve based on the scanned data and thus direct the biological fluid depending on if the undesirable constituent is present or not. However, it is not seen in the instant specification where there is support for the valve identifying the presence of a tumor cell in the biological fluid.
Claims 2-3, 8-16, 19-20, 22-23, 37-42, 48-50, 52-53 are rejected by virtue of being dependent on a rejected claim.
Claim 26 recites “wherein the control unit is configured to control the valve to:
(a) indicate the presence of a circulating tumor cell (CTC) in the biological fluid when the one or more characteristics of the healthy cell are not recognized” on lines 17-20 where it is not seen in the instant specification where there is support for this limitation for similar reasons described above. It is not seen in the instant specification where there is support for the valve indicating the presence of a circulating tumor cell in the biological fluid.
Claims 27, 43-44, 46-47, and 51 are rejected by virtue of being dependent on a rejected claim.
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 1-3, 8-16, 19-20, 22-23, 26-27, 37-44, and 46-53 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 1 recites “wherein the control unit is configured to control the valve to:
(a) identify the presence of a tumor cell in the biological fluid when the one or more characteristics of the healthy cell are not recognized in the scanned data” on lines 16-18, where it is unclear how a valve would be identifying the presence of a tumor cell. Claim 1 has a scanner that is configured to scan the biological fluid that produces scanned data, where the scanner and valve are connected to a control unit. However, the valve is only described to have an inlet, first and second outlet, and is configured to direct the biological fluid. It is unclear how the valve will identify the presence of a tumor cell. Please see 112(a) rejection above where it is not seen in the instant specification where there is support for this limitation.
Claims 2-3, 8-16, 19-20, 22-23, 37-42, 48-50, 52-53 are rejected by virtue of being dependent on a rejected claim.
Claim 26 recites “wherein the control unit is configured to control the valve to:
(a) indicate the presence of a circulating tumor cell (CTC) in the biological fluid when the one or more characteristics of the healthy cell are not recognized” on lines 17-20, where it is unclear how a valve would be indicating the presence of a circulating tumor cell. Claim 26 does have a scanner that is configured to scan the biological fluid and produce scanned data, where the scanner and valve are connected to a control unit. However, the valve is only described to have an inlet, first and second outlet, and is configured to direct the biological fluid. It is unclear how the valve will indicate the presence of CTCs. Please see 112(a) rejection above where it is not seen in the instant specification where there is support for this limitation.
Claims 27, 43-44, 46-47, and 51 are rejected by virtue of being dependent on a rejected claim.
Claim 46 recites “a tumor cell.” on line 2, where it is unclear if this tumor cell is the same or different from the circulating tumor cell described on line 18 of claim 26.
For examination, it will be interpreted that they are the same.
It is suggested to amend claim 46 to recite “[[a]] the circulating tumor cell.”
Claim 48 recites “a tumor cell.” on line 2, where it is unclear if this tumor cell is the same or different from the tumor cell described on line 17 of claim 1.
For examination, it will be interpreted that they are the same.
It is suggested to amend claim 48 to recite “[[a]] the tumor cell.”
Claim 52 recites “wherein the reference data comprise one or more characteristics of two or more healthy cell types.” where it is unclear if the two or more healthy cell types includes the healthy cell described in claim 1.
Claim 53 recites “wherein the reference data comprise one or more characteristics of only healthy cell types.” where it is unclear if the healthy cell types are the same or different from the healthy cell described in claim 1.
Response to Arguments
Applicant arguments filed 12/09/2025 have been fully considered. Due to amendments filed 12/09/2025, the rejections set forth in the Office Action dated 07/10/2025 are withdrawn. However, new rejections under 112(a) and 112(b) are set forth above.
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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/S.Y.L./Examiner, Art Unit 1796
/ELIZABETH A ROBINSON/Supervisory Patent Examiner, Art Unit 1796