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 .
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 2-21 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 2 is unclear reciting “method for determining an immune activation state of a subject comprising for a leukocyte from a blood sample [...]”, because it would appear the method is directed to an intended use without reciting any steps involved for a leukocyte from a blood sample. Claims 9-12, 15-17 and 19 are similarly unclear. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced. For the reasons given above, remaining dependent claims are unclear.
Regarding claim 2, the phrase "it" renders the claim indefinite because it is unclear what the phrase is referring to.
Claims 3 and 6 are is unclear reciting “handedness”. Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999).
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) 2-4 & 8-21 is/are rejected under 35 U.S.C. 102a1/a2 as being anticipated by Tse et al. (US 2017/0284924).
Regarding claim 2, Tse et al. teach:
2. A method for determining an immune activation state of a subject (¶ 0019+) comprising:
(a) for a leukocyte from a blood sample of the subject (¶ 0019):
i. deforming the leukocyte within a deformation region of a microfluidic channel (Abstract & Fig. 3+);
ii. acquiring a plurality of images of the leukocyte (see Fig. 2 for example);
iii. determining one or more biophysical parameters of the leukocyte based on the plurality of images (see ¶ 0064 for example); and
iv. adjusting a metric (mdetermined) of the one or more biophysical parameters to generate an adjusted metric (madjusted) (see ¶ 0063-0066 for example);
(b) determining an index based on madjusted of the leukocyte (¶ 0067+); and
(c) based on the index, determining the immune activation state of the subject (see ¶ 0068 for example).
Regarding claims 9-12, 15-17 and 19, the claims are directed to an intended use without reciting any steps involved. It has been held that to be entitled to weight in method claims, the recited structure limitations therein must affect the method in a manipulative sense, and not to amount to the mere claiming of a use of a particular structure. Ex parte Pfeiffer 135 USPQ 31 (BPAI 1961).
Regarding claims 3, 4, 8-14, 18-21, Tse et al. teach:
3. The method of claim 2, wherein the adjusting the metric is based on at least one of a flow rate of the microfluidic channel, or a path traversed by the leukocyte (¶ 0028, 0058+).
4. The method of claim 3, wherein the adjusting the metric is based on at least two of the flow rate of the microfluidic channel, or the path traversed by the leukocyte (¶ 0028, 0058+).
8. The method of claim 2, further comprising updating the operation of a microfluidic device comprising the microfluidic channel based on madjusted (¶ 0063-0066+).
9. The method of claim 8, wherein madjusted is capable of being used to adjust a flow rate of the microfluidic channel (¶ 0028, 0058+).
10. The method of claim 8, wherein madjusted is capable of being used to adjust a temperature of the microfluidic channel (¶ 0053+).
11. The method of claim 2, wherein (a) is capable of being performed for at least about 10,000 leukocytes (¶ 0019, 0028+).
12. The method of claim 11, wherein a plurality of adjusted metrics are determined for the at least about 10,000 leukocytes (¶ 0019, 0028+), and wherein the plurality of adjusted metrics are capable of being used to determine the index in (b) (¶ 0067-0068+).
13. The method of claim 2, further comprises determining a particle from the subject blood sample is the leukocyte, wherein the subject blood sample comprises a plurality of particle types (¶ 0019+).
14. The method of claim 13, wherein the adjusting the metric is based in part on a particle type (see ¶ 0032 for example).
18. The method of claim 2, wherein determining the immune activation state of the subject comprises comparing the index to a threshold (see ¶ 0060 for example).
19. The method of claim 2, wherein the immune activation state is capable of being used to indicate sepsis (¶ 0019+).
20. The method of claim 2, wherein the plurality of images comprises at least ten images (¶ 0067).
21. The method of claim 2, wherein the one or more biophysical parameters comprises a leukocyte structural parameter, a leukocyte trajectory parameter, a patient parameter, a leukocyte location parameter, or any combination thereof (see ¶ 0019, 0066, 0068 for example).
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) 5-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tse et al. (US 2017/0284924) in view of Shi et al. (US 2018/0305758).
Regarding claims 5-7, Tse et al. do not explicitly teach: 5. The method of claim 3, wherein madjusted = mdetermined + k * (Qo - Qmeasured), wherein k is a constant and Qo is a parameter of the flow rate. 6. The method of claim 3, wherein madjusted = mdetermined + c * (ζ), wherein c is a constant and ζ is a handedness parameter of the handedness of the leukocyte. 7. The method of claim 3, wherein madjusted = mdetermined + m * (zplane), wherein m is a constant and zplane is a parameter of the path traversed by the leukocyte in a z-plane of the microfluidic channel.
Shi et al. teach data analysis algorithms including mathematical and statistical models to determine the probability of sepsis (¶ 0274-0283+, 0290, 0304, 0312+, 0343).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Tse et al., with the teaching of Shi et al. for the purpose of using a mathematical model suitable for analyzing data and determining an immune state in a subject such as sepsis.
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