DETAILED ACTION
This application is being examined under pre-AIA first-to-invent provisions.
Status of claims
Canceled:
2-31
Pending:
1 and 32-50
Withdrawn:
none
Examined:
1 and 32-50
Independent:
1 and 40
Allowable:
none
Rejections applied
Abbreviations
x
112/b Indefiniteness
PHOSITA
"a Person Having Ordinary Skill In The Art before the effective filing date of the claimed invention"
112/b "Means for"
BRI
Broadest Reasonable Interpretation
112/a Enablement,
Written description
CRM
"Computer-Readable Media" and equivalent language
112 Other
IDS
Information Disclosure Statement
x
102, 103
JE
Judicial Exception
101 JE(s)
112/a
35 USC 112(a) and similarly for 112/b, etc.
101 Other
N:N
page:line or column:line
x
Double Patenting
MM/DD/YYYY
date format
Priority
As detailed on the 10/20/2021 filing receipt, this application claims priority to no earlier than 9/22/2010. All claims have been interpreted as being accorded this priority date.
Objection to the specification: title
The title should be amended to more specifically reflect the claims, particularly the independent claims and referencing steps/elements: setting the context of the invention, particular to all claims, and distinguishing the instant application from any related applications, for example a title including terms such as: serpentine channel or cell aligning. The title should be "descriptive" and "as... specific as possible" (MPEP 606, 1st para. and 37 CFR 1.72; also MPEP 606.01 pertains).
Claim rejections - 112/2nd
The following is a quotation of 112/2nd:
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 and 32-39 are rejected under 112/2nd, as indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention. Claims depending from rejected claims are rejected similarly, unless otherwise noted, and any amendments in response to the following rejections should be applied throughout the claims, as appropriate. With regard to any suggested amendment below, for claim interpretation during the present examination it is assumed that each amendment suggested here is made. However, equivalent amendments also would be acceptable.
The following issues cause the respective claims to be rejected under 112/2nd as indefinite:
Claim
Recitation
Comment (suggestions in bold)
1
wherein a particle passes from the serpentine region through the junction without being trapped
Claim 1 is rejected as directly reciting a machine and a process in the same claim. A claim to a machine, e.g. here a "system," cannot directly recite a process step such as "...a particle passes...." MPEP 2173.05(p).II pertains. It may suffice to add some form of "configured to" relative to the structure and the process step so as properly focus on claimed structure. MPEP 2173.05(p).II pertains regarding a claim directed to both product and process.
1
at least one processor configured to determine a parameter of the particle
Claim 1 is to a 101 machine or manufacture, i.e. a "system" in this instance, interpreted by statute according to its claimed physical structure, but it is not clear what is the structure associated with the recited "determine..." step. Therefore, it is not clear whether the claim is limited according to these steps. MPEP 2106.03, 5th-6th paras. pertain. The recited "system" and "processor" are interpreted as not clearly requiring structure linking the "system" to the recited steps in a structural sense appropriate to a claim to a machine or manufacture. While the recited elements may comprise unrecited software storage in some embodiments, it is not clear that all embodiments of these elements must comprise software storage corresponding to the recited process steps. Structure should be recited specifically corresponding to stored software. The recited process steps are not properly claimed without corresponding structure. This rejection might be overcome by, for example, reciting a data storage device, comprised by the "system," and instructions stored therein and configured according to the recited elements and steps. MPEP 2173.05(p).II pertains regarding a claim directed to both product and process.
Claim rejections - 35 USC 103
In the event the determination of the status of the application as subject to AIA 35 USC 102 and 103 is incorrect, any correction of the statutory basis 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 USC 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 of this title, 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.
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 USC 102(b)(2)(C) for any potential 35 USC 102(a)(2) prior art against the later invention.
Claims 1, 32-37, 43 and 46-47
Claims 1, 32-37, 43 and 46-47 are rejected under 35 USC 103(a) as unpatentable over Toner (2009-0014360 as cited on the 10/7/2021 IDS) in view of Shelby (NPL as cited on the 10/7/2021 IDS).
Claim 1 recites a system comprising a microfluidic chip.
The recited chip is taught by Toner as "microfabricated chip... can have at least one microfluidic channel..." (Toner: [126]; and entire document).
The recited inlet, serpentine region and junction are taught by Toner as "an inlet and an outlet," and Toner teaches wherein the channels can vary in shape and configuration in order to obtain optimal ordering and focusing (Toner: abstract, [143-148]; FIG. 4A and 4C; and the entire document). Additionally, the junction reads on Shelby's "constriction" (Shelby: Fig. 1; and entire document). Toner also teaches particle ordering and alignment (Toner: [9, 121 and 217]; and the entire document). The particles in Toner may move continuously (Toner: [121]; and the entire document).
The imaging device reads on "image" (Toner: [127, 179, 201, 204]; and the entire document).
Toner teaches imaging but not the parameter determination, which is taught by Shelby.
The recited imaging and parameter determination are taught by Shelby as timelapse-imaging-based, microfluidic measurement of cell deformation, including imaging-aided visual quantification of changes in cell morphology from initial diameter to deformed diameter to recovered diameter (Shelby: title; p. 14619, "Cell Visualization," Behavior of Infected Erythrocytes" and "Erythrocyte Shape Recovery" and Fig. 2 caption; and entire document).
Claims 32, 43 and 46 specify types of parameter, which limitation is taught by Shelby as measurement of cell deformation, including quantification of changes in cell morphology from initial diameter to deformed diameter to recovered diameter (Shelby: title; p. 14619, "Cell Visualization," Behavior of Infected Erythrocytes" and "Erythrocyte Shape Recovery" and Fig. 2 caption; and entire document). In the absence of a secondary consideration to the contrary, substitution of one parameter and/or formula for another would have been prima facie obvious as an example of simple substitution of one PHOSITA-known element for another to obtain predictable results with a reasonable expectation of success (MPEP 2143 pertains).
Regarding claim 33, the recited filter reads on "filtering" (Toner: [186]; and entire document).
Regarding claims 34-35, the recited pump and controlled pumping force read on "pumping element" (Toner: abstract; and entire document).
Regarding claim 36, the recited alignment reads on "focus the particles into one or more stream lines." (Toner: abstract; and entire document).
The art is applied to claim 37 as described above for claim 1, teaching the "imaging device" embodiments for which the optical collector is optional.
Regarding claim 47, the recited velocity change reads on Shelby (Shebly: p. 14619, 1st col., 3rd para.; and entire document).
Combining Toner and Shelby
In the absence of a secondary consideration to the contrary, it would have been prima facie obvious for PHOSITA to modify the teaching of Toner using the related teaching of Shelby. As motivation to combine, an advantage taught by Shelby of modifying methods such as those of Toner would have been the teaching of Shelby regarding progress in quantitatively measuring both stress-induced deformability of flowing cells and the conditions causing their deformation (p. 14618, 1st and 2nd col.). Thus, PHOSITA would have been motivated to modify Toner using the above techniques of Shelby in order to achieve the above advantage. One would have had a reasonable expectation of success in doing so because Toner and Shelby are generally drawn to related teaching, and PHOSITA would have understood how to and would have been motivated to apply the teaching of Shelby to the related teaching of Toner.
Claims 39-43
Claims 39-43 are rejected under 35 USC 103(a) as unpatentable over Toner in view of Shelby as applied above and further in view of Vesely (as cited on the attached Form 892).
Toner does not teach leukocytes or distribution and regression analyses relating to cell activation, however Vesely does teach the utility of this type of analysis.
Regarding claims 39 and 41, the recited leukocyte activation analysis reads on "In the multivariate regression analysis we obtained as the most significant a model using only a single parameter... involved in early events of lymphocyte... activation" (Vesely: p. 130; and entire document).
Regarding claim 40, the art is applied to claims 40 and 48 as described for claim 1 above. The recited parameter distribution analysis reads on Vesely's multivariate regression analysis as above.
Regarding claim 42, the recited metastatic potential reads on "...prognosis in patients with metastatic breast, colorectal and ovarian carcinomas..." (Toner: p. 130; and entire document).
Regarding claim 43, the recited analytical cell classification based on morphology reads on Toner's "The ability to rapidly analyze and extract information from whole blood, for example, and its component cells is of great importance for medical diagnostics and applications..." (Toner: [125]; and entire document) and "" (Toner: [186]; and entire document). The recited subset analysis reads on Toner's "sorting" (Toner: [195]; and entire document).
Combining Toner and Vesely
In the absence of a secondary consideration to the contrary, it would have been prima facie obvious for PHOSITA to modify the teaching of Toner using the related teaching of Vesely. As motivation to combine, an advantage taught by Vesely of modifying methods such as those of Toner would have been the teaching of Vesely regarding need to evaluate the prognostic significance of parameters of the immune system (p. 126). Thus, PHOSITA would have been motivated to modify Toner using the above techniques of Vesely in order to achieve the above advantage. One would have had a reasonable expectation of success in doing so because Toner and Vesely are generally drawn to related teaching, and PHOSITA would have understood how to and would have been motivated to apply the teaching of Vesely to the related teaching of Toner.
101 -- no rejections
35 USC 101 reads:
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.
Patent eligible claims
Referring to 101 JE analysis as organized in MPEP 2106, no rejection applies to claims 1 and 32-50, at least by analogy to:
the analysis step 2A, 2nd prong, 3rd consideration, relating to a particular machine integrating any possible judicial exceptions into a practical application, in that a particular machine in this instance comprises at least the recited microfluidic hardware.
Nonstatutory double patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine to prevent the improper timewise extension of the "right to exclude" granted by a patent and to prevent multiple suits against an accused infringer by different assignees of the same invention (MPEP 804.II.B, 1st para.). A nonstatutory double patenting rejection is appropriate where the conflicting claims (instant v. reference) are not identical, but an examined-application claim (instant claim) is not patentably distinct from a reference claim because the instant claim is either anticipated by, or would have been obvious over, the reference claim (MPEP 804.II.B, 2nd para.).
In cases of double patenting rejections versus reference claims of pending applications, as opposed to claims of an issued patent, the rejections are provisional because the reference claims have not been patented. Presently, no rejections are provisional.
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the application or patent of the reference claim either is shown to be commonly owned with the instant application or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must comply fully with 37 CFR 3.73(b).
Applicant may wish to consider electronically filing a terminal disclaimer (MPEP 1490.V pertains, along with https://www.uspto.gov/patents-application-process/applying-online/eterminal-disclaimer). Electronic filing may lead to faster approval of the disclaimer. Also, if filing electronically, Applicant is encouraged to notify the examiner by telephone so that examination may resume more quickly.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used.
A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Double patenting rejections of instant claims 1 and 32-50
Instant claims 1 and 32-50 are rejected on the grounds of nonstatutory double patenting as unpatentable over one or more claims in reference patents:
11,169,078 (from application 15/868,025);
9,897,532 (from application 14/552,256);
8,935,098 (from application 13/823,109);
12,546,699 (from application 19/025,868); and
12,546,700 (from application 19/025,994)
in view of Toner (2009-0014360 as cited on the 10/7/2021 IDS), Shelby (NPL as cited on the 10/7/2021 IDS) and Vesely (as cited on the attached Form 892).
Each reference patent and application as well as the instant application recite claims which involve microfluidic imaging assays of cells to determine cell parameters for diagnostics. While some of the reference claims recite high-throughput speed timing limitations, the instant independent claims do not.
Although the reference claims are not identical to the instant claims, in a BRI they also are not patentably distinct from the instant claims: either (i) because the instant claims recite obviously equivalent or broader limitations in comparison to the reference claims or (ii) because the instant claims recite limitations which are obvious over the cited art. It is not clear that the instant claims recite limitations which are narrower than limitations in the reference claims.
It would have been obvious in view of the cited art to modify reference claims to arrive at the rejected instant claims. Either the instant limitations are interpreted as reading on a reference limitation, or the instant limitations would have been obvious in view of the cited art. That is, to the extent that any instant claims are narrower than reference claims, then any such narrowing would have been obvious over the cited art.
Citations to art
In the above citations to documents in the art, rejections refer to the portions of each document cited as example portions as well as to the entirety of each document, unless otherwise noted in the situation of lengthy, multi-subject documents. Other passages not specifically cited within a document may apply as well.
Conclusion
No claim is allowed.
A shortened statutory period for reply is set to expire THREE MONTHS from the mailing date of this communication.
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The examiner for this Office action, G. Steven Vanni, may be contacted at:
(571) 272-3855 Tu-F 8-7 (ET). If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Larry D. Riggs, II, may be reached at (571) 270-3062.
/G. STEVEN VANNI/Primary patents examiner, Art Unit 1686
Prosecution Insights