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 (filed on 4/13/26), “Applicant elects Group I, which includes claims 44-53 and 58-63 as set forth in the Restriction Requirement.” contains no traverse and is thus an election without traverse.
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.
Claims 43-53 & 58 -63 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2017/167361 (SIEMENS) AND WO 01/48455 (UNION).
Siemens teaches (figures 1 and 4-14) a method for detecting cell aggregates of biological cells (page 10, lines 10-30) using a quantitative phase-contrast microscope (page 33, lines 21-25) by preparing a suspension, the suspension a viscoelastic fluid and cells (page 10, lines 10-30) from a sample. The viscoelastic fluid comprises a shear-thinning polymer (page 29 lines 1-13), is PVP with a MW of about 1.3 million Da and present in 0.9% w/v in the solvent. Other polymers with sufficiently high viscosity (e.g. >5 cP) and elasticity may also be used for with MW of ranging between 50 to 1000 kDa. e.g. Polyacrylamide, polyethylene glycol, polyglucose, a cellulose derivative, polysaccharides, and combinations with a mass fraction of the shear-thinning polymer in the suspension is less than 0.2 % (page 29, lines 13-15). The method includes generating a flow of the suspension along a microfluidic channel to viscoelastically focus cell aggregates in the suspension in a focal plane of the quantitative phase-contrast microscope (fig. 1, page 10, lines 10-15); taking one or more phase shift images of the biological cells in the suspension using the quantitative phase-contrast microscope (page 19, line 22); and identifying cell aggregates in the one or more phase shift images (page 19, lines 9-15, page 31, lines 29-34 and page 33, lines 21-32) which determines number and type of cell. Siemens preferred polymer is Polyvinylpyrrolidone (PVP), which, as described at page 29, lines 3-6, has a molecular weight of 1.3MDa which is utilized to focus a non-spherical biological entity, such as a red blood cell, a leukocyte or a platelet, in a desired central axial region of flow chamber 10 (fig. 7, 13 and 14, and page 18, lines 5-29). Though Siemens teaches a wide range of polymers and MW thereof, they do not specifically exemplify applicant’s MW range of 2-10 MDa however given the breadth of teaching of Siemens and the teachings of using the polymer for the same purpose (above), one of ordinary skill in the art at the time the invention was filed would have considered the disclosed ranges close enough to render obvious the claimed MW range especially in the absence of evidence to the contrary.
Further guidance to modify the MW range of Siemens to at least 2-10mDa is provided by Union who teaches in a method of cell detection (fig. 1-4) using a viscosity-increasing agent (shear-thinning polymer), having an average molecular weight between 0.01 MDa and 10 MDa (claims 8-10) to centrally align a sample fluid along an analysis section.
Applicant is directed to pages 12-13 of KSR v Teleflex (500 US 398 2007) “ … the Court has held that a “patent for a combination which only unites old elements with no change in their respective functions . . . obviously withdraws what is already known into the field of its monopoly and diminishes the resources available to skillful men.” Great Atlantic & Pacific Tea Co. v. Supermarket Equipment Corp., 340 U. S. 147, 152 (1950). This is a principal reason for declining to allow patents for what is obvious. The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” “When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one(emphasis added). If a person of ordinary skill can implement a predictable variation, §103 likely bars its patentability. For the same reason, if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill.”
Siemens and Union clearly establish that MW, mass fraction, flow velocity, marker objects, etc are all result effective variables in a cell detection method. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); >see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.");< ** In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BLAINE LANKFORD whose telephone number is (571)272-0917. The examiner can normally be reached M-Th 8-6:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Louise Humphrey can be reached at 571-272-5543. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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BLAINE LANKFORD
Examiner
Art Unit 1657
/BLAINE LANKFORD/Primary Examiner, Art Unit 1657
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