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 .
DETAILED ACTION
Election/Restrictions
1. Applicant's election of Group I, claims 1 and 2, without traverse, filed September 11, 2025 is acknowledged and has been entered. Claims 3-12 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being claims drawn to a non-elected invention. Accordingly, claims 1-12 are pending. Claims 1 and 2 are under examination.
Priority
2. Receipt is acknowledged of certified copies of foreign priority papers required by 37 CFR 1.55, which papers have been placed of record in the file.
3. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119(b) or 365(b), and 37 CFR 1.55 on the basis of the filing date of CHINA 202110892012.X filed 08/04/2021. Based on the filing receipt, the effective filing date of this application is August 4, 2021 which is the filing date of Foreign Application CHINA 202110892012.X from which the benefit of foreign priority is claimed.
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.
4. Claims 1 and 2 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 is indefinite in reciting “A circulation system” in the preamble and “a porcine erythrocyte suspension … is injected into the mobile-phase liquid storage bottle” in lines 6-8 because the limitation appears to recite a method step for intended use which is “for detecting immune adherence of porcine erythrocytes”; whereas the claim is drawn to a system. Perhaps, Applicant intends “A circulation system” in the preamble and “a porcine erythrocyte suspension … configured to be injected into the mobile-phase liquid storage bottle.”
Claim Rejections - 35 USC § 102
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.
5. Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sedlak et al. (A Modified Parallel Plate Flow Chamber to Study Local Endothelial Response to Recirculating Disturbed Flow. Journal of Biomechanical Engineering 142 (041003): 1-11 (April 2020)).
Sedlak et al. teach a circulation system (in vitro parallel plate flow chamber) modified with protruding baffles to produce large recirculating flow regions to study recirculating disturbed flow (Abstract). The circulation system comprises: a flow chamber with nine baffles, each 5 mm long; a gasket (disturbed flow gasket (DFG) or laminar flow gasket (LFG)); a mobile-phase liquid storage bottle (open medium reservoir storage); a peristaltic pump; silicone hoses (silicone tubing), and a cell culture dish provided with a glass slide (polystyrene microscope slide seeded with cells). The flow chamber, the mobile-phase liquid storage bottle, and the peristaltic pump are connected in sequence with the silicone hoses to form the circulation system with the gasket placed (cushioned) on an edge of the glass slide and the flow chamber being covered on the gasket (p. 041003-2, right col. 1st, 2nd , 3rd full ¶s). Sedlak et al. teach that the circulation system is applicable for use in detecting and quantifying monocyte adhesion and endothelial morphological response and immune adhesion (p. 041003-3, right col. last ¶ to p. 041003-5, left col. 1st full ¶; p. 041003-5, right col. 2nd full ¶ to p. 041003-6, left col. 1st ¶)).
With respect to the recitation of “for detecting immune adherence of porcine erythrocytes” the recitation appears to encompass intended use of the claimed circulation system. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Accordingly, Sedlak et al appears to read on Applicant’s claimed invention.
Claim Rejections - 35 USC § 103
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.
6. Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Sedlak et al. (Journal of Biomechanical Engineering 142 (041003): 1-11 (April 2020)) in view of Cui et al. (Identification of immune adherence receptor on porcine erythrocyte membrane. Master’s Degree Dissertation, Shanxi Agriculture University. Shanxi, P. R. China (June 2015)).
Sedlak et al. is discussed supra. Sedlak et al. does not teach using the circulation system to detect immune adherence of porcine erythrocytes; wherein 20 mL of a porcine erythrocyte suspension of immune adherence-sensitized GFP-E.coli is injected into the mobile-phase liquid storage bottle.
Cui et al. teach assaying for immune adherence of porcine erythrocytes which have been stimulated or sensitized with green fluorescent protein Escherichia coli (GFP-E.coli) (Abstract: page 43).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to have substituted the monocytes and endothelial cells in the circulation system taught by Sedlak with the porcine erythrocytes suspension of adherence-sensitized GFP-E.coli taught by Cui to enable detection of porcine erythrocyte immune adherence because Sedlak taught that the modified circulation system is enabled for use in in vitro detection and quantification of cellular immune adhesion involved in cardiovascular disease. One of ordinary skill in the art would have been motivated to incorporate the porcine erythrocytes suspension of adherence-sensitized GFP-E.coli taught by Cui into the circulation system of Sedlak to detect immune adherence of porcine erythrocytes because Sedlak taught that the modified circulation system is capable of improving scientific understanding of complex cell interactions within the vascular system including immune adherence of cells. One of ordinary skill would have had reasonable expectation of success in incorporating the porcine erythrocyte suspension of adherence-sensitized GFP-E.coli as taught by Cui into the circulation system of Sedlak because both of Sedlak and Cui teach analogous art in immune cellular adhesion studies.
As to recitation of “20 mL of porcine erythrocyte suspension of immune adherence-sensitized GFP-E. coli;” generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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 Lab. 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); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions."). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (identifying "the need for caution in granting a patent based on the combination of elements found in the prior art."). Since Applicant has not disclosed that the specific limitation recited in claim 2 is for any particular purpose or solve any stated problem and the prior art teaches that reagent or sample concentrations often vary according to the sample being analyzed and various matrices, solutions and parameters appear to work equally as well; absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the methods disclosed by the prior art by normal optimization procedures.
7. No claims are allowed.
Remarks
8. Prior art made of record are not relied upon but considered pertinent to the applicants' disclosure:
Van Kooten et al. (Development and use of parallel-plate flow chamber for studying cellular adhesion to solid surfaces. Journal of Biomedical Materials Research 26: 725-738 (1992)) developed a parallel-plate flow chamber to study cell adhesion phenomena (Abstract).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GAILENE R. GABEL whose telephone number is (571)272-0820. The examiner can normally be reached Monday, Tuesday, and Thursday 5:30 AM to 4:00 PM.
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/GAILENE GABEL/Primary Examiner, Art Unit 1678
September 27, 2025