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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “encapsulation means” in claims 9, 10, 12, 21, 22; “means of storing at least one cell marker”, “means for the controlled release”, and “means of illuminating” in claim 18; “means for displacing” in claim 19; “heating means” and “temperature control and regulation means” in claim 22; and “means for conveying said cell marker” in claim 23.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
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 reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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.
Claim 3 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,180,532. Although the claims at issue are not identical, they are not patentably distinct from each other because limitations of the Application claim are all present in the corresponding patent claim.
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.
Claim(s) 1-2 are rejected under 35 U.S.C. 103 as being unpatentable over US 20180043357 A1 (Bocchi) in view of US 20190384962 A1 (Hayut).
As per claim 1, Bocchi teaches a method for detecting, on a solid detection support, at least one microorganism, of
a) depositing said sample to be analysed on said solid detection support (Bocchi: paras (shown below); Fig. 1: 2, 3;
“[0133] e) Charging said one or more biological samples through one or more of said input ports 8;”
“[0181] e) Loading said one or more biological samples through one or more of those said input ports (8), wherein said one or more biological samples are contained in biological sample reservoirs (7);”);
b) illuminating said detection support at least once with light radiation capable of revealing said at least one cell marker (Bocchi:
paras (shown below): “phase-contrast and fluorescence image acquisition”;
“[0087] Said automated management system is achieved by assembling elements which are known in the art as a temperature, humidity and CO.sub.2 control incubator, microplate pipetting systems, fluorescence and phase-contrast microscopy lenses connected to an image acquisition camera, such as a CMOS or CCD camera, where said elements are managed in whole or in part by software known to those skilled in the art through hardware connected thereto”;
“[0226] Microscopy [0227] The images were acquired brightfield (BF) to evaluate the morphological characteristics and then in fluorescence to evaluate the signal in DAPI bands (ex: 360/40 nm, 460/50 nm), FITC (ex: 480/30 nm, em: 535/40 nm), TRITC (ex: 540/25 nm, em: 605/55 nm). All images were acquired with 10× lens with a Nikon camera. During the imaging, the microscope worked in a controlled atmosphere at 37° C., 95% humidity, 5% CO.sub.2.”);
c) acquiring at least one image (Io) in a first phase Po of said sample on at least one portion of said detection support by means of an optical imaging device targeting a field of view (Bocchi:
“[0135] j) Acquiring images from one or more of said microwells 2, wherein said images are defined images T0;”;
“[0183] j) Acquiring images from one or more of said microwells (2), wherein said images are defined images T0;”);
d) carrying out a controlled release of said at least one cell marker, through the detection support, to bring said marker into contact with said microorganism (Bocchi:
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“[0132] d) Charging reagents through one or more of said input ports 8 for reagents, where said reagents comprise: filling buffer and/or washing solution and/or one or more drugs and/or one or more dyes, and/or one or more labeled antibodies and or one or more cell viability markers;”;
“[0180] d) Charging reagents through one or more of said input ports (8), where said reagents comprise: filling buffer and/or washing solution and/or one or more drugs and/or one or more dyes, and/or one or more labeled antibodies and or one or more cell viability markers and wherein said reagents are contained in reservoirs for (6) reagents;”;
Figs. 25, 26;
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para 223: “10̂5 CAM labeled cells for each batch were seeded in duplicate on a 96 well plate.”
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para 9: “movement of fluids in microfluidic devices typically uses vacuum or pressure pumps and/or valves. The combination of pumps and valves allows a fine control of the movements of fluids in a circuit”; para 14: “present invention offers … high precision charging, pumping and optionally discharging of fluids in a microfluidic device”);
e) acquiring, by means of said optical device, an image (I) (i=1) of each portion of the detection support of which an image was acquired at Po in at least one subsequent phase Pi after the step of the controlled release of said marker, and detecting said at least one microorganism according to a change in staining kinetics of said microorganism (Bocchi:
“[0155] In an even more preferred embodiment, said method further comprises, after said step 1):
[0156] m) Acquiring at least two images from said one or more microwells 2, at different times during said incubation, wherein said images are defined images T1, T2, Tn, wherein n is any number equal to or greater than 2, preferably 1,000 or 100, even more preferably 25, in a preferred embodiment is 9;”;
“[0186] m) Acquiring at least two images from said one or more microwells (2), at different times during said incubation, wherein said images are defined images T1, T2, Tn, wherein n is any number equal to or greater than 2, preferably 1,000 or 100, even more preferably 25, in a preferred embodiment is 9;
[0187] ) Optionally, between said acquisitions of said images T1, T2, Tn, further dyeing said cells with one or more dyes and/or one or more labeled antibodies and or one or more cell viability markers;”;
Figs. 14-17); and
f) carrying out a comparative analysis, per portion of the detection support, between said image (Io) acquired at P0 and each image (Ii) acquired in at least one subsequent phase Pi and drawing a conclusion as regards the presence or absence of at least one microorganism in said sample (Bocchi:
“[0159] and said classification of step p) comprises the comparison of morphological and/or functional parameters detected from images T0, T1, Tn and optionally Tbaseline.”;
“[0189] p) Classifying the cells displayed, wherein said classification is made with morphological and/or functional parameters detected from the images T1, T1, Tn and, optionally, Tbaseline.
[0190] Cancer cells are identified by dimensional and shape parameters, such as membrane roughness, and by the bonding with labeled antibody specific for tumor antigens, where the presence or absence of a specific signal emitted by one or more specific labeled antibodies determines the identification of the cell type. By way of example, if the tumor under investigation is a lymphoma, an anti-CD38 antibody is used for the differential analysis of tumor cells; if the tumor under investigation is acute myeloid leukemia (AML), an anti-CD34, or anti-CD117, or anti-HLA-DR, or anti-CD33/CD14 antibody is used.”;
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“[0197] FIG. 8 shows the graphs of the acquired data analysis, in relation to the classification of cancer cells. (C) shows the distribution of the cells stained with dye CMAC and not stained with anti-CD34/CD45 antibodies. This distribution allows to determine the maximum signal identified in such negative control, and as a result to set a minimum threshold for the classification. Subsequently, in (D), the count made after anti-CD34/CD45 labeling was carried out keeping the threshold identified at (C) and classifying the cells characterized by a signal emitted by the antibody higher than the threshold as cancer cells. In particular, the cancer cells can be classified as such as they are positive to the anti-CD34 antibody (CD34+) and as they are positive to both anti-CD34 and anti-CD45 antibodies (CD34+/CD45+). As a control of the method, panels (A) and (B) show the results obtained by flow cytometry on the same samples. These results show that the data obtained with the method of the present invention are absolutely comparable with those obtained for the same sample by flow cytometry, which is the technique of choice for this type of analysis and cell counting.”).
Bocchi does not teach bacteria, yeast or mould type; and field of view that is at least 10 mm long by at least 10 mm wide.
Hayut teaches bacteria, yeast or mould type (Hayut: paras 68: bacteria identification); and
field of view that is at least 10 mm long by at least 10 mm wide (Hayut:
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;
Also see paras 72-74: FOV length and width over 10 mm).
Thus, it would have been obvious for one of ordinary skill in the art, prior to filing, to implement the teachings of Hayut into Bocchi since both Bocchi and Hayut suggest a practical solution and field of endeavor of microorganism detection via staining and microscopic imaging in general and Hayut additionally provides teachings that can be incorporated into Bocchi in that the microorganism is bacteria as for “bacteria identification” (Hayut: para 68). The teachings of Hayut can be incorporated into Bocchi in that the microorganism is bacteria. Furthermore, one of ordinary skill in the art could have combined the elements as claimed by known methods and, in combination, each component functions the same as it does separately. One of ordinary skill in the art would have recognized that the results of the combination would be predictable.
Also, it would have been obvious for one of ordinary skill in the art, prior to filing, to select FOV width and length over 10 mm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980) (MPEP 2144.05 (II-B)).
Also, it would have been obvious for one of ordinary skill in the art, prior to filing, to select FOV width and length over 10 mm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum range involves only routine skill in the art. In re Aller, 105 USPQ 233 (MPEP 2144.05 (II-A)).
As per claim 2, Bocchi in view of Hayut teaches the detection method according to claim 1, wherein said detection support is illuminated locally, with light radiation every time an image is acquired at Po, Pi (Bocchi: See arguments and citations offered in rejecting claim 1 above;
Paras 87 and 227.
Bocchi’s illumination is per microwell and per channel imaging pass, which is local illumination||
Hayut:
Fig. 1: mainly 110: Para 49: “illumination assembly 110 may be configured to illuminate sample 114 in a series of different illumination conditions. In one example, illumination assembly 110 may include a plurality of light sources arranged in different illumination angles, such as a two-dimensional arrangement of light sources. In this case, the different illumination conditions may include different illumination angles. For example, FIG. 1 depicts a beam 118 projected from a first illumination angle α1, and a beam 120 projected from a second illumination angle α2. As another example, illumination assembly 110 may include a plurality of light sources configured to emit light in different wavelengths. In this case, the different illumination conditions may include different wavelengths. In yet another example, illumination assembly 110 may configured to use a number of light sources at predetermined times. In this case, the different illumination conditions may include different illumination patterns. Accordingly and consistent with the present disclosure, the different illumination conditions may be selected from a group including: different durations, different in”).
Allowable Subject Matter
Claim 3 would be allowable if rewritten or amended to overcome the non-statutory double patenting rejection(s) set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter: Limitations below, in conjunction with other limitations of the independent claim, distinguish over the prior art:
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Claims 4-31 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Atiba Fitzpatrick whose telephone number is (571) 270-5255. The examiner can normally be reached on M-F 10:00am-6pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Bee can be reached on (571) 270-5183. The fax phone number for Atiba Fitzpatrick is (571) 270-6255.
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Atiba Fitzpatrick
/ATIBA O FITZPATRICK/
Primary Examiner, Art Unit 2677
Prosecution Insights