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 .
Status of Claims
The claim set submitted on 27 JUNE 2023 is acknowledged and considered. In the claim set, Claims 1-20 are presented and are considered on the merits below.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 28 JUNE 2023 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
The information disclosure statement (IDS) submitted on 28 JUNE 2023 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
The information disclosure statement (IDS) submitted on 28 JUNE 2023 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification/Abstract
The abstract of the disclosure is objected to because the abstract is not within the range of 50 to 150 words in length. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The currently submitted abstract consists of 1 sentence, about 14 words.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: Figure 1(c) and 2 , character 910. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,605,805 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant invention is directed towards a device while the ‘805 patent is directed towards a method, the device is described verbatim in the method in ‘805. The structural features of the device are described in the method, in which steps b-d of the method are generically claimed. Step a of the method merely claims providing the device.
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:
A “temperature control element that maintains the sample…” in Claim 20.
An ‘element’ does not connotate any particular structure. The specification does not provide any description of what an ‘element’ is.
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.
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.
Claim 1 is 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.
In the instant claim in element (ii), it recites ‘on its respective sample surface’, however, a sample surface is not yet positively claimed on each plate yet. To overcome this rejection Examiner suggests ‘(ii) each of the plates has a sample surface, a sample contact area…’
Claims 2-20 depend direct or indirectly from Claim 1 and are also rejected under 112(b).
Claim 12 is 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 12 recites the limitation "the mobile communication device". There is insufficient antecedent basis for this limitation in the claim.
Claim 20 is 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 limitation “element that maintains the sample…” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The specification is devoid of adequate structure to perform the claimed function. In particular, the specification merely states the claimed function of that maintains the sample deposited between the two plates at a temperature that facilitates the survival and/or division of the microorganisms is performed by the “element”. There is no disclosure of any particular structure, either explicitly or inherently, to maintain the sample deposited between the two plates. The use of the term “facilitates” is not adequate structure for performing the maintaining function because it does not describe a particular structure for the function and does not provide enough description for one of ordinary skill in the art to understand which brightening structure or structures perform(s) the claimed function. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 20 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. As described above, the disclosure does not provide adequate structure to perform the claimed function of “maintains the sample deposited between the two plates at a temperature that facilitates the survival and/or division of the microorganisms” . The specification does not demonstrate that applicant has made an invention that achieves the claimed function because the invention is not described with sufficient detail that one of ordinary skill in the art can reasonably conclude that the inventor had possession of the claimed invention.
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) 1-20 are is/are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by CHOU, WO 2017/048871 A1 .
The applied reference has a common inventors and assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Applicant’s invention is directed towards a device.
Regarding Claim 1, the reference CHOU discloses a device for examining drug effects on microorganisms, at least Figure 1, page 21, comprising:
a first plate, a second plate, and spacers, at least Figure 1, pages 24-25, wherein
(i) the plates are movable relative to each other into different configurations, including an open configuration and a closed configuration, at least Figure 1, pages 24-25;
(ii) each of the plates has, on its respective sample surface, a sample contact area for contacting a sample, wherein the sample comprises a microorganism to be analyzed, at least Figure 1, pages 24-25, and
(iii) one or both of the plates comprise the spacers that are fixed to the respective sample contact area, the spacers have a predetermined substantially uniform height, and at least one of the spacers is inside the sample contact area, wherein in the open configuration, the two plates are partially or entirely separated apart, the spacing between the plates is not regulated by the spacers, and the sample is deposited on one or both of the plates; wherein in the closed configuration, which is configured after deposition of the sample in the open configuration, at least part of the sample is compressed by the two plates into a layer of substantially uniform thickness, and the thickness of the layer is confined by the sample contact surfaces of the plates and is regulated by the plates and the spacers, at least Figure 1, at least Figure 1, pages 24-25, 28.
Applicant’s invention is directed towards a system.
Regarding Claim 2, the CHOU reference discloses a system for examining drug effects on microorganisms, comprising:(a) a device of claim 1, see Rejection of Claim 1 above and Claim 68 of CHOU; (b) an imager, comprising a camera and a light source for imaging the microorganism in the layer, page 32, 128-129, Claim 68 of CHOU; and (c) a processor, comprising electronics, signal processors, hardware and software for receiving and processing the images and identifying and analyzing the microorganisms in the images, page 23, 131, Claim 68 of CHOU.
Applicant’s invention is directed towards a system.
Regarding Claim 3, the reference CHOU discloses a system for examining drug effects on microorganisms, at least Figure 1, page 21, Claim 68 of CHOU, comprising:(a) a device of claim 1, see Rejection of Claim 1 above; (b) a mobile communication device, Claim 68 of CHOU, comprising: (i) an imager that comprises one or a plurality of cameras for imaging the microorganisms in the sample, page 32, 128-129, Claim 68 of CHOU; (ii) a processor that comprises electronics, signal processors, hardware and software for receiving and/or processing the image of the microorganisms and for remote communication, page 23, 131, Claim 68 of CHOU; and (c) a light source from either the mobile communication device or an external source, wherein the light source is configured to provide illumination to the sample for imaging with the cameras, page 23, 29, 131, Claim 68 of CHOU.
Additional Disclosures Included are: Claim 4: wherein the device of claim 1, wherein one or both of the plates comprise, on the respective sample contact area, one or more test reagents that, upon contacting the sample, are dissolved and diffuses in the sample, page 49, 50-52, Embodiment 7, 8 and 11. ; Claim 5; wherein the device of claim 1, wherein one or both of the plates comprise, on the respective sample contact area, a control zone and an experimental zone, wherein the experimental zone comprises one or more test reagents that, upon contacting the sample, are dissolved and diffuses in the sample, and wherein the control zone comprises no such test reagents, page 49, 50, 51, Figure 10-12; Claim 6: wherein the device of claim 1, wherein the height of the spacers is equal to or less than an average dimension of the microorganisms, page 6 and 62-69. ; Claim 7: wherein the device of claim 1, wherein the height of the spacers is in the range of 75% to 125% of an average dimension of the microorganisms, page 6 and 62-69. ; Claim 8: wherein the device of claim 1, wherein at least one of the plates is transparent, page 27. ; Claim 9: wherein the device of claim 1, wherein one or both of the plates comprise, on the respective sample contact area, a dye that, upon contacting the sample, is dissolved in the sample and stains the microorganisms, page 171. Examiner Note: The instant claim language is directed towards the material worked upon or to be added to onto the device and does not structurally define the invention. Thus, “[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims.” In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963); see also In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935). ; Claim 10: wherein the device of claim 8, wherein the dye is fluorescently labeled, page 28, 38, 134. ; Claim 11: wherein the device of claim 1, wherein one or both of the plates comprise, on the respective sample contact area, reagents that facilitate the survival and/or division of the microorganism, Figure 10-12, pages 141-142.; Claim 12: wherein the system of claim 2, further comprising :a housing configured to hold the sample and to be mounted to the mobile communication device, page 29.; Claim 13: wherein the system of claim 2, wherein the imager is configured to acquire a series of images of the microorganism at discrete time points, Claim 11 of CHOU, page 32. ; Claim 14: wherein the system of claim 2, wherein the processor is configured to receive and analyze the series of images, identify and count the microorganism in a first area of each of the images, page 23-24, 32.; Claim 15: wherein the system of claim 2, wherein the imager is configured to acquire a video that comprises a series of images of the microorganisms over a first time period, page 140. ; Claim 16: wherein the system of claim 2, wherein the processor is configured to receive and analyze the video, identify and track at least a portion of the microorganisms in the video, and evaluate changes of the tracked microorganisms over at least a portion of the first time period, page 140.; Claim 17: wherein the system of claim 2, wherein the housing comprises optics for facilitating the imaging and/or signal processing of the sample by the mobile communication device, and a mount configured to hold the optics on the mobile communication device, Claims 70-72 of CHOU.; Claim 18: wherein the system of claim 2, wherein the mobile communication device is configured to communicate a test result with a medical professional, a medical facility or an insurance company, page 38-39. ; Claim 19: wherein the system of claim 3, wherein the mobile communication device is a mobile phone, page 28, -29, 38-39. ; and Claim 20: wherein the system of claim 2, further comprising a temperature control element that maintains the sample deposited between the two plates at a temperature that facilitates the survival and/or division of the microorganisms, page 190-191, 194.
Claims 1-20 are is/are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by METZGER, US Patent 9,657,327.
Applicant’s invention is directed towards a device.
Regarding Claim 1, the reference METZGER discloses a device for examining drug effects on microorganisms, Figure 1A-L, Figure 3A-F, comprising:
a first plate, a second plate, and spacers, Figure 3A-F, Column 15 line 24-Column 16 line 2, Column 56 line 51-58, wherein (i) the plates are movable relative to each other into different configurations, including an open configuration and a closed configuration, Column 4 line 8-14; (ii) each of the plates has, on its respective sample surface, a sample contact area for contacting a sample, wherein the sample comprises a microorganism to be analyzed, Column 15 line 24-67, detection surfaces 520, and (iii) one or both of the plates comprise the spacers that are fixed to the respective sample contact area, the spacers have a predetermined substantially uniform height, Figure 1A-D, and at least one of the spacers is inside the sample contact area, Figure 1A-D, wherein in the open configuration, the two plates are partially or entirely separated apart, the spacing between the plates is not regulated by the spacers, and the sample is deposited on one or both of the plates; wherein in the closed configuration, which is configured after deposition of the sample in the open configuration, at least part of the sample is compressed by the two plates into a layer of substantially uniform thickness, and the thickness of the layer is confined by the sample contact surfaces of the plates and is regulated by the plates and the spacers, Figure 1A-L, 3A-F.
Applicant’s invention is directed towards a system.
Regarding Claim 2, the reference METZGER discloses a system for examining drug effects on microorganisms, comprising:(a) a device of claim 1, see Rejection to Claim 1 above; (b) an imager, comprising a camera and a light source for imaging the microorganism in the layer, Column 63 line 8-46, Column 64 line 35-58; and (c) a processor, comprising electronics, signal processors, hardware and software for receiving and processing the images and identifying and analyzing the microorganisms in the images, Column 64 line 35-58, Column 34 line 53-64.
Applicant’s invention is directed to a system.
Regarding Claim 3, the reference METZGER discloses a system for examining drug effects on microorganisms, comprising:(a) a device of claim 1, see Rejection to Claim 1 above; (b) a mobile communication device comprising: (i) an imager that comprises one or a plurality of cameras for imaging the microorganisms in the sample, Column 63 line 8-46, Column 64 line 35-58; (ii) a processor that comprises electronics, signal processors, hardware and software for receiving and/or processing the image of the microorganisms and for remote communication, Column 64 line 35-58, Column 34 line 53-64; and (c) a light source from either the mobile communication device or an external source, wherein the light source is configured to provide illumination to the sample for imaging with the cameras, Column 64 line 35-58.
Additional Disclosures Included are: Claim 4: wherein the device of claim 1, wherein one or both of the plates comprise, on the respective sample contact area, one or more test reagents that, upon contacting the sample, are dissolved and diffuses in the sample, Figure 1A-L, 3A-F, Column 13 line 7-20.; Claim 5: wherein the device of claim 1, wherein one or both of the plates comprise, on the respective sample contact area, a control zone and an experimental zone, wherein the experimental zone comprises one or more test reagents that, upon contacting the sample, are dissolved and diffuses in the sample, and wherein the control zone comprises no such test reagents, Figure 1A-L, 3A-F, see different distinct detection surfaces 520, Column 34 line 33-43.; Claim 6: wherein the device of claim 1, wherein the height of the spacers is equal to or less than an average dimension of the microorganisms, Column 15 line 14-23, Column 30 line 8-35.; Claim 7: wherein the device of claim 1, wherein the height of the spacers is in the range of 75% to 125% of an average dimension of the microorganisms, Column 15 line 14-23, Column 30 line 8-35.; Claim 8: wherein the device of claim 1, wherein at least one of the plates is transparent, Column 64 line 35-64, detector, lenses, illuminators implies that at least part of the plate is transparent for detection.; Claim 9: wherein the device of claim 1, wherein one or both of the plates comprise, on the respective sample contact area, a dye that, upon contacting the sample, is dissolved in the sample and stains the microorganisms, Figure 1-A-L, 3A-F, Column 25 line 14-44, Column 26 line 45-67, Column 33 line 45-67. Examiner Note: The instant claim language is directed towards the material worked upon or to be added to onto the device and does not structurally define the invention. Thus, “[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims.” In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963); see also In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935). ; Claim 10: wherein the device of claim 8, wherein the dye is fluorescently labeled, Column 8 line 42-50, Column 25 line 27-31. ; Claim 11: wherein the device of claim 1, wherein one or both of the plates comprise, on the respective sample contact area, reagents that facilitate the survival and/or division of the microorganism, Column 30 line 9-35, Column 42 line 7-26, Column 48 line 62-Column 49 line 6. ; Claim 12: wherein the system of claim 2, further comprising: a housing configured to hold the sample and to be mounted to the mobile communication device, Figure 2B, Column 9 line 7-23. ; Claim 13: wherein the system of claim 2, wherein the imager is configured to acquire a series of images of the microorganism at discrete time points, Column 42 line 27-45, Claim 1.; Claim 14: wherein the system of claim 2, wherein the processor is configured to receive and analyze the series of images, identify and count the microorganism in a first area of each of the images, Claim 1.; Claim 15: wherein the system of claim 2, wherein the imager is configured to acquire a video that comprises a series of images of the microorganisms over a first time period, Column 42 line 27-45. ; Claim 16: wherein the system of claim 2, wherein the processor is configured to receive and analyze the video, identify and track at least a portion of the microorganisms in the video, and evaluate changes of the tracked microorganisms over at least a portion of the first time period, Column 42 line 27-45, Claim 1. ; Claim 17: wherein the system of claim 2, wherein the housing comprises optics for facilitating the imaging and/or signal processing of the sample by the mobile communication device, and a mount configured to hold the optics on the mobile communication device, Column 33 line 5-18, Column 34 line 8-33.; Claim 18: wherein the system of claim 2, wherein the mobile communication device is configured to communicate a test result with a medical professional, a medical facility or an insurance company, Column 48 line 1-4. ; Claim 19: wherein the system of claim 3, wherein the mobile communication device is a mobile phone, Column 34 line 53-64, Column 45 line 24-30, Column 48 line 1-4. ; Claim 20: wherein the system of claim 2, further comprising a temperature control element that maintains the sample deposited between the two plates at a temperature that facilitates the survival and/or division of the microorganisms, Column 31 line 1-4, Column 32 line 1-18, Column 68 line 64-Column 69 line 2.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. EP 0 961 110 A2 to BERNDT, submitted on the IDS on 28 JUNE 2023, discloses a device for examining microorganisms, [0001], comprising: a first plate, Figure 2, 3; a second plate, Figure 2, 3; and spacers, Figure 2, 3; wherein (i) the plates are movable relative to each other into different configurations, including an open configuration and a closed configuration, Figure 3; (ii) each of the plates has, on its respective sample surface, a sample contact area for contacting a sample, wherein the sample comprises a microorganism to be analyzed, Figure 3, and (iii) one or both of the plates comprise the spacers that are fixed to the respective sample contact area, the spacers have a predetermined substantially uniform height, and at least one of the spacers is inside the sample contact area, wherein in the open configuration, the two plates are partially or entirely separated apart, the spacing between the plates is not regulated by the spacers, and the sample is deposited on one or both of the plates, Figure 1-16; wherein in the closed configuration, which is configured after deposition of the sample in the open configuration, at least part of the sample is compressed by the two plates into a layer of substantially uniform thickness, and the thickness of the layer is confined by the sample contact surfaces of the plates and is regulated by the plates and the spacers, Figure 1-16.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINE T MUI whose telephone number is (571)270-3243. The examiner can normally be reached M-Th 5:30 -15:30 EST.
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CTM
/CHRISTINE T MUI/Primary Examiner, Art Unit 1797