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
Summary
This is the Non-Final Office action based on the 18/604656 filed 03/14/2024.
Claims 1-12 are pending and have been fully considered.
This application has been examined as part of the PBA pilot program.
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.
Claim 1 contains the limitations “detection means.” From the instant specification and claims, this detection means can be an image sensor or microscope (paragraph 0029, 0027).
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.
Claims 7-8 & 10-12 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.
With respect to Claims 7-8, “turned upside down,” and “to come to bear,” are confusing/unclear in the claims as both are relative terms not defined by the claim and could mean different things to different people reading the claims and therefore are confusing.
With respect to Claim 10, it is unclear if another method step is being claimed for the claimed method, or if instead just a configuration or capability of the image sensor. The same thing applies to the limitations in Claims 11 and 12.
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 non-obviousness.
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 1-12 are rejected under U.S.C. 103 as being obvious by OCZAN in WO 2018102346 in view of OLSON in WO 2011009213 (both as cited on IDS dated 03/14/2024) and further in view of PERLEMOINE in US 20210147899.
With respect to Claim 1, OCZAN teaches of a method of performing antimicrobial susceptibility testing (AST) on a bacteria-containing sample using an opto-mechanical reader device configured to mount on a portable electronic device having a camera comprising:
securing the opto-mechanical reader device to the portable electronic device;
loading an optically transparent plate having an array of wells containing the bacteria- containing sample, growth medium, and a panel of drugs of differing concentrations into the opto-mechanical reader device;
illuminating the wells in the optically transparent plate using an array of illumination sources contained in the opto-mechanical reader device;
acquiring one or more images of the wells in the array with the camera of the portable electronic device, wherein the one or more images represent light transmittance through the wells in the array;
processing the one or more acquired images with image processing software executed by at least one processor to classify each well as turbid or not turbid and generating MIC values and a susceptibility characterization for each drug in the panel based on the turbidity classification of the array of wells; and
displaying MIC values and the susceptibility characterizations for each drug in the panel on the portable electronic device or other computing device (Claim 1).
More specifically, OCZAN teaches that the plate used is a microtiter plate containing 96 (multiple) wells (so is a multi-well plate) (abstract, paragraph 0005, 0049, 0062), and that it is made of a material that is transparent to light/optically transparent (paragraph 0011-0016 among other places), emitted from light sources (paragraph 0040, 0042) and that the wells in the plate are loaded with a bacteria containing sample, growth medium, and a panel of different drugs (paragraph 0011). The drugs can be antibiotics (paragraph 0005-0006, 0010, 0036, 0042, 0048).
Even further OCZAN teaches of loading/depositing onto the wells in the plate with a bacteria containing sample, growth medium, and a panel of different drugs (paragraph 0011). These are loaded on the transparent plate.
OCZAN teaches that in addition to the microtiter plate with wells a base plate is used (paragraph 0025, 0033, 0037-0038).
OCZAN further teaches of placing the microtiter plate and base plate having an opto-mechanical attachment which illuminates the plate and obtains images from it (paragraph 0008). The plate is loaded into the opto-mechanical device and then it is illuminated using an array of illumination sources contained in it and the images/light are detected by a camera (paragraph 0011). This can be considered placed “between,” through broadest reasonable interpretation (BRI). The opto-mechanical device includes a slot to receive the plate device having the sample (paragraph 0016, 0035, Figure 1 & 2).
OCZAN even further teaches of emitting light signals through each well using the light source (0035, 0032).
And finally, OCZAN teaches of determining using the camera and processor which can be in a phone the absence or presence of antibiotic activity with respect to the bacteria based on the intensity of light detected over time and averaging intensities (paragraph 0014, 0016, 0045-0047, 0024, 0045).
OCZAN does not teach of the bacteria being loaded on to one part which is the “support,” that then comes into contact with the multi-well plate, as claimed, however as claimed since OCZAN claims all the claimed parts and components mixed together, this seems like only rearranging or method steps.
See In reBurhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946) (selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results); In reGibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930) (Selection of any order of mixing ingredients is prima facie obvious.).
However, if this is not apparent to one of ordinary skill, OLSON is used to remedy this and teaches of a method and device for testing for anti-microbial susceptibility (abstract). OLSON further teaches of two plates or structures including a lid with projections both having a different reaction component on them and pushing the plates/lids (or supports) together to cause them to react(Page 19, line 17-30).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention to use the plates/support structure/lid structure with different components on them as is done in OLSON in the method of OCZAN due to the advantage this has for causing one component to move across or act/interact with the other when the components are together (Page 19, paragraph 3).
OCZAN and OLSON does not call out that the plate is permeable to apolar gases.
PERLEMOINE remedies this and teaches of a method for determining the sensitivity of a bacterial strain of interest to a viral strain of bacteriophages (abstract), and further teaches that the system uses a sample and placing the sample between a light source and imagining sensor where the source has emission between 500 and 600 nm (abstract). PERLEMOINE further teaches of that the device where the sample is kept have be a fluidic chip with fluidic chambers and that the chambers can be filled with a material such as a hydrogel (paragraph 0158). PERLEMOINE further teaches that the chambers and sidewalls of the support structures are permeable to oxygen (paragraph 0124-0125), which is an apolar gas.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention to make the container/structures holding the sample permeable to apolar gases as is done in PERLEMOINE in the methods and devices of OCZAN and OLSON due to the advantage that this offers for oxygenating the fluidic chamber, which is necessary for development of certain bacteria’s (PERLEMOINE, paragraph 0124-0125).
With respect to Claim 2, OCZAN and OLSON teach of the above, but do not teach of use of a hydrogel.
PERLEMOINE remedies this and teaches of a method for determining the sensitivity of a bacterial strain of interest to a viral strain of bacteriophages (abstract), and further teaches that the system uses a sample and placing the sample between a light source and imagining sensor where the source has emission between 500 and 600 nm (abstract). PERLEMOINE further teaches of that the device where the sample is kept have be a fluidic chip with fluidic chambers and that the chambers can be filled with a material such as a hydrogel (paragraph 0158). PERLEMOINE further teaches that the chambers and sidewalls of the support structures are permeable to oxygen (paragraph 0124-0125), which is an apolar gas.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention to hold the bacteria in a gel as is done in PERLEMOINE in the methods and devices of OCZAN and OLSON due to the advantage that this offers for allowing the sample to be divided/deposited into various spatial regions (PERLEMOINE, paragraph 0159).
With respect to Claim 3, OCZAN and OLSON teach of the above, but do not teach of use of a hydrogel.
PERLEMOINE remedies this and teaches of a method for determining the sensitivity of a bacterial strain of interest to a viral strain of bacteriophages (abstract), and further teaches that the system uses a sample and placing the sample between a light source and imagining sensor where the source has emission between 500 and 600 nm (abstract). PERLEMOINE further teaches of that the device where the sample is kept have be a fluidic chip with fluidic chambers and that the chambers can be filled with a material such as a hydrogel (paragraph 0158). PERLEMOINE further teaches that the chambers and sidewalls of the support structures are permeable to oxygen (paragraph 0124-0125), which is an apolar gas.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention to hold the bacteria in a gel as is done in PERLEMOINE in the methods and devices of OCZAN and OLSON due to the advantage that this offers for allowing the sample to be divided/deposited into various spatial regions (PERLEMOINE, paragraph 0159).
With respect to Claim 4, OCZAN and OLSON teach of the inventions as shown above. They call out microwells and titers, however PERLEMOINE made this even more clear in that they teach of various fluidic chambers, each corresponding to one spatial region of the sample (paragraph 0005), which allows each chamber to be individually addressed (paragraphs 0105-0116) and further the divisions seal the chambers from other none sample liquids from passing through or leakage, but is permeable to gas (paragraphs 0125-0127). It would have been obvious to have distinct compartments as is done in PERLEMOINE in the device of OCZAN and OLSON due to the advantage this offers in allowing the compartments to being individually addressable (paragraph 0105-0116).
With respect to Claim 5, OCZAN does not teach of the bacteria being loaded on to one part which is the “support,” that then comes into contact with the multi-well plate, as claimed, however as claimed since OCZAN claims all the claimed parts and components mixed together, this seems like only rearranging or method steps.
See In reBurhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946) (selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results); In reGibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930) (Selection of any order of mixing ingredients is prima facie obvious.).
However, if this is not apparent to one of ordinary skill, OLSON is used to remedy this and teaches of a method and device for testing for anti-microbial susceptibility (abstract). OLSON further teaches of two plates or structures including a lid with projections both having a different reaction component on them and pushing the plates/lids (or supports) together to cause them to react (Page 19, line 17-30).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention to use the plates/support structures for contacting the sample and antibiotics/different components on them as is done in OLSON in the method of OCZAN due to the advantage this has for causing one component to move across or act/interact with the other when the components are together (Page 19, paragraph 3).
With respect to Claim 6, OCZAN does not teach of the bacteria being loaded on to one part which is the “support,” that then comes into contact with the multi-well plate, as claimed, however as claimed since OCZAN claims all the claimed parts and components mixed together, this seems like only rearranging or method steps.
See In reBurhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946) (selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results); In reGibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930) (Selection of any order of mixing ingredients is prima facie obvious.).
However, if this is not apparent to one of ordinary skill, OLSON is used to remedy this and teaches of a method and device for testing for anti-microbial susceptibility (abstract). OLSON further teaches of two plates or structures including a lid with projections both having a different reaction component on them and pushing the plates/lids (or supports) together to cause the mixing of elements and things disposed on the projections in the lid to cause them to react with the things in the titer plates(Page 19, line 17-30). This reads on the instantly claimed “turned upside down and moved so as to come to bear via open face).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention to use the plates/support structures for contacting the sample and antibiotics/different components on them as is done in OLSON in the method of OCZAN due to the advantage this has for causing one component to move across or act/interact with the other when the components are together (Page 19, paragraph 3).
With respect to Claim 7, OCZAN does not teach of the bacteria being loaded on to one part which is the “support,” that then comes into contact with the multi-well plate, as claimed, however as claimed since OCZAN claims all the claimed parts and components mixed together, this seems like only rearranging or method steps.
See In reBurhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946) (selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results); In reGibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930) (Selection of any order of mixing ingredients is prima facie obvious.).
However, if this is not apparent to one of ordinary skill, OLSON is used to remedy this and teaches of a method and device for testing for anti-microbial susceptibility (abstract). OLSON further teaches of two plates or structures including a lid with projections both having a different reaction component on them and pushing the plates/lids (or supports) together to cause the mixing of elements and things disposed on the projections in the lid to cause them to react with the things in the titer plates(Page 19, line 17-30). This reads on the instantly claimed “turned upside down and moved so as to come to bear via open face).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention to use the plates/support structures for contacting the sample and antibiotics/different components on them as is done in OLSON in the method of OCZAN due to the advantage this has for causing one component to move across or act/interact with the other when the components are together (Page 19, paragraph 3).
With respect to Claim 8, OCZAN teaches of the devices detecting images with a camera (abstract, 0008, 0011, 0013).
With respect to Claim 9, OCZAN teaches of the devices detecting images with a camera, which is an image sensor (abstract, 0008, 0011, 0013).
With respect to Claim 10, OZCAN teaches of taking bright, medium, and dim average intensities of the wells (Figure 6) (paragraph 0046). This can considered taking first and second images with second image taken at a later time through broadest reasonable interpretation BRI. OZCAN then teaches of making susceptibility characterizations for the bacteria’s/antibiotics based on this, and based on comparison to thresholds, so measuring above or below the threshold (paragraph 0024, paragraph 0046).
With respect to Claim 11, OCZAN and OLSON teach of the invention as shown above. They do not teach of lensless imaging. PERLEMOINE is used to remedy this and teaches of using lensless imagining (paragraph 0093). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention to use the lensless imaging as is done in PERLEMOINE in the methods o OCZN and OLSON due to the advantage this allows for the field of observation of the image sensor to be maximized (PERLEMOINE, paragraph 0093).
With respect to Claim 12, OCZAN teaches of the light source being from light emitting diodes which have an emitting wavelength between 400 and 600 nm (paragraph 0035), which is included in the claimed range.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA M FRITCHMAN whose telephone number is (303)297-4344. The examiner can normally be reached 9:30-4:30 MT Monday-Friday.
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/REBECCA M FRITCHMAN/Primary Examiner, Art Unit 1758
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