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 Status
Claims 1-20 are currently pending and under exam herein.
It is noted that claim 1 has been assigned steps (a)-(e) for ease of discussion. It is recognized that such designations do not appear in the claims as originally filed.
Priority
The instant application is a Continuation of US 16/361,016, filed 21 March 2019, now US Patent 11,761,023 which is a Continuation of US 16/292,608, filed 5 March 2019, now US Patent 11,708,596, which is a Continuation of US 15/883,485, filed 30 January 2018, now US Patent 10,266,867 and claiming the benefit of priority to US Provisional Application 62/453,605, filed 2 February 2017. Priority for each of claims 1-20 is granted to the provisional application (EFD 2 February 2017).
Information Disclosure Statement
The Information Disclosure Statements filed 8 August 2023 and 21 March 2024 are in compliance with the provisions of 37 CFR 1.97 and have therefore been considered. Signed copies of the IDS documents are included with this Office Action.
It is noted herein that the listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered. See [0131] of the Specification as published.
Drawings
The Drawings submitted on 8 August 2023 are accepted.
Specification
Note: All reference sot the “Specification” in this Office Action refer to the Published Specification US 20230392184A1.
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. See [0119] of the Specification. It is noted that all instances of hyperlinks that appear in the Specification should be deleted and that the above is merely exemplary. Applicant is asked to review the Specification at each page for compliance.
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.
Claims 1-20 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 1, step (c) recites, “analyzing, for the one or more individual microorganisms of one or more strains, motion by the one or more individual microorganisms of one or more strains, the analyzing being based on the one or more captured images of the sample”. The claim step is unclear with respect to the analysis based on one or more captured image because there are no steps of any actual analysis that take place in the limitation as recited. Thus, the metes and bounds of the analysis step are not clear. Therefore, for examination purposes the claim is interpreted only as a step of assessing the captured image. Clarification is requested.
Claim 1, step (e) recites, “applying mathematical processing to the generated kinematics data to determine at least one of a presence, identity, or count of individual microorganisms of one or more strains, or a susceptibility to the one or more antibiotics of the one or more strains of microorganisms”. The step is unclear with respect to the determination of said parameters from the application of mathematical processing, as there are no steps of actual processing claimed nor are there any steps that provide parameters of the mathematical processing applied to any kinematic data that would include a range or other value applied such that a presence, identity, or count of one or more strains of microorganisms would be “determined”. A such, the metes and bounds of coverage sought are unclear. Clarification is requested.
Claim 2 recites, “applying of the mathematical processing to the generated kinematics data comprises applying stored criteria” wherein the claim is indefinite with respect to the application of a stored criteria as no criteria are defined as any particular variable in the mathematical processing applied to the kinematic data and therefore the application of that data is unclear. This also applies to the recitations in claim 3. It is noted that claims 4-20 define the data, however, the application of that to kinematic data to determine the presence, identity or count remains indefinite as here are no steps by which the determining occurs.
Claim 6 recites, “in which the statistical values comprise values determined by applying mathematical processes”, wherein the claim is indefinite with respect to the recitation of “applying mathematical processes” as it is not clear if this is the same “mathematical processing” as in claim 1 or a different mathematical process. It is suggested that the claim be amended to recite either, “in which the statistical values comprise values determined by applying the mathematical processes” or “in which the statistical values comprise values determined by applying different mathematical processes from those in claim 1” or the like. Clarification is requested.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
The instant rejection reflects the framework as outlined in the MPEP at 2106.04:
Framework with which to Evaluate Subject Matter Eligibility:
(1) Are the claims directed to a process, machine, manufacture or composition of matter;
(2A) Prong One: Do the claims recite a judicially recognized exception, i.e. a law of nature, a natural phenomenon, or an abstract idea;
Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application (Prong Two); and
(2B) If the claims do not integrate the judicial exception, do the claims provide an inventive concept.
Framework Analysis as Pertains to the Instant Claims:
Step 1 Analysis: Are claims directed to process, machine, manufacture/composition of matter
With respect to step (1): yes, the claims are directed to a method.
Step 2A, Prong 1 Analysis: Do claims recite abstract idea
With respect to step (2A)(1), the claims recite abstract ideas. The MPEP at 2106.04(a)(2) further explains that abstract ideas are defined as:
mathematical concepts, (mathematical formulas or equations, mathematical relationships and mathematical calculations);
certain methods of organizing human activity (fundamental economic practices or principles, managing personal behavior or relationships or interactions between people); and/or
mental processes (procedures for observing, evaluating, analyzing/ judging and organizing information).
With respect to the instant claims, under the (2A)(1) evaluation, the claims are found herein to recite abstract ideas that fall into the grouping of mental processes (in particular procedures for observing, analyzing and organizing information) and in conjunction with mathematical concepts (in particular mathematical relationships and formulas).
Note: The claims elements are italicized herein to highlight the judicial exceptions in the claim steps and underlined to represent the additional claim elements.
Claim 1:
subjecting a bodily sample of a human or an animal to one or more antibiotics, the bodily sample containing one or more individual microorganisms of one or more strains;
by an imaging device, capturing one or more images of the sample, including the one or more individual microorganisms of one or more strains;
analyzing, for the one or more individual microorganisms of one or more strains, motion by the one or more individual microorganisms of one or more strains, the analyzing being based on the one or more captured images of the sample, wherein said operation is directed to mental processes whereby making an analysis of motion in am image (presumably from a microscope-derived image, can be performed by observation of said microorganism by a human or alternatively, using a computer as a tool or in a computing environment ;
automatically by computer, generating kinematics data for the one or more individual microorganisms of one or more strains based on the analyzed motion; and
applying mathematical processing to the generated kinematics data to determine at least one of a presence, identity, or count of individual microorganisms of one or more strains, or a susceptibility to the one or more antibiotics of the one or more strains of microorganisms, wherein said operations is of “generating kinematic data” may be performed in a mental capacity by observation of, for example, of swimming direction of a microorganism or other motility parameter. Further “applying mathematical processes” are directed to mathematical concepts that include computation of mean values. See claim 7 and the Specification at [0086].
Dependent claims 2-20 recite additional steps that further limit the judicial exceptions in independent claim 1 and as such, are further directed to abstract ideas (applying stored criteria [claims 2-3]; types of quantitative properties [claims 4-10]; distributions [claims 12-15]; comparisons [claims 16-20]).
Hence, the claims explicitly recite numerous elements that, individually and in combination, constitute abstract ideas.
The abstract ideas recited in the claims are evaluated under the Broadest Reasonable Interpretation (BRI) and determined herein to each cover performance either in the mind (calculations by hand or pen and paper or computer as a tool) and performance by mathematical operation (mathematical means, comparisons, distributions). as to the methodology involved in steps (c)-(e) in instant claim 1 and thus, under the BRI, one could simply provide an analysis based on observation of images and assign kinematics data that is further processed using math. Save for the generic computing aspects of the claim, the operations could be performed via pen and paper. Other steps, recited in dependent claims, further include that statistical operations are implemented, as well as quantitative properties. Each of said recitations in the independent claim and dependent claims can be performed using mathematics and mental operation. The instant Specification indicates that, for example, the mathematics involved can include comparisons to known data from a database [0007] and statistical assessments (throughout Specification).
These recitations are similar to the concepts of collecting information, analyzing it and providing certain results from the collection and analysis (Electric Power Group, LLC, v. Alstom (830 F.3d 1350, 119 USPQ2d 1739 (Fed. Cir. 2016)), organizing and manipulating information through mathematical correlations (Digitech Image Techs., LLC v Electronics for Imaging, Inc. (758 F.3d 1344, 111 U.S.P.Q.2d 1717 (Fed. Cir. 2014)) and comparing information regarding a sample or test to a control or target data in (Univ. of Utah Research Found. v. Ambry Genetics Corp. (774 F.3d 755, 113 U.S.P.Q.2d 1241 (Fed. Cir. 2014) and Association for Molecular Pathology v. USPTO (689 F.3d 1303, 103 U.S.P.Q.2d 1681 (Fed. Cir. 2012)) that the courts have identified as concepts that can be practically performed in the human mind with pen and paper, and can include mathematical concepts.
Further, see MPEP § 2106.04(a)(2), subsection III. The courts do not distinguish between mental processes that are performed entirely in the human mind and mental processes that require a human to use a physical aid (e.g., pen and paper or a slide rule) to perform the claim limitation (see, e.g., Benson, 409 U.S. at 67, 65, 175 USPQ at 674-75, 674: noting that the claimed "conversion of [binary-coded decimal] numerals to pure binary numerals can be done mentally," i.e., "as a person would do it by head and hand."); Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1139, 120 USPQ2d 1473, 1474 (Fed. Cir. 2016): holding that claims to a mental process of "translating a functional description of a logic circuit into a hardware component description of the logic circuit" are directed to an abstract idea, because the claims "read on an individual performing the claimed steps mentally or with pencil and paper"). Nor do the courts distinguish between claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer. As the Federal Circuit has explained, "[c]ourts have examined claims that required the use of a computer and still found that the underlying, patent-ineligible invention could be performed via pen and paper or in a person’s mind" (see Versata Dev. Group v. SAP Am., Inc., 793 F.3d 1306, 1335, 115 USPQ2d 1681, 1702 (Fed. Cir. 2015); Mortgage Grader, Inc. v. First Choice Loan Servs. Inc., 811 F.3d 1314, 1324, 117 USPQ2d 1693, 1699 (Fed. Cir. 2016): holding that computer-implemented method for "anonymous loan shopping" was an abstract idea because it could be "performed by humans without a computer").
Step 2A, Prong 2 Analysis: Integration to a Practical Application
Because the claims do recite judicial exceptions, direction under (2A)(2) provides that the claims must be examined further to determine whether they integrate the abstract ideas into a practical application (MPEP 2106.04(d). A claim can be said to integrate a judicial exception into a practical application when it applies, relies on, or uses the judicial exception in a manner that imposes a meaningful limit on the judicial exception. This is performed by analyzing the additional elements of the claim to determine if the abstract idea is integrated into a practical application (MPEP 2106.04(d).I.; MPEP 2106.05(a-h)). If the claim contains no additional elements beyond the abstract idea, the claim is said to fail to integrate the abstract idea into a practical application (MPEP 2106.04(d).III).
With respect to the instant recitations under the (2A)(2) assessment, the claims recite the following additional elements:
Claim 1: subjecting a bodily sample of a human or an animal to one or more antibiotics, the bodily sample containing one or more individual microorganisms of one or more strains;
by an imaging device, capturing one or more images of the sample
Claim 1 further includes steps directed to automatically by a computer with respect to the kinematics data generation. Dependent steps that refer to a computer aspect to the instant claims include “stored data”.
The “additional elements” herein are steps directed to data gathering, such as “subjecting…sample…to…antibiotics” and “capturing one or more images” perform functions of collecting the data needed to carry out the abstract idea. Said data gathering do not impose any meaningful limitations on the abstract idea, or on how the abstract idea is performed. Data gathering steps are not sufficient to integrate an abstract idea into a practical application. (MPEP 2106.05(g).
The steps directed to additional non-abstract elements of “computing”, as above, do not describe any specific computational steps by which the “computer parts” perform or carry out the abstract idea, nor do they provide any details of how specific structures of the computer are used to implement these functions. The claims state nothing more than a generic computer which performs the functions that constitute the abstract idea. Hence, these are mere instructions to apply the abstract idea using a computer, and therefore the claim does not integrate that abstract idea into a practical application. The courts have weighed in and consistently maintained that when, for example, a memory, display, processor, machine, etc… are recited so generically (i.e., no details are provided) that they represent no more than mere instructions to apply the judicial exception on a computer, and these limitations may be viewed as nothing more than generally linking the use of the judicial exception to the technological environment of a computer. (see MPEP 2106.05(f)).
Further, the computer “processing” is part of a general purpose computer system and there are no details herein wherein of how the specific computer structures are used to implement the judicial exceptions beyond generic computing operations, i.e., the computer elements of the claims do not provide improvements to the functioning of the computer itself (see: DDR Holdings, LLC v. Hotels.com LP); they do not provide improvements to any other technology or technical field (see: Diamond v. Diehr); nor do they utilize a particular machine (see: Eibel Process Co. v. Minn. & Ont. Paper Co.). Hence, these are mere instructions to apply the judicial exception using a computer, and therefore the claim does not provide integration into a practical application of any judicial exception.
None of the recited dependent claims recite additional elements which would integrate a judicial exception into a practical application.
Step 2B Analysis: Do Claims Provide an Inventive Concept
The claims are lastly evaluated using the (2B) analysis, wherein it is determined that because the claims recite abstract ideas, and do not integrate that abstract ideas into a practical application, the claims also lack a specific inventive concept. Applicant is reminded that the judicial exception alone cannot provide the inventive concept or the practical application and that the identification of whether the additional elements amount to such an inventive concept requires considering the additional elements individually and in combination to determine if they provide significantly more than the judicial exception. (MPEP 2106.05.A i-vi).
With respect to the instant claims, the additional elements of data gathering described above do not rise to the level of significantly more than the judicial exception. As directed in the Berkheimer memorandum of 19 April 2018 and set forth in the MPEP, determinations of whether or not additional elements (or a combination of additional elements) may provide significantly more and/or an inventive concept rests in whether or not the additional elements (or combination of elements) represents well-understood, routine, conventional activity. Said assessment is made by a factual determination stemming from a conclusion that an element (or combination of elements) is widely prevalent or in common use in the relevant industry, which is determined by either a citation to an express statement in the specification or to a statement made by an applicant during prosecution that demonstrates a well-understood, routine or conventional nature of the additional element(s); a citation to one or more of the court decisions as discussed in MPEP 2106(d)(II) as noting the well-understood, routine, conventional nature of the additional element(s); a citation to a publication that demonstrates the well-understood, routine, conventional nature of the additional element(s); and/or a statement that the examiner is taking official notice with respect to the well-understood, routine, conventional nature of the additional element(s).
With respect to the instant claims, the prior art to Kreuger et al. (2016/0186231-IDS reference) discloses that the routine nature of imaging techniques in the presence of antibiotics, which is considered here as routine, well-understood and conventional data gathering step, as recited above. See Kreuger at least at [0034] [0042]; [0061]. As such, activities such as data gathering do not improve the functioning of a computer, or comprise an improvement to any other technical field; they do not require or set forth a particular machine; they do not effect a transformation of matter; nor do they provide a non-conventional or unconventional step. Rather, the data gathering steps as recited in the instant claims constitute a general link to a technological environment which is insufficient to constitute an inventive concept which would render the claims significantly more than the judicial exception (MPEP2106.05(g)&(h)).
With respect to claims 1-20 and any computer-related elements/general purpose computer said additional elements do not rise to the level of significantly more than the judicial exception. Further exemplified prior art to, for example, Son et al. (PNAS (2016) Vol. 113:8624-8629-IDS reference) teaches that computing elements are routine, well-understood and conventional in the art, wherein Son et al. employ computational models for chemotaxis (see at least page 8629). The additional elements are set forth at such a high level of generality that they can be met by a general purpose computer. Therefore, the computer components constitute no more than a general link to a technological environment, which is insufficient to constitute an inventive concept that would render the claims significantly more than an abstract idea (see MPEP 2106.05(b)I-III). Dependent claims have been analyzed with respect to step 2B and none of these claims provide a specific inventive concept, as they all fail to rise to the level of significantly more than the identified judicial exception.
For these reasons, the claims, when the limitations are considered individually and as a whole, are rejected under 35 USC § 101 as being directed to non-statutory subject matter.
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 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.
1. Claims 1-9 and 11-14 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by US 4,896,966 to Boisseau et al. (IDS reference). Portions of the prior art applicable to each claim limitation are indicated in italics below.
Instant Claim 1 is directed a method comprising:
(a) subjecting a bodily sample of a human or an animal to one or more antibiotics, the bodily sample containing one or more individual microorganisms of one or more strains (Boisseau et al. disclose a method of characterizing motility of a microorganism at column 2, lines 20-22 or a change in motility or count (live and dead sperm counted using movement data (motility); column 9, lines 45-59), or determine the identity of a species or strain of the at least one individual microorganism, or determine a susceptibility of the at least one individual microorganism to one or more antibiotics or other antimicrobials.
(b) by an imaging device, capturing one or more images of the sample, including the one or more individual microorganisms of one or more strains (Boisseau disclose using an imaging device to capture said images (column 2; column 3));
(c) analyzing, for the one or more individual microorganisms of one or more strains, motion by the one or more individual microorganisms of one or more strains, the analyzing being based on the one or more captured images of the sample (Boisseau et al. analyze motion of a specimen; column 1);
(d) automatically by computer, generating kinematics data for the one or more individual
microorganisms of one or more strains based on the analyzed motion (Boisseau do not use the term “kinematics” however, Boisseau et al. are specifically concerned with motility and velocity in a sample and assess motion by generating data for said motion (see column 3 and analysis by assessment of Brownian motion , for example)); and
(e ) applying mathematical processing to the generated kinematics data to determine at least one of a presence, identity, or count of individual microorganisms of one or more strains, or a susceptibility to the one or more antibiotics of the one or more strains of microorganisms (Boisseau et al. disclose assessment of motion data to provide information regarding the presence of the microorganism in the sample at column 7; Boisseau et al. disclose the number of objects, as well at Example 1, column 9; Boisseau et al. disclose computer implementation and a scanning device for imaging (column 1; column 5).
With respect to claim 2, Boisseau et al. disclose previously programmed data for use in the assessment of velocity and distribution functions (column 8).
With respect to claim 3, Boisseau et al. disclose using stored data (column 8).
With respect to claim 4, Boisseau et al. disclose properties of motion (column 8-velocity, e.g.).
With respect to claim 5, Boisseau et al. disclose assessment of statistical properties (column 8 to column 9; ratio of distances and mean values).
With respect to claim 6, Boisseau et al. disclose application of mathematical processes (column 8-9)
With respect to claim 7, Boisseau et al. disclose mean value assessment (column 9).
With respect to claim 8, Boisseau et al. disclose quantitative properties such as velocity (column 9).
With respect to claim 9, Boisseau et al. disclose the properties that include a number of microorganisms exhibiting motion (column 9-Example 1).
With respect to claim 11, Boisseau et al. disclose assessment of motion distribution (column 9, 1-8).
With respect to claim 12, Boisseau et al. disclose determining information from distributions (Example 1-column 9).
With respect to claim 13, Boisseau et al. disclose the quantitative properties that include velocity (column 9).
With respect to claim 14, Boisseau et al. disclose the properties that include a number of microorganisms exhibiting motion (column 9-Example 1).
2. Claims 1, 3-4, 10-11, and 15 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by US 2007/0298454 to Green et al. (IDS reference). Portions of the prior art applicable to each claim limitation are indicated in italics below.
With regard to the claim 1 limitations outlined above, Green teaches said embodiments including a method of characterizing motility of a spermatozoa (microorganism) cells determined; (paragraphs [0001], [0017]-[0021 ]) or a change in motility of at least one individual microorganism or both, and using the characterized motility or change in motility to detect the presence or count of the at least one individual microorganism (number of motile cells determined; paragraph [0022]; motility data is equivalent to kinematic data), or determine the identity of a species or strain of the at least one individual microorganism, or determine a susceptibility of the at least one individual microorganism to one or more antibiotics or other antimicrobials. Green further discloses the method comprising using an imaging device to capture at successive times two or more digital images of the at least one individual microorganism (first and second digital frames; paragraphs[0018]-[0019]).
With respect to claim 3, Green et al. disclose processing using stored data (paragraph [0039] wherein data may be stored for use).
With respect to claim 4, Green et al. disclose information about motion (paragraph [0039] wherein stored data may be motility data; paragraph [0109]).
With respect to claim 10, Green et al. disclose assessments of size (paragraph [0005]; [0030]).
With respect to claim 11, Green et al. disclose a distribution of properties of motion (paragraph [0010] to frequency distributions of features)
With respect to claim 15, Green et al. disclose quantitative properties of size (paragraph [0030]).
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 for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
1. Claims 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over US 4,896,966 to Boisseau et al. (IDS reference), with respect to claim 1 above and in view of US 4,603,977 to Bennett et al. (IDS reference).
With respect to claim 1 limitations as outlined above. The prior art to Boisseau et al. disclose said limitations (see above). Boisseau et al. do not specifically disclose the steps of comparing kinematic data for two conditions that comprise two different concentrations of antibiotics at different time points as in claims 16-20 herein. However, the prior art to Bennett et al. discloses other antimicrobials. Bennett discloses at least one individual microorganism is subjected to two different antibiotic or other antimicrobial conditions, including at least one of: presence and absence of an antibiotic or other antimicrobial, presence of two or more different antibiotics or other antimicrobials, presence of different concentrations of an antibiotic or other antimicrobial, or presence of different combinations of one or more antibiotics or other antimicrobials (test high number of solutions (two or more different) of drugs such as anti-helminthic (antimicrobial); column 2, lines 56-57; column 4, lines 12-13). Further Bennett et al. disclose different time assessments (column 4).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Boisseau et al. to include the drug testing application of Bennett, as both use the detection and determination of motility, and the drug evaluation of Bennett provides a useful application for the motility detection device of Boisseau et al. Boisseau et al. provide that their improved motility scanner and method is specifically designed for characterizing the motion of sperm, bacteria, particles suspended in flowing fluids, Brownian motion and the like and thus advantages of the addition of time assessments and varying concentrations of antibiotics to make motility assessments would have been obvious and predictable to one of skill in the art (see Boisseau et al. at column 10).
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
1. Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,266,867. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims include the same steps directed to subjecting a sample to antibiotic treatment containing a microorganism (bacteria); capturing image data; analyzing motion data (trajectory) in the image data; generating kinematic data of the motion data (trajectory data); and processing the data to determine susceptibility to one or more antibiotics. The claims of the patent include using two separate portions of a sample for imaging and performing said steps. However, it would have been prima facie obvious to one of skill in the art at the time of the claimed invention to have included applications of more than one portion for imaging assessment, as analysis claimed in the instant claim 1 includes capturing more than one image. As such the claims are obvious variants one of the other.
2. Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 11,708,596 Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims and the copending claims in the ‘’596 patent are each directed to the same steps wherein the claims of ‘596 are directed to “measuring trajectories” data instead of “analyzing motion” which are equivalent steps and further wherein the instant application applies mathematical processing to the “determining” of presence, identity, or count. The step of “determining” in ‘596 can be performed using mathematical steps as is defined in the Specification therein at least at page 23. As such, the claim steps are obvious variants one of the other.
3. Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,761,023 Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims and the ‘023 patent claims are each directed to the same steps wherein the claims of ‘023 are directed to “measuring trajectories” data instead of “analyzing motion” which are equivalent steps and further wherein the instant application applies mathematical processing to the “determining” of presence, identity, or count. The step of “determining” in the ‘023 patent can be performed using mathematical steps as defined in the Specification therein at least at page 23. As such, the claim steps are obvious variants one of the other.
Conclusion
No claims are allowed.
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/Lori A. Clow/Primary Examiner, Art Unit 1687
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