DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Amendments
2. The claim amendments filed October 3, 2025 have been entered. Claims 1, 5, 11 and 17 were amended. Claims 4, 16 and 21-30 were cancelled. Claims 1-3, 5-15 and 17-20 are under consideration in this Office Action.
Information Disclosure Statement
3. The information disclosure statement (IDS) submitted on Oct. 6, 2025 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.
Withdrawal of Rejection
4. The following rejections have been withdrawn in view of Applicants Amendments:
a) The rejection of claims 1-5, 7 and 10 under 35 U.S.C. 103 as being unpatentable over Embree in view of Theriot et al., and Domin et al;
b) The rejection of claims 6-8 under 35 U.S.C. 103 as being unpatentable over Embree; Theriot et al., and Domin et al., as applied to claims 1-5 and 10 above, and further in view of Sun et al;
c) The rejection of claim 9 under 35 U.S.C. 103 as being unpatentable over Embree; Theriot et al; Domin et al., and Sun et al., as applied to claims 1-6 and 10 above, and further in view of Givan et al; and
d) The rejection of claim 16 under 35 U.S.C. 103 as being unpatentable over Theriot et al., in view of Sun et al., because claim 16 is cancelled.
New Grounds of Rejection Necessitated By Applicants Amendment
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
5. Claims 11, 17-19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Theriot et al., (mSphere. 2016 Jan 6;1(1):e00045-15) in view of Petchakup et al., (Micromachines 2017, 83(3), 87) and Sun et al., (Microfluid Nanofluid (2010) 8:423–443).
Claim 11 is drawn to a method for quantifying bacterial spore germination, the method comprising: creating an ex vivo assay including bacteria spores and a homogenized stool sample; loading the ex vivo assay into a microfluidic chip; and detecting vegetative bacteria and the bacteria spores by sampling the ex vivo assay in the microfluidic chip using single cell impedance cytometry.
Theriot et al., teach a method for quantifying bacterial spore germination where the method comprises creating an ex vivo assay including bacteria spores and a homogenized stool sample; loading the ex vivo (assay into a microfluidic chip; and detecting vegetative bacteria cells; and the bacteria spores by sampling the ex vivo assay [See page 11, para 2- 3 & 8; and page 12, para. 4]. Theriot et al., teach the bacteria spores comprise Clostridioides difficile and the vegetative bacteria are Clostridioides difficile [See vegetative cells; page 2, paragraph 3]. However, Theriot et al., does not teach the instantly claimed microfluidic chip using single cell impedance cytometry.
Petchakup et al., teach microfluidics impedance cytometry is a research tool for high throughput analysis of dielectric properties of cells and internal cellular components. This label-free method can be used in different biological assays including particle sizing and enumeration, cell phenotyping and disease diagnostics. Herein, we review recent developments in single cell impedance cytometer platforms, their biomedical and clinical applications [abstract]. Characterization of electrical impedance at different frequencies provides important information about biological cells and the suspending medium, making it attractive tool for single cell analysis. In the kHz range, there is α-dispersion which originates from the displacement of counterions around the charged shell of the cell [Introduction]. Besides reducing reagent and sample volume consumption and expensive equipment, a key advantage over the traditional methods is that sample preparation and impedance detection modules can be readily integrated in a single device, commonly known as lab-on-a-chip (LOC), for POC testing. Besides the discrimination of blood cells and tumours, impedance cytometry has also been utilized to characterize various kinds of samples such as bacteria [Microbes]. For bacteria detection, a novel resonator enhanced impedance based cytometer for the detection of sub-micrometre beads and bacteria. By adding a series resonator circuit at excitation part, the sensitivity at high frequency can be improved. Instead of using impedance magnitude, they used the phase shift (at 89.2 MHz) as the characterization parameters to distinguish bacteria. Interestingly, bacteria can be discriminated by using phase polarity at 87.2 MHz and 89.2 MHz due to difference in dielectric properties of their internal structure [Bacteria]. Petchakup et al., references Sun et al.
Sun et al., disclose impedance cytometry is single-cell impedance cytometry (title). Sun et al., teach detecting an impedance phase for each cell sampled at Figure 11b in the microfluidic chip recording a number of events within an impedance phase range based on the detected impedance phase for each cell; and grouping the events based on an impedance phase of each event [See phase of impedance signal and Figure 11b]. Sun et al., teach a microfluidic chip and microfluidic chip using impedance cytometry [See sections impedance cytometry; microfluidic, and lab-on-a chip]. Sun et al., detect an impedance phase for each cell sampled in the microfluidic chip recording a number of events within an impedance phase range based on the detected impedance phase for each cell and grouping the events based on an impedance phase of each event [See phase of impedance signal and Figure 11b]. Sun et al., teach impedance cytometry is conducted at 500 kHz,2 MHz, and 10 MHz [See Table 1; page 11, paragraph 4, Figure 11b].
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of the invention to modify Theriot et al., to provide a microfluidic chip using single cell impedance cytometry as taught by Petchakup et al., and Sun et al., in order to provide a method for identifying and monitoring the functions within cells. Additionally, no more than routine skill would have been required to incorporate detecting an impedance phase for each single cell sampled in the microfluidic chip; recording a number of events within an impedance phase range based on the detected impedance phase for each cell; and grouping the events based on an impedance phase of each event, as taught by Petchakup et al., and Sun et al, in order to provide detailed identification of cellular function.
Moreover, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses combining prior art elements according to known methods to yield predictable results, thus the combination is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses that "The combination of familiar element according to known methods is likely to be obvious when it does no more than yield predictable results". It is well known to take a method of prediction where there is no change in the respective function of the components and procedures, thus the combination would have yielded a reasonable expectation of success along with predictable results to one of ordinary skill in the art at the time of the invention. Therefore, it would have been obvious to a person of ordinary skill in the art to combine prior art elements according to known methods that is ready for improvement to yield predictable results. The claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Claim Rejections - 35 USC § 103
6. Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Theriot et al., (mSphere. 2016 Jan 6;1(1):e00045-15), Petchakup et al., (Micromachines 2017, 83(3), 87) and Sun et al., (Microfluid Nanofluid (2010) 8:423–443) as applied to claims 11, 17-19 and 20 and 10 above, and further in view of Embree et al (US 20190390246 published Dec 2019; priority to Dec 28, 2016).
Theriot et al., Petchakup et al., and Sun et al., in combination, disclose the method of claim 11, where Theriot et al., further teach creating the ex vivo assay which includes: microcentrifuging [page 11, paragraph 3 and page 12, paragraph 4]. However Theriot et al., does not disclose wherein a slurry to separate stool solids is disclosed.
Embree et al., clearly teach a slurry to separate stool solids [See para 7040]. Embree teach creating an ex vivo assay including bacteria spores [para 68] and a homogenized stool sample [para 703-704] from an in vivo model; loading the ex vivo assay into a microfluidic chip (sample run through a microfluidic chip; paragraphs [0182] and [0200]; detecting vegetative bacteria and the bacteria spores paragraphs [0526-0527] by sampling the ex vivo assay in the microfluidic chip using impedance cytometry (flow cytometry; paragraph [0719]; and predicting colonization of the bacteria of the in vivo model based on the detected vegetative bacteria (vegetative cells; paragraphs [0526] and [0527] and bacteria spores (spores; paragraphs [0526] and [0527]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify Theriot, Petchakup et al., and Sun et al., to include a slurry (to separate stool solids, as taught by Embree, in order to provide a sample that contains bacterial growth. Moreover, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses combining prior art elements according to known methods to yield predictable results, thus the combination is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses that "The combination of familiar element according to known methods is likely to be obvious when it does no more than yield predictable results". It is well known to take a method of prediction where there is no change in the respective function of the components and procedures, thus the combination would have yielded a reasonable expectation of success along with predictable results to one of ordinary skill in the art at the time of the invention. Therefore, it would have been obvious to a person of ordinary skill in the art to combine prior art elements according to known methods that is ready for improvement to yield predictable results. The claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Claim Rejections - 35 USC § 103
7. Claims 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Theriot et al., (mSphere. 2016 Jan 6;1(1):e00045-15); Petchakup et al., (Micromachines 2017, 83(3), 87); Sun et al., (Microfluid Nanofluid (2010) 8:423–443), and Embree et al (US 20190390246 published Dec 2019; priority to Dec 28, 2016) as applied to claims 11-12, 17-19 and 20 above, and further in view of Domin et al. (Front Microbiol. 2018 Apr 24:9:728).
Theriot, Petchakup et al., Sun and Embree, teach the method of claim 12, while Theriot et sl., further teach creating the ex vivo assay. Theriot et al., taught conditioning the bacteria spores in taurocholate or in fecal supernatant. spore germination. See page 5, paragraph 1. Theriot et al., teach germinating the bacteria spores in growth agar media. See page 5, paragraph 1; and page 12, paragraph 4. Embree et al., teach bacterial spores with the sterile-filtered supernatant [para 704]. However none teach co-culturing bacteria spores with the sterile-filtered supernatant. Here Domin et al., teach co-culturing or co-occurrence. [See abstract; and page 2, paragraph 3]. It is noted Theriot, Sun, Embree and Domin et al., have each been discussed in great detail above.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of the invention to modify Theriot et al., Petchakup et al., Sun and Embree et al., to incorporate co-culturing as taught by Domin, in order to provide bacteria that has proper growth. No more than routine skill would have been required to provide bacteria spores with the sterile-filtered supernatant, as taught by EMBREE, to ensure the sample contains sufficient bacterial growth. Moreover, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses combining prior art elements according to known methods to yield predictable results, thus the combination is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses that "The combination of familiar element according to known methods is likely to be obvious when it does no more than yield predictable results". It is well known to take a method of prediction where there is no change in the respective function of the components and procedures, thus the combination would have yielded a reasonable expectation of success along with predictable results to one of ordinary skill in the art at the time of the invention. Therefore, it would have been obvious to a person of ordinary skill in the art to combine prior art elements according to known methods that is ready for improvement to yield predictable results. The claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Response to Arguments
8. Applicant’s arguments, filed October 3, 2025, with respect to the rejections of claims 11-15 and 17-20 under Theriot et al., Sun et al., Embree et al., and/or Domin et al., have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, new grounds of rejection is made in view of Petchakup et al., (Micromachines 2017, 83(3), 87). In short, teach single cell impedance cytometry of bacterial cells. Theriot et al., teach a method for quantifying bacterial spore germination where the method comprises creating an ex vivo assay including bacteria spores and a homogenized stool sample; loading the ex vivo (assay into a microfluidic chip; and detecting vegetative bacteria cells; and the bacteria spores by sampling the ex vivo assay. Embree et al., teach flow cytometry detection of bacterial cells and spores in fecal samples. Domin et al., teach co-culturing or co-occurrence. Sun et al., disclose impedance cytometry is single-cell impedance cytometry. Therefore, each and every element of the claims are taught.
Applicants argue that Sun does not apparently discuss the use of single-cell impedance cytometry for the detection of detecting vegetative bacteria or bacteria spores. In response to applicant's arguments against the Sun et al., reference individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In this case, Sun et al., describe Single-cell microfluidic impedance cytometry: a review. In this case, the rejection is based upon Theriot et al., in view of Petchakup et al., and Sun et al. Theriot et al., teach a method for quantifying bacterial spore germination where the method comprises creating an ex vivo assay including bacteria spores and a homogenized stool sample; loading the ex vivo (assay into a microfluidic chip; and detecting vegetative bacteria cells; and the bacteria spores by sampling the ex vivo assay. Petchakup et al., teach single cell impedance cytometry within microfluidic device with bacterial cells. Sun et al., clearly Lab-on-chip technologies are being developed for multiplexed single cell assays. The references teach the advantages of impedance because it offers a simple non-invasive method for counting, identifying and monitoring cellular function. A number of different microfluidic devices for single cell impedance have been developed. This technology has applications in basic research, diagnostics, or non-invasively probing cell function at the single-cell level. Sun et al., documents experiments showing the differences in the electrical properties of bacterial cells and products. Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of the invention to modify Theriot et al., to provide a microfluidic chip using single cell impedance cytometry as taught by Petchakup et al., and Sun et al., in order to provide a method for identifying and monitoring the functions within cells using single cell impedance cytometry.
In response to applicant's argument that Sun et al., is drawn only to RBC detection, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). In this case, Sun et al., clearly lab-on-chip for multiplexed single cell assays where impedance offers a simple non-invasive method for counting, identifying and monitoring cellular function of a single cell. Therefore, the argument is not persuasive because Sun et al., is relevant for all it teaches and Sun et al., is not limited to specific embodiments. Furthermore, Petchakup et al., teach counting, identifying and monitoring a single bacterial cell.
Accordingly, no more than routine skill would have been required to incorporate detecting an impedance phase for each cell sampled in the microfluidic chip; recording a number of events within an impedance phase range based on the detected impedance phase for each cell; and grouping the events based on an impedance phase of each event, as taught by Petchakup et al., and Sun et al, in order to provide detailed identification of cellular function.
With respect to the rejection of claim 12 and the rejection of claims 13-15; Applicants argue that the prior art references do not teach using single cell impedance cytometry for bacterial cells. The prior art reference teach single cell impedance cytometry of bacterial cells. Therefore the rejections have been set forth.
New Grounds of Rejection Necessitated By Applicant Amendments
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.
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.
9. Claim 1-3 and 5-10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without including additional elements that are sufficient to amount to significantly more than the judicial exception itself. The claimed invention is directed to an abstract idea and mathematical concepts without significantly more.
Framework with which to Evaluate Subject Matter Eligibility:
Step 1: Are the claims directed to a process, machine, manufacture, or composition of matter?
Step 2A, Prong One: Do the claims recite a judicially recognized exception, i.e. an abstract idea, a law of nature, or a natural phenomenon?
Step 2A, Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application?
Step 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: Yes, the claims are directed to a method for predicting in vivo colonization and infection dynamics by quantifying bacterial spore germination in an ex vivo assay, the method comprising: creating an ex vivo assay including bacteria spores and a homogenized stool sample from an in vivo model; dividing the ex vivo assay into at least two aliquots; conditioning a first aliquot in taurocholate; conditioning a second aliquot in sterile-filtered fecal supernatant; loading the conditioned first aliquot and the conditioned second aliquot into a microfluidic chip; detecting vegetative bacteria and the bacteria spores by sampling the ex vivo assay conditioned first aliquot and the conditioned second aliquot in the microfluidic chip using impedance cytometry; and
predicting colonization of the bacteria of the in vivo model based on a ratio of vegetative-cell counts obtained from the conditioned first aliquot and the conditioned second aliquot as determined by impedance cytometry. (See MPEP § 2106.03).
Step 2A, Prong One: The claims recite abstract ideas and natural law. The MPEP at 2106.04(a)(2) defines abstract ideas as:
• mathematical concepts, (mathematical formulas or equations, mathematical
relationships and mathematical calculations); and/or
• mental processes (procedures for observing, evaluating, analyzing/ judging and organizing information).
With respect to the instant claims, under the Step 2A, Prong One evaluation, the claims are found herein to recite abstract ideas in the form of mental processes (in particular, mathematical relationships for determining a ratio and analyzing information) as follows: For Instance, the rejected claims recites the following abstract ideas in the form of mental processes: predicting in vivo colonization and infection dynamics by quantifying bacterial spore germination in an ex vivo assay. The mental processes recited in the claims are evaluated under the Broadest Reasonable Interpretation (BRI) and determined herein to each cover performance either in the mind because the steps involve nothing more than instructions that could be mentally performed. There are no specifics as to the methodology involved in the detecting and predicting steps; thus, under the BRI, one could simply, load, detect and predict by merely looking at the data. This could be done using pen and paper, as there are no specifics in how to determine colonization based on the ratio obtained from the samples. Therefore, the claim recites elements that constitute judicial exceptions. (Step 2A, Prong One: Yes; see MPEP § 2106.04.). The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because based upon an analysis with respect to the claim as a whole.
Step 2A, Prong Two:
Because the claims do recite judicial exceptions, direction under Step 2A, Prong Two provides that the claims must be examined further to determine whether they integrate the abstract ideas into a practical application. 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, alone or in combination, to determine if the abstract idea is integrated into a practical application [see MPEP § 2106.04(d)I and MPEP § 2106.05(a-h)]. If there are no additional claim elements besides the abstract idea, or if the additional claim elements merely recite another judicial exception, that is insufficient to integrate the abstract idea into a practical application [see MPEP § 2106.04(d)III].
With respect to the instant claim, the claim recites dividing a stool sample, conditioning the sample, loading the samples onto a microfluidic chip for detection and predicting colonization. These additional elements represent data gathering steps. Data gathering steps are considered abstract ideas, needed to perform the predicting function which carries out the abstract idea. These steps are considered insignificant extra-solution activity, and are not sufficient to integrate an abstract idea into a practical application as they do not impose any meaningful limitation on the abstract idea or how it is performed. To integrate a judicial exception into a practical application, the additional limitations must not be mere instructions to apply the judicial exception [see MPEP § 2106.04(d) and MPEP § 2106.05(g)].
Patents cannot be obtained on subject matter identified by the courts as being exempted from eligibility (i.e., laws of nature, natural phenomenon, and abstract ideas). Nonetheless, this one step is conventional and routine in the art for the reasons stated above and the claims do not amount to significantly more than the recited natural principle. The claims do not "practically apply" the natural principle; rather, the claims "simply inform" the natural principle to one performing routine active method steps and do not amount to significantly more than the natural principle itself. In the instant case, the outcome of the claimed method is predicting colonization of the bacteria of the in vivo model based on a ratio of vegetative-cell counts obtained from the conditioned first aliquot and the conditioned second aliquot as determined by impedance cytometry.
Therefore, the claim does not recite additional elements which would integrate a judicial exception into a practical application, and the claims are directed to an abstract idea. [Step 2A, Prong 2: No; see MPEP § 2106.04(d).].
Step 2B:
Because the additional claim elements do not integrate the abstract ideas into a practical application, the claims are further examined under Step 2B, which evaluates whether the additional elements, individually and in combination, amount to significantly more than the judicial exception itself by providing an inventive concept. An inventive concept is furnished by an element or combination of elements that is recited in the claim in addition to the judicial exception, and is sufficient to ensure that the claim, as a whole, amounts to significantly more than the judicial exception itself (see MPEP § 2106.05).
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exceptions because the claims recite additional elements that are generic, conventional, or nonspecific. The claim recite the following additional elements:
Regarding claim 1, the recommendation is not based on the on any specific ratio result. The claims do not provide any guidance regarding how to determine the prediction. The claims do not recite what predictive infection dynamics are acquired. The claims do not quantify the bacterial spore germination. At best detection of the vegetative bacteria and spores is determined by impedance cytometry, the claims do not recite quantitative data is obtained. Therefore the recited elements do not cause the claim to rise to the level of significantly more than the judicial exception. This part of the eligibility analysis evaluates whether the claim as a whole amounts to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim. MPEP 2106.05. As explained with respect to Step 2A Prong Two, the claims recite do not require any particular application of the recited determination to the judicial exception. Mere instructions to apply an exception cannot provide an inventive concept (Step 2B: NO). The claims are not eligible.
Thus, in light of the MPEP § 2106.05(d)(II), the data gathering steps are shown to be routine, well-understood, and conventional in the art. As a result, the additional element of data gathering steps does not provide an inventive concept by amounting to significantly more than the judicial exceptions.
The claim has been further analyzed with respect to Step 2B, and it has been found that the determination and categorization steps do not provide a specific inventive concept, as they all fail to rise to the level of significantly more than the identified judicial exception.
Considering the elements alone and in combination, they do not provide an inventive concept, do not amount to significantly more than the judicial exception itself, and thus, do not provide an inventive concept that transforms the judicial exception into a patent eligible application of that exception. Therefore, the claims do not amount to significantly more that the judicial exception itself. (Step2B: No; see MPEP § 2106.04.)
For these reasons, the claims, when the limitations are considered individually and as a whole, are rejected under 35 U.S.C. § 101 as being directed to non-statutory subject matter.
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.
10. Claim 1 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The claims are drawn to a method for predicting in vivo colonization and infection dynamics by quantifying bacterial spore germination in an ex vivo assay. The claims fail to recite an quantification step.
While claim 1 recites detecting vegetative bacteria and the bacteria spores in the microfluidic chip using impedance cytometry; there is no step which results in obtaining vegetative cell counts. Detection is not equivalent to quantification. Additionally, there are no steps which recite to interpret the ratio into predicting in vivo colonization and infection dynamics by quantifying bacterial spore germination in an ex vivo assay. Therefore the omitted steps are necessary to overcome the rejection.
Pertinent Art
8. The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. Combined Dielectrophoresis and Impedance Systems for Bacteria Analysis in Microfluidic On-Chip Platforms. Cristina Páez-Avilés et al. Sensors 2016, 16(9), 1514.
David et al., (Biotechnol Bioeng. 2012 Feb;109(2):483-92.Epub 2011 Oct 17) teach Viability and membrane potential analysis of Bacillus megaterium cells by impedance flow cytometry.
Conclusion
9. No claims allowed.
10. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
/JANA A HINES/Primary Examiner, Art Unit 1645
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