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 .
Information Disclosure Statement
2. The information disclosure statement (IDS) submitted on 08/22/24 was filed and entered. The submission is in compliance with the provisions of 37 CFR 1.97 and has been considered by the Examiner.
Election/Restrictions
3. Applicant’s election without traverse of Group I, in the reply filed on 09/04/25, is acknowledged.
Claim Status
4. Claims 1-20 are pending. Claims 15-20 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/04/25. Claims 1-14 are under examination.
5. Claim 1 is objected to because of the following informalities: improper formatting. MPEP 608.01(m) states that “Each claim begins with a capital letter and ends with a period”. However instant claim 1 also uses periods to separate the method steps (e.g. “a.” line 3); therefore the periods should be removed and only the period at the completion of the claim should remain. The office suggests the use of parenthesis (e.g. “(a)”). Appropriate correction is required.
Claim Rejections - 35 USC § 112
6. 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.
7. Claims 1-14 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 is indefinite because the goal of the preamble is not met by the body of the claim. For example, claim 1 is drawn to “A method of analyzing a fecal sample containing parasitic material and non-parasitic material…” but the positively recited steps in the body of the claim do not actually analyze anything (i.e. see steps of: deposit the sample, deposit a medium, shake, settle, separate, and pour). Therefore, the independent claim is either missing one or more essential steps or the preamble is inappropriate. Regardless, clarification is required.
Claim 1 is also indefinite because it is unclear how step (f) follows from step (e) because when (in step (e)), the filter device is used to collect the parasitic material, it would not, by definition contain liquid which is both not parasitic and not retained by a filter. Thus, it is unclear how “pouring” from one filter to another filter (i.e. the capture filter) is then executed since there would not be any fluid with the first filter. In the interest of compact prosecution, the use of first and second filters will be interpreted to meet the broadest reasonable interpretation of the claim. Nevertheless, clarification is required.
Dependent claims do not clarify to issue. Therefore, clarification is required to remove scope ambiguity and ascertain the metes and bounds of the claims.
Claim Rejections - 35 USC § 103
8. 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.
9. 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.
10. 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.
11. 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.
12. Claims 1-2, 4, and 8-13 are rejected under 35 U.S.C. 103 as being unpatentable over Slusarewicz et al. 2019 (US 2019/0145973).
Slusarewicz teaches methods, devices, and kits for determining (i.e. analyzing) the presence or absence of parasitic helminth eggs in environmental samples, including fecal samples comprising using N-acetyl-D-glucosamine specific ligands conjugated to detectable moieties, including fluorescent labels for image analysis, and comprising flowing a fecal solution (i.e. defined as a fecal sample suspended in a solution, including a flotation medium) through at least two filters (i.e. “pouring” from first and second filters with second filter being a capture filter) of decreasing pore sizes with the number and pore size determined by the species of animal from which the feces are obtained and/or the types of eggs or oocysts being detected and encompassing pore sizes from about 5 microns to about 350 microns (e.g. abstract; Figures 1, 5, and 9; [0027-32, 0049, 0110, 0170-0171]; and Example 1; meeting limitations found in instant claims 1, 4, and 12-13 with sufficient specificity). Slusarewicz teaches physical methods can be incorporated into the method including centrifugation, filtration, flotation and/or particle counting and that detection can be facilitated by chemical methods such as use of surfactants (i.e. dispersal aids; e.g. [0080-0083]; meeting limitations found in instant claims 1, 10 and 11). Slusarewicz teaches the sample is collected with a collection vessel (i.e. a carrier; a container) in which the fecal sample is placed and diluted by a suitable buffer, including flotation media, and then the vessel is sealed and shaken to produce a uniformly mixed fecal solution prior to being attached to a filtration apparatus (e.g. [0120-0124]; meeting limitations found in claim 1). The device in instant Figure 1 (i.e. left side) appears to comprise a tube, filter and plunger meeting limitations in claims 2 and 8. With regards to using the plunger (i.e. drawing back the plunger to a metered position and depositing a sample via depressing the plunger; found in dependent claim 9); it is the Office’s position that one of ordinary skill in the art would understand the operation of such a device and would be motivated to use the plunger in this manner in order to precisely control the volume of sample analyzed; see MPEP 2144(II).
Therefore, the apparent difference between the invention and the prior art seems to be “…inserting a filter device into the carrier” (instant) as compared to having the filter device “attached” thereto (prior art). However, it is the Office’s position that the net result is the same, i.e., capturing the targeted parasitic material onto a capture filter for analysis and thus the difference amounts to an obvious variant based on semantics.
Consequently, the instant claims are not patentably distinct from the prior art, absent convincing evidence to the contrary.
Claim Rejections - 35 USC § 103
13. Claims 1-13 are rejected under 35 U.S.C. 103 as being unpatentable over Slusarewicz et al. 2019 (US 2019/0145973) in view of Kawaguchi et al. 2020 (US 2020/0353383).
The teachings of Slusarewicz are set forth above. The difference between the invention and the prior art appears to be structural details of the filtration device used.
However, Kawaguchi teaches useful filtration devices that suppress a decrease in filtration efficiency of a filtration target object and prevent the target from entering the tube and/or being contaminated by old media (e.g. [0006, 0037-0039, 0072]). For example, Kawaguchi teaches a filtration device that includes: a filtration filter having a first main surface that captures a filtration target object contained in a liquid and a second main surface that faces the first main surface; and a housing that holds the filtration filter, and defines a liquid inflow path that faces the first main surface and a liquid discharge path that faces the second main surface, the housing including a tubular portion that extends in a direction away from the second main surface of the filtration filter and defines the liquid discharge path, and a flange portion that extends from an outer peripheral surface of the tubular portion, and the flange portion includes a vent hole extending away from the outer peripheral surface of the tubular portion (see abstract; Figures 1-3; [0037-39]; meeting limitations found in instant claims 1, 2, 3, 5 and 6). Kawaguchi teaches the outer diameter of the tubular portion is smaller than the inner diameter of the opening end of the container and is set inside thereof (i.e. is inserted; see Figure 3; and [0059-61, 0072]; meeting limitations found in instant claims 3 and 7). With regards to the depth at which the tubular portion is inserted into the container, it is the Office’s position that this depth is a results-effective variable (e.g. would affect effectiveness) and therefore there is motivation for one of ordinary skill to optimize it through routine experimentation (see MPEP 2144.05II(B)).
Therefore, it would have been prima facie obvious, before the effective filing date of the claimed invention, to a person of ordinary skill in the art, to modify the methods for analyzing a fecal sample for parasitic material comprising depositing a fecal sample and a flotation medium into a container, shaking to provide a uniform suspension, settling the fecal material in the suspension via centrifugation, and filtering the suspension to obtain parasitic material on a capture filter, as taught by Slusarewicz, by using the filtration device of Kawaguchi, thereby arriving at the claimed invention, in order to prevent the targeted filtration target from becoming contaminated, as taught by Kawaguchi. Therefore, each and every element is taught in the prior art and the combination has a beneficial result; however, the combination amounts to no more than a predictable use of prior art elements according to their established functions. The person of ordinary skill in the art would have been motivated to make the modification in order to improve filtration efficiency, as taught by Kawaguchi. The person of ordinary skill in the art would have had a reasonable expectation of success because Slusarewicz had already taught methods for analyzing parasitic material from fecal samples comprising the use of diluting, shaking, settling, centrifuging, and filtering onto capture filters and Kawaguchi had already taught similar filtration devices that improved art-recognized problems with filtering targeted objects. Therefore, the combination leads to expected results because each element performs the same function as it does individually.
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that combining prior art elements according to known methods to yield predictable results, 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 elements according to known methods is likely to be obvious when it does no more than yield predictable results. In the instant case, all elements (i.e. methods for analyzing fecal samples for parasitic material of interest comprising filtration; and filtration devices for isolating a target of interest) were known in the art. In addition, combining these elements yields a method wherein each element merely performs the same function as it does separately; thus the results of the combination would be recognized as predictable to one of ordinary skill in the art. Therefore, it would have been obvious to a person of ordinary skill in the art to combine these prior art elements according to a known method to yield predictable results.
Thus 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
14. Claims 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over Slusarewicz et al. 2019 (US 2019/0145973) in view of Holmgren 1982 (US 4,318,803) and O’Grady et al. 1980 (An investigation of variable in the fecal flotation technique; Can. J. Comp. Med. 44:48-155).
The teachings of Slusarewicz are set forth above. The difference between the invention and the prior art appears to be structural details of the filtration device and the density of the flotation medium.
However, Holgrem recognized problems associated with analysis of fecal samples for parasite eggs including the need to remove larger-than-desired non-parasitic particles (see column 1). Holgrem teaches an easy to use, commercially available, disposable apparatus designed to minimize sample contamination both during and after a test is performed (see column 1). For example, Holgrem teaches an apparatus for preparing liquid suspensions of parasite eggs comprising a vial with a flanged lip and a plunger having a base that functions as a filter selective for particle sizes and is fully receivable with the vial (i.e. is inserted therein; see abstract; column 2; and Figures 1-5; meeting limitations found in instant claims 2, 3, 5, 6 and 8). Holgrem teaches the device is designed to pass a variety of different endoparasite eggs but to prevent passage of larger suspended fecal material (e.g. see column 2). With regards to the depth at which the tubular portion is inserted into the container (see dependent claim 7), it is the Office’s position that this depth is a results-effective variable (e.g. would affect effectiveness) and therefore there is motivation for one of ordinary skill to optimize it through routine experimentation (see MPEP 2144.05II(B)). Holgrem teaches the suspension comprises a salt solution (i.e. a flotation medium) such as sodium nitrate having a density that is greater than the density of the eggs to be assayed (e.g. see column 3).
Further, O’Grady teaches the specific gravity (i.e. ratio of a substance’s density to the density of a reference material such as water) of the sodium nitrate flotation medium, the time allowed for flotation, and the mesh size of the strainers used in methods for analyzing fecal samples for parasitic eggs are each results-effective variables in need of optimization (e.g. see abstract; Tables I and IV; and Discussion on page 152). O’Grady evaluated mesh sizes of 250 to 500 microns (e.g. see Table VI; meeting limitations found in instant claim 4) and flotation media having specific gravities of 1.11 to 1.38 (i.e. densities of 1.11 to 1.38 g/ml; see Table 1; meeting limitations found in instant claim 14).
Therefore, it would have been prima facie obvious, before the effective filing date of the claimed invention, to a person of ordinary skill in the art, to modify the methods for analyzing a fecal sample for parasitic material comprising depositing a fecal sample and a flotation medium into a container, shaking to provide a uniform suspension, settling the fecal material in the suspension via centrifugation, and using filters to obtain parasitic material on a capture filter, as taught by Slusarewicz, by using the filtration device of Holgrem and the flotation medium of O’Grady, thereby arriving at the claimed invention, in order to remove larger than desired particles and to optimize the analysis of parasitic eggs in fecal matter, as taught by Holgrem and/or O’Grady. Therefore, each and every element is taught in the prior art and the combination has a beneficial result; however, the combination amounts to no more than a predictable use of prior art elements according to their established functions. The person of ordinary skill in the art would have been motivated to make the modifications because the device of Holgrem was easy to use, commercially available, convenient (i.e. disposable) and designed to minimize sample contamination both during and after a test is performed; and the density of the flotation media affected the percentage of eggs recovered, as taught by O’Grady. The person of ordinary skill in the art would have had a reasonable expectation of success because Slusarewicz already taught the scaffold for a method of analyzing fecal samples for parasitic material; and Holgrem already taught an easy to use filtration device that would separate out the larger than desirable particles from parasitic materials (e.g. eggs); and O’Grady already demonstrated that the specific gravity of the flotation medium was important variable to control in methods for the analysis of parasitic eggs in fecal samples. Therefore, the combination leads to expected results because each element performs the same function as it does individually.
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that applying a known technique to a known device, method or product ready for improvement is obvious because a particular known technique is recognized as part of the ordinary capabilities of one skilled in the art. In the instant case, Slusarewicz contains a “base” method of analyzing fecal samples for parasitic material; and Holmgren and O’Grady contain similar methods for the analysis of fecal samples for parasitic material wherein the techniques of optimizing separation of the parasitic material from the non-parasitic material, including via an easy to use filtration device, and optimized mesh sizes and flotation media, are each taught as advantageous. Thus, one of ordinary skill in the art would have recognized that applying the known techniques taught by Holmgren and O’Grady would have yielded predictable results (i.e. the same advantages) and an improved system.
Therefore, the claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Conclusion
15. No claims are allowed.
16. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARY MAILLE LYONS whose telephone number is (571)272-2966. The examiner can normally be reached on Monday-Friday 8 am to 5 pm EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http: //www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gary Nickol can be reached on (571)-272-0835. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARY MAILLE LYONS/Examiner, Art Unit 1645
September 25, 2025