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 .
Election/Restrictions
2. Applicant’s election without traverse of Group C in the reply filed on Dec. 22, 2025 is acknowledged. Claims 1 and 31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on Dec. 22, 2025.
Claim Status
3. Claims 1 and 31 have been withdrawn. Claims 2-30, 32-45, 48-49, 60, 62, 64-67, and 71 are cancelled. Claims 46-47, 502-59, 61, 63, 68-70 and 72 are under consideration in this Office Action.
Information Disclosure Statement
4. The information disclosure statement (IDS) submitted on Oct. 22, 2024 and April 9, 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.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
5. Claims 46-47, 502-59, 61, 63, 68-70 and 72 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method for determining the presence of Eimeria infection in a sample; does not reasonably provide enablement for a method for detecting a parasitic infection in a sample. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims. This is a scope of enablement rejection.
The specification teaches determining the number of Eimeria oocysts present in the imaging window; and determining a size distribution of Eimeria oocysts present in the imaging window. However, the specification does not detection of any type of parasitic infections. Example 2 and Table 1 are directed only Eimeria. There is no detection of parasitic infections such as Toxoplasma gondii oocysts and/or Toxocara egg detection. There are numerous parasitic infections such as protozoa infections, ectoparasiteis such as lice, bedbugs and scabies which will not be detected by the instantly claimed steps. The specification fails to teach examples of detecting any other pathogenic infections that meet the limitations of the claims or can be detected in the manner instantly claimed. Therefore, the specification fails to enable a method for detecting parasitic infection as instantly claimed.
Applicants’ have provided no guidance to enable one of ordinary skill in the art as to how detect, without undue experimentation, every parasitic infection; therefore, one of skill in the art would have to locate de novo steps required for a method of detecting parasitic infection.
Enterocytozoon bieneusi (microsporidia) are diagnosed by detecting tiny, oval, chitin-walled spores in stool, urine, or tissue samples, not eggs or oocysts. Detection involves specialized staining or PCR to identify the parasite's DNA in liquid stool or biopsy specimens.
Babesiosis is a parasitic disease caused by Babesia protozoa that infect red blood cells, rather than a disease diagnosed by detecting "eggs" or "oocysts" in human samples. The parasites are transmitted by Ixodes ticks and, within the tick, undergo a sexual cycle that produces sporozoites, while in the human host, they undergo asexual budding.
Trypanosoma cruzi, the parasite that causes Chagas disease, does not produce eggs or oocysts in the human host. It is a protozoan parasite that replicates by dividing into different cellular forms.
Trichinella species do not produce eggs or oocysts in the conventional sense that can be detected in feces. They are viviparous nematodes, meaning the female releases live, newborn larvae directly into the intestinal mucosa. Consequently, stool examinations for eggs or oocysts are ineffective for diagnosing Trichinella.
Determining the presence of Plasmodium oocysts is achieved by dissecting the midgut of infected Anopheles mosquitoes, and observing them under a microscope, often aided by staining or fluorescence if using GFP-tagged parasites. However, the instant claims do not recite method steps for acquiring a sample of possibly infected Anopheles mosquitoes. Thus, the instantly claimed method will not detect any type of parasitic infection or determine the number of any types of parasite oocysts or eggs present in the imaging window; or determine the size distribution of any type of parasite oocysts or eggs present in the imaging window.
Given the lack of guidance contained in the specification and the unpredictability for detection and determination of parasitic infection, one of skill in the art could not make or use the broadly claimed invention without undue experimentation. The specification fails to provide an enabling disclosure for a method for detecting any type of parasitic infection, simply determining a number of parasite oocysts or eggs present in the imaging window; and determining a size distribution of parasite oocysts or eggs present in the imaging window despite the fact that all parasites do not produce eggs or oocysts. There is no requirement or limitation for only the detection of Eimeria, which is what is enabled by the instant specification. In view of the lack of guidance contained in the specification and the unpredictability for the detection of any type of parasitic infection via the claimed method steps, one skilled in the art could not make or use the broadly claimed invention without undue experimentation.
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.
6. Claims 46-47, 50-59, 61, 63, 68-70 and 72 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
A) Claim 46 does not detect a parasitic infection, instead the claims recite determining a number of parasite oocysts or eggs and a size distribution of parasite oocysts or eggs. Therefore, at best the method detects the potential presence of oocysts or eggs from the sample. Furthermore, if no oocysts or eggs are present; then the method would not detect any type of parasitic infection; yet the claims are only set up for positive determination. Moreover, detection of a parasitic infection would require identifying the parasite. Thus the claim method steps are not commensurate with the preamble of the claims.
B) Claim 46 recites adding NaOH to a sample in the first side of the sample filter bag to form a first mixture which is homogenized, incubated and homogenized again. The claim also adds Sheather’s solution to the second side of the sample filter bag. However, it is unclear how to remove an aliquot of the first mixture from the second side of the filter bag. The first mixture is only on the first side of the filter bag and second side only contains Sheather’s solution and no first mixture. It is unclear if the two sides of the sample bag are separate and distinct; or if there is a filter placed between the first and second sides of the two-sided bag. It is unclear where the filter is within the sample filter bag.
C) Within claim 46, it is unclear how can the first mixture can be removed from the second side. Also it is unclear what mixture is on the second side if only Sheather’s solution is on the second side.
D) Claim 46 recites adding a ferrofluid to the tube to provide a second mixture. However, it is unclear if the ferrofluid is added to: 1) the first mixture, comprising the NaOH and sample; 2) the sample, NaOH and Sheather’s solution; 3) the Sheather’s solution; or 4) the sample and Sheather’s solution. Furthermore, it is unclear what is in the second mixture, other than the added ferrofluid. It is noted, that no method step, stated that sample was placed into the second side of the two-sided sample filter bag. Therefore it is unclear how this method step correlates the entire detection method.
E) In claim 46, it is unclear where the pushed cells came from? Were the pushed cells present in the sample originally? Additionally, cell homogenization is the process of breaking down cell membranes and tissues to release intracellular components into a uniform suspension, or "homogenate". Therefore, the pushed cells were homogenized on two separate occasions and additionally vortexed; therefore, it is unclear how the “pushed cells” are viewable in the imaging window instead of images of oocysts and/or sporocysts.
F) The method of detection as recited by claim 46 requires a detection reagent, such an intercalating dye. For instance, sporulation is visualized by exposing the at least one sample with at least one staining agent, the at least one staining agent may comprise a DNA intercalating dye, and wherein the DNA intercalating dye can comprise SYBR. Additionally, the specification teach exposing each sample to at least one fluorophore or fluorophore labeled agent is configured such that at least one of SYBR, fluorescent labeled lectins, fluorescent labeled antibodies, acid fast stains, membrane stains, and fluorophore labeled in-situ-hybridization probes can be visualized. Thus, the claims fail to recite a detectable label which would enable the ability to determine the number and size distribution of the eggs or oocysts. Therefore, clarification is required to overcome the rejection.
G) Claim 48 recites the limitation "the surface" within claim 46. There is insufficient antecedent basis for this limitation in the claim.
H) Claims 68 and 70 are drawn to characterizing a level of sporulation. The phrase “characterizing a level” in claims 68 and 70 is a relative phrase which renders the claims indefinite. The phrase is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The metes and bounds for defining the characterization regarding the level of sporulation is not defined by the claims or specification. For instance, the sporulation levels depend upon conditions, sporulation rates and species variability. Clarification is required to overcome the rejection.
I) Claim 69 recites determining a state of oocyst or egg sporulation. The phrase “determining a state of oocysts or egg sporulation” in claim 69 is a relative phrase which renders the claims indefinite. The phrase is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree or state of sporulation, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The metes and bounds for defining the characterization regarding the level of sporulation is not defined by the claims or specification. For instance, the sporulation levels depend upon conditions, sporulation rates and species variability. Clarification is required to overcome the rejection.
7. Claim 46 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 omitted steps are that the sample was never actually added to the two-sided filter bag. It is unclear if the two-sided filter bag comes with the sample already in place. Therefore, clarification is required to overcome the rejection.
Pertinent Art
8. The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. Rapid detection and quantification of Cryptosporidium baileyi oocysts in feces and organs of chickens using a microscopic slide flotation method. H Abbassi et al., (Parasitol Res. 2000 Mar;86(3):179-87).
Hauck et al., (US9933425) teach A method of detecting the presence or absence of helminth eggs or protozoan oocysts in a fecal sample without the use of a floatation media, the method comprising, contacting helminth eggs or protozoan oocysts physically captured on the second filtration membrane with a chitin exposing reagent selected from a surfactant, an oxidizing agent, a chaotrope, an enzyme, and bleach;
contacting helminth eggs or protozoan oocysts physically captured on the second filtration membrane with a N-acetyl-D-glucosamine binding protein or fragment thereof conjugated to a detectable moiety; and imaging the sample captured on the second filtration membrane using an imaging device appropriate for visualizing the detectable moiety to produce an image of particles comprising the detectable moiety;
electronically parsing the particles in the image by size and shape; and
detecting the presence or absence of helminth eggs or protozoan oocysts in the fecal sample captured on the second filtration membrane based on the electronic parsing of the particles in the image; wherein the imaging device is a portable imaging device, and
wherein the detection step is performed without suspending helminth eggs or protozoan oocysts captured on the second filtration membrane in water, a sample buffer or floatation media.
Dufour et al., (International Journal of Paleopathology. Volume 3, Issue 3, September 2013, Pages 199-203) teach 10% NaOH solution were added to the sample, homogenized and placed in a water bath at 80 °C for 1 h. After this time, the sample was centrifuged, the supernatant eliminated and 35 ml of ultrapure water (Millipore, Direct Q5 system) were added to rinse it. The sample was centrifuged and the supernatant eliminated a second time. Rinsing was repeated until the supernatant was clear in order to return the sample pH to near neutral and make it safer to handle.
Shusterman et al., (Int J Parasitol Parasites Wildl. 2021 May 26;15:208–213) teach a soil recovery protocol was initially optimized testing TW-derived soil with Trichuris egg recovery and evaluated using four different detergents: 0.05% v/v Tween 20 in water, 0.1 N NaOH in water, 0.05% v/v Dawn™ (Procter and Gamble) in water, and 0.9% w/v NaCl in water on each individual soil sample. These ionic detergents were chosen based on their accessibility in a clinic setting and their non-toxic nature relative to waste generation and disposal. Only NaCl and NaOH were used as the dispersion and first wash solution based on preliminary results of unreadable microscope slides using v/v Tween 20 and Dawn™ in water. This was followed by the use of Sheather's sugar (SG 1.27) as a flotation solution. Sheather's sugar was chosen as the flotation medium based on the results from the egg recovery from the fecal samples.
De Waal et al., (WO 2018206802 published 2018-11-15) teach use in concentrating matter in a sample suspension, the cassette comprising a housing having a support and an enclosed sample-receiving channel, the enclosed sample-receiving channel having an upper portion and a base connected by at least two walls; in which the upper portion is configured to have a width less than a width of the base and a depth greater than 400 µm.
Koser et al., 20180029035 published 2018-02-01) teach an inflatable bladder lid that configures with a cartridge configured for assay testing. The inflatable bladder provides substantially uniform pressure to the cartridge. The pressure is substantially distributed across the one or more regions of the cartridge to extend pressure over a wide cartridge surface. At least a portion of the bladder lid may comprise a flexible membrane material that inflates and stretches over at least a portion of the cartridge to conformally contact its first/top surface.
Conclusion
9. No claims are allowed.
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JA-NA A HINES whose telephone number is (571)272-0859. The examiner can normally be reached Monday thru Thursday.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor Dan Kolker, can be reached on 571-272-3181. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JANA A HINES/Primary Examiner, Art Unit 1645