Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Claims 1-20 are pending.
Election/Restrictions
Applicant's election with traverse of the species of pollution inhibition rate (claim 12) in the reply filed on 11/25/2025 is acknowledged. The traversal is on the grounds that search any search and examination relating to the subject matter of elected claim 12 would necessarily result in a search and examination relating to the subject matter of claims 13-20. This argument is not found persuasive because each evaluation index method requires separate active method steps, thus the restriction is reasonable since examination of all species would require significant search effort.
The requirement is still deemed proper and is therefore made FINAL.
Claims 13-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 11/25/2025.
Claims 1-12 are examined herein.
Information Disclosure Statement
The information disclosure statement filed 8/23/2023 fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. It has been placed in the application file, but the information referred to therein has not been considered. Specifically, foreign patent documents 1-3 have not been considered.
Claim Objections
Claims 1, 8, and 11-12 are objected to because of the following informalities:
In claim 1 step 4 ”suspected patients with H. pylori infection” should be “patients suspected of having H. pylori infection.”
In claim 1 step 6, “wherein typical colony morphology is purple, circular, or diffusion colony morphology may appear” is a run-on sentence (the complete sentence “typical colony morphology is purple, circular or diffusion colony morphology” and the complete sentence “purple, circular, or diffusion colony morphology may appear”).
In claim 1 step 8, 20µL should be 20 µL. Also, “plate culture medium” is redundant and should be replaced with just “plate.”
In claims 1, 8, and 11, H. pylori should be italicized because it is a Latin scientific name.
Similarly, in claim 12 steps 1) and 2), Escherichia coli, Staphylococcus aureus, and Candida albicans should all be italicized. There is also a space missing between ATCC and the deposit number for Escherichia coli ATCC 25922 in steps 1) and 2) of claim 12.
In claim 12, “a isolation plate” in step 3) should be corrected to “an isolation plate.”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is indefinite for I, primary isolation, II, cryopreservation and recovery, III, single colony growth, and IV, single colony subculture. It is unclear whether these are descriptors of the subsequent method steps or whether they are method steps. In the latter case, the method steps are indefinite because there are no complete sentences.
Claim 1 step 1 recites “taking out a Gu's plate for rapid culture of H. pylori, performing vacuum sealed packaging and storing the Gu’s plate under waterproof and dark conditions.” It is unclear whether the Gu’s plate or something else is vacuum sealed and packaged. It is further unclear whether the plate that is stored is the original plate or a vacuum sealed package of the plate.
Claim 1 step 2 recites “EP tube,” which is not defined in the specification and does not have a plain and ordinary meaning.
Claim 1 step 3 recites “placing it in an EP tube for sterilization.” There is a lack of antecedent basis for “it” because step 3 recites both the kit and Gu’s culture medium, so it is unclear what is placed in the EP tube. Furthermore, it is unclear whether sterilization is actually performed or whether this is an intended use.
In step 4 of claim 1, the acronym PPI is not defined and this term further lacks a plain and ordinary meaning. The claim recites “requiring suspected patients with H. pylori infection to have not been treated with PPI or antibiotics for at least 20 days, taking gastrointestinal tissue samples...” It is unclear whether the gastrointestinal tissue samples are taken from the patients suspected of having H. pylori infection or from another source because the claim does not recite “taking gastrointestinal tissue samples from the patients.” In addition, the limitation “requiring suspected patients with H. pylori infection to have not been treated with PPI or antibiotics for at least 20 days” further renders the claim indefinite because this limitation can reasonably be interpreted as the duration of PPI or antibiotics treatment or as the duration of lack of treatment by PPI or antibiotics. Under the first interpretation, treatment with PPI or antibiotics for 15 days would fall within the claim scope because 15 days is less than “at least 20 days.” Under the second interpretation, patients treated with PPI or antibiotics for any length of time would fall within the claim scope so long as the patients did not receive PPI or antibiotics for at least 20 days before the gastrointestinal tissue samples are taken.
Step 6 of claim 1 further renders the claim indefinite because the limitation “sucking 100-200 μL ground sample” can be reasonably interpreted as pipetting or the action of drawing liquid or air into the mouth by creating a vacuum (mouth pipetting). Step 6 further recites “inoculating it on the Gu’s plate for rapid culture of H. pylori under sterile conditions.” There is a lack of antecedent basis for “it,” which could refer to either H. pylori or the tissue sample.
Claim 1 is indefinite for “a local temperature below 40 °C” in steps 6 and 9 because the location is not defined, so it is unclear what the local temperature is.
Claim 1 is further indefinite for “observing the colony morphology, wherein typical colony morphology is purple, circular, or diffusion colony morphology may appear” in step 6. The conditional language (may appear) renders the claim indefinite since the metes and bounds of the claim are undefined.
Step 7 recites -70~-80 °C. It is unclear whether this is a range (i.e. between -70 and -80 °C) or alternatives with an approximation (i.e. -70 °C or about -80 °C).
Step 7 of claim 1 recites “sucking 100-200 µL samples,” which has multiple reasonable interpretations (pipetting or mouth pipetting), which differ in scope. In addition, step 7 of claim 1 recites “cryopreserving liquid samples of H. pylori” and it is unclear whether these are the same samples recited in step 4 (before or after storage), step 5 (after grinding), or other liquid samples of H. pylori.
Step 7 of claim 1 recites “performing recovery culture according to the method in step 6.” However, step 6 has multiple components and is specific to ground sample, thus it is unclear what the recovery culture steps are and how they are applied to the thawed liquid samples of H. pylori.
Step 8 of claim 1 recites “mixing the H. pylori colonies with sterile physiological saline to prepare a bacterial solution with a turbidity of 1.0 McF, continuously diluting it multiple times to above the 13th gradient.” There is a lack of antecedent basis for “the H. pylori colonies.” Furthermore, “continuously” and “multiple times” are contradictory limitations as “times” indicates a non-continuous process. Step 8 of claim 1 also recites “opening the vacuum sealed package.” There is a lack of antecedent basis for this limitation in the claim because although step 1 recites “performing vacuum sealed packaging,” step 6 recites “opening the vacuum sealed package,” thus it is unclear whether there are multiple sealed packages and which package is required in step 8.
There is a lack of antecedent basis for “its back” and “it” in step 8 (“drawing a line on the center of its back and evenly dividing it into 2 areas) because “its” and “it” could refer to the vacuum sealed package, either of the 2 Gu’s plates, or both of the 2 Gu’s plates.
Step 8 of claim 1 recites “taking 20μL diluted bacterial solution and inoculating it separately in the areas of the drawn plate culture medium.” It is unclear whether this step requires two separate aliquots of 20 μL diluted bacterial solution (one aliquot for each of the 2 areas) or whether the 20 μL is divided between the 2 areas. In the latter case, it is unclear how the 20 μL is divided between the areas (e.g. 10 μL for each area, or some other division).
Step 8 of claim 1 recites “using a sterile inoculation ring for continuous and dense circular coating” but does not specify how the ring is used (e.g. the claim does not recite spreading the colonies or any other action verb), further rendering the claim indefinite.
In step 9 of claim 1, there is a lack of antecedent basis for “the vacuum sealed package” because although step 1 recites “performing vacuum sealed packaging,” step 6 recites “opening the vacuum sealed package,” thus it is unclear whether there are multiple sealed packages and which package is required in step 9.
Step 9 of claim 1 further renders the claim indefinite because the claim does not recite whether the line is drawn on the plate or the package.
Claim 1 is further indefinite for the final wherein clause “wherein, the microaerobic conditions refer to: 3-6% O2, 5-10% CO2, 5-10% H2 and 76-86% N2” as it is unclear whether this applies to the microaerobic conditions in step 6, step 9, or both steps 6 and step 9.
Claims 1, 8, and 11-12 each recite a gradient. Claim 1 step 8 recites “continuously diluting it multiple times to above the 13th gradient.” Claim 8 recites “continuously diluting it multiple times to above a 13th gradient.” Claim 11 step 1 requires “diluting to a 17th gradient.” Claim 12 step 2 requires “diluting it to a 11th gradient continuously.” In each of these cases, it is unclear what the dilution is. For example, “above the 13th gradient” may refer to performing a dilution by a factor of 1:10 at least 13 times. However, no dilution factor is recited within the claim. The metes and bounds of the claims are undefined because there is no plain and ordinary meaning or art-recognized definition for gradient in the context of dilution in microbiology.
Claim 2 recites the limitation "culture plate" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 3 recites the limitation "the microaerobic conditions" in line 2. There is insufficient antecedent basis for this limitation in the claim. “microaerobic conditions” are recited in both step 6 and step 9 of claim 1.
Claim 4 is indefinite for “a local temperature below 40 °C” because the location is not defined, so it is unclear what the local temperature is. Furthermore, it is unclear whether this limitation refers back to the local temperature below 40 °C recited in step 6, step 9, or both step 6 and step 9.
Claim 5 recites the limitation "the preservation culture medium" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 is indefinite for “as soon as possible,” which is subjective terminology. See MPEP 2173.05(b) part IV: A claim term that requires the exercise of subjective judgment without restriction may render the claim indefinite.
Claim 6 is further indefinite for “the EP tube is completely immersed in the culture medium,” which contradicts the limitation in step 4 of claim 1 in which the tissue sample is immersed in the culture medium in an EP tube (the tissue sample is immersed in the culture medium rather than the EP tube is immersed in the culture medium). Also, it is unclear which EP tube the samples are placed into: step 2 of claim 1 recites “taking two zirconium beads with a particle size of 3-6 mm, and placing them in a 1-2 mL EP tube for sterilization” and step 3 of claim 1 recites “taking a 0.5-1.0 mL Gu's culture medium for preservation of H. pylori, and placing it in an EP tube for sterilization.” Claim 6 appears to require that the samples are placed into the EP tube of step 2 because the EP tube contains zirconium beads. However, claim 6 also recites “the tube is tightly capped, and then placed at 2-8°C for preservation,” which appears to be further limiting step 4 of the method of claim 1.
Claim 7 is indefinite for “wherein the EP tube samples containing zirconium beads are ground for 1-2 minutes.” There is a lack of antecedent basis for “the EP tube samples containing zirconium beads.” Claim 1 step 4 recites samples in an EP tube (a single tube containing multiple samples rather than multiple samples of EP tubes), whereas claim 1 step 2 recites EP tubes containing zirconium beads but no samples. It is further unclear whether the limitations in claim 7 are further limiting step 5 of claim 1, which recites an active method step of grinding or whether the method further comprises an additional method step.
Claim 8 is indefinite for “continuously diluting it multiple times.” Reciting both “continuously” and “multiple times” are conflicting limitations, since “multiple times” is a non-continuous process. Claim 8 is further indefinite for “wherein single colony growth involves…” because it is unclear whether claim 8 is attempting to limit step 8 of claim 1 or is further limiting “III, Single colony growth,” which can reasonably be interpreted as either the name of step 8 or a separate method step.
Claim 9 is similarly indefinite for “wherein single colony subculture involves…” because it is unclear whether claim 9 is attempting to further limit step 9 of claim 1 or “IV, single colony subculture” of claim 1 since “IV, single colony subculture” can either be interpreted as the name of step 9 or a separate method step.
Claim 10 is indefinite for the conditional language “if there are abnormalities in the gastrointestinal tissue.” Although the claim later recites “wherein abnormal gastrointestinal tissue comprises inflammation, ulcer, erosion or lump,” it is unclear whether the abnormalities are present or not. Applicant may consider amending as follows: The method according to claim 1, wherein taking gastrointestinal tissue samples in step 4 comprises taking the samples at the junction of normal and abnormal tissues, wherein the abnormal tissues comprise inflammation, ulcer, erosion or lump.
Claim 11 recites “an effect evaluation method for culture of H. pylori, where an effect evaluation index for culture of H. pylori comprises pollution inhibition rate.” Claim 11 is indefinite because there is no active method step. Furthermore, the claim recites “where” (refers to a location) rather than “wherein,” which renders the claim indefinite because no location is recited.
Claim 12 is indefinite for “wherein when the evaluation index is the pollution inhibition rate.” Claim 12 depends from claim 11, which recites “where an effect evaluation index for culture of H. pylori comprises pollution inhibition rate.” Claim 12 is indefinite because the conditional language makes it unclear whether the evaluation index is pollution inhibition rate, as required by claim 11 from which claim 12 depends.
Claim 12 step 1) recites “inoculating Escherichia coli ATCC25922 and Staphylococcus aureus ATCC 25923 on blood agar plates, respectively.” Respectively is defined as separately or individually and in the order already mentioned. It is unclear whether there are two separate blood agar plates, one with E. coli and the other with S. aureus, or whether there are two plates, each with both bacteria, but inoculated separately (first with E. coli and then with S. aureus).
Claim 12 is further indefinite for “taking 10 µL of the diluted bacterial liquid to be inoculated on the blood agar plates.” The use of future tense makes it unclear whether the inoculation step is part of the claimed method.
Claim 12 is further indefinite for “preparing the cultured Escherichia coli ATCC25922 and Staphylococcus aureus ATCC 25923 with sterile physiological saline, respectively” in step 1) because it is unclear how the bacteria are prepared with the saline. Claim 12 step 1) also recites “diluting to a 17th gradient,” but it is unclear whether this limitation refers to the preparation of E coli ATCC 25922, the preparation of S. aureus ATCC 25923, or both the preparation of E coli ATCC 25922 and the preparation of S. aureus ATCC 25923.
In claim 12 step 3), there is a lack of antecedent basis for “culturing them” because “them” could refer to any combination of E. coli, S. aureus, and C. albicans or all three bacteria.
Claim 12 recites “pollution inhibition rate ≥99% indicates high culture efficiency.” This statement is not grammatically connected to the active method steps and the statement leads to ambiguity in the claim scope as it is unclear whether the calculating step is limited to when the pollution inhibition rate is ≥99%.
Finally, although claim 12 depends from claim 11, which recites “An effect evaluation method for culture of H. pylori,” none of the steps in claim 12 require H. pylori. Claim 12 refers to “a isolation plate,” which can be reasonably interpreted in light of the specification as any plate capable of isolating bacteria or as Gu’s plate, which is an isolation plate for H. pylori.
Claims 2-10 and 12 are rejected for depending from a rejected base claim and not rectifying the source of indefiniteness discussed above.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2, 4, and 8-9 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 2 recites “wherein the culture plate is vacuum sealed and packaged to meet the waterproof and light-proof conditions.” Under the interpretation in which the Gu’s plate is the culture plate, claim 2 fails to further limit the subject matter of the claim upon which it depends because claim 1 step 1 already recites “performing vacuum sealed packaging, and storing the Gu's plate under waterproof and dark conditions.”
Claim 4 recites “wherein a local temperature for inoculation under sterile conditions is below 40 °C.” However claim 4 depends from claim 1, which recites the same condition in step 6. Therefore, claim 4 fails to further limit the subject matter of the claim upon which it depends.
Claim 8 recites the same limitation as step 8 of claim 1, so claim 8 fails to further limit the subject matter of claim 1.
Claim 9 recites the same limitations as step 9 of claim 1, so claim 9 fails to further limit the subject matter of claim 1.
Applicant may cancel the claims, amend the claims to place the claim in proper dependent form, rewrite the claims in independent form, or present a sufficient showing that the dependent claims comply with the statutory requirements.
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.
Claims 1-12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor, at the time the application was filed, had possession of the claimed invention.
Claim 1 recites a “Gu's kit for rapid isolation culture, identification, drug sensitivity and preservation of H. pylori” containing a “Gu’s plate.” The specification lacks written description for both Gu’s kit and Gu’s plate, as neither is described within the specification.
Claims 11-12 are drawn to “an effect evaluation method for culture of H. pylori” and claim 12 recites “a isolation plate,” which under one interpretation is Gu’s plate (see specification [06] and [07] and [34]).
The prior art does not teach a Gu’s kit or a Gu’s plate.
There is no structure-function correlation known for Gu’s kit or Gu’s plate.
The person of ordinary skill in the art would not have recognized that Applicant was in possession of the claimed genus of “Gu’s kit” or “Gu’s medium” because there are no species of the disclosed genus taught by the prior art or disclosed within the specification, nor is there a structure-function correlation taught by the prior art or described in the specification. The person of ordinary skill in the art would have been unable to predict the structure of the kit or the medium based on the state of the art.
Claims 1-12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Per MPEP 2164.01(a), the following eight factors should be considered when determining whether the person of ordinary skill in the art would face undue experimentation to make and/or use the invention: (1) The nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary. While it is not essential that every factor be examined in detail, those factors deemed most relevant should be considered.
Nature of the invention. Claim 1 and its dependents claims 2-10 are drawn to a bacterial colony formation method for sensitive and rapid culture of H. pylori. Claims 11-12 are drawn to “an effect evaluation method for culture of H. pylori” and claim 12 recites “a isolation plate,” which under one interpretation is Gu’s plate (see specification [06] and [07] and [34]).
Breadth of the claims. Performing the method of claims 1-10 requires “Gu’s kit for rapid isolation culture, identification, drug sensitivity and preservation of H. pylori.” The kit contains Gu’s plate for rapid culture of H. pylori (step 1 of claim 1) as well as Gu’s culture medium (step 3 of claim 1). Under the interpretation in which the isolation plate in step 3 of claim 12 is Gu’s plate, performing the method of claims 11-12 also requires Gu’s plate.
State of the prior art and unpredictability. The prior art does not teach a medium by the name of Gu’s culture medium or Gu’s plates.
Guidance in the specification and working examples. The specification discloses that step 1 of the claimed method comprises opening a kit for Gu’s medium for rapid isolation of Heliobacter pylori ([07]). Gu's Medium for Rapid Isolation of Helicobacter pylori is indicated as “TianKuo, Xunjian Biotechnology Co., Ltd,Ningbo, China” in parenthesis. This appears to be a source of Gu’s medium. However, it is unclear whether the name of the company is “TianKuo” or “Xunjian Biotechnology Co.” or “TianKuo, Xunjian Biotechnology Co.” Regardless, search for all of these terms in conjunction with Ningbo, China does not return any results. Therefore, Gu’s kit does not appear to be commercially available. Per MPEP 2404.1, The Office will accept commercial availability as evidence that a biological material is known and readily available only when the evidence is clear and convincing that the public has access to the material.
Amount of experimentation necessary. The person of ordinary skill in the art would not be able to perform the claimed method without access to Gu’s kit, which is required in Step 1 of the claimed method. Since the composition of Gu’s medium in Gu’s kit is not disclosed within the specification or taught by the prior art, undue experimentation would be required by one of ordinary skill in the art to practice the claimed invention. Thus, the claims are not fully enabled by the disclosure.
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 11 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The rationale for this determination is explained below.
Claim 11 recites “an effect evaluation method for culture of H. pylori, where an effect evaluation index for culture of H. pylori comprises pollution inhibition rate.” Although the claim preamble recites a method, there is no active method step. Thus, claim 11 is not drawn to one of the four statutory categories of invention.
Claims 1-10 and 12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to the judicial exception of an abstract idea without significantly more.
A flowchart has been established to determine subject matter eligibility under 35 U.S.C. 101. See MPEP 2106 part (III) and 2106.04 part (II)(A). The flowchart comprises answering: Step 1) Is the claim to a process, machine, manufacture or composition of matter? Step 2A Prong One) Does the claim recite an abstract idea, law of nature or natural phenomenon? Step 2A Prong Two) Does the claim recite additional elements that integrate the judicial exception into a practical application? Step 2B) Does the claim recite additional elements that amount to significantly more than the judicial exception? The claims are analyzed for eligibility in accordance with their broadest reasonable interpretation.
Although claim 1 is drawn to a process, which is one of the four statutory categories of invention, claim 1 recites “observing the colony morphology, wherein typical colony morphology is purple, circular, or diffusion colony morphology may appear” (step 6), “observing the growth of individual colony on the culture medium plate” (step 8), as well as “observing the colony morphology” (step 9). Each of these observation steps are a mental process (abstract idea) of determining the colony morphology based upon visual observation.
Claim 12 recites in step 1) “recording the number of colonies formed on the plates CN1 and CN2 respectively.” This step has an implicit mental step of counting the number of colonies formed on the plates since the number must be known in order to be recorded.
Claim 12 recites in step 2) “recording the number of colonies formed on the plate as CN3,” which encompasses an implicit mental step of counting the number of colonies formed on the plate.
Claim 12 recites in step 3) “recording a total number of colonies in the three areas as CN,” which encompasses the mental process of counting the total number of colonies.
Claim 12 recites in step 4) “calculating the pollution inhibition rate,” which is a mental process, and the claim also recites a specific mathematical formula for the pollution inhibition rate and colony growth rate, Thus, claim 12 recites the judicial exception of a mathematical formula and a mental process (abstract idea grouping).
The claims are not integrated into a practical application (Step2A Prong Two: No). Claims 1-10 are drawn to “A bacterial colony formation method for sensitive and rapid culture of H. pylori.” However, no practical application is recited in the claims. For example, the claims do not recite administering a specific antibiotic treatment to the patient from which the gastrointestinal tissue sample is taken based on results of the observation steps. Claim 12 is purely drawn to calculating the pollution inhibition rate. Although the claim recites “pollution inhibition rate ≥99% indicates high culture efficiency,” the result of performing the method steps is purely the calculated value of the pollution inhibition rate with no practical application taken in response to the information.
Each of the additional elements recited in the claims are well-understood, routine, and conventional. For example, isolation, cryopreservation, colony growth, and subculture of H. pylori are standard microbiology practices. See, for example, the Materials and Methods headers on page 51 of Ansorg et al. (Journal of clinical microbiology 29.1 (1991): 51-53): Isolation and characterization, subcultivation, preservation. Likewise in step 12, inoculating bacteria on blood agar plates, culturing, and counting colonies is also standard microbiology practice. For example, Ansorg teaches culturing H. pylori on sheep’s blood agar to form colonies (page 51, right column, Subcultivation paragraph).
Furthermore, each of the additional elements set forth in the dependent claims 2-10 are well-understood, routine, and conventional. For example, storing culture plates under waterproof and light-proof conditions (claim 2) is a standard microbiology practice to prevent degradation of the plates. Culturing H. pylori under microaerobic conditions at a temperature below 40 °C is also well-understood, routine, and conventional: Ansorg teaches culturing H. pylori at 37 °C in microaerophilic conditions with a similar gas mixture to the claimed gas mixture (see Ansorg page 51, left column, bottom paragraph and compare to claim 3). Tissue grinding with zirconium beads (claims 5-7) at low temperatures (to prevent thermal degradation) is also well-understood, routine, and conventional (OPS Diagnostics, 2016 website, page 1, paragraphs 1-2). Dilution with physiological saline to achieve a specific bacterial concentration (claim 8), using sterile inoculum rings to scrape a single colony for continuous and dense circular coating in one area of a plate (claim 9) are also well-understood, routine, and conventional. In addition, H. pylori’s ability to cause ulcers in gastrointestinal tissue (claim 10) is well-understood, routine, and conventional (Mayo Clinic, page 2, Overview, paragraph 3). Thus, none of the claims are eligible subject matter under 35 U.S.C. 101.
Examiner’s Comment
Sabao weak medium (recited in step 2) of claim 12) is available to the public from Hangzhou Microbial Reagent Company. See line 149 on page 6 of “The role of HMGB1 in invasive Candida albicans infection Jiaojiao Wang, Chuanxin Wu, Yunying Wang, Chongxiang Chen, Jing Cheng, Xiaolong Rao, Hang Sun bioRxiv 2020.01.21.914895; as well as the company website for Hangzhou Microbial Reagent Company cited on the PTO-892 with this action.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CANDICE LEE SWIFT whose telephone number is (571)272-0177. The examiner can normally be reached M-F 8:00 AM-4:30 PM (Eastern).
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/CANDICE LEE SWIFT/Examiner, Art Unit 1657
/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657