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 1-2, 5-7, and 10-20 are pending. Claims 3-4 and 8-9 are cancelled. Claims 13-20 are withdrawn. Claims 1-2, 5-7, and 10-12 are under examination on their merits.
Response to Arguments
Applicant's arguments filed 6/16/2026 have been fully considered but they are not persuasive.
Applicant argues against the rejection of claims 11-12 under 35 U.S.C. 101 on the grounds that the claimed method integrates the judicial exception into a practical application (Arguments, paragraph 3 on page 14). Applicant argues that the claims do not recite mental processes (Arguments, section I on page 16).
In response, this argument is unpersuasive because there is no practical application recited in the claim. Rather, the output of performing the claimed method is the pollution inhibition rate. The pollution inhibition rate, once calculated, is not tied to any practical application. Furthermore, claim 12 clearly recites the judicial exception of an abstract idea and a mathematical concept. 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).
Claim Objections
Claims 11-12 are objected to because of the following informalities:
In claims 11-12, H. pylori should be italicized because it is a Latin scientific name.
In claim 12 there is a space missing between ATCC and the deposit number for Escherichia coli ATCC 25922 in steps 3) of claim 12.
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.
(New Rejection Necessitated by Amendment) Claims 1-2, 5-7, and 10-12 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 recites a preservation medium in step 2. Preservation medium ambiguously encompasses any H pylori medium known in the art, including culture medium, medium for rapid isolation, storage medium, transport medium, or cryopreservation medium. Therefore, the metes and bounds of the claim are undefined.
Claim 1 step 1 recites placing two zirconium beads having a particle size of 3-6 mm in a sterile 1-2 mL EP tube with two zirconium beads and step 2 recites placing 0.5-1.0 mL of a preservation medium into the sterile EP tube with two zirconium beads. It is unclear whether there are two or four zirconium beads in the EP tube after step 1. Since step 1 recites placing two zirconium beads into an EP tube with two zirconium beads, then in one interpretation there are four zirconium beads in the EP tube after step 1. However, step 2 recites placing preservation medium into the sterile EP tube with two zirconium beads, which seems to suggest there are only two zirconium beads in the EP tube after step 1.
Claim 1 recites “EP tube,” which is not defined in the specification and does not have a plain and ordinary meaning.
Step 8 of claim 1 recites serially diluting the bacterial suspension by a factor of 1:10 through at least 13 dilution stages. The dilution stages can either be interpreted as the number of dilution steps (e.g. serially diluting 13 times a single bacterial suspension by 1:1.19 in order to generate a single bacterial suspension of 1:10 dilution) or as 13 separate dilutions of 1:10 (i.e. generating 13 separate bacterial suspensions each at a dilution of 1:10). Step 8 is further indefinite for inoculating 20 µL of the diluted bacterial suspension onto respective regions of a culture plate. It is unclear whether there are 13 separate regions for each dilution “stage” or whether the 20 µL is distributed into an unknown number of respective regions.
Claim 2 recites the limitation "the waterproof and light-proof conditions" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites the preservation medium contains zirconium beads. However, claim 5 depends from claim 1. Step 2 of claim 1 recites placing 0.5-1.0 mL of a preservation medium into the sterile EP tube with two zirconium beads. Thus, it is unclear whether the preservation medium itself further comprises zirconium beads before the medium is added to the sterile EP tube already containing zirconium beads.
Claim 11 recites the method further comprises evaluating culture efficiency of the H. pylori culture method by determining a pollution inhibition rate. Claim 11 lacks an active method step.
Claim 12 recites in step 1) serially diluting each bacterial suspension by a factor of 1: 10 through seventeen consecutive dilution stages. Claim 12 is indefinite because this limitation has multiple reasonable interpretations. The dilution stages can either be interpreted as the number of dilution steps (e.g. serially diluting 17 times a single bacterial suspension by 1:1.145 in order to generate a single bacterial suspension of 1:10 dilution) or as 17 separate dilutions of 1:10 (i.e. generating 17 separate bacterial suspensions each at a dilution of 1:10). Similarly, step 2 of claim 12 recites the analogous limitation “serially diluting the bacterial suspension by a factor of 1: 10 through eleven consecutive dilution stages,” thus step 2) further renders claim 12 indefinite for having multiple reasonable interpretations of this limitation.
Claim 12 is further indefinite for the limitation preparing the respective bacterial suspensions with sterile physiological saline because it is unclear how the bacteria are prepared with the saline.
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%.
Claims 2, 5-7, and 10-12 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.
(New Rejection Necessitated by the Amendment) Claims 6-7 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 6 is rejected for failing to further limit the subject matter of the claim upon which it depends. Each of the limitations recited in claim 6 is already recited in step 3 of claim 1.
Claim 7 is rejected for failing to further limit the subject matter of claim 1. Each of the limitations recited in claim 7 is already recited in step 4 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.
(New Rejection Necessitated by Amendment) Claims 1-2, 5-7, and 10-12 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 claim(s) 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(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
Claim 1 step 8) recites the limitation serially diluting the bacterial suspension by a factor of 1:10 through at least 13 dilution stages. Claim 12 step 1) recites serially diluting each bacterial suspension by a factor of 1:10 through seventeen consecutive dilution stages and claim 12 step 2) recites serially diluting the bacterial suspension by a factor of 1:10 through eleven consecutive dilution stages. The specification never discloses a 1:10 dilution factor. Rather, the specification discloses performing 1-fold serial dilution to over 13 sterile tubes ([16] and [26]), diluting to a 17th gradient ([32] and [90]), diluting to an 11th gradient ([33] and [91]), and diluting to above a 16th gradient ([83]).
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.
(New Rejection Necessitated by the Amendment) Claims 11-12 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.
Claim 11 recites evaluating culture efficiency of the H. pylori culture metho by determining a pollution inhibition rate. “Determining a pollution inhibition rate” is an abstract idea.
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 judicial exception is not integrated into a practical application (Step2A Prong Two: No). Claims 11-12 ultimately depend from claim 1, which is drawn to “A bacterial colony formation method for sensitive and rapid culture of H. pylori.” However, no practical application is recited in the claims. Claims 11-12 are purely drawn to calculating the pollution inhibition rate. Although claim 12 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 independent claim 1, from which claims 11-12 depend, is 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; cited in the Non-Final Action mailed on 1/16/2026): Isolation and characterization, subcultivation, preservation. Culturing H. pylori under microaerobic conditions at a temperature below 40 °C (claim 1 step 5) 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). Tissue grinding with zirconium beads (claim 1 step 4) at low temperatures (to prevent thermal degradation) is also well-understood, routine, and conventional (OPS Diagnostics, 2016 website; cited in the Non-Final Action mailed on1/16/2026; page 1, paragraphs 1-2). Dilution with physiological saline to achieve a specific bacterial concentration (claim 1 step 8) is also well-understood, routine, and conventional.
In claim 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).
Thus, claims 11-12 is not eligible under 35 U.S.C. 101.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
The following rejections are necessitated by the amendment.
Claims 1 and 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Ansorg et al. (Journal of clinical microbiology 29.1 (1991): 51-53; cited in the Non-Final Action mailed on 1/16/2026) in view of Sulami et al. (EMHJ-Eastern Mediterranean Health Journal, 14 (2), 268-276, 2008), OPS Diagnostics (2016, website), and Hortelano et al. (International Microbiology 23.4 (2020): 481-487).
Steps 1-2 are interpreted as requiring placing two zirconium beads having a particle size of 3-6 mm in a sterile 1-2 mL EP tube and placing 0.5-1.0 mL of a preservation medium into the sterile EP tube with the zirconium beads.
EP tube is interpreted as any tube.
“Step (f)” recited in step (8) is interpreted as step (6).
Regarding step (3), Ansorg teaches keeping gastric biopsy specimens in transport medium (brain heart infusion broth) and bringing the specimens to the laboratory on the day of endoscopy (page 51, left column, Isolation and identification, paragraph 1).
Regarding step (1), Ansorg does not teach placing two zirconium beads having a particle size of 3-6 mm in a sterile 1-2 mL EP tube.
Regarding step (3), Ansorg does not teach obtaining a gastrointestinal tissue sample from a patient suspected of having H. pylori infection who has not received proton pump inhibitor (PPI) treatment or antibiotic treatment for at least 20 days.
Further, regarding step (3), Ansorg does not teach placing the gastrointestinal tissue sample into the EP tube with two zirconium beads, completely immersing the gastrointestinal tissue sample in the preservation medium, tightly capping the EP tube with two zirconium beads, and storing the EP tube with two zirconium beads at 2-8°C for no more than 10 days.
Regarding step (4), Ansorg does not teach grinding the gastrointestinal tissue sample in the preservation medium with the zirconium beads for 1-2 minutes to obtain a ground sample suspension.
OPS Diagnostics teaches 3.0 mm zirconium beads are appropriate for homogenizing animal tissues (page 1, paragraph 1).
Sulami teaches collecting gastric tissue specimens (page 269, right column, Data collection, paragraph 1), transporting biopsy specimens in tryptic soy broth to the laboratory and then grinding the specimens in a sterile mortar until the formation of a homogenate (page 270, left column, first full paragraph).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to place the zirconium beads, the gastrointestinal tissue, and sufficient volume of brain heart infusion broth to cover the tissue in any order into a tube and to tightly cap the tube. It would have been further obvious to homogenize (grind) the gastric biopsy specimens of Ansorg with the zirconium beads prior to culturing. The person of ordinary skill in the art would have been motivated by the teaching of Sulami, who suggests homogenizing the gastric tissue specimens and further by the teaching of OPS Diagnostics, who suggests 3 mm zirconium beads as an alternative method of homogenizing tissue (i.e. bead beating).
Regarding the number of beads, the duration of bead beating, the size and type of tube, and the duration and temperature of storage, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to optimize these standard laboratory variables and the person of ordinary skill in the art would have had a reasonable expectation of success in doing so. The person of ordinary skill in the art would have been motivated to select a sterile tube in order to avoid introducing any bacterial contaminants. The person of ordinary skill in the art would have been motivated to store the sample in under refrigeration (i.e. at 2-8°C) prior to homogenizing the sample in order to maintain viability of the bacteria.
Regarding the origin of the gastric biopsy sample, Ansorg does not teach the type of patient from which the sample was collected.
Sulami teaches collecting the gastric tissue specimens from patients with symptoms suggestive of peptic ulcer (page 269, right column, Methods, Sample, paragraph 1).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to collect the gastric tissue specimens from a patient suspected of having H. pylori infection but prior to receiving any treatment for H. pylori infection (e.g. antibiotics or proton pump inhibitors). The person of ordinary skill in the art would have been motivated to confirm the presence of H. pylori infection. The person of ordinary skill in the art would have been motivated to time the collection of the sample before any H. pylori treatment is administered to the patient in order to maximize chances of a successful bacterial isolation and cultivation.
Regarding steps (5) and (6), Ansorg teaches streaking equal portions of the specimen on the media and incubating the plates at 37°C for 4 to 5 days in microaerophilic gas mixture comprising 8 to 10% CO2, 5 to 7% O2 and 83 to 87% N2 (page 51, left column, Isolation and Identification, paragraph 1).
37°C is within the presently claimed range of 35-37°C.
4 to 5 days overlaps with the presently claimed range of 48-120 h (2-5 d).
8 to 10% CO2 overlaps with the presently claimed range of 5-10% CO2.
5 to 7% O2 overlaps with the presently claimed range of 3-6% O2.
83 to 87% N2 overlaps with the presently claimed range of 76-86% N2.
Ansorg does not teach the volume of the gastric biopsy specimens streaked on the plates or that the streaking on the plates is under sterile conditions.
However, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to optimize the volume of the gastric biopsy specimens streaked on the plate and the person of ordinary skill in the art would have had a reasonable expectation of success in doing so. It would have been further obvious to maintain sterile conditions in order to avoid introducing foreign bacteria into the culture.
Ansorg does not teach that the microaerophilic gas mixture further comprises 5-10% H2 .
Ansorg does not teach the relative humidity during step (6).
Hortelano teaches culturing H. pylori in an incubation atmosphere of 5% CO2, 5% O2, and 3% H2 (page 482, right column, paragraph 1). Hortelano also teaches culturing H. pylori on blood agar plates under 90-95% humidity (page 482, right column, Materials and methods, Bacteria strain and culture conditions, paragraph 1).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Ansorg modified by Sulami and OPS Diagnostics by introducing 3% H2 into the microaerobic conditions for culturing H. pylori. It would have been further obvious to culture the plates under 90-95% humidity. The person of ordinary skill in the art would have been motivated by the teachings of Hortelano. The person of ordinary skill in the art would have had a reasonable expectation of success in these modifications.
3% H2 is a value approaching the claimed range of 5-10% H2.
90-95% humidity is a value approaching 100% humidity.
Regarding step (7), Ansorg teaches introducing fifty microliters of a suspension of H. pylori into storage media and storing the vials at -70°C (page 51, right column, Preservation, paragraph 1). Ansorg teaches spotting the storage media on a plate and incubating the plates at 37°C for 4 to 5 days in microaerophilic gas mixture comprising 8 to 10% CO2, 5 to 7% O2 and 83 to 87% N2 (page 51, right column, paragraph 1).
Regarding steps (8) and (9), Ansorg teaches subculturing colonies of primary isolates of H. pylori on sheep blood agar at intervals of 4 to 5 days (page 51, right column, Subcultivation, paragraph 1). 4 to 5 days overlaps with the claimed range of 48-96 hours. Ansorg teaches streaking several colonies to areas approximately 1 cm in diameter on three different plates (page 51, right column, Subcultivation, paragraph 1). Areas 1 cm (10 mm) in diameter approach the presently claimed range of 13-17 mm. Ansorg also teaches preparing a saline suspension equivalent to a McFarland no. 6 standard (page 51, right column, Preservation, paragraph 1). Ansorg teaches a solution of 0.9% sodium chloride in water (page 51, right column, bottom paragraph).
Ansorg does not teach a separate step of diluting the bacteria prior to culturing the bacteria to form colonies, and then selecting a colony for subsequent culture. Ansorg does not teach the concentration of the suspension inoculated onto the plates (“a bacterial suspension having a turbidity of 1.0 McFarland, serially diluting the bacterial suspension by a factor of 1: 10 through at least 13 dilution stages” ) or the volume inoculated. Ansorg teaches inoculating onto three different plates rather than different regions of the same plate.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to add a step of diluting the bacteria with physiological saline and culturing the bacteria to form colonies prior to Ansorg’s explicit subculture step. The person of ordinary skill in the art would have been motivated to reduce the concentration of the bacteria in order to obtain bacterial isolates. It would have been further obvious to optimize by routine experimentation the concentration and the volume inoculated onto the plate. It would have been further obvious to specifically use physiological saline (0.9% sodium chloride) to dilute the bacteria because the solution is a low, non-toxic concentration of salt. It would have been further obvious to inoculate the suspension onto different regions of the same plate rather than three different plates in order to reduce the number of plates required to perform the method. The person of ordinary skill in the art would have had a reasonable expectation of success in these modifications.
Regarding the duration of culture in step (9), Ansorg teaches culturing 4 to 5 days (page 51, left column, Isolation and identification, paragraph 1; page 51, right column, Subcultivation, paragraph 1) rather than 24 hours.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to optimize by routine experimentation the duration of culture until single colonies appear on the plate. The person of ordinary skill in the art would have had a reasonable expectation of success in doing so.
Regarding claim 5, placing the zirconium beads in a tube (which is required for performing bead beating to homogenize the tissue) and adding the transport medium containing the tissue specimen necessarily results in a preservation medium containing zirconium beads.
Claims 6-7 are also rejected here because they do not further limit the subject matter of claim 1, from which they depend, as discussed above in the rejection under 35 U.S.C. 112(d).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Ansorg et al. (Journal of clinical microbiology 29.1 (1991): 51-53; cited in the Non-Final Action mailed on 1/16/2026) in view of Sulami et al. (EMHJ-Eastern Mediterranean Health Journal, 14 (2), 268-276, 2008), OPS Diagnostics (2016, website), and Hortelano et al. (International Microbiology 23.4 (2020): 481-487), as applied to claims 1 and 5-7 above, further in view of Choi et al. (J Microbiol Exp 2.7 (2015): 00075).
See discussion of Ansorg, Sulami, OPS Diagnostics, and Hortelano above, which is incorporated into this rejection as well.
Claim 2 is interpreted as requiring that the plates are vacuum sealed and stored at 2-8°C prior to inoculating with the ground sample suspension.
Ansorg does not teach that the sheep blood agar plates (Table 1) are vacuum sealed and stored at 2-8°C prior to use.
Choi teaches vacuum-sealing and storing agar plates at 2 to 8 °C (Abstract and page 2, left column, paragraph 1).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to store the plates under refrigeration and vacuum at 2-8°C prior to use in order to avoid the risk of bacterial contamination and desiccation. The person of ordinary skill in the art would have had a reasonable expectation of success in storing the plates under vacuum at 2-8°C.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Ansorg et al. (Journal of clinical microbiology 29.1 (1991): 51-53; cited in the Non-Final Action mailed on 1/16/2026) in view of Sulami et al. (EMHJ-Eastern Mediterranean Health Journal, 14 (2), 268-276, 2008) , OPS Diagnostics (2016, website), and Hortelano et al. (International Microbiology 23.4 (2020): 481-487) as applied to claims 1 and 5-7 above, further in view of Noh et al. (Scientific reports 10.1 (2020): 18483).
See discussion of Ansorg, Sulami, OPS Diagnostics, and Hortelano above, which is incorporated into this rejection as well.
Ansorg, Sulami, OPS Diagnostics, and Hortelano do not teach obtaining the gastrointestinal tissue sample from a junction between normal tissue and abnormal tissue, wherein abnormal tissue comprises inflammation, ulcer, erosion, or lump.
Noh teaches that the detection rate of biopsy-based tests for H. pylori are reduced by gastric atrophy, intestinal metaplasia, and peptic ulcer bleeding (second paragraph after Abstract on page 1).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Ansorg, Sulami, OPS Diagnostics, and Hortelano by sampling at the junction of healthy tissue and the ulcer rather than at the ulcer itself in order to increase the chances of detecting H. pylori. The person of ordinary skill int eh art would have been motivated to avoid the area of peptic ulcer bleeding, which Noh suggests decreases the detection rate of H. pylori. The person of ordinary skill in the art would have had a reasonable expectation of success in this modification.
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 the Non-Final Action mailed on 1/16/2026.
Conclusion
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.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Louise Humphrey can be reached at (571)272-5543. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/CANDICE LEE SWIFT/Examiner, Art Unit 1657
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