DETAILED ACTION
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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-4 in the reply filed on March 23rd, 2026 is acknowledged. Claims 5-8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)).
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-4 are pending and were examined on the merits.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in the instant application.
Information Disclosure Statement
The information disclosure statement filed on March 7th, 2024 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because the foreign patent documents cited on the IDS are missing (EP-2600881-A1 and JP-2003300859-A) and because there is text cut off of the right hand margin of the provided copy of Piazza et al. (Planta Med 2019, 85 (18), 1550). It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
The examiner was able to retrieve legible copies of Piazza et al. (Planta Med 2019, 85 (18), 1550), JP-2003300859-A, and a machine translation of JP-2003300859-A; accordingly, these documents have been attached and cited on the PTO-892 form.
Specification
The disclosure is objected to because of the following informalities: t.
Appropriate correction is suggested.
Claim Objections
Claim 1 is objected to because of the following informalities: for grammatical correctness, the phrase "A method of treatment . Appropriate correction is required.
Claim 4 is objected to because of the following informalities: for clarity, t. Appropriate correction is required.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. Without evidence to the contrary, the plant parts listed in claim 4 (leaves, bark, seeds/fruits) are understood as comprising a list of alternatives as supported by the instant specification (page 3, lines 10-11).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 1 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Cviljević et al. (Food in Health and Disease 2019, 9 (2), 52-56); 3/7/2024 IDS, NPL doc. # 2, abbreviated "Cviljević".
Claim 1 recites a method of treatment Helicobacter pylori infections in patients in need thereof, said method comprising: administering to said patients a pharmaceutical effective amount of an extract of Castanea sativa. Claim 4 recites the method according to claim 1, wherein the extract is obtained from leaves, bark, seeds/fruits.
Cviljević recites honey comprising a pollen share from Castanea sativa of 90-98% inhibiting the growth of Helicobacter pylori (H. pylori) in vitro. (Cviljević, Results and Discussion, page 53, right column; instant claim 1). Although Cviljević recites this activity for honey rather than explicitly an extract, Cviljević provides suggestion that the Castanea sativa organism produces compounds that inhibit the growth of H. pylori. One of skill in the art would have had a reasonable expectation of success at making an extract of Castanea sativa by contacting the plant material with a solvent such as water or ethanol. Therefore, it would be obvious to one of skill in the art to make a Castanea sativa extract and administer it to patients to treat their H. pylori infections (claim 1). Leaves, bark, seeds, and fruits are among a finite number of plant tissues of the Castanea sativa to try using in the preparation of such an extract. Therefore, it would at least have been obvious to one of skill in the art to try preparing a Castanea sativa extract from the leaves, bark, seeds, or fruits of this plant species (instant claim 4).
Claims 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Cviljević et al. (Food in Health and Disease 2019, 9 (2), 52-56), abbreviated "Cviljević" as applied to claims 1 and 4 above, and further in view of Piazza et al. (Planta Med 2019, 85 (18), 1550); 3/7/2024 IDS, NPL doc. # 3, abbreviated "Piazza".
The teachings of the claims and cited prior art are of record above.
Claim 2 recites the method according to claim 1, wherein the extract is titrated in ellagitannins. Claim 3 recites the method according to claim 2, wherein the extract has a castalagin and vescalagin content by weight ranging between 1 and 6%.
Cviljević does not recite titrating a Castanea sativa extract with ellagitannins, the extract comprising the ellagitannins castalagin and vescalagin, or making the extract from leaves. However, Piazza recites using a chestnut leaves extract, castalagin, and vescalagin to inhibit or impair H. pylori-induced IL-8 secretion:
“IL-8 plays a central role in the immune-pathogenesis of H. pylori-induced tissue injury. H. pylori cag strains are clinically related to more severe outcomes of gastritis, like ulcers and cancer. The present study investigated the biological effect of tannins-containing extracts from Castanea sativa Mill., using in vitro models of gastric inflammation. Gastric epithelial cells (AGS and GES-1) were stimulated with TNFα (10 ng/mL) or co-cultured with different bacterial strains from clinical samples. … Moreover, we investigated the effect of an extract from chestnut leaves, rich in tannins, which was never previously evaluated against gastric inflammation, in addition to castalagin and vescalagin, ellagitannins which occur in bark and leaves. Leaves extract inhibited TNFα and H. pylori-induced IL-8 secretion at 10 μg/mL and 50 μg/mL, respectively. Both ellagitannins strongly inhibited TNFα-induced IL-8 with the same IC50 (0.04 μM), whereas H. pylori-induced IL-8 was impaired at 50 μM. Although the extracts exhibited a lower inhibitory potency in co-culture model with respect to TNFα induced gastric epithelial cells, the higher concentrations of extracts tested (25-50 μg/mL) may be easily achieved in vivo after oral consumption” (Abstract; instant claims 2-4).
Chestnut leaves extract, castalagin, and vescalagin inhibit or impair the secretion of an immune-pathogenesis molecule IL-8, induced by H. pylori in an in vitro model of gastric inflammation. Therefore, it would be obvious to one of skill in the art to improve on a chestnut extract that inhibits the growth of H. pylori (per the suggestion of Cviljević, of record above) to additionally treat immune-pathogenesis of H. pylori-induced tissue injury, by sourcing the extract from leaves (instant claim 4) and titrating it with the ellagitannins castalagin and vescalagin (instant claims 2 and 3).
Although Piazza does not recite the extract having a castalagin and vescalagin content by weight ranging between 1 and 6%, this weight percentage is obvious over routine optimization (instant claim 3). One of skill in the art would have access to castalagin and vescalagin solutions of known concentration, as Piazza would have needed to perform the experiments recited above and obtain inhibitory concentrations. By titrating known volumes of these solutions into a chestnut extract, and measuring the volume of the resulting composition, one of skill in the art could produce a composition with known concentrations of castalagin and vescalagin. One of skill in the art could weigh a known volume of this composition, and calculate the weight percentage of castalagin and vescalagin based on their concentrations and molecular weights. One of skill in the art could administer compositions differing by known content of castalagin and vescalagin to patients with H. pylori infections. One of skill in the art could then observe whether the patient’s symptoms improve, and how quickly they improve, and adjust the castalagin and vescalagin content to improve patient recovery while also attempting to minimize expense.
Cviljević and Piazza are relied upon for the reasons discussed above. If not expressly taught thereby, based upon the overall beneficial teachings provided by the references with respect to providing the content of castalagin and vescalagin in the claimed extract (instant claim 3), the adjustments of particular conventional working conditions (e.g., the selection from among known components and determining one or more suitable ranges (amounts, proportions, ratios thereof) in which to provide the a method of treating Helicobacter pylori infections using a chestnut extract), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
From the teachings of Cviljević in view of Piazza, the invention as a whole, drawn to a method of treating Helicobacter pylori infections using a chestnut extract as described in Claim 1, would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, and one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Please note, since the Office does not have the facilities for examining and comparing Applicants’ methods with the methods (including compositions thereof) of the prior art, the burden is on applicant to show a novel or unobvious difference between the claimed methods and the methods of the prior art (and compositions thereof). See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980), and “as a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
Conclusion
No claims are allowed
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/R.F.S./Examiner, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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