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
The preliminary amendment filed 07/27/2023, amended claims 1-8 and added claims 9-10.
Note: The claim set dated 06/20/2024 is not a claim set, but a translation of the International Application. See the Transmittal Letter of 06/20/2024 that states that “Applicant hereby submits a corrected English translation of the international application no. PCT/CN2022/093212. An accurate English translation of International Application is filed along with this paper.” As such, the Specification, Claims, Abstract, and Drawings dated 06/20/2024 is the English Translation of the International Application.
Priority
This application claims the following priority:
PNG
media_image1.png
105
701
media_image1.png
Greyscale
Information Disclosure Statement
NPL Cite No. 2 of the 12/22/2023 IDS does not recite a date. As such it is not being considered.
Claim Rejections - 35 USC § 112(b)
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 1-10 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 method of using a ferroptosis inhibitor in a preparation of a drug for treating a gastritis.” As such, it is not clear if claim 1 is a method of use, i.e., treating gastritis by administering a ferroptosis inhibitor, of if claim 1 is method of making a preparation comprising a ferroptosis inhibitor for the intended use of treating a gastritis.
Claim 1 is further indefinite because it does not recite any active steps. As such, the metes and bounds of the claim are unclear.
In view of compact prosecution, for the purpose of applying prior art, claim 1 is interpreted as, “A method of treating gastritis by administering to a subject, a drug preparation comprising a ferroptosis inhibitor.”
Claims 3-7 and 9-10, which ultimately depend from claim 1, are also indefinite, as they also do not recite any active steps.
All other claims not specifically recited are rejected for depending from an indefinite claim and failing to cure the deficiency.
Claim Rejections - 35 USC § 112(d)
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 3 and 10 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 3 depends from claim 2 which recites “wherein the ferroptosis inhibitor comprises ferrostatin-1 as the active ingredient.” Claim 3 recites “wherein the ferroptosis inhibitor is a derivative, an isomer, or a pharmaceutically acceptable salt of the ferrostatin-1.” As such, claim 3 is broadening the scope of the ferrostatin-1 in claim 2, which does not include derivatives, isomers, or pharmaceutically acceptable salts of ferrostatin-1. As such, claim 3 fails to further limit the subject matter of claim 2, from which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
All other claims not specifically recited are rejected for depending from an indefinite claim and failing to cure the deficiency.
Claim Rejections - 35 USC § 112(a)-Written Description
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, 3-8 and 10 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.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See MPEP 2163.
Independent claim 1 recites a method of treating gastritis by administering a ferroptosis inhibitor.
Dependent claim 3 recites a derivative, isomer, or pharmaceutically acceptable salt of ferrostatin-1.
Dependent claim 6 recites a method of treating chronic atrophic gastritis by administering a ferroptosis inhibitor configured to inhibit an expression of a spasmolytic polypeptide expression metaplasia gene.
However, the instant specification only teaches and exemplifies a single ferroptosis inhibitor, ferrostatin-1,
PNG
media_image2.png
249
154
media_image2.png
Greyscale
.
Example 10 exemplifies the proliferation viability of a GES-1-134 cell intervened with ferrostatin-1. Example 11 exemplifies the expression of ferroptosis markers in a GES-1-134 cells and a GRIM-19 mouse that were intervened with ferrostatin-1. Example 12 exemplifies the expression of inflammatory factors in a GES-1-134 cell and a GRIM-19 mouse that were intervened with ferrostatin-1. Example 13 exemplifies the expression of SPEM markers in a GRIM-19 mouse gastric mucosal tissue intervened with ferrostatin-1 (pgs. 9-11 and Figures 8-11 Specification).
The prior art only teaches two ferroptosis inhibitors in methods of treating gastritis:
Ji (Baicalin protects against ethanol-induced chronic gastritis in rats by inhibiting Akt/NF-kB pathway, published 2019, PTO-892) teaches a method of treating chronic gastritis by administering baicalin,
PNG
media_image3.png
262
262
media_image3.png
Greyscale
a ferroptosis inhibitor (abstract, title).
Ablin (Deferiprone, an Oral Iron Chelator, Ameliorates Experimental Colitis and Gastric Ulceration in Rats, published 1999, PTO-892) teaches a method of treating gastritis by administering deferiprone (L1),
PNG
media_image4.png
147
106
media_image4.png
Greyscale
, an oral iron chelator, i.e., a ferroptosis inhibitor (title, abstract).
Regarding ferroptosis inhibitors, in general, Zhang (Ferroptosis inhibitors: past, present and future, published 2024, PTO-892) teaches that the clinical translation of ferroptosis inhibitors as therapeutic agents has many challenges and that patients have shown adverse effects (pg. 2, Graphical Abstract).
Zhang teaches a five page table exemplifying small molecule ferroptosis inhibitors, wherein pg. 1 of the Table is:
PNG
media_image5.png
778
614
media_image5.png
Greyscale
(Table 1, pgs. 7-11).
As can be seen from just the first page of Table 1, ferroptosis inhibitors comprises structurally distinct compound that treat etiologically distinct diseases. And as taught by Zhang, the art of treating diseases with ferroptosis inhibitors in unpredictable.
As can be seen from Ji and Ablin, ferroptosis inhibitors that are known to treat gastritis have distinct, unrelated chemical structures.
The prior art is silent regarding ferroptosis inhibitors configured to inhibit an expression of a spasmolytic polypeptide expression metaplasia gene.
Thus, it is impossible to determine a structure-function relationship of ferroptosis inhibitors that is critical to treat gastritis or inhibit expression of a spasmolytic polypeptide expression metaplasia gene.
Moreover, none of CN111529518, CN113440409, or CN110755420 (IDS of 12/22/2023) describe derivatives, isomers, or salts of ferrostatin-1 that are therapeutically useful.
As such, claims 1, 3-8 and 10 are broader than what the specification supports.
This rejection can be overcome by amending the claims to recite ferrostatin-1 as the ferroptosis inhibitor.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ji (Baicalin protects against ethanol-induced chronic gastritis in rats by inhibiting Akt/NF-kB pathway, published 2019, PTO-892).
Ji teaches a method of treating chronic gastritis by administering baicalin, a ferroptosis inhibitor (abstract, title).
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.
Claims 1 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Ji (Baicalin protects against ethanol-induced chronic gastritis in rats by inhibiting Akt/NF-kB pathway, published 2019, PTO-892) in view of Murra (Atrophic Gastritis, published 12/09/2021, PTO-892)
Ji is applied to claim 1 as discussed above and incorporated herein.
While Ji teaches a method of treating gastritis by administering baicalin, it differs from that of instant claim 4 in that it does teach the chronic gastritis as chronic atrophic gastritis.
Murra teaches atrophic gastritis as the end stage of chronic gastritis (2nd paragraph).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to select chronic atrophic gastritis as the chronic gastritis of Ji, to arrive at instant claim 4. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-Ji teaches the treatment of chronic gastritis,
-Murra teaches atrophic gastritis as the end stage of chronic gastritis.
As such, an ordinary skilled artisan would have been motivated to make such a selection, to predictably arrive at a method of treating chronic gastritis, and the end stage of chronic gastritis, atrophic gastritis.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Ji (Baicalin protects against ethanol-induced chronic gastritis in rats by inhibiting Akt/NF-kB pathway, published 2019, PTO-892) and Murra (Atrophic Gastritis, published 12/09/2021, PTO-892), as applied to claims 1 and 4 above, and further in view of Huang (Mitochondrial GRIM-19 as a potential therapeutic target for STAT3-dependent carcinogenesis of gastric cancer, published 2016, PTO-892)
Ji and Murra are applied as discussed above and incorporated herein.
Regarding claim 5, the combination of Ji and Murra does not teach the chronic atrophic gastritis as induced by a defect in a GRIM-19 gene.
Huang teaches that GRIM-19 is severely depressed or lost in chronic atrophic gastritis tissues (abstract; pg. 41409, Fig. 2).
As such, an ordinary skilled artisan would have reasonably expected the chronic atrophic gastritis of the combination of Ji and Murra as induced by a defect in a GRIM-19 gene since Huang teaches that GRIM-19 is severely depressed or lost in chronic atrophic gastritis tissues.
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Ji (Baicalin protects against ethanol-induced chronic gastritis in rats by inhibiting Akt/NF-kB pathway, published 2019, PTO-892) and Murra (Atrophic Gastritis, published 12/09/2021, PTO-892), as applied to claims 1 and 4 above, and further in view of Claassen (Intraperitoneal Drug Administration, published 1994, PTO-892)
Ji and Murra are applied as discussed above and incorporated herein.
Regarding claim 7, the combination of Ji and Murra does not teach intraperitoneal injection.
Claassen teaches that intraperitoneal injection is widely used in rodents as a route of drug administration. The disappearance of drugs from the peritoneal cavity upon injection is because of diffusion into the surrounding tissues. Thereafter, the compound may be carried away by capillary blood or lymph, metabolized by tissue enzymes, or bound to tissue proteins (Summary).
Claassen teaches intraperitoneal administration as resulting in rapid absorption (In Summary).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to substitute the gastric gavage administration of Ji with intraperitoneal administration to arrive instant claim 7. One of ordinary skill in the art would have been motivated to make such a substitution, with a reasonable expectation of success, because:
-Ji teaches administration to rodents (pg. 3 of Ji), and Claassen teaches intraperitoneal injection as widely used in rodents as a route of drug administration,
- Claassen teaches intraperitoneal administration as resulting in rapid absorption.
As such, an ordinary skilled artisan would have been motivated to make such a substitution, to predictably arrive at a method of treatment chronic atrophic gastritis that is therapeutically effective immediately following administration since the intraperitoneal administration results in rapid administration of the baicalin.
Regarding claim 8, the combination of Ji, Murra, and Claassen does not teach administration of 1mg/kg to 1.5mg/kg baicalin.
It would have been prima facie obvious to one of ordinary skill in the art to modify the dosage of baicalin to arrive at instant claim 8. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
-Ji teaches an amount of baicalin that treats the gastritis, and
-"[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation," MPEP 2144.05(II).
The optimization of known percent amounts for known active agents is considered well within the competence level of an artisan of ordinary skill in the pharmaceutical sciences. It has been held that the selection of optimal parameters, such as amounts of active agents, to achieve a beneficial effect, is within the skill in the art of an ordinary artisan. See In re Boesch, 205 USPT 215 (CCPA 1980) and MPEP 2144.05.
Free of the Prior Art
Claims 2-3, 6, and 9-10 are free of the prior art. The closest prior art is Ji which teaches a method of treating chronic gastritis by administering baicalin, a ferroptosis inhibitor, as described above. However, the prior art does not teach ferrostatin-1 as a ferroptosis inhibitor for the treatment of gastritis.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN WELLS whose telephone number is (571)272-7316. The examiner can normally be reached M-F 7:00-4:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James (Jim) Alstrum-Acevedo can be reached on 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LAUREN WELLS/Examiner, Art Unit 1622
Prosecution Insights