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 claims 1-5 and 9-10, which correspond to Group I of the Restriction requirement of 3/03/2026, and depression as the disease in the reply filed on 4/29/2026 is acknowledged.
Claims 1-5 and 9-10 are currently pending and under consideration.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements filed on 2/02/2024 are acknowledged and have been considered except lined through. It is note that while the foreign documents contain an abstract in English, the body of the documents have not been translated. As such, the foreign documents have been considered to the extent of the English abstracts.
Specification
The disclosure is objected to because of the following informalities: There are multiple words which are missed spelled throughout the specification. For example, on page 3 of the specification, there is the word “base” when defining a chemical name or “embodiment 17” on page . Moreover, .
Appropriate correction is required.
Claim Interpretation
Claim 1 recites a method of treating pyroptosis comprising administering an effective amount of an aminothiazole derivative to cells derived from a human or animal. The specification teaches that pyroptosis is a new inflammatory mechanism, which plays an important role in various kinds of inflammation (see page 1, 3rd full paragraph). In view of this, it would appear that pyroptosis is involved with certain types of inflammatory disorders. As such, administration of the compound to a disease or disorder that is associated with pyroptosis would be considered to meet the limitation of treating pyroptosis. Moreover, “derived from” implies obtained from. As such, the claims appear to encompass both in vitro and in vivo administration consistent with the specification on page 2, last paragraph.
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 2-3 and 5 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.
Regarding claims 2 and 5, claims 2 and 5 recite the word “group” when referring to the name of a chemical compound. For example, claim 2 refers to 2-(4-phenylpiperazine-1-group) -N-(4-phenylthiazole-2-group) acetamide and 2-(4-benzylpiperazine-1-group) -N-(4-(4-methylphenyl) thiazole-2-group) acetamide. However, it is unclear what “group” encompasses. In view of the specification on page 3, for prior art purposes the first compound will be interpreted as compound 1603. Regarding the second compound, it is unclear what the second compound chemical formula should be.
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 (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 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.
Claim(s) 1-5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhou and Jiang (US2014/0073648A1, 2014-04-13) as evidenced by Zheng et al (Front. Immunol. 2021; 12: 711939) referred to as Zheng 1 and Zheng et al. (Biomolecules 2022; 12: 1625) referred to herein as Zheng 2.
Zhou and Jiang teach methods of treating immunologic diseases comprising administering an aminothiazole-based inhibitor of MyD88 to a patient, wherein the immunologic diseases included, but are not limited to, rejections after organ transplantation, chronic inflammatory disease, autoimmune disease, ischemia-reperfusion injuries and endotoxemia and sepsis (abstract). With regards to the aminothiazole-based inhibitor, Zhou and Jiang teach that the aminothiazole-based specific inhibitor have the formulas:
PNG
media_image1.png
577
304
media_image1.png
Greyscale
which read on compounds 1602, 1603, 1604 and 1606 of instant claim 2 and claim 5 (see specification page 3 for name to structure correlation). Moreover, Zhou and Jiang teach numerous in vitro and in vivo models of the use of the inhibitors of MyD88 in the treatment of autoimmune diseases, ischemia-reperfusion injuries, chronic inflammatory diseases and sepsis, wherein the inhibitors were administered via intraperitoneal injection (see Examples 2-5). Thus, while the prior art does not specifically teach that pyroptosis is involved in ischemia-reperfusion injuries or sepsis, as evidenced by Zheng et al (Front. Immunol. 2021; 12: 711939) referred to as Zheng 1 and Zheng et al. (Biomolecules 2022; 12: 1625) referred to herein as Zheng 2 pyroptosis is involved in both ischemia-reperfusion injuries and sepsis (see abstract from both articles). It is noted that the instant specification utilizes a mouse model of hepatic ischemia-reperfusion injury to show suppression or inhibition of pyroptosis (see Embodiment 17). Regarding the inhibitory activity of NLRP3, Caspase-1, Caspase-11 and Gasdermin D in cells derived from a human or animal by the compounds, the specification acknowledges the inhibition by aminothiazole derivatives of MYD-88 and the resulting “effects” and notes that “this study conducted further research on the process of pyroptosis and found a new effective pathway of this aminothiazole derivative in the inhibition of pyroptosis.” (page 2, 1st and 2nd paragraph). As such, it appears that Applicants have discovered an alternative pathway which the claimed compounds work in the same patient population. In this regards, Applicants are reminded that "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). In In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004). (see MPEP 2112).
Claim(s) 1-5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jiang et al. (US9771340B2, 2014-04-13) as evidenced by Song et al. (Life Science 2024; 359: 123232).
Jiang et al. teach 2-aminothiazole derivatives for use in inhibiting acetylcholine esterase and PARP-1 for treatment of diseases such as Alzheimer’s disease and for use in inhibiting MyD-88 to produce an immunosuppressive effect in treatment of anti-transplant rejection, anti-autoimmune disease, anti-ischemia-reperfusion injury, anti-chronic inflammation and anti-endotoxemia (Column 3, lines 21-30). Regarding the 2-aminothiazole derivatives, Jiang et al. teach the 2-aminothiazole derivatives have the general formula
PNG
media_image2.png
84
220
media_image2.png
Greyscale
and particular species including, but not limited to, the following:
- 2-(4-(4-methoxyphenyl) piperazin-1-yl)-N-(4-phenyl-thiazol-2-yl) acetamide (labeled as TJ-M201005);
- 2-(4-(4-methoxyphenyl) piperazin-1-yl)-N-(4-phenyl-thiazol-2-yl) butyramide (labeled as TJ-M201018);
- 3-(4-benzyl-piperazin-1-yl)-N-(4-phenyl-thiazol-2-yl)-propionamide (labeled as TJ-M201015);
- 3-(4-(4-methoxyphenyl) piperazin-1-yl-N-(4-phenyl-thiazol-2-yl)-propionamide (labeled as TJ-M201021);
- 3-(N,N-pyridylmethyl-ethyl amine)-N-(4-phenyl-thiazole-5-methyl-2-yl)-propionamide (labeled as TJ-M201041), which read on compounds 1616, 1605 and 1604 of instant claim 2 and claim 5 (see specification page 3 for name to structure correlation) (see Examples 4-9 of Jiang et al.). Moreover, Jiang et al. teach numerous in vitro and in vivo models of the use of the inhibitors for treatment of autoimmune diseases and diabetes, wherein the inhibitors were administered via intraperitoneal injection (see Examples 18). Thus, while the prior art does not specifically teach that pyroptosis is involved in autoimmune diseases such as diabetes, as evidenced by Song et al. pyroptosis is involved in autoimmune diseases including type 1 diabetes (see abstract and section 6.1). It is noted that the instant specification utilizes a mouse model of hepatic ischemia-reperfusion injury to show suppression or inhibition of pyroptosis (see Embodiment 17). Regarding the inhibitory activity of NLRP3, Caspase-1, Caspase-11 and Gasdermin D in cells derived from a human or animal by the compounds, the specification acknowledges the inhibition by aminothiazole derivatives of MYD-88 and the resulting “effects” and notes that “this study conducted further research on the process of pyroptosis and found a new effective pathway of this aminothiazole derivative in the inhibition of pyroptosis.” (page 2, 1st and 2nd paragraph). As such, it appears that Applicants have discovered an alternative pathway which the claimed compounds work in the same patient population. In this regards, Applicants are reminded that "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). In In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004). (see MPEP 2112).
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.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jiang et al. (US9771340B2, 2014-04-13) as evidenced by Song et al. (Life Science 2024; 359: 123232), as applied to claims 1-5 above, in view of Shaikh, Aamir, “Levels of PARP-1 immunoreactivity in the Human Brain in Major Depressive Disorder” (2020). Undergraduate Honors Theses. Page 547.
Jiang et al. teach 2-aminothiazole derivatives for use in inhibiting acetylcholine esterase and PARP-1 for treatment of diseases such as Alzheimer’s disease and for use in inhibiting MyD-88 to produce an immunosuppressive effect in treatment of anti-transplant rejection, anti-autoimmune disease, anti-ischemia-reperfusion injury, anti-chronic inflammation and anti-endotoxemia (Column 3, lines 21-30). Regarding the 2-aminothiazole derivatives, Jiang et al. teach the 2-aminothiazole derivatives have the general formula
PNG
media_image2.png
84
220
media_image2.png
Greyscale
and particular species including, but not limited to, the following:
- 2-(4-(4-methoxyphenyl) piperazin-1-yl)-N-(4-phenyl-thiazol-2-yl) acetamide (labeled as TJ-M201005)
PNG
media_image3.png
130
317
media_image3.png
Greyscale
;
- 2-(4-(4-methoxyphenyl) piperazin-1-yl)-N-(4-phenyl-thiazol-2-yl) butyramide (labeled as TJ-M201018);
- 3-(4-benzyl-piperazin-1-yl)-N-(4-phenyl-thiazol-2-yl)-propionamide (labeled as TJ-M201015)
PNG
media_image4.png
78
266
media_image4.png
Greyscale
;
- 3-(4-(4-methoxyphenyl) piperazin-1-yl-N-(4-phenyl-thiazol-2-yl)-propionamide (labeled as TJ-M201021)
PNG
media_image5.png
95
292
media_image5.png
Greyscale
;
- 3-(N,N-pyridylmethyl-ethyl amine)-N-(4-phenyl-thiazole-5-methyl-2-yl)-propionamide (labeled as TJ-M201041), which read on compounds 1616, 1605 and 1604 of instant claim 2 and claim 5 (see specification page 3 for name to structure correlation) (see Examples 4-9 of Jiang et al.). Moreover, Jiang et al. teach numerous in vitro and in vivo models of the use of the inhibitors for treatment of autoimmune diseases and diabetes, wherein the inhibitors were administered via intraperitoneal injection (see Examples 18).
Jiang et al. does not specifically teach that the disease or disorder is depression.
Shaikh, Aamir teaches that PARP-1 inhibition produces antidepressant-like effects in rodents, suggesting that PARP-1 inhibitors hold promise as novel antidepressant drugs. (Abstract).
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 modify the method taught by Jiang et al. so as to administer the 2-aminothiazole derivatives to include a patient suffering from depression in view of the teachings of Shaikh, Aamir. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
-Jiang et al. teach that the 2-aminothiazole derivatives are inhibitors of PARP-1 and
-Shaikh, Aamir teaches that PARP-1 inhibition produces antidepressant-like effects in rodents, suggesting that PARP-1 inhibitors hold promise as novel antidepressant drugs.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jiang et al. (US9771340B2, 2014-04-13) as evidenced by Song et al. (Life Science 2024; 359: 123232) in view of Shaikh, Aamir, “Levels of PARP-1 immunoreactivity in the Human Brain in Major Depressive Disorder” (2020). Undergraduate Honors Theses. Page 547, as applied to claims 1-5 and 9, in further view of Mazza et al. (Brain, Behavior, and Immunity 2020; 89: 594-600).
The combination of Jiang et al. as evidenced by Song et al. and Shaikh, Aamir has been discussed above and incorporated herein. In short, the combination teaches a method of treating depression comprising administering a PARP-1 inhibiting amount of a 2-aminothiazole derivative.
The combination does not teach that the depression is induced by COVID-19
Mazza et al. investigated the role of inflammatory and clinical predictors of anxiety and depression in COVID-19 survivors (Title). In particular, Mazza et al. found that a significant proportion of patients self-rated in the psychopathological range: 28% for PTSD, 31% for depression, 42% for anxiety, 20% for OC symptoms and 40% for insomnia (Abstract, 3rd paragraph). Moreover, Mazza et al. teach that considering the alarming impact of COVID-19 infection on mental health, the current insights on inflammation in psychiatry, and the present observation of worse inflammation leading to worse depression, we recommend to assess psychopathology of COVID-19 survivors and to deepen research on inflammatory biomarkers, in order to diagnose and treat emergent psychiatric conditions (Abstract, 4th full 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 modify the method taught by the combination for treating depression to include a patient whom has or has had COVID-19 in view of the teachings of Mazza et al.. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
-Mazza et al. taches that 31% of COVID-19 patients self-rated as having depression and further, Mazza et al. recognizes that worsening inflammation associated with COVID-19 will lead to worsen depression.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 9,771,340 (Issued 2017-09-26). Although the claims at issue are not identical, they are not patentably distinct from each other because the US Patent claims the compound 3-(4-(4-methoxyphenyl)piperazin-1-yl)-N-(4-phenyl-thiazol-2-yl)-propionamide which anticipates the 2-aminothiazole derivatives of instant claim 1 and 4 and is specifically claimed in claims 2 and 5 of the instant application.
The portion of the specification of 9,771,340 that describes subject matter that falls within the scope of claim 10 may be relied upon to properly construe the scope of that claim, including all of the composition’s disclosed uses or utilities. (MPEP 804(II)(B)(1)). In Sun Pharm. v. Lilly, the Court affirms this use of the specification and states,
A ‘claim to a method of using a composition is not patentably distinct from an earlier claim to the identical composition in a patent disclosing the identical use,’ extends to any and all such uses disclosed in the specification of the earlier patent.
. . .
[i]t would shock one’s sense of justice if an inventor could receive a patent upon a composition of matter, setting out at length in the specification the useful purposes of such composition, . . . and then prevent the public from making any beneficial use of such product by securing patents upon each of the uses to which it may be adapted.
611 F.3d 1381, 1387 (Fed. Cir. 2010).
In this case, the specification of 9,771,340 describes the utility of the compound of claim 1 to include use in inhibiting acetylcholine esterase and PARP-1 for treatment of diseases such as Alzheimer’s disease and for use in inhibiting MyD-88 to produce an immunosuppressive effect in treatment of anti-transplant rejection, anti-autoimmune disease, anti-ischemia-reperfusion injury, anti-chronic inflammation and anti-endotoxemia (Column 3, lines 21-30). Claims 1-5, drawn to a method of using 2-aminothiazole derivates to treat diseases, are not patentably distinct from claim 1 of 9,771,340, drawn to the identical compound, which is disclosed in the specification to be useful for treating diseases.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Badaway (Bioschience Reports 2020; 40: BSR20202856)
Chen et al. (European Journal of Medicinal Chemistry 2019; 161: 22-38)
Zheng et al. (Nature Immunology 2021; 22: 829-838)
US20180318291 to Zhou, Ping (2018-11-08).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRANDON J FETTEROLF whose telephone number is (571)272-2919. The examiner can normally be reached M-F 6AM-4PM.
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, Jeffrey S Lundgren can be reached at 571-272-5541. 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.
BRANDON J. FETTEROLF, PHD
Primary Patent Examiner
Art Unit 1626
/BRANDON J FETTEROLF/Primary Examiner, Art Unit 1626
Prosecution Insights