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 compound III-2 in the reply filed on 2026 May 26 is acknowledged. Due to no prior against the elected species, a search against the entirety of claim 1 has been done. Claims 1-10 and 12-18 are examined on the merits.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 2021 October 1 and 2026 May 26 were submitted in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are considered by the examiner.
Claim Objections
Claims 2-6 are objected to because of the following informalities:
in claim 2, the phrase “a mixture of enantiomer” should say –-a mixture of enantiomers—to be consistent with claim 1;
in claim 3, the language “wherein the unsubstituted bicyclic residues can be substituted…as defined in claim 1” is extraneous because the recited variables are assumed to have the same definitions as the parent claim 1 unless they represent a different scope in claim 3;
in claim 4, the language “wherein the unsubstituted bicyclic residues can be substituted…as defined in claim 1” is extraneous because the recited variables are assumed to have the same definitions as the parent claim 1 unless they represent a different scope in claim 4;
in claim 5, the language “substituted by one more of … have the same meanings as defined in claim 1” is extraneous because the recited variables are assumed to have the same definitions as the parent claim 1 unless they represent a different scope in claim 5;
in claim 6, the language “and R2 … have the same meanings as defined in claim 1” is extraneous because the recited variables are assumed to have the same definitions as the parent claim 1 unless they represent a different scope in claim 6;
in claim 15, the language “wherein L, R2, …as defined in claim 1” (see steps 4c, 4d. 4e) is extraneous because the recited variables are assumed to have the same definitions as the parent claim 1 unless they represent a different scope in claim 6
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 12-14 and 18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification is enabling for treatment of alleviation of Alzheimer’s disease, Huntington’s Disease, celiac disease, cataracts, kidney fibrosis, liver fibrosis, pulmonary fibrosis, and atherosclerosis with a compound of formula (I) and non-enabling for the treatment or prevention of the scope of disorders recited in claims 12-14 and 18 with a compound of formula (I). The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
The factors to be considered in determining whether a disclosure meets the enablement requirements of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir., 1988). The court in Wands states, “Enablement is not precluded by the necessity for some experimentation, such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is ‘undue’, not ‘experimentation’” (Wands, 8 USPQ2sd 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. “Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations” (Wands, 8 USPQ2d 1404). Among these factors are: (1) the nature of the invention; (2) the breadth of the claims; (3) the state of the prior art; (4) the predictability or unpredictability of the art; (5) the relative skill of those in the art; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
Consideration of the relevant factors sufficient to establish a prima facie case for lack of enablement is set forth herein below:
The nature of the invention and (2) the breadth of the claims:
The claims are drawn to a method of treating or preventing a disease with a compound of formula (I). Thus, the claims taken together with the specification imply that a compound of formula (I) can treat or prevent a disease recited in claims 12-14 and 18 .
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The state of the prior art and (4) the predictability or unpredictability of the art:
WODZINSKA (Mini-Reviews, 2025, 5, 279-292, cited in IDS) describes the following ideas: transglutaminase is linked to the alleviation of Alzheimer’s disease, Huntington’s Disease, celiac disease, cataracts, kidney fibrosis, liver fibrosis, pulmonary fibrosis, and atherosclerosis (page 283, column 2, paragraph 3 to page 285, column 1, paragraph 4); and more research is needed to understand the relationship of transglutaminases to diseases (page 289, section 6).
Breast cancer cannot be prevented, only the chances of getting can be reduced (Breast Cancer Prevention, http://www.mayoclinic.com/health/breast-cancer-prevention/WO00091, 2012 December 12, accessed 2013 August 28).
PULLEY (US 7067507, issued 2006 June 27) describes that Alzheimer’s disease cannot be prevented (column 2, line 40-45).
TYE-DIN (Frontiers in Pediatrics, 2018, pages 1-19) describes that celiac disease prevention requires more research (page 11, “Conclusions and Future Perspectives” section).
TURCIOS (Liver, Pancreas, and Biliary Tract: Clinical Review, 2005, 39(4), 307-317) describes that cystic fibrosis is an inherited disorder and thus cannot be prevented.
The relative skill of those in the art:
While the artisan generally would have an advanced degree in [area of claims], their high level of skill and knowledge is insufficient to overcome the lack of understanding as to how [disease] functions in the body or to overcome the art recognition that this disease is poorly understood and treatments have generally failed.
The amount of direction or guidance presented and the presence or absence of working examples:
The specification has provided guidance for treatment of alleviation of Alzheimer’s disease, Huntington’s Disease, celiac disease, cataracts, kidney fibrosis, liver fibrosis, pulmonary fibrosis, and atherosclerosis with a compound of formula (I).
The specification does not provide guidance for treatment or prevention of the scope of disorders recited in claims 12-14 and 18 with a compound of formula (I).
The quantity of experimentation necessary:
Considering the state of the art as discussed by the references above, particularly with regards to treatment or prevention of the scope of disorders recited in claims 12-14 and 18 with a compound of formula (I) and the high unpredictability in the art as evidenced therein, and the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to practice the invention commensurate in the scope of the claims.
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.
Claim 15 is 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 claim 15 , the phrase "carboxylic acid (R2-CO2H)” is interpreted as “such as” language because the carboxylic acid represent the broader concept of a carboxylic and the text R2-CO2H” represent on example of a carboxylic acid. This language renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. Is a compound of formulae 7c, 7d., or 7e reacting a carboxylic acid generically or a carboxylic acid of formula R2-CO2H? One way to fix this issue is to amend the language “´to --R2-CO2H--. See MPEP § 2173.05(d).
Conclusion
Claims 1, 7-10, 16, and 17 are allowed. Claims 2-6, 12-15, and 18 are not allowable
The following is a statement of reasons for the indication of allowable subject matter: CAMPBELL (WO 2020033784, 2020 February 18, cited in IDS) describes compound 1 (page 188). This compound does not anticipate or render obvious a compound of formula (I) because examined variable R3 cannot be a heteroaryl group.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to NOBLE E JARRELL whose telephone number is (571)272-9077. The examiner can normally be reached 9:00 AM to 5:00 PM.
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/NOBLE E JARRELL/Primary Examiner, Art Unit 1699
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