DETAILED ACTION
Claims 1-10 are currently pending in the instant application. Claims 1-10 are rejected. Claims 1 and 6 are objected.
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 in the reply filed on 21 January 2026 is acknowledged.
Specification
The disclosure is objected to because of the following informalities: the scheme on page 1 of the specification is in a font that is too small to be legible.
Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 does not end in a period. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: the phrase “adding ethyl acetate and water are added in a weight amount” should be written as either “adding ethyl acetate and water in a weight amount” or “ethyl acetate and water are added in a weight amount.” 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.
Claim 1 and its dependent claims 2-10 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. Specifically, the substituent “Act” on the formula of the active ester X compound is not defined in the claim which renders the claim indefinite as it is unclear what “Act” is.
Claim 1 and its dependent claims 2-10 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. Step b) states that an “active ester X” further reacts, however, the scheme provided has “x” reacted. Additionally, the scheme also has “x acid” and defines “x” as 0.5-3. It is unclear what “x” is being reacted with the formula IV and how both “x” can be defined as a number. Additionally, step b) states that the active ester X further reacts with organic acid salt IV, but the scheme provided just provides x acid, not specifying that the acid is an organic acid. It is therefore unclear if step b) utilizes any acid of formula IV as in the provided scheme or only uses an organic acid of formula IV.
Claims 1 and dependent claims 3-6 and 10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted steps are: how to arrive at (S)-2-(3S,8S)-3-(4-(3,4-dichlorobenzyloxy)phenyl-7-((S)-1-phenylpropyl)-2,3,6,7,8,9-hexahydro-[1,4]-dioxino[2,3-g]isoqinolin-8-ylformylamino)-3-(4-(2,3-dimethylpyridin-4-yl)phenyl)propionic acid free base from the formula II. It is suggested that claim 2 be added to claim 1 and claim 2 be canceled.
Claims 4, 5, and 7 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 4, 5, and 7 the phrases which have “preferably” found in multiple instances of each claim renders the claims indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 4 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. Claim 4 states that in step a) compound III is first reacted with a condensation agent to give an active ester, however, there is only one step in parent claim 1 and there is also no second step provided in claim 4 or a “then” statement. It is therefore unclear what is after the “first” in step a).
Claims 4 and 7 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. Claims 4 and 7 recite the limitation “the reaction solvent” in step a). There is insufficient antecedent basis for this limitation in the claim as there is no “a reaction solvent” in claim 4 or 7 or parent claim 1. Additionally, claim 7 refers to “the solvent” in step b), however, there is no “a solvent” in step b) of claim 1 and there are multiple “solvents” in claim 7, such as “the reaction solvent” and “a mixed solvent”, so it is unclear what “solvent” weight amount is being limited.
Claims 6 and 9 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. Claims 6 and 9 recite the limitation “the workup mode of step” There is insufficient antecedent basis for this limitation in the claim as there is no “work up mode” in claims 6, 9 or parent claim 1 to refer to “the workup mode”.
Claims 6 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. Specifically, claim 6 states that the “yield being recorded as 100%.” This statement renders the claim indefinite as it is unclear if the yield is 100%, or if the yield is just being recorded as 100%. It is suggested that claim 6 be amended to stated that the yield is 100%. Additionally, it is unclear what the yield is of. It is unclear if the yield is of the organic layer or of the compound III or of a different compound such as the active ester X. Claim 6 is also indefinite as it is unclear how “after the completion of reaction” in step a) anything can be added in a weight amount times to that of compound III as compound III is utilized in the start of the reaction of step a) and after completion you would have the active ester X.
Claim 8 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. Specifically, claim 8 states that the neutralization occurs with an acidic aqueous solution and then defines “wherein the acid”. As claim 8 refers to step b), which it is noted does not contain a neutralization reaction, it is unclear what “acid” is being limited. It is unclear if the acid in the acidic aqueous solution is being limited, or the acid in the organic acid salt IV of step b).
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.
Claim 3 is 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 defines the organic acid salt IV as being selected from “oxalate, citrate, L-tartrate…etc.” However, the organic salt IV in claim 1 from which claim 3 depends is:
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, of which the listed salts in claim 3 do not fall within. It appears that applicant is intending to define the variable “acid” of the “x acid” or the “organic acid” of the “organic acid salt IV”. 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.
Claim 4 is 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 4 defines the active ester X as:
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, however, the active ester X in claim 1 from which claim 4 depends is
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, of which the formula provided in claim 4 do not fall within. It appears that applicant is intending to define the variable “Act.” 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.
Claim 5 is 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 5 states that “in step a)” “after the addition of organic acid salt IV”. However, the addition of organic acid salt IV occurs in step b). Claim 5 additionally states “wherein organic acid salt IV” is “fed” in step a), which again, the addition of organic acid salt IV occurs in step b). Lastly claim 5 states that “the organic acid salt IV is a salt formed from…” in step a), however, the organic acid salt IV does not get added until step b). 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.
Claims 7, 8 and 9 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. Specifically, claims 7, 8 and 9 state that “in step b)” and refer to “the hydrolysis,” “compound II,” “reaction solvent,” “neutralized,” and “after the neutralization” However, there is no hydrolysis in step b) as the hydrolysis step is in step c). Compound II is prepared in step b), but reacted in step c). There is also no “solvent” in step b). Neutralization happens in step c) not in step b) 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.
Conclusion
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/REBECCA L ANDERSON/Primary Examiner, Art Unit 1626 ____________________ 22 June 2026
Rebecca Anderson
Primary Examiner
Art Unit 1626, Group 1620
Technology Center 1600
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