DETAILED ACTION
Claims 1-10 are currently pending. Claims 1-10 are objected and rejected.
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 .
Drawings
The drawings are objected to because the text of the Figures is too small a font and illegible. See Fig. 3, Figure 6, and Figure 9: which have font too small, for example from Figure 3:
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and Figure 4, Figure 7, and Figure 10 which have illegible font, for example in Figure 4:
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. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The abstract of the disclosure is objected to because the abstract should not include the word “novel.” A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b) the abstract should not refer to purported merits or speculative applications of the invention.
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. The word “Novel” should not appear in the title, see MPEP 606.
The following title is suggested: Crystal Forms of Peptide Boric Acid Compound and Preparation Methods Therefor.
The disclosure is objected to because of the following informalities: It appears there may be a naming error and/or structural depiction error. The specification provides:
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The disclosure is objected to as the compound of CN112384519 is the compound V-9A:
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which differs from the structure in the instant specification. Additionally, as seen in Meng LEI et al. (cite no. 3 NPL of IDS filed 5/8/2024) the compound 8t (table 1) is:
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which is named:
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on page 690, which name differs from that of the instant specification by c instead of an l as in the instant specification
Appropriate correction or clarification is required.
Claim Objections
Claims 1-6 and 8-10 are objected to because of the following informalities: The spacing in the chemical names in the claims is incorrect and in excess. For example, see claim 1:
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. This spacing issue is found throughout all pending claims. Appropriate correction is required.
Claims 2 and 8 are objected to because of the following informalities: step (3) has “a eutectic”. which should be “an eutectic.” Appropriate correction is required.
Claim 7 is objected to as there should be an “a” between (b) and (c) for proper Markush language. 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.
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. Specifically, the claims are drawn to products of crystal forms A, B, and D of N-((R)-1-(((R)-1-(1,3,6,2-dioxazaborolan-2- yl)-3 -methylbutyl)amino)-3-(methylthio)- l-oxoprop-2-yl)-2,5-dichlorobenzamide and processes of preparation. It is unclear what compound is being claimed as pages 1 and 2 of the specification provide
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However, the compound of CN112384519 is the compound V-9A:
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which differs from the structure in the instant specification. Additionally, as seen in Meng LEI et al. (cite no. 3 NPL of IDS filed 5/8/2024) the compound 8t (table 1), which is the same compound as compound V-9A in CN112384519, is:
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which is named:
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on page 690, which name differs from that of the instant specification by c instead of an l as in the instant specification. It is therefore unclear exactly what compound is being claimed in crystalline form.
Claims 2, 4, and 6 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 claims 2, 4, and 6 are drawn to crystal forms wherein the crystal form is prepared “mainly by the following steps.” This phrase renders the claims indefinite as it is unclear what other steps can be utilized in the preparation either in addition to, or in replacement of the steps found in the pending claims. “Mainly” can be defined, for example, as for the most part, usually or to a large degree, which does not exclude other unknown preparation steps used in addition to or unknown steps in replacement of the stated steps.
Claims 4 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. Specifically, claims 4 and 9 step (2) state adding “a proper amount” of a solvent IV. The use of “a proper amount” in the claims does not particularly point out or distinctly claim what amount of solvent IV is required. There is no definition provided in the specification to determine what “a proper amount” of solvent IV would be or how to determine what amount would be considered “proper.”
Claim 7 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. Claims must, under modern claim practice, stand alone to define an invention, and incorporation into claims by express reference to the specification is not permitted. Ex parte Fressola, 27 USPQ 2d 1608 (1993). Instant claim 7 is drawn to a pharmaceutical composition comprising the crystal form A, the crystal form B, the crystal form D, or combinations thereof, however, to know what crystal form A, crystal form B, or crystal form D is, one must refer to the specification which has varying information provided form crystal form A, B, and D. For example, page 2 provides characteristic peaks in the X-ray diffraction pattern for form A, but Figure 2 shows the x-ray powder diffraction pattern. Referring back to the specification to determine what is claimed in claim 7 makes it unclear if certain characteristic peaks are required or if the entire x-ray powder diffraction pattern is required for the crystal form in the composition.
Claims 1-6 and 8-10 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. The claims recite multiple instances which have insufficient antecedent bases for the limitations in the claims. For Claims 1, 3, 4, 5, 6, 9, and 10: the claims recites “the X-ray powder diffraction” and “the measurement error” when referring back to the crystalline form, however there is no “a X-ray powder diffraction” or “a measurement error”. It is suggested that the claims 1, 3, and 5 be rewritten as “A crystal form …with X-ray powder diffraction pattern characteristic peaks at the following diffraction angles… with a measurement error…” For claims, 4, 6, 9, and 10, these claims also refer back to “the crystal form A”, however, there is no “a crystal form A” in the claims from which they depend or in themselves. It is suggested that these claims read “dissolving crystal form A…with X-ray powder diffraction patter characteristic peaks at the following diffraction angles…with a measurement error…”it is suggested as “…the crystal fort For instant claim 2, step (2) refers to “the solution obtained in step (1)”, however, step (1) does not state it prepares a solution. Claim 2 also has an organic solvent I and organic solvent II, but then refers back only to “the solvent I or II”. It is suggested that “the solvent I or II” is amended to “the organic solvent I or II”. Instant claim 4 refers multiple times to “the solvent III” and “the mixture”, however, there is an “organic solvent III” and no “a mixture”. It is suggested that “the solvent III” be amended to “the organic solvent III” and “the mixture” is amended to “mixtures.” Claim 4 also refers to “the raw material crystal form A”, however, there is only “crystal form A” there is no “a raw material.” Instant claim 6 refers multiple times to “the solvent V” and “the mixture”, however, there is an “organic solvent V” and no “a mixture”. It is suggested that “the solvent V” be amended to “the organic solvent V” and “the mixture” is amended to “mixtures.” Claim 6 also refers to “the raw material crystal form A”, however, there is only “crystal form A” there is no “a raw material.” Instant claim 8 refers to “the solution obtained in step (1)”, however, step (1) does not state it prepares a solution. Claim 8 also refers to “the solvent I or II”, however, claim 8 has “organic solvent I” and “organic solvent II.” Instant claim 9 refers to “the solution obtained in step (1)”, however, step (1) does not state it prepares a solution. Claim 9 also refers to “solvent III”, however, claim 9 has “organic solvent III.” Claim 9 also refers to “the mixture”, however, there is no “a mixture”. It is suggested that “the mixture” is amended to “mixtures.” Claim 9 also refers to “the raw material crystal form A”, however, there is only “crystal form A” there is no “a raw material.” Instant claim 10 refers to “solvent V”, however, claim 10 has “organic solvent V.” Claim 10 also refers to “the mixture”, however, there is no “a mixture”. It is suggested that “the mixture” is amended to “mixtures.” Claim 10 also refers to “the raw material crystal form A”, however, there is only “crystal form A” there is no “a raw material.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA L ANDERSON whose telephone number is (571)272-0696. The examiner can normally be reached Monday-Friday from 6am-2pm.
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/REBECCA L ANDERSON/Primary Examiner, Art Unit 1626 ____________________ 18 August 2026
Rebecca Anderson
Primary Examiner
Art Unit 1626, Group 1620
Technology Center 1600
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