NEW CRYSTAL FORM OF COMPOUND, AND PREPARATION METHOD THEREFOR AND USE THEREOF

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 with traverse of Group I, claims 1-4 and 8, drawn to the crystalline form A of the compound of formula (I) and a pharmaceutical composition comprising thereof; and the crystalline form A of the compound of formula (I) having specific characteristic peaks in claim 1 as the elected species of crystalline form A, in the reply filed on July 17, 2026 is acknowledged. The traversal is on the ground(s) that Group I-V satisfy the unity of invention requirement under 37 CFR 1.475(a) and PCT Rule 13.1. Specifically, applicant argues even though the prior art, i.e., Shen et al. (CN 110483514 A) cited in the restriction requirement, disclosed the compound of formula (I), said prior art fails to disclose the specific crystalline forms A and Q of compound of formula (I) of the present application; therefore, it fails to teach the technical feature shared between the groups of inventions. Applicant further argues that the concurrent examination of Groups I-V does not create a serious search burden. This is not found persuasive, because the serious search burden applicant relies upon is not part of the restriction requirement for PCT application; Rather, the restriction requirements under PCT Rule 13.1 use the “unity of invention” to evaluate whether the groups of invention and the groups of species share the same or corresponding technical feature. As noted in the previous Office Action, the groups of inventions, i.e., Group I-V, only share the technical feature of the compound of formula (I) in common. In other words, the group of invention drawn to different polymorphism, i.e., crystalline form A and crystalline form Q, only share the same chemical formula (i.e., “the compound of formula (I)”) but does not share the same spatial arrangement of the atoms in the crystal lattice. Thus, the characteristics peaks positively recited in different groups of invention is not a common technical feature share between the groups of inventions. The fact that Shen et al. teaches the compound of formula (I), the common feature of compound of formula (I) shared between the groups of invention is, in fact, lacking novelty. The requirement is still deemed proper and is therefore made FINAL. Claims 5-7, 9-10 and 17-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on July 17, 2026. Priority The instant application 18/713,607 filed on May 24, 2024 is a 371 of PCT/CN2022/133494 filed on November 22, 2022, which claims priority to, and the benefits of Foreign Application No. PCT/CN2021/133228 filed on November 25, 2021. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Information Disclosure Statement The information disclosure statements (IDS) submitted on 5/24/2024, 6/27/2026 and 9/29/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner. Please note that foreign references without an English translation but have an English translation of the abstract will only have the abstract considered by the Examiner. The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered. Status of Claims Acknowledgement is made of the receipt and entry of the amendment to the claims filed on July 17, 2026, wherein claims 1-10 and 17-26 are unchanged; and claims 11-16 are cancelled. Claims 1-10 and 17-26 are pending. Claims 5-7, 9-10 and 17-26 are withdrawn. Claims 1-4 and 8 are under examination in accordance with the elected species. Specification According to MPEP § 606 with respect to the Title of Invention, the term “New” should not be included at the beginning of the title of the invention and will be deleted when the Office enters the title into the Office’s computer records, and when any patent issues. Once the determination of the novelty of a claimed invention has been established and the disclosure of the invention made public and/or patented, the claimed invention is no longer novel or new, since the scope of the invention no longer embraces what is considered “new”. Thus, the incorporation of the term “new” into the title of the Invention is not appropriate. The following title is suggested: “CRYSTAL FORM OF COMPOUND, AND PREPARATION METHOD THEREFOR AND USE THEREOF” The disclosure is objected to because of the following informalities: the specification repeatedly recites the term “new” to describe the inventions, for instance, “new crystalline form” (see e.g., page 1, first paragraph) and “new crystal form” (see e.g., page 36, line 14). The term “new” should be deleted from the language of the disclosure. Once the determination of the novelty of a claimed invention has been established and the disclosure of the invention made public and/or patented, the claimed invention is no longer new, since the scope of the invention no longer embraces what is considered “new”. Thus, the incorporation of the term “new” into the language of the specification to describe the invention is not appropriate. Appropriate correction is required. Drawings The drawings are objected to because of the following informalities: Figure 17: the symbol for “cycle 1 absorption” and “cycle 2 absorption” groups appear to be small and indistinguishable in the figure, because they all look like a dot. It is not clear if this PNG media_image1.png 28 20 media_image1.png Greyscale is supposed to be cycle 1 or cycle 2? Figure 21-25: each of these drawings use the same color (black) and symbol to label more than one different group; and without distinctive labeling for each group, it is not clear what they represent. For example, Figure 21 uses circle PNG media_image2.png 16 26 media_image2.png Greyscale to label “blank control group” and “Crystal form A 10 mg/kg”; and uses square PNG media_image3.png 18 23 media_image3.png Greyscale to label “negative control group” and “crystal form A 30 mg/kg”. Thus, it is not clear which circle in said figure is supposed to be the blank control or 10mg/kg of crystal form A; same logic also applies to other symbols. Additionally, the symbol for some groups appears to be small and indistinguishable in each of these figures. For example, PNG media_image4.png 19 182 media_image4.png Greyscale and PNG media_image5.png 20 161 media_image5.png Greyscale both look like a dot in the line graph shown below (see e.g., Figure 22): PNG media_image6.png 430 125 media_image6.png Greyscale , and it is not clear which these are. 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. Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification: The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee. Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2). Claim Objections Claims 1-4 are objected to because of the following informalities: Regarding claims 1-2, “wherein the X-ray powder diffraction pattern comprises characteristic peaks at 2θ” should read –, wherein the crystalline form A is characterized by having an X-ray powder diffraction pattern comprising characteristic peaks at 2θ--, so it is clear that the X-ray powder diffraction pattern (XRPD) recited therein is a characterization of crystalline form A. Regarding claims 3-4, the recitation of “wherein the X-ray powder diffraction pattern is substantially as shown” should read –wherein the crystalline form A is characterized by having an X-ray powder diffraction pattern substantially as shown--, so it is clear that the X-ray powder diffraction pattern (XRPD) recited therein is a characterization of crystalline form A. 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. Claim 8 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling to the extent that the claims encompass solid pharmaceutical compositions comprising a specifically disclosed crystalline Form A of the compound of formula (I) and pharmaceutically acceptable carriers, diluents or excipients under formulation and processing conditions that do not materially alter the disclosed crystalline form, does not reasonably provide enablement for full scope of the claims. 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 use the invention commensurate in scope with these claims. In the present case, claim 8 is directed to pharmaceutical composition comprising an effective therapeutic amount of the crystalline form A of claim 1, and pharmaceutically acceptable carriers, diluent or excipients. Claim 1, from which claim 8 ultimately derives its crystalline-form limitation, recites 8 characteristic peaks in the X-ray powder diffraction pattern. The specification demonstrates the compound of formula (I) is capable of existing in multiple solid-state crystal forms and that the solid-state crystal form obtained is dependent upon the conditions under which the compound of formula (I) is processed. For example, the specification identifies crystalline Forms A, H, S, O, P, Q and M and further describes certain crystalline forms are obtained by combining the crystal Form A with solvent, such as acetonitrile (ACN) or methanol (MeOH), at room temperatures (see e.g., page 17, Example 4 and Example 7). Thus, Applicant’s own disclosure establishes that the solid-state crystal form of compound of formula (I) is sensitive to its physicochemical environment and the solvent they combine with to arrive at a composition. The specification provides general disclosure concerning pharmaceutical compositions and identifies numerous pharmaceutically acceptable carriers, diluents and excipients, and conventional dosage forms (see e.g., page 10, last line to page 11, line 20). The specification also provides the range of therapeutically effective amount and administration teachings of crystalline form A on page 9, line 16-19 and line 23-24. However, these teachings do not provide representative experimental pharmaceutical formulations demonstrating that the claimed crystalline form A is maintained when combined across the full scope of pharmaceutically acceptable carriers, diluents and excipients encompassed by claim 9. The concern is supported by the state of the pharmaceutical solid-state art. Sood et al. (Ther Deliv, 2015. Vol. 6(6): 721-740) teaches that excipients and formulation variables are used to modify stability and physiochemical properties of dosage forms and importantly, that excipients may influence the crystal structure of solid and may modify the rate and direction of crystal growth. Thus, the effect of incorporating a crystalline active pharmaceutical ingredient into a formulation is not necessarily neutral. Sood et al. further teaches that crystal habit may influence pharmacokinetic properties of a dosage form (see e.g., abstract). Censi et al. (Molecules 2015, 20, 18759-18776) similarly teaches that crystalline polymorphs having the same chemical composition possess different internal crystal structures and, consequently, can possess different physiochemical properties because of their different lattice structures and/or molecular conformations (see e.g., p. 18761, last paragraph). Censi et al. further teaches that polymorphic forms may differ in properties including melting point, density, stability, and solubility, and that particular excipients and technological processes may promote solid-state transitions. Censi et al. additionally explains that solid-state transformation must be monitored during formulation, manufacture and storage to ensure reproducible pharmaceutical performance (see e.g., p. 18762-18763). The teachings of Sood et al. and Censi et al. are relied upon not to establish that every pharmaceutically acceptable carrier, diluent and excipient necessarily converts the claimed crystalline form A into a different crystalline form. Rather, these teachings are used as evidence that the effect of pharmaceutically acceptable carriers, diluents and excipients and formulation condition upon crystalline form cannot reasonably be presumed to be invariant across the broad scope encompassed by the claim. Accordingly, while the specification enables preparation and characterization of crystalline form A of the compound of Formula (I) and generally teaches that those materials may be formulated into pharmaceutical compositions, the disclosure does not provide sufficient representative examples, formulation-specific solid-state characterization, or a general applicable technical principle by which a person of ordinary skill could determine, without undue experimentation, which of the numerous carriers, diluents and excipients, concentrations, processing conditions, and dosage forms would preserve the requisite crystalline material throughout preparation of the claimed pharmaceutical composition. I. Legal Standard The enablement requirement of 35 U.S.C. 112(a) requires the specification to teach a person of ordinary skill in the art how to make and use the claimed invention without undue experimentation. Attention is directed to In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors: (1) the nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and, (8) the quantity of experimentation necessary. No single factor is dispositive, and the factors must be weighed together. MPEP 2164.01(a). All of the Wands factors have been considered and discussed below: Factor 1: Breadth of the claims In the present case, claim 9 is drawn to a broad genus of pharmaceutical composition. Said claim is not restricted to a particular carrier, diluent or excipient; nor restricted to a particular class of carriers/diluents/excipients, amount of carriers/diluents/excipients, dosage form, manufacturing process, or formulation condition. It therefore encompasses pharmaceutical composition employing essentially any pharmaceutically acceptable carriers, diluents or excipients compatible with the claim language. The breadth of possible combination of carriers/diluents/excipients, amount of carriers/diluents/excipients, and processing conditions is therefore substantial. Factor 2: Nature of the invention The claimed subject matter concerns pharmaceutical compositions containing the crystalline form A of the compound of formula (I) as active pharmaceutically active ingredient. Applicant’s own specification establishes that the crystalline form A of the compound of formula (I), characterized by having particular characteristics peaks in the X-ray powder diffraction pattern (see e.g., Table 1 and Figure 2), is prepared using a particular processing method (see e.g., Example 2-3). The specification further established said crystalline form A when combined with solvent, such as acetonitrile (ACN) or methanol (MeOH), at room temperatures can arrive at different crystalline forms of the compound of formula (I) (see e.g., page 17, Example 4 and Example 7), and that includes crystalline form H with different X-ray powder diffraction pattern (see e.g., p. 4-5). Therefore, the nature of the invention is not merely mixing an invariant molecular species with an inert carriers, diluents or excipients, but depends upon the preservation of the crystalline material within a pharmaceutical composition concerns solid-state interactions and formulation conditions. Factor 3: State of the prior art The state of the art establishes that polymorphism and solid-state transformation are recognized concerns in pharmaceutical development. Sood et al. (Ther Deliv, 2015. Vol. 6(6): 721-740) teaches that excipients and formulation variables can influence crystal structure and crystal growth. Censi et al. (Molecules 2015, 20, 18759-18776) teaches chemical composition of crystalline polymorphs possess different physiochemical properties, and the excipients and technological processes can influence solid-state transitions. Accordingly, the state of the art establishes that formulation components cannot universally be presumed to have no effect upon the crystalline state of an active pharmaceutical ingredient. Factor 4: Level of ordinary skill A person of ordinary skill in the art would have possessed substantial knowledge concerning pharmaceutical formulation, polymorphism, crystallization, and conventional analytical techniques such as XRPD and DSC. This factor weighs in Applicant’s favor to the extent that the skilled artisan would have known how to formulate and characterize individual compositions. However, a high level of skill does not provide a predictive teaching identifying which members of the broad universe of pharmaceutically acceptable carriers, diluents or excipients encompassed by the claim will preserve a particular crystalline lattice under the numerous processing and storage conditions encompassed by the claims. Rather, the skilled artisan’s knowledge provides the means for experimentally determining the resulting solid-state. Factor 5: Predictability or unpredictability of the art Although persons of ordinary skill possessed conventional methods for preparing pharmaceutical formulations and characterizing solid-state forms, the evidence does not establish that the effect of the broad range of carriers/diluents/excipients, carriers/diluents/excipients concentrations, processing conditions, and dosage forms encompassed by the claim on the crystalline state of crystalline Form A of compound of formula (I) could reliably extrapolated across the full scope of the claims. Applicant’s own specification demonstrates that the other crystalline forms can be prepared by combining the claimed crystalline Form A of compound of formula (I) with a solvent, e.g., ACN, under room temperatures. Thus, the specification itself demonstrates that the excipient(s) and processing conditions can change the solid-state form of the compound of formula (I). In view of Sood’s teachings that excipients may influence crystal structure and crystal growth behavior and Censi’s teachings that formulation components and technological processes may facilitate solid-state transitions, even though individual formulations could be prepared and evaluated using routine techniques, the specification does not provide a generally applicable predictive principle permitting the skilled artisan to identify operative embodiments throughout the full breadth claimed without the need for substantial empirical formulation and solid-state characterization. Factor 6: Amount of guidance or direction provided in the specification The specification provides substantial general guidance regarding pharmaceutical dosage forms, routes of administration, ranges of therapeutically effective amount, and pharmaceutically acceptable carriers, diluents or excipients. However, the specification does not provide corresponding guidance identifying which carriers/diluents/excipients or classes thereof preserve the claimed crystalline material; which carriers/diluents/excipients or processing condition induce conversion to another polymorph, solvate, hydrate or amorphous material; permissible concentrations of the respective carriers/diluents/excipients for preservation of the crystalline state; or a general predictive relationship between carriers/diluents/excipients identity and maintenance of the claimed crystalline lattice. Therefore, while the specification teaches the skilled artisan numerous materials that may be selected, it does not provide sufficient direction concerning which selections will produce pharmaceutical compositions retaining the crystalline subject matter required by the claims. Factor 7: Existence of working examples The specification contains working examples concerning preparation and solid-state characterization of particular forms of the compound of formula (I). Those examples establish enablement of at least those particular crystalline materials and closely corresponding embodiments. Although the pharmacological efficacy experiment (see Example A) and pharmacodynamic experiment (see Example B) disclosed oral formulations that was prepared by adding crystalline form A to methylcellulose and sterile deionized water and then shake with ultrasound until fully dissolved (see. e.g., Table 7); However, after preparing said formulation, these experiments do not confirm whether the crystalline state of crystalline form A is still retained in the solution. Thus, no representative working pharmaceutical-composition examples have been identified demonstrating retention of the claimed crystalline material across the broad range of carriers/diluents/excipients and dosage forms. The rejection therefore does not take the position that Applicant has enabled no embodiment. Rather, the concern is that the demonstrated embodiments and general formulation disclosure are not reasonably commensurate with the substantially broader claimed scope. Factor 8: Quantity of experimentation necessary. To practice the full scope of claim 8 while ensuring that the composition contains the required crystalline form A, a person of ordinary skill would have to select among the numerous encompassed carriers/diluents/excipients, carriers/diluents/excipients concentrations, formulation processes and prepare the respective compositions; and determine experimentally whether the crystalline state of crystalline form A is retained or transformed. Such determination would reasonably require solid-state characterization, e.g., XRPD, DSC, and/or other appropriate analytical testing across materially different formulations and processing conditions. While each individual characterization technique may have been conventional, the issue is not whether XPRD and DSC was difficult to perform. Rather, the issue is the extent of empirical formulation and characterization required to identify operative embodiments throughout the broad scope of claim 8 in the absence of a disclosed predictive principle identifying which formulation conditions preserve the claimed crystalline state. The necessity to proceed through the claimed scope by formulation, testing and solid-state characterization weighs toward undue experimentation. Conclusion Upon consideration of Wand factors as a whole, the breadth of claim 8, the polymorphic nature of crystalline form A of the compound of formula (I) demonstrated by Applicant’s own specification, the recognized ability of carriers/diluents/excipients and formulation variables to influence crystal structure and solid-state transitions, the absence of representative pharmaceutical-composition examples reasonably commensurate with the breadth claimed, and the quantity of empirical formulation and the solid-state characterization required to establish that the specification does not enable the full scope of clam 8 without undue experimentation. The Examiner acknowledged that the specification enables preparation of the specifically disclosed crystalline forms of the compound of formula (I) and provides sufficient general teachings to prepare at least certain pharmaceutical compositions containing such crystalline material. The rejection is therefore not based upon an assertion that the pharmaceutic compositions containing the compound of formula (I) cannot be made. Rather, the rejection is directed to the substantial broader scope of claim 8, which encompass the claimed crystalline form A in combination with broadly unrestricted pharmaceutical acceptable carriers/diluents/excipients, without disclosure reasonably enabling preservation and use of the claimed crystalline state throughout that scope without undue experimentation. 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 2-4 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 claim 2-4, each of these claims is indefinite because it is unclear whether the recited X-ray powder diffraction further characterizes the same crystalline Form A recited in claim 1 or defines a distinct crystalline solid-state form the nevertheless possesses the characteristic peaks required by claim 1. In the present case, claim 1 defined crystalline Form A by an X-ray diffraction pattern comprising characteristic peaks at 2θ angles at 8.6o ±0.2o, 9.8o ±0.2o, 10.7o±0.2o, 11.2o±0.2o, 12.3o±0.2o, 12.9o±0.2o, 16.0o ±0.2o, and 19.0 o±0.2o. Claim 2, while referring to “the crystalline Form A of claim 1,” separately recites an X-ray powder diffraction pattern comprising the foregoing peaks together with peaks at 17.0o±0.2o, 17.4o±0.2o, 17.8o ±0.2o, 19.9o±0.2o, and 21.2o±0.21o. Although the specification describes embodiments of crystalline Form A using these different sets of characteristic peaks, limitations or relationships disclosed only in the specification may not be imported into the claims. The language of claim 2 does not expressly state the additionally recited peaks are “additional,” peaks of or “further characterize,” the same crystalline Form A defined in claim 1. Accordingly, it is unclear from the claim language whether claim 2 merely provides additional characterization of the Form A of claim 1 or whether the additionally recited diffraction characteristics define a different solid-state form falling within the broader diffraction limitations of claim 1. Thus, the metes and bounds of the crystalline subject matter encompassed by claim 2 cannot be determined with reasonably certainty. Same logic is applicable to instant claims 3-4, which also comprising the peaks set forth in claim 1 together with additional peaks in Table 1 or Figure 2. Regarding claim 3, The claim is direct to Table 1 of the specification. According to MPEP 2173.05(s), “[w]here possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table ‘is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience.’ Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted)”. In this case, applicant fails to particularly points out what is the X-ray powder diffraction pattern recites in Table 1. In addition, the term “substantially” renders the claim indefinite, because the specification provides special definition to includes “measurement error of the diffraction angle of the X-ray powder diffraction pattern that is 5% or less, typically ±0.2° difference from the given value is considered appropriate”(see page 10, line 3-15 of the specification). However, when the term “substantially” is used in the phrase of “substantially as shown in Table 1” in claim 3, which contains interplanar spacings and relative intensities in addition to the diffraction angles 2θ, is not clear if said term is referring to the (i) number of peaks present in the X-ray powder diffraction pattern or (ii) the position of each peak in the X-ray powder diffraction pattern. The lack of clarity renders the claim indefinite, because one of ordinary skill in the art cannot determine what is considered substantial or non-substantial with reasonable certainty. 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 3-4 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. Regarding claim 3-4, the claimed term “substantially”, when given its broadest reasonable interpretation in view of the definition set forth in page 10, line 3-15 of the specification to include “measurement error of the diffraction angle of the X-ray powder diffraction pattern that is 5% or less”. To the extent that said term is incorporating measurement error for the position of each peak in the X-ray powder diffraction pattern, then the diffraction angle 2θ recited therein (Table 1 in claim 3 or Figure 2 in claim 4) fails to further limit the X-ray powder diffraction pattern set forth in claim 1. For instance, incorporating the 5% measurement error to the diffraction angle 2θ at 8.6° recited in Table 1 or illustrated in Figure 2, which when calculated by 8.6 + 8.6   × 0.05 = 9.03 8.6 - 8.6   × 0.05 = 8.17 , gives a range of 8.17° to 9.03°; and that is broader than 8.6°±0.2° (that is 8.4° to 8.8°) as claimed in claim 1. Therefore, to the extent that the term “substantially” is referring to the position of each peak in the X-ray powder diffraction pattern in Table 1 or Figure 2, the claims fail to further limit the X-ray powder diffraction pattern. Same logic is applicable to other diffraction angles. 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. Free of the Art Claims 1-4 and 8 are free of the art. Conclusion No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Chihyi Lee whose telephone number is (571)270-0663. The examiner can normally be reached Monday - Friday 8:30 am - 5:00 pm EST. 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, Amy L. Clark can be reached at (571) 272-1310. 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. /CHIHYI LEE/Examiner, Art Unit 1628 /JEAN P CORNET/Primary Examiner, Art Unit 1628