DETAILED ACTION
Notice of AIA Status
The instant application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the Leahy-Smith America Invents Act (AIA ).
Status of the Claims
The listing of claims filed on 26 October 2025 in a third preliminary amendment has been examined.
Claims 1–15 are pending. Claims 1, 2, and 11 are amended.
A second preliminary amendment was filed on 13 April 2025.
Claims 1–15 were pending. Claims 11 and 12 were amended. Claims 13–15 were added.
A first preliminary amendment was filed on 20 September 2024.
Claims 1–12 were pending. Claims 2–7 and 9 were amended.
Priority
The instant application was filed 20 September 2024; is a national stage application of PCT/CN2022/131030, filed 10 November 2022, and claims priority to CN 202210553395.2, filed 20 May 2022. Applicant’s claim for foreign priority is acknowledged, and a copy of the priority document has been received.
Information Disclosure Statement
An information disclosure statement (IDS) has not been received.
Objections to the Specification
The abstract of the disclosure is objected to because it recites phrases that can be implied (“The present invention relates to”; “in the present invention”; “of the present invention”; and “of the present invention”).
Appropriate correction is required.
Examiner recommends deleting the phrases from each corresponding sentence.
For guidelines for the preparation of patent abstracts, see MPEP § 608.01(b) (Explaining: The abstract should be in narrative form and avoid legal phraseology (e.g., means, said), terms referring to purported merits of the invention (e.g., new, novel), and phrases that can be implied (e.g., The disclosure concerns, The disclosure defined by this invention). The language should be clear and concise, and not repeat information given in the title. It should not compare the invention with the prior art. The abstract is generally limited to a single paragraph within the range of 50 to 150 words in length.).
Claim Objections
(i) Claims 1–7 and 9 are objected to for using improper capitalization. Trademarks may not be improperly used in claims. (MPEP § 2173.05(u)). In this case, the capitalization appears to be a typographical error rather than a reference to a trademark because vonoprazan is a common name for the referenced compound. The capitalization of a common name is not necessary or proper.
(ii) Claim 1 is objected to for minor informalities. Claim 1 recites “X-ray powder diffraction patterns” (plural), which should be “X-ray powder diffraction pattern” (singular).
(iii) Claim 5 is objected to for minor informalities. Claim 5 recites “dropping ketone solvent, stirring to crystallize, filtering, and drying.” The dropping, stirring, filtering, and drying steps do not refer to a subject for those actions. Examiner understands, for example, the dropping step likely refers to adding a ketone solvent dropwise to the methanol solution of vonoprazan pyroglutamate. The claims should be amended to recite more detail in each of the steps, including the subject of each active step.
(iv) Claims 10–15 are objected to because they are presented as dependent claims referring back to claim 9 (“The pharmaceutical composition according to claim 9”) but recite a different category of invention than that recited in claim 9 (“An application”). Accordingly, the claims are inconsistent with one another as a matter of form.
Appropriate correction is required.
Claim Rejections - 35 U.S.C. § 101
35 U.S.C. § 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Subject matter eligibility for patentability is determined by evaluating the claimed invention in accordance with the flowchart in MPEP § 2106(III). Step 1 asks whether the claims are directed to one of the four categories of statutory subject matter (process, machine, manufacture, or composition of matter). Step 2 is a two-part test to determine if the claims are directed to a judicial exception (Step 2A); and whether additional elements of the claim provide an inventive concept encompassing significantly more than the judicial exception (Step 2B).
Claims 6–9 are rejected under 35 U.S.C. § 101 because the claimed invention is not directed to subject matter that is eligible for patentability.
Claims 6–9 are directed to “An application of the crystal form I.” An application is not a process, machine, manufacture, or composition of matter. Therefore, the claims are not directed to one of the four categories of statutory subject matter (Step 1).
Appropriate correction is required.
Claim Rejections - 35 U.S.C. § 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.
Claims 2, 8, and 10–15 are rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
(i) Claim 2 recites: “A crystal form I of Vonoprazan pyroglutamate, wherein an X-ray powder diffraction pattern has 27 characteristic peaks . . .”
The written description and the claims are separate statutory requirements. Under modern claim practice, claims must stand alone to define an invention. Ex parte Fressola, 27 USPQ2d 1608 (BPAI 1993). Instant claim 2 does not recite the 27 characteristic peaks or refer to a figure displaying the 27 characteristic peaks. As a result, one of ordinary skill in the art must refer back to the specification to understand what the claimed invention is.
Examiner recommends canceling the claim in view of claim 1.
(ii) Claims 8, 11, and 13 recite the phrase “such as.”
The phrase such as renders the claims indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d) (explaining that exemplary claim language can render the claim indefinite when the scope of the claim is not clear).
(iii) Claims 11 and 13 recite the term “etc.,” which is an abbreviation for etcetera—a word used to imply “a number of unspecified additional things.”
The term etc. renders the claims indefinite because it is unclear what unspecified additional things are included by the phrase and therefore included within the scope of the claim.
(iv) Claims 12, 14, and 15 recite, “injections (containing powder for injection).”
It is unclear whether the phrase inside the parenthetical limits the scope of the preceding term “injections.” For example, one of ordinary skill in the art would not be apprised whether an injection without powder is encompassed by the claim.
(v) Claim 10 recites, “other potassium-containing acid blockers.”
A claim is indefinite when it contains words or phrases whose meaning is unclear. MPEP § 2173.05(e). The term “other” implies that a potassium-containing acid blocker was previously recited in the claims; however, none of claims 1, 9, or 10 recite or refer to a potassium-containing acid blocker. Accordingly, the term “other” lacks context and one of ordinary skill in the art would not be apprised of which claimed components are defined as a potassium-containing acid blocker.
(vi) Claims 12, 14, and 15 recite a phrase with broad terms (“tablets, capsules, injections”) followed by a phrase with narrow terms (“including extended-release tablets, extended-release capsules, and extended-release injections as preferred dosage forms”).
A broad limitation together with a narrow limitation falling within the broad limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the instant claims, it is unclear whether the narrow terms limit the scope of the broad terms.
Furthermore, the phrase “preferred dosage forms” renders the claims indefinite because it is unclear whether the narrow terms preceding the phrase limit the scope of the broad terms. See MPEP § 2173.05(d) (explaining that exemplary claim language can render the claim indefinite when the scope of the claim is not clear).
Appropriate correction is required.
Conclusion
No claims are allowed.
Communication
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/JASON M. NOLAN/Patent Examiner, Art Unit 1623
/GEORGE W KOSTURKO/Primary Examiner, Art Unit 1621
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