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 .
Priority
This Application is a 371 of PCT/CN2021/143075, filed Dec. 30, 2021, and claims foreign priority benefit of CN202011613724.5, filed Dec. 30, 2020 in the People’s Republic of China.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on June 29, 2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Status
Claims 1-10 are currently pending and subject to examination.
Claim Objections
Claims 3-8 are objected to because of the following informalities: there should be a space between comprises and 3 in claims 3-5. In claims 6-8, “a” should be deleted before “crystal form I”, “crystal form II” and “crystal form III” at the end of each claim respectively. Appropriate correction is required.
Claim Rejections – 35 USC § 112(b)
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 6-8 and 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.
Regarding claims 6 and 7, the phrase “preferably” renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claims 6-8 are also indefinite because they each recite “subjecting the [first/ second/ third] solution to a devitrification treatment so as to form a crystal form [I/ II/ III].” The devitrification step is defined solely by the result it must achieve – production of the recited crystal form – without reciting any objective parameters (e.g. temperature, duration, rate of cooling, sequence of operation, etc.) that delimit which treatments fall within the claim scope.
The Specification shows the breadth of the term, stating that “the devitrification treatment comprises cooling, standing, volatilizing or a combination thereof” (Specification, p. 6). On its face, the claim therefore encompasses any thermal or evaporative manipulation, in any order, at any conditions, provided the recited crystal form happens to result. Because polymorphic outcomes are highly sensitive to crystallization conditions, and because the specification provides only a single working example tied to each form, one of ordinary skill in the art cannot ascertain from the claim language which combinations of cooling, standing and volatilizing fall within the claim and which outside it, except by performing the treatment and characterizing the resulting solid. A claim whose metes and bounds can only be determined by carrying out the recited process and inspecting the product does not inform those of ordinary skill in the art “about the scope of the invention with reasonable certainty.” Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898, 910 (2014). The indefiniteness is heightened because the functional language operates at the point of novelty: the claim seeks to capture the very result that distinguishes the invention (Form I, II or III), while leaving the conditions producing that result undefined. (See MPEP § 2173.05(g)).
To overcome this rejection, Applicant may amend claims 6-8 to recite the specific conditions (e.g. temperatures, durations, order of operations) that distinguish the treatments yielding each crystal form, consistent with the working examples in the Specification.
Claims 10 is 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.
Claim 10 is indefinite because it is a “use” claim, which attempts to claim a process: “the preparation of a medicament,” but it does not set forth any of the steps involved.
Attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. For example, a claim which read: "[a] process for using monoclonal antibodies of claim 4 to isolate and purify human fibroblast interferon" was held to be indefinite because it merely recites a use without any active, positive steps delimiting how this use is actually practiced. Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986).
MPEP § 2173.05(q).
Claim Rejections – 35 USC § 112(d)
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 3-5 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. Claims 3-5 fail to limit the subject matter of claim 2 because they recite the 2θ values for crystal forms I, II and III respectively, but these 2θ values are already inherent in crystal forms I, II and III. Crystal forms I, II, and III necessarily have all of the 2θ values in Figures 1-3, respectively. 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 Rejections - 35 USC § 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.”
Claim 10 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claim recites a “use” which is not one of the four statutory categories (a process, machine, manufacture, or composition of matter).
"Use" claims that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101. In re Moreton, 288 F.2d 708, 709, 129 USPQ 227, 228 (CCPA 1961)("one cannot claim a new use per se, because it is not among the categories of patentable inventions specified in 35 U.S.C. § 101 "). In Ex parte Dunki, 153 USPQ 678 (Bd. App. 1967), the Board held the following claim to be an improper definition of a process: "The use of a high carbon austenitic iron alloy having a proportion of free carbon as a vehicle brake part subject to stress by sliding friction."
MPEP § 2173.05(q).
Claim Rejections – 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
“A person shall be entitled to a patent unless -
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.”
Claim(s) 1 and 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li & Lu (CN1331082A, published July 16, 2003).
Claim 1 is directed towards a crystal of a compound of formula I:
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Li teaches a crystal of a compound of formula I (compound AHP-003) which is prepared by crystallization in water and recrystallization in ethanol:
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Li, Specification, p. 1;
Example 4, preparing 2 α, 17-α-di-ethynyl, A-seco-4-norcholestane, 5-α-androstane, 2 β, 17 β-double hydroxyl double propionate (AHP-003) II 3.5 g propionic, 2 g propionic acid, 0.1 g P.T.S. 20 degrees centigrade after dissolving, stirring and reacting for 12 hours, adding water and placing in room temperature gradually separating out crystal 0.8 g, using ethanol to re-crystallize the mp, 152-153 degrees centigrade (α) 0-32 degrees.
Li, Specification, Translation, p. 3.
Therefore, claim 1 is anticipated.
Claim 10 is directed towards a use of a crystal according to claim I: (II) the preparation of a medicament for treating prostatic hyperplasia. Li teaches that “the compounds of the invention to be further used as medicine for treating hyperplasia of prostate.” (Li, Specification, Translation, p. 2).
Therefore, claim 10 is anticipated.
Claim Rejections – 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
“A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.”
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 9 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Li & Lu (CN1331082A, published July 16, 2003), as applied to claims 1 and 10 above, and further in view of Chen (US 10,537,583 B2).
The rejection of claims 1 and 10 above as anticipated by Li is incorporated herein by reference. As such, claims 1 and 10 were prima facie obvious at the time of filing.
Claim 9 is directed towards a pharmaceutical composition comprising the crystal of claim 1 and pharmaceutically acceptable carriers.
As shown in the rejection of claim 10, Li teaches that the crystal of claim 1 can be used to prepare a medicine for the treatment of benign prostatic hyperplasia. Li suggests an oral pharmaceutical dosage form as Li teaches that rats were given 5 mg/kg of oral test drug per day (Li, Translation, Specification, p. 2). While Li does not explicitly teach a pharmaceutical composition comprising the crystal of claim 1 and a pharmaceutically acceptable carrier, one of ordinary skill in the art would have a reasonable expectation of success to formulate a pharmaceutical composition comprising the crystal of claim 1 and a pharmaceutically acceptable carrier because such compositions are commonly known in the art.
For example, Chen teaches an oral formulation comprising a compound of formula I and one or more pharmaceutically acceptable carriers:
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Chen, Specification, col. 2, lines 54-67;
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Id., col. 5, lines 38-42.
Therefore, claim 9 was prima facie obvious at the time of filing.
Claim Objections – Dependent on Rejected Base Claim
Claim 2 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
No claim is found to be allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HEATHER DAHLIN whose telephone number is (571)270-0436. The examiner can normally be reached 9-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Lundgren can be reached on (571) 272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HEATHER DAHLIN/Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
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