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 .
Detailed Action
Response to Amendments
The amendments made to the claims 07/14/2026 have been entered.
In view of the amendments, the objection over the drawings is withdrawn.
Withdrawn Claim Objections
In view of the arguments made, the objection over the use of “till” in claim 13 is withdrawn.
Withdrawn Rejections
In view of the amendments made, the rejection made over claim 15 and 16 are now moot and are therefore withdrawn.
The 112(b) rejection over the 2θ value in claims 2-4 is withdrawn.
The 112(b) rejection made over the use of “substantially” in claims 5-12 is withdrawn.
The 112(b) rejection made over claim 13 is withdrawn.
Election/Restrictions
Newly submitted claims 17 and 18 directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
Claim 17 is drawn to a method of inhibiting DNA-PK.
Claim 18 is drawn to a method of treating general cancer.
The examined claims in the previous office action were drawn to a crystal form (Claim 1) and a method for preparing the crystalline form I in claim 2 (claim 13).
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 17 and 18 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Maintained Rejections
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.
KSR Rationales
The MPEP in section 2143, subsection I gives examples of Rationales for supporting a conclusion of obvious. These rationales are non-exhaustive and include (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Claim(s) 1, 13, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wei (US2023/0165867, published 2023, priority to CN202010302603.2, filed 04/17/2020, and CN202010679647.7, filed 07/15/2020) in view of Tipson (Mellon Institute, Pittsburgh 12, Pa, Vol. 22, No. 5, 1950) as evidenced by Jacob (American Journal of Surgery, Vol. 114, Iss. 3, 1967).
Claim 1 is drawn to a crystal form of compound A.
Claim 13 is drawn to a method of preparing the crystalline form I.
Claim 14 is drawn to a composition comprising the crystalline form I and a pharmaceutically acceptable carrier.
Wei in para. [0537]-[0543] discloses methods of synthesis compound 62, shown below, as a white solid.
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Wei also teaches the compound above in DMSO for 1H NMR. Jacobs in it abstract teaches that DMSO is pharmaceutically acceptable solvent where it states “Dimethyl sulfoxide has a wide range of primary pharmacologic actions including membrane penetration, anti-inflammation, local analgesia, bacteriostasis, diuresis, cholinesterase inhibition, enhancement of the action of a concomitantly administered drug, solvent for collagen…”.
Wei does not teach methods of recrystallizing the compound above. This is addressed by Tipson.
Tipson teaches methods of recrystallization (title). Tipson in sec. Simple Batchwise Repeated Recrystallization teaches a basic method of recrystallization involving dissolving a starting material (product) in a solvent. Solvent choice for crystallization is within the skillset of one of ordinary skill in the art and the solvents ethanol and water are common solvents used for crystallization. Tipson in sec. Some Advantages and Disadvantages of Recrystallization states “The advantages of recrystallization as a method for separation and purification are as follows. It yields the material in a form susceptible to special tests characteristic of the crystalline state. Oftentimes it may be accomplished without elaborate apparatus…Recrystallization from a solvent is particularly indicated for substances sensitive to heat -e.g., those which decompose at their melting points-for it can often be accomplished either without heating at all, or by heating of very short duration.” One of ordinary skill would naturally include cooling after heating to allow crystallization.
Tipson teaches that recrystallization to purify a compound is well known within the art and would be within the skillset of one of ordinary skill. Therefore, the method I of claim 13 would be obvious in view of Wei and Tipson.
One of ordinary skill would also be able to create a solution comprising the crystalized compound and DMSO to arrive at the composition of claim 14.
It would have been prima facie obvious at the time of the effective filing date for one of ordinary skill in the art to apply the crystallization techniques taught in Tipson to the compound 62 of Wei to arrive at a crystal form of claim 1 with a reasonable assumption of success. The methods described in Tipson also make obvious the method of claim 13. One of ordinary skill would also be able to dissolve a crystal form of compound 62 in DMSO to arrive at instant claim 14.
One of ordinary skill in the art would find motivation to make the combination of Wei and Tipson in order to purify the compound 62. One of ordinary skill would dissolve the crystallized compound 62 in DMSO for 1H NMR.
Response to Arguments
Applicant argues that Wei should be exempted as prior art under 35 § 102(b)(2)(C) because “[b]oth Wei and the instant application were owned by or subject to an obligation of assignment to CHENGDU BAIYU PHARMACEUTICAL CO., LTD. no later than the effective filing date of the instant application.”
The effective filing date of claims 1, 13, and 14 is 09/23/2021.
The oath filed 03/22/2024 indicates that the reference patent literature and the instant application were not commonly shared until after the effective filing date. Therefore, this argument does not sufficiently exempt Wei as prior art.
Examiner notes that there is a shared inventor between Wei and the instant application. Applicant has not indicated whether the inventive subject matter of the instant disclosure was received from the shared inventor. Wei can be exempted as prior art if the inventive subject matter was received directly from the shared inventor.
New Rejections
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 3-4 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.
Claims 2-4 are drawn to a specific crystalline form I which has characteristic peaks.
Claim 2 specifies the characteristics peaks 9.859o, 14.759o, 19.679o, and 19.961o ±0.3o.
Claim 3 specifies characteristic peaks 4.979o, 15.759o, 19.339o, 22.481o, and 24.641o±0.2o.
Claim 4 specifies characteristic peaks 12.120o, 18.802o, and 21.822o ±0.2o.
The instant specification on p. 12, Table 1 indicates that the all of the characteristics peaks in claims 2-4 are characteristic peaks for crystalline form I. See entries 1-22.
Claim 2 specifies that the crystal form being claimed is crystalline form I. The peaks in claims 3 and 4 are also characteristic peaks which belong to the same crystalline form I in claim 2. Essentially, by naming the specific crystalline form in claim 2, applicant is already claiming the peaks of claims 3 and 4. Therefore, claims 3 and 4 are not further limiting as the crystalline form in claims 3 and 4 is the same crystalline form in claim 2.
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.
Allowable Subject Matter
Claims 2 and 5-7 are 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 claims allowed.
Allowable subject matter indicated.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUISALBERTO GONZALEZ whose telephone number is (571)272-1154. The examiner can normally be reached M-F 8:30-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.G./Examiner, Art Unit 1624
