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 .
Current Status of 18/728,652
This Office Action is responsive to the amended claims of 7/12/2024.
Claims 1, and 34-52 are examined on the merits.
Priority
This application is a national stage entry of PCT/CN2023/073077 and also claims foreign priority to CN202210060175.6.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
A review of the file wrapper indicates a foreign language priority document. However, since it is not in English, a judgement cannot be made as to whether it supports the instant claims, which is required to perfect foreign priority. The conditions of 35 U.S.C. § 119(a)-(d) or (f) are not met.
Therefore, the effective filing date for the instant claims is the international filing date of 01/19/2023.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/12/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claims 41-52 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
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.
All of the Wands factors have been considered with regard to the instant claims, with the most relevant factors discussed below.
The nature of the invention: The nature of the invention pertains a method of treating or preventing (of formula 1 in claim 1) the diseases listed in claims 41 and 47.
The breadth of the claims: The breadth of the claims is drawn to a method of using of the crystal form of claim 1 for diseases listed in claims 41 and 47.
The predictability or unpredictability of the art:
For example, Claims 41 and 47 recites a method of preventing diseases like cancer, which cannot be fully prevented. University of Colorado teaches that 4 in 10 cancers are preventable while the others are not predictably preventable (page 1).
The amount of direction or guidance presented: No guidance is presented in the Instant Specification on how to prevent the diseases of claims 41 and 47 with the instant combinations. Applicants do not show any data or evidence that the composition of the claims had been tested for this purpose.
The presence or absence of working examples: No working examples are shown in the Instant Specification for preventing the diseases of claims 41 and 47. Applicants do not show any data or evidence that the composition of the claims had been tested for preventing. Applicants do not provide guidance for how the instant composition would be work preventively. Lack of a working example is a factor to be considered, especially in a case involving an unpredictable art. See MPEP § 2164.02.
The quantity of experimentation necessary: The quantity of experimentation would be “undue” because of the amount of time and resources needed to experimentally find the amounts of the instant combination needed to prevent the diseases of claims 41 and 47.
The artisan would not be able to anticipate the amount of the instant combination in order to prevent the diseases of claims 41 and 47 without undue experimentation, absent working examples from Applicants or the art. Preventing the diseases of claims 41 and 47 is unpredictable.
Moreover, the lack of a working example is noteworthy. There are no teachings or guidance in the specification which would lessen the amount of experimentation to a reasonable amount. Additionally, a person of ordinary skill in the art would have to engage in undue experimentation to create an effective preventative, with no assurance of success.
Thus, Claims 41-52 are rejected as lacking enablement.
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 36, 41-52 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 metes and bounds of claim 36 are unclear because the figures used in the claims have unlabeled x and y axis. Because the metes and bounds of the claim are unclear, claim 36 is indefinite.
Claims 41 and 47 recite the limitations “or related condition” and “or related syndrome”. The metes and bounds of these claims are not defined and thus indefinite.
Similarly, dependent claims 42-46 and 48-52 are rejected for not resolving the rationale underpinning this rejection.
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 34, 35, 36 and 37 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.
Claim 34 has more peaks listed for each Crystal form then what is listed in base claim 1, which claim 34 depends on.
Claim 35 has more peaks listed for each Crystal form then what is listed in base claim 1, which claim 35 depends on.
Claim 36 (which describes the XRPD is represented by a Figure in the instant drawings) has more peaks and information shown than compared to what is listed for each Crystal form then what is listed in base claim 1, which claim 36 depends on.
Claim 37 (which recites an error range) includes more information and is broader than base claim 1 (which does not recite an error range for each of the claimed peaks).
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
The compound of formula (I) was indexed into STN on February 03, 2022.
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783
797
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The only result of a crystal form of compound of formula I is CN 116462660 (which is published after the effective filing date).
Conclusion
Claims 1 and 40 are allowable as written.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GILLIAN A HUTTER whose telephone number is (571)272-6323. The examiner can normally be reached M-F 7:30-5.
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/G.A.H./ Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
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