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
Claims 1-3, 5-6, 8-9, 11-12, and 14-23 are currently pending and are examined on the merits herein.
Priority
Acknowledgment is made of applicant's claim for foreign priority. It is noted, however, that applicant has not provided an English translation of the certified copy of the Chinese application CN202210639488.7 as required by 35 U.S.C. 119(b). Nonetheless, the priority date of the instant invention is June 07th, 2022 (the date of the Chinese document). Without the English translation, one cannot ascertain if the instant invention is present in the Chinese application. Therefore, art prior to the PCT date, but not before the date of the Chinese application may be cited against the claims.
IDS
The information disclosure statement (IDS) submitted 12/05/24 and 03/04/25 are acknowledged and have been entered. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
Claim Rejections - 35 USC § 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 was pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
"The primary purpose of this requirement of definiteness of claim language is to ensure that the scope of the claims is clear so the public is informed of the boundaries of what constitutes infringement of the patent. A secondary purpose is to provide a clear measure of what applicant(s) regard as the invention so that it can be determined whether the claimed invention meets all the criteria for patentability and whether the specification meets the criteria of 35 U.S.C. 112, first paragraph with respect to the claimed invention.", (see MPEP § 2173).
Claims 1-3, 5-6, 8-9, 11-12, 14-15, 17-18, 20-21, and 23 rejected under 35 U.S.C. 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Specifically, the aforementioned claims recite “the error range of the 2θ angle is…” and yet applicant recites various crystal forms ranging from A to E and thus it is unclear which crystal’s error range of the 2θ angle is applicant referring to. Encompassed in the rejection are claims 1, 18, 21, and 23.
Additionally, claims 2, 5, 8, 11 and 14 recite “the differential scanning calorimetry (DSC)” in claim 1 and yet claim 1 fails to discuss “DSC”. Consequently, such claims lack antecedent basis.
Claims 3, 6, 9, and 12 recite in step b “performing stirring”, such recitation is unclear and ambiguous as the Examiner is unsure if a specific method is being performed or just the action of stirring is taking place in step b. Appropriate correction is required from applicant.
Claims 3 and 15 recite the term “preferably” which reflects the use of a narrow range that falls within a broader range within the same claim and thus render the claims indefinite. The Examiner is unable to discern the limitation of the claims since such preferences lead to confusion over the intended scope of the claims.
As a result of the above inconsistencies, the aforementioned claims are unable to be examined as disclosed given that the scope of the claimed subject matter would not be able to be determined by one of ordinary skill in the art. For the sake of compact prosecution, the examiner will construe that the claims refer to the broad scope of the subject matter and error change is applicable to all crystal forms, and step b simply entails “stirring” in all applicable claims.
Claim Rejections - 35 USC § 112
Notice of AIA Status
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.
Claims 17, 20, and 23 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because while the claims are enabled for inhibiting cathepsin C activity or treating diseases in which cathepsin C activity causes or results in said diseases by administering the crystal compounds delineated in claim 16, does not reasonably provide enablement for preventing said diseases delineated in claims 17, 20, and 23 comprising administering the aforementioned crystalline forms of benzo[c]chromene compounds. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The instant claims are drawn to a method for preventing and/or treating various diseases including cancer and rheumatoid arthritis (RA) comprising administering the crystalline forms of the benzo[d]chromene compounds delineated in claim 17. The instant specification fails to provide information that would allow the skilled artisan to practice the prevention of any disorders or diseases comprising administering said crystal forms recited in the aforementioned claims.
[In re Sichert, 196 USPQ 209 (CCPA 1977)]
To be enabling, the specification of the patent must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993). Explaining what is meant by “undue experimentation,” the Federal Circuit has stated:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which the experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996).1
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth by 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 quantity of experimentation necessary,
2) the amount of direction or guidance provided,
3) the presence or absence of working examples,
4) the nature of the invention,
5) the state of the prior art,
6) the relative skill of those in the art,
7) the predictability of the art, and
8) the breadth of the claims.
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
1. The nature of the invention, state and predictability of the art, and relative
skill level
The invention relates to a method for preventing and/or treating various diseases including cancer and rheumatoid arthritis (RA) comprising administering the crystalline forms of the benzo[d]chromene compounds delineated in claim 17. The relative skill of those in the art is high, that of an MD or PHD. That factor is outweighed, however, by the unpredictable nature of the art. The claims teach the term “preventing” which encompasses under BRI prophylactic measures, i.e. prevention of said disorders listed in the aforementioned claims. As illustrative of the state of the art, the examiner cites Garutti et al. (Genes, 2023, Vol. 14, pgs. 1-27) who teach that hereditary cancers are a result of gene mutations that confer an elevated susceptibility to cancer development (see pg. 1 and abstract). Consequently, this suggests that genes are involved in the causation of cancer and thus not preventable. Moreover, Masoumi et al. (Biochemistry & Biophysics Reports, 2025, Vol. 43, pgs. 1-17), teach that RA is prevalent in families which has an RA patient and that a genetic factor plays an important role in its occurrence with a genetic contribution of 50-60% (see abstract and pg. 2). Again, based on these prior art references, the conclusion is that genes are involved in certain diseases as delineated in claim 17 and given that genes cannot be prevented, the prevention of the aforementioned diseases thus is highly unlikely. Nowhere in the specification or prior art, did applicant demonstrate prevention of any disorders or diseases comprising administering said crystal forms of the benzo[d]chromene compounds. Nowhere in the specification was it demonstrated that the crystal compounds of the invention were effective in preventing any disorder or disease. Thus, the examiner maintains that prevention of the aforementioned various disorders or diseases including cancer and RA is unlikely and unpredictable.
2. The breadth of the claims
The claims are thus very broad insofar as they recite that the “prevention of various diseases or disorders with the crystal compounds of the invention delineated in claim 17”. While “inhibition of cathepsin C activity” might theoretically be possible by administering the aforementioned compounds, as a practical matter it is nearly impossible to achieve the prevention of tumors or RA with every single compound of the generic formula delineated in claim 17.
3. The amount of direction or guidance provided and the presence or absence of working examples
The specification provides no direction or guidance for the use of the compounds of formula (I) of claim 17 in preventing various disorders. While specific guidance is provided concerning the use of said crystal compounds A-E in inhibiting Cathepsin C activity in the specification, pgs. 14-16 and example 3, no actual prevention was shown utilizing said compounds of the generic formula (I) as recited in claim 17.
4. The quantity of experimentation necessary
Because of the known unpredictability of the art, and in the absence of experimental evidence demonstrating the use of the crystalline compounds of the generic formula (I) in claim 17 in preventing said disorders or diseases, no one skilled in the art would accept the assertion that said compounds encompassed by the aforementioned generic formula (I) of claim 17 could be predictably used for preventing said disorders as inferred by the claims and contemplated by the specification. Accordingly, the instant claims do not comply with the enablement requirement of §112, since to practice the invention claimed in the patent a person of ordinary skill in the art would have to engage in undue experimentation, with no assurance of success.
Objections
Claims 16, 19, and 22 are objected to because of the following informalities: Claims are dependent upon rejected claims. Applicant is required to incorporate all of the limitations of said claims into the independent claims. Appropriate correction is required.
Conclusion
No claims are allowed.
The closest prior art is WO 2022/1107059 A1 (cited by applicant and filed on an IDS 1449) who teach the parental benzo[c]chromene compound of the instant invention wherein said compound is taught as a small molecule inhibitor of cathepsin C and which can be useful for treating diseases wherein inhibition of cathepsin C is useful in said treatment (see abstract).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Director Bonnie Eyler whose telephone number is 571-272-1200. The Supervisory Primary Examiner can normally be reached on 12:00-8:00 PM EST M-F at 571-270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAMIRA J JEAN-LOUIS/Supervisory Patent Examiner, Art Unit 1642
1 As pointed out by the court in In re Angstadt, 537 F.2d 498 at 504 (CCPA 1976), the key word is “undue”, not “experimentation”.
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