DETAILED ACTION
Claims 1-11, 13-16 are pending in the instant application.
2. Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 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 13-14 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for inhibition of dysregulation of Discoidin Domain Receptor, does not reasonably provide enablement for treating a disease, disorder or condition associated with dysregulation of Discoidin Domain Receptor. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue”. These factors include 1) the breadth of the claims, 2) the nature of the invention, 3) the state of the prior art, 4) the level of one of ordinary skill, 5) the level of predictability in the art, 6) the amount of direction provided by the inventor, 7) the existence of working examples, and 8) the quantity of experimentation needed to make or use the invention based on the content of the disclosure. In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
1) The breadth of the claims.
2) The nature of the invention,
3) The state of the prior art,
4) The level of one of ordinary skill,
5) The level of predictability in the art,
6) The amount of direction provided by the inventor,
7) The existence of working examples,
8) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
The nature of the invention: The instant invention is drawn to method for treating a disease, disorder or condition associated with dysregulation of Discoidin Domain Receptor, said method comprising administration of the compound or pharmaceutically acceptable salt thereof according to claim 1.
The state of the prior art: The state of the prior art: As indicated by the prior art, there is not any association between dysregulation of Discoidin Domain Receptor inhibitors and treating diseases in which dysregulation of Discoidin Domain Receptor inhibitors have a therapeutic benefit other than diopathic pulmonary fibrosis, renal fibrosis, cardiac fibrosis, arterial fibrosis, systemic sclerosis. There is no guidance in the prior art that a disease, disorder or condition associated with dysregulation of Discoidin Domain Receptor inhibitor could be useful to treat diseases other than diopathic pulmonary fibrosis, renal fibrosis, cardiac fibrosis, arterial fibrosis, systemic sclerosis.
The predictability in the art: At present using between dysregulation of Discoidin Domain Receptor inhibitors to treat a disease associated with dysregulation of Discoidin Domain Receptor inhibitors is purely speculative. It is noted that the pharmaceutical art is unpredictable, requiring each embodiment to be individually assessed for physiological activity. In re Fisher, 427 F. 2d 833, 166 USPQ 18 (CCPA 1970) indicates that the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statute. They have not shown a nexus to treat diseases but have provided only reports in vitro which, absent a correlation to treat of diseases, are not sufficient to enable the invention.
The level of the skill in the art: The level of skill in the art is high.
Amount of guidance/working examples: Applicant provides examples of the test compounds to inhibit dysregulation of Discoidin Domain on pages 299-306. However, there is no guidance for using a therapeutically effective amount of a compound of Formula (I) to treat a disease disorder or condition associated with dysregulation of Discoidin Domain Receptor.
The breadth of the claims: The claims encompass a method for treating a disease disorder or condition associated with dysregulation of Discoidin Domain Receptor.
The quantity of experimentation needed: Since the guidance and teaching provided by the specification is insufficient for treating diseases associated with therapeutically effective amount of a compound of formula (I) is efficacious, one of ordinary skill in the art, even with high level of skill, is unable to use the instant compounds as claimed without undue experimentation.
Taking all of the above into consideration, it is not seen where the instant claims 13-14, for treating diseases associated with therapeutically effective amount of a compound of Formula (I) is efficacious, have been enabled by the instant specification.
3. Claim Rejections - Obvious Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. See In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and, In re Thorington, 418 F.2d 528, 168 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.130 (b).
Effective January 1,1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-11, 13-16 are provisional rejected under the judicially created doctrine obviousness-type double patenting as being unpatentable over the claims 1-11, 13-16 of ap# 18/283,867. Although the conflicting claims are not identical, they are not patentably distinct from each other because the current invention embraces the invention claimed in the above application.
Determination of the scope and content of the prior art (MPEP §2141.01)
Ap# ‘867 claimed analogues compounds in claims 1-11,13-16 as the instant claims 1-11, 13-16.
Ascertainment of the difference between the prior art and the claims (MPEP §2141.02)
The difference between the instant claims and the claims 1-11, 13-16 of ap# ‘867 is the claims are not word for word identical but the scope of the two sets of claims overlaps significantly with each other.
Finding of prima facia obviousness-rational and motivation (MPEP §2142.2143)
All the elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
This is provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been issued.
4. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Niloofar Rahmani whose telephone number is
571-272-4329. The examiner can normally be reached on Monday through Friday from 8:30 am to 5:00 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor, can be reached on 571-272-8394. The fax phone number for the organization where this application or proceeding is assigned is 703-872-9306.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/NILOOFAR RAHMANI/
12/03/2025