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 .
Non-Final Rejection
The Status of Claims:
Claims 1-10, 12, 15-23 are pending.
Claims 1-10, 12, 15-22 are rejected.
Claim 23 is objected.
DETAILED ACTION
1. Claims 1-10, 12, 15-23 are under consideration in this Office Action.
Priority
2. It is noted that this application is a 371 of PCT/GB2022/050727 03/23/2022 , which has a foreign priority document, UNITED KINGDOM GB2104033.2 03/23/2021.
Drawings
3. None.
IDS
4. The IDS filed on 1/8/24 and 1/24/24 are reviewed by the examiner.
Claim Objections
Claim 23 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.
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 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 1-10, 12, 15-22 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 pre-AIA the applicant regards as the invention.
In claim 1 , the limitation recites “R4 represents C1-6 alkyl, C1-6 alkoxy, C1-6 alkoxy-C1-6 alkyl, the alkyl part of which are optionally substituted by one or more halogen atoms” ; also another limitation recites “ R4 represents aryl, C1-6 alkylaryl, C1.3 alkenylaryl, heteroaryl, C1-6 alkylheteroaryl or C1-6 alkenylheteroaryl, each of which are optionally substituted by one or more substituents selected from halogen, -CF3, CF30-, C 1-3 alkyl, and C1-6 alkoxy”. These expressions can be confusing because the variable “R4 ” is defined twice in the same claim. The examiner recommends to combine the two separate limitations into one limitation about the variable “R4 ”.
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.
Claim 15 is 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.
Also, enablement for the scope of “an autoimmune disease “ is not present. Formula I to be effective against autoimmune disease generally are contrary to medical science. The autoimmune disorder is a condition arising from an abnormal immune response to a normal body part There are at least 80 types of autoimmune diseases. Nearly any body part can be involved. Common symptoms include low grade fever and feeling tired. Often symptoms come and go.
The cause is generally unknown. Some autoimmune diseases such as lupus run in families, and certain cases may be triggered by infections or other environmental factors. Some common diseases that are generally considered autoimmune include celiac disease, diabetes mellitus type 1, Graves' disease, inflammatory bowel disease, multiple sclerosis, psoriasis, rheumatoid arthritis, and systemic lupus erythematosus.[1][4] The diagnosis can be difficult to determine.
Treatment depends on the type and severity of the condition. Nonsteroidal anti-inflammatory drugs (NSAIDs) and immunosuppressants are often used. Intravenous immunoglobulin may also occasionally be used. While treatment usually improves symptoms, they do not typically cure the disease.
About 24 million (7%) people in the United States are affected by an autoimmune disease. Women are more commonly affected than men.[1] Often they start during adulthood.[1] The first autoimmune diseases were described in the early 1900s.
The human immune system typically produces both T cells and B cells that are capable of being reactive with self-antigens, but these self-reactive cells are usually either killed prior to becoming active within the immune system, placed into a state of anergy (silently removed from their role within the immune system due to over-activation), or removed from their role within the immune system by regulatory cells. When any one of these mechanisms fail, it is possible to have a reservoir of self-reactive cells that become functional within the immune system. The mechanisms of preventing self-reactive T cells from being created takes place through negative selection process within the thymus as the T cell is developing into a mature immune cell.
Some infections, such as Campylobacter jejuni, have antigens that are similar (but not identical) to our own self-molecules. In this case, a normal immune response to C. jejuni can result in the production of antibodies that also react to a lesser degree with gangliosides of myelin sheath surrounding peripheral nerves' axons (i.e., Guillain–Barré). A major understanding of the underlying pathophysiology of autoimmune diseases has been the application of genome wide association scans that have identified a degree of genetic sharing among the autoimmune diseases.
Autoimmunity, on the other hand, is the presence of self-reactive immune response (e.g., auto-antibodies, self-reactive T cells), with or without damage or pathology resulting from it. This may be restricted to certain organs (e.g. in autoimmune thyroiditis) or involve a particular tissue in different places (e.g. Goodpasture's disease which may affect the basement membrane in both the lung and the kidney).
For a disease to be regarded as an autoimmune disease it needs to answer to Witebsky's postulates (first formulated by Ernest Witebsky and colleagues in 1957 and modified in 1994):
Direct evidence from transfer of disease-causing antibody or disease-causing T lymphocyte white blood cells
Indirect evidence based on reproduction of the autoimmune disease in experimental animals
Circumstantial evidence from clinical clues
Genetic evidence suggesting "clustering" with other autoimmune diseases
Autoimmune diseases have a wide variety of different effects. They do tend to have one of three characteristic pathological effects which characterize them as autoimmune diseases:
Damage to or destruction of tissues
Altered organ growth
Altered organ function
It has been estimated that autoimmune diseases are among the leading causes of death among women in the United States in all age groups up to 65 years.
A substantial minority of the population suffers from these diseases, which are often chronic, debilitating, and life-threatening
There are more than 80 illnesses caused by autoimmunity. The above list is by no means complete, but demonstrates the extraordinary breadth of causes, mechanisms and treatment (or lack thereof) for any immune or autoimmune disorder. It establishes that it is not reasonable to any agent to be able to treat any immune or autoimmune disorder generally. Therefore, an appropriate correction is required.
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. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); 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, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-10, 12, 15-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9, 11,14-21 of copending Application No.18/283,487 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the scope of the claims between the current application and copending Application No. is overlapped with each other.
The claims 1-2 of copending Application No. 18/283,487 describes the following:
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wherein: R1 represents C 1-4 alkyl, optionally substituted by one or more fluorine atoms and/or with OR7;
2. (Original) A compound as claimed in Claim 1, wherein R1 represents methyl, ethyl, isopropyl or tert-butyl, optionally substituted with one or more fluorine atoms.
Similarly, the current claim 1 does disclose the following as shown below:
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R1 represents C1-2 alkyl (optionally substituted by one or more fluorine atoms), OR7 or a fluorine atom;
However, the current claims differ from the co-pending Application No. 18/283,487 in that the scope of the claimed invention with respect to the variable R1 is slightly narrower than that of the co-pending Application No.
Even so, the dependent claim 2 of the co-pending Application does teach that R1 can represent tert-butyl. From this, it seems reasonable that the limitation of R1 being tert-butyl can be incorporated into the claim 1. Moreover, such a limitation can be anticipated; there is very little difference as to the patentable distinction.
So, if the skilled artisan in the art had desired to emphasize the particular limitation of R1 being tert-butyl in the claim 1 of the co-pending Application, it would have been obvious to the skilled artisan to be motivated to add that limitation to the claim 1 of the co-pending Application in order to make it narrowed so as to arrive at the claimed invention. This is because the skilled artisan in the art would expect such a manipulation to be feasible and successful as guidance shown in the application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1-10, 12, 15-22 are rejected.
Claim 23 is objected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAYLOR V OH whose telephone number is (571)272-0689. The examiner can normally be reached 8:00-5:00.
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/TAYLOR V OH/Primary Examiner, Art Unit 1625 12/13/2025