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 .
Claims 1-4, 7, 8, 10-12, 16, 19, 22-24, 27, 32, 37, 42, 47 and 48 are presented for examination.
Applicants’ drawings, information disclosure statements, and preliminary amendment filed September 29, 2023 have been received and entered.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
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 1, 10-12, 16, 19, 22-24, 27, 32, 37, 42, 47 and 48 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 written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
This is a Written Description rejection.
A lack of adequate written description issue arises if the knowledge and level of skill in the art would not permit one skilled in the art to immediately envisage the product claimed from the disclosed process. See, e.g., Fujikawa v. Wattanasin, 93 F.3d 1559, 1571, 39 USPQ2d 1895, 1905 (Fed. Cir. 1996) (a "laundry list" disclosure of every possible moiety does not constitute a written description of every species in a genus because it would not "reasonably lead" those skilled in the art to any particular species); In re Ruschig, 379 F.2d 990, 995, 154 USPQ 118, 123 (CCPA 1967).
An applicant may also show that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics which provide evidence that applicant was in possession of the claimed invention, i.e., complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics.
In particular, the specification as original filed fails to provide sufficient written bases of any of the agents demonstrating wherein possession of use of the broad term; An autoimmune disease. The mere fact that Applicant may have discovered one type of autoimmune disease is treated with the combination of a BTK inhibitor and a fumaric acid ester is not sufficient to claim the entire genus that incudes type 1 diabetes, psoriasis, Addison’s disease, and Bechet’s disease.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure "indicates that the patentee has invented species sufficient to constitute the gen[us]."
Claims 1, 10-12, 16, 19, 22-24, 27, 32, 37, 42, 47 and 48 are not allowed.
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 11 and 47 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.
Claim 11 is rendered indefinite by the phrase “evobrutinb”. Is the phrase misspelled? Please correct.
Claim 47 is rendered indefinite and vague by the phrase “a standard dose of the FAE is administered to the subject”. What is a standard dose of FAE given to all subjects to treat an autoimmune disease?
Claims 11 and 47 are not allowed.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-4, 7, 8, 10-12, 16, 19, 22-24, 27, 32, 37, 42 and 48 are rejected under 35 U.S.C. 103 as being unpatentable over W0 2012/170976 A2, hereby known as Hodous et al., WO 2013/067274 A1, hereby known as Crawford et al., WO 2015/048662 A2, hereby known as Chen et al., WO 2016/196840 A1, hereby known as Goldstein et al., and WO 2018/191577 A1, hereby known as Hopkins et al. in view of Joshi et al. (7,619,001 B2) or Derfuss et al., “Advances in oral immunomodulating therapies in relapsing multiple sclerosis”, Lancet Neurology, Vol. 19, No. 4, pages 336-347 (2020).
Hodous et al. teach pyrimidine and pyridine compounds with BTK inhibitory activity (see the abstract). Note page 25, under Description of the Figures, teaches 1-(4-(((6-amino-5-(4-phenoxyphenyl)pyrimidin-4-yl)amino)methyl)piperidin-1-yl)prop-2-en-1-one, also known as evobrutinib, is effective in the treatment of autoimmune diseases such as systemic lupus erythematosus. Also note page 26, lines 15-21 teaches the various autoimmune diseases such as rheumatoid arthritis, systemic lupus erythematosus, Sjӧgren’s disease, psoriasis, and diabetes, that are treated.
Crawford et al. teach heteroaryl pyridine and aza-pyridone compounds as inhibitors of BTK activity (see the abstract). Note these heteroaryl pyridine and aza-pyridone compounds includes fenebrutinib. Note page 507, claim 24 teaches such as the various autoimmune diseases such as rheumatoid arthritis, systemic lupus erythematosus, Sjӧgren’s disease, psoriasis, and multiple sclerosis.
Chen et al. teach substituted nicotinamide inhibitors of BTK and use in the treatment of autoimmune disease (see the abstract). Note page 15, lines 3-13 teaches the various autoimmune diseases such as rheumatoid arthritis, psoriatic arthritis, osteoarthritis, Still's disease, juvenile arthritis, lupus, diabetes (type I and type II), myasthenia gravis, Hashimoto's thyroiditis, Ord's thyroiditis, Graves' disease Sjogren's syndrome, multiple sclerosis, Guillain- Barre syndrome, acute disseminated encephalomyelitis, Addison's disease, opsoclonus- myoclonus syndrome, ankylosing spondylitisis, antiphospholipid antibody syndrome, aplastic anemia, autoimmune hepatitis, coeliac disease, Goodpasture's syndrome. Also note page 38, Example 3, teaches the compound orelabrutinib.
Goldstein et al. teach BTK inhibitor such as tolebrutinib (see page 82, Example 3). Note page 120, claims 48 and 49 teaches the various autoimmune diseases treated.
Hopkins et al. teach benzoazepine analogs as BTK inhibitors (see the abstract). Note the benzoazepine analogs includes BIIB-091. Note page 196, claims 59 and 60 teaches the compound is used to treat autoimmune disorder, especially multiple sclerosis.
The instant invention differs from the cited references in that the cited references do not teach the addition of a fumaric acid ester to treat an autoimmune disease. However, the secondary reference Joshi et al., teaches dialkylfumarates are used to treat autoimmune diseases (see column 1, lines 29-33). Also note column 8, claim 1, teaches the various dialkylfumarates such as dimethyl fumarate (DMF), and methyl hydrogen fumarate (MMF). Note the other secondary reference, Derfuss et al., teaches on page 343, second paragraph teaches diroximel fumarate (DRF) administered to patients with relapsing multiple sclerosis to have superior results over DMF.
Clearly, one skilled in the art would have assumed the combination of each individual agent, a BTK inhibitor and a fumaric acid ester, known to treat autoimmune diseases into a single composition would give an additive effect in the absence of evidence to the contrary.
The instant invention differs from the cited references in that the cited references do not teach a low dosage of a fumaric acid ester is administered to the subject. However, to determine a low dosage amount may be calculated according to body weight, body surface area or organ sizes. Further refinement of the calculations necessary to determine the appropriate dosage involving each of the above active agent(s) is routinely made by those of ordinary skill in the art and is within the ability of tasks routinely performed by them without undue experimentation.
Claim(s) 1-4, 7, 8, 10-12, 16, 19, 22-24, 27, 32, 37, 42 and 48 are not allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEVIN E WEDDINGTON whose telephone number is (571)272-0587. The examiner can normally be reached M-F 1:30-10:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeff Lundgren can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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KEVIN E. WEDDINGTON
Primary Examiner
Art Unit 1629
/KEVIN E WEDDINGTON/Primary Examiner, Art Unit 1629