DETAILED ACTION
Notice of Pre-AIA or AIA Status
The inventor or joint inventor should note that the instant invention, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1-13 are pending in the instant invention. According to the Amendments to the Claims, filed November 10, 2025, claim 14 was cancelled.
Status of Priority
This invention is a 35 U.S.C. § 371 National Stage Filing of International Application No. PCT/IB2021/054516, filed May 25, 2021, which claims priority under 35 U.S.C. § 119(e) to US Provisional Application Nos.: a) 63/037,366, filed June 10, 2020; and b) 62/704,796, filed May 28, 2020.
Restrictions / Election of Species
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The inventor’s or joint inventor’s provisional election of the following, without traverse, in the reply filed on November 10, 2025, is acknowledged: a) Group I - claims 1-7; and b) 3-hydroxy-N-(3-(methyl(7H-pyrrolo[2,3-d]-pyrimidin-4-yl)amino)cyclobutyl)propane-1-sulfonamide of formula I - p. 6, formula IB, shown to the right, and hereafter referred to as 3-hydroxy-N-(cis-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)-cyclobutyl)propane-1-sulfonamide, where R1 = -H; and R2 = -OH. Claims 1, 3 and 5-7 read on the elected species. Affirmation of this election must be made by the inventor or joint inventor in replying to this Office action.
Similarly, the inventor or joint inventor should further note that the requirement is still deemed proper and is therefore made FINAL.
Likewise, the inventor or joint inventor should further note that the elected species, shown to the right above, was found to be free of the prior art.
Next, the inventor or joint inventor should further note that claim 1 is directed to allowable substituted pyrrolo[2,3-d]pyrimidines of the formula I. Pursuant to the procedures set forth in MPEP § 821.04(b), claims 8 and 10-13, directed to a method of treating or preventing a disease or condition…., comprising administering… a substituted pyrrolo[2,3-d]pyrimidine of the formula I, previously withdrawn from consideration as a result of a restriction requirement, are hereby rejoined and fully examined for patentability under 37 CFR 1.104.
Then, the inventor or joint inventor should further note that since all claims withdrawn from consideration under 37 CFR 1.142 have been rejoined, the restriction requirement as set forth in the Office action, mailed on May 15, 2025, is hereby withdrawn. In view of the withdrawal of the restriction requirement as to the rejoined inventions, the inventor or joint inventor is advised that if any claim presented in a continuation or divisional invention is anticipated by, or includes all the limitations of, a claim that is allowable in the present invention, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant invention.
Moreover, the inventor or joint inventor should further note that once the restriction requirement is withdrawn, the provisions of 35 U.S.C. § 121 are no longer applicable. {See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971); and MPEP § 804.01}.
Thus, a first Office action and prosecution on the merits of claims 1-13 is contained within.
Specification Objection - Disclosure
The inventor or joint inventor is advised to format the specification according to 37 CFR 1.77(c). Revisions should particularly address bold-type, underline, and/or upper case formatting. Appropriate correction may be required.
Specification Objection - Title
The inventor or joint inventor is reminded of the proper content of the title of the invention.
The title of the invention should be brief, but technically accurate and descriptive and should contain fewer than 500 characters. See 37 CFR 1.72(a) and MPEP § 606.
The title of the invention is not technically accurate and descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. In the revised title, the examiner suggests additionally identifying a particular utility for the substituted pyrrolo[2,3-d]-pyrimidines of the formula I.
The following title is suggested: SUBSTITUTED PYRROLO[2,3-d]PYRIMIDINES AS JAK INHIBITORS.
Appropriate correction is required.
Specification Objection - Abstract
The inventor or joint inventor is reminded of the proper content of an abstract of the disclosure.
With regard particularly to chemical patents, for compounds or compositions, the general nature of the compound or composition should be given as well as the use thereof, e.g., The compounds are of the class of alkyl benzene sulfonyl ureas, useful as oral anti-diabetics. Exemplification of a species could be illustrative of members of the class. For processes, the reactions, reagents and process conditions should be stated, generally illustrated by a single example, unless variations are necessary. See MPEP § 608.01(b), Section B.
The abstract of the disclosure is objected to because it fails to exemplify any members or formulae illustrative of its class. Correction is required. See MPEP § 608.01(b).
The examiner suggests incorporating the structure of formula I into the abstract, to overcome this objection.
Claim Objections
Claim 1 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
A compound of formula I:
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I
or a pharmaceutically acceptable salt thereof,
wherein:
R1 is H or OH; and
R2 is H or OH;
with the provisos that:
(1) if R1 is H, then R2 is OH; and
(2) if R2 is H, then R1 is OH.
Appropriate correction is required. See MPEP § 2173.02.
Claim 2 is objected to because of the following informalities: for brevity, clarity and precision, the existing recitation should be replaced with the following recitation:
A compound of formula IA:
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IA
or a pharmaceutically acceptable salt thereof.
Appropriate correction is required. See MPEP § 2173.02.
Claim 3 is objected to because of the following informalities: for brevity, clarity and precision, the existing recitation should be replaced with the following recitation:
A compound of formula IB:
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IB
or a pharmaceutically acceptable salt thereof.
Appropriate correction is required. See MPEP § 2173.02.
Claim 4 is objected to because of the following informalities: for brevity, clarity and precision, the existing recitation should be replaced with the following recitation:
A compound:
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,
or a pharmaceutically acceptable salt thereof.
Appropriate correction is required. See MPEP § 2173.02.
Claim 5 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
A compound:
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,
or a pharmaceutically acceptable salt thereof.
Appropriate correction is required. See MPEP § 2173.02.
Claim 7 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
A pharmaceutical composition comprising a pharmaceutically acceptable excipient and a compound of claim 1, or a pharmaceutically acceptable salt thereof.
Appropriate correction is required. See MPEP § 2173.02.
Claim 8 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(a), the existing recitation should be replaced with the following recitation(s):
8. A method for inhibiting Janus kinase (JAK) activity in a subject, wherein the method comprises administering to the subject in need thereof a therapeutically effective amount of a compound of claim 1, or a pharmaceutically acceptable salt thereof.
15. The method of claim 8, wherein the subject suffers from a condition or disease selected from the group consisting of acute graft-versus-host disease, acute respiratory disease, Addison’s disease, an allergy, alopecia areata, Alzheimer’s disease, asthma, atherosclerosis, a bacterial infection, bone degradation, brain edema, brain trauma, cachexia, cancer, candidiasis, cardiomyopathy, cardiopulmonary dysfunction, cardiovascular disease, chronic graft-versus-host disease, chronic obstructive pulmonary disease, chronic pruritis of unknown origin (CPUO), congestive heart failure, diabetic neuropathy, dry eye syndrome, eczema, endometriosis, endotoxic shock, epidermal hyperplasia, fever, fibrosis, glaucoma, a hypertrophic scar, an immune disorder associated with or arising from activity of a pathogenic lymphocyte, inflammation, ischemia, keloid, a lichen disease, liver disease, macular degeneration, major depression disorder, menstrual cramps, muscular dystrophy, myocardial infarction, neurodegeneration, obesity, pain, prurigo, psoriasis, pulmonary sarcoidosis, Raynaud’s Phenomenon, a reperfusion injury, retinopathy, a rheumatic disease, sarcoidosis, scarring alopecia, septic shock, silicosis, skin flushing, a spondylopathy, Stevens-Johnson syndrome, stroke, sunburn, thrombosis, toxic shock syndrome, transplant rejection, type 1 diabetes, type 2 diabetes, a type 1 interferonopathy, urticaria, a viral infection, and vitiligo.
16. The method of claim 15, wherein the asthma is allergic asthma.
18. The method of claim 15, wherein the epidermal hyperplasia is psoriatic epidermal hyperplasia.
19. The method of claim 15, wherein the inflammation is selected from the group consisting of arteritis, cartilage inflammation, dermatitis, inflammatory bowel disease, myelitis, myositis, nephritis, neuroinflammation, noninfectious uveitis, polymyalgia rheumatica, retinitis, Still’s disease, vaginitis, and vasculitis.
20. The method of claim 19, wherein the dermatitis is atopic dermatitis.
21. The method of claim 19, wherein the inflammatory bowel disease is Crohn’s disease or ulcerative colitis.
22. The method of claim 19, wherein the myositis is polymyositis.
23. The method of claim 19, wherein the nephritis is lupus nephritis.
24. The method of claim 19, wherein the vasculitis is juvenile vasculitis.
25. The method of claim 15, wherein the lichen disease is lichen planus.
26. The method of claim 15, wherein the liver disease is selected from the group consisting of non-alcoholic fatty liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, and sclerosing cholangitis.
27. The method of claim 26, wherein the sclerosing cholangitis is primary sclerosing cholangitis.
28. The method of claim 15, wherein the pain is myalgia.
29. The method of claim 15, wherein the prurigo is prurigo nodularis.
30. The method of claim 15, wherein the psoriasis is selected from the group consisting of erythrodermic psoriasis, guttate psoriasis, inverse psoriasis, plaque psoriasis, and pustular psoriasis.
31. The method of claim 15, wherein the reperfusion injury is cardiac reperfusion injury.
32. The method of claim 15, wherein the rheumatic disease is selected from the group consisting of arthritis, an autoimmune disease, dermatomyositis, osteoporosis, sclerosis, and seronegative enthesopathy and arthropathy (SEA) syndrome.
33. The method of claim 32, wherein the arthritis is selected from the group consisting of ankylosing spondylitis, enteropathic arthritis, gouty arthritis, juvenile arthritis, osteoarthritis, psoriatic arthritis, reactive arthritis, Reiter’s syndrome, and rheumatoid arthritis.
34. The method of claim 33, wherein the ankylosing spondylitis is juvenile ankylosing spondylitis.
35. The method of claim 34, wherein the juvenile arthritis or rheumatoid arthritis is selected from the group consisting of juvenile enteropathic arthritis, juvenile psoriatic arthritis, juvenile rheumatoid arthritis, pauciarticular rheumatoid arthritis, polyarticular rheumatoid arthritis, and systemic onset rheumatoid arthritis.
36. The method of claim 35, wherein the juvenile rheumatoid arthritis or pauciarticular rheumatoid arthritis is selected from the group consisting of pauciarticular juvenile rheumatoid arthritis, polyarticular juvenile rheumatoid arthritis, and systemic onset juvenile rheumatoid arthritis.
37. The method of claim 33, wherein the Reiter’s syndrome is juvenile Reiter’s syndrome.
38. The method of claim 32, wherein the sclerosis is multiple sclerosis or primary biliary sclerosis.
39. The method of claim 38, wherein the multiple sclerosis is primary progressive multiple sclerosis or relapsing remitting multiple sclerosis.
40. The method of claim 32, wherein the autoimmune disease is autoimmune hepatitis, Behcet,s disease, Celiac Sprue, dermatomyositis, Guillain-Barré syndrome, Graves’ disease, idiopathic thrombocytopenic purpura, lupus, myasthenia gravis, pemphigus, polyarteritis nodosa, scleroderma, Sjogren’s syndrome, Vogt-Koyanagi-Harada syndrome, and Wegener’s granulomatosis.
41. The method of claim 40, wherein the dermatomyositis is juvenile dermatomyositis.
42. The method of claim 40, wherein the lupus is selected from the group consisting of central nervous system lupus, cutaneous lupus, discoid lupus, and systemic lupus erythematosus.
44. The method of claim 42, wherein the systemic lupus erythematosus is juvenile systemic lupus erythematosus.
45. The method of claim 40, wherein the scleroderma is juvenile scleroderma.
46. The method of claim 15, wherein the spondylopathy is a spondyloarthropathy.
47. The method of claim 15, wherein the thrombosis is thrombotic thrombocytopenic purpura.
48. The method of claim 15, wherein the type 1 interferonopathy is Aicardi-Goutiéres syndrome or a mendelian disease of overexpression of type 1 interferon.
Appropriate correction is required. See MPEP § 2173.02.
Claim 9 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
49. The method of claim 15, wherein the compound is:
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,
or a pharmaceutically acceptable salt thereof.
Appropriate correction is required. See MPEP § 2173.02.
Claim 10 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
50. The method of claim 15, wherein the compound is:
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,
or a pharmaceutically acceptable salt thereof.
Appropriate correction is required. See MPEP § 2173.02.
Claim 11 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
19. The method of claim 18, wherein the dermatitis is atopic dermatitis.
Appropriate correction is required. See MPEP § 2173.02.
Claim 12 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
17. The method of claim 15, wherein the eczema is hand eczema.
Appropriate correction is required. See MPEP § 2173.02.
Claim 13 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
43. The method of claim 40, wherein the lupus is cutaneous lupus.
Appropriate correction is required. See MPEP § 2173.02.
Claim Rejections - 35 U.S.C. § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. § 112:
(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.
Method of treating or preventing a disease or condition…., comprising administering… a substituted pyrrolo[2,3-d]pyrimidine of the formula I
Claims 8-13 are rejected under 35 U.S.C. § 112(a) as failing to comply with the enablement requirement because the claims contain subject matter, particularly a method of treating or preventing a disease or condition…., comprising administering… a substituted pyrrolo[2,3-d]-pyrimidine of the formula I, which was not described in the specification in such a way as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use (perform) 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, but are not limited to: (a) breadth of the claims; (b) nature of the invention; (c) state of the prior art; (d) level of one of ordinary skill in the art; (e) level of predictability in the art; (f) amount of direction provided by the inventor or joint inventor; (g) existence of working examples; and (h) quantity of experimentation needed to make or use the invention based on the content of the disclosure. {See Ex parte Forman 230 USPQ 546 (Bd. Pat. App. & Inter. 1986); and In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988)}.
The above factors, regarding the present invention, are summarized as follows:
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(a) Breadth of the claims - the breadth of the claims includes a method of treating or preventing a disease or condition…., comprising administering… a substituted pyrrolo[2,3-d]pyrimidine of the formula I, shown to the right;
(b) Nature of the invention - the nature of the invention is performance of a method of treating or preventing a disease or condition…., comprising administering… a substituted pyrrolo[2,3-d]pyrimidine of the formula I, shown to the right above;
(c) State of the prior art - Nature Reviews: Drug Discovery offers a snapshot of the state of the drug development art. Herein, drug development is stated to follow the widely accepted Ehrlich model which includes: (1) development of a broad synthetic organic chemistry program; (2) subsequent testing of compounds in an appropriate laboratory model for the disease to be treated; and (3) screening of compounds with low toxicity in prospective clinical trials (Jordan, V. C. Nature Reviews: Drug Discovery, 2, 2003, 205). Similarly, no single drug has been discovered that is effective in treating or preventing the myriad of conditions or diseases, including, but not limited to, inflammation,… and/or Vogt-Koyanagi-Harada syndrome {See In re Hokum, 226 USPQ 353 (ComrPats 1985)}. Moreover, WO 21/240356 illustrates the synthesis of substituted pyrrolo[2,3-d]pyrimidines of the formula I, and/or methods of use thereof {Dowty, et al. WO 21/240356, 2021};
(d) Level of one of ordinary skill in the art - the artisans performing the inventor’s or joint inventor’s method of treating or preventing a disease or condition…., comprising administering… a substituted pyrrolo[2,3-d]pyrimidine of the formula I would be a collaborative team of synthetic chemists and/or health practitioners, possessing commensurate degree level and/or skill in the art, as well as several years of professional experience;
(e) Level of predictability in the art - Synthetic organic chemistry is quite unpredictable (See In re Marzocchi and Horton 169 USPQ at 367 ¶3). Similarly, it is well established that [T]he scope of enablement varies inversely with the degree of unpredictability of the factors involved, and physiological activity is generally considered to be an unpredictable factor {See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970)}.
Moreover, the following excerpt is taken from Hackam, et al., with respect to the poor replication of animal research in human clinical trials {Hackam, et al. JAMA, 296(14), 2006, 1731-1732}:
Only about a third of highly cited animal research translated at the level of human randomized trials. This rate of translation is lower than the recently estimated 44% replication rate for highly cited human studies. Nevertheless, we believe these findings have important implications. First, patients and physicians should remain cautious about extrapolating the findings of prominent animal research to the care of human disease. Second, major opportunities for improving study design and methodological quality are available for preclinical research. Finally, poor replication of even high-quality animal studies should be expected by those who conduct clinical research.
(f) Amount of direction provided by the inventor - the invention lacks direction with respect to making and/or using (performing) a method of treating or preventing a disease or condition…., comprising administering… a substituted pyrrolo[2,3-d]-pyrimidine of the formula I;
(g) Existence of working examples - the disclosure is insufficient to allow extrapolation of the limited examples to enable performing the instantly recited method of treating or preventing a disease or condition…., comprising administering… a substituted pyrrolo[2,3-d]pyrimidine of the formula I.
Similarly, according to the specification, substituted pyrrolo[2,3-d]pyrimidines of the formula I are capable of treating a variety of conditions or diseases, including, but not limited to, inflammation,… and/or Vogt-Koyanagi-Harada syndrome; however, the specification fails to set forth any convincing in vitro and/or in vivo assays corroborating the alleged activity in association with any conditions or diseases, including, but not limited to, inflammation,… and/or Vogt-Koyanagi-Harada syndrome. There is insufficient disclosure to reasonably conclude that the method of treating or preventing a disease or condition…., comprising administering… a substituted pyrrolo[2,3-d]pyrimidine of the formula I, as recited, would contribute to treatment of any conditions or diseases, including, but not limited to, inflammation,… and/or Vogt-Koyanagi-Harada syndrome. Furthermore, the combination of the instant specification and Dowty, et al. in WO 21/240356, lacks adequate credible evidence to support the assertion that a method of treating or preventing a disease or condition…., comprising administering… a substituted pyrrolo[2,3-d]pyrimidine of the formula I, as recited, would contribute to the prophylaxis of any conditions or diseases, including, but not limited to, inflammation,… and/or Vogt-Koyanagi-Harada syndrome, since the inventor or joint inventor has neither provided convincing data for any patient population, nor indicated any art recognized correlation between the disclosed data and the breadth of the claims.
Within the specification, [A]t least one specific operative embodiment or example of the invention must be set forth. The example(s) and description should be of sufficient scope as to justify the scope of the claims. Markush claims must be provided with support in the disclosure for each member of the Markush group. Where the constitution and formula of a chemical compound is stated only as a probability or speculation, the disclosure is not sufficient to support claims identifying the compound by such composition or formula. See MPEP § 608.01(p) and MPEP § 2173.05.
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(h) Quantity of experimentation needed to make and/or use (perform) the invention based on the content of the disclosure - predicting whether a recited compound is in fact one that produces a desired physiological effect at a therapeutic concentration and with useful kinetics, is filled with experimental uncertainty, and without proper guidance, would involve a substantial amount of experimentation (Jordan, V. C. Nature Reviews: Drug Discovery, 2, 2003, 205-213). Furthermore, it is unclear, based on the guidance provided by the specification, whether a substituted pyrrolo[2,3-d]pyrimidines of the formula I, such as 3-hydroxy-N-(cis-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)cyclobutyl)propane-1-sulfonamide, shown to the left above, possesses utility as a therapeutic agent, useful in a method of treating or preventing a disease or condition…., comprising administering… a substituted pyrrolo[2,3-d]-pyrimidine of the formula I. Thus, one of ordinary skill in the art, at the time this invention was made, would have an unreasonable expectation of success and undue experimentation in transferring the in vitro and/or in vivo method of treating or preventing a disease or condition…., comprising administering… a substituted pyrrolo[2,3-d]pyrimidine of the formula I, wherein the condition or includes, but is not limited to, inflammation,… and/or Vogt-Koyanagi-Harada syndrome, to any subject population.
A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the invention was filed, would not have taught one skilled in the art how to make and/or use (perform) the full scope of the claimed invention without undue experimentation. {See In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)}.
The determination that undue experimentation would have been needed to make and use the claimed invention is not a single, simple factual determination. Rather, it is a conclusion reached by weighing all the above noted factual considerations. (See In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404). These factual considerations are discussed comprehensively in MPEP § 2164.08 (scope or breadth of the claims), § 2164.05(a) (nature of the invention and state of the prior art), § 2164.05(b) (level of one of ordinary skill), § 2164.03 (level of predictability in the art and amount of direction provided by the inventor or joint inventor), § 2164.02 (the existence of working examples) and § 2164.06 (quantity of experimentation needed to make or use the invention based on the content of the disclosure).
Based on a preponderance of the evidence presented herein, the conclusion that the inventor or joint inventor is insufficiently enabled for making and/or using (performing) a method of treating or preventing a disease or condition…., comprising administering… a substituted pyrrolo[2,3-d]pyrimidine of the formula I, is clearly justified.
The examiner suggests amending the claims, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claim Rejections - 35 U.S.C. § 112(b)
The following is a quotation of the second paragraph of 35 U.S.C. § 112:
(b) CONCLUSION. The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or joint inventor regards as the invention.
Claims 8-10 are rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that a broad limitation together with a narrow limitation that falls within the broad limitation (in the same claim) is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c), MPEP § 2173.05(h), and/or Eli Lilly & Co. v. Teva Parenteral Meds., 845 F.3d 1357, 1371, 121 USPQ2d 1277, 1287 (Fed. Cir. 2017).
Similarly, the inventor or joint inventor should further note that claim 8 recite the broad limitation, numerous broad diseases, and the claim also recites numerous specific diseases, which is the narrower statement of the limitation.
Likewise, the inventor or joint inventor should further note the explanation given by the Board of Patent Appeals and Interferences in Ex parte Wu, 10 USPQ2d 2031, 2033 (Bd. Pat. App. & Inter. 1989), pertaining to where broad language is followed by such as and then narrow language. The Board stated that this can render a claim indefinite by raising a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and consequently, not required, or (b) a required feature of the claim.
Next, the inventor or joint inventor should further note the explanation given by the Board of Patent Appeals and Interferences in the decisions of Ex parte Steigewald, 131 USPQ 74 (Bd. App. 1961); Ex parte Hall, 83 USPQ 38 (Bd. App. 1948); and Ex parte Hasche, 86 USPQ 481 (Bd. App. 1949).
Moreover, the inventor or joint inventor should further note that [C]laims which depend from indefinite claims are also indefinite. {See Ex parte Cordova, 10 USPQ 2d 1949, 1952 (PTO Bd. App. 1989)}.
The examiner suggests amending the claims, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claim 9 is further rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
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The inventor or joint inventor should note that claim 9 recites the limitation, The method according to claim 8, wherein the compound is… (shown to the right), in lines 1-3 of the claim. There is insufficient antecedent basis, in claim 8, for this limitation, with respect to the substituted pyrrolo[2,3-d]pyrimidines of the formula I administered within the method of treating or preventing a disease or condition. According to claim 8, the cis stereoisomer is recited, with respect to the substituted pyrrolo[2,3-d]pyrimidines of the formula I administered within the method of treating or preventing a disease or condition.
The examiner suggests amending the claim, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claim 10 is further rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
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The inventor or joint inventor should note that claim 10 recites the limitation, The method according to claim 8, wherein the compound is… (shown to the right), in lines 1-2 of the claim. There is insufficient antecedent basis, in claim 8, for this limitation, with respect to the substituted pyrrolo[2,3-d]pyrimidines of the formula I administered within the method of treating or preventing a disease or condition. According to claim 8, the cis stereoisomer is recited, with respect to the substituted pyrrolo[2,3-d]pyrimidines of the formula I administered within the method of treating or preventing a disease or condition.
The examiner suggests amending the claim, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claim Rejections - 35 U.S.C. § 112(d)
The following is a quotation of the fourth paragraph of 35 U.S.C. § 112:
(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.
Claim 6 is rejected under 35 U.S.C. § 112(d) 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.
The inventor or joint inventor should note that claim 6 is rejected under 35 U.S.C. § 112(d) because the recitation of a physicochemical property for a compound must result in a further structural limitation in the compound, in order to be further limiting. In the instant dependent claim, the substituted pyrrolo[2,3-d]pyrimidines of the formula I, as recited in claim 1, are in an isolated form. Consequently, since the physicochemical property of the substituted pyrrolo[2,3-d]pyrimidines of the formula I, as recited in claim 1, whereby the substituted pyrrolo[2,3-d]-pyrimidines of the formula I are in an isolated form, fails to result in a further structural limitation to the substituted pyrrolo[2,3-d]pyrimidines of the formula I, as recited in claim 1, and/or fails to include all the limitations of the substituted pyrrolo[2,3-d]pyrimidines of the formula I, as recited in claim 1, it is not given patentable weight and thus, renders the instant dependent claim improperly dependent under 35 U.S.C. § 112(d). {See MPEP § 2111.02; and 37 CFR 1.75(c)}.
Similarly, the inventor or joint inventor should further note that the U.S. Court of Appeals for the Federal Circuit indicated that although the requirements of 35 U.S.C. § 112(d) are related to matters of form, non-compliance with 35 U.S.C. § 112(d) renders the claim unpatentable just as non-compliance with other subsections of 35 U.S.C. § 112 would. {See Pfizer, Inc. v. Ranbaxy Labs., Ltd., 457 F.3d 1284, 1291-92 (Fed. Cir. 2006)}.
Moreover, the inventor or joint inventor should further note that if a dependent claim does not comply with the requirements of 35 U.S.C. § 112(d) the dependent claim should be rejected under 35 U.S.C. § 112(d) as unpatentable rather than objecting to the claim. {See also MPEP § 608.01(n), Section III, Infringement Test for dependent claims}.
The examiner suggests the inventor or joint inventor (1) cancel the dependent claim, (2) amend the dependent claim to place the dependent claim in proper dependent form, (3) rewrite the dependent claim in independent form, or (4) present a sufficient showing that the dependent claim complies with the statutory requirements, to overcome this rejection.
Claim 9 is rejected under 35 U.S.C. § 112(d) 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.
The inventor or joint inventor should note that claim 9 is rejected under 35 U.S.C. § 112(d) because the recitation of a physicochemical property of a compound administered within a method from which the claim depends, must result in a patentably distinct methodical step in the recited method, in order to be further limiting. In the instant dependent claim, (S)-2-hydroxy-N-(3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)cyclobutyl)propane-1-sulfonamide administered within the method of treating or preventing a disease or condition, as recited in claim 8, is in an isolated form. Consequently, since the physicochemical property of (S)-2-hydroxy-N-(3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)cyclobutyl)propane-1-sulfonamide administered within the method of treating or preventing a disease or condition, whereby (S)-2-hydroxy-N-(3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)cyclobutyl)propane-1-sulfonamide administered within the method of treating or preventing a disease or condition is in an isolated form, fails to result in a further patentably distinct methodical step in the method of treating or preventing a disease or condition, as recited in claim 8, and/or fails to include all the limitations of the method of treating or preventing a disease or condition, as recited in claim 8, it is not given patentable weight and thus, renders the instant dependent claim improperly dependent under 35 U.S.C. § 112(d). {See MPEP § 2111.02; and 37 CFR 1.75(c)}.
Similarly, the inventor or joint inventor should further note that the U.S. Court of Appeals for the Federal Circuit indicated that although the requirements of 35 U.S.C. § 112(d) are related to matters of form, non-compliance with 35 U.S.C. § 112(d) renders the claim unpatentable just as non-compliance with other subsections of 35 U.S.C. § 112 would. {See Pfizer, Inc. v. Ranbaxy Labs., Ltd., 457 F.3d 1284, 1291-92 (Fed. Cir. 2006)}.
Moreover, the inventor or joint inventor should further note that if a dependent claim does not comply with the requirements of 35 U.S.C. § 112(d) the dependent claim should be rejected under 35 U.S.C. § 112(d) as unpatentable rather than objecting to the claim. {See also MPEP § 608.01(n), Section III, Infringement Test for dependent claims}.
The examiner suggests the inventor or joint inventor (1) cancel the dependent claim, (2) amend the dependent claim to place the dependent claim in proper dependent form, particularly as stated in the section above entitled Claim Objections, (3) rewrite the dependent claim in independent form, or (4) present a sufficient showing that the dependent claim complies with the statutory requirements, to overcome this rejection.
Claim 10 is rejected under 35 U.S.C. § 112(d) 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.
The inventor or joint inventor should note that claim 10 is rejected under 35 U.S.C. § 112(d) because the recitation of a physicochemical property of a compound administered within a method from which the claim depends, must result in a patentably distinct methodical step in the recited method, in order to be further limiting. In the instant dependent claim, 3-hydroxy-N-(3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)cyclobutyl)propane-1-sulfonamide administered within the method of treating or preventing a disease or condition, as recited in claim 8, is in an isolated form. Consequently, since the physicochemical property of 3-hydroxy-N-(3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)cyclobutyl)propane-1-sulfonamide administered within the method of treating or preventing a disease or condition, whereby 3-hydroxy-N-(3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)cyclobutyl)propane-1-sulfonamide administered within the method of treating or preventing a disease or condition is in an isolated form, fails to result in a further patentably distinct methodical step in the method of treating or preventing a disease or condition, as recited in claim 8, and/or fails to include all the limitations of the method of treating or preventing a disease or condition, as recited in claim 8, it is not given patentable weight and thus, renders the instant dependent claim improperly dependent under 35 U.S.C. § 112(d). {See MPEP § 2111.02; and 37 CFR 1.75(c)}.
Similarly, the inventor or joint inventor should further note that the U.S. Court of Appeals for the Federal Circuit indicated that although the requirements of 35 U.S.C. § 112(d) are related to matters of form, non-compliance with 35 U.S.C. § 112(d) renders the claim unpatentable just as non-compliance with other subsections of 35 U.S.C. § 112 would. {See Pfizer, Inc. v. Ranbaxy Labs., Ltd., 457 F.3d 1284, 1291-92 (Fed. Cir. 2006)}.
Moreover, the inventor or joint inventor should further note that if a dependent claim does not comply with the requirements of 35 U.S.C. § 112(d) the dependent claim should be rejected under 35 U.S.C. § 112(d) as unpatentable rather than objecting to the claim. {See also MPEP § 608.01(n), Section III, Infringement Test for dependent claims}.
The examiner suggests the inventor or joint inventor (1) cancel the dependent claim, (2) amend the dependent claim to place the dependent claim in proper dependent form, particularly as stated in the section above entitled Claim Objections, (3) rewrite the dependent claim in independent form, or (4) present a sufficient showing that the dependent claim complies with the statutory requirements, to overcome this rejection.
Allowable Subject Matter
No claims are allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DOUGLAS M. WILLIS, whose telephone number is 571-270-5757. The examiner may normally be reached on Monday thru Thursday from 8:00-6:00 EST. The examiner is also available on alternate Fridays.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mr. Jeffrey Murray, may be reached on 571-272-9023. The fax phone number for the organization where this invention or proceeding is assigned is 571-273-8300.
Information regarding the status of an invention may be obtained from Patent Center. For more information about Patent Center, see https://www.uspto.gov/patents/apply/patent-center. Should you have questions on access to Patent Center, contact the Patent Electronic Business Center (PEBC) at 866-217-9197 (toll-free) or ebc@uspto.gov.
/DOUGLAS M WILLIS/
Primary Examiner, Art Unit 1624