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 12-30 are pending in the instant invention. According to the Amendments to the Claims, filed October 22, 2024, claims 7 and 9 were amended, claims 1-11 were cancelled and claims 12-30 were added.
Status of Priority
This invention is a Continuation (CON) of US Application No. 17/962,798, filed October 10, 2022 and now US 12,086,788, which is a Divisional (DIV) of US Application No. 16/996,516, filed August 18, 2020 and now US 11,501,284, which is a Continuation (CON) of International Application No. PCT/US2019/018139, filed February 15, 2019, which claims priority under 35 U.S.C. § 119(e) to US Provisional Application No. 62/631,945, filed February 19, 2018.
Restrictions / Election of Species
The forthcoming first Office action and prosecution on the merits includes (1) claims 12 and 13, drawn to (S)-N-(5-((6-(2-(7,7-dimethyl-1-oxo-1,3,4,6,7,8-hexahydro-2H-cyclopenta[4,5]-pyrrolo[1,2-a]pyrazin-2-yl)-3-(hydroxymethyl)pyridin-4-yl)-4-methyl-3-oxo-3,4-dihydropyrazin-2-yl)amino)-2-(2-methyl-4-(tetrahydro-2H-pyran-4-yl))piperazin-1-
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yl)phenyl)acrylamide, shown to the right, and/or a pharmaceutical composition thereof; and (2) claims 14-30, drawn to a method of treating a neoplastic disease, an autoimmune disease, or an inflammatory disorder, comprising administering… (S)-N-(5-((6-(2-(7,7-dimethyl-1-oxo-1,3,4,6,7,8-hexahydro-2H-cyclopenta[4,5]-pyrrolo[1,2-a]pyrazin-2-yl)-3-(hydroxymethyl)pyridin-4-yl)-4-methyl-3-oxo-3,4-dihydropyrazin-2-yl)amino)-2-(2-methyl-4-(tetrahydro-2H-pyran-4-yl))piperazin-1-yl)phenyl)acrylamide, shown to the right above, respectively.
Thus, a first Office action and prosecution on the merits of claims 12-30 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 (S)-N-(5-((6-(2-(7,7-dimethyl-1-oxo-1,3,4,6,7,8-hexa-hydro-2H-cyclopenta[4,5]pyrrolo[1,2-a]pyrazin-2-yl)-3-(hydroxymethyl)pyridin-4-yl)-4-methyl-3-oxo-3,4-dihydropyrazin-2-yl)amino)-2-(2-methyl-4-(tetrahydro-2H-pyran-4-yl))piperazin-1-yl)phenyl)acrylamide.
The following title is suggested: (S)-N-(5-((6-(2-(7,7-DIMETHYL-1-OXO-1,3,4,6,7,8-HEXAHYDRO-2H-CYCLOPENTA[4,5]PYRROLO[1,2-a]PYRAZIN-2-YL)-3-(HYDROXYMETHYL)PYRIDIN-4-YL)-4-METHYL-3-OXO-3,4-DIHYDROPYRAZIN-2-YL)AMINO)-2-(2-METHYL-4-(TETRAHYDRO-2H-PYRAN-4-YL))PIPERAZIN-1-YL)PHENYL)ACRYLAMIDE AS AN INHIBITOR OF BTK, AND MUTANTS THEREOF.
Appropriate correction is required. See MPEP § 2173.02.
Claim Objections
Claim 12 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, wherein the compound is of the following formula:
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,
or a pharmaceutically acceptable salt thereof.
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:
A pharmaceutical composition comprising a pharmaceutically acceptable diluent or carrier and the compound according to claim 12, or a pharmaceutically acceptable salt thereof.
Appropriate correction is required. See MPEP § 2173.02.
Claim 14 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(a), 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation(s):
14. A method for inhibiting Bruton’s tyrosine kinase activity in a subject, wherein the method comprises administering to the subject in need thereof a therapeutically effective amount of the compound according to claim 13, or a pharmaceutically acceptable salt thereof.
31. The method according to claim 14, wherein the subject has a disease or disorder selected from the group consisting of a neoplastic disease, an autoimmune disease, and an inflammatory disorder.
Appropriate correction is required. See MPEP § 2173.02.
Claim 15 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:
32. The method according to claim 31, wherein the neoplastic disease is a B-cell malignancy or a solid tumor.
Appropriate correction is required. See MPEP § 2173.02.
Claim 16 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:
33. The method according to claim 32, wherein the B-cell malignancy or solid tumor is selected from the group consisting of chronic lymphocytic leukemia (CLL), diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), multiple myeloma (MM), and small lymphocytic lymphoma (SLL).
Appropriate correction is required. See MPEP § 2173.02.
Claim 17 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:
34. The method according to claim 32, wherein the B-cell malignancy is chronic lymphocytic leukemia (CLL).
Appropriate correction is required. See MPEP § 2173.02.
Claim 18 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:
35. The method according to claim 32, wherein the B-cell malignancy is small lymphocytic lymphoma (SLL).
Appropriate correction is required. See MPEP § 2173.02.
Claim 19 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:
36. The method according to claim 32, wherein the B-cell malignancy is mantle cell lymphoma (MCL).
Appropriate correction is required. See MPEP § 2173.02.
Claim 20 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:
37. The method according to claim 32, wherein the B-cell malignancy is diffuse large B-cell lymphoma (DLBCL).
Appropriate correction is required. See MPEP § 2173.02.
Claim 21 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:
38. The method according to claim 32, wherein the B-cell malignancy is multiple myeloma (MM).
Appropriate correction is required. See MPEP § 2173.02.
Claim 22 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(s):
39. The method according to claim 31, wherein the neoplastic disease is selected from the group consisting of acute lymphocytic leukemia (ALL), acute myelogenous leukemia (AML), chronic lymphocytic leukemia (CLL), chronic myelogenous leukemia (CML), lymphoma, and multiple myeloma.
40. The method according to claim 39, wherein the lymphoma is selected from the group consisting of B-cell lymphoma, hairy cell lymphoma, Hodgkin’s lymphoma, mantle cell lymphoma (MCL), non-Hodgkin’s lymphoma, and small lymphocytic lymphoma (SLL).
41. The method according to claim 40, wherein the B-cell lymphoma is diffuse large B-cell lymphoma (DLBCL).
Appropriate correction is required. See MPEP § 2173.02.
Claim 23 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:
42. The method according to claim 32, wherein the B-cell malignancy is marginal zone lymphoma.
Appropriate correction is required. See MPEP § 2173.02.
Claim 24 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 according to claim 32, wherein the B-cell malignancy is Waldenstrom’s macroglobulinemia.
Appropriate correction is required. See MPEP § 2173.02.
Claim 25 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:
44. The method according to claim 31, wherein the autoimmune disease or inflammatory disorder is selected from the group consisting of an allergy, asthma, multiple sclerosis, pemphigus vulgaris, rheumatoid arthritis (RA), and systemic lupus erythematosus.
Appropriate correction is required. See MPEP § 2173.02.
Claim 26 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(s):
45. The method according to claim 31, wherein the autoimmune disease or inflammatory disorder is selected from the group consisting of Addison’s disease, an allergy, Alzheimer’s disease, asthma, atherosclerosis, an autoimmune hemolytic state, an autoimmune thrombocytopenic state, chronic idiopathic thrombocytopenic purpura (ITP), Crohn’s disease, dermatomyositis, diabetes, Goodpasture’s syndrome, a hyperacute rejection of a transplanted organ, irritable bowel syndrome, multiple sclerosis, myasthenia gravis, Parkinson’s disease, psoriasis, rheumatoid arthritis, scleroderma, septic shock, Sjogren’s disease, systemic lupus erythematosus, tissue graft rejection, and vasculitis.
46. The method according to claim 45, wherein the Goodpasture’s syndrome is associated with glomerulonephritis or a pulmonary hemorrhage.
47. The method according to claim 45, wherein the systemic lupus erythematosus is associated with glomerulonephritis.
48. The method according to claim 45, wherein the vasculitis is ANCA-associated vasculitis.
Appropriate correction is required. See MPEP § 2173.02.
Claim 27 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 according to claim 45, wherein the autoimmune disease or inflammatory disorder is multiple sclerosis.
Appropriate correction is required. See MPEP § 2173.02.
Claim 28 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 according to claim 45, wherein the autoimmune disease or inflammatory disorder is rheumatoid arthritis.
Appropriate correction is required. See MPEP § 2173.02.
Claim 29 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:
51. The method according to claim 45, wherein the autoimmune disease or inflammatory disorder is systemic lupus erythematosus.
Appropriate correction is required. See MPEP § 2173.02.
Claim 30 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:
52. The method according to claim 45, wherein the autoimmune disease or inflammatory disorder is chronic idiopathic thrombocytopenic purpura (ITP).
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 a neoplastic disease, an autoimmune disease, and an inflammatory disorder, comprising administering… a substituted heterocycle of the Formula (I)
Claims 14-30 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 a neoplastic disease, an autoimmune disease, and an inflammatory disorder, comprising administering… (S)-N-(5-((6-(2-(7,7-dimethyl-1-oxo-1,3,4,6,7,8-hexahydro-2H-cyclopenta[4,5]-pyrrolo[1,2-a]pyrazin-2-yl)-3-(hydroxymethyl)pyridin-4-yl)-4-methyl-3-oxo-3,4-dihydropyrazin-2-yl)amino)-2-(2-methyl-4-(tetrahydro-2H-pyran-4-yl))piperazin-1-yl)phenyl)acrylamide, 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 a neoplastic disease, an autoimmune disease, and an inflammatory disorder, comprising administering… (S)-N-(5-((6-(2-(7,7-dimethyl-1-oxo-1,3,4,6,7,8-hexahydro-2H-cyclopenta[4,5]pyrrolo[1,2-a]pyrazin-2-yl)-3-(hydroxymethyl)pyridin-4-yl)-4-methyl-3-oxo-3,4-dihydropyrazin-2-yl)amino)-2-(2-methyl-4-(tetrahydro-2H-pyran-4-yl))piperazin-1-yl)phenyl)acrylamide, shown to the right;
(b) Nature of the invention - the nature of the invention is performance of a method of treating a neoplastic disease, an autoimmune disease, and an inflammatory disorder, comprising administering… (S)-N-(5-((6-(2-(7,7-dimethyl-1-oxo-1,3,4,6,7,8-hexahydro-2H-cyclopenta[4,5]pyrrolo[1,2-a]pyrazin-2-yl)-3-(hydroxymethyl)pyridin-4-yl)-4-methyl-3-oxo-3,4-dihydropyrazin-2-yl)amino)-2-(2-methyl-4-(tetrahydro-2H-pyran-4-yl))piperazin-1-yl)phenyl)acrylamide, shown to the right above;
(c) State of the prior art - Nature Reviews: Drug Discovery, as provided in the file and cited on the IDS, 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 the myriad of neoplastic diseases, autoimmune diseases, and/or inflammatory disorders in a subject, including, but not limited to, B-cell lymphoma, Hodgkin’s lymphoma, non-Hodgkin’s lymphoma, hairy cell lymphoma, small lymphocytic lymphoma (SLL), mantle cell lymphoma (MCL), multiple myeloma, acute myelogenous leukemia, chronic myelogenous leukemia, acute lymphocytic leukemia, chronic lymphocytic leukemia, psoriasis, allergy, Crohn’s disease, irritable bowel syndrome, Sjogren’s disease, tissue graft rejection, hyperacute rejection of transplanted organs, asthma, systemic lupus erythematosus, glomerulonephritis, dermatomyositis, multiple sclerosis, scleroderma, vasculitis, autoimmune hemolytic and thrombocytopenic states, Goodpasture’s syndrome, atherosclerosis, rheumatoid arthritis, chronic idiopathic thrombo-cytopenic purpura (ITP), Addison’s disease, Parkinson’s disease, Alzheimer’s disease, diabetes, septic shock, and/or myasthenia gravis {See In re Hokum, 226 USPQ 353 (ComrPats 1985)}. Moreover, WO 19/161152, as provided in the file and cited on the IDS, illustrates the synthesis of (S)-N-(5-((6-(2-(7,7-dimethyl-1-oxo-1,3,4,6,7,8-hexahydro-2H-cyclopenta[4,5]pyrrolo[1,2-a]pyrazin-2-yl)-3-(hydroxy-methyl)pyridin-4-yl)-4-methyl-3-oxo-3,4-dihydropyrazin-2-yl)amino)-2-(2-methyl-4-(tetrahydro-2H-pyran-4-yl))piperazin-1-yl)phenyl)acrylamide, and/or methods of use thereof {Y. Chen, WO 19/161152, 2019};
(d) Level of one of ordinary skill in the art - the artisans performing the inventor’s or joint inventor’s method of treating a neoplastic disease, an autoimmune disease, and an inflammatory disorder, comprising administering… (S)-N-(5-((6-(2-(7,7-dimethyl-1-oxo-1,3,4,6,7,8-hexahydro-2H-cyclopenta[4,5]pyrrolo[1,2-a]pyrazin-2-yl)-3-(hydroxymethyl)pyridin-4-yl)-4-methyl-3-oxo-3,4-dihydropyrazin-2-yl)amino)-2-(2-methyl-4-(tetrahydro-2H-pyran-4-yl))piperazin-1-yl)phenyl)acrylamide, 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., as provided in the file and cited on the IDS, 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 a neoplastic disease, an autoimmune disease, and an inflammatory disorder, comprising administering… (S)-N-(5-((6-(2-(7,7-dimethyl-1-oxo-1,3,4,6,7,8-hexahydro-2H-cyclopenta[4,5]-pyrrolo[1,2-a]pyrazin-2-yl)-3-(hydroxymethyl)pyridin-4-yl)-4-methyl-3-oxo-3,4-dihydropyrazin-2-yl)amino)-2-(2-methyl-4-(tetrahydro-2H-pyran-4-yl))piperazin-1-yl)phenyl)acrylamide;
(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 a neoplastic disease, an autoimmune disease, and an inflammatory disorder, comprising administering… (S)-N-(5-((6-(2-(7,7-dimethyl-1-oxo-1,3,4,6,7,8-hexa-hydro-2H-cyclopenta[4,5]pyrrolo[1,2-a]pyrazin-2-yl)-3-(hydroxymethyl)pyridin-4-yl)-4-methyl-3-oxo-3,4-dihydropyrazin-2-yl)amino)-2-(2-methyl-4-(tetrahydro-2H-pyran-4-yl))piperazin-1-yl)phenyl)acrylamide.
Similarly, according to the specification, (S)-N-(5-((6-(2-(7,7-dimethyl-1-oxo-1,3,4,6,7,8-hexahydro-2H-cyclopenta[4,5]pyrrolo[1,2-a]pyrazin-2-yl)-3-(hydroxy-methyl)pyridin-4-yl)-4-methyl-3-oxo-3,4-dihydropyrazin-2-yl)amino)-2-(2-methyl-4-(tetrahydro-2H-pyran-4-yl))piperazin-1-yl)phenyl)acrylamide is capable of treating a variety of neoplastic diseases, autoimmune diseases, and/or inflammatory disorders in a subject, including, but not limited to, B-cell lymphoma, Hodgkin’s lymphoma, non-Hodgkin’s lymphoma, hairy cell lymphoma, small lymphocytic lymphoma (SLL), mantle cell lymphoma (MCL), multiple myeloma, acute myelogenous leukemia, chronic myelogenous leukemia, acute lymphocytic leukemia, chronic lymphocytic leukemia, psoriasis, allergy, Crohn’s disease, irritable bowel syndrome, Sjogren’s disease, tissue graft rejection, hyperacute rejection of transplanted organs, asthma, systemic lupus erythematosus, glomerulonephritis, dermatomyositis, multiple sclerosis, scleroderma, vasculitis, autoimmune hemolytic and thrombocytopenic states, Goodpasture’s syndrome, atherosclerosis, rheumatoid arthritis, chronic idiopathic thrombocytopenic purpura (ITP), Addison’s disease, Parkinson’s disease, Alzheimer’s disease, diabetes, septic shock, and/or myasthenia gravis; however, the specification fails to set forth any convincing in vitro and/or in vivo assays corroborating the alleged activity in association with any neoplastic diseases, autoimmune diseases, and/or inflammatory disorders in a subject, including, but not limited to, B-cell lymphoma, Hodgkin’s lymphoma, non-Hodgkin’s lymphoma, hairy cell lymphoma, small lymphocytic lymphoma (SLL), mantle cell lymphoma (MCL), multiple myeloma, acute myelogenous leukemia, chronic myelogenous leukemia, acute lymphocytic leukemia, chronic lymphocytic leukemia, psoriasis, allergy, Crohn’s disease, irritable bowel syndrome, Sjogren’s disease, tissue graft rejection, hyperacute rejection of transplanted organs, asthma, systemic lupus erythematosus, glomerulonephritis, dermatomyositis, multiple sclerosis, scleroderma, vasculitis, autoimmune hemolytic and thrombocytopenic states, Goodpasture’s syndrome, atherosclerosis, rheumatoid arthritis, chronic idiopathic thrombocytopenic purpura (ITP), Addison’s disease, Parkinson’s disease, Alzheimer’s disease, diabetes, septic shock, and/or myasthenia gravis. There is insufficient disclosure to reasonably conclude that the method of treating a neoplastic disease, an autoimmune disease, and an inflammatory disorder, comprising administering… (S)-N-(5-((6-(2-(7,7-dimethyl-1-oxo-1,3,4,6,7,8-hexahydro-2H-cyclopenta[4,5]pyrrolo[1,2-a]pyrazin-2-yl)-3-(hydroxymethyl)pyridin-4-yl)-4-methyl-3-oxo-3,4-dihydropyrazin-2-yl)amino)-2-(2-methyl-4-(tetrahydro-2H-pyran-4-yl))piperazin-1-yl)phenyl)acrylamide, as recited, would contribute to treatment of any neoplastic diseases, autoimmune diseases, and/or inflammatory disorders in a subject, including, but not limited to, B-cell lymphoma, Hodgkin’s lymphoma, non-Hodgkin’s lymphoma, hairy cell lymphoma, small lymphocytic lymphoma (SLL), mantle cell lymphoma (MCL), multiple myeloma, acute myelogenous leukemia, chronic myelogenous leukemia, acute lymphocytic leukemia, chronic lymphocytic leukemia, psoriasis, allergy, Crohn’s disease, irritable bowel syndrome, Sjogren’s disease, tissue graft rejection, hyperacute rejection of transplanted organs, asthma, systemic lupus erythematosus, glomerulonephritis, dermatomyositis, multiple sclerosis, scleroderma, vasculitis, autoimmune hemolytic and thrombocytopenic states, Goodpasture’s syndrome, atherosclerosis, rheumatoid arthritis, chronic idiopathic thrombocytopenic purpura (ITP), Addison’s disease, Parkinson’s disease, Alzheimer’s disease, diabetes, septic shock, and/or myasthenia gravis. Furthermore, the combination of the instant specification and Y. Chen in WO 19/161152, as provided in the file and cited on the IDS, lacks adequate credible evidence to support the assertion that a method of treating a neoplastic disease, an autoimmune disease, and an inflammatory disorder, comprising administering… (S)-N-(5-((6-(2-(7,7-dimethyl-1-oxo-1,3,4,6,7,8-hexahydro-2H-cyclopenta[4,5]pyrrolo-[1,2-a]pyrazin-2-yl)-3-(hydroxymethyl)pyridin-4-yl)-4-methyl-3-oxo-3,4-dihydro-pyrazin-2-yl)amino)-2-(2-methyl-4-(tetrahydro-2H-pyran-4-yl))piperazin-1-yl)-phenyl)acrylamide, as recited, would contribute to the prophylaxis of any neoplastic diseases, autoimmune diseases, and/or inflammatory disorders in a subject, including, but not limited to, B-cell lymphoma, Hodgkin’s lymphoma, non-Hodgkin’s lymphoma, hairy cell lymphoma, small lymphocytic lymphoma (SLL), mantle cell lymphoma (MCL), multiple myeloma, acute myelogenous leukemia, chronic myelogenous leukemia, acute lymphocytic leukemia, chronic lymphocytic leukemia, psoriasis, allergy, Crohn’s disease, irritable bowel syndrome, Sjogren’s disease, tissue graft rejection, hyperacute rejection of transplanted organs, asthma, systemic lupus erythematosus, glomerulonephritis, dermatomyositis, multiple sclerosis, scleroderma, vasculitis, autoimmune hemolytic and thrombocytopenic states, Goodpasture’s syndrome, atherosclerosis, rheumatoid arthritis, chronic idiopathic thrombo-cytopenic purpura (ITP), Addison’s disease, Parkinson’s disease, Alzheimer’s disease, diabetes, septic shock, and/or myasthenia gravis, 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 method 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 (S)-N-(5-((6-(2-(7,7-dimethyl-1-oxo-1,3,4,6,7,8-hexahydro-2H-cyclopenta[4,5]pyrrolo[1,2-a]pyrazin-2-yl)-3-(hydroxy-methyl)pyridin-4-yl)-4-methyl-3-oxo-3,4-dihydropyrazin-2-yl)amino)-2-(2-methyl-4-(tetrahydro-2H-pyran-4-yl))piperazin-1-yl)phenyl)acrylamide, shown to the left above, possesses utility as a therapeutic agent, useful in a method of treating a neoplastic disease, an autoimmune disease, and an inflammatory disorder, comprising administering… (S)-N-(5-((6-(2-(7,7-dimethyl-1-oxo-1,3,4,6,7,8-hexahydro-2H-cyclopenta[4,5]pyrrolo[1,2-a]pyrazin-2-yl)-3-(hydroxymethyl)pyridin-4-yl)-4-methyl-3-oxo-3,4-dihydropyrazin-2-yl)amino)-2-(2-methyl-4-(tetrahydro-2H-pyran-4-yl))piperazin-1-yl)phenyl)acrylamide. 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 a neoplastic disease, an autoimmune disease, and an inflammatory disorder, comprising administering… (S)-N-(5-((6-(2-(7,7-dimethyl-1-oxo-1,3,4,6,7,8-hexahydro-2H-cyclopenta[4,5]pyrrolo[1,2-a]pyrazin-2-yl)-3-(hydroxymethyl)pyridin-4-yl)-4-methyl-3-oxo-3,4-dihydropyrazin-2-yl)amino)-2-(2-methyl-4-(tetrahydro-2H-pyran-4-yl))piperazin-1-yl)phenyl)acrylamide, wherein the neoplastic disease, autoimmune disease, and/or inflammatory disorder, includes, but is not limited to, B-cell lymphoma, Hodgkin’s lymphoma, non-Hodgkin’s lymphoma, hairy cell lymphoma, small lymphocytic lymphoma (SLL), mantle cell lymphoma (MCL), multiple myeloma, acute myelogenous leukemia, chronic myelogenous leukemia, acute lymphocytic leukemia, chronic lymphocytic leukemia, psoriasis, allergy, Crohn’s disease, irritable bowel syndrome, Sjogren’s disease, tissue graft rejection, hyperacute rejection of transplanted organs, asthma, systemic lupus erythematosus, glomerulonephritis, dermatomyositis, multiple sclerosis, scleroderma, vasculitis, autoimmune hemolytic and thrombocytopenic states, Goodpasture’s syndrome, atherosclerosis, rheumatoid arthritis, chronic idiopathic thrombocytopenic purpura (ITP), Addison’s disease, Parkinson’s disease, Alzheimer’s disease, diabetes, septic shock, and/or myasthenia gravis, 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 a neoplastic disease, an autoimmune disease, and an inflammatory disorder, comprising administering… (S)-N-(5-((6-(2-(7,7-dimethyl-1-oxo-1,3,4,6,7,8-hexahydro-2H-cyclopenta[4,5]-pyrrolo[1,2-a]pyrazin-2-yl)-3-(hydroxymethyl)pyridin-4-yl)-4-methyl-3-oxo-3,4-dihydropyrazin-2-yl)amino)-2-(2-methyl-4-(tetrahydro-2H-pyran-4-yl))piperazin-1-yl)phenyl)acrylamide, 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.
Claim 13 is 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 claim 13 recites the limitation, A pharmaceutical composition comprising the compound… according to claim 1,…, in lines 1-2 of the claim. There is insufficient antecedent basis, in claim 1, for this limitation, with respect to (S)-N-(5-((6-(2-(7,7-dimethyl-1-oxo-1,3,4,6,7,8-hexahydro-2H-cyclopenta[4,5]pyrrolo[1,2-a]-pyrazin-2-yl)-3-(hydroxymethyl)pyridin-4-yl)-4-methyl-3-oxo-3,4-dihydropyrazin-2-yl)amino)-2-(2-methyl-4-(tetrahydro-2H-pyran-4-yl))piperazin-1-yl)phenyl)acrylamide. According to the Amendments to the Claims, filed October 22, 2024, claim 1 was cancelled by the inventor or joint inventor.
The examiner suggests amending the claims, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claims 14-30 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 claim 14 recites the limitation, A method of treating a neoplastic disease, an autoimmune disease, or an inflammatory disorder, comprising administering… the compound… according to claim 1,…, in lines 1-4 of the claim. There is insufficient antecedent basis, in claim 1, for this limitation, with respect to the method of treating a neoplastic disease, an autoimmune disease, or an inflammatory disorder, comprising administering… (S)-N-(5-((6-(2-(7,7-dimethyl-1-oxo-1,3,4,6,7,8-hexahydro-2H-cyclopenta[4,5]-pyrrolo[1,2-a]pyrazin-2-yl)-3-(hydroxymethyl)pyridin-4-yl)-4-methyl-3-oxo-3,4-dihydropyrazin-2-yl)amino)-2-(2-methyl-4-(tetrahydro-2H-pyran-4-yl))piperazin-1-yl)phenyl)acrylamide. According to the Amendments to the Claims, filed October 22, 2024, claim 1 was cancelled by the inventor or joint inventor.
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 22 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.
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 17 recites the broad limitations, (1) lymphoma; and (2) B-cell lymphoma, respectively, and the claim also recites (1) B-cell lymphoma, hairy cell lymphoma, Hodgkin’s lymphoma, mantle cell lymphoma (MCL), non-Hodgkin’s lymphoma, and small lymphocytic lymphoma (SLL); and (2) diffuse large B-cell lymphoma (DLBCL), respectively, which are the narrower statements of the limitations.
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.
Moreover, 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).
The examiner suggests amending the claim, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claim 26 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.
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 26recites the broad limitations, (1) systemic lupus erythematosus; (2) vasculitis; and (3) Goodpasture’s syndrome, respectively, and the claim also recites (1) (and associated glomerulonephritis); (2) (ANCA-associated and other vasculitides); and (3) (and associated glomerulonephritis and pulmonary hemorrhage), respectively, which are the narrower statements of the limitations.
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.
Moreover, 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).
The examiner suggests amending the claim, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claim Rejections - Obviousness-type 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 obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined invention claim is not patentably distinct from the reference claims because the examined invention claim is either anticipated by, or would have been obvious over, the reference claims. {See 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)}.
US Patent No. 12,086,788
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Consequently, claims 12-30 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-23 of US Patent No. 12,086,788. Although the conflicting claims are not identical, they are not patentably distinct from each other because claim 12 in the instant invention recites (S)-N-(5-((6-(2-(7,7-dimethyl-1-oxo-1,3,4,6,7,8-hexahydro-2H-cyclopenta[4,5]pyrrolo[1,2-a]pyrazin-2-yl)-3-(hydroxymethyl)pyridin-4-yl)-4-methyl-3-oxo-3,4-dihydropyrazin-2-yl)amino)-2-(2-methyl-4-(tetrahydro-2H-pyran-4-yl))piperazin-1-yl)phenyl)acrylamide, shown to the left above, which is administered within the method for inhibiting Bruton’s tyrosine kinase activity in a subject, wherein the method comprises administering… a substituted pyrazine of the Formula (I), shown to the right, where Warhead = -CH=CH2; Q1 = -5- or 6-membered aryl; m = 1; R1 = -heterocyclo-alkyl, substituted with two Rd, wherein Rd = -alkyl and Rd = -heterocycloalkyl; W = CRa, wherein Ra = -H; R2 = -alkyl; Y = CRa, wherein Ra = -H; Z1 = CRa, wherein Ra = -H; X = N; R3 = -hydroxy-alkyl; R4 = -H; Q2 = -5- to 7-membered heterocycloalkyl; Q3 = -5-membered heteroaryl; n = 2; and two R5, taken together with the carbon atoms to which they are attached, form a 1,2-cycloalkylene, substituted with two Rd, wherein each Rd = -alkyl, respectively, as recited in claim 1 of US 12,086,788.
The inventor or joint inventor should note that [T]he discovery of a previously unappreciated property of a prior art compound, or of a scientific explanation for the prior art’s functioning, does not render the old compound patentably new to the discoverer. {See Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999)}.
Similarly, the inventor or joint inventor should further note that [T]he claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. {See In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977); and In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004)}.
Likewise, the inventor or joint inventor should note that [W]hen the claim recites using an old compound and the use is directed to a result or property of that compound, then the claim is anticipated. {See In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978); and In re Tomlinson, 363 F.2d 928, 150 USPQ 623 (CCPA 1966)}.
Next, the inventor or joint inventor should further note that [P]roducts of identical chemical composition may not have mutually exclusive properties. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties the inventor or joint inventor discloses and/or claims are necessarily present. {See In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990)}.
Moreover, the inventor or joint inventor should further note that [A] claim to a method of using a composition is not patentably distinct from an earlier claim to the identical composition in a patent disclosing the identical use. {See Sun Pharmaceuticals Industries Ltd. v. Eli Lilly and Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010); Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d 1353, 1363, 86 USPQ2d 1001 (Fed. Cir. 2008); and Geneva
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Pharmaceuticals, Inc. v. GlaxoSmithKline PLC,
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349 F.3d 1373, 68 USPQ2d 1865, (Fed. Cir. 2003)}.
US Patent No. 11,501,284
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At least claims 12 and 13 are further rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over at least claim 5 of US Patent No. 11,501,284. Although the conflicting claims are not identical, they are not patentably distinct from each other because claim 5 in US 11,501,284 recites (S)-N-(5-((6-(2-(7,7-dimethyl-1-oxo-1,3,4,6,7,8-hexahydro-2H-cyclopenta[4,5]pyrrolo[1,2-a]pyrazin-2-yl)-3-(hydroxymethyl)-pyridin-4-yl)-4-methyl-3-oxo-3,4-dihydropyrazin-2-yl)amino)-2-(2-methyl-4-(tetrahydro-2H-pyran-4-yl))piperazin-1-yl)phenyl)acrylamide, shown to the left above, which provides overlapping subject matter with respect to the instantly recited (S)-N-(5-((6-(2-(7,7-dimethyl-1-oxo-1,3,4,6,7,8-hexahydro-2H-cyclopenta[4,5]pyrrolo[1,2-a]pyrazin-2-yl)-3-(hydroxymethyl)pyridin-4-yl)-4-methyl-3-oxo-3,4-dihydropyrazin-2-yl)amino)-2-(2-methyl-4-(tetra-hydro-2H-pyran-4-yl))piperazin-1-yl)phenyl)acrylamide, shown to the right above.
The inventor or joint inventor should note that [I]t is obvious to add a carrier or solvent to an unpatentable compound. {See Ex parte Douros and Vanderweff, 163 USPQ 667, (BPAI 1968)}.
US Application No. 17/431,460
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At least claims 12 and 13 are further rejected on the ground of nonstatutory obviousness- type double patenting as being unpatentable over at least claims 1 and 6 of copending US Application No. 17/431,460. Although the conflicting claims are not identical, they are not patentably distinct from each other because claim 1 in the copending invention recites a substituted pyrazine of the Formula (III), shown to the left above, where R0 = -H; Q1 = -phenyl; m = 1; R1 = -heterocycloalkyl, substituted with two Rd, wherein Rd = -alkyl and Rd = -heterocycloalkyl; R7 = -alkyl; R3 = -hydroxymethyl; R4 = -H; Q2 = -piperazinyl; i = 0; Q3 = -pyrrolyl; n = 2; and two R5, taken together
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with the carbon atoms to which they are attached, form a 1,2-cycloalkylene, substituted with two Rd, wherein each Rd = -alkyl, respectively, which provides overlapping subject matter, with respect to the instantly recited (S)-N-(5-((6-(2-(7,7-dimethyl-1-oxo-1,3,4,6,7,8-hexa-hydro-2H-cyclopenta[4,5]pyrrolo[1,2-a]pyrazin-2-yl)-3-(hydroxymethyl)pyridin-4-yl)-4-methyl-3-oxo-3,4-dihydropyrazin-2-yl)amino)-2-(2-methyl-4-(tetrahydro-2H-pyran-4-yl))piperazin-1-yl)phenyl)acrylamide, shown to the right above.
The inventor or joint inventor should note that this is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Similarly, the inventor or joint inventor should further note that a timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 37 CFR 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground, provided the conflicting invention or patent either is shown to be commonly owned with this invention, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Likewise, the inventor or joint inventor should further note that the USPTO internet Web site contains terminal disclaimer forms which may be used, and the inventor or joint inventor is encouraged to visit http://www.uspto.gov/forms/, where (i) the filing date of the invention will determine what form should be used, and (ii) a web-based eTerminal Disclaimer may be filled out completely online using web-screens, respectively.
Moreover, the inventor or joint inventor should further note that an eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission.
Finally, for more information about eTerminal Disclaimers, the inventor or joint inventor should refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
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
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