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 .
DETAILED ACTION
This final office action is replacing the previous non-final office action mailed on 7/21/2026, which has been vacated.
Status of Claims
Claims 1-17 are pending.
Claim Rejections - 35 USC § 112 (b)
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 3 and 7 recite “sustained glycemic control (HbA1c <7%)”. It is unclear whether the feature enclosed in the parenthesis is (a) merely exemplary, and therefore not required, or (b) a required feature of the claim. See MPEP § 2173.05(d).
For examination purpose, the feature (HbA1c <7%) enclosed in the parenthesis is interpreted as not required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-7 and 9-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gallwitz et al. (Lancet, 380:475-483, published online June 28, 2012, with supplementary appendix). The copies of Gallwitz et al. and its supplementary appendix are not provided because they were provided during the prosecution of the parent case, 17/260235.
As to claims 1, 5, 7, and 17, Gallwitz et al. disclose a controlled trial regarding 2-year efficacy and safety of linagliptin compared with glimepiride in patients with type 2 diabetes wherein linagliptin was associated with significantly fewer cardiovascular events including CV death, non-fatal stroke, non-fatal myocardial infarction, and hospitalization for unstable angina compared with glimepiride (Summary and Figure 3), which reads on “does not increase the risk of CV event as claimed. Gallwitz et al. disclose that most participants received other treatments in addition to study drugs, most commonly antihypertensive agents, lipid-lowering agents, and aspirin, and the prescription pattern was similar in both treatment groups (p478, col 2, para 4). Gallwitz et al. further disclose that the treatment with linagliptin does not increase risk of death from all cause compared to a patient treated with glimepiride (Table 3).
As to claims 3, 7, and 12-13, Gallwitz et al. disclose that in patients with type 2 diabetes inadequately controlled on metformin, linagliptin was non-inferior to glimepiride in lowering HbA1c, but was associated with significantly less hypoglycaemia and weight loss (p481, col 1, para 2 and Table 3). Gallwitz et al. further disclose that the linagliptin caused significant and sustained reductions in HbA1c as add-on to metformin (p481, col 1, para 4). Gallwitz et al. further disclose that the completers cohorts remain in the study without the use of rescue treatment, meeting specific glycemic target (p478, col 1, para 1 and p481, col 1, para 4). Gallwitz et al. state that present guidelines recommend that HbA1c goals of less than 7% should be individually tailored for most adults with diabetes (p481, col 1, para 3).
As to claims 9-11 and 14-15, Gallwitz et al. also disclose that baseline cardiovascular risk factors such as hypertension, smoking, dyslipidemia, mild or moderate renal insufficiency (impaired renal function) are identified in the study participants before treating with linagliptin (see appendix p1, Baseline cardiovascular characteristics in the TS). Thus, the diabetic patients of the prior art include those at increased or high cardiovascular risk based on two or more CV risk factor such as hypertension, smoking, dyslipidemia, mild, or moderate renal insufficiency and the prior art implicitly discloses the step of identifying patients at increased or high risk of CV events prior to treatment with linagliptin.
As to claim 16, Gallwitz et al. specifically disclose administering 5 mg of linagliptin once daily to patients with type 2 diabetes (Summary, Methods).
As to the odd ratio and hazard ratio recited in claims 2, 4 and 6, those are intended results of the active method step (i.e., administering linagliptin to type 2 diabetic patients at high or increased risk of major adverse cardiovascular events), and as such are non-limiting since the language does not result in manipulative difference in method steps of the claims. The prior art teaches the same method step, i.e., administering the same compound (linagliptin) in the same amount (daily dose of 5 mg) to the same patient population (type 2 diabetic patients at high or increased risk of major adverse cardiovascular events as claimed, the linagliptin treatment of the prior art would necessarily result in the claimed intended results, odd ratio and hazard ratio when compared with glimepiride. It should be noted that products of identical chemical composition cannot exert mutually exclusive properties when prepared or used in the same manner under the same circumstances. In other words, if the prior art teaches the identical chemical or physical structure of the composition, and the composition is used in the same manner (i.e., administered in the same manner to the same subject, in the same therapeutically effective amount) the properties that Applicant discloses and/or claims is necessarily present. “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art' s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir.1999). Thus the 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. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). “[N]ewly discovered results of known processes directed to the same purpose are not patentable." Bristol-Myers Squibb, 246 F.3d at 1376. Also, see In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980) (a case indicating that the burden of proof can be shifted to the applicant to show that the subject matter of the prior art does not possess the characteristic relied on whether the rejection is based on inherency under 35 U.S.C.102 or obviousness under 35 U.S.C. 103).
As such, the instant claims are anticipated by Gallwitz et al.
Claims 1-17 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by US2016/0089373 (hereafter, Johansen).
Johansen teaches a method of reducing the risk of and/or delays the occurrence of: a cardio- or cerebrovascular disease or event selected from the group consisting of cardiovascular (CV) death (fatal stroke, fatal myocardial infarction, fatal heart failure, cardiogenic shock and sudden death), non-fatal stroke, non-fatal myocardial infarction (MI), and hospitalization for unstable angina pectoris, comprising administering linagliptin in a dose of 5 mg to a type 2 diabetic patient, optionally in combination with one or more other active agents ([0021], [0027]-[0028], [0445], and claims 1, 3-4, 13-14).
Johansen teaches the present invention relates to a method of therapy of a patient with type 1 or type 2 diabetes who is at high risk of CV events such as a patient having: abuminuria (e.g. micro- or macro-abuminuria), previous macrovascular (e.g. cardio- or cerebrovascular) disease (such as e.g. myocardial infarction, coronary artery disease, (ischemic or haemorrhagic) stroke, carotid artery disease and/or peripheral artery disease), mild or moderate renal impairment, moderate or severe renal impairment ([0027], [0031], [0386]-[0397]).
Johansen further teaches that a patient at high vascular risk (e.g. at high risk of CV events) may be particularly type 2 diabetes patients with one or more of the following CV risk factors A), B), C) and/or D): A) previous vascular disease, such as myocardial infarction (e.g. within previous 6 weeks), coronary artery disease (e.g. >=50% luminal diameter narrowing of left main coronary artery or in at least two major coronary arteries in angiogram), percutaneous coronary intervention (e.g. within previous 6 weeks), coronary artery by-pass grafting (e.g. within previous 4 years or with recurrent angina following surgery), ischemic or hemorrhagic stroke (e.g. within previous 3 months), peripheral occlusive arterial disease (e.g. previous limb bypass surgery or percutaneous transluminal angioplasty; previous limb or foot amputation due to circulatory insufficiency, angiographic or ultrasound detected significant vessel stenosis (>50%) of major limb arteries (common iliac artery, internal iliac artery, external iliac artery, femoral artery, popliteal artery), history of intermittent claudication, with an ankle:arm blood pressure ratio <0.90 on at least one side), B) vascular related end-organ damage, such as impaired renal function (e.g. moderately impaired renal function e.g. as defined by MDRD formula, with eGFRF 30-59 mL/min/1.73 m2), micro- or macroalbuminuria (e.g. microalbuminuria, or random spot urinary abumin:creatinine ratio >/=30 μg/mg), retinopathy (e.g. proliferative retinopathy, or retinal neovascularisation or previous retinal laser coagulation therapy), C) elderly (e.g. age >/=70 years), D) at least two of the following CV risk factors: advanced type 2 diabetes mellitus (e.g. >10 years duration), hypertension (e.g. systolic blood pressure >140 mmHg or on at least one blood pressure lowering treatment), current daily cigarette smoking, (atherogenic) dyslipidemia or high LDL cholesterol blood levels (e.g. LDL cholesterol >/=135 mg/dL) or on at least one treatment for lipid abnormality ([0096]-[0112]). Thus, the prior art implicitly discloses the step of identifying patients at increased or high risk of CV events based on the above CV risk factors prior to treatment with linagliptin.
As to claim 8, Johansen teaches that for primary prevention of CV events or reducing the risk thereof, the duration of treatment with linagliptin is at least 5-6 years or at least 7-10 years ([0027], [0465] and [0466]), which reads on “at least 5.85 years” and/or observed for at least 6.25 years as claimed.
As to claims 12-13, Johansen discloses that the diabetes patients include drug-naïve patients or those with inadequate glycemic control on one, two or more conventional oral and/or non-oral antidiabetic drugs such as patients with insufficient glycemic control despite (mono-therapy with metformin ([0323]). Johansen further discloses that linagliptin is used as mono-therapy or in add-on combination therapy with one or two conventional antidiabetic agents ([0326]-[330] and claim 19).
In addition, Johansen states that therapeutic success can be found in greater proportion of patients on study treatment at study end maintain glycemic control (e.g., HbA1c </=7%) without need for additional antidiabetic medication ([0716] and [0717]) and additional therapeutic success can be found in lower change from baseline in body weight or greater proportion of patients with ≦2% weight gain ([0719]).
While the prior art does not specifically disclose the treatment results of linagliptin compared with glimepiride as recited in claims 1, 3, 5, 7, and 17 and the odd ratio and hazard ratio recited in claims 2, 4 and 6, those are intended results of the active method step (i.e., administering linagliptin to type 2 diabetic patients at high or increased risk of major adverse cardiovascular events), and as such are non-limiting since the language does not result in manipulative difference in method steps of the claims. The prior art teaches the same method step, i.e., administering the same compound (linagliptin) in the same amount (daily dose of 5 mg) to the same patient population (type 2 diabetic patients at high or increased risk of major adverse cardiovascular events as claimed, the linagliptin treatment of the prior art would necessarily result in the claimed intended results, odd ratio and hazard ratio when compared with glimepiride. It should be noted that products of identical chemical composition cannot exert mutually exclusive properties when prepared or used in the same manner under the same circumstances. In other words, if the prior art teaches the identical chemical or physical structure of the composition, and the composition is used in the same manner (i.e., administered in the same manner to the same subject, in the same therapeutically effective amount) the properties that Applicant discloses and/or claims is necessarily present. “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art' s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir.1999). Thus the 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. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). “[N]ewly discovered results of known processes directed to the same purpose are not patentable." Bristol-Myers Squibb, 246 F.3d at 1376. Also, see In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980) (a case indicating that the burden of proof can be shifted to the applicant to show that the subject matter of the prior art does not possess the characteristic relied on whether the rejection is based on inherency under 35 U.S.C.102 or obviousness under 35 U.S.C. 103.
As such, the instant claims are anticipated by Johansen.
Claim Rejections - 35 USC § 103
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-17 are rejected under 35 U.S.C. 103 as being unpatentable over Gallwitz et al. (Lancet, 2012 Aug 4;380:475-483) in view of US2016/0089373 (hereafter, Johansen).
Gallwitz et al. as applied supra is herein applied for the same teachings in their entirety.
Gallwitz et al. does not specifically disclose that the patient is exposed to treatment for at least 5.86 years and/or observed for at least 6.25 years recited in claim 8.
However, Johansen teaches a method of reducing the risk of and/or delays the occurrence of: a cardio- or cerebrovascular disease or event selected from the group consisting of cardiovascular (CV) death (fatal stroke, fatal myocardial infarction, fatal heart failure, cardiogenic shock and sudden death), non-fatal stroke, non-fatal myocardial infarction (MI), and hospitalization for unstable angina pectoris, comprising administering linagliptin in a dose of 5 mg to a type 2 diabetic patient, optionally in combination with one or more other active agents ([0021], [0027]-[0028], [0445], claim 1, 3-4, 13-14). Johansen further teaches that for primary prevention of CV events or reducing the risk thereof, the duration of treatment with linagliptin is at least 5-6 years or at least 7-10 years ([0027], [0465] and [0466]), which reads on “at least 5.85 years” and/or observed for at least 6.25 years as claimed.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use linagliptin and observe its efficacy and safety for a longer duration because 2-year efficacy and safety of linagliptin has been demonstrated in patients with type 2 diabetes compared with glimepiride as evidenced by Gallwitz et al. The skilled artisan would know that diabetic therapy is long term. Also, Johansen teaches and suggest the duration of treatment with linagliptin can be at least 5-6 years or at least 7-10 years for primary prevention of CV events or reducing the risk thereof. Thus, one of ordinary skill in the art would have been motivated to do so on the reasonable expectation that the long-term treatment with linagliptin would provide similar efficacy and would not increase the risk of the cardiovascular evets compared with glimepiride in the absence of evidence to the contrary.
Double Patenting Rejections
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-17 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-28 of co-pending application 18/800173.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims of ‘173 application are also drawn to a method for treating a type 2 diabetes patient without increasing the risk of cardiovascular events such as cardiovascular death, nonfatal myocardial infarction (MI), and nonfatal stroke, comprising administering linagliptin in an amount of 5 mg per day, optionally in combination with one or more other active agents, to a patient in need thereof, wherein treatment of said patient with linagliptin does not increase the risk of one or more cardiovascular events compared to a patient treated with placebo, wherein the patient is identified to be at high or increased risk of cardiovascular and/or renal events, prior to treatment with linagliptin and the patient is treated with linagliptin over at least for 2.2 years.
While the claims of the co-pending application do not specifically disclose the treatment results of linagliptin compared with glimepiride as recited in claims 1, 3, 5, 7, and 17 and the odd ratio and hazard ratio recited in claims 2, 4 and 6, those are intended results of the active method step (i.e., administering linagliptin to type 2 diabetic patients at high or increased risk of major adverse cardiovascular events), and as such are non-limiting since language does not result in manipulative difference in method steps of claims. The claims of the co-pending application teach the same method step, i.e., administering the same compound (linagliptin) in the same amount (daily dose of 5 mg) to the same patient population (type 2 diabetic patients at high or increased risk of major adverse cardiovascular events) as claimed, thus the linagliptin treatment as recited in the claims of the co-pending application would necessarily result in the claimed intended results, odd ratio and hazard ratio when compared with glimepiride. It should be noted that products of identical chemical composition cannot exert mutually exclusive properties when prepared or used in the same manner under the same circumstances. In other words, if the identical chemical or physical structure of the composition is used in the same manner (i.e., administered in the same manner to the same subject, in the same therapeutically effective amount), the properties that Applicant discloses and/or claims is necessarily present. “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art' s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir.1999). Thus the 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. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). “[N]ewly discovered results of known processes directed to the same purpose are not patentable." Bristol-Myers Squibb, 246 F.3d at 1376. Also, see In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980) (a case indicating that the burden of proof can be shifted to the applicant to show that the subject matter of the prior art does not possess the characteristic relied on whether the rejection is based on inherency under 35 U.S.C.102 or obviousness under 35 U.S.C. 103.
As such, the instant claims are anticipated by or would have been obvious over the claims of the co-pending application.
Claims 1-17 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-15 of co-pending application 18/907618.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims of ‘618 application are drawn to a method for reducing the risk of and/or delays the occurrence of: a cardio- or cerebrovascular disease or event, including CV death, non-fatal stroke, non-fatal myocardial infarction, and hospitalization for unstable angina in a type 2 diabetes patient, comprising administering linagliptin in an amount of 5 mg per day, wherein the patient is naive or exhibits insufficient glycemic control despite therapy with one or more antidiabetic agents or the patient has increased or high risk of CV events based on the same risk factor as claimed, and the patient is treated with linagliptin, optionally in combination with one or more other active agents, over least 2 years.
While the claims of the co-pending application do not specifically disclose the treatment results of linagliptin compared with glimepiride as recited in claims 1, 3, 5, 7, and 17 and the odd ratio and hazard ratio recited in claims 2, 4 and 6, those are intended results of the active method step (i.e., administering linagliptin to type 2 diabetic patients at high or increased risk of major adverse cardiovascular events), and as such are non-limiting since language does not result in manipulative difference in method steps of claims. The claims of the co-pending application teach the same method step, i.e., administering the same compound (linagliptin) in the same amount (daily dose of 5 mg) to the same patient population (type 2 diabetic patients at high or increased risk of major adverse cardiovascular events) as claimed, thus the linagliptin treatment as recited in the claims of the co-pending application would necessarily result in the claimed intended results, odd ratio and hazard ratio when compared with glimepiride. It should be noted that products of identical chemical composition cannot exert mutually exclusive properties when prepared or used in the same manner under the same circumstances. In other words, if the identical chemical or physical structure of the composition is used in the same manner (i.e., administered in the same manner to the same subject, in the same therapeutically effective amount), the properties that Applicant discloses and/or claims is necessarily present. “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art' s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir.1999). Thus the 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. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). “[N]ewly discovered results of known processes directed to the same purpose are not patentable." Bristol-Myers Squibb, 246 F.3d at 1376. Also, see In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980) (a case indicating that the burden of proof can be shifted to the applicant to show that the subject matter of the prior art does not possess the characteristic relied on whether the rejection is based on inherency under 35 U.S.C.102 or obviousness under 35 U.S.C. 103).
As such, the instant claims would have been obvious variants of the claims of the co-pending application.
Claims 1-17 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-23 of US patent 10155000.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims of the patent are drawn to a method for using linagliptin for treating type 2 diabetes and reducing the risk of and/or delaying the occurrence of a cardio- or cerebrovascular complication or event selected from: cardiovascular (CV) death (including fatal stroke, fatal myocardial infarction and sudden death), non-fatal stroke, non-fatal myocardial infarction (MI) and, optionally, hospitalization for unstable angina wherein the 5 mg daily dose is administered as 2.5 mg linagliptin twice daily or 5 mg linagliptin once daily.
While the claims of the patent do not specifically disclose the treatment results of linagliptin compared with glimepiride as recited in claims 1, 3, 5, 7, and 17 and the odd ratio and hazard ratio recited in claims 2, 4 and 6, those are intended results of the active method step (i.e., administering linagliptin to type 2 diabetic patients), and as such are non-limiting since language does not result in manipulative difference in method steps of claims. The claims of the patent teach the same method step, i.e., administering the same compound (linagliptin) in the same amount (daily dose of 5 mg) to the same patient population (type 2 diabetic patients) as claimed, thus the linagliptin treatment as recited in the claims of the patent would necessarily result in the claimed intended results, odd ratio and hazard ratio when compared with glimepiride. It should be noted that products of identical chemical composition cannot exert mutually exclusive properties when prepared or used in the same manner under the same circumstances. In other words, if the identical chemical or physical structure of the composition is used in the same manner (i.e., administered in the same manner to the same subject, in the same therapeutically effective amount), the properties that Applicant discloses and/or claims is necessarily present. “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art' s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir.1999). Thus the 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. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). “[N]ewly discovered results of known processes directed to the same purpose are not patentable." Bristol-Myers Squibb, 246 F.3d at 1376. Also, see In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980) (a case indicating that the burden of proof can be shifted to the applicant to show that the subject matter of the prior art does not possess the characteristic relied on whether the rejection is based on inherency under 35 U.S.C.102 or obviousness under 35 U.S.C. 103).
As such, the instant claims are anticipated or would have been obvious over the claims of the patent.
Claims 1-17 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-2 of US patent 10080754.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims of the patent are drawn to a method for treating type 2 diabetes in a patient with heart failure, comprising administering 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine (known as linagliptin) in an amount of 5 mg per day with digoxin (other active agent). Since the patient of the patent has heart failure, the patient of the patent is at high or increased risk of major adverse cardiovascular events as claimed.
While the claims of the patent do not specifically disclose the treatment results of linagliptin compared with glimepiride as recited in claims 1, 3, 5, 7, and 17 and the odd ratio and hazard ratio recited in claims 2, 4 and 6, those are intended results of the active method step (i.e., administering linagliptin to type 2 diabetic patients), and as such are non-limiting since language does not result in manipulative difference in method steps of claims. The claims of the patent teach the same method step, i.e., administering the same compound (linagliptin) in the same amount (daily dose of 5 mg) to the same patient population (type 2 diabetic patients) as claimed, thus the linagliptin treatment as recited in the claims of the patent would necessarily result in the claimed intended results, odd ratio and hazard ratio when compared with glimepiride. It should be noted that products of identical chemical composition cannot exert mutually exclusive properties when prepared or used in the same manner under the same circumstances. In other words, if the identical chemical or physical structure of the composition is used in the same manner (i.e., administered in the same manner to the same subject, in the same therapeutically effective amount), the properties that Applicant discloses and/or claims is necessarily present. “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art' s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir.1999). Thus the 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. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). “[N]ewly discovered results of known processes directed to the same purpose are not patentable." Bristol-Myers Squibb, 246 F.3d at 1376. Also, see In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980) (a case indicating that the burden of proof can be shifted to the applicant to show that the subject matter of the prior art does not possess the characteristic relied on whether the rejection is based on inherency under 35 U.S.C.102 or obviousness under 35 U.S.C. 103.
As such, the instant claims are anticipated by or would have been obvious over the claims of the patent.
Claims 1-17 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-14 of US patent 9486526.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims of the patent are drawn to a method for treating type 2 diabetes in a patient having moderate or severe chronic renal impairment or end-stage renal disease, comprising administering 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine (known as linagliptin) in an amount of 5 mg per day. Since the patient of the patent has moderate or severe chronic renal impairment or end-stage renal disease, the patient is at high or increased risk of major adverse cardiovascular events as claimed.
While the claims of the patent do not specifically disclose the treatment results of linagliptin compared with glimepiride as recited in claims 1, 3, 5, 7, and 17 and the odd ratio and hazard ratio recited in claims 2, 4 and 6, those are intended results of the active method step (i.e., administering linagliptin to type 2 diabetic patients), and as such are non-limiting since language does not result in manipulative difference in method steps of claims. The claims of the patent teach the same method step, i.e., administering the same compound (linagliptin) in the same amount (daily dose of 5 mg) to the same patient population (type 2 diabetic patients) as claimed, thus the linagliptin treatment as recited in the claims of the patent would necessarily result in the claimed intended results, odd ratio and hazard ratio when compared with glimepiride. It should be noted that products of identical chemical composition cannot exert mutually exclusive properties when prepared or used in the same manner under the same circumstances. In other words, if the identical chemical or physical structure of the composition is used in the same manner (i.e., administered in the same manner to the same subject, in the same therapeutically effective amount), the properties that Applicant discloses and/or claims is necessarily present. “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art' s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir.1999). Thus the 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. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). “[N]ewly discovered results of known processes directed to the same purpose are not patentable." Bristol-Myers Squibb, 246 F.3d at 1376. Also, see In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980) (a case indicating that the burden of proof can be shifted to the applicant to show that the subject matter of the prior art does not possess the characteristic relied on whether the rejection is based on inherency under 35 U.S.C.102 or obviousness under 35 U.S.C. 103.
As such, the instant claims are anticipated by or would have been obvious over the claims of the patent.
Claims 1-17 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-20 of US patent 10022379 in view of US2016/0089373 (hereafter, Johansen).
Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims of the patent are drawn to a method for treating type 2 diabetes, comprising administering 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine (known as linagliptin) in an amount of 5 mg per day with metformin. The claims of the patent are silent about the patient being at high or increased risk of major adverse cardiovascular events as claimed. However, it would have been prima facie obvious to use linagliptin for those having high or increased risk of major adverse cardiovascular events because linagliptin is taught to reduce the risk of and/or delays the occurrence of: a cardio- or cerebrovascular disease or event selected from the group consisting of cardiovascular (CV) death (fatal stroke, fatal myocardial infarction, fatal heart failure, cardiogenic shock and sudden death), non-fatal stroke, non-fatal myocardial infarction (MI), and hospitalization for unstable angina pectoris in claimed patients as evidenced by Johansen (see details in the 102 rejection above).
While the claims of the patent do not specifically disclose the treatment results of linagliptin compared with glimepiride as recited in claims 1, 3, 5, 7, and 17 and the odd ratio and hazard ratio recited in claims 2, 4 and 6, those are intended results of the active method step (i.e., administering linagliptin to type 2 diabetic patients), and as such are non-limiting since language does not result in manipulative difference in method steps of claims. The claims of the patent teach the same method step, i.e., administering the same compound (linagliptin) in the same amount (daily dose of 5 mg) to the same patient population (type 2 diabetic patients) as claimed, thus the linagliptin treatment as recited in the claims of the patent would necessarily result in the claimed intended results, odd ratio and hazard ratio when compared with glimepiride. It should be noted that products of identical chemical composition cannot exert mutually exclusive properties when prepared or used in the same manner under the same circumstances. In other words, if the identical chemical or physical structure of the composition is used in the same manner (i.e., administered in the same manner to the same subject, in the same therapeutically effective amount), the properties that Applicant discloses and/or claims is necessarily present. “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art' s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir.1999). Thus the 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. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). “[N]ewly discovered results of known processes directed to the same purpose are not patentable." Bristol-Myers Squibb, 246 F.3d at 1376. Also, see In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980) (a case indicating that the burden of proof can be shifted to the applicant to show that the subject matter of the prior art does not possess the characteristic relied on whether the rejection is based on inherency under 35 U.S.C.102 or obviousness under 35 U.S.C. 103).
As such, the instant claims would have been obvious over the claims of the patent.
Claims 1-17 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-22 of US patent 9173859 in view of US2016/0089373 (hereafter, Johansen).
Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims of the patent are drawn to a method for treating type 2 diabetes, comprising administering 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine (known as linagliptin) in an amount of 5 mg per day with metformin.
The claims of the patent are silent about the patient being at high or increased risk of major adverse cardiovascular events as claimed. However, it would have been prima facie obvious to use linagliptin for those having high or increased risk of major adverse cardiovascular events because linagliptin is taught to reduce the risk of and/or delays the occurrence of: a cardio- or cerebrovascular disease or event selected from the group consisting of cardiovascular (CV) death (fatal stroke, fatal myocardial infarction, fatal heart failure, cardiogenic shock and sudden death), non-fatal stroke, non-fatal myocardial infarction (MI), and hospitalization for unstable angina pectoris in claimed patients as evidenced by Johansen (see details in the 102 rejection).
While the claims of the patent do not specifically disclose the treatment results of linagliptin compared with glimepiride as recited in claims 1, 3, 5, 7, and 17 and the odd ratio and hazard ratio recited in claims 2, 4 and 6, those are intended results of the active method step (i.e., administering linagliptin to type 2 diabetic patients), and as such are non-limiting since language does not result in manipulative difference in method steps of claims. The claims of the patent teach the same method step, i.e., administering the same compound (linagliptin) in the same amount (daily dose of 5 mg) to the same patient population (type 2 diabetic patients) as claimed, thus the linagliptin treatment as recited in the claims of the patent would necessarily result in the claimed intended results, odd ratio and hazard ratio when compared with glimepiride. It should be noted that products of identical chemical composition cannot exert mutually exclusive properties when prepared or used in the same manner under the same circumstances. In other words, if the identical chemical or physical structure of the composition is used in the same manner (i.e., administered in the same manner to the same subject, in the same therapeutically effective amount), the properties that Applicant discloses and/or claims is necessarily present. “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art' s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir.1999). Thus the 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. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). “[N]ewly discovered results of known processes directed to the same purpose are not patentable." Bristol-Myers Squibb, 246 F.3d at 1376. Also, see In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980) (a case indicating that the burden of proof can be shifted to the applicant to show that the subject matter of the prior art does not possess the characteristic relied on whether the rejection is based on inherency under 35 U.S.C.102 or obviousness under 35 U.S.C. 103.
As such, the instant claims would have been obvious over the claims of the patent.
Conclusion
No claims are allowed.
This is a continuation of applicant's earlier Application No. 17/260235. All claims are drawn to the same invention claimed in the earlier application and could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the earlier application. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action in this case. See MPEP § 706.07(b). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no, however, event will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/BONG-SOOK BAEK/
Primary Examiner, Art Unit 1611
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