DETAILED ACTION
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 .
Please note that “use” claims are not accepted in US practice. Claims were interpreted as methods for examination, however, proper amendment of the claims to recite methods of use are required.
Election/Restrictions
Applicant’s election without traverse of Group I, drawn to the use of NRG in the manufacture of a medicament for the treatment of heart failure claimed in claims 1-4 in the reply filed on 2/3/26 is acknowledged. After further consideration, claims 5-7 (Group II) are rejoined.
Claims 8-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim.
Claims 1-10 are pending.
Claims 1-7 are under consideration.
Claim Objections
Claim 1 is objected to because of the following informalities: Neuregulin should be spelled out the first time it appear followed by the acronym “NRG” in parenthesis.
Claim 4 is objected to because of the following informalities: “…contains an amino acid sequence of SEQ ID NO: 1” should be amended to “comprises the amino acid sequence of SEQ ID NO: 1”.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-4 are rejected under 35 U.S.C. 101 because the claimed recitation of a use, without setting forth any steps involved in the process, results in an improper definition of a process, i.e., results in a claim which is not a proper process claim under 35 U.S.C. 101. See, for example, Ex parte Dunki, 153 USPQ 678 (Bd.App. 1967), Clinical Products, Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966), and M.P.E.P. § 2173.05(q).
Claims 5-7 are rejected under 35 U.S.C. 101 because the claimed invention is not directed to patent eligible subject matter. Based upon an analysis with respect to the claim as a whole, claims 5-7 do not recite something significantly different than a judicial exception. The rationale for this determination is explained below and is based on the analysis presented in the USPTO’s 2019 Revised Patent subject matter Eligibility Guidance (referred to as 2019 PEG) published January 2019 and the “PEG update” in October 2019.
Claim Interpretation
Claims 5-7 are drawn to a method of screening a HF patient suitable for treatment with NRG. T
Subject Matter Eligibility Test for Products and Processes
Step 1: Is the claim to a process, machine, manufacture, or composition of matter (see, e.g., 79 FR 74621)?
Yes, the instant claims are directed to a statutory patent-eligible subject matter category, namely a process.
Step 2A (1): Is the claim directed to a law of nature, a natural phenomenon, or an abstract idea (see, e.g., 79 FR 74621)?
Yes, the claims are directed to a law of nature and abstract idea. The method comprises the generic step of performing pre-treatment diagnostic test and determining the eligibility of the patient to NRG treatment according to the test results. The judicial exception is not integrated into a practical application because the selecting step is a mental step. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the selection step is generic.
Step 2A (2): Does the Claim recite additional Elements that integrate the judicial Exception into a Practical Application?
No, the claim does not recite additional elements that integrate the judicial exception and abstract idea into a practical application. The claims recite a correlation between plasma NT-proBNP and suitability for treatment of HF.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception (see, e.g., 79 FR 74621)?
No, the claims do not recite additional elements that amount to significantly more than the judicial exception. The pretreatment diagnostic test is too generic to be considered a practical application because generic gathering steps typically constitute insignificant extra-solution activity.
Factors for determining if the claim directed to a product of nature, as a whole, recites something significantly more than the judicial exception, are provided in the Guidance (74623; see esp. 79 FR 74623 at §I.A.3.b). see also, 79 FR.
In sum, when the relevant considerations are analyzed, they weigh against a significant difference. Accordingly, claims 5-7 do not qualify as eligible subject matter.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-4 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claims 1-4 provide for the use of NRG, but, since the claims do not set forth any steps involved in the method/process, it is unclear what method/process applicant is intending to encompass. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced. It is not clear whether the claim is intended to include, for example, some administration step, and M.P.E.P. § 2173.05(q) clearly indicates that it is generally considered improper to read limitations contained in the specification into the claims. See In re Prater, 415 F.2d 1393, 162 USPQ 541 (CCPA 1969) and In re Winkhaus, 527 F.2d 637, 188 USPQ 129 (CCPA 1975), which discuss the premise that one cannot rely on the specification to impart limitations to the claim that are not recited in the claim. Clarification is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
Claims 5-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhou et al. (US20170326204).
With respect to claim 5, Zhou et al. teach and claim treatment of heart failure comprising measuring the level of NT-proBNP in a patient before treatment and administering neuregulin to the patient when the plasma level of NT-proBNP is less than or equal to 1600 fmol/ml (claims 1,40,49 and 53), meeting the limitation of “screening a HF patient suitable for treatment with neuregulin…performing a pre-treatment diagnostic test and determining the eligibility for neuregulin treatment according to the test results”.
With respect to claim 6, Zhou et al. teach and claim the diagnostic test is for plasma levels of NT-proBNP (claims 1, 40, 49 and 53).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Zhou et al. (US20170326204) in view of Eisenberg et al. (Clinical Cardiology , 2018;41:211-216).
With respect to claims 1 and 5-7, Zhou et al. teach treatment of heart failure comprising measuring the level of NT-proBNP a patient before treatment and administering neuregulin to the patient when the plasma level of NT-proBNP is less than or equal to 1600 fmol/ml.
Zhou et al. does not specifically teach the patient with heart failure is a female. However, the teachings of Eisenberg et al. cure this deficiency.
In addition to the teachings above, Zhou et al. teach the status criteria for the randomized, multi-blinded, multi center placebo controlled study has a criteria to be between the ages of 18-65, LVEF≦40%, in relatively stable clinical condition (including clinical signs, symptoms and accepted standard treatment for CHF at the target dose or maximum tolerance dose for over 1 month).Inclusion criteria is not limited to male subjects. Exclusion criteria includes pregnant female subjects. The reference does not teach women in general are excluded [0107].
Eisenberg et al. teach heart failure numbers continue to grow in the US and approximately 50% of patients living with heart failure are women (Abstract).
With respect to claims 1 and 7, It would have been obvious to a person of ordinary skill in the art to include female patients when practicing the heart failure treatment of Zhou et al. because Zhou et al. teach the treatment of adults with heart failure without limiting the patient population to male subjects. Furthermore, the teachings of Eisenberg et al. teaching that half of patients with heart failure are women, a skilled artisan would reasonably expected the disclosed heart failure treatment of neuregulin to be applicable to female patients. There is a reasonable expectation of success to apply the known treatment for heart failure to female patients absent any contraindications for treating females.
With respect to claims 2-4, Zhou et al. teach the neuregulin is the NRG-1β2 isoform containing the amino acid sequence: SHLVKCAEKEKTFCVNGGECF MVKDLSNPSRYLCKCPNEFTGDRCQNYVMASFYKAEELYQ (SEQ ID NO:1). The peptides including the 177-237 residues of NRG-1 (β2 isoform comprises the EGF-like domain [0024]. SEQ ID NO: 1 from Zhou et al. is identical to instantly claimed SEQ ID NO: 1.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. USPN 7,226,907 in view of Zhou et al. and Eisenberg et al. Although the claims at issue are not identical, they are not patentably distinct from each other.
The USPN claims treatment of heart failure with NRG.
The USPN does not teach the NT-proBNP level or specifically teach the patient with heart failure is a female. However, the teachings of Zhou et al. and Eisenberg et al. cure this deficiency.
With respect to claims 1 and 5-7, Zhou et al. teach treatment of heart failure comprising measuring the level of NT-proBNP a patient before treatment and administering neuregulin to the patient when the plasma level of NT-proBNP is less than or equal to 1600 fmol/ml.
In addition to the teachings above, Zhou et al. teach the status criteria for the randomized, multi-blinded, multi center placebo controlled study has a criteria to be between the ages of 18-65, LVEF≦40%, in relatively stable clinical condition (including clinical signs, symptoms and accepted standard treatment for CHF at the target dose or maximum tolerance dose for over 1 month).Inclusion criteria is not limited to male subjects. Exclusion criteria includes pregnant female subjects. The reference does not teach women in general are excluded [0107].
Eisenberg et al. teach heart failure numbers continue to grow in the US and approximately 50% of patients living with heart failure are women (Abstract).
With respect to claims 1 and 7, It would have been obvious to a person of ordinary skill in the art to include female patients when practicing the heart failure treatment of the USPN because Zhou et al. teach the treatment of adults with heart failure without limiting the patient population to male subjects. Furthermore, the teachings of Eisenberg et al. teaching that half of patients with heart failure are women, a skilled artisan would reasonably expected the disclosed heart failure treatment of neuregulin to be applicable to female patients. There is a reasonable expectation of success to apply the known treatment for heart failure to female patients absent any contraindications for treating females.
With respect to claims 2-4, Zhou et al. teach the neuregulin is the NRG-1β2 isoform containing the amino acid sequence: SHLVKCAEKEKTFCVNGGECF MVKDLSNPSRYLCKCPNEFTGDRCQNYVMASFYKAEELYQ (SEQ ID NO:1). The peptides including the 177-237 residues of NRG-1 (β2 isoform comprises the EGF-like domain [0024]. SEQ ID NO: 1 from Zhou et al. is identical to instantly claimed SEQ ID NO: 1.
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. USPN 7,795,521 in view of Zhou et al. and Eisenberg et al. Although the claims at issue are not identical, they are not patentably distinct from each other.
The USPN claims treatment of viral myocarditis or cardiomyopathy in a mammal in need thereof comprising neuregulin, wherein the neuregulin is alpha 1 or beta 2, wherein the mammal is human, wherein the acute viral myocarditis has a clinical feature of heart failure (claims 1-26).
The USPN does not claim the NT-proBNP level or specifically teach the patient with heart failure is a female. However, the teachings of Zhou et al. and Eisenberg et al. cure this deficiency.
With respect to claims 1 and 5-7, Zhou et al. teach treatment of heart failure comprising measuring the level of NT-proBNP a patient before treatment and administering neuregulin to the patient when the plasma level of NT-proBNP is less than or equal to 1600 fmol/ml.
In addition to the teachings above, Zhou et al. teach the status criteria for the randomized, multi-blinded, multi center placebo controlled study has a criteria to be between the ages of 18-65, LVEF≦40%, in relatively stable clinical condition (including clinical signs, symptoms and accepted standard treatment for CHF at the target dose or maximum tolerance dose for over 1 month).Inclusion criteria is not limited to male subjects. Exclusion criteria includes pregnant female subjects. The reference does not teach women in general are excluded [0107].
Eisenberg et al. teach heart failure numbers continue to grow in the US and approximately 50% of patients living with heart failure are women (Abstract).
With respect to claims 1 and 7, It would have been obvious to a person of ordinary skill in the art to include female patients when practicing the heart failure treatment of the USPN because Zhou et al. teach the treatment of adults with heart failure without limiting the patient population to male subjects. Furthermore, the teachings of Eisenberg et al. teaching that half of patients with heart failure are women, a skilled artisan would reasonably expected the disclosed heart failure treatment of neuregulin to be applicable to female patients. There is a reasonable expectation of success to apply the known treatment for heart failure to female patients absent any contraindications for treating females.
With respect to claims 2-4, the USPN claims beta 2 isoform and Zhou et al. teach the neuregulin is the NRG-1β2 isoform containing the amino acid sequence: SHLVKCAEKEKTFCVNGGECF MVKDLSNPSRYLCKCPNEFTGDRCQNYVMASFYKAEELYQ (SEQ ID NO:1). The peptides including the 177-237 residues of NRG-1 (β2 isoform comprises the EGF-like domain [0024]. SEQ ID NO: 1 from Zhou et al. is identical to instantly claimed SEQ ID NO: 1.
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-51 of U.S. Patent No. USPN 7,964,555 in view of Zhou et al. and Eisenberg et al. Although the claims at issue are not identical, they are not patentably distinct from each other.
The USPN claims therapeutic treatment of heart failure comprising administering SEQ ID NO: 2. SEQ ID NO: 2 is neuregulin.
The USPN does not claim the NT-proBNP level or specifically teach the patient with heart failure is a female. However, the teachings of Zhou et al. and Eisenberg et al. cure this deficiency.
With respect to claims 1 and 5-7, Zhou et al. teach treatment of heart failure comprising measuring the level of NT-proBNP a patient before treatment and administering neuregulin to the patient when the plasma level of NT-proBNP is less than or equal to 1600 fmol/ml.
In addition to the teachings above, Zhou et al. teach the status criteria for the randomized, multi-blinded, multi center placebo controlled study has a criteria to be between the ages of 18-65, LVEF≦40%, in relatively stable clinical condition (including clinical signs, symptoms and accepted standard treatment for CHF at the target dose or maximum tolerance dose for over 1 month).Inclusion criteria is not limited to male subjects. Exclusion criteria includes pregnant female subjects. The reference does not teach women in general are excluded [0107].
Eisenberg et al. teach heart failure numbers continue to grow in the US and approximately 50% of patients living with heart failure are women (Abstract).
With respect to claims 1 and 7, It would have been obvious to a person of ordinary skill in the art to include female patients when practicing the heart failure treatment of the USPN because Zhou et al. teach the treatment of adults with heart failure without limiting the patient population to male subjects. Furthermore, the teachings of Eisenberg et al. teaching that half of patients with heart failure are women, a skilled artisan would reasonably expected the disclosed heart failure treatment of neuregulin to be applicable to female patients. There is a reasonable expectation of success to apply the known treatment for heart failure to female patients absent any contraindications for treating females.
With respect to claims 2-4, SEQ ID NO: 2 of the USPN is identical to instantly claimed SEQ ID NO: 1. Zhou et al. teach the neuregulin is the NRG-1β2 isoform containing the amino acid sequence: SHLVKCAEKEKTFCVNGGECF MVKDLSNPSRYLCKCPNEFTGDRCQNYVMASFYKAEELYQ (SEQ ID NO:1). The peptides including the 177-237 residues of NRG-1 (β2 isoform comprises the EGF-like domain [0024]. SEQ ID NO: 1 from Zhou et al. is identical to instantly claimed SEQ ID NO: 1.
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-49 of U.S. Patent No. USPN 8,785,387 in view of Zhou et al. and Eisenberg et al. Although the claims at issue are not identical, they are not patentably distinct from each other.
The USPN claims therapeutic treatment of heart failure or myocardial infarction in a mammal comprising administering neuregulin, wherein the neuregulin is alpha 2 or beta 2, wherein the neuregulin is SEQ ID NO: 4.
The USPN does not claim the NT-proBNP level or specifically teach the patient with heart failure is a female. However, the teachings of Zhou et al. and Eisenberg et al. cure this deficiency.
With respect to claims 1 and 5-7, Zhou et al. teach treatment of heart failure comprising measuring the level of NT-proBNP a patient before treatment and administering neuregulin to the patient when the plasma level of NT-proBNP is less than or equal to 1600 fmol/ml.
In addition to the teachings above, Zhou et al. teach the status criteria for the randomized, multi-blinded, multi center placebo controlled study has a criteria to be between the ages of 18-65, LVEF≦40%, in relatively stable clinical condition (including clinical signs, symptoms and accepted standard treatment for CHF at the target dose or maximum tolerance dose for over 1 month).Inclusion criteria is not limited to male subjects. Exclusion criteria includes pregnant female subjects. The reference does not teach women in general are excluded [0107].
Eisenberg et al. teach heart failure numbers continue to grow in the US and approximately 50% of patients living with heart failure are women (Abstract).
With respect to claims 1 and 7, It would have been obvious to a person of ordinary skill in the art to include female patients when practicing the heart failure treatment of the USPN because Zhou et al. teach the treatment of adults with heart failure without limiting the patient population to male subjects. Furthermore, the teachings of Eisenberg et al. teaching that half of patients with heart failure are women, a skilled artisan would reasonably expected the disclosed heart failure treatment of neuregulin to be applicable to female patients. There is a reasonable expectation of success to apply the known treatment for heart failure to female patients absent any contraindications for treating females.
With respect to claims 2-4, SEQ ID NO: 2 of the USPN is identical to instantly claimed SEQ ID NO: 1. Zhou et al. teach the neuregulin is the NRG-1β2 isoform containing the amino acid sequence: SHLVKCAEKEKTFCVNGGECF MVKDLSNPSRYLCKCPNEFTGDRCQNYVMASFYKAEELYQ (SEQ ID NO:1). The peptides including the 177-237 residues of NRG-1 (β2 isoform comprises the EGF-like domain [0024]. SEQ ID NO: 1 from Zhou et al. is identical to instantly claimed SEQ ID NO: 1.
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. USPN 9,089,524 in view of Zhou et al. and Eisenberg et al. Although the claims at issue are not identical, they are not patentably distinct from each other.
The USPN claims a method of treating or delaying heart failure in a human comprising administering neuregulin, wherein the neuregulin is beta 2 isoform, wherein the neuregulin is SEQ ID NO: 1.
The USPN does not claim the NT-proBNP level or specifically teach the patient with heart failure is a female. However, the teachings of Zhou et al. and Eisenberg et al. cure this deficiency.
With respect to claims 1 and 5-7, Zhou et al. teach treatment of heart failure comprising measuring the level of NT-proBNP a patient before treatment and administering neuregulin to the patient when the plasma level of NT-proBNP is less than or equal to 1600 fmol/ml.
In addition to the teachings above, Zhou et al. teach the status criteria for the randomized, multi-blinded, multi center placebo controlled study has a criteria to be between the ages of 18-65, LVEF≦40%, in relatively stable clinical condition (including clinical signs, symptoms and accepted standard treatment for CHF at the target dose or maximum tolerance dose for over 1 month).Inclusion criteria is not limited to male subjects. Exclusion criteria includes pregnant female subjects. The reference does not teach women in general are excluded [0107].
Eisenberg et al. teach heart failure numbers continue to grow in the US and approximately 50% of patients living with heart failure are women (Abstract).
With respect to claims 1 and 7, It would have been obvious to a person of ordinary skill in the art to include female patients when practicing the heart failure treatment of the USPN because Zhou et al. teach the treatment of adults with heart failure without limiting the patient population to male subjects. Furthermore, the teachings of Eisenberg et al. teaching that half of patients with heart failure are women, a skilled artisan would reasonably expected the disclosed heart failure treatment of neuregulin to be applicable to female patients. There is a reasonable expectation of success to apply the known treatment for heart failure to female patients absent any contraindications for treating females.
With respect to claims 2-4, SEQ ID NO: 1 of the USPN is identical to instantly claimed SEQ ID NO: 1. Zhou et al. teach the neuregulin is the NRG-1β2 isoform containing the amino acid sequence: SHLVKCAEKEKTFCVNGGECF MVKDLSNPSRYLCKCPNEFTGDRCQNYVMASFYKAEELYQ (SEQ ID NO:1). The peptides including the 177-237 residues of NRG-1 (β2 isoform comprises the EGF-like domain [0024]. SEQ ID NO: 1 from Zhou et al. is identical to instantly claimed SEQ ID NO: 1.
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. USPN 11,826,400 in view of Zhou et al. and Eisenberg et al. Although the claims at issue are not identical, they are not patentably distinct from each other.
The USPN claims a method of treating or delaying myocardial ischemia reperfusion injury caused by coronary artery bypass graft surgery comprising neuregulin, wherein the neuregulin is neuregulin 1, wherein the EFG like domain, wherein its SEQ ID NO: 1.
The USPN does not claim the NT-proBNP level or specifically teach the patient with heart failure is a female. However, the teachings of Zhou et al. and Eisenberg et al. cure this deficiency.
With respect to claims 1 and 5-7, Zhou et al. teach treatment of heart failure comprising measuring the level of NT-proBNP a patient before treatment and administering neuregulin to the patient when the plasma level of NT-proBNP is less than or equal to 1600 fmol/ml.
In addition to the teachings above, Zhou et al. teach the status criteria for the randomized, multi-blinded, multi center placebo controlled study has a criteria to be between the ages of 18-65, LVEF≦40%, in relatively stable clinical condition (including clinical signs, symptoms and accepted standard treatment for CHF at the target dose or maximum tolerance dose for over 1 month).Inclusion criteria is not limited to male subjects. Exclusion criteria includes pregnant female subjects. The reference does not teach women in general are excluded [0107].
Eisenberg et al. teach heart failure numbers continue to grow in the US and approximately 50% of patients living with heart failure are women (Abstract).
With respect to claims 1 and 7, It would have been obvious to a person of ordinary skill in the art to include female patients when practicing the heart failure treatment of the USPN because Zhou et al. teach the treatment of adults with heart failure without limiting the patient population to male subjects. Furthermore, the teachings of Eisenberg et al. teaching that half of patients with heart failure are women, a skilled artisan would reasonably expected the disclosed heart failure treatment of neuregulin to be applicable to female patients. There is a reasonable expectation of success to apply the known treatment for heart failure to female patients absent any contraindications for treating females.
With respect to claims 2-4, SEQ ID NO: 1 of the USPN is identical to instantly claimed SEQ ID NO: 1. Zhou et al. teach the neuregulin is the NRG-1β2 isoform containing the amino acid sequence: SHLVKCAEKEKTFCVNGGECF MVKDLSNPSRYLCKCPNEFTGDRCQNYVMASFYKAEELYQ (SEQ ID NO:1). The peptides including the 177-237 residues of NRG-1 (β2 isoform comprises the EGF-like domain [0024]. SEQ ID NO: 1 from Zhou et al. is identical to instantly claimed SEQ ID NO: 1.
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. USPN 9,012,400 in view of Zhou et al. and Eisenberg et al. Although the claims at issue are not identical, they are not patentably distinct from each other.
The USPN claims a method of treating heart failure comprising administering NRG consisting of SEQ ID NO: 5 in a human.
The USPN does not claim the NT-proBNP level or specifically teach the patient with heart failure is a female. However, the teachings of Zhou et al. and Eisenberg et al. cure this deficiency.
With respect to claims 1 and 5-7, Zhou et al. teach treatment of heart failure comprising measuring the level of NT-proBNP a patient before treatment and administering neuregulin to the patient when the plasma level of NT-proBNP is less than or equal to 1600 fmol/ml.
In addition to the teachings above, Zhou et al. teach the status criteria for the randomized, multi-blinded, multi center placebo controlled study has a criteria to be between the ages of 18-65, LVEF≦40%, in relatively stable clinical condition (including clinical signs, symptoms and accepted standard treatment for CHF at the target dose or maximum tolerance dose for over 1 month).Inclusion criteria is not limited to male subjects. Exclusion criteria includes pregnant female subjects. The reference does not teach women in general are excluded [0107].
Eisenberg et al. teach heart failure numbers continue to grow in the US and approximately 50% of patients living with heart failure are women (Abstract).
With respect to claims 1 and 7, It would have been obvious to a person of ordinary skill in the art to include female patients when practicing the heart failure treatment of the USPN because Zhou et al. teach the treatment of adults with heart failure without limiting the patient population to male subjects. Furthermore, the teachings of Eisenberg et al. teaching that half of patients with heart failure are women, a skilled artisan would reasonably expected the disclosed heart failure treatment of neuregulin to be applicable to female patients. There is a reasonable expectation of success to apply the known treatment for heart failure to female patients absent any contraindications for treating females.
With respect to claims 2-4, Zhou et al. teach the neuregulin is the NRG-1β2 isoform containing the amino acid sequence: SHLVKCAEKEKTFCVNGGECF MVKDLSNPSRYLCKCPNEFTGDRCQNYVMASFYKAEELYQ (SEQ ID NO:1). The peptides including the 177-237 residues of NRG-1 (β2 isoform comprises the EGF-like domain [0024]. SEQ ID NO: 1 from Zhou et al. is identical to instantly claimed SEQ ID NO: 1.
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. USPN 9,555,076 in view of Zhou et al. and Eisenberg et al. Although the claims at issue are not identical, they are not patentably distinct from each other.
The USPN claims treatment of preventing or treating cardiac toxicity with NRG. The USPN specification defines cardiac toxicity includes heart failure.
The USPN does not claim the NT-proBNP level or specifically teach the patient with heart failure is a female. However, the teachings of Zhou et al. and Eisenberg et al. cure this deficiency.
With respect to claims 1 and 5-7, Zhou et al. teach treatment of heart failure comprising measuring the level of NT-proBNP a patient before treatment and administering neuregulin to the patient when the plasma level of NT-proBNP is less than or equal to 1600 fmol/ml.
In addition to the teachings above, Zhou et al. teach the status criteria for the randomized, multi-blinded, multi center placebo controlled study has a criteria to be between the ages of 18-65, LVEF≦40%, in relatively stable clinical condition (including clinical signs, symptoms and accepted standard treatment for CHF at the target dose or maximum tolerance dose for over 1 month).Inclusion criteria is not limited to male subjects. Exclusion criteria includes pregnant female subjects. The reference does not teach women in general are excluded [0107].
Eisenberg et al. teach heart failure numbers continue to grow in the US and approximately 50% of patients living with heart failure are women (Abstract).
With respect to claims 1 and 7, It would have been obvious to a person of ordinary skill in the art to include female patients when practicing the heart failure treatment of the USPN because Zhou et al. teach the treatment of adults with heart failure without limiting the patient population to male subjects. Furthermore, the teachings of Eisenberg et al. teaching that half of patients with heart failure are women, a skilled artisan would reasonably expected the disclosed heart failure treatment of neuregulin to be applicable to female patients. There is a reasonable expectation of success to apply the known treatment for heart failure to female patients absent any contraindications for treating females.
With respect to claims 2-4, Zhou et al. teach the neuregulin is the NRG-1β2 isoform containing the amino acid sequence: SHLVKCAEKEKTFCVNGGECF MVKDLSNPSRYLCKCPNEFTGDRCQNYVMASFYKAEELYQ (SEQ ID NO:1). The peptides including the 177-237 residues of NRG-1 (β2 isoform comprises the EGF-like domain [0024]. SEQ ID NO: 1 from Zhou et al. is identical to instantly claimed SEQ ID NO: 1.
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. USPN 10,894,481 in view of Zhou et al. and Eisenberg et al. Although the claims at issue are not identical, they are not patentably distinct from each other.
The USPN claims therapeutic treatment of cardiac complications in a human diabetic patient comprising administering NRG of SEQ ID NO: 1, wherein the cardiac complication is heart failure.
The USPN does not claim the NT-proBNP level or specifically teach the patient with heart failure is a female. However, the teachings of Zhou et al. and Eisenberg et al. cure this deficiency.
With respect to claims 1 and 5-7, Zhou et al. teach treatment of heart failure comprising measuring the level of NT-proBNP a patient before treatment and administering neuregulin to the patient when the plasma level of NT-proBNP is less than or equal to 1600 fmol/ml.
In addition to the teachings above, Zhou et al. teach the status criteria for the randomized, multi-blinded, multi center placebo controlled study has a criteria to be between the ages of 18-65, LVEF≦40%, in relatively stable clinical condition (including clinical signs, symptoms and accepted standard treatment for CHF at the target dose or maximum tolerance dose for over 1 month).Inclusion criteria is not limited to male subjects. Exclusion criteria includes pregnant female subjects. The reference does not teach women in general are excluded [0107].
Eisenberg et al. teach heart failure numbers continue to grow in the US and approximately 50% of patients living with heart failure are women (Abstract).
With respect to claims 1 and 7, It would have been obvious to a person of ordinary skill in the art to include female patients when practicing the heart failure treatment of the USPN because Zhou et al. teach the treatment of adults with heart failure without limiting the patient population to male subjects. Furthermore, the teachings of Eisenberg et al. teaching that half of patients with heart failure are women, a skilled artisan would reasonably expected the disclosed heart failure treatment of neuregulin to be applicable to female patients. There is a reasonable expectation of success to apply the known treatment for heart failure to female patients absent any contraindications for treating females.
With respect to claims 2-4, SEQ ID NO: 1 of the USPN is identical to instantly claimed SEQ ID NO: 1. Zhou et al. teach the neuregulin is the NRG-1β2 isoform containing the amino acid sequence: SHLVKCAEKEKTFCVNGGECF MVKDLSNPSRYLCKCPNEFTGDRCQNYVMASFYKAEELYQ (SEQ ID NO:1). The peptides including the 177-237 residues of NRG-1 (β2 isoform comprises the EGF-like domain [0024]. SEQ ID NO: 1 from Zhou et al. is identical to instantly claimed SEQ ID NO: 1.
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 U.S. Patent No. USPN 9,655,949 in view of Zhou et al. and Eisenberg et al. Although the claims at issue are not identical, they are not patentably distinct from each other.
The USPN claims therapeutic treatment of heart failure comprising administering neuregulin, wherein the NRG is SEQ ID NO: 1.
The USPN does not claim the NT-proBNP level or specifically teach the patient with heart failure is a female. However, the teachings of Zhou et al. and Eisenberg et al. cure this deficiency.
With respect to claims 1 and 5-7, Zhou et al. teach treatment of heart failure comprising measuring the level of NT-proBNP a patient before treatment and administering neuregulin to the patient when the plasma level of NT-proBNP is less than or equal to 1600 fmol/ml.
In addition to the teachings above, Zhou et al. teach the status criteria for the randomized, multi-blinded, multi center placebo controlled study has a criteria to be between the ages of 18-65, LVEF≦40%, in relatively stable clinical condition (including clinical signs, symptoms and accepted standard treatment for CHF at the target dose or maximum tolerance dose for over 1 month).Inclusion criteria is not limited to male subjects. Exclusion criteria includes pregnant female subjects. The reference does not teach women in general are excluded [0107].
Eisenberg et al. teach heart failure numbers continue to grow in the US and approximately 50% of patients living with heart failure are women (Abstract).
With respect to claims 1 and 7, It would have been obvious to a person of ordinary skill in the art to include female patients when practicing the heart failure treatment of the USPN because Zhou et al. teach the treatment of adults with heart failure without limiting the patient population to male subjects. Furthermore, the teachings of Eisenberg et al. teaching that half of patients with heart failure are women, a skilled artisan would reasonably expected the disclosed heart failure treatment of neuregulin to be applicable to female patients. There is a reasonable expectation of success to apply the known treatment for heart failure to female patients absent any contraindications for treating females.
With respect to claims 2-4, SEQ ID NO: 1 of the USPN is identical to instantly claimed SEQ ID NO: 1. Zhou et al. teach the neuregulin is the NRG-1β2 isoform containing the amino acid sequence: SHLVKCAEKEKTFCVNGGECF MVKDLSNPSRYLCKCPNEFTGDRCQNYVMASFYKAEELYQ (SEQ ID NO:1). The peptides including the 177-237 residues of NRG-1 (β2 isoform comprises the EGF-like domain [0024]. SEQ ID NO: 1 from Zhou et al. is identical to instantly claimed SEQ ID NO: 1.
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-63 of U.S. Patent No. USPN 10,098,834 in view of Zhou et al. and Eisenberg et al. Although the claims at issue are not identical, they are not patentably distinct from each other.
The USPN claims therapeutic treatment of heart failure in a mammal comprising administering NRG, wherein the NRG comprising the EGF-like domain of NRG, is SEQ ID NO: 1-4.
The USPN does not claim the NT-proBNP level or specifically teach the patient with heart failure is a female. However, the teachings of Zhou et al. and Eisenberg et al. cure this deficiency.
With respect to claims 1 and 5-7, Zhou et al. teach treatment of heart failure comprising measuring the level of NT-proBNP a patient before treatment and administering neuregulin to the patient when the plasma level of NT-proBNP is less than or equal to 1600 fmol/ml.
In addition to the teachings above, Zhou et al. teach the status criteria for the randomized, multi-blinded, multi center placebo controlled study has a criteria to be between the ages of 18-65, LVEF≦40%, in relatively stable clinical condition (including clinical signs, symptoms and accepted standard treatment for CHF at the target dose or maximum tolerance dose for over 1 month).Inclusion criteria is not limited to male subjects. Exclusion criteria includes pregnant female subjects. The reference does not teach women in general are excluded [0107].
Eisenberg et al. teach heart failure numbers continue to grow in the US and approximately 50% of patients living with heart failure are women (Abstract).
With respect to claims 1 and 7, It would have been obvious to a person of ordinary skill in the art to include female patients when practicing the heart failure treatment of the USPN because Zhou et al. teach the treatment of adults with heart failure without limiting the patient population to male subjects. Furthermore, the teachings of Eisenberg et al. teaching that half of patients with heart failure are women, a skilled artisan would reasonably expected the disclosed heart failure treatment of neuregulin to be applicable to female patients. There is a reasonable expectation of success to apply the known treatment for heart failure to female patients absent any contraindications for treating females.
With respect to claims 2-4, SEQ ID NO: 1 of the USPN is identical to instantly claimed SEQ ID NO: 1. Zhou et al. teach the neuregulin is the NRG-1β2 isoform containing the amino acid sequence: SHLVKCAEKEKTFCVNGGECF MVKDLSNPSRYLCKCPNEFTGDRCQNYVMASFYKAEELYQ (SEQ ID NO:1). The peptides including the 177-237 residues of NRG-1 (β2 isoform comprises the EGF-like domain [0024]. SEQ ID NO: 1 from Zhou et al. is identical to instantly claimed SEQ ID NO: 1.
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. USPN 11,638,746 in view of Zhou et al. and Eisenberg et al. Although the claims at issue are not identical, they are not patentably distinct from each other.
The USPN claims ameliorating or delaying heart disease in a mammal comprising administering NRG (SEQ ID NO: 1), wherein the heart disease is heart failure.
The USPN does not claim the NT-proBNP level or specifically teach the patient with heart failure is a female. However, the teachings of Zhou et al. and Eisenberg et al. cure this deficiency.
With respect to claims 1 and 5-7, Zhou et al. teach treatment of heart failure comprising measuring the level of NT-proBNP a patient before treatment and administering neuregulin to the patient when the plasma level of NT-proBNP is less than or equal to 1600 fmol/ml.
In addition to the teachings above, Zhou et al. teach the status criteria for the randomized, multi-blinded, multi center placebo controlled study has a criteria to be between the ages of 18-65, LVEF≦40%, in relatively stable clinical condition (including clinical signs, symptoms and accepted standard treatment for CHF at the target dose or maximum tolerance dose for over 1 month).Inclusion criteria is not limited to male subjects. Exclusion criteria includes pregnant female subjects. The reference does not teach women in general are excluded [0107].
Eisenberg et al. teach heart failure numbers continue to grow in the US and approximately 50% of patients living with heart failure are women (Abstract).
With respect to claims 1 and 7, It would have been obvious to a person of ordinary skill in the art to include female patients when practicing the heart failure treatment of the USPN because Zhou et al. teach the treatment of adults with heart failure without limiting the patient population to male subjects. Furthermore, the teachings of Eisenberg et al. teaching that half of patients with heart failure are women, a skilled artisan would reasonably expected the disclosed heart failure treatment of neuregulin to be applicable to female patients. There is a reasonable expectation of success to apply the known treatment for heart failure to female patients absent any contraindications for treating females.
With respect to claims 2-4, Zhou et al. teach the neuregulin is the NRG-1β2 isoform containing the amino acid sequence: SHLVKCAEKEKTFCVNGGECF MVKDLSNPSRYLCKCPNEFTGDRCQNYVMASFYKAEELYQ (SEQ ID NO:1). The peptides including the 177-237 residues of NRG-1 (β2 isoform comprises the EGF-like domain [0024]. SEQ ID NO: 1 from Zhou et al. is identical to instantly claimed SEQ ID NO: 1.
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. USPN 10,702,585 in view of Zhou et al. and Eisenberg et al. Although the claims at issue are not identical, they are not patentably distinct from each other.
The USPN claims a formulation comprising NRG, wherein the NRG is SEQ ID NO: 2. The USPN states that the therapy involved administration to a patient suffering from heart failure. The MPEP 804 states: The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim. In particular, when ascertaining the scope of the reference’s claim(s) to a compound, the examiner should consider the reference’s specification, including all of the compound’s uses that are disclosed.
The USPN does not claim the NT-proBNP level or specifically teach the patient with heart failure is a female. However, the teachings of Zhou et al. and Eisenberg et al. cure this deficiency.
With respect to claims 1 and 5-7, Zhou et al. teach treatment of heart failure comprising measuring the level of NT-proBNP a patient before treatment and administering neuregulin to the patient when the plasma level of NT-proBNP is less than or equal to 1600 fmol/ml.
In addition to the teachings above, Zhou et al. teach the status criteria for the randomized, multi-blinded, multi center placebo controlled study has a criteria to be between the ages of 18-65, LVEF≦40%, in relatively stable clinical condition (including clinical signs, symptoms and accepted standard treatment for CHF at the target dose or maximum tolerance dose for over 1 month).Inclusion criteria is not limited to male subjects. Exclusion criteria includes pregnant female subjects. The reference does not teach women in general are excluded [0107].
Eisenberg et al. teach heart failure numbers continue to grow in the US and approximately 50% of patients living with heart failure are women (Abstract).
With respect to claims 1 and 7, It would have been obvious to a person of ordinary skill in the art to include female patients when practicing the heart failure treatment of the USPN because Zhou et al. teach the treatment of adults with heart failure without limiting the patient population to male subjects. Furthermore, the teachings of Eisenberg et al. teaching that half of patients with heart failure are women, a skilled artisan would reasonably expected the disclosed heart failure treatment of neuregulin to be applicable to female patients. There is a reasonable expectation of success to apply the known treatment for heart failure to female patients absent any contraindications for treating females.
With respect to claims 2-4, Zhou et al. teach the neuregulin is the NRG-1β2 isoform containing the amino acid sequence: SHLVKCAEKEKTFCVNGGECF MVKDLSNPSRYLCKCPNEFTGDRCQNYVMASFYKAEELYQ (SEQ ID NO:1). The peptides including the 177-237 residues of NRG-1 (β2 isoform comprises the EGF-like domain [0024]. SEQ ID NO: 1 from Zhou et al. is identical to instantly claimed SEQ ID NO: 1.
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. USPN 11,253,573 in view of Eisenberg et al. Although the claims at issue are not identical, they are not patentably distinct from each other.
The USPN claims a method of treating chronic heart failure comprising measuring the level of plasma NT-proBNP in patient before treatment and administering NRG to a subject with the NT-proBNP according to the results if the NT-proBNP is less than 4000 fmol/ml, wherein the NRG comprises SEQ ID NO: 1.
The USPN does not claim the patient with heart failure is a female. However, the teachings of Zhou et al. and Eisenberg et al. cure this deficiency.
With respect to claims 1 and 5-7, Zhou et al. teach treatment of heart failure comprising measuring the level of NT-proBNP a patient before treatment and administering neuregulin to the patient when the plasma level of NT-proBNP is less than or equal to 1600 fmol/ml.
Eisenberg et al. teach heart failure numbers continue to grow in the US and approximately 50% of patients living with heart failure are women (Abstract).
With respect to claims 1 and 7, It would have been obvious to a person of ordinary skill in the art to include female patients when practicing the heart failure treatment of the USPN because Eisenberg et al. teaching that half of patients with heart failure are women, a skilled artisan would reasonably expected the disclosed heart failure treatment of neuregulin to be applicable to female patients. There is a reasonable expectation of success to apply the known treatment for heart failure to female patients absent any contraindications for treating females.
With respect to claims 2-4, the NRG of the USPN is identical to the NRG instantly claimed.
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. USPN 10,441633 in view of Zhou et al. and Eisenberg et al. Although the claims at issue are not identical, they are not patentably distinct from each other.
The USPN claims treating ventricular arrythmias in a mammal comprising administering NRG 1 comprising the EGF like domain. The broadest reasonable interpretation of ventricular arrythmias include heart failure.
The USPN does not claim the NT-proBNP level or specifically teach the patient with heart failure is a female. However, the teachings of Zhou et al. and Eisenberg et al. cure this deficiency.
With respect to claims 1 and 5-7, Zhou et al. teach treatment of heart failure comprising measuring the level of NT-proBNP a patient before treatment and administering neuregulin to the patient when the plasma level of NT-proBNP is less than or equal to 1600 fmol/ml.
In addition to the teachings above, Zhou et al. teach the status criteria for the randomized, multi-blinded, multi center placebo controlled study has a criteria to be between the ages of 18-65, LVEF≦40%, in relatively stable clinical condition (including clinical signs, symptoms and accepted standard treatment for CHF at the target dose or maximum tolerance dose for over 1 month).Inclusion criteria is not limited to male subjects. Exclusion criteria includes pregnant female subjects. The reference does not teach women in general are excluded [0107].
Eisenberg et al. teach heart failure numbers continue to grow in the US and approximately 50% of patients living with heart failure are women (Abstract).
With respect to claims 1 and 7, It would have been obvious to a person of ordinary skill in the art to include female patients when practicing the heart failure treatment of the USPN because Zhou et al. teach the treatment of adults with heart failure without limiting the patient population to male subjects. Furthermore, the teachings of Eisenberg et al. teaching that half of patients with heart failure are women, a skilled artisan would reasonably expected the disclosed heart failure treatment of neuregulin to be applicable to female patients. There is a reasonable expectation of success to apply the known treatment for heart failure to female patients absent any contraindications for treating females.
With respect to claims 2-4, Zhou et al. teach the neuregulin is the NRG-1β2 isoform containing the amino acid sequence: SHLVKCAEKEKTFCVNGGECF MVKDLSNPSRYLCKCPNEFTGDRCQNYVMASFYKAEELYQ (SEQ ID NO:1). The peptides including the 177-237 residues of NRG-1 (β2 isoform comprises the EGF-like domain [0024]. SEQ ID NO: 1 from Zhou et al. is identical to instantly claimed SEQ ID NO: 1.
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. USPN 10,561,709 in view of Zhou et al. and Eisenberg et al. Although the claims at issue are not identical, they are not patentably distinct from each other.
The USPN claims treating heart failure in a mammal comprising administering NRG-1, comprising SEQ ID NO: 1.
The USPN does not claim the NT-proBNP level or specifically teach the patient with heart failure is a female. However, the teachings of Zhou et al. and Eisenberg et al. cure this deficiency.
With respect to claims 1 and 5-7, Zhou et al. teach treatment of heart failure comprising measuring the level of NT-proBNP a patient before treatment and administering neuregulin to the patient when the plasma level of NT-proBNP is less than or equal to 1600 fmol/ml.
In addition to the teachings above, Zhou et al. teach the status criteria for the randomized, multi-blinded, multi center placebo controlled study has a criteria to be between the ages of 18-65, LVEF≦40%, in relatively stable clinical condition (including clinical signs, symptoms and accepted standard treatment for CHF at the target dose or maximum tolerance dose for over 1 month).Inclusion criteria is not limited to male subjects. Exclusion criteria includes pregnant female subjects. The reference does not teach women in general are excluded [0107].
Eisenberg et al. teach heart failure numbers continue to grow in the US and approximately 50% of patients living with heart failure are women (Abstract).
With respect to claims 1 and 7, It would have been obvious to a person of ordinary skill in the art to include female patients when practicing the heart failure treatment of the USPN because Zhou et al. teach the treatment of adults with heart failure without limiting the patient population to male subjects. Furthermore, the teachings of Eisenberg et al. teaching that half of patients with heart failure are women, a skilled artisan would reasonably expected the disclosed heart failure treatment of neuregulin to be applicable to female patients. There is a reasonable expectation of success to apply the known treatment for heart failure to female patients absent any contraindications for treating females.
With respect to claims 2-4, SEQ ID NO: 1 from the USPN is identical to instantly claimed SEQ ID NO: 1. Zhou et al. teach the neuregulin is the NRG-1β2 isoform containing the amino acid sequence: SHLVKCAEKEKTFCVNGGECF MVKDLSNPSRYLCKCPNEFTGDRCQNYVMASFYKAEELYQ (SEQ ID NO:1). The peptides including the 177-237 residues of NRG-1 (β2 isoform comprises the EGF-like domain [0024]. SEQ ID NO: 1 from Zhou et al. is identical to instantly claimed SEQ ID NO: 1.
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. USPN 11,246,909 in view of Zhou et al. and Eisenberg et al. Although the claims at issue are not identical, they are not patentably distinct from each other.
The USPN claims a method of treating heart failure comprising administering NRG, wherein the NRG is SEQ ID NO: 1.
The USPN does not claim the NT-proBNP level or specifically teach the patient with heart failure is a female. However, the teachings of Zhou et al. and Eisenberg et al. cure this deficiency.
With respect to claims 1 and 5-7, Zhou et al. teach treatment of heart failure comprising measuring the level of NT-proBNP a patient before treatment and administering neuregulin to the patient when the plasma level of NT-proBNP is less than or equal to 1600 fmol/ml.
In addition to the teachings above, Zhou et al. teach the status criteria for the randomized, multi-blinded, multi center placebo controlled study has a criteria to be between the ages of 18-65, LVEF≦40%, in relatively stable clinical condition (including clinical signs, symptoms and accepted standard treatment for CHF at the target dose or maximum tolerance dose for over 1 month).Inclusion criteria is not limited to male subjects. Exclusion criteria includes pregnant female subjects. The reference does not teach women in general are excluded [0107].
Eisenberg et al. teach heart failure numbers continue to grow in the US and approximately 50% of patients living with heart failure are women (Abstract).
With respect to claims 1 and 7, It would have been obvious to a person of ordinary skill in the art to include female patients when practicing the heart failure treatment of the USPN because Zhou et al. teach the treatment of adults with heart failure without limiting the patient population to male subjects. Furthermore, the teachings of Eisenberg et al. teaching that half of patients with heart failure are women, a skilled artisan would reasonably expected the disclosed heart failure treatment of neuregulin to be applicable to female patients. There is a reasonable expectation of success to apply the known treatment for heart failure to female patients absent any contraindications for treating females.
With respect to claims 2-4, SEQ ID NO: 1 from the USPN is identical to instantly claimed SEQ ID NO: 1. Zhou et al. teach the neuregulin is the NRG-1β2 isoform containing the amino acid sequence: SHLVKCAEKEKTFCVNGGECF MVKDLSNPSRYLCKCPNEFTGDRCQNYVMASFYKAEELYQ (SEQ ID NO:1). The peptides including the 177-237 residues of NRG-1 (β2 isoform comprises the EGF-like domain [0024]. SEQ ID NO: 1 from Zhou et al. is identical to instantly claimed SEQ ID NO: 1.
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentabe over claims 1-18 of U.S. Patent No. USPN 11,179,323 in view of Zhou et al. and Eisenberg et al. Although the claims at issue are not identical, they are not patentably distinct from each other.
The USPN claims treating chronic heart failure comprising administering NRG.
The USPN does not claim the NT-proBNP level or specifically teach the patient with heart failure is a female. However, the teachings of Zhou et al. and Eisenberg et al. cure this deficiency.
With respect to claims 1 and 5-7, Zhou et al. teach treatment of heart failure comprising measuring the level of NT-proBNP a patient before treatment and administering neuregulin to the patient when the plasma level of NT-proBNP is less than or equal to 1600 fmol/ml.
In addition to the teachings above, Zhou et al. teach the status criteria for the randomized, multi-blinded, multi center placebo controlled study has a criteria to be between the ages of 18-65, LVEF≦40%, in relatively stable clinical condition (including clinical signs, symptoms and accepted standard treatment for CHF at the target dose or maximum tolerance dose for over 1 month).Inclusion criteria is not limited to male subjects. Exclusion criteria includes pregnant female subjects. The reference does not teach women in general are excluded [0107].
Eisenberg et al. teach heart failure numbers continue to grow in the US and approximately 50% of patients living with heart failure are women (Abstract).
With respect to claims 1 and 7, It would have been obvious to a person of ordinary skill in the art to include female patients when practicing the heart failure treatment of the USPN because Zhou et al. teach the treatment of adults with heart failure without limiting the patient population to male subjects. Furthermore, the teachings of Eisenberg et al. teaching that half of patients with heart failure are women, a skilled artisan would reasonably expected the disclosed heart failure treatment of neuregulin to be applicable to female patients. There is a reasonable expectation of success to apply the known treatment for heart failure to female patients absent any contraindications for treating females.
With respect to claims 2-4, Zhou et al. teach the neuregulin is the NRG-1β2 isoform containing the amino acid sequence: SHLVKCAEKEKTFCVNGGECF MVKDLSNPSRYLCKCPNEFTGDRCQNYVMASFYKAEELYQ (SEQ ID NO:1). The peptides including the 177-237 residues of NRG-1 (β2 isoform comprises the EGF-like domain [0024]. SEQ ID NO: 1 from Zhou et al. is identical to instantly claimed SEQ ID NO: 1.
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. USPN 11,969,458 in view of Zhou et al. and Eisenberg et al. Although the claims at issue are not identical, they are not patentably distinct from each other.
The USPN claims a pharmaceutical formulation comprising NRG, wherein the NRG is SEQ ID NO: 2. The USPN teaches treatment of heart failure. The MPEP 804 states: The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim. In particular, when ascertaining the scope of the reference’s claim(s) to a compound, the examiner should consider the reference’s specification, including all of the compound’s uses that are disclosed.
The USPN does not claim the NT-proBNP level or specifically teach the patient with heart failure is a female. However, the teachings of Zhou et al. and Eisenberg et al. cure this deficiency.
With respect to claims 1 and 5-7, Zhou et al. teach treatment of heart failure comprising measuring the level of NT-proBNP a patient before treatment and administering neuregulin to the patient when the plasma level of NT-proBNP is less than or equal to 1600 fmol/ml.
In addition to the teachings above, Zhou et al. teach the status criteria for the randomized, multi-blinded, multi center placebo controlled study has a criteria to be between the ages of 18-65, LVEF≦40%, in relatively stable clinical condition (including clinical signs, symptoms and accepted standard treatment for CHF at the target dose or maximum tolerance dose for over 1 month).Inclusion criteria is not limited to male subjects. Exclusion criteria includes pregnant female subjects. The reference does not teach women in general are excluded [0107].
Eisenberg et al. teach heart failure numbers continue to grow in the US and approximately 50% of patients living with heart failure are women (Abstract).
With respect to claims 1 and 7, It would have been obvious to a person of ordinary skill in the art to include female patients when practicing the heart failure treatment of the USPN because Zhou et al. teach the treatment of adults with heart failure without limiting the patient population to male subjects. Furthermore, the teachings of Eisenberg et al. teaching that half of patients with heart failure are women, a skilled artisan would reasonably expected the disclosed heart failure treatment of neuregulin to be applicable to female patients. There is a reasonable expectation of success to apply the known treatment for heart failure to female patients absent any contraindications for treating females.
With respect to claims 2-4, SEQ ID NO: of the USPN meets the limitation of SEQ ID NO: 1. Zhou et al. teach the neuregulin is the NRG-1β2 isoform containing the amino acid sequence: SHLVKCAEKEKTFCVNGGECF MVKDLSNPSRYLCKCPNEFTGDRCQNYVMASFYKAEELYQ (SEQ ID NO:1). The peptides including the 177-237 residues of NRG-1 (β2 isoform comprises the EGF-like domain [0024]. SEQ ID NO: 1 from Zhou et al. is identical to instantly claimed SEQ ID NO: 1.
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6-7, 9 and 11-13 of copending Application 17/420,974 in view of Zhou et al. and Eisenberg et al. Although the claims at issue are not identical, they are not patentably distinct from each other.
The copending application claims treating or preventing myocardial infarction with NRG. Myocardial infarction meets the limitation of heart failure.
The copending application does not claim the NT-proBNP level or specifically teach the patient with heart failure is a female. However, the teachings of Zhou et al. and Eisenberg et al. cure this deficiency.
With respect to claims 1 and 5-7, Zhou et al. teach treatment of heart failure comprising measuring the level of NT-proBNP a patient before treatment and administering neuregulin to the patient when the plasma level of NT-proBNP is less than or equal to 1600 fmol/ml.
In addition to the teachings above, Zhou et al. teach the status criteria for the randomized, multi-blinded, multi center placebo controlled study has a criteria to be between the ages of 18-65, LVEF≦40%, in relatively stable clinical condition (including clinical signs, symptoms and accepted standard treatment for CHF at the target dose or maximum tolerance dose for over 1 month).Inclusion criteria is not limited to male subjects. Exclusion criteria includes pregnant female subjects. The reference does not teach women in general are excluded [0107].
Eisenberg et al. teach heart failure numbers continue to grow in the US and approximately 50% of patients living with heart failure are women (Abstract).
With respect to claims 1 and 7, It would have been obvious to a person of ordinary skill in the art to include female patients when practicing the heart failure treatment of the copending Application because Zhou et al. teach the treatment of adults with heart failure without limiting the patient population to male subjects. Furthermore, the teachings of Eisenberg et al. teaching that half of patients with heart failure are women, a skilled artisan would reasonably expected the disclosed heart failure treatment of neuregulin to be applicable to female patients. There is a reasonable expectation of success to apply the known treatment for heart failure to female patients absent any contraindications for treating females.
With respect to claims 2-4, Zhou et al. teach the neuregulin is the NRG-1β2 isoform containing the amino acid sequence: SHLVKCAEKEKTFCVNGGECF MVKDLSNPSRYLCKCPNEFTGDRCQNYVMASFYKAEELYQ (SEQ ID NO:1). The peptides including the 177-237 residues of NRG-1 (β2 isoform comprises the EGF-like domain [0024]. SEQ ID NO: 1 from Zhou et al. is identical to instantly claimed SEQ ID NO: 1.
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12,208,158 in view of Zhou et al. and Eisenberg et al. Although the claims at issue are not identical, they are not patentably distinct from each other.
The USPN claims a method of treating chronic heart failure comprising administering NRG.
The USPN does not claim the NT-proBNP level or specifically teach the patient with heart failure is a female. However, the teachings of Zhou et al. and Eisenberg et al. cure this deficiency.
With respect to claims 1 and 5-7, Zhou et al. teach treatment of heart failure comprising measuring the level of NT-proBNP a patient before treatment and administering neuregulin to the patient when the plasma level of NT-proBNP is less than or equal to 1600 fmol/ml.
In addition to the teachings above, Zhou et al. teach the status criteria for the randomized, multi-blinded, multi center placebo controlled study has a criteria to be between the ages of 18-65, LVEF≦40%, in relatively stable clinical condition (including clinical signs, symptoms and accepted standard treatment for CHF at the target dose or maximum tolerance dose for over 1 month).Inclusion criteria is not limited to male subjects. Exclusion criteria includes pregnant female subjects. The reference does not teach women in general are excluded [0107].
Eisenberg et al. teach heart failure numbers continue to grow in the US and approximately 50% of patients living with heart failure are women (Abstract).
With respect to claims 1 and 7, It would have been obvious to a person of ordinary skill in the art to include female patients when practicing the heart failure treatment of the USPN because Zhou et al. teach the treatment of adults with heart failure without limiting the patient population to male subjects. Furthermore, the teachings of Eisenberg et al. teaching that half of patients with heart failure are women, a skilled artisan would reasonably expected the disclosed heart failure treatment of neuregulin to be applicable to female patients. There is a reasonable expectation of success to apply the known treatment for heart failure to female patients absent any contraindications for treating females.
With respect to claims 2-4, Zhou et al. teach the neuregulin is the NRG-1β2 isoform containing the amino acid sequence: SHLVKCAEKEKTFCVNGGECF MVKDLSNPSRYLCKCPNEFTGDRCQNYVMASFYKAEELYQ (SEQ ID NO:1). The peptides including the 177-237 residues of NRG-1 (β2 isoform comprises the EGF-like domain [0024]. SEQ ID NO: 1 from Zhou et al. is identical to instantly claimed SEQ ID NO: 1.
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12,076,370 in view of Eisenberg et al. Although the claims at issue are not identical, they are not patentably distinct from each other.
The USPN claims a method of treating chronic heart failure comprising administering NRG (SEQ ID NO: 1),wherein the NT-proBNP is less than or equal to 1600 fmol/ml.
The USPN does not claim the patient with heart failure is a female. However, the teachings of Eisenberg et al. cure this deficiency.
Eisenberg et al. teach heart failure numbers continue to grow in the US and approximately 50% of patients living with heart failure are women (Abstract).
With respect to claims 1 and 7, It would have been obvious to a person of ordinary skill in the art to include female patients when practicing the heart failure treatment of the USPN because Eisenberg et al. teaching that half of patients with heart failure are women, a skilled artisan would reasonably expected the disclosed heart failure treatment of neuregulin to be applicable to female patients. There is a reasonable expectation of success to apply the known treatment for heart failure to female patients absent any contraindications for treating females.
With respect to claims 2-4, the NRG of the USPN is identical to instantly claimed NRG.
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 12,133,882 in view of Zhou et al. and Eisenberg et al. Although the claims at issue are not identical, they are not patentably distinct from each other.
The USPN claims a method of treating chronic heart failure comprising administering NRG, wherein the NRG is SEQ ID NO: 1.
The USPN does not claim the NT-proBNP level or specifically teach the patient with heart failure is a female. However, the teachings of Zhou et al. and Eisenberg et al. cure this deficiency.
With respect to claims 1 and 5-7, Zhou et al. teach treatment of heart failure comprising measuring the level of NT-proBNP a patient before treatment and administering neuregulin to the patient when the plasma level of NT-proBNP is less than or equal to 1600 fmol/ml.
In addition to the teachings above, Zhou et al. teach the status criteria for the randomized, multi-blinded, multi center placebo controlled study has a criteria to be between the ages of 18-65, LVEF≦40%, in relatively stable clinical condition (including clinical signs, symptoms and accepted standard treatment for CHF at the target dose or maximum tolerance dose for over 1 month).Inclusion criteria is not limited to male subjects. Exclusion criteria includes pregnant female subjects. The reference does not teach women in general are excluded [0107].
Eisenberg et al. teach heart failure numbers continue to grow in the US and approximately 50% of patients living with heart failure are women (Abstract).
With respect to claims 1 and 7, It would have been obvious to a person of ordinary skill in the art to include female patients when practicing the heart failure treatment of the USPN because Zhou et al. teach the treatment of adults with heart failure without limiting the patient population to male subjects. Furthermore, the teachings of Eisenberg et al. teaching that half of patients with heart failure are women, a skilled artisan would reasonably expected the disclosed heart failure treatment of neuregulin to be applicable to female patients. There is a reasonable expectation of success to apply the known treatment for heart failure to female patients absent any contraindications for treating females.
With respect to claims 2-4, SEQ ID NO: 1 from the USPN is identical to instantly claimed SEQ ID NO: 1. Zhou et al. teach the neuregulin is the NRG-1β2 isoform containing the amino acid sequence: SHLVKCAEKEKTFCVNGGECF MVKDLSNPSRYLCKCPNEFTGDRCQNYVMASFYKAEELYQ (SEQ ID NO:1). The peptides including the 177-237 residues of NRG-1 (β2 isoform comprises the EGF-like domain [0024]. SEQ ID NO: 1 from Zhou et al. is identical to instantly claimed SEQ ID NO: 1.
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6 and 9 of copending application 17/642,855 in view of Zhou et al. and Eisenberg et al. Although the claims at issue are not identical, they are not patentably distinct from each other.
The copending application claims NRG fusion protein. The instant specification teaches treatment of heart failure [PGPUB 0008]. The MPEP 804 states: The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim. In particular, when ascertaining the scope of the reference’s claim(s) to a compound, the examiner should consider the reference’s specification, including all of the compound’s uses that are disclosed.
The copending application does not claim the NT-proBNP level or specifically teach the patient with heart failure is a female. However, the teachings of Zhou et al. and Eisenberg et al. cure this deficiency.
With respect to claims 1 and 5-7, Zhou et al. teach treatment of heart failure comprising measuring the level of NT-proBNP a patient before treatment and administering neuregulin to the patient when the plasma level of NT-proBNP is less than or equal to 1600 fmol/ml.
In addition to the teachings above, Zhou et al. teach the status criteria for the randomized, multi-blinded, multi center placebo controlled study has a criteria to be between the ages of 18-65, LVEF≦40%, in relatively stable clinical condition (including clinical signs, symptoms and accepted standard treatment for CHF at the target dose or maximum tolerance dose for over 1 month).Inclusion criteria is not limited to male subjects. Exclusion criteria includes pregnant female subjects. The reference does not teach women in general are excluded [0107].
Eisenberg et al. teach heart failure numbers continue to grow in the US and approximately 50% of patients living with heart failure are women (Abstract).
With respect to claims 1 and 7, It would have been obvious to a person of ordinary skill in the art to include female patients when practicing the heart failure treatment of the copending application because Zhou et al. teach the treatment of adults with heart failure without limiting the patient population to male subjects. Furthermore, the teachings of Eisenberg et al. teaching that half of patients with heart failure are women, a skilled artisan would reasonably expected the disclosed heart failure treatment of neuregulin to be applicable to female patients. There is a reasonable expectation of success to apply the known treatment for heart failure to female patients absent any contraindications for treating females.
With respect to claims 2-4, Zhou et al. teach the neuregulin is the NRG-1β2 isoform containing the amino acid sequence: SHLVKCAEKEKTFCVNGGECF MVKDLSNPSRYLCKCPNEFTGDRCQNYVMASFYKAEELYQ (SEQ ID NO:1). The peptides including the 177-237 residues of NRG-1 (β2 isoform comprises the EGF-like domain [0024]. SEQ ID NO: 1 from Zhou et al. is identical to instantly claimed SEQ ID NO: 1.
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 86-98 of copending application 18/188,831 in view of Zhou et al. and Eisenberg et al. Although the claims at issue are not identical, they are not patentably distinct from each other.
The copending application claims a method of treating heart disease or disorder in a mammal comprising administering a polymer coupled NRG to the mammal, wherein the disease is heart failure, wherein the NRG is NRG-1beta, wherein the NRG is SEQ ID NO: 1.
The copending application does not claim the NT-proBNP level or specifically teach the patient with heart failure is a female. However, the teachings of Zhou et al. and Eisenberg et al. cure this deficiency.
With respect to claims 1 and 5-7, Zhou et al. teach treatment of heart failure comprising measuring the level of NT-proBNP a patient before treatment and administering neuregulin to the patient when the plasma level of NT-proBNP is less than or equal to 1600 fmol/ml.
In addition to the teachings above, Zhou et al. teach the status criteria for the randomized, multi-blinded, multi center placebo controlled study has a criteria to be between the ages of 18-65, LVEF≦40%, in relatively stable clinical condition (including clinical signs, symptoms and accepted standard treatment for CHF at the target dose or maximum tolerance dose for over 1 month).Inclusion criteria is not limited to male subjects. Exclusion criteria includes pregnant female subjects. The reference does not teach women in general are excluded [0107].
Eisenberg et al. teach heart failure numbers continue to grow in the US and approximately 50% of patients living with heart failure are women (Abstract).
With respect to claims 1 and 7, It would have been obvious to a person of ordinary skill in the art to include female patients when practicing the heart failure treatment of the copending application because Zhou et al. teach the treatment of adults with heart failure without limiting the patient population to male subjects. Furthermore, the teachings of Eisenberg et al. teaching that half of patients with heart failure are women, a skilled artisan would reasonably expected the disclosed heart failure treatment of neuregulin to be applicable to female patients. There is a reasonable expectation of success to apply the known treatment for heart failure to female patients absent any contraindications for treating females.
With respect to claims 2-4, SEQ ID NO: 1 of the copending Application is identical to instantly claimed SEQ ID NO: 1. Zhou et al. teach the neuregulin is the NRG-1β2 isoform containing the amino acid sequence: SHLVKCAEKEKTFCVNGGECF MVKDLSNPSRYLCKCPNEFTGDRCQNYVMASFYKAEELYQ (SEQ ID NO:1). The peptides including the 177-237 residues of NRG-1 (β2 isoform comprises the EGF-like domain [0024]. SEQ ID NO: 1 from Zhou et al. is identical to instantly claimed SEQ ID NO: 1.
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 63-70 of copending application 18/784,736 in view of Zhou et al. and Eisenberg et al. Although the claims at issue are not identical, they are not patentably distinct from each other.
The copending application claims treatment of heart failure comprising administering NRG, wherein the plasma level of NT-proBNP is between 1600-4000 fmol/ml, wherein the NT-proBNP is less than 1600 fmol/ml. The instant specification teaches treatment of heart failure [PGPUB 0008].
The copending application does not claim the patient with heart failure is a female. However, the teachings of Zhou et al. and Eisenberg et al. cure this deficiency.
Eisenberg et al. teach heart failure numbers continue to grow in the US and approximately 50% of patients living with heart failure are women (Abstract).
With respect to claims 1 and 7, It would have been obvious to a person of ordinary skill in the art to include female patients when practicing the heart failure treatment of the copending application because Zhou et al. teach the treatment of adults with heart failure without limiting the patient population to male subjects. Furthermore, the teachings of Eisenberg et al. teaching that half of patients with heart failure are women, a skilled artisan would reasonably expected the disclosed heart failure treatment of neuregulin to be applicable to female patients. There is a reasonable expectation of success to apply the known treatment for heart failure to female patients absent any contraindications for treating females.
With respect to claims 2-4, SEQ ID NO: 1 from the copending application is identical to the instantly claimed SEQ ID NO: 1.
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of copending application 18/902,133 in view of Zhou et al. and Eisenberg et al. Although the claims at issue are not identical, they are not patentably distinct from each other.
The copending application claims treating heart failure by administering NRG, wherein the NRG is SEQ ID NO: 1.
The copending application does not claim the NT-proBNP level or specifically teach the patient with heart failure is a female. However, the teachings of Zhou et al. and Eisenberg et al. cure this deficiency.
With respect to claims 1 and 5-7, Zhou et al. teach treatment of heart failure comprising measuring the level of NT-proBNP a patient before treatment and administering neuregulin to the patient when the plasma level of NT-proBNP is less than or equal to 1600 fmol/ml.
In addition to the teachings above, Zhou et al. teach the status criteria for the randomized, multi-blinded, multi center placebo controlled study has a criteria to be between the ages of 18-65, LVEF≦40%, in relatively stable clinical condition (including clinical signs, symptoms and accepted standard treatment for CHF at the target dose or maximum tolerance dose for over 1 month).Inclusion criteria is not limited to male subjects. Exclusion criteria includes pregnant female subjects. The reference does not teach women in general are excluded [0107].
Eisenberg et al. teach heart failure numbers continue to grow in the US and approximately 50% of patients living with heart failure are women (Abstract).
With respect to claims 1 and 7, It would have been obvious to a person of ordinary skill in the art to include female patients when practicing the heart failure treatment of the copending application because Zhou et al. teach the treatment of adults with heart failure without limiting the patient population to male subjects. Furthermore, the teachings of Eisenberg et al. teaching that half of patients with heart failure are women, a skilled artisan would reasonably expected the disclosed heart failure treatment of neuregulin to be applicable to female patients. There is a reasonable expectation of success to apply the known treatment for heart failure to female patients absent any contraindications for treating females.
With respect to claims 2-4, SEQ ID NO: 1 from the copending Application is identical to instantly claimed SEQ ID NO: 1. Zhou et al. teach the neuregulin is the NRG-1β2 isoform containing the amino acid sequence: SHLVKCAEKEKTFCVNGGECF MVKDLSNPSRYLCKCPNEFTGDRCQNYVMASFYKAEELYQ (SEQ ID NO:1). The peptides including the 177-237 residues of NRG-1 (β2 isoform comprises the EGF-like domain [0024]. SEQ ID NO: 1 from Zhou et al. is identical to instantly claimed SEQ ID NO: 1.
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 8-19, 27 of copending application 18/988,434 in view of Zhou et al. and Eisenberg et al. Although the claims at issue are not identical, they are not patentably distinct from each other.
The copending application claims treating cardiovascular disease comprising administering NRG, wherein the disease if heart failure.
The copending application does not claim the NT-proBNP level or specifically teach the patient with heart failure is a female. However, the teachings of Zhou et al. and Eisenberg et al. cure this deficiency.
With respect to claims 1 and 5-7, Zhou et al. teach treatment of heart failure comprising measuring the level of NT-proBNP a patient before treatment and administering neuregulin to the patient when the plasma level of NT-proBNP is less than or equal to 1600 fmol/ml.
In addition to the teachings above, Zhou et al. teach the status criteria for the randomized, multi-blinded, multi center placebo controlled study has a criteria to be between the ages of 18-65, LVEF≦40%, in relatively stable clinical condition (including clinical signs, symptoms and accepted standard treatment for CHF at the target dose or maximum tolerance dose for over 1 month).Inclusion criteria is not limited to male subjects. Exclusion criteria includes pregnant female subjects. The reference does not teach women in general are excluded [0107].
Eisenberg et al. teach heart failure numbers continue to grow in the US and approximately 50% of patients living with heart failure are women (Abstract).
With respect to claims 1 and 7, It would have been obvious to a person of ordinary skill in the art to include female patients when practicing the heart failure treatment of the copending application because Zhou et al. teach the treatment of adults with heart failure without limiting the patient population to male subjects. Furthermore, the teachings of Eisenberg et al. teaching that half of patients with heart failure are women, a skilled artisan would reasonably expected the disclosed heart failure treatment of neuregulin to be applicable to female patients. There is a reasonable expectation of success to apply the known treatment for heart failure to female patients absent any contraindications for treating females.
With respect to claims 2-4, Zhou et al. teach the neuregulin is the NRG-1β2 isoform containing the amino acid sequence: SHLVKCAEKEKTFCVNGGECF MVKDLSNPSRYLCKCPNEFTGDRCQNYVMASFYKAEELYQ (SEQ ID NO:1). The peptides including the 177-237 residues of NRG-1 (β2 isoform comprises the EGF-like domain [0024]. SEQ ID NO: 1 from Zhou et al. is identical to instantly claimed SEQ ID NO: 1.
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-44 of copending application 19/116,520 in view of Zhou et al. and Eisenberg et al. Although the claims at issue are not identical, they are not patentably distinct from each other.
The copending application claims use of NRG for treating heart failure, wherein the NRG is SEQ ID NO: 1, wherein the NT-proBNP does not exceed 4000 pg/ml.
The copending application does not claim the NT-proBNP level or specifically teach the patient with heart failure is a female. However, the teachings of Zhou et al. and Eisenberg et al. cure this deficiency.
With respect to claims 1 and 5-7, Zhou et al. teach treatment of heart failure comprising measuring the level of NT-proBNP a patient before treatment and administering neuregulin to the patient when the plasma level of NT-proBNP is less than or equal to 1600 fmol/ml.
In addition to the teachings above, Zhou et al. teach the status criteria for the randomized, multi-blinded, multi center placebo controlled study has a criteria to be between the ages of 18-65, LVEF≦40%, in relatively stable clinical condition (including clinical signs, symptoms and accepted standard treatment for CHF at the target dose or maximum tolerance dose for over 1 month).Inclusion criteria is not limited to male subjects. Exclusion criteria includes pregnant female subjects. The reference does not teach women in general are excluded [0107].
Eisenberg et al. teach heart failure numbers continue to grow in the US and approximately 50% of patients living with heart failure are women (Abstract).
With respect to claims 1 and 7, It would have been obvious to a person of ordinary skill in the art to include female patients when practicing the heart failure treatment of the copending application because Zhou et al. teach the treatment of adults with heart failure without limiting the patient population to male subjects. Furthermore, the teachings of Eisenberg et al. teaching that half of patients with heart failure are women, a skilled artisan would reasonably expected the disclosed heart failure treatment of neuregulin to be applicable to female patients. There is a reasonable expectation of success to apply the known treatment for heart failure to female patients absent any contraindications for treating females.
With respect to claims 2-4, SEQ ID NO: 1 from the copending Application is identical to instantly claimed SEQ ID NO: 1. Zhou et al. teach the neuregulin is the NRG-1β2 isoform containing the amino acid sequence: SHLVKCAEKEKTFCVNGGECF MVKDLSNPSRYLCKCPNEFTGDRCQNYVMASFYKAEELYQ (SEQ ID NO:1). The peptides including the 177-237 residues of NRG-1 (β2 isoform comprises the EGF-like domain [0024]. SEQ ID NO: 1 from Zhou et al. is identical to instantly claimed SEQ ID NO: 1.
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-32 of copending application 19/430,359 in view of Zhou et al. and Eisenberg et al. Although the claims at issue are not identical, they are not patentably distinct from each other.
The copending application claims a kit for use in treating cardiac complications in a diabetic patient comprising administering NRG (SEQ ID NO: 1).
The copending application does not claim the NT-proBNP level or specifically teach the patient with heart failure is a female. However, the teachings of Zhou et al. and Eisenberg et al. cure this deficiency.
With respect to claims 1 and 5-7, Zhou et al. teach treatment of heart failure comprising measuring the level of NT-proBNP a patient before treatment and administering neuregulin to the patient when the plasma level of NT-proBNP is less than or equal to 1600 fmol/ml.
In addition to the teachings above, Zhou et al. teach the status criteria for the randomized, multi-blinded, multi center placebo controlled study has a criteria to be between the ages of 18-65, LVEF≦40%, in relatively stable clinical condition (including clinical signs, symptoms and accepted standard treatment for CHF at the target dose or maximum tolerance dose for over 1 month).Inclusion criteria is not limited to male subjects. Exclusion criteria includes pregnant female subjects. The reference does not teach women in general are excluded [0107].
Eisenberg et al. teach heart failure numbers continue to grow in the US and approximately 50% of patients living with heart failure are women (Abstract).
With respect to claims 1 and 7, It would have been obvious to a person of ordinary skill in the art to include female patients when practicing the heart failure treatment of the copending application because Zhou et al. teach the treatment of adults with heart failure without limiting the patient population to male subjects. Furthermore, the teachings of Eisenberg et al. teaching that half of patients with heart failure are women, a skilled artisan would reasonably expected the disclosed heart failure treatment of neuregulin to be applicable to female patients. There is a reasonable expectation of success to apply the known treatment for heart failure to female patients absent any contraindications for treating females.
With respect to claims 2-4, SEQ ID NO: 1 from the copending Application is identical to instantly claimed SEQ ID NO: 1. Zhou et al. teach the neuregulin is the NRG-1β2 isoform containing the amino acid sequence: SHLVKCAEKEKTFCVNGGECF MVKDLSNPSRYLCKCPNEFTGDRCQNYVMASFYKAEELYQ (SEQ ID NO:1). The peptides including the 177-237 residues of NRG-1 (β2 isoform comprises the EGF-like domain [0024]. SEQ ID NO: 1 from Zhou et al. is identical to instantly claimed SEQ ID NO: 1.
Conclusion
No claims are allowed.
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/TARA L MARTINEZ/Examiner, Art Unit 1654