Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
This office action is in response to applicant’s reply filed on February 24, 2024.
Status of Claims
Amendment of claims 1-3, 9, 15-16 and 26 is acknowledged.
Claims 1-3, 9, 15-16 and 26 are currently pending and are the subject of this office action.
Claims 1-3, 9, 15-16 and 26 are presently under examination.
Priority
The present application is a 371 of PCT/CN2016/098304 filed on 09/07/2016, and claims priority to provisional application No. 6062/216,658filed on 09/10/2015.
Rejections and/or Objections and Response to Arguments
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated (Maintained Rejections and/or Objections) or newly applied (New Rejections and/or Objections, Necessitated by Amendment or New Rejections and/or Objections not Necessitated by Amendment). They constitute the complete set presently being applied to the instant application.
Responses to Applicant’s arguments have been addressed immediately after the corresponding rejections, or in the section: Withdrawn Rejections and/or Objections, if the rejection was withdrawn.
Claim Rejections - 35 USC § 112 (New Rejections Necessitated by Amendment).
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-3, 9, 15-16 and 26 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
1) Claims 1-3, 9, 15-16 and 26 recite:
“a method of treating ventricular dysfunctional hypertrophy with increased mass of myocardium and size of cardiomyocytes as well as interstitial fibrosis”.
However, a careful review of the specification and the claims, as originally filed, do not appear to lend support for the above limitation.
2) Claims 1-3, 9, 15-16 and 26 recite:
“wherein said ventricular dysfunctional hypertrophy is induced by persistent arterial or chronic myocarditis”.
However, a careful review of the specification and the claims, as originally filed, do not appear to lend support for the above limitation.
3) Claim 2 recites:
“is characterized by excessive production of fibroblasts or myofibroblasts, collagen deposition and brain natriuretic peptide”
However, a careful review of the specification and the claims, as originally filed, do not appear to lend support for the above limitation.
4) Claim 9 recites:
“is characterized by improving deteriorated cardiac function with reducing the cytosol Ca++ in cardiomyocyte,”
However, a careful review of the specification and the claims, as originally filed, do not appear to lend support for the above limitation.
5) Claim 15 recites:
“is characterized by a pathological ECG involves increased QT variations, prolonged QT interval and action duration (QRS interval), and depressed or elevated ST segment from the baseline”
However, a careful review of the specification and the claims, as originally filed, do not appear to lend support for the above limitation.
6) Claim 16 recites:
“is characterized by enhanced cardiac sympathetic activity with a higher LF/HF ratio”.
However, a careful review of the specification and the claims, as originally filed, do not appear to lend support for the above limitation.
6) Claim 26 recites:
“is characterized by decreased systolic plasticity during contraction and increased diastolic stiffness during relaxation in a deteriorated hypertrophic heart”
However, a careful review of the specification and the claims, as originally filed, do not appear to lend support for the above limitation.
Claim Rejections - 35 USC § 112 (New Rejections Necessitated by Amendment).
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 1-3, 9, 15-16 and 26 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
1) it is not clear if the phrase: “treating ventricular dysfunctional hypertrophy with increased mass of myocardium and size of cardiomyocytes as well as interstitial fibrosis” means that two things are being treated at the same time:
1- ventricular dysfunctional hypertrophy with increased mass of myocardium and size of cardiomyocytes, and 2- interstitial fibrosis, or
If interstitial fibrosis is a characteristic of “ventricular dysfunctional hypertrophy”
2) Claims 1-3, 9, 15-16 and 26 recite the phrase “a patient in need”. It is not clear who the individuals in need of “treatment of ventricular dysfunctional hypertrophy” are. Neither the instant specification nor the prior art describes the patients that are in need of “treatment of ventricular dysfunctional hypertrophy”.
The metes and bounds of the claims are not clearly defined.
3) claim 15 recites: “wherein the said ventricular dysfunctional hypertrophy is characterized by a pathological ECG involves increased QT variation, prolonged QT interval…”. However, there is some improper grammar construction in the above phrase since it is not clear if the word “involves” is related to ECG of to the “ventricular dysfunctional hypertrophy”
NOTE: without a clear definition of what is being treated it is impossible to run any prior art search.
Conclusion
No claims are allowed.
Applicant's submission of an information disclosure statement under 37 CFR 1.97(c) with the fee set forth in 37 CFR 1.17(p) on 05/10/10 prompted the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 609.04(b). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCOS L SZNAIDMAN whose telephone number is (571)270-3498. The examiner can normally be reached Flexing M-F 7 AM-7 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L. Clark can be reached on 571 272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARCOS L SZNAIDMAN/
Primary Examiner, Art Unit 1628
February 28, 2024.