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 .
Claim Rejections - 35 USC § 112
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 16-21, 25-28 and 30-32 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.
Please note that the current claim set was filed 9/12/2024 as a preliminary amendment. Only claims 15, 17, 19 and 20 are original claims, filed 9/10/2024.
In regards to claim 16, the subject matter appears to refer to the method depicted, for example, in Figure 23 and paragraphs 0358-0363. The preliminary amendment drawn to a step of “determining whether the patient’s heart has a right bundle branch block (RBBB)” appears to introduce new matter because there does not appear to be support in the original disclosure of carrying out this step twice (the step already appears in claim 15 -- please also see the rejection under section 112(b) below).
In regards to claims 18, 25 and 30, the amendments drawn to deleting and inserting “not” appears to introduce new matter because this relationship, as amended, appears to be the opposite to what is supported in the original disclosure (e.g., original claim 18, Fig. 23, step 856 showing the opposite relationship as now claimed, and original paragraph 0361 textually describing the relationship opposite to what is now claimed).
The remaining claims are rejected by virtue of their dependency.
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 16-21 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.
In regards to claim 16, it is unclear whether “determining whether the patient’s heart has a right bundle branch block (RBBB)” refers back to the same step in claim 15, or is setting forth a requirement that the step is performed twice.
The remaining claims are rejected by virtue of their dependency.
Allowable Subject Matter
Claims 15, 22-24, 29, 33 and 34 are allowed.
The following is a statement of reasons for the indication of allowable subject matter: the closest prior art is to Maskara et al. (US 2013/0123653). Although Maskara discloses using LBBB and RBBB patterns to differentiate between the two and confirm the presence of these conditions, Maskara, alone or in combination with the remaining prior art, fails to disclose or fairly render obvious the combination of elements currently recited in the independent claims, including determining positioning of an electrode for pacing while advancing towards a bundle of His or bundle branch based on the recited relationships between RBBB and LBBB patterns and presence of RBBB and LBBB (for instance, determining a position for LBBB pacing based on RBBB patterns and/or whether the patient has RBBB).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Sambelachvili et al. (US 2013/0053918) is another example of differentiating between RBBB and LBBB.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL W KAHELIN whose telephone number is (571)272-8688. The examiner can normally be reached M-F, 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at (571)270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL W KAHELIN/Primary Examiner, Art Unit 3792
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