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 .
Drawings
The drawings are objected to because:
figure 2 includes figure number 12, figure number 12 is described in the specification as;
“a body 12” page 6 line 21 line 21,
“training device 12” page 7
“ALVAD training device 12” on page 7 line 16,
“two openings 12, 14” on page 8 line 21,
“primary conduit 12” on page 9 line 4.
In figure 2, figure number 12 appears to be a conduit, in figure 2A figure number 12 seems to be an opening or conduit. Figure 3 includes two separate 12 figure numbers. It is requested that applicant review the figures in light of this discrepancy and either amend the figures and/or amend the specification for consistency in labeling.
The drawings are objected to under 37 CFR 1.83(a) because they fail to show a network of ribs with a spiral configuration (claim 1, page 3, lines3 and 13) as described in the specification. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
Please see the drawing rejections which reflect some issues with the specification and/or drawings.
Page 9, line 9 recites “cannula/conduit 16”, no figure number 16 is found in the drawings.
Page 2 lines 18-19 include a hyper link.
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Appropriate correction is required.
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 1-8 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.
Claim 1, lines 14-15 and claim 5, lines 13-14 each recite “until said training member is transformed into an autologous pumping device”. It is unclear what applicant intends this transformation to be. As is understood by the examiner the device itself 10 (figure 1) remains unchanged, the structural characteristics of the device 10 do not change. The training is for the latissimus dorsi muscle which is integrally attached to the device. This would be the same device with the muscles trained to contract and relax at appropriate intervals. This language is therefore considered indefinite. Page 6, lines 12-15 recite that once the muscles are integrated into the device. It is suggested that the language is amended to recite this muscle integration as opposed to the use of the word “transformed”.
The remainder of the claims are also rejected in that they depend from previously rejected claims.
Allowable Subject Matter
Claims 2-4 and 6-8 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a). Please see the drawing and specification objections as well as the 35 USC 112 rejections.
The following is a statement of reasons for the indication of allowable subject matter. The method (claims 1-4) and device (claims 5-9) includes an ALVAD implanted in a patient. The ALVAD includes an external layer which promotes tissue integration, a continuous wall which creates an internal chamber (interior area), an inlet opening and an outlet opening. The invention further includes skeletal muscles integrally attached to the continuous wall, these muscles are then trained to contract and relax using electrodes integrated into the continuous wall. The prior art fails to disclose or render obvious all of the limitations of the claimed invention in combination with the wall including a network of ribs connected to the wall with a plurality of electrodes distributed along the network of ribs. The electrodes are used to first train the skeletal muscle to expand and contract prior to the device being connected to the heart.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Francischelli US 6,086,526 discloses a cardiac assist system (figure 1) which includes an inflatable mandrel 41 (figure 2B) which is used to wrap muscle 62 (figure 2C) into an SMV which includes a cavity once the mandrel is removed. In order to create contraction and reaction in the SMV of Francischelli the nerves 38 (figure 4) innervating the muscle 62 (figure 3) are stimulated. Francischelli differs from the claimed invention in that Francischelli does not disclose or render obvious an ALVAD implanted in a patient which includes a member including an external layer, which creates an interior area with a network of ribs which include electrodes connected to the network of ribs which are used to cause contraction and relaxation of the muscle wrapped around and integrated into the external layer.
Guldner et al. US 5,814,102 discloses a biomechanical heart which dynamically trains skeletal muscle (title and abstract). The device of Guldner includes muscle 1 (figure 1) wrapped around a training apparatus 2 (figure 1) to create an internal chamber (column 3, lines 1-10). The muscle is then trained/exercised using a myostimulator. However, the biomechanical ventricle is created only of the muscle (column 4, lines 18-25). Guldner differs from the claimed invention in that Guldner does not disclose or render obvious an ALVAD implanted in a patient which includes a member including an external layer, which creates an interior area with a network of ribs which include electrodes connected to the network of ribs which are used to cause contraction and relaxation of the muscle wrapped around and integrated into the external layer.
Jarvik US 5,603,337 discloses muscle grafted directly to the heart to cause contraction and relaxation of the heart. However Jarvic does not disclose or render obvious an ALVAD implanted in a patient which includes a member including an external layer, which creates an interior area with a network of ribs which include electrodes connected to the network of ribs which are used to cause contraction and relaxation of the muscle wrapped around and integrated into the external layer.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAULA J. STICE whose telephone number is (303)297-4352. The examiner can normally be reached Monday - Friday 7:30am -4pm MST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carl H Layno can be reached at 571-272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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PAULA J. STICE
Primary Examiner
Art Unit 3796
/PAULA J STICE/Primary Examiner, Art Unit 3796