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 .
Response to Amendment
This Office Action is responsive to the amendment filed on 15 July 2026. As directed by the amendment: Claim 20 has been amended, Claims 1-19 have been cancelled, and no claims have been added. Claims 25-33 have been previously withdrawn due to a Restriction Requirement. Thus, Claims 20-24 are presently under consideration in this application.
The amendments to the Specification filed on 15 July 2026 have been fully considered and accepted by the Examiner.
The Applicant has requested rejoinder of Claims 25-33. As described below, the Examiner will consider rejoinder of Claims 25-33 if the claims are amended to include all of the allowable subject matter of Claim 20 and similarly amended to overcome all previously described 35 U.S.C. 112(b) and Claim Objection issues with respect to Claims 20-24 that may be present in Claims 25-33 (see Non-Final Rejection Office Action mailed 16 March 2026).
Claim Objections
Claim 20 is objected to because of the following informalities:
The claim recites “said average strain characteristics” in the last line of the claim. This should be amended to “said average heart strain characteristics” to match the other instances of this limitation in the claims.
Claim 21 is objected to because of the following informalities:
The claim recites “wherein said external drive provides a pressure differential to said construct that cause deformations”. This should be amended to “wherein said external drive provides a pressure differential to said construct that causes deformations” for grammatical clarity in the claims.
Claim 22 is objected to because of the following informalities:
The claim recites “said heart” in the last line of the claim. This should be amended to “said deficient heart” to match the other instances of this limitation in the claims.
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 20-24 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.
Regarding Claim 20, the claim recites “wherein said construct, as altered by said external drive, acts upon said deficient heart to provide said deficient heart with dynamic strain characteristics”. However, it is unclear as to what is intended by “dynamic strain characteristics”, and whether these are calculated or inherent values, and whether these are the same as “the strain discrepancies” recited in other areas of the claims. Therefore, this limitation is indefinite. It is recommended by the Examiner that this limitation be amended to “wherein said construct, as altered by said external drive, acts upon said deficient heart to provide said deficient heart with dynamic strain characteristics based on said strain discrepancies” and will be interpreted as such by the Examiner. Appropriate correction or clarification is required. Claims 21-24 are rejected for depending on Claim 20.
Regarding Claims 22-24, the claims recite “inherent strain characteristics [of said construct]”. However, Claim 20 (from which these claims depend) also recites “said deficient heart strain characteristics that are inherent”. It is unclear therefore indefinite as to whether these are referring to the same or different strain characteristics that are both ‘inherent’. It is recommended by the Examiner that these limitations be amended to “construct strain characteristics” to clarify these terms in Claims 22-24 and will be interpreted as such by the Examiner. Appropriate correction or clarification is required.
Allowable Subject Matter
Claims 20-24 would be allowable if rewritten or amended to overcome the rejections under 35 U.S.C. 112(b) and Claim Objections set forth in this Office action. It is noted that the claims have been interpreted as described in the 35 U.S.C. 112(b) rejection section above.
Prior Art
The prior art made of record and not relied upon is considered pertinent to the Applicant's disclosure:
Criscione ‘420 (US Publication No. 2005/0004420) discloses a direct cardiac assist device with elastomeric features which proactively modulates cardiac strain pattern to produce a contraction strain pattern that induces beneficial growth and remodeling of the myocardium or prevents or reduces apoptosis of the myocytes (Abstract; Claims 1-7; Paragraph 0019; Fig. 1).
Criscione ‘108 (US Publication No. 2007/0260108) discloses a contoured heart assist device which includes a selectively inflatable end-systolic heart shaped bladder with one or more contoured supports configured to surround at least a portion of the heart and provide curvatures similar to the proper shape of the heart based on strain patterns (Abstract; Paragraph 0013, 0020-0021, 0026, 0069-0076; Claim 29).
Response to Arguments
The previous Objections to the Specification have been withdrawn due to the Applicant’s amendments to Page 1 of the Specification.
The previous 35 U.S.C. 112(b) rejections of Claims 20-24 as made in the Non-Final Rejection Office Action mailed 16 March 2026 have been corrected by the Amendment/Response filed 15 July 2026. However, new 35 U.S.C. 112(b) rejections and Claim Objections have been made above due to the amendments.
The Applicant’s arguments with respect to the previous 35 U.S.C. 103 rejections as filed in the Amendment/Response filed 15 July 2026 (Pages 7-11) have been fully considered and are fully persuasive. The Examiner agrees that neither previously cited Roche et al. (US Publication No. 2016/0346449) nor Corbett (US Publication No. 2012/0203056) teaches or suggests the method of customizing a heart pump system with the specific method steps as claimed in Claim 20 as amended. Thus the previous 35 U.S.C. 103 rejections as made in the Non-Final Rejection Office Action mailed 16 March 2026 have been withdrawn.
The Examiner agrees that none of the cited prior art, including the pertinent references newly cited above, discloses or teaches all of the claimed elements of Claim 20 as amended. Therefore, Claims 20-24 would be allowable if rewritten or amended to overcome the rejections under 35 U.S.C. 112(b) and Claim Objections set forth above. It is noted that the claims have been interpreted as described in the 35 U.S.C. 112(b) rejection section above.
The Applicant has requested rejoinder of Claims 25-33. The Examiner will consider rejoinder of Claims 25-33 if the claims are amended to include all of the allowable subject matter of Claim 20 and similarly amended to overcome all previously described 35 U.S.C. 112(b) and Claim Objection issues with respect to Claims 20-24 (see Non-Final Rejection Office Action mailed 16 March 2026).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAMELA M BAYS whose telephone number is (571)270-7852. The examiner can normally be reached 9:00am - 6:00pm EST.
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/PAMELA M. BAYS/Primary Examiner, Art Unit 3796
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