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 .
Election/Restrictions
The Applicant's election with traverse of Species A, Claims 20-24, in the Reply/Amendment filed on 16 February 2026 is acknowledged. The traversal is on the grounds that Species A and B are not patentable distinct because Claims 20 and 25 have been amended. This is not found persuasive because Species A (Claims 20-24) and Species B (Claims 25-33) are directed to distinct methods with different methodologies of determining comparison strain characteristics and different structural elements (e.g. Species A requires an external drive, whereas Species B requires an elastomeric shell and inflatable membranes), which would require different search strategies. Furthermore, Prior Art applicable to one Species would likely not be applicable to the other Species due to the distinct subject matter.
The requirement is still deemed proper and is therefore made FINAL. Therefore, Claims 25-33, directed to Species B, have been withdrawn.
The Examiner will consider the possibility of rejoinder after allowable subject matter has been indicated.
Status of Claims
Claims 1-19 were previously cancelled. Claims 20, 25, and 26 have been amended in the Reply/Amendment filed 16 February 2026. Claims 25-33 have been withdrawn as explained above. Therefore, Claims 20-24 are presently under consideration.
Specification
The disclosure is objected to because of the following informalities:
Page 1 of the Specification should be amended to include the issued U.S. Patent No. 12,263,332 of related Application No. 18/150,746.
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 ejected 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 “the needs of a deficient heart”. However, the term “needs” is a relative term which renders the claim indefinite. The term “needs” is not defined by the claim, the Specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore, this limitation is indefinite. For purposes of examination, the Examiner is interpreting “needs” as “characteristics”. Appropriate correction or clarification is required. Claims 21-24 are rejected for depending on Claim 20.
Regarding Claim 20, the claim recites “referencing average strain characteristics for an average healthy human heart of average size and morphology”. However, it is unclear as to what is intended by the limitation “referencing” in this limitation, since this appears to be claiming looking something up and/or referring to data, which is unclear in the context of these method steps. Therefore, this limitation is indefinite. For purposes of examination, the Examiner is interpreting this limitation as “calculating”. It is noted that any amendments to the claims must have full support in the Specification/Drawings as originally filed. Appropriate correction or clarification is required. Claims 21-24 are rejected for depending on Claim 20.
Regarding Claim 20, the claim recites “wherein said dynamic strain characteristics combine with said deficient strain characteristics to provide the deficient heart with overall strain characteristics closer to said average strain characteristics.” It is unclear as to how strain characteristics can “combine” in order “to provide the deficient heart with overall strain characteristics closer to said average strain characteristics”, since this step appears to be done by the construct/external drive, and cannot be performed by the data/characteristics themselves. Therefore, these limitations are indefinite. For purposes of examination, the Examiner is interpreting this limitation as, “wherein said dynamic strain characteristics combine with said deficient strain characteristics to enable the construct and external drive to provide the deficient heart with overall strain characteristics closer to said average strain characteristics.” Appropriate correction or clarification is required. Claims 21-24 are rejected for depending on Claim 20.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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.
Claims 20-24 are rejected under 35 U.S.C. 103 as being unpatentable over Roche et al. (US Publication No. 2016/0346449) in view of Corbett (US Publication No. 2012/0203056).
Regarding Claim 20, Roche et al. discloses a method of customizing a heart pump system to the needs of a deficient heart (Abstract, Paragraph 0059, 0155-0158), said method comprising the steps of:
referencing strain characteristics for a baseline healthy human heart (Paragraph 0155, 0177, 0196, 0197);
measuring strain characteristics in vivo of said deficient heart to determine deficient strain characteristics (deficient/failing heart, Abstract, Paragraph 0011, 0059, 0155-0158, 0166, 0199, 0207, 0212);
comparing said deficient strain characteristics to said healthy baseline strain characteristics (see Figs. 20(a)-20(b), Paragraph 0011, 0059, 0155-0158, 0166, 0196-0197, 0199-0201, 0207, 0212);
providing an external drive (control system, Fig. 26(a)-26(c); Paragraph 0203-0206);
providing a construct having elastomeric features that are selectively altered by said external drive (100, Fig. 14A, 16A-E; Paragraph 0013, 0018, 0080, 0116, 0203-0206; Claim 1, 18);
placing said construct in contact with said deficient heart in vivo (Paragraph 0062, 0082, See Figs. 16A-16E), wherein said construct, as altered by said external drive (control system, Fig. 26(a)-26(c); Paragraph 0203-0206), embodies dynamic strain characteristics that produce forces that act upon said deficient heart (Paragraph 0059, 0155-0158, 0162, 0174-0175, 0199, see Figs. 13b-c),
wherein said dynamic strain characteristics combine with said deficient strain characteristics to provide the deficient heart with overall strain characteristics closer to said normal strain characteristics (Abstract, Paragraph 0112-0113, 0192, 0196-0199; optimizing construct characteristics, Paragraph 0116, 0147, 0162).
However, Roche et al. does not explicitly disclose wherein referencing characteristics for a baseline healthy human heart includes referencing average characteristics for an average healthy human heart of average size and morphology.
Corbett teaches method of customizing a heart pump system to the needs of a deficient heart (Abstract; Paragraph 0002-0003) comprising providing a providing a construct to aid the deficient heart (Paragraph 0004-0007), wherein referencing characteristics for a baseline healthy human heart includes referencing/calculating average characteristics for an average healthy human heart of average size and morphology (Paragraph 0015, 0024, 0035, 0044, 0051, 0052, 0057) based on studies of average anatomy (Paragraph 0035, 0044, 0056-0058).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the referencing characteristics for a baseline healthy human heart as taught by Roche et al. to include referencing/calculating average characteristics for an average healthy human heart of average size and morphology, as taught by Corbett, in order to match the anatomy of a majority of patients, thus providing more preferable therapy outcome (see Paragraph 0004-0005, 0035 of Corbett).
Regarding Claim 21, Roche et al. discloses the method of customizing a heart pump system further wherein said external drive (control system, Fig. 26(a)-26(c); Paragraph 0203-0206) provides a pressure differential to said construct that cause deformations in said elastomeric features (100, Fig. 14A, 16A-E; Paragraph 0013, 0018, 0080, 0116; Claim 1, 18).
Regarding Claim 22-24, Roche et al. discloses the method further including measuring inherent strain characteristics of said construct when said construct is unloaded and not in contact with said heart (test conditions, Paragraph 0014, 0016, 0094-0096, 0154-0155, 0174-0175), wherein measuring said inherent strain characteristics includes measuring deformations in said elastomeric features caused by said pressure differential (Paragraph 0117, 0154, 0157, 0161, 0164), and wherein measuring said inherent strain characteristics includes measuring a first axis strain from a first long axis and a second axis strain from a second short axis (horizontal and vertical strain distribution, Paragraph 0059, 0097, 0162-0164), where said first long axis is angled relative to said short axis (horizontal and vertical strain distribution, which are axes that are angled relative to one another, Paragraph 0059, 0097, 0162-0164).
Conclusion
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