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 .
Objection to the Specification
The disclosure is objected to because of the following informalities:
The “Related Applications” section on Page 1 of the Specification should be updated with the issued US Patent numbers of the related applications.
Appropriate correction is required.
Election/Restrictions
Claims 11-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Invention II, there being no allowable generic or linking claim.
The Applicant timely traversed the restriction requirement in the reply filed on 23 April 2026. The traversal is on the grounds that Claim 11 (Invention II) has been amended to incorporate subject matter from Claim 1 (Invention I). However, the Examiner does not find these arguments persuasive. Inventions I and II are still directed to distinct method claims, and Invention II incudes “operating said cardiac assist device in vivo, includes operating said cardiac assist device while said cardiac assist device is structurally reinforced by said flexible guides, wherein said plurality of flexible guides prevent said cardiac assist device from expanding beyond a first diameter and collapsing under a lesser second diameter when said cardiac assist device acts upon the heart,” which is a distinct mode of operation/effect from Invention I. Therefore, Claims 1-10 are presently pending in this application.
The Examiner will consider the possibility of rejoinder of Claims 11-17 if the claims are amended to depend from a claim or claims which are in otherwise in condition for allowance.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-5 of U.S. Patent No. 12,440,338 in view of Roche et al. (US Publication No. 2016/0346449). Both sets of claims recite nearly identical inventions, with Claims 1-10 of the instant application being directed to a method of implementing the cardiac assist device of Claims 1-5 of U.S. Patent No. 12,440,338.
Claim 1 of the instant application is substantially encompassed by Claim 1 of U.S. Patent No. 12,440,338, except wherein the controlled forces are specifically strain forces. Roche et al. teaches a method comprising providing a cardiac assist device for increasing a pumping efficiency of a heart (Paragraph 0013, 0016, “Specific, non-limiting, applications explored herein have focused on simulating the motion of the heart and developing an implantable direct cardiac compression device to assist with pumping in the failing heart.”, Paragraph 0017), with a cup assembly (100, Fig. 16A-E; Paragraph 0044, 0080, 0112) including struts for receiving a portion of the heart (110, Fig. 16D-E; Paragraph 0062) therein (Paragraph 0013, 0040-0041, 0140, 0185), and operating said cardiac assist device in vivo to apply strain forces (application of strain force characteristics, Paragraph 0019-0020, 0062, 0112, 0117) to the heart in systole and diastole that assist both said systolic pumping capacity and said diastolic pumping capacity (calculation and application of pressure forces by the PAMs/DCC device, Paragraph 0013, 0016, 0017, 0075-0082, 0094, 0097, 0100, 0109, 0112, 0114; see force/pressure plots of Figs. 1(a), 1(b), 2, 6-9). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to apply specifically strain forces to the heart as taught by Roche et al. as the applied forces in the method disclosed by the method of Claim 1 of the instant application, in order to synchronize mechanical assistance to the heart and to augment cardiac function along the force vectors of the native heart muscle, as also taught by Roche et al. (Paragraph 0011-0013).
Claim 2 of the instant application is fully encompassed by Claim 1 of U.S. Patent No. 12,440,338.
Claim 3 of the instant application is fully encompassed by Claim 1 of U.S. Patent No. 12,440,338.
Claim 4 of the instant application is fully encompassed by Claims 1, 3, and 4 of U.S. Patent No. 12,440,338.
Claim 5 of the instant application is fully encompassed by Claims 1, 3, and 4 of U.S. Patent No. 12,440,338.
Claim 6 of the instant application is fully encompassed by Claims 1 and 5 of U.S. Patent No. 12,440,338.
Claim 7 of the instant application is fully encompassed by Claim 1 of U.S. Patent No. 12,440,338.
Claim 8 of the instant application is fully encompassed by Claims 1 and 5 of U.S. Patent No. 12,440,338.
Claim 9 of the instant application is fully encompassed by Claims 1 and 3-5 of U.S. Patent No. 12,440,338.
Claim 10 of the instant application is fully encompassed by Claims 1 and 3-5 of U.S. Patent No. 12,440,338.
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 1-10 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 1, the claim recites, “In a patient with a heart a systolic pumping capacity during systole and a diastolic pumping capacity during diastole, a method comprising”. However, this limitation is grammatically awkward since it appears to be missing words and/or commas, and furthermore, it is unclear as to what is intended by the limitation “in a patient” (i.e. whether the patient/heart is actively being claimed). Therefore this limitation is indefinite. For purposes of examination, the Examiner is interpreting this limitation as, “A method to be implemented within a patient having a heart with a systolic pumping capacity during systole and a diastolic pumping capacity during diastole comprising”. Appropriate correction or clarification is required. Claims 2-10 are rejected for depending on Claim 1.
Regarding Claim 2, the claim recites “wherein providing a cardiac assist device includes providing a cardiac assist device with conduits”. However, this limitation is grammatically awkward and “a cardiac assist device” is unclear since this limitation is already defined in Claim 1 (from which Claim 2 depends). For purposes of examination, the Examiner is interpreting this limitation as, “wherein said cardiac assist device
Regarding Claim 3, the claim recites, “said plurality of flexible guides are free to slide through said conduits in said construct”. However, “said construct” lacks antecedent basis in the claims. It appears that this limitation was intended to recite “said plurality of flexible guides are free to slide through said conduits in said cardiac assist device” and will be interpreted as such by the Examiner. Appropriate correction or clarification is required.
Regarding Claim 6, the claim recites “wherein said conduits are formed in said outer shell”. However, “said conduits” lacks antecedent basis in the claims. It appears that Claim 6 was intended to depend from Claim 2, which recites “providing a cardiac assist device with conduits through which said plurality of flexible guides pass”. Therefore, Claim 6 will be interpreted as depending from Claim 2. Appropriate correction or clarification is required. Claims 7-10 are rejected for depending on Claim 6.
Regarding Claim 10, the claim recites “wherein said cardiac assist device has a collapsed configuration and an operable configuration, wherein said flexible guides maintain said construct in said operable configuration”. However, “said construct” and “said flexible guides” lack antecedent basis in the claims, and “an operable configuration” has been previously recited in Claim 1. It appears that this limitation was intended to recite “wherein said cardiac assist device has a collapsed configuration and said operable configuration, wherein said plurality of flexible guides maintain said cardiac assist device in said operable configuration” and will be interpreted as such by the Examiner. Appropriate correction or clarification is required.
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.
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 1, 2, and 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Snyders (US Patent No. 5,256,132) in view of Roche et al. (US Publication No. 2016/0346449).
Regarding Claim 1, Snyders discloses in a patient with a heart having a systolic pumping capacity during systole and a diastolic pumping capacity during diastole (”both systolic and diastolic assist features”, Col. 1, Lines 42-45; Col. 3, Lines 34-47), a method comprising:
advancing a plurality of flexible guides in vivo into positions proximate the heart (12, Figs. 1-2; Col. 2, Lines 32-40, Lines 63-67);
providing a cardiac assist device (10, 11; Figs. 1-2; Abstract);
advancing said cardiac assist device along said plurality of flexible guides (struts 12 are enclosed in lumens/conduits within the shell 10/11, Figs. 1-2; Col. 2, Lines 32-40, Lines 63-67) into an operable position where said cardiac assist device can act upon the heart (see operable configuration of Fig. 1; Abstract, Claims 2, 5, 8; Col. 1, Lines 53-60);
operating said cardiac assist device in vivo (Col. 1, Lines 42-45; Col. 3, Lines 34-47; Claim 1; Abstract), wherein said cardiac assist device and said plurality of flexible guides (12, Figs. 1-2; Col. 2, Lines 32-40, Lines 63-67) in combination apply forces to the heart in systole and diastole that assist both said systolic pumping capacity and said diastolic pumping capacity (”both systolic and diastolic assist features”, Col. 1, Lines 42-45; Col. 3, Lines 34-47; Claim 1; Abstract).
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Although Snyders discloses wherein said cardiac assist device and said plurality of flexible guides (12, Figs. 1-2; Col. 2, Lines 32-40, Lines 63-67) in combination apply forces to the heart in systole and diastole that assist both said systolic pumping capacity and said diastolic pumping capacity (”both systolic and diastolic assist features”, Col. 1, Lines 42-45; Col. 3, Lines 34-47; Claim 1; Abstract), Snyders does not explicitly define these forces as strain forces.
Roche et al. teaches a method comprising providing a cardiac assist device for increasing a pumping efficiency of a heart (Paragraph 0013, 0016, “Specific, non-limiting, applications explored herein have focused on simulating the motion of the heart and developing an implantable direct cardiac compression device to assist with pumping in the failing heart.”, Paragraph 0017), with a cup assembly (100, Fig. 16A-E; Paragraph 0044, 0080, 0112) including struts for receiving a portion of the heart (110, Fig. 16D-E; Paragraph 0062) therein (Paragraph 0013, 0040-0041, 0140, 0185), and operating said cardiac assist device in vivo to apply strain forces (application of strain force characteristics, Paragraph 0019-0020, 0062, 0112, 0117) to the heart in systole and diastole that assist both said systolic pumping capacity and said diastolic pumping capacity (calculation and application of pressure forces by the PAMs/DCC device, Paragraph 0013, 0016, 0017, 0075-0082, 0094, 0097, 0100, 0109, 0112, 0114; see force/pressure plots of Figs. 1(a), 1(b), 2, 6-9).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to apply specifically strain forces to the heart as taught by Roche et al. as the applied forces in the method disclosed by Snyders, in order to synchronize mechanical assistance to the heart and to augment cardiac function along the force vectors of the native heart muscle, as also taught by Roche et al. (Paragraph 0011-0013).
Regarding Claim 2, Snyders discloses the method further wherein providing a cardiac assist device includes providing a cardiac assist device with conduits through which said plurality of flexible guides pass (struts 12 are enclosed in lumens/conduits within the shell 10/11, Figs. 1-2; Col. 2, Lines 32-40, Lines 63-67).
Regarding Claim 4, Snyders discloses the method further including collapsing said cardiac assist device (collapsed configuration of Fig. 2) and advancing said cardiac assist device in vivo along said plurality of flexible guides in a collapsed configuration (Abstract, Claims 2, 5, 8; Col. 1, Lines 53-60).
Regarding Claim 5, Snyders discloses the method further wherein said plurality of flexible guides move said cardiac assist device from said collapsed configuration (Fig. 2) into said operable configuration (Fig. 1) in vivo proximate said heart (Abstract, Claims 2, 5, 8; Col. 1, Lines 53-60).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Snyders (US Patent No. 5,256,132) in view of Roche et al. (US Publication No. 2016/0346449), further in view of Otiz et al. (US Patent No. 6,808,483).
Regarding Claim 3, Snyders further discloses that the plurality of flexible guides comprise a plurality of spring mental/wire members (12, Figs. 1-2; Col. 2, Lines 32-40, Lines 63-67) which extend through conduits of the outer shell (struts 12 are enclosed in lumens/conduits within the shell 10/11, Figs. 1-2; Col. 2, Lines 32-40, Lines 63-67), which may allow for some movement within the conduits. However, Snyders and Roche et al. in combination does not explicitly disclose wherein said plurality of flexible guides are free to slide through said conduits.
Otiz et al. teaches a cardiac assist device (Abstract; Claim 1) wherein the plurality of flexible guides (86, Fig. 6) extend into conduits (84, Fig. 6), and wherein said outer shell is free to move along said plurality of flexible guides (86, Fig. 6), wherein said plurality of flexible guides (86, Fig. 6) are free to slide through said conduits (84, Fig. 6) in the cardiac assist device (Col. 8, Lines 9-35). 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 outer shell to be free to move along said plurality of flexible guides, and wherein said plurality of flexible guides are free to slide through said conduits in said construct, as taught by Otiz et al., in the cardiac assist device disclosed by Snyders and Roche et al. in combination, in order to add additional flexibility and support to the construct structure by allowing the struts to move within the conduits without damage or breakage from excessive stress forces.
Allowable Subject Matter
Claims 6-10 would be allowable if rewritten to overcome the rejections under 35 U.S.C. 112(b) and Double Patenting Rejections set forth in this Office action and to include all of the limitations of the base claim and any intervening claims, and/or if a Terminal Disclaimer is filed to overcome the Double Patenting Rejections. It is noted that the claims have been interpreted as described in the 35 U.S.C. 112(b) rejections above, including that Claim 6 depends from Claim 2.
Prior Art
The prior art made of record and not relied upon is considered pertinent to the Applicant's disclosure:
Anstadt et al. (US Publication No. 2006/0142634) discloses a cardiac assist device (Abstract; 100, Fig. 2C) comprising inflatable membranes within an outer shell (Paragraph 0212, 0310, 0370, 0389) that provide pressure and force to support pumping efficiency through the analysis of pressure/force profiles (Abstract; Paragraph 0046, 0049, 0139, 0411-0415, 0420; Claim 1).
Goetz (US Patent No. 4,048,990) discloses a cardiac assist device including a cup structure (28, 14, Fig. 5; 36, 14, Fig. 6), wherein said cup structure has a base (28, 14, includes base, Fig. 5; 36, 14, Fig. 6) that attaches to said outer shell to form said cup structure (constructs of Figs. 1-7 have cup structure with outer section which encircles bladder; Col. 2, Lines 28-50; “cup-like bladder”, Col. 3, Lines 1-5; Claim 1), including a plurality of flexible guides pass through said base (struts 30 attach to and pass through base 28, 14, Fig. 5; 36, 14, Fig. 6; Col. 2, Lines 30-41; Col. 2, Lines 58-67; Claim 1).
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 10:00am - 6:00pm EST.
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/PAMELA M. BAYS/Primary Examiner, Art Unit 3796
