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 .
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: the limitation “a resiliently collapsible portion configured to transition between an expanded configuration in contact with the shunting device…” as recited in lines 3-4 of section (B) of claim 1.
The present disclosure does not provide basis for this language, but only states that “The compliant implant may include a substantially flattened section… which is configured to expand to a rounded shape under a second higher amount of internal blood pressure… The compliant implant may be keyed to the shunting device such that the collapsible portion of the implant substantially faces the shunting device. The shunting device may protrude into the pulmonary artery enough such that when the compliant implant expands due to the systolic pressure wave the expansion around the shunt is limited” (PP [0027]) and “during systole the flattened wall of the compliant implant is configured to expand and substantially fill the space of the pulmonary artery, in the process forcing blood or fluid (saline, radio-opaque contrast, etc.) through the shunting device. During diastole the flattened wall is configured to return to its lower energy shape as depicted in Fig. 3” (PP [0028]).
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the resiliently collapsible portion having an expanded configuration in contact with the shunting device (claim 1), the secondary anchoring elements (claim 2) comprising barbs or hooks (claim 3) and the proximal and distal anchoring segments comprising a folded up skirting material (claim 17) must be shown or the features canceled from the claims. No new matter should be entered.
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.
Claim Objections
Claim 12 is objected to because of the following informality:
Claim 12, line 1: “wherein the compliant implant is comprises…” is grammatically incorrect and should be amended to remove the erroneous “is” such that the claim reads “wherein the compliant implant comprises…” instead.
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 15-16 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 14 introduces “at least one tubular extrusion”, but then claim 15 recites “wherein the at least one tubular extrusion and/or a stiffening bar is configured…”. This claim is indefinite because the “and/or” language presents a device which has tubular extrusions or a stiffening bar, opening up the potential for the device to only comprise a stiffening bar when claim 14 explicitly requires at least one tubular extrusion. It is unclear whether at least one tubular extrusion is actually required by claim 15 or not.
It is recommended that claim 15 be amended to recite “The system of claim 14, further comprising a stiffening bar configured to adjust a pressure differential required to collapse and expand the compliant implant” instead since claim 14 already requires at least one tubular extrusion, and particularly since the present disclosure does not provide support for the stiffening bar(s) being present without the tubular extrusions (PP [0031]: “The tubular extrusions of Fig. 3 are configured for accepting a number of stiffening bars as necessary. For example, a single stiffening bar may be inserted in the central tubular extrusion for some patients, while other patients may require the use of all three stiffening bars”).
Claim 16 inherits the deficiencies of claim 15 but would be allowable if claim 15 were amended as described above.
Allowable Subject Matter
Claims 1-14 and 17-20 are allowed.
The subject matter of the independent claims 1 and 10 filed on 6/18/2024 could either not be found or was not suggested in the prior art of record.
With respect to independent claims 1 and 10, the prior art does not disclose or render obvious at the effective filing date of the invention: the system as claimed comprising a shunting device and a compliant implant in combination with the other limitations of the independent claim.
The closest prior art is Chang (US PGPub 2026/0007407 A1), which discloses a system for treating heart failure (see Figs. 4A-C), the system comprising a shunting device (402) and a compliant implant (404) configured to transition between an expanded configuration (Fig. 4A) and a collapsed configuration spaced apart from the shunting device (402, Fig. 4B, PP [0065]: “the stent 404 (e.g., at least the midsection 413 of the stent 404) may be at least partially elastic and/or may be configured to elastically recoil back to an original and/or default form. The reduced pressure of the RPA 13 may allow spring-like materials of the stent 404 to push the blood back into the RPA 13 and/or towards the lungs”).
However, the filing date of Chang renders it unusable as prior art.
Duffy et al. (US PGPub 2013/0204176 A1) discloses a system for treating heart failures comprising a shunting device (900 in Figs. 10A-C) including a resilient valve (920) for controlling the flow of blood between an artery (A) and a vein (V), but fails to disclose or teach a compliant implant as claimed.
Furthermore, the prior art of record does not suggest any motivation to modify the Duffy et al. reference to arrive at a compliant implant configured to expand and collapse adjacent a shunt between an artery and a vein.
Claims 15-16 are presently rejected under 35 U.S.C. 112(b) but would also be allowable if this rejection were to be obviated via amendment.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Bridget E. Rabaglia whose telephone number is (571)272-2908. The examiner can normally be reached Monday - Thursday, 7am - 5pm.
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/BRIDGET E. RABAGLIA/Examiner, Art Unit 3771
/TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771