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 .
This action is in response to the amendment filed on 04/21/2026. Claims 85-93, 95, 96, 98-100, and 102-107 are pending. Claims 85 and 106 are independent. Claims 93, 95, 96, and 98-100 are withdrawn. Claims 1-84, 94, 97, and 101 are canceled. Claim 107 is newly added.
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in Italian Republic on 11/02/2020. It is noted, however, that applicant has not filed a certified copy of the IT102020000026056 application as required by 37 CFR 1.55.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Currently, none of the claim limitations are interpreted under 35 U.S.C. 112(f).
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 106 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McNamara (US Pub. No.: 2011/0257723).
Regarding claim 106, McNamara discloses an occluder device (500, Figs. 24 and 25 and Paras. [0029]-[0032] and [0241]) comprising: a supporting structure (501, Figs. 24 and 25) configured to anchor the occluder device to a septum of a heart of a patient when crossing a septum defect (see Figs. 13-19), the supporting structure comprising a supporting structure periphery (periphery defined by the support structure 501, Figs. 24 and 25) delimiting a structure central opening (central opening defined by 501/506, Fig. 25); and an elastic membrane (504, Fig. 24 and Para. [0197], the flow control element can be formed nitinol which is elastic) coupled to the supporting structure to cover the structure central opening, the membrane including a shunt lumen (See figure below; alternatively, the one shunt lumen is defined by the entire central opening shown in Fig. 24) extending through the membrane, wherein the membrane is fully capable to deform to create a passage lumen when actively engaged by an external device after implantation of the occluder device during a subsequent operation (Paras. [0029]-[0032] and [0199] and Fig. 24, the membrane is fully capable to deform to create a passage lumen when actively engaged by an external device after implantation of the occluder device during a subsequent operation because the member is deformable), wherein the elastic membrane has a closed position when not engaged by the external device in which the elastic membrane provides maximum occlusion to the structure central opening (Fig. 24), and wherein the shunt lumen remains open when the elastic membrane is in the closed position (Fig. 24 and Para. [0083]).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claim(s) 85-92, 102-105, and 107 is/are rejected under 35 U.S.C. 103 as being unpatentable over McNamara’723 (US Pub. No.: 2011/0257723) in view of McNamar et al.’784 (US Pub. No.: 2013/0178784).
Regarding claim 85, McNamara’723 discloses [claim 85] an occluder device (500, Figs. 24 and 25 and Paras. [0029]-[0032] and [0241]) comprising: a supporting structure (501, Figs. 24 and 25) adapted to anchor a septum of a heart of a patient when crossing a septum defect (see Figs. 13-19); said supporting structure comprising a supporting structure periphery (periphery defined by the support structure 501, Figs. 24 and 25) delimiting a structure central opening (central opening defined by 501/506, Fig. 25); said occluder device further comprising a membrane (504, Fig. 24); said membrane comprises a membrane body having a membrane periphery (Fig. 24); said membrane has a closed position in which the membrane is in a configuration which provides maximum occlusion to the structure central opening (Fig. 24); the membrane periphery is fastened to said supporting structure periphery to cover the structure central opening (Fig. 24 and Para. [0029]); when actively engaged by an external device the membrane deforms, creating a passage lumen (Paras. [0029]-[0032] and [0199] and Fig. 24, a large passage lumen is created when the slits between the membrane parts/valves open up); said membrane comprises at least one shunt lumen (See figure below; alternatively, the one shunt lumen is defined by the entire central opening shown in Fig. 24) which remains open when the membrane is in the closed position (Paras. [0029] and [0083]); and said at least one shunt lumen is smaller with respect to said passage lumen (said at least one shunt lumen is smaller with respect to said passage lumen, Fig. 24). McNamara’723 discloses that the shunt lumen can be different shapes (Figs. 26 and 29A-29C) However, McNamara’723 does not disclose that the at least one shunt lumen having a circular shape.
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McNamar’784 teaches, in the same field of endeavor (occluder device); a shunt lumen having a circular shape (shunt lumen 93 shown in Fig. 18 or shunt lumen 93a should in Fig. 20 is circular).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the at least one shunt lumen of McNamara’723 to be circular shape as taught by McNamar’784 was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular shape of the claimed the shunt lumen was significant. See MPEP 2144 IV
[claim 86] McNamara’723 discloses that wherein said supporting structure comprises a central supporting structure portion (506, Fig. 24 and Para. [0241]) delimiting a lumen (Fig. 24), wherein said supporting structure comprises a first anchoring portion (502 formed of 502a-502l, Fig. 24 and Para. [0241]) and a second anchoring portion (503 formed of 503a-503l, Figs. 24 and 25 and Para. [0241]) opposite the first anchoring portion, wherein said supporting structure is configured to expand and contract between a compressed tubular configuration for insertion through the patient's vasculature and an expanded configuration in which the first anchoring portion and the second anchoring portion extend radially outwards from said central supporting structure portion to compress the septum therebetween by arranging said supporting structure astride said septum through a defect or hole or opening present in the septum (Paras. [0077], [0078], and [0089]-[0091] and also see Figs. 14-19 for example);
[claim 87] McNamara’723 discloses that wherein said supporting structure is made of a less elastic material with respect to a material of said membrane (Para. [0190], [0196], and [0197], e.g. supporting structure is made of stainless steel which is less elastic than valve tissue material / nitinol forming the membrane / flow control element);
[claim 88] McNamara’723 discloses that wherein said first anchoring portion and said second anchoring portion comprise a plurality of supporting structure arms made of elastic material adapted to allow expanding and contracting between the compressed tubular configuration and the expanded configuration for anchoring the plurality of supporting structure arms to opposite surfaces of the septum (Paras. [0190] and [0077], e.g. stainless steel / nitinol);
[claim 89] McNamara’723 discloses that wherein said supporting structure is in a separate piece or pieces with respect to said membrane (Paras. [0028], [0029], [0190], [0196], and [0197] and Figs. 24 and 25);
[claim 90] McNamara’723 discloses that wherein said at least one slit extends from a first membrane periphery portion placed near the supporting structure to a second membrane periphery portion placed near the supporting structure (see Figure above, the slit can be defined as a slit extending from one periphery of the membrane to another periphery of the membrane with one periphery edge extending from one periphery of the membrane to another periphery of the membrane);
[claim 91] McNamara’723 discloses that wherein said at least one slit extends from the membrane periphery placed near the supporting structure to near a center of the membrane (see Figure above, when the slit is defined as a slit extending from near a periphery of the membrane to the shunt lumen, it extends from the membrane periphery placed near the supporting structure to near a center of the membrane);
[claim 92] McNamara’723 discloses that wherein said at least one slit is a notch (Fig. 24. Also see Fig. 2 for example);
[claim 102] McNamara’723 discloses that wherein said at least one shunt lumen substantially maintains a dimension thereof during normal operation of the heart to maintain a defined blood flow when the occluder device is implanted across the septum defect (Paras. [0083] and [0010]);
[claim 103] McNamara’723 discloses that wherein a cross-sectional area of said at least one shunt lumen is an unobstructed lumen (Fig. 24 and Para. [0083]);
[claim 104] McNamara’723 discloses that wherein said membrane defines an obstructed area of the structure central opening, said obstructed area is defined as the structure central opening minus a cross-sectional area of said at least one shunt lumen (Fig. 24);
[claim 105] McNamara’723 discloses that wherein the membrane further comprises at least one slit (see Figure above, the slit can be defined as a slit extending from near a periphery of the membrane to the shunt lumen; alternatively, the slit can be defined as a slit extending from one periphery of the membrane to another periphery of the membrane with one periphery edge extending from one periphery of the membrane to another periphery of the membrane), the at least one slit defining the passage lumen (see Figure below, the at least one sit defines the passage lumen when it opens up).
Regarding claim 107, McNamara’723 discloses substantially all the limitations of the claim but fails to disclose that the shunt lumen is defined in the elastic membrane by a shunt lumen edge having a circular shape.
McNamar’784 teaches, in the same field of endeavor (occluder device); a shunt lumen is defined in a membrane by a shunt lumen edge having a circular shape (shunt lumen 93 shown in Fig. 18 or shunt lumen 93a should in Fig. 20 is circular).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the at least one shunt lumen of McNamara’723 to be defined in the membrane by a shunt lumen edge having a circular shape as taught by McNamar’784 was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular shape of the claimed the shunt lumen was significant. See MPEP 2144 IV
Response to Arguments
Applicant’s arguments on pages 5-6 of the remarks with respect to claim(s) 85-92, 102-105, and 107 have been considered but are moot in view of new ground(s) of rejection.
Applicant's arguments regarding claim 106 filed 04/21/2026 have been fully considered but they are not persuasive. McNamara discloses an occluder device (500, Figs. 24 and 25 and Paras. [0029]-[0032] and [0241]) comprising: a supporting structure (501, Figs. 24 and 25) configured to anchor the occluder device to a septum of a heart of a patient when crossing a septum defect (see Figs. 13-19), the supporting structure comprising a supporting structure periphery (periphery defined by the support structure 501, Figs. 24 and 25) delimiting a structure central opening (central opening defined by 501/506, Fig. 25); and an elastic membrane (504, Fig. 24 and Para. [0197], the flow control element can be formed nitinol which is elastic) coupled to the supporting structure to cover the structure central opening, the membrane including a shunt lumen (See figure below; alternatively, the one shunt lumen is defined by the entire central opening shown in Fig. 24) extending through the membrane, wherein the membrane is fully capable to deform to create a passage lumen when actively engaged by an external device after implantation of the occluder device during a subsequent operation (Paras. [0029]-[0032] and [0199] and Fig. 24, the membrane is fully capable to deform to create a passage lumen when actively engaged by an external device after implantation of the occluder device during a subsequent operation because the member is deformable).
The limitation “configured to deform to create a passage lumen when actively engaged by an external device after implantation of the occluder device during a subsequent operation” is a functional limitation or recitation of intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
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 JING RUI OU whose telephone number is (571)270-5036. The examiner can normally be reached M-F 9:00am -5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571) 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JING RUI OU/Primary Examiner, Art Unit 3771
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