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 Election/Restriction response filed on 08/25/2025. Claims 83-93, 95, 96, and 98-106 are pending. Claims 85 and 106 are independent. Claims 93, 95, 96, and 98-100 are withdrawn. Claims 1-84, 94, and 97 are canceled. Claims 105 and 106 are newly added.
Election/Restrictions
Applicant’s election without traverse of Species A (Figures 1-4) in the reply filed on 08/25/2025 is acknowledged.
Claims 93, 95, 96, and 98-100 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/25/2025.
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.
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.
Claim 101 is 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 101 recites the limitation "said at least one slit" two times in line 2 of the claim. There is insufficient antecedent basis for this limitation in the claim.
The art rejection(s) below is/are made as best understood by the examiner because of the 35 U.S.C. 112 issue(s) stated above.
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) 85-92 and 101-106 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McNamara (US Pub. No.: 2011/0257723).
Regarding claims 85-92 and 101-105, McNamara 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);
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[claim 86] 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] 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] 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] 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] 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] 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] wherein said at least one slit is a notch (Fig. 24. Also see Fig. 2 for example);
[claim 101] wherein the at least one shunt lumen consists of said at least one slit; and said at least one slit comprises slit edges delimiting the at least one shunt lumen, wherein the slit edges are separated creating an opening therebetween when the membrane is in the closed position (see Figure above and Para. [0083]);
[claim 102] 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] wherein a cross-sectional area of said at least one shunt lumen is an unobstructed lumen (Fig. 24 and Para. [0083]);
[claim 104] 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] 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 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 a membrane (504, Fig. 24) 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 configured to deform to create a passage lumen when actively engaged by an external device (Paras. [0029]-[0032] and [0199] and Fig. 24, a large passage lumen is created when the slits between the membrane parts/valves open up), wherein the membrane has a closed position when not engaged by the external device in which the membrane provides maximum occlusion to the structure central opening (Fig. 24), and wherein the shunt lumen remains open when the membrane is in the closed position (Fig. 24 and Para. [0083]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20150148731 A1 MCNAMARA; Edward I. et al. discloses device comprising a shunt lumen for directing blood flow from one heart chamber to another heart chamber.
US 20200179663 A1 McDaniel; Tom R. et al. discloses a heart tissue occluder comprising a shunt lumen.
US 20200197178 A1 Vecchio; Christopher J. discloses a heart tissue occluder comprising a shunt lumen.
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/JING RUI OU/ Primary Examiner, Art Unit 3771