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 non-provisional application filed on 06/09/2025. Claims 1-20 are pending. Claims 1 and 16 are independent.
Claim Objections
Claim 5 is objected to because of the following informalities:
Claim 5, line 1-2, “a plurality of undulating connection member connecting” should be amended to --a plurality of undulating connection members each connecting--.
Appropriate correction is required.
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.
Claims 1-20 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 1 recites that limitation “the proximal tubular section comprising a proximal end section configured to occlude a central lumen of the tissue connection stent when the proximal tubular section and the distal flange section are in the second diametrically expanded state.” As described in the specification, the second diametrically expanded state is shown in Figs 3B, 4B, and 5B. It is unclear how the proximal end section is configured to occlude a central lumen of the tissue connection stent when the proximal tubular section and the distal flange section are in the second diametrically expanded state (open, expanded state). Therefore, the claim is indefinite. Claims 2-15 are rejected because they depend on claim 1.
Claim 5 recites the limitation “a plurality of undulating connection member connecting an apex of the plurality of second strut members (18a, Fig. 1) with an apex of the plurality of the first strut members (18b, Fig. 1).” However, as described in the specification, the plurality of undulating connection members (26, Fig. 1) are not connecting an apex of the plurality of second strut members with an apex of the plurality of the first strut members. Instead, the plurality of undulating connection members (26, Fig. 1) each connects an apex of the plurality of first strut members (18a, Fig. 1) and an apex of a plurality of third struts members (24, Fig. 1)
Claim 16 recites that limitation “the proximal tubular section comprising a proximal end section configured to occlude a central lumen of the tissue connection stent when the proximal tubular section and the distal flange section are in the second diametrically expanded state.” As described in the specification, the second diametrically expanded state is shown in Figs 3B, 4B, and 5B. It is unclear how the proximal end section is configured to occlude a central lumen of the tissue connection stent when the proximal tubular section and the distal flange section are in the second diametrically expanded state (open, expanded state). Therefore, the claim is indefinite. Claims 17-20 are rejected because they depend on claim 16.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 10441416 B2 Oba; Travis Zenyo et al. discloses a prosthetic heart valve having a stent frame having a proximal tubular section and a distal flange section.
US 10610362 B2 Quadri; Arshad et al. discloses a prosthetic heart valve having a stent frame having a proximal tubular section and a distal flange section.
US 20050049678 A1 Cocks, Graeme et al. discloses a stent frame having a proximal tubular section and a distal flange section.
US 20200046525 A1 Kónya; András et al. discloses a stent frame having a proximal tubular section and a distal flange section.
US 20230329855 A1 Banas; Christopher E. et al. discloses an anastomosis device comprising a stent frame having a proximal tubular section and a distal flange section.
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/JING RUI OU/Primary Examiner, Art Unit 3771
