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 01/20/2026. Claims 1-15 are pending. Claims 8-15 are withdrawn.
Claim Objections
Claim 4 is objected to because of the following informalities:
Claim 4, line 3, “device the lamellae” is grammatically in correct.
Claim 4, line 5, the limitation “receiving” should be amended to --for receiving--.
Appropriate correction is required.
Election/Restrictions
Applicant's election with traverse of Invention I (claims 1-7) in the reply filed on 01/20/2026 is acknowledged. The traversal is on the ground(s) that EP2638869, cited in the application at para. [0009], relates to an ancillary device according to the preamble of claim 1, however EP2638869 does not disclose the characterizing portion "the body of the device includes a closable longitudinal opening giving access to the longitudinal channel at said handling portion and of the shaping assembly." Further EP2638869 certainly does not disclose that "the body of the device includes a closable longitudinal opening extending along an entire length of said body, and giving access to the longitudinal channel at said handling portion and of the shaping assembly." This is not found persuasive because the limitation “wherein the body of the device include a closable longitudinal opening extending along an entire length of said body” in claim 1 raises new matter issue. Based on the disclosure, closable longitudinal opening extends along the handing portion (Fig. 10), but not along the entire length of the shaping assembly because the proximal portion of the slits/openings between the adjacent lamellae are not closable (not able to be closed). The proximal portion of the slits/openings between the adjacent lamellae are shown to be slightly open even in a clamped position (e.g. Fig. 5. Fig. 2B also shows that). Furthermore, the specification is completely silent that the closable longitudinal opening extending along an entire length of said body. Therefore, the limitation “wherein the body of the device include a closable longitudinal opening extending along an entire length of said body” raises new matter issue.
EP2638869 discloses that the body of the device includes a closable longitudinal opening (central opening along the longitudinal axis of the device, Fig. 4) giving access to the longitudinal channel (the channel at the handling portion 18, Fig. 4) at said handling portion and of the shaping assembly (Fig. 4); and the body of the device includes a closable longitudinal opening extending along an length of said body, and giving access to the longitudinal channel at said handling portion and of the shaping assembly (the body of the device includes a closable longitudinal opening extending along an length of said body, and giving access to the longitudinal channel at said handling portion and of the shaping assembly as shown in Fig. 4. The catheter, which supports the graft unit, extends from the proximal end of the handling portion 18, Fig. 4).
The requirement is still deemed proper and is therefore made FINAL.
Claims 8-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 01/20/2026.
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.
The limitation “means for locking said closed configuration” recited in claim 3 meets the 3-prong test and properly invokes 35 U.S.C. 112(f). Based on the disclosure, the “means for locking said closed configuration” is the interlocking between the rail and the groove (PGPub, Para. [0058]).
The limitation “actuating means configured to radially compress the lamellae and activate their clamp position” in claim 5 meets the 3-prong test and properly invokes 35 U.S.C. 112(f). Based on the disclosure, the actuating means configured to radially compress the lamellae and activate their clamp position” is an external ring, hook, and a clip-on system (Para. [0050] and [0056]).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-7 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The limitation “wherein the body of the device include a closable longitudinal opening extending along an entire length of said body” in claim 1 raises new matter issue. Based on the disclosure, closable longitudinal opening extends along the handing portion (Fig. 10), but not along the entire length of the shaping assembly because the proximal portion of the slits/openings between the adjacent lamellae are not closable (not able to be closed). The proximal portion of the slits/openings between the adjacent lamellae are shown to be slightly open even in a clamped position (e.g. Fig. 5. Fig. 2B also shows that). Furthermore, the specification is completely silent that the closable longitudinal opening extending along an entire length of said body. Therefore, the limitation “wherein the body of the device include a closable longitudinal opening extending along an entire length of said body” raises new matter issue. Claims 2-7 are rejected because they depend on claim 1.
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 1-7 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 the limitation " the longitudinal channel…of the shaping assembly " in line 9 of the claim. There is insufficient antecedent basis for this limitation in the claim. Line 3 of claim 1 provides the elongate body provides with a longitudinal and through channel but does not specific that the longitudinal channel is part of the shaping assembly. Claims 2-7 are rejected because they depend on claim 1.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20050075655 A1 Bumbalough, Timothy et al. discloses a prosthesis delivery device having a splittable distal end.
US 20050149078 A1 Vargas, Jaime et al. discloses a trocar having a plurality of tines at the distal portion of the trocar for deploying an anastomosis device.
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/JING RUI OU/Primary Examiner, Art Unit 3771
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