DETAILED ACTION
This office action is in response to applicant’s amendment filed on 5/12/2026.
Claim 1 has been amended. Claims 1-3, 5-10 are pending in this present application.
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 § 102
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) 1-3, 5-6, 9-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Frassica et al U.S 2012/0149985.
Claims 1, 5: Frassica et al disclose a stent 301/341 as best seen in figures 16, 22 comprising: an elongated tubular body 342 defining a longitudinal axis and comprising a proximal end, a distal end, and a central lumen extending between the proximal end and the distal end, wherein the central lumen is configured for passage of a guide wire therethrough (it is noted that a recitation of intended use and functional languages in the underline phrase of the claimed invention must result in a structural difference between the claimed invention and the prior arts in order to patentably distinguish the claim invention from the prior arts. If the prior art structure is capable of performing the intended use, then it meets the claim. In this case, Frassica et al, figures 16, 22 looks and functional similar to claim 1 that is used for with tip 354 protruding, such that the distal end 345 of stent-follower 341 mates with a self-centering action with the proximal end of stent 301 when the two devices are brought into contact with approximate axial alignment. When stent-follower 341 and stent 301 are thus mated, tip 334 (FIG. 19) of stylet 331 may be extended through aperture 352 (FIG. 22) and into aperture 309 (FIG. 17), thereby locking stent 301 and stent-follower 341 into a fixed rotational relationship. In this condition, the rotation of the proximal end of stylet 331 and stent-follower 341 causes the concurrent rotation of stent 301, whether to rotatingly advance or retract the stent. Stylet 331 may be withdrawn and stent-follower 341 rotatingly retracted, leaving stent 301 positioned at any useful point within a passageway (see paragraph 257); and a tapered distal tip portion 354 disposed at the distal end of the elongated tubular body 342, wherein the tapered distal tip portion 354 comprises one 343 or more spiral threads located on an outer surface of the tapered distal tip portion (see paragraphs 256,257).
Claims 2-3: Frassica et al disclose wherein the elongated tubular body and the
tapered distal tip portion comprise a biocompatible polymer (see paragraph 95); wherein the tapered distal tip portion is frustoconical in shape (see fig. 22).
Claims 6, 9-10: Frassica et al disclose further comprising at least one flexible retention flange 820, fig. 40 configured to inhibit migration of the stent by a -traumatically engaging tissue following insertion or implantation into a subject; wherein the elongated tubular body comprises at least one aperture 352 configured to allow fluid communication between the central lumen and tissue proximate the stent; wherein at least a portion of the central lumen comprises a hexagonal cross section (see fig. 22, paragraph 257).
Claim Rejections - 35 USC § 103
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.
Claim(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Frassica et al.
Claims 7-8: Frassica et al. discloses the invention substantially as claimed but is silent regarding at least one retention flange comprises a curved flat projection or a round disk attached to an external surface of the elongated tubular body. It would have been to one ordinary skill in the art at the time the invention was made to construct the device that is with a curved flat projection or a round disk attached to an external surface of the elongated tubular body, since the applicant has not disclosed that doing so solves any stated problem or is anything more than selecting one of numerous shapes or configurations a person ordinary skill in the art would find available to substitute with a round disk of a flange that is known in the surgical arts.
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.
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/VI X NGUYEN/Primary Examiner, Art Unit 3771
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