DETAILED ACTION
Election/Restrictions
Applicant's election with traverse of Group 1, claims 1-12 in the reply filed on 1/8/2026 is acknowledged. The traversal is on the ground(s) that all groups can be examined at the same time without serious burden. This is not found persuasive because the examination of invention 2-4 would require a complete search of the CPC group 2- A61B2017/00951 (5,897 hits), group 3-A61B2017/00238 (4,240 hits), group 4- A61B2017/00495 (8,030 hits) where the elected of group 1 would not. The CPC of group 1 A61B17/00234 contains over 74,562 patent documents that are not classified in any of the search area for non-elected groups 2-4. Thus, this would place a serious search burden if a restriction were not required.
The requirement is still deemed proper and is therefore made FINAL.
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) 1-5,7,10,12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Machold et al U.S Pat 10,172,621.
Claim 1: Machold et al disclose a device for treating a hollow structure (i.e., blood vessel -see col. 1, lines 53-54) within an organism to remove fluid from or add a fluid to the hollow structure, the device comprising: a main body 870 in figure 62a comprising a thin, fluid-impermeable layer (it is noted that a bridge stop 870 positioned between at least two layers of pericardium 872. Pericardium 872 may be a single piece of pericardium having a butterfly cut to allow the bridge stop 870 to be positioned between the two layers, or the pericardium may include at least two separate pads, so as to allow the bridge stop 870 to be positioned between the at least two pads, see col. 35, lines 51-65). having a distal surface and a proximal surface and including a septum (at the central portion at area 876), wherein the septum is adapted to allow a needle (i.e., a bridge element 12, fig. 62a) to be inserted therethrough and to form a fluid-tight seal around a periphery of the needle; and an adhesive layer (it is noted that pads 862 and 872 may be composed of biological tissue other than pericardium and further may be lined with polyester fabric or equivalent to promote tissue in-growth, see col. 36, lines 9-14) disposed on the distal surface of the main body, the adhesive layer surrounding the septum, wherein the adhesive layer is adapted to fix the main body to a surface of the hollow structure and to create a fluid-tight seal between the septum and the hollow structure (it is noted that fig. 62b shows a tight seal at bridge stop 870 and pads 872 that is packed in a deployment configuration within a catheter 24).
Claims 2-3: Machold et al disclose wherein the septum at area 876 is self-sealing or self -expanding, (see col. 35, lines 64-67)., wherein the septum and the main body are contiguous and formed from the same material, see fig. 62a.
Claims 4-5: Machold et al disclose wherein one or more of the main body and the septum are formed from an elastomer (see col. 31, lines 66-67); wherein one or more of the main body, the septum, and the adhesive layer are bioabsorbable (see col. 36, lines 9-14).
Claims 7,10,12: Machold et al disclose wherein the main body further comprises one or more tabs (fig. 62a has a plurality of arms 874) protruding from the proximal surface, wherein the one or more tabs are adapted to be grasped by a surgical instrument (by a plunger, see col. 36, lines 2-4); wherein the hollow structure is a cyst, a lesion, a gallbladder, a part of a urinary system, an intestine, a blood vessel (see col. 1, lines 53-54) or another organ; further comprising a contrast agent (see col. 14, lines 26-29) administered to the hollow structure by the needle.
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) 6, 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Machold et al.
Claims 6, 11: Machold et al disclose the invention substantially as claimed but is silent regarding wherein the adhesive layer comprises one or more of a contact
adhesive, a ultraviolet light-cured adhesive, a two-component adhesive, a fibrin-based adhesive, a collagen-based adhesive, a gelatin-based adhesive, an albumin-based adhesive, a chitosan-based adhesive, a chondroitin sulfate-based adhesive, a dextran- based adhesive, a cyanoacrylate adhesive, a polycthylene glycol-based adhesive, a polyurethane-based adhesive, a hydrogel-based adhesive, and a biomimetic adhesive; the device further comprising an antiparasitic agent administered to the cyst by the needle. It would have been obvious to one having ordinary skill in the art at the time the invention was made to construct the device included the adhesive layer comprises one or more of a contact adhesive, a ultraviolet light-cured adhesive, a two-component adhesive, a fibrin-based adhesive, a collagen-based adhesive, a gelatin-based adhesive, an albumin-based adhesive, a chitosan-based adhesive, a chondroitin sulfate-based adhesive, a dextran- based adhesive, a cyanoacrylate adhesive, a polycthylene glycol-based adhesive, a polyurethane-based adhesive, a hydrogel-based adhesive, and a biomimetic adhesive; the device further comprising an antiparasitic agent administered to the cyst by the needle, since it has been held to be within the general skill of a worker in the art to select a known material on the basic of its suitability for the intended use or as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Allowable Subject Matter
Claims 8-9 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 8: the prior arts fail to disclose or reasonably suggest the claimed including a main body forms a circle, wherein a septum is located at a center of the circle, wherein the main body has a first thickness at the center and a second thickness at a perimeter of the circle, and wherein the first thickness is greater than the second thickness. Claim 9 is also allowed by virtue of their dependency from claim 8.
Conclusion
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/VI X NGUYEN/Primary Examiner, Art Unit 3771