DETAILED ACTION
Election/Restrictions
Applicant's election with traverse of Group 1, claims 1-7 in the reply filed on 1/9/2026 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 non-elected groups 2-3 would require a complete search of the CPC group in A61B2017/12054 (10930 hits in group 2); A61M25/04 (17500 hits in group 3), wherein the elected of group 1 would not. The CPC of group 1 A61B17/00234 contains over 74700 patent documents that are not classified in any of the required search area for non-elected groups 2-3. Thus, this places 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 pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 1-7 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Kirkman U.S Pat 6,071,263.
Claim 1: Kirkman discloses a device for providing access for a medical device to a nodule, a lesion, or a pathological area in a lung or other body organ or lumen as best seen in fig. 3, the device comprising: a sheath (a tube 41) portion including: a proximal end; a distal end; a primary lumen at 44 that extends from the proximal end to the distal end, wherein the lumen is configured to receive the medical device; and one or more secondary lumens at 42 that extend from the proximal end to the distal end; one or more stabilization elements (positioning wires 50), wherein the one or more stabilization elements are configured to deploy from respective ones of the one or more secondary lumens, wherein the one or more stabilization elements 50 are extendable beyond the one or more secondary lumens as best seen in fig. 3; and a stabilization element control device configured to allow independent deployment of the one or more stabilization elements (see claim 17-Kirkman stated “manipulating the control assembly of the tip retainer to deploy the tip retainer assembly into abutting contact with the blood vessel wall such that the tip retainer assembly contacts the blood vessel wall with sufficient force”)
Claim 2: Kirkman discloses wherein the primary lumen comprises a first diameter dimension, wherein the one or more secondary lumens comprises a second diameter dimension, wherein the first diameter dimension is larger than the second diameter dimension (it is noted that Fig. 3 shows two of the wires 50 are located along the major axis (is equivalent as a primary lumen which has a larger dimension) of the elliptical tube 41 while the other wires are located along the minor axis (is equivalent as a secondary lumen which has a second smaller dimension). In this embodiment, the two wires 50 located along the major axis may extend from the tube 41 at a different angle than the two positioning wires which are located along the minor axis (see col. 8, lines 59-62).
Claims 3-4: Kirkman discloses wherein the primary lumen 44 and the one or more secondary lumens 42 include central longitudinal axes, wherein the central longitudinal axes of the one or more secondary lumens are located further from a central longitudinal axis of the sheath portion 41 than the central longitudinal axis of the primary lumen; wherein the central longitudinal axis of the primary lumen 44 is collocated with the central longitudinal axis of the sheath portion (fig. 3, col. 8, lines 59-62).
Claims 5-7: Kirkman discloses wherein at least one of the one or more
stabilization elements 50 is keyed to a predefined orientation within a respective one of the one or more secondary lumens 42; wherein the one or more stabilization elements 50 are configured to deploy away from a center axis of the sheath portion 41., wherein the distal end includes a distal face and the primary lumen and the one or more secondary lumens 42 are exposed at the distal face as best seen in fig. 3.
Conclusion
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/VI X NGUYEN/Primary Examiner, Art Unit 3771
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