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 .
The current application has the effective filing date of 12/22/2020 to PRO 63129454.
Claim Status
Claims 1, 3, 5-9, 17, 22-25, 34, 46, 54, 56, 57, 59 and 61 are pending, claims 2, 4, 10-16, 18-21, 26-33, 35-45, 47-53, 55, 58, and 60 have been cancelled.
Claims 5, 8-9, 17, 22-25, 34, 46, 57, 59 and 61 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Groups 2-5, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/06/2025.
Elected Group I: Claims 1, 3, 6, 7, 54 and 56 are examined.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Such claim limitation(s) is/are:
“radially expandable element” in claims 1, 3, 6, 7, and 56.
“locomotion element” in claims 1 and 3
“friction augmenting features” in claim 6
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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, 3, 6, 7, 54 and 56 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.
Regarding claims 1, 6 and 54, the phrase "optionally" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 3 recites the limitation "the central lumen" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 56, the phrase "e.g." and “such as” individually renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 3, 6, 7, 54 and 56 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ortiz US 2007/0106302 A1 (hereinafter “Ortiz”).
Regarding claim 1, Ortiz discloses a device (Abstract and [0004-0005]: (body) lumen traversing device; see Figs.1: device 10) configured to move within a body cavity, the device comprising:
a) an elongated support (elongate body 12);
b) a proximal radially expandable element (tubing elements or balloon 18a) and a distal radially expandable element (tubing elements or balloon 18b) positioned along the length of the elongated support (12), optionally wherein the radially expandable elements are independently controllably expandable (This limitation is not positively required by the claim due to “optionally” limitation, but it is taught in Figs. 6-10 and [0028: 1st sentence], each balloon is independently and selectively expandible and contractible),
wherein the radially expandable elements (18a and 18b) comprise outer surfaces configured to frictionally engage a wall of a body cavity (traction surface 22, see [0030: 3rd sentence] “the balloons can include a friction-enhancing treatment or surface feature 22 to assist the balloons [18a, 18b] in gripping the lumen wall”), and
wherein the distal radially expandable element (18b) is fixed relative to the elongated support (12; see Figs. 6-10 and 18b is fixed relative to distal tip 17 on body 12, also see Fig. 3 and [0036] 18b is attached to mated end 31b and retention band 34); and
c) a locomotion system (Figs. 3-4: actuating rods 40 and actuating/control elements 20) comprising:
i) a proximal locomotion element (rod 40a) having a part that is fixed relative to the proximal radially expandable element (18a) and slidable along the length of the elongated support (12), such that the proximal radially expandable element (18a) is slidable along the length of the elongated support (12) (This is shown in [0036-0037] and Fig. 3:18a is fixed onto rod 40a; also see Figs. 6-7 and [0042] “Actuating handle 20b moves second proximal and distal handle members 50a, 50b relative to one another, causing rods 40a, 40b to move relative to one another. Movement of rods 40a, 40b causes balloon 18b to expand/contract as discussed above.”), and
ii) a distal locomotion element (rod 40b) having a part fixed relative to the elongated support (12) (see Figs. 3-4),
wherein the locomotion system effects sliding movement of the proximal radially expandable element (18a) along the length of the elongated support (12), thereby effecting relative movement between the radially expandable elements and movement of the device within the body cavity (See relative sliding movements in Figs. 6-10 and see [0042] “Actuating handle 20b moves second proximal and distal handle members 50a, 50b relative to one another, causing rods 40a, 40b to move relative to one another. Movement of rods 40a, 40b causes balloon 18b to expand/contract as discussed above.”, also see [0042-0043, 0046]).
Regarding claim 3, Ortiz discloses the device of claim 1, wherein one or both of the expandable elements (18a, 18b) and/or one or both of the locomotion elements (20, 40) are in fluid or gas communication (gas communication because the inner lumen is filled with at least air) with one or more chambers, one or more channels, one or more tubes, and/or one or more wires in the central lumen (This is interpreted as lumen within body 12, shown in Fig. 2 and [0039] “In another embodiment, body 12 includes an outer protective shell defining an inner lumen (not shown) and rods 40a, 40b can be disposed therein.” See the rest of [0039] which discusses the inner lumen of body 12 contains therein channels, tubes and/or chambers, which can carry fluids or other therapeutics therein, for delivery to body lumen. The interior of body 12 is illustrated in Figs. 3-4).
Regarding claim 6, Ortiz discloses the device of claim 1, wherein the proximal and the distal radially expandable elements (18a, 18b respectively) are capable of expanding radially outwardly to engage a wall of a body cavity ([0046] and Figs. 6-10), optionally wherein friction augmenting features (friction-enhancing treatment or surface feature 22) are molded into the proximal and/or distal radially expanding elements. (This limitation is not positively required by the claim due to “optionally” limitation, but it is taught in [0030] “…traction surface 22 can be a porous or rough coating or overlayer which is positioned on the surface of balloons 18a, 18b”)
Regarding claim 7, Ortiz discloses the device of claim 1, wherein alternating extensions and retractions of a distance between the outer surfaces (22) of the proximal and the distal radially expandable elements (18a, 18b) effects movement of the device (10) within the body cavity. (See Figs. 6-10 which illustrates alternating extensions and retractions of balloons 18a and 18b; also see [0028, 0046] with regard to repeating the alternating extensions and retractions to advance device 10 within a body lumen/cavity)
Regarding claim 54, Ortiz discloses the device of claim 1, wherein the body cavity (i.e. body lumen described in Ortiz) is a vascular body lumen, a digestive body lumen, a respiratory body lumen, or a urinary body lumen (see Abstract and [0027:last sentence] discusses intended application of device 10 in the gastrointestinal tract), optionally wherein the digestive body lumen is a gastrointestinal tract, optionally wherein the digestive body lumen comprises esophagus, stomach, small intestine, duodenum, jejunum, ileum, colon, and/or rectum. (This limitation is not positively required by the claim due to “optionally” limitation, but it is taught in Abstract, Background of Invention and [0027])
Regarding claim 56, Ortiz discloses the device of claim 1, wherein the expandable elements (18a, 18b) are connected to the elongated support (e.g., tubular structure such as tether) (12) using an elastic O-ring that mechanically holds the expandable elements; using adhesive only securing the edges of the expandable elements; mechanically securing the edges of an expandable element by a deformable material such as a metal by swaging or radially compressing it around the expandable element; or by a combination thereof. (See [0036] and Fig. 3: 18a and 18b are connected to body 12 by retention band 34; this is interpreted as “elastic O-ring” in this claim. Alternatively, [0036] “For example, the balloons can be bonded, welded, adhered, and/or mated with a friction fit to body 12”, this is taken to encompass “using adhesives… mechanically securing…” in this claim)
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Sharma US 2019/0388133 A1 see Abstract and Fig 11B regarding a catheter comprising a proximal and distal radially expandable elements.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIRLEY X JIAN whose telephone number is (571)270-7374. The examiner can normally be reached M-F 8:00-4:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHIRLEY X JIAN/ Primary Examiner, Art Unit 3792
December 4, 2025