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 .
Status of Claims
Claims 1-4, 7, 13-16, 18-19, and 21-29 are pending, claims 5-6, 8-12, 17, and 20 have been cancelled, claims 21-29 have been added, and claims 1-4, 7, 13-16, 18-19, and 21-29 are currently under consideration for patentability under 37 CFR 1.104. Previous claim objection and 35 USC 112 Rejections have been withdrawn in light of Applicant’s amendments.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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: “an imaging device” and “a lighting element” in claims 7 and 18.
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 25-26 and 29 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 claim 25, the limitation “a third distance…is greater at a distal portion of the bottom surface than at a middle portion of the bottom surface” is unclear with respect to “a second distance between…and the middle portion” in claim 16. It is unclear if the third distance is 1) a set distance between two features and/or 2) includes the second distance (i.e. distance between the central longitudinal axis and the middle portion). Claim 26 is rejected due to its dependency on claim 25.
Regarding claim 29, the limitation “the distance is a first distance….a second distance…than at a distal portion of the distal tip” is unclear with respect to “a distance between the first side surface…than at a distal portion of the distal tip” in claim 18. It is unclear if the second distance is 1) a set distance between two features and/or 2) includes the first distance (i.e., the distance between the first and second side surfaces at the distal portion).
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) 1-4, 13-16, 18, 21-22, 24-25, and 28-29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sorensen (US 2021/0228064).
Regarding claim 1, Sorensen discloses a distal tip (2, figures 3-4) of a duodenoscope, the distal tip comprising: a first side surface (see left side surface of 2, figure 6b | in figure 6b, the endoscope appears to be flipped upside down compared to figures 2); a second side surface (see right side surface of 2, figure 6b); a top surface (see bottom surface of 2, figure 6b); a bottom surface (see upper surface of 2, figure 6b); and a distal surface (distal or front wall 11, figures 4 and 6b), wherein the first side surface, the top surface, and the distal surface meet at a first junction (lower left quadrant, see figure 6b), wherein the first side surface, the bottom surface, and the distal surface meet at a second junction (upper left quadrant, see figure 6b), wherein the second side surface, the bottom surface, and the distal surface meet at a third junction (upper right quadrant, see figure 6b), and wherein the second side surface, the top surface, and the distal surface meet at a fourth junction (lower right quadrant, see figure 6b); wherein the first side surface and the second side surface flare outwardly in a distal direction (see figures 3-4 | the outer surface increases in diameter distally | interpreted the increase in diameter is the same among all surfaces due to the circular shape, see figure 6b), such that a distance from each of the first side surface and the second side surface to a central longitudinal axis of the distal tip increases in the distal direction (see diameter of the distal end vs. the proximal end of 2, figure 4).
Regarding claim 2, Sorensen further discloses the first junction and the fourth junction are approximately symmetrical (see lower left vs. right quadrants in figure 6b), wherein the second junction and the third junction are approximately symmetrical (see upper left vs. right quadrants in figure 6b), wherein the first junction and the third junction are approximately symmetrical (see upper right vs. lower left quadrants in figure 6b), and wherein the second junction and the fourth junction are approximately symmetrical (see upper left vs. lower right quadrants in figure 6b).
Regarding claim 3, Sorensen further discloses upon viewing the distal surface of the distal tip facing proximally, the distal surface is approximately symmetrical about at least two planes including a line that extends parallel to or coaxial with the central longitudinal axis of the distal tip (see 2 and xy axes, figure 6b).
Regarding claim 4, Sorensen further discloses a portion of the distal surface is approximately symmetrical about at least four planes including the line that extends parallel to or coaxial with the central longitudinal axis of the distal tip (see circular shape at distal surface of 2, figure 6b | the portion of the distal surface is symmetrical about at least four planes due to its circular shape).
Regarding claim 13, Sorensen further discloses at least a portion of the distal tip has a cross-sectional shape perpendicular to [[a]] the central longitudinal axis of the distal tip that is approximately circular (see figure 6b).
Regarding claim 14, Sorensen further discloses the top surface tapers downward from a proximal end of the top surface to a distal end of the top surface (see middle portion to the distal portion of the top surface of 2, figure 4).
Regarding claim 15, Sorensen further discloses a central portion of the distal surface extends further in the distal direction than side portions of the distal surface do (see annotated image below).
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Regarding claim 16, Sorensen discloses a distal tip (2, figures 3-4) of a duodenoscope, the distal tip comprising: a first side surface (see left side surface of 2, figure 6b | in figure 6b, the endoscope appears to be flipped upside down compared to figures 2); a second side surface (see right side surface of 2, figure 6b); a top surface (see bottom/lower surface of 2, figure 6b); a bottom surface (see upper/top surface of 2, figure 6b); and a distal surface (distal or front wall 11, figures 4 and 6b), wherein each of the first side surface and the second side surface includes a proximal portion (see 134, figures 21), a distal portion (see annotated image below, and a middle portion (see annotated image below | interpreted the change in diameter is the same among all surfaces due to the circular shape, see figure 6b), and wherein, for each of the first side surface and the second side surface, a first distance between a central longitudinal axis of the distal tip and the distal portion is greater than a second distance between the central longitudinal axis of the distal tip and the middle portion (see annotated image below | interpreted the change in diameter is the same among all surfaces due to the circular shape, see figure 6b).
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Regarding claim 18, Sorensen discloses a distal tip (2, figures 3-4) of a duodenoscope, the distal tip comprising: a first side surface (see left side surface of 2, figure 6b | in figure 6b, the endoscope appears to be flipped upside down compared to figures 2); a second side surface (see right side surface of 2, figure 6b); a top surface (see bottom/lower surface of 2, figure 6b); a bottom surface (see top/upper surface of 2, figure 6b); and a distal surface (distal or front wall 11, figures 4 and 6b), wherein the top surface includes at least one opening (see opening for window component 14, figure 2b | [0175]) for receiving an imaging device (this element is interpreted under 35 USC 112f as a camera | camera 30, figure 8a; [0167]) or a lighting source (this element is interpreted under 35 USC 112f as an LED or optical fiber | see LEDs 32, figure 8a [0197]), and wherein a distal portion of each of the first side surface and the second side surface flares outwardly in a distal direction such that a distance between the first side surface and the second side surface is smaller at a middle portion of the distal tip than at a distal portion of the distal tip (see annotated image below).
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Regarding claim 21, Sorensen further discloses when viewed from a top of the distal tip, a first line drawn alongside the first side surface and a second line drawn alongside the second side surface diverge from one another in the distal direction (see annotated image below | overall diameter changes in the distal direction).
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Regarding claim 22, Sorensen further discloses a distal portion of the distal tip is laterally wider than a proximal portion of the distal tip (see annotated image immediately above | overall diameter changes in the distal direction).
Regarding claim 24, Sorensen further discloses when viewed from a top of the distal tip, a first line drawn alongside the first side surface and a second line drawn alongside the second side surface diverge from one another in a distal direction (see annotated image below | overall diameter changes in the distal direction).
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Regarding claim 25, Sorensen further discloses a third distance between the bottom surface (interpreted the increase in diameter is the same among all surfaces due to the circular shape, see figure 6b) and the central longitudinal axis is greater at a distal portion of the bottom surface than at a middle portion of the bottom surface (see annotated image below | see change in diameter between middle portion and distal portion).
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Regarding claim 28, Sorensen further discloses a distal portion of the distal tip is laterally wider than a proximal portion of the distal tip (see annotated image below | interpreted the increase in diameter is the same among all surfaces due to the circular shape, see figure 6b).
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Regarding claim 29, Sorensen further discloses the distance is a first distance, wherein a proximal portion of each of the first side surface and the second side surface flares outwardly in a distal direction such that a second distance between the first side surface and the second side surface is smaller at a proximal portion of the distal tip than at a distal portion of the distal tip (see annotated image immediately above | interpreted the increase in diameter is the same among all surfaces due to the circular shape, see figure 6b.
Claim(s) 1, 7, 16, 18-19, 23 and 25-27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yamaya (US 2019/0208992).
Regarding claim 1, Yamaya discloses a distal tip (see endoscope cover, figures 21) of a duodenoscope, the distal tip comprising: a first side surface (see bottom surface of 102, figure 21a | see right side surface of 14, figure 7a); a second side surface (see upper surface of 102, figure 21a | see left side surface of 14, figure 7a); a top surface (see upper/top surface of 14, figure 7a); a bottom surface (see bottom/lower surface of 14, figure 7a); and a distal surface (see left side surface of 102, figure 21a | see surface of 112a, figure 7a), wherein the first side surface, the top surface, and the distal surface meet at a first junction (upper right quadrant of 14, figure 7a), wherein the first side surface, the bottom surface, and the distal surface meet at a second junction (lower right quadrant, see figure 7a), wherein the second side surface, the bottom surface, and the distal surface meet at a third junction (lower left quadrant, see figure 7a), and wherein the second side surface, the top surface, and the distal surface meet at a fourth junction (upper left quadrant, see figure 7a); wherein the first side surface and the second side surface flare outwardly in a distal direction (see annotated image bellow), such that a distance from each of the first side surface and the second side surface to a central longitudinal axis of the distal tip increases in the distal direction (see change in diameter from the middle to the distal portions of the first and second side surfaces with the inclined line in the image).
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Regarding claim 7, Yamaya further discloses the top surface defines a first opening and a second opening (see edges 126, 128, and 130 forming the first and second opening, figure 21a), wherein the first opening is configured to receive an imaging device (this element is interpreted under 35 USC 112f as a camera | observation optical system 34, figure 5a), and wherein the second opening is configured to receive a lighting element (this element is interpreted under 35 USC 112f as an LED or optical fiber | illumination optical system 32, figure 5a; interpreted as intended use, where the illumination optical system can be an LED light source).
Regarding claim 16, Yamaya discloses a distal tip (see endoscope cover, figures 21) of a duodenoscope, the distal tip comprising: a first side surface (see bottom surface of 102, figure 21a | see right side surface of 14, figure 7a); a second side surface (see upper surface of 102, figure 21a | see left side surface of 14, figure 7a); a top surface (see upper/top surface of 14, figure 7a); a bottom surface (see bottom/lower surface of 14, figure 7a); and a distal surface (see left side surface of 102, figure 21a | see surface of 112a, figure 7a), wherein each of the first side surface and the second side surface includes a proximal portion (see 134, figures 21), a distal portion (see annotated image below), and a middle portion (see annotated image below), and wherein, for each of the first side surface and the second side surface, a first distance between a central longitudinal axis of the distal tip and the distal portion is greater than a second distance between the central longitudinal axis of the distal tip and the middle portion (see annotated image below | see change in diameter from the middle portion to the distal portion with the inclined line in the image).
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Regarding claim 18, Yamaya discloses a distal tip (see endoscope cover, figures 21) of a duodenoscope, the distal tip comprising: a first side surface (see bottom surface of 102, figure 21a | see right side surface of 14, figure 7a); a second side surface (see upper surface of 102, figure 21a | see left side surface of 14, figure 7a); a top surface (see upper/top surface of 14, figure 7a); a bottom surface (see bottom/lower surface of 14, figure 7a); and a distal surface (see left side surface of 102, figure 21a | see surface of 112a, figure 7a), wherein the top surface includes at least one opening (see edges 126, 128, and 130 forming an opening, figure 21a) for receiving an imaging device (this element is interpreted under 35 USC 112f as a camera | observation optical system 34, figure 5a) or a lighting source (this element is interpreted under 35 USC 112f as an LED or optical fiber | illumination optical system 32, figure 5a), and wherein a distal portion of each of the first side surface and the second side surface flares outwardly in a distal direction such that a distance between the first side surface and the second side surface is smaller at a middle portion of the distal tip than at a distal portion of the distal tip (see annotated image below | see change in diameter from the middle portion to the distal portion with the inclined line in the image).
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Regarding claim 19, Yamaya further discloses the at least one opening is at least one first opening (see edges 126, 128, and 130 forming the first opening, figure 21a), wherein the top surface further defines a second opening (see open edge 116 and right side edge 122, figure 21a) for receiving an elevator (42, figure 7a), and wherein the distal surface includes a recess (124, figure 7a | [0124]) in communication with the second opening.
Regarding claim 23, Yamaya further discloses for each of the first side surface and the second side surface, a third distance between the central longitudinal axis of the distal tip and the proximal portion is greater than the second distance between the central longitudinal axis of the distal tip and the middle portion (see annular depressed portion 132a vs. 134, figure 21b).
Regarding claim 25, Sorensen further discloses a third distance between the bottom surface and the central longitudinal axis is greater at a distal portion of the bottom surface than at a middle portion of the bottom surface (see annotated image above).
Regarding claim 26, Sorensen further discloses the third distance is greater at a proximal portion of the bottom surface than at the middle portion of the bottom surface see 132a vs 134, figure 21b).
Regarding claim 27, Yamaya further discloses a proximal portion of each of the first side surface and the second side surface tapers inwardly in a distal direction such that a distance between the first side surface and the second side surface is smaller at a middle portion of the distal tip than at a proximal portion of the distal tip (see annular depressed portion 132a vs. 134, figure 21b).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAMELA F WU whose telephone number is (571)272-9851. The examiner can normally be reached M-F: 8-4 PM.
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PAMELA F. WU
Examiner
Art Unit 3795
September 17, 2026
/RYAN N HENDERSON/Primary Examiner, Art Unit 3795
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