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 .
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: imaging unit … that images the subject” in claim 1 (see [0048] of specification as filed for corresponding structure).
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 1-11 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 1-11, claim 1 recites in part in line 4-5 “an ultrasonic transducer … that emits an ultrasonic wave toward one side in a first direction orthogonal to the longitudinal axis direction”. A direction by definition is “the line or course on which something is moving or is aimed to move or along which something is pointing or facing” https://www.merriam-webster.com/dictionary/direction. It follows that, with respect to the defined longitudinal axis and the emitted ultrasonic wave in the claim, two directions exist, a first direction along which the ultrasonic wave propagates on one side with respect to the longitudinal axis, and a second direction opposite the first direction on the other side of the longitudinal axis. Line 12-14 of the claim “a first bottom surface portion of the first region and a second bottom surface portion of the second region are each disposed on the other side in the first direction, which is opposite to the one side” sets forth that the first and second bottom surface portion are on the other side in the first direction is indefinite because the other side is necessarily on a direction opposite the first direction and not on the first direction. Moreover, the recitation in line 15-16 of the claim “… the first bottom surface portion is disposed on the other side in the first direction with respect to the second bottom surface portion” further renders the claim indefinite because this recitation directly contradicts that the preceding statement that the first and second bottom surface are on the other side. Claims 2-11 are likewise rejected, because they include all limitations and deficiencies of claim 1. For examination purposes, it will be presumed that lines 12-14 refers to the other side opposite the first direction and lines 15-16, the first bottom surface defines a plane that is not coplanar with a plane of the second bottom surface portion e.g. as depicted in Figs. 4-5C with respect to first bottom surface 54A and second bottom surface 112A.
Regarding claim 11, the structure implied by “other side” and “one side” is unclear considering the rejection above in regards to the one side and other side in regards to the longitudinal axis.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shimoyama US 20230108503 A1.
Regarding claim 1, as best understood, Shimoyama discloses an ultrasonic endoscope (e.g. Figs. 1-5, [0035-0036]) comprising: a distal end portion (“34” - [0040], [0046-0047]) that is disposed on a distal end side of an insertion part (“12” - [0040]) extending along a longitudinal axis direction (see Fig. 1); an ultrasonic transducer (“50” - [0050]) that is provided at the distal end portion and that emits an ultrasonic wave toward one side in a first direction orthogonal to the longitudinal axis direction (e.g. illustration Fig 4 and [0048], ultrasonic wave will propagate on the Y(+) direction); and an imaging unit (“40c” - [0056]) that is disposed on a base end side in the longitudinal axis direction with respect to the ultrasonic transducer and that images a subject (see illustration Figs. 2-5), wherein the distal end portion includes a first region (“34a” Figs. 2-5) in which the ultrasonic transducer is provided and a second region (“34b”, “34c” Figs. 2-5) that is disposed on the base end side in the longitudinal axis direction with respect to the first region and in which the imaging unit is provided (see as illustrated in Figs. 2-5), a first bottom surface portion of the first region and a second bottom surface portion of the second region are each disposed on the other side in the first direction, which is opposite to the one side(see illustration Figs. 2-5), and the first bottom surface portion is disposed on the other side in the first direction with respect to the second bottom surface portion (as illustrated in Figs. 2-5, a first bottom surface of region “34a” is not on the same plane (not co-planar) with a second bottom surface of region “34b”, “34c”.
Regarding claims 2-3, a central axis and/or plane direction of region “34a” and “34b”,“34c” is parallel and would thus define an angle that is less than 1 degree.
Regarding claims 4-5, see illustration Figs. 2, 4-5 and [0066] regarding groove portion “92” between first region (“34a”) and second region (“34b”, “34c”) for fitting balloon 120 the groove portion “92” has a first and second surface as claimed.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 6-11 are rejected under 35 U.S.C. 103 as being unpatentable over Shimoyama as applied to claim 1 above, and further in view of Miyagishima et al US 20230018150 A1 "Miyagishima").
Regarding claims 6-8, Shimoyama discloses the invention of claim 1 as discussed above, [0051-0052] disclose a treatment tool outlet port (“52”) and a pipe member (“74”) that communicates with the tool outlet port (see illustration Fig. 2-3). Shimoyama does not explicitly disclose an elevator unit in which an elevator is provided in a rotationally moveable manner, that includes the elevator and a case member that defines a space to which the elevator is housed.
Miyagishima discloses an analogous ultrasonic endoscope (Figs. 1 and 6) that comprise an elevator unit (“370” - [0092-0093]) in which an elevator is provided in a rotationally moveable manner, that includes the elevator that varies a lead-out direction of the treatment tool introduced from the treatment tool outlet port, an elevation angle of the elevator changes with a push/pull operation, the elevator is housed within space portion that reads on a case member. In view of these teachings, at the time of filing the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the treatment outlet port of Shimoyama to include an elevator unit that comprise an elevator and a case member that defines a space to house the elevator, for the added advantage of allowing for varying a lead-out direction of the treatment tool during a surgical procedure to target adjacent tissue of interest during a surgical procedure.
Regarding claims 9-11, Shimoyama in view of Miyagishima discloses the ultrasonic endoscope of claim 8 as discussed above, the imaging unit of Shimoyama comprises a housing portion that houses the imaging unit ([0053], [0056] of Shimoyama, housing portion “82” - Fig. 3, as modified by Miyagishima, a portion of the housing portion would overlap with the elevator unit when viewed in the first direction, a portion of the housing portion would overlap with the pipe member when viewed in a direction perpendicular to the longitudinal axis and first direction, and a position of an outermost end portion side of the imaging unit housing portion. Examiner contends that in Shimoyama in view of Miyagishima, a position of an outermost end portion side of the imaging unit housing portion on the other side in the first direction is provided on the other side in the first direction with respect to a position of an outermost end portion side of the pipe member on the one side in the first direction because the modified ultrasonic device of Shimoyama in view of Miyagishima would have a substantially similar structure, if not the same as the claimed invention. Where the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. Whether the rejection is based on "inherency" under 35 USC § 102, on prima facie obviousness" under 35 USC § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO's inability to manufacture products or to obtain and compare prior art products." In re Best, 562 F2d 1252, 1255, 195 USPQ 430,433-4 (CCPA 1977). (see MPEP 2112.01 (I)).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BONIFACE N NGANGA whose telephone number is (571)270-7393. The examiner can normally be reached Mon. - Thurs. 5:30 am - 4:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ANNE M KOZAK can be reached at (571) 270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BONIFACE N NGANGA/Primary Examiner, Art Unit 3797