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 .
Election/Restrictions
Applicant’s election without traverse of group I and species a in the reply filed on 03/20/2026 is acknowledged.
Status of Claims
Claim 1-4, 6-15, 17, 19-21, 23, and 26 are pending, claims 17, 19-21, 23, and 26 have been withdrawn from consideration, and claims 1-4 and 6-15 currently under consideration for patentability under 37 CFR 1.104
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/17/2024 has been considered by the examiner.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the actuation member coupled between the proximal mechanical assembly and the focus driver (claim 3) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the seal member is configured to move between a collapsed configuration and an expanded configuration when the control input moves the focus driver between a first focus position and a second focus position (claim 4) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the optics chamber has a first volume when the seal member is in the collapsed configuration and a second volume when the seal member is in the expanded configuration; and the second volume is greater than the first volume. (claim 6) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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:
a focus driver positioned within the optics chamber and operably coupled to the focusing element, the focus driver being configured to move a longitudinal position of the focusing element in response to a control input in claim 1
a seal member coupled to the housing, the seal member configured to maintain a hermetic seal of the optics chamber while the control input affects the focus driver in claim 1
a proximal mechanical assembly coupled to the proximal end portion of the elongated body, the proximal mechanical assembly being configured to receive the control input in claim 3
an actuation member positioned within the elongated body and coupled between the proximal mechanical assembly and the focus driver, the actuation member being configured to apply a mechanical force to the focus driver in a longitudinal direction in response to the control input in claim 3
an energy storage device positioned between a portion of the housing and a portion of the focus driver, the energy storage device being configured to exert a biasing force on the focus driver in claim 9
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 § 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) 1-3, 8 and 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kennedy et al. (U.S. 5,575,757).
With respect to claim 1, Kennedy et al. teaches an imaging instrument, comprising:
an elongated body (FIG. 6 for example) defining a channel (interior of 20,16, seen in FIG. 2 for example) extending longitudinally through the elongated body between a proximal end portion of the elongated body and a distal end portion of the elongated body, the distal end portion coupled to a distal tip (FIG. 1, 2); and
an imaging system positioned within the elongated body, the imaging system including:
an optics chamber (lumen of 31) defined at least in part by a housing (31), the optics chamber being hermetically sealed,
a focusing element (33a,b) movably positioned within the optics chamber,
an image sensor (24) operably coupled to the focusing element (4:9-22),
a focus driver (33) positioned within the optics chamber and operably coupled to the focusing element (FIG. 1,2), the focus driver being configured to move a longitudinal position of the focusing element in response to a control input (5:56-6:11), and
a seal member coupled to the housing (98,100), the seal member configured to maintain a hermetic seal of the optics chamber while the control input affects the focus driver (5:29-34).
With respect to claim 2, Kennedy et al. teaches a fiber-optic bundle (26) positioned within the channel, the fiber-optic bundle including an input end operably coupled to a light source (FIG. 2) and an output end positioned at the distal tip (FIG. 1), at least a portion of the fiber-optic bundle configured to be in fluid communication with an environment surrounding the imaging instrument (FIG. 2).
With respect to claim 3, Kennedy et al. teaches a proximal mechanical assembly (17) coupled to the proximal end portion of the elongated body (FIG. 2), the proximal mechanical assembly being configured to receive the control input; and
an actuation member (63) positioned within the elongated body and coupled between the proximal mechanical assembly and the focus driver, the actuation member being configured to apply a mechanical force to the focus driver in a longitudinal direction in response to the control input (5:56-6:11).
With respect to claim 8, Kennedy et al. teaches the seal member is a sealing assembly, the sealing assembly including at least one O-ring (98); and the at least one O-ring surrounds either a proximal portion of the focus driver or an actuation member (FIG. 2).
With respect to claim 10, Kennedy et al. teaches a plurality of optical elements positioned to establish an optical axis from a target location, through the focusing element (FIG. 3).
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) 1, 9, 10 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wataya et al. (U.S. 2017/0290497).
With respect to claim 1, Wataya et al. teaches an imaging instrument, comprising:
an elongated body (9) defining a channel (interior of 6,7, seen in FIG. 2 for example) extending longitudinally through the elongated body between a proximal end portion of the elongated body and a distal end portion of the elongated body, the distal end portion coupled to a distal tip (FIG. 2); and
an imaging system (30) positioned within the elongated body, the imaging system including:
an optics chamber (lumen of 31) defined at least in part by a housing (31), the optics chamber being hermetically sealed,
a focusing element (66) movably positioned within the optics chamber,
an image sensor (37) operably coupled to the focusing element (FIG. 3),
a focus driver (65,49) positioned within the optics chamber and operably coupled to the focusing element (FIG. 3), the focus driver being configured to move a longitudinal position of the focusing element in response to a control input (FIG. 3-4), and
a seal member coupled to the housing (28,42,69).
Wataya et al. does not explicitly state a hermetic seal of the optics chamber. However, Wataya et al. teaches several structures whose purpose is to provide water tightness (see para [0049], [0056], [0069]). It would be obvious to one of ordinary skill in the art to hermetically seal the optics chamber of Wataya et al. because it was well known in the art that water or debris becoming trapped in the lens system would degrade the quality of images produced by the scope.
With respect to claim 9, Wataya et al. teaches an energy storage device (68) positioned between a portion of the housing and a portion of the focus driver, the energy storage device being configured to exert a biasing force on the focus driver (FIG. 3, 4).
With respect to claim 10, Wataya et al. teaches a plurality of optical elements positioned to establish an optical axis from a target location, through the focusing element (FIG. 3, 4).
With respect to claim 15, Wataya et al. teaches the plurality of optical elements includes a lens group at a fixed longitudinal position that is distal of the focusing element and proximal of the distal tip (FIG. 3, 4).
Claim(s) 4 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kennedy et al. (U.S. 5,575,757) as applied to claim 1 above and further in view of Higuma et al. (U.S. 2002/0128539).
Kenney et al. teaches an imaging instrument as set forth above. However, Kennedy et al. does not teach the seal member is configured to move between a collapsed configuration and an expanded configuration when the control input moves the focus driver between a first focus position and a second focus position.
With respect to claim 4, Higuma et al. teaches an imaging device with a seal member (85,87 FIG. 8), wherein the seal member is configured to move between a collapsed configuration and an expanded configuration when the control input moves the focus driver between a first focus position and a second focus position (para [0160] for example).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify Kennedy et al. to further include a bellows as taught by Higuma et al. in order to provide an endoscope that can withstand repeated autoclave sterilization cycles (para [0017] of Higuma et al.).
With respect to claim 6, Kennedy et al. in view of Higuma et al. teaches the optics chamber has a first volume when the seal member is in the collapsed configuration and a second volume when the seal member is in the expanded configuration; and the second volume is greater than the first volume (5:56-6:11 of Kennedy et al. for example).
With respect to claim 7, Kennedy et al. teaches the housing includes a flange portion (34); the focus driver includes a proximal portion that extends longitudinally through the flange portion (FIG. 2).
However, Kennedy et al. does not teach the seal member has a distal end that is coupled to the flange portion and a proximal end that is coupled to the proximal portion of the focus driver.
With respect to claim 7, Higuma et al. teaches an imaging device with a seal member (85,87 FIG. 8).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify Kennedy et al. to further include a bellows as taught by Higuma et al. in order to provide an endoscope that can withstand repeated autoclave sterilization cycles (para [0017] of Higuma et al.). This modification would result in the seal member having a distal end that is coupled to the flange portion and a proximal end that is coupled to the proximal portion of the focus driver (FIG. 2 of Kennedy et al, FIG. 8 of Higuma et al.).
Claim(s) 11, 13, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wataya et al. (U.S. 2017/0290497) as applied to claim 10 above and further in view of Navok et al. (U.S. 2006/0173242).
Wataya et al. teaches an imaging instrument as set forth above. However, Wataya et al. does not teach a prism.
With respect to claim 11, Navok et al. teaches an imaging instrument comprising a plurality of optical elements which includes a prism (36, FIG. 2B).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify Wataya et al. to utilize a prism before the image sensor in the manner taught by Navok et al. in order to allow for a the image sensor to be arranged longitudinally instead of perpendicularly (FIG. 2B of Navok et al.) thereby allowing for a larger surface area of the sensor. Modifying Wataya et al. in such a manner would result in the prism being positioned between the focus driver and the focusing element.
With respect to claim 13, Navok et al. teaches the image sensor is displaced from an optical axis defined by the plurality of optical elements (FIG. 2B).
With respect to claim 14, Navok et al. teaches the plurality of optical elements includes a window (34) that is positioned at the distal tip; and the window defines a portion of the optics chamber (FIG. 2B).
Allowable Subject Matter
Claim 12 is 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.
The following is a statement of reasons for the indication of allowable subject matter: the prior art of record does not teach or otherwise render obvious the invention of dependent claim 12 comprising inter alia:
the imaging system includes a movable lens holder;
the movable lens holder includes a middle portion extending between a distal end and a proximal end;
the focusing element is coupled to the distal end of the movable lens holder;
the proximal end of the movable lens holder is coupled to the focus driver; and
the middle portion of the movable lens holder is positioned radially outward of the prism such that the prism is between the movable lens holder and the image sensor.
Wataya et al. teaches a movable lens holder 65. However Wataya et al. does not teachthe focusing element is coupled to the distal end of the movable lens holder. Wataya et al. does not teach the proximal end of the movable lens holder is coupled to the focus driver. Finally, Wataya et al. does not teach the middle portion of the movable lens holder is positioned radially outward of the prism such that the prism is between the movable lens holder and the image sensor. Therefore Wataya et al. does not meet all of the limitations of claim 12.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Alexandra Newton Surgan whose telephone number is (571)270-1618. The examiner can normally be reached Monday-Friday 8am-4pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Carey can be reached at (571) 270-7235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALEXANDRA L NEWTON/ Primary Examiner, Art Unit 3799
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