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: “constriction mechanism” in claims 1, 4-6, 8-9, 11-13, and 15-19. Note that claims 2, 3, 7, 10, 14, and 20 recite sufficient structure (diaphragm, knob, or pressure limiter) for the constriction mechanism to no longer invoke 35 USC 112f for those particular claims.
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 § 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) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Poll et al. (US 2010/0168520) in view of Vazales (US 2013/0023729)). Poll discloses an assembly comprising: a handle 900; fig. 16); a tunneling shaft (210) coupled to the handle, the tunneling shaft extending from the handle to a distal end; an optical window (when 210’ fully encloses distal end of scope, it is made of a material that permits visualization as disclosed in [0067]; thus, the distal end forms an optical window) disposed at the distal end of the tunneling shaft; an insertion pathway extending through the handle and the tunneling shaft to the optical window (see fig. 2c); a constriction mechanism (locking grommet 2250 and locking knob 2000; figs. 16, 17a-c, which is consistent with corresponding structure invoked by 35 USC 112f) coupled to the handle defining a portion of the insertion pathway, wherein the constriction mechanism is configured to selectively constrict the insertion pathway (via actuation of knob 2000; [0136]), and an endoscope (100) configured to be inserted in the handle to the optical window along the insertion pathway (see fig. 2c and [0136]). Poll does not expressly disclose that at least a portion of the tunneling shaft extends in a curved orientation between the handle and the distal end.
Vazales discloses another tunneling shaft (122; fig. 3b) through which an endoscope (128) is inserted, the tunneling shaft having an optical window (142) formed at the distal end. Vazales discloses that the tunneling shaft may have at least a portion that extends in a curved orientation (fig. 3B) between a handle and the tunneling shaft’s distal end in order to approximate the bend radius of a standard endotracheal tube ([0018], [0128]). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Poll to include a curve in the tunneling shaft such that it extends in a curved orientation between its ends as taught by Vazales in order to facilitate insertion of the tunneling shaft through a standard endotracheal tube when visualization of a patient’s trachea or lungs is desired.
Regarding claim 2, the constriction mechanism comprises an inner diaphragm (rubber grommet 2250) defining the portion of the insertion pathway ([0138]).
Regarding claims 3 and 10, the constriction mechanism comprises a manually engageable knob (2000).
Regarding claims 4, 11, and 17, the constriction mechanism is configured for selective disengagement and reengagement of the endoscope (e.g., by inserting or withdrawing the endoscope through the insertion pathway, or by actuating knob 2000 to change size of insertion path into and out of engagement with outer surface of endoscope).
Regarding claims 7, 14, and 20, the constriction mechanism of Poll has a pressure limiter (2410; fig. 17a-b of Poll) configured to limit compression of the insertion pathway ([0134] – tabs limit extent to which collet 2210 is compressed).
Regarding claims 8 and 15, the magnitude of constriction of the constriction mechanism is adjustable by a user (by actuating knob 2000 of Poll).
Regarding claims 9 and 16, Poll discloses that the tunnelling shaft is flexible ([0077]), and thus considered bendable.
Regarding claims 5, 12, and 18, Poll fails to disclose an optical material as claimed. Vazales teaches including an optical material (silicone oil) disposed in the insertion pathway and in contact with the optical window (142) formed at the distal end of the tunneling shaft (122) ([0103] – silicone oil placed on one or both sides of window; see also [0062]) in order to act as an optical coupling agent that creates an approximately equivalent refractive index between the window and the scope. It would have been obvious to one of ordinary skill in the art to have modified the prior art of Poll to include an optical material disposed in the insertion pathway in contact with the optical window as taught by Vazales to reduce the difference in refractive index between the window and the scope, thereby reducing reflecting and improving contrast of the images ([0103]).
Regarding claims 6, 13, and 19, Poll fails to disclose an orientation indicator as claimed. Vazales teaches including an orientation indicator (see [0097]) on an optical window (142) of a tunneling shaft in order to orient the user to the patient anterior and/or posterior. It would have been obvious to one of ordinary skill in the art to have modified the prior art of Poll to include an orientation indicator on the optical window of Poll as taught by Vazales in order to allow the user to more easily determine the orientation of the device with respect to the patient.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 5,695,448 to Kimura discloses a tunneling shaft (151; fig. 31) having an optical window at its distal end (transparent cap 151b) and a constriction mechanism comprising a diaphragm (161) and a manually engageable knot (153) that is rotated to squeeze diaphragm (161) thereby constricting the insertion pathway of the device. Kimura discloses another embodiment of a tunneling shaft configured to receive an endoscope wherein the tunneling shaft extends in a curved configuration between its proximal and distal ends (fig. 42).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHLEEN SONNETT HOLWERDA whose telephone number is (571)272-5576. The examiner can normally be reached M-F, 8-5, with alternate Fridays off.
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KSH 5/22/2026
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771
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