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 .
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
Claim Objections
Claim 11 is objected to because of the following informalities: in claim 11, line 3, “(a”) is a duplicate and should be “(b)” and line 6, “(b)” should be “(c)”. Appropriate correction is required.
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, 5, 8, 10 and 20 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.
As to claim 1, term “anchoring component” lacks antecedent basis. It appears that this term was intended to be “anchoring mechanism”.
Claim 5 recites a method of use step of “wherein the anchoring mechanism is rotated to adjust the number of windings”. Claim 5 ultimately depends from apparatus claim 1 and thus inherently incorporates the limitations therefrom. A single claim which claims both an apparatus and method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) (see MPEP 2173.05(p)(II)). For the purposes applying prior art, this claim will be interpreted as the anchoring mechanism being configured to be rotated.
Claim 8 recites a method of use step of “wherein the pre-determined number of windings are determined based at least in part on a load requirement and a coefficient of friction between the pull wire and the anchoring mechanism.”. Claim 8 ultimately depends from apparatus claim 1 and thus inherently incorporates the limitations therefrom. A single claim which claims both an apparatus and method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) (see MPEP 2173.05(p)(II)). For the purposes of applying prior art, this claim will be interpreted as the number of windings being configured to be determined.
As to claim 10 and 20, since anything can be “disposed of” or “used once”, it is not clear what further limiting structure is conveyed by labeling the endoscope as “disposable” or “single-use”, and thus the scope of the claim is indeterminant.
Claim Interpretation
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:
“driving mechanism” in claim 1.
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) 1-6, 8, and 11-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang et al. (US 2021/0059506, hereinafter “Wang”).
As to claim 1, Wang discloses an articulating flexible endoscope comprising:
a proximal portion (operating section 3, Fig.2) comprising a driving mechanism (pulley 21, Fig.2) for applying a force to a pull wire ([0051]);
the pull wire (wire 25, Fig.2) for articulating a bending section of the articulating flexible endoscope upon the force [0051]); and
an anchoring mechanism (wire fixing structure 30, Fig.5, comprising fixing member 31) coupled to the driving mechanism (Fig.4), wherein a proximal end of the pull wire is configured to wind around the anchoring mechanism with a pre-determined number of windings (shown in Figs.6-8 as being wound around member 31), thereby reducing a holding tension at the proximal end of the pull wire (the more wire that is wound around member 31, the less holding tension at the proximal end of the pull wire because of friction).
As to claim 2, wherein the driving mechanism comprises a capstan (pulley 21 constitutes a “capstan”).
As to claim 3, wherein the capstan comprises a cutout to receive the anchoring mechanism (fixing member 31 can be received in a cutout 24 in the pulley 21, Fig.16, [0096]).
As to claim 4, wherein the anchoring mechanism is freely rotatable within the cutout (Fig.16, Wang describes circular fixing member 31 as “engaging” the circular recessed portion 24, [0096], so in its broadest sense, without teachings of any other fixing structure or materials (e.g. screws), the fixing member 31 would be capable of freely rotating around the central axis of the recess because of the corresponding circular shapes).
As to claim 5, as best understood (see 112(b) rejection above), wherein the anchoring mechanism is configured to be rotated to adjust the number of windings (since the fixing structure 31 is separate from the pulley 21 when the wire is wound around it, the wire fixing structure is configured to be rotated about any axis in order to facilitate winding of the wire around it).
As to claim 6, wherein the anchoring mechanism is coupled to the driving mechanism via a screw (screw 32, [0055]-[0056], Figs.4,5).
As to claim 8, as best understood (see 112(b) rejection above), wherein the pre-determined number of windings are configured to be determined based at least in part on a load requirement and a coefficient of friction between the pull wire and the anchoring mechanism (the assembly is configured such that the number of windings for proper holding tension can be determined through simple calculations based on load and friction coefficients).
As to claim 11, Wang discloses a method for coupling a pull wire to an articulating flexible endoscope comprising:
(a) providing an anchoring mechanism (wire fixing structure 30 is provided in Fig.5, comprising fixing member 31);
(b) wrapping a proximal end of the pull wire to the anchoring mechanism with a pre- determined number of windings (shown in Figs.6-8 as being wound around member 31), thereby reducing a holding tension at the proximal end of the pull wire (the more wire that is wound around member 31, the less holding tension at the proximal end of the pull wire because of friction); and
(c) assembling the anchoring mechanism to a driving mechanism (wire fixing structure 30 is fixed to a pulley 21 using screws 32, Fig.4) located at a proximal portion of the articulating flexible endoscope (pulley 21 is a proximal end of endoscope 1, Fig.2).
As to claim 12, wherein the driving mechanism is configured for applying a force to a pull wire ([0051]).
As to claim 13, wherein a bending section of the articulating flexible endoscope is articulated by the pull wire upon the force ([0051]).
As to claim 14, wherein the driving mechanism comprises a capstan (pulley 21 constitutes a “capstan”).
As to claim 15, wherein the capstan comprises a cutout to receive the anchoring mechanism (fixing structure 31can be received in a cutout 24 in the pulley 21, Fig.16, [0096]).
As to claim 16, wherein the anchoring mechanism is freely rotatable within the cutout (Fig.16, Wang describes circular fixing member 31 as “engaging” the circular recessed portion 24, [0096], so in its broadest sense, without teachings of any other fixing structure or materials (e.g. screws), the fixing member 31 would be capable of freely rotating around the central axis of the recess because of the corresponding circular shapes).
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) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US 2021/0059506, hereinafter “Wang”).
As to claim 7, Wang, as set forth above with respect to claim 3, further discloses that the fixing member (31) is not limited to a circular shape and could alternatively be in a quadrangular (e.g. square) shape (Fig.14, [0086]). As set forth with respect to claim 3, Wang also teaches that the fixing member 31 can be received in a cutout in the pulley, but only exemplifies this with a circular shaped fixing member (see Fig.16). Thus, Wang fails to explicitly teach that the anchoring mechanism and the cutout have a non-circular shape such that the anchoring mechanism is not rotatable within the cutout. However, given Wang’s teachings, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have applied the recessed fixing member embodiment (Fig.16) to the square fixing member embodiment (Fig.14) in order to provide the predictable result of holding the fixing member to the pulley without the need of screws. In obviously combining these embodiments, the cutout would have to be shaped to correspond with the shape of the fixing member (Fig.14), and thus be of a square shape to receive the square shaped fixing member. This would provide for an anchoring mechanism and the cutout have a non-circular shape (e.g. square) such that the anchoring mechanism is not rotatable within the cutout (because of the square shape).
Claim(s) 9-10 and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US 2021/0059506, hereinafter “Wang”) in view of Au (US 2017/0273542).
As to claims 9 and 19, Wang, as set forth above with respect to claims 1 and 11, discloses that the endoscope (1) has a distal tip (6) which includes an imaging device and an illumination device ([0031]) but fails to disclose a position sensor in the distal tip. Au teaches, in the endoscope art, that it is known to dispose a position sensor at the distal end of a flexible endoscope (Au: flexible endoscope 104/200/300, Figs.1,2,3, [0027],[0038], can include a position sensor 222/220, Fig.2, [0039],[0045] at the distal end) in order to obtain positional information of the distal tip to aid in proper navigation to a surgical site as well as positional behavior at a surgical site ([0004]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided a position sensor at the distal end of the endoscope of Wang to provide the predictable result of aiding in navigation of the endoscope to a target site within the body, as taught by Au. One having ordinary skill in the art would do this knowing there would be a reasonable expectation of success.
As to claims 10 and 20, wherein the entire articulating flexible endoscope is disposable or single-use (the endoscope of Wang is capable of being disposed of or used only once).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US 2021/0059506, hereinafter “Wang”) in view of Yeung et al. (US 2007/0299427, hereinafter “Yeung”).
As to claim 17, Wang, as set forth above with respect to claim 16, fails to explicitly teach adjusting the number of windings by rotating the anchoring mechanism. Yeung teaches, in a wire driving assembly using pulleys (Fig.2), to anchor the end of the wire by wrapping the end around an anchoring member (Fig.5e) provided in a recess of the pulley (note tensioning screw 96a inside hole 144a in pulley 20, Figs.5a,5e, [0170]). Yeung further teaches that enabling further rotation of the anchoring member, and thus increasing cable windings on the anchoring member, allows for the tension on the cable to be set to a desired level ([0171]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have enabled further rotation of the anchoring mechanism of Wang to increase the windings around the anchoring mechanism to provide the predictable result of allowing the wire to be set at a desired tension for proper operation of the assembly or to remove slack caused by wire stretching over time. One having ordinary skill in the art would do this knowing there would be a reasonable expectation of success.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US 2021/0059506, hereinafter “Wang”).
As to claim 18, Wang teaches to wind the pull wire around the anchoring mechanism in order to secure such pull wire at least in large part by friction of the windings around the anchoring mechanism ([0070]). However, Wang fails to explicitly teach determining the pre-determined number of windings based at least in part on a load requirement and a coefficient of friction between the pull wire and the anchoring mechanism. However, when constructing the Wang anchoring mechanism to function properly, one of ordinary mechanical skill would recognize that the amount of force applied to the pull wire (load requirement), the static coefficient of friction between the pull wire and anchoring mechanism, and the amount of surface contact (provided by each winding) will dictate whether or not the pull wire will slip when the force is applied (e.g. whether or not there is enough holding tension). Since the load requirement and coefficient of friction would be known, it would be beneficial to determine how much surface contact (windings) between the pull wire and anchoring mechanism would be needed to adequately hold the wire from slipping (i.e. do the number of windings shown in, for example Fig.7 of Wang, provide adequate surface contact between the wire and anchoring mechanism to provide a large enough friction force). Therefore, it would have been obvious to one of ordinary mechanical skill in the art before the effective filing date of the claimed invention to have determined the number of windings (amount of surface contact) in order to provide the predictable result of verifying adequate holding tension on the pull wire for proper operation of the pull wire assembly.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See references cited on the PTO-892. Of particular relevance are US 2023/0037743 to Hallauer et al. and US 2019/0125465 to Evans et al., both of which show pull wire anchoring mechanisms inside a pulley (Hallauer: Fig.5; Evans: Figs.11-15).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN P LEUBECKER whose telephone number is (571)272-4769. The examiner can normally be reached Generally, M-F, 5:30-2:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan T Nguyen can be reached at 571-272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOHN P LEUBECKER/Primary Examiner, Art Unit 3795