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 .
DETAILED ACTION
Claim Rejections - 35 USC § 112b
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, 16, 19, and dependent claims 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.
Claims 1, 16, and 19 recite “at least one working channel” but subsequently refers to “the working channel” which is indefinite since multiple ones could exist.
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, 6-10, 13, 15, 16, 18, 19 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Saadat US2005/0234296.
Saadat discloses for claim 1, “A medical device comprising:
a shaft (elongate body 12; fig 1A-E; 0026) defining at least one working channel (one or more working lumens 16; fig 1A-E; 0027) extending from a proximal end of the shaft to a distal end of the shaft along a longitudinal axis, the working channel having a cross-sectional dimension that allows passage of an instrument therethrough (0032); and
a distal tip (housing 14; fig 1A-E; 0027) coupled to the shaft and comprising a first arm and a second arm (articulating elements 20 with linkages 21a,b; fig 1A-E; 0027), the first arm being moveable relative to the second arm between a first configuration that obstructs a portion of the working channel and a second configuration that provides unobstructed access to the working channel to allow the instrument to extend distal to the medical device (fig 1A-E; 0027 describes the collapsed and expanded profiles)”.
Saadat discloses for claim 2, “The medical device of claim 1, wherein a cross-sectional dimension of the working channel at the distal end of the shaft is at least 50% of a cross-sectional dimension of the distal end of the shaft (0027 describes “one or more working lumens 16” where the figure 1A is provided as “illustratively shown” in the condition for two lumens and fig 5 is considered to provide an illustration of the condition for one working lumen 54)”.
Saadat discloses for claim 3, “The medical device of claim 1, wherein the first arm is moveable relative to the second arm via a hinge (hinges 22a, b)”.
Saadat discloses for claim 6, “The medical device of claim 1, wherein the distal tip is biased to the first configuration (0029, 0031 describes the articulating elements configured to articulate off-axis or out-of-line from working axis W and in a collapsed delivery configuration having a reduced delivery profile suited for delivery within a body orifice)”.
Saadat discloses for claim 7, “The medical device of claim 1, wherein the distal tip includes at least one of an imaging device or a light source (0034 describes illumination sources and optics; 0035 describes imaging sensors as included in the optics) and the shaft further comprises at least one lumen containing an electronic connection to the at least one of the imaging device or light source (0034 descries electrical wires running along push/pull members 24)”.
Saadat discloses for claim 8, “The medical device of claim 7, wherein the at least one of the imaging device or light source is on a distal-most surface of the distal tip (fig 1A-E)”.
Saadat discloses for claim 9, “The medical device of claim 1, wherein one of the first arm or the second arm includes an imaging device and the other of the first arm or the second arm includes a light source (0034 describes illumination sources and optics/image sensors on each arm)”.
Saadat discloses for claim 10, “The medical device of claim 1, wherein the shaft further comprises a lumen for irrigation or suction, the lumen extending through the distal tip to a distal opening in the first arm or the second arm (0034 describes “flushing lumens” running along push/pull members 24 to the arms)”.
Saadat discloses for claim 13, “The medical device of claim 1, wherein the working channel is defined by a tube moveable relative to the shaft and the distal tip (0055 describes liner 160 which is not described as anchored or adhered to the shaft and therefore considered movable relative thereto)”.
Saadat discloses for claim 15, “The medical device of claim 1, wherein the distal tip is detachable from the shaft via complementary mating features of the distal tip and the shaft (fig 1A-E show the housing 14 and elongate body 12 as concentric cylinders, i.e. having complementary mating features)”.
Saadat discloses for claim 16, “A medical device comprising:
a shaft (elongate body 12; fig 1A-E; 0026) defining at least one working channel (one or more working lumens 16; fig 1A-E; 0027) extending along a longitudinal axis from a proximal end of the shaft to a distal end of the shaft; and
a distal tip (housing 14; fig 1A-E; 0027) coupled to the shaft and comprising a first arm and a second arm (articulating elements 20 with linkages 21a,b; fig 1A-E; 0027), the first arm being moveable relative to the second arm via a hinge between a first configuration that obstructs a portion of the working channel and a second configuration that provides unobstructed access to the working channel to allow an instrument to extend distal to the medical device (fig 1A-E; 0027 describes the collapsed and expanded profiles), the distal tip being biased to the first configuration (0029, 0031 describes the articulating elements configured to articulate off-axis or out-of-line from working axis W and in a collapsed delivery configuration having a reduced delivery profile suited for delivery within a body orifice)”.
Saadat discloses for claim 18, “The medical device of claim 16, wherein the distal tip includes an imaging device and a light source (0034 describes illumination sources and optics; 0035 describes imaging sensors as included in the optics) each disposed on a distal-most surface of the distal tip (fig 1A-E).
Saadat discloses for claim 19, “A medical device comprising:
a shaft (elongate body 12; fig 1A-E; 0026) defining at least one working channel (one or more working lumens 16; fig 1A-E; 0027) extending from a proximal end of the shaft to a distal end of the shaft; and
a distal tip (housing 14; fig 1A-E; 0027) coupled to the shaft and comprising a first arm and a second arm (articulating elements 20 with linkages 21a,b; fig 1A-E; 0027), wherein each of the first arm and the second includes one of a light source or an imaging device at a distal end of the respective first or second arm (0034 describes illumination sources and optics; 0035 describes imaging sensors as included in the optics), and wherein the first arm is moveable relative to the second arm between a first configuration that obstructs a portion of the working channel and a second configuration that provides unobstructed access to the working channel (fig 1A-E; 0027 describes the collapsed and expanded profiles)”.
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) 4, 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Saadat.
The relied upon embodiment of Saadat does not disclose for claim 4, “The medical device of claim 3, wherein the hinge includes a leaf spring or a torsion spring”, although another embodiment as shown in fig 5 and at 0041-0042 describes a torsion spring which is used help release the arms. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of the alternative embodiment of Saadat into the primary embodiment of Saadat in order to configure the medical device e.g. as claimed because provides assisted release of the arms.
The relied upon embodiment of Saadat does not disclose for claim 17, “The medical device of claim 16, wherein the working channel extends through the distal tip between the first arm and the second arm”, although another embodiment as shown in fig 6 and at 0043-0045 describes articulating element 80 with steerable shaft 82 which provides “added functionality for performing complex procedures” and “may be used to setter therapeutic or diagnostic tools … into better position” 0045. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of the alternate embodiment of Saadat into the invention of the primary embodiment in order to configure the medical device e.g. as claimed because it assist in performing complex procedures (0045).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Saadat as applied to claim 3 above, and further in view of Smith US 20210361147.
Saadat does not disclose for claim 5, “The medical device of claim 3, wherein the hinge is a living hinge, the first arm being integral with the second arm and moveable via the living hinge”. Smith teaches in the same field of endeavor, providing an attachment at a distal tip of an endoscope using a hinge bracket or a living hinge (fig 2B; 0036). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Smith into the invention of Saadat in order to configure the medical device e.g. as claimed because it provides a joint with fewer moving parts reducing complexity and mechanical points of failure.
Claim(s) 11 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Saadat as applied to claim 1 above, and further in view of Ramanujam US2020/0315444.
Saadat does not disclose for claim 11, “The medical device of claim 1, wherein the cross-sectional dimension of the working channel is at least 0.1 cm”, i.e. does not specify the dimension in question. Ramanujam teaches in the same field of endeavor, providing working channels ranging from 0.001 cm to 0.5 cm (0109). Since Saadat fails to disclose the specific dimension, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used any suitable dimension known in the art, including the one taught by Ramanujam to achieve the predictable result of providing a working channel.
Modified Saadat (as in claim 11) discloses for claim 12, “The medical device of claim 1, wherein a cross-sectional dimension of the shaft is greater than 0.1 cm and less than 0.3 cm (0109 describes providing a range of dimensions encompassing and including the claimed dimensions).
Claim(s) 14, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Saadat as applied to claim 1 above, and further in view of Takahashi US 20020040179.
Saadat does not disclose for claim 14, “The medical device of claim 1, further comprising a flexible or elastic sleeve around at least a portion of the distal tip”. Takahashi teaches in the same field of endeavor, a sleeve 10 and an outer skin 11 which operates to protect the cap (0026). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Takahashi into the invention of Saadat in order to configure the device e.g. as claimed because it provides protection for the tip.
Saadat does not disclose for claim 20, “The medical device of claim 19, further comprising a flexible or elastic sleeve around at least a portion of the distal tip”. Takahashi teaches in the same field of endeavor, a sleeve 10 and an outer skin 11 which operates to protect the cap (0026). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Takahashi into the invention of Saadat in order to configure the device e.g. as claimed because it provides protection for the tip.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAE K WOO whose telephone number is (571)272-0837. The examiner can normally be reached M-F 8:30-2:30p, 6p-9p.
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/Jae Woo/Examiner, Art Unit 3795
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
01/23/2026