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 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 2-8, 10-11, and 19-20 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.
Claims 2 and 10 claim a method step in an apparatus claim by stating “from which the exoskeleton is selected” and “from which the camera unit is selected”. This is indefinite as the selection step is not part of an apparatus. As such, a person having ordinary skill in the art cannot determine the metes and bounds of the claim. The Examiner is treating the limitations as requiring the product of the claim and not the selection step. Appropriate correction is required.
Claims 2, 10, and their dependent claims list options for selection, but those lists are open-ended and do not clearly set forth the structure of the exoskeleton or camera unit. The claims are not directed to a kit where all of these options are presented to a user in a single place and moment in time. Instead, these options just exist and are then chosen. The Examiner argues that any endoscope was made using this process. None of the options are novel or even asserted as being novel. When an endoscope is made, the entity making the endoscope has to select the characteristics of that particular device. That selection is made from all known options. What exactly is the claimed machine or manufacture (this is not a method or composition of matter)? The Examiner asserts that a person having ordinary skill in the art would not be able to determine the metes and bounds of the claimed subject matter. The Examiner is treating the claim as limited to a single device. Appropriate correction is required.
Claims 2 and 10 include groups (“set of exoskeletons” and “set of camera units”) that are defined as open ended groups in that the term “comprising” is used and not “consisting of”. This is indefinite because the set is not necessarily limited to the listed structures. The listed features, for example the “elongate solid shaft; an elongate tubular body defining a single lumen; and an elongate tubular body defining a plurality of lumens” are not the only conceivable shafts for an exoskeleton. An exoskeleton may have perforations or openings along its circumference for instance. By not limiting the sets to the listed features, the scope of the list is left undefined. A person having ordinary skill in the are would not be able to determine the metes and bounds of the claims. The Examiner assumes that the sets are limited to the listed features. Appropriate correction is required.
Claims 3-8 and 11 depend from the rejected claims and are, therefore, also rejected.
Claim 2 is also rejected because the claim indicates that the set of exoskeletons comprises an elongate solid shaft. How can an exoskeleton be a solid shaft? The term “exoskeleton” means an external supportive covering. If the shaft is solid, then what is it covering? How is this an exoskeleton? The terminology is not clear as to its scope. Appropriate correction is required.
Claims 19 and 20 recite the limitation "the disposable components" and “the reusable components”. There is insufficient antecedent basis for this limitation in the claim. The claim does not clarify what is and what is not a disposable component or reusable component and whether or not any of the previously claimed components are disposable or reusable. The Examiner is treating all components as disposable and/or reusable in that they can be disposed of or reused as desired. Appropriate correction is required.
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.
Claims 1-5, 9-11, and 13-19 are rejected under 35 U.S.C. 103 as being unpatentable over Elia et al. (US 2017/0135560) in view of Chin et al. (US 2004/0092794).
Regarding Claim 1, Elia discloses:
A modular endoscope system comprising:
an exoskeleton (102);
a camera unit (104) couplable to the exoskeleton;
a therapeutic unit (112) couplable to the exoskeleton; and
a control unit (130) couplable to the exoskeleton.
Elia does not explicitly disclose a guidance or steering unit couplable to the exoskeleton. Chin teaches using an attachable steering unit 70 for controlling deflection of a sheath (Paragraph 0015). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Elia’s system to include Chin’s guidance/steering unit. Such a modification provides a removable means for controlling the direction of the distal tip of a sheath.
Regarding Claim 2, Elia as modified further discloses wherein the modular endoscope system comprises a set of exoskeletons from which the exoskeleton is selected, the set of exoskeletons comprising: an elongate solid shaft; an elongate tubular body defining a single lumen; and an elongate tubular body defining a plurality of lumens (see Fig. 1 showing the sheath with multiple lumens; the set does not define the exoskeleton).
Regarding Claim 3, Elia as modified further discloses wherein the set of exoskeletons from which the exoskeleton is selected further comprises: a straight shaft; a shaft including a single pre-curve; and a shaft including a plurality of pre-curves (see Fig. 1 showing the straight shaft; the set does not define the exoskeleton).
Regarding Claim 4, Elia as modified further discloses wherein the set of exoskeletons from which the exoskeleton is selected further comprises: a telescoping shaft; an expandable shaft; and a peelable shaft (the set does not define the exoskeleton; these shafts are known such that the selection of the exoskeleton is from a set including all known exoskeletons).
Regarding Claim 5, Elia as modified further discloses wherein the peelable shaft comprises one of: an inner tube defining a lumen; and an outer sheath peelable away from the inner tube and a bundle of tubes that each define a lumen, wherein individual tubes of the bundle of tubes are peelable from the bundle (the set does not define the exoskeleton; these shafts are known such that the selection of the exoskeleton is from a set including all known exoskeletons).
Regarding Claim 9, Elia as modified further discloses at least one of a set of pull wires configured to attach to the exoskeleton and a guidewire configured to be inserted into a lumen of the exoskeleton (Chin discloses that the steering mechanism is pull wires, see Paragraph 0015).
Regarding Claim 10, Elia as modified further discloses wherein the modular endoscope system comprises a set of camera units from which the camera unit is selected, the set of camera units comprising: a charge-coupled device (CCD); a Complementary Metal Oxide Semiconductor (CMOS); a High Definition (HD) camera; and a low-resolution camera (these are all well-known camera units and would be obvious for that reason; the claim does not require any of them and Elia discloses using an image sensor as the camera unit in Paragraph 0062).
Regarding Claim 11, Elia as modified further discloses wherein the camera unit further comprises a lighting unit (Elia 122; the Examiner also notes that including illumination is obvious in that cameras need light to image as is known and standard in the art).
Regarding Claim 13, Elia as modified further discloses wherein the camera unit comprises a wireless communication device or a cable configured to extend alongside or within the exoskeleton (Elias Paragraph 0062).
Regarding Claim 14, Elia as modified further discloses wherein the therapeutic unit comprises at least one of an ablation unit, an acoustic unit, a cryogenic unit, a cauterizing unit, a resecting unit, a cutting unit, a biologies collection unit, and an attaching unit (Elia Paragraph 0073 lists several tool types including ablation and cutting).
Regarding Claim 15, Elia as modified further discloses wherein the modular endoscope system further comprises one or more ancillary therapeutic units comprising at least one of an aspiration unit, a suction unit, an insufflation unit, and an injection unit (Elia discloses using more than one working port and those ports can include tools for injecting (Paragraph 0073) and using fluid delivery and/or suction units (Paragraphs 0073-0075)).
Regarding Claim 16, Elia discloses:
A method of processing modular endoscope components for performing a surgical procedure, the method comprising:
identifying a specific treatment (numerous procedures are mentioned including biopsy in Paragraph 0047 and ablation in Paragraph 0049); and
selecting components of a modular endoscope to perform the specific treatment (see Paragraphs 0047 and 0051 discussing selecting components for the particular procedure), the modular endoscope comprising:
an exoskeleton (102);
a camera unit (104) couplable to the exoskeleton;
a therapeutic unit (112) couplable to the exoskeleton; and
a control unit (130) couplable to the exoskeleton.
Elia does not explicitly disclose a guidance or steering unit couplable to the exoskeleton. Chin teaches using an attachable steering unit 70 for controlling deflection of a sheath (Paragraph 0015). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Elia’s system to include Chin’s guidance/steering unit. Such a modification provides a removable means for controlling the direction of the distal tip of a sheath.
Regarding Claim 17, Elia as modified further discloses assembling the device (see Fig. 11, for example). Elia does not explicitly disclose the location of the assembly. The Examiner asserts that things are made in manufacturing facilities (it’s in the name). One could argue that wherever Elia’s device is assembled, that is the final step in manufacturing and therefore a manufacturing facility. Anyway, that is at least an obvious option in that the device can be made and then shipped to the user. The other option is assembling it on site, which is also obvious and done in all sorts of environments. Furniture can be ordered and assembled at home, for example. Assembling at the facility allows for selections to be made on the spot from various options. This seems to be what Elia has in mind given the number of options listed and the simplicity of assembly contemplated. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to assembly Elia’s device in a manufacturing facility or on site at the surgical facility. This gets the user a fully assembled device at the time of use.
Regarding Claim 18, Elia as modified further discloses diagnosing the specific patient as having a specific condition, wherein identifying a specific treatment comprises determining a treatment plan and associated diagnostics or therapeutics to perform the specific treatment (see Paragraphs 0047 and 0051). The Examiner notes that it is not standard practice to perform, for example, biopsies on random people for no reason. A person has a problem, a doctor identifies the problem, and a treatment plan is put in place. That problem can be a known issue or an unknown issue that needs diagnosis. Either way a plan is devised and treatment follows.
Regarding Claim 19, Elia as modified further discloses disposing of the disposable components (Paragraph 0058).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Elia et al. (US 2017/0135560) and Chin et al. (US 2004/0092794), as applied to claims 1 and 2 above, and further in view of McWeeney et al. (US 8,608,649).
Elia and Chin disclose the invention substantially as claimed as stated above; however, they do not explicitly disclose wherein the modular endoscope system further comprises a set of exoskeleton sheathing components comprising: a spiral band tubing; a wire mesh tubing; and a polymeric outer tubing. The Examiner notes that these features are well-known in the art. McWeeney is one reference that teaches making tubes with multiple layers including a braid (mesh), a coil (spiral band), and an outer polymeric tube (see Col 7 Line 65 – Col 8 Line 15 and elsewhere in the disclosure) for providing strength and flexibility to the tubular member. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Elia and Chin’s system to include McWeeney’s coil, braid, and polymer tube. Such a modification incorporates well-known components that improve strength while maintaining flexibility to allow the device to be pushed through a body.
Claims 7-8 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Elia et al. (US 2017/0135560) and Chin et al. (US 2004/0092794), as applied to claims 1 and 2 above, and further in view of Ravo (US 2007/0106113).
Elia and Chin disclose the invention substantially as claimed as stated above.
Regarding Claim 7, they do not explicitly disclose a plurality of elongate tubes configured to be attached to an exterior of the exoskeleton via a coupling system configured to secure each of the plurality of elongate tubes to the exterior of the exoskeleton. Ravo teaches attaching tubes to a central sheath (see Figs. 3-5b, for example) as a means to form a multi-tubular member. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Elia and Chin’s system to include Ravo’s multi-tubular configuration. Such a modification allows for multiple tubular members to be inserted into a patient to the same target location. Those tubular members can serve different functions or provide for multiple tools to be inserted.
Regarding Claim 8, Elia as modified further discloses wherein the coupling system comprises one of: a plurality of dovetail coupling components that correspond to the plurality of elongate tubes (see Ravo Figs. 2a-4 for example); and a sheath configured to hold the plurality of elongate tubes against the exoskeleton.
Regarding Claim 12, they do not explicitly disclose wherein the camera unit comprises a fastener for securing to a distal end of the exoskeleton. Ravo teaches attaching units to the distal end of a sheath using a fastener (216 or 236) to securely and removably attach the component. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Elia and Chin’s system to include Ravo’s fastener. Such a modification allows for a secure and reversable attachment of the camera unit to the sheath. The Examiner also notes that using a fastener to fasten something to something else is considered obvious as this is simply using a known component in the manner in which it is designed to function.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Elia et al. (US 2017/0135560) and Chin et al. (US 2004/0092794), as applied to claim 15 above, and further in view of Adair (US 5,402,768).
Elia and Chin disclose the invention substantially as claimed as stated above; however, they do not explicitly disclose cleaning and sanitizing the reusable components; and reusing the cleaned and sanitized reusable components in a subsequent medical procedure. Adair teaches sterilizing or soaking a reusable portion of a system prior to reuse with another disposable portion (see Col 2 Lines 29-32 and Claim 1). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Elia and Chin’s method to include Adair’s cleaning and sanitizing of reusable components. Such a modification allows for more expensive components to be cleaned and reused while less expensive components can simply be thrown away.
Conclusion
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/TIMOTHY J NEAL/ Primary Examiner, Art Unit 3795