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 Species 1, sub-species G, and sub-species G’ in the reply filed on December 2, 2025, is acknowledged.
Claim Interpretation
The terminology “high friction surface” is not considered indefinite under the law because the Specification provides a standard for ascertaining the requisite degree as to what is and is not a “high friction surface”. See MPEP see 21730.5(b). A “high friction surface” is considered to mean “a surface having a higher friction coefficient than a contact surface on which the high friction surface is not formed” based on the definition in the Specification (see Paragraph 0062; Paragraph 0101 in the PGPub). With this definition, the terminology is not indefinite because the Specification provides a standard for ascertaining the requisite degree, and one of ordinary skill in the art would be reasonably apprised of the scope of the invention. The “high friction surface” has a higher friction coefficient than the other contact surfaces on which it is not formed.
For claim 2, the high friction surface is either on the first contact surface or the second contact surface but not both (the claim requires “at least part of any one contact surface”, emphasis added). This allows for one surface to have a greater friction coefficient than the other. If both contact surfaces included a high friction surface, then one would not have a higher friction coefficient than the other. The Examiner considers the claim sufficiently clear in that one of the contact surfaces has a higher friction coefficient than the other.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 14 are rejected under 35 U.S.C. 102a1/a2 as being anticipated by Hosono (US 3,998,216).
Regarding Claim 1, Hosono discloses:
A medical instrument guide device that guides a medical instrument into a body, the medical instrument guide device comprising:
a tube main body (3) that includes an outer tube (18; see Fig. 14) having flexibility (see Abstract and Col 2 Lines 50-54; the tube is designed to bend) and an inner tube (11) having flexibility and being arranged inside the outer tube (see Fig. 14; as stated above, the tube is designed to bend); and
a shape deformable body (16, see Fig. 11) that is provided between the outer tube and the inner tube and is deformable along a shape of the tube main body (16 is a flex framework for braid 15; see Col 3 Lines 13-15).
Regarding Claim 14, Hosono further discloses wherein the shape deformable body includes a spiral tube (16 as shown in Fig. 11) formed by spirally winding a band-shaped member around an outer peripheral side of the inner tube (16 is wound around the inner member 11; see Figs. 13-14 showing different views with the inner tube 11 being surrounded by 15 and 16).
Claims 1 and 16 are rejected under 35 U.S.C. 102a1/a2 as being anticipated by Bauerfeind et al. (US 5,337,733).
Regarding Claim 1, Bauerfeind discloses:
A medical instrument guide device that guides a medical instrument into a body, the medical instrument guide device comprising:
a tube main body (14) that includes an outer tube (18) having flexibility (the tube is flexible, see Abstract and Col 6 Lines 11-12) and an inner tube (16) having flexibility (the tube is flexible, see Abstract and Col 6 Lines 11-12) and being arranged inside the outer tube (see Figs. 4-6, for example); and
a shape deformable body (32) that is provided between the outer tube and the inner tube (see Figs. 4-6 showing 32 between 16and 18) and is deformable along a shape of the tube main body (the entire tube is flexible and designed to be flexible such that 32 deforms as the other tubular members 16/18 deform).
Regarding Claim 16, Bauerfeind discloses:
An endoscope apparatus comprising:
a medical instrument (50); and
the medical instrument guide device according to claim 1 (see Fig. 1 and rejection above),
wherein the medical instrument is an endoscope having an insertion part to be inserted into a body (50 is a colonoscope; see Fig. 3b showing it inserted into the body).
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 15 is rejected under 35 U.S.C. 103 as being unpatentable over Hosono (US 3,998,216) in view of McWeeney et al. (US 2005/0272975).
Hosono discloses the invention substantially as claimed but does not explicitly disclose wherein at least one surface of an outer peripheral surface of the outer tube or an inner peripheral surface of the inner tube has a hydrophilic coating. The Examiner notes that such coatings are common in the art. McWeeney is one example teaches applying a hydrophilic coating to the external surface of a sleeve to ease insertion into the body (see Paragraph 0084). 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 Hosono’s device to include McWeeney’s coating. Such a modification is a common way in the art to ease insertion into the body.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Bauerfeind et al. (US 5,337,733) in view of McWeeney et al. (US 2005/0272975).
Bauerfeind discloses the invention substantially as claimed but does not explicitly disclose wherein at least one surface of an outer peripheral surface of the outer tube or an inner peripheral surface of the inner tube has a hydrophilic coating. The Examiner notes that such coatings are common in the art. McWeeney is one example teaches applying a hydrophilic coating to the external surface of a sleeve to ease insertion into the body (see Paragraph 0084). 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 Bauerfeind’s device to include McWeeney’s coating. Such a modification is a common way in the art to ease insertion into the body.
Claims 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Bauerfeind et al. (US 5,337,733).
Bauerfeind discloses the invention substantially as claimed as stated above. Bauerfeind also discloses in the Background the features of claims 17-19 as set forth below. These dimensions and clearances are not, strictly speaking, stated with regard to the disclosed system, so the Examiner is making an obviousness and not an anticipation rejection.
Regarding Claim 17, Bauerfeind discloses wherein the insertion part is able to be inserted into the tube main body (see Fig. 3b), and further teaches that it is known in the art in a state in which the insertion part is inserted into the tube main body, a clearance for preventing a body tissue from being interposed is formed between the tube main body and the insertion part (see Col 1 Lines 46-50). The clearance allows the colonoscope to be pushed through the outer tube easily. 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 Bauerfeind’s system to include the clearance. Such a configuration allows the scope to fit within the outer tube easily.
Regarding Claim 18, Bauerfeind further discloses wherein the clearance is 4 mm or less (see Col 1 Lines 46-50 indicating that the clearance can be about 1 mm to 4 mm).
Regarding Claim 19, Bauerfeind teaches that it is known in the art wherein the insertion part has an effective length that is longer than an entire length of the tube main body (see Fig. 3b, for example, showing the insertion part being longer than the guide) by 300 mm or more (see Col 1 Lines 50-52 where the tube is 40 cm (insertion part) and colonoscope is between 130-180 cm). As shown in Figs. 3a-3f, the scope is longer than the guide tube and extends beyond the guide tube by a significant amount. Bauerfeind teaches that it is known to make scopes over 100 cm longer than the guide tube, which allows for the scope to have slack and be held away from the patient by the user. 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 make Bauerfeind’s scope longer than the tube main body by 300 mm or more. Such a modification allows the scope to extend beyond the guide while still providing slack to extend back to the user as is known in the art.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Bauerfeind et al. (US 5,337,733) in view of Takano (US 2005/0159644).
Bauerfeind discloses the invention substantially as claimed but does not explicitly disclose wherein the insertion part includes an insertion part balloon that is expandable and contractible and is provided at a distal end part of the insertion part. The Examiner notes that such balloons are common in the art. Takano discloses one such balloon (42) for helping navigate the scope through the colon (see Figs. 3A-3H). 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 Bauerfeind’s insertion part to include Takano’s balloon. Such a modification helps the device navigate through the intestine. Balloons are also known to help anchor the device in a particular location.
Allowable Subject Matter
Claims 2-13 are 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.
Claims 2 and 9 require a “high friction surface” in combination with the other elements of the claim. This surface is understood to require one of the contact surfaces to have a higher coefficient of friction relative to the other (see discussion above under Claim Interpretation). The Examiner did not find any art with such a combination of elements. Both Hosono and Bauerfeind are silent as to the relative friction coefficient of the various surfaces. The prior art failing to provide a reason to make such a modification, the claims are considered to overcome the art of record.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY JAY NEAL whose telephone number is (313)446-4878. The examiner can normally be reached Mon-Fri 7:30-5:30.
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/TIMOTHY J NEAL/ Primary Examiner, Art Unit 3795