DETAILED ACTION
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 3, 5, 10, 12 and 13 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.
Claim 3 recites the limitation "in a distal end region of the instrument" in line 2. It is unclear whether “a distal end region” is referring to the distal end region disclosed in lines 7-8 of claim 3, or if a new distal end region is being claimed. For the purpose of examining the claim, “a distal end region of the instrument” in line 2 of claim 3 will be interpreted as “the distal end region of the instrument”.
Claim 5 recites the limitation "wherein the bristles of the set of bristles are made of an elastic polymer and/or of a shape-memory alloy and/or of spring steel and/or of nitinol". The phrase “and/or” renders the claim indefinite, as it is unclear what material exactly is being claimed. For the purpose of examining the claim, “wherein the bristles of the set of bristles are made of an elastic polymer and/or of a shape-memory alloy and/or of spring steel and/or of nitinol” will be interpreted as “wherein the bristles of the set of bristles are made of an elastic polymer or of a shape-memory alloy or of spring steel or of nitinol”.
Claim 10 recites the limitation "the set of bristles is bendable, and/or wherein the set of bristles are adapted to be oriented substantially radially". The phrase “and/or” renders the claim indefinite, as it is unclear what feature exactly is being claimed. For the purpose of examining the claim, “the set of bristles is bendable, and/or wherein the set of bristles are adapted to be oriented substantially radially” will be interpreted as “the set of bristles is bendable, or wherein the set of bristles are adapted to be oriented substantially radially”.
Claim 12 recites the limitation "wherein the instrument is adapted to be rotated relative to the guide tube about its extension direction and/or is axially fixed relative to the guide tube". The phrase “and/or” renders the claim indefinite, as it is unclear what feature exactly is being claimed. For the purpose of examining the claim, “wherein the instrument is adapted to be rotated relative to the guide tube about its extension direction and/or is axially fixed relative to the guide tube” will be interpreted as “wherein the instrument is adapted to be rotated relative to the guide tube about its extension direction or is axially fixed relative to the guide tube”.
Claim 13 recites the limitation "a cannulated working sleeve; and/or a working channel of an endoscope, wherein the instrument of the instrument set is axially movable or is adapted to be introduced within the working sleeve and/or within the working channel". The phrase “and/or” renders the claim indefinite, as it is unclear what feature exactly is being claimed. For the purpose of examining the claim, “a cannulated working sleeve; and/or a working channel of an endoscope, wherein the instrument of the instrument set is axially movable or is adapted to be introduced within the working sleeve and/or within the working channel” will be interpreted as “a cannulated working sleeve; or a working channel of an endoscope, wherein the instrument of the instrument set is axially movable or is adapted to be introduced within the working sleeve or within the working channel”.
Appropriate corrections are required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1, 2 and 6-14, as best understood, are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Siegal et al. (U.S. Publication No.2014/0058394 A1; hereinafter “Siegal”).
Regarding claim 1, Siegal discloses a medical instrument set comprising: a guide tube (20); and a medical instrument (drive shaft 36 connected with tissue disrupter 12) that is adapted to be introduced into the guide tube (drive shaft 36 resides within guide tube 20 as shown in Figure 15A) for processing and removing tissue in an intervertebral disc space between two adjacent vertebral bodies (Figures 7A-7C), the medical instrument having a shaft (36) that is rotatable about an extension direction (see direction 16 in Figure 3A); and a set of bristles comprising at least two bristles (blades 48, described as brush-like elements in [0088]) are arranged on a distal end region of the instrument (12), the set of bristles having at least one intermediate space (space between blades 48) such that, during rotation of the shaft about its extension direction, processed tissue is movable in a substantially proximal direction within the at least one intermediate space (para.0095), wherein the guide tube (20) is a part of a deflection instrument (see components 20, 22 and 24 in Figure 3C) of the instrument set, the deflection instrument having a pivot head (34) that is articulatedly connected to the guide tube and is adapted to be pivoted relative to the guide tube (via hinge 22), the guide tube having a distal opening into which the instrument is adapted to be introduced at least in portions (see Figures 15A, 15B).
Regarding claim 2, Siegal further discloses wherein the set of bristles is arranged helically, and wherein the at least one intermediate space is formed between two windings of the set of bristles (see the embodiment of Figure 21).
Regarding claim 6, Siegal further discloses wherein a distal end face of the instrument has an atraumatic or at least partially round surface (rounded non-cutting tip 18).
Regarding claim 7, Siegal further discloses wherein the distal end region of the instrument has a radial or conical projection (see distal tips of disruptor 12 in Figures 13A-13D).
Regarding claim 8, Siegal further discloses wherein the distal end region of the instrument is adapted to be deflected or pivoted by an angle not equal to 00 relative to an extension direction of a proximal end region or in a user-defined manner (see Figure 3A).
Regarding claim 9, Siegal further discloses wherein the shaft of the instrument is flexible at least in portions (44).
Regarding claim 10, Siegal further discloses wherein, in a transport position of the instrument relative to the shaft, the set of bristles (48) are adapted to be oriented substantially radially in a working position of the instrument (see Figure 2B).
Regarding claim 11, Siegal further discloses wherein the pivot head (24) is pivotable in a user-defined manner relative to the guide tube (see Figures 3A-3C).
Regarding claim 12, Siegal further discloses wherein the instrument (36) is adapted to be rotated relative to the guide tube (20) about its extension direction (para.0085).
Regarding claim 13, Siegal further discloses a cannulated working sleeve (see sleeve 100 om Figure 6A); wherein the instrument of the instrument set is adapted to be introduced within the working sleeve (para.0076).
Regarding claim 14, Siegal further discloses a medical method for processing and removing tissue at an intervention site in an intervertebral disc space between two adjacent vertebral bodies (figures 7A-7C), the method comprising: creating access to the intervention site; introducing the medical instrument set according to claim 1 at the intervention site; and rotating the medical instrument of the instrument set at the intervention site about the extension direction of the instrument such that the tissue of the intervention site is processed and removed (para.0093, Figures 7A-7C).
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Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 3-5, as best understood, are rejected under 35 U.S.C. 103 as being unpatentable over Siegal (U.S. Publication No.2014/0058394 A1as applied to claim 1 above, in further view of Tao et al. (U.S. Patent No.5,713,369; hereinafter “Tao”).
Regarding claims 3 and 4, Siegal discloses the "blades" or "cutting elements", can be implemented as flexible or brush-like elements [0088], however Siegal is silent to the bristles/blades being configured with at least two helically arranged wires, twisted together, are provided in the distal end region of the instrument, and wherein the set of bristles are connectable to the wires in a form-fitting manner for conjoint rotation.
Tao discloses a tissue sample brush 10 having two helically arranged wires (22), twisted together (Figure 7), are provided in the distal end region of the instrument, and wherein the set of bristles (120, 122) are connectable to the wires in a form-fitting manner for conjoint rotation (col.8, ll.9-25).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Siegal’s tissue disruptor to have at least two helically arranged wires, twisted together, and wherein the set of bristles are connectable to the wires in a form-fitting manner, as taught by Tao, in order to provide an alternate means of effectively collecting tissue in a surrounding area.
Regarding claim 5, Siegal discloses the claimed invention except for wherein the bristles of the set of bristles are made of an elastic polymer and/or of a shape-memory alloy and/or of spring steel and/or of nitinol. Tao discloses bristles made of steel (col.5, ll.29-31). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Siegal’s tissue disruptor to have bristles made of steel, as taught by Tao, since stainless steel is a material shown as suitable in the art for a material of a brush-like tissue disruptor.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Cha U.S. Publication No.2010/0057087 A1
Dougherty et al. U.S. Publication No.2017/0100136 A1
Goldin et al. U.S. Publication No.2008/0114364 A1
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Christina Negrelli whose telephone number is 571-270-7389. The examiner can normally be reached on Monday-Friday, between 8:00am to 4:00pm. If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo Robert, at (571) 272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTINA NEGRELLI/
Examiner, Art Unit 3773
/JACQUELINE T JOHANAS/ Primary Patent Examiner, Art Unit 3773