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.
Claim(s) 1, 12 is/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.
In regard to claim 1, the term “very slightly” is a relative term which renders the claim indefinite. The term “very slightly” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The instant disclosure does not provide any further guidance to the scope of “very slightly” and the central bridge appears to have significant curvature in the figures.
In regard to claim 12, the claim recites “a polymer material with flexibility similar to the human septum but has sufficient stiffnesses in order to straighten a curved septum in the long term, and without requiring a severing of the septum in order to bring about a weakening”. Since human septums have different stiffnesses and flexibility depending on age, size and genetic features, requiring a plastic with a flexibility of the human septum is indefinite. The instant disclosure does not provide additional details such as the exact polymer material (aside from plastic in general) or specific details of strength or flexibility measurements. Further, “similar” is a relative term which renders the claim indefinite. The term “similar” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The instant disclosure does not provide any further guidance to the scope of “similar”.
Since claims 2-11 and 13-16 depend directly or indirectly from claim 1, claims 2-11 and 13-16 are also rejected under 112b.
Claim Objections
Claim(s) 1 is/are objected to because of the following informalities:
In regard to claim 1, the last paragraph of the claim recites “the implant further comprises a third subsection connected to an end of each respective first subsection opposite the respective second subsection”. The claim should recite “each of the first subsections” for consistent antecedent basis throughout. Please proofread this section of the claim for clarity.
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.
Claim(s) 1-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Awengen (DE102012107123A1).
In regard to claim 1, Awengen teaches a rhinological implant for straightening a nasal septum of a human nose (abstract), the implant being configured to be fastened on both sides of the septum of the human nose on a respective outer surface of the septum in a respective left and right side of the nasal cavity (abstract of translation), the implant comprising:
a central bridge section 31a which is flat or curved upward very slightly from a horizontal plane (see fig 3a, a section is flat and a section us curved very slightly from a horizontal plane) at a spread angle w> 100 degrees (see abstract: angle of spread of greater than 100 degrees) or is bent upward from the horizontal plane in a barrel-shaped manner at a radius of curvature r > 0.5 mm (abstract),
and which, in an implanted state, encompasses a free lower edge of the septum, two side sections disposed on both sides of the central bridge section and extending upwards in a folded manner and symmetrically to the central bridge section at an angle p of in each case about 90 degrees against the central bridge section (see figure 4b, abstract),
and which, in the implanted state, fully abut against the two opposite outer surfaces of the septum (abstract: in the implanted state lie fully on the two opposite outer surfaces of the septum),
wherein the implant, before implantation, has been unfolded from an initially flat blank to a subsequent, implantable spatial shape (abstract: unfolded from an initially flat shape; further, this is a product by process limitation, patentable only based on the end structure),
wherein the two side sections (33a, 32a) of the implant each have a first subsection (central section at the corner where 32a is labeled in figure 3a) and extends substantially parallel thereto (extend parallel thereto the opposite side section, see fig 3a, c)
wherein the two side sections (32a, 33a) each have a second subsection 32a” which connects to the respective first subsection (central portion of 32a) and extends at an angle (this could be at any angle, including 0 degrees) relative thereto (see figure 3a, 32a” extends at an angle relative to the central section of 32a),
and wherein the implant further comprises a third subsection 32a’ connected to an end of each respective first subsection (central 32a) opposite the respective second subsection 32a”, the third subsection 32a’ extending at an angle (this could be at any angle including at 0 degrees) relative to the respective first subsection (32a’ extends at an angle compared to the central portion of 32a in figure 3a).
However, Awengen does not teach that the first subsection (central portion of 32a) connects directly to the central bridge section 31a. (The central bridge 31a is to one end instead of located centrally).
It has been held that a mere rearrangement of the working parts of an invention, yielding a predictable result, requires no more than routine skill in the art. Accordingly, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to move the bridge 31a from the third subsection 32a’ to the first subsection (central portion of 32a) therefore resulting in the first subsection connecting directly to the central bridge section) because it appears the bridge would function equally well in either position. Absent a teaching of criticality (new or unexpected results), this arrangement is deemed to have been known by those skilled in the art at the time the invention was filed. MPEP 2144.04C
In regard to claim 2, Awengen meets the claim limitations as discussed in the rejection of claim 1, but is not clear if the third subsection has a larger longitudinal extension than a longitudinal extension of the second subsection.
It has been held that a mere optimization of the working parts of an invention, yielding a predictable result, requires no more than routine skill in the art. Accordingly, it would have been obvious to one of ordinary skill in the art at the time the invention was made to optimize the size of the implant to have a large longitudinal extension in the third subsection than the second subsection in order to match the individual user’s anatomy. Absent a teaching of criticality (new or unexpected results), this arrangement is deemed to have been known by those skilled in the art at the time the invention was filed. MPEP 2144.04IVA
In regard to claim 3, Awengen meets the claim limitations as discussed in the rejection of claim 1, and further teaches the two side sections (32a, 33a) of the implant (fig 3a) each have a boomerang-shaped contour. (fig 3a; pg 3 of translation, paragraph 3: the implant has a boomerang shaped contour)
In regard to claim 4, Awengen meets the claim limitations as discussed in the rejection of claim 1, and further teaches the two side sections (32a, 33a) of the implant are provided with perforations 35 (see fig 3a) and further teaches the side sections have fixed webs-shaped subsections (page 3, paragraphs 6-7 of translation: webs of mesh structure; webs of a network structure).
However, Awengen remains silent to the perforations having a larger surface area than fixed web-shaped subsections of the side sections.
It has been held that a mere optimization of the working parts of an invention, yielding a predictable result, requires no more than routine skill in the art. Greater perforation area will allow more ingrowth and different types of ingrowth while smaller and less perforations will allow less ingrowth and different types of ingrowth in that area. Accordingly, it would have been obvious to one of ordinary skill in the art at the time the invention was made to optimize the size/amount of the perforations of the implant have a larger total surface area than the webbed portions in order to allow more ingrowth in that area. Absent a teaching of criticality (new or unexpected results), this arrangement is deemed to have been known by those skilled in the art at the time the invention was filed. MPEP 2144.04IVA
In regard to claim 5, Awengen meets the claim limitations as discussed in the rejection of claim 4, but does not teach the perforations of the shape of a polyhedron of honeycomb.
It has been held that a mere change in shape of the working parts of the invention, yielding a predictable result, requires no more than routine skill in the art. Accordingly, it would have been obvious to one of ordinary skill in the art at the time the invention was made to make the perforations in the shape of the shape of a polyhedron or honeycomb since it appears either arrangement would work equally well. Absent a teaching of criticality (new or unexpected results), this arrangement is deemed to have been known by those skilled in the art at the time the invention was filed. MPEP 2144.04IVB
In regard to claim 6, Awengen meets the claim limitations as discussed in the rejection of claim 1, wherein the central bridge section 31a is provided with perforations (page 3 of translation, paragraph 6: the spine portion is constructed of webs of mesh structure to provide increased flexibility; by definition a web has perforations between the webs) and fixed subsections of the central bridge section 31a (figure 3a; the webs between the perforations are the fixed subsections).
However, Awegen remains silent to the surface area of the perforations within the web compared to the fixed subsections (web) surrounding the perforations.
It has been held that a mere optimization of the working parts of an invention, yielding a predictable result, requires no more than routine skill in the art. The amount of web versus perforations is a result effective variable with more perforation between the webs resulting in a greater flexibility and less perforation resulting in less flexibility of the bridge. Accordingly, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to optimize the amount of perforation compared to surrounding web structure of the central bridge webbing to be less than fixed subsections (interpreted as the web of the webbing) of the central bridge section surrounding the perforations in order to have the desired amount of flexibility. MPEP 2144.04IVB
In regard to claim 7, Awengen meets the claim limitations as discussed in the rejection of claim 6, wherein the perforations are in the shape of slots (claim 7) extending parallel to one another (at least some of holes/slots 35 are parallel to one another in figure 3a), in a direction of the two side sections adjoining the central bridge section 31a. (fig 3a)
In regard to claim 8, Awengen meets the claim limitations as discussed in the rejection of claim 1, and further teaches the two side sections 32a, 33a are exact mirror images of each other. (see fig 3a-c)
In regard to claim 9, Awengen meets the claim limitations as discussed in the rejection of claim 1, and further teaches all corners of the side sections are rounded. (figure 3a, no sharp corners)
In regard to claim 10, Awengen meets the claim limitations as discussed in the rejection of claim 1, and further teaches the implant is made of a material with a memory effect and/or superelastic properties. (pg 3 of translation, paragraph 13: nitinol; shape memory or super elastic materials)
In regard to claim 11, Awengen meets the claim limitations as discussed in the rejection of claim 1, and further teaches the implant is made entirely or partially of plastic. (pg 3 of translation, paragraph 12: may consist of a suitable plastic)
In regard to claim 12, Awengen meets the claim limitations as discussed in the rejection of claim 11, and further teaches the implant is made of a polymer material (pg 3 of translation, paragraph 12: may consist of a suitable plastic) with flexibility similar to the human septum (septums have different flexibility), but has sufficient stiffnesses in order to straighten a curved septum in the long term, and without requiring a severing of the septum in order to bring about a weakening. Every human septum will have a different stiffness and flexibility depending on the age and size of the person and the individual genetic features. The instant disclosure specifies plastic but not specifically what type. Since the prior art meets the limitations of the specific material of a general plastic, any properties inherent to the material such as the flexibility and stiffness have also been met.
In regard to claim 13, Awegen meets the claim limitations as discussed in the rejection of claim 1, and further teaches the implant has a body-compatible coating. (pg 3, paragraph 14 of the translation: biocompatible or germ repellent coating)
In regard to claim 14, Awengen meets the claim limitations as discussed in the rejection of claim 1, and further teaches the implant is produced by 3D printing technology and/or by laser technology. (pg 3 of translation, paragraph 14: may be prepared by laser technology) Additionally, this is a product by process claim, patentable only based on the resulting structure.
In regard to claim 15, Awegen meets the claim limitations as discussed in the rejection of claim 1, and further teaches the implant is produced using machining technology selected from the group consisting of milling technology, sliding grinding, magnetic sliding grinding, satellite centrifugal grinding, polishing technology, electropolishing and etching technology. This is a product by process claim, patentable only based on the resulting structure. Since it appears the end structure would be the same regardless of the manufacturing technique of either lasering or grinding, the limitations have been met.
In regard to claim 16, Awegen meets the claim limitations as discussed in the rejection of claim 1, and further teaches the implant is manufactured by micro injection molding (MIM). (pg 3 of the translation, paragraph 15) Additionally, this is a product by process claim, patentable only based on the resulting structure.
Conclusion
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/CHRISTIE BAHENA/Primary Examiner, Art Unit 3774