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 23,25,28,29,31,36-38 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.
The term “substantially” in claims 23,28 is a relative term which renders the claims indefinite. The term “substantially” is not defined by the claims, 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. It is not evident to what degree the anode has to be structured to be considered “substantially smaller” that the metal component or what amount is sufficient to have a surface area of the anode being substantially smaller than a surface area of the surface (of locking part).
The phrase “tight-fitting” or “tightly fit” or “tightly fitting” in claims 25,36,38 respectively are relative clauses which render the claims indefinite. The phrases “tight-fitting” or “tightly fit” or “tightly fitting” are not defined by the claims, 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. It is not evident to what type the securement has to be structured to be considered “tight-fitting” or “tightly fit” or “tightly fitting” that the metal component and anode are attached, since no boundaries are in claim 25 and claim 36 has a vague clause “non-circular” which can encompass a vast number of possible cross-sectional shapes.
In addition claim 29 recites "at least 50% less than" raises an issue of indefiniteness because one does not know the lower percentage of surface area for the anode as it could even encompass 0 according to the scope of 50% less than since it is an open- ended limitation. It must be noted that MPEP 2173.05(c) states open-ended ranges can raise an issue of indefiniteness by lacking clear boundaries.
Claim 31 recites the limitation "said anodes " in line 1 of the claim. There is insufficient antecedent basis for this limitation in the claim. Where is this second anode or to what is it secured therewith?
Claim 38 recites the limitation "the enclosure " in lines 1,2 of the claim. There is insufficient antecedent basis for this limitation in the claim. What is the structure of the metal component? It is not defined, thus it is not inherent it defines an enclosure.
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) 21-32,35,39,40 are rejected under 35 U.S.C. 103 as being unpatentable over Olafsson et al. CN (101553192) in view of Shirkhanzadeh (US 5383935). Olafsson et al. disclose a prosthetic device (Fig. 10A). Olafsson et al. additionally disclose (Fig. 3A) a metal component 320 defining an opening 322; a protective (page 9 of translation discusses protective coated element) structure 310 for the metal component Olafsson et al. show (Fig. 3B) the protective structure is secured within the opening of the metal component.. Fig. 3C shows the metal component 320 is connected to a prosthetic component 100 including a prosthetic foot (1010, 1020) see Fig. 10A. However, Olafsson et al. did not explicitly state the fastening component having a coating thereon defines a sacrificial anode. Shirkhanzadeh teaches (col. 3, lines 27-49) to provide protective coatings on metal components coupled together to define an anode structure. Shirkhanzadeh shows (Figs. 1,2) a sacrificial anode 9 for placement in an opening of a metal component 5 and secured therein. It would have been obvious to one of ordinary skill in the art to alternatively utilize a reactive coating to provide a sacrificial anode as taught by Shirkhanzadeh with the prosthetic coupling components of Olafsson et al. in order to improve stability and protection of the prosthetic components, see Shirkhanzadeh. With respect to claim 22, it can be construed that the anode structure resulting from modification with Shirkhanzadeh (since the coating is about the structure 310 of Olafsson’s coupling element) it defines a cross-sectional shape corresponding to the opening 322 in component 320. Regarding claim 23, it can be construed that the anode (modified coating per teaching of Shirkhanzadeh on protective coated element of Olafsson) is substantially smaller than the metal component inherently since placed within the opening of metal component. Regarding claim 24, Fig. 3A shows the metal component 320 is an adapter having a locking part since it is threaded. With respect to claim 25, as best understood it can be construed that the structure of the resulting anode per the modification with Shirkhanzadeh and the coated component of Olafsson provides a “tight-fitting” relationship between the anode and adapter. Regarding claim 26, Olafsson et al. disclose (Fig. 2A) an embodiment in which the adapter 200 defines an extension 222, the locking part defines the opening configured and dimensioned to receive the anode correspondingly shaped to the opening. Please note the recitation of configured and dimensioned to receive is broad and relatively unlimited in scope as per the teaching of Shirkhanzadeh one can place a structure within an opening to define an anode functioning element and additionally Olafsson discloses in giving a broadest reasonable interpretation that protective coatings are placed about coupling elements. Therefore, it would have been obvious to one of ordinary skill in the art per the teaching of Shirkhanzadeh to provide about an adapter with an extension in the prosthetic device of Olafsson et al. with a locking part having an opening configured and dimensioned to receive the anode correspondingly shaped to the opening. Note this could encompass a material either placed within or about the opening’s surrounding structure. Regarding claim 27, it is noted that Olafsson disclose (Figs. 3C,7B) coupling element 310 is inserted in metal component 320 such that it would be flush with top surface of locking part. Thus in giving the broadest reasonable interpretation, it would have been obvious to one of ordinary skill in the art to alternatively use opening defines a depth corresponding to a height of the anode such that a first end of the anode is flush with a surface of the locking part, such that a surface area of the first end of the anode is exposed per the modification with Shirkhanzadeh to utilize anode material in an opening of a metal component thus no interference occurs against a top element. Regarding claim 28, it can be construed since Shirkhanzadeh teaches an inserted anode element smaller than the opening the surface area of the anode is substantially smaller than a surface of the surface. With respect to claim 29, it can be construed that the surface of the anode is at least 50% less than a surface area of the surface for example in embodiment of Fig. 12C of Olafsson the element 310 inserted in locking element 1200 can be considered much larger and meets the scope of 50% less. Regarding claim 30, Fig. 3B of Olafsson show the anode (per the modification with Shirkhanzadeh) defines a diameter (d) at least at the first end that corresponds to a diameter or width of the opening whereat it opens along the surface. Regarding claim 31, Olafsson disclose (Figs. 2A,3A,4B) a plurality of elements to define an adapter with interlocking or coupling of elements. It is also noted as mentioned above, Olafsson disclose use of a protective coating on joining of interlocking elements of different metal. Thus per the modification with Shirkhanzadeh to utilize an anode material, it would have been obvious to one of ordinary skill to utilize anode material per Shirkhanzadeh and define an anode structure as elements are inserted or coupled together in the prosthetic device of Olafsson to establish a protected arrangement from corrosion. With respect to claim 32, it is noted that Olafsson disclose (page 6 of translation) alternative coupling arrangements, including press fit. Thus, it would have been obvious to one of ordinary skill in the art to provide anodes that are press-fitted into the opening and retained to the metal component by said press-fitting. Regarding claim 35, Olafsson et al. disclose (page 10 of translation) he metal component is formed from at least one of the following metals selected from the group consisting of aluminum and stainless steel. Regarding claim 39, Olafsson et al. disclose (Fig. 12C) an alternative embodiment 1200 of a metal component with first 1208 and second openings 1202 configured to receive first and second anodes. As mentioned already, Olafsson had disclosed (page 9 of translation) that coating of protective material is used for engagement of components with different metals. Thus, since it is known in the art different fastener materials could be used of which are inserted in opening 1202, it would have been obvious to one of ordinary skill in the art to use an anode for the material of elements inserted in the first opening 1208 and the second opening 1202 per the teaching of Shirkanzadeh in order to protect the coupled components. Regarding claim 40, it is noted that components of the prosthetic device all are shown (Fig. 3A) with at least one opening. As mentioned above, Olafsson et al. did disclose using metals for the components, (page 9 of translation) such that one would want to protect the coupling of elements as mentioned by Olafsson using a protective coating and thus it would have been obvious to one of ordinary skill in the art to use anode material as taught by Shirkanzadeh in order to protect the coupled components.
Claim(s) 33,34,36-38 are rejected under 35 U.S.C. 103 as being unpatentable over Olafsson et al. CN (101553192) in view of Shirkhanzadeh (US 5383935) as applied to claim 21 above, and further in view of Wellington et al. (US 3226314). Olafsson et al. in view of Shirkhanzadeh is explained supra. However, Olafsson et al. as modified with Shirkhanzadeh did not disclose the anode comprise a zinc alloy. Wellington et al. teach (col. 1, lines 18-21, 64-66) that sacrificial anodes are important in preventing corrosion and selecting the appropriate metal alloy, such as zinc provides an advantageous structure. It would have been obvious to one of ordinary skill in the art to select the appropriate metal alloy and use zinc as taught by Wellington et al. with the prosthetic coupling have a protective metal coating in the prosthetic device of Olafsson modified per Shirkhanzadeh to sufficient protect the components in the particular environment, see for example Wellington col. 2, lines 1-3. Regarding claim 34, Wellington et al. teach (col. 1, lines 67,68) that the zinc alloy is at least 99% pure zinc (col. 2, lines 20,21, 48-54). Regarding claim 36, it is noted that Shirkhanzadeh teaches that a cylindrical rod section of element 9 as seen in Fig. 1 is defining a cylindrical shape configured and dimensioned to “tightly fit” within the opening of a metal component 5 seen in Fig. 2. Additionally as mentioned above, Olafsson discloses alternative embodiments of interlocking components of an adapter, which is well known in the art to reverse interchangeable interlocking elements as it only involves routine skill in the art. Again as already mentioned above, Olafsson disclose there is a protective coating, which alternatively per the teaching of Shirkhanzadeh can be an anode structure material. Wellington et al. additionally teach (col. 3, lines 9-14) that a zinc anode can be constructed as a cylindrical shaped structure. It would have been obvious to one of ordinary skill in the art to alternatively construct the zinc anode material in the shape of a cylindrical cross-section as taught by both Wellington et al. and Shirkhanzadeh in the prosthetic of Olafsson et al. to provide a tightly fit between the opening formed by the metal component and the shape corresponds to a shape formed by the opening in the prosthetic. Regarding claim 37, it is noted Wellington et al. teach (col. 2, lines 63-69) that anode shape cross-sections can be constructed to any shape. Further, Olafsson et al. disclose (Figs. 5A,C) that an opening in adapter components can be designed with an undulating profile. Thus, per the combined teachings of Shirkhanzadeh and Wellington et al. in providing a protective anode coating or billet one can construct the shape to be undulating in taking the teachings in combination, especially since Wellington states any desired shape cross section can be achieved, see col. 3, lines 41-44. Regarding claim 38, per the teaching with Wellington, as mentioned prior the shape matches or as best understood the anode locks within the enclosure defined by the metal component by tightly fitting with the opening.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN E PELLEGRINO whose telephone number is (571)272-4756. The examiner can normally be reached 8:30am-5:00pm M-F.
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/BRIAN E PELLEGRINO/Primary Examiner, Art Unit 3799
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