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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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 1-7 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 1 recites the limitation "it comprises removable means…" in line 10. There is insufficient antecedent basis for this limitation in the claim. It is not clear, what “it” is referring to, the first anchoring portion, the shank, the first cylindrical cavity, or another component entirely. Claim 5 line 1 also recites “it” and has the same issue. For examination purposes, the examiner will treat “it” as referring to the nail.
Furthermore, claim 5 recites “gap of material” where this phrase is unclear since a gap would an empty space or lack of material. The examiner will treat with art as best understood.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-2, 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Kilpela US 6,123,708 in view of McCormick US 2015/0223848.
Regarding Claim 1, Kilpela discloses an intramedullary nail (Figs 1-3) for insertion into the medullary canal of long bones, comprising:
a first anchoring portion at a relative distal end area (see Fig below), comprising at least a plurality of first transversal through holes (see Fig below) designed to allow the passage of first locking screws (#44),
a shank extending longitudinally from said first anchoring portion (see Fig below),
a second anchoring portion at the relative proximal end area longitudinally opposite said first anchoring portion (see Fig below), the second anchoring portion having two prongs (#35) configured to elastically expand away from each other starting from a close configuration (as seen in Fig 1, Col 4 lines 40-45, elastically expand via slot #24), said first anchoring portion and shank presenting therein a first cylindrical cavity (#18, Col 4 lines 25-30) facing said second anchoring portion (not shown, Col 4 lines 25-30, cylindrical cavity can extend to slot #24 such that a guide wire can be received through the nail).
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Kilpela discloses the use of a guide wire or k-wire (Col 4 lines 25-30) but does not disclose removable means of fixing said prongs, configured for keeping said prongs in a close position and, once removed, allow the elastic expansion of the prongs themselves.
McCormick discloses a similar intramedullary device (see Fig below Figs 47-49, abstract), with prongs having latch plates with second and third cylindrical cavities (#170, #166, see Fig below, paragraph 89), a first cylindrical cavity (#4) facing the second anchoring portion (see Fig below), wherein it comprises removable means of fixing said prongs (k-wire or guide wire #60, see Fig below), configured for keeping said prongs in a close position (Fig 48) and, once removed, allow the elastic expansion of the prongs themselves and engage bone (Fig 49, paragraph 89-90).
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It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the prongs of Kilpela to have latch plates with eyelets and elastically expand in view of McCormick above because this allows the guide/k-wire (removable means) to extend through the eyelets to keep prongs in a close position and once removed, allow the elastic expansion of the prongs themselves and engage bone, which aids in securing the nail to the bone.
Regarding Claim 2, Kilpela as modified discloses said removable fixing means comprise second and third cylindrical cavities respectively formed in said two prongs, said second and third cylindrical cavities (#170 and #166 in McCormick) being aligned, with each other and with said first cylindrical cavity, when said prongs are in a close configuration (as discussed above with the modification in view of McCormick, paragraph 89 in McCormick).
Regarding Claim 5, Kilpela as modified discloses it has a gap of material between said prongs when close to each other (see annotated Fig 1 of Kilpela below, see also Fig 2 in Kilpela where the gap receives screw #34).
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Regarding Claim 6, Kilpela as modified disclose said gap is defined by two curved walls formed respectively on said prongs and facing each other (see Fig above in claim 5).
Regarding Claim 7, Kilpela as modified disclose said gap is configured to define a housing (as seen in Fig 2 in Kilpela) designed to engage a screw for locking the nail itself (gap receives screw #34, Col 4 lines 32-36 in Kilpela).
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Kilpela US 6,123,708 and McCormick US 2015/0223848, as applied to claim 2 above, and in further view of Cachia US 2001/0049529.
Regarding Claim 3-4, Kilpela as modified discloses said removable means for fixing said prongs comprise a wire (Col 4 lines 25-30 in Kilpela where a guide wire or k-wire is used, likewise see k-wire #60 in McCormick) slidable in said first cylindrical cavity and designed to engage simultaneously inside said second and third cylindrical cavities aligned in said close configuration of said prongs (paragraph 89, Figs 48 as discussed in the modification in view of McCormick), wherein said wire is slidable in said first, second and third cylindrical cavities to be extracted from said second and third cylindrical cavities and allow the elastic expansion of said prongs starting from said close configuration thereof (Fig 49, paragraph 89 in McCormick).
Kilpela as modified does not disclose the wire is a metal wire.
Cachia teaches a guide wire (#150, Fig 13) made from metal such as stainless steel or titanium (paragraph 126).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify wire of Kilpela as modified to be made out of metal in view of Cachia because metal is a known type of metal used in the art for guide wires.
Conclusion
See PTO-892 for art of cited interest, in particular other nails with prongs.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAN CHRISTOPHER L MERENE whose telephone number is (571)270-5032. The examiner can normally be reached Mon-Fri 8:30 am - 6pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached 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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/JAN CHRISTOPHER L MERENE/ Primary Examiner, Art Unit 3773
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