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 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.
The Examiner notes in claim 3, Applicant uses the term “coupling means” and has therefore been interpreted as invoking 35 U.S.C. 112(f) language.
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 6 is 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 6 recites the limitation "the upper part of the cortical upright" in line 3. There is insufficient antecedent basis for this limitation in the claim.
For the purpose of examination, the limitation has been interpreted to read “an upper part of the cortical upright”.
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.
Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Carvani et al. (US 2016/0100947).
Regarding claim 1, Carvani et al. disclose a device (10) for fixing a cranial flap to the cranial vault (17) capable of being positioned in a craniotomy hole, comprising at least one cortical support upright (12); first closing means (11, 13) operatively connected to the cortical upright (12); second closing means (14) suitable to be fixed to the cortical upright (12) to complete its closing; at least one handle (15) connected in a removable way to the cortical upright (¶43) and suitable for driving the device (10) to bring it from its rest position to its operational fixing position; wherein the first closing means (11, 13) are connected to the distal end of the cortical upright (12) and the second closing means (14) are adapted to be fixed to the cortical upright (12) in a position close to the distal end of the cortical upright (12), such that, when the device (10) is in its operative fixing position, the first closing means (11, 13) are placed against the distal surface internal part of the skull and the second closing means (14) are placed against the near external surface of the skull, the first closing means (11, 13) being constituted by at least two elongated elastic arms (11) operatively connected to the cortical upright (12), each of the elongated elastic arms (11) ending in an elongated arm (13) placed transversely with respect to the elongated elastic arms (figures 5-10), wherein the device (10) is also equipped with at least one lower base (5) to be assembled to the device (10) for fixing a cranial flap and for simultaneously closing the holes made to perform the craniotomy, the lower base (5) having a cut (6) through which the device (10) passes when the device (10) moves into its operative fixing position, and a seat (7) where the transverse arms (13) tied to it are housed and slide to the elastic arms (figures 1-4, 11-14); and in that the second closing means (14) are equipped with a cylindrical collar (9) designed to centre the second closing means (14) in the craniotomy hole (¶52).
Carvani et al. fail to expressly teach or disclose the transverse elongated arms are substantially semi-circular in shape with greater transverse thickness in their central part compared to their two ends, each of the transverse elongated arms having its ends oriented towards the respective ends of the other of the transverse elongated arms so as to leave a space between the ends. It would have been an obvious matter of design choice to one skilled in the art at the time the invention was made to construct the transverse elongated arms of Carvani et al. with a substantially semi-circular in shape with greater transverse thickness in their central part compared to their two ends, each of the transverse elongated arms having its ends oriented towards the respective ends of the other of the transverse elongated arms so as to leave a space between the ends, since applicant has not disclosed that such solve any stated problem or is anything more than one of numerous shapes or configurations a person ordinary skill in the art would find obvious for the purpose of providing a forming edge in the heating portion or clamp. In re Dailey and Eilers, 149 USPQ 47 (1966). Regarding claim 2, Carvani et al. disclose the transverse arms (13) are blocked in opening by the shape of the seat (7) of the base (¶51).
Regarding claim 3, Carvani et al. disclose the transverse arms (13') are blocked in opening by coupling means (8) provided at two ends of the seat (7) of the base (¶51).
Regarding claim 4, Carvani et al. disclose the base (5) has a centring system (9) intended for use when the device (10) is used in holes made by a drill (¶52).
Regarding claim 5, Carvani et al. disclose the device is made of elastic biocompatible plastic material (¶48).
Regarding claim 6, Carvani et al. disclose the second closing means (14) are composed of an upper plate (14) suitable for being inserted in the upper part of the cortical upright (figures 5-10).
Regarding claim 7, Carvani et al. disclose the cortical upright (12) is also equipped with a plurality of fixing elements (16’s) placed at as many levels along the length of the upright (12), the fixing elements (16) being capable of engaging the upper plate (14) after its operational coupling with the upright (¶34, ¶43, ¶47).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW JAMES LAWSON whose telephone number is (571)270-7375. The examiner can normally be reached Mon - Fri 6:30-3:00.
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/MATTHEW J LAWSON/Primary Examiner, Art Unit 3619
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