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 1-5 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 "the lower end of the tensor" in line 15, “the four small transverse arms” in line 17, “the epidural space” and “the dura mater” in line 19. There is insufficient antecedent basis for these limitations in the claim.
Additionally, claim 1 recites “the small transverse arms having a contact surface with the dura mater of substantially oval shape”. It is unclear which has the “substantially oval shape”, the dura mater or the small transverse arm’s contact surface. Appropriate correction and clarification is required.
Claim 2 recites the limitation "the lower base" in line 2. There is insufficient antecedent basis for this limitation in the claim. Additionally, claim 2 recites “the lower base made up of elastic arms and small transverse arms”. It is unclear if these elastic arms and small transverse arms are the same or different from those cited in claim 1 which claim 2 depends from. Appropriate correction and clarification is required.
Claims 3-5 are rejected under 35 U.S.C. 112(b) as they depend from a rejected base claim and do not rectify the issues at hand.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “second closing means” in claim 1. Applicant’s specification recites that the second closing means can be a plate slidably mounted onto the tensor.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Gazzani et al. (WO 2019/167092).
Regarding claim 1, Gazzani et al. disclose a fixing device (10, figure 1) for fixing a craniotomy operculum to a cranial vault (figure 3), designed to be positioned in a craniotomy slot (figure 2), comprising:- at least one support tensor (12); first closing means (11, 13) operatively connected to the support tensor (12); second closing means (14) designed to be fixed to the support tensor (12) to complete its closure (figure 3); at least one handle (15) removably connected to the support tensor (12) and designed to manipulate the device (10) to bring it from its rest position to its operational fixing position (figures 1-3), in which the first closing means are connected to a distal end of the support tensor (figure 3) and the second closing means are designed to be fixed to the support tensor at a position close to the distal end of the support tensor (figures 1, 3), so that, when the device is in its operational fixing position, the first closing means are placed against the internal distal cranial surface and the second closing means are placed against the external cranial surface (figure 3), wherein the first closing means comprise elongated elastic arms (11) operatively connected to the lower end of the tensor (12), each of the elongated elastic arms terminating in a small arm (13) positioned transversely with respect to its own elongated elastic arm (figure 1), in which the small transverse arms have a tapered skate shape (figure 1), suitable for facilitating a wedging of the four small transverse arms and their subsequent sliding into the epidural space over the dura mater and the cranial vault (figure 3), causing only a minimal detachment of the dura mater (figure 3), reducing the risk of bleeding to a minimum (Page 5, lines 17-23), the small transverse arms having a contact surface with the dura mater of substantially oval shape (figure 3), and having rounded ends with a geometry designed to make them slide during insertion into the epidural space, the elongated elastic arms also having an elliptical section (Page 11, line 25 – Page 12, line 4). Gazzani et al. only teach the use of two elongated elastic arms having a respective transverse arm (figures 1-3) instead of the claims required four elongated elastic arms and small transverse arms. It would have been obvious to one having ordinary skill in the art at the time of filing to construct the fixing device of Gazzani et al. to have four elongated elastic arms each having a respective small transverse arm, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. Regarding claim 2, Gazzani et al. disclose the overall size of the lower base, made up of elastic arms and small transverse arms, varies from 18.5 x 12.5 mm to 13' .5 x 12 mm (Page 11, lines 19-22.
Regarding claim 3, Gazzani et al. disclose the elliptical section of the elongated elastic arms has a major axis of length equal to the width (w) of the craniotomy slot (figures 1-3).
Regarding claim 4, Gazzani et al. disclose the elliptical section of the elongated elastic arms has a minor axis of length equal to the thickness (t) of the small transverse arms (figures 1-3).
Regarding claim 5, Gazzani et al. disclose the small transverse arms have a first radius of curvature (r1, figure 3) and a second radius of curvature (r2, figure 3), the first radius of curvature (r1) being much smaller than the second radius of curvature (r2), the first radius of curvature (r1) configured to enable the wedging of the small transverse arms under the dura mater, the second radius of curvature (r2) configured to facilitate the sliding of the small transverse arms under the dura mater (figure 3, Page 12, lines 9-16).
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
