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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites “wherein the at least one coated fiber of the core region comprises a concentration of the continuous filaments of about 20 volume percent or more”. Applicant has not pointed to nor has the Office found support for such an amendment in the specification as originally filed. Applicant is advised to point to support for such an amendment or amend the claim.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 2 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 1 recites “the at least one coated fiber of the core region has a cross-section perpendicular to a length direction characterized by an aspect ratio of about 3.0” and claim 2 which depend upon claim 1 recites “the at least one coated fiber has a cross-section perpendicular to a length direction characterized by an aspect ratio of about 1.2 or more”. Claim 2 recites a broader range than claim 1 which makes claim 2 indefinite for reciting a broader range than claim 1 which claim 2 depends from. Applicant is advised to amend the claim language to remedy this. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-2 are rejected under 35 U.S.C. 103 as being unpatentable over D’Agostino et al. (PG Pub. 2016/0106838).
Regarding claim 1, D’Agostino et al. teaches a composite comprising a coated fiber (can be reinforcing elements 15) in the composite with a polymeric matrix (injectable matrix which is taught as being through and around the reinforcing elements or could be considered as the sizing) comprising a plurality of filaments (can be construed at 40) [0027, 0145, 0176 and Figures]. D’Agostino et al. teach the coated fiber has a substantially uniform profile along its length (Figure 7) and the filaments have a polymeric or polymerizable coating over at least a portion of their surface [0144]. The composite comprises a plurality of regions wherein the plurality of regions comprises a core region (construed as the coated fiber 15 which contained filaments 40) and an outer region wherein the core region comprises the at least one coated fiber and the plurality of filaments 40 of the at least one coated fiber of the core region are continuous filaments [0129]. D’Agostino et al. states in paragraph 0138 “It will also be appreciated that the reinforcing properties, and degradation profiles, of the one or more reinforcing elements 15 may be modified by changing the material, dimensions, shape, orientation, volume, and surface features of the fibers, filaments, and/or particulates used to form the one or more reinforcing elements 15.”. Therefore D’Agostino et al. teach the concentration of the continuous filaments as a results effective variable affecting reinforcing properties and degradation profiles and it would have been obvious to one of ordinary skill in the art to arrive at the claimed concentration of continuous filaments in the coated fiber of the core region through routine experimentation in order to affect the reinforcing properties and degradation profile and arrive at the claimed invention. In paragraph 0043, D’Agostino et al. states “Preferably the size and number of concentric reinforcing tubes and reinforcing rods are selected so as to meet the individual needs of a particular patient. The number of concentric reinforcing tubes utilized in the composite implant, and/or their lengths and/or cross-sectional dimensions, and/or the number of reinforcing rods used, and/or their lengths and/or cross-sectional dimensions, may be selected according to the individual needs of a particular patient. Preferably the number, length, and cross-sectional dimensions of the reinforcing tubes, and the number, length, and cross-sectional dimensions of the reinforcing rods, are selected so as to provide a composite implant having variable stiffness along its length, e.g., a composite implant having a stiffer central region (e.g., 20 GPa) and less stiff distal and proximal ends (e.g., 3 GPa), whereby to prevent stress risers from being created at the ends of the composite implant. To this end, the reinforcing tubes, and the reinforcing rods, are preferably provided in a variety of sizes with a range of mechanical properties for appropriate selection by the physician; alternatively, the reinforcing tubes and/or reinforcing rods may be sized at the time of use by the physician.” Therefore, D’Agostino et al. teaches the claimed aspect ratio of the at least one coated fiber of the core region as a results effective variable affecting the stiffness, mechanical properties and suited to the needs of the patient. It therefore would have been obvious to one of ordinary skill in the art to arrive at the claimed aspect ratio of the at least one coated fiber of the core region through routine experimentation stiffness, mechanical properties and suited to the needs of the patient in order to affect the given the teachings of D’Agostino et al. The outer region comprises a plurality of filaments with the aspect ratio in the claimed range (could be construed as the nanotubes in the bag with an aspect ratio in the claimed range [0121] or could be construed as an outer layer of 15 with filaments which by definition filaments inherently have an aspect ratio in the claimed range.
Regarding claim 2, D’Agostino et al. teach the plurality filaments of the at least one coated fiber are twisted at a twist rate in the claimed range [Examples] and the at least one coated a fiber cross-section perpendicular to the length direction characterized by an aspect ratio in the claimed range is obvious over D’Agostino [as set forth in the rejection of claim 1 above and as rejected under 35 USC 112 above]. D’Agostino is silent regarding the claimed diameter of the filaments. However, D’Agostino et al. teach in paragraphs 0135-0138 “ In another embodiment, the reinforcing properties of the one or more reinforcing elements 15 may be modified by changing the orientation, volume, twist, and angle of the fibers and filaments within the reinforcing elements. In preferred constructions, the fibers and filaments are typically set at an acute angle to intersecting fibers and filaments in order to strengthen the reinforcing structure, but the angle may be any angle between 0 degrees and 90 degrees.
[0136] In another embodiment, the properties of the composite implant may be modified by changing the orientation of one or more of the reinforcing elements 15, and/or by changing the volume of one or more of the reinforcing elements 15.
[0137] It will be appreciated that the properties of the composite implant may be modified by changing the layup or selection of one or more of the reinforcing elements 15.
[0138] It will also be appreciated that the reinforcing properties, and degradation profiles, of the one or more reinforcing elements 15 may be modified by changing the material, dimensions, shape, orientation, volume, and surface features of the fibers, filaments, and/or particulates used to form the one or more reinforcing elements 15.”. Therefore, D’Agostino et al. teach the twist and aspect ratio as a results effective variable affecting reinforcing properties and degradation profile of the reinforcing elements and also the composite. It would have been obvious to one of ordinary skill in the art to arrive at the claimed twist and aspect ratio through routine experimentation in order to impact reinforcing properties and degradation profile and arrive at the claimed invention.
Response to Arguments
Applicant's arguments filed 08/12/2025 have been fully considered but they are not persuasive.
Applicant stated the art does not teach the newly amended claim language. D’Agostino does in fact teach the newly amended claims as set forth above. Applicant is invited to amend the claims over the cited art.
Art not Cited, but Relevant
PG Pub. 2019/0175734 teaches a coated fiber and implant.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHAWN MCKINNON whose telephone number is (571)272-6116. The examiner can normally be reached Monday thru Friday generally 8:00am-5:00pm EST.
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/Shawn Mckinnon/Examiner, Art Unit 1789