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 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.
Claims 1-24 are 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.
Independent claims 1, 9, and 15 recite the limitation that the monolithic continuum morphable hollow shell structure includes a single opening to the internal cavity at the distal end. This is not supported by the specification or drawings. The only opening to the internal cavity is described and shown as opening 108 in the proximal end. There is no disclosure of both an opening in the proximal end and in the distal end as claimed, nor is there any disclosure of an opening in the distal end in any configuration. Therefore claims 1, 9 and 15 contain new matter.
Dependent claims 2-8, 10-14, 16-24 are rejected under 112(a) as they contain all the deficiencies of claims 1, 9 and 15 from which they depend.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-4, 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fallin et al. (US Patent No. 10,485,595 B2).
Regarding Claim 1, Fallin discloses a bone fixation device (Fig. 41), comprising: a monolithic (described as integrally formed in [col 9; ln. 1-11]) continuum morphable hollow shell structure (186) including a proximal end and a distal end and a morphable length therebetween (see how length will morph in Fig. 8-10), and defining an internal cavity extending along the length with a single opening to the internal cavity at the proximal end and a single opening to the internal cavity at the distal end; an implantation head at the proximal end including an aperture; and a screw thread (194) positioned external to the shell structure between the implantation head and a screw tip positioned at the distal end (shown below);
wherein the continuum morphable hollow shell structure is configured to retain a castable filler material; wherein the castable filler material is substantially 1contained within the internal cavity and stiffens into a fixed core within the monolithic continuum morphable shell structure, thereby preserving a morphed geometry of the shell structure (The limitations towards the capability of the shell structure to receive a filler are functional. The hollow nature of the device of Fallin would be fully capable of accepting a filler material through the internal cavity which could harden.).
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Regarding Claim 2, the implantation head comprises a screw head (head is used to transmit screwing action from the other component to the thread 194, therefore it acts as a screw head, see also col.7; ln. 50-65).
Regarding Claim 3, the shell structure is cylindrical (shown in figure above).
Regarding Claim 4, Fallin discloses the device of claim 1 as described in the rejection above. Fallin discloses that the screw may have a major diameter 114 in the range of 4-6.5 mm, a minor diameter 116 in the range of 2.5-3.5 [mm] and a cannulation 101 with a diameter in the range of 1-2 mm (col. 3; ln. 55-62).
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As can be seen in the figure above, the dimension 116 corresponds with the outer diameter of the shell structure, and 2.5-3.5mm is in the range of 2 mm to 20 mm. The dimension of 101 corresponds with an inner diameter and 1-2 mm is in the range of 1.5 mm to 19.5 mm. The difference between dimension 116 and 101 is equivalent to the wall thickness, this difference would be .5-2.5mm which is in the range of 0.1 mm to 2 mm.
Regarding Claim 7, the shell structure comprises at least one of ABS, PLA, biomaterial, polyamide, PEEK, titanium, nitinol, and cobalt-chrome alloys (col. 8: ln. 41-62).
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) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable Fallin et al. (US Patent No. 10,485,595 B2) in view of Fallin et al. (US Patent No. 10,492,838 B2, hereon referred to as “Fallin2”).
Regarding Claim 5, Fallin discloses that the screw has a thread pitch (128, Fig. 2) but is silent to the dimensions of the thread pitch being in the range of 1 mm to 2 cm.
Fallin2 teaches a flexible bone implant in the same field of endeavor comprising a flexible shell structure with a thread having a pitch which is most preferably 2.75mm (col. 15; ln. 44-46) for the purpose of securing to a particular bone for repair.
It would have been obvious to one having ordinary skill in the art to modify the dimension of the thread pitch of Fallin to be 2.75mm as taught by Fallin2 in order to be suitable to secure to the bone.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable Fallin et al. (US Patent No. 10,485,595 B2).
Regarding Claim 6, Fallin discloses that the screw has a length but is silent to the dimensions of the length being in the range of 1 cm to 50 cm. However, Fallin does show the screw within the anatomical region of the clavicle in Fig. 33. In relation to the bone, it can be seen that the length of the threaded section of the screw (shell structure) is at least 1 cm and less than 50 cm because the average length of a clavicle is 5-6 inches (~13-16cm). It would have been obvious to one having ordinary skill in the art to create the length of the shell structure to be more than 1cm and less than 50 cm in order to appropriately size the implant to the bone.
Claim(s) 8 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as being unpatentable Fallin et al. (US Patent No. 10,485,595 B2).
Regarding Claim 8, Fallin discloses that the shell structure is preferably made from polymer (col. 8; ln. 34-63) however is silent to the process by which the shell is made being 3D printing. The structure of Fallin appears to be the same as the product set forth in a product-by-process claim although produced by a different process, therefore the claim is anticipated by Fallin. Alternatively, it would have been obvious to one having ordinary skill in the art to make the polymer shell structure with a 3D printing manufacturing process since this is one of a limited number of known manufacturing methods to create products which would produce predictable results of creating desired structure of the components (other methods including casting/molding, or subtractive manufacturing/machining). See In re Marosi, 710 F.2d 799, 218 USPQ 289 (Fed. Cir. 1983) and In re Thorpe, 777 F.2d 695, 227 USPQ 964(Fed. Cir. 1985). See also MPEP § 2113.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-24 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 JACQUELINE T JOHANAS whose telephone number is (571)270-5085. The examiner can normally be reached Mon. - Fri. 9:00-5:00.
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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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/JACQUELINE T JOHANAS/ Primary Patent Examiner, Art Unit 3773
1 The examiner has understood “substantially” to mean all but a negligible amount. One of ordinary skill in the art would understand “substantially contained within” to mean all or all but a negligible amount is contained within [the internal cavity].
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