DETAILED ACTION
This office action is responsive to the amendment filed February 2, 2026. By that amendment, claim 1 was amended. Claims 1, 2, and 4-11 are pending. That amendment was entered upon submission of a Request for Continued Examination on March 3, 2026.
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 3, 2026, has been entered.
Response to Arguments
Applicant’s arguments with respect to the outstanding rejection of claim(s) 1, 2, and 4-11 under 35 USC 103 in view of Biedermann (US 2013/0012336) and Fallin (US 2017/0079699) 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. The newly presented rejection is necessitated by the amendments to the claims of February 2, 2026.
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, 2, and 4-11 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.
The following limitations newly added to claim 1 are considered to be new matter:
Non-expandable (line 2)
Completely enclosed along an entire length thereof (lines 6-7)
Entirely isolate (line 12)
Regarding “non-expandable”, applicant states support for this limitation is found at figures 1a and 1c. Examiner respectfully takes the position that this negative limitation is subject matter which cannot effectively be demonstrated by a figure. While examiner would agree that the outer part is not demonstrated expanding, examiner does not agree that this provides evidence that applicant has originally presented support for claiming that the outer part is non-expandable. This is considered new matter.
Regarding ‘completely enclosed along an entire length’, applicant states that this is supported at fig. 1a and 1c and paragraph [0016]. Examiner is of the position that this limitation is contrary to what is demonstrated in figures 1a and 1c, and is not supported by the language of [0016]. Paragraph [0016], in relevant part, reads “Further, the orthopedic screw includes an inner part enclosed by the outer part. In one example, the inner part is removable from the outer part via an opening of the head.” Examiner notes that the word “completely” is not present in this paragraph, and that the teaching positively provides for an opening to provide access to the inner part. Particularly viewing figs. 1b and 1c, it can be seen that a portion of the proximal end of the inner part 112 is not enclosed by the outer part 102.
Regarding ‘entirely isolate’, no additional support is identified. Examiner points to the same features as he used to refute the ‘completely enclosed’ limitation. For the same reasons, the inner part is also not entirely isolated. (E.g. it is accessible from the exterior at the proximal most end).
Depending on response to these rejections, applicant is advised that specification and/or drawing objections may be presented in a subsequent office action.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1, 2 and 6-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Moumene (US 2010/0082071 A1).
Regarding claim 1, Moumene teaches an orthopedic screw 51 at fig. 4 comprising:
a non-expandable, outer part 61, the outer part 61 being a continuous tubular structure without openings or slits extending through a wall thereof (note that fig. 4 is demonstrated in cross-section [0027]), and having a tip to the right in fig. 4, a head ot the left in fig. 4, threads 65 disposed on an outer surface of the outer part 61 between the tip and the head, and a longitudinal cavity seen receiving 53 therein; and
an inner part 53 positioned in an axially stationary manner (e.g. relative to 61), and completely enclosed along an entire length of 63 thereof, within the longitudinal cavity of the outer part 61, such that the inner part 53 does not protrude from the outer part 61 (53 does not protrude from 61 in the same way that the instant invention does not protrude; both designs are accessible through a proximal end of the outer part), the inner part being removable from the longitudinal cavity of the outer part 61 (upon sufficient application of force), the inner part 53 comprising a reinforcing rod (a portion, thereof) to support the outer part 61, the reinforcing rod of 53 filling the longitudinal cavity of 61,
wherein the outer part 61 is configured to entirely isolate the inner part 53 from direct contact with surrounding structure during use (53 is entirely within the body of 61),
wherein the outer part 61 is made of a material softer than a material of the inner part (61 is made of polymer; 53 is made of metal [0045], etc.),
wherein the material of the outer part forms an interfacing layer between the inner part 53 and a bone, and wherein the material of the outer part 61 is a biocompatible and bio-absorbable polymeric material (the instant application teaches polyethylenes as such materials; the prior art teaches various polyethylenes used as at [0047]-[0051]).
Regarding claim 2, the longitudinal cavity in 61 has a cross-section corresponding to a cross-section of the inner part 53 as seen in the figures.
Regarding claims 6-8, the inner part 53 is a reinforcement for structural stability – inherently based on its material properties and design and placement within 61. 53 is made of metal which is a biocompatible alloy [0046].
Regarding claim 9, the inner part 53 comprises a head 55 at a top surface thereof, and wherein the head 55 comprises a slot on the top surface as can be seen in fig. 4 for removal of the inner part 53 from the outer part 61.
Regarding claim 10, as can be seen at fig. 4, the reinforcement 53 has a cross section of a regular polygon (a triangle).
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) 4 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moumene in view of Fallin (US 2017/0079699 A1).
Regarding claim 4, Moumene teaches the limitations of claim 1 as above, but is silent as to the threadform of the threads 65 except to state that they are for insertion into vertebral bone.
Fallin teaches an orthopedic screw design including an inner and outer member. The outer member is threaded and includes a self-tapping thread [0042].
It would have been obvious to one with ordinary skill in the art at the time of the invention to form the Moumene threads 65 to be self-cutting or self-forming based on the Fallin teaching. One would have done so in order to obviate the need for use of a tap when installing the Moumene screw as suggested by Fallin at [0042].
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moumene.
Moumene teaches the limitations of claim 6, as above, and demonstrates the inner part 53 in cross section as in fig. 4.
It is impossible to discern from the figure or from the disclosure whether 53 is circular in a cross section orthogonal to that shown in fig. 4; though it is strongly presumed that it is.
Examiner sees no advantage gained from having the form of the orthogonal cross-section being circular of any other particular shape. Examiner is of the position that circular and other shaped cross sections would have functioned identically for purposes of reinforcement and insertion into bone. It would have been obvious as a matter of design choice to form 53 as a conical structure, such that it has circular cross sections along its length.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to David Bates whose telephone number is (571)270-7034. The examiner can normally be reached Monday through Friday, 10AM-6PM
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/DAVID W BATES/Primary Examiner, Art Unit 3799