DETAILED ACTION
This office action is responsive to the Response to Restriction Requirement of November 28, 2025. By that response, claims 1, 2, 16, and 33 were amended. Claims 1-16 and 19-33 are pending.
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 .
Election/Restrictions
Applicant’s election without traverse of Species 1 (claims 1, 6, 7, 15, and 16) in the reply filed on November 28, 2025, is acknowledged. No election of Group was made, but since the claims related to this species fell entirely within Group I, this election is also treated as having elected Group I.
Claims 2-5, 8-14 and 19-33 are hereby withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and/or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on November 28, 2025.
Examiner is open to rejoinder of any claim which requires all of the limitations of a claim eventually found to be allowable.
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:
“Bone connection device” in claim 1 – this is considered to correlate to structures 28 and 528.
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.
Specification
The disclosure is objected to because of the following informalities: The acronym ADLC is seen to relate to the term “amorphous diamond-like coating” at [0079]. However, the acronym is used before it is defined (earliest instance noted at [0043]). The acronym should be defined at the first instance of use.
Appropriate correction is required.
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 15 and 16 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.
Regarding claims 15 and 16, the limitation “hard” is considered to be a relative term.
Further regarding claim 16, the term “the pocket of the head” lacks antecedent basis in the claims. It is unclear which portion of the head is being referred to in this instance. Correction is required. For examination purposes, examiner treats this as “a central passage of the rod pathway”.
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, 6, and 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jackson et al. (US 2013/0072992 A1).
Regarding claim 1, Jackson teaches an implantable apparatus 1 as at fig. 1 for connecting a rod 22 to a bone (vertebra 17, [0156]), comprising:
a set screw 18 having a threaded outer surface;
a bone connection device 4;
a head 10 having a first pair of opposing threaded arms 62 (threads 72) and a portion of a rod pathway 68 defined between the arms, said head 10 including a first travel stop 95 [0167]; and
a rod retainer 14 having a surface 174 adapted and configured to enclose a portion of the rod pathway 68, said rod retainer 14 having a second pair of opposing arms 157 that define a channel 176 therebetween, said rod retainer including a second travel stop 159 [0191];
wherein said rod retainer 14 is slidably received between the first pair of opposing arms 62, said set screw 18 is slidably received (in threads 72) in the channel of the second pair of arms 176 (as seen at fig. 36, set screw 18 fully occludes the channel 176, and fully fills the open top end of the channel 176), and threaded engagement and tightening of said set screw 18 in said first threaded arms 62 moves said rod retainer 14 relative to the rod pathway 68 until the first travel stop 95 and the second travel stop 159 come into abutting contact as can be seen in fig. 37 [0191].
Regarding claim 6, tightening of said set screw 18 results in bottoming contact of said rod retainer 14 in the first pair of arms 62 as at figs. 36-37.
Regarding claim 7, the device includes means 84/168 for preventing rotation of said rod retainer relative to said head [0186] (see figs. 17, 22, esp. fig. 32).
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) 15 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jackson in view of Kloss et al. (US 2008/0195159 A1).
Regarding claims 15 and 16, as best understood, Jackson has taught the apparatus of claim 1, as above. Jackson further teaches contemplation of coating portions of the device as at [0162]. Further, throughout the specification, Jackson makes clear that titanium is an appropriate material for components of the system.
However, Jackson does not particularly teach portions of the rod pathway including a hard coating.
Kloss teaches application of coatings to individual components of a pedicle screw, especially contact surfaces, thereof. The coating is taught to be ceramic, or a list of other materials considered to be “hard”. [0042], [0043]
Portions of the rod pathway are considered to be ‘contact surfaces’ (e.g. contact between the rod and the head).
It is noted that the list of materials provided by Kloss includes “diamond like carbon” which examiner believes to be the same as the instant disclosed “amorphous diamond like coating”. If this particular material is to become important to patentability, examiner requests discussion of any distinction between DLC and ADLC.
It would have been obvious to one with ordinary skill in the art at the time of the invention to apply a coating to contact regions of the Jackson device. It has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. One would have applied the hard coating to the portions of the Jackson device as a matter of providing for a highly polished surface at the junction between components, and prevent abrasion of the components of the system. [0043]
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