DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 August 24th, 2026 has been entered.
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 1-4, 7-10, and 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over White (U.S. Patent 6,656,184) in view of Paul (U.S. Publication 2004/0236328) further in view of Palmer (U.S. Publication 2016/0213412) further in view of Paul (U.S. Publication 2004/0236328).
White discloses a device (for example see Figures 1-2) comprising an elongated body having a proximal end and a distal end, a head (16) region at the proximal end, a bone engagement part (12) at the distal end configured to engage a bone, and a dynamic compression portion (20) between the head region and the bone engagement part, wherein the dynamic compression portion is made from a material configured to transform between a first axially compact configuration (Figure 1) and a second axially elongated configuration (Figure 2). The dynamic compression portion comprises a cannulated rod with a rod wall and a first helical slit through in the wall, wherein the ends of the first helical slit include an end geometry different from the geometry of a middle portion of the first helical slit. White fails to disclose the device wherein the end geometry includes a curved portion, a straight portion, and a circular portion, wherein the elongated configuration is at least 0.5% longer than the compact configuration, wherein the curved portion has a radius substantially the same as the radius of the cannulated rod, about 10% the radius of the cannulated rod, or about 500% the radius of the cannulated rod, wherein the straight portion has a length between 15% and 100% of the outer diameter, and the cannulated rod wall having a second helical slit identical to and opposite the first helical slit, i.e. a double helix.
Regarding the end geometry including a curved portion, a straight portion, and a circular portion, Paul teaches a device (for example see Figures 26-29) comprising a dynamical compressible cannulated rod including a rod wall and a first helical slot in the rod wall, wherein each end of the first helical slot further comprises an end geometry including a curved portion, a straight portion aligned with the longitudinal axis of the rod, and a circular portion opposite the curved portion such that the curved portion transitions the direction of the first helical slot from the circular helical pitch to the straight portion extending along the longitudinal axis to the circular portion to lower stress levels at the ends and control flexibility in multiple directions along the length of the first helical slot (for example see page 8 paragraph 106 to page 9 paragraph 119). It would have been an obvious matter of design choice to one skilled in the art at the time the invention filed to provide the device of White wherein the first helical slot includes an end geometry having a curved portion, a straight portion, and a circular portion to lower stress levels at the ends and control flexibility in multiple directions along the length of the first helical slot in view of Paul, since applicant has not disclosed that such solve any stated problem or is anything more than one of numerous shapes or configurations a person ordinary skill in the art would find obvious for the purpose of providing a helical slot including an end geometry in a rod element. In re Dailey and Eilers, 149 USPQ 47 (1966).
Regarding the curved portion has a radius substantially the same as the radius of the cannulated rod, about 10% the radius of the cannulated rod, or about 500% the radius of the cannulated rod, the device of White as modified by Paul discloses the invention as discussed above wherein the end geometry includes a circular portion, a straight portion, and a curved portion opposite the circular portion, wherein the circular portion includes a radius of curvature that is relative to the outer radius of the cannulated rod (this meets the general conditions of the claim limitations), but the Paul reference is silent regarding the specific dimension of the radius of the curved portion relative to the outer radius of the cannulated rod. Therefore, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984).
Regarding the straight portion having a length between 15% and 100% of the outer diameter, the device of White as modified by Paul discloses the invention as discussed above wherein the end geometry includes a circular portion, a curved portion opposite the circular portion, and a straight portion between the circular portion and the curved portion, wherein the straight portion includes a length that is relative to the outer radius of the cannulated rod (this meets the general conditions of the claim limitations), but the Paul reference is silent regarding the specific length of the straight portion relative to the outer radius of the cannulated rod. Therefore, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984).
Regarding the elongated configuration being at least 0.5% longer than the compact configuration, Palmer teaches a device comprising an elongate body having a proximal end, a distal end, and a dynamic compression portion (130) positioned between the ends having a compact configuration and an elongated configuration, wherein the elongated configuration is at least 0.5% the length of the compact configuration (page 4 paragraph 67) in order to control the amount of compression force applied by the device. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the device of White as modified by Paul wherein the elongated configuration of the dynamic compression portion is at least 0.5% the length of the compact configuration in view of Palmer in order to control the amount of compression force applied by the device.
Regarding the device wherein the cannulated rod includes a rod wall having a second helical slit identical to but opposite the first helical slit, i.e. a double helix pattern, the device of White as modified by Paul as further modified by Palmer discloses the invention as claimed (see above) except for the rod wall having a second helix identical to the first helix (claims 5, 6, 9, and 10 all limit the second helix with the same limitations and structure as the first helix in claims 1-4 as discussed above) that is opposite the first helix, i.e. an interdigitated double helix configuration. Paul teaches a device comprising a rod or a hollow rod (paragraph 107) having a rod wall including a flexibility segment (paragraph 107), wherein the flexibility segment includes two opposite helical slits, i.e. a double helix configuration (see paragraphs 108-109) in order to control the flexibility and the range of motion of the flexibility segment. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the device of White as modified by Paul as further modified by Palmer wherein the cannulated rod includes a rod wall having a second helix identical to and opposite the first helix, i.e. an interdigitated double helix configuration in view of Paul in order to control the flexibility and the range of motion of the flexibility segment.
Regarding claims 7 and 8, it is noted that the device of White as modified by Paul as further modified by Palmer as further modified by Paul appears to be substantially identical to the device claimed, although produce by a different process, therefore the burden is upon the applicant to come forward with evidence establishing an unobvious difference between the two. In re Marosi, 218 USPQ 289 (Fed. Cir. 1983).
Response to Arguments
Applicant's arguments filed August 24th, 2026 have been fully considered but they are not persuasive. The applicant’s arguments that the invention of White (U.S. Patent 6,656,184) in view of Paul (U.S. Publication 2004/0236328) further in view of Palmer (U.S. Publication 2016/0213412) further in view of Paul (U.S. Publication 2004/0236328) does not disclose the invention as claimed is not persuasive. As discussed above, the combination of references disclose the claim limitations as presented. The slots of the invention allow for controlled range of motion, flexibility, and axial compression while reducing the buildup of undesirable stress concentrations along the device (for example see paragraphs 108 of Paul). Therefore, the combination of references disclose the claim limitations as presented. The applicant’s argument that the teachings of Paul are only for a single-orientation helix and does not address end-of-slit stress concentration is not persuasive. First, Paul explicitly discloses the solid rod having flexible section including one or more helical cuts. Second, Paul discloses that the circular portion of the slit, i.e. the starting hole, helps reduce the possible occurrence of stress concentrations that could form cracks in the rod. The applicant’s argument that Paul does not disclose two slits with the end geometry is not persuasive. Paul discloses a method of using EDM wire that cuts through the rod to create both slits at the same time with the same geometry. In response to Applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgement on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. However, as long as the examiner takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. In re McLaughlin, 443 F.2d 1392; 170 USPQ 209 (CCPA 1971). In response to Applicant's argument that there is no suggestion to combine the references, the examiner recognizes that references cannot be arbitrarily combined and that there must be some reason why one skilled in the art would be motivated to make the proposed combination of primary and secondary references. In re Nomiya, 184 USPQ 607 (CCPA 1975). However, there is no requirement that a motivation to make the modification be expressly articulated. The test for combining references is what the combination of disclosures taken as a whole would suggest to one of ordinary skill in the art. In re McLaughlin, 170 USPQ 209 (CCPA 1971). The references are evaluated by what they suggest to one versed in the art, rather than by their specific disclosures. In re Bozek, 163 USPQ 545 (CCPA) 1969. The applicant’s argument that design-choice does not apply to the end geometry of the slit is not persuasive. The Paul reference shows that the end geometry is known to be used in a rod and is therefore an obvious design choice to one of ordinary skill in the art to provide in a rod. The remaining arguments include certain features of the invention not stated in the claims, such as synergistic results and stress concentrations.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 Nicholas Woodall whose telephone number is (571) 272-5204. The examiner can normally be reached on Monday-Friday 8am to 5:30pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Kevin Truong, at (571. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NICHOLAS W WOODALL/Primary Examiner, Art Unit 3775
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