DETAILED ACTION
This office action is responsive to the amendment filed July 23, 2026. Claims 2-13 and 15-20 were amended. Claims 1-20 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 .
Response to Arguments
The outstanding rejection of claim 2 under 35 USC 101 was overcome by the amendment to the claim of July 23, 2026.
The outstanding rejections of claims 2, 5, 7-13, 15, 19 and 20 under 35 USC 112(b) were overcome by the amendments to the claims of July 23, 2026.
Applicant's arguments regarding the rejection of claims 1-5, 7-9, 11-15, and 17-20 under 35 USC 102(a)(1) in view of Schoenefeld (US 2008/0114370); and the rejection of claims 6 and 16 under 35 USC 103 in view of Schoenefeld; have been fully considered but they are not persuasive.
The relevant arguments begin at p. 2 of the remarks, and begin by addressing the rejection of claim 1. It is argued that Schoenefeld does not teach every claimed element of claim 1. Specifically, it is argued that Schoenefeld’s tool 200 cannot properly be construed to be a “structural accessory rod”.
Examiner respectfully disagrees. Initially, examiner reviews the claim and discovers there is no structure required to the claimed accessory rod. Examiner takes the position that a structure of a drill bit is essentially the same as that of a threaded rod. Examiner then turns to the Schoenefeld reference and notes that element 200 is described as a tool, a drill, a drill bit, an other end tool that can be used for preparing a surgical site, or another instrument. [0023], [0020] Examiner is of the position that tools other than drill bits are included in the Schoenefeld teaching, including rods which are capable of use in preparing a surgical site.
Even more: Examiner further reads [0023], which describes securing alignment guide 100 to the patient using guide wires or drill bits or other temporary fasteners or supporting devices, being passed through passages 110. Any of these types of tools are also capable of use in place of 200 – and are considered to read on the claimed limitation.
The rejection is maintained.
The argument continues at p. 3 by arguing that Schoenefeld’s introducers are not pointed, but rather “terminate in blunt, contoured faces designed to match anatomy”.
Examiner considers the term “pointed” to be a relative term, particularly when taken in combination with the disclosure.
1) When compared to the body 102 of Schoenefeld, the introducers are considered to be narrow extensions from a wider body, such that they can be considered relatively pointed.
2) when considering the instant disclosure, the ‘pointed introducers’ are shown as elements 1 and 2. In this figures it is noted these are bulbous extensions on the device. Examiner notes fig. 2A which potentially demonstrates a single point on element 1. However, examiner understands this point to be a portion of surface 19 – the patient-matched surface. It is clear that the patient matched surface may have points to correspond to patient anatomy, in this application, and also in the Schoenefeld disclosure.
3) Most importantly: Schoenefeld specifically provides for portion 120 including a tapered or pointed tip for anchoring [0021].
The rejection of record is maintained.
At p. 3, it is argued that Schoenefeld does not disclose the introducers matching surface anatomy to fit in a single secure position – related to claim 2.
Examiner strongly disagrees: [0020] describes a patient-matched surface 120 designed pre-operatively to nest to include a footprint 122 corresponding portion of the patient’s anatomy – a three dimensional patient specific contour surface. This is exactly what the argument states is not taught.
The rejection is maintained.
The argument continues at p. 3 to argue that subject matter of claim 4 is not demonstrated in Schoenefeld – in particular, use of “image-based design” methods. The argument then goes on to note that use of CT or MRI data is disclosed – examiner understands, as is most reasonably broad, that CT or MRI data are image-based design methods, so therefore does not find this argument to be persuasive.
The instant disclosure is studied for what image methods were intended: It appears X-ray, CT, and Ultrasound are clearly discussed, as well as mention of a “potable 3D scanner with mechanical touch probe and saved in Dicom format.” It would appear this touch probe is not producing an image based data – and that CT has been disclosed as an acceptable means for achieving the claimed skin/bone scanning and design steps.
Claim 4 positively requires “CT” as one its image based methods – examiner takes umbrage with the argument then arguing that CT methods disclosed by Schoenefeld being unable to be understood to be the same imaging methods used to form skin and bony landmarks. Examiner notes particularly Schoenefeld teaches the modelling can include soft tissue [0017]. Schoenefeld specifically calls these methods “image methods” [0016].
Additionally, while not invoked in the prior rejection, Examiner is of the position that claims 4 and 5 are Product-by-process claims – and is of the position that until a structural distinction between the claim and the prior art is required, there is no reason the device has to be built in the same method as claimed. MPEP 2113.
The argument goes on to state that the MRI or CT data does not account for skin. Examiner notes that length of extensions can be modified in Schoenefeld based on skin and other soft tissue depths: [0019], [0022], [0024], claim 17. Again – while particular use of the image methods that applicant seems to be intending may not be disclosed, it is unclear that such would change the structure of the device.
The rejection of record is maintained.
It is argued at p. 3 that regarding claim 7, pointed introducers at ends of the detachable accessory rods and flying arc portions are not taught by Schoenefeld. Those on the arc portions have already been addressed, above, regarding the arguments re claim 1. Examiner respectfully disagrees that drill bits or any of the other types of tools disclosed at 200 or for passing through 110 are not also including pointed introducer tips. The rejection is maintained.
Regarding the rejection of claims 8 and 9, it is argued that Schoenefeld’s holes 110 are guiding passages – not fastening passages. Examiner disagrees – see Schoenefeld [0023] – discussion of temporary fasteners, supporting devices, etc. The rejections are maintained.
The argument related to claims 11-13 are not persuasive – there is no reason the tools or rods passed through 110 cannot be considered “accessory rods”. This term is given no structure, or even intended use. The rejections are maintained.
Arguments related to claims 14-20 are all related to intended uses of the passages – there is no reason the passages are not capable of carrying inferred structures of the claimed type; it is clear that cannulated sleeves are present, as claimed. Examiner wishes to point to disclosure of Schoenefeld at [0022] in which extensions 104 are modular, telescopically extendable, can be added or removed, etc. Passage of guide wires (considered to be capable of identifying locations) is discussed at [0023]. The rejections of record are maintained.
The rejection of claim 6 under 35 USC 103 is attacked. It is argued that Schoenefeld’s failure to use a touch probe scanner makes Schoenefeld’s device completely different. Examiner disagrees. The heights of the extensions, which are demonstrated to be sufficient to function percutaneously, were determined in the pre-operative plan which used CT or MRI. Examiner continues to be of the position that at least this length component of 104/110 is the same as what is required in the instant claims – just arrived at by a different mechanism. Even more, the instant claim can be treated as a product by process claim, such that so long as the claimed structure is present, the method of forming the structure is not germane. The rejection is maintained.
Finally – the rejection of claim 16 is attacked. It is argued that selection of PEEK is not obvious because Schoenefeld does not teach applicant’s radiolucent material properties. All of the arguments considered, this does not change the fact that the claimed device is a surgical jig; and that prior art surgical jigs are known to be formed of PEEK, due to PEEK’s material properties which are known to be useful in the surgical theatre. Forming a surgical jig out of PEEK is an obvious choice based on the prior art, whether for the purpose of making a radiolucent structure, or not. The rejection is maintained.
Each of these rejections will be maintained, below, as modified only to correlate to amendments to the claim language of July 23, 2026.
Regarding claim 10 - The argument related to claim 10 is considered moot in that the amendment to the claim has changed scope of the claim to positively recite the reduction indicator. A new rejection will be made, below.
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) 1-9, 11-15, and 17-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schoenefeld (US 2008/0114370 A1).
Regarding claim 1, Schoenefeld teaches a patient-specific surgical guide 100 capable of use in percutaneous fixation of fractures, dislocation and osteotomies of bony structures that are palpable under the skin. The guide 100 is designed for detection of the point of insertion and trajectory of metal-ware including wires, screws, plates or nails (as by interfacing between patient-specific tips 120 with bone portions; [0023], [0017], etc.), comprising a flying arc 102 with pointed introducers 104 at its ends (104 are considered pointed in their overall structure; 104 can also include pointed ends for anchoring as at [0021]), detachable accessory rods 200 at medial and lateral sides with pointed introducers (there being no reason that 200 cannot be considered a detachable accessory rod which is insertable at both lateral and medial sides with a pointed introducer tip; no reason that there cannot be more than a single drill bit in a kit; use of drills, fasteners, etc. discussed [0023]), and trajectory sleeves 110.
Regarding claim 2, the guide being configured to be seated on a bony landmark wherein an internal surface 122 of the pointed introducers 104 matches the surface anatomy of bones and fit in a single secure position (see e.g. fig. 2; see [0020]) for the capability of use in reduction of bone or joint displacement and to permit insertion of wires or metal ware in bone and joints without need for fluoroscopic imaging [0023], [0017].
Regarding claim 3, the shape of the flying arc 102, detachable accessory rods 200 and trajectory sleeves 110 is capable of being modified according to the percutaneous procedures on bone and joints in undisplaced and displaced fractures of clavicle, proximal humerus, distal humerus, proximal radius and ulna, distal radius and ulna, hand bones, clavicle, patella, distal fibula, medial malleolus, spine and feet bones. (e.g. pre-operative planning [0019]-[0020]; based on patient images [0016]; capable on use with any joints including knee, hip shoulder, etc. [0025]; etc. )
Regarding claims 4 and 5, the guide is designed based on the 2D images captured from one of an X-ray, CT-scan and Ultrasound. [0002], [0016]
Regarding claim 6, Schoenefeld teaches the limitations of claim 1. Further, Schoenefeld’s guide is designed based on collecting the data of the surface shape of the bony and soft tissue landmarks. [0017], [0025] etc.
Even further, examiner is of the position that this claim is a Product-by-process claim. All the claimed structures are formed by Schoenefeld’s methods, whether they are the same methods claimed or not. It is proper to reject this claim under both 35 USC 102 and 103. It is now applicant’s burden to demonstrate that Schoenefeld’s device is structurally different from what is claimed as a result of the different method of production. MPEP 2113.
Regarding claim 7, the guide 100 includes the pointed introducers at 120 of 104 on each end of the flying arc 102 (pointed as discussed, above) and at the ends of the two detachable accessory rods 200 (all structures 200 include a pointed tip) capable of being seated percutaneously or subcutaneously on bony landmark in any region of the body that has a surface anatomy including shoulder and scapula, elbow joint, carpal and hand joints, pelvic, distal femoral trochanteric region, distal femur, proximal tibia, or ankle joint [0025].
Regarding claim 8, an internal surface 122 of the pointed introducers 104 matches the bone landmarks anatomy at the area that will be seated on it [0020].
Regarding claim 9, the pointed introducers 104 have fastening holes 110 on its body to allow and secure the fixation of the patient-specific surgical guide 100 over the skin in the bony landmarks: as at [0023], the holes can receive screws or other fasteners. (some holes 110 can be used as fastening holes while simultaneously others can be used as trajectory sleeves as discussed at [0023]).
Regarding claim 11, the detachable accessory rods 200 are attached and de-attached to the flying arc 102 through assembly holes in its body (any of the holes 110 can be considered ‘an assembly hole’ at such time as 200 is seated therein and not being used to drill a hole).
Regarding claims 12 and 13, the lateral or medial detachable accessory rod 200 is capable of seating on a respective lateral medial bony landmark on various bones [0025].
Regarding claim 14, the trajectory sleeves 110 are cannulated to be capable of directing the wires through the internal hole in the trajectory sleeve to determine the required trajectory in the bone to fix the displaced fractures. [0017], [0023] etc.
Regarding claim 15, the guide 100 comprises the trajectory sleeves 110 that are located medially and/or laterally to be capable of use in fixing the fractures of various bones [0025].
Regarding claims 17 and 18, the guide 100 comprises a design that allows assembly of the detachable accessory rods 200 to the flying arc 102 medially or laterally according to the orientation and location of the displaced fracture to provide additional stability to the guide over the bone. There is no reason that the device cannot be configured for use in any of the claimed bones. [0025]
Regarding claim 19, the guide 100 comprises pointed introducers 104 which are capable of locating positions of inferred pre-operatively inserted fiducial markers on the bone. (In a situation where the introducers are aimed at the fiducial markers)
Regarding claim 20, the trajectory sleeves 110 are capable of directing percutaneous pins toward hidden landmarks. [0017], [0023], etc.
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) 6 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schoenefeld. The rejection of claim 6 is an alternate rejection.
Regarding claim 6, Schoenefeld teaches the limitations of claim 1. Further, Schoenefeld’s guide is designed based on collecting the data of the surface shape of the bony and soft tissue landmarks.
However, Schoenefeld’s data is not collected using a portable 3D scanner with a mechanical touch probe.
It is examiner’s position that Schoenefeld’s teachings would be capable of designing the guide with other data provided to the system, as by use of a mechanical touch probe. Examiner further takes official notice of use of pointer probes to designate locations in space in navigation systems. One would have done so in a case where a CT or MRI machine was not available.
Even further, examiner is of the position that this claim is a Product-by-process claim. All the claimed structures are formed by Schoenefeld’s methods, whether they are the same methods claimed or not. It is proper to reject this claim under both 35 USC 102 and 103. It is now applicant’s burden to demonstrate that Schoenefeld’s device is structurally different from what is claimed as a result of the different method of production. MPEP 2113.
Regarding claim 16, Schoenefeld teaches the limitations of claim 1, as above. However, the material of the device is not taught.
It would have been obvious to one with ordinary skill in the art at the time of the invention to form the guide 100 of PEEK or other plastic material (commonly used materials in surgical jigs), which is known to be radiolucent and rigid to allow manipulation without bending. 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.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schoenefeld in view of Singh et al. (US 10,849,665 B2).
Regarding claim 10, Schoenfeld teaches the flying arc 102 comprises two parts (ends) with a gap between the two parts.
The device does not include the claimed reduction indicator positioned in the gap and when the two parts meet together it means the displaced fracture being treated is reduced.
Singh teaches a device as at fig. 34 which is patient-specific and works to snap onto a bone. The device includes two parts 270’ and 280’ with a gap 250a/b/c /d therebetween including a reduction indicator positioned in the gap (e.g. nadir portions 251a-d). When the two parts 270’ and 280’ meet together (about the bone 200’’) it means that if the device were used on a displaced fracture, then the displaced fracture is being reduced.
Examiner notes as presently claimed, no structure is given to the reduction indicator, and the claimed reduction indicator is not required to be the structure displaying the bone reduction.
It would have been obvious to one with ordinary skill in the art at the time of the invention to include gaps in the Schoenefeld device as suggested by Singh between the two ends. One would have done so in order to permit Schoenefeld to be a snap-on arrangement which is not necessitating use of guide pins or other fixation equipment (Singh, col. 18, lines 25-32).
Conclusion
THIS ACTION IS MADE FINAL. 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 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
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