DETAILED ACTION
This office action is responsive to the amendment filed October 23, 2025. By that amendment, claims 1, 10, and 17 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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 October 23, 2025, has been entered.
Response to Arguments
The outstanding objection to the drawings is maintained. Examiner understands that applicant is relying upon specification paragraph [0044] and step 6 of the flow-chart of figure 12 to provide support for the drawings. Examiner disagrees that these teachings provide for sufficient support.
Claim 1 positively recites a first configuration and a second configuration, a first where a portion of the arms is connected, and a second where the arms are deformed such that they move in an outward direction. These configurations are required by the claims. These configurations are not demonstrated by the figures.
Examiner will now present a new rejection of the claims under 35 USC 112(a) based on his failure to understand how the functions now being claimed are capable of occurring. Regarding at least claims 1 and 12, Examiner is of the position that neither the drawings nor the disclosure make clear how the expansion of the arms from the first configuration to the second configuration occurs – or how breaking a bridge between the arms causes expansion. See the rejection, below.
Applicant’s arguments with respect to claim(s) 1-20 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 rejections are necessitated by the amendments to the claims of October 23, 2025. The outstanding rejections are overcome, as agreed in the October 20, 2025, interview.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore:
the first and second configurations of claim 1 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are further objected to for failure to demonstrate the claimed “opposed recesses” of claim 10. Examiner suggests that these correlate to the shaft recesses 126a/b, and suggests amendment to use terms in the claims which find support in the specification.
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 1-9 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.
Claim 1 now requires that the opposing arms have a first configuration when subject to less than a predetermined torque and a second configuration when subject to the predetermined torque; and further describes the configurations. The specification has been carefully studied as to how these two configurations can be achieved. The most relevant description appears to be at [0008]: “…the predetermined torque… causes the internal bridge to break separating the two arms”; [0021]: “the breaking of the internal bridge of the shaft causes the distal portion of the shaft to spread outward”; [0056] “If the central core 128 breaks, a split is formed toward the distal portion of the fastener, thereby fully separating opposing arms 127a, 127b. As the drilling continues with the altered structure of the fastener 100, the split arms 127a, 127b may transform by moving laterally in an outward direction from a central longitudinal axis of the shaft 120 or in other directions relative to the central longitudinal axis. As the split arms bend and spread, the fastener 100 may push into the receiving material, which may be a soft tissue such as cancellous bone when the implantation is into a maxilla. The pushing action creates a press fit within the receiving material. The dual-configuration characteristic of the fastener, in other words, a fastener with a pre- and post- central core breakage configuration, provides stronger structural fixation and reinforcement to the bone than fasteners without such transformative characteristics.”
Examiner finds that this teaching is clear as to what happens, but does not clarify how the arms are to become spread. It is examiner’s position that the material into which the screw is threaded will press against the arms of the fastener to retain the arms in the first configuration, without some external force being applied, thereto (such as a mandrel passing through the screw to spread the arms apart). Threading of a screw and providing torque thereto functions to apply inward-forces upon the screw, not external forces which would cause the arms of the screw to spread apart.
What applies this spreading force? Is it an elastic nature of the arms (are they spring loaded to separate)? Is there some mechanism which functions to drive the arms apart (such as a mandrel)? Is it a feature of the threadform causing the arms to separate? Examiner is unclear from the disclosure that the claimed separation will occur, or that applicant has disclosed the mechanism of expansion sufficiently clearly that one with ordinary skill in the art at the time of the invention would know how to build the claimed invention, or be clear of what features do or do not fall within the metes and bounds of what is claimed.
Examiner can find no disclosure related to how the arms become deformed from the first configuration to the second. Simply breaking a bridge between the two arms does not cause them to separate from one another without some additional external force applied thereto.
Clarification of how this functionality occurs, without entry of new matter, is required. Examiner is happy to withdraw this rejection upon sufficient showing and/or description of the mechanism which causes the arms to transform between the two configurations.
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.
Claim 15 recites “a size of the recess being smaller at the first end than the second end”. As claimed, it is unclear what aspect of the recess is being measured to ascertain ‘size’ of the recess. Clarification is required.
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 9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Leclair (US 2004/0254581 A1).
Regarding claim 1, Leclair teaches a fastener as at figs. 1-5, comprising:
a head 32; and
a shaft above head 32 in fig. 1 extending from the head 32, the shaft including a threaded surface 20 and the shaft including opposing arms 22/24/26 that extend to a distal tip (at a top of fig. 1) of the shaft with a first configuration (fig. 3) when the shaft is subject to less than a predetermined torque and a second configuration (fig. 4) when the shaft is subject to the predetermined torque (further shown at fig. 5; 34 equating to fig. 3, before full insertion into the bone, and 36 equating to fig. 4, after a further insertion into the bone (additional torque applied) [0023]), the second configuration being different from the first configuration,
wherein in the first configuration of fig. 3, the opposing arms are at least partially connected along a length of the respective opposing arms 22/24/26 (the gaps 28 are closed), and
wherein in the second configuration of fig. 4, the shaft is deformed such that the opposing arms 22/24/26 that define a portion of the distal tip are moved in an outward direction from a central longitudinal axis of the shaft (to increase openings at gaps 28).
Regarding claim 2, in the first configuration of fig. 3, an outer surface of the distal tip has a first shape and in the second configuration of fig. 4, the outer surface of the distal tip has a second shape different from the first shape.
Regarding claim 3, the first shape of fig. 3 has a first maximum cross-sectional dimension and the second shape of fig. 4 has a second maximum cross-sectional dimension larger than the first maximum cross-sectional dimension.
Regarding claim 4, when the distal tip has the first shape of fig. 3, a root surface of the shaft between crests of the thread and measured along a length of the shaft is parallel to a central longitudinal axis of the shaft and when the distal tip has the second shape of fig. 4, the root surface measured along the length of the shaft is non-parallel to the central longitudinal axis (due to the arms being spread apart as at fig. 4).
Regarding claim 5, when the distal tip is in the first configuration of fig. 3, the distal tip is static with respect to a proximal portion of the shaft and when the distal tip is in the second configuration of fig. 4, at least a first part of the distal tip is moveable with respect to one or both of a second part of the distal tip and the proximal portion of the shaft (the arms 22/24/26 have flexed to a plastically deformed state, and are capable of being deformed by application of force thereon).
Regarding claim 6, when the distal tip is in the first configuration of fig. 3, a distal tip of the distal tip is a first distance from the head, and when the distal tip is in the second configuration of fig. 4, the distal tip of the distal tip is a second distance from the head, the first distance being greater than the second distance (due to bending of the screw out of perfect alignment).
Regarding claim 9, Leclair teaches a system comprising the fastener of claim 1 and a plate configured to receive the fastener such that a head of the fastener is flush with the plate surface when received in the plate. [0028]
Claim(s) 10, 12, and 13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zander et al. (US 2020/0289179 A1).
Regarding claim 10, Zander teaches a fastener as at fig. 2b comprising:
a head 120;
a shaft 110 extending from the head 120, the shaft having a convex surface (exterior thereof);
a thread 151 disposed on the convex surface; and
opposing recesses 153 in the convex surface of the shaft 110, the opposing recesses 153 being separated from the head 120 by a portion 160 of the shaft 110,
wherein over at least part of a length of the opposing recesses 153 (in region 150), the opposing recesses are separated by an integral core extending along a central axis of the shaft 110 (the portion of the shaft in which no threads or recesses have been formed, e.g. the middle portion of the shaft), the core being monolithic with at least a portion of the shaft 120, and wherein the length of the opposing recesses 153 (having extent 152 as at fig. 3B) is parallel to the central axis of the shaft (helically extending along the central axis of the shaft 110).
Regarding claim 12, the core of 110 separating the opposing recesses 153 is an internal bridge of material breakable upon exertion of a predetermined torque on the shaft. (It is considered inherent that a central portion of a shaft of a screw may break upon application of a certain torque, that torque predetermined by material properties and configuration of the screw).
Regarding claim 13, the thread 151 is a first thread and the fastener further comprises a second thread 152, the first and second threads starting at different locations at a base 160 of the shaft 110 abutting the head 120.
Each of the individual cuts between rhombic protrusions 154 is now being considered a recess 153. The entirety of the form 153, taken together, is considered a second thread. Figs. 3A-3D demonstrate formation steps of the two threads on the screw to clearly demonstrate the presence of both two threads and individual recesses formed across thread 151.
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) 7 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Leclair.
Regarding claim 7, Leclair teaches the limitations of claim 1, as above, and further teaches and the threaded surface of the shaft includes a first thread and a second thread (choosing different regions of the thread 20).
Leclair fails to teach the fastener being comprised of polymeric material. Leclair does, though, teach the fastener can be formed of a “material having sufficient elasticity to be plastically deformed during manufacture”; “the material can be chosen to match the screw material to the material of an existing plate or other implant…” [0026]
Use of polymers in forming bone screws is well known in the bone screw art. It would have been obvious to one having ordinary skill in the art at the time the invention was made to form the Leclair screw of polymer, since 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 done so in order to form the screw of a material which is well known to be biocompatible, and to have desirable resiliency as a material property, thereof.
Regarding claim 8, the first and second threads of 20 include interruptions 28 at intervals along a length of the shaft.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zander in view of Leclair.
Regarding claim 11, Zander teaches the limitations of claim 10, as above, and further teaches at least part of the length of the opposing recesses (in region 150) is coincident with a central portion of the shaft 110 separating a base portion 160 of the shaft 110 adjacent to the head 120 and a free-end portion of the shaft (distal to 150).
Zander fails to teach the shaft 110 having a pair of separated arms in the free- end portion, the pair of separated arms being deformable upon exertion of a predetermined torque on the shaft.
Leclair teaches a shaft including a distal portion with a pair (two of 22/24/26) separated arms in the free end portion of the screw (top, fig. 1). The pair of separated arms are deformable upon exertion of a predetermined torque upon the shaft (from position of fig. 3 to position of fig. 4, as demonstrated in fig. 5).
It would have been obvious to one with ordinary skill in the art at the time of the invention to form the Zander screw with a tip portion modified as taught in Leclair to include deformable arms thereon. One would have done so to permit the screw to better engage the bone or prosthetic to resist pull-out and compensate for stripped threads or soft bone (Leclair, abstract).
Regarding claim 14, Zander teaches the limitations of claim 10, as above, and further teaches the core of the shaft 151 is a central core of material that separates the opposing recesses 153 along a portion of the length of the recesses 150.
Zander fails to teach the length 150 being less than the length of the respective recesses.
Leclair teaches a design including a central core in a region of the shaft proximal to arms which deform. The length of the deformable region is “at least half of the shaft” [0007]. The region including the deformable arms includes no central core.
In modifying the Zander device as suggested in rejecting claim 11, above, at least half of the shaft would no longer include a central core. As seen in fig. 2B of Zander, this would result in the deformable arms extending from the distal tip and into at least the region 150. Therefore, the proposed modification results in the length of the central core now being less than the length of 150. One would have made the modification so to permit the screw to better engage the bone or prosthetic to resist pull-out and compensate for stripped threads or soft bone (Leclair, abstract).
Claim(s) 15 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zander in view of Sinnott et al. (US 12,226,129 B2).
Regarding claim 15, Zander teaches the limitations of claim 10, as above. However, Zander does not teach the opposing recesses has a first end in between the head and a distal tip of the fastener and a second end at the distal tip, a size of the recess being smaller at the first end than at the second end, each of the opposing recesses 153 has a first end in between the head and a distal tip of the fastener and a second end at the distal tip, a size of the recess being smaller at the first end than the second end.
Sinnott teaches a fastener including opposing recesses 107. For purposes of making this rejection, these structures will now be referred to as the recesses as opposed to the structures of Zander. Those recesses have a first end between the head and a distal tip and a second end at the distal tip. The first end is smaller than the second end (due to the rounded sidewall at the first end).
It would have been obvious to one with ordinary skill in the art at the time of the invention to include recesses as taught by Sinnott on the Zander screw. One would have done so in order to permit the Zander screw to be a self-tapping screw.
Regarding claim 16, each of the opposing recesses is considered to flare outward from the first end toward the second end due to the configuration of the opening at the second end.
Allowable Subject Matter
Claims 17-20 are allowed.
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
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Kevin Truong, at (571)272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DAVID W BATES/Primary Examiner, Art Unit 3799