DETAILED ACTION
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
Newly submitted claims 28-30 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: Newly added independent system Claim 28 recites a combination including a prosthetic device, but this claim does not require the particulars of the prosthetic device of Claim 1, specifically “wherein the distal end of the peg does not include the osteogenic coating such that osteointegration is mitigated on the distal end of the peg”. Furthermore, the subcombination (of Claim 1) has separate utility such as being used for anchoring dry wall sheets together.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 28-30 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim Objections
Claim 6 is objected to because of the following informalities: In Line 1, the word “extends” should be replaced with the words --is configured to extend--. In Line 2, the words “a distal end” should be replaced with the words --the distal end-- and the words “configured to be” should be deleted. Appropriate correction 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, 9, 11, & 18-27 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hodorek et al. (US PG Pub No. 2022/0241077).
Regarding Claim 1, Hodorek et al. discloses a prosthetic device (Figs. 2-7, 11, 13, 15, 18, Paragraphs [0046-0059, 0070]) comprising: an implant body (base plate 102, Figs. 4-5) having a bone-contacting surface (bottom surface 112 including any one of the porous protrusions 122, Fig. 5, Paragraph [0053]) and a peripheral bore (any one of the peripheral holes 118, Fig. 5, Paragraph [0050]); a central screw (104, Figs. 2-3 & 6, Paragraph [0047]) extending from the bone-contacting surface of the implant body (Fig. 1); and a peg (augmentation device 200, Figs. 11 & 2-3) coupled to the peripheral bore of the implant body (via 202, Fig. 2, Paragraphs [0064 & 0070]) such that the peg is configured to extend a first length beyond the bone-contacting surface of the implant body (length measured to end of tip of 226 from adjacent 122, Fig. 2) and capable of extending into a hole (344, Fig. 15, Paragraph [0067]) formed in a bone (Figs. 13 & 18, Paragraph [0070]), the hole having a first diameter and a depth (Fig. 15) that is greater than the first length such that a distal end of the peg (tip end at 226) and a bottom of the hole define a gap in which the distal end of the peg does not contact the bottom of the hole (See examiner annotated Fig. 11 below)(Fig. 18, “The footing portion 226 has a conical shape and again presses against the surface of the bone within the defect 14. The conical bottom footing portion 226 may abut against the bone within the defect 14 over an even smaller percentage of its surface area than that of the flat bottom footing portion 204. As such, there may be less reaming and bone removal required, relative to the flat bottom footing portion 204, to prepare the surface of the bone within the defect 14.” Paragraph [0070]. Thus, a gap would exist between the distal-most tip surface placed at the bottom of the defect and the remaining conical distal end of 226, which is not configured to contact the bottom of the hole.)(It is even further noted that the peg of the device is fully and structurally capable of extending into a hole as recited in the functional language above, such as wherein the peg could be inserted into a hole which has a depth a couple millimeters or more spaced from the distal-most tip of the peg, such that the gap between the bottom of the hole and 226 extends fully around the conical footing portion 226 to include the distal-most tip.), wherein sides of the peg (206, Fig. 11) include an osteogenic coating (“The post 206 may include a porous surface to provide sites for bone ingrowth when inserted into a prepared glenoid cavity. The porous surface may be comprised of, for example, a porous metal structure, or a porous coating.”, Paragraph [0062]) such that the peg, inclusive of the osteogenic coating, has a second diameter (outermost diameter measured at 206 including coating, Fig. 11) capable of being greater than the first diameter of the hole (based on the size of the hole drilled, or if a hole is not drilled and 200 is press-fit inserted into a defect, Paragraph [0082, 0085]), and wherein the distal end of the peg (226) does not include the osteogenic coating (post 206 is porous/has a porous coating whereas 226 does not) such that osteointegration is mitigated on the distal end of the peg; and wherein a body of the peg (226, Fig. 11) has a third diameter (diameter measured at a midpoint of portion 226, See examiner annotated Fig. 11 below) that is less than the first diameter of the hole such that the osteogenic coating, and not the body of the peg is configured to interfere with the hole in the bone to aid in osseointegration (Paragraph [0070]).
PNG
media_image1.png
478
467
media_image1.png
Greyscale
Regarding Claim 6, Hodorek et al. discloses wherein the peg is capable of extending into the bone such that the distal end of the peg is in a cancellous portion of the bone (each peg is fully and structurally capable of being located in a cancellous portion of a bone when the baseplate is installed based upon the size of the defect and bone condition and anatomy at the implantation site. Paragraph [0070]).
Regarding Claim 9, Hodorek et al. discloses wherein the gap is at least one millimeter (the gap between the tip placed at the bottom of the defect and the conical surface of 226 is capable of being at least one millimeter based on the placement of the implant, the size of the defect and bone condition and anatomy at the implantation site. Paragraph [0070]).
Regarding Claim 11, Hodorek et al. discloses wherein the peripheral bore includes a threaded portion (any of the peripheral holes 118 include female threads for engaging with corresponding threads on 202, Paragraph [0063]).
Regarding Claim 18, Hodorek et al. discloses a neck adapter (coupling member 106, Figs. 2-3, 7, Paragraphs [0046-0047]) configured to be coupled to the implant body such that the neck adapter protrudes from a surface of the implant body (upper surface of 102, Fig. 2) that opposes the bone-contacting surface of the implant body.
Regarding Claim 19, Hodorek et al. discloses wherein the implant body further includes a central bore (114, Fig. 4, Paragraph [0047]).
Regarding Claim 20, Hodorek et al. discloses wherein the neck adapter is configured to be at least partially insertable into the central bore of the implant body (Fig. 2, Paragraph [0058]).
Regarding Claim 21, Hodorek et al. discloses a boss (the other two of the porous protrusions 122, Fig. 5, Paragraph [0053]) extending from the bone-contacting surface of the implant body.
Regarding Claim 22, Hodorek et al. discloses wherein the boss and the implant body are monolithic (Fig. 5).
Regarding Claim 23, Hodorek et al. discloses wherein the implant body further includes a central bore (114, Fig. 4, Paragraph [0047]), and the central screw is configured to be at least partially insertable through the central bore and at least partially through the boss (Fig. 2).
Regarding Claim 24, Hodorek et al. discloses wherein the peg and the central screw are generally parallel to each other (Figs. 2-3).
Regarding Claim 25, Hodorek et al. discloses wherein the peg is generally perpendicular to the implant body (Figs. 2-3).
Regarding Claim 26, Hodorek et al. discloses wherein the peg is shorter length-wise than the central screw (Figs. 2-3).
Regarding Claim 27, Hodorek et al. discloses wherein the implant body is a baseplate for a shoulder implant (glenosphere or liner, Figs. 19-21, Paragraphs [0033, 0041, 0046]).
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) 2 & 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hodorek et al. (US PG Pub No. 2022/0241077) in view of Budge (US PG Pub No. 2015/0289984).
Regarding Claims 2 & 5, Hodorek et al. discloses the claimed invention as stated above in claim 1, except wherein the osteogenic coating of the peg comprises particulate metal, and wherein the bone-contacting surface of the baseplate implant body includes an osteogenic coating. Hodorek et al. does disclose that “The post 206 may include a porous surface to provide sites for bone ingrowth when inserted into a prepared glenoid cavity. The porous surface may be comprised of, for example, a porous metal structure, or a porous coating.” in Paragraph [0062] And ““The protrusions 122 may be comprised of a porous metal structure to provide sites for bone in growth when inserted into a prepared glenoid cavity.” in Paragraph [0053]).
Budge discloses a shoulder arthroplasty prosthesis with a biocompatible metal glenoid component and a biocompatible metal humeral component (Abstract), wherein a baseplate of the glenoid component (Figs. 3A-5) "may be made of cobalt chrome, titanium, ceramic or other suitable biocompatible metal" and wherein a bone-contacting surface thereof "may be coated in a porous ingrowth surface such as sintered metal beads, hydroxyapatite, plasma-spray, or porous tantalum to allow ingrowth of the host bone directly into the back of the body of the component or may be made directly out of an ingrowth surface such as porous tantalum or ceramic. In these Figures, a broken line seen on the side of the glenoid face (e.g., FIGS. 4, 425 and 435) indicates a boundary line between the ingrowth-coated backside and the non-coated, polished articular face. Placing porous coating on the entire back of the body of the component is important in that when fully grown-in it prevents additional shear force across any pegs on the back of the component. There may be several smaller additional pegs (e.g., three additional pegs, as shown in the Figures, and identified in the back side orthogonal view, FIGS. 4, 410, at 412, 414 and 416) protruding from the bone side of the body of the component. These may be about 3-5 mm long by about 1-3 mm in diameter. There may be one on the superior aspect of the body (412) which is directly midline, and two which may be on the inferior aspect (414, 416) and which may be offset about 2-4 mm from the vertical midline of the component. The smaller pegs may be coated in a porous ingrowth surface or may be smooth with small (less than 0.5 mm) grooves cut in them." (Paragraph [0041]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the porous coating of each peg and each porous bone-contacting arcuate protrusion of Hodorek et al. to comprise a particulate metal coating material such as sintered metal beads or plasma spray as taught by Budge as a common and well-known porous surface used for facilitating increased ingrowth of the host bone directly along each peg after implantation.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hodorek et al. (US PG Pub No. 2022/0241077) in view of Eickmann et al. (US PG Pub No. 2013/0218284).
Regarding Claim 7, Hodorek et al. discloses the claimed invention as stated above in claim 1, and further discloses a peripheral screw (154, Figs. 19-20, Paragraph [0046, 0052]) configured to be coupled to a second peripheral bore of the implant body (another one of the peripheral holes 118, Fig. 5, Paragraphs [0050, 0052, 0080, 0087]) such that the peripheral screw extends a second length beyond the bone-contacting surface (Figs. 19-20). Hodorek et al. does not disclose the second length being greater than the first length. It appears from Fig. 19 that 154 is longer lengthwise than the peg 200 but it is not positively disclosed.
Eickmann et al. discloses various embodiments of baseplate assembly for a joint prosthesis, wherein in Fig. 3, a baseplate is shown and includes a combination of pegs and screws inserted therethrough, wherein each screw has an overall total length which is longer than an overall total length of each peg (Fig. 3), and in Figs. 15-16, a combination of pegs (130) and a threaded screw (205) inserted through the peripheral bores of the baseplate are shown (Paragraph [0077]), and Paragraph [0077] states that "looking now at FIGS. 15 and 16, one or more pegs 160 may be replaced by a bone screw 205. More particularly, in this form of the invention, bone screw 205 preferably comprises distal threads 210 for passing through threaded bore 190 of baseplate 115 and engaging the resected tibia below the baseplate, and proximal threads 215 for engaging threaded bore 190 of baseplate 115, whereby to create downward compression between the baseplate and the bone”.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the overall length of each peripheral screw of Hodorek et al. be longer than the overall length of each peg as taught by Eickmann et al. in order to allow the screws to better anchor the device into the bone by creating a downward compression with the peripheral screws between the baseplate and the bone.
Response to Arguments
In regards to Applicant’s arguments, filed on 08/21/26, with respect to the Hodorek et al. rejection of claims 1, 6, 9, 11 & 18-27 and the Applicant’s contention that Hodorek does not disclose “a specific structural dimensional relationship among three distinct diameters: 1) the third diameter of the body of the peg; 2) the first diameter of the hole; and 3) the second diameter of the peg inclusive of the osteogenic coating. The claim requires that the body of the peg has a third diameter that is less than the first diameter of the hole, while the peg inclusive of the osteogenic coating has a second diameter that is greater than the first diameter of the hole, such that the osteogenic coating, and not the body of the peg, is configured to interfere with the hole in the bone. Thus Hodorek does not disclose this three-diameter structural relationship.”: As seen in the office action above and specifically in the examiner annotated Fig. 11, Hodorek discloses the prosthetic device as claimed, to include a peg (augmentation device 200, Figs. 11 & 2-3) coupled to the peripheral bore of the implant body (via 202, Fig. 2, Paragraphs [0064 & 0070]) and extending a first length beyond the bone-contacting surface of the implant body (length measured to end of tip of 226 from adjacent 122, Fig. 2), the peg capable of extending into a hole (344, Fig. 15, Paragraph [0067]) formed in a bone (Figs. 13 & 18, Paragraph [0070]), the hole having a first diameter and a depth (Fig. 15) that is greater than the first length such that a distal end of the peg (tip end at 226) and a bottom of the hole define a gap in which the distal end of the peg does not contact the bottom of the hole (See examiner annotated Fig. 11 above)(It is noted that the hole and its dimensions recited are fully functional and not positively recited), wherein a body of the peg (226, Fig. 11) has a third diameter (diameter measured at a midpoint of portion 226, See examiner annotated Fig. 11 above) that is less than the first diameter of the hole such that the osteogenic coating, and not the body of the peg is configured to interfere with the hole in the bone to aid in osseointegration (Paragraph [0070])(The portion of the peg body where the third diameter is measured is fully and structurally capable of being less than the first diameter of the hole so as to not interfere with the hole to aid in osseointegration). Hodorek discloses in Paragraph [0070] that “The footing portion 226 has a conical shape and again presses against the surface of the bone within the defect 14. The conical bottom footing portion 226 may abut against the bone within the defect 14 over an even smaller percentage of its surface area than that of the flat bottom footing portion 204. As such, there may be less reaming and bone removal required, relative to the flat bottom footing portion 204, to prepare the surface of the bone within the defect 14.” Thus, firstly, a gap would exist between the distal-most tip surface placed at the bottom of the defect and the remaining conical distal end of 226, which is not configured to contact the bottom of the hole, as seen in the examiner annotated figure 11. Secondly, it is noted that the hole formed in the bone and its recited dimensions are fully functional, as is the gap recited as being defined between the distal end of the peg at the bottom of the hole. Thus, in regards to the functional language of Claim 1 regarding the hole in the bone, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The peg is fully and structurally capable of being inserted into a different sized hole which has a depth a couple millimeters or more from the distal-most tip of the peg, such that the gap between the bottom of the hole and 226 extends fully around the conical footing portion 226 to include the distal-most tip. The size of the hole would depend on the patient’s anatomy and quality of bone, and the size of the gap which exists between the distal-most tip and the bottom of the hole would depend upon the type of tool used to create the hole and the flat bottom, or a hole with a different configuration all together. Paragraph [0085] of Hodorek even states that “the one or more augmentation devices 200 may be inserted depending on the type and severity of the defects encountered.” Thus, the Applicant’s argument has been fully considered but is not persuasive as Hodorek discloses the claimed invention as stated above.
In regards to Applicant’s arguments, filed on 08/21/26, with respect to the Applicant’s contention that the mapping of the body of the peg of Hodorek in the office action is inconsistent and does not correspond to the structural relationship recited in the claims: The structural limitations of Claim 1 require that the peg has a distal end, sides include an osteogenic coating such that the peg, inclusive of the osteogenic coating, has a second diameter, wherein the distal end of the peg does not include the osteogenic coating, and wherein a body of the peg has a third diameter. As seen in the examiners annotated Fig. 11 above, the peg 200 includes a distal end (tip end at 226), sides include an osteogenic coating (post 206 is porous circumferentially along the outer peripheral surfaces thereof) and the distal end not including the osteogenic coating (226 including the tip end is not porous), and a body (226) having a third diameter (measured at the midpoint thereof.) The body is defined by the conical portion non-porous portion 226 and the distal end is the tip end at 226. The Applicant further contends that the body of the peg should be the main shaft portion that bears the osteogenic coating – however, the claim does not require that the body have an osteogenic coating. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “the osteogenic coating is on the body) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Thus, Hodorek does disclose a peg with the structural features as claimed and the Applicant’s argument is not persuasive.
In regards to Applicant’s arguments, filed on 08/21/26, with respect to the Applicant’s contention that the hole-related limitations are structural limitations and not mere statements of intended use: 35 USC 101, Section 33(a) of the America Invents Act reads: Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism. Human organisms, which in this case specifically is the recited bone, are excluded from the scope of patentable subject matter. Thus any dimensions of the bone recited in the claims is treated as functional language only. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In regards to Applicant’s arguments, filed on 08/21/26, with respect to the Applicant’s contention that Hodorek’s design purpose differs fundamentally from the claimed invention: As stated above, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 JESSICA WEISS whose telephone number is (571) 270-5597. The examiner can normally be reached Monday through Friday, 8:00 am to 4:00 pm EST. If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, KEVIN T. 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.
/JESSICA WEISS/Primary Examiner, Art Unit 3775
Prosecution Insights