DETAILED ACTION
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, 2, 7, and 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2018/0256336 (Mueller) in view of U.S. Patent Application Publication No. 2018/0303604 (Melsheimer).
Regarding claim 1, Mueller discloses a monolithic cervical or lumbar implant body (10) for fusing spinal column segments, comprising an upper side (16/18/36) and a lower side (17/19/37) which are spaced apart from one another while maintaining an intermediate space (30), wherein the upper side and the lower side are connected by webs (intersections of sides 13/14/24/26), furthermore the upper side and the lower side, with the exception of space-defining and structure-reinforcing edge regions (16/18/17/19), are designed as a surface (15) having openings and enclosing an angle (see angle between surfaces 36 and 37 in Fig. 7), at least one completely or partially open side surface (24 partially open via slot 25) for introducing bone substitute material (material may be introduced via open slot 25, e.g.), and a further side surface (14) having a stabilization region (28) and a recess (20) for temporarily receiving a surgical instrument in the stabilization region (see paragraph [0050]), characterized in that the recess is formed as a continuous or interrupted thread (see paragraph [0050]).
Mueller fails to explicitly disclose the thread being a round thread. However, Melsheimer discloses that a threaded connection between parts of an implant can include many possible threads, including the use of knuckle threads (i.e., round threads) (see paragraph [0064]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the recess of Mueller to have a round thread as such as modification merely involves a simple substitution of one type of known threaded connection from a known medical implant for another type of known threaded connection from a known medical implant with the predictable result of establishing a threaded connection between two parts of an implant.
Regarding claims 2 and 13, Mueller discloses the surface is designed as a honeycomb surface (see paragraph [0049]; honeycomb), and the honeycomb wall thickness as a fraction of the honeycomb size, defined as the distance between opposite honeycomb walls (see Fig. 18, e.g.; wall thickness shown as fraction of honeycomb size). Additionally, it would have been obvious to provide a honeycomb surface with honeycombs in the recited range of claim 13 as it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Additionally, there is no evidence in the record that the recited range has criticality.
Regarding claim 7, Mueller discloses the stabilization region having the recess and the round thread is essentially located centrally in the further side surface (see paragraph [0050] and Fig. 1; recess 20 is a “central threaded bore” and the region surrounding recess 20 is also central to surface 14).
Regarding claim 10, Mueller discloses at least one side surface (13) is designed to be closed (see Fig. 2, closed nose 29 defines surface 13) and forms a product labelling surface (surface 13 may be labeled as desired by the user).
Regarding claim 11 Mueller discloses the closed side surface is opposite the stabilization region having the recess and the round thread (see Figs. 1 and 2 showing opposite sides of the implant; side surface 13 is opposite stabilization region 28).
Regarding claim 12, Mueller discloses the monolithic cervical or lumbar implant body is additively manufactured including the round thread without any machining methods by selective laser melting (see Abstract and paragraph [0009]; discloses that implant is manufactured using 3-d printing without a discussion of selective laser melting).
Claims 3 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Mueller in view of Melsheimer, and further in view of U.S. Patent Application Publication No. 2011/0125266 (Rodgers).
Regarding claims 3 and 9, Mueller fails to disclose, starting from the surfaces of the shape-defining and structure-reinforcing edge regions several pin-shaped or mandrel-shaped protrusions extend in the direction of adjacent spinal column segments (claim 3); the protrusions each are located in the corner regions of the implant body (claim 9). However, Rodgers discloses an intervertebral implant (10), wherein corners of the implant include pin-shaped protrusions (40) configured to extend toward adjacent spinal column segments (see Fig. 3 and paragraph [0038]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the implant body of Mueller to include protrusions in the corner regions as suggested by Rodgers in order to increase the friction between the implant body and adjacent vertebrae to prevent migration of the implant out of its surgically placed position (see Rodgers, paragraph [0038]).
Claims 4, 5, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Mueller in view of Melsheimer, and further in view of U.S. Patent Application Publication No. 2005/0240267 (Randall).
Regarding claims 4, 5, and 14, Mueller fails to disclose the upper side has a spherical, convex surface shape, and the lower side is designed as a beveled surface (claim 4); the beveled surface angle is in the range from 1 to 15 degrees (claim 5), and between 4 and 12 degrees (claim 14). However, Randall discloses an intervertebral implant (10) wherein an upper side (14) of the implant has a spherical, convex surface shape (see Fig. 3 and paragraph [0073]), and a lower side (16) of the implant is designed as a beveled surface (see Fig. 3 and paragraph [0073]), wherein the beveled surface angle is in a range from 1 to 15 degrees, and between 4 and 12 degrees (see paragraph [0073]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the shape of the implant body of Mueller as suggested by Randall in order to provide a good fit within the natural contours of normal surfaces of adjacent vertebrae, while also restoring desired natural lordosis between adjacent vertebrae (see Randall, paragraph [0073]). Additionally, in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Mueller in view of Melsheimer, and further in view of U.S. Patent Application Publication No. 2019/0350673 (Kieser).
Regarding claim 6, Mueller fails to disclose the surface dimension of the upper side is smaller than the surface dimension of the lower side. However, Kieser discloses an intervertebral implant (100), wherein an upper surface (118) of the implant is smaller in surface area than a lower surface (120) of the implant (see Fig. 3). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the implant of Mueller to have an upper surface be chamfered so as to be smaller in surface area than a lower surface as such a modification still facilitates insertion of the implant (see Kieser, paragraph [0027]). Additionally, Applicant does not state that the relative dimensions of the upper and lower sides has any criticality, thus, it would be an obvious matter of design choice to change the relative dimensions of the upper and lower sides, as the modified implant would not perform differently. See Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Mueller in view of Melsheimer and Rodgers, and further in view of U.S. Patent Application Publication No. 2006/0217806 (Peterman).
Regarding claim 8, Mueller fails to disclose in at least one of the webs connecting the upper side and the lower side, a recess or a setback is formed for guiding an instrument. However, Peterman discloses an intervertebral implant (1) wherein edges of the lateral surfaces (11/10) connecting upper and lower surfaces (3/5) of the implant include recesses (16/18) formed for guiding an instrument (see Figs. 2 and 3 and paragraph [0062]) It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the implant body of Mueller to have recesses formed for guiding an instrument as suggested by Peterman in order to provide additional securing engagement between the instrument for inserting the implant into a desired surgical position and the intervertebral implant (see Peterman, paragraph [0062]).
Response to Arguments
Applicant's arguments filed August 12, 2025 have been fully considered but they are not persuasive.
Applicant argues on pages 7-8 of the Remarks that Melsheimer does not disclose an implant or a threaded connection between parts of an implant. The examiner disagrees. Melsheimer discloses a system for implanting in tissue (see Abstract and paragraphs [0053] and [0079]). The system includes an implant part (locking screw 12) that has an internal thread (36) that mates with the external thread (92) another implant part (manipulator 14) (see paragraph [0059]). Thus, Melsheimer does discloses implant parts and a threaded connection between implant parts.
Applicant argues on page 8 of the Remarks that a tissue fixation device is dissimilar to a cervical or lumbar implant body, and the forces/stresses/strains acting on the implants are different. However, Applicant provides no evidence that the forces/stresses/strains that act on the different implants in Melsheimer and Mueller would affect the proposed modification, which involves the substitution of one type of internal threads for another. Applicant provides no evidence that the use of knuckle threads (i.e., round threads) in the implant of Mueller would render the implant inoperative for its intended use, or change the principle of operation of the implant of Mueller.
Applicant argues on page 8 of the Remarks that Melsheimer does not disclose an implant as recited in claim 1. However, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Melsheimer is not relied on for disclosing a cervical or lumbar implant; Mueller is relied on for disclosing this feature.
Applicant argues on pages 8-9 of the Remarks that the Examiner has not sufficiently explained why one having ordinary skill in the art would make the suggested modification of Mueller in view of Melsheimer. Specifically, Applicant notes the examiner did not explain why knuckle threads would be better suited or advantageous to existing threads in the implant of Mueller (the examiner acknowledges that, as noted by Applicant in footnote 1 on page 9 of the Remarks, paragraph [0064] of Melsheimer is intended to be relied on for disclosing the use of knuckle threads, and appreciates Applicants consideration given to this paragraph). The examiner is relying on a “simple substitution of one known element for another to obtain predictable results” obviousness rationale (see MPEP 2143(I)(B)). In such a rationale, the substitution of one known type of threading for another does not need to result in an advantage or improvement; rather, the substitution predictably results in an internal threading allowing for mating engagement of the implant by a tool.
Applicant argues on pages 9-11 of the Remarks that Melsheimer is non-analogous art, as the tissue fixation system of Mueller is not in the same field of endeavor of cervical or lumbar implants, nor is Melsheimer reasonably pertinent to a particular problem to be solved by Applicant’s invention. It has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Applicant is too narrowly construing the field of endeavor to a specific type of medical implant, rather than medical implants generally. See Stevenson v. Int'l Trade Comm., 612 F.2d 546, 550, 204 USPQ 276, 280 (CCPA 1979) (“In a simple mechanical invention a broad spectrum of prior art must be explored and it is reasonable to permit inquiry into other areas where one of ordinary skill in the art would be aware that similar problems exist.”). See also In re Bigio, 381 F.3d 1320, 1325-26, 72 USPQ2d 1209, 1211-12 (Fed. Cir. 2004). As suggested by Melsheimer in paragraph [0064], a large variety of thread types are known in medical implant prior art for securing parts of an implant together, and it is obvious to substitute one type of thread for another, absent evidence from Applicant that the use of knuckle threads/round threads specifically produces an unexpected result.
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 NICHOLAS J PLIONIS whose telephone number is (571)270-3027. The examiner can normally be reached on Monday - Friday, 10:00 a.m. - 6:00 p.m. EST.
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/NICHOLAS J PLIONIS/Primary Examiner, Art Unit 3773