DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . This action is responsive to the amendments received after a Non-Final Rejection on 06 March 2026. Claims 1, 3-4, 8-15, 17-21, 23-25 and 29-31 are currently pending. Of these, claims 24 and 25 have been withdrawn from further consideration as being drawn to a non-elected invention.
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, 3, 8-9, 17 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Dang et al. (U.S. Patent Application Publication 2021/0022882) in view of Parr et al. (International Publication WO 2020/113276).
Regarding claims 1, 3, 8-9 and 17, Dang et al. disclose (as to part of claim 1) an integrally formed medical device (101, i.e. embodiment shown in Figures 5A-5D), wherein the medical device is integrally formed by an additive manufacturing process (see paragraph 0064 referring to an “additive fabrication process” and paragraph 0063 referring to “single piece”) using a biocompatible material (e.g. see paragraphs 0056, 0065), the medical device comprising a substantially trapezoidal body portion (102, see paragraph 0078 referring to “rounded trapezoidal” shape) having at least one surface (i.e. top and bottom surfaces as best seen in Figure 5B) capable of being contoured to fit (i.e. shaped to fit the outline/form of a vertebrae) an anatomy of a patient (see paragraphs 0068-0069 and 101, and Note below regarding the term “contoured”); a graft window (i.e. defined by interior of 102, see paragraph 0015) defining a vertical aperture (see Figure 5A) through the body portion, such that the body portion defines a cage (see paragraph 0033 referring to a “cage” structure); and a radiographic alignment aid (i.e. triangular window) defining an aperture (i.e. aperture as best seen in Figure 5B) from an external wall (i.e. wall defined by external periphery of 102) of the body portion to an inner wall (104) of the graft window (see Figures 5A-5B, and paragraph 0019), wherein the aperture comprises a feature (i.e. triangular-shape window/void) with a lower radio-density than the body portion (i.e. not discussed, but inherent given the radiographic nature of a window/void relative to a solid body), wherein (as to claim 3) the body portion has a superior surface (e.g. bottom surface as best seen in Figure 5B) contoured to fit (i.e. shaped to fit the outline/form of a vertebrae) the anatomy of the patient (see paragraphs 0068-0069, and Note 1 below regarding the term “contoured”), wherein (as to claim 8) the radiographic alignment aid is an asymmetric shape (i.e. triangular) capable of indicating a correct orientation of the medical device (see paragraph 0019, and Note 2 below regarding functional language), wherein (as to claim 9) the radiographic alignment aid is a triangle window (see paragraph 0019), with an upper vertex (i.e. vertex pointing down as best seen in Figure 5B, wherein “upper” is a relative term depending upon the orientation of the device) capable of indicating a top of the medical device (see paragraph 0019, and Note 2 below regarding functional language), and wherein (as to claim 17) the medical device is a spinal implant device selected from the group consisting of anterior lumbar interbody fusion device or lateral approach device (see paragraphs 0067-0069) (see Figures 1A-5D, and paragraphs 0015-0098).
Dang et al. disclose the claimed invention except for wherein (as to the remainder of claim 1) the at least one surface is patient-specific.
Parr et al. teach the use of a medical device (10a), wherein the medical device is capable of being formed by an additive manufacturing process (see paragraph 0074) using a biocompatible material (e.g. see paragraph 0094), the medical device having at least one patient-specific surface (40a’ and 40a”) capable of being contoured to fit an (i.e. spinal bone/joint surface) anatomy of a patient (see paragraphs 0073-0074) (see Figures 1-2, and paragraphs 0072-0076).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to construct the invention of Dang et al. with wherein the at least one surface is patient-specific in view of Parr et al. in order to provide an alternative, well-known and obvious surface shape (i.e. non-linear) designed for a certain patient to substantially match surfaces of a spinal bone/joint surface to yield predictable results.
Regarding claim 31, Dang et al. disclose that the medical device is designed and manufactured using an additive manufacturing process (see paragraph 0064), but are silent as to the method of manufacturing the radiographic alignment aid. The claimed phrase “wherein the radiographic alignment aid is a subtractive design radiographic alignment aid.” is being treated as a product-by-process limitation; that is, that the radiographic alignment aid is manufactured using a subtractive design process. As set forth in MPEP 2113, product-by-process claims are NOT limited to the manipulations of the recited steps, only to the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 U.S.C. 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. Thus, even though Dang et al. are silent as to the process used to manufacture the radiographic alignment aid, it appears that the product in Dang et al. would be the same or similar as that claimed; especially since both applicant’s product and the prior art product are additively manufactured. As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith (see In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972)).
Note 1: For examination purpose and in light of the broadest reasonable interpretation, the term “contoured” is being interpreted as shaped to fit the outline or form of something (definition retrieved from https://www.thefreedictionary.com/
contoured).
Note 2: Regarding functional language, "[a]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987) (see MPEP 2114(II)).
Claims 4, 15 and 29-30 are rejected under 35 U.S.C. 103 as being unpatentable over Dang et al. (U.S. Patent Application Publication 2021/0022882) in view of Parr et al. (International Publication WO 2020/113276), as applied to claim 1 above, further in view of Chaput (U.S. Patent Application Publication 2020/0261239).
Regarding claim 4, Dang et al. in view of Parr et al. disclose the claimed invention except for wherein the medical device further comprises an identifier, wherein the identifier is one of debossed or embossed on a surface of the body portion.
Chaput teaches the use of a medical device (1700), wherein the medical device is capable of being formed by an additive manufacturing process (see paragraph 0070) using a biocompatible material (e.g. see paragraph 0062), the medical device comprising a body portion (i.e. portion defined by 1700), and an identifier (2501A or 2501B), wherein the identifier is debossed on a surface (905) of the body portion (see Figure 25, and paragraphs 0073 and 0138-0141).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to construct the invention of Dang et al. in view of Parr et al. with wherein the medical device further comprises an identifier, wherein the identifier is one of debossed or embossed on a surface of the body portion in view of Chaput in order to provide a well-known, obvious means for improving identification of the unique medical device using conventional imaging methods to yield predictable results.
Regarding claims 15 and 30, Dang et al. in view of Parr et al. disclose the claimed invention except for wherein (as to claim 15) the medical device further comprises a set of anti-expulsion teeth defining a plurality of linear channels in an exterior surface of the body portion, and wherein (as to claim 30) a region of the exterior surface of the body portion in which the anti-expulsion teeth are located is contoured to fit the anatomy of the patient.
Chaput teaches the use of a medical device (100), wherein the medical device is capable of being formed by an additive manufacturing process (see paragraph 0070) using a biocompatible material (e.g. see paragraph 0062), the medical device comprising a body portion (101), and a set of anti-expulsion teeth (123A) defining a plurality of linear channels (i.e. channels defined between each instance of 123A by 601 and 605 as best seen in Figures 1 and 6) in an exterior surface (121) of the body portion, wherein a region (i.e. region defined by 121) of the exterior surface of the body portion in which the anti-expulsion teeth are located is contoured to fit (i.e. shaped to fit the outline/form of a spinal bone) the anatomy of the patient (see paragraph 0075, and Note 1 above regarding the term “contoured”) (see Figure 1, and paragraphs 00075 and 0085-0086).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to construct the invention of Dang et al. in view of Parr et al. with wherein the medical device further comprises a set of anti-expulsion teeth defining a plurality of linear channels in an exterior surface of the body portion, and wherein a region of the exterior surface of the body portion in which the anti-expulsion teeth are located is contoured to fit the anatomy of the patient in view of Chaput in order to provide a well-known, obvious means for resisting expulsion of and increasing a minimum pull-out force of the medical device from a target site (i.e. a site defined between bones of the spine) to yield predictable results.
Regarding claim 29, Dang et al. in view of Parr et al. further in view of Chaput disclose the claimed invention except for wherein the identifier is formed on an inner wall of the graft window.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to construct the invention of Dang et al. in view of Parr et al. further in view of Chaput with wherein the identifier is formed on an inner wall of the graft window in order to provide a well-known, obvious means for improving identification of the unique medical device using conventional imaging methods in a desired location to yield predictable results. It has been held that rearranging parts of an invention involves only routine skill in the art (In re Japikse, 86 USPQ 70).
Claims 10-14 are rejected under 35 U.S.C. 103 as being unpatentable over Dang et al. (U.S. Patent Application Publication 2021/0022882) in view of Parr et al. (International Publication WO 2020/113276), as applied to claim 1 above, further in view of Schoenly et al. (U.S. Patent Application Publication 2012/0232599).
Dang et al. in view of Parr et al. disclose the claimed invention except for wherein (as to claim 10) the medical device further comprises at least one screw hole capable of receiving a fixation screw at a predefined angle, wherein (as to claim 11) at least one of the at least one screw holes is integrally formed as being threaded, wherein (as to claim 12) the medical device includes a pair of screw holes in an anterior face of the body portion, the pair of insertion holes being offset relative to each other at a predefined angle, wherein (as to claim 13) the medical device further comprises a threaded hole in a face of the body portion, the threaded hole capable of receiving one of a threaded medical device insertion instrument and a locking cap, and wherein (as to claim 14) the medical device further comprises at least one screw hole capable of receiving a fixation screw at a predefined angle, wherein the threaded hole is positioned such that when a locking cap is received in the at least one screw hole, the locking cap covers at least a portion of at least one of the at least one screw hole.
Schoenly et al. teach the use of a medical device (200) comprising a body portion (216), and at least one screw hole (228) capable of receiving a fixation screw (99a, see paragraph 0059) at a predefined angle (i.e. trajectory, see paragraph 0101), wherein at least one of the at least one screw holes is integrally formed as being threaded (see paragraph 0101), wherein the medical device includes a pair of screw holes (e.g. one upper and one lower instance of 228 as best seen in Figure 8) in an anterior face (i.e. face defined by 218a) of the body portion, the pair of screw holes being offset relative to each other at a predefined angle (i.e. trajectory, see Figure 8 showing offset and paragraph 0101), wherein the medical device further comprises a threaded hole (226) in a face (i.e. face defined by 218a) of the body portion, the threaded hole capable of receiving a locking cap (i.e. cap defined by 232 and 238), and wherein the threaded hole is positioned such that when a locking cap (i.e. cap defined by 232 and 238) is received in the at least one screw hole (i.e. when portion 238 is received in the screw hole), the locking cap covers at least a portion of at least one of the at least one screw holes (see paragraph 0109) (see Figures 1A-8, and paragraphs 0051-0122).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to construct the invention of Dang et al. in view of Parr et al. with wherein the medical device further comprises at least one screw hole capable of receiving a fixation screw at a predefined angle, wherein at least one of the at least one screw holes is integrally formed as being threaded, wherein the medical device includes a pair of screw holes in an anterior face of the body portion, the pair of insertion holes being offset relative to each other at a predefined angle, wherein the medical device further comprises a threaded hole in a face of the body portion, the threaded hole capable of receiving one of a threaded medical device insertion instrument and a locking cap, and wherein the medical device further comprises at least one screw hole capable of receiving a fixation screw at a predefined angle, wherein the threaded hole is positioned such that when a locking cap is received in the at least one screw hole, the locking cap covers at least a portion of at least one of the at least one screw hole in view of Schoenly et al. in order to provide a well-known, obvious means for more securely anchoring the medical device relative to bone and preventing undesired backing-out of the fixations screws to yield predictable results.
Claims 18-20 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Dang et al. (U.S. Patent Application Publication 2021/0022882) in view of Parr et al. (International Publication WO 2020/113276), as applied to claim 1 above, further in view of Hodrinsky et al. (U.S. Patent Application Publication 2021/0093457).
Dang et al. in view of Parr et al. disclose the claimed invention except for wherein (as to claim 18) the medical device further comprises a plate abutting the body portion, wherein (as to claim 19) an exterior surface of the plate is contoured to fit the anatomy of the patient, wherein (as to claim 20) the plate is in-line with a predominant load transmission pathway and is capable of increasing a contact surface area between the device and the anatomy of the patient; or perpendicular to a predominant load transmission pathway and is capable of acting as an insertion stop governing a depth of insertion of the device, and wherein (as to claim 23) the plate includes at least one integral screw hole offset from a plane of the body portion.
Hodrinsky et al. teach the use of a medical device (see Figures 56C-7 and 14B) capable of being integrally formed (see paragraph 0048), wherein the medical device is integrally formed by an additive manufacturing process (i.e. via 3D printing, see paragraph 0054) using a biocompatible material (see paragraph 0054), the medical device comprising a body portion (i.e. portion defined between each endplate as best seen in Figures 6C and 7); and a plate (i.e. top or bottom endplate as best seen in Figures 6C and 7) abutting the body portion, wherein an exterior surface (i.e. top-most or bottom-most surfaces as best seen in Figure 6C) of the plate is contoured to fit the anatomy of the patient (see paragraphs 0053 and 0054), wherein the plate is in-line with a predominant load transmission pathway (i.e. pathway defined from top-to-bottom through a vertebral body as best seen in Figure 7) and is capable of increasing a contact surface area between the device and the anatomy of the patient (see paragraph 0054), and wherein the plate is capable of including at least one integral screw hole offset from a plane of the body portion (see Figure 14B, and paragraph 0063) (see Figures 6C-7 and 14B, and paragraphs 0048, 0053-0054 and 0063).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to construct the invention of Dang et al. in view of Parr et al. with wherein the medical device further comprises a plate abutting the body portion, wherein an exterior surface of the plate is contoured to fit the anatomy of the patient, wherein the plate is in-line with a predominant load transmission pathway and is capable of increasing a contact surface area between the device and the anatomy of the patient, and wherein the plate includes at least one integral screw hole offset from a plane of the body portion in view of Hodrinsky et al. in order to provide a well-known, obvious means for providing endplate surfaces matching the bone surfaces and extending to the perimeter of the vertebral bodies for optimal homogenous load carrying and distribution, support, and marriage to the bone and for providing screws/screw holes in the endplates to prevent device migration from too high angle differences and resulting anterior posterior shearing forces to yield predictable results.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Dang et al. (U.S. Patent Application Publication 2021/0022882) in view of Parr et al. (International Publication WO 2020/113276) further in view of Hodrinsky et al. (U.S. Patent Application Publication 2021/0093457), as applied to claim 18 above, and further in view of Sack (U.S. Patent 10,405,992).
Dang et al. in view of Parr et al. further in view of Hodrinsky et al. disclose the claimed invention except for wherein the medical device further comprises at least one buttress support between the body portion and the plate.
Sack teaches the use of a component (241) of medical device (100) capable of being integrally formed by an additive manufacturing process (i.e. 3D printing, see paragraph 0146), wherein the component comprises a first component (420), a second component (422), and a buttress support (1350, see column 11, lines 15-20) formed therebetween (see Figures 13 and 15, and column 10, line 44 – column 12, line 27).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to construct the invention of Dang et al. in view of Parr et al. further in view of Hodrinsky et al. with wherein the medical device further comprises at least one buttress support between the body portion and the plate in view of Sack in order to provide a well-known, obvious means for increasing the structural stability of the medical device by resisting external pressures and forces applied to the plate to yield predictable results.
Response to Arguments
The applicant’s arguments with respect to claims 1, 3-4, 8-15, 17-21, 23 and 29-31 have been considered but are moot in view of the new ground of rejection (i.e. necessitated by the claims amendments including, for example, “at least one patient-specific surface” and “wherein the aperture comprises a feature with a lower radio-density than the body portion”).
The applicant's arguments filed 06 March 2026 regarding the Dang et al. and Chaput references have been fully considered but they are not persuasive.
Regarding the Dang et al. reference, the applicant argues that 1) there is not teaching or suggestion in Dang et al. of a window being used for radiographic alignment, and 2) Dang et al. fail to teach any surface of a body portion that is contoured to fit the anatomy of a patient (e.g. pertaining to claim 3). The examiner respectfully disagrees.
Regarding 1), as stated in Note 2 above, a claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. As such, Dang et al. disclose the claimed structure (i.e. an aid defining an aperture from an external wall of the body portion to an inner wall of the graft window, wherein the aperture comprises a feature with a lower-density than the body portion). It is the examiner’s position that, given the triangular shape of the aperture, it would be fully capable of being functionally used to indicate an alignment of the medical device.
Regarding 2), as stated in Note 1 above, the term “contoured” is being interpreted as shaped to fit the outline or form of something. Under this broadest reasonable interpretation, and given the plain meaning of the term “contoured,” there is no requirement that the surface be specific to a particular patient or to have a specific conformation. This interpretation specifically applies to claim 3. It is the examiner’s position that Dang et al. disclose the contoured surface as required by claim 3.
Regarding the Chaput et al. reference, the applicant argues that 1) Chaput teaches away from integrally formed medical devices and would not have been considered by a person of ordinary skill in the art, and 2) Chaput fails to teach the “plurality of linear channels” as required by claim 15. The examiner respectfully disagrees.
Regarding 1), in response to applicant's arguments against the references individually, one cannot show non-obviousness 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)). Chaput was relied upon to teach wherein the identifier is one of debossed or embossed on a surface of the body portion, not the particulars of the integrally formed medical device. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1) determining the scope and contents of the prior art, 2) ascertaining the differences between the prior art and the claims at issue, 3) resolving the level of ordinary skill in the pertinent art, and 4) considering objective evidence present in the application indicating obviousness or non-obviousness. As such, the Dang et al./Parr et al. references (i.e. to disclose/teach the particulars of claim 1) applied to steps 1) and 2), and the Chaput reference applied to steps 3) and 4) (i.e. to teach the particulars of claims 4 and 29). It is the examiner’s position that the Chaput reference is indeed relevant/analogous art and does not teach away from its combination with the Dang et al./Parr et al. references.
Regarding 2), the examiner did not indicate that the “anti-expulsion teeth” were being interpreted as the “plurality of linear channels.” As recited in the rejection above, the examiner has provided further clarification in the event that the rejection was unclear (e.g. Chaput teach...”a set of anti-expulsion teeth (123A) defining a plurality of linear channels (i.e. channels defined between each instance of 123A by 601 and 605 as best seen in Figures 1 and 6) in an exterior surface (121) of the body portion”).
Conclusion
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 LARRY E WAGGLE, JR whose telephone number is (571)270-7110. The examiner can normally be reached TEAP: Monday - Friday (7:45am - 3:45pm).
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, the examiner’s supervisor, Kevin Truong can be reached at 571-272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LARRY E WAGGLE, JR/Primary Examiner, Art Unit 3775
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