Detailed Action
This office action is for US application number 17/694,136 evaluates the claims as filed on December 16, 2025.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 December 16, 2025 has been entered.
Response to Arguments
Applicant's arguments filed December 16, 2025 have been fully considered but they are not persuasive. The rejections in this office action have been amended to address the amended claims. Examiner asserts that Motley teaches all the newly-amended limitations and is capable of performing the functions as claimed. Examiner directs Applicant to the rejection below for a more in-depth description of the limitations.
With regards to Applicant’s argument that the amendments to claims 6 and 16 address the clarity issues noted in paragraphs 12, 13, 15, and 16 (Remarks p. 6-7), Examiner disagrees and notes that no amendment has been made regarding the claimed “the surface” in line 2 of each of claims 6 and 16 and thus, such has note been clarified. Accordingly, this rejection has been repeated with updated location information of the related surface recitations.
With regards to Applicant’s argument that Motleys insert is a porous mass structures where interconnected holes are distributed throughout the porous material and is not a hollow body member that defines an internal cavity (Remarks p. 8), Examiner notes that, as shown in at least Fig. 1A, hollow body member 102 defines internal cavity 121, which is expressly described in paragraph 78 as “insert 120 having its own vertical (or axially extending) opening(s) 121”.
With regards to Applicant’s argument that a comparison of Motley Fig. 1B with Applicant’s Fig. 2C illustrates the structural distinction/difference between a porous mass with distributed holes of Motley and a hollow shell with surfaces defining an enclosed internal cavity as provided by Applicant’s claim 1 (Remarks p. 8), Examiner notes that there appear to be some confusion in this argument. To start, Fig. 2C is part of the non-elected species a) of Figs. 1-2C. Fig. 2C is similar to Fig. 4A, where Fig. 4A shows the hollow body member for the elected species. Applicant’s claim 1 does not provide “an enclosed internal cavity” nor does Applicant’s hollow body member 302 provide “an enclosed internal cavity”, where Figs. 4A and 4B show the elected hollow body member comprising interior surfaces that define an internal cavity with apertures that are in communication with the internal cavity. It is Motley that appears to have the “an enclosed internal cavity” based on review of Figs. 1A-1C and 5A and not Applicant’s invention. Finally, it does not appear that the argued “enclosed internal cavity” would read on the claimed “apertures formed in the surfaces of the hollow body member that provide an osteoconductive path into the cavity”. Thus, it appears that Motley does not disclose the osteoconductive path extending through the apertures and into the cavity, which Examiner notes is addressed by the teaching of Huang in the rejection below.
With regards to Applicant’s argument that Motley does not disclose that a sidewall of the insert cooperates with an inner surface of the body to create and enclosed osteoconductive pate and Motley’s insert 120 is a porous mass and not a structure with a sidewall that cooperates with an inner surface of the cased to form a tubular tunnel and Examiner has not identified any portion of Motley that teaches an enclosed osteoconductive path formed in cooperation between a sidewall of an insert and an inner surface of the cage (Remarks p. 4), Examiner refers Applicant to Motley Figs. 1A-1C and 5A and paragraph 80 and notes that Figs. 1A-1C clearly show that insert/hollow body member 120 comprises many surfaces that form at least four sidewalls to form a generally rectangular shape which is received within an opening/bone fusion channel of cage 105 that constitutes an ‘enclosed osteoconductive path’ and therefore such are ‘in cooperation with’ one another. Examiner notes that, based on Applicant’s remarks, it appears that there is an intended meaning of ‘enclosed’ that is either unclear, contrary to the ordinary meaning of the term, or interpreted inconsistently within Applicant’s remarks; thus, Examiner suggests that it may be beneficial to amend to clarify the intended scope, but notes that it is unclear how such could reasonably overcome Motely.
Claim Rejections - 35 USC § 112
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.
Claim(s) 1, 3-6, 9, 12, and 14-16 is/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 pre-AIA the applicant regards as the invention.
Claim(s) 1 is/are unclear with regards to “each of the surfaces and a sidewall of the hollow body member has a given thickness which defines a cavity” in lines 4-5 and how a surface can be reasonably construed to have a thickness and how a thickness can be reasonably construed to define a cavity. This is further unclear with respect to lines 9-12 and how the surfaces that somehow have a thickness that defines a cavity are substantially coplanar with surfaces of the prosthesis. It does not appear that Applicant has acted as their own lexicographer and provided alternate meanings of ‘surface’ or ‘thickness’; thus the ordinary meanings have been applied. Examiner is interpreting this as referring to, and suggests amending as, “wherein the hollow body member defines a cavity;”.
Claim(s) 6 is/are unclear with regards to “the surface” in line 2 and if such is intended to refer to the surfaces of the hollow body of claim 1 line 2, the first surface of the spinal fusion cage of claim 1 line 10, the second surface of the spinal fusion cage of claim 1 line 12, or the surface of claim 6 line 1. Examiner is interpreting this as referring to the surface of claim 6 line 1, and suggests amending to clarify.
Claim(s) 12 is/are unclear with regards to “a hollow body member comprising surfaces including a sidewall” in line 5 and how a surface can be reasonably construed to include a sidewall. It does not appear that Applicant has acted as their own lexicographer and provided alternate meanings of ‘surface’ or ‘sidewall’/’wall’; thus the ordinary meanings have been applied. Examiner is interpreting this as referring to, and suggests amending as, “a hollow body member comprising surfaces and a sidewall”.
Claim(s) 16 is/are unclear with regards to “the surface” in line 2 and if such is intended to refer to the surfaces of the hollow body of claim 12 line 5, the first surface of the spinal fusion cage of claim 12 line 12, the second surface of the spinal fusion cage of claim 12 line 13, or the surface of claim 16 lines 1-2. Examiner is interpreting this as referring to the surface of claim 16 lines 1-2, and suggests amending to clarify.
Claim(s) 3-5, 9, 14, and 15 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for its/their dependence on one or more rejected base claims.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 12 and 14-16 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Motley et al. (US 2021/0106433, hereinafter “Motley”).
The claimed phrase “formed” is being treated as a product by process limitation; that is the product reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113.
As to claim 12, Motley discloses an system (110, Figs. 1A-1C, 5A, and 5B, ¶s 80 and 97; where ¶80 discloses and embodiment with insert 120 having a plurality of interconnected holes extending throughout a section of the porous insert and see holes 3 in Fig. 5A that are applied to insert 120) comprising: a spinal fusion cage (105, Figs. 1A-1C) comprising a bone fusion channel (shown containing 120 in Figs. 1A-1C, Figs. 1A-1C); and an osteoconductive device (120, Figs. 1A-1C, 5A, and 5B, ¶s 80 and 97; where ¶80 discloses and embodiment with insert 120 having a plurality of interconnected holes extending throughout a section of the porous insert and see holes 3 in Fig. 5A that are applied to insert 120) capable of use for insertion into the bone fusion channel of the spinal fusion cage (Figs. 1A-1C, 5A, and 5B), the osteoconductive device comprising: a hollow body member (120) comprising surfaces (Figs. 1A-1C and 5A) and a sidewall (Figs. 1A-1C and 5A), the hollow body member having a shape (Figs. 1A-1C) that substantially conforms to an inner cross-sectional area (Figs. 1A-1C) of the bone fusion channel (shown containing 120 in Figs. 1A-1C, Figs. 1A-1C); and apertures (3) formed in the surfaces of the hollow body member (Figs. 5A and 5B, ¶80) provide an osteoconductive path (via 3s and 3cs, Figs. 5A and 5B, ¶s 97 and 102, where ¶102 discloses that the interconnected openings 3c are for promoting bone growth in 3cs and 3s) through the hollow body member (Fig .5A); and wherein, when the osteoconductive device is inserted into the bone fusion channel, one of the surfaces of the hollow body member is substantially coplanar with a first surface of the spinal fusion cage (upper surfaces as shown in Fig. 1B, Figs. 1A-1C) and another surface of the hollow body member is substantially coplanar with a second surface of the spinal fusion cage (lower surfaces as shown in Fig. 1B, Fig. 1B), and wherein the sidewall cooperates with an inner surface of the bone fusion channel (Figs. 1A-1C) defining an enclosed osteoconductive path (within the bone fusion channel and enclosed due to the absence of apertures in the cage inner surface as shown in Figs. 1A-1C, Figs. 1A-1C, where ¶82 discloses that the cage is formed of materials such as cobalt chrome, stainless steel, titanium, various plastics, various ceramics or medical grade PEEK).
As to claim 14, Motley discloses the apertures are aligned to form rows (Figs. 5A and 5B, ¶97), wherein at least a portion of the first surface or the second surface is provided with any of surface roughening (Figs. 1A-1C).
As to claim 15, Motley discloses that at least one of the one or another surface of the hollow body member is provided with an additional porosity (3c, Figs. 5A and 5B, ¶97), wherein the additional porosity of the hollow body member comprises trenches (3c, Figs. 5A and 5B, ¶97) formed across a portion of the rows (Figs. 5A and 5B).
As to claim 16, Motley discloses that a surface of the surfaces of the hollow body member comprises protrusions (Figs. 5A and 5B) that extend normally to the surface (Figs. 5A and 5B), the protrusions being capable of engaging with an inner sidewall of the bone fusion channel (106, Figs. 1A-1C, 5A, and 5B) when the osteoconductive device is inserted into the bone fusion channel (Figs. 1A-1C, 5A, and 5B).
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 of this title, 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) 1, 3-6, and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Motley et al. (US 2021/0106433, hereinafter “Motley”) in view of Huang (US 2012/0191188).
The claimed phrase “formed” is being treated as a product by process limitation; that is the product reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113.
As to claim 1, Motley discloses an osteoconductive device (120, Figs. 1A-1C, 5A, and 5B, ¶s 80 and 97; where ¶80 discloses and embodiment with insert 120 having a plurality of interconnected holes extending throughout a section of the porous insert and see holes 3 in Fig. 5A that are applied to insert 120) comprising: a hollow body member (120) comprising surfaces (Figs. 1A-1C and 5A), the hollow body member having a shape (Figs. 1A-1C) that substantially conforms to a cross-sectional area (Figs. 1A-1C) of an opening (shown containing 120 in Figs. 1A-1C, Figs. 1A-1C) of an orthopedic prosthesis (105, Figs. 1A-1C), wherein the hollow body member defines a cavity (121, Fig. 1A, ¶78); and apertures (3) formed in the surfaces of the hollow body member (Figs. 5A and 5B, ¶80) that provide an osteoconductive path (via 3s and 3cs, Figs. 5A and 5B, ¶s 97 and 102, where ¶102 discloses that the interconnected openings 3c are for promoting bone growth in 3cs and 3s) through the hollow body member (Fig .5A); and wherein, when the osteoconductive device is inserted into the opening of the orthopedic prosthesis, one of the surfaces of the hollow body member is substantially coplanar with a first surface of the orthopedic prosthesis (upper surfaces as shown in Fig. 1B, Figs. 1A-1C) and another surface of the hollow body member is substantially coplanar with a second surface of the orthopedic prosthesis (lower surfaces as shown in Fig. 1B, Fig. 1B), further wherein the first surface of the orthopedic prosthesis and the second surface of the orthopedic prosthesis are each outer surfaces of the orthopedic prosthesis (as defined, Figs. 1A-1C). As to claim 3, Motley discloses the apertures are aligned to form rows (Figs. 5A and 5B, ¶97). As to claim 4, Motley discloses that at least a portion of the first surface or the second surface is provided with any of surface roughening (Figs. 1A-1C). As to claim 5, Motley discloses that at least one of the one or another surface of the hollow body member is provided with an additional porosity (3c, Figs. 5A and 5B, ¶97), wherein the additional porosity of the hollow body member comprises trenches (3c, Figs. 5A and 5B, ¶97) formed across a portion of the rows (Figs. 5A and 5B) to create a trench matrix (Figs. 5A and 5B) defining surface objects (Figs. 5A and 5B). As to claim 6, Motley discloses that a surface of the surfaces of the hollow body member comprises protrusions (Figs. 5A and 5B) that extend normally to the surface (Figs. 5A and 5B), the protrusions being capable of engaging with an inner sidewall of the opening of the orthopedic prosthesis (106, Figs. 1A-1C, 5A, and 5B), when the osteoconductive device is inserted into the opening of the orthopedic prosthesis (Figs. 1A-1C, 5A, and 5B). As to claim 9, Motley discloses that the surfaces of the hollow body member comprise a first surface (Figs. 1A-1C) and a sidewall (Fig. 1B) that extends normally from an outer peripheral edge of the first surface (Fig. 1B), further wherein the sidewall engages with an inner surface of the orthopedic prosthesis (106, Fig. 1B).
Motley is silent to the osteoconductive path extending into the cavity.
Huang teaches a similar osteoconductive device comprising (Figs. 5-8, ¶25): a hollow body member (10) comprising surfaces (Figs. 5-8), wherein the hollow body member defines a cavity (16, Figs. 5-8, ¶25); apertures (13s) formed in the surfaces of the hollow body member (Figs. 5-8, ¶25) provide an osteoconductive path through the hollow body member into the cavity (Figs. 5-8, ¶25).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the apertures and osteoconductive path as disclosed by Motley with to extend into the cavity as taught by Huang in order to provide communication between the apertures and the cavity (Huang ¶25) for bone tissues to grow to fill in the cavity in carrying out intervertebral stabilization and increasing the probability of a satisfactory recovery of a patient (Huang ¶25).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY R SIPP whose telephone number is (313)446-6553. The examiner can normally be reached on Mon - Thurs 6-4.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached on (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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/AMY R SIPP/Primary Examiner, Art Unit 3775