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 .
Status of Claims
Claims 1-28 are pending, of which claims 1-16 have been withdrawn. Therefore, claims 17-28 are examined below.
Claim Objections
Regarding claim 28 – the claim reads “the ceramic granules have a diameter of from about 100 μm to about 300 μm”. Examiner believes this should read “the ceramic granules have a diameter of
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) 17, 18, 21-23, and 25-27 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2016/0058568 A1 (Bagga)
Regarding claim 17, Bagga discloses a surgical implant (Fig. 15), comprising:
an outer body (see annotated Fig. 15 below)
at least one internal strut (Fig. 15, 210), coupled to the outer body
wherein at least one internal strut has a smaller diameter than the outer body (see annotated Fig. Fig. 15a, where struts are significantly smaller in diameter than outer body)
PNG
media_image1.png
588
1039
media_image1.png
Greyscale
ceramic granules deposited (¶0082, “bioactive ceramic fillers”) at a surface of the internal strut (¶0172, “calcium phosphate migrating into a bioactive E-glass ceramic filler at the surface were noted”)
Regarding claim 18, Bagga further discloses wherein the ceramic granules are at least partially exposed at a surface of the surgical implant (¶0172, “Several observations of the CaP migrating into a bioactive E-glass ceramic filler at the surface were noted”)
Regarding claim 21, Bagga further discloses wherein the ceramic granules comprise an osteoconductive mineral (¶0172, wherein “calcium phosphate” corresponds to a osteoconductive mineral”)
Regarding claim 22, Bagga further discloses wherein the osteoconductive mineral comprises calcium or silicate (¶0172, wherein “calcium phosphate” comprises calcium”)
Regarding claim 23, Bagga further discloses wherein the osteoconductive mineral is selected from monocalcium phosphate, tricalcium phosphate, hydroxyapatite, silicon dioxide, or bioglass (¶0172, wherein “calcium phosphate” corresponds to monocalcium phosphate)
Regarding claim 25, Bagga further discloses wherein the ceramic granules comprise less than 30% of the surgical implant by weight (¶0082, wherein 10% to 90% overlaps the claimed range)
Regarding claim 26, Bagga further discloses wherein the ceramic granules are disposed at a greater density along the internal strut compared to the outer body (¶0172, wherein “Several observations of the CaP migrating into a bioactive E-glass ceramic filler at the surface were noted”)
Regarding claim 27, Bagga discloses wherein the surface comprises a substantially regular polymer surface interspersed with ceramic granules comprising substantially irregular outer surfaces (¶0172, wherein “Several observations of the CaP migrating into a bioactive E-glass ceramic filler at the surface were noted”)
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) 19 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable US 2016/0058568 A1 (Bagga) in view of US 2013/0123935 A1 (Hunt)
Regarding claim 19, Bagga discloses an inner strut (see rejection of claim 17) but doesn't explicitly teach or disclose a plurality of inner struts.
Hunt discloses a surgical implant (Fig. 1A) comprising a plurality of inner struts (Fig. 1A, see also ¶0065, “one or more inner trusses”)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the surgical implant of Bagga with a plurality of inner trusses, as taught by Hunt, in order to provide both structural support and a framework for bone growth.
Regarding claim 20, Bagga doesn't explicitly teach or disclose wherein the plurality of internal struts form a lattice structure defining one or more channels through the implant.
Hunt discloses wherein the plurality of internal struts form a lattice structure defining one or more channels through the implant (see Fig. 1, wherein trusses 102 form lattice structure 101 defining one or more channels as seen in Fig. 1)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the surgical implant of Bagga with a plurality of inner struts which form a lattice structure defining one or more channels thought the implant, as taught by Hunt, in order to allow for both structural support and bone ingrowth.
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0058568 A1 (Bagga) in view of US 2016/0166610 (De Groot-Barrere)
Regarding claim 24, Bagga discloses a surgical implant comprising ceramic granules (see rejection of claim 17) but doesn't explicitly teach or disclose wherein the ceramic granules comprise an irregular outer surface.
De Groot-Barrere discloses using ceramic granules with an irregular outer surface (¶0055, “particles having irregular shapes”)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the ceramic granules of Christensen in view of Bagga to have an irregular surface, as taught by De Groot-Barrere, in order to provide more favorable surface conditions for osteogenesis.
Claim(s) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0058568 A1 (Bagga) in view of US 2021/0023263 (Dunkley)
Regarding claim 28, Bagga discloses a surgical implant with ceramic granules (see rejection of claim 17) but doesn't explicitly teach or disclose wherein the ceramic granules have a diameter of from about 100 m to about 300 m. Bagga doesn't explicitly teach or disclose wherein the ceramic granules have a diameter of from about 100 m to about 300 m.
Dunkley discloses wherein the ceramic granules have a diameter of about 100 m to about 300 m (¶0008, wherein “50 μm to 800 μm” overlaps the claimed range)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the ceramic granules of Bagga to have a diameter from about 100 m to about 300 m, as taught by Dunkley, in order to promote greater bone volume and density.
Conclusion
Included below is relevant prior art that was considered but not relied upon for this office action:
US 2004/0258732 – Fig. 5 discloses a cervical spacer with porous article 1 comprising
US 2020/0078189 – discloses an intervertebral spacer with struts that can be formed of ceramic materials (¶0045)
2003/0125739 – Fig. 15 has embodiment with strut 210
2012/0185047 – Fig. 3 has a strut, ¶0050 has osteopromotive coatings
2017/018222 – ¶0049 discloses bioglass in a polymeric carrier
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAXIMILIAN TOBIAS SPENCER whose telephone number is (571)272-8382. The examiner can normally be reached M-F 8am-5pm.
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, Jerrah Edwards can be reached on 408.918.7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MAXIMILIAN TOBIAS SPENCER/Examiner, Art Unit 3774
/YASHITA SHARMA/Primary Patent Examiner, Art Unit 3774
