DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
A preliminary amendment was filed on 10/07/2024.
Information Disclosure Statement
Information disclosure statements were filed 07/30/2024.
Claim Status
Claims 21-40 are pending in the application.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 21-24, 27, 28, 31-33 are rejected under 35 U.S.C. 102(b) as being anticipated by EP 0 806 212 A1 (Matrix Medical B.V.).
Matrix Medical B.V. disclose a metal implant comprising a porous region wherein the porous region exhibits a nano-textured surface and a calcified material layer coating the nano-textured surface. Protrusions have a range of 50 nm to about 200 nm. (see Page 2, lines 1-5, 18-37, 50-55; page 3 lines 3,4, 25-27, 40 and 41; claims 1-5). The surface is calcified at page 3, line 30. Biodegradable polymers may be added at page 1, lines 57-58. Growth factors are listed page 2, lines 10-14, and 25-27. At page 3, line 39, the construct is a joint prosthesis. The instant claims are anticipated by Matrix Medical B.V.
Claims 21 – 24 , 32 are rejected under 35 U.S.C. 102(b) as being anticipated by EP 1 449 544 (Depuy Products Inc).
Depuy Products Inc disclose a metal implant comprising a porous region wherein the porous region exhibits a nano-textured surface and a calcified material layer coating the nano-textured surface. Protrusions have a range of 50 nm to about 200 nm. The device additionally comprises a biocompatible polymer . Calcium phosphate can be added to the textured surface .(see page 3, paragraphs 13-15; page 7, paragraph 53; page 8, paragraphs 59 and 60; claims 1, 16, 20, 21). The metal implant can be an orthopedic implant ([0060]). The claims are anticipated by Depuy Products.
Claims 21 - 24, 27, 30, and 32 are rejected under 35 U.S.C. 102(b) as being anticipated by US Patent No. 6, 129, 928 (Sarangapani et al).
Sarangapani et al disclose a metal implant comprising a porous region wherein the porous region exhibits a nano-textured surface and a calcified material layer coating the nano-textured surface. Protrusions have a range of 50 nm to about 200 nm. The calcified layer consists of nanoscale hydroxyapatite particles, calcium phosphate and bioactive agents The device additionally comprises a biocompatible polymer. Hydroxyapatite is found in the implant in a gel . The implants are used for orthopedic implants of the hip and knee (see [4]). Growth factors are added. (see Col. 1, lines 16, 17, 30-32; col. 3, lines 21-26, 58-60; col. 4, lines 45-50; [0018] examples 3, 6, 7; claims 1, 10,20,24-33, 56-58 and 84; figure 7). The claims are anticipated by Sarangapani et al.
Claims 21-24, 26-28, and 31-34 are rejected under 35 U.S.C. 102(b) as being anticipated by US Patent No. 6,214,049 (Gayer et al).
Gayer et al disclose a metal implant comprising a porous region wherein the porous region exhibits a nano-textured surface and a calcified material layer coating the nano-textured surface. The device additionally comprises a biocompatible polymer. The calcified layer consists of nanoscale hydroxyl apatite particles and bioactives which are located in a collagen based matrix. Protrusions range from 50 nm to 200 nm. The calcified layer comprises an extracellular matrix and an inorganic material. Specific growth factors such as BMP-2 through BMP- 7 are included. The implants include joint prostheses of knees, digits and elbows. (see figure 8; col. 1, lines 6-10; col. 8, lines 62 to col. 9, line 21; col. 10, lines 21-46; col. 11, line 40 to col. 12, line 2; claims, especially claims 40, 41, 44-51, 53). The claims are anticipated by Gayer et al.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 21- 26, 30 -38 and 40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 8.329,202 (US’202). Although the claims at issue are not identical, they are not patentably distinct from each other because US’202 claims:
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Claim 2 sets out protrusions on the nano-textured surface with a height selected from the range of about 50 nm to about 200 nm. In claim 3 , the calcified layer comprises hydroxyapatite nanoparticles. These nanoparticles further comprise bioactives in claims 4, and may be located in the collagen based matrix (claim 9).The calcified layer may also comprise biocompatible polymers such as collagen (claim 5 and 6). The calcified layer can comprise bioactives (claim 7). These calcified materials are listed at claim 8. The calcified material can comprise a naturally occurring extracellular matric and an exogenously added biocompatible inorganic material such as hydroxyapatite (claims 10 and 11). This may take the form of a fluidized gel wherein the biocompatible inorganic material is dispersed in the submucosa (claim12). A scaffold layer may be calcified or uncalcified (claims 13-14). While the claims are directed to a surgical construct rather than a joint prosthesis, applicant sets this out in Figure 1 of the specification, and could have claimed this specific this specific type of surgical construct in this file. As such, the instant claims would have been obvious to one of ordinary skill in the art at the time of filing given the teachings of US’202.
Claims 21 – 26, 29-38, and 40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 8.906.402 (US’402). Although the claims at issue are not identical, they are not patentably distinct from each other because US’402 claims:
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Claims 3-5 set out that the protrusions on the metal surface display nanosurface roughness with an average height of from about 20 nm to about 200 nm. Claims 6 and 7 sets out that the nanosurface roughness comprises a calcified material such as hydroxyapatite. Claims 8-11 set out that the calcified material may further comprise cells (claim 8), and bioactives (claims 9-11).Claim 12 adds that the metal of the implant may comprise titanium alloy. Claim 13 specifically sets out that the implant may be a joint prosthesis. Claim 14 adds biocompatible polymer to the calcified material. Those of ordinary skill would have been able to claim the instant joint prosthesis at the time of filing given the claims of US’402.
Claims 21 – 26, 30-38, and 40 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 8 - 23 of U.S. Patent No. 9,788,953 (US’953). Although the claims at issue are not identical, they are not patentably distinct from each other because US’953 claims:
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Claim 3 sets out a titanium alloy. Claim 4 sets out a sintered porous metal. Claim 8 sets out nanosurface roughness. Claim 9 adds a calcified layer , which may further comprise a bioactive (claims 10, 21 and 23). The scaffold may also be uncalcified (claim 11). Claims 12 and 13 set out specific bioactives. The calcified layer may comprise hydroxyapatite as set out in claim 14. Claim 15 adds a biocompatible polymer to the calcified layer, which may comprise collagen (claim 16). The nanotextured surface can be coated with a calcified surface (claim 17), which may comprise hydroxyapatite (claim 18).The surface may further comprise a bioactive scaffold layer (claims 19 and 20). While the claims do not specifically set out a joint prosthesis , Figure 2 specifically sets one out which would have permitted applicant to claim a joint prosthesis in that filing, It would have been obvious for one of ordinary skill to claim a joint prosthesis at the time of filing given the teachings of US’928.
Conclusion
No claims are allowed.
Claim 39 I objected to as dependent upon a rejected base claim.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CARLOS A AZPURU whose telephone number is (571)272-0588. The examiner can normally be reached 9 am- 3 pm, 4 pm-8pm.
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/CARLOS A AZPURU/Primary Examiner, Art Unit 1617 caz
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