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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/22/2025 has been entered.
Priority
This application claims priority from Foreign application 202019106375.0, filed 11/15/2019
Status of Claims
Claims 1-9 and 12 are pending.
Claims 10 and 11 have been cancelled.
Claim Objections
Claim 3 is objected to because the applicant failed to amend it to be consistent with the amendments to claim 1. Claim 3 should have the requirement for it to be an inner portion deleted because that was added to claim 1.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1-6 and 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Defelice et al (Defelice) US 2011/0144752 A1.
(It is noted that for claims 1-5, the claims are directed at the implant not a method of making it, and the recitations addressing these methods are given limited weight. Accordingly, any implant capable of being 3-D printed and having the claimed structures anticipates the claims.)
1. Defelice discloses an orthopedic implant [0049] wherein the implant is a 3D printed part [0035] and comprises at least one first portion ( scaffolding [0049]) and at least one second portion (the encapsulating carrier for the drugs [0051]), the first portion forming a support structure [0049] and the second portion being at least partially made of a biodegradable material ([0051] discloses the biodegradable polymer PLA), wherein the first portion surrounds the second portion (scaffolding surrounds and contains pores which receive the encapsulated drugs [0051]) and contacts the second portion (scaffolding includes pores which are in contact with the encapsulated drugs [0051]), wherein the second portion is an inner portion of the orthopedic implant (the pores are considered inner portions because the very nature of a pore requires it to extend within something else).
2. Defelice discloses the first portion is an outer portion at least partially made of PEEK and/or PEKK and/or PAEK and/or PEI and/or PPSU and/or PSU and/or PAI ([0025] discloses the use of PEEK for the implant scaffold).
3. Defelice discloses the second portion is an inner portion (see explanation above) at least partially made of a biodegradable material, the biodegradable material being one of the following materials or material combinations: polydioxanone (PDS or PPDX or PPDO), polylactide (PLA), poly(lactide-co-glycolide) (PLGA), a mixture of polylactide (PLA) and poly(lactide-co-glycolide) (PLGA) ([0051] discloses the use of PLA for the second portion).
4. Defelice discloses the first portion and/or the second portion is/are formed to be porous at least in parts (Defelice discloses a variety of pores throughout the lattice [0049], specifically discloses pores for containing the drugs [0051], and the second portion inherently has a central pore because it encapsulates another portion [0051]).
5. The implant of Defelice is disclosed as being capable of use within a backbone cage ([0049]-[0051] and Claim 7).
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) 6-9 and 12is/are rejected under 35 U.S.C. 103 as being unpatentable over Defelice.
Defelice generally discloses the invention substantially as claimed being an implant which is 3D printed, see rejection above. Defelice discloses the different portions and different materials but fails to specifically say that each aspect of the implant is 3D printed or get into if and when each portion is joined.
The methods of combining the two portions initially with the same process, printing a second portion onto a first portion, or joining two previously printed portions are all extremely well known methods of manufacturing. Forming an object as a unitary object with all portions directly joined or printed together is one of the principal advantages of 3D printing because it speeds up production and forms a seamless product. Forming two things separately and then joining them is one of the oldest forms of production.
Therefore it would have been obvious to one having ordinary skill in the art at the time the invention was made to form the implant of Defelice including the first and second portions by 3D printing them as a single project in order to print the entire object with a single printer taking up less space (claims 7-8) or if printing each portion separately then then joining by a method other than printing such as adhesive or heat welding in order to allow multiple printers in order to print smaller portions faster (Claim 9).
6. Defelice discloses a method of manufacturing an orthopedic implant [0049] comprising at least the following steps: a first portion of the implant (scaffolding [0049] identified above) is produced by means of 3D printing [0035], wherein the first portion forms a support structure of the implant (see explanation with respect to claim 1 above); a second portion (the encapsulating carrier for the drugs [0051]) is produced by means of 3D printing (See 103 explanation above), wherein the second portion is at least partially made of a biodegradable material ([0051] discloses the biodegradable polymer PLA), wherein the first portion surrounds and contacts the second portion which is an inner portion of the implant (see explanation with respect to claim 1 above).
12. Defelice discloses the implant is produced by means of a FLM method [0045].
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-9 and 12 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Additionally the applicant is advised to review the following prior art as they also anticipate the claims along or in combination.
("7226481" "7682400" "5192326" "6620196")
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER D PRONE whose telephone number is (571)272-6085. The examiner can normally be reached Monday-Friday 10 am - 6 pm (HST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie R Tyson can be reached on (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CHRISTOPHER D. PRONE
Primary Examiner
Art Unit 3774
/Christopher D. Prone/Primary Examiner, Art Unit 3774
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