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 .
Information Disclosure Statement
The information disclosure statement filed 12/08/2025 fails to comply with the provisions of 37 CFR 1.98(a)(4) because it lacks the appropriate size fee assertion. It has been placed in the application file, but the information referred to therein has not been considered as to the merits.
The information disclosure statement filed 12/08/2025 fails to comply with the provisions of 37 CFR 1.97(a) because it lacks the appropriate size fee set forth in 37 CFR 1.17(v). It has been placed in the application file, but the information referred to therein has not been considered as to the merits.
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 1, 8 and 17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 15 and 16 of copending Application No. 18/203,128 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Independent claim 1 recites all of the elements of claim 3 (which depends from claims 1 and 2) of the reference application. The difference between independent claim 1 of the application and claim 3 of the reference application lies in the fact that the reference application claim recites “pedicle screw” instead of “surgical implant” as disclosed in the application. Thus, the invention of claim 3 of the reference application is in effect a “species” of the “generic” invention of claim 1 of the application. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Circ. 1993). Since claim 1 of the application is anticipated by respective claim 3 of the reference application, it is not patently distinct from claim 3.
Furthermore, claim 1 (line 9) of the reference application recites “the second part being retained by the first part”, thus reciting all of the elements of claim 8 of the application.
Independent claim 17 recites all of the elements of claim 16 (which depends from 15) of the reference application. The difference between independent claim 17 of the application and claim 16 of the reference application lies in the fact that the reference application claim recites “pedicle screw housing assembly” instead of “surgical implant”, “first part” instead of “body component”, and “second part” instead of “fastener component”. Thus, the invention of claim 16 of the reference application is in effect a “species” of the “generic” invention of claim 17 of the application. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Circ. 1993). Since claim 17 of the application is anticipated by respective claim 16 of the reference application, it is not patently distinct from claim 16.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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.
Claims 17-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Biedermann et al. (U.S. Publication No.2013/0345758 A1; hereinafter “Biedermann”).
Regarding claim 17, Biedermann discloses a surgical implant formed through an additive manufacturing process (see embodiment of Figures 1 and 2) comprising: a body component (receiving part 5) formed layer-by-layer by depositing and fusing a first plurality of successive layers of a first material; and a fastener component (anchoring element 1) disposed within a cavity of the body component (bore 53), the fastener component formed layer-by- layer by depositing and fusing a second plurality of successive layers of a second material, an initial layer of the second plurality of successive layers being formed prior to the formation of a final layer of the first plurality of successive layers, wherein the body component and the fastener component is formed such that the fastener component is retained within the body component (see Figures 12-13).
It is noted that claims 17-20 are product-by-process claims. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). With this respect, receiving part 5 and anchoring element 1 of Biedermann, are the same as the product disclosed above. It is also noted that Biedermann discloses construction of an implant that allows to provisionally hold the pieces together, for example, a welding point that is broken or a spring that is pressed away when the predetermined torque is exceeded (para.0062). Biedermann further discloses wherein the pedicle assembly can be manufactured by an additive layer manufacturing method (see para.0061). Thus, Biedermann’s receiving part 5 and anchoring element 1 can be made by the process disclosed in claim 17.
Regarding claim 18, Biedermann further discloses wherein the body component (5) is a spinal implant (receiving part 5 is part of a polyaxial bone anchoring device as shown in Figure 1).
Regarding claim 19, Biedermann further discloses wherein the body component (5) and the fastener component (1) are formed such that the fastener component is irremovably disposed within the body component (anchor 1 is unable to move through bottom end 52 of receiving part 5 as head 3 is held within the receiving part 5, see para.0039) .
Regarding claim 20, Biedermann further discloses a support structure, the support structure formed layer-by-layer by depositing and fusing a third plurality of successive layers of the first source material or the second source material, wherein the support structure bridges the body component and the fastener component (via a welding point, see para.0062)
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Allowable Subject Matter
Claims 2-7 and 9-11 are objected to as being dependent upon a rejected base claim (see double patenting rejection disclosed above), but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 12-16 are allowed.
Claims 12-16 in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found to disclose, or suggest a method of manufacturing a surgical implant comprising: alternately depositing and heating successive layers of a first source material to form a first portion of a body component of the surgical implant; alternately depositing and heating successive layers of a second source material subsequent to formation of the first portion to form a fastener component of the surgical implant, the fastener component being retained by the body component; and alternately depositing and heating successive layers of the first source material subsequent to formation of the first portion to form a second portion of the body component, wherein the body component and the fastener component are fully assembled upon completion of formation of the body component and the fastener component. Biedermann fails to disclose these method steps.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Cawley et al. U.S. Publication No.2016/0157908 A1
Kirschman et al. U.S. Publication No.2010/0249926 A1
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Christina Negrelli whose telephone number is 571-270-7389. The examiner can normally be reached on Monday-Friday, between 8:00am to 4:00pm. If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo Robert, at (571) 272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTINA NEGRELLI/
Examiner, Art Unit 3773
/EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773