DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Interpretation - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
Use of the word “means” (or “step for”) in a claim with functional language creates a rebuttable presumption that the claim element is to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is invoked is rebutted when the function is recited with sufficient structure, material, or acts within the claim itself to entirely perform the recited function.
Absence of the word “means” (or “step for”) in a claim creates a rebuttable presumption that the claim element is not to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is not invoked is rebutted when the claim element recites function but fails to recite sufficiently definite structure, material or acts to perform that function.
Claim elements in this application that use the word “means” (or “step for”) are presumed to invoke 35 U.S.C. 112(f) except as otherwise indicated in an Office action. Similarly, claim elements that do not use the word “means” (or “step for”) are presumed not to invoke 35 U.S.C. 112(f) except as otherwise indicated in an Office action.
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 and 5-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 4, 5, 6, and 8 of U.S. Patent No. 8,439,947. Although the claims at issue are not identical, they are not patentably distinct from each other because claims of the patent encompass subject matter of claims of the present application. See the table below.
Claims 2-4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 8,439,947 in view of Nelson et al. (2010/0094347). See the table below. U.S. Patent No. 8,439,947 claims the system substantially as claimed in the present application, but does not explicitly claim that the system comprises an implant or bone implant, wherein the implant is configured to be rotatably aligned using the flexible inserter. Nelson et al. teach, in figures 17 and 18 and para. [0099]-[0101], a system including an implant or bone implant (148), wherein the implant is configured to be rotatably aligned using a flexible inserter (114). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, in view of Nelson et al. to include an implant or bone implant, as claimed, with the system as claimed in U.S. Patent No. 8,439,947. Such a modification would allow preparation of fractured bone and fixation of the bone with an implant or bone implant.
Claims of U.S. Pat. App. No. 18/751,615
Claims of U.S. Pat. No. 8,439,947
1
1
2
1 (in view of Nelson et al.)
3
1 (in view of Nelson et al.)
4
1 (in view of Nelson et al.)
5
1
6
1
7
1
8
3
9
4
10
1
11
5
12
6
13
8
Claim Rejections - 35 USC § 103
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-5, 11, 12, 14-17, 19, and 20 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Nelson et al. (2010/0094347) in view of Corcoran et al. (2005/0080400) and further in view of Barber (4,541,423).
Nelson discloses in figures 17 and 18 and para. [0097] and [0099]-[0101]; a system for inserting an implant (148) into an internal anatomical site comprising: a drill (126, [0087]) (Fig. 17-18) configured to form a bore in bone at the internal anatomical site (according to para. [0097]), and a flexible inserter (114) including a shaft (114) (Fig. 5 and 17-18) having a flexible portion interlocking segments (portions in Fig. 17-18), the flexible inserter configured to insert the implant into the bore in bone (where it is capable of performing this function); wherein the system further comprises an implant or a bone implant (Fig. 18-19, [0087], and [0076]); wherein the implant is configured to be rotatably aligned using the flexible inserter ([0101]); wherein the system further comprises a flexible obturator ([0066]); wherein the shaft of the flexible inserter is substantially cannulated and comprises a thickness between an outer surface and an inner surface (Fig. 18); wherein the interlocking segments are constructed from a solid, continuous length of material (Fig. 18-23); and wherein adjacent interlocking segments are axially offset from one another (when the shaft is curved within the bone it would be offset).
Nelson also disclose a method for inserting an implant (148) into a bore in bone, comprising: forming the bore in bone with a drill (according to para. [0097], and inserting an implant into the bore in bone with a flexible inserter (114) including a shaft (114) having a flexible portion including interlocking segments (Fig. 17-20); wherein the shaft of the flexible inserter is substantially cannulated and comprises a thickness between an outer surface and an inner surface (Fig. 18-23); wherein the interlocking segments are constructed from a solid, continuous length of material (Fig. 18-23); wherein adjacent interlocking segments are axially offset from one another (when the shaft is curved within the bone it will be offset); and wherein inserting the implant into the bore in bone with the flexible inserter includes rotatably aligning the implant in the bone using the flexible inserter ([0080] and [0094]).
Nelson teaches all the claimed limitations discussed above, however Nelson does not disclose that the interlocking segments are discrete interlocking segments.
Corcoran discloses another well-known flexible shaft where the interlocking segments can be either connected (Fig. 6b) or independent (Fig. 3-4) as discloses in [0026]. Thus, Corcoran discloses that these arrangements for the interlocking segments is well known equivalents in the art.
Therefore, it would have been obvious to one of ordinary skill in the art to modify the interlocking segments of Nelson to be independent/discrete, as taught by Corcoran, since it has been held that a simple substitution of one known element for another will yield predictable results. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Nelson in view of Corcoran teach all the claimed limitations discussed above however Nelson in view of Corcoran do not explicitly disclose that the drill is a flexible drill.
Barber teaches, in figures 1, 4, and 5 and col. 2, line 46 to col. 3, line 26 and col. 4, lines 29-42; a flexible drill (10) configured to form a bore in bone at the internal anatomical site and a method of forming the bore with the flexible drill.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, in view of Barber, to apply a flexible drill in the system and method of Nelson et al. Such a modification would allow the drilling of a curved bore in bone for receiving and proper positioning of an implant.
Claims 13 and 18 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Nelson et al. (2010/0094347) in view of Corcoran et al. (2005/0080400) and Barber (4,541,423), and further in view of Krause et al. (6,053,922).
Nelson in view of Corcoran and Barber discloses the invention substantially as claimed, but do not explicitly disclose that the interlocking segments are constructed from a solid, continuous length of material by a plurality of laser cuts extending completely through the thickness of the shaft.
Krause teach, in col. 10, lines 27-42; interlocking segments of a shaft constructed from a solid, continuous length of material by a plurality of laser cuts extending completely through the thickness of the shaft. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, in view of Krause et al., to construct, as claimed, the interlocking segments of the shaft of Nelson in view of Corcoran and Barber. Such a modification would allow convenient and precise cutting of the shaft to produce a desired slot pattern (i.e., slots between segments) and a shaft with a predetermined flexibility.
Response to Arguments
Applicant’s arguments filed 3/5/26 have been considered but are moot in view of the new grounds of rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The cited prior art when considered in combination appears to teach the claimed limitations.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DIANNE DORNBUSCH whose telephone number is (571)270-3515. The examiner can normally be reached Monday-Wednesday 9 am-3 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at (571) 272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DIANNE DORNBUSCH/Primary Examiner, Art Unit 3771
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