DETAILED ACTION
This is the first office action on the merits in this application. The claims as amended December 4, 2024, are under consideration. Claims 1-22 were amended, and are pending.
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 .
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 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8 of copending Application No. 18/683271 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because elements in the claims are considered to correspond such that they read upon one another. See the comparison chart, below.
18/684187 (instant)
18/683271 (reference)
A disk-shaped augment for filling bone defects having
a proximal side,
a distal side,
an outer sheath on lateral sides, and an inner wall for a through-opening running from the proximal side to the distal side for an anchoring keel of an endoprosthesis arranged on the proximal side, wherein the augment is C-shaped with two legs flanking the through-opening,
characterized in that a connecting piece between the legs is formed in an articulated manner and interacts resiliently with the legs so that when the legs are compressed an outwardly directed restoring force is generated, and
the outer sheath is designed as a porous structure which promotes bone ingrowth,
and a cover plate is provided on the proximal side, which cover plate has a ribbed structure as an interlocking for cement bonding.
A disk-shaped augment for filling bone defects comprising:
a first side;
a second side;
an outer sheath on lateral sides; and an inner wall for a through-opening running from the first side to the second side for an anchoring keel of an endoprosthesis arranged on the second side, wherein the augment is C-shaped with two legs flanking the through-opening,
wherein a connecting piece between the legs is formed in an articulated manner and interacts elastically with the legs so that a frame is formed, and when the legs are compressed an outwardly directed restoring force is generated,
wherein the legs are designed in a skeletal construction with multiple adjacent disk segments separated by slots, and arranged on the frame via webs.
8. wherein the slots are a narrow size that is configured to act as a gap seal for bone cement, having a maximum width of 0.7 mm.
The limitation “skeletal construction” is considered to be referring to a porous structure. Further discussion of the porous structure is found throughout the claims. The claimed “outer sheath” over the lateral sides is understood to be a portion of the claimed legs.
The claimed “cover plate” is not considered to be required to be a separate structure, as claimed. A top structure with slots, therein, for holding cement, at claims 1 and 8 of the reference application are considered to read on the claimed ribbed structure for cement bonding of the instant claim.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Objections
Claim 2 is objected to because of the following informalities: the word “are” is inadvertently omitted at line 3. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, the claim teaches the augment being “disk-shaped” at line 1, and C-shaped at line 5. These are considered to be contradictory terms. Clarification or correction is required. For purposes of this office action, the term “disk-shaped” will be omitted from the claim when making the rejection.
Claim 1 requires “resiliency” at line 7. The claim also requires the legs are “formed in an articulated manner”. These appear to be contradictory limitations. Examiner understands “articulated” to mean “made of separate sections or segments connected by joints, hinges, or pivots that allow them to move or bend independently” (Merriam Webster Dictionary, 2026). Examiner understands applicant’s invention to be a unitary, resilient, structure which is not properly understood to be an articulated structure. Examiner believes that this limitation may also necessitate a drawing objection in a future office action absent remedy. Clarification or correction is required. For purposes of this office action, the term “articulated” will be omitted from the claim when making the rejection. For applicant’s consideration and examiner’s understanding, the Maxson reference cited below includes embodiments which show alternative bending structures which are agreed to be articulated – e.g. at fig. 5.
Claim 1 teaches an inner wall for a through opening at line 3, then teaches that the two legs “flank the through opening” at line 6. It is unclear if the through opening is intended to be positively recited in the claim. Examiner believes the through opening was intended to be positively recited, and treats the claims as such for examination purposes. Correction is required.
Claim 9 teaches the limitation “gap seal”. This is not a term familiar to examiner. Is this a particular structural term? What are the slots sealing? Presumably cement – but what are they keeping the cement away from? Examiner requests clarification as to how this structure is required to be formed based on the claim, and what the function of these seals is.
Claim 10 teaches that the fastening hole has a “solid perforated sheath”. Is this a different sheath than was required by claim 1? (That sheath was porous) This sheath is required to be both “solid” and “perforated” which appear to be contradictory terms. Clarification as to the structure of this sheath is required. It is suggested that the name of this sheath be changed for clarity of the term in claim 10 and claim 1.
Claim Interpretation
The limitation “solid” understood in terms of context of the disclosure. Solid is understood to be “nonporous”.
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.
Claim(s) 1, 2, 4-8, 10, 12 and 14-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Maxson et al. (US 2014/0172116 A1).
Regarding claim 1, as best understood, Maxson teaches an augment 10 capable of use in filling bone defects having a proximal side (34, up in fig. 3), a distal side (36, down in fig. 2), an outer sheath (at portions 20, about portions 44) on lateral sides, and an inner wall 30 about a through-opening inside of 30 running from the proximal side 34 to the distal side 36 for an inferred anchoring keel of an inferred endoprosthesis capable of being arranged on the proximal side. The augment 10 is C-shaped as in fig. 2 with two legs 24/26 flanking the through-opening between legs 24/26, characterized in that a connecting piece at 22/42 between the legs 24/26 interacts resiliently with the legs 24/26 (flexibility of 22 discussed at [0024], [0027]; “flexibility of the hinge” can be adjusted based on structure of 42 [0027]) so that when the legs 24/26 are compressed an outwardly directed restoring force is generated, and
the outer sheath at portions 20 is designed as a porous structure which promotes bone ingrowth, and a cover plate at the plurality of portions 44, taken together, is provided on the proximal side 34, which cover plate 44 has a ribbed structure (portions 44 described as ribs at [0022]) as an interlocking for cement bonding (there is no reason that cement cannot be applied to and couple to the proximal surface 34, taking purchase at least between the ribs 44).
Regarding claim 2, the distal side 36 is designed as a porous structure at portions 20 (36 understood to be identical to 34), wherein edges at at least 22/44 are solid.
Regarding claim 4, the porous structure 20 has porous areas that are framed by a solid edge 22/44.
Regarding claim 5, the legs have a solid core on 44 an outside of which pockets are formed, in which the porous structure 20 is arranged. (The regions between portions 44 are considered to be in the form of pockets).
Regarding claim 6, the legs are formed from a porous structure 20.
Regarding claim 7, there is nothing in this claim that prevents the figure 3 embodiment of Maxson from reading on what is claimed. As discussed at [0025], the implant is formed to be similar to the implant of fig. 2, and made of the same materials – it is therefore considered that this embodiment simply omitted structures 44 from the figure as a matter of simplicity. The outermost (lateral) portion of the legs is now considered to the claimed ‘sheath’. There is no structural limitation in the claim that prevents such understanding. The inner walls 22 on the legs are solid of this embodiment are taught being solid (non-porous).
Regarding claim 8, there is nothing in this claim which prevents use of the figure 4 embodiment. The sheath is now considered arranged at an outermost portion of 20A-F. The legs comprise a skeletal construction with multiple adjacent disk segments 34 separated by slots 28, and arranged on a frame 22/42A-E via flexible webs 42A-E, wherein the frame 22/42A-E is an outer edge which encloses at least half of the legs, and on an outside of which the outer sheath is arranged (20A-F are outside of (e.g. not co-located with) portions 22/42A-E).
Regarding claim 10, there is no reason that the figure 6 embodiment cannot be relied upon for rejecting this claim. The device includes at least one fastening hole 84 for receiving a fastening screw 82 is provided in the legs. The fastening hole has a solid perforated sheath 86. (The portion 86 is either a threaded insert (solid) as in fig. 6; or fastener 82 can be screwed directly into sheath 20 (perforated due to pores)) [0030].
Regarding claim 12, the through-opening inside 30 is an elongated receiving space capable of receiving a properly sized and configured anchoring keel.
Once a single alternative is met, the additional optional limitations need not be further considered.
Regarding claim 14, relying again on the figure 4 embodiment, the structures 20A-E are considered to be in a form that comprises radially outwardly directed spikes provided on the outer sheath 20 (the configuration of each portion 20 has a narrowed portion in the radially outward direction which can be considered a spike).
Regarding claim 15, the ribbed structure 44 has continuous grooves (the portions between each element 44 in which a portion 20 resides is considered a continuous groove).
Regarding claim 16, the claims is treated as a product by process claim as at MPEP 2113. Only the structures are understood to be required by the claim, not the actual process. The burden is applicant’s to demonstrate that the methods of manufacture of claim 16 cause a non-obvious difference. It is examiner’s position that the claimed processes do not result in materially different structures from any other methods of manufacture.
Regarding claim 17, the term “cement tight” is given a special definition in the disclosure to mean that no cement is able to pass therethrough. There is no structural limitation which requires the cover plate be a separate structure from any part of the device. The top surface of portions 44 is considered to be cement tight in that these portions are non-porous.
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) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maxson.
Regarding claim 3, Maxson teaches the limitations of claim 1, as above. Further, Maxson teaches the porosity of his device being for the purpose of boney ingrowth ([0024], claim 3) yet having sufficient strength to support loads in an implanted situation [0021]. It is considered old and well known in the art that for pores to function for purposes of boney ingrowth, they pores must be connected to one another in a depth of the porous structure to permit the ingrown bone to pass therethrough.
Maxson does not teach the pores have a width of 0.4 to 1.0 mm.
It would have been obvious to one with ordinary skill in the art at the time of the invention to form the Maxson device with pores of the claimed size. One would have done so as a matter of selection of sizes which are predictable solutions with a reasonable expectation of success. Such would have been a matter of forming the Maxson device of a structure which can be determined as an acceptable structure for improving bone ingrowth while maintaining sufficient structural strength to support weight in the desired surgical use [0021].
Regarding claim 13, Maxson teaches the limitations of claim 1, above. Maxson further teaches the outer sheath 20 is conically inclined, tapering towards the distal side.
A particular angle of taper is not disclosed, though the figures appear to be similar to the claimed range of 5 to 10 degrees.
It would have been obvious to one with ordinary skill in the art at the time of the invention to form the Maxson device at a taper angle of 5 to 10 degrees as a matter of forming the implant for a particular patient anatomy, size, and shape. One would have done so in order that Maxson would fit into its intended location of use.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maxson in view of Bauer (US 2018/0193152 A1)
Regarding claim 18, Maxson teaches the limitations of claim 1, as above. However, Maxson does not teach the porous structure is provided with a bone ingrowth-promoting coating comprising calcium phosphate.
Bauer teaches an augment 7 for use with an implant 6 formed with a porous structure 71. As at [0063], a coating 30 can be provided on the porous structure which includes a calcium phosphate coating.
It would have been obvious to one with ordinary skill in the art at the time of the invention to coat the porous portion of Maxson with calcium phosphate, since such a coating is known to be a bone growth promoting material (Bauer, [0028]).
Once a first alternative is shown to be met, the other alternatives need not be considered further.
Claim(s) 19-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maxson in view of Sandoz et al. (US 5,938,698).
Regarding claim 19, Maxson teaches the augment, as above. However, Maxson does not teach interaction with a particularly formed implant.
Sandoz teaches use of an augment 3 for use with an implant having an anchoring keel which is received in a through-opening of the augment: see figs. 2 and 3A, augment 3 receiving rib 18 through slot 19.
It would have been obvious to one with ordinary skill in the art at the time of the invention to modify the formation of the through opening of Maxson to include slots similar to 19 of Sandoz such that the Maxson device can be used in conjunction with an implant. One would do so in order to make the Maxson device useful in additional types of procedures, and to permit additional fixation of the Maxson device through use of a ribbed implant.
Regarding claim 20, as can be seen in Sandoz, the disk-shaped augment 3 is similar in size to an outer contour but undersized in relation to the endoprosthesis (see fig.1).
Regarding claim 21, the disk-shaped augment is configured to support a left half or a right half of the endoprosthesis as seen at fig. 2 of Sandoz.
Regarding claim 22, the through-opening is dimensioned for receiving the anchoring keel and its wing-like extensions with a defined free space.
Sandoz does not specify an amount of defined free space to be 1 to 3 mm. It would have been obvious to select an implant and spacer relationship such that such the claimed amount of free space is provided: Sandoz teaches use of various sizes and shapes of spacers. (col. 1, lines 53-60)
Allowable Subject Matter
Claims 9 and 11 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The claims cannot be allowed until such time as the outstanding rejections under 35 USC 112(b) are overcome.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to David Bates whose telephone number is (571)270-7034. The examiner can normally be reached Monday through Friday, 10AM-6PM
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/DAVID W BATES/Primary Examiner, Art Unit 3799
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