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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the disk-shaped augment comprising a first side, a second side, an outer sheath on lateral sides, and having an outer facia which is conically inclined, tapering towards the first side at an angle of 5º-10º (claim 13), and the disk-shaped augment comprising a first side, a second side, an outer sheath on lateral sides, and having radially outwardly directed spikes on an outer facia (claim 14) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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, which sets forth the parameter of “an outer sheath on lateral sides”, on line 5; however, this parameter is found to be confusing since it is not clear what exactly, structurally, is meant by the term “outer sheath”. Specifically, is the “outer sheath” a separate covering/casing type material which is applied/placed on the lateral sides of the augment, meeting the tradition definition of a “sheath”; or is it just meant as a descriptive term for the lateral/outer sides of the augment. Furthermore, the last two lines of the claim set forth the parameter(s) of “the legs are designed in a skeletal construction with multiple adjacent disk segments separated by slots, and arranged on the frame via webs” (emphasis added); however, this/these parameter(s) is/are found to be confusing for multiple reasons. Firstly, it is unclear what exactly, structurally/chemically, is meant by “a skeletal construction”, does this mean the legs look like skeletons, or bones, or have the chemical make-up of bone/skeletons, or does it mean something else completely different. Secondly, it is unclear if the disk segments are located/placed “on” the frame/legs, or if they are located/arranged between/amidst the frame/legs; specifically, the parameter states the skeletal construction is formed by the legs and multiple adjacent disk segments which are “separated by slots”, but the parameter also states that the multiple adjacent disk segments are “arranged on the frame”, therefore it is unclear how/where the multiple adjacent disk segments are placed/located. Lastly, it is unclear what exactly, structurally, is meant by the term “webs”; is this term merely meant to mean thin connecting structures, or is there more structural/chemical meaning to the term. Thus, one having ordinary skill in the art would not reasonably be apprised of the scope of the invention, thereby rendering the claim indefinite.
Regarding claim 3, which recites the limitation “the material”, on line 3, there is insufficient antecedent basis for this limitation in the claim; furthermore, it is unclear what exact structure “the material” is part of/referencing. Additionally, lines 2-3 sets forth the parameter of “pores connected to one another in a depth of the material” (emphasis added); however, this parameter is found to be confusing since it is not clear what exactly is meant by the pores being connected “in a depth of the material”. Does this mean the pores are connected to one another/are located only a specific “depth” in the material or does it mean the pores are connected to one another/are located throughout the entirety of the material, as opposed to just a surface, or does it mean something else completely different. Thus, one having ordinary skill in the art would not reasonably be apprised of the scope of the invention, thereby rendering the claim indefinite.
Regarding claim 5, which sets forth the parameter of “the legs have a solid core, on an outside of which pockets are formed”; however, this parameter is found to be confusing since it is not clear what exactly is meant by the pockets being formed “on an outside of” the solid core/legs. Specifically, the direction/location of outside is found to be unclear, outside of what; outside of the legs, the core, something else and/or outside in what direction/location; outside the legs, such as on the disk segments or on some other different structure of the augment. Thus, one having ordinary skill in the art would not reasonably be apprised of the scope of the invention, thereby rendering the claim indefinite.
Regarding claim 9, which sets forth the parameter of “the frame is an outer edge which encloses at least half of the disk segments and on an outside of which the outer sheath is arranged”; however, this parameter is found to be confusing for a few reasons. Firstly, it is unclear what is meant the frame being “an outer edge”, an outer edge of what; is it referring to the outer edge side of the frame, or does this mean the frame acts as an outer/ edge/periphery of the disk-shaped augment, or does it mean something else completely different. Secondly, it is unclear what exactly is meant by “an outside of which the outer sheath is arranged”; specifically outside of what, the frame, the disk segments, or some other structure and/or outside in what direction/location, outside the frame, outside the disk segments, outside the augment, or somewhere else. Also, claim 1, from which claim 9 depends, has already set forth that the outer sheath is “on lateral sides” of the disk-shaped augment, so it is further unclear if “the outer sheath”, of claim 9, is the same structure as the outer sheath set forth in claim 1, or is it another additional outer sheath. Thus, one having ordinary skill in the art would not reasonably be apprised of the scope of the invention, thereby rendering the claim indefinite.
Regarding claim 10, the last line of the claim sets forth the parameter of “the fastening hole has a solid perforated facia”; however this parameter is found to be confusing for a couple of reasons. First, it is unclear what exactly, structurally, is meant by the term “facia”; specifically, what exact structure and/or material would be needed in order to meet the term “facia”. Second, it is confusing how something can be solid and perforated, in fact the terms are considered opposites of each other, i.e. if something is solid it does not contain any holes/spaces/perforations, and if something is perforated it has holes/spaces and cannot be solid. Thus, one having ordinary skill in the art would not reasonably be apprised of the scope of the invention, thereby rendering the claim indefinite.
Regarding claim 11, which ultimately depends from independent claim 1, which on the last two lines sets forth that the disk segments are “arranged on the frame via webs”; and claim 11 further sets forth the parameter of “said disk segment is arranged on the frame by means of a bridge which is wider than the webs”, however this parameter is found to be confusing. Specifically, it is unclear how the disk segment is actually arranged on the frame, is it by “webs” or by “bridges” or by both webs and bridges. Additionally, it is further unclear if the arrangement set forth in claim 11 is only directed to the disk segment which comprise the fastening hole, or is it for all the disk segments. Thus, one having ordinary skill in the art would not reasonably be apprised of the scope of the invention, thereby rendering the claim indefinite.
Regarding claim 13, which sets forth the parameter of “an outer facia is conically inclined, tapering towards the first side”; however this parameter is found to be confusing for a couple of reasons. First, it is unclear what exactly, structurally, is meant by the term “facia”; specifically, what exact structure and/or material would be needed in order to meet the term “facia”. Secondly, it is unclear where exactly this “outer facia” is actually located on the final structure of the disk-shaped augment. Thus, one having ordinary skill in the art would not reasonably be apprised of the scope of the invention, thereby rendering the claim indefinite.
Regarding claim 14, which sets forth the parameter of “radially outwardly directed spikes are provided on an outer facia”; however this parameter is found to be confusing for a couple of reasons. First, it is unclear what exactly, structurally, is meant by the term “facia”; specifically, what exact structure and/or material would be needed in order to meet the term “facia”. Secondly, it is unclear where exactly the “outer facia”, and thereby the radially outwardly directed spikes, is/are actually located on the final structure of the disk-shaped augment. Thus, one having ordinary skill in the art would not reasonably be apprised of the scope of the invention, thereby rendering the claim indefinite.
Regarding claim 22, which sets forth the parameter of “the through-opening is configured for receiving the anchoring keel and its wing-like extensions are dimensioned with a defined free space of 1 to 3 mm”; however this parameter is found to be confusing since it is not clear what exact structure(s) are actually be set forth by this claim. Specifically, it is unclear what the structures of “wing-like extensions” and “free space” actually are/where they are; specifically, are the wing-like extensions part of the anchoring keel, or are they other separate and distinct structures, and if so, where exactly on the final structure of the disk-shaped augment are they located, and where on the final structure of the disk-shaped augment is the “defined free space” located. Thus, one having ordinary skill in the art would not reasonably be apprised of the scope of the invention, thereby rendering the claim indefinite.
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, 2, 8 and 9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8 and 9 of copending Application No. 18/684,187 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims disclose a disk-shaped augment, for filling bone defects, having a first/distal side, a second/proximal side, an outer sheath on lateral sides, and an inner wall for a through-opening running from the first/distal side to the second/proximal side for an anchoring keel of an endoprosthesis arranged on the second/proximal side, wherein the augment is C-shaped with two legs flanking the through-opening, wherein a connecting piece between the legs, forms a frame, in an articulated manner and interacts resiliently with the legs so that when the legs are compressed an outwardly directed restoring force is generated, wherein the legs comprise a skeletal construction with multiple adjacent disk segments separated by slots, and arranged on the frame via webs, the outer sheath is designed as a porous structure which promotes bone ingrowth, and wherein the frame is an outer edge which encloses at least half of the legs, and on an outside of which the outer sheath is arranged.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DINAH BARIA whose telephone number is (571)270-1973. The examiner can normally be reached Monday - Friday 10am - 5pm.
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/DINAH BARIA/Primary Examiner, Art Unit 3774 06/04/2026
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