DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of the Claims
Claims 1-20 are pending in the application and are currently under examination.
Information Disclosure Statements
The IDS’s filed 11/18/2024 and 11/4/2025 have been considered. Signed copies are enclosed herewith.
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994)
The disclosure of the prior-filed applications, Application Nos. 61/187,081 and 61/252,800, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Claims 112-114 and 121-123 require the limitations, “wherein said hollows have a diameter ranging from about 125 to 650 microns and wherein the first phase has a height of between 1-7 mm”. Said limitations are not supported by the aforementioned provisional applications. However, said limitations are described in PCT/IL10/00410 and, as such, claims 1-20 are afforded a priority date of 5/23/2010.
Claim Objections
Claims 1 and 10 are objected to because of the following informalities: the claims recites, “the hollows have a diameter ranging from about 125 to 650 mm”. The units appear to be an obvious error as the specification teaches that the units should be in microns (see [0056] and claim 16). For purposes of compact prosecution and applying art, the limitation is being interpreted in microns. 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.
Claim 7 is 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.
Claim 7 recites, “wherein the hollows have an average diameter ranging from about 60-160 microns”. Claim 7 depends from 1. Claim 1 recites, “the hollows have a diameter ranging from about 125 to 650 mm”. Even assuming that the units should be in microns in claim 1, the claim is indefinite because the range recited in claim 7 is not possible, i.e., there are embodiments that allow for an average diameter to be outside of the diameter range.
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.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1, 6 and 8-20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Stone et al. (US 2008/0249632 A1, Oct. 9, 2008, hereafter as “Stone”) in view of Sherwood et al. (US 2003/0114936 A1, Jun. 19, 2003, hereafter as “Sherwood”) as evidenced by Merriam-Webster (see PTO-892).
The instant invention is drawn to a bi-phasic scaffold for tissue repair, the bi-phasic scaffold having two phases wherein: a first phase of the two phases extending to an upper surface of the bi-phasic scaffold, the first phase comprises a series of hollows extending from an upper surface of the bi-phasic scaffold along a longitudinal axis in the first phase; wherein the hollows have a diameter ranging from about 125 to 650 microns and wherein the first phase has a height of between 1-7 mm; and a second phase of the two phases extending to a lower surface of the bi-phasic scaffold; and a method of inducing or enhancing repair, regeneration or enhancement of cartilage, bone or a combination thereof.
Regarding instant claims 1 and 10, Stone teaches a method of repairing cartilage defects comprising implanting a cartilage repair plug ([0001] and [0003]). The cartilage plug includes a top or articulation layer 12 (i.e., a first phase), a base 14 (i.e., a second phase), and optionally, a bore 16 containing a bioactive material 18 ([0014]; Fig. 4). Stone teaches that the articulation layer and base layer can be made of the same material including the particular material, coral ([0023] and [0024]). Stone also teaches that the articulation layer and base layer can be formed from a monolithic piece of material ([0025]). Stone further teaches that the plug can accommodate ingrowth of new cartilage and/or new bone ([0019] and [0023]). Stone also teaches the particular bioactive material, live cells including chondrocytes ([0027]).
Stone is silent to the first phase comprising a series of hollows along a longitudinal axis, wherein said hollows have a diameter ranging from about 125 to 650 microns, and wherein the first phase has a height of between 1-7 mm.
Sherwood teaches implantable composite devices for the purpose of repair and replacement of cartilage and/or bone and a method of using thereof (abstract; claim 23). One such device is a fully resorbable synthetic scaffold containing a cartilage-appropriate region and bone appropriate region ([0020]). Sherwood also teaches staggered channels in the cartilage region to facilitate transport of nutrients to cells and removal of cellular by-products ([0020], [0063] and [0064]). Said channels can be fabricated radially or vertically ([0067]). Sherwood teaches that said channels can range from about 150 to 500 microns, with 250 microns preferred ([0063]). Sherwood also teaches that cartilage region can have a thickness (height) of 2 mm ([0020] and [0172]).
Both of the references are drawn to implantable scaffolds for bone and/or cartilage repair, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to a series of hollows along a longitudinal axis, having a diameter ranging from about 125 to 650 microns in the first phase into the invention of Stone as suggested by Sherwood with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Sherwood teaches said staggered channels having the claimed diameters facilitate transport of nutrients to cells and removal of cellular by-products. It also would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have a cartilage region having a thickness (height) of between 1-7 mm because Sherwood teaches that a cartilage region thickness of 2 mm is effective for an implantable scaffold for the purpose of cartilage repair.
Regarding instant claim 6, Stone and Sherwood teach the elements discussed above.
Stone, as discussed above, teaches that the articulation layer and base layer can be made of the same material including the particular material, coral ([0023] and [0024]) and that the articulation layer and base layer can be formed from a monolithic piece of material ([0025]). Stone further teaches that the bore/channel can be shaped using any suitable cutting tool such as a scalpel, saw, or surgical drill ([0033]). A surgical drill is known to generally create round hollows/channels. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include circular hollows by using a surgical drill to create multiple circular channels with a reasonable expectation of success because Stone teaches that drilling a bore/channel is a suitable method for a material such as coral and a surgical drill is known to create a circular hollow/channel.
Regarding instant claims 8, 9 and 16, Stone and Sherwood teach the elements discussed above. Stone also teaches that the articulation layer can be porous to allow integration of cartilage with the implant ([0019]), the bore comprising an active agent facilitates tissue ingrowth into the implant site ([0039]), the bore can be in any region in the cartilage plug so long as the bore location does not impact the load distribution and that the bore can be defined by the cartilage plug articular layer and/or the cartilage plug base ([0026]). In other words, Stone teaches that the bore can be present in the articular layer, the base layer or both. Sherwood teaches a highly porous cartilage region to facilitate seeding chondrocytes selectively in this region and staggered channels in the cartilage region to promote homogeneous seeding throughout the 2-mm thickness of the region [0020]. Sherwood also teaches that the channels facilitate the transport of nutrients to the cells and removal of cellular/polymer degradation by-products ([0064]). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a series of hollows in only the first phase and not the second phase of the biphasic scaffold with a reasonable expectation of success because Stone and Sherwood teach treating articular cartilage defects ([0003] of Stone and [0280] of Sherwood) wherein the articular layer of Stone and the cartilage region of Sherwood are the outermost layers of the respective implants that align to the cartilage portion of the surrounding tissue (see Fig. 7C of Stone and [0093] of Sherwood) and both references teach including a bore or channels within only the outer articular layer/cartilage region for the same purpose of facilitating transport of nutrients and tissue ingrowth.
Regarding instant claims 11-15, Stone and Sherwood teach the elements discussed above. Stone also teaches that inclusion of bioactives within the bore such as polysaccharides ([0027]). Additionally, Sherwood teaches the polymers can be incorporated into the scaffold such as glycosaminoglycans including hyaluronic acid and that the pores may be fully or partially filled with an interpenetration substance such as polymers ([0102] and [0132]). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the particular polymer/polysaccharide, hyaluronic acid in the hollows of the first phase and not in the second phase with a reasonable expectation of success because the references teach that the hollows/channels can be included in only the first (cartilage) phase, a bioactive polymer/polysaccharide can be included in said hollows/channels, and the particular bioactive polysaccharide/polymer, hyaluronic acid, is a suitable material for the purpose of tissue regeneration.
Regarding instant claim 17, Stone and Sherwood teach the elements discussed above. Stone, as discussed above, teaches that the articulation layer and base layer can be made of the same material including the particular material, coral ([0023] and [0024]) and that the articulation layer and base layer can be formed from a monolithic piece of material ([0025]). Stone further teaches that the bore/channel can be shaped using any suitable cutting tool such as a scalpel, saw, or surgical drill ([0033]). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to drill the from the upper surface in order to only go through the cartilage portion of the plug, as suggested by Stone, to drill the multiple channels of Sherwood with a reasonable expectation of success because Stone teaches that drilling a bore/channel is a suitable method for a material such as coral.
Regarding instant claim 18, Stone and Sherwood teach the elements discussed above and Stone further teaches a tapered outer sidewall (Fig. 2A-2C). It is noted that “tapered” is not explicitly defined in the instant specification. As such, the examiner is giving the term the broadest reasonable interpretation. MPEP 2173.01 states,
Under a broadest reasonable interpretation, words of the claim must be given their plain
meaning, unless such meaning 1is inconsistent with the specification. The plain meaning
of a term means the ordinary and customary meaning given to the term by those of ordinary skill in the art at the time of the invention.
The plain meaning of “taper” is “to become progressively smaller toward one end” as evidenced by Merriam Webster. FIGs 2A-2C clearly illustrate the outer wall progressively getting smaller toward one end.
Regarding instant claims 19 and 20, Stone and Sherwood teach the elements discussed above. Stone, as stated above, teaches that the articulation layer and base layer can be made of the same material including the particular material, coral ([0023] and [0024]) and that the articulation layer and base layer can be formed from a monolithic piece of material ([0025]).
Thus, the combined teachings of Stone and Sherwood render the instant claim prima facie obvious.
Claims 2-5 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Stone et al. (US 2008/0249632 A1, Oct. 9, 2008, hereafter as “Stone”) in view of Sherwood et al. (US 2003/0114936 A1, Jun. 19, 2003, hereafter as “Sherwood”), as applied to claim 1 above, and further in view of Lindholm et al. (US 2005/0142164 A1, Jun. 30, 2005, hereafter as “Lindholm”).
The instant invention is described above.
Stone and Sherwood teach the elements discussed above including a monolithic piece of material and the particular material, coral.
Stone and Sherwood are silent to the specific attributes of the coral including a porosity of about 35% to about 55%.
Lindholm teaches osteogenic devise comprising coral for the purpose of repairing/regenerating bone (abstract; [0011] and [0063]). Lindholm teaches that coral is the limestone skeleton of various species of marine invertebrates and the porous structure and dimensions in certain types of coral microscopically resemble human trabecular (cancellous) bone ([0057] and[0140]). The porosity of natural coral can range from 20-50% ([0140]).
The references are all drawn to repairing/regenerating bone comprising implanting a bone scaffold/graft, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a porous coral, as suggested by Lindholm, in the invention of Stone/Sherwood with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Stone and Lindholm teach that coral is a suitable material for a bone scaffold/graft and Lindholm further teaches coral has a similar porous structure to that of human bone. It is noted that the claimed range of about 35% to about 55% overlaps with the range of 20-50% disclosed by the prior art. “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists (MPEP 2144.05(I)). It is further noted that “about” is defined in the instant specification as up to ±25 variance of the recited values ([0092]) which would broaden the claimed range to about 26.25% to about 68.75%.
Thus, the combined teachings of Stone, Sherwood and Lindholm render the instant claims prima facie obvious.
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 8,790,681 in view of Sherwood et al. (US 2003/0114936 A1, Jun. 19, 2003, hereafter as “Sherwood”).
Although the claims at issue are not identical, they are not patentably distinct from each other because the subject matter of the instant claims and the subject matter of the patented claims are significantly overlapping.
The instant invention is drawn to a bi-phasic scaffold for tissue repair, the bi-phasic scaffold having two phases wherein: a first phase of the two phases extending to an upper surface of the bi-phasic scaffold, the first phase comprises a series of hollows extending from an upper surface of the bi-phasic scaffold along a longitudinal axis in the first phase; wherein the hollows have a diameter ranging from about 125 to 650 microns and wherein the first phase has a height of between 1-7 mm; and a second phase of the two phases extending to a lower surface of the bi-phasic scaffold; and a method of inducing or enhancing repair, regeneration or enhancement of cartilage, bone or a combination thereof.
The patented invention is drawn to a scaffold for tissue repair, said scaffold consisting essentially of two phases wherein: a first phase of said two phases comprises solid coral and a biocompatible polymer, wherein said biocompatible polymer comprises a glycosaminoglycan comprising hyaluronic acid, sodium hyaluronate, cross-linked hyaluronic acid or combinations thereof, wherein said first phase further comprises a series of hollows along a longitudinal axis in said first phase, and wherein said biocompatible polymer penetrates to within said hollows; and a second phase of said two phases comprises a solid coral; a kit thereof; and a method of inducing or enhancing repair, regeneration or enhancement of formation of cartilage, bone or a combination thereof comprising implanting the scaffold of claim 1 in a subject in need thereof.
The patented invention does not explicitly recite, “wherein the hollows have a diameter ranging from about 125 to 650 microns and wherein the first phase has a height of between 1-7 mm”.
However, Sherwood teaches implantable composite devices for the purpose of repair and replacement of cartilage and/or bone and a method of using thereof (abstract; claim 23). Said method comprises the step of implanting the implantable composite into a patient at a site in need of repair or replacement (claim 23; paragraph [0028]). Sherwood teaches a fully resorbable synthetic scaffold containing a cartilage-appropriate region and bone-appropriate region for repair of articular defects (paragraph [0020]). Sherwood also teaches staggered channels in the cartilage region to promote homogenous seeding throughout the cartilage region (paragraph [0020]). Sherwood also teaches that the channels/pores may be fully or partially filled with an interpenetration substance including polymers (paragraph [0132]). Sherwood teaches that said channels can be between about 150-500 microns, preferably about 250 microns in diameter (paragraphs [0030], [0063] and [0172]). Sherwood also teaches that the cartilage region can have a thickness (height) of 2 mm (paragraphs [0020] and [0172]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the above dimensions as suggested by Sherwood with a reasonable expectation of success because Sherwood teaches a similar implant for the same purpose. A skilled artisan would have been motivated to do so because Sherwood teaches that staggered channels between about 150-500 microns and a cartilage region having a thickness (height) of 2 mm are suitable for the same purpose of repairing/replacing cartilage and bone (MPEP 2144.07).
Thus, the instant claims and the patented claims are not patentably distinct from one another in view of Sherwood.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 8,802,115 in view of Sherwood et al. (US 2003/0114936 A1, Jun. 19, 2003, hereafter as “Sherwood”).
Although the claims at issue are not identical, they are not patentably distinct from each other because the subject matter of the instant claims and the subject matter of the patented claims are significantly overlapping.
The instant invention is described above.
The patented claims are drawn to a scaffold for tissue repair, said scaffold consisting essentially of two phases wherein: a first phase of said two phases comprises solid coral comprising a biocompatible polymer; and a second phase of said two phases comprises solid coral and said second phase further comprises a series of hollows along a longitudinal axis in said second phase, wherein said first phase does not comprise a series of hollows along a longitudinal axis said second phase does not comprise a biocompatible polymer and said scaffold is cut from or shaped from a single piece of coral, and wherein said biocompatible polymer in said first phase comprises a glycosaminoglycan comprising hyaluronic acid, sodium hyaluronate, cross-linked hyaluronic acid, or a combination thereof; a kit thereof; and a method of inducing or enhancing repair, regeneration or enhancement of formation of cartilage, bone or a combination thereof comprising implanting the scaffold of claim 1 in a subject in need thereof.
The patented invention does not explicitly recite, “wherein the hollows have a diameter ranging from about 125 to 650 microns and wherein the first phase has a height of between 1-7 mm”.
However, Sherwood teaches implantable composite devices for the purpose of repair and replacement of cartilage and/or bone and a method of using thereof (abstract; claim 23). Said method comprises the step of implanting the implantable composite into a patient at a site in need of repair or replacement (claim 23; paragraph [0028]). Sherwood teaches a fully resorbable synthetic scaffold containing a cartilage-appropriate region and bone-appropriate region for repair of articular defects (paragraph [0020]). Sherwood also teaches staggered channels in the cartilage region to promote homogenous seeding throughout the cartilage region (paragraph [0020]). Sherwood also teaches that the channels/pores may be fully or partially filled with an interpenetration substance including polymers (paragraph [0132]). Sherwood teaches that said channels can be between about 150-500 microns, preferably about 250 microns in diameter (paragraphs [0030], [0063] and [0172]). Sherwood also teaches that the cartilage region can have a thickness (height) of 2 mm (paragraphs [0020] and [0172]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the above dimensions as suggested by Sherwood with a reasonable expectation of success because Sherwood teaches a similar implant for the same purpose. A skilled artisan would have been motivated to do so because Sherwood teaches that staggered channels between about 150-500 microns and a cartilage region having a thickness (height) of 2 mm are suitable for the same purpose of repairing/replacing cartilage and bone (MPEP 2144.07).
Thus, the instant claims and the patented claims are not patentably distinct from one another in view of Sherwood.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 8,808,725 in view of Sherwood et al. (US 2003/0114936 A1, Jun. 19, 2003, hereafter as “Sherwood”).
Although the claims at issue are not identical, they are not patentably distinct from each other because the subject matter of the instant claims and the subject matter of the patented claims are significantly overlapping.
The instant invention is described above.
The patented claims are drawn to a scaffold for repair of cartilage or an osteochondral defect, said scaffold comprising coral having at least a first portion of an exposed surface, which first portion is raised with respect to at least a second portion of said exposed surface in said coral, wherein said at least a first portion of said coral is proximal to a hollow or hollows along a longitudinal axis of said first portion and wherein said at least a second portion abuts said hollow or hollows and wherein said first portion comprises at least a region, which specifically positions and confines said coral within a site of cartilage repair; and a method of inducing or enhancing repair, regeneration or enhancement of formation of cartilage, bone or a combination thereof comprising implanting the scaffold of claim 1 in a subject in need thereof.
The patented invention does not explicitly recite, “wherein the hollows have a diameter ranging from about 125 to 650 microns and wherein the first phase has a height of between 1-7 mm”.
However, Sherwood teaches implantable composite devices for the purpose of repair and replacement of cartilage and/or bone and a method of using thereof (abstract; claim 23). Said method comprises the step of implanting the implantable composite into a patient at a site in need of repair or replacement (claim 23; paragraph [0028]). Sherwood teaches a fully resorbable synthetic scaffold containing a cartilage-appropriate region and bone-appropriate region for repair of articular defects (paragraph [0020]). Sherwood also teaches staggered channels in the cartilage region to promote homogenous seeding throughout the cartilage region (paragraph [0020]). Sherwood also teaches that the channels/pores may be fully or partially filled with an interpenetration substance including polymers (paragraph [0132]). Sherwood teaches that said channels can be between about 150-500 microns, preferably about 250 microns in diameter (paragraphs [0030], [0063] and [0172]). Sherwood also teaches that the cartilage region can have a thickness (height) of 2 mm (paragraphs [0020] and [0172]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the above dimensions as suggested by Sherwood with a reasonable expectation of success because Sherwood teaches a similar implant for the same purpose. A skilled artisan would have been motivated to do so because Sherwood teaches that staggered channels between about 150-500 microns and a cartilage region having a thickness (height) of 2 mm are suitable for the same purpose of repairing/replacing cartilage and bone (MPEP 2144.07).
Thus, the instant claims and the patented claims are not patentably distinct from one another in view of Sherwood.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-31 of U.S. Patent No. 10,046,084 in view of Sherwood et al. (US 2003/0114936 A1, Jun. 19, 2003, hereafter as “Sherwood”).
Although the claims at issue are not identical, they are not patentably distinct from each other because the subject matter of the instant claims and the subject matter of the patented claims are significantly overlapping.
The instant invention is described above.
The patented claims are drawn to a calcium carbonate containing biomaterial consisting essentially of two phases wherein: a first phase of said two phases comprises a solid calcium carbonate containing biomaterial and a biocompatible polymer, said solid calcium carbonate containing biomaterial comprising a series of hollows along a longitudinal axis in said first phase; and a second phase of said two phases comprises said solid calcium carbonate containing biomaterial, wherein both said first phase and said second phase are cut into or shaped from a single piece of said solid calcium carbonate containing biomaterial and the biomaterial remains intact as a single piece after being cut or shaped; a kit thereof; and a method of inducing or enhancing repair, regeneration or enhancement of formation of cartilage, bone or a combination thereof comprising implanting the calcium carbonate containing biomaterial of claim 1 in a subject in need thereof.
The patented invention does not explicitly recite, “wherein the hollows have a diameter ranging from about 125 to 650 microns and wherein the first phase has a height of between 1-7 mm”.
However, Sherwood teaches implantable composite devices for the purpose of repair and replacement of cartilage and/or bone and a method of using thereof (abstract; claim 23). Said method comprises the step of implanting the implantable composite into a patient at a site in need of repair or replacement (claim 23; paragraph [0028]). Sherwood teaches a fully resorbable synthetic scaffold containing a cartilage-appropriate region and bone-appropriate region for repair of articular defects (paragraph [0020]). Sherwood also teaches staggered channels in the cartilage region to promote homogenous seeding throughout the cartilage region (paragraph [0020]). Sherwood also teaches that the channels/pores may be fully or partially filled with an interpenetration substance including polymers (paragraph [0132]). Sherwood teaches that said channels can be between about 150-500 microns, preferably about 250 microns in diameter (paragraphs [0030], [0063] and [0172]). Sherwood also teaches that the cartilage region can have a thickness (height) of 2 mm (paragraphs [0020] and [0172]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the above dimensions as suggested by Sherwood with a reasonable expectation of success because Sherwood teaches a similar implant for the same purpose. A skilled artisan would have been motivated to do so because Sherwood teaches that staggered channels between about 150-500 microns and a cartilage region having a thickness (height) of 2 mm are suitable for the same purpose of repairing/replacing cartilage and bone (MPEP 2144.07).
Thus, the instant claims and the patented claims are not patentably distinct from one another in view of Sherwood.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 10,080,818 in view of Sherwood et al. (US 2003/0114936 A1, Jun. 19, 2003, hereafter as “Sherwood”).
Although the claims at issue are not identical, they are not patentably distinct from each other because the subject matter of the instant claims and the subject matter of the patented claims are significantly overlapping.
The instant invention is described above.
The patented claims are drawn to a scaffold for tissue repair, said scaffold consisting essentially of two phases wherein: a first phase of said two phases comprises solid coral and a biocompatible polymer and said first phase further comprises a series of hollows along a longitudinal axis in said first phase, and wherein said polymer penetrates to within said hollows; and a second phase of said two phases comprises a solid coral wherein said biocompatible polymer is a glycosaminoglycan, a chitosan, an alginate or a combination thereof; a kit thereof; and a method of inducing or enhancing repair, regeneration or enhancement of formation of cartilage, bone or a combination thereof comprising implanting the scaffold of claim 1 in a subject in need thereof.
The patented invention does not explicitly recite, “wherein the hollows have a diameter ranging from about 125 to 650 microns and wherein the first phase has a height of between 1-7 mm”.
However, Sherwood teaches implantable composite devices for the purpose of repair and replacement of cartilage and/or bone and a method of using thereof (abstract; claim 23). Said method comprises the step of implanting the implantable composite into a patient at a site in need of repair or replacement (claim 23; paragraph [0028]). Sherwood teaches a fully resorbable synthetic scaffold containing a cartilage-appropriate region and bone-appropriate region for repair of articular defects (paragraph [0020]). Sherwood also teaches staggered channels in the cartilage region to promote homogenous seeding throughout the cartilage region (paragraph [0020]). Sherwood also teaches that the channels/pores may be fully or partially filled with an interpenetration substance including polymers (paragraph [0132]). Sherwood teaches that said channels can be between about 150-500 microns, preferably about 250 microns in diameter (paragraphs [0030], [0063] and [0172]). Sherwood also teaches that the cartilage region can have a thickness (height) of 2 mm (paragraphs [0020] and [0172]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the above dimensions as suggested by Sherwood with a reasonable expectation of success because Sherwood teaches a similar implant for the same purpose. A skilled artisan would have been motivated to do so because Sherwood teaches that staggered channels between about 150-500 microns and a cartilage region having a thickness (height) of 2 mm are suitable for the same purpose of repairing/replacing cartilage and bone (MPEP 2144.07).
Thus, the instant claims and the patented claims are not patentably distinct from one another in view of Sherwood.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12,508,343.
Although the claims at issue are not identical, they are not patentably distinct from each other because the subject matter of the instant claims and the subject matter of the patented claims are significantly overlapping.
The instant invention is described above.
The patented claims are drawn to a bi-phasic scaffold for tissue repair, said bi-phasic scaffold having two phases wherein: a first phase of said two phases comprises solid coral and said first phase further comprises a series of hollows each extending in the same orientation along a longitudinal axis in said first phase; a second phase of said two phases consisting of the solid coral, the second phase being devoid of the series of hollows; wherein said hollows have a diameter ranging from about 125 to 650 mm and a height that extends entirely through the first phase, and wherein said first phase has a height of between 1-7 mm; a kit thereof; and a method of inducing or enhancing repair, regeneration or enhancement of formation of cartilage, bone or a combination thereof.
Thus, the instant claims are anticipated by the patented claims and, as such, are not patentably distinct.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 77-93 of copending Application No. 17/191,522 in view of in view of Sherwood et al. (US 2003/0114936 A1, Jun. 19, 2003, hereafter as “Sherwood”).
Although the claims at issue are not identical, they are not patentably distinct from each other because the subject matter of the instant claims and the subject matter of the copending claims are significantly overlapping.
The instant invention is described above.
The copending claims are drawn to a scaffold for tissue repair, the scaffold formed of an individual piece of solid coral containing pores, the individual piece of solid coral consisting essentially of a first portion and a second portion that longitudinally abuts the first portion, wherein the first portion is raised to an elevation above the second portion when the scaffold is implanted in a site in need of repair and comprises a series of hollows along the longitudinal axis of the scaffold and wherein the second portion does not include any longitudinally extending hollows, wherein the series of hollows are longitudinally extending cavities with internal exposed surfaces within the individual piece of solid coral, wherein the internal exposed surfaces provide locations for regeneration of cartilage tissue when the scaffold is implanted in a cartilage or an osteochondral defect, and wherein the longitudinal axis of the scaffold has a length of 2 - 200 mm, and wherein the scaffold has an average pore size of 1 µm - 1 mm.; a kit thereof; and a method of inducing or enhancing repair, regeneration or enhancement of formation of cartilage, bone or a combination thereof.
The copending claims do not explicitly recite, “wherein the hollows have a diameter ranging from about 125 to 650 microns and wherein the first phase has a height of between 1-7 mm”.
However, Sherwood teaches implantable composite devices for the purpose of repair and replacement of cartilage and/or bone and a method of using thereof (abstract; claim 23). Said method comprises the step of implanting the implantable composite into a patient at a site in need of repair or replacement (claim 23; paragraph [0028]). Sherwood teaches a fully resorbable synthetic scaffold containing a cartilage-appropriate region and bone-appropriate region for repair of articular defects (paragraph [0020]). Sherwood also teaches staggered channels in the cartilage region to promote homogenous seeding throughout the cartilage region (paragraph [0020]). Sherwood also teaches that the channels/pores may be fully or partially filled with an interpenetration substance including polymers (paragraph [0132]). Sherwood teaches that said channels can be between about 150-500 microns, preferably about 250 microns in diameter (paragraphs [0030], [0063] and [0172]). Sherwood also teaches that the cartilage region can have a thickness (height) of 2 mm (paragraphs [0020] and [0172]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the above dimensions as suggested by Sherwood with a reasonable expectation of success because Sherwood teaches a similar implant for the same purpose. A skilled artisan would have been motivated to do so because Sherwood teaches that staggered channels between about 150-500 microns and a cartilage region having a thickness (height) of 2 mm are suitable for the same purpose of repairing/replacing cartilage and bone (MPEP 2144.07).
Thus, the instant claims and the copending claims are not patentably distinct from one another.
This is a provisional nonstatutory double patenting rejection.
Conclusion
All claims have been rejected; no claims are allowed.
Correspondence
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/CASEY S HAGOPIAN/Examiner, Art Unit 1617
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