DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions. Claims included in the prosecution are claims 77-93.
Applicants' arguments, filed 06/23/2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 103
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.
1. Claims 77-80 and 82-86 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Stone et al. (US 2008/0249632, Oct. 9, 2008) in view of Semler et al. (US 2008/0255676, Oct. 16, 2008), Chen et al. (US 2009/0024224, Jan. 22, 2009), and Nyez et al. (US 2007/0233264, Oct. 4, 2007).
Stone et al. disclose an apparatus for repairing cartilage defects (¶ [0001]). Exemplary cartilage defects include those caused by trauma, excessive use (such as sport injuries, for example) or diseases, including, but not limited to osteoarthritis and osteochondrosis dissecans (¶ [0034]). The apparatus is a cartilage plug 10 (i.e., scaffold) (¶ [0014]). The cartilage plug includes a top or articulation layer 12 (i.e., claimed second portion), a base 14 (i.e., claimed first portion), and optionally, a bore 16 (see Fig. 4) (¶ [0014]). The bore 16 provides a void (i.e., cavity) in the cartilage plug 10 (¶ [0027]). The bore 16 (i.e., hollow) can be located entirely within the cartilage plug base 14 (i.e., claimed first portion) (¶ [0026]). Fig. 4 shows wherein bore 16 (i.e., hollow) is along the longitudinal axis of the cartilage plug base 14 (i.e., claimed first portion) and wherein the articulation layer 12 (i.e., claimed second portion) longitudinally abuts the base 14 (i.e., claimed first portion). The articulation layer 12 (i.e., claimed second portion) and the cartilage plug base 14 (i.e., claimed first portion) can be formed from a monolithic piece of material (¶ [0025]). The cartilage plug base (i.e., claimed first portion) can be a porous material such as coral (¶ [0023]). The articulation layer 12 (i.e., claimed second portion) can also be a porous material (¶ [0019]). The articulation layer 12 (i.e., claimed second portion) and the cartilage plug base 14 (i.e., claimed first portion) can be made of the same material (¶ [0024]). A bioactive agent can be absorbed into a first or second resorbable material. The first resorbable material can comprise the articulation layer 12 (i.e., claimed second portion) and the second resorbable material can comprise at least one layer of the cartilage plug base 14 (i.e., claimed first portion) (¶ [0029]). Suitable bioactive agents include chondrocytes (¶ [0027]). Fig. 7B shows wherein articulation layer 12 (i.e., claimed second portion) is within cartilage tissue 24 and wherein the cartilage plug base (i.e., claimed first portion) is within subchondral bone tissue 28 and cancellous bone tissue 29. The cartilage plug may be cylindrical (¶ [0017]).
Stone et al. differ from the instant claims insofar as not disclosing wherein the cartilage plug comprises more than one bore (i.e., series of hollows) and wherein the bores have internal exposed surfaces,
However, Semler et al. disclose a two piece allograft cancellous bone implant having a demineralized cancellous bone cap member and a mineralized or partially demineralized cancellous bone base member, both pieces being held together with an allograft bone pin. The base member is provided with a plurality of through going bores, which allow transport of cellular materials throughout the implant site to stimulate cartilage growth (¶ [0005]).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have formulated the cartilage plug of Stone et al. to comprise more than one bore (i.e., hollows), wherein the bores have an internal exposed surface, motivated by the desire to allow transport of cellular materials throughout the implant site to stimulate cartilage growth as taught by Semler et al.
The combined teachings of Stone et al. and Semler et al. do not disclose wherein the cartilage plug (i.e., scaffold) has a length of 2-200 mm.
However, Chen et al. disclose an osteochondral plug having a length of between about 1 and 20 mm (¶ [0076]).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have formulated the cartilage plug of Stone et al. to have a length of between 1 and 20 mm since Stone et al. does not disclose a length and this is a known and effective length for formulating a cartilage plug as taught by Chen et al.
The combined teachings of Stone et al., Semler et al., and Chen et al. do not disclose wherein the cartilage plug (i.e., scaffold) has an average pore size of 1 µm-1mm.
However, Nyez et al. disclose a resorbable osteoconductive matrix having pores of a sufficient size and quantity to permit growing tissue to infiltrate therein. The pore size preferably ranges from about 10 µm to about 500 µm (¶ [0051]).
As discussed above, Stone et al. disclose wherein the articulation layer 12 and the cartilage plug base may be porous. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have formulated the cartilage plug of Stone et al. to have a pore size ranging from about 10 µm to about 500 µm since Stone et al. does not disclose a pore size and this pore size permits tissue growth as taught by Nyez et al.
In regards to instant claims 77 and 78 reciting the transitional phrase “consisting essentially of,” there is no description in the specification or in the claims of what would be excluded from the scaffold. Absent a clear indication in the specification or claims of what the basic and novel characteristics of the claimed composition actually are, the term “consisting essentially of” is construed as being equivalent in meaning to the term “comprising”. See MPEP 2111.03 (III).
In regards to instant claims 77 and 78 reciting wherein the second portion does not include any longitudinally extending hollows, Semler et al. disclose wherein the through going bores are present in the base member and not in the cap member. Thus, it would have been obvious to one of ordinary skill in the art that when formulating the cartilage plug of Stone et al. to have through going bores, to have the through going bores in the base 14 (i.e., claimed first portion) of Stone et al. and not in the top or articulation layer 12 (i.e., claimed second portion) of Stone et al.
In regards to instant claims 77 and 78 reciting wherein the first portion is raised to an elevation above the second portion when the scaffold is implanted in cartilage or an osteochondral defect, as shown in Fig. 7B of Stone et al., the base 14 (i.e., claimed first portion) is above (i.e., raised) the top or articulation layer 12 (i.e., claimed second portion).
2. Claim 81 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Stone et al. (US 2008/0249632, Oct. 9, 2008) in view of Semler et al. (US 2008/0255676, Oct. 16, 2008), Chen et al. (US 2009/0024224, Jan. 22, 2009), Nyez et al. (US 2007/0233264, Oct. 4, 2007), and further in view of Gomes (US 2004/0230303, Nov. 18, 2004).
The teachings of Stone et al., Semler et al., Chen et al., and Nyez et al. are discussed above. Stone et al., Semler et al., Chen et al., and Nyez et al. do not disclose wherein the cartilage plug has a diameter of 3.5 mm.
However, Gomes et al. disclose an allograft bone plug with a plurality of bores (claim 4). The diameter of the plug may range from 1 mm to 30 mm (¶ [0052]).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have formulated the cartilage plug of Stone et al. to have a diameter ranging from 1 mm to 30 mm since Stone et al. does not disclose a diameter and this is a known and effective diameter for formulating a cartilage plug as taught by Gomes et al.
3. Claims 87-89 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Stone et al. (US 2008/0249632, Oct. 9, 2008) in view of Semler et al. (US 2008/0255676, Oct. 16, 2008).
Stone et al. disclose an apparatus for repairing cartilage defects (¶ [0001]). Exemplary cartilage defects include those caused by trauma, excessive use (such as sport injuries, for example) or diseases, including, but not limited to osteoarthritis and osteochondrosis dissecans (¶ [0034]). The apparatus is a cartilage plug 10 (i.e., scaffold) (¶ [0014]). The cartilage plug includes a top or articulation layer 12 (i.e., claimed second portion), a base 14 (i.e., claimed first portion), and optionally, a bore 16 (see Fig. 4) (¶ [0014]). The bore 16 provides a void (i.e., cavity) in the cartilage plug 10 (¶ [0027]). The bore 16 (i.e., hollow) can be located entirely within the cartilage plug base 14 (i.e., claimed first portion) (¶ [0026]). Fig. 4 shows wherein bore 16 (i.e., hollow) is along the longitudinal axis of the cartilage plug base 14 (i.e., claimed first portion) and wherein the articulation layer 12 (i.e., claimed second portion) longitudinally abuts the base 14 (i.e., claimed first portion). The articulation layer 12 (i.e., claimed second portion) and the cartilage plug base 14 (i.e., claimed first portion) can be formed from a monolithic piece of material (¶ [0025]). The cartilage plug base (i.e., claimed first portion) can be a porous material such as coral (¶ [0023]). The articulation layer 12 (i.e., claimed second portion) can also be a porous material (¶ [0019]). The articulation layer 12 (i.e., claimed second portion) and the cartilage plug base 14 (i.e., claimed first portion) can be made of the same material (¶ [0024]). A bioactive agent can be absorbed into a first or second resorbable material. The first resorbable material can comprise the articulation layer 12 (i.e., claimed second portion) and the second resorbable material can comprise at least one layer of the cartilage plug base 14 (i.e., claimed first portion) (¶ [0029]). Suitable bioactive agents include chondrocytes (¶ [0027]). Fig. 7B shows wherein articulation layer 12 (i.e., claimed second portion) is within cartilage tissue 24 and wherein the cartilage plug base (i.e., claimed first portion) is within subchondral bone tissue 28 and cancellous bone tissue 29. The cartilage plug may be cylindrical (¶ [0017]).
Stone et al. differ from the instant claims insofar as not disclosing wherein the cartilage plug comprises more than one bore (i.e., series of hollows) and wherein the bores have internal exposed surfaces.
However, Semler et al. disclose a two piece allograft cancellous bone implant having a demineralized cancellous bone cap member and a mineralized or partially demineralized cancellous bone base member, both pieces being held together with an allograft bone pin. The base member is provided with a plurality of through going bores, which allow transport of cellular materials throughout the implant site to stimulate cartilage growth (¶ [0005]).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have formulated the cartilage plug of Stone et al. to comprise more than one bore (i.e., hollows), wherein the bores have an internal exposed surface, motivated by the desire to allow transport of cellular materials throughout the implant site to stimulate cartilage growth as taught by Semler et al.
In regards to instant claim 87 reciting the transitional phrase “consisting essentially of,” there is no description in the specification or in the claims of what would be excluded from the scaffold. Absent a clear indication in the specification or claims of what the basic and novel characteristics of the claimed composition actually are, the term “consisting essentially of” is construed as being equivalent in meaning to the term “comprising”. See MPEP 2111.03 (III).
In regards to instant claim 87 reciting wherein the second portion does not include any longitudinally extending hollows, Semler et al. disclose wherein the through going bores are present in the base member and not in the cap member. Thus, it would have been obvious to one of ordinary skill in the art that when formulating the cartilage plug of Stone et al. to have through going bores, to have the through going bores in the base 14 (i.e., claimed first portion) of Stone et al. and not in the top or articulation layer 12 (i.e., claimed second portion) of Stone et al.
In regards to instant claim 87 reciting wherein the first portion is raised to an elevation above the second portion when the scaffold is implanted in the site in need of repair, as shown in Fig. 7B of Stone et al., the base 14 (i.e., claimed first portion) is above (i.e., raised) the top or articulation layer 12 (i.e., claimed second portion).
4. Claims 90-93 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Stone et al. (US 2008/0249632, Oct. 9, 2008) in view of Semler et al. (US 2008/0255676, Oct. 16, 2008), Chen et al. (US 2009/0024224, Jan. 22, 2009), Nyez et al. (US 2007/0233264, Oct. 4, 2007), and further in view of Simon et al. (US 2004/0039447, Feb. 26, 2004).
The teachings of Stone et al., Semler et al., Chen et al., and Nyez et al. are discussed above. Stone et al., Semler et al., Chen et al., and Nyez et al. do not disclose wherein the cartilage plug is included in a kit with a tool for insertion and a series of cartilage plugs of different sizes and shapes.
However, Simon et al. disclose a self-contained orthopedic surgical cartilage repair and replacement system which includes an assortment of preformed, artificial, biocompatible cartilage replacement plugs of varying sizes, shapes and configurations, together with a set of surgical instruments for performing a cartilage removal and replacement procedure, all maintained under sterile conditions in a portable container, so as to enable an orthopedic surgeon to have all the elements for performing one or more cartilage removal and replacement procedures readily and conveniently available (¶ [0029]).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have placed the cartilage plug of Stone et al. in a self-contained orthopedic surgical cartilage repair and replacement system (i.e., kit) with tools for insertion and a series of cartilage plugs of different sizes and shapes motivated by the desire to enable an orthopedic surgeon to have all the elements for performing one or more cartilage removal and replacement procedures readily and conveniently available as taught by Simon et al.
In regards to instant claim 90 reciting wherein the kit comprises directions for utilizing the scaffold in tissue repair, instructions are non-functional descriptive material. Patentable weight need not be given to printed matter absent a new and unobvious functional relationship between the printed matter and the substrate. See MPEP 2111.05. In the instant case, the instructions of claim 90 for utilizing the scaffold in tissue repair do not entail a new and unobvious functional relationship with scaffold; therefore, no patentable weight was given for this claim.
Response to Arguments
Applicant argues that Semler, alone with the other cited prior art, does not teach or suggest the claimed elements, including at least, “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 “wherein the second portion does not include any longitudinally extending hollows,” at least because the through going bores of Semler are instead located exclusively in and extend entirely through the base member 22 thereof for a different purpose.
The Examiner does not find Applicant’s argument to be persuasive. As discussed in the rejections, in regards to instant claims reciting wherein the first portion is raised to an elevation above the second portion when the scaffold is implanted in the site in need of repair, as shown in Fig. 7B of Stone, the base 14 (i.e., claimed first portion) is above (i.e., raised) the top or articulation layer 12 (i.e., claimed second portion). As discussed in the rejections, in regards to instant claims reciting wherein the second portion does not include any longitudinally extending hollows, Semler discloses wherein the through going bores are present in the base member and not in the cap member. Thus, it would have been obvious to one of ordinary skill in the art that when formulating the cartilage plug of Stone to have through going bores, to have the through going bores in the base 14 (i.e., claimed first portion) of Stone and not in the top or articulation layer 12 (i.e., claimed second portion) of Stone. Applicant has not addressed these remarks made by the Examiner in the previous office action. Therefore, Applicant’s argument is unpersuasive and the rejections are maintained.
Applicant argues that altering Stone as proposed would appear to render Stone unsuitable for its intended purpose (e.g., holding a biomaterial in its temporary bore which has a bounded lower surface/does not extend through entirely through the relevant lower portion of the structure of Stone).
The Examiner disagrees. Stone discloses in paragraph [0014] wherein a bore is optional. Thus, incorporating throughgoing bores would not render Stone unsuitable for its intended purpose since Stone does not need to have a bore with a biomaterial. As such, Applicant’s argument is unpersuasive.
Applicant argues that the purported benefit of allowing transport of cellular materials through the structure appears irrelevant in the context of Stone and hence does not provide sufficient motivation to modify Stone as proposed.
The Examiner does not find Applicant’s argument to be persuasive. Applicant has not explained why allowing transport of cellular materials through the structure is irrelevant in the context of Stone. Stone discloses repairing cartilage. Therefore, allowing transport of cellular materials through the structure to stimulate cartilage growth would be relevant in the context of Stone. As such, Applicant’s argument is unpersuasive.
Applicant argues that it is unclear where the through going bores described in Semler would be positioned within the structurally distinct design of Stone.
The Examiner does not find Applicant’s argument to be persuasive. Stone discloses in Fig. 4 how a bore is to be positioned within the plug. Thus, one of ordinary skill in the art would know where to position the through going bores of Semler. The through going bores would be positioned in the same location that the bore in Fig. 4 is positioned in. As such, Applicant’s argument is unpersuasive.
Applicant argues that claim 77 recites “wherein the first portion is raised to an elevation above the second portion when the scaffold is implanted in a site in need or repair.” In contrast, the structures of Stone (e.g., when implanted) employ a different implanted configuration where a base layer 14 is below the top or articulation layer 12 to permit delivering a bioactive agent to the shaped implant site 32.
The Examiner does not find Applicant’s argument to be persuasive. According to Fig. 7B of Stone, the base layer 14 is above the top or articulation layer 12. Fig. 7B shows a pyramid shaped plug wherein the articulation layer 12 is the bottom layer of the pyramid shaped plug. As such, Applicant’s argument is unpersuasive.
Applicant argues that the presently claimed invention demonstrates superior and unexpected results (e.g., improved cartilage regeneration). The coral implants as claimed provide superior efficacy in promoting healing of osteochondral defects.
The Examiner does not find Applicant’s argument to be persuasive. As discussed in the rejection, it was known in the art that hollows allow transport of cellular materials throughout the implant site to stimulate cartilage growth. Thus, one of ordinary skill in the art would have expected greater chondrogenesis with the claimed invention comprising a series of hollows. As such, Applicant’s argument is unpersuasive.
Applicant argues that the specification at para. [0051] describes that the exposed surface provides a place for mesenchymal stem cell attachment, growth, proliferation, or differentiation, or a combination thereof, all processes which induce or enhance cartilage repair. Further, paragraph [0163] states that this invention induces or enhances cartilage repair, wherein an exposed surface of a scaffold of this invention is maximized such that a cell population has maximal surface area for adhesion, growth, proliferation or differentiation, or a combination thereof.
The Examiner does not find Applicant’s argument to be persuasive. As discussed above, it was known in the art that hollows allow transport of cellular materials throughout the implant site to stimulate cartilage growth. Thus, one of ordinary skill in the art would have expected with the claimed invention comprising a series of hollows provides a place for mesenchymal stem cell attachment, growth, proliferation, or differentiation and for cell population to have maximal surface area for adhesion, growth, proliferation or differentiation. As such, Applicant’s argument is unpersuasive.
Applicant argues that the resultant structures of Stone, at least due to the presence of the biomaterial 18 and/or use of an individual bore 18, necessarily have an absence of hollows with internal exposed surfaces that provide locations for regeneration of cartilage tissue when the scaffold is implanted in cartilage or an osteochondral defect.
The Examiner does not find Applicant’s argument to be persuasive. As discussed above, Stone discloses in paragraph [0014] wherein a bore is optional. Since a bore is optional. The presence of the biomaterial 18 and/or use of an individual bore 18 is also optional. Thus, incorporating throughgoing bores would not render Stone unsuitable for its intended purpose since Stone does not need to have a bore with a biomaterial. As such, Applicant’s argument is unpersuasive.
Applicant argues that Semler merely describes through going bores located exclusively in and extend entirely through the base member 22.
The Examiner does not find Applicant’s argument to be persuasive. It is not clear how such teaching teaches away from the instant claims. As discussed in the rejection, Semler discloses wherein the through going bores are present in the base member and not in the cap member. Thus, it would have been obvious to one of ordinary skill in the art that when formulating the cartilage plug of Stone to have through going bores, to have the through going bores in the base 14 (i.e., claimed first portion) of Stone and not in the top or articulation layer 12 (i.e., claimed second portion) of Stone. As such, Applicant’s argument is unpersuasive.
Applicant argues that the cited art neither teaches nor suggests the presence of the Applicant’s claimed structure, let alone the resultant benefits such as “improved” cartilage regeneration.
The Examiner disagrees. The rejection states why the claimed structure would have been obvious. Applicant has not provided persuasive arguments suggesting wherein the claimed structure would not have been obvious. Also, as discussed above, it was known in the art that hollows allow transport of cellular materials throughout the implant site to stimulate cartilage growth. Thus, one of ordinary skill in the art would have expected improved cartilage regeneration with the claimed invention comprising a series of hollows. As such, Applicant’s argument is unpersuasive.
Applicant argues that the claimed elements and their associated benefits (e.g., superior healing in the form of at least “improved” cartilage regeneration) are not taught or suggested by the cited art (e.g., as Semler merely makes one passing mention of allowing transport of cellular materials throughout the implant site to stimulate cartilage growth and does not provide any supporting evidence of such an alleged effect nor any improvement in cartilage regeneration attributable thereto).
The Examiner disagrees. Stimulating cartilage growth is considered improving cartilage regeneration compared to having nothing to affect cartilage regeneration. As such. Applicant’s argument is unpersuasive.
Conclusion
Claims 77-93 are rejected.
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TRACY LIU whose telephone number is (571)270-5115. The examiner can normally be reached Mon-Fri 9 am - 5 pm.
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/TRACY LIU/Primary Examiner, Art Unit 1614
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