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 .
A request for continued examination under 37 CFR 1.114 was filed in this application after a decision by the Patent Trial and Appeal Board, but before the filing of a Notice of Appeal to the Court of Appeals for the Federal Circuit or the commencement of a civil action. Since this application is eligible for continued examination under 37 CFR 1.114 and the fee set forth in 37 CFR 1.17(e) has been timely paid, the appeal has been withdrawn pursuant to 37 CFR 1.114 and prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant’s submission filed on March 27, 2026 has been entered.
Status of Claims
Claims 1-22 are currently pending. Claim 13 is amended.
Claims 1-12 and 22 are withdrawn as being drawn to a nonelected invention or species.
Claims 13-21 are examined on their merits.
Information Disclosure Statement
The Information Disclosure Statement filed April 3, 2024 has been reviewed.
Previous Rejections
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn as are those rejections and/or objections expressly stated to be withdrawn.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.
Rejections Maintained
Claim Rejections - 35 USC § 103
The rejection of claims 13-21 under 35 U.S.C. 103 as being unpatentable over Carson et al. US 2009/0162436 (7/25/2009) in view of Everland et al. US 2010/0322908 (12/23/2010), Soo et al. US 2012/0171253 (7/5/2012), Menei et al. US 2015/0174072 (5/3/2002), Martens et al. US 8,512,734 (8/20/2013), Betz et al. US 2005/0136042 (6/23/2005), and DeWoolfson et al. US 2005/0231682 (10/20/2005) is maintained.
Carson et al. (Carson) teaches a method of making a biocompatible implant that comprises providing monomers and an initiator and applying a therapeutically effective amount of a wound healing enhancing agent (growth factor) and forming the biocompatible device by allowing the polymer to form around the wound -healing enhancing agent and encapsulate it in the polymer carrier. (See Carson [0015] and [0058]). Carson teaches that the polymer carrier can be a synthetic polymer or a natural polymer. (See [0053]). Thus, Carson teaches that the polymer carrier can be a synthetic polymer as called for in instant claim 13.
Growth factor is a traditional healing agent that is used to assist with wound healing. It is thus a wound healing agent as called for in instant claim 13. (See [0015]). Carson is directed to regenerating tissue at a wound site and this tissue includes ligament, tendon, bone, cartilage, skin, cornea, and periodontal tissues. (See [004]). Thus Carson teaches cornea repair too. (See Carson [0004], [0047]). Furthermore, Carson teaches at [0047] that fibroblast growth factors are extremely useful. Carson also expressly teaches at [0047] that vascular endothelial growth factors are useful.
A scaffold can be provided that would serve as a body structure that can be a biocompatible material such as a ceramic, which could support the polymer carrier. (See [0050]). This reads on the method of fabricating a biocompatible device comprising providing a body structure of the device and applying a wound-healing-enhancing agent in a wound healing effective amount to at least a portion of the body structure and forming the biocompatible device that comprises a carrier that includes the wound-healing-enhancing agent. Carson teaches a collagen coating. (See [0071-72]). Collagen is a polymer as called for in claim 15. The collagen forms a coating that is a top layer on top of a layer that comprises a therapeutically effective amount of the wound-healing-enhancing agent as called for in claim 16. Carson teaches that collagen has great strength but can still be easily prepared for use in many ways. (See [0059]).
Carson teaches that the biocompatible device may be a carrier that encapsulates the wound healing-enhancing agent as called for in claim 17. (See [0015] and [0058]). Alternatively, the wound healing-enhancing agent can be encapsulated inside a microparticle as called for in claim 18. (See [0058] and [0061]). Additionally, the microparticles can be buried within the polymeric matrix material as called for in claim 18. (See [0015] and [0058]).
Carson teaches that collagen supports the binding of fibromodulin (See [0008]). Carson teaches a medical implant as called for in instant claim 21. (See [0029]). Carson teaches that its method provides for a sustained release of a therapeutic amount of growth factor which is very helpful in regenerating tissue at a wound site. (See [0015]).
Carson teaches that collagen supports the binding of fibromodulin (See [0008]). However, Carson does not teach fibromodulin as the wound healing enhancing agent itself or a carrier which comprises a gene construct encoding fibromodulin or a polymeric coating. Carson also does not teach a coating which contains the wound-healing enhancing agent and a carrier such that the microparticles are buried within the matrix material. Carson also does not teach a FMOD peptide or an amount of one. While Carson teaches that collagen is very strong, it does not expressly teach a device that is configured for effecting wound-closure. These deficiencies are made up for in the teachings of Everland et al., Soo et al., Menei et al., Martens et al., Betz et al. and DeWoolfson et al.
Everland teaches a fibromodulin as a therapeutic agent as called for in instant claim 20. Everland also teaches using a gene construct as called for in instant claim 14. (See [012] and [183]). Everland teaches that fibromodulin may be used for reinforcing weakened tissue (such as a wound) throughout the body. (See [0083]).
Soo et al. (Soo) teaches a fibromodulin peptide as called for in instant claim 20. (See [0177] and [0179]). Soo also teaches that the fibromodulin peptide can be included with a carrier as a coating on medical devices which allows for local delivery. (See Soo claim 10). The wound –healing enhancing agent forming a coating with the carrier is called for in instant claim 13. Soo also expressly teaches that it can be a wound closure device. (See [0066]). Soo teaches that the FMOD peptide in combination with TGF.beta.significantly increased fibroblast proliferation which significantly assisted with the healing of chronic wounds. (See [0182].
Menei et al. teaches a method of repairing tissue includes implanting into a patient a therapeutically effective amount of a pharmaceutical composition including microparticles including a biodegradable, biocompatible material having cells of interest or fragments thereof adhered to at least a portion of a surface; and at least one substance active on the cells or their environment upon implantation of the microparticles in a patient associated with the material wherein the substances is released in a controlled or extended manner. (See Abstract).
Menei et al. teaches microparticles that encapsulate an active that assists with wound-healing, or a wound-healing enhancing agent as called for in instant claim 18. (See [Abstract and claim 2 and throughout]). Menei teaches microparticles that comprise a biocompatible material that can be polylactide-co-glycolide). This reads on wherein the microparticles are formed from poly(lactide-co-glycolide) called for in instant claim 13. Menei also teaches having microparticles containing an active and mixed with a carrier as called for in instant claim 18 wherein the active agent forms a coating with carrier and microparticles, when the carrier is a matrix material as called for in instant claims 13 and 18. Menei teaches that this composition and configuration can repair tissue by releasing the active locally in a controlled and sustained manner. (See Abstract).
Martens et al. (Martens) teaches a medical device coating comprising a matrix and particles of one or more molecular sieves which can comprise a bioactive agent. (See Abstract). Martens teaches that the particles of the molecular sieves are embedded within the matrix material. (See Martens claim 3). Martens teaches that the coating comprising the molecular sieve material has excellent biocompatibility and provides very good drug delivery into the body of a human. (See Abstract and column 1).
Martens et al. (Martens) teaches a medical device coating comprising a matrix and particles of one or more molecular sieves which can comprise a bioactive agent. (See Abstract). Martens teaches that the particles of the molecular sieves are embedded within the matrix material. (See Martens claim 3). Martens teaches that the coating comprising the molecular sieve material has excellent biocompatibility and provides very good drug delivery into the body of a human. (See Abstract and column 1).
Betz et al. (Betz) teaches methods and compositions for tissue repair are provided. The methods involve obtaining tissue from a patient, including for example, muscle or fat tissue, and contacting the tissue with one or more bioactive agents to induce at least a portion of the cells in the tissue to differentiate into cells of a desired type. The methods and compositions may be used to treat lesions in a variety of tissues, including bone fractures or other injuries. (See Abstract).
Betz teaches that its composition can be used to treat a variety of wounds including the promotion of wound closure, including both internal and external wounds. Its composition may achieve complete or partial closure of the wound and a bioactive agent may be combined with its composition. (See [0187]-[0188]). Betz teaches a method wherein the tissue is configured to an appropriate size and shape for implantation into a lesion or wound. (See Betz claim 67.). This reads on a body structure configured for effecting wound closure as called for in instant claim 13. Betz teaches that there is a great need for effective tissue repair. (See [0002]). Betz teaches that its compositions is useful for promoting and effecting wound closure. (See [0187]).
DeWoolfson et al. (DeWoolfson) teaches a stabilizing agent for corneal tissue that comprises a fibromodulin peptide that is able to stabilize the corneal tissues to maintain the desired shape. (See claims 1, 7 and 8, Abstract). The fibromodulin peptide is present in an amount of from about 40 µg/mL to about 100 µg/mL. (See claim 8). From about 40 µg/mL to about 100 µg/mL overlaps with the from 10 to 250 µg/mL called for in instant claim 13. DeWoolfson teaches that this is the amount of fibromodulin peptide that stabilizes the corneal tissues to allow them to maintain their desired shape.
It would have been prima facie obvious to one of ordinary skill in the art making the Carson biocompatible implant before the earliest effective filing date to encapsulate the wound-healing enhancing agent in microparticles to allow for the reinforcing of weakened tissue throughout the body as taught by Everland.
It would have been prima facie obvious to one or ordinary skill in the art making the Carson biocompatible implant before the earliest effective filing date to use from about 40 µg/mL to about 100 µg/mL FMOD peptide along with TGF.beta. in a coating as taught by DeWoolfson and Soo in order to significantly increase fibroblast proliferation which significantly assisted with the healing of chronic wounds and also to allow for local delivery as taught by Soo.
It would have been prima facie obvious to one of ordinary skill in the art making the Carson biocompatible implant before the earliest effective filing date to encapsulate the wound-healing enhancing agent in microparticles and to include these microparticles in the matrix in the body structure and as a coating to allow for the repair tissue by releasing the active in a controlled and sustained manner as taught by Menei as well as best allowing for ideal local delivery by implantation of the composition as taught by Menei.
It would have been prima facie obvious to one of ordinary skill in the art making the Carson biocompatible implant before the earliest effective filing date to have the microparticles be encapsulated within the matrix of the coating as taught by Martens in order to have an excellent drug carrying interface that has excellent biocompatibility and provides very good drug delivery into the body of a human as taught by Martens.
It would have been prima facie obvious to one of ordinary skill in the art making the Carson biocompatible implant before the earliest effective filing date to configure the biocompatible implant for effecting wound-closure as taught by Betz in order to have an effective wound closure device for both internal and external wounds that can meet the great need for effective tissue repair and wound closure as taught by Betz.
With respect to claim 13, it would have been prima facie obvious to one of ordinary skill in the art before the earliest effective filing date making the Carson biocompatible implant to encapsulate the fibroblast growth factor wound-healing agent in microparticles in order to encourage the growth and proliferation of bone cells and/or cartilage cells as taught by Carson. (See [0047]). The FMOD peptides would also be encapsulated in microparticles and would allow for the reinforcing of weakened tissue throughout the body as taught by Everland. The fibroblast growth factor (wound healing-agent) is different from the FMOD peptides (wound healing enhancing agent) as called for in instant claim 13. There would be a reasonable expectation of success because both Carson and Everland are directed to living tissue repair.
Response to Arguments
Applicants’ comments on March 27, 2026 have been fully considered and are found to be unpersuasive for the reasons described below.
Applicants note the amendments to the claims and note where support can be found for the amendments to the claims.
Applicants maintain that the cited references individually or in combination would not teach the element “a vascularizing effective amount” required by the claims of the instant application. Further the cited references fail to teach a wound-healing agent and a wound-healing enhancing agent.
Applicants assert that Carson in view of Everland, Soo, Menei, Martens, Betz and DeWoolfson would not teach a method as defined by claim 13 or a claim dependent therefrom. Applicants further assert that that Carson, Everland, Soo, Menei, Martens, Betz and DeWoolfson teach away from the claimed method. Applicants provide no discussion of why Carson, Everland, Soo, Menei, Martens, Betz and DeWoolfson teach away from the claimed method
Applicants arguments are not found to be persuasive. As described in the rejection above, with respect to claim 13, it would have been prima facie obvious to one of ordinary skill in the art before the earliest effective filing date making the Carson biocompatible implant to encapsulate the fibroblast growth factor wound-healing agent in microparticles in order to encourage the growth and proliferation of bone cells and/or cartilage cells as taught by Carson. (See [0047]). The FMOD peptides would also be encapsulated in microparticles and would allow for the reinforcing of weakened tissue throughout the body as taught by Everland. The fibroblast growth factor (wound healing-agent) is different from the FMOD peptides (wound healing enhancing agent) as called for in instant claim 13. There would be a reasonable expectation of success because both Carson and Everland are directed to living tissue repair.
Thus, Applicants’ argument that Carson in view of Everland, Soo, Menei, Martens, Betz and DeWoolfson would not teach a method as defined by claim 13 is not found to be persuasive.
Applicants’ argument that Carson, Everland, Soo, Menei, Martens, Betz and DeWoolfson teach away from the claimed method is also not found to be persuasive.
Respectfully, Applicants’ argument that the prior art references teach away from the claimed invention does not have any supporting discussion, so Applicants’ reasoning is unclear since none is provided. It is assumed that Applicant’s reasoning would be the same as that which Applicants have made previously in support of this argument.
DeWoolfson teaches cornea repair that requires avascularity which is the opposite of vascularization of the instant invention, so DeWoolfson teaches away from the claimed subject matter is not found to be persuasive. Carson is directed to cornea repair too. (See Carson [0004], [0047]). Carson is directed to regenerating tissue at a wound site and this tissue includes ligament, tendon, bone, cartilage, skin, cornea, and periodontal tissues. (See [004]). Furthermore, Carson teaches at [0047] that fibroblast growth factors are extremely useful.
DeWoolfson is cited only for its teaching of an amount of an FMOD peptide. Carson is the primary reference in the rejection and it teaches wound healing that would benefit from increased fibroblast proliferation. Cornea healing is not at issue in the rejection at hand. Wounds which benefit from increased fibroblast proliferation and increased vascularization to aid in healing are at issue and they are taught in the primary reference, Carson. This would be abundantly clear to the person of ordinary skill in the art.
DeWoolfson does not teach away additionally because it expressly teaches that fibromodulins are effective in stabilizing the cornea. (See [0029]). DeWoolfson actually encourages the use of fibromodulin and does not amount to a teaching away because it does not discourage a skilled artisan from using a wound-healing-enhancing agent. FMOD peptides are expressly contemplated in DeWoolfson and even DeWoolfson teaches that they have benefits for the cornea. As described by DeWoolfson at paragraph [0029]:
The components of the stabilizing composition also include proteoglycans, such as SLRPs. Adding these SLRPs to the composition has been found to be effective in stabilizing the cornea. Despite its misleading nomenclature, SLRPs are large molecules. For example, several types of SLRPs can be chosen from decorin, keratocan, biglycan, epiphycan, lumican, mimican, and fibromodulin.
There is absolutely no discouragement or disparagement of using FMOD to be found anywhere in the DeWoolfson reference. Quite the opposite, actually. A teaching away must be clear. See MPEP Sec. 2143.03 (VI).
Applicants’ argument that Carson teaches cartilage repair that requires avascularity which is the opposite of vascularization of the instant invention, so Carson teaches away from the claimed subject matter is also not found to be persuasive. Carson teaches repairing and regenerating tissue at a wound site generally and cartilage is only an example of such tissue. (See Carson claim 1). Carson is not just directed to cartilage repair. Carson is directed to regenerating tissue at a wound site and this tissue includes ligament, tendon, bone, skin, cornea and periodontal tissues. Carson teaches that devices and methods to accelerate tissue regeneration are highly desired. Carson expressly teaches at [0047] that vascular endothelial growth factors are extremely useful.
This does not amount to a teaching away because it does not discourage a skilled artisan from using a wound-healing-enhancing agent.
Just as Carson teaches that vascular endothelial growth factor is a useful factor in healing of cartilage and bone, there is still absolutely no discouragement or disparagement of using a wound-healing-enhancing agent to be found anywhere in the Carson reference. A teaching away must be clear. See MPEP Sec. 2143.03 (VI).
Applicants’ assertion of a teaching away is unpersuasive because what Applicants are pointing to (cartilage repair) does not constitute a teaching away; it is just a preferred embodiment. “Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments”. MPEP 2123. Thus, the prior art’s disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit or otherwise discourage the solution claimed. In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004).
Applicants’ argument that the prior art does not teach a vascularizing effective amount is still found to be unpersuasive. Carson in view of Everland, Soo, Menei and Martens does actually teach a wound healing agent (the fibroblast growth factor taught in Carson) and a wound healing-enhancing agent (the fibromodulin taught in Everland and Soo). DeWoolfson teaches a concentration of a stabilizing agent including fibromodulin from about 40 µg/mL to about 100 µg/mL FMOD peptide along with TGF-β.
Thus, the method and elements of the claims are taught by the prior art references and there is motivation to combine the teachings of the prior art references. Namely, it would have been prima facie obvious to one or ordinary skill in the art making the Carson biocompatible implant to use from about 40 µg/mL to about 100 µg/mL FMOD peptide along with TGF-β in a coating as taught by DeWoolfson and Soo in order to significantly increase fibroblast proliferation which significantly assisted with the healing of chronic wounds and also to allow for local delivery as taught by Soo.
Applicant is reminded that the prior art need only suggest the concentration of FMOD and not necessarily a "vascularized effective amount", and since the concentration that is taught by the prior art overlaps with the claimed concentration, it is obvious and would necessarily be a ‘vascularizing effective amount’.
Applicant is reminded that the reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result covered by Appellant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006) (motivation question arises in the context of the general problem confronting the inventor rather than the specific problem solved by the invention); Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1323, 76 USPQ2d 1662, 1685 (Fed. Cir. 2005) (“One of ordinary skill in the art need not see the identical problem addressed in a prior art reference to be motivated to apply its teachings.”); In re Linter, 458 F.2d 1013, 173 USPQ.
Respectfully, Applicant is reminded that the Patent Trial and Appeal Board agreed with the Examiner and found that the prior art teaches or suggests the recited “vascularizing effective amount” limitation because it teaches providing FMOD in an amount that overlaps with the claimed concentration, which the Specification teaches is an effective amount (See Specification [0114]). The Board found that there was reason to believe that the disclosure of FMOD in an overlapping amount in the prior art would provide the same function. (See Patent Board Decision of January 27, 2026, pp 9-10).
Conclusion
No claims are allowed.
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/SARAH CHICKOS/
Examiner, Art Unit 1619
/DAVID J BLANCHARD/Supervisory Patent Examiner, Art Unit 1619
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