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 . Claims included in the prosecution are claims 1-19.
Claim Objections
Claims 1 and 18 are objected to because of the following informalities: “the concentration between approximately 0.5 mg” should be recited as --- the concentration being between approximately 0.5 mg ---. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1 and 18 recite an acellular tissue matrix having the ability to maintain the same shape, size and sponge property after being implanted for one week as was observed prior to application to a tissue site. The claims are indefinite since it is unclear how an acellular tissue matrix having the ability to maintain the same shape, size, and sponge property was observed prior to application to a tissue site if the property is after being implanted for one week, which means after application to a tissue site.
Claim 18 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The claim omits describing what happens to the native tissue after it is removed and how it relates to the tissue filler that is applied to a tissue site. Paragraph [0011] of the specification discloses wherein the acellular tissue matrix is derived from a native tissue.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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 1-5, 9, 10, 12-16, 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over McQuillan et al. (US 2005/0028228, Feb. 3, 2005) (hereinafter McQuillan) in view of Di Napoli (WO 2004/073759, Sep. 2, 2004) and Yang et al. (US 2010/0063539, Mar. 11, 2010) (hereinafter Yang)
McQuillan discloses an acellular tissue matrix comprising a decelluarized collagen-containing tissue of an animal genetically modified such that tissues in the animal lack, or substantially lack, galactose α-1,3-galactose epitopes (claim 1). The animal may be a pig (claim 2). The tissue may be dermis tissue (i.e., skin) (claim 3). The tissue may also be bladder tissue (claim 4). In brief, the steps involved in the production of an acellular tissue matrix generally include harvesting the tissue from a donor (e.g., a pig), removal of the epithelial basement membrane, chemical treatment so as to stabilize the tissue, followed by cell removal. After thorough removal of dead and/or lysed cell components, the acellular tissue matrix is ready for implantation and only need to be processed into a desired shape or size. Alternatively, the acellular tissue matrix may be treated with a cryopreservation agent and cryopreserved, and optionally freeze dried. After freeze drying, the tissue can be pulverized or micronized to produce a particulate acellular tissue matrix (¶ [0029]). The dried tissue may be directly immersed in a rehydration solution prior to transplantation. Antibiotics may also be included in the rehydration solution to inhibit bacterial contamination. Oncotic agents being in the form of hyaluronan (i.e., hyaluronic acid) may also be included to prevent osmotic damage to the matrix during rehydration (¶ [0038]). Biological functions retained by the acellular tissue matrix include cell recognition and cell binding as well as the ability to support cell spreading, cell proliferation, and cell differentiation. Such functions are provided by a variety of non-collagenous molecules (e.g., hyaluronan). Structural functions retained by useful acellular tissue matrices include maintenance of the three-dimensional array of the tissue’s components and physical characteristics such as elasticity (¶ [0023]). Fibroblast growth factors (FGF) may be incorporated into the acellular tissue matrix (¶ [0054]). The acellular tissue matrix can be applied to a tissue in order to repair or regenerate that tissue and/or a neighboring tissue (¶ [0051]). Such tissues include skin (claim 28).
McQuillan et al. differ from the instant claims insofar as not disclosing wherein the hyaluronan (i.e. hyaluronic acid) is exogenous.
However, Di Napoli discloses wherein in addition to its biocompatibility, easy availability from biological sources, and ability in supporting the dermal structures, exogenous hyaluronic acid substitutes the endogenous hyaluronic acid naturally occurring in the skin, which has been degraded upon reaction with free radicals (page 2, lines 9-13).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. McQuillan discloses wherein the acellular tissue matrix may be applied to skin and comprise hyaluronan (i.e., hyaluronic acid). Accordingly, it would have been obvious to one of ordinary skill in the art to have the acellular tissue matrix of McQuillan comprise exogenous hyaluronic acid since it is suitable for dermal structures and is a suitable substitute for endogenous hyaluronic acid naturally occurring in the skin as taught by Di Napoli.
In regards to instant claims 1, 18 and 19 reciting wherein the exogenous hyaluronic acid is on a surface of the acellular tissue matrix, it would have been obvious to one of ordinary skill in the art that the exogenous hyaluronic acid incorporated would be on a surface of the acellular tissue matrix since McQuillan discloses incorporating hyaluronan in the rehydration solution and immersing the acellular tissue matrix in the rehydration solution. Some exogenous hyaluronic acid would be expected to be on the surface of the acellular tissue matrix when the acellular tissue matrix is immersed in the rehydration solution comprising exogenous hyaluronic acid.
However, even if this were not obvious, Yang discloses wherein one or more bioactive agents may be incorporated within and/or applied to a reinforced acelluar matrix (¶ [0027]).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have applied hyaluronic acid on the surface of the acellular tissue matrix since hyaluronic acid is a bioactive agent and it was known in the art to apply bioactive agents to acellular matrices instead of within as taught by Yang.
In regards to instant claims 1 and 18 reciting an acellular tissue matrix having the ability to maintain the same shape, size, and sponge property after being implanted for one week, the claimed recitation is merely a functional recitation requiring the ability to fulfill that function; the claim does not require, however, that function to actually occur. Paragraph [0046] of the instant specification disclose wherein the acellular tissue matrix may be derived from bladder. McQuillan discloses an acellular tissue matrix derived from bladder. Therefore, since McQuillan discloses substantially the same acellular tissue matrix as the claimed invention, the acellular tissue matrix of McQuillan has the ability to maintain the same shape, size, and sponge property after being implanted for one week like the claimed acellular tissue matrix.
In regards to instant claims 1, 18 and 19 reciting wherein a concentration of HA on the acellular tissue matrix is between 0.5 mg and approximately 5.0 mg per gram of tissue filler, McQuillan discloses wherein hyaluronan (i.e., hyaluronic acid) provides cell recognition and cell binding as well as the ability to support cell spreading, cell proliferation, and cell differentiation functions to the acellular tissue matrix. Accordingly, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to arrive at the claims amount of HA depending on the amount of cell spreading, cell proliferation, and cell differentiation to the acellular tissue matrix desired for the acellular tissue matrix. Additionally, generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. See MPEP 2144.05.
In regards to the instant claims 9 and 10 reciting wherein the composition is capable of being compressed up to approximately 2/3 of its length or width and is capable of returning to its original dimensions after release of compression, the claimed recitation "capable of" is merely a functional recitation requiring the ability to fulfill that function; the claim does not require, however, that activation actually occur. McQuillan discloses wherein the acellular tissue matrix is elastic. Accordingly, the composition of the prior art is capable of being compressed and returning to its original dimensions.
2. Claims 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over McQuillan et al. (US 2005/0028228, Feb. 3, 2005) (hereinafter McQuillan in view of Di Napoli (WO 2004/073759, Sep. 2, 2004), Yang et al. (US 2010/0063539, Mar. 11, 2010) (hereinafter Yang), and further in view of Ladet et al. (US 2013/0078285, Mar. 28, 2013) (hereinafter Ladet).
The teachings of McQuillan, Di Napoli, and Yang are discussed above. McQuillan, Di Napoli, and Yang do not teach wherein the composition comprises chlorhexidine and silver.
However, Ladet discloses an implant (abstract). The implant may comprise antimicrobial agents such as both chlorhexidine and silver (¶ [0077]).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. McQuillan discloses wherein the composition comprises antibiotics. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated chlorhexidine and silver into the composition of McQuillan since they are known antibiotics and implants may comprise more than one antibiotic as taught by Ladet.
In regards to instant claims 7 and 8, McQuillan discloses wherein antibiotics inhibit bacterial contamination. Therefore, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived at the claimed amounts of CHX and silver depending on the level of bacterial contamination inhibition desired. Additionally, generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. See MPEP 2144.05.
3. Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over McQuillan et al. (US 2005/0028228, Feb. 3, 2005) (hereinafter McQuillan) in view of Di Napoli (WO 2004/073759, Sep. 2, 2004), Yang et al. (US 2010/0063539, Mar. 11, 2010) (Yang), and further in view of Nahas et al. (US 2012/0189588, Jul. 26, 2012) (Nahas).
The teachings of McQuillan, Di Napoli, and Yang are discussed above. McQuillan, Di Napoli, and Yang do not teach wherein the acellular tissue comprises an adipose matrix.
However, Nahas discloses a process adipose tissue composition having a decellularized adipose tissue extracellular matrix to which viable cells securely attach (¶ [0005]). The processed adipose tissue contains 50% or more of collagen (¶ [0020]). In the field of reconstructive surgery there is a significant need for appropriate soft tissue replacement. Adipose tissue continues to be the tissue of choice in repairing soft tissue defects due to trauma and surgical resections for tumors or congenital defects (¶ [0131]).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have the acellular tissue matrix of McQuillan comprise adipose tissue since it is a known and effective decellularized collagen-containing tissue and is the tissue of choice in repairing soft tissue defects as taught by Nahas.
Allowable Subject Matter
Claim 11 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 9,089,523, claims 1-18 of U.S. Patent No. 9,504,770, claims 1-23 of U.S. Patent No. 10,092,677, and claims 1-20 of U.S. Patent No. 10,610,615. Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims recite a more specific version of the instant claims (i.e., the conflicting claims recite additional components such as decoroin or a method of using the pending claim composition) and thus read on the instant claims.
Conclusion
Claims 1-19 are rejected.
No claims are allowed.
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/TRACY LIU/Primary Examiner, Art Unit 1614
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