DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 2-6 and 8-9 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 2-6 and 8-9 recite the limitation "the tissue matrix" in line 1. There is insufficient antecedent basis for this limitation in the claim, in that parent claim 1 recites both “a porous decellularized adipose extracellular tissue matrix” and “acellular particulate adipose tissue matrix” and it is not clear to which tissue matrix the limitation refers.
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 of this title, 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 negatived by the manner in which the invention was made.
Claims 1-16 and 18-20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Malaviya et al. (US 2003/0044444 A1; published 06 March 2003) in view of Nahas et al. (WO 2011/019822 A2; published 17 February 2011; filed 11 August 2010; priority to 11 August 2009) and Baksh et al. (US 2011/0293667 A1; published 01 December 2011; filed 14 January 2011; priority to 24 May 2010 and 14 January 2010).
Malaviya et al. discloses making an implantable device for repairing or regenerating body tissue by providing a naturally occurring extracellular matrix (i.e., ECM) in raw form, comminuting the extracellular matrix (i.e., mechanically processing the ECM to reduce to particle size) in the presence of a liquid to form a slurry of naturally occurring extracellular matrix (i.e., suspending the ECM particles in a solution), and lyophilizing (i.e., freeze-drying) the slurry of extracellular matrix to form an open cell foam (i.e., a porous sponge) (claim 59) wherein the extracellular matrix foam can be at least partially chemically or physically cross-linked (paragraphs [0007], [0063]) wherein the extracellular matrix can be treated to substantially remove lipids (claim 77) wherein the porous implantable scaffold has mechanical properties to fit the needs of a given scaffold design such as desired structural rigidity (paragraph [0078]) wherein bioactive agents may be included in the ECM foam such as hyaluronic acid and chondroitin sulfate (paragraphs [0066]-[0067]) wherein comminuting can be cutting (paragraphs [0030], [0035], [0036], [0042], [0048], [0054]) wherein the slurry of ECM may be heated in a vacuum (paragraph [0031]).
Malaviya et al. does not disclose the ECM as from adipose or cross-linking including heating in a vacuum as claimed.
Nahas et al. discloses compositions and methods for implantation of processed adipose tissue products (title) for tissue reconstruction or restoration (page 9 lines 16-17). In Example 2, acellular biomaterial / processed human adipose tissue (PhAT) is prepared by isolating subcutaneous fat (i.e., selecting an adipose tissue) from a tissue sample by scraping, homogenizing the scraped adipose tissue in a blender or with a press or mincing by forcing through a die while rinsing with water to remove lipid (i.e., mechanically processing the adipose tissue to reduce the tissue size and mechanically removing freed lipids from the tissue), washing with water to remove lipid and cellular debris (i.e., treating the mechanically processed tissue to remove substantially all cellular material from the tissue), treating with TRITON X-100 (i.e., detergent), and solubilizing (i.e., forming a solution, wherein a “solution” encompasses a “suspension” per page 19 line 13) using weak acid and water with shaking to promote chemical decellularization (Example 2) (i.e., suspending the tissue in a solution to form a suspension). The processed adipose tissue preferably contains hyaluronic acid and/or chondroitin sulfate (page 3 lines 27-30). The material is then optionally lyophilized (i.e., freeze-dried, which would form a sponge as instantly claimed) prior to storage (Example 2). The processed adipose material is then made into particles for injection with or without a biopolymer scaffold and cross-linking agents (Example 2), wherein a biopolymer scaffold provides a three dimensional framework (page 25 lines 1-5). An aqueous suspension of the material can be injected (page 17 lines 10-11; page 36 lines 22-29). An external mold can be applied to shape an injected solution, the injected implant can be molded like one would mold clay, or the mixture can be injected into a mold (i.e., producing a desired shape), then the biomaterial allowed to harden (i.e., cross-linked), then the material implanted (page 36 lines 11-15). The material is cross-linked (i.e., fixed, hardened, maintains porous structure and shape) with cross-linking agents such as glutaraldehyde, genipin, carbodiimides, or diisocyanates (page 38 line 24 to page 40 line 10). Acellular tissue can be cross-linked with genipin at 37˚C (i.e., heating) (page 39 lines 17-20). The cross-linking temperature can be varied depending on the desired level of cross-linking depending on the final use of the processed adipose tissue (page 39 lines 31-33). The amount of cross-linker to be used is determined based on the desired physical properties of the processed adipose tissue (i.e., partial cross-linking) (page 5 lines 1-3) and 60%-degree crosslinking of acellular tissue is preferred (page 39 lines 1-16). The implant can be formed into a desired shape for implantation (page 42 lines 18-20). The implant is volume-stable in vivo (Example 9) (i.e., a stable three-dimensional structure when contacted with an aqueous environment and when implanted in a body). The adipose tissue is human adipose tissue or porcine adipose tissue (page 4 lines 4-6). The ECM (i.e., extracellular material, acellular material) is porous in nature (i.e., a sponge) which facilitates cell migration and nutrient diffusion (page 48 lines 11-12; Example 5). The processed adipose tissue preferably may contain 0.001% or less lipid (i.e., substantially all lipid is removed) (page 3 lines 6-8). The agent to promote decellularization may comprise an agent selected from an acid or a non-ionic detergent (claim 29), wherein an example of a non-ionic detergent used to decellularize the adipose or extract lipid from the adipose is TRITON X-100 (claims 32, 33).
It would have been prima facie obvious to a person of ordinary skill in the art at the time the invention was made to combine the teachings of Malaviya et al. and Nahas et al. by using the acellular processed human adipose tissue of Nahas et al. as the extracellular matrix (ECM) in the implant of Malaviya et al., with a reasonable expectation of success, given that the ECM of Malaviya et al. and the acellular processed human adipose tissue of Nahas et al. are both extracellular material used in making implants, and a person of ordinary skill in the art at the time the invention was made could have substituted one for the other with the predictable result of obtaining an implant suitable for tissue repair. See MPEP 2143(I)(B).
Baksh et al. discloses bioengineered constructs comprising extracellular matrix such as decellularized constructs (paragraph [0005]) wherein ECM is comprised mainly of fibrous proteins and polysaccharides (paragraph [0029]) wherein pores therein are created by lyophilization (paragraph [0081]) wherein the ECM can be crosslinked to control its rate of bioremodeling and increase its persistence when implanted (paragraph [0091]) wherein crosslinking provides strength and durability to the construct and improves its handling properties (paragraph [0096]) wherein various crosslinking agents known in the art can be used such as genipin and dehydrothermal (DHT) methods (paragraph [0096]) wherein DHT involves exposing the implant to heat under vacuum which can be advantageous over chemical crosslinking for certain regenerative medicine applications since the process does not introduce potentially cytotoxic or inflammatory chemicals into the implants for therapeutic use which would stimulate the patient’s immune responses (paragraph [0099]) wherein an example uses a vacuum oven at 100°C for crosslinking (paragraph [0160]).
It also would have been prima facie obvious to a person of ordinary skill in the art at the time the invention was made to combine the teachings of Malaviya et al. and Baksh et al. by using the DHT crosslinking including vacuum and heat of 100°C of Baksh et al. as the crosslinking agent/method in the implant and method of Malaviya et al. as discussed above, with a reasonable expectation of success. A person of ordinary skill in the art at the time the invention was made would have been motivated to do so to reduce or eliminate potentially cytotoxic or inflammatory chemicals in the implant in order to reduce or eliminate stimulation of the patient’s immune responses, and to provide strength and durability to the implant (i.e., maintain the porous structure of the implant), as suggested by Baksh et al., given that Malaviya et al. teaches that either chemical or physical (e.g., DHT) cross-linking can be used.
Regarding the claimed recitations of particulate adipose tissue matrix, as noted above, Malaviya et al. teaches comminution of the extracellular matrix, which means mechanically processing the ECM to reduce to particle size, and teaches such comminution in the presence of a liquid to form a slurry of naturally occurring extracellular matrix, which means suspending the ECM particles in a solution. In addition, Nahas et al. discloses that the acellular processed human adipose tissue of Nahas et al. can be formed into particles for use, and thus it would have been prima facie obvious to a person of ordinary skill in the art at the time the invention was made to follow the suggestions of Malaviya et al. and Nahas et al. as discussed above and to cut the ECM into particles for use in the implant of Malaviya et al. in view of Nahas et al. and Baksh et al. as discussed above, with a reasonable expectation of success, given that particles are a form of ECM that Nahas et al. discloses as suitable for use in ECM implants, and given that particles would be a suitable form that could form an ECM slurry as in Malaviya et al.
Although Baksh et al. discloses 100°C heat for crosslinking instead of the claimed ranges of 70-90°C and 70-85°C, a prima facie case of obviousness nevertheless exists based on such prior art teachings because the claimed ranges are so close to the prior art value of 100°C such that a person of ordinary skill in the art at the time the invention was made would have expected properties resulting from such range and value to be the same. See MPEP 2144.05(I). See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%).
It also would have been prima facie obvious to a person of ordinary skill in the art at the time the invention was made to follow the suggestions of Malaviya et al. as discussed above and to treat the extracellular matrix of Malaviya et al. to substantially remove lipids therefrom, with a reasonable expectation of success.
The crosslinking of Malaviya et al. increases the stiffness of the implant which therefore maintains the porous structure of the implant, and also maintains the size and shape of the implant. Moreover, as discussed above, the implant of Malaviya et al. has a desired structural rigidity, and thus maintains a porous structure, size, and shape when implanted in a body, which is a compressed aqueous environment.
It also would have been prima facie obvious to a person of ordinary skill in the art at the time the invention was made to use any of the methods and materials of Nahas et al. and Baksh et al. as discussed above in the method of Malaviya et al. as discussed above, with a reasonable expectation of success, given that Malaviya et al., Nahas et al., and Baksh et al. are all directed to tissue implants, and given that a person of ordinary skill in the art at the time the invention was made could have combined such elements by known methods as disclosed in such prior art, wherein each element merely performs the same function as it does separately, with the predictable result of obtaining a tissue implant.
It also would have been prima facie obvious to a person of ordinary skill in the art at the time the invention was made to follow the suggestions of Malaviya et al. as discussed above and to include hyaluronic acid and chondroitin sulfate in the ECM implant of Malaviya et al., with a reasonable expectation of success.
Claims 1-20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Malaviya et al. in view of Nahas et al. and Baksh et al. as applied to claims 1-16 and 18-20 above, and further in view of Ksander et al. (U.S. Patent No. 4,950,483; issued 21 August 1990).
Malaviya et al., Nahas et al., and Baksh et al. are relied upon as discussed above.
Although Nahas et al. teaches that the implant can be formed into a desired shape for implantation, Malaviya et al., Nahas et al., and Baksh et al. do not specifically teach contacting the tissue with a flat surface and applying force to compress the tissue to a thickness of about 2.0mm or less as in claim 17.
Ksander et al. discloses collagen implants that are compressed to increase the tensile strength of the implant (column 2 lines 40-46). Such compression can be accomplished by passing a sheet of the implant product through a press, or through rollers or the like to achieve the desired degree of compression and to decrease the thickness of the implant (column 4 lines 42-50). An example discloses an implant compressed to a thickness of about 1 mm, which increases density and tear resistance (Example 3).
The teachings of Malaviya et al., Nahas et al., Baksh et al., and Ksander et al. are each directed to biopolymer implants. It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to combine their teachings by compressing the implants of Malaviya et al. in view of Nahas et al. and Baksh et al. as discussed above to a thickness of about 1 mm using a press as suggested by Ksander et al., with a reasonable expectation of success. A person of ordinary skill in the art at the time the invention was made would have been motivated to combine these teachings in order to increase the tensile strength, density, and tear resistance of the implant, as suggested by Ksander et al.
Although Ksander et al. does not specifically teach that the press has a flat surface, as noted in MPEP 2144.04(IV)(B), changes in shape are obvious absent persuasive evidence that a particular configuration is significant. No such evidence is present in the instant case. Thus, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to use a flat surface, rather than a roller or rounded surface, to contact the implant and thereby compress it, in the method and product of Malaviya in view of Nahas et al., Baksh et al., and Ksander et al. as discussed above.
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 1-18 of U.S. Patent No. 11,957,814.
Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘814 claims merely recite additional properties.
Conclusion
No claims are allowed.
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/MICHAEL B. PALLAY/Primary Examiner, Art Unit 1617
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