Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined pursuant to the first inventor to file provisions of the AIA .
DETAILED ACTION
Status of the Claims
Applicants filed claims 1 – 30 with the instant application on 24 February 2023. In a Preliminary Amendment filed on the same date, Applicants canceled claims 1 - 30 and added new claims 31 – 50. Currently, claims 31 – 50 are available for substantive examination.
Priority
The Examiner acknowledges receipt of papers submitted pursuant to 35 U.S.C. §§ 119(a)-(d), which papers are now of record in the file.
Information Disclosure Statement
The Examiner has considered the information Disclosure Statement (IDS) filed 30 May 2023, which is now of record in the file.
Claim Issues
The Examiner notes that claim 31 recites a limitation directed to a bone graft prepared according to the method of the invention wherein the graft comprises “an unasked portion.” Given the context of the limitation in the claim, the Examiner presumes that it was Applicants’ intent to recite “an unmasked portion,” and that the current form of the limitation arises from an inadvertent error.
In addition, the Examiner notes that claims 31, 47, and 50 recites limitations directed to the application of a masking agent “to a thickness of less than 1.5 mm.” Although Applicants’ specification provides support for this wording, it is the Examiner’s position that using the word thickness in this context is at least awkward logically and/or grammatically. Given that Applicants use a step of “dipping” the bone tissue into the masking agent (see claim 41), it would make more sense to recite the limitation as application of the masking agent “to a depth of less than 1.5 mm.” Furthermore, this would be consistent with claim 41, and would also comport with the more conventional use of the term, “thickness,” in claim 31.
The Examiner would suggest that Applicants amend these claims along the lines suggested immediately above.
Rejections Pursuant to 35 U.S.C. § 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.
Claim 37, independent claims 47 and 50, and claims 48 and 49, dependent from claim 47, are rejected pursuant to 35 U.S.C. § 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claims 37, 47, and 48 are indefinite in reciting that the “concentration of PMMA in the masking agent is between about 4% and about 12%.” The claims are unclear because no units for the percent concentration are given (e.g., vol/vol, wgt/vol, wgt/wgt) and one skilled in the art, therefore, would not be reasonably apprised of the metes and bounds of the claims.
Rejections Pursuant to 35 U.S.C. § 103
The following is a quotation of 35 U.S.C. § 103 that 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness pursuant to 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.
This application currently names joint inventors. In considering patentability of the claims the Examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention absent any evidence to the contrary. Applicants are advised of the obligation pursuant to 37 CFR § 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the Examiner to consider the applicability of 35 U.S.C. § 102(b)(2)(C) for any potential 35 U.S.C. § 102(a)(2) prior art against the later invention.
Claims 31 – 36 and 39 – 46, 48, and 49 are rejected pursuant to 35 U.S.C. § 103, as being obvious over US 2014/0188242 A1 to Nauman, E. and D. Dickerson, published 3 July 2014 (“Nauman ‘242”), in view of US 2014/0255506 A1 to Behnam, K., et al., published 11 September 2014 (“Behnam ‘506”), US 2017/0216482 A1 to Jonn, J., et al., published 3 August 2017 (“Jonn ‘482”), and US 7,753,963 to Boyer, M., et al., issued 13 July 2010 (“Boyer ‘963”), as evidenced by Ethoxyethyl 2-cyanoacrylate – PubChem, obtained from the Internet at https://Ethoxyethyl 2-cyanoacrylate | C8H11NO3 | CID 89125 - PubChem on 1 April 2026 (“PubChem”).
The Invention As Claimed
Applicants claim a method of forming a bone graft comprising the steps of cutting donor bone tissue into a thin layer less than 5.5 mm thick, washing the cut donor bone tissue with a protease, defatting the bone tissue, applying a masking agent to a first side of the bone tissue to a thickness [depth] of less than 1.5 mm, wherein the masking agent comprises a cyanoacrylate having a polar side chain including an oxygen, demineralizing the unmasked portion of the donor bone tissue, and removing the masking agent resulting in a graft with a first layer of demineralized bone and a second layer of mineralized bone with a thickness less than 1.5 mm, wherein the masking agent comprises ethoxyethyl cyanoacrylate, wherein defatting the cut donor bone tissue comprises washing in acetone, wherein the masking agent comprises a thickener, wherein the thickener comprises polymethyl methacrylate (PMMA), wherein the method further comprises the step of trimming the cut donor bone tissue to a length of between about 15 and 50 mm, and a width of between about 10 - 25 mm, wherein applying the masking agent comprises dipping the cut donor bone tissue into the masking agent for less than 1 minute to a depth of less than 1.5 mm, wherein the method further comprises the step of drying the masking agent for 1 hour or less, wherein removing the masking agent comprises rinsing the cut donor bone tissue in acetone, wherein the method further comprises the step of dehydrating the graft, wherein the donor bone tissue comprises cancellous human bone, and wherein the method further comprises confirming the density or the porosity of the cut donor bone tissue before applying the masking agent.
The Teachings of the Cited Art
Nauman ‘242 discloses a cancellous bone scaffold to use in the replacement or repair of connective tissue such as ligaments and tendons, the cancellous bone scaffold having a fully demineralized segment with at least one adjacent mineralized end segment (see Abstract), wherein the scaffolds must display a porosity in order to allow more rapid cell incorporation along the surface and through its thickness (see ¶[0007]), wherein the fully demineralized bone segment may have a calcium content of from about 0 to about 2% wgt, and there may also be a partially demineralized bone segment between the mineralized end segment and the fully demineralized segment (see ¶[0009]), wherein cancellous bone scaffolds have an advantage over the prior art scaffolds of cortical bone in that it can vascularize much more easily, in comparison to cortical bone that has a dense surface layer of bone with little vascularization, with the cancellous bone being a spongy material that makes up the bulk of the interior of bones, with lower density and strength than cortical bone, but very high surface area (see ¶[0023]), wherein the partially demineralized bone segment may have a calcium content from about 2% to about 10% (see ¶[0026]), wherein the cancellous bone scaffold may be an autograft, an allograft or a xenograft (see ¶[0027]), wherein, after being obtained from bone, the marrow is removed from the cancellous bone (id.), wherein the cancellous bone portion may be shaped into any shape desired for the scaffold depending on the application and where in the body the scaffold will be placed, with shapes of the scaffold including sheets, rectangular blocks, cylinders, dog-bone shapes, or parallelepipeds (is.), wherein the size of the scaffold may also vary according to the desired use of the scaffold, having a thickness of about 0.1 mm to about 15 mm, or about 0.5 mm to about 10 mm, although it may be smaller or larger as required (id.), wherein the fully demineralized bone segments can be prepared by any well-known method, while the end segments that will remain mineralized are masked before demineralization using any method or substance may be used to mask the bone provided that it is resistant to demineralization conditions and may be readily removed after demineralization, the methods and substances including wax, or a polymer such as a polycyanoacrylate polymer that is used as a liquid bandage, the polymer being any polymer that may be removed with acetone or ethanol (see ¶[0029]), wherein the mineralized segment may be further machined to comprise a groove, an external thread, an internal thread, a tooth-like serration or a driver head or any other shape or form that allows for attachment to bone, and the recipient bone may then be machined in a complimentary fashion so that the cancellous bone scaffold may be inserted into the recipient bone (see ¶[0036]), wherein, in exemplified embodiments, bone tissue samples were prepared from bovine cancellous bone harvested from the vertebral bodies of commercially obtained steers, residual tissue soft tissue was removed from the vertebral bodies, using a diamond saw, the samples were sectioned into 3 mm x 3 mm x 40 mm blocks, and small scaffolds were created by cutting these samples to a height of 2 mm, then the samples were washed in a detergent solution to remove fat and marrow from the intertrabecular spaces and subsequently washed well in deionized water for 4 hours, while samples were defatted by soaking in acetone for 12 hours (see ¶[0044]), wherein, in order to create a contiguous scaffold with mineralized and demineralized sections, samples were coated with a polymer to protect the sections from being demineralized (see ¶[0053]), and wherein the ends of long cancellous bone samples were coated in the polymer solution and placed in demineralizing solution for the minimum treatment time, resulting in a structure comprising a cancellous bone-soft tissue-cancellous bone scaffold (see ¶[0054]). The reference does not disclose a method for preparing a bone graft wherein organic material was removed from the donor bone tissue by washing with a protease, or a method wherein the masking agent is ethoxyethyl cyanoacrylate, or a masking agent comprising PMMA as a thickener, or a method comprising applying the masking agent to a depth of less than 1.5 mm. The teachings of Behnam ‘506, Jonn ‘482, and Boyer ‘963 remedy those deficiencies.
Behnam ‘506 discloses an osteoinductive demineralized bone matrix, corresponding osteoimplants, and methods for making the osteoinductive demineralized bone matrix, which matrix may form an osteogenic osteoimplant that, when implanted in a mammalian body, may induce at the locus of the implant the full developmental cascade of endochondral bone formation including vascularization, mineralization, and bone marrow differentiation (see Abstract), wherein at least partially demineralized bone matrix is treated with enzymes or chemicals to enhance the osteoinductive activity of the bone matrix (see ¶[0021]), wherein the term, proteases, refers to protein-cleaving enzymes that cleave peptide bonds that link amino acids in protein molecules to generate peptides and protein fragments (see ¶[0039]), wherein the bone may be cancellous, corticocancellous, cortical, or a composite bone that is fully demineralized, partially demineralized, or surface demineralized (see ¶[0042]), wherein the at least partially demineralized bone is exposed to a biological or chemical agent or to a combination of agents, including a cleavage agent, e.g. proteases such as collagenases (see ¶[0047]), wherein the cleavage agents may be applied either together or sequentially, optionally washing the matrix between application of different agents to remove residual agent as used in an effective amount and for a time sufficient to achieve a desired outcome (see ¶[0077]), and wherein allogenic cancellous bone, when treated with collagenase enzymes for approximately one hour, becomes osteoinductive, approximately as osteoinductive as allogenic cortical demineralized bone (see ¶[0090]).
Jonn ‘482 discloses a tissue bonding article includes a flexible material, an adhesive substance applied over at least a portion of a bottom side of the flexible material, and a polymerizable adhesive composition permeated throughout at least a portion of the flexible material (see Abstract), wherein a composite structure is formed by applying a polymerizable adhesive composition to the flexible substrate, and allowing the polymerizable adhesive composition to polymerize (see ¶[0112]), wherein the polymerizable (i.e., monomer and/or prepolymeric) adhesive composition may include one or more polymerizable monomers, which are synthetic or semi-synthetic monomers (see ¶[0113]), wherein preferred monomers include 1,1-disubstituted ethylene monomers, such as α-cyanoacrylates including, but not limited to, alkyl α-cyanoacrylates having an alkyl chain length of from about 1 to about 20 carbon atoms or more (see ¶[0114]), wherein a preferred α-cyanoacrylate monomers comprises ethoxyethyl cyanoacrylate (see ¶[0116]), wherein the composition also includes at least one other plasticizing agent that assists in imparting flexibility to the polymer formed from the monomer, such as polymethylmethacrylate (PMMA) (see ¶[0119]).
Boyer ‘963 discloses selectively demineralized bone-derived implants (see Abstract), wherein the implant is in the form of a bone sheet, the sheet including a demineralized field substantially surrounding at least one mineralized region (see Col. 3, ll. 55 – 57), wherein the sheet comprises a masked region and the sheet is demineralized around the masked region (see Col 3, l. 64 – Col. 4, l. 3), wherein the masking is provided by a tape, a paint, or a coating (see Col. 4, ll. 6 – 7), wherein tapes or paints may be applied to serve as masking elements to seal particular regions by dipping or otherwise painting select regions of an implant to mask the regions from
Treatment, with the masking techniques being not only resistant to the bone treatments, but are
readily removed following treatment (see Col. 6, ll. 20 – 26).
Application of the Cited Art to the Claims
It would have been prima facie obvious before the filing date of the claimed invention to prepare a cancellous bone scaffold to use in the replacement or repair of connective tissue, the cancellous bone scaffold having a fully demineralized segment with at least one adjacent mineralized end segment, and there may also be a partially demineralized bone segment between the mineralized end segment and the fully demineralized segment, wherein the cancellous bone scaffold may be an autograft, an allograft or a xenograft, wherein, after being obtained from bone, the marrow is removed from the cancellous bone, wherein the cancellous bone portion may be shaped into any shape desired for the scaffold depending on the application and where in the body the scaffold will be placed, with shapes of the scaffold including sheets, rectangular blocks, cylinders, dog-bone shapes, or parallelepipeds, wherein the size of the scaffold may also vary according to the desired use of the scaffold, having a thickness of about 0.1 mm to about 15 mm, or about 0.5 mm to about 10 mm, although it may be smaller or larger as required, wherein the fully demineralized bone segments can be prepared by any well-known method, while the end segments that will remain mineralized are masked before demineralization using any method or substance may be used to mask the bone provided that it is resistant to demineralization conditions and may be readily removed after demineralization, the methods and substances including wax, or a polymer such as a polycyanoacrylate polymer that is used as a liquid bandage, the polymer being removed with acetone, wherein, in exemplified embodiments, bone tissue samples were prepared from bovine cancellous bone harvested from the vertebral bodies of commercially obtained steers, residual tissue soft tissue was removed from the vertebral bodies, and, using a diamond saw, the samples were sectioned into 3 mm x 3 mm x 40 mm blocks, and small scaffolds were created by cutting these samples to a height of 2 mm, then the samples were washed in a detergent solution to remove fat and marrow from the intertrabecular spaces and subsequently washed well in deionized water for 4 hours, while samples were defatted by soaking in acetone for 12 hours, wherein, in order to create a contiguous scaffold with mineralized and demineralized sections, samples were coated with a polycyanoacrylate polymer to protect the sections from being demineralized, and wherein the ends of long cancellous bone samples were coated in the polymer solution and placed in demineralizing solution for the minimum treatment time, resulting in a structure comprising a cancellous bone-soft tissue-cancellous bone scaffold, as taught by Nauman ‘242, wherein the at least partially demineralized bone is exposed to a biological or chemical agent, in combination with the detergent solution of Nauman ‘242, or to a combination of agents, including a cleavage agent, e.g. proteases such as collagenases, wherein the cleavage agents may be applied either together or sequentially, optionally washing the matrix between application of different agents to remove residual agent as used in an effective amount and for a time sufficient to achieve a desired outcome, as taught by Behnam ‘506, wherein a composite wound closure structure is formed by applying a polymerizable adhesive composition to the flexible substrate, and allowing the polymerizable adhesive composition to polymerize, wherein the polymerizable (i.e., monomer and/or prepolymeric) adhesive composition may include one or more polymerizable monomers, wherein preferred monomers include 1,1-disubstituted ethylene monomers, such as α-cyanoacrylates including, but not limited to, alkyl α-cyanoacrylates having an alkyl chain length of from about 1 to about 20 carbon atoms or more, wherein a preferred α-cyanoacrylate monomers comprises ethoxyethyl cyanoacrylate, wherein the composition also includes at least one other plasticizing agent that assists in imparting flexibility to the polymer formed from the monomer, such as polymethylmethacrylate (PMMA), as taught by Jonn ‘482, and wherein the masking agent is applied to the bone tissue by dipping the bone tissue into a volume of the masking agent, as taught by Boyer ‘963. One of skill in the art would be motivated to do so, with a reasonable expectation of success in so doing, by the express teachings of Behnam ‘506 to the effect that enzymes such as proteases are effective in removing unwanted biological components from bone tissue intended for use in a bone graft, and by the teachings of Jonn ‘482 to the effect that ethoxyethyl cyanoacrylate is a particularly preferred adhesive polymer for use on porous surfaces (see ¶¶[0113] – [0114]). Furthermore, Nauman ‘242 explicitly states that liquid bandages comprising polycyanoacrylates polymers can be used as masking agents in preparation of bone repair grafts, and that such polymers can be removed with acetone (see ¶[0030]).
==With respect to the limitations recited in claims 31, 47, and 50, directed to the depth to which the masking agent penetrates the bone tissue (less than 1.5 mm), the Examiner notes that the cited references do not explicitly disclose a specific penetration depth for the masking agent. However, the Examiner notes that the cited references teach the same masking agent, being applied to the same type of bone tissue, such that the chemical and physical factors impacting penetration depth would be the same as those acting during practice of the method of the invention. In addition, or in the alternative, one of ordinary skill in the art would recognize that the depth of penetration would be also be a function, in a dip method, such as that taught by Boyer ‘963, of how long the bone tissue was in contact with the masking agent and, thus, would amount to nothing more than an optimization of a result-effective variable, the exercise of which is well with the expertise of one of ordinary skill in the appropriate art. Consequently, in the absence of evidence as to the criticality of such parameter, this limitation cannot support patentability. See MPEP § 2144.05 II. A.
With respect to claims 33 and 34, which claims recite limitations directed to the structural properties of the masking agent, the Examiner notes first that the cited references disclose the use of the same agent as recited in claim 32, and that, as evidenced by PubChem, the structure of ethoxyethyl cyanoacrylate would read on the structural limitations recited in those claims.
With respect to claim 46, which claim recites a limitation directed to the method of the invention comprising a step confirming a density or porosity of the bone tissue before applying the masking agent, the Examiner notes that Nauman ‘242 discloses that the bone tissue of the implant, in order to function effectively in the repair or healing of bone tissue defects, must possess sufficient porosity to allow the facile influx of cells critical bone reformation (see ¶[0007]). It is the Examiner’s position, therefore, that this teaching is properly understood to be directed to a necessary step in the disclosed preparation method before treatment of the tissue to mask and selectively demineralize the bone tissue, thus reading on the limitation in question.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by claims 31 – 36 and 39 – 46, 48, and 49 would have been obvious within the meaning of 35 USC § 103.
Claims 37, 38, 47 and 50 are rejected pursuant to 35 U.S.C. § 103 as obvious over Nauman ‘242, in view of Behnam ‘506, and Jonn ‘482, as applied in the above rejection of claims 31 – 36 and 39 – 46, 48, and 49, and further in view of US 5,739,205 to Nishino, Y. and C. Hata, issued 14 April 1998, identified on the Information Disclosure Statement (IDS) filed 30 May 2023, cite no. 87 (USPAT) (“Nishino ‘205”).
The Invention As Claimed
The invention with respect to claim 31 is described above. In addition, Applicants claim a method of preparing a bone graft by using a masking agent that comprises PMMA at a concentration of from about 4% to about 12%, wherein the PMMA has a molecular weight of 350,000, or less.
The Teachings of the Cited Art
The teachings of Nauman ‘242, Behnam ‘506, Jonn ‘482, and Boyer ‘963 are relied upon as set forth in the above rejection of claims 31 – 36 and 39 – 46, 48, and 49. The references do not disclose the use of a masking agent that further comprises PMMA at a concentration between about 4% and 12%, with a molecular weight of 350,000, or less. The teachings of Nishino ‘205 remedy those deficiencies.
Nishino ‘205 discloses an α-cyanoacrylate adhesive composition having high thixotropy, excellent stability with age, including difficulty of separation and excellent adhesiveness, wherein the compositions comprise 10 through 20 parts by weight of polymers containing alkyl methacrylate having a molecular weight of 100,000 through 300,000 (see Abstract), wherein one of the problems encountered when α-cyanoacrylate adhesives that flow easily is that uniform coating on inclined planes is difficult to obtain, and is poor adhesion is encountered when an application is made on porous substrates because the adhesives penetrate into the surface of the substrates, while an approach to solve these problems is that polymer thickeners are blended with a-cyanoacrylate adhesives in order to increase viscosity (see Col. 1, ll. 14 – 23), wherein an α-cyanoacrylate composition is used that comprises 10 through 20 parts by weight of polyalkyl methacrylates having a weight average molecular weight of 100,000 through 300,000, or copolymers of alkyl methacrylates, and other methacrylates or acrylates, the copolymers having the same average molecular weight as that of polyalkyl methacrylates (see Col. 2, ll. 13 – 19), wherein the identified issues with α-cyanoacrylates are addressed by using a specific amount of polyalkyl methacrylates, or copolymers thereof, having a relatively small weight average molecular weight as the thickeners (see Col. 2, ll. 39 – 42), wherein the polyalkyl methacrylate comprises polymethyl methacrylate (see Col. 2, ll. 63 – 65), and wherein the polyalkyl methacrylates are present in amounts of 10 through 20 parts by weight, on the basis of 100 parts by weight of the α-cyanoacrylates (see Col. 3, ll. 20 – 25).
Application of the Cited Art to the Claims
It would have been prima facie obvious before the filing date of the claimed invention to prepare a cancellous bone scaffold to use in the replacement or repair of connective tissue, the cancellous bone scaffold having a fully demineralized segment with at least one adjacent mineralized end segment, as taught by Nauman ‘242, Behnam ‘506, Jonn ‘482, and Boyer ‘963, wherein the PMMA used in the masking agent is present at a level of 10 through 20 parts by weight of polymers on the basis of 100 parts by weight of the α-cyanoacrylate masking agent, the PMMA having a molecular weight of 100,000 through 300,000, as taught by Nishino ‘205. One of ordinary skill in the art would be motivated to do so, with a reasonable expectation of success in so doing by the teachings of Nishino ‘205 to the effect that using polymer thickeners blended with α-cyanoacrylate adhesives in order to increase viscosity solves the problems associated with use of α-cyanoacrylate adhesives that flow easily that lead to difficulty in obtaining uniform coating on inclined planes, and poor adhesion when an application is made on porous substrates because the adhesives penetrate into the surface of the substrates (see Col. 1, ll. 14 – 23).
With respect to the quantitative range of concentrations of PMMA in the α-cyanoacrylate masking agent, the Examiner notes that the reference does not disclose a range that is exactly congruent with the claimed range. However, it is the Examiner’s position that the cited art teaches a range of loadings of the PMMA component that significantly overlaps with the claimed loadings and, as such, would render the claimed invention obvious. See MPEP § 2144.05. “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).”
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by claims 37, 38, 47 and 50 would have been obvious within the meaning of 35 USC § 103.
Obviousness-Type 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 31 - 50 are provisionally rejected on the basis of nonstatutory double patenting as being unpatentable over claims 1 – 30 of co-pending Application No. 17/410,160 (“the ‘160 application”), in view of Behnam ‘506.
The instant claims have been described supra.
Claims 1 –30 of the ‘160 application are directed to a method of forming a compressible and compliant graft from a porous bone, the method comprising cutting donor bone tissue into a thin layer having a thickness; applying a masking agent to a first side of a body of the donor bone tissue to a thickness of less than 1.5 mm, forming a masked portion and an unasked portion, wherein the masking agent comprises a cyanoacrylate having a polar side chain including an oxygen; demineralizing the unmasked portion of the donor bone tissue; and removing the masking agent to form a graft comprising a first layer of demineralized bone extending a length and a width of the body; and a second layer of mineralized bone that is continuously adjacent to the first layer, wherein the second layer has a thickness that is less than 1.5 mm, wherein the masking agent comprises ethoxyethyl cyanoacrylate, wherein the cyanoacrylate having a polar side chain including an oxygen is selected from the group consisting of ethoxyethyl cyanoacrylates, methoxypropyl cyanoacrylates and ethoxymethyl cyanoacrylates, wherein the cyanoacrylate having a polar side chain including an oxygen is selected from the group of cyanoacrylates having a low blooming and relatively quick curing properties, wherein the masking agent comprises a thickener to reduce viscosity, wherein the thickener comprises polymethyl methacrylate (PMMA), wherein a concentration of PMMA in the masking agent is between about 4% and about 12%, wherein the PMMA comprises an average molecular weight of about 350,000 or less, wherein cutting the donor bone tissue into a thin layer having a thickness comprises cutting to a thickness of less than 5.5 mm, wherein the method further comprises washing the thin layer of donor bone tissue to remove organic material by exposing the cut donor bone tissue to a detergent including a protease, wherein the method further comprises washing the thin layer of donor bone tissue to remove organic material by exposing the cut donor bone tissue to a defatting agent, wherein the defatting agent comprises acetone, wherein the method further comprises trimming the cut donor bone tissue to a length of between about 15 and 50 mm, and a width of between about 10 - 25 mm, wherein applying the masking agent comprises dipping the cut donor bone tissue into the masking agent for less than 1 minute to a depth of less than 1.5 mm, wherein the method further comprises drying the masking agent for 1 hour or less, wherein removing the masking agent comprises rinsing the cut donor bone tissue in acetone, wherein the method further comprises dehydrating the graft for storage, wherein the donor bone tissue comprises cancellous human bone, and wherein the method further comprises confirming a density or porosity of the cut donor bone tissue before applying the masking agent. The claims do not disclose a method to prepare a bone graft comprising a step of washing cut donor bone tissue with protease to remove organic material and defatting the cut donor bone tissue. The teachings of Behnam ‘506, as set forth above, remedy that deficiency.
Thus, it would be prima facie obvious to prepare a bone graft according to the claims of the ‘160 application, wherein the method includes a step of washing cut donor tissue with a protease to remove organic matter and defat the tissue as taught by Behnam ‘506. One of ordinary skill in the art would be motivated to do so, with a reasonable expectation of success in so doing by the teachings of Behnam ‘506 as to the utility of proteases such as collagenase in breaking down collagen-based tissue and other unwanted components of donor bone tissue.
This is a provisional obviousness-type double patenting rejection.
NO CLAIM IS ALLOWED.
CONCLUSION
Any inquiry concerning this communication or any other communications from the examiner should be directed to Daniel F. Coughlin whose telephone number is (571)270-3748. The examiner can normally be reached on M-F 8:30 am - 5:30 pm.
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/DANIEL F COUGHLIN/
Examiner, Art Unit 1619
/DAVID J BLANCHARD/ Supervisory Patent Examiner, Art Unit 1619