DETAILED ACTION
Claims 1-20 are pending and under consideration on the merits.
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 .
Notice of Subject Matter Free of the Prior Art
Claim 19 is free of the prior art. Clineff (US Pat. Pub. 2008/0187571) discloses producing a crosslinked bone repair composition comprising collagen (see 103 rejection, infra), but the prior art does not teach or suggest crosslinking a collagen composition by exposing it to formaldehyde vapors released from an airstone containing a formaldehyde solution as recited by the claim.
Claim Objections
Claim objected to because of the following informalities:
In claim 7, the word “percentage” is redundant and should be deleted. Correction is required.
In claim 20, line 2, “cross-lining” should be “cross-linking.” Correction is required.
Claim 20 is objected to as depending from a rejected base claim, but would be in condition for allowance if rewritten in independent form and including all limitations of its base claim.
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 and 7-9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as 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.
Claim 2 is indefinite because it recites a weight range for the collagen without specifying what it is with respect to, e.g., is it with respect to the total weight of the crosslinked collagen composition? Clarification is required.
Claim 7 recites that the collagen comprises “0.85% percentage,” which is indefinite because the units are unknown, e.g., is it a weight percentage? Clarification is required.
Claim 8 recites “after the mixing,” which is unclear because claim 5, from which claim 8 depends, recites a mixing step, but base claim 1, from which claim 8 also depends, also recites forming a first collagen mixture and a second collagen mixture, and it is unclear which mixing is being referred to by claim 8. Clarification is required. Dependent claim 9 does not clarify the confusion so is also indefinite.
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.
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(s) absent any evidence to the contrary. Applicant is advised of the obligation under 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 1-2, 4, 10, 12-18 are rejected under 35 U.S.C. 103 as unpatentable over Clineff (US Pat. Pub. 2008/0187571).
As to claims 1-2, 4, 10, 12-18, Clineff discloses a method for producing a bone graft material (“bone repair composition” of claim 1) comprising mixing collagen, bioactive glass, and calcium phosphate (a “bone growth stimulator”), adding the resultant mixture to a mold, freeze drying to remove water (which will form a porous product of claim 17), and crosslinking to form a crosslinked bone graft material comprising the collagen, bone growth stimulator, and bioactive glass as recited by claim 18 (paragraph 58). The bone graft material also may be packaged into a kit and sterilized (paragraphs 144, 80). Clineff further teaches the importance of monitoring the pH as the ingredients are mixed together because the bioactive glass is sensitive to aqueous environments and can be altered via premature leaching of ions necessary for promoting osteactivity (paragraph 58).
As to claim 4, Clineff nowhere requires the presence of hydroxyapatite in the composition.
Regarding claim 10, the collagen may comprise a type I collagen (paragraph 52).
As to claim 12, the bone stimulator particles have a size from 250-1000 microns, which is within the claimed range (paragraph 51).
Regarding claim 13, the bioactive glass particles may be sized from 1-2 mm (1000-2000 microns), which overlaps the recited range (paragraph 56).
As to claim 14, the composition may comprise up to about 40 wt% of the bioactive glass, which encompasses the claimed range (paragraph 66).
Regarding claim 15, the bone growth stimulator may be tricalcium phosphate and may comprise up to 80 wt% of the composition, which overlaps the recited range (paragraph 64).
As to claims 2 and 16, the collagen is present in amounts of up to 20 wt%, which encompasses the claimed range (paragraph 65).
As to claims 1-2, 4, 10, 12-18, Clineff does not further expressly disclose a step of adding an acid to the collagen to form a collagen dispersion prior to adding the bone growth stimulator and bioactive glass as recited by claim 1.
As to claims 1-2, 4, 10, 12-18, it would have been prima facie obvious to one of ordinary skill in the art at the effective filing date of the present invention to modify the Clineff method by adding an acid to the collagen at the first step of the method, because Clineff expressly teaches the importance of monitoring the pH as the ingredients are mixed together because the bioactive glass is sensitive to aqueous environments and can be altered via premature leaching of ions necessary for promoting osteactivity, such that the skilled artisan utilizing the Clineff method would have been motivated to monitor the pH and add an acid if the pH was high enough to cause undesirable effects such as those taught by Clineff.
Claim 3 is rejected under 35 U.S.C. 103 as unpatentable over Clineff (US Pat. Pub. 2008/0187571) as applied to claims 1-2, 4, 10, 12-18 above, and further in view of Wilson et al. (US Pat. Pub. 2019/0388585; priority date of 6.25.18).
The teachings of Clineff are relied upon as discussed above, but Clineff does not further expressly disclose that the crosslinked collagen comprises particles or flakes milled to pass through a 2000 micron mesh. Wils
Wilson teaches bone repair materials comprising collagen and hydroxyapatite as bone growth stimulator, and further teaches that the collagen is milled into a powder (paragraphs 5-7 and 31).
It would have been prima facie obvious to one of ordinary skill in the art at the effective filing date of the present invention to modify the Clineff method by milling the collagen into a powder, because Wilson expressly teaches that milling the collagen into a powder is a suitable way to prepare collagen for incorporation into a bond repair material comprising a bone growth stimulator. Such a modification is merely the combining of known elements according to known methods to yield predictable results, which is prima facie obvious. MPEP 2143. It further would have within the purview of the skilled artisan to select an appropriate size of the collagen powder that would read on the passage through a 2000 micron mesh recited by claim 3 with a reasonable expectation of success, because the skilled artisan would have been optimizing the collagen particles for the same function as in the claimed invention, i.e., to serve as a portion of the matrix in a bone repair composition. Discovering optimum or working ranges involves only routine skill in the art in cases where the general conditions of a claim are disclosed in the prior art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claims 5-9 rejected under 35 U.S.C. 103 as unpatentable over Clineff (US Pat. Pub. 2008/0187571) as applied to claims 1-2, 4, 10, 12-18 above, and further in view of McKay (US Pat. Pub. 2011/0182961).
The teachings of Clineff are relied upon as discussed above, but Clineff does not further expressly disclose adding lactic acid as the acid to form the collagen dispersion as recited by claim 5, nor the percentage of collagen in the dispersion (claims 6-7), nor resting the collagen dispersion in a refrigerator for a first period of time followed (claim 8), and while Clineff teaches blending the collagen and bioactive glass with the calcium phosphate bone growth stimulator to form a substantially homogeneous mixture (paragraph 58), it does not expressly teach blending a mixture comprising the collagen dispersion as recited by claim 8.
McKay discloses a bone repair composition comprising a matrix for augmenting bone formation (paragraphs 1-4), and teaches that the composition may comprise excipients such as lactic acid (paragraph 36).
As to claims 5-9, it would have been prima facie obvious to one of ordinary skill in the art at the effective filing date of the present invention to modify the Clineff method by selecting lactic acid as the type of acid to add as an aqueous solution when adjusting the pH, because McKay expressly teaches that lactic acid is a suitable acid for incorporation into a bone repair composition, such that the skilled artisan reasonably would have expected that it could be used as the type of acid in the method of Clineff as modified supra. Such a modification is merely the combining of known elements elements according to known methods to yield predictable results, which is prima facie obvious. MPEP 2143.
It further would have within the purview of the skilled artisan to select an amount of the collagen that would read on the amounts recited by claims 6-7 with a reasonable expectation of success, because the collagen is serving the same function in the Clineff composition as in the claimed composition, i.e., to serve as a portion of the matrix in a bone repair composition. Discovering optimum or working ranges involves only routine skill in the art in cases where the general conditions of a claim are disclosed in the prior art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claims 8-9, it further would have been prima facie obvious to cool the collagen dispersion followed by blending and addition of the bone growth stimulator and bioactive glass with a reasonable expectation of success because Clineff expressly teaches blending to mix ingredients during the process taught therein and because the collagen is serving the same function in the Clineff composition as in the claimed composition, i.e., to serve as a portion of the matrix in a bone repair composition. Differences in concentration or temperature generally will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim 11 is rejected under 35 U.S.C. 103 as unpatentable over Clineff (US Pat. Pub. 2008/0187571) as applied to claims 1-2, 4, 10, 12-18 above, and further in view of Yannas (US Pat. No. 4,280,954).
The teachings of Clineff are relied upon as discussed above, but they do not further expressly disclose that the composition comprises a type I collagen-glycosaminoglycan coprecipitate.
Yannas discloses a composite material comprising crosslinked collagen-mucopolysaccaride for use in prostheses having controlled biodegradability (Abstract), wherein the mucopolysaccharide may be chondroitin 4 sulfate or chondroitin 6 sulfate (i.e., a glycosaminoglycan)(column 2, 3rd full paragraph) which will result in a collagen-chondroitin sulfate coprecipitate. Yannas teaches that the addition of a mucopolysaccaride results in a composite that retains the advantageous properties of native collagen while also exhibiting superior mechanical properties, and that crosslinking can be carried out to provide any desired degree of increased resistance to resorption, resulting in heretofore unavailable design flexibility for surgical prostheses (column 3, 1st full paragraph).
As to claim 11, it would have been prima facie obvious to one of ordinary skill in the art at the effective filing date of the present invention to modify the collagen bone repair composition of Clineff by incorporating a type I collagen-chondroitin 4 sulfate or chondroitin 6 sulfate composite material to impart enhanced mechanical properties to the composition, since Yannas teaches that such a composite material possesses enhanced mechanical properties and unparalleled design flexibility for surgical prostheses that can be tuned to provide any desired resistance to unwanted resorption. Yanna’s explicit teaching of an advantage to a collagen/glycosaminoglycan coprecipitate in a surgical prosthesis over a collagen-only material establishes a strong case of prima facie obviousness, because the strongest rationale for combining references is a recognition, expressly or impliedly in the prior art or drawn from a convincing line of reasoning based on established scientific principles or legal precedent, that some advantage or expected beneficial result would have been produced by their combination. In re Sernaker, 702 F.2d 989, 994-95, 217 USPQ 1, 5-6 (Fed. Cir. 1983).
Claim 19 is rejected under 35 U.S.C. 103 as unpatentable over Clineff (US Pat. Pub. 2008/0187571) as applied to claims 1-2, 4, 10, 12-18 above, and further in view of Bagga (US Pat. No. 8,567,162).
The teachings of Clineff are relied upon as discussed above and Clineff further teaches that the composition is configured as a rectangular strip (paragraph 112 and Figure 2), but Clineff does not further expressly disclose that the strip is placed in a tray having one or more grip regions to facilitate access to the rectangular strip.
Bagga discloses a tray that is used to mold bone graft materials into shapes including strips (abstract, column 8, line 14), where the tray is configured to fit the shape of the bone repair composition (see Figures 5B and 5C). The tray also includes one or more grip regions to facilitate access to the bone repair composition (column 15, lines 45-49).
It would have been prima facie obvious to modify the Clineff package by placing the rectangular strip bone repair composition into a rectangular tray having grip regions to facilitate access to the strip, because Bagga teaches that such a tray is useful for molding and holding bone repair compositions.
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 unpatentable over all claims of US Pat. No. 11,09,0412 and in view of Clineff (US Pat. Pub. 2008/0187571), Wilson et al. (US Pat. Pub. 2019/0388585), Bagga (US Pat. No. 8,567,162), and/or McKay (US Pat. Pub. 2011/0182961) where indicated below.
The teachings of the cited secondary references are relied upon as discussed above.
The reference claims recite a bone repair composition comprising a type I collagen-glycosaminoglycan coprecipitate in the amount of 1-5 wt%, tricalcium phosphate bone growth stimulator in the amount of 75-85 wt% and having a particle size of 500 to 1400 microns, and bioactive glass in the amount of 15-25 wt% and having a size from 500 to 1000 microns, the collagen comprising fine flakes or particles obtained by milling collagen through a 20 mesh screen, wherein the composition is configured as a rectangular strip. The reference claims do not require the presence of hydroxyapatite.
Although the reference claims do not recite a method of forming the composition comprising the steps recited by claim 1, it would have been prima facie obvious to form a porous crosslinked composition of the claims using these steps because Clineff teaches that these steps may be used to produce a bone repair composition comprising a bone growth stimulator, collagen, and bioactive glass and McKay teaches that lactic acid is suitable for use in bone repair compositions such that the skilled artisan reasonably would have expected it could be used as an acid to vary the pH during the pH monitoring process which Clineff teaches is important.
Although the reference claims do not disclose that the strip is placed in a tray having one or more grip regions to facilitate access to the rectangular strip, it would have been prima facie obvious to place the rectangular strip bone repair composition into a rectangular tray having grip regions to facilitate access to the strip, because Bagga teaches that such a tray is useful for molding and holding bone repair compositions.
It further would have within the purview of the skilled artisan to select an amount of the collagen that would read on the amounts recited by claims 6-7 with a reasonable expectation of success, because the collagen is serving the same function in the reference composition as in the claimed composition, i.e., to serve as a portion of the matrix in a bone repair composition. Discovering optimum or working ranges involves only routine skill in the art in cases where the general conditions of a claim are disclosed in the prior art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claims 8-9, it further would have been prima facie obvious to cool the collagen dispersion followed by blending and addition of the bone growth stimulator and bioactive glass with a reasonable expectation of success because Clineff expressly teaches blending to mix ingredients during the process taught therein and because the collagen is serving the same function in the reference composition as in the claimed composition, i.e., to serve as a portion of the matrix in a bone repair composition. Differences in concentration or temperature generally will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claims 1-19 are rejected on the ground of nonstatutory double patenting as unpatentable over all claims of US Pat. No. 12,144909 and in view of and in view of Clineff (US Pat. Pub. 2008/0187571), Wilson et al. (US Pat. Pub. 2019/0388585), Bagga (US Pat. No. 8,567,162), and/or McKay (US Pat. Pub. 2011/0182961) where indicated below where indicated below.
The teachings of the cited secondary references are relied upon as discussed above.
The reference claims recite a crosslinked bone repair composition comprising a type I collagen-glycosaminoglycan coprecipitate in the amount of 1-5 wt%, tricalcium phosphate bone growth stimulator in the amount of 75-85 wt% and having a particle size of 400 to 1500 microns, and bioactive glass in the amount of 15-25 wt% and having a size from 250 to 2000 microns, wherein the composition is configured as a rectangular strip. The reference claims do not require the presence of hydroxyapatite.
Although the reference claims do not recite a method of forming the composition comprising the steps recited by claim 1, it would have been prima facie obvious to form a porous crosslinked composition of the claims using these steps because Clineff teaches that these steps may be used to produce a bone repair composition comprising a bone growth stimulator, collagen, and bioactive glass and McKay teaches that lactic acid is suitable for use in bone repair compositions such that the skilled artisan reasonably would have expected it could be used as an acid to vary the pH during the pH monitoring process which Clineff teaches is important.
Although the reference claims do not recite that the collagen comprises fine flakes or particles obtained by milling collagen through a 20 mesh screen, it would have been prima facie obvious to modify the reference composition by milling the collagen into a powder, because Wilson expressly teaches that milling the collagen into a powder is a suitable way to prepare collagen for incorporation into a bond repair material comprising a bone growth stimulator. Such a modification is merely the combining of known elements elements according to known methods to yield predictable results, which is prima facie obvious. MPEP 2143. It further would have within the purview of the skilled artisan to select an appropriate size of the collagen powder that would read on the passage through a 2000 micron mesh recited by claim 3 with a reasonable expectation of success, because the skilled artisan would have been optimizing the collagen particles for the same function as in the claimed invention, i.e., to serve as a portion of the matrix in a bone repair composition. Discovering optimum or working ranges involves only routine skill in the art in cases where the general conditions of a claim are disclosed in the prior art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Although the reference claims do not recite that the bone growth stimulator is tricalcium phosphate or that it is present in the amount of 1-5 wt%, it would have been prima facie obvious to select tricalcium phosphate because Clineff teaches that the bone growth stimulator of a bone repair composition may be tricalcium phosphate and may comprise up to 80 wt% of the composition, which overlaps the recited range. Discovering optimum or working ranges involves only routine skill in the art in cases where the general conditions of a claim are disclosed in the prior art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Although the reference claims do not disclose that the strip is placed in a tray having one or more grip regions to facilitate access to the rectangular strip, it would have been prima facie obvious to place the rectangular strip bone repair composition into a rectangular tray having grip regions to facilitate access to the strip, because Bagga teaches that such a tray is useful for molding and holding bone repair compositions.
It further would have within the purview of the skilled artisan to select an amount of the collagen that would read on the amounts recited by claims 6-7 with a reasonable expectation of success, because the collagen is serving the same function in the reference composition as in the claimed composition, i.e., to serve as a portion of the matrix in a bone repair composition. Discovering optimum or working ranges involves only routine skill in the art in cases where the general conditions of a claim are disclosed in the prior art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claims 8-9, it further would have been prima facie obvious to cool the collagen dispersion followed by blending and addition of the bone growth stimulator and bioactive glass with a reasonable expectation of success because Clineff expressly teaches blending to mix ingredients during the process taught therein and because the collagen is serving the same function in the reference composition as in the claimed composition, i.e., to serve as a portion of the matrix in a bone repair composition. Differences in concentration or temperature generally will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claims 1-19 are rejected on the ground of nonstatutory double patenting as unpatentable over all claims of US Pat. Appl. No. 17/713,748 and in view of and in view of Clineff (US Pat. Pub. 2008/0187571), Wilson et al. (US Pat. Pub. 2019/0388585), Bagga (US Pat. No. 8,567,162), and/or McKay (US Pat. Pub. 2011/0182961) where indicated below where indicated below.
The teachings of the cited secondary references are relied upon as discussed above.
The reference claims recite a bone repair composition comprising a type I collagen-glycosaminoglycan coprecipitate in the amount of 0.2-1.5 wt%, tricalcium phosphate bone growth stimulator in the amount of 15-30 wt% and having a particle size of 50-300 microns, and bioactive glass in the amount of 3-7.5 wt% and having a size from 50-300 microns. The reference claims do not require the presence of hydroxyapatite.
Although the reference claims do not recite a method of forming the composition comprising the steps recited by claim 1, it would have been prima facie obvious to form a porous crosslinked composition of the claims using these steps because Clineff teaches that these steps may be used to produce a bone repair composition comprising a bone growth stimulator, collagen, and bioactive glass and McKay teaches that lactic acid is suitable for use in bone repair compositions such that the skilled artisan reasonably would have expected it could be used as an acid to vary the pH during the pH monitoring process which Clineff teaches is important.
Although the reference claims do not recite that the collagen comprises fine flakes or particles obtained by milling collagen through a 20 mesh screen, it would have been prima facie obvious to modify the reference composition by milling the collagen into a powder, because Wilson expressly teaches that milling the collagen into a powder is a suitable way to prepare collagen for incorporation into a bond repair material comprising a bone growth stimulator. Such a modification is merely the combining of known elements elements according to known methods to yield predictable results, which is prima facie obvious. MPEP 2143. It further would have within the purview of the skilled artisan to select an appropriate size of the collagen powder that would read on the passage through a 2000 micron mesh recited by claim 3 with a reasonable expectation of success, because the skilled artisan would have been optimizing the collagen particles for the same function as in the claimed invention, i.e., to serve as a portion of the matrix in a bone repair composition. Discovering optimum or working ranges involves only routine skill in the art in cases where the general conditions of a claim are disclosed in the prior art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Although the reference claims do not recite that the tricalcium phosphate is present in the amount of 1-5 wt% it would have been prima facie obvious to select tricalcium phosphate because Clineff teaches that the bone growth stimulator of a bone repair composition may be tricalcium phosphate and may comprise up to 80 wt% of the composition, which overlaps the recited range. Discovering optimum or working ranges involves only routine skill in the art in cases where the general conditions of a claim are disclosed in the prior art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Although the reference claims do not recite that the bioactive glass is used in an amount within the claimed range, it would have been prima facie obvious to do so since Clineff teaches that a bone repair composition may comprise bioactive glass in such amounts.
Although the reference claims do not disclose that composition is in the form of a rectangularstrip is placed in a tray having one or more grip regions to facilitate access to the rectangular strip, it would have been prima facie obvious to place the rectangular strip bone repair composition into a rectangular tray having grip regions to facilitate access to the strip, because Bagga teaches that such a tray is useful for molding and holding bone repair compositions in the form of a strip.
It further would have within the purview of the skilled artisan to select an amount of the collagen that would read on the amounts recited by claims 6-7 with a reasonable expectation of success, because the collagen is serving the same function in the reference composition as in the claimed composition, i.e., to serve as a portion of the matrix in a bone repair composition. Discovering optimum or working ranges involves only routine skill in the art in cases where the general conditions of a claim are disclosed in the prior art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claims 8-9, it further would have been prima facie obvious to cool the collagen dispersion followed by blending and addition of the bone growth stimulator and bioactive glass with a reasonable expectation of success because Clineff expressly teaches blending to mix ingredients during the process taught therein and because the collagen is serving the same function in the reference composition as in the claimed composition, i.e., to serve as a portion of the matrix in a bone repair composition. Differences in concentration or temperature generally will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claims 1-19 are rejected on the ground of nonstatutory double patenting as unpatentable over all claims of US Pat. Appl. No. 18/304,036 and in view of and in view of Clineff (US Pat. Pub. 2008/0187571), Bagga (US Pat. No. 8,567,162), and/or McKay (US Pat. Pub. 2011/0182961) where indicated below where indicated below.
The teachings of the cited secondary references are relied upon as discussed above.
The reference claims recite a bone repair composition comprising a type I collagen-glycosaminoglycan coprecipitate in the amount of 0.5-25 wt%, tricalcium phosphate bone growth stimulator in the amount of 5-95 wt% and having a particle size of 10-2500 microns, and bioactive glass in the amount of 3-7.5 wt% and having a size from 10-1500 microns, the collagen comprising fine flakes or particles obtained by milling collagen through a 20 mesh screen. The reference claims do not require the presence of hydroxyapatite.
Although the reference claims do not recite a method of forming the composition comprising the steps recited by claim 1, it would have been prima facie obvious to form a porous crosslinked composition of the claims using these steps because Clineff teaches that these steps may be used to produce a bone repair composition comprising a bone growth stimulator, collagen, and bioactive glass and McKay teaches that lactic acid is suitable for use in bone repair compositions such that the skilled artisan reasonably would have expected it could be used as an acid to vary the pH during the pH monitoring process which Clineff teaches is important.
Although the reference claims do not recite that the tricalcium phosphate is present in the amount of 1-5 wt% it would have been prima facie obvious to select tricalcium phosphate because Clineff teaches that the bone growth stimulator of a bone repair composition may be tricalcium phosphate and may comprise up to 80 wt% of the composition, which overlaps the recited range. Discovering optimum or working ranges involves only routine skill in the art in cases where the general conditions of a claim are disclosed in the prior art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Although the reference claims do not recite that the bioactive glass is used in an amount within the claimed range, it would have been prima facie obvious to do so since Clineff teaches that a bone repair composition may comprise bioactive glass in such amounts.
Although the reference claims do not disclose that composition is in the form of a rectangular strip is placed in a tray having one or more grip regions to facilitate access to the rectangular strip, it would have been prima facie obvious to place the rectangular strip bone repair composition into a rectangular tray having grip regions to facilitate access to the strip, because Bagga teaches that such a tray is useful for molding and holding bone repair compositions in the form of a strip.
It further would have within the purview of the skilled artisan to select an amount of the collagen that would read on the amounts recited by claims 6-7 with a reasonable expectation of success, because the collagen is serving the same function in the reference composition as in the claimed composition, i.e., to serve as a portion of the matrix in a bone repair composition. Discovering optimum or working ranges involves only routine skill in the art in cases where the general conditions of a claim are disclosed in the prior art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claims 8-9, it further would have been prima facie obvious to cool the collagen dispersion followed by blending and addition of the bone growth stimulator and bioactive glass with a reasonable expectation of success because Clineff expressly teaches blending to mix ingredients during the process taught therein and because the collagen is serving the same function in the reference composition as in the claimed composition, i.e., to serve as a portion of the matrix in a bone repair composition. Differences in concentration or temperature generally will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Conclusion
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/GAREN GOTFREDSON/Examiner, Art Unit 1619
/ANNA R FALKOWITZ/ Primary Examiner, Art Unit 1600
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