DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4/26/2026 has been entered.
Status of the Claims
Claims 1 and 8 have been amended. Claim 2, 4, 6, 7, 9, 11 and 13 are cancelled. No claims are newly added. Accordingly, claims 1, 3, 5, 8, 10, 12 and 14-20 remain pending in the application. Claims 8, 10, 12, 14-18 and 20 stand withdrawn from further consideration, without traverse. Claims 1, 3, 5 and 19 are currently under examination.
Withdrawn Rejections
Applicant’s amendment renders the rejection of claims 1, 3, 5 and 19 under 35 USC 112(a) moot. Specifically, the new matter limitation “due to the absence of pores” has been deleted from the claim. Thus, said rejection has been withdrawn.
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, 3, 5 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Gleeson et al. (US 2015/0257870 A1, Sep. 17, 2015; hereafter as “Gleeson”) in view of McKay (US 2010/0049322 A1, Feb. 25, 2010, hereafter as “McKay”) and Lu et al. (WO 2008/100534 A2, Aug. 21, 2008, hereafter as “Lu”) as evidenced by Dimitriou et al. (The role of barrier membranes for guided bone regeneration and restoration of large bone defects: current experimental and clinical evidence. BMC Med. 2012 Jul 26;10:81, pp. 1-24; hereinafter as “Dimitriou”) and Captal® ‘R’ Unsintered Hydroxyapatite Technical Data Sheet (2016).
The instant invention is drawn to an integrated biomaterial for bone tissue regeneration, the integrated biomaterial consisting of: a lower structure comprising collagen and a bone mineral component; and an upper layer comprising collagen, as a gelled lyophilizate in which the upper layer and the lower structure are gel bound to one another, and wherein protein chains in the lower structure are aligned, wherein a content of the collagen of the upper layer ranges from 2 wt% to 5 wt% with respect to a total weight of the integrated biomaterial; and an amount ratio (weight ratio) of the collagen of the upper layer to the collagen of the lower structure is 0.5:1, wherein the upper layer functions as a barrier membrane capable of inhibiting overgrowth of connective tissue by preventing the infiltration of connective tissue, wherein the collagen in the integrated biomaterial is type I collagen or type III collagen, wherein a content of the bone mineral component ranges from 80 wt% to 94 wt% with respect to a total weight of the integrated biomaterial, wherein the upper layer has a thickness of 20% to 35% of total thickness of the integrated biomaterial, and wherein the collagen in the upper layer is cross-linked.
Regarding instant claims 1 and 19, Gleeson teaches multilayer scaffolds for tissue engineering applications having at least two layers but may comprise three, four or more layers including a particular embodiment drawn to a two layer scaffold comprising a base bone layer composed of type I collagen and hydroxyapatite (a bone mineral component) and a top cartilage layer composed of type I and type II collagen and a particular embodiment drawn to a three layer scaffold comprising a base bone layer composed of type I collagen and hydroxyapatite, an intermediate layer composed of type I collagen, type II collagen and hydroxyapatite and a top cartilage layer composed of type I and type II collagen (abstract; [0012] and [0100]-[0114]; Examples 1 and 2). In Example 2, the bone layer contains the collagen/hydroxyapatite (CHA) slurry of Example 1 which contains 1.2 g of collagen and 0-500% HA (0-6 g, preferably 2.4 g HA) ([0100], [0108]), the intermediate layer contains the type I collagen (Col1) slurry of Example 1 which contains 0.8 g of collagen type I but can be varied between 5 g/l and 50 g/l, 0.2 g of type II collagen (Col2) but can be varied between 5 g/l and 50 g/l, and the CHA slurry discussed above (i.e., 1.2 g of collagen and 0-500% HA), wherein each of the CHA, Col1 and Col2 can be varied between 0% and 100% ([0105], [0110] and [0111]), and the cartilage layer includes the Col1 and Col2 discussed above, wherein the ratio of Col1 to Col2 can vary from 0:1 to 1:0 ([0114]). Gleeson also teaches that the layers can mimic both the morphology and composition of anatomical tissue such as subchondral bone, intermediate articular calcified cartilage, and overlying cartilage ([0029]) and that varying/optimizing the composition of each layer can optimize the properties of the scaffold, bone and/or cartilage production, and ultimately, the repair of an osteochondral defect ([0076]-[0081]). Gleeson further teaches crosslinking the individual layers ([0037], [0046] and [0047]). Gleeson also teaches that the individual layer thicknesses can be varied ([0039] and [0069]).
Gleeson is silent to explicitly including a bone mineral component (e.g., hydroxyapatite) in the range of 80-95% with respect to the total weight of the integrated biomaterial. However, Gleeson teaches the elements discussed above including varying/optimizing the amounts and proportions of hydroxyapatite in one or more scaffold layers ([0057]; Examples 1 and 2) in order to optimize the properties of the scaffold, bone and/or calcified cartilage production, and ultimately, the repair of an osteochondral defect ([0076]-[0081]). Gleeson also teaches that the hydroxyapatite-containing layers can mimic both the morphology and composition of anatomical tissue such as subchondral bone and intermediate articular calcified cartilage ([0029]).
MPEP 2144.05(II)(A) also states, “Generally, differences in concentration or temperature 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’”.
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have optimized the amount of hydroxyapatite to arrive at the claimed range by way of routine experimentation with a reasonable expectation of success because Gleeson teaches the general conditions of the claim as well as varying the amounts and proportions of hydroxyapatite in one or more layers. A skilled artisan would have been motivated to do so because it is the normal desire of scientists or artisans to improve upon what is already generally known (MPEP 2144.05(II)(A)) and because Gleeson explicitly teaches that varying/optimizing the composition of each layer can optimize the properties of the scaffold and optimize the bone and/or calcified cartilage production. One of ordinary skill in the art would have reasonably expected an osteochondral implant comprising optimized amounts of hydroxyapatite depending on the desired properties.
Gleeson is silent to a particular embodiment consisting of a lower layer/structure and an upper layer wherein the upper layer comprises 2 wt% to 5 wt% collagen with respect to a total weight of the integrated biomaterial and an amount ratio (weight ratio) of the collagen of the upper layer to the collagen of the lower structure of 0.5:1.
MPEP 2144.05(II)(A) states, “Generally, differences in concentration or temperature 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’”.
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine a two-layered structure with optimized amounts and ratios of collagen in the upper layer and lower structure to arrive at the claimed range and ratio by way of routine experimentation with a reasonable expectation of success because Gleeson teaches the general conditions of the claim as well as varying the amounts and proportions of collagen in each layer. A skilled artisan would have been motivated to do so because it is the normal desire of scientists or artisans to improve upon what is already generally known (MPEP 2144.05(II)(A)) and because Gleeson explicitly teaches that varying/optimizing the composition of each layer can optimize the properties of the scaffold and optimize the bone and/or cartilage production. One of ordinary skill in the art would have reasonably expected an osteochondral implant consisting of two layers wherein said layers comprise optimized amounts and proportions of collagen depending on the desired properties.
Gleeson is silent to the explicit recitation, “wherein the upper layer has a thickness of 20% to 35% of total thickness of the integrated biomaterial”.
However, as discussed, Gleeson teaches varying the thickness of each layer.
MPEP 2144.05(II)(A) states, “Generally, differences in concentration or temperature 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’”.
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to optimize the thickness of each layer by way of routine experimentation with a reasonable expectation of success because Gleeson teaches the general conditions of the claim and explicitly teaching that varying the thickness of each layer. A skilled artisan would have been motivated to do so because it is the normal desire of scientists or artisans to improve upon what is already generally known (MPEP 2144.05(II)(A)) and because Gleeson teaches mimicking the morphology of the healthy osteochondral tissue ([0029]). One of ordinary skill in the art would have reasonably expected an osteochondral implant having optimized layer thicknesses depending on the desired characteristics.
Gleeson is silent to an explicit recitation that the upper layer functions as a barrier membrane capable of inhibiting overgrowth of connective tissue by preventing the infiltration of connective tissue. It is important to note that the instant specification describes the function of preventing infiltration of connective tissue as directly connected to the lower structure and upper layer having no space between said lower structure and upper layer (paragraph bridging pages 10 and 11 of the instant specification).
Dimitriou teaches typical materials utilized in barrier membranes including collagen (Table 1). Dimitriou also teaches that barrier membranes are porous and that the pore size is an important factor in the functionality of a barrier membrane because said barrier membrane is intended to prevent excessive penetration of fibrous tissue (i.e., connective tissue) into the bone defect (soft tissue ingrowth) but to allow neovascularization and bone formation (page 5, left col. 1st para.). Dimitriou further teaches that a pore size of 50-100 microns allows bone (hard tissue) ingrowth.
As discussed above, Gleeson teaches an “upper” layer comprising collagen. Gleeson also teaches pore sizes of 80-100 microns ([0027]) which overlaps with the pore sizes taught by Dimitriou to allow bone formation but prevent excessive penetration of fibrous tissue. In light of the evidentiary teachings of Dimitriou, the “upper” layer of Gleeson has the structural characteristics of a barrier membrane that is capable of preventing the infiltration of connective tissue such as fibrous tissue. Gleeson further demonstrates that there is no space between upper layer and the adjacent layer (see Figures 9, 15 and 16).
MPEP 2173.05(g) states, “A functional limitation must be evaluated and considered, just like any other limitation of the claim, for what it fairly conveys to a person of ordinary skill in the pertinent art in the context in which it is used”.
MPEP 2112.01 states, “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established”.
In this case, not only does Gleeson exhibit an “upper” layer having the structural characteristic (i.e., no space between the upper layer and adjacent lower layer) that correlates with the function of inhibiting overgrowth of connective tissue by preventing the infiltration of connective tissue, but Gleeson also describes an “upper” layer that possesses the structural characteristics of a barrier membrane as evidenced by Dimitriou. Thus, a person of ordinary skill in the pertinent art would have reasonably concluded that the “upper” layer described in Gleeson would function as a barrier membrane capable of preventing the infiltration of connective tissue.
Regarding the limitation, “a gelled lyophilizate in which the upper layer and the lower structure are gel bound to one another”, Gleeson teaches rehydrating the first lyophilized formed layer before adding an additional layer and lyophilizing both layers (abstract) as well as teaches minimizing gelatinization ([0062]) but does not teach that gelatinization is absent. It should be noted that the claims do not indicate to what degree gelatinization occurs. Gleeson’s teaching implies that some gelatinization is present albeit minimally. MPEP 2112.01 states, “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established”. In this case, Gleeson describes adjacent layers that are lyophilized and that gelatinization is minimized. Thus, a person of ordinary skill in the pertinent art would have reasonably concluded that the layered composition of Gleeson would possess the same characteristics as claimed barring evidence to the contrary.
Gleeson is silent to type III collagen.
McKay teaches an osteochondral repair implant comprising a tissue scaffold to allow growth of at least bone and/or cartilage at the site of repair and a biodegradable carrier ([0009]). McKay teaches said scaffold and/or carrier can include hydroxyapatite as well as collagen ([0044], [0045], [0082] and [0083]). McKay further teaches the particular collagens, collagen type I, collagen type II and collagen type III as well as combinations thereof ([0045]).
Gleeson and McKay are both drawn to implantable compositions for osteochondral repair comprising hydroxyapatite and collagen, thus, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to substitute collagen type II with collagen type I and/or collagen type III into the invention of Gleeson as suggested by McKay with a reasonable expectation of success. A skilled artisan would have been motivated to do so because McKay teaches that including collagen type I, II and/or III are all suitable materials for an implantable osteochondral repair composition. MPEP 2144.06 states that substituting and combining equivalents known for the same purpose is prima facie obvious. In this case, McKay effectively teaches collagen type I, II and III are equivalents.
Gleeson and McKay are silent to protein chains in the lower structure are aligned.
Lu teaches an implantable scaffold comprising a biodegradable polymer (e.g., collagen) and a biocompatible ceramic for tissue repair (abstract; [0051]). Lu teaches that collagen orientation impacts mechanical properties of tendon insertion sites and that collagen alignment is a critical design parameter for interface tissue engineering ([0014]-[0015]; Figs. 1 and 2).
The references are all drawn to tissue repair/regeneration thus, it would have been prima facie obvious before the effective filing date of the claimed invention to align the collagen proteins in the lower structure as suggested by Lu into the invention of Gleeson/McKay with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Lu teaches that collagen alignment improves the mechanical properties of an implantable scaffold at a tissue engineering interface.
Regarding instant claim 3, Gleeson teaches the particular hydroxyapatite powder,
Captal® ‘R’ Reactor Powder by Plasma Biotal ([0102]) which is a synthetic hydroxyapatite as evidenced by the Captal® ‘R’ Unsintered Hydroxyapatite Technical Data Sheet.
Regarding instant claim 5, Gleeson teaches the elements discussed above.
Gleeson is silent to a total (upper and lower layers) amount of extracellular matrix protein (e.g., collagen) in the range of 5-20% with respect to the total weight of the integrated biomaterial.
MPEP 2144.05(II)(A) states, “Generally, differences in concentration or temperature 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’”.
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have optimized the amount of collagen in the upper layer and lower structure to arrive at the claimed range by way of routine experimentation with a reasonable expectation of success because Gleeson teaches the general conditions of the claim as well as varying the amount of collagen in each layer. A skilled artisan would have been motivated to do so because it is the normal desire of scientists or artisans to improve upon what is already generally known (MPEP 2144.05(II)(A)) and because Gleeson explicitly teaches that varying/optimizing the composition of each layer can optimize the properties of the scaffold and optimize the bone and/or cartilage production. One of ordinary skill in the art would have reasonably expected an osteochondral implant comprising optimized amount of collagen depending on the desired properties.
Thus, the combined teachings of Gleeson, McKay and Lu render the instant claims prima facie obvious.
Response to Arguments
Applicant's arguments, filed 3/28/2026, regarding the 103 rejection over Gleeson, McKay and Lu have been fully considered but they are not persuasive.
Applicant argues that Gleeson teaches a porous structure and states that “[a] high level of porosity is a vital requirement for scaffold used for tissue regeneration in order to allow the infiltration of cells” ([0126]) and “[o]ne of its main advantages of the present invention [of Gleeson] is the high degree of porosity within all regions of the scaffold” ([0126]). Gleeson states, “[a] high level of porosity is necessary in order to ensure the infiltration of cells into the center of the scaffold”. Fig. 7 of Gleeson shows the average porosity of the top layer as approaching 99.5%. Fig. 8 of Gleeson shows average pore diameters of the top layer of greater than 120 microns. Applicant asserts that, in Gleeson, porosity and pore size are design parameters chosen to facilitate, rather than inhibit, tissue penetration. Applicant asserts that Gleeson does not identify connective or fibrous tissue infiltration as a problem to be addressed, nor does Gleeson disclose providing or configuring an upper layer to perform a tissue-exclusion or barrier function. Remarks, pages 6-7.
In response, it is respectfully submitted that while Gleeson teaches a high level of porosity in the multi-layer collagen scaffold, Gleeson teaches that the scaffold or each layer has an average pore diameter of at least 80-100 microns ([0027]). Thus, while applicant points to Fig. 8 demonstrating 120 microns, disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments (MPEP 2123). Looking to the evidentiary reference Dimitriou, Dimitriou teaches typical materials utilized in barrier membranes including collagen (Table 1). Dimitriou also teaches that barrier membranes are porous and that the pore size is an important factor in the functionality of a barrier membrane because said barrier membrane is intended to prevent excessive penetration of fibrous tissue (i.e., connective tissue) into the bone defect (soft tissue ingrowth) but to allow neovascularization and bone formation (page 5, left col. 1st para.). Dimitriou further teaches that a pore size of 50-100 microns allows bone (hard tissue) ingrowth. Gleeson’s pore sizes of at least 80-100 microns overlaps with the pore sizes of 50-100 microns taught by Dimitriou. Said range of Dimitriou is taught to allow bone formation but prevent excessive penetration of fibrous (connective) tissue. In light of the teachings of Dimitriou, the “upper” layer of Gleeson has the structural characteristics of a barrier membrane that is capable of preventing the infiltration of connective tissue such as fibrous tissue. It is also important to note that the instant claims do not require or exclude pores and the instant application’s drawings demonstrates a porous upper layer at Fig. 2B. As Dimitriou discusses, pore size matters in allowing for particular tissue growth (i.e., bone) to take place while inhibiting other tissue growth (i.e., fibrous). Thus, contrary to applicant’s assertions, a person of ordinary skill in the pertinent art would have reasonably concluded that the “upper” layer described in Gleeson would function as a barrier membrane capable of preventing the infiltration of connective tissue. Furthermore, Gleeson need not identify connective or fibrous tissue infiltration as a problem to be addressed because Gleeson teaches the structural characteristics that Dimitriou discusses as being critical in providing the function of preventing the infiltration of fibrous (connective) tissue. For these reasons, applicant’s arguments are unpersuasive.
Applicant argues that neither McKay or Lu provide no basis or incentive to modify Gleeson to include an upper layer performing a tissue-exclusion or barrier function. Remarks, page 7.
In response, the examiner agrees with applicant in that McKay and Lu provide no basis or incentive to modify Gleeson to include an upper layer performing a tissue-exclusion or barrier function because the rejection does not rely on any additional references including McKay and Lu to modify the upper layer of Gleeson. Dimitrious, as discussed above, is an evidentiary reference, that demonstrates that having a porous structure having overlapping pore sizes with Gleeson is effective in preventing infiltration of fibrous (connective) tissue. Thus, applicant’s argument is irrelevant to the rejection at hand.
Applicant asserts that scaffolds and graft materials are addressed in the context of supporting bone ingrowth, whereas barrier membranes are discussed separately as devices for soft-tissue exclusion and space maintenance. Applicant asserts that Dimitriou does not teach or suggest that a porous scaffold layer designed for tissue ingrowth – such as the upper layer of Gleeson – should be repurposed, modified, or recharacterized as a barrier membrane. Applicant also asserts that Dimitriou does not provide any criterion by which an existing porous scaffold layer is deemed to “have the structural characteristics of a barrier membrane”. Remarks, pages 7-8.
In response, it is respectfully submitted that applicant appears to be arguing that Dimitriou teaches that barrier membranes and scaffold/graft materials are two distinct products having different functions/purposes, however Dimitrious states, “Barrier membranes are among the most widely studied scaffolds for tissue regeneration, including bone” (page 6, right col., 3rd paragraph). Contrary to applicant’s assertion, Dimitriou’s teaching is an explicit statement that barrier membranes are scaffolds. It is also submitted that Dimitriou is an evidentiary reference to demonstrate that the upper layer of Gleeson has the structural features to provide the function of the claimed barrier membrane. Thus, the teachings of Dimitriou are not looked to for suggestion or motivation to modify Gleeson. As explained above, Dimitriou teaches typical materials utilized in barrier membranes including collagen which overlaps with the teaching of the upper layer comprising collagen in Gleeson. Dimitriou also teaches that barrier membranes are porous and that the pore size is an important factor in the functionality of a barrier membrane because said barrier membrane is intended to prevent excessive penetration of fibrous tissue (i.e., connective tissue) into the bone defect (soft tissue ingrowth) but to allow neovascularization and bone formation (page 5, left col. 1st para.). Dimitriou further teaches that a pore size of 50-100 microns allows bone (hard tissue) ingrowth. Gleeson’s pore sizes of at least 80-100 microns overlaps with the pore sizes of 50-100 microns taught by Dimitriou. Said range of Dimitriou is taught to allow bone formation but prevent excessive penetration of fibrous (connective) tissue. In light of the teachings of Dimitriou, the “upper” layer of Gleeson has the structural characteristics of a barrier membrane that is capable of preventing the infiltration of connective tissue such as fibrous tissue. It is also important to note that the instant claims do not require or exclude pores and the instant application’s drawings demonstrates a porous upper layer at Fig. 2B. Gleeson’s upper layer appears to possess the compositional and structural characteristics that yield a barrier membrane. MPEP 2112.01 states, “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established”. MPEP 2112.01 also states, “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not”. Applicant’s argument is unpersuasive.
Applicant argues that an overlap in pore size in Gleeson and Dimitriou does not establish a teaching of barrier function. Gleeson teaches pore size is selected to promote cellular infiltration and tissue integration within a scaffold whereas Dimitriou teaches pore size is discussed in the context of optimizing barrier membranes that are expressly intended to exclude fibrous connective tissue while permitting vascularization. Remarks, pages 8-9.
In response, it is respectfully submitted that it is important to note that the instant specification describes the function of preventing infiltration of connective tissue as directly connected to the lower structure and upper layer having no space between said lower structure and upper layer (paragraph bridging pages 10 and 11 of the instant specification). Gleeson demonstrates that there is no space between an upper layer and the adjacent lower layer (see Figures 9, 15 and 16). Thus, according to the instant specification the lack of space between an upper layer and an adjacent lower layer is the contributing factor to preventing infiltration of connective tissue and Gleeson teaches the same spatial orientation that yields the claimed function. MPEP 2112.01 states, “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established”. MPEP 2112.01 also states, “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not”. Regarding Dimitriou, it is noted the rejection explains that not only does Dimitriou and Gleeson teach overlapping pore sizes, Dimitriou and Gleeson also teach collagen as a useful upper/barrier layer material. Thus, the overlapping pore size is not the only element relied upon to establish that Gleeson appears to teach a structure that would function as a barrier membrane. Applicant also appears to be arguing that because Gleeson teaches that pore size is selected to promote cellular infiltration and tissue integration within a scaffold is contradictory to Dimitriou’s teaching that pore size is discussed in the context of optimizing barrier membranes that are expressly intended to exclude fibrous connective tissue while permitting vascularization; however the teachings appear to be congruent to one another. Gleeson and Dimitriou both recognize the importance of pore size in allowing cellular movement and tissue integration and Dimitriou more specifically explains that said pore sizes selectively allows for both particular tissue growth and inhibition. For these reasons, applicant’s argument is unpersuasive.
Applicant argues that the conclusion that Gleeson’s upper layer “has the structural characteristics of a barrier membrane” in view of Dimitriou is based on hindsight reconstruction and neither Gleeson not Dimitriou teach or suggest selecting, configuring, or evaluating the upper layer of a porous scaffold with the objective of inhibiting connective tissue overgrowth. Remarks, page 9.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Additionally, there is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Gleeson need not explicitly teach that the upper layer inhibits connective tissue overgrowth. As stated above, Gleeson teaches the structure that the instant specification establishes as the contributing factor to yield this function; the instant drawings demonstrate a porous upper layer which implies that a lack of porosity is not the contributing factor to this function; and Dimitriou provides an evidentiary showing that the upper layer of Gleeson comprising collagen and particular pore sizes provide the function of a barrier membrane capable of inhibiting fibrous (connective) tissue. Thus, applicant’s argument is unpersuasive.
For the above reasons, Applicant’s arguments are found unpersuasive.
Conclusion
All claims have been rejected; no claims are allowed.
Correspondence
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/CASEY S HAGOPIAN/Examiner, Art Unit 1617
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