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 .
Claim Status
Claims 21-26 are new. In claim 25, the limitation: "the inner portion being completely enclosed by the outer portion” finds reasonable support in Figure 1.
Claims 12 and 16-20 are cancelled.
Claims 1-11, 13-15 and 21-26 are pending.
Claims 2-6 are withdrawn. Applicant’s amendment has necessitated new grounds of rejection. Accordingly, this Action is FINAL.
Withdrawn rejections
Applicant's amendments and arguments filed 12/17/25 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below is herein withdrawn. Claim(s) 1, 7-8, 14 and 15 were rejected under 35 U.S.C. 102(a)(1) as being anticipated by Suddaby (US200600400878). Applicant has amended claim 1 with limitations of claim 12 to overcome the rejection.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 7-8, 12, 14-15 and 25-26 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Croes et al. (European Cells and Materials Vol. 33; 2017: ( pages 2 1 1 - 2 2 6; IDS filed 4/18/25).
Regarding claims 1, 14, 15 and 25, Croes et al. disclose forming a matrix of porous biphasic calcium phosphate blocks, hence comprising a plurality of pores, comprising a first material of β-tricalcium phosphate and a second material of hydroxyapatite (Page 212, right column, Materials) and applied the bacterial antigens lipopolysaccharide and lipoteichoic acid to the porous matrix by pipetting (Page 213, Construct preparation) to produce an immunomodulatory implant operatively arranged to chemotactically facilitate bone morphogenesis. Regarding claim 1 and 25, the limitation of “wherein the matrix further comprises an inner portion arranged therein and spaced apart from the outer surface comprising a second material different from the first material” the specification teaches that the inner portion is just further pores within the matrix [0057], which the matrix structure of Croes et al. inherently has such pores spaced apart from the outer surface and comprises hydroxyapatite which his different than the first material β-TCP. As shown in Figure 2b below, the outer portion completely encloses the inner portion.
Regarding claim 7, Croes et al. show that the porous matrix has large recesses on the surface in Figure 2b:
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The large recesses naturally allow the antigen to be infused into the matrix.
Regarding claim 8, Croes et al. disclose pipetting the pro-inflammatory mediators onto the scaffolds (Page 213, right column 2nd paragraph), which naturally covers the exterior recesses and thereby provides a layer of the antigen arranged in the recess.
Regarding claim 26, Croes et al. disclose adding the cytokine BMP-2 to the BCP construct where the porous construct naturally wicks the solution like a sponge to the interior and subsequently a fibrin glue is added onto the scaffold (Page 213, right column 2nd paragraph). Thus, the cytokine BMP-2 serves as a second material in the inner portion different than the first material in the outer portion.
Response to Arguments
Applicant’s arguments filed 12/17/25 have been carefully considered but are not persuasive. On page 8 of remarks, Applicant asserts: “Croes does not disclose such a matrix having two materials. Even if Croes does disclose a matrix having two
materials, which Applicant strongly asserts it does not, Croes most certainly does not disclose an inner portion having the second material that is spaced apart from the outer surfaces of the implant.” Respectfully, the Examiner does not agree. First of all, Applicant’s assert, without explanation, that the cited art does not teach or suggest the required limitations. That is not persuasive. Applicants’ arguments are legally insufficient to properly raise an issue concerning the patentability of the invention claimed. See In re Lovin, 652 F.3d 1349, 1357 (Fed. Cir. 2011). Secondly, how the second material is different from the first material is left to interpretation. The specification does not have any specific definition for what is meant for “different” and teaches that it could be a structural difference such as porosity [0057] or it could be the presence of some other component such as interleukin [0010]. The pores contained in the interior portion of the matrix of Croes are at least spatially different from the pores on the exterior surface that are in contact with the environment. Thus, the inner portion has a material different from the first matrix material. The Examiner also asserted that Croes also discloses in the construct preparation adding PBS or PBS and the cytokine BMP-2 to the BCP construct and subsequently a fibrin glue containing proinflammatory mediators pipetted onto the BCP scaffolds. Thus, the inner portion has a component material (PBS and BMP-2) different from the first matrix material. Respectfully, Applicant’s arguments are not persuasive.
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 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 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.
Claims 9-10, 13 and 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Croes et al. (European Cells and Materials Vol. 33; 2017: ( pages 211-226; IDS filed 4/18/25), as applied to claims 1, 7-8, 14-15 and 25-26 above.
Applicant claims, for example:
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Claim interpretation: The term “recess” has no specific definition. At best the specification teaches: “Recess or hole 230 extends from outer surface 214 radially inward.” [0079] Surface pores also extend from the outer surface radially inward. The Examiner can discern no difference between the term “recess” and a pore on the surface of the matrix.
Level of Ordinary Skill in the Art
(MPEP 2141.03)
MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The level of skill is that of a tissue engineering research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from tissue engineering scaffold construction, materials and methods— without being told to do so.
In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Determination of the scope and content of the prior art
(MPEP 2141.01)
It is well settled that “a disclosure that anticipates under § 102 also renders the claim invalid under §103, for anticipation is the epitome of obviousness. See MPEP 1207.03(a)(II) states: “"lack of novelty is the epitome of obviousness." May, 574 F.2d at 1089, 197 USPQ at 607 (citing In re Pearson, 494 F.2d 1399, 1402, 181 USPQ 641, 644 (CCPA 1974))”. Accordingly, the claims rejected under §102 above are also invalid under §103.
The reference of Croes et al. is discussed in detail above and that discussion is incorporated by reference.
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02) and Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
1. The difference between the instant application and Croes et al. is that Croes et al. do not expressly teach arranging a layer of cytokine in the recess before arranging a layer of the antigen on top of the cytokine layer/in the recess/in at least one pore of the plurality of pores. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to perform the method of Croes et al. and arrange a layer of cytokine in the recess before arranging a layer of the antigen on top of the cytokine layer/in the recess/in at least one pore of the plurality of pores, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because Croes et al. expressly teach applying a layer of the cytokine TNF-α (Page 213, Construct preparation; Table 2) where: “Constructs containing 10 ng TNF-α were associated with the most prominent bone formation seen in this study.” (Page 219, left column). But Croes et al. note that: “In the current study, the incorporation of a single inflammatory mediator was not an effective strategy to induce a significant amount of new bone formation in the intramuscular location.” (Page 222, left column 2nd paragraph). Accordingly, because a single inflammatory mediator was not effective to induce a significant amount of new bone, then the ordinary artisan is then motivated to combine more than one inflammatory mediator for an additive effect in inducing greater amounts of new bone with a reasonable expectation of success. It is then merely selection of order of process steps to first apply a layer of cytokine, such as TNF-α, to the matrix which is infused into the matrix to contact any other materials in the matrix and then arrange a layer of the antigen on top of the cytokine layer/in the recess/in at least one pore of the plurality of pores with a reasonable expectation of success.
Response to Arguments:
Applicant asserts on page 8 of remarks that none of the references teach that the matrix is formed with a recess arranged in the outer surface, and a layer of cytokine and a layer of antigen is formed in that recess. However, the Examiner has shown that the surface of the construct of Croes is littered with recesses where that pipetting of a cytokine and/or antigen onto the construct is going to be arranged in the recesses. It is then merely a matter of pipetting the layer of cytokine first and the antigen second, to have the layer of antigen on top of the cytokine layer, which the ordinary artisan can do without any difficulty.
On page 9 of remarks, Applicant asserts that: “Applicant respectfully asserts that a teaching that incorporation of a single inflammatory mediator is not effective would not motivate a person having skill in the art to combine two inflammatory mediators.” Applicant asks: “why would a person having skill in the art combine TNF-a and LPS if the teaching of Croes is that one stimulates bone growth and the other decreases bone growth?” Obviously, the ordinary artisan that desired bone growth would add a bone growth stimulating agent; and not a one that discourages bone growth. Applicant’s argument is not persuasive.
On page 9 of remarks, Applicant asserts: “Croes' disclosure that proinflammatory mediators are pipetted onto a scaffold is hardly a disclosure that a layer of cytokine is arranged in a recess and a layer of antigen is arranged in the recess.” Respectfully, the Examiner does not agree and has a different perspective. As explained above, a reasonable interpretation of Croes et al. is that pipetting the PBS or PBS and cytokine BMP-2 onto the scaffold naturally results in wicking the PBS and BMP-2 into the interior by capillary action thereby coating the pores/recesses of the construct with a layer of the BMP-2. The subsequent addition of pro-inflammatory mediator antigens provides a second layer of the pro-inflammatory mediators on top of the cytokine BMP-2. Only the disclosure of Croes et al. was employed to arrive at this interpretation without any hindsight bias. The Examiner has mapped to the best of his ability how the prior art reads upon each and every claimed limitation. Applicant’s argument is not persuasive.
Claims 11 is rejected under 35 U.S.C. 103 as being unpatentable over Croes et al. (European Cells and Materials Vol. 33; 2017: (pages 211-226; IDS filed 4/18/25), as applied to claims 1, 7-8, 12, 14-15 and 25-26 above, in further view of Jariwala et al. (3D PRINTING 2015;2(2):56-64) and Bose et al. (Materials Today Volume 16, Number 12 December 2013) and Guobao (US20180296343).
Applicant claims:
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The reference of Croes et al. is discussed in detail above and that discussion is incorporated by reference.
Croes et al. do not expressly teach how the matrix was produced via 3D printing or to apply the antigen to the matrix by printing the antigen in the plurality of pores. However, as taught by Jariwala et al., it is conventional practice to manufacture bone scaffolds by 3D printing (Title; Abstract; Table 1) where the printing includes desired cells and biomaterials (Figure 1) including BCP scaffolds of HA-TCP (Page 60, left column 1st paragraph). Furthermore, Bose et al. teach: “the use of additive manufacturing technologies in bone tissue engineering has been growing in recent years. Among the different technology options, three dimensional printing (3DP) is becoming popular due to the ability to directly print porous scaffolds with designed shape, controlled chemistry and interconnected porosity. Some of these inorganic scaffolds are biodegradable and have proven ideal for bone tissue engineering, sometimes even with site specific growth factor/drug delivery abilities.” (Abstract). See also Tables 1-3. Porous scaffolds with recesses are shown in Figure 2(a) and 2(d). Bose et al. also teach that: “3D printed scaffolds have also been used for growth factor and drug delivery to enhance bone growth in scaffolds. The localized delivery of growth factors and drugs has attracted significant attention due to the potential for dose reduction, controlled release pattern, and the negligible side effects compared to systemic delivery.” (Page 502, left column Growth factor and drug delivery using 3D printed scaffolds). In addition, Guobao teach a method for producing a porous implant, the method comprising: obtaining a 3-D image of an intended tissue repair site; generating a 3D digital model of the porous implant based on the 3-D image of the intended tissue repair site, the 3-D digital model of the porous implant being configured to fit within the tissue repair site (Abstract; [0175]; Claim 15). Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to perform the method of Croes et al. and 3D print the BCP scaffold and print the biomaterial antigen in the plurality of pores for site specific delivery, as suggested by Jariwala et al., Bose et al. and Guobao, with a reasonable expectation of success. The artisan is motivated to do so because 3D printing allows for specific control of the shape of the bone implant for the repair site as taught by the combined references.
Response to Arguments: Applicant appears to have traversed this rejection as grouped with the 103 rejection above. The Examiner’s response is found supra.
Claims 1, 7-15 and 21-26 are rejected under 35 U.S.C. 103 as being unpatentable over Suddaby (US20060040878) in further view of Jariwala et al. (3D PRINTING 2015;2(2):56-64) and Bose et al. (Materials Today Volume 16, Number 12 December 2013) and Guobao (US20180296343) and Bao et al. (Nature Scientific Reports 2017(7):13 pages) and Zhao et al. (Zhao et al. Arthritis Research & Therapy 2011, 13:234; 10 pages).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Regarding claims 1, 7-8, 14-15, 21 and 25, Suddaby teach applying an antigen comprising at least one bacterial antigen to a matrix material for forming an immunomodulatory implant that is operatively arranged to chemotactically facilitate bone morphogenesis (Examples I-XII). Suddaby discloses the combination of a bone material or matrix and an antigen (Claim 17) such as hydroxyapatite and tricalcium phosphate or combinations thereof (Claim 21) with an antigen from weakened or dead bacteria/parasitic organisms (Claims 23-25; Examples I-II) comprising lipopolysaccharide, teichuronic acid and crude bacterial lysate (Claim 26; Example III) and further comprising a chemoattractant (Claim 28) such as cytokines interleukins I and II or lymphokine or C-reactive protein (Claim 29; Examples VIII-XII). Suddaby discloses macrophage infiltration into the matrix [0021], which indicates a porous matrix with a plurality of pores, which provide a recess on the outer surface for the macrophages to enter into. Adding the antigen to the matrix necessarily covers the matrix and pores/recesses thereby ‘arranging’ a layer of the antigen in the recess.
In addition to the discussion above, Suddaby is directed to bacterial antigen induced bone morphogenesis (title) with a composition for inducing bone morphogenesis comprising an effective amount of bone material or matrix and an antigen (Claim 17) such as hydroxyapatite and tricalcium phosphate or combinations thereof (Claim 21) with an antigen from weakened or dead bacteria/parasitic organisms (Claims 23-25) comprising lipopolysaccharide, teichuronic acid and crude bacterial lysate (Claim 26) and further comprising a chemoattractant (Claim 28) such as cytokines interleukins I and II or lymphokine or C-reactive protein (Claim 29). Suddaby teaches that macrophage infiltration into the matrix is believed to be required [0021], hence a porous matrix is needed. With regard to methods of making the composition, Suddaby simply directs the artisan to add the antigens or chemoattractants to the matrix (Examples I-XII).
Regarding claim 24, Zhao et al. teach that IL-4, IL-10 and IL-13 regulate osteoclast differentiation (Figure 1, page 2) where “IL-4 and IL-13 indirectly suppress osteoclastogenesis by inhibiting RANKL but enhancing OPG expression in osteoblastic cells.” Page 2, right column 1st paragraph). Zhao et al. further teach: “A large body of work has established an important role for IL-10 in suppressing osteoclastogenesis in vitro and in vivo.” (Page 3, left column 1st paragraph).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02) and Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
The difference between the instant application and Suddaby is that Suddaby do not expressly teach arranging a layer of cytokine in the recess before arranging a layer of the antigen on top of the cytokine layer by 3D printing and wherein the matrix further comprises an inner portion arranged therein and spaced apart from the outer surface, the inner portion comprising a second material, different than the first material that comprises a cytokine. However, Suddaby teaches that both cytokines and antigens can induce/enhance bone morphogenesis [0015] and it is then obvious to combine them for at least an additive effect in inducing/enhancing bone morphogenesis. With regard to the layering of the cytokine in the recess before arranging the antigen on top of the cytokine limitations by 3D printing, as taught by Jariwala et al., it is conventional practice to manufacture bone scaffolds by 3D printing (Title; Abstract; Table 1) where the printing includes desired cells and biomaterials (Figure 1) including BCP scaffolds of HA-TCP (Page 60, left column 1st paragraph). Furthermore, Bose et al. teach: “the use of additive manufacturing technologies in bone tissue engineering has been growing in recent years. Among the different technology options, three dimensional printing (3DP) is becoming popular due to the ability to directly print porous scaffolds with designed shape, controlled chemistry and interconnected porosity. Some of these inorganic scaffolds are biodegradable and have proven ideal for bone tissue engineering, sometimes even with site specific growth factor/drug delivery abilities.” (Abstract). See also Tables 1-3. Porous scaffolds with recesses are shown in Figure 2(a) and 2(d). Bose et al. also teach that: “3D printed scaffolds have also been used for growth factor and drug delivery to enhance bone growth in scaffolds. The localized delivery of growth factors and drugs has attracted significant attention due to the potential for dose reduction, controlled release pattern, and the negligible side effects compared to systemic delivery.” (Page 502, left column Growth factor and drug delivery using 3D printed scaffolds). In addition, Guobao teach a method for producing a porous implant, the method comprising: obtaining a 3-D image of an intended tissue repair site; generating a 3D digital model of the porous implant based on the 3-D image of the intended tissue repair site, the 3-D digital model of the porous implant being configured to fit within the tissue repair site (Abstract; [0175]; Claim 15). Moreover, Bao et al. teach adding cytokines in a PLGA-PEG-PLGA hydrogel material different from the HA/PCL composite material scaffold filled into recesses of the HA/PCL composition material scaffold to make a biomimetic bone scaffold (Abstract; Figure 1D shows cavities in the artificial bone scaffold thus showing the porosity with interconnected pores (Page 2, Results, page 8 bottom); Figure 13 shows hydrogel in a recess of the porous construct). Consequently, Bao et al. teach and suggest a matrix that comprises an inner portion arranged therein and spaced apart from the outer surface, the inner portion comprising a second material, different than the first material that comprises a cytokine and the inner portion is enclosed by the outer portion. Bao et al. also teach: “The “structure-anatomy-function” trinity strategy for large weight-bearing bone regeneration can promote osteogenesis and accelerate bone repair with less costly cytokines requirement. It is also implied that with proper design of materials, suitable cytokine induction and individual fabrication technique of artificial bone, efficient bone tissue repair could be achieved without preimplantation cell seeding.” (Page 9, 5th paragraph). Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to perform the method of Suddaby as modified by the combined references and 3D print the BCP scaffold and print the biomaterial antigen in the plurality of pores/recesses on top of the cytokine layer for site specific delivery, as suggested by Jariwala et al., Bose et al., Bao et al. and Guobao, to produce an immunomodulatory implant operatively arranged to chemotactically facilitate bone morphogenesis comprising a matrix with an inner portion arranged therein and spaced apart from the outer surface, the inner portion comprising a second material, different than the first material that comprises a cytokine with a reasonable expectation of success. It is then obvious to arrange the antigen layer of Suddaby on top of the layer of cytokine, for at least an additive effect in facilitating bone morphogenesis, by printing with a reasonable expectation of success. The artisan is motivated to do so because 3D printing allows for specific control of the shape of the bone implant for the repair site as taught by the combined references.
The difference between the instant application and Suddaby is that Suddaby do not expressly teach the cytokine is at least one of IL-4, IL-10 or IL-13. As noted above, Suddaby teaches IL-1 and IL-2 but as examples (“secondary messengers, such as interleukin I”) of a genus of secondary messengers [0015, 0019]. Thus, the disclosure of Suddaby is not limited to those species. However, Zhao et al. teach that it is well known that IL-4, IL-10 and IL-13 suppress osteoclastogenesis, which is contrary to the desired outcome of bone morphogenesis. Thus, it is desirable to select and add at least one of IL-4, IL-10 and IL-13 for that beneficial function and arrange it in a recess/pore of the matrix and have the antigen arranged on the cytokine layer in the recess/pore. The ordinary artisan would do so with a reasonable expectation of success.
The difference between the instant application and Suddaby is that Suddaby do not expressly teach that the inner portion is completely enclosed by the outer portion. However, the inner portion is either completely or partially enclosed by the outer portion. Figure 1 of Bao et al. show the inner porous section is completely enclosed by the outer portion in the cross-sectional view. In the absence of any unexpected results, it would be obvious to have the inner portion completely enclosed by the outer portion, as suggested by Bao et al., for at least the sake of biomimicry of the implant. The ordinary artisan would do so with a reasonable expectation of success.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a).
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date, as evidenced by the combined references, especially in the absence of evidence to the contrary.
Response to arguments:
Applicant’s arguments have been carefully considered but are not persuasive.
On page 8 of remarks, Applicant discusses the references of Bao et al. as teaching cytokines on the surface of the construct (Figure 13 of Bao). However, it appears to the Examiner that the hydrogel entraps the cytokines and is inside the composite and not on the surface as alleged by Applicant. See below:
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It certainly appears to the Examiner that Bao et al. teach and suggest an inner portion with a different material enclosed by an outer portion. Bao et al. even state: “the hydrogel loaded in the inner of scaffolds thoroughly.” (Page 11, Preparation of hydrogel-loaded artificial bone scaffolds and the bone defect repair in vivo). Also note Figure 1 of Bao et al. showing the inner porosity of the bone scaffold:
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Accordingly, Bao et al. reasonably teach and suggest an inner portion with a different material from the outer portion and is enclosed by the outer portion. The cross-sectional view shows that it is completely enclosed. Respectfully, Applicant’s arguments are not persuasive. That appears to be the extent of Applicant’s traversal of this rejection.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERNST V ARNOLD whose telephone number is (571)272-8509. The examiner can normally be reached M-F 7-3:30.
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/ERNST V ARNOLD/Primary Examiner, Art Unit 1613