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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/09/2026 has been entered.
Response to Amendment
The Amendment filed 03/09/2026 has been entered. Applicant’s amendment is in response to in the Final Office Action mailed 09/08/2025 and PTOL-303 filed 12/15/2025. Applicant’s claims have been amended in the following manner: independent claim 1 has been modified by specifying “alginate” as the hydrogel (supported on pg 7 of Applicant’s Specification) and “beta-tricalcium phosphate” as the biocompatible inorganic material (supported on pg 10 of Applicant’s Specification), while also specifying instructions regarding the composition “parts” (supported on pg 3-4 of Applicant’s Specification). This narrows claim 1, prompting a new ground of rejection that primarily relies on the Art of the previous Action. Furthermore, new claim 44 has been entered to draw a new ground of rejection. The following objections/rejections are withdrawn: none.
The Examiner further acknowledges the following:
Claims 1-4, 9-15, 25-29, and 44 are pending.
Claims 25-29 are withdrawn from consideration as directed to non-elected inventions.
Claims 1-4, 9-15, and 44 are presented for examination and rejected as set forth below.
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 9-13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 9-13 recite “the composition according to claim 8”, where claim 8 has been deleted, and therefore there is insufficient antecedent basis. For the purpose of examination, the examiner will presume that claims 9-13 depend from claim 1.
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.
Claims 1-4, and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Mulhaupt (US20030090034A1), and in further view of Cuomo (Polymers, 2019), Bendtsen (Journal of Biomedical Materials Research A, 2017), and Noori (International Journal of Nanomedicine, 2017).
Independent claim 1 is directed to a “multi-part composition” intended for 3D printing of bone composite, generally comprising a first part (comprising fibrinogen), a second part (comprising thrombin), and a third part (comprising alginate and beta-tricalcium phosphate).
The 3D printing for a bone composite is an intended use and does not impact the structure of the composition (although it requires a suitable flowable form for printing). Particularly, a recitation of an intended use will not limit the scope of the claim because it merely defines a context in which the invention may operate. Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d 1339, 1345 (Fed. Cir. 2003). The further wherein clause suggests a mixing order for obtaining the final composite and does not affect the compositional identity of the mixed composite except that the first, second, and third parts must be separate (so that they can be mixed later). It must be remembered: "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). The wherein clause specifying “wherein the third part is not mixed with the first part and the second part in the multi-part composition” does not provide patentable weight for a composition in an obviousness analysis.
Mulhaupt teaches a device and a process for producing three-dimensional (3D) objects (abstract) which may serve to remove bone defects [0085]. Mulhaupt teaches that the formation of the 3D printed structures for bone tissue application [0085] (including layer by layer [0002, 0004, 0049-0052]), depend from rheological parameters such as viscosity [0078, 0080] in order to precisely control structure shape, incorporating projections, undercuts, and/or cavities without supporting structures [0091] and to create small structures with high resolution [0088], where even higher resolution can be obtained from different microdispensers [0068].
Regarding claims 1 and 44: Mulhaupt teaches a multi-part composition including one composition combining human fibrinogen (reads on claim 1(i)), sodium alginate (reads on claim 1(iii)), and living cells in water and a second composition combining thrombin (reads on claim 1(ii)), calcium ions, and gelatin in water [0082]. Mulhaupt teaches that when these two compositions are combined, they form a gel via calcium alginate or fibrin formation, and the composition can incorporate the inorganic filler (reads on biocompatible inorganic material) such as hydroxylapatite [0084-0085] (whereby Applicant’s Specification on pg 9 names hydroxyapatites, as suitable biocompatible inorganic materials), where the filler can improve the mechanical properties of the finished 3-D object (Mulhaupt – claim 15) [0083-0085].
Thus, Mulhaupt teaches mixing of a first material and second material of suitable theological properties to form 3D dimensional solid structures [0010-0014], incorporating thrombin, fibrinogen, calcium alginate, and an inorganic compound, by way of an example [0082-0085]. The novelty of separating out a material (i.e., the alginate with an inorganic filler) in which to add a "third" separate and standalone composition (based on components from the first and second materials) to form a final composition (where you effectively arrive at the same final composition) is prima facie obvious: In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.); In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice). Thus, the rearrangement of components into three distinct starting compositions that are intended to make the same final composition is prima facie obvious, as a design choice (especially when the mechanisms for forming viscous 3D objects are taught).
As such, Mulhaupt teaches two mechanisms for gelling: (a) a complex formation of the alginate to form insoluble calcium alginate and (b) a gelling of fibrinogen (via known thrombin catalysis) to form fibrin [0083], whereby additionally an inorganic filler can further modify mechanical properties [0083-0084]. A principal objective of Mulhaupt is to take lower viscosity materials [0015] to make higher viscosity 3D objects [0080]. Thus, it would make sense to keep lower viscosity materials separate and unreacted prior to printing, whereby once combined the materials form higher viscosity 3D objects.
From this teaching, the "third composition" is from being broken up into smaller parts (to be recombined later to remake a final composition) where in all parts/compositions maintain the same eventual purpose (i.e., as suitable materials providing structure within a hydrogel for medical application). Thus, a prima facie case of obviousness was established based on the combined Prior Art (see previous 103 rejection for full details) for the proposed invention.
In summary, Mulhaupt teaches 3D printed structure based on multiple starting compositions that incorporate fibrinogen (instant claim 1(i)), thrombin (instant claim 1(ii)), alginate (instant claim 1(iii)), and an inorganic filler (instant claim 1(iii)). However, Mulhaupt does not explicitly teach the combination of the three instant compositions (as described by instant claim 1), the beta-tricalcium phosphate (instant claim 1), the fibrinogen and thrombin amounts (instant claims 2-3), or the viscosity of the hydrogel (instant claims 1 and 4).
Bendtsen teaches alginate hydrogels that can include hydroxyapatite (noted by Applicant as a suitable biocompatible inorganic material on pg 9 of the Specification), as independently suitable for 3D printing for bone tissue engineering (i.e., capable of making 3D structures, as imaged by Bendtsen in pg 1461, Table 2) (abstract, pg 1460-61, Table 2). Bendtsen also teaches material selection is the most important step when applying 3D printing technology, in that the material must be printable or have sufficient viscoelasticity to allow extrusion through a small needle followed by recovery, and that alginate is a perfect candidate for 3D bioprinting in that in can support live cells and provide structure to the final composite (pg 1462-1463, discussion). Thus, hydrogels mixed with inorganic materials of sufficient viscosity are able to independently create 3D printed layers and/or objects (reads on instant component iii of claim 1). Bendtsen also teaches hydroxyapatite (the main inorganic component of bone) is incorporated into the hydrogel to increase viscosity, biocompatibility, and osteoconductivity (pg 1458, paragraph 3).
Cuomo teaches rheological characterization of alginate-based hydrogels containing calcium that have application in pharmaceutical, medical, coating, and food industries (abstract). Cuomo teaches that understanding rheological properties of gelled systems is necessary to improve the systems’ characteristics. Cuomo teaches the apparent viscosity of alginate hydrogels (pg 5, Figure 2(a)) at a shear rate of 0.1 s-1 (approximately 50 to 500 Pa-s, looking at Figure 2(a)) and 1 s-1 (approximately 10 to 50 Pa-s, looking at Figure 2(a)) that overlaps the instant ranges (instant claims 1 and 4). Furthermore, the U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the infinite number of ways that a subsequent applicant may present previously unmeasured characteristics. When as here, the prior art appears to contain the exact same ingredients and applicant's own disclosure supports the suitability of the prior art composition as the inventive composition component, the burden is properly shifted to applicant to show otherwise.
Noori teaches fibrin composites for bone tissue engineering (abstract). Noori teaches that Bolheal (containing 80 mg/mL fibrinogen, 250 IU/mL thrombin, and beta-tricalcium phosphate, which read on the amounts of instant claims 2-3 and the beta-tricalcium phosphate of claim 1) can be used for bone regeneration (Table 1, Ref 197 title). Noori teaches adjacent materials such as beta-tricalcium phosphate among other inorganics afford different properties that lead to different results in vitro and in vivo (pg 4939, paragraph 1 and Table 1) and also different fibrinogen and thrombin concentrations and the effects on gel properties (Table 2).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify Mulhaupt’s teachings by combining an additional alginate hydrogel part, incorporating a biocompatible inorganic material, (instant claim 1(iii)) taught by Bendtsen with Mulhaupt’s fibrinogen (instant claim 1(i)) and thrombin (instant claim (ii)) compositions, using Mulhaupt’s 3D printing device or a similar device known to person of ordinary skill in the art, because Bendtsen teaches alginate hydrogels (which incorporate a biocompatible inorganic material) are suitable for 3D printed objects, in which Mulhaupt makes 3D printed objections. The combination of these element leads to little more than a combination of old elements with each performing the same function it had been known to perform, yielding no more than one would expect from such an arrangement. KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)), see also Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) (Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify Mulhaupt’s teachings by specifying the numerical apparent viscosity parameters of a hydrogel composition (e.g., the alginate hydrogel of Bendtsen) used for 3D printing, as taught by Cuomo, because Cuomo teaches rheological parameters like viscosity (e.g., 50 to 500 Pa-s @ shear rate of 0.1 s-1 and/or 10 to 50 Pa-s @ a shear rate of 1 s-1) are important in characterizing hydrogel structure and strength (pg 9, ‘4. Conclusions’), where Bendtsen also teach viscosity affects printability of hydrogels (abstract). Mulhaupt similarly teaches that the formation of the 3D printed structures for bone tissue application [0085], depend from rheological parameters such as viscosity [0078, 0080] in order to precisely control structure shape, incorporating projections, undercuts, and/or cavities without supporting structures [0091] and to create small structures with high resolution [0088], where even higher resolution can be obtained from different microdispensers [0068].
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the amounts of fibrinogen and thrombin of the multi-part composition comprising a fibrinogen part, a thrombin part, and a hydrogel part comprising an inorganic filler taught by Mulhaupt with the amounts taught by Noori (containing 80 mg/mL fibrinogen, 250 IU/mL thrombin, and beta-tricalcium phosphate), because Noori teaches that the amounts of fibrinogen and thrombin in the presence of an beta-tricalcium phosphate are suitable to form material used for bone tissue engineering, which is the same use applied to Mulhaupt’s 3D bone composition based on fibrinogen and thrombin [0083-0085].
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the inorganic filler of the multi-part composition comprising a fibrinogen part, a thrombin part, and a hydrogel part comprising an inorganic filler taught by Mulhaupt, with a beta-tricalcium phosphate, because Noori teaches beta-tricalcium phosphate to be useful in hydrogel compositions comprising fibrinogen and thrombin. The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). Because the combined Prior Art teaches inorganic fillers in hydrogel compositions for bone tissue engineering, it would be obvious to select a particular beta-tricalcium phosphate shown by the Prior Art to be useful in bone tissue engineering applications. Furthermore, Mulhaupt teaches that final 3D printed objects intended for bone application [0085] can incorporate an inorganic filler (i.e., biocompatible inorganic material), where the filler can improve the mechanical properties of the finished 3D object (Mulhaupt – claim 15) [0083-0085].
Claims 1-4, 9-15, and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Mulhaupt (US20030090034A1), Cuomo (Polymers, 2019), Bendtsen (Journal of Biomedical Materials Research A, 2017), and Noori (International Journal of Nanomedicine, 2017), and as applied to claims 1-4, and 44 above, and in further view of Rocca (US 2006/0073202 A1), Gatenholm (US 2019/0307923 A1), and Tavares (J Appl Oral Sci., 2013).
As discussed above, the combined Prior Art teach a multi-part composition comprising a fibrinogen part, a thrombin part, and a hydrogel part comprising an inorganic filler such a beta-tricalcium phosphate, the hydrogel having a specific apparent viscosity, that is suitable for the 3D printing of a bone composite. They do not teach density (instant claims 9-10), the particle size (instant claims 11-12 and 14-15), or the xrpd (instant claim 13) of the beta-tricalcium phosphate inorganic filler.
Rocca teaches a medicament delivery system (abstract) with descending agents [0027]. Rocca teaches the descending agent tricalcium phosphate to have a density of 3.1 g/cm3 [0027].
Gatenholm teaches a bioink for bioprinting that has application to bone (abstract). Gatenholm teaches beta-tricalcium phosphate particles that are smaller than 400 microns and more preferably smaller than 200 microns (abstract). Gatenholm teaches the smaller particle size is to make it possible to handle in printing a nozzle without clogging and to obtain a good resolution (abstract). Gatenholm also teaches combining beta-tricalcium phosphate with alginate, fibrinogen, thrombin, etc. [0008, 0012] to provide a biocompatible material to induce bone formation and repair defects [0012], where layering is possible in the 3D printing [0006].
Tavares teaches the characterization of beta-tricalcium phosphate and magnesium substituted beta-tricalcium phosphate for application to bone therapy (abstract). Tavares teaches shows the xrpd of beta-tricalcium phosphate, and it matches the listed peaks of the instant claim. Furthermore, the U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the infinite number of ways that a subsequent applicant may present previously unmeasured characteristics. When as here, the prior art appears to contain the exact same ingredients and applicant's own disclosure supports the suitability of the prior art composition as the inventive composition component, the burden is properly shifted to applicant to show otherwise.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the inorganic filler of the multi-part composition comprising a fibrinogen part, a thrombin part, and a hydrogel part comprising an inorganic filler such as beta-tricalcium phosphate taught by the Prior Art, with a beta-tricalcium phosphate having a density of 3.1 g/cm3, a particle size smaller than 200 microns, and the claimed xrpd, because this combines prior art elements to yield a predictable result of a composition for bone regeneration (furthermore, with regard to the particle size, the smaller particle size would avoid clogging of a printing nozzle, as taught by Gatenholm). The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). Because the combined Prior Art teaches inorganic fillers in hydrogel compositions for bone tissue engineering, it would be obvious to select a particular beta-tricalcium phosphate shown by the Prior Art to be useful in bone tissue engineering applications. Furthermore, the defining the density, xrpd profile, and particle size for the beta-tricalcium phosphate would be obvious because these are properties of the ingredient that are typical of the Art. Furthermore, inorganic component/filler such as beta-tricalcium phosphate is taught by Mulhaupt, Bendtsen, and Noori to modify properties of hydrogels, including their viscosity, biocompatibility, and osteoconductivity for the purpose of building better 3D objects for use in bone applications.
Response to Arguments
Applicants arguments, see pg 7-13, filed 03/09/2026, with respect to the 103 rejection of claims 1-15 under rejection have been fully considered but they are not persuasive. The 103 rejection has been modified with respect to amendments made to the claim set and new added claim 44.
On page 7, Applicant discusses amendments regarding the previous claim objection regarding the term “about” which are acceptable, and the objection is removed.
On page 7, Applicant argues that claim is not a “product-by-process” claim. The Examiner understands the Applicant’s interpretation, but leaves the information in the claim interpretation section, in case Applicant reframes the claims with respect to a method outcome.
On page 7-8, Applicant provides multiple arguments regarding unexpected results, as shown by the Specification. Note that the Examiner emphasizes that there are specific criteria used for an obviousness analysis, which is different from an evaluation of unexpected results to demonstrate non-obviousness (which will be explained further below).
When discussing the obviousness of combining three separate compositions to form 3D objects for bone applications, this is discussed in the 103 rejection above. Mulhaupt teaches that gel compositions suitable for 3D object construction (including layer by layer [0002, 0004, 0049-0052]), form via calcium alginate and/or fibrin formation (providing the mechanism to construct 3D objects), and the compositions can incorporate the inorganic filler (i.e., biocompatible inorganic material), where the filler can improve the mechanical properties of the finished 3-D object (Mulhaupt – claim 15) [0083-0085]. Mulhaupt teaches two mechanisms for gelling: (a) a complex formation of the alginate to form insoluble calcium alginate and (b) a gelling of fibrinogen (via known thrombin catalysis) to form fibrin [0083], whereby additionally an inorganic filler can further modify mechanical properties [0083-0084]. A principal objective of Mulhaupt is to take lower viscosity materials [0015] to make higher viscosity 3D objects [0080]. Thus, it would make sense to keep lower viscosity materials separate and unreacted prior to printing, whereby once combined the materials form higher viscosity 3D objects. Mulhaupt also teaches that the formation of the 3D printed structures for bone tissue application [0085], depend from rheological parameters such as viscosity [0078, 0080] in order to precisely control structure shape, incorporating projections, undercuts, and/or cavities without supporting structures [0091] and to create small structures with high resolution [0088], where even higher resolution can be obtained from different microdispensers [0068]. Thus, a separation of the ingredients into separate “parts”, as long as the underlying mechanism (i.e., whereby the gelling mechanisms are taught by Mulhaupt [0083] and discussed above) utilized to form the 3D object is available to recombine the parts in the final 3D object, is prima facie obvious to a PHOSITA, based on the teachings of the combined Prior Art.
Furthermore, Bendtsen teaches alginate hydrogels that can include an inorganic filler as independently suitable for 3D printing for bone tissue engineering (abstract), thus able to print 3D patterns such as objects and/or layers (pg 1461, Table II), and thus, it would additionally be obvious to add this component to Mulhaupt’s teachings to make 3D objects comprising fibrinogen and thrombin in a layered fashion, where Mulhaupt teaches layering [0002, 0004, 0049-0052]. Thus, sufficient teachings are provided by the combined Prior Art to make the 3-part composition of the instant claims prima facie obvious.
In discussion of the unexpected results, the Examiner focuses largely on the teachings of the closest Prior Art, and the teachings of the combined Prior Art (with respect to expected results of certain features and/or limitations), in comparison to the data provided by Applicant.
On pg 8-10, with respect to “Difference i)”, Applicant argues on the basis of a 3-part vs. 2-part printed composition, as critical to unexpected results. When emphasizing “layering” on pg 9, the method of alternating layers of compositions in order to make a final 3D object is known in the Art. See Mulhaupt at [0052]: “For example, backbone-like or scaffolding three-dimensional objects may be produced in this manner, by forming strands running parallel to one another in a first direction within the first layer. A gap may thus be present between the strands of one plane. Strands parallel to one another in a second direction are then formed during the formation of the second layer. A backbone of layers of strands is then constructed by repeating these steps.” In this case, the beneficial results are expected based on the teachings of the prior art: “Expected beneficial results are evidence of obviousness of a claimed invention, just as unexpected results are evidence of unobviousness thereof.” In re Gershon, 372 F.2d 535, 538, 152 USPQ 602, 604 (CCPA 1967), see also In re Skoner, 517 F.2d 947, 950 (CCPA 1975). Thus, alternating layers to make a multi-layered 3D object is an expected result, as taught by Mulhaupt.
Further note, that the unexpected results as related to Figures 1 and 5, incorporate hyaluronic acid (instead of alginate; for compositional information, see Tables of pg 26 and 30)), which is no longer within the scope of claim 1 (due to amendment). Thus, it is unclear if results based on compositions comprising hyaluronic acid (and not containing alginate) would extend to the current claim scope (i.e., it requires alginate to be the “hydrogel”), and there is so far no objective evidence that demonstrates that it would.
The objective data purported to represent unexpected (in which the general compositions, representing Figure 1 and Figure 5, each comprise fibrinogen, thrombin, hyaluronic acid, beta-tricalcium phosphate, but that Figure 5 represents a “3-part” composition and Figure 5 represents a “2-part” composition) focuses on the “macro layers” (in which the Examiner attempts to interpret Applicant’s meaning of “macro layer”) and “large runoffs”:
For the “macro layer”: In the inventive final 3D object (figure 1, panel 1, originating from a “3-part” composition), the layering in the “tower” part is deemed visually similar to the “tower” of Figure 5 (comparative “2-part” composition). The so-called “macro layer” that the arrow refers to in “Figure 1 (arrows)” is a printed line of viscous material (“a hydrogel combined with beta-tricalcium phosphate” on pg 9). The “macro layer” shape is exactly what one would expect if you printed a line of viscous hydrogel in the shape of a line. Mulhaupt teaches printing of viscous layers [0052] that containing alginate and inorganic filler [0080-0084] such that the “macro layer” below is an expected result. Regarding the “L-shape” of the inventive composition of Figure 1, Mulhaupt teaches how to precisely control structure shape (i.e., the “macro layer”), incorporating projections, undercuts, and/or cavities without supporting structures [0091] and to create small structures with high resolution [0088], where even higher resolution can be obtained from different microdispensers [0068]. Finally, Bendtsen teaches alginate hydrogels that can include an inorganic filler, as independently suitable for 3D printing for bone tissue engineering (abstract), thus able to print “macro layer” like patterns (pg 1461, Table II), similar to the “arm” structure in the L-shaped printed object (as reproduced below), paralleling the instant “third part” of claim 1 (i.e., a composition comprising a hydrogel and inorganic material).
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<- “macro layer” like (Bendtsen)
For the “large runoffs”: In the inventive final 3D object (figure 1, panel 1, originating from a “3-part” composition), runoff is also visible on the right-hand portion of the image of the inventive “3-part” composition (see inserted orange arrow), which is similar to the runoff of Figure 5 that is noted by Applicant (comparative “2-part” composition). The data is reproduced below for emphasis.
[AltContent: textbox (Similar runoff, as Fig 5)][AltContent: arrow]
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On pg 10-12, with respect to “Difference ii)”, Applicant argues in support of an unexpected result on the basis of ingredient selection (i.e., Applicant’s claimed beta-tricalcium phosphate vs. the embodiment of Mulhaupt teaching hydroxylapatite [0082-0085]). Mulhaupt teaches an 3D printed object embodiment already containing fibrinogen, thrombin, alginate, and an inorganic filler (such as hydroxylapatite) for bone applications [0082-0085]. Thus, the results related to alginate would be considered expected, because Mulhaupt teaches a hydrogel based on alginate [0082-0085]. Applicant points to panels 7 and 8, where the only difference is the use of 5.250 g of beta-tricalcium phosphate for inventive composition of panel 7 vs. a mixture of 3.53 g hydroxylapatite and 1.18 g beta-tricalcium phosphate from inventive composition of panel 8 (see images below).
[AltContent: textbox (Similar layering)][AltContent: textbox (Similar layering)][AltContent: arrow][AltContent: arrow]
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A PHOSITA would not objectively say that Panel 7 (selecting the inorganic material, as 5.250 g of beta-tricalcium phosphate) shows improved printing resolution compared to Panel 8 (selecting the inorganic material, as a mixture of 3.53 g hydroxylapatite and 1.18 g beta-tricalcium phosphate), with particular attention drawn to layers present in both Panel 7 and 8 (see inserted yellow arrows). Note that any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Consequently, we must determine whether the results obtained in the closest prior art and those set forth by Applicants are sufficiently different in kind, and not merely in degree, so as to be unexpected by a person of ordinary skill in the art at the time of invention. See Iron Grip Barbell Co. v. USA Sports, Inc., 392 F.3d 1317, 1322 (Fed. Cir. 2004) (Unexpected results that are probative of nonobviousness are those that are "different in kind and not merely in degree from the results of the prior art") (citation omitted). In this case, the layering of Panels 7 and 8 look similar, and within the realm of experimental differentiation of similar performing materials.
Furthermore, when Mulhaupt teaches a 3D printed object based on fibrinogen, thrombin, alginate, and an inorganic filler such as hydroxylapatite, the selection of beta-tricalcium phosphate (in place of hydroxylapatite as taught by Mulhaupt) to afford a similarly resolved printed structure does not constitute an unexpected result. Furthermore, Mulhaupt teaches a mechanism whereby two structuring-forming elements are able to be present (i.e., calcium alginate complex and gelled fibrin), whereby an inorganic filler can further modify mechanical properties [0083-0084].
Finally, Mulhaupt also teaches an improvement in mechanical properties of the finished three-dimensional object may be achieved by adding inorganic or organic fillers [0084], and so the similar structural performance of 3D objects that incorporate beta-tricalcium phosphate and/or hydroxylapatite in combination with fibrinogen, thrombin, and alginate is expected by the Art. The layering of the images above (panels 7 and 8) does not provide objective evidence, demonstrating the contrary.
On page 12-14, Applicant asks for rejoinder and concludes. The claim set remains under rejection by 103.
As a final note on general claim construction (in attempting to define a claim scope commensurate with purported unexpected results), when Applicant includes “comprising” to describe both the “multi-part composition” and each individual “part”, understand that “comprising” is open-ended that may include any conceivable ingredient (as related to a separation into a first part, second part, third part).
Correspondence
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/R.P./Examiner, Art Unit 1614 4/6/2026
/SEAN M BASQUILL/Primary Examiner, Art Unit 1614
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