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 .
Election/Restrictions
The applicant's election with traverse of Group II (claims 9, 12, and 13) in the reply filed on 17 February 2026 is acknowledged.
The traversal is on the ground(s) that CN 109266549 (“Cao”) (cited in an IDS) does not disclose the spacing of the patterned layers by plural supports recited in claims 1, 9 and 10, and that this spacing therefore constitutes a special technical feature linking Groups I-III. The applicant’s argument is persuasive as to Cao, and the requirement is no longer maintained on the basis of Cao. The requirement is maintained on the basis set forth below, which addresses the shared technical feature in full.
Groups I-III lack unity of invention because, even though the inventions of these groups require the technical feature of a cell culture scaffold comprising a series of porous cell growth walls, the series of walls being arranged in a generally concentric pattern, each wall being spaced from its concentrically adjacent wall by an open channel suitable for nutrient supply, said scaffold being formed by repeatedly printing a layer of spaced single polymer strands in said pattern and repeatedly forming plural supports between each, or some of, the layers so as to space apart the patterned layers, whereby the walls have said porosity by virtue of the spacing of the patterned layers by the supports, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of CN 105056302 (“Li”), Gupta et al., “A Review on 3D Printable Techniques for Tissue Engineering,” BioNanoScience, Vol. 8, pp. 868-883 (2018) (“Gupta”), and CN 109676915 (“Ding”), each of which was cited in the IDS filed 25 August 2023.
Each element of the above shared technical feature is addressed in the rejection of claim 9 under 35 U.S.C. 103 set forth below. That rejection maps every element of the shared technical feature to Li, Gupta and Ding, and the applicant is directed to that rejection rather than to a separate analysis repeated here.
It is further noted that Ding alone teaches each element of the above shared technical feature. Ding discloses a wheel-shaped porous scaffold of biomaterial formed by 3D printing from stacked units, each unit comprising a layer of concentric circular beams of differing diameter arranged at equal intervals with a spacing of from 100 µm to 5 cm between adjacent circular beams, and a layer of radially extending straight beams placed on the circular beam layer, whereby stacked circular beam layers are spaced apart from one another by the straight beams (see Figures 1-3 and [0013]-[0015] and [0020]-[0024] of the provided translation), each beam being a single extruded strand of polylactic acid printed by fused deposition modeling at an extruder diameter of 0.2 mm (see [0051] and [0072]), the resulting connectivity of the internal and external pores facilitating the exchange of nutrients and waste products (see [0005] and [0028]).
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-8, 10, and 11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
The applicant is further advised that, having elected Group II, a process, the rejoinder practice of MPEP § 821.04 is not available to secure examination of the Group I product claims.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: 22 (see page 6 of the specification, reciting “just twelve supports 12/22 are used (30 degrees apart)”).
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it contains legal phraseology, specifically “said pattern” and “said porosity”, and because it begins with the implied phrase “Disclosed is”. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because of the following informalities:
On page 2, “WO 20211086058” should be replaced with “WO 2021/086058”. As printed, the publication number does not identify any document.
Appropriate correction is required.
Claim Objections
Claim 9 is objected to because of the following informalities:
In the preamble, “cell growth scaffold” should be replaced with “cell culture scaffold”, for consistency with the title, the abstract, and claim 1.
In step a), “each wall being spaced from its adjacent wall” should be replaced with “each wall being spaced from its concentrically adjacent wall”, for consistency with the specification and with claim 1.
In step b), “converting said in STL data into instructions” should be replaced with “converting said STL data into instructions”.
In step b), the term “native” should be deleted. The specification uses this term to describe the internal data format employed by the modelling software (see page 8 of the specification, reciting that “[t]he software used utilises native Standard Tessellation Language (STL) data format both internally and outputting to a file”), whereas the claim provides no referent for the term.
In step c), “respective patterned layers” should be replaced with “respective layers printed in said pattern”.
In step c), “whereby the walls have said porosity” should be replaced with “whereby the walls have a porosity”. Claim 9 recites “porous cell growth walls” in step a) but does not previously recite a porosity.
In step c), the recitation “each wall being spaced from its adjacent wall by an open channel suitable for nutrient supply” duplicates the corresponding recitation in step a) and should be deleted.
Appropriate correction is required.
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.
Claims 9, 12, and 13 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 9 recites in step a) “defining a further layer which is intended to be printed between the, or some of, the multiplicity of wall layers,” and recites in step c) “repeatedly forming plural supports between each, or some of, the layers.” The claim does not state whether the plural supports of step c) are the further layer defined in step a), whether the plural supports are an additional structure distinct from that further layer, or whether the further layer of step a) is printed at all. Step a) requires only that the further layer be defined, and no subsequent step of the claim recites printing that further layer. The scope of the claim therefore cannot be determined.
The recitation “between the, or some of, the multiplicity of wall layers” in step a) is further indefinite because it is grammatically incomplete. The recitation “the layers” in step c) is further indefinite because it does not identify whether it refers to the wall layers of step a), the further layer of step a), or both.
For purposes of examination, claim 9 is being interpreted as requiring that the further layer defined in step a) is the layer of plural supports formed in step c), consistent with the description at page 5 of the specification, which states that a second STL file represents “the radially extending supports 12 which space apart the layers depicted in Figure 2 when printed”.
Claims 12 and 13 are rejected based on their dependency from claim 9.
Claim 12 recites that “the STL data is graphically represented as rectangular primitives”. It is unclear what this limitation requires. The recitation is in the passive voice and is not attributed to any actor, nor is it tied to any step recited in claim 9. On page 5 of the specification, the disclosure states that the modelling software graphically utilises rectangular primitives to design the cell scaffold layer by layer, and that the resulting model constructs are described in a file using Standard Tessellation Language (STL) data format. Claim 12, in contrast, attributes the graphic representation to the STL data itself rather than to the modelling software. It is therefore unclear whether claim 12 requires (i) a further step of graphically representing or displaying the STL data, (ii) that the model of the scaffold defined in step a) of claim 9, and represented by the STL data prepared in step b) of claim 9, be composed of rectangular primitives, or (iii) that the STL data itself be composed of rectangular tessellated facets. These interpretations differ materially in scope, and the specification does not indicate which is intended.
It is further unclear whether the recited “rectangular primitives” are two-dimensional rectangles or three-dimensional rectangular prisms. On page 5, the specification describes the wall elements 11 as having a radial thickness of 0.2 mm and a height of 0.2 mm, and describes the support constructs 12 as having a thickness of 0.2 mm, a height of 0.3 mm, and a length of 6.0 mm, such that the corresponding model constructs are three-dimensional. However, at least some of the constructs depicted in the figures are depicted as planar rectangles or squares, for example in Figures 9 and 11. The specification does not state whether a “rectangular primitive” is a planar rectangle, a rectangular prism, or a planar rectangle from which a three-dimensional construct is subsequently generated. Because a scaffold printed in three dimensions cannot be composed of planar, two-dimensional rectangles, the scope of claim 12 cannot be determined.
Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “Standard Tessellation Language (STL) data format”, recited in step b) of claim 9 and referred to in claim 12 as “the STL data”, is used by claim 12 to mean data that is graphically represented as rectangular primitives, while the accepted meaning of the term is a data format in which the surface of a three-dimensional object is represented as a mesh of triangular facets. The term is indefinite because the specification does not clearly redefine the term. This inconsistency is reflected in the drawings. For example, in Figure 9, each of the square constructs making up the radially extending supports 32 is depicted as divided by both of its diagonals into four triangles, indicating that each square construct is itself composed of triangular facets rather than constituting a facet of the STL data.
For purposes of examination, claim 12 is being interpreted as requiring that the model of the scaffold represented by the STL data be composed of rectangular primitives, consistent with the description on page 5 of the specification that the modelling software graphically utilises rectangular primitives to design the scaffold. Claim 12 is not being interpreted as requiring a step of graphically representing or displaying the STL data, as no such step is positively recited. Claim 12 is likewise not being interpreted as requiring that the tessellated facets of the STL data be rectangular, as such an interpretation is inconsistent with both the accepted meaning of the STL data format and with Figures 2-4 and 8-11, which depict each rectangular construct as being composed of plural triangular facets.
Claim 13 is rejected based on its dependency from claim 12.
For purposes of examination, claim 13 is being interpreted as requiring no more than the rectangular primitives of claim 12. Figures 2-4 and 8-11 depict rectangular and square constructs arranged in concentric wall element layers and in radial support layers, and claim 13 does not recite any further structural or procedural limitation distinguishing those constructs from the rectangular primitives already defined by the combination of claims 9 and 12.
Claim 13 is rejected under 35 U.S.C. 112(b) as being indefinite in that it fails to point out what is included or excluded by the claim language. This claim is an omnibus type claim. See MPEP § 2173.05(r).
Claim 13 recites that “said rectangular primitives are as shown in any one or more of Figures 2,3,4,8,9,10 and/or 11”. The claim does not identify what feature of the referenced figures constitutes the claimed rectangular primitives, and the referenced figures depict complete scaffold layers and scaffold assemblies rather than any identified rectangular primitive. The claim further does not identify which of the seven referenced figures the rectangular primitives must correspond to, the recitation “any one or more of” and “and/or” leaving it undetermined whether correspondence to a single figure, to several figures, or to all of the figures is required. Accordingly, one of ordinary skill in the art would not be able to determine what subject matter is included in or excluded from the claim.
Incorporation of the drawings by reference into a claim is permitted only where there is no practical way to define the invention in words, which is not the case here. See 37 CFR 1.75 and MPEP § 2173.05(s).
Claim Interpretation
The preamble of claim 9 recites “A method for printing a cell growth scaffold for in-vitro use”. The phrase “for in-vitro use” recites an intended use of the scaffold produced by the claimed method. The body of claim 9 sets forth a complete method of defining the layers of the scaffold, preparing instructions for a 3D printer, and printing the scaffold, and the recited intended use of the resulting scaffold does not impose any further limitation on those steps. Accordingly, the phrase “for in-vitro use” does not limit the claimed method. See MPEP 2111.02(II). Notwithstanding this interpretation, the prior art applied below is directed to a scaffold that is used in vitro.
The recitation in step c) of claim 9 that “the walls have said porosity by virtue of the spacing of the respective patterned layers” is given patentable weight. A whereby clause is given weight when it states a condition that is material to patentability. See MPEP § 2111.04. In the present instance, the recited porosity is a consequence of the positively recited steps of printing the layers of spaced single polymer strands and repeatedly forming the plural supports that space those layers apart, and the clause therefore defines a characteristic of the scaffold produced by the claimed method rather than a statement of intended result.
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.
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 9, 12, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over CN 105056302 (“Li”) (cited in an IDS) in view of Gupta et al., “A Review on 3D Printable Techniques for Tissue Engineering,” BioNanoScience, Vol. 8, pp. 868-883 (2018) (“Gupta”) (cited in an IDS) and CN 109676915 (“Ding”) (cited in an IDS).
Regarding claim 9, Li discloses a method for printing a cell growth scaffold for in-vitro use (a method of preparing a biological composite artificial trachea by 3D printing, the porous structure of which facilitates nutrient diffusion and ingrowth of blood vessels; see [0020] and [0073]; the completed structure is immersed in culture medium; see [0072]), the method comprising the steps of:
a) defining a wall layer of the scaffold including wall elements of the scaffold which, once combined with a multiplicity of similar wall layers would form a series of porous cell growth walls (constructing, using modeling software, four concentric circular structures, each having a height of 1 mm and a width of 0.5 mm, the smallest circle diameter being the same as the 30 mm inner diameter of the spoke structure and the largest circle diameter being the same as the 37 mm outer diameter thereof; see [0033], [0065], and Figures 3 and 4) and defining a further layer which is intended to be printed between the, or some of, the multiplicity of wall layers (constructing a spoke-shaped structure having a height of 1 mm, with spokes disposed at 15 degree intervals and spanning a 30 mm inner diameter to a 37 mm outer diameter, the four concentric circular structures being superimposed on the spoke-shaped structure; see [0032], [0064], [0065], and Figures 1-3; all model structures are thereafter copied and accumulated to obtain the complete model, see [0019], [0066], and Figure 5); the series of walls being arranged in a generally concentric pattern (the centers of the four circles coincide; see [0033] and Figures 3 and 4) each wall being spaced from its adjacent wall by an open channel suitable for nutrient supply (the four circular structures, each 0.5 mm wide, are distributed across a radial span of 3.5 mm between the 30 mm inner diameter and the 37 mm outer diameter, such that adjacent circular structures are radially separated from one another by open gaps; see [0033], [0065], and Figure 4; the resulting porous structure facilitates nutrient diffusion; see [0073]),
b) preparing instructions for a 3D printer for printing each layer (the model structures constructed in the modeling software are copied and accumulated to obtain the complete structural model, which is imported into the printer driver and parsed layer by layer; see [0019], [0023], [0066], and [0067]); and
c) sending said instructions to a 3D printer and printing repeatedly a layer of spaced polymer strands in said pattern (the structural model is imported into the printer driver and parsed layer by layer, a sterile glass slide is placed on the work platform and the printing needles are calibrated and positioned, the operating parameters are set, and printing is commenced; the hard material is a mixture of polylactic acid-glycolic acid copolymer and polyethylene glycol extruded through a printing needle having a diameter of 0.1 mm; see [0016], [0018], [0023]-[0026], and [0067]-[0070]) and repeatedly forming plural supports between each, or some of, the layers, for spacing apart respective patterned layers (the spoke layer, comprising discrete spokes disposed at 15 degree intervals and having a height of 1 mm, is printed between successive layers of concentric circular structures; see [0032], [0064]-[0066], and Figure 5), whereby the walls have said porosity by virtue of the spacing of the respective patterned layers, each wall being spaced from its adjacent wall by an open channel suitable for nutrient supply (because the spokes are discrete and disposed at 15 degree intervals about the circumference, the regions between circumferentially adjacent spokes remain open, such that successive layers of concentric circular structures are separated by openings extending through the wall; see [0032] and Figure 5).
Li does not disclose that the instructions prepared in step b) are in Standard Tessellation Language (STL) data format for printing each layer, or the converting of said STL data into instructions suitable for operating a 3D printer.
Gupta is a review of 3D printing techniques for tissue engineering. Gupta describes the general procedure for producing a tissue engineering scaffold as designing the geometry, converting the design into an STL file, selecting the raw material, printing the geometry layer by layer, and post-processing (see page 872). Gupta further describes that the CAD file of the geometry to be printed is converted into a standard tessellation language (STL) file, which provides a polygonal representation of the surface of the geometry that the machine reads as digital cross sections in order to lay down the layers of material, and that the STL format is subsequently converted into G-code, which is sent to the 3D printer through driver software so that printing may commence (see pages 872-873 and Figures 4 and 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have prepared the instructions for the 3D printer of Li in Standard Tessellation Language data format, and to have converted that STL data into G-code instructions suitable for operating the 3D printer, as taught by Gupta. Li already requires that the structural model be imported into the printer driver and parsed layer by layer (see [0023] and [0067]), but does not specify the file formats by which that importing and parsing is accomplished. Gupta identifies conversion of the modeled geometry into an STL file, followed by conversion of the STL file into G-code delivered through driver software, as the conventional sequence by which a three-dimensional model is communicated to a 3D printer for layer-by-layer printing of a tissue engineering scaffold (see pages 872-873). One of ordinary skill in the art would therefore have been motivated to employ the STL and G-code formats taught by Gupta in the method of Li in order to accurately dictate to the 3D printer how the modeled scaffold is to be rendered, and would have done so with a reasonable expectation of success, as this represents the use of a known technique to improve a similar method in the same way. See MPEP 2143(I)(C).
Li does not expressly disclose that each wall element of the layer printed in step c) is a single polymer strand. Li recites that each concentric circular structure has a width of 0.5 mm (see [0033] and [0065]) and that the hard material is extruded through a printing needle having a diameter of 0.1 mm (see [0018] and [0062]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have formed each wall element of Li from a single extruded polymer strand. The width of the wall element and the diameter of the printing needle are result-effective parameters that one of ordinary skill would select in the ordinary course of implementing the printing method of Li, and forming each wall element in a single pass rather than in multiple adjacent passes is a matter of routine optimization yielding the predictable result of reduced printing time. See MPEP 2144.04(IV)(A) and 2144.05.
Ding further evidences that such an arrangement was known in the art in a closely analogous context. Ding is directed to a wheel-shaped porous scaffold of biomaterial for tissue repair, produced by 3D printing, in which each wheel-shaped unit comprises a layer of concentric circular beams of differing diameter arranged in a common plane and a layer of radially extending straight beams placed thereon, the units being stacked to form the scaffold (see [0013], [0020]-[0024], and Figures 1-3). Ding discloses that the circular beams are arranged concentrically at equal intervals and that the spacing between adjacent circular beams is from 100 µm to 5 cm (see [0014] and [0015]), so as to maintain the connectivity of the internal and external pores of the scaffold and facilitate the exchange of nutrients and waste products (see [0005] and [0028]). In Example 1, the circular beams and the straight beams each have a diameter of 0.2 mm and the center-to-center distance between adjacent circular beams is 0.7 mm (see [0051]), and the scaffold is printed from polylactic acid filament by fused deposition modeling using an extruder diameter of 0.2 mm and a layer height of 0.2 mm, by layer-by-layer stacking (see [0072]). Each beam of Ding is therefore a single extruded polymer strand having the width of the extruder, and the concentric circular beams are spaced apart from one another.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have formed the wall elements of Li as spaced single extruded polymer strands, as taught by Ding, since Ding demonstrates that concentric circular scaffold elements printed as single extruded strands of the extruder diameter and spaced apart from one another were known to maintain the connectivity of the pores of a tissue engineering scaffold and to facilitate the exchange of nutrients and waste products (see [0005] and [0028] of Ding), which is the same purpose for which Li provides its porous structure (see [0073] of Li). The combination amounts to no more than the use of known printing parameters, according to known methods, to yield the predictable result of a concentric wall structure having open channels between adjacent walls. See MPEP 2143(I)(A).
Regarding claim 12, modified Li discloses that the STL data is graphically represented as rectangular primitives (the scaffold model of Li is constructed in modeling software from spoke constructs and concentric circular constructs; each spoke construct is a straight member having a height of 1 mm and extending radially between a 30 mm inner diameter and a 37 mm outer diameter, and each concentric circular construct has a height of 1 mm and a width of 0.5 mm, such that each construct from which the model is built is rectangular in section; see [0032], [0033], [0064], and [0065] and Figures 1-5). Li further depicts the concentric circular constructs as closed chains of straight-sided segments meeting at discrete corners, rather than as true circles, such that the concentric circular constructs are themselves composed of rectangular elements (see Figure 4).
In the alternative, and to the extent applicant contends that the constructs of Li are not rectangular primitives, Gupta discloses that the CAD file of the geometry to be printed is converted into an STL file which provides a polygonal representation of the surface of the geometry (see page 872). Conversion of the concentric circular constructs of Li into STL data, as set forth in the rejection of claim 9 above, therefore requires that each curved surface be approximated by a series of planar, straight-sided segments, each such segment spanning the 1 mm height of the circular construct and being rectangular in form. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the STL representation of the concentric circular constructs of Li would be so composed, since Gupta identifies polygonal representation of the surface as a characteristic of the STL data format (see page 872). This is consistent with the present application, in which each rectangular primitive is itself composed of plural triangular facets (see Figure 9 of the present application).
Regarding claim 13, modified Li discloses that said rectangular primitives are as shown in any one or more of Figures 2, 3, 4, 8, 9, 10 and/or 11 (Figure 4 of Li depicts a layer of concentric circular constructs composed of rectangular elements and separated from one another by radial gaps, corresponding to the layer of concentric wall elements 11 depicted in Figure 2 of the present application; Figures 1 and 2 of Li depict a layer of radially extending spoke constructs, corresponding to the layer of radially extending supports 12 depicted in Figure 3 of the present application). As set forth above in the rejection of claim 13 under 35 U.S.C. 112(b), claim 13 is being interpreted as requiring no more than the rectangular primitives of claim 12. The number of concentric constructs, and the relative size of the region interior to the innermost construct, for example, are not recited in claim 13 and therefore do not distinguish the claim over Li.
Conclusion
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/John J DeRusso/Primary Examiner, Art Unit 1744
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