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 .
Priority
Applicant’s claim to foreign priority in application no. App #DE10 2021 203 391.1, filed April 6, 2021, is acknowledged.
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.
Claim 13, and dependent Claims 14-24, 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.
Regarding Claim 13, the term “long” in claim 13 is a relative term which renders the claim indefinite. The term “long” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Regarding Claim 13, the claim recites “fibers superimposed in multiple layers, each in the form of a nonwoven”. It is unclear what ‘each’ refers to, and whether each is in regards to each fiber, each fiber layer, each layer of superimposed fibers, or each of the multiple layers of superimposed fibers (i.e., each stack of fiber layers).
The claim further recites ‘fibers in each layer’ and “one of the layers’; however, it is unclear what comprises ‘a layer’. It is unclear if a layer is a singular layer of long fibers (not superimposed), or a layer is the mass of superimposed fibers, or if a layer is multiple layers of superimposed fibers (i.e., a stack of superimposed fiber layers). It is unclear if one layer is the nonwoven, or many (superimposed) layers comprise the nonwoven, or multiple layers of the superimposed fibers (stacks) form a nonwoven. It is therefore unclear what needling is carried out on, and which fibers exactly are aligned, as it is unclear what a layer comprises or what comprises the non-woven.
The claim further recites “superimposed layers are materially fitted to each other”. It is unclear what is meant by ‘superimposed layers are materially fitted to each other’ because it is unclear what the superimposed layers comprise, or if they are already fitted to each other in the form of the nonwoven.
Regarding Claim 13, the claim refers to wherein ‘fibers are superimposed in multiple layers’, but also ‘the superimposed layers’. Because it is unclear what constitutes a layer or versus superimposed fibers (see above), and because it is unclear what the metes and bounds of superimposed fibers is and the metes and bounds of a layer is, there is insufficient antecedent basis for ‘the superimposed layers’ for this limitation in the claim.
Regarding Claim 14, it is unclear which layers in “that layers” are being referred to. As pointed out above, it is unclear what comprises a layer and what layers comprise a nonwoven and if multiple layers are nonwovens are fitted together, or if layers of superimposed fibers are fitted together, and the superimposed layers therefore are the nonwoven. It is further unclear if the claim is directed towards layers from independent Claim 13, or new and different layers.
Regarding Claim 15, the claim recites “fiber of different layers, which are directly superimposed, are needled together”. It is unclear which fibers are referred to and what constitutes a layer. It is unclear if nonwovens are superimposed together and one nonwoven is one layer, and it is unclear if aligned fibers constitute a single layer or if multiple layers of aligned fibers superimposed together create a nonwoven, which is then regarded as one layer.
Regarding Claim 16, it is unclear what ‘layers’ the claim refers to. It is unclear what constitutes a layer(s) and what fibers constitute the layer(s) and if superimposed fibers mean a singular layer or not, and if the claim refers to layers within the nonwoven or layers of the nonwoven or any of the multiple layers of superimposed fibers.
Regarding Claim 17, it is unclear what ‘the fibers of the layers’ refers to because it is unclear what constitutes a layer. The claim refers to ‘fibers of the layers’ and ‘superimposed layers’, while the independent claim also refers to wherein ‘fibers are superimposed’. It is unclear what the metes and bounds of superimposed fibers is and the metes and bounds of superimposed layers is, and how to distinguish between the two concepts.
Regarding Claim 18, the claim recites the limitation "the superimposed layers". Because it is unclear what the metes and bounds of superimposed fibers is and the metes and bounds of a layer is (see Claim 13 rejection above), there is insufficient antecedent basis for ‘the superimposed layers’ for this limitation in the claim.
Regarding Claim 19, the claim recites ‘the constant total thickness’. There is insufficient antecedent basis for ‘the constant total thickness’ for this limitation in the claim.
Regarding Claim 21, the claim recites “the separation”, “the interior”, “the hardening” and “the infiltrate”. There is insufficient antecedent basis for ‘the separation”, “the interior”, “the hardening” and “the infiltrate” for these limitations in the claim.
Regarding Claim 21, it is unclear what is meant by “removed again” as the claim, and the independent claim 13, fail to recite a first instance of removing the infiltrate.
Regarding Claim 22, the claim recites “the infiltrate”. There is insufficient antecedent basis for “the infiltrate” for this limitation in the claim.
Regarding Claim 23, the claim recites “the infiltrate”. There is insufficient antecedent basis for “the infiltrate” for this limitation in the claim.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 13-15, 17 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Andersen (cited by Applicant in IDS filed October 5, 2023, US 20140324188 A1) in view of Ducheyne (cited by Applicant in IDS filed October 5, 2023, US 4693721 A) and Hamlyn (US 20200189207 A1).
Regarding Claim 13, Andersen discloses a method for producing an open-porous bone implant, with freely accessible guide structures made from fibers, which are formed from a biocompatible magnesium metal or metal alloy (Abstract; para. [0027]; one of ordinary skill in the art would appreciate that a fiber mesh which guides the growth of bone to be a freely accessible guide structure), in which
long fibers are superimposed in layers and materially fitted to one another point by point via sinter bridges on fibers by sintering in a heating device (para. [0011]; para. [0019]; para. [0021]; para. [0034], wherein fibers are arranged layer-by-layer, which reads on superimposed layers; see 112b rejection regarding the term ‘long’).
Andersen discloses wherein the fibers layers are deposited, for example, by scattering evenly (para. [0034]); however, Andersen but does not disclose wherein the fiber layers are each in the form of a nonwoven, nor wherein the fibers in each layer are arranged in a mutually preferred axial direction.
Additionally, Andersen fails to disclose wherein needling is carried out in at least one of the layers, by means of which individual fibers of the respective layer are aligned in an axial direction which differs by at least 60 degrees from the preferred axial direction in which the other fibers of the layer are aligned.
Ducheyne teaches a metal fiber mesh sheet for a bone implant material, wherein the metal fiber mesh is formed by fibers which are compressed to form a sheet, a non-woven, which may be superimposed with other layers and may be sintered to further improve coherence (Col. 8, lines 17-27; Col. 9, 31-36; Fig. 5, Col. 10, lines 10-14; Abstract). Ducheyne teaches careful handling of the metallic fibers in steps prior to sintering in order to maintain a linear (axially aligned) configuration, thereby preserving the flexibility and deformability of the nonwoven sheet (Col. 7, lines 65-Col. 8, line 3).
Ducheyne teaches wherein the non-woven sheets are highly malleable without loss of structural integrity, and may comprise a selected porosity and thickness (Abstract; Col. 6, lines 9-21; Col. 9, lines 4-9).
Hamlyn teaches a preform of continuous unidirectional fibers oriented along at least one fiber orientation, applying nonwoven filaments on the surface thereof, and needling the filaments in order to arrange the filaments in a direction substantially perpendicular (90 degrees) to the continuous fibers of the preform, thereby increasing cohesion of the fibers and avoiding unwanted displacement of fibers during subsequent steps (para. [0010]-[0013]; para. [0069]-[0070]; para. [0059], metallic fibers; para. [0060], superimposed piles of fiber placement; para. [0098], unidirectional fibers; para. [0078], nonwoven comprising preferential orientation). One of ordinary skill in the art would appreciate that substantially perpendicular filaments would be an axial direction which is about 90 degrees the preferred axial orientation of the unidirectional fibers.
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 a non-woven metal fiber mesh sheet for one of the metal fiber layers of Andersen, as taught by Ducheyne, in order to improve flexibility and deformability in making the bone implant (see teaching above).
Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have applied needling to the nonwoven, by means of which individual fibers of the respective layer are aligned substantially perpendicular to the preferred axial direction in which the other fibers of the layer are aligned, which reads on the claimed range of aligned in an axial direction which differs by at least 60 degrees from the preferred axial direction, as taught by Hamlyn, for the invention disclosed by Andersen, in order to further increase the cohesion of the fibers and avoid unwanted displacement of fibers during any subsequent steps, which is a feature also desired by Ducheyne (see teachings above).
Regarding Claim 14, Hamlyn teaches wherein layers, whose preferred axial direction, in which the respective fibers are aligned, differs from one another by at least 45 degrees, are superimposed (para. [0026]-[0030]; para. [0105]).
Regarding Claim 15, Hamlyn discloses wherein fibers of different layers, which are directly superimposed, are needled together (Fig. 7, needling occurs through all plies (layers) of superimposed fibers).
Regarding Claim 17, Ducheyne discloses compacting the fibers between two surfaces into a sheet-like structure to produce the non-woven prior to sintering, which reads on the claimed limitation wherein the superimposed layers are subjected to compressive force by two opposite surfaces which are aligned perpendicular to the preferred axial directions in which the fibers of the layers are aligned, in order to achieve a predetermined thickness of the nonwoven (Col. 7, 41-58).
Ducheyne further teaches wherein the sintering of the metal fiber sheets are carried out between two alumina plates (Col. 8, lines 25-30; one of ordinary skill in the art would appreciate that the weight plates would exert compressive and reaction compressive forces on the metal fiber sheets), which reads on the claimed limitation wherein the superimposed layers are subjected to compressive force by two opposite surfaces which are aligned perpendicular to the preferred axial directions in which the fibers of the layers are aligned, during sintering.
Regarding Claim 20, Andersen discloses wherein a semi-finished product is produced using the layers that are superimposed and sintered together, and at least one bone implant is separated from the respective semi-finished product using a separating process and brought into shape (para. [0024]).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Andersen (cited by Applicant in IDS filed October 5, 2023, US 20140324188 A1) in view of Ducheyne (cited by Applicant in IDS filed October 5, 2023, US 4693721 A) and Hamlyn (US 20200189207 A1), as applied to Claim 13 above, in further view of Karadoga (US 20200246155 A).
Regarding Claim 16, Hamlyn fails to disclose wherein layers comprise different densities or thicknesses in which the fibers are arranged, and different porosities are superimposed prior to sintering.
Karadoga teaches a intervertebral disc implant which comprises multiple layers of biocompatible fibers, wherein the fibers are rotationally oriented adjacently to one another (para. [0049]; para. [0026]; para. [0031]; para. [0020]).
Karadoga teaches wherein the thickness, material type, and/or number of fibers, and therefore density, of a layer of fibers varies, wherein a layer may have a different thickness or properties than an adjacent one, thereby varying the stiffness based on location of the layer in the implant (para. [0034]-[0035]; para. [0047]). Karadoga discloses the fiber structure improves biomechanical response (para. [0106]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included superimposed layers comprising different thicknesses and/or densities, such as by varying the layer’s thickness, the fiber size or number of fibers in each layer, or by varying the material composition, as taught by Karadoga, for the invention disclosed by Andersen, Ducheyne and Hamlyn, in order to vary the stiffness at different locations within the implant, and to improve biomechanical response (see teachings above).
While Karadoga does not expressly disclose wherein the porosity of a layer differs, Karadoga teaches wherein the number of, or size of fibers, may differ from one layer to another, and one of ordinary skill in the art would appreciate that the number or size of fibers in a layer would vary the porosity. For example, Ducheyne teaches wherein the amount of fibers is used based on a desired thickness and porosity, an therefore density of the amount of fibers (Col. 7, lines 42-46). Thus, one of ordinary skill in the art would appreciate that the invention of Andersen in view of Hamlyn and Karadoga results in layers comprising different porosities as claimed, per the variations in fiber size or fiber number (density) from one layer to another.
Because layer formation is produced prior to sintering (see Anderson, para. [0034]), one of ordinary skill in the art would appreciate that the layers with different thicknesses and/or densities, and therefore difference porosities, would be superimposed prior to sintering, as claimed.
Claims 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Andersen (cited by Applicant in IDS filed October 5, 2023, US 20140324188 A1) in view of Ducheyne (cited by Applicant in IDS filed October 5, 2023, US 4693721 A) and Hamlyn (US 20200189207 A1), as applied to Claim 13 above, in further view of Tanida (JP 2004137590 A, English Machine Translation provided).
Regarding Claim 18 and Claim 19, Andersen discloses obtaining particular dimensions, including a particular thickness, of the sintered bulk volume produced from the superimposed fibers (para. [0036]). Ducheyne additionally discloses obtaining a specific thickness after sintering and sintering between two weighted plates (Abstract; Col. 6, lines 14 and 56-64; Col. 8, lines 25-30).
However, Andersen and Ducheyne fail to expressly disclose (Claim 18) maintaining a constant total thickness of the superimposed layers during sintering, or wherein (Claim 19) spacers are used to maintain a constant total thickness.
Tanida teaches a similar invention, wherein sintering a mat of metallic fibers occurs between two pressing plates and further wherein a spacer is used between the two plates, in order to maintain a constant predetermined thickness during sintering (Abstract; para. [0035]-[0038]; Fig. 8, spacer 75).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have (Claim 18) maintained a constant total thickness of the superimposed layers during sintering, and to have (Claim 19) used spacers to maintain a constant total thickness, as taught by Tanida, for the invention disclosed by Andersen and Ducheyne, in order to achieve the desired dimensions thicknesses of the sintered fibers and in order to maintain the desired and predetermined thickness during sintering/processing (see teachings above).
Claims 21-24 are rejected under 35 U.S.C. 103 as being unpatentable over Andersen (cited by Applicant in IDS filed October 5, 2023, US 20140324188 A1) in view of Ducheyne (cited by Applicant in IDS filed October 5, 2023, US 4693721 A) and Hamlyn (US 20200189207 A1), as applied to Claim 13 above, in further view of Oya (JP 3698172 B2, English Machine Translation provided).
Regarding Claim 21 and Claim 22, Andersen discloses forming a semi-finished product, wherein an implant is separated from the semi-finished product, for instance, by cutting (para. [0024]). Andersen fails to disclose (Claim 21) wherein prior to a separation process, an interior of the semi-finished product is filled with an infiltrate and hardened, and further removed after the separation process, and fails to disclose (Claim 22) using a non-crosslinking polymer, which is removed with a solvent, as an infiltrate (see 112b rejection above).
Oya teaches wherein a sintered porous body is manufactured from a bulk portion in order to reduce variation, and the sintered porous body is therefore first impregnated with an infiltrate such as a wax, an addition-polymerizable resin monomer or a thermosetting resin, then cut to size, and further the infiltrate is completely removed after cutting by extraction, decomposition and/or thermal treatment, such as removal through solubilization and extraction using a solvent and heating, and/or by heating to a maximum temperature in air of 800C or less, in order to prevent abrasive or cutting medium from entering the pores and deteriorating, and to improve the ease of chipping (para. [0017]-[0021]).
One of ordinary skill in the art would appreciate that to impregnate with a wax, addition-polymerizable resin monomer, or a thermosetting resin, that the wax, monomer or resin would be hardened prior to cutting in order to properly impregnate and seal the pores as desired and taught by Oya (see Claim 21, hardening of infiltrate). One of ordinary skill in the art would also appreciate that addition-polymerizable resin monomers include polymers which harden without crosslinking, such as styrene, and therefore reads on a polymer which is non-crosslinking and which may be removed using a solvent (see Claim 22).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have infiltrated the sintered filaments, such as with a hardened wax, addition-polymerizable resin monomer or thermosetting resin, prior to separation (cutting), and further removed the infiltrate after cutting by means of extraction, decomposition and/or thermal treatment, such as removal through solubilization and extraction using a solvent and heating, and/or by heating to a maximum temperature in air of 800C or less, as taught by Oya, for the invention disclosed by Andersen. One would be motivated to do this in order to manufacture from a bulk portion, thereby reducing variation, while preventing abrasive or cutting medium from entering the pores and deteriorating, and while improving the ease of chipping during the separation (cutting) process (see teaching by Oya above).
Infiltrating with a hardenable wax, addition-polymerizable resin monomer or thermosetting resin, and cutting and then removing of the infiltrate reads on the claim limitations of Claim 21, and using an infiltrate such as an addition-polymerizable resin monomer, for example styrene, and further removing the infiltrate by using a solvent, reads on the claim limitations of Claim 22.
Regarding Claim 23, Oya discloses using waxes as the infiltrate, which reads on the claimed hard wax, which is removed by thermal decomposition and heating, which reads on thermally liquified again and removed, as claimed (para. [0020]). One of ordinary skill in the art would appreciate that the wax would liquify with removal by thermal decomposition and further at the heating temperatures disclosed by Oya.
Regarding Claim 24, Oya discloses removing residual infiltrate by vaporization at a temperature of up to 550C at a reduced pressure and/or thermal decomposition (evacuation) by heating in air to a maximum temperature of 800C or less, which reads on the claimed range of a maximum temperature of 390C or less (para. [0020]-[0021]; see also extraction by heating to 300-400C). Thermal evacuation is interpreted as thermal decomposition. One of ordinary skill in the art would appreciate that vaporization at reduced pressure is conducted in air unless vacuum is specified.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
DeRovere (US 20200002861 A1): teaches a nonwoven web of filaments wherein a mat of filaments are impregnated with a binder and then needle punched in order to improve tensile strength and handling of the nonwoven mat (para. [0112]-[0114]; needle punching reads on needling; para. [0030], wherein nonwoven article comprises metal fibers). One of ordinary skill in the art would appreciate that in order to infiltrate the mat of filaments with a binder, the binder would be in liquid form and then solidified by cooling, curing or cross-linking, which reads on the claimed hardening of the infiltrate. De Rovere further discloses wherein the organics, and therefore the binder, is removed during a pre-fire burnout segment of the sintering process, enabling microstructurally uniform fiber mats which are easily handled without breakage or dusting (para. [0161]).
Ohya (US 5686172 A): teaches wherein waxes for impregnation include paraffin wax, bees wax and haze wax, and wherein addition-polymerizable resin monomers include styrene, acrylic acid, methacrylic acid, epoxy,
Tacktill (US 20150335364 A): teaches wherein alternate layers of unidirectional fibers can be positioned with different orientation to allow for added strength (para. [0035]). While Tacktill is directed to carbon fiber-metal alloy wire sandwich structures, one of ordinary skill in the art would appreciate that the orientation teaching extends to other material systems and those comprising fiber structures.
Kurz (US 20040247927 A): teaches a laminate comprising multiple layers of metal fiber web, where multiple layers may be laid in different angular orientations and bonded together and compressed to a desired permeability or pore size (para. [0003]).
Dendooven (US 4779322 A): teaches wherein metal fiber nonwoven web can be manufactured by rolling or pressing a bundle of fibers and then densified by needling prior to a sintering operation (Col. 3, line 66-Col. 4, line 16).
Johns (US 20080128054 A1): teaches sintering metal fiber layers wherein a support mesh or scrim is applied in order to produce a structure which may be used or filtration or other applications (para. [0034]). One of ordinary skill in the art would appreciate that such a support mesh or scrim reads on a spacer, and one of ordinary skill in the art would appreciate that the support mesh or scrim would maintain a thickness throughout sintering in order to enable the filtration, i.e., porosity. One of ordinary skill in the art would therefore appreciate adding a support mesh or scrim (spacer) in order to maintain a desired porosity in the metal fiber mesh layer during sintering.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERINE P SMITH whose telephone number is (303)297-4428. The examiner can normally be reached Monday - Friday 9:00-4:00 MT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Walker can be reached at (571)-272-3458. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CATHERINE P. SMITH
Patent Examiner
Art Unit 1735
/CATHERINE P SMITH/ Examiner, Art Unit 1735
/KEITH WALKER/ Supervisory Patent Examiner, Art Unit 1735