DETAILED ACTION
Status of the Claims
Claims 20-31 are pending in the instant application and are being examined on the merits in the instant application.
Advisory Notice
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
The instant Application is Continuation Application (CON) of U.S. Application No. 17/347,583 filed 06/14/2021, which is a CON of 16/803,982 filed 02/27/2020, which is a CON of 14/916,826 filed 03/04/2016 filed 03/04/2016, which was the U.S. entry (371) of PCT/AU2014/050211 filed 09/05/2014, and claims priority to AUSTRALIA 2013903399 filed 09/05/2013.
The U.S. effective filing date has been determined to be 09/05/2013, the filing date of the document AUSTRALIA 2013903399.
Information Disclosure Statement
The information disclosure statements submitted on 04/01/2025, 05/21/2025 and 05/06/2026 were filed before the mailing date of the first office action on the merits. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the Examiner.
Specification
The instant Specification is objected to because the Specification includes citations to references without any references (see, e.g., p. 3, paragraph [0004], line 3) throughout (see whole Specification). Applicant should either include the references in the Specification corresponding to the citations or delete the citations from the Specification. Correction is required. See MPEP § 608.01(b).
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 20-31 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a Written Description Rejection.
Scope of the Claimed Invention:
Applicant claims a method of preparing a biocidal dental, medical or veterinary implant comprising providing a dental, medical or veterinary implant substate and applying a synthetic biocidal surface thereon, the synthetic biocidal surface including an array of disordered nanospikes than are from 20 nm to 150 nm in diameter at half maximum height (instant claim 20).
The scope of dental, medical or veterinary implant is broad encompassing any implantable material (e.g. an endoprosthesis) with utility in dental, medical or veterinary field. The scope of the claimed method step of “applying” is generic to any method of applying. Additionally, the scope of “applying a synthetic biocidal surface thereon” includes any portion, in part or in whole.
Disclosure of the Prior Art:
Applicant cites Reference Nos. 4 & 5 for “More details on the RIE approach […].” (p. 18, 1st paragraph). Reference No. 4 corresponds to Reference No. 10 on the IDS dated 05/21/2025 (Gervinskas et al., “Surface-enhanced Raman scattering on black silicon”), and Reference No. 5 corresponds to Reference No. 11 on the IDS dated 05/21/2025 (Zukauskas et al. , “Black Silicon substrate for laser 3D micro/nan-polymerization”).
Gervinskas et al. discloses that: “Here we show the fabrication of black-Si over a large 4-inch diameter Si wafer surface in tens of minutes with high pattern uniformity. The reflectivity of the surface drops below 2% over the entire visible spectral range. The potential for applications of black-Si in sensing and spectroscopy applications is demonstrated using a dye under resonant and non-resonant SERS conditions. It is shown that the dependence of the SERS signal on the excitation/collection aperture is non-linear, in contrast with the linear behavior observed for 2D metal island films.” (p. 908, col. 1, 2nd paragraph).
Zukauskas et al. discloses that: “We demonstrate that black silicon (b-Si) made by dry plasma etching is a promising substrate for laser three-dimensional (3D) micro/nano-polymerization. High aspect ratio Si-needles, working as sacrificial support structures, have flexibility required to relax interface stresses between substrate and the polymerized micro-/nano- objects.” (abstract, lines 1-5). And that: “A p-type boron doped 100 mm commercial silicon wafer was used as b-Si[l0] substrate.” (p. 3, §2.1, 1st paragraph, lines 7-8).
Disclosure of the Instant Application:
The instant Specification discloses that: “The present invention relates to materials that exhibit biocidal activity and in particular to surfaces that exhibit novel surface topography that is lethal to cells on contact. The invention also relates to devices comprising such surfaces, to methods of producing the surfaces and to methods of eliminating or reducing cellular survival wherein cells are exposed to the surfaces.” (p. 2, [0001]).
The Background of the Invention section discusses the basis for the claimed invention lies in the natural bactericidal activity of cicada Psaltoda claripennis, and particularly “Cicada wings are an example of a natural nanomaterial; the surfaces of which are covered by an array of regularly spaced nanopillar structures, which enables the entrapment of a relatively large quantity of air and results in the superhydrophobicity of the wing surface. Further, the bactericidal nature of the wing was shown to arise from a physical phenomenon based on the nanostructure of the surface, independent from the biochemical functionality of the wing, involving a stretching of the bacterial cell membrane in crevices between the nanopillars, which leads to strain across regions of the membrane and ultimate lysis and death of the cell. Based on this underlying physical principal, other topologies may possess surface architectures that exhibit structurally induced cell killing and antimicrobial characteristics.” (p. 3, [0004]).
The instant Specification discloses that: “In one embodiment of the present invention there is provided a synthetic biocidal surface comprising an array of nanospikes that are lethal to cells on said surf ace due to piercing of cell membranes by said nanospikes.” (p. 5, [0009]). And that: “In a further embodiment of the invention there is provided a method of producing a synthetic biocidal surf ace comprising an array of nanospikes that are lethal to cells on said surface due to piercing of cell membranes by said nanospikes, the method comprising exposing a silicon comprising substrate surface to reactive-ion etching.” (p. 5, [0011]).
The instant Specification discloses that: “As mentioned above, in one broad embodiment this invention relates to a synthetic biocidal surface comprising an array of nanospikes that are lethal to cells that come into contact with the surface due to piercing of cell membranes by the nano spikes. The surfaces of the invention are referred to as "synthetic" to make clear that the surfaces are produced in a man-made production or synthesis process, and to thereby exclude from the scope of the invention surfaces that may have similar surface topology that exist in nature.” ([0030]). And that: “The synthetic surf ace topographies according to the invention that are lethal to cells or exhibit antimicrobial and particularly antibacterial activity are generally referred to throughout this specification as exhibiting "biocidal" activity. That is, upon contact to the surfaces cells will be lysed and killed. It will be appreciated, however, that although "biocidal" the surfaces of the invention will not immediately kill all cells exposed to the surfaces. Rather, a period of exposure will be required that will enable a proportion of cells in a cell population exposed to the surface to physically come into contact with surface nanospikes (also referred to as "nanopillars") and for the cell membranes to be perforated thereby. Therefore, depending upon the concentration of cells exposed to the surface, the duration of exposure and the surface area of the surface to which they are exposed the surface may not be lethal to all cells. However, while the surfaces will be lethal to at least some of the cells from a cell population perspective reduction in cell growth and/or propagation may be observed. Routine assays to determine cell colony numbers and/or propagation (such as standard plate counts and staining to identity cell lysis are available to demonstrate biocidal activity. Microscopic techniques such as confocal laser scanning microscopy and scanning electron microscopy can also be used to observe the biocidal effect of surfaces according to the invention.” (pp. 10-11, [0031]).
The instant Specification discloses “The killing efficiency (a) of dragonfly and black silicon surfaces over 3 and 18 hour periods, together with the surface area required (b) to eliminate infective doses over the same time periods. The bactericidal activities of both these topologically related surfaces appear broadly comparable, which includes their activity towards spores.” (p. 12, Table 1).
The instant Specification discloses the height of the nanospikes is in the range of about 100 nm to about 600 nm, the half-height diameter from about 20 nm to about 300 nm (pp. 13-14, [0034]), the average diameter of the tip or free ends of the nanospikes, on average, is about 4 nm to about 50 nm (p. 14, [0035]). And that: “In one aspect the centre of nanospikes, when viewing the surface from above, can be located, on average, from about 200 nm to about 700 nm apart […].” (p. 14, [0036]).
The instant Specification discloses that: “It will be generally understood that the surfaces of the invention will usually be in some way attached or adhered to a substrate material or may be integral with the substrate material such as by being integrally formed from a single material or by being formed through a graded deposition process, for example, wherein there is no defined boundary between substrate and surface but where there is a gradual change in character from being more substrate material like to being more surf ace material like. For example, such graded interfaces between a substrate material and the surface material can be generated using a plasma deposition production approach where the plasma generating gas content is progressively changed from being more like the substrate material to being more like the surf ace material. Depending upon the nature of the substrate and surface materials the surface materials can be affixed to a substrate material by known means such as use of conventional adhesives, heat bonding or the like. The surface of the invention may also take the form of a coating, sheath or covering that is shaped and sized to ready fit to the substrate article or device, for example allowing for removable fitting.” (p. 15, [0039]).
The instant Specification discloses that: “Substrates to which surfaces according to the present invention can be applied include, but are not limited to, metal, semiconductor, polymer, composite and/or ceramic materials. Such materials can form, or can form parts or components of other devices, tools, fittings or apparatus on the surface of which is it desired to eliminate or at least slow the growth or progression of biological cells, and in particular cells that are infective, pathogenic, malodorous and/or unsightly, for example. Devices, tools, fittings and apparatus according to the present invention include but are not limited to walls, floors, ceilings, hand rails, door knobs, handles, seat covers, tables, chairs, light switches, toilets, taps, sinks, basins, bench tops, beds, mattress and pillow covers, hospital furniture, food preparation surfaces, cooking and food preparation utensils and devices, food and beverage packaging and storage vessels, food wrap, medical, surgical, veterinary and dental tools, instruments and equipment, medical, dental and veterinary implants, gloves, combs, brushes, razors, scissors, food and beverage mixers and processing/packaging devices or machines, food and beverage processing lines, abattoir fittings and tools, protective clothing, goggles and glasses, water and sewerage pipes, tanks and drains, boat hulls and aquatic and marine installations; and components thereof including but not limited to wall and floor tiles and laminates for floors, furniture, walls, bench tops and other surfaces It is also possible for the nanostructured surfaces of the invention to be applied to materials in the form, for example of strands, fibres, pieces or particles (eg. a nano- or micro-particle such as a nano- or micro-spheres) that can be included in polymer production blends and in coating or punting compositions, such as paints, dyes or inks (including 3D printing inks) to form a substrate, or that can be applied to a substrate, to impart biocidal activity on the substrate so treated. Fibres, yarns or strands of material to which the nanostructured surf aces of the invention have been imparted can be incorporated in woven fabrics and materials that can in turn be incorporated into products such as clothing including protective clothing, drapery, bed linen, furniture coverings, cloths, towels, wound dressings, face masks, bandages and wipes to impart biocidal/disinfecting character upon the product. The surfaces of the invention can also be used to initiate lysis or rupture of cells, the contents of which it may be desirous to analyse, such as may be the case for human or other mammalian cells to detect for infection, disease, cellular biochemistry, genetic predisposition or the like. Specifically this technique may be applied to blood cells and particularly red blood cells, with the surfaces of the invention being employed in specimen jars, microscope slides, assay components, microfluidic devices, and the like.” [emphasis added](pp. 16-17, [0040]).
The instant Specification discloses that: “The nanostructured surfaces of the present invention can be formed from a variety of materials such as metal, semiconductor, polymer, composite and/or ceramic materials. Such materials may take the form of a block, sheet, film, foil, tube, strand, fibre, piece or particle (eg. a nano- or micro-particle such as a nano- or micro-sphere), powder, shaped article, indented, textured or moulded article or woven fabric or massed fibre pressed into a sheet (for example like paper) of metal, semiconductor, polymer, composite and/or ceramic. Depending upon the nature of the material being used to form the nanostructured surface the manufacturing process will necessarily be modified. However, conventional techniques in the art of nanofabrication can be adopted such as lithography and chemical deposition approaches Examples of specific techniques that can be adopted with the appropriate materials include X-ray lithography, photolithography, extreme ultraviolet lithography (EUV), thermochemical nanolithography (TCNL), magnetolithography (ML), scanning probe lithography (SPL), atomic force microscopic nanolithography (AFM), electron-beam direct-write lithography (EBDW), nanoimprint lithography (NIL), scanning tunnelling microscope lithography (STM) and reactive-ion etching (RIE).” (p. 17, [0041]).
For example, reactive-ion etching ERIE) can be carried out in the presence of SF6 and O2 in one embodiment a boron doped silicon material is used as the substrate exposed to RIE, although other substrates such as polymers or Si substrata of any type (including n- and p-type or semi-insulating) can equally be utilised. In one specific example a p-type boron-doped 100 mm diameter commercial Si wafer with specific resistivity of 10-20 Ωcm-1, (100) oriented surface and 525.+-.25 μm thickness (Atecom Ltd, Taiwan) can be used as a substrate for RIE, in this case resulting in bSi formation. For example a process pressure of from about 30 mTorr to about 40 mTorr and an RIE power of from about 80W to about 120W can conveniently be adopted. More details on use of the RIE approach, specifically in relation to fabrication of black-Si, are provided elsewhere [citing Gervinskas et al. and Zukauskas et al., as cited above].” (pp. 17-18, [0042]).
The instant Specification discloses that: “In one aspect of the invention the material from which the nanostructured surface of the invention is formed is black silicon (bSi) Black silicon is a nanomaterial that has received significant attention as a promising photovoltaic material which can be made by plasme or laser treatment. The material is termed 'black silicon' due to its light scattering and absorption properties, which are due to the needle-shaped pillars etched into the surface it can readily be produced by a relatively simple reactive-ion etching technique. By manipulating the etching conditions, a degree of control over the nanoscale feature dimensions can be achieved. To date however, no study has reported on the biological properties of bSi, especially bSi with the specific features according to the present invention.” [emphasis added](p. 19, [0046]).
The instant Specification discusses “plasma treatment conditions” (p. 23, [0054]).
The instant Specification discloses Example 1 showing “Bactericidal Activity of Black Silicon” “In this study we assessed and compared the antibacterial potential of two nanomaterials: synthetic bSi and the wings of the dragonfly Diplacodes bipunctata. The physicochemical properties of silicon and native wing surfaces were chemically and structurally characterized prior to assessing their antibacterial activity against three different bacterial strains with a variety of cell wall structures: the Gram-negative rod-shaped bacterium Pseudomonas aeruginosa, the Gram positive coccus Staphylococcus aureus and both vegetative cells and spores of the Gram-positive rod Bacillus subtilis.” (p. 24, [0057]). And particularly that: “Reactive-ion etching cRLF) with SF6 and O2 was performed for 5 minutes to produce the nanospikes on silicon wafers using an Oxford PlasmaLab 100 ICP380 instrument. A p-type boron-doped 100 mm diameter commercial Si wafer with specific resistivity of 10-20 Ωcm-1, (100) oriented surface and 525.+-.25 μm thickness (Atecom Ltd, Taiwan) was used as a substrate for the bSi formation.” (p. 25, [0058]).
The instant Specification provides no example of “preparing a biocidal dental, medical or veterinary implant”, and indeed does not disclose a single species of “a biocidal dental, medical or veterinary implant” according to the claimed invention. The single example within the scope of the claim is a black silicon (b-Si) surface on a commercial silicon wafer (Example 1), which is characterized using various techniques including surface wettability, cell viability analysis, surface characterization, as well as bactericidal surface activity (pp. 26-35).
Discussion:
The instant Specification discloses a single example of a synthetic biocidal coating which is so-called black silicon on a commercial silicon wafer using reactive ion etching with SF6 and O2 (performed for 5 minutes to produce the nanospikes on silicon wafers). The instant Specification does not describe a silicon wafer as “a dental, medical or veterinary implant” and provides no guidance as to go from a biocidal surface on a silicon wafer to a biocidal surface on “a dental, medical or veterinary implant”, and therefore lacks written description of the same.
In the case Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co., 598 F.3d 1336 (Fed. Cir. 2010), the court found that: “Patents are not awarded for academic theories, no matter how groundbreaking or necessary to the later patentable inventions of others. “[A] patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion.” Id. at 930 n.10 (quoting Brenner, 383 U.S. at 536). Requiring a written description of the invention limits patent protection to those who actually perform the difficult work of “invention”—that is, conceive of the complete and final invention with all its claimed limitations—and disclose the fruits of that effort to the public.” In the instant case, the claims cover a breadth of subject matter not supported by the application as filed.
In the instant case, huge list of various possible substrates to which “the present invention can be applied” are disclosed ([0040]) which includes among many others “a dental, medical or veterinary implant”. However, the instant Specification provides no example of “preparing a biocidal dental, medical or veterinary implant”, and indeed does not disclose a single species of “a biocidal dental, medical or veterinary implant” according to the claimed invention. The single example within the scope of the claim is a black silicon (b-Si) surface on a commercial silicon wafer (Example 1), and no description as to how one of ordinary skill in the art would go from applying the claimed biocidal surface on a commercial silicon wafer to the claimed “biocidal dental, medical or veterinary implant” is provided. Therefore, the claims are properly rejected for lack of written description of the claimed subject matter as failing to comply with the written description requirement, as the claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim Rejections - 35 USC § 112(b)
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 21-31 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 pre-AIA the applicant regards as the invention.
Claim 21 recites the limitation "the surface" in line 1. There is insufficient antecedent basis for this limitation in the claim. Appropriate clarification is required.
Claim 22 recites the limitation "the nanospikes" in line 1. There is insufficient antecedent basis for this limitation in the claim. Appropriate clarification is required.
Claim 23 recites the limitation "the nanospikes" in line 1. There is insufficient antecedent basis for this limitation in the claim. Appropriate clarification is required.
Claim 24 recites the limitation "said nanospikes" in line 1. There is insufficient antecedent basis for this limitation in the claim. Appropriate clarification is required.
Claim 25 recites the limitation "the nanospikes" in line 1. There is insufficient antecedent basis for this limitation in the claim. Appropriate clarification is required.
Claim 26 recites the limitation "the nanospikes" in line 1. There is insufficient antecedent basis for this limitation in the claim. Appropriate clarification is required.
Claim 27 recites the limitation "said nanospikes" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Appropriate clarification is required.
Claim 28 recites the limitation "said surface" in line 1. There is insufficient antecedent basis for this limitation in the claim. Appropriate clarification is required.
Claim 30 recites the limitation "said surface" in line 1. There is insufficient antecedent basis for this limitation in the claim. Appropriate clarification is required.
Claim 31 is rejected as being indefinite because the claim recites a Markush group of alternatives with the transitional phrase “comprising.” MPEP §2173.05(h) makes clear that: “A Markush grouping is a closed group of alternatives, i.e., the selection is made from a group "consisting of" (rather than "comprising" or "including") the alternative members. […] If a Markush grouping requires a material selected from an open list of alternatives (e.g., selected from the group "comprising" or "consisting essentially of" the recited alternatives), the claim should generally be rejected under 35 U.S.C. 112(b) as indefinite because it is unclear what other alternatives are intended to be encompassed by the claim.” Appropriate clarification is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 20-31 are rejected under 35 U.S.C. 103 as being unpatentable over Mehran et al. (“Controllable silicon nano-grass formation using a hydrogenation assisted deep ion etching,” 2011, ELSEVIER; Materials Science in Semiconductor Processing, Vol. 14, pp. 199-206) in view of SPATZ (WO 2013/007354 A1)1; Schmidt et al. (“Towards Easily Reproducible Nano-structured SERS Substrates,” 2009, IEEE, Sensors, pp. 1763-1767); Hasan et al. (“Selective bactericidal activity of nanopatterned superhydrophobic cicada Psaltoda Claripennis wing surfaces,” 20132, SPRINGER; Applied Microbiology and Biotechnology, Vol. 97, No. 20, pp. 9257-9262); and as evidenced by Ivanova et al. (“Antibacterial surfaces: the quest for a new generation of biomaterials,” 2013, CrossMark, Trends in Biotechnology, Vol. 31, No. 5, pp. 295-304).
Applicants Claims
Applicant claims a method of preparing a biocidal dental, medical or veterinary implant comprising providing a dental, medical or veterinary implant substate and applying a synthetic biocidal surface thereon, the synthetic biocidal surface including an array of disordered nanospikes than are from 20 nm to 150 nm in diameter at half maximum height (instant claim 20).
Determination of the scope
and content of the prior art (MPEP 2141.01)
Mehran et al. teaches that: “Highly controllable silicon nano-grass formation is reported based on a hydrogen assisted reactive ion etching method in desirable shapes and locations. By controlling the etching parameters, one can achieve grass-free high aspect ratio vertical or three- dimensional structures on silicon substrates. On the other hand, one can program the etching procedure to arrive at grass-full surfaces and structures in pre-designed features and in desired places. The improved wetting properties of the grass-full surfaces have been investigated. In addition, the grass-full surface has been used to entrap kidney cells. Aspect ratios of the order of 40–50 and features of the size of 250 nm can be achieved.” (Abstract, see whole document).
Mehran et al. teaches that: “As a more recent application, the grassy surface has been used to control the cell–substrate interactions. For such biological trends, it is important that cells show good adhesion to the surface such as cell cultivation for biochips and implanted biosensors in the neural system for stimulation or signal collection. Textured silicon is a promising biomaterial that is non-toxic and biodegradable and there is a good cell adhesion to it.” (p. 199, col. 2, 2nd paragraph)(instant claim 1, “dental, medicinal or veterinary implant”).
Mehran et al. teaches that: “In this paper, we propose a highly controllable method for the evolution of nano-grass on desired shapes and locations. The effect of important parameters such as gas flows, pressure and plasma power in the etch rate of the silicon substrate has been investigated. Although in high aspect ratio etching, grasses are the undesirable side effects, we have been able to control their formation to realize heavy grass coverage at desirable places and geometries. In addition, we have examined the adhesion of oil and water liquids on the grass-full surfaces and used these surfaces as templates to hold the liquid in pre- designed locations. A Hitachi SE 4160 field emission scanning electron microscope has been exploited to investigate the surface morphology of the processed samples.” (p. 199, col. 2, last paragraph through, p. 200, col. 1, 1st paragraph).
Mehran et al. teaches that: “As it is seen from the optical images in Fig. 8(a), the water wetting angle of bare silicon is 40° while for the case of nano-grass-full or black silicon it is only 6°, making the black silicon a highly hydrophilic material.” (p. 205, col. 1, 2nd paragraph, lines 5-8)(instant claim, 21, 28-29).
As depicted in Figures 3 & 4, the nano-grass (nanospikes) have a diameter that is greater at the base than the tip (free end thereof)(instant claim 22), having branched tips (instant claims 26-27).
Ascertainment of the difference between
the prior art and the claims (MPEP 2141.02)
The difference between the rejected claims and the teachings of Mehran et al. is that Mehran et al. does not expressly teach the “diameter at half maximum height” (instant claim 21), the center to center spacing (instant claim 23), the flexing properties (instant claims 24-25), or the substrate comprises a metal such as silver (instant claims 30-31).
Hasan et al. teaches that: “The nanopattern on the surface of Clanger cicada
(Psaltoda claripennis) wings represents the first example of a new class of biomaterials that can kill bacteria on contact based solely on its physical surface structure. As such, they provide a model for the development of novel functional surfaces that possess an increased resistance to bacterial contamination and infection. Their effectiveness against a wide spectrum of bacteria, however, is yet to be established. Here, the bactericidal properties of the wings were tested against several bacterial species, possessing a range of combinations of morphology and cell wall type.” (Abstract, see whole document). And that: “Postoperative infections and antibiotic resistance continue to be significant health concerns however, surfaces that possess cicada wing-like topographies may eliminate pathogenic bacteria without the need for drug-based treatments. It is thought that cicada wing nanopillar patterns may be suitable for use in vivo , such as on the surfaces of medical implants; however the effectiveness of such topographies against a range of pathogenic bacteria first needs to be established.” [emphasis added, citations omitted](paragraph bridging pp. 9257-9258).
Hassan et al. teaches that: “however, surfaces that possess cicada wing-like topographies may eliminate pathogenic bacteria without the need for drug-based treatments. It is thought that cicada wing nanopillar patterns may be suitable for use in vivo, such as on the surfaces of medical implants; however the effectiveness of such topographies against a range of pathogenic bacteria first needs to be established.” (p. 9261, col., last paragraph).
Ivanova et al. is cited as teaching the topography of cicada wings – “(b) Scanning micrograph of the hexagonal arrangement of nanopillars on the cicada wing surfaces; each nanopillar is approximately 200 nm in height, 70 nm in diameter, and the pillars are 170 nm apart from centre to centre, scale bar = 200 nm.” (p. 297, Figure 1).
Schmidt et al. teaches that: “In this paper we present a quick and easy method for producing relatively large areas of substrate that enhance the Raman effect, using standard semiconductor processing techniques such as reactive ion etching of silicon and electron beam metal deposition. As standard cleanroom processes are used, it is possible to narrowly control the parameters of the fabrication process to create silicon nano-pillars with controlled heights and spacing. The silicon nano-pillars are coated by thin films of silver and/or gold to create surfaces that greatly enhance the Raman effect. Surface enhanced Raman scattering (SERS) has numerous applications in chemical sensing, with high sensitivity and fast analysis speed seen as the main advantages, and these novel substrates are believed to be able to make SERS more applicable.” [emphasis added](Abstract, see whole document)(instant claims 30-31).
Schmidt et al. teaches that: “SERS has shown great potential of becoming a versatile analytical tool for both chemical and biochemical sensors” (p. 1763, §Introduction, 1st paragraph, lines 18-19).
SPATZ teaches “The present invention provides a method for preparing an antimicrobial surface which comprises providing a substrate surface with a 3-dimensional nanostructure comprising elevations with a predetermined height in the range of nm, preferably in the range of 10-600 nm, such as 50-600 nm, and a predetermined mean distance in the range of nm, preferably in the range of 10-300 nm, such as 100-300 nm, which is adjusted to be smaller than the size of target microorganisms so that the target microorganisms are not able to penetrate into the space between the elevations. Also provided is the use of a nanostructured surface for preventing and/or reducing the production of biofilms generated by target micro-organisms on surfaces, wherein the nanostructured surface comprises elevations with a predetermined height in the range of nm, preferably 10-600 nm, and a predetermined mean distance in the range of nm, preferably 10-300 nm, which is adjusted to be smaller than the size of the target microorganisms so that the target microorganisms are not able to penetrate into the space between the elevations. In a specific embodiment of the claimed method and claimed use, the elevations are nanopillars or nanocones.” (Abstract, see whole document). SPATZ teaches heights of 10-600 nm, therefore implying a half height of 5-300 nm (instant claim 1). SPATZ teaches “mean distance in the range of nm, preferably in the range of 10-300 nm” (instant claim 23). MPEP §2144.05(I) “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists.”
Finding of prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce a black silicon implantable biosensor, as suggested by Mehran et al., including an bactericidal coating as suggested by Hassan et al. and SPATZ, to minimize the possibility of bacterial contamination for the implantable biosensor, the black silicon having a cicada wing-like topography (“each nanopillar is approximately 200 nm in height, 70 nm in diameter, and the pillars are 170 nm apart from centre to centre”), as suggested by Hassan et al., and to include a SERS feature as suggested by Schmidt et al. for biosensors. Regarding the properties of instant claims 24-25, the examiner takes the position that the black silicon suggested by the combination of prior art would have had the same properties, as the same structure is suggested (MPEP §2112.01(II)).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention because the process of forming nano-grass/nanopillars on silicon to form black silicon is clearly taught by the prior art. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
Conclusion
Claims 20-31 are pending and have been examined on the merits. The instant Specification is objected to; claims 20-31 are rejected under 35 U.S.C. 112(a)(Written Description); claims 21-31 are rejected under 35 U.S.C. 112(b) and claims 20-31 are rejected under 35 U.S.C. 103. No claims allowed at this time.
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/IVAN A GREENE/Examiner, Art Unit 1619
/TIGABU KASSA/Primary Examiner, Art Unit 1619
1 Cited on Applicant’s IDS dated 05/21/2025, Foreign Patent Document Citation No. 2.
2 Published online 19-DEC-2012.
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