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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/12/2023. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 1 is objected to because of the following informalities: the phrase “apparatus for obtaining” in line 1 should be amended to read –apparatus configured for obtaining--. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: the phrase “particles for absorbing” in line 3 should be amended to read –particles configured for absorbing--. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: the phrase “the form” in line 2 should be amended to read –a form--. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: the phrase “a human or animal” in line 2 should be amended to read –the human or animal--. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: the phrase “a human or animal” in line 2 should be amended to read –the human or animal--. Appropriate correction is required.
Claim 11 is objected to because of the following informalities: the phrase “a sonication fluid” in line 6 should be amended to read –the sonication fluid--. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: the phrase “a human or animal” in line 2 should be amended to read –the human or animal--. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 2 and 7-9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Todd et al (GB 2506010 A).
As to claims 1 and 8, Todd teaches an apparatus (the apparatus in fig.8-9, abstract, page 1) and method for obtaining a biological sample from an exposed surface of a human or animal body (absorbing and/or extorting fluid containing one or more target molecules from a subject, par.1, page 1, par.2-3, page 8 and collecting biological samples from a wound site, page 12),
the apparatus including a plurality of separate and porous ceramic particles for absorbing and adsorbing biological material from the exposed surface (absorbent material 81 made from superabsorbent material and porous silica, par.2, page 43 fig.8-9, porous or ceramic particles, par.4-5, page 14, par.2-4, page 15); and
a permeable covering for containing the plurality of separate and porous ceramic particles (wicked material 73 and/or 78, page42, fig.8-9),
contacting the apparatus with the exposed surface to permit the plurality of separate and porous ceramic particles to absorb and adsorb biological material from the exposed surface (contacting said body with the apparatus to allow bodily fluid flow to absorbent materials in the apparatus, par.2-3, page 8 and collecting biological samples from a wound site, page 12), and
wherein the biological material having been absorbed and adsorbed by the plurality of separate and porous ceramic particles forms the biological sample (the apparatus to allow bodily fluid flow to absorbent materials in the apparatus, par.2-3, page 8 and collecting biological samples from a wound site, page 12, and pages 42-43, as best seen in fig.8-9).
As to claim 2, Todd teaches the apparatus, wherein the plurality of separate and porous ceramic particles are inert and have a porosity of between 25% and 85% (microporous material have prosperity between 10-99.9%, page 15, par.4).
As to claims 7 and 9, Todd teaches the apparatus and method, wherein the exposed surface is a wound (collecting biological samples from a wound site, page 12) of a human or animal and the biological material includes wound exudate containing any one or more selected from the group consisting of microorganisms, biomarkers, deoxyribonucleic acid (DNA), proteins, cellular molecules, endotoxins or combinations thereof, macrophages, neutrophils, fibroblasts, platelets, cytokines molecules including TNF-α, interleukins (ILs) and growth factors, including platelet-derived growth factor (PDGF), matrix metalloproteinases (MMPs), tissue inhibitors of metalloproteinases (TIMPs), IL-1, IL-6, and MMPs, proteases, protease inhibitors, and inflammatory markers, and the microorganisms include any one or more selected from the group consisting of bacteria, viruses, fungi and parasites (absorbing and/or extorting fluid containing one or more target molecules from interstitial fluid, blood and/or gastrointestinal fluid of a subject, par.1, page 1, par.2-3, page 8 and collecting biological samples from a wound site, page 12, inherently the microorganisms, bacterial and/or virus from interstitial fluid, blood, gastrointestinal fluid and/or wound of a subject, pages 1-12).
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.
Claim(s) 3 and 4 is/are rejected under 35 U.S.C. 103 as being obvious over Todd et al (GB 2506010 A).
As to claims 3 and 4, Todd teaches the pores defined by porous materials are often defined according to their size; micropores being less than 2 nm in diameter, mesopores being larger and having diameters up to 50 nm while macropores have diameters larger than 50 nm (page 6, par.2), but failed to explicitly teach wherein the plurality of separate and porous ceramic particles have pores with a diameter of between 0.3 and 30 micrometres and/or between 300 and 3000 micrometres, and wherein the pores are cellular in nature and are interconnected with one another by means of blow-holes.
However, it would have been obvious to one having an ordinary skill in the art at the time the invention was made to make the pores diameter between 0.3 and 30 micrometres and/or between 300 and 3000 micrometres, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or working ranges involves only routine skill in the art, In re Aller, 105 USPQ 233.
Claim(s) 5 and 6 is/are rejected under 35 U.S.C. 103 as being obvious over Todd et al (GB 2506010 A), in view of Caillat et al (EP 2523605 B1).
As to claim 5, Todd teaches the invention substantially as claimed above, but failed to explicitly teach the plurality of separate and porous ceramic particles have a charged surface caused by ionic and electrostatic interaction, hydrogen bonding and charge-transfer interactions.
However, Cailllat teaches a bodily fluid/tissue sampling device (par.1), the plurality of separate and porous ceramic particles have a charged surface caused by ionic and electrostatic interaction, hydrogen bonding and charge-transfer interactions (the capturing particles are charged groups of anionic or cationic type, par.25).
Since charging sampling particles is well-known in the art, so it would have been obvious to one having an ordinary skill in the art before the filing date of the invention to charge the porous particles taught by Todd’s invention, as taught by Caillat’s invention, to facilitate capturing biological samples, as taught by Caillat’s invention (par.25-26).
As to claim 6 Todd teaches the invention substantially as claimed above, wherein wicked materials 73 and 78 are wettable (absorbing bodily fluids), but failed to explicitly teach the permeable covering is in the form of a sterile permeable and wettable sachet formed from an organic, non-woven material.
However, Cailllat teaches a bodily fluid/tissue sampling device (par.1), the permeable covering is in the form of a sterile permeable and wettable sachet formed from an organic, non-woven material (capturing substrate/surface with at least biocompatible, porous crosslinked polymer layer that allows biological particles to pass through, par.14-16, capturing surface has selective permeability, par.16-19).
Since permeable and wetted covers are well known in the art, and since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. So, it would have been obvious to one having an ordinary skill in the art to form wicking material 73 and 78 taught by Todd’s invention from permeable wetted non-woven material, as taught by Caillat’s invention, to ensure passing targeted biological samples, as taught by Caillat’s invention (par.19-20).
Claim(s) 11-14 is/are rejected under 35 U.S.C. 103 as being obvious over Todd et al (GB 2506010 A), in view of Adams et al (US 2016/0220728).
As to claims 11-13, Todd, teaches a diagnostic method including the steps of providing the apparatus according to claim 1, contacting the apparatus with the exposed surface to permit the plurality of separate and porous ceramic particles to absorb and adsorb biological material from the exposed surface (contacting said body with the apparatus to allow bodily fluid flow to absorbent materials in the apparatus, par.2-3, page 8 and collecting biological samples from a wound site, page 12).
Todd teaches the invention substantially as claimed above, but failed to explicitly teach subjecting the apparatus to sonication to form a sonication fluid, the sonication step serving to disintegrate a biofilm of microorganisms present in the absorbed and adsorbed biological material so as to form a sonication fluid containing microorganisms, wherein the sonication is performed at frequencies of 20 kilohertz, and which includes an additional step of using the sonication fluid to cultivate a bacterial culture or cultures for identifying bacterial strains present in the sonication fluid.
However, Adams teaches a sample collection device and method (abstract and par.154, fig.5-6) in the same filed of endeavor, wherein the apparatus is subjected to sonication to form a sonication fluid (bottles/devices were sealed and sonicated (30 seconds, nominal main frequency 67 KHz, par.154-155, each wound dressing and membrane filter were transferred to 10 ml of D/E neutralizing broth, vortexed for 1 min and sonicated for 1 minute, par.163), the sonication step serving to disintegrate a biofilm of microorganisms present in the absorbed and adsorbed biological material so as to form a sonication fluid containing microorganisms, wherein the sonication is performed at frequencies of 20 kilohertz (Ultrasonicated in water >6.01 >6.01 for 5 minutes @ 20 KHz, par.154 and table 18), and which includes an additional step of using the sonication fluid to cultivate a bacterial culture or cultures for identifying bacterial strains present in the sonication fluid (bottles were sealed and sonicated (30 seconds, nominal main frequency 67 KHz, Cavitator® Ultrasonic Cleaner, Mettler Electronics, Anaheim, Calif.) to recover bacteria from the surface and cover slip. The D/E solution was diluted/enumerated as described before. Bacterial reductions were determined as described previously, end of par.154).
Since device sonication is well-known in the art, so it would have been obvious to one having an ordinary skill in the art to sonicate sampling device taught by todd’s invention, as taught by Adams’s invention, to reduce bacteria and/or obtain clean sample, as taught by Adam’s invention (par.154-155).
As to claim 14, Todd teaches the apparatus and method, wherein the exposed surface is a wound (collecting biological samples from a wound site, page 12) of a human or animal and the biological material includes wound exudate containing any one or more selected from the group consisting of microorganisms, biomarkers, deoxyribonucleic acid (DNA), proteins, cellular molecules, endotoxins or combinations thereof, macrophages, neutrophils, fibroblasts, platelets, cytokines molecules including TNF-α, interleukins (ILs) and growth factors, including platelet-derived growth factor (PDGF), matrix metalloproteinases (MMPs), tissue inhibitors of metalloproteinases (TIMPs), IL-1, IL-6, and MMPs, proteases, protease inhibitors, and inflammatory markers, and the microorganisms include any one or more selected from the group consisting of bacteria, viruses, fungi and parasites (absorbing and/or extorting fluid containing one or more target molecules from interstitial fluid, blood and/or gastrointestinal fluid of a subject, par.1, page 1, par.2-3, page 8 and collecting biological samples from a wound site, page 12, inherently the microorganisms, bacterial and/or virus from interstitial fluid, blood, gastrointestinal fluid and/or wound of a subject, pages 1-12).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAY A ABOUELELA whose telephone number is (571)270-7917. The examiner can normally be reached 8-5.
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/MAY A ABOUELELA/Primary Examiner, Art Unit 3791