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 .
Claim Status
Claims 16-30 are pending with claims 16-24 being examined, claims 25-30 are deemed withdrawn. Claims 1-15 are canceled.
Response to Amendment
As to the claim amendments and remarks filed on 03/02/2026, the previous 112(b) rejection is withdrawn. Applicant amended claim 1 to correct the deficiency and clarified claim 17.
The previous 101/112(b) stands. The amendment does not provide any structures that further define the fibrous mat and are intended use claims.
As to the remarks, the examiner has found the Applicant’s arguments not persuasive and will be addressed below.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 16 and 21-24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ensor et al (US 20120045752 A1; hereinafter “Ensor” previous of record).
Regarding claim 16, Ensor teaches a fibrous mat (Ensor; fig. 7. Nanofiber filter) for use in taking a metabolome sample (Ensor; [0077]) and for use in desorption of the metabolome sample (Ensor; [0204] “release of the collected material through dissolution”), the fibrous mat comprising an open network of at least one polymer-based nanofiber (Ensor; fig. 8 illustrates an open network [0077] “nanofibers from polymers”),
wherein the diameter of the at least one nanofiber is ranging between 50 nm and 1500 nm (Ensor; [0205]),
wherein a cover layer is provided at a top and/or at a bottom of the open network of at least one nanofiber (Ensor; [0124] “a macroscopic mesh provides adequate support for the nanofibers to withstand the forces exerted on filter mat” ) to exclude particles with a mass larger than 2000 Da from interacting with the open network of at least one nanofiber by blocking and/or excluding access to these particles (Ensor; [0125] teaches the fibrous mat includes mesh openings that range from 1.27cm down to 1000 times the Average Fiber Diameter (AFD).
Ensor’s cover layer (macroscopic mesh support) provides a porosity that would support to the fiber mat and would be capable of excluding particles larger than 2000 Da. Since Ensor’s bioparticles have a mass larger than 2000 Da, this meets the range limitation as claimed.
Regarding claim 21, Ensor teaches the fibrous mat according to claim 16 (see above) wherein the fibrous mat is configured to generate metabolome data suitable for diagnostic analysis.
Ensor teaches a fibrous mat (see above), and what the fibrous mat is used for is a matter of intended use.
Regarding claim 22, Ensor teaches the fibrous mat according to claim 16 (see above), the fibrous mat comprising nano- or micro-particles which are incorporated in the open network of the at least one polymer- based nanofiber or in the at least one polymer-based nanofiber (Ensor; fig. 3 and [0101]).
Regarding claim 23, Ensor teaches the fibrous mat according to claim 16 (see above) wherein the at least one nanofiber is comprising one or more materials selected from: a list of hydrophilic polymers comprising polyacrylate, polyacrylonitrile, polyvinylpyrrolidone (Ensor; [0135]), and/or from a list of hydrophobic polymers comprising polystyrene (Ensor; [0113]), divinylbenzene, polydimethylsiloxane, polydivinylbenzene, and/or from a list of combined hydrophobic/hydrophilic polymers comprising polydivinylbenzene-co-polyvinylpyrrolidone, hydrophilic- divinylbenzene, crosslinked polyvinylpyrrolidone.
Regarding claim 24, Ensor teaches a sampling device comprising a fibrous mat (Ensor; [0035] “growth tube and fiber filter”) according to claim 16 (see above), and a carrier to which the fibrous mat is secured (Ensor; fig. 5. “filter holder).
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.
Claim 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Ensor et al (US 20120045752 A1; hereinafter “Ensor” previous of record).
Regarding claim 17, Ensor teaches the fibrous mat according to claim 16 (see above).
Ensor teaches a fibrous mat comprising an open network of at least one polymer-based nanofiber (see above).
Ensor does not teach the fibrous mat wherein a hydrophilic/hydrophobic moiety ratio of the at least one nanofiber is selected such that deformation of the fibrous mat is less than 5% in size after exposure to water.
However, without some statement of criticality or showing of unexpected results, to one of ordinary skill in the art before the invention it would have been obvious to determine through routine experimentation a hydrophilic/hydrophobic moiety ratio of the at least one nanofiber is selected such that deformation of the fibrous mat is less than 5% in size after exposure to water.
Regarding claim 18, Ensor teaches the fibrous mat according to claim 17 (see above), wherein the hydrophilic/hydrophobic moiety ratio ranges from 75/25 to 10/90.
Ensor teaches a wide variety of polymers can be spun into fibers using both synthetic and natural polymers wherein, the polymers offer hydrophobic to hydrophilic properties similar to sugars and proteins.
Examiner notes that the ratio range of hydrophilic/hydrophobic moiety from 75/25 to 10-90 is so large that almost any combination of the hydrophobic to hydrophilic properties similar to sugars and proteins would be within that range.
It would have been obvious to include fiber polymers with a hydrophilic/hydrophobic moiety ratio that ranges from 75/25 to 10/90 which provides for a wide range of hydrophilic/hydrophobic moiety to allow multi-functional performance such as emulsion stabilizing and separation.
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Ensor et al (US 20120045752 A1; hereinafter “Ensor” previous of record) in view of Takats et al (US 20180047554 A1).
Regarding claim 19, Ensor teaches the fibrous mat according to claim 16 (see above) wherein the fibrous mat is configured to permit desorption (Ensor; [0204] “enhanced release using selective solvents and/or processing conditions”).
Ensor fails to teach the fibrous mat is configured to permit ionization of the metabolome sample.
However, Takats teaches the analogous art of a fibrous material (Takats; [0161] “fiber swab”) designed for sampling biological material (Takats; [0014]) wherein the fibrous material is configured to permit ionization of the metabolome sample (Takats; [0019] “sample provided on a swab may be directly analyzed by desorption electrospray ionization (DESI).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Ensor’s fibrous mat to be configured to permit ionization of the metabolome sample as taught by Takats because Takats teaches a fibrous material (Takats; [0161] “fiber swab”) designed for sampling biological samples (Takats; [0014]) wherein the fibrous material is used for ionization of the metabolome sample (Takats; [0019] “sample provided on a swab may be directly analyzed by desorption electrospray ionization (DESI).
Ionizing the metabolome sample allows to charge neutral molecules in the sample to enable detection.
Regarding claim 20, Ensor teaches the fibrous mat according to claim 16 (see above) to include desorption of the sample (see above).
Ensor fails to teach the fibrous mat is configured to permit laser-assisted desorption of the metabolome sample.
However, Takats teaches the analogous art of a fibrous material (Takats; [0161] “fiber swab”) designed for sampling biological samples (Takats; [0014]) wherein the fibrous material is configured to permit laser assisted desorption of the metabolome sample (Takats; [0090]-[0093] “the swab is further analyzed using matrix-Assisted Laser Desorption Ionization”).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Ensor’s fibrous mat to be configured to permit laser assisted desorption of the metabolome sample as taught by Takats because Takats teaches a fibrous material (Takats; [0161] “fiber swab”) designed for sampling biological samples (Takats; [0014]) wherein the fibrous material is configured to permit laser assisted desorption of the metabolome sample (Takats; [0090]-[0093])
This allows to analyze any organisms present in the sample (Takats; [0767]).
Response to Arguments
Applicant’s arguments, filed on 03/02/2026, with respect to the prior art rejections over Ensor and Takats have been fully considered and are not persuasive. The rejections have been modified in accord with the amendment.
With respect to claim 1, Applicant argues Ensor teaches the fiber mat is configured to collect and maintain viability of microbes and/or bioparticles.
In response, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Applicant also argues the bioparticles in Ensor have molecular masses ranging from several kilodaltons to millions of Daltons, and that Applicants threshold of 2000Da lies below the mass range of the bioparticles in Ensor.
Examiner notes Applicant recites in claim 1, the “nanofiber excludes particles with a mass larger than 2000 Da”. The limitation recites a very broad range and is interpreted to cover any particles with a mass larger than 2000 Da. Since Ensor’s bioparticles have a mass larger than 2000Da, therefore Ensor meets the range limitation.
Applicant further argues Ensor’s macroscopic mesh cannot perform molecular-mass-based exclusion and does not block proteins, virus, bacteria and other bioparticles.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a cover layer provided to exclude particles with a mass of 2000 Da and above) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Therefore, as mentioned above, Ensor’s cover layer meets the limitations of the claim since the cover layer is capable of excluding bio particles having masses larger than 2000 Da.
Applicant argues Ensor fails to suggest the reason for providing a cover layer is for excluding bioparticle from interacting with the nanofiber.
In response, as mentioned above, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEX RAMIREZ whose telephone number is (571)272-9756. The examiner can normally be reached Monday - Friday 8:00 - 5:00.
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/A.R./ Examiner, Art Unit 1798
/CHARLES CAPOZZI/ Supervisory Patent Examiner, Art Unit 1798
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