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 for the benefit of a prior-filed application under 35 U.S.C. 119(e)
or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. This application is a 371 National Stage application of PCT/US20/57289 filed 10/26/2020, which claims the benefit of
Application Number 62/926,376 filed 10/25/2019. Based on the filing receipt, the effective
filing date of this application is October 25, 2019 which is the filing date of Application
Number 62/926,376 from which the benefit of priority is claimed.
Status of Claims
Claims 3, 7-8, 11, 16, 18-20, 25, 30, and 32-56 are cancelled, in amended claims filed 04/02/2026.
Claims 12-15, 21-24, 26-27, 29, and 31 are withdrawn due to being directed to nonelected species, in the reply filed 09/04/2025.
Claims 1-2, 4-6, 9-10, 17, and 28 are examined herein.
Withdrawn Rejections
The rejection of claim 9 on the grounds of 35 U.S.C. 112(b) has been withdrawn, necessitated by amendments filed 2026-04-02, which amended claim 9 to depend on independent claim 1.
The rejection of claims 11 on the grounds of 35 U.S.C. 102(a)(1) as anticipated by Boisen (cited below) has been withdrawn, necessitated by amendments filed 2026-04-02, which cancelled claim 11.
The rejection of claims 11 on the grounds of 35 U.S.C. 102(a)(1) and 102(a)(2) as anticipated by Hood (cited below) has been withdrawn, necessitated by amendments filed 2026-04-02, which cancelled claim 11.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are:
“a molecular recognition group coupled to the substrate, the molecular recognition group being operable to bind to a target pathogen” in claim 1;
the molecular recognition group “operable to bind to the target pathogen by a third bond” in claims 5 and 21;
“the cantilever beam is operable to block passage of light prior to the molecular recognition group binding with the target pathogen and to transmit light upon the molecular recognition group binding with the target pathogen and bending of the substrate” in claim 10;
“the dispersive surfaces being operable to reflect different wavelengths of light” in claim 15;
and “a microbead bonded to a second molecular recognition group operable to bind to the target pathogen” in claim 31.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
The “molecular recognition group coupled to the substrate, the molecular recognition group being operable to bind to a target pathogen” in claim 1 is interpreted as the aptamers, antigens, and antibodies described from p. 11, line 10 to p. 12, line 25 of the specification (see, e.g., “Molecular recognition groups can generally include a surface bonding group and a viral bonding group”) and equivalents thereof.
The molecular recognition group “operable to bind to the target pathogen by a third bond” in claims 5 and 21 is interpreted as the aptamers, antigens, and antibodies described from p. 11, line 10 to p. 12, line 25 of the specification (see, e.g., “Molecular recognition groups can generally include a surface bonding group and a viral bonding group”) and equivalents thereof.
The cantilever beam “operable to block passage of light prior to the molecular recognition group binding with the target pathogen and to transmit light upon the molecular recognition group binding with the target pathogen and bending of the substrate” in claim 10 is interpreted as the “light valve” colorimetric sensor described on p. 16, lines 5-14 and FIGS. 8A and 8B of the specification and equivalents thereof.
The “dispersive surfaces being operable to reflect different wavelengths of light” in claim 15 is interpreted as the biomimetic device described on p. 17, lines 1-20 and FIGS. 10A and 10B of the specification (“When a pathogen is present and binds to the sensor's surface aptamers, the binding force creates a surface stress causing the Fabry-Perot length (L) to increase and reflect the red light”) and equivalents thereof.
The “microbead bonded to a second molecular recognition group operable to bind to the target pathogen” in claim 31 is interpreted as the plurality of bases described on p. 20, lines 10-18 and FIGS. 16A and 16B of the specification (“the bases can comprise microbeads that form a colloidal solution and coagulate when the pathogen is introduced”) and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitations recite sufficient structure to perform the claimed function so as to avoid them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Maintained Rejections
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.
(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 1-2, 4-6, 9-10, 17, and 28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Boisen, et al. ("Rapid molecular detection of food- and water-borne diseases", published 2007-08, cited in PTO-892 dated 2026-01-06). The following rejection has been modified, necessitated by amendments filed 2026-04-02.
With respect to claim 1, Boisen teaches a colorimetric pathogen sensor, comprising: a substrate; and a molecular recognition group coupled to the substrate, the molecular recognition group being operable to bind to a target pathogen, wherein, upon the molecular recognition group binding with the target pathogen, reflected light from the substrate is altered thereby changing apparent color (see, e.g., molecular recognition group coupled to the substrate – p. 3, col. 1, under “Catching bacteria”, para. 1: “the cantilever is coated with antibodies against Escherichia coli”; upon binding the molecular recognition group binding with the target pathogen, reflected light is altered thereby changing color – p. 4, col. 1, under “The ‘lid thing’”, para. 1: “Coloured marker molecules are loaded in a small container closed by a flexible lid. The lid is coated with specific detector molecules which bind the molecules under investigation. This binding causes the lid (just like a cantilever) to deflect, the marker molecules are released and they can be detected by the naked eye”). It is understood that the cantilever/lid of Boisen is equivalent to a substrate.
With respect to claim 2, Boisen teaches the molecular recognition group is an antibody and the target pathogen comprises bacteria (see, e.g., p. 3, col. 1, under “Catching bacteria”, para. 1: “the cantilever is coated with antibodies against Escherichia coli”).
With respect to claim 4, Boisen teaches upon the molecular recognition group binding with the target pathogen, the substrate is caused to bend thereby altering reflected light and changing apparent color (see, e.g., p. 4, col. 1, under “The ‘lid thing’”, para. 1: “Coloured marker molecules are loaded in a small container closed by a flexible lid. The lid is coated with specific detector molecules which bind the molecules under investigation. This binding causes the lid (just like a cantilever) to deflect, the marker molecules are released and they can be detected by the naked eye”). It is understood that the deflection of the lid is equivalent to the substrate bending.
With respect to claim 5, Boisen teaches a base bonded to the substrate by a first bond, wherein the molecular recognition group is bonded to the base by a second bond, the molecular recognition group being operable to bind to the target pathogen by a third bond, and wherein, upon the molecular recognition group binding with the target pathogen, the third bond generates a residual stress on the base that causes the substrate to bend (see, e.g., p. 4, col. 1, under “The ‘lid thing’”, para. 1: “Coloured marker molecules are loaded in a small container closed by a flexible lid. The lid is coated with specific detector molecules which bind the molecules under investigation. This binding causes the lid (just like a cantilever) to deflect, the marker molecules are released and they can be detected by the naked eye”).
[AltContent: textbox ([img-media_image1.png]
Fig. 4)]With respect to claim 6, Boisen teaches the base comprises a coating substantially covering a surface of the substrate (see, e.g., p. 4, col. 1, under “The ‘lid thing’”, para. 1: “The lid is coated with specific detector molecules which bind the molecules under investigation”, and see “Fig. 4.” from p. 3 below).
With respect to claim 9, Boisen teaches the substrate comprises a cantilever beams (see, e.g., p. 4, col. 1, under “The ‘lid thing’”, para. 1: “The lid is coated with specific detector molecules which bind the molecules under investigation”, and see “Fig. 4.” from p. 3 above). It is understood that the lid of Boisen is equivalent to a cantilever beam because the lid is a beam supported on one end and free on the other.
With respect to claim 10, Boisen teaches the cantilever beam is operable to block passage of light prior to the molecular recognition group binding with the target pathogen and to transmit light upon the molecular recognition group binding with the target pathogen and bending of the substrate (see, e.g., “Fig. 4.” from p. 3 above). It is understood that the cantilever beam of “Fig. 4.” is capable of blocking the passing of light prior to molecular binding and transmitting light upon molecular recognition group binding with the target due to bending of the substrate. As the cantilever beam bends, light blocked by the beam is now allowed to pass through, meeting the functional limitations of claim 10.
[AltContent: textbox ([img-media_image2.png]Fig. 1)]With respect to claim 17, Boisen teaches the substrate comprises a plurality of beams and the substrate is caused to bend by a binding force of the molecular recognition group and the target pathogen moving the target pathogen into a gap between at least two of the plurality of beams (see, e.g., p. 3, “Fig. 1” shown below).
With respect to claim 28, Boisen teaches the molecular recognition group is bonded to the substrate (see, e.g., p. 3, col. 1, under “Catching bacteria”, para. 1: “the cantilever is coated with antibodies against Escherichia coli”).
Claims 1-2, 4-6, 9-10, and 28 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102 (a)(2) as being anticipated by Hood (US 8898069 B2, published 2014-11-25, cited in PTO-892 dated 2026-01-06). The following rejection has been modified, necessitated by amendments filed 2026-04-02.
With respect to claim 1, Hood teaches a colorimetric pathogen sensor, comprising: a substrate; and a molecular recognition group coupled to the substrate, the molecular recognition group being operable to bind to a target pathogen, wherein, upon the molecular recognition group binding with the target pathogen, reflected light from the substrate is altered thereby changing apparent color (see, e.g., col. 40: “Hydrogels with covalently coupled […] influenza viral particles or influenza viral protein antigens (e.g. nucleoprotein or hemagglutinin) are coated on one face of a micro-cantilever and used to detect anti-influenza antibodies in salivary fluid. Micro-cantilever also act as valves on a reservoir of dye molecules that can be configured to be induced, resulting in deflection and release of the dye molecules […] For example, colorimetric changes in a transparent plastic discrete oral component with a micro-cantilever controlling release of a dye (e.g. Phenol red, Trypan blue, Congo red, Bromocresol purple, Ethyl orange; all available from Sigma-Aldrich, St. Louis, Mo.) in the oral component signals the presence of influenza virions in saliva”). It is understood that the micro-cantilever is equivalent to a substrate, the micro-cantilevers are coated with molecular recognition groups, and the influenza virions are equivalent to a target pathogen. It is understood that the release of a dye leads to reflected light being altered thereby changing apparent color.
With respect to claim 2, Hood teaches the molecular recognition group is an antigen and the target pathogen comprises a virus (see, e.g., col. 40: “Hydrogels with covalently coupled […] influenza viral particles or influenza viral protein antigens (e.g. nucleoprotein or hemagglutinin) are coated on one face of a micro-cantilever and used to detect anti-influenza antibodies in salivary fluid. Micro-cantilever also act as valves on a reservoir of dye molecules that can be configured to be induced, resulting in deflection and release of the dye molecules […] For example, colorimetric changes in a transparent plastic discrete oral component with a micro-cantilever controlling release of a dye (e.g. Phenol red, Trypan blue, Congo red, Bromocresol purple, Ethyl orange; all available from Sigma-Aldrich, St. Louis, Mo.) in the oral component signals the presence of influenza virions in saliva”).
With respect to claim 4, Hood teaches upon the molecular recognition group binding with the target pathogen, the substrate is caused to bend thereby altering reflected light and changing apparent color (see, e.g., col. 40: “Hydrogels with covalently coupled […] influenza viral particles or influenza viral protein antigens (e.g. nucleoprotein or hemagglutinin) are coated on one face of a micro-cantilever and used to detect anti-influenza antibodies in salivary fluid. Micro-cantilever also act as valves on a reservoir of dye molecules that can be configured to be induced, resulting in deflection and release of the dye molecules […] For example, colorimetric changes in a transparent plastic discrete oral component with a micro-cantilever controlling release of a dye (e.g. Phenol red, Trypan blue, Congo red, Bromocresol purple, Ethyl orange; all available from Sigma-Aldrich, St. Louis, Mo.) in the oral component signals the presence of influenza virions in saliva”). It is understood that the deflection of the micro-cantilever is equivalent to bending and the release of dye will alter reflected light by changing apparent color of the sensor.
With respect to claim 5, Hood teaches a base bonded to the substrate by a first bond, wherein the molecular recognition group is bonded to the base by a second bond, the molecular recognition group being operable to bind to the target pathogen by a third bond, and wherein, upon the molecular recognition group binding with the target pathogen, the third bond generates a residual stress on the base that causes the substrate to bend (see, e.g., col. 40: “Hydrogels with covalently coupled […] influenza viral particles or influenza viral protein antigens (e.g. nucleoprotein or hemagglutinin) are coated on one face of a micro-cantilever and used to detect anti-influenza antibodies in salivary fluid. Micro-cantilever also act as valves on a reservoir of dye molecules that can be configured to be induced, resulting in deflection and release of the dye molecules […] For example, colorimetric changes in a transparent plastic discrete oral component with a micro-cantilever controlling release of a dye (e.g. Phenol red, Trypan blue, Congo red, Bromocresol purple, Ethyl orange; all available from Sigma-Aldrich, St. Louis, Mo.) in the oral component signals the presence of influenza virions in saliva”). It is understood that the plastic transparent discrete oral components are equivalent to a base.
With respect to claim 6, Hood teaches the base comprises a coating substantially covering a surface of the substrate (see, e.g., col. 40: “Hydrogels with covalently coupled […] influenza viral particles or influenza viral protein antigens”).
With respect to claim 9, Hood teaches the substrate comprises a cantilever beams (see, e.g., col. 40: “Micro-cantilever also act as valves on a reservoir”).
With respect to claim 10, Hood teaches the cantilever beam is operable to block passage of light prior to the molecular recognition group binding with the target pathogen and to transmit light upon the molecular recognition group binding with the target pathogen and bending of the substrate (see, e.g., col. 40: “Hydrogels with covalently coupled […] influenza viral particles or influenza viral protein antigens (e.g. nucleoprotein or hemagglutinin) are coated on one face of a micro-cantilever and used to detect anti-influenza antibodies in salivary fluid. Micro-cantilever also act as valves on a reservoir of dye molecules that can be configured to be induced, resulting in deflection and release of the dye molecules […] For example, colorimetric changes in a transparent plastic discrete oral component with a micro-cantilever controlling release of a dye (e.g. Phenol red, Trypan blue, Congo red, Bromocresol purple, Ethyl orange; all available from Sigma-Aldrich, St. Louis, Mo.) in the oral component signals the presence of influenza virions in saliva”). It is understood that the cantilever beam of Hood is capable of blocking the passing of light prior to molecular binding and transmitting light upon molecular recognition group binding with the target due to bending of the substrate. As the cantilever beam bends, light that would have been blocked by the beam is now allowed to pass through, meeting the functional limitations of claim 10.
With respect to claim 28, Hood teaches the molecular recognition group is bonded to the substrate (see, e.g., col. 40: “Hydrogels with covalently coupled […] influenza viral particles or influenza viral protein antigens (e.g. nucleoprotein or hemagglutinin) are coated on one face of a micro-cantilever and used to detect anti-influenza antibodies in salivary fluid”).
Response to Arguments
Applicant's arguments filed 2026-04-02 have been fully considered but they are not persuasive.
The 35 U.S.C. 102(a)(1) Rejection as Anticipated by Boisen
The applicant argues that Boisen (cited above) does not teach the limitation of amended claim 1, specifically the limitation: “reflected light from the substrate is altered thereby changing apparent color”. The applicant asserts that Boisen’s color change from the introduction or release of a color-producing material. However, the broadest reasonable interpretation of claim 1 encompasses sensors such as Boisen’s. In Boisen, the molecular recognition group binding with the target pathogen causes the reflected light from the substrate to be altered thereby changing color (see “Fig. 4” above). The release of the colored marker molecules in Boisen leads to the substrate being covered by a different colored solution, which alters the reflected light from the substrate thereby changing apparent color. The reflected light from the substrate is altered by the presence of colored marker molecules over the substrate. Therefore, the 35 U.S.C. 102(a)(1) rejection over Boisen is maintained.
The 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) Rejection as Anticipated by Hood
The applicant asserts the same argument regarding the rejection over Hood (cited above). The applicant argues that Hood does not teach the limitation of amended claim 1, specifically the limitation: “reflected light from the substrate is altered thereby changing apparent color”. The applicant asserts that Hood’s color change from the introduction or release of a color-producing material. However, the broadest reasonable interpretation of claim 1 encompasses sensors such as Hood’s. In Hood, the molecular recognition group binding with the target pathogen causes the reflected light from the substrate to be altered thereby changing color (see, e.g., col. 40: “Hydrogels with covalently coupled […] influenza viral particles or influenza viral protein antigens (e.g. nucleoprotein or hemagglutinin) are coated on one face of a micro-cantilever and used to detect anti-influenza antibodies in salivary fluid. Micro-cantilever also act as valves on a reservoir of dye molecules that can be configured to be induced, resulting in deflection and release of the dye molecules […] For example, colorimetric changes in a transparent plastic discrete oral component with a micro-cantilever controlling release of a dye (e.g. Phenol red, Trypan blue, Congo red, Bromocresol purple, Ethyl orange; all available from Sigma-Aldrich, St. Louis, Mo.) in the oral component signals the presence of influenza virions in saliva”). The release of the colored dye necessitates the reflected light from the substrate being altered thereby changing color. The micro-cantilever substrates are in a saliva sample, therefore, the release of colored dye alters the light reflecting off that substrate. Therefore, the 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) rejection as anticipated by Hood is maintained.
Conclusion
No claims are allowed.
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.
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/MICHAEL CAMERON SVEIVEN/ Examiner, Art Unit 1678
/GREGORY S EMCH/ Supervisory Patent Examiner, Art Unit 1678
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