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 .
Detailed Action
Summary
This is the Non-Final Office action based on the 18/074988 application filed 12/05/2022.
Claims 1-25 are pending.
Claim Objections
Claim 1 is objected to because of the following informalities:
In line 2 of claim 1, “said system,” is used but in line 1, and in the dependent claims, “sensing system,” is used. It is understood that when applicant says “said system,” they mean “said sensing system,” however applicant should correct to prevent confusion. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-25 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
With respect to Claim 1, step (a) claims, “a polymer,” however the preamble of the claim states that the sensing system is “configured to measure the concentration of an antimicrobial agent in a polymer.” From how this is claimed, since no “the,” is used in front of “polymer,” in step (a) and instead only “a,” is used, it is unclear if applicant is referring back to the polymer in the preamble or not, or if instead the polymer in step (a) is a different polymer. Therefore, this part of the claim fails to have proper antecedent basis.
Claims 2-25 are rejected by virtue of their dependency on Claim 1.
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 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 non-obviousness.
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 1-23 are rejected under U.S.C. 103 as being obvious by WILLIAMS in US 20110250626 in view of in view of NOWAK in US 20160201005 and in further view of MENON in US 20080145948.
With respect to Claim 1, WILLIAMS teaches of sensing system, as instantly claimed that comprises the elements of an indicator material and a material formulation (paragraph 0007-0008). This sensing system is shows a visual indication upon detection of an amount/concentration of enzymatic or enzymatic and other reactive activity such antimicrobial activity (paragraph 0018).
More specifically, the indicator material comprises a visual indicator, that changes appearance upon a change in pH (paragraph 0008), and a substrate of an enzyme (paragraph 0007). This indicator reads on the instantly claimed “anti-microbial agent sensor.”
The indicator material (including the visual indicator and substrate of enzyme), is contacted with or coated with a material formulation (paragraph 0007-0008). The material formulation comprises an active enzyme that catalyzes a reaction upon the substrate of the enzyme, wherein the reaction produces a product that induces a visual change in the visual indicator (paragraph 0007).
WILLIAMS teaches that the material formulation can be a coating for the indicator material/sensing system that may be a polymeric film in which an enzyme might be incorporated into it to yield a functional film (paragraph 0019). WILLIAMS teaches that the polymeric coating/film can be a dispersion comprising two phases which are two liquid and/or two solid phases, which reads on the instantly claimed “polymer containing… a discrete structural phase comprising solid structural polymer and…a continuous transport phase comprising solid transport polymer,” through broadest reasonable interpretation (BRI) as both discrete structural phase and continuous transport phase can be interpreted broadly (paragraph 0726, 0999, 0994-0995, 1553). WILLIAMS even further teaches that the polymer used can be a polymer blend of two of more polymer materials, and the blend can be a multi-phase blend comprising two polymers (paragraph 0999).
WILLIAMS teaches that a biomolecule which is enzyme and can also include an antimicrobial protein (so--- the enzyme can be considered to be the instantly claimed carrier material, the antimicrobial protein is the instantly claimed responsive agent) is disposed within polymer/s or within the polymer support matrix (paragraph 0023, 2013) and that a visual change is indicative of enzymatic activity or change in the material formulation (paragraph 0007, 2013). The visual change can show enzymatic activity, or a combination of the enzyme and other activity such antimicrobial activity from an antimicrobial peptide being incorporated with the enzyme in the coating (paragraph 0010, 0018). WILLIAMS even further teaches that the enzyme and any other reacting component can be maintained within a continuous polymer phase either as solid or liquid (paragraph 1959)—again reading on the claimed continuous transport phase wherein it is “capable of containing,” “said antimicrobial agent,” since this is a reacting component.
WILLIAMS does not teach of specifically a discrete phase polymer and continuous phase polymer together.
NOWAK is used to remedy this and teaches of a system for making polymer coatings. NOWAK teaches of forming a polymer matrix wherein two polymers are joined together to form a copolymer (paragraph 0150) which contains inclusions of polymers, and wherein the inclusions are phase separated into discrete regions dispersed into a continuous matrix (paragraph 0160). NOWAK teaches that the continuous matrix is made up of one component and the inclusions are made up of a second component and that either or both component can be a polymer (paragraphs 0033-0034).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to use a polymer with a continuous and discrete phase as is done in NOWAK in the system of WILLIAMS due to the advantage inclusions and mixing of phases has for giving the matrix a measurable or chemical property (NOWAK, paragraph 0159).
If it is unclear that WILLIAMS and NOWAK teach of a material exhibiting an observable change specifically based on concentration of an antimicrobial agent, MENON is used to remedy this.
MENON teaches of a method for detection and or quantification of antimicrobial fatty acid monoesters (paragraph 0089). Detection is based on measuring color change and correlating the color change with the concentration of the analyte (paragraph 0015) and polymeric agents are used with this as a developing agent (paragraph 0082).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention for the system to detect antimicrobial agent as is done in MENON in the method of WILLIAMS and NOWAK due to the advantage this has for detection in instances such as for when antimicrobial treatments are performed for food items (MENON, paragraph 0089).
With respect to Claim 2, WILLIAMS teaches that the antimicrobial agent, which is the responsive material as claimed is disposed in a sheet (solid sheet) (paragraph 1158).
With respect to Claim 3, WILLIAMS teaches that the antimicrobial agent, which is the responsive material as claimed, can be disposed in a sheet such as a packaging film or carbon based polymer film/sheet (paragraph 1160).
With respect to Claim 4, WILLIAMS teaches that the material formulation includes an enzyme and the reactive material which can be an antimicrobial protein that is incorporated with the enzyme in the coating (paragraph 0010, 0018, 0020, 0178, 0183, 0251). WILLIAMS teaches that the coating which includes the material formulation, enzyme, and protein covers or is painted on the surface which reads on “completely covers” (paragraph 0020, 0008).
With respect to Claim 5, WILLIAMS teaches that the material formulation includes an enzyme and the reactive material which can be an antimicrobial protein that is incorporated with the enzyme in the coating (paragraph 0010, 0018, 0020, 0178, 0183, 0251). WILLIAMS teaches that the coating which includes the material formulation, enzyme, and protein covers or is painted on the surface which reads on “partially covers” (paragraph 0020, 0008). WILLIAMS teaches of the coating which includes the material formulation and also an adhesive (paragraph 0008, 0020).
With respect to Claim 6, WILLIAMS teaches that the antimicrobial agent, which is the responsive material as claimed is disposed in a sheet (solid sheet) (paragraph 1158) and or coating that is disposed in water solvent (paragraph 1988).
With respect to Claim 7, WILLIAMS teaches that the antimicrobial agent, which is the responsive material as claimed is disposed in a sheet (solid sheet) (paragraph 1158) in a coating and the coating/sheet can be a “solvent borne coating,” (paragraph 0860).
With respect to Claim 8, WILLIAMS teaches that the carrier which is the enzyme in coating that is disposed in water solvent (paragraph 1988, 1991).
With respect to Claim 9, WILLIAMS teaches that the solvent can be a ketone (paragraph 0021), alcohols, esters (paragraph 0056).
With respect to Claim 10, WILLIAMS teaches of using a viscosity modifier or thickening agent (paragraph 0460).
With respect to Claim 11, WILLIAMS teaches that the visually observable change may be a change in color/chromaticity (paragraph 2013).
With respect to Claim 12, WILLIALMS teaches that the visually observable change may be a change in opacity which is a measure of optical transparency (paragraph 0953, 1796).
With respect to Claim 13, WILLIAMS teaches that of determining the conductance/ionic conductivity of the material (paragraph 1658).
With respect to Claim 14, WILLIAMS teaches of determining the electrical resistance/conductivity of the material (paragraph 1658).
With respect to Claim 15, WILLIAMS teaches that one of the polymer components can be be non-fluorinated carbon based polymers including polycarbonate or polyether among others (paragraph 0093).
With respect to Claim 16, WILLIAMS teaches that one of the polymer components can be non-fluorinated carbon based polymers including polycarbonate or polyether among others (paragraph 0093, 1009, 1135-1139).
With respect to Claim 17, WILLIAMS teaches that fluorinated polymers can be used as one of the polymers which can include things including ethylene chlorotrifluoroethylene, an ethylene tetrafluoroethylene, a fluorinated ethylene propylene, a polyvinylidene fluoride, a polychlorotrifluoroethylene, a polytetrafluoroethylene, a polyvinyl fluoride (paragraph 1086).
With respect to Claim 18, WILLIAMS teaches that fluorinated polymers can be used as one of the polymers which can include things including ethylene chlorotrifluoroethylene, an ethylene tetrafluoroethylene, a fluorinated ethylene propylene, a polyvinylidene fluoride, a polychlorotrifluoroethylene, a polytetrafluoroethylene, a polyvinyl fluoride (paragraph 1086).
With respect to Claim 19, WILLIAMS teaches that the polymers can be branched polymers (paragraph 0544, 0982) and that the branched polymer can be a fluropolymer and that they copolymerize so there are pendant reactive groups (paragraph 1100).
With respect to Claim 20, WILLIAMS teaches that the polymer/s can be polyethylene glycol which is hydroscopic (paragraph 1112).
With respect to Claim 21, WILLIAMS teaches that one of the polymers can be polypropylene glycol- which is hydrophobic and non-lipophobic (paragraph 1114).
With respect to Claim 22, WILLIAMS teaches of the polymer comprising an ionic charge (paragraph 9994-9996).
With respect to Claim 23, WILLIAMS teaches that one of polymers can be polysiloxane (paragraph 1137) or a polyethylene oxide (paragraph 1112).
Claim 24 is rejected under U.S.C. 103 as being obvious by WILLIAMS in US 20110250626 in view of in view of NOWAK in US 20160201005 in view of MENON in US 20080145948 in view of GREENE in US 20100036230.
With respect to Claim 24, WILLIAMS and MENON teaches of the invention as shown above for Claim 1, but does not teach of the antimicrobial agent being a quaternary ammonium molecule. GREENE is used to remedy this and teaches of Sample 2 including acrylic adhesive including 20% by weight of quaternary ammonium salt (chemical active)(paragraph 0072). An adhesive and polymer can be used in alternative to one another (paragraph 0010, 0031-0032).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to use a quaternary ammonium salt as done in GREENE in the system and methods of WILLIAMS and MENON due to the advantage this has for functionalizing the components coated on while maintaining adhesive strength (paragraph 0078).
Claim 25 is rejected under U.S.C. 103 as being obvious by WILLIAMS in US 20110250626 in view of in view of NOWAK in US 20160201005 in view of MENON in US 20080145948 in view of GREENE2 in US 20100239679.
With respect to Claim 25, WILLIAMS and MENON teaches of the invention as shown above for Claim 1, but does not teach of the antimicrobial agent being one of the claimed agents. GREENE2 is used to remedy this and teaches of the antimicrobial agent being chlorite (paragraph 0061).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to use a chlorite antimicrobial agent as done in GREENE2 in the system and methods of WILLIAMS and MENON due to the advantage this offers as being an active ingredient for functionalizing polymers and plastics to functionalized carrier materials (GREENE2, abstract, paragraph 0004-0005).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 4-6 & 27-30 of copending Application No. 17/852307 in view of WILLIAMS in US 20110250626 MENON in US 20080145948.
Application 17/852307 claims an antimicrobial structure comprising:
(a) a discrete solid structural phase comprising a solid structural polymer, wherein said solid structural polymer is characterized by a glass-transition temperature from about 25°C to about 300°C;
(b) a continuous transport phase that is interspersed within said discrete solid structural phase, wherein said continuous transport phase comprises a solid transport material; and
(c) an antimicrobial agent contained within said continuous transport phase, wherein said antimicrobial agent is at least partially dissolved in a fluid, wherein said fluid is distinct from said antimicrobial agent, and wherein said fluid is contained within said continuous transport phase and/or wherein said antimicrobial agent is in a solid solution with said continuous transport phase, wherein said discrete solid structural phase and said continuous transport phase are separated by an average phase-separation length selected from about 100 nanometers to about 500 microns, and wherein said antimicrobial structure is characterized in that said antimicrobial agent has a diffusion coefficient from about 10⁻¹⁸ m²/s to about 10⁻⁹ m²/s, measured at 25°C and 1 bar, within said continuous transport phase.
Application17/852307 does not claim a responsive material that exhibits and observable and quantifiable change upon chemical reaction with an antimicrobial agent.
However, WILLIAMS in view of MENON teaches of this.
Specifically, WILLIAMS teaches of sensing system, as instantly claimed that comprises the elements of an indicator material and a material formulation (paragraph 0007-0008). This sensing system is shows a visual indication upon detection of an amount/concentration of enzymatic or enzymatic and other reactive activity such antimicrobial activity (paragraph 0018). More specifically, the indicator material comprises a visual indicator, that changes appearance upon a change in pH (paragraph 0008), and a substrate of an enzyme (paragraph 0007). This indicator reads on the instantly claimed “anti-microbial agent sensor,” in a multiphase polymer system (paragraph 0999).
The indicator material (including the visual indicator and substrate of enzyme), is contacted with or coated with a material formulation (paragraph 0007-0008). The material formulation comprises an active enzyme that catalyzes a reaction upon the substrate of the enzyme, wherein the reaction produces a product that induces a visual change in the visual indicator (paragraph 0007).
It would have been obvious to detect the visual change as is done in WILLIAMS in the patent application due to the advantage this has for showing enzymatic or reactive substance activity (WILLIAMS, paragraph 0003, 0007).
If it is unclear that WILLIAMS teaches of a material exhibiting an observable change specifically based on concentration of an antimicrobial agent, MENON is used to remedy this.
MENON teaches of a method for detection and or quantification of antimicrobial fatty acid monoesters (paragraph 0089). Detection is based on measuring color change and correlating the color change with the concentration of the analyte (paragraph 0015) and polymeric agents are used with this as a developing agent (paragraph 0082).
It would have been obvious one to detect antimicrobial agent as is done in MENON in the method of WILLIAMS and the patent application due to the advantage this has for detection in instances such as for when antimicrobial treatments are performed for food items (MENON, paragraph 0089).
This is a provisional nonstatutory double patenting rejection.
Claims 1-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 11369109 in view of WILLIAMS in US 20110250626 MENON in US 20080145948.
US patent 11369109 claims An antimicrobial structure comprising: (a) a solid structural phase comprising a solid structural material; and (b) a continuous transport phase that is interspersed within said solid structural phase, wherein said continuous transport phase comprises is a gel electrolyte; wherein said gel electrolyte contains containing (i) an electrolyte salt, (ii) an aqueous or non- aqueous transport-phase liquid solvent, and (iii) a polymer host comprising as a solid transport material, and (iv) an antimicrobial agent,, and (c) an antimicrobial agent contained within said continuous transport phase, wherein said aqueous or non-aqueous transport-phase liquid solvent at least partially dissolves said antimicrobial agent, wherein said solid transport material and said antimicrobial agent form a solution, and wherein said solid structural phase and said continuous transport phase are separated by an average phase-separation length from about 100 nanometers to about 500 microns.
US patent 11369109 does not claim a responsive material that exhibits and observable and quantifiable change upon chemical reaction with an antimicrobial agent.
However, WILLIAMS in view of MENON teaches of this.
Specifically, WILLIAMS teaches of sensing system, as instantly claimed that comprises the elements of an indicator material and a material formulation (paragraph 0007-0008). This sensing system is shows a visual indication upon detection of an amount/concentration of enzymatic or enzymatic and other reactive activity such antimicrobial activity (paragraph 0018). More specifically, the indicator material comprises a visual indicator, that changes appearance upon a change in pH (paragraph 0008), and a substrate of an enzyme (paragraph 0007). This indicator reads on the instantly claimed “anti-microbial agent sensor,” in a multiphase polymer system (paragraph 0999).
The indicator material (including the visual indicator and substrate of enzyme), is contacted with or coated with a material formulation (paragraph 0007-0008). The material formulation comprises an active enzyme that catalyzes a reaction upon the substrate of the enzyme, wherein the reaction produces a product that induces a visual change in the visual indicator (paragraph 0007).
It would have been obvious to detect the visual change as is done in WILLIAMS in the patent due to the advantage this has for showing enzymatic or reactive substance activity (WILLIAMS, paragraph 0003, 0007).
If it is unclear that WILLIAMS teaches of a material exhibiting an observable change specifically based on concentration of an antimicrobial agent, MENON is used to remedy this.
MENON teaches of a method for detection and or quantification of antimicrobial fatty acid monoesters (paragraph 0089). Detection is based on measuring color change and correlating the color change with the concentration of the analyte (paragraph 0015) and polymeric agents are used with this as a developing agent (paragraph 0082).
It would have been obvious one to detect antimicrobial agent as is done in MENON in the method of WILLIAMS and the patent due to the advantage this has for detection in instances such as for when antimicrobial treatments are performed for food items (MENON, paragraph 0089).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
MACKAY in US 20180059101.
MACKAY is used to remedy this and teaches a system for an impedance-based molecular sensing, the system comprising: a coating disposed on a substrate (abstract, paragraph 0126, 0125);
The coating of the substrate extends between two electrodes (paragraph 0126). Molecular recognition elements (MRE/s) are bound to the substrate or the coating of the substrate (paragraph 0126) (these MREs can be considered the “chemical active,” in the coating and can be considered to be ionically conductive- as claimed through broadest reasonable interpretation (BRI)).
MACKAY teaches that the MREs in the coating can be polymers (paragraph 0139). Further- MACKAY teaches that the substrate can be modified/coated with a layer or layers of chemically bound entities such as polymers (paragraph 0174).
MACKAY further teaches of the electrodes (704 & 706) with one being disposed at or near and external surface of the coating and the other is distally disposed at the other/opposite end of the coating (See Figure 7, paragraph 0147, 0126).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA M FRITCHMAN whose telephone number is (303)297-4344. The examiner can normally be reached 9:30-4:30 MT Monday-Friday.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached on 571-270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REBECCA M FRITCHMAN/Primary Examiner, Art Unit 1758
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