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
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 7/25/2025 has been entered.
Applicant’s amendment filed on 25 July 2025 is entered. The previous 112b rejection of claim 16 is withdrawn in light of Applicant’s amendment.
Claims 17-18 have been added. Claims 1, 4, 6-12, 15-16, and 17-18 are pending.
Claim Objections
Claim 1 is objected to because the lines are crowded with a statement “The following listing of claims will replace all prior versions, and listing of claims in the application:” together in the first paragraph, making reading difficult. A substitute claim set with each claim starting on a new line is required.
Claim 18 is objected to because of the following informalities: the hyphen between “water” and “soluble” is missing. 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, 4, 6-12, and 15-18 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.
Claim 1 step c) recites removing from the surface the polymer film comprising the at least one target microorganism. The limitation lacks antecedent basis because steps a)-b) do not recite any target microorganism. It is unclear how the at least one target microorganism enters the polymer film during step a) or step b). None of the dependent claims remediate this problem. Therefore, claims 4, 6-12 and 15-18 are also indefinite.
In claim 17, the term “the dissolved” on line 2 lacks antecedent basis. Claim 17 recites the foam composition of claim 1 is formed by introducing gas bubbles into a solution comprising “the dissolved” film-forming water soluble synthetic polymer. However, neither claims recite any dissolution of the film-forming water soluble synthetic polymer prior to reciting “a foam composition” in claim 1 step a. Although claim 1 step d does recite the polymer film is dissolved on contact with a semi-solid culture medium, this step occurs after deposition of the foam composition onto the tested surface, drying, and removal of the dried composition from the surface being tested. Thus, claim 1 step d’s dissolution is not relevant to the formation of the foam composition. Accordingly, there is no antecedent basis for the term “the dissolved” film-forming water soluble synthetic polymer that is recited to be used to form the foam composition. Applicant may delete the term “dissolved” in order to obviate this rejection.
Similarly, claim 18 is unclear because the claim recites the film-forming water soluble synthetic polymer is dissolved in a solution, whereas parent claim 1 requires the film-forming water soluble synthetic polymer to be in the form of a foam composition, not a solution. Thus, it is unclear when or how the film-forming water soluble synthetic polymer dissolved in a solution becomes a foam composition as required by claim 1 step a.
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 nonobviousness.
Claims 1, 4, 6-10, 15-16, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Imaoka et al. (WO 2018043636 A1, published 08 March 2018), in view of Zimbro et al. (Difco & BBL Manual, Manual of Microbiological Culture Media, Second Edition, Becton Dickinson and Company, 2009, hereinafter “Zimbro”), and Newman et al. (US 7938255 B2, 10 May 2011), and as evidenced by Sigma Aldrich (Polysorbate 80 CAS number 9005-65-6 Safety Data Sheet, publication date 07 January 2024).
Regarding claims 1, 4, 6, 8-10, and 18, Imaoka teaches a method of detecting and identifying skin resident bacteria by applying a solution containing water-soluble polymer polyvinyl alcohol (PVA) to a skin surface, allowing the solution to dry into a thin film, peeling off the thin film that now contains the living bacteria, dissolving the polymer film into an aqueous solvent, and analyzing the resident bacteria (Imaoka claims 1-2, Pg. 5 para. 8). Regarding claim 18, since a solution containing the water-soluble polymer PVA is applied to the skin surface in the form of a solution, the water soluble PVA was dissolved in the solution prior to the application on the skin surface. The PVA solution is taught to have viscosity (Imaoka claim 8). Imaoka also teaches different analysis/detection methods, including inoculating and incubating a culture medium to measure viable bacteria (Imaoka Pg. 6 para. 2, and Pg. 8 para. 6). The water soluble polymer was taught by Imaoka to be polyvinyl alcohol (PVA) (Imaoka claims 1-2).
However, Imaoka does not teach that the composition is in the form of a foam, that the solution comprising polyvinyl alcohol polymer further comprises a surfactant, the use of its method on inert surfaces, or that the polyvinyl alcohol polymer film is soluble on the surface of a semi-solid culture medium.
Zimbro teaches the use of solid culture medium tryptic soy agar in combination with surfactant polysorbate 80 in methods of monitoring and evaluating cleaning procedures in environmental sanitation in cosmetic and pharmaceutical industries by measuring the presence and number of microorganisms on flat impervious (inert) surfaces by application of the media onto the test surface (Zimbro Pg. 571 Summary and Explanation para. 1-2). Zimbro also teaches that polysorbate 80 is a commonly used neutralizer, added to the media to inactive residual disinfectants, such as phenolic disinfectants, when the sample is being collected (Zimbro Pg. 571 Principles of the Procedure sentences 2-3). Zimbro also teaches that culture media are aqueous solutions because purified water is used as the solvent to prepare the media (Zimbro Pg. 571 Directions for Preparation step 1). Prepared agar culture media, including the media taught by Zimbro, is readily known by one of ordinary skill in the art to be semi-solid. Also, since the semi-solid culture media are taught to be aqueous and thus contains water, one of ordinary skill in the art would conclude that the PVA polymer would be dissolved on contact with the semi-solid culture medium due to the water present in the semi-solid culture medium. Zimbro also teaches that polysorbate 80 is present in an amount of 5% m/v in the media (Zimbro Pg. 571 Formulae 5.0 g polysorbate 80 per liter of prepared media).
Zimbro does not teach that polysorbate 80 is added in an amount of 5% v/v in the media, as required by amended instant claim 10. However, MPEP §2144.05(I) para. 2 states “a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of "having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium" as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. "The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties.)”. In the instant case, the density of polysorbate 80 is 1.06 g/cm3 or g/mL, which means that 5 grams of polysorbate 80 would be equal to 4.72 mL of polysorbate 80 (5 grams / 1.06 grams/mL = 4.72 mL), as evidenced by Sigma (Sigma Page 4). This means that the weight in grams of polysorbate 80 is close to the volume in milliliters of polysorbate 80. Therefore, the amount of polysorbate 80 taught in the art to be added to the composition (5% w/v) is so close to the amount of polysorbate 80 recited in the claims to be added to the composition (5% v/v) that prima facie one of ordinary skill in the art would conclude that they would have the same properties within the composition, especially absent evidence to the contrary.
However, Zimbro does not teach that the composition is in the form of a foam.
Newman teaches of making a polyvinyl alcohol foam that has many advantageous properties, such as impressive retention and wicking properties, mechanical strength and abrasion resistance, the adaptability of the foam pore size and shape, and the ability to withstand the action of acids and solutions of common cleaning detergents (Newman Col. 8 lns. 35-46). Newman also teaches that when left untreated, the foam does not contribute to the growth of bacteria or molds (Newman Col. 8 lns. 46-47).
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the present invention to combine the microorganism detection method of Imaoka with the foam composition of Newman, using the industry-standard guidance taught by Zimbro and to measure and detect microorganism presence on living surfaces, as well as on inert surfaces, especially in the cosmetic and pharmaceutical industries, in order to monitor and evaluate subject health and cleaning procedures (Zimbro Pg. 571 Summary and Explanation para. 1-2).
One of ordinary skill in the art would have been motivated to make the film-forming PVA solution in the form of a foam because doing so provides many advantages including impressive retention and wicking properties, mechanical strength and abrasion resistance, the adaptability of the foam pore size and shape, the ability to withstand the action of acids and solutions of common cleaning detergents, and the ability to not contribute to the growth of bacteria or molds (Newman Col. 8 lns. 35-47). One of skill in the art would find it advantageous to have an adaptable shape-forming foam with resistance to common cleaning detergents and with impressive wicking properties to sample a surface for microbial contamination. One of skill in the art would find it especially advantageous that the foam would not contribute to growth of bacteria or molds on the surface or inside the foam until after it has been dissolved onto the surface of nutrient agar, thereby not skewing the sampling results. One of ordinary skill in the art would have a reasonable expectation of success because they would readily understand that the method of Imaoka would reasonably and predictably apply equally to inert surfaces as much as it does to skin surfaces because the active method steps would be functionally identical when used on inert surfaces, and that by adding polysorbate 80 to the polymer solution any residual disinfectants left behind during a cleaning procedure would be neutralized upon applying the polymer solution to the inert surface being tested, and since culture media are aqueous solutions the polymer film would be predictably expected to dissolve onto aqueous semi-solid culture media such as agar media.
One of ordinary skill in the art would have been motivated to add 5% v/v of surfactant polysorbate 80 to the polyvinyl alcohol solution of Imaoka because it was known that polysorbate 80 is a commonly used neutralizer of residual disinfectants for surfaces being microbiologically monitored (Zimbro Pg. 571 Principles of the Procedure sentences 2-3).
One of ordinary skill in the art would have been motivated to dissolve the polyvinyl alcohol film onto a semi-solid aqueous culture media with a reasonable expectation of success because doing so would reduce the amount of steps and materials required to detect and/or identify the microorganisms, i.e. an aqueous transfer solution, such as physiological saline, would not be necessary.
Regarding claim 7, Imaoka teaches the PVA solution has a concentration of PVA between 10 to 30% m/v (Imaoka claim 9), and the PVA is also taught to have an average molecular weight of 2,200 to 132,000 g/mol (Imaoka Pg. 4 para. 11).
Regarding claim 15, Imaoka teaches the application of a solution containing film-forming water-soluble polymer polyvinyl alcohol (PVA) to a skin surface (Imaoka claims 1-2, Pg. 5 para. 8), the liquid solution containing water-soluble polymer PVA would mix with the gases in the air (the gases in the air would be introduced or exposed to the liquid solution containing water-soluble polymer PVA) as a consequence of the deposition of the film-forming water-soluble PVA polymer onto the skin surface, and thus the teachings of Imaoka meet the limitations of claim 15.
Regarding claim 16, Imaoka teaches applying a solution containing water-soluble polymer polyvinyl alcohol (PVA) to a skin surface and then allowing the solution to dry into a thin film (Imaoka claims 1-2, Pg. 5 para. 8), and the PVA solution is taught to have viscosity (Imaoka claim 8). The solution containing water-soluble polymer PVA taught by Imaoka is liquid and/or viscous after deposition onto the skin surface, but then dries into a thin polymer film. Therefore, the water-soluble polymer PVA solution of Imaoka would be in a liquid and/or viscous form after deposition onto the surface and before the formation of the polymer film, and thus meets the limitations of instant claim 16.
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Imaoka, Zimbro, and Newman as applied to claims 1, 4, 6-10, 15-16, and 18 above, and further in view of Willcock (Beneath the surface: stainless steel for pharma production, Cleanroom Technology, 08 September 2014).
Imaoka, Zimbro, and Newman do not teach that the surface is a rough surface such as stainless steel.
Willcock teaches that stainless steel is a highly attractive material for use in environments where it will be exposed to chemicals, liquids, or foods (Willcock Pg. 1 para. 1 sentence 1). Willcock also teaches that in the pharmaceutical industry stainless steel is the most commonly used material due to its tolerance of constant cleaning (Willcock Pg. 4 para. 5 sentence 1).
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the present invention to apply the obvious method of Imaoka, Zimbro, and Newman as described above onto a stainless steel surface because Zimbro taught that there was a known need in the art to measure and detect microorganism presence on inert surfaces, especially in the cosmetic and pharmaceutical industries, in order to monitor and evaluate subject health and cleaning procedures (Zimbro Pg. 571 Summary and Explanation para. 1-2). Such inert surfaces commonly used in the cosmetic and pharmaceutical industries include stainless steel (Willcock Pg. 4 para. 5 sentence 1). One of ordinary skill in the art would have a reasonable expectation of success because Newman teaches that PVA foams have impressive retention and wicking properties, adaptability to change pore size and shape, and the ability to withstand the action of acids and solutions of common cleaning detergents (Newman Col. 8 lns. 35-46). Thus, one of skill in the art would recognize that these properties of the PVA foam would result in an advantageously better recovery rate as compared to a liquid composition being used for the same purpose because the foam composition would easily conform to the texture and shape of the surface such as rougher stainless steel and the microbial contaminants would be easily wicked up into the foam due to the impressive wicking properties of the PVA foam.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Imaoka, Zimbro, and Newman as applied to claims 1, 4, 6-10, 15-16, and 18 above, and further in view of Colosi et al. (Morphological Comparison of PVA Scaffolds Obtained by Gas Foaming and Microfluidic Foaming Techniques, Langmuir 2013, 29, 82−91).
Imaoka, Zimbro, and Newman do not teach that the PVA foam composition is formed by bubbling gas into a solution comprising the film-forming water-soluble synthetic polymer PVA.
Colosi teaches methods of forming a PVA foam composition by bubbling argon gas into a solution comprising the film-forming water-soluble synthetic polymer PVA (Colosi abstract, pg. 83 sec. 2.2, and pg. 84 sec. 2.2.2).
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the present invention to form the PVA foam composition used in Imaoka, Zimbro, and Newman’s method by bubbling gas into a solution comprising the film-forming water-soluble synthetic polymer PVA. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success because Colosi taught that a PVA foam can be produced by bubbling a gas into a solution comprising PVA, and that these “gas-in-liquid” and “microfluidic foaming” PVA foaming processes have the advantage of excluding organic solvents that are harmful to cultured cells, which would be contradictory to the goals of Imaoka, Zimbro, and Newman’s method of detecting microorganisms on a surface (Colosi pg. 83 left col. para. 2). Thus, one of ordinary skill in the art would understand that Colosi’s method of forming a PVA foam would advantageously produce a PVA foam composition that is not harmful to cultured cells, such as the target microorganisms that Imaoka, Zimbro, and Newman’s method is intended to detect and/or identify.
Response to Arguments
Applicant's arguments filed 25 July 2025 have been fully considered but they are not persuasive.
Applicant argues that Newman has nothing to do with detecting microorganisms because it relates to an altogether different invention: a soft contact lens package made of a PVA foam, and that it would be highly doubtful that one of ordinary skill in the art would even look at the teachings of Newman with respect to a contact lens package that includes an altogether different PVA foam sponge for a completely different purpose (Remarks Pg. 6-7 bridging para.).
Applicant argues that Newman is not analogous art per MPEP 2141.01(a)(I) because (1) Newman is not from the same field of endeavor as the instant invention because it relates to an altogether different invention: a soft contact lens package made of a PVA foam, and (2) Newman is not reasonably pertinent to the problem faced by the present inventors because Newman teaches nothing about the use of a foam composition to improve recovery of microorganisms on inert surfaces, and the instant invention’s foam composition solves the problem faced by the inventors for detecting microorganisms on surfaces have, namely the introduction of organic material to sensitive areas, such as controlled areas, which can be a source of contamination, a lack of reproducibility, low efficiency, and difficulty standardizing (Remarks Pg. 6 through pg. 7 para. 1).
The Newman reference was relied upon in the 103 rejections to teach that the water-soluble film-forming PVA solution taught by Imaoka is capable of forming a foam, and that there are many advantages for doing so. For example, Newman teaches making a PVA foam introduces many advantages, such as providing impressive retention and wicking properties, mechanical strength and abrasion resistance, the adaptability of the foam pore size and shape, and the ability to withstand the action of acids and solutions of common cleaning detergents (Newman Col. 8 lns. 35-46). Newman also teaches that when left untreated, the foam does not contribute to the growth of bacteria or molds (Newman Col. 8 lns. 46-47), which is advantageous in the method of Imaoka because a water-soluble film-forming PVA foam would not contribute to growth of bacteria or molds on the surface or inside the PVA foam until after it has dried into a thin film, been peeled off of the surface, dissolved onto the surface of a semi-solid surface (nutrient agar), and then incubated in sufficient growth conditions. This means that sampling results would not be skewed towards artificially high bacteria and/or mold counts, and also means that water-soluble film-forming PVA foam would not leave behind organic matter which can promote bacterial and mold growth on the surface. Newman does not need to be in the same field of endeavor because it is being used to teach the advantages or benefits discussed above for having the water-soluble film-forming PVA of Imaoka in a foam form. Accordingly, one of ordinary skill in the art would have recognized that the shared nexus between Imaoka and Newman is the same water-soluble film-forming synthetic polymer PVA, and thus would have reasonably expected the foam properties taught by Newman to be advantageous in the obvious method of Imaoka in view of Zimbro.
Applicant argues that Examiner misunderstands the analogous art requirement and Examiner has not established that Newman is either (1) from the same field of endeavor as the instant invention, or (2) is reasonably pertinent to the problem faced by the present inventors (Remarks pg. 7 para. 2).
Newman is used to teach the advantages or benefits discussed above for having the water-soluble film-forming PVA of Imaoka in a foam form. Accordingly, one of ordinary skill in the art would have recognized that there is a shared nexus between Imaoka and Newman because the two use the same water-soluble film-forming synthetic polymer PVA, and thus one of ordinary skill in the art would have reasonably expected the properties of the PVA foam as taught by Newman would be present and advantageous in the obvious method of Imaoka in view of Zimbro. Newman describes the PVA foam’s properties.
MPEP 2141.01(a)(I) states that the Supreme Court’s decision in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007), did not change the test for analogous art as stated in Bigio. Under Bigio, a reference need not be from the same field of endeavor as the claimed invention in order to be analogous art. Bigio, 381 F.3d at 1325, 72 USPQ2d at 1212. This is consistent with the Supreme Court's instruction in KSR that "[w]hen a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one." KSR, 550 U.S. at 417, 82 USPQ2d at 1396. The Federal Circuit reads KSR as "direct[ing] us to construe the scope of analogous art broadly" because "familiar items may have obvious uses beyond their primary purposes, and a person of ordinary skill often will be able to fit the teachings of multiple patents together like pieces of a puzzle." Wyers v. Master Lock Co., 616 F.3d 1231, 1238, 95 USPQ2d 1525, 1530 (Fed. Cir. 2010) (quoting KSR, 550 U.S. at 402, 127 S. Ct. at 1727).
Applicant argues that the instant invention’s foam is formed by introducing has bubbles into the liquid polymer compound, which is distinct from the foam of Newman; thus Newman’s foam would not be capable of being dried to allow the formation of a polymer film (Remarks pg. 8 para. 1 through pg. 9 para. 2).
Newman is not being used to teach the polymer film itself. Newman is used to teach properties and advantages of PVA foams. Applicant’s arguments regarding Newman’s formation and uses of their PVA foam is not convincing to overcome the prima facie case of obviousness because the means with which Newman forms their foam composition is not being relied upon. Rather, reference Imaoka teaches the foam formation and use in the method. The nexus between Imaoka and Newman is the same water-soluble film-forming synthetic polymer, PVA.
Conclusion
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/Alexander M Duryee/Examiner, Art Unit 1657