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
Applicant’s amendment filed on 11 May 2026 is entered. Claims 1 and 15-18 are amended. Claim 19 is new. Claims 1, 4, 6-12, 15-16, and 17-19 are pending.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
(New necessitated by amendment) Claims 1, 4, 6-12, and 15-19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
Claims 1 and 15-18 have been amended to recite a “liquid foam composition”. However, the instant disclosure has lacks written description support for a liquid foam composition. The specification describes the deposited composition comprising the film-forming water-soluble synthetic polymer as either a liquid and/or viscous composition, or a foam composition (see PGPB [0009], [0016], and [0024]). Since the foam composition is an alternative to the liquid and/or viscous composition, these specification paragraphs do not provide written support for a liquid foam composition. The rest of the disclosure, including the previous claim sets, also lack any recitation of a liquid foam composition.
Therefore, the new limitation “liquid foam composition” recited in claims 1 and 15-18, and dependent clams 4, 6-12, and 19, is not supported by written description within the original disclosure, and thus constitutes new matter not previously described within the disclosure.
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.
(New necessitated by amendment) Claims 1, 4, 6-10, and 15-19 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”), Colosi et al. (Morphological Comparison of PVA Scaffolds Obtained by Gas Foaming and Microfluidic Foaming Techniques, Langmuir 2013, 29, 82−91), and Jin et al. (US 8486676 B2, published 16 July 2013), 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, 15, and 17-18, 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 liquid foam, that the liquid foam solution is formed by introducing gas bubbles into the PVA solution during deposition on the surface, 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.
Zimbro does not teach that the composition is in the form of a liquid foam.
Colosi teaches methods of forming a liquid 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 combine Imaoka’s microorganism detection method with Colosi’s liquid foam composition 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 water soluble PVA solution in the form of a liquid foam with a reasonable expectation of success because Jin teaches that PVA foams are useful as carriers for immobilizing cells (Jin Abstract and col 3 lns 11-17), a useful property of PVA foams that one of ordinary skill in the art would recognize would enhance microorganism detection in Imaoka’s method.
One of ordinary skill in the art would have a reasonable expectation of success to use the obvious method on inert surfaces as well as skin surfaces because one of ordinary skill in the art would readily understand that the active method steps would be functionally identical when used on inert surfaces, and that by adding polysorbate 80 to the polymer solution, as taught by Zimbro, any residual disinfectants left behind during a cleaning procedure would be neutralized upon applying the liquid foam composition 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 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. The water-soluble PVA liquid foam of Imaoka in view of Zimbro and Colosi would be in a liquid foam form after deposition onto the surface, but before the formation of the polymer film, and thus meets the limitations of instant claim 16.
Regarding claim 19, Imaoka teaches the water-soluble polyvinyl alcohol (PVA) dries into a thin PVA film “network” that sufficiently collects/captures the microorganisms on the tested surface (Imaoka claims 1-2, Pg. 5 para. 8).
(New necessitated by amendment) Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Imaoka, Zimbro, Colosi, and Jin as applied to claims 1, 4, 6-10, and 15-19 above, and further in view of Willcock (Beneath the surface: stainless steel for pharma production, Cleanroom Technology, 08 September 2014).
Imaoka, Zimbro, Colosi, and Jin 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, Colosi, and Jin 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 the liquid PVA foam used in Imaoka, Zimbro, Colosi, and Jin’s method comprises polysorbate 80, which is a commonly used neutralizer of residual disinfectants for surfaces being microbiologically monitored (Zimbro Pg. 571 Principles of the Procedure sentences 2-3), and Jin teaches that PVA foams are useful as carriers for immobilizing cells (Jin Abstract and col 3 lns 11-17). Thus, one of ordinary skill in the art would recognize that these properties of the PVA liquid foam would result in an advantageously better recovery rate as compared to a liquid composition being used for the same purpose because the polysorbate 80 would neutralize any residual disinfectants on the stainless steel surface that might skew the detection results, and the liquid PVA foam would effectively immobilize the microbial cells that residue on the surface, ensuring that Imaoka, Zimbro, Colosi, and Jin’s method would accurately capture and evaluate the number and type of microbial cells present on the stainless steel surface.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 4, 6-12, and 15-18 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 Alexander M Duryee whose telephone number is (571)272-9377. The examiner can normally be reached Monday - Friday 9:00 am - 5:00 pm.
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/Alexander M Duryee/Examiner, Art Unit 1657
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