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 .
Status of Claims
Pursuant to the amendment dated 02/10/2026, new claim 68 has been added. Claims 3, 7-9, 11-22, 24, 25, 28, 30, 32-44, 46-49, and 51 were cancelled in a previous communication.
Claims 1, 2, 4-6, 10, 23, 26, 27, 29, 31, 45, 50, and 52-68 are pending and under current examination.
Withdrawn Rejections
The anticipation rejection has been withdrawn in view of the amendment to claims 1 and 2 requiring a range of available iodine of 0.3 to 1.5% wt in the initial iodophor composition because this implicitly imposes a limitation on the amount of available iodine in the final composition, and Bunting does not disclose the amount of available iodine in example compositions.
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.
Claim 68 is 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 68 recites “one or more polymer forming agents…” in line 5. This renders the claim indefinite because it is unclear what substances are embraced by the term. Anything from an atom to a pre-polymer, to e.g. uncrosslinked polymers could form another polymer; however, the only examples provided in specification are fully formed polymers rather than polymer precursors as implied by the term “polymer forming agent”. Thus the scope of the claim is indefinite.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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, 2, 4-6, 10, 23, 26, 27, 31, 45, 50, 52-60, and 62-67 are rejected under 35 U.S.C. 103 as being unpatentable over Bunting et al. (US 4,427,631; issue date: 01/24/1984; cited in the IDS filed 10/03/2022) as evidenced by Nguyen et al. (Cell Tissue Banking Vol 8, pages 81-91; publication year: 2008; of record), Huffer et al. (US 2002/0100194; publication date: 08/01/2002; of record), and Kolb et al. (US 20020004544; publication date: 01/10/2002; of record).
As noted in the anticipation rejection above Bunting anticipates claims 1, 2, 4-6, 10, 23, 26, 27, 31, 45, 56-60 and 62 and so in anticipating these claims, said claims are also considered obvious under 35 USC 103(a) over Bunting for the reasons set forth below ("lack of novelty is the epitome of obviousness" May, 574 F.2d at 1089, 197 USPQ at 607 (citing In re Pearson, 494 F.2d 1399, 1402, 181 USPQ 641, 644 (CCPA 1974))).
Bunting does not disclose the available iodine in the examples; however, Bunting discloses a range of at least 1% by weight iodine in col 5, lines 13). This range overlaps with the ranges in available iodine recited in instant claims 50, 53-55 and 63-66. Please see MPEP 2144.05 which states that when ranges disclosed in the prior art overlap with the ranges recited in the instant claims, a prima facie case of obviousness exists.
With regard to claims 1 and 2, which require the absence of any degradation byproducts produced by gamma irradiation of an initial iodophor composition, as noted above, the examiner considers this limitation to have been anticipated by Bunting. In the alternative, the limitation would have been prima facie obvious to one of ordinary skill because Bunting discloses this as the objective of their invention (abstract), Bunting provides a method of doing so (irradiating the composition in the presence of iodide and optionally iodate ions; abstract), and means for measuring success (gel permeation chromatography and observation of gellation; col 7).
With regard to claim 67, as described in the anticipation above, Bunting discloses a povidone-iodine (i.e. PVP-I) solution that has been sterilized by exposure to gamma irradiation in the presence of iodide, with or without iodate, ions to prevent the degradation of the povidone-iodine and gelation of iodine and povidone (abstract). Bunting discloses that the composition may contain alcohol (col 4, line 58). The examiner does not consider the limitation on amount of alcohol to patentably define over the cited prior art as it would have been a matter of routine to optimize the quantity of alcohol that would provide further disinfection, or tendency to evaporate on contact (see MPEP 2144.05).
With regard to the limitations of claims 1, 2, and 67 requiring the composition to have a sterility assurance level of 10-3 or less, and claims 10 and 59 requiring that the composition have a sterility assurance level of 10-6 or less, the compositions are irradiated with 2 - 30 megarads. This is equivalent to 20 - 300 kGy, using a conversion factor of 10 kGy = 1 Mrad (Huffer, para 0019). Nguyen discloses that 25 kGy was a standard dose of gamma radiation for achieving terminal sterilization (abstract) i.e. a sterility assurance level of 10-6 or less (page 81, right col). As the doses used in Bunting’s examples 1-3 and 5 are all above this threshold, the examiner considers Bunting to disclose compositions having the claimed sterility assurance levels.
With regard to claim 68, the relevant disclosures of Bunting, Nguyen, Hunter, and Kolb are set forth above.
With regard to the transitional phrase “consisting essentially of” recited in claim 68, the instant specification (see pages 32-33) indicates that this phrase is given its ordinary meaning in patent law and refers to MPEP 2111.03, which states “The transitional phrase ‘consisting essentially of’ limits the scope of a claim to the specified materials or steps ‘and those that do not materially affect the basic and novel characteristic(s)’ of the claimed invention. In re Herz, 537 F.2d 549, 551-52, 190 USPQ 461, 463 (CCPA 1976) (emphasis in original)”. Based upon the instant specification, the examiner considers the basic and novel characteristics of the instant invention to be a PVP-I solution lacking degradation products that may be formed during gamma-irradiation or prolonged heating beyond the duration indicated to be suitable for sterilizing the invention. See, e.g. page 1 of the specification, which states “known methods of sterilizing antiseptic compositions, such as exposure to gamma radiation, can have deleterious effects on iodophor compositions. Accordingly, improved systems and methods for sterilizing iodophor compositions are needed.” As this limitation has been fully addressed in the rejection of claims 1 and 2, the examiner considers the transitional phrase “consisting essentially of” not to patentably define over the cited prior art exactly as set forth in the rejection, supra.
With regard to the substances required by instant claim 68, Bunting contains the solvents water; thus the cited prior art renders obvious a sterilized iodophor composition, consisting essentially of: an iodine-polymer complex in an amount of at least 5.0 wt.% of the composition; and a solvent, wherein the sterilized iodophor composition has a sterility assurance level of 10-3 or less and a viscosity of 3000 cP or less.
Claims 29 and 61 are rejected under 35 U.S.C. 103 as being unpatentable over Bunting et al. (US 4,427,631; issue date: 01/24/1984; cited in the IDS filed 10/03/2022) as evidenced by Nguyen et al. (Cell Tissue Banking Vol 8, pages 81-91; publication year: 2008; of record), Huffer et al. (US 2002/0100194; publication date: 08/01/2002; of record), and Kolb et al. (US 20020004544; publication date: 01/10/2002; of record) as applied to claims 1, 2, 4-6, 10, 23, 26, 27, 31, 45, 50, 52-60, 62-66, and 68 above, and further in view of Rucinski (US 20010037095; publication date: 11/01/2001; of record).
The relevant disclosure of Bunting is set forth above. Bunting discloses further that the pH of the composition does not influence the protective effect exerted by the elemental iodine-iodide system unless such pH acts to destroy the iodine content and thereby modifies the ratio of iodine to iodide ion. Bunting does not disclose a specific pH range for the composition.
Rucinski discloses that a commonly used PVP-I scrub (betadine) has a pH of 4.5 (0070).
It would have been prima facie obvious to adjust the pH of Bunting’s composition to be within the range of 1.5 to 6.5 because one having ordinary skill in the art would have recognized values falling within this range to have been suitable for PVP-I solutions as of the instant effective filing date. See MPEP 2144.07.
Claims 1, 2, 4-6, 10, 23, 26, 27, 31, 45, 50, 52-60, and 62- 68 are rejected under 35 U.S.C. 103 as being unpatentable over Ernst et al. (US Patent 6,319,909; issue date: 11/20/2001; of record) in view of Aplicare (Povidone-lodine Products for Compliant Skin Antisepsis. (c) 2012 Clorox Professional Products Company, see NPL document submitted by third party on May 25, 2022; of record), Azo Materials (The Steam Sterilization Process, online; publication date: 11/19/2019), and Bunting et al. (US 4,427,631; issue date: 01/24/1984; cited in the IDS filed 10/03/2022).
It is noted that claims 1 and 2 recite product by process language. According to MPEP 2113: product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. “The structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art” therefore claims 1 and 2 are interpreted to claim a sterilized iodophor composition having sterility assurance level of 10-3 or less and a viscosity of 3000cP or less.
With regard to claims 1, 2, 10, 45, 59, and 62, Ernst et al. disclose a process for preparing liquid iodophores with poly-N-vinyllactams and dextrins as carrier materials, which comprises heating a mixture of the carrier materials, iodine and iodide ions or, in place of the iodide ions, a reducing agent, in aqueous medium in the presence of a monohydric or polyhydric alcohol having 1 to 6 carbon atoms at from 40 to 100 degrees Celsius (claim 1 of Ernst et al.). Specifically, Ernst et al. disclose that the iodophore is prepared by mixing the components and heating them at from 40 to 100, preferably 60 to 95 degrees Celsius wherein the reaction takes from 1 to 30 hours, depending on the amounts employed. In examples (col 5, example 4), 9% by weight polyvinylpyrrolidone (PVP K30) is mixed with dextrin and 6% by weight iodine in ethanol and water, followed by heating with stirring at 8C for four hours, and then another eight hours at 80C at which point the solution is cooled. The available iodine content based on solids was 13.2%, the iodine loss was 5.5%, the free iodine content was 8.2 ppm, the iodide content was 6.2% and the viscosity was 420 mPas. The composition contains 5-60% by weight polyvinyl pyrrolidone, 1-30% elemental iodine, and 0.5 – 15% iodide ions (col 1). This range overlaps with the range in amount of PVP-I required by instant claims 45 and 62. See MPEP 2144.05.
Thus, Ernst discloses an iodophor composition, wherein the iodophor composition is manufactured by a method comprising: heating an initial iodophor composition to produce the sterilized iodophor composition, wherein the iodophor composition has a viscosity of 3000 cP or less (noting that 1 cP is equivalent to 1 mPas), wherein heating the initial iodophor composition comprises exposing the initial iodophor composition to a sterilization temperature in a range from 65°C to 121C, wherein the method does not comprise gamma irradiation.
Ernst does not discuss sterility or mention the more specific criterion that the composition possess a sterility assurance level of 10-3 or less and the duration of exposure to elevated temperature in Ernst’s method is 12 hours rather than 1.5 minutes to 15 minutes.
Aplicare discloses a PVP-I solution that meets FDA standards for sterility and discloses that this is critical to patient and staff safety because sterility – the assurance that a product is not contaminated [with pathogenic microorganisms] – is key to delivering better patient outcomes and ensuring safety of medical teams. Incidences of product contamination have led to tragic patient outcomes and can be costly to a healthcare facility and its patient safety record (page 3).
Azo materials discloses that in the medical field the Sterility Assurance Level (SAL) must be considered when choosing the required lethality value for a specific application. The SAL required differs based on the application, but it is typically defined as sterile around 1/1,000,000, which means that only one out of a million bacteria will have survived the sterilization process (page 3). Thus, one having ordinary skill would have recognized a SAL of 10-6 as typical for the medical setting.
Azo discloses further that sterilization by heat depends upon both time of exposure and temperature. Specifically: As bacteria does not die instantly, time is a crucial factor, which is why a minimum time is needed in order to eliminate them all. The parameter is linked closely to temperature as the killing effect (death value/lethality value) is dependent on both. The correlation is logarithmic, which is why the same killing effect can be acquired by simply adjusting the exposure time and temperature accordingly. The killing effect is shown as the lethality value, which should reach the same value by sterilizing at 121 °C for 15 minutes as one would by sterilizing at 134 °C for 3 minutes. This means that quite a substantial amount of time can be saved by choosing 134 °C if a product is able to withstand the higher temperatures.
Bunting discloses that “while aqueous solutions of povidone are known to be relatively stable to heat, and short interval autoclaving has been used to sterilize povidone preparations, this use of heat is also known to cause degradation of the polymer. Thus for example, povidone which is stable to moderate heat will darken in color and decreases in water solubility when heated to about 150° C. The presence of certain substances in the povidone solution will accelerate cross-linking at even lower temperatures. When a povidone solution is heated to 100° C, in the alkaline pH range, the polymer becomes permanently altered to be irreversibly insoluble. Similar cross-linked changes occur when alkaline sodium phosphate buffers are used and when an oxidizing agent such as ammonium persulfate is added to a povidone solution, cross-linking gel formation occurs in about 30 minutes when the combination is heated at moderate temperatures of about 90° C.” (Col 2). Thus, in view of Bunting, one having ordinary skill in the art would have recognized that PVP-I could be heat sterilized but care must be taken in selecting a sterilization temperature in order to prevent cross-linking and degradation.
It would have been prima facie obvious to adjust time and temperature to achieve a SAL of 10-6 in the PVP-I solution disclosed by Ernst. The skilled artisan would have been motivated in view of Aplicare, to provide a sterile PVP-I solution so that it could be used for sterilization in settings where a patient would be susceptible to infection with bacteria, such as cleaning any body surface where the protective barrier of the skin is not intact. The skilled artisan would have had reasonable expectation of success because the relationship between time, temperature, sterility, and degradation of PVP were recognized as of the instant effective filing date. As noted above, the claims recite product by process language and the claims therefore do not require a step of heating to the specified temperature to the specified duration, but only that the sterilization method was equally mild such that the resulting solution is not distinguishable from a composition formed by the method recited in the instant claims. In view of the foregoing, one having ordinary skill would have had motivation and understanding to test heat sterilization times and temperatures to achieve a SAL of 10-6 while avoiding degradation or other damage to the product due to high temperature or prolonged heat exposure. With regard to the viscosity of the composition, Ernst’s examples possess viscosity well below the claims 3000 cP, and as noted above, one having ordinary skill would have had the understanding of how to sterilize the composition without affecting the chemical composition, particularly in view of Ernst’s disclosure that prolonged heating at 80C results in a functional solution.
With regard to claims 4-6 and 56-58, as noted above, Ernst discloses PVP-I.
With regard to claims 23, 27, and 31, as the claims are directed to a product and recite product by process language, limitations on the relative amounts of available iodine, pH, and viscosity of the starting material used to form the claimed composition vs. these values in the final product do not further limit the claimed composition itself and claims 23, 27, and 31 are obvious exactly as set forth above.
With regard to claims 26 and 60, Ernst’s compositions have an available iodine content of at least 1.0% (col 5).
With regard to claims 50, 53-55, and 63-66, Ernst does not discuss available iodine per se and Bunting does not disclose the available iodine in the examples; however, Bunting discloses a range of at least 1% by weight iodine in col 5, lines 13). It would have been prima facie obvious to formulate Ernst’s solutions to have the range of available iodine disclosed by Bunting because one having ordinary skill would have recognized this amount to be suitable for disinfection, see MPEP 2144.07 regarding the obviousness of art-recognized suitability. The range disclosed by Bunting overlaps with the ranges in available iodine recited in instant claims 50, 53-55 and 63-66. Please see MPEP 2144.05 which states that when ranges disclosed in the prior art overlap with the ranges recited in the instant claims, a prima facie case of obviousness exists.
With regard to claim 52, no mention is made of visible precipitate in the solutions that have been exposed to 80C for 12 hours in the presence of iodide, and the data indicate no physical changes to the composition and the objective is to generate a solution, therefore claim 52 is considered obvious.
With regard to claim 67, as noted above example 4 contains ethanol.
Claims 29 and 61 are rejected under 35 U.S.C. 103 as being unpatentable over Ernst et al. (US Patent 6,319,909; issue date: 11/20/2001; of record), Aplicare (Povidone-lodine Products for Compliant Skin Antisepsis. (c) 2012 Clorox Professional Products Company, see NPL document submitted by third party on May 25, 2022; of record), Azo Materials (The Steam Sterilization Process, online; publication date: 11/19/2019), and Bunting et al. (US 4,427,631; issue date: 01/24/1984; cited in the IDS filed 10/03/2022) as applied to claims 1, 2, 4-6, 10, 23, 26, 27, 31, 45, 50, 52-60, and 62-68 and further in view of Rucinski (US 20010037095; publication date: 11/01/2001; of record).
The relevant disclosures of Ernst, Aplicare, Azo Materials, and Bunting are set forth above. Bunting discloses further that the pH of the composition does not influence the protective effect exerted by the elemental iodine-iodide system unless such pH acts to destroy the iodine content and thereby modifies the ratio of iodine to iodide ion. None of these references disclose a specific pH range for the composition.
Rucinski discloses that a commonly used PVP-I scrub (betadine) has a pH of 4.5 (0070).
It would have been prima facie obvious to adjust the pH of Ernst’s composition to be within the range of 1.5 to 6.5 because one having ordinary skill in the art would have recognized values falling within this range to have been suitable for PVP-I solutions as of the instant effective filing date. See MPEP 2144.07.
With regard to claim 68, the relevant disclosures of Ernst, Aplicare, Azo Materials, and Bunting are set forth above.
With regard to the transitional phrase “consisting essentially of” recited in claim 68, the instant specification (see pages 32-33) indicates that this phrase is given its ordinary meaning in patent law and refers to MPEP 2111.03, which states “The transitional phrase ‘consisting essentially of’ limits the scope of a claim to the specified materials or steps ‘and those that do not materially affect the basic and novel characteristic(s)’ of the claimed invention. In re Herz, 537 F.2d 549, 551-52, 190 USPQ 461, 463 (CCPA 1976) (emphasis in original)”. Based upon the instant specification, the examiner considers the basic and novel characteristics of the instant invention to be a PVP-I solution lacking degradation products that may be formed during gamma-irradiation or prolonged heating beyond the duration indicated to be suitable for sterilizing the invention. See, e.g. page 1 of the specification, which states “known methods of sterilizing antiseptic compositions, such as exposure to gamma radiation, can have deleterious effects on iodophor compositions. Accordingly, improved systems and methods for sterilizing iodophor compositions are needed.” As Ernst does not expose the PVP-I solution to gamma-irradiation and it would have been obvious to one of ordinary skill to optimize duration and temperature of heat sterilization to avoid deleterious effects on the composition, the examiner considers the transitional phrase “consisting essentially of” not to patentably define over the cited prior art exactly as set forth in the rejection, supra.
With regard to the substances required by instant claim 68, Ernst contains the solvents water and ethanol; thus Ernst Aplicare, Azo Materials, and Bunting render obvious a sterilized iodophor composition, consisting essentially of: an iodine-polymer complex in an amount of at least 5.0 wt.% of the composition; and a solvent, wherein the sterilized iodophor composition has a sterility assurance level of 10-3 or less and a viscosity of 3000 cP or less.
Response to Arguments
Applicant's arguments filed 02/10/2026 have been fully considered but they are not persuasive.
On page 8, Applicant argues that new claim 68 distinguishes over Bunting because it relies on “consisting essentially of” language that distinguishes compositions comprising significant quantities of added iodide, the radiation exposure protectant added to the formulations of Bunting and relied on by Bunting to mitigate certain deleterious effects of radiation exposure.
The examiner respectfully disagrees with this narrower interpretation of the effect of the phrase “consisting essentially of” on the scope of the claims, see rejections above. The application, as filed, does not expressly state or imply that the amount of iodate in the composition is a basic and novel characteristic of the claimed invention.
On page 9, Applicant argues that Bunting does not teach a concentration of available iodine of 0.3 to 1.5 wt % in an initial iodophore composition that has not been exposed to sterilizing radiation. On page 9, Applicant argues that the Patent Office fails to appreciate the fact that there is a fundamental difference between the concentration of iodine (i.e. total iodine) and the amount of available iodine, citing Bunting’s statement:
The amount of such complexed water soluble forms of iodine to be used in place of the elemental iodine is based on its available iodine content which is determined by titration with standard thiosulfate or arsenite test solution. The amount of available iodine thus determined is used as an equivalent weight to the amount of elemental iodine.
Applicant argues further on page 10 that the available iodine in Bunting’s solutions cannot be inferred solely from the amount of povidone they contain and therefore Bunting does not teach overlapping ranges of available iodine content.
With regard to the limitation on amount of available iodine in the initial iodophor composition, this language is product by process language and is only limiting insomuch as it implies a limitation on the amount of available iodine in the claimed composition (i.e. the composition after exposure to the recited sterilization process). As the specification indicates that the sterilization process according to the instant invention has minimal effect on available iodine, the examiner considers this language to impart a loose limitation on the quantity of available iodine in the claimed composition. (See MPEP 2113: product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. “The structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art”).
The examiner maintains the opinion that Bunting provides sufficient information for one having ordinary skill in the art to optimize the quantity of available iodine in the composition. For clarity of the record, the examiner is well aware that total iodine is not necessarily equivalent to available iodine as explained in the portion of Bunting cited by Applicant on page 9 of the remarks. In the cited section, Bunting teaches using an amount of complexed iodine based on the amount of available iodine. The examiner considers this section to direct the artisan of ordinary skill to consider only available iodine quantity of complexed soluble iodine and therefore the percentage of iodine referred to in other sections of Bunting refers to available iodine. The foregoing notwithstanding, Bunting teaches available iodine is the species that provides antimicrobial effect of the composition and arriving at a suitable quantity of the recognized antimicrobial substance present in a composition intended to provide antimicrobial effect would have been merely routine for the artisan of ordinary skill. See MPEP 2144.05.
On page 10, Applicant argues that claims 1 and 2 are novel because the compositions of Bunting necessarily would contain irradiation byproducts resulting from gamma irradiation and materially affecting the composition that are precluded in the compositions according to claim 1.
The examiner respectfully disagrees for reasons of record. The examiner’s previously stated response to this position is replicated here for convenience:
As noted above, the claims employ product by process language to claim a composition (see MPEP 2113). Applicant has not provided evidence to contradict the examiner’s position that Bunting’s composition is indistinguishable from one manufactured according to the process recited in the instant claims. The limitation excluding sterilized iodophor compositions prepared by gamma irradiation does not limit a composition invention except insomuch as it imparts a structural limitation on the claimed composition. All measures of the consequences of exposing PVP-I to gamma irradiation that have been described in the specification (gamma irradiation generally causes deleterious effects (page 1); gamma radiation can induce degradation and/or gelation of povidone-iodine, thereby destroying or reducing its effectiveness (page 5)) are expressly described as absent from the PVP-I solutions described by Bunting (see rejection above). The preponderance of the evidence standard is the evidentiary standard that USPTO must meet in a patentability decision under any statute in order to shift the burden of proof to Applicant. As detailed in the rejection above, all measures of the negative impact of gamma irradiation appear to have been addressed by Bunting’s invention, such that no structural distinction would exist between Bunting’s PVP-I solutions and those circumscribed by the language recited in the instant claims. The examiner does not contest that the MPEP requires the examiner to establish that an inherent property necessarily is present, and the examiner maintains that she has done so under the preponderance of the evidence standard for the reasons stated above and in the rejection. MPEP 2112(IV) reads in part:
The fact that a certain result or characteristic may occur or be present in the prior art is not sufficient to establish the inherency of that result or characteristic. In re Rijckaert, 9 F.3d 1531, 1534, 28 USPQ2d 1955, 1957 (Fed. Cir. 1993) (reversed rejection because inherency was based on what would result due to optimization of conditions, not what was necessarily present in the prior art); In re Oelrich, 666 F.2d 578, 581-82, 212 USPQ 323, 326 (CCPA 1981). Also, "[a]n invitation to investigate is not an inherent disclosure" where a prior art reference "discloses no more than a broad genus of potential applications of its discoveries." Metabolite Labs., Inc. v. Lab. Corp. of Am. Holdings, 370 F.3d 1354, 1367, 71 USPQ2d 1081, 1091 (Fed. Cir. 2004) (explaining that "[a] prior art reference that discloses a genus still does not inherently disclose all species within that broad category" but must be examined to see if a disclosure of the claimed species has been made or whether the prior art reference merely invites further experimentation to find the species).
Thus, a property that must be reached by optimization of disclosed prior art parameters does not meet the requirement for inherency, nor does a broad genus necessarily inherently disclose each species belonging to the group. Analogously, a statistical likelihood cannot be relied upon to establish inherency. However, in this case, Bunting characterizes their invention as providing solutions whose physical and chemical properties remain unchanged after gamma irradiation. Applicant has failed to identify any structural characteristics imparted by Bunting’s method that are required to be absent from the instant invention, as claimed. (Please also see further discussion below regarding Applicant’s position that the instant claims exclude bacteria having degraded DNA.) This is sufficient under 35 USC 102 to shift the burden to Applicant to provide evidence that this is not the case. Finally, the examiner also notes that the claims have also been rejected under 35 USC 103 as obvious over Bunting because the objective in Bunting was to remove all adverse effects of gamma irradiation on PVP-I solutions, and Bunting provides methodology to do so. As explained previously, the examiner respectfully disagrees for the reasons detailed in the rejections under 35 USC §§ 102 and 103. Absent evidence that the methods disclosed by Bunting are not capable of achieving Bunting’s stated goal of preventing degradation of PVP-I during gamma irradiation, the rejection is maintained. When the reference relied on expressly anticipates or makes obvious all of the elements of the claimed invention, the reference is presumed to be operable. Once such a reference is found, the burden is on applicant to rebut the presumption of operability. In re Sasse, 629 F.2d 675, 207 USPQ 107 (CCPA 1980). Moreover, in this case Bunting expressly states that no degradation products were detectable in example 5. Finally, this limitation would have been obvious because preventing degradation of PVP-I due to exposure to gamma radiation is the objective of the invention and Bunting provides guidance as to how this may be accomplished and a means to test for success.
On page 11, Applicant argues that the absence of radiation degraded microorganisms is a patentably distinct feature of the inventions of independent claims 1 and 2 and that the Patent Office has not shown by any measure of evidence that similar byproducts could exist in a composition without exposure to a sterilizing dose of gamma irradiation.
The examiner maintains the opinion that there is nothing present in Bunting’s invention that is excluded by the product by process language recited in claims 1 and 2 for reasons of record. The examiner’s position is replicated here:
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the claims exclude bacteria having degraded DNA) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The phrase “wherein the method does not comprise gamma irradiation” does not exclude bacteria having degraded DNA because electron-beam irradiation (i.e. beta-irradiation) also degrades bacterial DNA (See Arshad, Food Sciences and Nutrition 2020, page 1021, left col: “Ionizing radiation destroys microbial cells by demolishing essential macromolecules such as DNA, RNA, and proteins. For example, the electrons disrupt the DNA chain or change the position of the DNA molecule”.) Therefore, excluding gamma irradiation but not other forms of ionizing radiation from the product by process language does not exclude the presence of bacteria having degraded DNA.
Moreover and most importantly, assuming arguendo, that the phrase “wherein the method does not comprise gamma irradiation” is interpreted to exclude bacteria whose DNA has been degraded, the claims continue to read on Bunting’s invention because the gamma irradiation is used to assure the absence of viable bacteria in case any were present in the PVP-I prior to end use. However, there are not necessarily bacteria present in the starting material, the sterilization is a precautionary measure to ensure that any bacteria that might have been introduced during preparation cannot infect a patient when applied to an area susceptible to infection. The possible presence of a wayward bacterium having degraded DNA is not a patentable distinction from the instant invention, as claimed.
On page 14, Applicant reminds the Office that Aplicare does not teach a PVP-I solution that meets the FDA standards of sterility for reasons of record.
The examiner respectfully disagrees for reasons of record (see discussion on pages 9-10 of the Office action mailed on 02/24/2025). However, in the instant case, Aplicare was not relied upon for a detailed methodology but rather for background information to establish that one having ordinary skill would have known that FDA standards for sterility are critical to patient and staff safety because sterility – the assurance that a product is not contaminated [with pathogenic microorganisms] – is key to delivering better patient outcomes and ensuring safety of medical teams. Incidences of product contamination have led to tragic patient outcomes and can be costly to a healthcare facility and its patient safety record. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
On page 14, Applicant argues that Bunting teaches away from heat sterilization because the deleterious effects on PVP-I composition are described in the background section and Bunting solves this problem with a different approach (stabilizing the compositions to gamma radiation exposure).
The examiner respectfully disagrees that this constitutes a teaching away. Bunting was cited to establish that the problem with long term heat sterilization of PVP-I solutions was recognized in the art as of the instant effective filing date, and the additional cited art provides evidence that the solution to this problem, optimizing time and temperature of heating, would have been obvious to the artisan of ordinary skill.
On page 15, Applicant argues that no cited reference provides a single example of heat sterilization of povidone actually being accomplished.
This is not persuasive because such is not the standard for an obviousness conclusion under 35 USC §103. See MPEP 2123(II): Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971).
On page 15, Applicant argues that there would have been no motivation to undertake lengthy and highly unpredictable experiments to develop a heat sterilization protocol for PVP-I.
The examiner respectfully disagrees with Applicant’s characterization of the type of experimentation required as lengthy and highly unpredictable. The relationship between time, temperature, and PVP-I degradation was known at the time the instant invention was filed and therefore sufficiently predictable. The experimentation would merely require testing several durations and temperatures to arrive at an acceptable stability profile for the method. "A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421, 82 USPQ2d 1385, 1397 (2007). "[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle." Id. at 420, 82 USPQ2d 1397. Office personnel may also take into account "the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418, 82 USPQ2d at 1396. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); see also In re Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."). See MPEP 2141.03 and 2144.05(II)(A). In the instant case, the artisan of ordinary skill is highly intelligent and well-educated. An individual with an advanced degree in pharmaceutical formulations science, such as a Ph.D., would have the capability and inclination to improve upon prior art products as needed by carrying out the type of routine testing of time and temperature noted above.
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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/KATHERINE PEEBLES/ Primary Examiner, Art Unit 1617
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