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 .
Applicants' arguments, filed 12/16/2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 112—Scope of Enablement (new by amendment)
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.
Claims 14-18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for stabilizing a certain species or type of catalase for at least 75 days at 37ºC with dipropylene glycol at certain concentrations, does not reasonably provide enablement for stabilizing catalase (genera) for at least 75 days at 37ºC with stabilizers comprising hydroxyl groups, generally, as claimed. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
Applicant’s argument supports the Offices notion of limited enablement, stating, ”Every propylene-glycol formulation failed at or before day 32, i.e., the residual peroxide readout was greater than 50 mg/L at the first date tested (day 32, i.e., the residual peroxide readout was greater than 50 mg/L at the first date tested (day 32), and none reached even 66 days, let alone 75-day point now recited in independent claim 14. . . . These data demonstrate that the performance feature recited in independent claim 14 is not an inherent property of ‘catalase + any hydroxyl stabilizer,’’ (Remarks p. 7 of 14). Note: propylene glycol suffices as a stabilizer comprising hydroxyl groups.
To be enabling, the specification of the patent must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993). Explaining what is meant by “undue experimentation,” the Federal Circuit has stated:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which the experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996).1
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth by In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors:
1) the quantity of experimentation necessary,
2) the amount of direction or guidance provided,
3) the presence or absence of working examples,
4) the nature of the invention,
5) the state of the prior art,
6) the relative skill of those in the art,
7) the predictability of the art, and
8) the breadth of the claims.
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
1. The nature of the invention, state and predictability of the art, and relative
skill level
The invention relates to storage stable aqueous compositions for removing calculus comprising catalase and a stabilizer. The relative skill of those in the art is high, that of an MD or PHD. That factor is outweighed, however, by the unpredictable nature of the art. As illustrative of the state of the art, the examiner cites Costa et al. (Enzyme and Microbial Technology, 2002). Costa et al. is pertinent for teaching, “The resistance of the catalytically active protein structure toward high temperatures, pHs and other denaturing influences is one of the most important criteria for commercialization and for industrial application of the enzymes” (p. 387, Introduction). Further, for purposes of stability, “The selection of the appropriate additive depends on the nature of the enzyme” (Id.) The authors discovered, “Amines, polyethylene glycol and glycerol shifted the pH activity maximum of the native catalase toward more alkaline region, while glycerol were the only additive to improve the temperature profile of the enzyme” (Abstract).
The breadth of the claims
The claims are broadly drawn to use of any catalase and any stabilizer comprising hydroxyl groups. The claims do not consider the nature of the catalase, influence of additives, nor pH, which are important factors of consideration for the commercialization and for industrial application of the enzymes, as discussed by the reference above.
3. The amount of direction or guidance provided and the presence or absence of working examples
The specification provides no direction or guidance for practicing the claimed invention in its “full scope”. No reasonably specific guidance is provided concerning useful protocols for carrying out the invention as claimed, other than catalase from specialty enzymes and biotechnology and dipropylene glycol. The latter is corroborated by the working examples. Table 3 of the instant specification shows that a formulation comprising 5% catalase and 5% dipropylene glycol achieved only 67 days of stability (p. 10). It is clear from applicant’s examples that the storage stability of catalase for at least 75 days cannot be achieved by simply combining a catalase with a stabilizer comprising hydroxyl groups, as claimed.
4. The quantity of experimentation necessary
Because of the known unpredictability of the art, and in the absence of experimental evidence, no one skilled in the art would accept the assertion that the instantly claimed agents could be predictably used as inferred by the claim and contemplated by the specification. Accordingly, the instant claims do not comply with the enablement requirement of §112, since to practice the claimed invention in its “full scope” a person of ordinary skill in the art would have to engage in undue experimentation, with no reasonable expectation of success.
Claim Rejections - 35 USC § 102/103--Previous
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
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.
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.
Claim(s) 14, 16-18 remain rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Desrosiers et al., (EP 3214180).
Desrosiers et al. teaches “a method for determining the cleanness of a surface comprising: applying on a zone of a surface an enzymatic solution comprising catalase and letting it dry” (Absract).
The prior art teaches the following embodiments of the enzymatic solution comprising catalase: “Composition A consisting of: - from 0.001% to 19%w/w of catalase corresponding to about 42 U/g to about 806 000 U/g; - from 0% to 10% w/w of propylene glycol; - from 0% to 0.01% w/w of chloro-2-methyl-4-isothiazolin-3-one; - from 0% to 5% w/w of ethoxylated C12-C15 alcohols; and - from 0% to 99.999% w/w of solvent selected from isopropanol, demineralized water and mixture thereof;” and
“Composition B consisting of: - 0.11% w/w of catalase corresponding to 4780 U/g; - 1% w/w of propylene glycol; - 0.0004% w/w of chloro-2-methyl-4-isothiazolin-3-one; - 0.085% w/w of ethoxylated C12-C15 alcohols; - 30% w/w of isopropanol; - 68.9146% w/w of demineralized water” (p. 3-4).
Both are free of amine compounds, as per claim 18.
The prior art is anticipatory insofar as it teaches an aqueous composition comprising catalase and a stabilizer comprising hydroxyl groups, i.e., propylene glycol.
Both compositions present as capable of performing the claimed intended use. Assuming that the combination is not sufficient enough to rise to the level of anticipation, it would have been obvious to combine catalase with a stabilizer comprising hydroxyl groups, since the prior art teaches adding propylene glycol to the catalase compositions.
Since the compositions comprise catalase and stabilizer comprising hydroxyl groups, after storage for at least 75 days at 37ºC, the aqueous composition would have comprised less than 50 mg/l of hydrogen peroxide when reacted with a 3% hydrogen peroxide solution, as per claim 16.
Claim Rejections - 35 USC § 103--Previous
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.
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.
Claim(s) 15 remains rejected under 35 U.S.C. 103 as being unpatentable over Desrosiers et al., (EP 3214180) as applied to claim 14 above, and further in view of Petronella et al., (US 4,720,352).
Desrosiers et al., which is taught above, differs from claim 15 insofar as it does not teach dipropylene glycol.
Petronella et a. teaches solutions of complexed mixed soaps of vanadium (Abstract), where “a stabilizer . . . can be used in the process of this invention” (col. 3, lines 56-58). Further, “As a stabilizer we use hydroxy-containing compounds such as alkanols containing from 1 to 10 carbon atoms, glycols having from 3 to 14 carbon atoms, glycol monoethers having from 3 to 14 carbon atoms such as . . . propylene glycol or dipropylene glycol and mixtures thereof . . . We have found that quantities ranging from about 5% to about 15% by weight based on the total weight of all of the other ingredients give satisfactory results” (col. 3, line 58 through col. 4, line 6).
Generally, it is obvious to replace one component for another equivalent component if it is recognized in the art that two components are equivalent and is not based on the Applicant’s disclosure (see MPEP 2144.06).
In this case, it would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to replace the propylene glycol of Desrosiers et al. with dipropylene glycol in view of the art recognized functional equivalence with propylene glycol, as taught by Petronella et al. The artisan would have reasonably expected success with the substitution since dipropylene glycol comprises propylene glycol, where propylene glycol is taught therein to function as a solvent/stabilizer (see p. 7, Table 1A).
Response to Arguments
i) Applicant argues does not teach the claimed wherein clause concerning storage stability. Applicant further argues that the stability profile is not an inherent property of the prior art simply because it fully and intrinsically sets forth all of the limitations of the claimed invention. Applicant presented Table 6 from the instant specification showing compositions comprising propylene glycol at varying concentrations and catalase at 5% and states, “none reached even 66 days, let alone 75-day point now recited in independent claim 14” (p. 7 of 14).
“Where . . . the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. Whether the rejection is based on “inherency” under 35 USC 102, on “prima facie obviousness” under 35 USC 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO's inability to manufacture products or to obtain and compare prior art products.” In re Best, 562 F.2d 1252, 1255 (CCPA 1977).
In this case, the prior art teaches two formulations comprising catalase and a stabilizer comprising hydroxyl groups, which fully and intrinsically sets forth all of the limitations of the claimed invention. Although the compositions of Table 6 in the instant specification comprise propylene glycol and catalase, they are not identical to the compositions of the prior art (applicant does not allege that they are the same). Since the prior art formulations anticipates the claimed combination of ingredients, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. No evidence has been presented proving that the compositions of the prior art do not inherently possess the claimed properties.
ii) Applicant argues that Petronella is not analogous art insofar as it “relates to the preparation of vanadium-containing mixed metal soap” (p. 9-12)
The Examiner disagrees.
In response to applicant's argument that Petronella is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Petronella is analogous as a secondary reference insofar as it teaches dipropylene glycol as a hydroxy-containing compound having equivalency with propylene glycol, as a stabilizer. The prior art and the instant specification teach the use polyols as stabilizers, which makes it reasonably pertinent to applicant’s concerns.
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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WALTER E WEBB whose telephone number is (571)270-3287 and fax number is (571) 270-4287. The examiner can normally be reached from Mon-Fri 7-3:30.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Walter E. Webb
/WALTER E WEBB/ Primary Examiner, Art Unit 1612
1 As pointed out by the court in In re Angstadt, 537 F.2d 498 at 504 (CCPA 1976), the key word is “undue”, not “experimentation”.
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