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 .
Applicant’s response filed 03/10/2026 has been received and entered into the case. All arguments and amendments have been considered.
Claims 1-8, 18, 19, 21, 22, 23 are pending. Claims 18 and 19 are withdrawn. Claim 1-8, 21-23 have been considered on the merits. All arguments and amendments have been considered.
New rejections necessitated by amendment
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.
Claims 1-8, 21-23 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.
Specifically, the amendment “…comprises one or more phosphate buffer salts and a total phosphate buffer concentration of the one or more phosphate buffer salts is…” in claim 1 and 6 introduces new matter, which is not described in the specification as originally filed. Applicants specification discloses that “(0010)The effective amount of the salt compound, when dissolved in the liquid composition, is present at a concentration of at least 0.5 mM and up to 50 mM of the salt compound in the liquid composition” and at (0078) “The ionic conditions (e.g., concentration) of the salt compound, when dissolved in the liquid composition, should be such that the enzyme and enzyme substrate are not substantially affected in a way that hinders detection of the enzyme activity. In some embodiments, the salt compound is used as part of the liquid composition, such as phosphate buffers, (e.g. phosphate buffered saline solution, potassium phosphate or potassium phosphate dibasic), tris(hydroxymethyl) aminomethane-HCl solution, or acetate buffer, or any other buffer suitable for sterilization known in the art. Salt compounds suitable for the present biological indicators should be compatible with fluorogenic and chromogenic enzyme substrates used as part of the liquid composition. Another consideration in choosing the salt compound is their influence on the enzyme activity. For example, a phosphate may contain a relatively high concentration of inorganic phosphate, which is a competitive inhibitor of alkaline phosphatase. Thus, for that enzyme, a Tris-HCl buffer is recommended. Example 1 discloses adding a phosphate buffer to a nutrient medium, wherein a potassium phosphate buffer is added to the nutrient medium and the potassium phosphate concentration in the buffer is taught at 0.25M (0123, 0124).
Thus, the specification teaches that the salt is added to a liquid composition which may be a buffer solution, however, the term “phosphate buffer salts” and “total phosphate buffer concentration” is not disclosed. Further, it is not clear if the amendment is intending to limit the buffer to a phosphate buffer and if any salt can be added to the phosphate buffer, for example, the additional salts of claim 2. It is not clear and there is no support for what “phosphate buffer salts” means with regards to applicant' s invention. Therefore, the amendment changes the scope of the claims and applicants invention for which no support is provided. This is a new matter rejection.
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 1-8, 21-23 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.
Specifically, claim 1 and 6 have been amended to include the terms “comprises one or more phosphate buffer salts and a total phosphate buffer concentration of the one or more phosphate buffer salts”. It is not clear if applicants claim is limited to salts added to phosphate buffer or if phosphate salts are added to a buffer.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 6-8 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Chandrapati et al. (US10047334, IDS) as evidenced by by Soto et al. (US20180245122).
The Examiner’s claim interpretation of claim 6 is that the claim is drawn to a “kit” which includes a housing, a plurality of test microorganisms, a nutrient composition, an enzyme substrate, a liquid composition and an effective amount of salt disposed in the housing in dry form separate from the liquid composition and is mixed with the test microorganisms prior to be being dissolved in the liquid composition. The amount of salt is taken to be an effect of what happens after a dissolving step and does not impart structure to the claimed product as currently claimed.
Regarding claim 6, Chandrapati teaches a biological sterilization indicator comprising a housing (col. 9, lines 24-53, col. 10 ,lines 54-col. 11, lines 1-7), spores as a source of biological activity, i.e. test microorganisms capable of producing an enzyme which cleaves an enzyme substrate (col. 4, lines 10-59, col. 7, lines 15-48, col. 19, lines 55-67), an enzyme substrate (col. 7, lines 28-33, 49-67), a liquid composition (col. 3, lines 58-67, col. 23, lines 30-52, for example) and a salt compound in the housing which is dried with the microorganisms (col. 1, lines 60-col. 2, lines 1-19, col. 3, lines 18-40, 58-67, col. 5, lines 25-51). The spores are on a spore carrier (col. 5, lines 25-32, col. 24, lines 35-62) wherein the spores can be mixed with a nutrient medium in dry form (col. 24, lines 51-60). The nutrient medium is taught to be Tryptic Soy broth, which contains dipotassium phosphate as a buffer (Ex. 1), for support see Soto (0009) who teach TSB to contain dipotassium phosphate as a buffer.
Regarding claim 7, the nutrient composition, enzyme substrate , liquid composition, microorganisms, and salt compound are disposed in the housing (col. 9, lines 24-col. 12, for example, see entire document, Fig. 1-6).
Regarding claim 8, the liquid composition is in a frangible container (col. 9, lines, 54-col. 10, lines 1-8, col. 24, lines 35-62, col. 25, lines 21-48, col. 6, lines 32-col. 7, lines 1-3, particularly lines 54-60, 65-67, for example).
Thus, the reference anticipates the claimed subject matter.
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.
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) 1-5, 21-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Franciskovich et al. (US2012/0196355) in view of Soto et al. (US20180245122).
Regarding claim 1, Franciskovich (US’355) teaches self-contained biological indicator comprising a carrier , i.e. housing; the carrier containing: a plurality of test microorganisms comprising and/or capable of producing an enzyme capable of catalyzing a cleavage of an enzyme substrate (0034-0036, 0039, 0047, 0048);
the enzyme substrate (0053, 0054, 0058, 0059, 0060, 0077);
an incubation medium comprising a nutrient source, i.e. a nutrient composition , wherein the nutrient composition facilitates germination and/or outgrowth of the plurality of test microorganisms (0041);
a container containing a liquid composition, wherein the container is adapted to allow selective fluid communication between the liquid composition and the plurality of test microorganisms (0033, 0039, 0040, 0044) and the liquid composition is in a frangible container, i.e. the tube and closure cap having projections which “When sterilization has been completed, the closure cap 46 is pressed downwardly into the tapered tube 42. The projections 48 press against the inner compartment 44 and cause it to rupture (0033); and
an effective amount of a salt compound, i.e. sodium salt, potassium salts, magnesium salts, manganese salts, calcium salts, metallic salts, sodium chloride, potassium chloride, magnesium sulfate, iron chloride, N,N-Bis(2-hydroxyethyl)-2-aminoethanesulfonic acid (BES), N,N-Bis(2-hydroxyethyl)glycine (Bicine), 3-(N-Morpholino)propanesulfonic acid (MOPS) and mixtures of two or more thereof (0041); wherein the salt compound is mixed with the plurality of test microorganisms in the incubation medium (0041), and when the salt compound is dissolved in the liquid composition, the salt compound is disclosed to be present in amounts ranging from 0.1 to about 1000g/l (of pH buffers which include the claimed salts, specifically dipotassium phosphate (0044)) and from about 0.1 to 50 g/l of agents for maintaining osmotic equilibrium which include the claimed salts (0041).
Regarding claim 2, the salt is sodium salt, potassium salts, magnesium salts, manganese salts, calcium salts, metallic salts, sodium chloride, potassium chloride, magnesium sulfate, iron chloride, N,N-Bis(2-hydroxyethyl)-2-aminoethanesulfonic acid (BES), N,N-Bis(2-hydroxyethyl)glycine (Bicine), 3-(N-Morpholino)propanesulfonic acid (MOPS) and mixtures of two or more thereof (0041)
Regarding claim 3, the enzyme is beta-D-glucosidase, alpha-D-glucosidase, alkaline phosphatase, acid phosphatase, butyrate esterase, caprylate esterase lipase, myristate lipase, leucine aminopeptidase, valine aminopeptidase, chymotrypsin, phosphohydrolase, alpha-D-galactosidase, beta-D-galactosidase, alpha-L-arabinofuranosidase, N-acetyl-beta-glucosaminidase, beta-D-cellobiosidase, aminopeptidase, beta-D-glucuronidase (0050-0053)
Regarding claim 4, the enzyme substrate comprises derivatives of 4-methylumbelliferone or 7-amido-4-methyl-coumarin (0053, 0054, 0058, 0059, 0060)
Regarding claim 5, the enzyme is alpha-D-glucosidase and the substate comprises 4-methylumbelliferyl-α-D-glucopyranoside (0050, 0051, 0077)
Regarding claim 21, the liquid composition, which includes salt, i.e. phosphate, or acetate buffer has a pH in the range of 5-about 9.5 (0078-0080). See MPEP2144.05
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%." The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) (Claim reciting thickness of a protective layer as falling within a range of "50 to 100 Angstroms" considered prima facie obvious in view of prior art reference teaching that "for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms]." The court stated that "by stating that ‘suitable protection’ is provided if the protective layer is ‘about’ 100 Angstroms thick, [the prior art reference] directly teaches the use of a thickness within [applicant’s] claimed range.")
Regarding the concentration of salt present at a concentration of at least 25 mM and up to 50 mM, while paragraph (0044) exemplifies dipotassium phosphate present at a concentration of 14.35 mM, the reference suggests that salts may be present in amounts ranging from 0.1 to about 1000g/l (of pH buffers which include the claimed salts) and from about 0.1 to 50 g/l of agents for maintaining osmotic equilibrium which include the claimed salts (0041). Therefore, a particular salt and its concentrations may be adjusted and determined using routine optimization.
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) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also 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 2144.05
Further, Soto teaches a biological indicator comprising test microorganisms producing an enzyme capable of cleaving an enzyme substrate (0002, 0003, 0023, 0031, 0032), an enzyme substrate (0018, 0037-0045), a nutrient composition, a container comprising a liquid composition, i.e. recovery medium comprising a salt compound (0013-0019, 0034, 0036) and potassium and dipotassium phosphate as a buffer (0009, 0036) according to claims 22, 23. Soto teaches the pH of the medium to range from 7.2-up to about 11 (0048). Soto teaches that the recovery medium contains salts within the concentration ranges indicated in Table 1, which teach low and high salt concentration range (0051, Table 1, 2) and exemplify those concentrations in Table 2, which when calculated equal 59 mM. Soto demonstrates that the salt concentrations to be used in a biological indicator producing a fluorescently detectable compound can be optimized and can fall within the disclosed low to high concentration ranges which would fall within applicants claimed range. Therefore, given that the art discloses general ranges, it would be within the purview of one of ordinary skill in the art to discover the optimum or workable ranges by routine experimentation.
Thus, the claimed invention is prima facie obvious in view of the teachings of the prior art.
Claim(s) 1-5, 21-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Franciskovich et al. (US20080070272 A1) in view of Soto et al. (US20180245122).
Regarding claim 1, Franciskovich (US’272) teaches self-contained biological indicator comprising a carrier , i.e. housing; the carrier (0008, 0023) containing: a plurality of test microorganisms comprising and/or capable of producing an enzyme capable of catalyzing a cleavage of an enzyme substrate (0032, 0033, 0039);
the enzyme substrate (0039);
an incubation medium comprising a nutrient source, i.e. a nutrient composition , wherein the nutrient composition facilitates germination and/or outgrowth of the plurality of test microorganisms (0039);
a container containing a liquid composition, wherein the container is adapted to allow selective fluid communication between the liquid composition and the plurality of test microorganisms (0033, 0039, 0040, 0044), the liquid composition is in a frangible container (0031) ; and
an effective amount of a salt compound, i.e. sodium salt, potassium salts, magnesium salts, manganese salts, calcium salts, metallic salts, sodium chloride, potassium chloride, magnesium sulfate, iron chloride, N,N-Bis(2-hydroxyethyl)-2-aminoethanesulfonic acid (BES), N,N-Bis(2-hydroxyethyl)glycine (Bicine), 3-(N-Morpholino)propanesulfonic acid (MOPS) and mixtures of two or more thereof (0039); wherein the salt compound is mixed with the plurality of test microorganisms in the incubation medium (0039), and when the salt compound is dissolved in the liquid composition, the salt compound is disclosed to be present in amounts ranging from 0.1 to about 1000g/l (of pH buffers which include the claimed salts) and from about 0.1 to 50 g/l of agents for maintaining osmotic equilibrium which include the claimed salts (0039).
Regarding claim 2, the salt is sodium salt, potassium salts, magnesium salts, manganese salts, calcium salts, metallic salts, sodium chloride, potassium chloride, magnesium sulfate, iron chloride, N,N-Bis(2-hydroxyethyl)-2-aminoethanesulfonic acid (BES), N,N-Bis(2-hydroxyethyl)glycine (Bicine), 3-(N-Morpholino)propanesulfonic acid (MOPS) and mixtures of two or more thereof (0039)
Regarding claim 3, the enzyme is beta-D-glucosidase, alpha-D-glucosidase, alkaline phosphatase, acid phosphatase, butyrate esterase, caprylate esterase lipase, myristate lipase, leucine aminopeptidase, valine aminopeptidase, chymotrypsin, phosphohydrolase, alpha-D-galactosidase, beta-D-galactosidase, alpha-L-arabinofuranosidase, N-acetyl-beta-glucosaminidase, beta-D-cellobiosidase, aminopeptidase, beta-D-glucuronidase (0048-0050)
Regarding claim 4, the enzyme substrate comprises derivatives of 4-methylumbelliferone or 7-amido-4-methyl-coumarin (0051, 0052, 0056, 0057)
Regarding claim 5, the enzyme is alpha-D-glucosidase and the substate comprises 4-methylumbelliferyl-α-D-glucopyranoside (0061, 0075)
Regarding claim 21, the liquid composition, which includes salt, i.e. phosphate, or acetate buffer has a pH in the range of 5-about 9.5 (0078-0080). See MPEP2144.05
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%." The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) (Claim reciting thickness of a protective layer as falling within a range of "50 to 100 Angstroms" considered prima facie obvious in view of prior art reference teaching that "for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms]." The court stated that "by stating that ‘suitable protection’ is provided if the protective layer is ‘about’ 100 Angstroms thick, [the prior art reference] directly teaches the use of a thickness within [applicant’s] claimed range.")
Regarding the concentration of salt present at a concentration of at least 25 mM and up to 50 mM, while paragraph (0044) exemplifies dipotassium phosphate present at a concentration of 14.35 mM, the reference suggests that salts may be present in amounts ranging from 0.1 to about 1000g/l (of pH buffers which include the claimed salts) and from about 0.1 to 50 g/l of agents for maintaining osmotic equilibrium which include the claimed salts (0041). Therefore, a particular salt and its concentrations may be adjusted and determined using routine optimization.
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) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also 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 2144.05
Further, Soto teaches a biological indicator comprising test microorganisms producing an enzyme capable of cleaving an enzyme substrate (0002, 0003, 0023, 0031, 0032), an enzyme substrate (0018, 0037-0045), a nutrient composition, a container comprising a liquid composition, i.e. recovery medium comprising a salt compound (0013-0019, 0034, 0036) and potassium and dipotassium phosphate as a buffer (0009, 0036) according to claims 22, 23. Soto teaches the pH of the medium to range from 7.2-up to about 11 (0048). Soto teaches that the recovery medium contains salts within the concentration ranges indicated in Table 1, which teach low and high salt concentration range (0051, Table 1, 2) and exemplify those concentrations in Table 2, which when calculated equal 59 mM. Soto demonstrates that the salt concentrations to be used in a biological indicator producing a fluorescently detectable compound can be optimized and can fall within the disclosed low to high concentration ranges which would fall within applicants claimed range. Therefore, given that the art discloses general ranges, it would be within the purview of one of ordinary skill in the art to discover the optimum or workable ranges by routine experimentation.
Thus, the claimed invention is prima facie obvious in view of the teachings of the prior art.
Claim(s) 1-5, 21-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chandrapati et al. (US20160186120) in view of Franciskovich et al. (US20120196355 and US20080070272 A1) and Soto et al. (US20180245122).
Regarding claim 1, Chandrapati teaches self-contained biological indicator comprising a housing; the housing containing: a plurality of test microorganisms comprising and/or capable of producing an enzyme capable of catalyzing a cleavage of an enzyme substrate (abstract, 0006, 0020, 0021, 0025, 0033, 0034, 0043, 0044, 0089-0095, 0183);
the enzyme substrate (0089-0095);
an incubation medium comprising a nutrient source, i.e. a nutrient medium, wherein the nutrient medium facilitates germination and/or outgrowth of the plurality of test microorganisms (0019, 0112, 0113);
a container containing a liquid composition, wherein the container is adapted to allow selective fluid communication between the liquid composition and the plurality of test microorganisms (0017, 0024, 0025, 0117) ; and
an effective amount of a salt compound, i.e. potassium salts, calcium salts, including potassium chloride, and calcium chloride (0113); wherein the salt compound is mixed with the plurality of test microorganisms in the incubation medium, and when the salt compound is dissolved in the liquid composition.
Regarding claim 2, the salt is potassium salts, calcium salts, including potassium chloride, and calcium chloride (0113).
Regarding claim 3, the enzyme is beta-D-glucosidase, alpha-D-glucosidase, alkaline phosphatase, acid phosphatase, butyrate esterase, caprylate esterase lipase, myristate lipase, leucine aminopeptidase, valine aminopeptidase, chymotrypsin, phosphohydrolase, alpha-D-galactosidase, beta-D-galactosidase, alpha-L-arabinofuranosidase, N-acetyl-beta-glucosaminidase, beta-D-cellobiosidase, aminopeptidase, beta-D-glucuronidase (0033, 0037)
Regarding claim 4, the enzyme substrate comprises derivatives of 4-methylumbelliferone or 7-amido-4-methyl-coumarin (0089-0092)
Regarding claim 5, the enzyme is alpha-D-glucosidase and the substate comprises 4-methylumbelliferyl-α-D-glucopyranoside (0094, 0095)
Regarding claim 8, the liquid composition is in a frangible container (0019, 0024, 0029, 0045, 0285).
The reference differs from the claimed invention in that the concentration of salt according to claims 1.
Franciskovich (US’355) teaches self-contained biological indicator comprising a carrier , i.e. housing; the carrier containing: a plurality of test microorganisms comprising and/or capable of producing an enzyme capable of catalyzing a cleavage of an enzyme substrate (0034-0036, 0039, 0047, 0048);
the enzyme substrate (0053, 0054, 0058, 0059, 0060, 0077);
an incubation medium comprising a nutrient source, i.e. a nutrient composition , wherein the nutrient composition facilitates germination and/or outgrowth of the plurality of test microorganisms (0041);
a container containing a liquid composition, wherein the container is adapted to allow selective fluid communication between the liquid composition and the plurality of test microorganisms (0033, 0039, 0040, 0044) ; and
an effective amount of a salt compound, i.e. sodium salt, potassium salts, magnesium salts, manganese salts, calcium salts, metallic salts, sodium chloride, potassium chloride, magnesium sulfate, iron chloride, N,N-Bis(2-hydroxyethyl)-2-aminoethanesulfonic acid (BES), N,N-Bis(2-hydroxyethyl)glycine (Bicine), 3-(N-Morpholino)propanesulfonic acid (MOPS) and mixtures of two or more thereof (0041); wherein the salt compound is mixed with the plurality of test microorganisms in the incubation medium (0041), and when the salt compound is dissolved in the liquid composition, the salt compound is disclosed to be present in amounts ranging from 0.1 to about 1000g/l (of pH buffers which include the claimed salts) and from about 0.1 to 50 g/l of agents for maintaining osmotic equilibrium which include the claimed salts (0041).
Thus, before the effective filing date of the claimed invention, it would have been obvious to add a salt compound to the indicator of Chandrapati given the teachings of Franciskovich because a person or ordinary skill in the art has good reason to pursue known options within his or her technical grasp with a reasonable expectation of success.
Regarding claim 21, the liquid composition, which includes salt, i.e. phosphate, or acetate buffer has a pH in the range of 5-about 9.5 (0078-0080). See MPEP2144.05
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%." The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) (Claim reciting thickness of a protective layer as falling within a range of "50 to 100 Angstroms" considered prima facie obvious in view of prior art reference teaching that "for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms]." The court stated that "by stating that ‘suitable protection’ is provided if the protective layer is ‘about’ 100 Angstroms thick, [the prior art reference] directly teaches the use of a thickness within [applicant’s] claimed range.")
Regarding the concentration of salt present at a concentration of at least 25 mM and up to 50 mM, while paragraph (0044) exemplifies dipotassium phosphate present at a concentration of 14.35 mM, the reference suggests that salts may be present in amounts ranging from 0.1 to about 1000g/l (of pH buffers which include the claimed salts) and from about 0.1 to 50 g/l of agents for maintaining osmotic equilibrium which include the claimed salts (0041). Therefore, a particular salt and its concentrations may be adjusted and determined using routine optimization.
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) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also 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 2144.05
Further, Soto teaches a biological indicator comprising test microorganisms producing an enzyme capable of cleaving an enzyme substrate (0002, 0003, 0023, 0031, 0032), an enzyme substrate (0018, 0037-0045), a nutrient composition, a container comprising a liquid composition, i.e. recovery medium comprising a salt compound (0013-0019, 0034, 0036) and potassium and dipotassium phosphate as a buffer (0009, 0036) according to claims 22, 23. Soto teaches the pH of the medium to range from 7.2-up to about 11 (0048). Soto teaches that the recovery medium contains salts within the concentration ranges indicated in Table 1, which teach low and high salt concentration range (0051, Table 1, 2) and exemplify those concentrations in Table 2, which when calculated equal 59 mM. Soto demonstrates that the salt concentrations to be used in a biological indicator producing a fluorescently detectable compound can be optimized and can fall within the disclosed low to high concentration ranges which would fall within applicants claimed range. Therefore, given that the art discloses general ranges, it would be within the purview of one of ordinary skill in the art to discover the optimum or workable ranges by routine experimentation.
Claim(s) 1-9, 21-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Swaminathan et al. (US20180015193 A1) in view of Franciskovich et al. (US20120196355 and US20080070272 A1) and Soto et al. (US20180245122).
Regarding claim 1, Swaminathan teaches self-contained biological indicator comprising a housing/carrier; the carrier containing: a plurality of test microorganisms comprising and/or capable of producing an enzyme capable of catalyzing a cleavage of an enzyme substrate (abstract, 0009, 0010, 0015, 0016, 0039, 0041, 0057, 0069, 0077);
the enzyme substrate (0069, 0083, 0180);
an incubation medium comprising a nutrient source, i.e. a nutrient medium, wherein the nutrient medium facilitates germination and/or outgrowth of the plurality of test microorganisms (0041, 0092, 0113);
a container containing a liquid composition, wherein the container is adapted to allow selective fluid communication between the liquid composition and the plurality of test microorganisms (0042, 0052) and the liquid composition is in a frangible container, for example, a sealed, openable, liquid-impermeable inner container containing growth medium is crushed by compressing an outer container, releasing the growth medium and bringing it into contact with the test microorganism (optionally, supported by a carrier) in the outer container (0059, 0064, 0065, 0088, 0092).
Regarding claim 3, the enzyme is beta-D-glucosidase, alpha-D-glucosidase, alkaline phosphatase, acid phosphatase, butyrate esterase, caprylate esterase lipase, myristate lipase, leucine aminopeptidase, valine aminopeptidase, chymotrypsin, phosphohydrolase, alpha-D-galactosidase, beta-D-galactosidase, alpha-L-arabinofuranosidase, N-acetyl-beta-glucosaminidase, beta-D-cellobiosidase, aminopeptidase, beta-D-glucuronidase (0077)
Regarding claim 4, the enzyme substrate comprises derivatives of 4-methylumbelliferone or 7-amido-4-methyl-coumarin including 4-methylumbelliferyl-glucoside (MUG) (0180)
Regarding claim 5, the enzyme is alpha-D-glucosidase as it is the enzyme identified in G. stearothermophilus (0080) and the substate comprises 4-methylumbelliferyl-α-D-glucopyranoside (0180)
The reference differs from the claimed invention in that the use of a salt and the concentration of salt according to claims 1.
Franciskovich (US’355) teaches self-contained biological indicator comprising a carrier , i.e. housing; the carrier containing: a plurality of test microorganisms comprising and/or capable of producing an enzyme capable of catalyzing a cleavage of an enzyme substrate (0034-0036, 0039, 0047, 0048);
the enzyme substrate (0053, 0054, 0058, 0059, 0060, 0077);
an incubation medium comprising a nutrient source, i.e. a nutrient composition , wherein the nutrient composition facilitates germination and/or outgrowth of the plurality of test microorganisms (0041);
a container containing a liquid composition, wherein the container is adapted to allow selective fluid communication between the liquid composition and the plurality of test microorganisms (0033, 0039, 0040, 0044) ; and
an effective amount of a salt compound, i.e. sodium salt, potassium salts, magnesium salts, manganese salts, calcium salts, metallic salts, sodium chloride, potassium chloride, magnesium sulfate, iron chloride, N,N-Bis(2-hydroxyethyl)-2-aminoethanesulfonic acid (BES), N,N-Bis(2-hydroxyethyl)glycine (Bicine), 3-(N-Morpholino)propanesulfonic acid (MOPS) and mixtures of two or more thereof (0041); wherein the salt compound is mixed with the plurality of test microorganisms in the incubation medium (0041), and when the salt compound is dissolved in the liquid composition, the salt compound is disclosed to be present in amounts ranging from 0.1 to about 1000g/l (of pH buffers which include the claimed salts) and from about 0.1 to 50 g/l of agents for maintaining osmotic equilibrium which include the claimed salts (0041).
Thus, before the effective filing date of the claimed invention, it would have been obvious to add a salt compound to the indicator of Swaminathan given the teachings of Franciskovich because a person or ordinary skill in the art has good reason to pursue known options within his or her technical grasp with a reasonable expectation of success.
Regarding claim 21, the liquid composition, which includes salt, i.e. phosphate, or acetate buffer has a pH in the range of 5-about 9.5 (0078-0080). See MPEP2144.05
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%." The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) (Claim reciting thickness of a protective layer as falling within a range of "50 to 100 Angstroms" considered prima facie obvious in view of prior art reference teaching that "for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms]." The court stated that "by stating that ‘suitable protection’ is provided if the protective layer is ‘about’ 100 Angstroms thick, [the prior art reference] directly teaches the use of a thickness within [applicant’s] claimed range.")
Regarding the concentration of salt present at a concentration of at least 25 mM and up to 50 mM, while paragraph (0044) exemplifies dipotassium phosphate present at a concentration of 14.35 mM, the reference suggests that salts may be present in amounts ranging from 0.1 to about 1000g/l (of pH buffers which include the claimed salts) and from about 0.1 to 50 g/l of agents for maintaining osmotic equilibrium which include the claimed salts (0041). Therefore, a particular salt and its concentrations may be adjusted and determined using routine optimization.
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) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also 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 2144.05
Further, Soto teaches a biological indicator comprising test microorganisms producing an enzyme capable of cleaving an enzyme substrate (0002, 0003, 0023, 0031, 0032), an enzyme substrate (0018, 0037-0045), a nutrient composition, a container comprising a liquid composition, i.e. recovery medium comprising a salt compound (0013-0019, 0034, 0036) and potassium and dipotassium phosphate as a buffer (0009, 0036) according to claims 22, 23. Soto teaches the pH of the medium to range from 7.2-up to about 11 (0048). Soto teaches that the recovery medium contains salts within the concentration ranges indicated in Table 1, which teach low and high salt concentration range (0051, Table 1, 2) and exemplify those concentrations in Table 2, which when calculated equal 59 mM. Soto demonstrates that the salt concentrations to be used in a biological indicator producing a fluorescently detectable compound can be optimized and can fall within the disclosed low to high concentration ranges which would fall within applicants claimed range. Therefore, given that the art discloses general ranges, it would be within the purview of one of ordinary skill in the art to discover the optimum or workable ranges by routine experimentation.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-5, 21-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 12228555 in view of Franciskovich et al. (US20120196355 and US20080070272 A1) and Soto et al. (US20180245122).
Although the claims at issue are not identical, they are not patentably distinct from each other because the inventions are drawn to self-contained biological indicators comprising a housing, a source of biological activity (microorganisms), the source comprising and/or capable of producing an enzyme capable of catalyzing a cleavage of an enzyme substrate; and a container comprising a liquid composition, comprising the enzyme substrate; wherein the container allows the liquid composition to contact a bacterial spore. The enzyme in the self-contained biological is selected from the group consisting of α-glucosidase, α-galactosidase, lipase, esterase, acid phosphatase, alkaline phosphatase, proteases, aminopeptidase, chymotrypsin, β-glucosidase, β-galactosidase, α-glucoronidase, β-glucoronidase, phosphohydrolase, plasmin, thrombin, trypsin, calpain, α-mannosidase, β-mannosidase, a-L-fucosidase, leucine aminopeptidase, a-L-arabinofuranosidase, cysteine aminopeptidase, valine aminopeptidase, β-xylosidase, α-L-iduronidase, glucanase, cellobiosidase, cellulase, α-arabinosidase, glycanase, sulfatase, butyrate, glycosidase, arabinosidase, and a combination thereof and the enzyme substrate comprises a derivative of 4-methylumbelliferone or a derivative of 7-amino-4-methylcoumarin. Further, both inventions claim that the enzyme comprises α-D-glucosidase, wherein the enzyme substrate comprises 4-methylumbelliferyl-α-D-glucopyranoside.
The instant claims differ in that they require a salt compound.
Franciskovich (US’355) teaches self-contained biological indicator comprising a carrier , i.e. housing; the carrier containing: a plurality of test microorganisms comprising and/or capable of producing an enzyme capable of catalyzing a cleavage of an enzyme substrate (0034-0036, 0039, 0047, 0048);
the enzyme substrate (0053, 0054, 0058, 0059, 0060, 0077);
an incubation medium comprising a nutrient source, i.e. a nutrient composition , wherein the nutrient composition facilitates germination and/or outgrowth of the plurality of test microorganisms (0041);
a container containing a liquid composition, wherein the container is adapted to allow selective fluid communication between the liquid composition and the plurality of test microorganisms (0033, 0039, 0040, 0044) ; and
an effective amount of a salt compound, i.e. sodium salt, potassium salts, magnesium salts, manganese salts, calcium salts, metallic salts, sodium chloride, potassium chloride, magnesium sulfate, iron chloride, N,N-Bis(2-hydroxyethyl)-2-aminoethanesulfonic acid (BES), N,N-Bis(2-hydroxyethyl)glycine (Bicine), 3-(N-Morpholino)propanesulfonic acid (MOPS) and mixtures of two or more thereof (0041); wherein the salt compound is mixed with the plurality of test microorganisms in the incubation medium (0041), and when the salt compound is dissolved in the liquid composition, the salt compound is disclosed to be present in amounts ranging from 0.1 to about 1000g/l (of pH buffers which include the claimed salts) and from about 0.1 to 50 g/l of agents for maintaining osmotic equilibrium which include the claimed salts (0041).
Regarding claim 21, the liquid composition, which includes salt, i.e. phosphate, or acetate buffer has a pH in the range of 5-about 9.5 (0078-0080). See MPEP2144.05
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%." The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) (Claim reciting thickness of a protective layer as falling within a range of "50 to 100 Angstroms" considered prima facie obvious in view of prior art reference teaching that "for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms]." The court stated that "by stating that ‘suitable protection’ is provided if the protective layer is ‘about’ 100 Angstroms thick, [the prior art reference] directly teaches the use of a thickness within [applicant’s] claimed range.")
Thus, it would have been obvious to add a salt compound to the indicator of US’555 given the teachings of Franciskovich because a person or ordinary skill in the art has good reason to pursue known options within his or her technical grasp with a reasonable expectation of success.
Regarding the concentration of salt present at a concentration of at least 25 mM and up to 50 mM, while paragraph (0044) exemplifies dipotassium phosphate present at a concentration of 14.35 mM, the reference suggests that salts may be present in amounts ranging from 0.1 to about 1000g/l (of pH buffers which include the claimed salts) and from about 0.1 to 50 g/l of agents for maintaining osmotic equilibrium which include the claimed salts (0041). Therefore, a particular salt and its concentrations may be adjusted and determined using routine optimization.
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) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also 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 2144.05
Further, Soto teaches a biological indicator comprising test microorganisms producing an enzyme capable of cleaving an enzyme substrate (0002, 0003, 0023, 0031, 0032), an enzyme substrate (0018, 0037-0045), a nutrient composition, a container comprising a liquid composition, i.e. recovery medium comprising a salt compound (0013-0019, 0034, 0036) and potassium and dipotassium phosphate as a buffer (0009, 0036) according to claims 22, 23. Soto teaches the pH of the medium to range from 7.2-up to about 11 (0048). Soto teaches that the recovery medium contains salts within the concentration ranges indicated in Table 1, which teach low and high salt concentration range (0051, Table 1, 2) and exemplify those concentrations in Table 2, which when calculated equal 59 mM. Soto demonstrates that the salt concentrations to be used in a biological indicator producing a fluorescently detectable compound can be optimized and can fall within the disclosed low to high concentration ranges which would fall within applicants claimed range. Therefore, given that the art discloses general ranges, it would be within the purview of one of ordinary skill in the art to discover the optimum or workable ranges by routine experimentation.
Response to Arguments
Applicant's arguments filed 3/10/2026 have been fully considered but they are not persuasive. Regarding the 103 rejections, Applicants argue that the claimed product yields unexpected results; that when using the claimed salt concentrations of at least 25 mM and up to 50 mM there is an increase in the enzymes activity and provides fluorescent intensity that is stable for up to 2 hours after initiating a kinetic assay. Applicants provide data from Table 1, 3 and 5 to demonstrate unexpected results and criticality regarding fluorescence positive performance, faster fluorescence time and enzymatic kinetic data, when the liquid composition includes the phosphate buffer salt and thus the composition exhibits measurable-structural function behavior. Applicants argue that the enzyme activity, fluorescence intensity and time-to-positive are physical measurable effects.
Applicants unexpected results and criticality are directed to the intended use of the indicator and when the salt is dissolved in a composition, which is not required in the claimed product. The concentration of salt is important and critical when the salt is dissolved in a composition. The present claimed product does not claim the salt to be in the liquid composition, only that “when the salt compound is dissolved”, it has a specific concentration, and the measurable effects are a result of the use of the indicator and the dissolving of the salt in a composition, and not the current claimed product itself. The prior art of record demonstrates that salt concentrations used in biological indicators are optimizable within the low and high ranges, which would fall within applicants claimed range. Therefore, given that the art discloses general ranges, it would be within the purview of one of ordinary skill in the art to discover the optimum or workable ranges by routine experimentation.
Regarding Franciskovich (355), applicants argue their teaching of a low buffering capacity medium; however, the reference teaches that their medium may focus on how rapidly growth may be detected, and thus, related to the intended use of the product.
Regarding Soto, applicants argue that while Soto exemplify about 23mM of phosphate buffer concentration (in Table 2), the reference does not provide motivation to reach a higher total phosphate buffer concentration recited in the pending claims.
The Soto reference teaches low to high ranges of phosphate salts to be used in the biological indicator (Table 1), which the claimed ranges would lie inside of those taught by Soto.
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%." The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) (Claim reciting thickness of a protective layer as falling within a range of "50 to 100 Angstroms" considered prima facie obvious in view of prior art reference teaching that "for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms]." The court stated that "by stating that ‘suitable protection’ is provided if the protective layer is ‘about’ 100 Angstroms thick, [the prior art reference] directly teaches the use of a thickness within [applicant’s] claimed range.").
Regarding applicants arguments directed to Franciskovich(272) that the reference teaches that “phosphate buffered saline contains high concentration of inorganic phosphate which is a strong competitive inhibitor of alkaline phosphatase and thus a Tris-HCl buffer maybe used”, the same statement is found in applicants specification at (0078), however, this statement is buffer and enzyme specific, which is not commensurate in scope with the current claims. Further, in this regard, applicants criticality may additionally lie in specificity of enzyme, enzyme substrate and buffer used.
Applicants wish to hold the ODP rejection is abeyance until allowable subject matter is indicated.
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 TIFFANY MAUREEN GOUGH whose telephone number is (571)272-0697. The examiner can normally be reached M-Thu 8-5.
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/TIFFANY M GOUGH/ Examiner, Art Unit 1651
/MELENIE L GORDON/Supervisory Patent Examiner, Art Unit 1651
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