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 .
Election/Restrictions
Applicant's election with traverse of claims 1-17 in the reply filed on 8/25/2025 is acknowledged. The traversal is on the ground(s) that Witcher merely teaches C12-C22 alcohols and not a wax composition (greater than C22) linear or branched alkyl or alkenyl alcohols. This is not found persuasive because Witcher teaches a wax composition comprising C12-C22 linear or branched alkyl or alkenyl alcohols, thus considered to be long-chain linear or branched alkyl or alkenyl alcohols.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-20 are pending.
Claims 18-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 8/25/2025.
Claims 1-17 have been considered on the merits herein.
Specification
The disclosure is objected to because of the following informalities: The use of the term UNILIN™, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks. Appropriate correction is required.
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 1-17 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. Claim 1 recites “the wax composition comprises a long-chain (greater than C22) linear or branched alkyl or alkenyl alcohol; wherein the alkyl or alkenyl alcohol is not linked through an ester bond or an ether bond to a short chain alkyl or aryl (C1-C6) group; wherein the alkyl or alkenyl alcohol is not linked through an ester bond or an ether bond to a long chain (C8-C36) alkyl or alkenyl group; wherein the alkyl or alkenyl alcohol is not linked through an amide bond to a linear or branched long chain (C8-C36) alkyl or alkenyl amine or acid, wherein the wax composition has a melting point between 78-120°C”.
The specification exemplifies only UNILIN™ 350, 425, 550 and 700 as the wax composition and no description of what the UNILIN™ compositions are.
The specification does not provide adequate written description of the claimed genus of wax compositions comprising a long-chain linear or branched alkyl or alkenyl alcohol; wherein the alkyl or alkenyl alcohol is not linked through an ester bond or an ether bond to a short chain alkyl or aryl (C1-C6) group; wherein the alkyl or alkenyl alcohol is not linked through an ester bond or an ether bond to a long chain (C8-C36) alkyl or alkenyl group; wherein the alkyl or alkenyl alcohol is not linked through an amide bond to a linear or branched long chain (C8-C36) alkyl or alkenyl amine or acid” according to claim 1. Further, as seen below in the 112(b) rejection, the metes and bounds of “long-chain” are not clearly forth in the claims and the specification fails to provide an adequate description of a “long-chain” linear or branched alkyl or alkenyl alcohol. The legal standard for sufficiency of a patent's (or a specification's) written description is whether that description "reasonably conveys to the artisan that the inventor had possession at that time of the. . .claimed subject matter", Vas-Cath, Inc. V. Mahurkar, 19 USPQ2d 1111 (Fed. Cir. 1991). In the instant case, the specification does not convey to the artisan that the Applicant had possession at the time of invention of the genus of wax compositions according to claim 1.
The guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112, § 1 "Written Description" Requirement make clear that if a claimed genus does not show actual reduction to practice for a representative number of species, then the Requirement may be alternatively met by reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the Applicant was in possession of the genus (Federal Register, Vol. 66, No. 4, pages 1099-1111, Fri. January 5, 2001, see especially page 1106 column 3).
The specification does not provide adequate written description of the claimed invention. The legal standard for sufficiency of a patent's (or a specification's) written description is whether that description "reasonably conveys to the artisan that the inventor had possession at that time of the. . .claimed subject matter", Vas-Cath, Inc. V. Mahurkar, 19 USPQ2d 1111 (Fed. Cir. 1991). In the instant case, the specification does not convey to the artisan that the Applicant had possession at the time of invention of the claimed invention, i.e. the genus of wax compositions having long chain alcohols of either C8-C36 or greater than C22 according to claim 1.
The Federal Circuit addressed the application of the written description requirement to DNA-related inventions in University of California v. Eli Lilly and Co., 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997). The court stated that “[a] written description of an invention involving a chemical genus, like a description of a chemical species, requires a precise definition, such as by structure, formula, [or] chemical name, of the claimed subject matter sufficient to distinguish it from other materials.” Id. At 1567, 43 USPQ2d at 1405. The court concluded that “naming a type of material generally known to exist, in the absence of knowledge as to what that material consists of, is not a description of that material.” Id.
The Federal Circuit clarified that a molecule can be adequately described without disclosing its complete structure. See Enzo Biochem, Inc. V. Gen-Probe Inc., 296 F.3d 1316, 63 USPQ2d 1609 (Fed. Cir. 2002). The Enzo court adopted the standard that the written description requirement can be met by “show[ing] that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics, i.e., complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics. “Id. At 1324, 63 USPQ2d at 1613 (emphasis omitted, bracketed material in original).
However, without a correlation between structure and function, the claim does little more than define the claimed invention by function. That is not sufficient to satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (“definition by function … does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is”).
Thus, the specification does not provide an adequate written description of the genus of wax compositions comprising a long-chain (greater than C22) linear or branched alkyl or alkenyl alcohol; wherein the alkyl or alkenyl alcohol is not linked through an ester bond or an ether bond to a short chain alkyl or aryl (C1-C6) group; wherein the alkyl or alkenyl alcohol is not linked through an ester bond or an ether bond to a long chain (C8-C36) alkyl or alkenyl group; wherein the alkyl or alkenyl alcohol is not linked through an amide bond to a linear or branched long chain (C8-C36) alkyl or alkenyl amine or acid” according to claim 1 that is required to practice the claimed invention. Applicants have not described the genus of wax compositions comprising a long-chain (greater than C22 or between C8-C36) linear or branched alkyl or alkenyl alcohol sufficiently to show they had possession of the claimed genus. Since the disclosure fails to provide sufficient relevant identifying characteristics, and because the genus is highly variant, one of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus as broadly claimed.
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 and 8 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, the use of phrases within parenthesis “(greater than C22), (C1-C6), (C8-C36)” renders the claim indefinite because it is unclear whether the limitations within the parenthesis are part of the claimed invention. See MPEP § 2173.05(d).
Further, the metes and bounds of the term “long-chain” cannot be ascertained by the claim language as “long-chain” is only suggested by the terms in parenthesis to be C8-C36 and/or greater than C22. Thus, it is not clear what a long-chain alcohol would include, i.e. C8-C36 alcohols or only those greater than C22. For examination purposes, “long-chain” is interpreted consistent with the ordinary and customary meaning of the term to include C6-C22 alcohols.
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) 1-12 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Witcher et al. (US20030215923, IDS).
Witcher teaches a sterilization process biological indicator comprising an outer tube, i.e. a housing, a sealed inner tube and a vented cap. The inner tube is a frangible, thus an openable container. The test microorganisms are disposed on a carrier between the walls of the inner tube and the outer tube/housing (0038). The housing comprises an opening that permits the sterilant to enter the outer tube through the vents of the cap, thus, from outside the housing into the housing (0039). The inner tube contains a substrate solution comprising a growth solution, i.e. nutrient medium, and detectable substrate solutions which react with the enzyme of the microorganism to produce a detectable product (0040, 0043, 0044) once the tube is crushed. The test microorganisms that have been treated with a sterilant-resistant chemical (0018, 0044, 0045, 0046). The sterilant-resistant chemical to alleviate premature inactivation of the enzyme in the indicator (0034, 0045) is disclosed to be a composition comprising a hydrophobic additive which is a wax comprising a long-chain C12-C22 linear or branched alkyl or alkenyl alcohol (0049). It is noted that Witcher teaches long-chain esters or ethers bound to short or long chain alkyl or alkenyl groups, as well as amides or acids; however, the reference also teaches that the additive is a C12-C22 alkyl or alkenyl alcohol (on its own), thus meeting the applicants claimed long-chain alkyl or alkenyl alcohol of claim 1. The test microorganisms are mixed with the sterilant-resistant chemical and deposited on paper strips placed in the bottom of an outer container (housing) of the indicator and a barrier inserted between the spore strip and the inner container (openable container) containing the nutrient medium and detectable enzyme substrate (0092, 0093, Fig. 1 and 2).
While Witcher does not specifically teach that the microorganisms are enveloped by the wax composition according to claims 1 and 6, this taken to necessarily happen when the microorganisms are treated with the composition as long-chain alkyl alcohols are solids/waxes at room temperature and Witcher teaches the compositions to be wax compositions. Additionally, while the melting point of the wax composition is not disclosed by Witcher this is taken to be an inherent characteristic of the long-chain wax composition disclosed by Witcher. Therefore, the wax composition of Witcher would necessarily have the melting point recited in claims 1 and 9-12. See MPEP 2112 II.
II. INHERENT FEATURE NEED NOT BE RECOGNIZED AT THE TIME OF THE INVENTION
There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003) (rejecting the contention that inherent anticipation requires recognition by a person of ordinary skill in the art before the critical date and allowing expert testimony with respect to post-critical date clinical trials to show inherency); see also Toro Co. v. Deere & Co., 355 F.3d 1313, 1320, 69 USPQ2d 1584, 1590 (Fed. Cir. 2004) ("[T]he fact that a characteristic is a necessary feature or result of a prior-art embodiment (that is itself sufficiently described and enabled) is enough for inherent anticipation, even if that fact was unknown at the time of the prior invention."); Abbott Labs v. Geneva Pharms., Inc., 182 F.3d 1315, 1319, 51 USPQ2d 1307, 1310 (Fed. Cir. 1999) ("If a product that is offered for sale inherently possesses each of the limitations of the claims, then the invention is on sale, whether or not the parties to the transaction recognize that the product possesses the claimed characteristics."); Atlas Powder Co. v. IRECO, Inc., 190 F.3d 1342, 1348-49, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999) ("Because ‘sufficient aeration’ was inherent in the prior art, it is irrelevant that the prior art did not recognize the key aspect of [the] invention.... An inherent structure, composition, or function is not necessarily known."); SmithKline Beecham Corp. v. Apotex Corp., 403 F.3d 1331, 1343-44, 74 USPQ2d 1398, 1406-07 (Fed. Cir. 2005) (holding that a prior art patent to an anhydrous form of a compound "inherently" anticipated the claimed hemihydrate form of the compound because practicing the process in the prior art to manufacture the anhydrous compound "inherently results in at least trace amounts of" the claimed hemihydrate even if the prior art did not discuss or recognize the hemihydrate); In re Omeprazole Patent Litigation, 483 F.3d 1364, 1373, 82 USPQ2d 1643, 1650 (Fed. Cir. 2007) (The court noted that although the inventors may not have recognized that a characteristic of the ingredients in the prior art method resulted in an in situ formation of a separating layer, the in situ formation was nevertheless inherent. "The record shows formation of the in situ separating layer in the prior art even though that process was not recognized at the time. The new realization alone does not render that necessary [sic] prior art patentable."
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) 1-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Swaminathan et al. (US20180015193A1, IDS) in view of Witcher et al. (US20030215923, IDS).
Swaminathan teaches a self-contained biological indicator comprising an outer container, i.e. a housing, having at least one liquid impermeable wall and an inner volume and an openable liquid impermeable inner container containing a liquid medium within the housing, and a plurality of test microorganisms (abstract, 0004-0006, 0009, 0010, 0015, 0016, 0039, 0041, 0042, 0052). The openable container is in selective fluid communication with the compartment as it is frangible to allow contact between the growth medium and test microorganisms (0063, 0064, 0066). The test microorganisms are deposited on a hydrophobic carrier between the walls of the inner and outer container, thus, taken to be enveloped by the wall of the housing according to claim 8 (0004, 0018, 0020, 0021, 0046, 0053,0059, 0067, 0070). The housing comprises an opening to allow passage of the sterilant (0042).
Regarding claim 2, the openable container is within the housing (0009, 0052, 0059).
Regarding claim 3, a nutrient medium is disposed in the openable container (0059, 0063, 0092)
Regarding claims 4 and 5, a detection reagent/indicator reagent (0057, 0058) is disposed in the housing, in the openable container (0059, 0060, 0061, 0092).
Swaminathan differs from the claimed invention in that it does not teach the test microorganisms to be at least partially enveloped by a wax composition, wherein the wax composition comprises a long-chain linear or branched alkyl or alkenyl alcohol according to claims 1 and 6.
Witcher teaches a sterilization process biological indicator comprising an outer tube, i.e. a housing, a sealed inner tube and a vented cap. The inner tube is a frangible, thus an openable container. The test microorganisms are disposed on a carrier between the walls of the inner tube and the outer tube/housing (0038). The housing comprises an opening that permits the sterilant to enter the outer tube through the vents of the cap, thus, from outside the housing into the housing (0039). The inner tube contains a substrate solution comprising a growth solution, i.e. nutrient medium, and detectable substrate solutions which react with the enzyme of the microorganism to produce a detectable product (0040, 0043, 0044) once the tube is crushed. The test microorganisms that have been treated with a sterilant-resistant chemical (0018, 0044, 0045, 0046). The sterilant-resistant chemical to alleviate premature inactivation of the enzyme in the indicator (0034, 0045) is disclosed to be a composition comprising a hydrophobic additive which is a wax comprising a long-chain C12-C22 linear or branched alkyl or alkenyl alcohol (0049). It is noted that Witcher teaches long-chain esters or ethers bound to short or long chain alkyl or alkenyl groups, as well as amides or acids; however, the reference also teaches that the additive is a C12-C22 alkyl or alkenyl alcohol (on its own), thus meeting the applicants claimed long-chain alkyl or alkenyl alcohol of claim 1.The test microorganisms are mixed with the sterilant-resistant chemical and deposited on paper strips placed in the bottom of an outer container (housing) of the indicator and a barrier inserted between the spore strip and the inner container (openable container) containing the nutrient medium and detectable enzyme substrate (0092, 0093, Fig. 1 and 2).
While Witcher does not specifically teach that the microorganisms are enveloped by the wax composition according to claims 1 and 6, this taken to necessarily happen when the microorganisms are treated with the composition as long-chain alkyl alcohols are solids/waxes at room temperature and Witcher teaches the compositions to be wax compositions. Additionally, while the melting point of the wax composition is not disclosed this is taken to be an inherent characteristic of the long-chain wax composition disclosed by Witcher. Therefore, the wax composition of Witcher would necessarily have the melting point recited in claims 1 and 9-12. See MPEP 2112 II.
II. INHERENT FEATURE NEED NOT BE RECOGNIZED AT THE TIME OF THE INVENTION
There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003) (rejecting the contention that inherent anticipation requires recognition by a person of ordinary skill in the art before the critical date and allowing expert testimony with respect to post-critical date clinical trials to show inherency); see also Toro Co. v. Deere & Co., 355 F.3d 1313, 1320, 69 USPQ2d 1584, 1590 (Fed. Cir. 2004) ("[T]he fact that a characteristic is a necessary feature or result of a prior-art embodiment (that is itself sufficiently described and enabled) is enough for inherent anticipation, even if that fact was unknown at the time of the prior invention."); Abbott Labs v. Geneva Pharms., Inc., 182 F.3d 1315, 1319, 51 USPQ2d 1307, 1310 (Fed. Cir. 1999) ("If a product that is offered for sale inherently possesses each of the limitations of the claims, then the invention is on sale, whether or not the parties to the transaction recognize that the product possesses the claimed characteristics."); Atlas Powder Co. v. IRECO, Inc., 190 F.3d 1342, 1348-49, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999) ("Because ‘sufficient aeration’ was inherent in the prior art, it is irrelevant that the prior art did not recognize the key aspect of [the] invention.... An inherent structure, composition, or function is not necessarily known."); SmithKline Beecham Corp. v. Apotex Corp., 403 F.3d 1331, 1343-44, 74 USPQ2d 1398, 1406-07 (Fed. Cir. 2005) (holding that a prior art patent to an anhydrous form of a compound "inherently" anticipated the claimed hemihydrate form of the compound because practicing the process in the prior art to manufacture the anhydrous compound "inherently results in at least trace amounts of" the claimed hemihydrate even if the prior art did not discuss or recognize the hemihydrate); In re Omeprazole Patent Litigation, 483 F.3d 1364, 1373, 82 USPQ2d 1643, 1650 (Fed. Cir. 2007) (The court noted that although the inventors may not have recognized that a characteristic of the ingredients in the prior art method resulted in an in situ formation of a separating layer, the in situ formation was nevertheless inherent. "The record shows formation of the in situ separating layer in the prior art even though that process was not recognized at the time. The new realization alone does not render that necessary [sic] prior art patentable."
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to add a wax composition comprising a long-chain linear or branched alkyl or alkenyl alcohol as taught by Witcher to the biological indicator of Swaminathan because Witcher teaches that the addition of a sterilant-resistant composition comprising wax additives alleviate premature inactivation of the enzyme in sterilization process biological indicators.
Claim(s) 1-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith et al. (US20130302849, IDS) in view of Witcher et al. (US20030215923, IDS).
Regarding claim 1, Smith teaches a self-contained biological sterilization indicator comprising a housing and a container within the housing. The container contains a liquid disposed therein and a portion of the container is frangible, i.e. an openable container once fractured, to allow liquid to flow into the interior of the housing. The housing contains a first chamber in which the container is positioned and a second chamber. The second chamber contains the plurality of test microorganisms, i.e. spores of Geobacillus, Bacillus, and Clostridium (0005, 0006, 0029) not in fluid communication with the liquid when the container is not fractured and intact, thus taken to be a moisture-impermeable carrier/wall to which the spores are affixed according to claims 1,6, and 8. When the container is fractured, the microorganisms are in fluid communication with the liquid. The first and second chambers of the housing contain a fluid path and is positioned to allow a sterilant to move from the first chamber into the second chamber when the container is intact and allowing the liquid to move from the first chamber into the second once the container is fractured (0005, 0006, 0016, 0022, 0023, 0043, 0045, 0047-0051, 0084, 0192-0198). The housing contains at least one liquid-impermeable wall that forms an opening into a compartment (0042, 0056-0058) and the housing has an opening (chambers and sterilant path) which permits the passing of the sterilant into the housing (0186, 0187, 0192-0198). The liquid medium within the openable container contains a nutrient medium/composition to promote germination or growth of spores (0018, 0089). The indicator further includes a wicking material to be positioned near the spores in the spore reservoir or form a portion of or be coupled to a spore substrate (0179).
Regarding claim 2, the openable container is disposed in the housing (0005, 0006).
Regarding claim 3, the nutrient medium/composition is disposed in the openable container (0018, 0022).
Regarding claims 4 and 5, a detection reagent/indicator reagent (0032, 0033, 0091) is disposed in the housing, in the openable container (0076, 0091).
The spores are affixed to a substrate/carrier (0023, 0073, 0093, 0094
Smith differs from the claimed invention in that it does not teach the test microorganisms to be at least partially enveloped by a wax composition, wherein the wax composition comprises a long-chain linear or branched alkyl or alkenyl alcohol according to claims 1 and 6.
Witcher teaches a sterilization process biological indicator comprising an outer tube, i.e. a housing, a sealed inner tube and a vented cap. The inner tube is a frangible, thus an openable container. The test microorganisms are disposed on a carrier between the walls of the inner tube and the outer tube/housing (0038). The housing comprises an opening that permits the sterilant to enter the outer tube through the vents of the cap, thus, from outside the housing into the housing (0039). The inner tube contains a substrate solution comprising a growth solution, i.e. nutrient medium, and detectable substrate solutions which react with the enzyme of the microorganism to produce a detectable product (0040, 0043, 0044) once the tube is crushed. The test microorganisms that have been treated with a sterilant-resistant chemical (0018, 0044, 0045, 0046). The sterilant-resistant chemical to alleviate premature inactivation of the enzyme in the indicator (0034, 0045) is disclosed to be a composition comprising a hydrophobic additive which is a wax comprising a long-chain C12-C22 linear or branched alkyl or alkenyl alcohol (0049). It is noted that Witcher teaches long-chain esters or ethers bound to short or long chain alkyl or alkenyl groups, as well as amides or acids; however, the reference also teaches that the additive is a C12-C22 alkyl or alkenyl alcohol (on its own), thus meeting the applicants claimed long-chain alkyl or alkenyl alcohol of claim 1.The test microorganisms are mixed with the sterilant-resistant chemical and deposited on paper strips placed in the bottom of an outer container (housing) of the indicator and a barrier inserted between the spore strip and the inner container (openable container) containing the nutrient medium and detectable enzyme substrate (0092, 0093, Fig. 1 and 2).
While Witcher does not specifically teach that the microorganisms are enveloped by the wax composition according to claims 1 and 6, this taken to necessarily happen when the microorganisms are treated with the composition as long-chain alkyl alcohols are solids/waxes at room temperature and Witcher teaches the compositions to be wax compositions.
Additionally, while the melting point of the wax composition is not disclosed this is taken to be an inherent characteristic of the long-chain wax composition disclosed by Witcher. Therefore, the wax composition of Witcher would necessarily have the melting point recited in claims 1 and 9-12. See MPEP 2112 II.
II. INHERENT FEATURE NEED NOT BE RECOGNIZED AT THE TIME OF THE INVENTION
There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003) (rejecting the contention that inherent anticipation requires recognition by a person of ordinary skill in the art before the critical date and allowing expert testimony with respect to post-critical date clinical trials to show inherency); see also Toro Co. v. Deere & Co., 355 F.3d 1313, 1320, 69 USPQ2d 1584, 1590 (Fed. Cir. 2004) ("[T]he fact that a characteristic is a necessary feature or result of a prior-art embodiment (that is itself sufficiently described and enabled) is enough for inherent anticipation, even if that fact was unknown at the time of the prior invention."); Abbott Labs v. Geneva Pharms., Inc., 182 F.3d 1315, 1319, 51 USPQ2d 1307, 1310 (Fed. Cir. 1999) ("If a product that is offered for sale inherently possesses each of the limitations of the claims, then the invention is on sale, whether or not the parties to the transaction recognize that the product possesses the claimed characteristics."); Atlas Powder Co. v. IRECO, Inc., 190 F.3d 1342, 1348-49, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999) ("Because ‘sufficient aeration’ was inherent in the prior art, it is irrelevant that the prior art did not recognize the key aspect of [the] invention.... An inherent structure, composition, or function is not necessarily known."); SmithKline Beecham Corp. v. Apotex Corp., 403 F.3d 1331, 1343-44, 74 USPQ2d 1398, 1406-07 (Fed. Cir. 2005) (holding that a prior art patent to an anhydrous form of a compound "inherently" anticipated the claimed hemihydrate form of the compound because practicing the process in the prior art to manufacture the anhydrous compound "inherently results in at least trace amounts of" the claimed hemihydrate even if the prior art did not discuss or recognize the hemihydrate); In re Omeprazole Patent Litigation, 483 F.3d 1364, 1373, 82 USPQ2d 1643, 1650 (Fed. Cir. 2007) (The court noted that although the inventors may not have recognized that a characteristic of the ingredients in the prior art method resulted in an in situ formation of a separating layer, the in situ formation was nevertheless inherent. "The record shows formation of the in situ separating layer in the prior art even though that process was not recognized at the time. The new realization alone does not render that necessary [sic] prior art patentable."
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to add a wax composition comprising a long-chain linear or branched alkyl or alkenyl alcohol as taught by Witcher to the biological indicator of Smith because Witcher teaches that the addition of a sterilant-resistant composition comprising wax additives alleviate premature inactivation of the enzyme in sterilization process biological indicators.
Claims 1-12 is/are rejected under 35 U.S.C. 103 as being obvious over Ahimou et al. (WO2020/028333A1, IDS) in view of Witcher et al. (US20030215923, IDS).
Regarding claims 1 and 2, WO2020/028333A1 teaches a self-contained biological indicator comprising a housing, a plurality of test microorganisms, i.e. spores (p. 8, lines 30-32, p. 9, lines 25-p. 10 , lines 1-10), and a frangible container comprising a liquid composition (p. 2, lines 25-30, p. 7, lines 4-14). The housing is a container having walls impermeable to a sterilant where other components of the indicator are located, yet having an opening to allow the flow of the sterilant into the interior of the housing, i.e. a sterilant pathway. The housing contains a body, i.e. a compartment and an openable container, i.e. a cap, which when open, allows the flow of liquid or sterilant into the compartment of the housing (p. 8, lines 9-28, p. 24, whole page, p. 25, lines 1-9, p. 26, whole page) and an actuatable container (p. 16, lines 35-p. 17, lines 1-17, p. 24, whole page, p. 25, lines 1-9). The microorganisms/spores are disposed on a substrate/carrier within the indicator which may be a tube or glass slide, for example, thus taken to be moisture-impermeable according to claim 7 and having microorganisms affixed to a portion of the wall according to claim 8 (p. 20, lines 24-30).
Regarding claims 3, the indicator comprises a liquid medium in an actuatable container comprising a nutrient medium that facilitates growth or germination of surviving microorganisms (p. 9, lines 5-10, p. 16, lines 13-p. 17, lines 1-6, p. 28, lines 18-23) which is released into the interior of the housing by fracturing, crushing or cracking the actuatable container (p. 22, lines 11-20.
Regarding claims 4 and 5, a detection reagent is disposed in the container in the housing as it is disclosed to be in the liquid medium within the actuatable container within the housing (p. 6, lines 7-14, p. 10, lines 31-p. 11, lines 1-15, p. 16, lines 13-p. 17, lines 1-17, p. 19, lines 11-17).
WO’833 differs from the claimed invention in that it does not teach the test microorganisms to be at least partially enveloped by a wax composition, wherein the wax composition comprises a long-chain linear or branched alkyl or alkenyl alcohol according to claims 1 and 6.
Witcher teaches a sterilization process biological indicator comprising an outer tube, i.e. a housing, a sealed inner tube and a vented cap. The inner tube is a frangible, thus an openable container. The test microorganisms are disposed on a carrier between the walls of the inner tube and the outer tube/housing (0038). The housing comprises an opening that permits the sterilant to enter the outer tube through the vents of the cap, thus, from outside the housing into the housing (0039). The inner tube contains a substrate solution comprising a growth solution, i.e. nutrient medium, and detectable substrate solutions which react with the enzyme of the microorganism to produce a detectable product (0040, 0043, 0044) once the tube is crushed. The test microorganisms that have been treated with a sterilant-resistant chemical (0018, 0044, 0045, 0046). The sterilant-resistant chemical to alleviate premature inactivation of the enzyme in the indicator (0034, 0045) is disclosed to be a composition comprising a hydrophobic additive which is a wax comprising a long-chain C12-C22 linear or branched alkyl or alkenyl alcohol (0049). It is noted that Witcher teaches long-chain esters or ethers bound to short or long chain alkyl or alkenyl groups, as well as amides or acids; however, the reference also teaches that the additive is a C12-C22 alkyl or alkenyl alcohol (on its own), thus meeting the applicants claimed long-chain alkyl or alkenyl alcohol of claim 1.The test microorganisms are mixed with the sterilant-resistant chemical and deposited on paper strips placed in the bottom of an outer container (housing) of the indicator and a barrier inserted between the spore strip and the inner container (openable container) containing the nutrient medium and detectable enzyme substrate (0092, 0093, Fig. 1 and 2).
While Witcher does not specifically teach that the microorganisms are enveloped by the wax composition according to claims 1 and 6, this taken to necessarily happen when the microorganisms are treated with the composition as long-chain alkyl alcohols are solids/waxes at room temperature and Witcher teaches the compositions to be wax compositions. Additionally, while the melting point of the wax composition is not disclosed this is taken to be an inherent characteristic of the long-chain wax composition disclosed by Witcher. Therefore, the wax composition of Witcher would necessarily have the melting point recited in claims 1 and 9-12. See MPEP 2112 II.
II. INHERENT FEATURE NEED NOT BE RECOGNIZED AT THE TIME OF THE INVENTION
There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003) (rejecting the contention that inherent anticipation requires recognition by a person of ordinary skill in the art before the critical date and allowing expert testimony with respect to post-critical date clinical trials to show inherency); see also Toro Co. v. Deere & Co., 355 F.3d 1313, 1320, 69 USPQ2d 1584, 1590 (Fed. Cir. 2004) ("[T]he fact that a characteristic is a necessary feature or result of a prior-art embodiment (that is itself sufficiently described and enabled) is enough for inherent anticipation, even if that fact was unknown at the time of the prior invention."); Abbott Labs v. Geneva Pharms., Inc., 182 F.3d 1315, 1319, 51 USPQ2d 1307, 1310 (Fed. Cir. 1999) ("If a product that is offered for sale inherently possesses each of the limitations of the claims, then the invention is on sale, whether or not the parties to the transaction recognize that the product possesses the claimed characteristics."); Atlas Powder Co. v. IRECO, Inc., 190 F.3d 1342, 1348-49, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999) ("Because ‘sufficient aeration’ was inherent in the prior art, it is irrelevant that the prior art did not recognize the key aspect of [the] invention.... An inherent structure, composition, or function is not necessarily known."); SmithKline Beecham Corp. v. Apotex Corp., 403 F.3d 1331, 1343-44, 74 USPQ2d 1398, 1406-07 (Fed. Cir. 2005) (holding that a prior art patent to an anhydrous form of a compound "inherently" anticipated the claimed hemihydrate form of the compound because practicing the process in the prior art to manufacture the anhydrous compound "inherently results in at least trace amounts of" the claimed hemihydrate even if the prior art did not discuss or recognize the hemihydrate); In re Omeprazole Patent Litigation, 483 F.3d 1364, 1373, 82 USPQ2d 1643, 1650 (Fed. Cir. 2007) (The court noted that although the inventors may not have recognized that a characteristic of the ingredients in the prior art method resulted in an in situ formation of a separating layer, the in situ formation was nevertheless inherent. "The record shows formation of the in situ separating layer in the prior art even though that process was not recognized at the time. The new realization alone does not render that necessary [sic] prior art patentable."
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to add a wax composition comprising a long-chain linear or branched alkyl or alkenyl alcohol as taught by Witcher to the biological indicator of WO’833 because Witcher teaches that the addition of a sterilant-resistant composition comprising wax additives alleviate premature inactivation of the enzyme in sterilization process biological indicators.
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, 9-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 7, 8, 9 of copending Application No. 17758585 in view of Witcher et al. (US20030215923, IDS). The claimed inventions are drawn to self-contained biological indicators comprising a housing, the housing containing a plurality of test microorganisms, a nutrient composition which facilitates germination and/or outgrowth of the microorganisms, a frangible/openable container comprising a liquid medium wherein the container is adapted to allows selective fluid communication within the indicator, and a detectable product/enzyme substrate. The inventions differ in the that the examined claims require the test microorganisms to be at least partially enveloped by a wax composition comprising a long-chain linear or branched alkyl or alkenyl alcohol not required by the reference claims. It is noted that the reference claims require a salt compound not required by the instant claims, however the claimed indicators are drawn to indicators “comprising” and thus would not exclude additional components present in the indicator.
Witcher teaches a sterilization process biological indicator comprising an outer tube, i.e. a housing, a sealed inner tube and a vented cap. The inner tube is a frangible, thus an openable container. The test microorganisms are disposed on a carrier between the walls of the inner tube and the outer tube/housing (0038). The housing comprises an opening that permits the sterilant to enter the outer tube through the vents of the cap, thus, from outside the housing into the housing (0039). The inner tube contains a substrate solution comprising a growth solution, i.e. nutrient medium, and detectable substrate solutions which react with the enzyme of the microorganism to produce a detectable product (0040, 0043, 0044) once the tube is crushed. The test microorganisms that have been treated with a sterilant-resistant chemical (0018, 0044, 0045, 0046). The sterilant-resistant chemical to alleviate premature inactivation of the enzyme in the indicator (0034, 0045) is disclosed to be a composition comprising a hydrophobic additive which is a wax comprising a long-chain C12-C22 linear or branched alkyl or alkenyl alcohol (0049). It is noted that Witcher teaches long-chain esters or ethers bound to short or long chain alkyl or alkenyl groups, as well as amides or acids; however, the reference also teaches that the additive is a C12-C22 alkyl or alkenyl alcohol (on its own), thus meeting the applicants claimed long-chain alkyl or alkenyl alcohol of claim 1.The test microorganisms are mixed with the sterilant-resistant chemical and deposited on paper strips placed in the bottom of an outer container (housing) of the indicator and a barrier inserted between the spore strip and the inner container (openable container) containing the nutrient medium and detectable enzyme substrate (0092, 0093, Fig. 1 and 2).
While Witcher does not specifically teach that the microorganisms are enveloped by the wax composition according to claims 1 and 6, this taken to necessarily happen when the microorganisms are treated with the composition as long-chain alkyl alcohols are solids/waxes at room temperature and Witcher teaches the compositions to be wax compositions. Additionally, while the melting point of the wax composition is not disclosed this is taken to be an inherent characteristic of the long-chain wax composition disclosed by Witcher. Therefore, the wax composition of Witcher would necessarily have the melting point recited in claims 1 and 9-12. See MPEP 2112 II.
II. INHERENT FEATURE NEED NOT BE RECOGNIZED AT THE TIME OF THE INVENTION
There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003) (rejecting the contention that inherent anticipation requires recognition by a person of ordinary skill in the art before the critical date and allowing expert testimony with respect to post-critical date clinical trials to show inherency); see also Toro Co. v. Deere & Co., 355 F.3d 1313, 1320, 69 USPQ2d 1584, 1590 (Fed. Cir. 2004) ("[T]he fact that a characteristic is a necessary feature or result of a prior-art embodiment (that is itself sufficiently described and enabled) is enough for inherent anticipation, even if that fact was unknown at the time of the prior invention."); Abbott Labs v. Geneva Pharms., Inc., 182 F.3d 1315, 1319, 51 USPQ2d 1307, 1310 (Fed. Cir. 1999) ("If a product that is offered for sale inherently possesses each of the limitations of the claims, then the invention is on sale, whether or not the parties to the transaction recognize that the product possesses the claimed characteristics."); Atlas Powder Co. v. IRECO, Inc., 190 F.3d 1342, 1348-49, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999) ("Because ‘sufficient aeration’ was inherent in the prior art, it is irrelevant that the prior art did not recognize the key aspect of [the] invention.... An inherent structure, composition, or function is not necessarily known."); SmithKline Beecham Corp. v. Apotex Corp., 403 F.3d 1331, 1343-44, 74 USPQ2d 1398, 1406-07 (Fed. Cir. 2005) (holding that a prior art patent to an anhydrous form of a compound "inherently" anticipated the claimed hemihydrate form of the compound because practicing the process in the prior art to manufacture the anhydrous compound "inherently results in at least trace amounts of" the claimed hemihydrate even if the prior art did not discuss or recognize the hemihydrate); In re Omeprazole Patent Litigation, 483 F.3d 1364, 1373, 82 USPQ2d 1643, 1650 (Fed. Cir. 2007) (The court noted that although the inventors may not have recognized that a characteristic of the ingredients in the prior art method resulted in an in situ formation of a separating layer, the in situ formation was nevertheless inherent. "The record shows formation of the in situ separating layer in the prior art even though that process was not recognized at the time. The new realization alone does not render that necessary [sic] prior art patentable."
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to add a wax composition comprising a long-chain linear or branched alkyl or alkenyl alcohol as taught by Witcher to a biological indicator because Witcher teaches that the addition of a sterilant-resistant composition comprising wax additives alleviate premature inactivation of the enzyme in sterilization process biological indicators.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Claims 13-17 are free of the art.
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/TIFFANY M GOUGH/ Examiner, Art Unit 1651
/MELENIE L GORDON/Supervisory Patent Examiner, Art Unit 1651
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