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 .
Amendments to claims 1-3, 5, and 13-19, in the response filed January 26, 2026, have been entered.
Claims 1-11 and 13-21 are currently pending in the above identified application.
Claim Rejections - 35 USC § 102 /103
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-2, 5-6, 11, 13-14, and 20-21 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Ha-Lactase 5200 to Fromagex as evidenced by Ha-Lactase Product Information to Chr Hansen.
Regarding claims 1-2, 5-6, 11, 13-14, and 20-21, Fromagex teaches Ha-Lactase 5200 product (package lactase solution) comprising a liquid neutral liquid neutral lactase solution in a 1 gallon container (container having a volume in a range of 10 mL to 20,000kL, having a strength before-date of greater than 4800 NLU/g (claim 2, 13-14) and shown with a headspace within the claimed range (Fromagex, p.1-3). Based on the image, the head space is greater than 0% and less than 20% (claim 1), more than 0% to 15% (claim 11), from 1% to 20% (claim 6), based on the image shown, absent to the contrary. The gallon container is shown with a removable lid (Id), reading on the container having an opening which is sealable (claim 20). Once the lid is removed, the headspace, would be filled with air and read on the head space being filled with at least one gas selected from the group consisting of air and oxygen. Examiner would like to note that the lactase expiration date in 15Oct15, indicating that the product was on sale before the effective filing date. As evidenced by Chr, Ha-Lactase 5200 storage condition is cool, 0-8°C, in closed original container (Chr, p. 1), indicating the headspace would be air, including oxygen (claim 21). Chr states the version is March 14, 2014.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-5, 11, 13-15, and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over US Pub. No. 2017/0245513 to Ogasawara in view of US Pub. No. 2017/0304445 to Ogez, and optionally “Effect of Dissolved Oxygen Level on Lactase Production by Kluyveromyces fragilis” to Barberis.
Regarding claims 1-5, 11, 13-15, and 20-21, Ogasawara teaches a lactase solution, specifically a neutral lactase, having a lactase activity of 10 to 100,000 NLU/g (claim 2), (Ogasawara, abstract, para 0001, 0022, 0040). Ogasawara teaches that physical stimulation such as shaking or vibration or the like generated during transportation after product of a lactase solution can form aggregates and yields an occurrence of clogging (Id., para 0012, 0145, 0149). While not explicitly stated, a container would necessarily be needed in order to transport and use the lactase solution. Ogasawara teaches using nitrogen gas, air, oxygen, argon, or the like used to apply pressure for sample and testing (Id., para 0100-0102), indicating the presences of air or oxygen does not negatively impact performance of the lactase solution for testing. Additionally, Barberis teaches the use of dissolves oxygen in the production of lactase supporting the presence of oxygen in the head space and would not kill or destroy the lactase (Barberis, abstract, p. 73).
Ogasawara does not teach the lactase solution present in a container wherein a head space volume in the container is controlled to 20% or less relative to a total volume of the container and the container has a volume in a range of 10 mL to 20,000 kL.
However, Ogez teaches a filled container that has no headspace for aqueous pharmaceutical compositions (Ogez, abstract, para 0001), reading on a head space volume in the container that is controlled to 20% or less relative to a total volume of the container. Ogez teaches mechanical stresses and chemical stresses of aqueous drug products when manufactured, packages, transported, stored and handle are detrimental and teaches the presence of headspace in a container exacerbates the mechanical stresses place upon the product (Id., para 0002-0003). Ogez teaches the volume of the container being about 15L (Id., para 0344). Ogez teaches “no detectable headspace” refers to a closed container comprising the aqueous drug substance in which no headspace can be detected by human vision (Id., para 0198), which encompasses more than 0%, such as detectable by extreme magnification, as any level above 0% meets the limitation (claim 1, 11). Additionally, Ogez teaches an embodiment having a headspace less than 0.1% of the volume of the container (Id., para 0283).
It would have been obvious to one of ordinary skill in the art before the effective filing date to form the lactase solution of Ogasawara, wherein the solution is in a container, such as 15L container, having low headspace as taught by Ogez, motivated by the desire to use conventionally known containers for transporting pharmaceutical composition and by the desire to minimize the mechanical stresses placed upon the solution which is known to form aggregates as taught by Ogasawara and by the desired volume for transportation and sale. Additionally, it would have been obvious to one of ordinary skill in the art before the effective filing date to fill the head space with air or oxygen (claim 21) as taught by Ogasawara as suitably used in testing of the lactase solution and indicative that does not negatively affect lactase performance and based on the available of gas to fill the head space and taught by Barberis as not destroying lactase but used in lactase formation.
Regarding claim 3, the prior art combination teaches the lactase being recovered and purified from a microorganism, including the removal of impurities (Ogasawara, para 0042, 0106). Regarding the claimed transparency of the solution being transparent, in general, a limitation is inherent if it is the “natural result flowing from” the explicit disclosure of the prior art. Schering Corp. v. Geneva Pharms., Inc., 339 F.3d 1373, 1379 (Fed. Cir. 2003). Therefore, although the prior art does not disclose this feature, the claimed properties are deemed to be inherent to the structure in the prior art since Ogasawara teaches an invention with a substantially similar structure and chemical composition as the claimed invention. Ogasawara teaches a purified lactase solution. The instant disclosure teaches the presence of microorganism causing the solution to be turbid. The microorganism are remove and the solution of the prior art combination is purified. Products of identical structure and composition cannot have mutually exclusive properties. The burden is on the Applicants to prove otherwise. Alternatively, it would have been obvious to one of ordinary skill in the art before the effective filing date to form lactase solution, wherein the solution is purified and the microorganism removed as taught Ogasawara as desirable and would therefore result in a substantially transparent solution, as best understood by Examiner.
Regarding claim 4, the prior art combination teaches the use of polypropylene and polyurethane containers (Ogez, para 0154-0155, 0254-0260).
Regarding claim 5, the prior art combination teaches storage and transportation at 10°C (Ogasawara, para 0004, 0095), reading on a temperature of the lactase solution and a temperature of the container each being above 0°C and 20°C or lower.
Regarding claims 13-14, the prior art combination teaches a lactase solution having a lactase activity of 10 to 100,000 NLU/g (Ogasawara, abstract, para 0001, 0022).
While the reference does not specifically teach the claimed range of 1,000 to 100,000 NLU/g (claim 13), or 10 to 50,000 NLU/g (claim 14), the disclosed range of the prior art combination overlaps with the instant claimed range. It should be noted that 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 existence of overlapping or encompassing ranges shifts the burden to Applicant to show that his invention would not have been obvious. In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003). Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date to adjust, vary, and optimize the lactase activity, such as within the claimed range, motivated by the desire to successfully practice the invention of the prior art based on the totality of the teachings of the prior art.
Regarding claim 15, the prior art combination teaches the solution comprising an aggregation inhibitor for preventing aggregation of a lactase and other proteins contained in the lactase solution (Ogasawara, para 0044), reading on the lactase solution further including protein other than lactase protein.
Regarding claim 20, the prior art teaching the container maintaining a seal (Ogez, para 0226, 0243, 0283), reading on container having an opening which is sealable. In order to charge the solution, the container would necessarily have an opening. Additionally, it would have been obvious to one ordinary skill in the art before the effective filing date to ensure the container is sealed to avoid loss or evaporation of the solution as while avoiding contamination.
Claims 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over US Pub. No. 2017/0245513 to Ogasawara in view of US Pub. No. 2017/0304445 to Ogez, and optionally “Effect of Dissolved Oxygen Level on Lactase Production by Kluyveromyces fragilis” to Barberis, as applied to claims 1-5, 11, 13-15, and 20-21, further in view of US Pub. No. 2017/0215449 to Nagahata.
Regarding claims 16-19, the prior art combination teaches the solution further comprising a stabilizer (Ogez, para 0023, 0035). The prior art combination teaches the solution can also include metal salts, various saccharides, ascorbic acid glycerin, or the like that contribute to stabilization of a lactase (Id., para 0066).
The prior art combination is silent with regards to the specific amount of the stabilizer.
However, Nagahata teaches a lactase solution comprising a stabilizer that maintains the lactase activity of the lactase solution over a long period of time (Nagahata, abstract, para 0031). Nagahata teaches the stabilizer can be used in conjunction with carious other components, such as metal salts contributing to the stabilization of lactase (Id., para 0033). Nagahata teaches the amount of the stabilizer in the lactase solution being 10 to 90% by mass, particularly preferably 40 to 60% by mass (Id., para 0036), Nagahata teaches that when the amount of the stabilizer is lower limit value or more, it becomes easy to maintain the lactase activity of the lactase solution over a long period of time (Id.). Nagahata teaches that when the amount of the stabilizer exceeds the upper limit, the viscosity of a lactase solution is increase and the workability is lowered (Id.).
It would have been obvious to one of ordinary skill in the art before the effective filing date to form the solution of the prior art combination, wherein the stabilizer is contained in an amount of 40 to 60% by mass as taught by Nagahata, motivated by the desire of forming conventionally known lactase solution with conventionally known and predictably suitable stabilizer additive amounts and by the desire to ensure lactase activity over a long period of time when ensuring the viscosity is not too high and the workability reduced.
Claims 1-3, 5-11, 13-15, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over US Pub. No. 2017/0245513 to Ogasawara in view of US Pub. No. 2017/0304445 to Ogez, “Concentrate Food-Grade Lactase Powder for Dairy Processing” to Creative Enzyme and “Insight Into Mixing and Blending” to Clark, and optionally “Effect of Dissolved Oxygen Level on Lactase Production by Kluyveromyces fragilis” to Barberis.
Regarding claims 1-3, 5-11, 13-15, and 21, Ogasawara teaches a lactase solution, specifically neutral lactase, having a lactase activity of 10 to 100,000 NLU/g (claim 2), (Ogasawara, abstract, para 0001, 0022, 0040). Ogasawara teaches that physical stimulation such as shaking or vibration or the like generated during transportation after product of a lactase solution can form aggregates and yields an occurrence of clogging (Id., para 0012, 0145, 0149). While not explicitly stated, a container would necessarily be needed in order to transport and use the lactase solution. Ogasawara teaches using nitrogen gas, air, oxygen, argon, or the like used to apply pressure for sample and testing (Id., para 0100-0102), indicating the presences of air or oxygen does not negatively impact performance of the lactase solution for testing.
Ogasawara does not teach the lactase solution present in a container wherein a head space volume in the container is controlled to 20% or less relative to a total volume of the container and the container has a volume in a range of 1 L to 10,000 kL.
However, Creative Enzyme teaches it is known to use a polyester barrel for the liquid form of lactase, such as containing 30 kg (Creative Enzymes, p. 1), which would be expected to fall within the claim range of 1 L to 10,000 kL. One of ordinary skill in the art would before the effective filing date would have appreciated that filling of a drum could lead to splashing if filled to very low head space level. Additionally, Clark teaches it is known in mixing blending that a degree of head space is needed for mixing, volume changes, or displacement for equipment (Clark, p. 1-2). It would have been obvious to an ordinary skilled artisan to factor in the ability to fill the container on an industrial scale to required amounts while minimize loss due to splashing due to processing systems that can lead to splashing and product lost. Ogez teaches mechanical stresses and chemical stresses of aqueous drug products when manufactured, packages, transported, stored and handle are detrimental and teaches the presence of headspace in a container exacerbates the mechanical stresses place upon the product (Id., para 0002-0003). Therefore, there would need to be a balance needed with providing adequate product into container for shipment and minimizing mechanical stresses while ensuring head space to accommodate volume changes dues to temperature, minimize spillage during filling due to splashing, mixing, and or moving while reducing mechanical and chemical stresses on the product. Additionally, Barberis teaches the use of dissolves oxygen in the production of lactase supporting the presence of oxygen in the head space and would not kill or destroy the lactase (Barberis, abstract, p. 73).
It would have been obvious to one of ordinary skill in the art before the effective filing date to use a drum container such as taught by Creative Enzyme, motivated by the desire of using conventionally known and commercially available containers predictably suitable for use with lactase enzyme in liquid form, wherein the head space is select to allow adequate space for mixing, moving, and volume changes, as taught by Clark, while balancing mechanical and chemical stresses as taught by Ogez, such as within the claimed range. Absent unexpected results, it would have been obvious to one of ordinary skill in the art at the time the invention was made to optimize the head space since it has been held that where general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 220 F.2d 454, 105 USPQ 233 (CCPA 1955). In the present invention, one would have been motivated to optimize the head space in order to allow head space of mixing, volume changes, and minimize spilling while ensuring mechanical and chemical stress is kept within acceptable range as can be detrimental. Additionally, as lactase solution is known to be storage in rigid containers, as products is drained or/added to the lactose containing product, the head space would increase, such as within the claimed range for claims 1 and 6-11.
Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date to fill the head space with air or oxygen (claim 21) as taught by Ogasawara as suitably used in testing of the lactase solution and indicative that does not negatively affect lactase performance and based on the available of gas to fill the head space and taught by Barberis as not destroying lactase but used in lactase formation.
Regarding claim 3, the prior art combination teaches the lactase being recovered and purified from a microorganism, including the removal of impurities (Ogasawara, para 0042, 0106). Regarding the claimed transparency of the solution being transparent, in general, a limitation is inherent if it is the “natural result flowing from” the explicit disclosure of the prior art. Schering Corp. v. Geneva Pharms., Inc., 339 F.3d 1373, 1379 (Fed. Cir. 2003). Therefore, although the prior art does not disclose this feature, the claimed properties are deemed to be inherent to the structure in the prior art since Ogasawara teaches an invention with a substantially similar structure and chemical composition as the claimed invention. Ogasawara teaches a purified lactase solution. The instant disclosure teaches the presence of microorganism causing the solution to be turbid. The microorganism are remove and the solution of the prior art combination is purified. Products of identical structure and composition cannot have mutually exclusive properties. The burden is on the Applicants to prove otherwise. Alternatively, it would have been obvious to one of ordinary skill in the art before the effective filing date to form lactase solution, wherein the solution is purified and the microorganism removed as taught Ogasawara as desirable and would therefore result in a substantially transparent solution, as best understood by Examiner.
Regarding claim 5, the prior art combination teaches storage and transportation at 10°C (Ogasawara, para 0004, 0095), reading on a temperature of the lactase solution and a temperature of the container each being above 0°C and 20°C or lower.
Regarding claims 2 and 13-14, the prior art combination teaches a lactase solution having a lactase activity of 10 to 100,000 NLU/g (Ogasawara, abstract, para 0001, 0022).
While the reference does not specifically teach the claimed range of 1,000 to 100,000 NLU/g (claim 13) or 10 to 50,000 NLU/g (claim 14), the disclosed range of the prior art combination overlaps with the instant claimed range. It should be noted that 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 existence of overlapping or encompassing ranges shifts the burden to Applicant to show that his invention would not have been obvious. In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003). Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date to adjust, vary, and optimize the lactase activity, such as within the claimed range, motivated by the desire to successfully practice the invention of the prior art based on the totality of the teachings of the prior art.
Regarding claim 15, the prior art combination teaches the solution comprising an aggregation inhibitor for preventing aggregation of a lactase and other proteins contained in the lactase solution (Ogasawara, para 0044), reading on the lactase solution further including protein other than lactase protein.
Claims 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over US Pub. No. 2017/0245513 to Ogasawara in view of US Pub. No. 2017/0304445 to Ogez, “Concentrate Food-Grade Lactase Powder for Dairy Processing” to Creative Enzyme and “Insight Into Mixing and Blending” to Clark, and optionally “Effect of Dissolved Oxygen Level on Lactase Production by Kluyveromyces fragilis” to Barberis, as applied to claims 1-3, 5-11, 13-15, and 21, further in view of US Pub. No. 2017/0215449 to Nagahata.
Regarding claims 16-19, the prior art combination teaches the solution further comprising a stabilizer (Ogez, para 0023, 0035). The prior art combination teaches the solution can also include metal salts, various saccharides, ascorbic acid glycerin, or the like that contribute to stabilization of a lactase (Id., para 0066).
The prior art combination is silent with regards to the specific amount of the stabilizer.
However, Nagahata teaches a lactase solution comprising a stabilizer that maintains the lactase activity of the lactase solution over a long period of time (Nagahata, abstract, para 0031). Nagahata teaches the stabilizer can be used in conjunction with carious other components, such as metal salts contributing to the stabilization of lactase (Id., para 0033). Nagahata teaches the amount of the stabilizer in the lactase solution being 10 to 90% by mass, particularly preferably 40 to 60% by mass (Id., para 0036), Nagahata teaches that when the amount of the stabilizer is lower limit value or more, it becomes easy to maintain the lactase activity of the lactase solution over a long period of time (Id.). Nagahata teaches that when the amount of the stabilizer exceeds the upper limit, the viscosity of a lactase solution is increase and the workability is lowered (Id.).
It would have been obvious to one of ordinary skill in the art before the effective filing date to form the solution of the prior art combination, wherein the stabilizer is contained in an amount of 40 to 60% by mass as taught by Nagahata, motivated by the desire of forming conventionally known lactase solution with conventionally known and predictably suitable stabilizer additive amounts and by the desire to ensure lactase activity over a long period of time when ensuring the viscosity is not too high and the workability reduced.
Claims 1-2, 5-11, 13-14, and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Ha-Lactase 5200 to Fromagex as evidenced by Ha-Lactase Product Information to Chr Hansen, as applied to claims 1-2, 5-6, 11, 13-14, and 20-21 above.
Regarding claims 1-2, 5-6, 11, 13-14, and 20-21, in the event that the headspace is not necessarily air, it would have been obvious to one of ordinary skill in the art before the effective filing date to form the container of neutral lactase of Fromagex, wherein the headspace is air as being readily available and based on the teachings of Chr not requiring a special environment beyond being cool and use of original container.
Regarding claims 6-11, throughout the use of the container and replacement of cap, the headspace will change and become within the claimed ranges.
Response to Arguments
Applicant's arguments and Declaration filed January 26, 2026 have been fully considered but they are not persuasive.
It should be noted that the Declarant is a co-inventor of the currently examined Application, and therefore, Declarant’s interest in the matter is a factor which can legitimately be taken into consideration. However, Declarant does not refer to any prior art documents to support his conclusions. Nothing in the Patent Office jurisprudence requires an examiner to credit unsupported assertions of an expert witness. Cf Rohm & Haas Co. v. Brotech Corp., 127 F.3d 1089, 1092 (Fed. Cir. 1997). Declarant states that when headspace is small, liquid movement is restricted making it difficult for bubble to form and protein aggregation is suppressed with a notable reduction of foaming when HS volume is 20% or less, regardless of container size. However, Ogasawara already establishes that physical stimulation such as shaking or vibration or the like generated during transportation after product of a lactase solution can form aggregates and yields an occurrence of clogging (Ogasawara, para 0012, 0145, 0149). Ogez teaches the presence of headspace in a container exacerbates the mechanical stresses place upon the product (Ogez, para 0002-0003). Physical stimulation such as shaking or vibration is a mechanical stress. Ogasawara already establishes shaking is detrimental to the neutral lactase solution and Ogez establishes headspace is linked with mechanical stress. The results are not unexpected based on the combined teachings.
Applicant argues that Ogez criticizes/discredits/discourages filling the headspace with reactive gas, rather than merely describing an alternative or general preference and therefore leads away from the claimed subject matter and oxygen is used in Ogasawara used oxygen in testing, different from long-term storage. Examiner respectfully disagrees. As highlighted in the interview and Applicant’s response, Ogasawara teaches the use of air and oxygen to force lactase solution through a filter for testing. If the use of oxygen and/or air would have been determinantal to the lactase solution, it would not be suitable for using in performance testing. As Ogasawara teaches the use of nitrogen, air, and/air oxygen for testing, the use of these same materials in the headspace of the package container would have been obvious to one of ordinary skill in the art before the effective filing date. Applicant has provided no evidence to the contrary. Additionally, as shown in Ha-Lactase Product Information to Chr Hansen, the storage required for a neutral lactase solution is cool within original container (Chr, p. 1). There is no indication a special environment is required. Therefore, during use, the headspace would be filled with air. The use of air is the most prevalent and cheapest option. Applicant has present no evidence of unexpected results due to the presence or air or oxygen.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Headspace Discussion at Cetie to Harris teaches container have headspace to allow for volumetric expansion due to temperature to over pressure and uses an example with 3%.
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 JENNIFER ANN GILLETT whose telephone number is (571)270-0556. The examiner can normally be reached 7 AM- 4:30 PM EST M-H.
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/JENNIFER A GILLETT/Examiner, Art Unit 1789
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