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 Group I, claims 1-6 and 12-15 in the reply filed on 3/27/26 is acknowledged. The traversal is on the ground(s) that there is no examination burden and a special technical feature between the groups exists. This is not found persuasive because see the restriction requirement mailed 1/27/16 p4-5.
The requirement is still deemed proper and is therefore made FINAL.
Claims 7-13 and 16-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 3/27/26.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The IDS filed on 3/6/24, 6/3/24, 10/31/25 has been fully considered except where references have been lined through.
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.
Claim 1, 2-6 and 14 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.
Regarding claims 1, 3-6 and 14, unlimited functional claim limitations that extend to all means or methods of resolving a problem may not be adequately supported by the written description or may not be commensurate in scope with the enabling disclosure, both of which are required by 35 U.S.C. 112(a) and pre-AIA 35 U.S.C. 112, first paragraph. In re Hyatt, 708 F.2d 712, 714, 218 USPQ 195, 197 (Fed. Cir. 1983); Ariad, 598 F.3d at 1340, 94 USPQ2d at 1167. For instance, a single means claim covering every conceivable means for achieving the stated result was held to be invalid under 35 U.S.C. 112, first paragraph because the court recognized that the specification, which disclosed only those means known to the inventor, was not commensurate in scope with the claim. Hyatt, 708 F.2d at 714-715, 218 USPQ at 197. In instant case, the claims do not have support for all possible means of providing the claimed functionality.
Regarding claim 2, option (ii) and (iii) requires one to several amino acid substitutions or 70% or more identity to the SEQ ID. As evidenced by Xue, there are over 800 natural amino acids and thousands of unnatural amino acids (introduction). Therefore, there is a nearly limitless number of SEQ ID NO 1 variants that could be generated. Instant specification has not identified any structure-function relationship as to which residues and/or domains are important for the claimed lactase activity and therefore applicants are not in possession of the entire genus. A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when … the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed. (MPEP 2163.05, I., B.). Instant specification has only disclosed a single SEQ ID, and one of ordinary skill in the arts would be unable to ascertain how the lactase could be mutated and retain the claimed functionality.
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 1-6 and 12-15 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 claim requires “an added amount of protein in the lactase” it is unclear if this “added amount of protein” is referring to the lactase protein or some other source of protein.
Further, options (1)-(4) require “… residual lactose concentration of XX or less after 16 hours at 10 oC is XXmg/L or less…”. It is unclear if the percentages and mg/ml is in reference to the protein concentration or the lactose concentration. For examination purposes either the protein concentration or the lactose concentration meeting either condition meets the claim limitations.
Claims 1, 3-6 and 14 merely recite a function or result achieved by the invention without reciting the particular structure, materials or steps that accomplish the function or achieve the result, and thus fails to provide a clear-cut indication of the scope of the subject matter embraced by the claim (see MPEP 2173.05(g)). The claims require a lactase without a specific sequence that allows for the claimed functionality. Therefore, one of ordinary skill in the arts would be unable to create a lactase capable of the claimed results as there is no structure in the claims capable of generating the claimed results.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3-4 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Raj (US20210032615A1).
Regarding claim 1, Raj teaches lactase enzymes (title). Raj teaches the enzymes are capable of producing lactose free products (concentration of 0.1% or less lactose) ([0011]). Raj teaches cow milk can be used ([0032-0033]). Raj teaches the lactase can be added to milk (added amount of protein) at 10 oC ([0024]). Raj teaches that the enzyme is capable of digesting lactase to less than 0.1% after 10 hours at 4oC (fig 25).
It is obvious to one of ordinary skill in the that the lactase of Raj would be capable of performing the recited functions. All of the claimed steps were known in the arts at the time of filing of instant invention and would be yield nothing more than predictable results with a reasonable expectation of success to one of ordinary skill in the arts. Further, MPEP 2144.04 states that “selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results”
Regarding claim 3, Raj teaches the lactose concentration in milk is 0.002% or higher ([0089]). This overlaps the claimed range and therefore the claimed range is obvious.
Regarding claims 4 and 14, Raj teaches the lactase can be in a buffer (example 7).
Claims 2, 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Raj (US20210032615A1), as applied to claims 1, 3-4, and 14 above, and further in view of Yoshida ("Bifidobacterium longum subsp. infantis uses two different β-galactosidases for selectively degrading type-1 and type-2 human milk oligosaccharides." Glycobiology 22.3 (2012): 361-368.)
Regarding claim 2, Raj teaches the lactase can be from Bifidobacterium longum ([0134]). Raj teaches that lactase enzymes are classified as beta galactosidase ([0004]). Raj does not specifically teach SEQ ID NO 1.
Yoshida teaches beta galactosidase from Bifidobacterium longum (title). Yoshida teaches a 98% match to claimed SEQ ID NO 1. (appendix).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the specific SEQ ID of Yoshida in the composition of Raj. One of ordinary skill in the art would be motivated to do so because Raj teaches the peptide can be from the same bacterial species disclosed by Yoshida. Further, this is a simple substutition of known beta galactosidase. There would be a reasonable expectation of success as both Raj and Yoshida are in the same field of endeavor of beta galactosidase from Bifidobacterium longum.
Regarding claim 12, Raj teaches the lactose concentration in milk is 0.002% or higher ([0089]). This overlaps the claimed range and therefore the claimed range is obvious.
Regarding claim 13, Raj teaches the lactase can be in a buffer (example 7).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Raj (US20210032615A1) as applied to claims 1, 3-4, and 14 above, and further in view of Haider ((2007), Preparation of lactose-free milk by using salt-fractionated almond (Amygdalus communis) β-galactosidase. J. Sci. Food Agric., 87: 1278-1283).
Regarding claim 5, Raj does not specifically teach magnesium chloride.
Haider studies the effects of salt on beta galactosidase (abstract). Hiader teaches magnesium chloride and sodium chloride can be used with beta galactosidase (materials and methods). Haider teaches both magnesium chloride and sodium chloride increase the activity of the enzyme (fig 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use magnesium or sodium chloride in the composition of Raj as taught by Haider. One of ordinary skill in the art would be motivated to do so because Haider teaches these salts improve enzyme activity. Further, one of ordinary skill in the art would be motivated to do so because these salts have been successfully used to increase enzyme activity and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. There would be a reasonable expectation of success as both Raj and Haider are in the same field of endeavor of beta galactosidase.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Raj (US20210032615A1) as applied to claims 1, 3-4, and 14 above, and further in view of Vrese, ("A combination of acid lactase from Aspergillus oryzae and yogurt bacteria improves lactose digestion in lactose maldigesters synergistically: A randomized, controlled, double-blind cross-over trial." Clinical nutrition 34.3 (2015): 394-399)
Regarding claim 6, Raj does not specifically teach a combination of lactases having a different origin or properties.
Vrese teaches a combination of acid lactase and yogurt bacteria (title and abstract). Vrese teaches that the yogurt bacteria comprises lactase (second lactase of different origin and properties) (introduction). Vrese teaches the combination of the lactases improves lactose digestion (abstract and conclusion).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a second lactase in the composition of Raj as taught by Vrese. One of ordinary skill in the art would be motivated to do so because Vrese teaches that a combination improves lactose digestion. There would be a reasonable expectation of success as both Raj and Vrese are in the same field of endeavor of lactase.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Raj (US20210032615A1) and Yoshida ("Bifidobacterium longum subsp. infantis uses two different β-galactosidases for selectively degrading type-1 and type-2 human milk oligosaccharides." Glycobiology 22.3 (2012): 361-368.), as applied to claims 2, 12, and 13 above, and further in view of Vrese, ("A combination of acid lactase from Aspergillus oryzae and yogurt bacteria improves lactose digestion in lactose maldigesters synergistically: A randomized, controlled, double-blind cross-over trial." Clinical nutrition 34.3 (2015): 394-399)
Regarding claim 6, Raj and Yoshida does not specifically teach a combination of lactases having a different origin or properties.
Vrese teaches a combination of acid lactase and yogurt bacteria (title and abstract). Vrese teaches that the yogurt bacteria comprises lactase (second lactase of different origin and properties) (introduction). Vrese teaches the combination of the lactases improves lactose digestion (abstract and conclusion).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a second lactase in the composition of Raj and Yoshida as taught by Vrese. One of ordinary skill in the art would be motivated to do so because Vrese teaches that a combination improves lactose digestion. There would be a reasonable expectation of success as both Raj Yoshida, and Vrese are in the same field of endeavor of lactase.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TREVOR L KANE whose telephone number is (571)272-0265. The examiner can normally be reached M-F 7:00 am-4:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Louise Humphrey can be reached at 571-272-5543. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TREVOR KANE/Examiner, Art Unit 1657
/ROBERT J YAMASAKI/Primary Examiner, Art Unit 1657
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