DETAILED CORRESPONDENCE
Status of the Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-10 are pending in the application.
Restriction/Election
Applicant's election with traverse of Group I, claims 1-6, in the reply filed August 31, 2026 is acknowledged. The traversal is on the ground that the reference of Ritter et al. (US 2010/0215738 A1; cited on the IDS filed August 23, 2024) does not teach or suggest a single embodiment that is encompassed by the galacto-oligosaccharide composition of instant claim 7.
Applicant’s arguments are not found persuasive. The process of claim 1 does not recite a particular concentration of lactase and the instant specification discloses that gal-β1,2-glc and gal-β1,3-glc become substrates for the lactase enzyme at low concentration (p. 3, lines 4-8), and the process of claim 1 does not require the resulting solution in step d) to comprise the disaccharides gal-β1,2-glc and gal-β1,3-glc. As such, the closest shared same or corresponding technical feature between Groups I and II is considered to be a galacto-oligosaccharide composition comprising less than 6 wt % lactose and less than 6 wt% of monosaccharides. As stated in the previous Office action, Ritter et al. (supra) disclose the single embodiment of a GOS composition comprising less than about 5% digestible saccharides such as lactose, glucose, and galactose (paragraph [0075]). Also, Pázmándi et al. (Yeast 37:515-530, 2020; cited on the IDS filed August 23, 2024) disclose a two-step fermentation of galacto-oligosaccharide syrup, which removes glucose in the first step and removes lactose and galactose in the second step (beginning at p. 525, column 2, middle). As such, the shared same or corresponding technical feature between Groups I and II is not a contribution over the prior art.
The requirement is still deemed proper and is therefore made FINAL.
Claims 7-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Priority
This application is filed under 35 U.S.C. 371 as a national stage of international application PCT/EP2023/054512, filed February 23, 2023, which claims foreign priority under 35 U.S.C. 119(a-d) to European application no. 22158755.3, filed February 25, 2022. A certified copy of the foreign priority application has been filed in this application on August 23, 2024.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on August 23, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS has been considered by the examiner.
Claim Objections
Claims 1-6 are objected to because of the following informalities:
Claims 1-6 are objected to for reciting “Process…” and in the interest of improving claim form and grammar, it is suggested that claim 1 be amended to recite “A process” and claims 2-6 are amended to recite “The process.”
Claim 1 is also objected to for failing to recite the conjunction “and” between steps c) and d).
Claim Rejections - 35 USC § 112(b)
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.
Claims 2-6 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claims 2-6 are indefinite in the recitation of “preferably…” According to MPEP § 2173.05(d), description of preferences is properly set forth in the specification rather than the claims and if stated in the claims, preferences may lead to confusion over the intended scope of a claim. In this case, the term “preferably” renders the claims indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention.
Claim Rejections - 35 USC § 112(a)
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.
Claims 1-6 are rejected under 35 U.S.C. 112(a) 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 at the time the application was filed, had possession of the claimed invention.
MPEP 2163.II.A.2.(a).i) states, “Whether the specification shows that applicant was in possession of the claimed invention is not a single, simple determination, but rather is a factual determination reached by considering a number of factors. Factors to be considered in determining whether there is sufficient evidence of possession include the level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention.”
For claims drawn to a genus, MPEP § 2163 states the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, 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 claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
MPEP § 2163 further states that “[s]atisfactory disclosure of a ‘representative number’ depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus…Instead, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are ‘representative of the full variety or scope of the genus,’ or by the establishment of ‘a reasonable structure-function correlation.’ Such correlations may be established ‘by the inventor as described in the specification,’ or they may be ‘known in the art at the time of the filing date.’"
The factors considered in the Written Description requirement are (1) level of skill and knowledge in the art, (2) partial structure, (3) physical and/or chemical properties, (4) functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and (5) the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient." MPEP § 2163.
The claims are drawn to process for reducing the lactose content of a galacto-oligosaccharide composition, comprising the steps of:
a) providing an aqueous solution of a galacto-oligosaccharide composition with a lactose content of 10-30 wt %, based on total carbohydrate weight, and a weight ratio of (gal-β1,2-glc+gal-β1,3-glc):lactose in the range 1.5:1 to 3.0:1, said solution having a dry matter content of at most 54 wt %,
b) adding to this solution a lactase enzyme,
c) conducting an enzymatic reaction at 30-50° C. to allow hydrolysis of lactose towards monosaccharides, the reaction being conducted until the lactose content of the solution is reduced to at most 6 wt % of lactose, based on total carbohydrate content,
d) removing monosaccharides from the solution obtained in step c).
Example 1 of the specification (beginning at p. 9) discloses a Biotis™ GOS-O syrup with 75 wt% dry matter, 13.2 wt% lactose, and 24 wt% of gal-β1,2-glc and gal-β1,3-glc (p. 9, lines 14-18) and teaches diluting the Biotis™ GOS-O syrup to a dry matter content of 45, 50, or 55 wt% and hydrolyzing the lactose in the syrup with Kluyveromyces lactis lactase at 2.5, 5.0, or 7.5 U/g with only the conditions of 2, 3, 5, 6, 8, and 9 of Table 1 resulting in reducing lactose content to at most 6 wt% as recited in claim 1.
The source/type and concentration/specific activity of the lactase enzyme and the concentration of monosaccharides in the aqueous solution of the galacto-oligosaccharide composition are unlimited and other than the specific conditions disclosed in Example 1, the specification does not disclose other conditions, e.g., lactase enzymes other than Kluyveromyces lactis lactase, concentrations of lactase enzyme other than 5.0 and 7.5 U/g, and other concentrations of monosaccharides, that result in reducing lactose content to at most 6 wt% as recited in claim 1.
Regarding the source/type and concentration/specific activity of the lactase enzyme, the specification suggests that lactase (beta-galactosidase) from Aspergillus oryzae does not enable the formation of the right lactose and bifidogenic disaccharide levels to enable the retention of said disaccharides in the present process (p. 4, lines 5-8), thus providing evidence of unpredictability that lactase enzymes other than Kluyveromyces lactis lactase would be suitable for use in the claimed process. Also, Table 1 of the specification shows that even Kluyveromyces lactis lactase at a concentration below 5.0 U/g and a dry matter content of 45, 50, or 55 wt% did not result in reducing lactose content to at most 6 wt% as recited in claim 1.
Regarding the concentration of monosaccharides in the aqueous solution of the galacto-oligosaccharide composition, Pázmándi et al. (Yeast 37:515-530, 2020; cited on the IDS filed August 23, 2024) disclose enzymatic synthesis of galacto-oligosaccharides results in products that contain high amounts of glucose (p. 515, Abstract) and Cao et al. (Bioactive Carbohydrates and Dietary Fibre 30: 100387, 2023; cited on the attached Form PTO-892) acknowledge that commercial galacto-oligosaccharides often contain significant amounts of glucose and galactose (p. 1, abstract) while Boon et al. (Biotechnol. Bioeng. 64:558-567, 1999; cited on the attached Form PTO-892) teach that lactase (beta-galactosidase) is inhibited by glucose and galactose (p. 559, Figure 1) and Cao et al. (supra) teach that mono sugars (glucose and galactose are mono sugars) exhibit an inhibiting effect on lactase (p. 4, column 2, bottom). Given that the aqueous solution of the galacto-oligosaccharide composition would be expected to contain high amounts of glucose and galactose, which have an inhibiting effect on lactase, there is a high level of unpredictability that a lactase would maintain sufficient activity to reduce lactose content to at most 6 wt% as recited in claim 1.
Given that: 1) the claimed process is widely variant with respect to the source/type of the lactase enzyme, the concentration/specific activity of the lactase enzyme, and additional, unrecited components of the aqueous solution of the galacto-oligosaccharide composition, e.g., monosaccharides that are inhibitory to lactase enzyme, 2) there is a high level of unpredictability that any lactase enzyme(s) at any concentration(s) would achieve a reduction of lactose content of the recited aqueous solution of galacto-oligosaccharide composition to at most 6 wt%, and 3) the specification discloses only a relative few representative species among a widely variant genus, one of skill would reasonably conclude that the applicant was not in possession of the claimed invention.
Conclusion
Status of the claims:
Claims 1-10 are pending.
Claims 7-10 are withdrawn from further consideration.
Claims 1-6 are rejected.
No claim is in condition for allowance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID J STEADMAN whose telephone number is (571)272-0942. The examiner can normally be reached Monday to Friday, 7:30 AM to 4:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MANJUNATH N RAO can be reached on 571-272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/David Steadman/Primary Examiner, Art Unit 1656
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