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 without traverse of Group I (i.e., method for producing β-galactosidase, claims 11-17 and newly added claims 28-38) in the reply filed on 11/10/2025 is acknowledged.
Status of Claims
Claims 1-10 and 18-27 are cancelled.
Claims 11-17 and 28-38 are currently and under consideration.
Priority
The present application claims status as a 371 (National Stage) of PCT/CN2020/105159 filed on 07/28/2020. The present application and all claims are being examined with an effective filing date of 07/28/2020. In future actions, the effective filing date may change due to amendments or further review of priority documents.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/19/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Claim Objections
Claim 11 is objected to because of improper grammar. The phrase “method for preparing of β-galactosidase” should be amended to “method for preparingthe preparation
Appropriate correction is required.
Claim 16 is objected to because of the following informalities:
Claim 16 recites that the fermentation is conducted at a pH of 6.5-7.0 for 0-8 hours, followed by a pH of 7.2-7.6 after 8 hours. The recitation of a time period encompassing zero hours renders the duration of the fermentation period unclear. For improved clarity, it is suggested that the claim be amended, for example, to recite “a pH of 6.5-7.0 for up to 8 h” or “for the first 8 h”.
Appropriate correction is required.
Claim 34 is objected to for containing a repetition of listed elements. The claim recites “a calcium soap” and “an aluminum soap” twice, when referring to defoaming agents.
Appropriate correction is required.
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.
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 12, 14, and 28 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.
Claims 12 and 28 are indefinite due to the recitation of “step 1”. Claims 11 and 15-16, from which claims 12 and 28 directly or indirectly depends, do not recite numbered steps. As a result, the claims lack proper antecedent basis for “step 1”, and the scope of the dependent claims is not defined.
Claim 14 is indefinite and unclear due to the recitation of “the balance of the fermentation medium is water”. Claims 11 and 13, from which claim 14 depend, do not define the total composition of the fermentation medium or provide a basis for determining what constitutes “the balance”. As a result, the scope of claim 14 cannot be reasonably ascertained. For examination purposes, the examiner interprets this limitation as merely indicating that water is present in the fermentation medium in an unspecified amount.
Response and clarification to all of the above is requested.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 37 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 37 recited that the phytone is “soya peptone” (i.e., soy peptone); however, phytone is a soy derived peptone. Accordingly, claim 37 does not impose any additional limitation.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 112(a) or First Paragraph (pre-AIA )
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 12 and 28 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The invention appears to employ a specific strain (i.e., Bacillus circulans CCTCC NO: M 2015424). Since the strain is essential to the claimed invention, it must be obtainable by a repeatable method set forth in the specification or otherwise be readily available to the public.
It appears that a deposit was made in this application, as noted on page 3, paragraph 0014, of the specification, and as recited in claims 12 and 28. However, there is no indication that the strain is readily available to the public and does not appear to meet all the criteria set forth in 37 CFR 1.801-1.809.
If a deposit was made under the terms of the Budapest Treaty, then an affidavit or declaration by applicants, or a statement by an attorney of record over his or her signature and registration number, stating that the specific strain has been deposited under the Budapest Treaty and that the strain will be available to the public under the conditions specified in 37 CFR 1.808, would satisfy the deposit requirement made herein. If a deposit has not been made under the Budapest treaty, then in order to certify that the deposit meets the criteria set forth in 37 CFR 1.801-1.809, Applicant may provide assurance or compliance by an affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number, showing that:
a. during the pendency of this application, access to the invention will be afforded to the
Commissioner upon request;
b. upon granting of the patent, the strain will be available to the public under the conditions
specified in 37 CFR 1.808;
c. the deposit will be maintained in a public repository for a period of 30 years or 5 years after
the last request or for the effective life of the patent, whichever is longer; and
d. the deposit will be replaced if it should ever become non-viable.
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.
Claim 17 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Xianjing et al. (CN102676614, cited in the IDS).
Claim 17 recites a limitation that requires a β-galactosidase liquid prepared by the method according claim 11, which is a product by process limitation that is given little patentable weight because determination of patentability is based on the characteristics of the product itself. Pursuant to MPEP 2113, "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production.” Furthermore, "[b]ecause validity is determined based on the requirements of patentability, a patent is invalid if a product made by the process recited in a product-by-process claim is anticipated by or obvious from prior art products, even if those prior art products are made by different processes." Amgen Inc. v. F. Hoffmann-La Roche Ltd., 580 F.3d 1340, 1370 n 14, 92 USPQ2d 1289, 1312, n 14 (Fed. Cir. 2009). See also Purdue Pharma v. Epic Pharma, 811 F.3d 1345, 117 USPQ2d 1733 (Fed. Cir. 2016).
Xianjing et al. teaches β-galactosidase liquid (Specification, para 0041-0046, Example 1, and Example 4) from Bacillus circulans.
Thus, claim 17 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Xianjing et al.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 11, 13-17, and 30-38 are rejected under 35 U.S.C. 103 as being unpatentable over Xianjing et al. (CN102676614, cited in the IDS).
Regarding claims 11, 17 and 35-37, Xianjing et al. discloses a method for preparing liquid β-galactosidase comprising taking Bacillus circulans as the starting strain, followed by activation, seed tank culture, fermentation, sterilization, and concentration (Specification, para 0042). Specifically, Xianjing et al. disclose an exemplary process comprising inoculating Bacillus circulans into LB medium and incubating for 18 hours, thereby “activating” the B. circulans; inoculating the activated B. circulans into a fermenter containing LB medium (i.e., seed tank) for 4 hours to obtain a seed culture solution (i.e., seed culture broth); inoculating the seed culture solution with lactose, galactose, soy peptone (corresponding to the recited phytone in claim 11 – see 112b above; and the soya peptone recited in claim 37), corn extract, yeast extract, diammonium hydrogen phosphate (as recited in claim 35), sodium carbonate (as recited in claim 36), soybean oil, defoamer and water in a fermenter, to undergo fermentation for 18 hours; and then performing centrifugation (Example 1) or cross-flow filtration (Example 4) and concentrating the fermentation broth, thereby obtaining a crude enzyme solution (Ex 1: para 0053-0060 and Ex 4: para 0070-0077). While the claimed medium recites cornmeal, the medium of Xianjing et al. uses corn extract as a corn derived carbohydrate nutrient source. Such a component is well-known and widely recognized in the art as interchangeable corn derived carbohydrate sources in microbial fermentation media. Therefore, it would be obvious for a person of ordinary skill in the art, to make such a substitution and expect predictable results (see MPEP 2144.06, “Substituting equivalents known for the same purpose”).
It is noted that the limitation of claim 17 that requires a β-galactosidase liquid prepared by the method according claim 11 is a product by process limitation that is given little patentable weight because determination of patentability is based on the characteristics of the product itself. Pursuant to MPEP 2113, "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production.” Furthermore, "[b]ecause validity is determined based on the requirements of patentability, a patent is invalid if a product made by the process recited in a product-by-process claim is anticipated by or obvious from prior art products, even if those prior art products are made by different processes." Amgen Inc. v. F. Hoffmann-La Roche Ltd., 580 F.3d 1340, 1370 n 14, 92 USPQ2d 1289, 1312, n 14 (Fed. Cir. 2009). See also Purdue Pharma v. Epic Pharma, 811 F.3d 1345, 117 USPQ2d 1733 (Fed. Cir. 2016). Nevertheless, Xianjing et el. teaches a β-galactosidase liquid, obtained by the method of claim 11, as detailed above.
Regarding claims 13 and 33, in the method for obtaining β-galactosidase liquid above, Xianjing et al. teaches fermentation medium comprising 5-15 g/L lactose, 5-10 g/L galactose, 10-30 g/L soy peptone, 4-6 g/L corn extract, 2-4 g/L yeast extract, 2-4 g/L diammonium hydrogen phosphate, 1-2 g/L sodium carbonate, and 0.5-2 g/L defoamer (as recited in claim 33) (para 0045). Pursuant to MPEP 2144.05, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). Furthermore, while the claimed medium recites dried corn steep liquor powder, the medium of Xianjing et al. uses corn extract as a corn derived carbohydrate nutrient source. Such a component is well-known and widely recognized in the art as interchangeable corn derived carbohydrate sources in microbial fermentation media. Therefore, it would be obvious for a person of ordinary skill in the art, to make such a substitution and expect predictable results (see MPEP 2144.06, “Substituting equivalents known for the same purpose”).
Regarding claim 14, in the method for obtaining β-galactosidase liquid above, Xianjing et al. specifically discloses wherein the fermentation medium comprises 1000 kg of water (Example 4, para 0074) (see above rejection under 112 (b)).
Regarding claim 15-16, 30-31, with respect to the pH and length (time period) of fermentation in the process described above, Xianjing et al. teaches culture conditions are 36°C-38°C, pH 7.0-7.5, for 20-28 hours. Pursuant to MPEP 2144.05, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
Regarding claim 29, as described above, the fermentation media of Xianjing et al. comprises 10-30 g/L soy peptone and 2-4 g/L of yeast extract, both of which overlap with the claimed ranges, and therefore are obvious to persons of ordinary skill in the art. With respect to the medium comprising 2-8 g/L sodium chloride, as recited by the instant claim, LB medium is a well known culture medium that conventionally comprises sodium chloride (and peptone and yeast extract). Specifying an amount of sodium chloride within a conventional LB formulation represents routine optimization of a known medium component. Accordingly, the claimed range of sodium chloride would have been obvious to a person of ordinary skill in the art.
Regarding claim 32, Xianjing et al. specifically discloses fermentation conducted with a stirring speed of 120-220 rpm and a ventilation (aeration or air) rate of 125 L/min (Ex. 1, para 0057).
Regarding claim 38, Xianjing et al. discloses a fermentation broth obtained by the methods described above, wherein fermentation broth is centrifuged and concentrated, resulting in crude enzyme with an enzyme activity of 115 U/ml (Ex. 1); and wherein the fermentation broth is filtered and concentrated, resulting in crude enzyme solution with an enzyme activity of 98.5 U/ml (Ex. 4). While Xianjing et al. does not explicitly report conductivity, conductivity is a direct physical property of an enzyme solution that depends on ionic strength and concentration. The prior art process includes concentration, washing, and salt containing media, and the claimed conductivity range therefore reflects a result-effective variable that would have been obtained through routine optimization by control of salt content and concentration level during the known concentration treatment, which would have been obvious to a person of ordinary skill in the art. Accordingly, the claimed conductivity range does not distinguish the claimed method over the prior art.
An invention would have been obvious to a person of ordinary skill in the art if some teaching in the prior art would have led that person to arrive at the claimed invention. Before the effective filing date of the claimed invention, Xianjing et al. disclosed a successful method for producing β-galactosidase liquid using Bacillus circulans ATCC 31382 under fermentation conditions and media compositions overlapping and similar to those recited in the instant claims. Given that Xianjing et al.’s method is not limited to B. circulans ATCC 31382, and that cornmeal, corn extract and dried corn steep liquor powder are all corn-derived carbohydrate sources used in fermentation media, it would have been obvious to a person of ordinary skill in the art to employ Xianjing et al.’s process to obtain β-galactosidase liquid using other strains of B. circulans and alternative corn derived carbohydrate sources, and expect predictable results (see MPEP 2144.06, “Substituting equivalents known for the same purpose”). There is a reasonable expectation of success because Xianjing et al. demonstrates a successful method of obtaining β-galactosidase liquid comprising activating and seeding B. circulans, followed by fermentation in media containing lactose, galactose, soy peptone, corn extract, yeast extract, a phosphate salt, a carbonate salt, and water; and filtering or centrifuging and concentrating the enzyme solution. Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention.
Thus, claims 11, 13-17, and 30-38 are rejected under 35 U.S.C. 103 as being unpatentable over Xianjing et al.
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Xianjing et al., as applied to claims 11 and 33 above, and further in view of Shonaka et al. (EP0843004, cited in PTO-892).
The teachings of Xianjing et al. as they apply to claims 11 and 33 have already been discussed. Briefly, Xianjing et al. discloses a method for obtaining β-galactosidase liquid comprising activating and seeding B. circulans, followed by fermentation in media containing lactose, galactose, soy peptone, corn extract, yeast extract, a phosphate salt, a carbonate salt, defoamer and water; and then filtering or centrifuging the fermentation broth. Xianjing et al. expressly teaches 0.5-2 g/L defoamer, but does not disclose a specific or particular defoamer, including lauric acid, palmitic acid, a glyceride of a fatty acid, a calcium soap, an aluminum soap, a magnesium soap of stearic acid, a magnesium soap of palmitic acid, and a fatty alcohol.
Shonaka et al. discloses antifoaming agents for use in fermentation media , wherein the defoamer comprises components (A) and (B), wherein the compounds for (B) are selected from…fatty acids, alcohols, polyoxyalkylene polyhydric alcohol ethers, polyoxyalkylene alkyl ethers, polyoxyalkylene fatty acid esters, polyoxyalkylene alkyl ether fatty acid esters, and polyoxyalkylene polymers (Specification, para 0007). Shonaka et al. further teaches that suitable “alcohols” include linear or branched, saturated or unsaturated C1-22 aliphatic alcohols (para 0017), which constitutes “fatty alcohols”, as recited by the instant claim.
An invention would have been obvious to a person of ordinary skill in the art if some teaching in the prior art would have led that person to combine prior art teachings to arrive at the claimed invention. Before the effective filing date of the claimed invention, given Xianjing et al.’s teaching of a method for obtaining β-galactosidase liquid comprising activating and seeding B. circulans, followed by fermentation in media containing lactose, galactose, soy peptone, corn extract, yeast extract, a phosphate salt, a carbonate salt, defoamer and water, and the teachings of Shonaka et al., which discloses various formulations of antifoaming agents, including fatty alcohols, for use in fermentation media, it would have been obvious to a person of ordinary skill in the art to substitute a fatty alcohol defoamer, as taught by Shonaka et al., for the unspecified defoamer used in the method of Xianjing et al. There is a reasonable expectation of success because Shonaka et al. teaches the use of fatty alcohol formulations as defoaming agents in fermentation. Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention.
Thus, claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Xianjing et al., as applied to claims 11 and 33 above, and further in view of Shonaka et al.
Conclusion
No claim is in condition for allowance.
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/NAGHMEH NINA MOAZZAMI/ Examiner, Art Unit 1652
/RICHARD G HUTSON/ Primary Examiner, Art Unit 1652