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 . 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 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.
DETAILED NON-FINAL ACTION
This is the initial Office Action (OA), on the merits, based on the 18/569,986 application filed on December 13, 2023. Claims 1-20 are pending and have been fully considered. The examined claims are directed to a method.
Priority
Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
Information Disclosure Statement
The Examiner has considered the information disclosure statements (IDS) submitted on 11/06/2024. Please refer to the signed copy of the PTO-1449 form attached herewith.
Claim Interpretation
In the patentability analysis below, the bolded portions represent structural aspects of the claim. The italicized portions represent one or more portions of the manipulative steps. If a prior art device, in its normal and usual operation necessarily performs a manipulative step, act, or the method claimed, then Examiner will consider the particular manipulative step or act to be disclosed by the prior art device. That is, when the prior art device is the same as a device described in Applicant’s specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. MPEP §2112.02.
Claim Rejections - 35 USC § 112
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 1-20 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 pre-AIA the applicant regards as the invention.
Claim 1 recites the limitations "the nanofiltration membrane" and “the active layer of the membrane.” There is insufficient antecedent basis for these limitations in the claim.
Also, the claim mentions “a separated HMO-containing stream” but not “a purified HMO-containing stream” or “a separated and purified HMO-containing stream.” Thus, the phrase “the purified HMO-containing stream” appears to lack antecedent basis.
Claims 7, and 8 and 10 are unclear because of the manner in which they refer to optional step c). If step c) is not performed, then claims 7 and 8 cannot be conducted and the treatment in claim 10 must follow step b. Thus the interpretation of claims 7, 8 and 10 is confusing if step c) is not mandatory in claim 1.
Claims 2-20 depend on claims 1.
Claim Rejections - 35 USC § 102
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.
Claims 1-4, 6, 8-10, 12 and 14-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Khanzhin et al. (US2020215486, Khanzhin) (IDS of 11/06/2024).
Regarding claims 1-4, 6, 8-10, 12 and 14-19, Khanzhin discloses a method for recovery and purification of a neutral or sialylated human milk oligosaccharide (HMO) from a fermentation broth (Abstract, [0001], [0002]), comprising the steps of:
a) separating the fermentation broth to form a separated HMO-containing stream and a biomass waste stream;
b) purifying the separated HMO-containing stream by nanofiltration ([0013]-[0031], [0035], [0056]-[0074);
c) optionally concentrating the purified HMO-containing stream ([0201]); and
d) drying the purified HMO-containing stream to obtain a solidified HMO,
wherein the nanofiltration membrane in step b) has a molecular weight cut-off (MWCO) of 500-3000 Da, the active layer of the membrane is composed of polyamide, and its MgSO4 rejection is about 50-90% ([0013]-[0031], [0056]-[0074], claims 1, 2, 4 and 8, where there is overlap of sufficient specificity for the MWCO),
and which does not comprise an ion exchange resin treatment step or an electrodialysis step ([0086]).
Additional Disclosures Included: Claim 2: Step a) comprises ultrafiltration or centrifugation ([0204]); Claim 3: The step b) is performed so that the pH is set below 5.0 ([0193]); Claim 4: Step b) further comprises nanofiltration conducted in diafiltration mode ([0015]). Claim 6: In the method, step c) comprises evaporation, nanofiltration, reverse-osmosis filtration, or a combination thereof ([0198]); Claim 8: Step c) comprises concentration with a nanofiltration membrane, the nanofiltration membrane is in the range of 500-3000 Da MWCO, has an active (top) layer composed of piperazine-based polyamide, a MgSO4 rejection factor of about 50-90% and a NaCl rejection factor of not more than 50%, and the nanofiltration step is performed so that the pH is set below 5.0 (claim 1 analysis); Claim 9: In the method, step c) is conducted and step d) consists of spray-drying to obtain solidified HMO ([0198]); Claim 10: The method further comprises an active carbon treatment step following step b) or step c) ([0201]); Claim 12: The method comprises the following steps:
i. separating the fermentation broth to form a separated neutral or sialylated HMO-containing stream and a biomass waste stream by ultrafiltration (0198]);
ii. purifying the separated neutral or sialylated HMO-containing stream by combined nanofiltration and diafiltration ([0015], [0024]);
iii. purifying the neutral or sialylated HMO-containing stream by active carbon treatment ([0201]);
iv. optionally purifying the separated neutral or sialylated HMO-containing stream by a second nanofiltration step, optionally combined with diafiltration (claim 1 analysis);
v. concentrating the purified neutral or sialylated HMO-containing stream by evaporation ([0198]); and
vi. spray-drying the purified neutral or sialylated HMO-containing stream to obtain solidified neutral or sialylated HMO ([0198]); Claim 14: The method comprises the following steps:
i. separating the fermentation broth to form a separated neutral or sialylated HMO-containing stream and a biomass waste stream by ultrafiltration (0198]);
ii. purifying the separated neutral or sialylated HMO-containing stream by combined nanofiltration and diafiltration ([0015], [0024]);
iii. purifying the neutral or sialylated HMO-containing stream by active carbon treatment;
iv. optionally purifying the separated neutral or sialylated HMO-containing stream by a second nanofiltration step, optionally combined with diafiltration, wherein the nanofiltration membrane is in the range of 500-3000 Da MWCO, has an active (top) layer composed of polyamide, a MgSO4 rejection factor of about 50-90% and a NaCl rejection factor of not more than 50%, and the nanofiltration step is performed so that the pH is set below 5.0 (claim 1 analysis);
v. concentrating the purified neutral or sialylated HMO-containing stream by evaporation ([0198]); and
vi. spray-drying the purified neutral or sialylated HMO-containing stream to obtain solidified neutral or sialylated HMO ([0198]); Claim 15: The method according to claim 1, wherein the HMO is a neutral HMO ([0041]); Claim 16: The method according to claim 15, wherein the HMO is selected from the group consisting of: 2′-fucosyllactose, 3-fucosyllactose, 2′,3-difucosyllactose, lacto-N-triose II, lacto-N-tetraose, lacto-N-neotetraose, lacto-N-fucopentaose I, lacto-N-fucopentaose II, lacto-N-fucopentaose III, lacto-N-fucopentaose V, lacto-N-fucopentaose VI, lacto-N-difucohexaose I, lacto-N-difucohexaose II, lacto-N-difucohexaose III, 6′-galactosyllactose, 3′-galactosyllactose, lacto-N-hexaose and lacto-N-neohexaose ([0038], [0041]); Claim 17: The the HMO is 2′-fucosyllactose, 3-fucosyllactose, 2′,3-difucosyllactose, lacto-N-triose II, lacto-N-tetraose, lacto-N-neotetraose or a lacto-N-fucopentaose ([0038]); Claim 18: The method according to claim 1, wherein the HMO is a sialylated HMO ([0041], [0042]); and Claim 19: The pH is set to between 3.0 and 4.5 ([0193]).
Claims 1-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Jennewein et al. (US20220251130, Jennewein).
Regarding claims 1-20, Jennewein discloses a method for recovery and purification of a neutral or sialylated human milk oligosaccharide (HMO) from a fermentation broth (Abstract, [0001]), comprising the steps of:
a) separating the fermentation broth to form a separated HMO-containing stream and a biomass waste stream ([0025]-[0034]);
b) purifying the separated HMO-containing stream by nanofiltration (Id.);
c) optionally concentrating the purified HMO-containing stream (Id.); and
d) drying the purified HMO-containing stream to obtain a solidified HMO (Id.),
wherein the nanofiltration membrane in step b) has a molecular weight cut-off (MWCO) of 500-3000 Da, the active layer of the membrane is composed of polyamide, and its MgSO4 rejection is about 50-90% (Id., [0020], [0050], [0052]-[0055], [0058], [0066], [0074], where there is overlap of sufficient specificity for the MWCO),
and which does not comprise an ion exchange resin treatment step or an electrodialysis step ([0032], where this step 6) embodiment has two options, including one without either electrodialysis or ion exchange resin treatment).
Additional Disclosures Included: Claim 2: Step a) comprises ultrafiltration or centrifugation ([0026]); Claim 3: The step b) is performed so that the pH is set below 5.0 ([0019], [0098]); Claim 4: In the method, step b) further comprises nanofiltration conducted in diafiltration mode ([0032]); Claim 5: The method according to claim 1, wherein step b) comprises a second nanofiltration step, wherein the nanofiltration membrane has a molecular weight cut-off (MWCO) of 150-300 Da ([0074]); Claim 6: Step c) comprises evaporation, nanofiltration, reverse-osmosis filtration, or a combination thereof ([0029]-[0032], [0033], [0072]); Claim 7:Step c) comprises concentration with a nanofiltration membrane, wherein the nanofiltration membrane has a molecular weight cut-off (MWCO) of 150-300 Da ([0074]); Claim 8: Step c) comprises concentration with a nanofiltration membrane, the nanofiltration membrane is in the range of 500-3000 Da MWCO, has an active (top) layer composed of piperazine-based polyamide, a MgSO4 rejection factor of about 50-90% and a NaCl rejection factor of not more than 50%, and the nanofiltration step is performed so that the pH is set below 5.0 (claim 1 analysis; [0066], [0098]); Claim 9: Step c) is conducted and step d) consists of spray-drying to obtain solidified HMO ([0034], [0110]-[0112]); Claim 10: The method further comprises an active carbon treatment step following step b) or step c) ([0031], [0082]-[0085]); Claim 11: The method comprises the following steps:
i. separating the fermentation broth to form a separated neutral or sialylated HMO-containing stream and a biomass waste stream by ultrafiltration ([0023], [0056]);
ii. purifying the separated neutral or sialylated HMO-containing stream by combined nanofiltration and diafiltration ([0032]);
iii. purifying the neutral or sialylated HMO-containing stream by active carbon treatment ([0082]-[0085]);
iv. purifying the separated neutral or sialylated HMO-containing stream by a second nanofiltration step ([0030], [0072]);
v. concentrating the purified neutral or sialylated HMO-containing stream by evaporation ([0072]); and
vi. spray-drying the purified neutral or sialylated HMO-containing stream to obtain solidified neutral or sialylated HMO ([0034], [0110]-[0112]); Claim 12: The method comprises the following steps:
i. separating the fermentation broth to form a separated neutral or sialylated HMO-containing stream and a biomass waste stream by ultrafiltration ([0023], [0056]);
ii. purifying the separated neutral or sialylated HMO-containing stream by combined nanofiltration and diafiltration ([0032]);
iii. purifying the neutral or sialylated HMO-containing stream by active carbon treatment ([0082]-[0085]);
iv. optionally purifying the separated neutral or sialylated HMO-containing stream by a second nanofiltration step, optionally combined with diafiltration ([0030], [0072]);
v. concentrating the purified neutral or sialylated HMO-containing stream by evaporation ([0072]); and
vi. spray-drying the purified neutral or sialylated HMO-containing stream to obtain solidified neutral or sialylated HMO ([0034], [0110]-[0112]); Claim 13: The nanofiltration membrane has an active (top) layer composed of polyamide, the membrane has a MgSO4 rejection factor of about 50-90% and a NaCl rejection factor of not more than 50%, and the nanofiltration step is performed so that the pH is set below 5.0 (claim 1 analysis); Claim 14: The method comprises the following steps:
i. separating the fermentation broth to form a separated neutral or sialylated HMO-containing stream and a biomass waste stream by ultrafiltration (claims 11 and 12 analyses);
ii. purifying the separated neutral or sialylated HMO-containing stream by combined nanofiltration and diafiltration (claims 11 and 12 analyses);
iii. purifying the neutral or sialylated HMO-containing stream by active carbon treatment (claims 11 and 12 analyses);
iv. optionally purifying the separated neutral or sialylated HMO-containing stream by a second nanofiltration step, optionally combined with diafiltration, wherein the nanofiltration membrane is in the range of 500-3000 Da MWCO, has an active (top) layer composed of polyamide, a MgSO4 rejection factor of about 50-90% and a NaCl rejection factor of not more than 50%, and the nanofiltration step is performed so that the pH is set below 5.0 (claims 11-13 analyses);
v. concentrating the purified neutral or sialylated HMO-containing stream by evaporation (claims 11 and 12 analyses); and
vi. spray-drying the purified neutral or sialylated HMO-containing stream to obtain solidified neutral or sialylated HMO (claims 11 and 12 analyses); Claim 15: The method according to claim 1, wherein the HMO is a neutral HMO ([0023], [0056], [0089]); Claim 16: The HMO is selected from the group consisting of: 2′-fucosyllactose, 3-fucosyllactose, 2′,3-difucosyllactose, lacto-N-triose II, lacto-N-tetraose, lacto-N-neotetraose, lacto-N-fucopentaose I, lacto-N-fucopentaose II, lacto-N-fucopentaose III, lacto-N-fucopentaose V, lacto-N-fucopentaose VI, lacto-N-difucohexaose I, lacto-N-difucohexaose II, lacto-N-difucohexaose III, 6′-galactosyllactose, 3′-galactosyllactose, lacto-N-hexaose and lacto-N-neohexaose ([0004], [0120], Table 1); Claim 17: The HMO is 2′-fucosyllactose, 3-fucosyllactose, 2′,3-difucosyllactose, lacto-N-triose II, lacto-N-tetraose, lacto-N-neotetraose or a lacto-N-fucopentaose ([0004], [0120], Table 1); Claim 18: The HMO is a sialylated HMO ([0016], [0023], [0120]); and Claims 19 and 20: The pH is set to between 3.0 and 4.5 ([0019], [0098]).
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 claims at issue 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); and 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 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of co-pending Application No. 18/570,003. Although the claims at issue are not identical, they are not patentably distinct from each other because the applications recite the same or similar limitations relating to the recovery and purification of human milk oligosaccharide (HMO) from a fermentation broth. One of ordinary skill in the art would have understood that one could adjust the molecular weight cut-off (MWCO) and the rejection factor based on routine experimentation and optimization to achieve a desired result.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Examiner recommends that Applicant carefully review each identified reference and all objections/rejections before responding to this office action to properly advance the case in light of the pertinent objections/rejections and the prior art. With respect to the patentability analysis, Examiner has attempted to claim map to one or more of the most suitable structures or portions of a reference. However, with respect to all OAs, Examiner notes that citations to specific pages, columns, paragraphs, lines, figures or reference numerals, in any prior art or evidentiary reference, and any interpretation of such references, should not be considered to be limiting in any way. A reference is relevant for all it contains and may be relied upon for all that it would have reasonably disclosed and/or suggested to one having ordinary skill in the art. The use of publications and patents as references is not limited to what one or more applicant/inventor/patentee describes as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain. MPEP §2123.
Examiner further recommends that for any substantive claim amendments made in response to this Office Action, or to otherwise advance prosecution, or for any remarks concerning support for added subject matter or claim priority, that Applicant include either a pinpoint citation to the original Specification (i.e. page and/or paragraph and/or line number and/or figure number) to indicate where Applicant is drawing support for such amendment or remarks, or a clear explanation indicating why the particular limitation is implicit or inherent to the original disclosure.
Electronic Inquiries
Any inquiry concerning this communication or an earlier communications from the examiner should be directed to Hayden Brewster whose telephone number is (571) 270-1065. The examiner can normally be reached M-Th 9 AM - 4 PM.
Alternatively, to contact the examiner, Applicant may send a communication, via e-mail or fax. Examiner’s direct fax number is: (571) 270-2065. Examiner's official e-mail address is: "Hayden.Brewster@uspto.gov." However, since e-mail communication may not be secure, Examiner will not respond to a substantive e-mail unless Applicant’s communication is in accordance with the provisions of MPEP §502.03 & related sections that discuss the required Authorization for Internet Communication (AIC). Nonetheless, all substantive communications will be made of record in Applicant’s file.
To facilitate the Internet communication authorization process, Applicant may file an appropriate letter, or may complete the USPTO SB439 fillable form available at https://www.uspto.gov/sites/default/files/documents/sb0439.pdf, preferably in advance of any substantive e-mail communication. Since one may use an electronic signature with this particular form, Applicant is encouraged to file this form via the Office’s system for electronic filing of patent correspondence (i.e., the electronic filing system (Patent Center)). Otherwise, a handwritten signature is required. In addition to Patent Center, Applicant can submit their Internet authorization request via US Postal Service, USPTO Customer Service Window, or Central Fax. Examiner can also provide a one-time oral authorization, but this will only apply to video conferencing. It is improper to request Internet Authorization via e-mail.
Examiner interviews are available via telephone, in-person, and via video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, Applicant is encouraged to use the USPTO Automated Interview Request (AIR) form available at http://www.uspto.gov/interviewpractice, or Applicant may call Examiner, if preferable. Applicant can access a general list of patent application forms at either https://www.uspto.gov/patent/forms/forms-patent-applications-filed-or-after-september-16-2012 (applications filed on or after September 16, 2012) or https://www.uspto.gov/patent/forms/forms (applications filed before September 16, 2012). Note that the language in an AIR form is not a substitute for the requirements of an AIC, where appropriate. The mere filing of an Applicant Initiated Interview Request Form (PTOL-413A) or a Letter Requesting Interview with Examiner, in EFS-Web, may not apprise Examiner of such a request in a timely manner.
If attempts to reach the Examiner are unsuccessful, Applicant may reach Examiner’s supervisor, Bobby Ramdhanie at 571-270-3240. The central fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/HAYDEN BREWSTER/Examiner, AU 1779
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