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 .
Status of the Application
1. Claims 80-134 are pending and subject to examination on the merits. Claims 92-93, 95-96, 99, 120-134 are withdrawn from consideration as being drawn to non-elected subject matter. Claims 80-91, 94, 97-98, and 100-119 are currently under examination.
Election/Restrictions
2. Applicant’s election without traverse of group 1, claims 80-119, in the reply filed on 22 April 2026 is acknowledged. Additionally, applicant chose Species 1b, polypeptides encoded by the multiple coding DNA sequences have glucosyltransferase activity; Species 1bb: N-acetylglucosaminyl transferases; Species 1bbb: β-1,3-N-acetylglycosaminyl transferases supported in claim 104(i), specifically SEQ ID NOs: 2-6 and 80; Species 2: N-acetylglucosaminylation pathway; Species 3: bacterium. Therefore, claims 92-93, 95-96, 99, and 120-134 are withdrawn as to being drawn to unelected groups and species.
Priority
3. Acknowledgement is made of applicant’s claim for foreign priority based on an application filed in EP (EP20190204.6) on 10 August 2020, EP (EP21168997.1) on 16 April 2021, EP (EP21186203.2). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
4. The information disclosure statements (IDS) submitted on 07 September 2021 and 12 July 2022 have been considered by the examiner. See initialed and signed PTO/SB/08’s.
Specification
5. The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (paragraph 0045, three instances; paragraph 0046, two instances; paragraph 0050; paragraph 0093; paragraph 0134; paragraph 0141; paragraph 0142, two instances; paragraph 0145, paragraph 0733). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Objections
6. Claim 97 is objected to because of the following informalities: “oligosaccharide the precursor(s)” should be amended to “oligosaccharide, wherein the precursor(s) are” to improve grammar. Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
7. 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.
Written Description:
8. Claims 80-90, 97-98, 100-103, 107-110, 112, and 115-119 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.
The claims are drawn to a cell for producing a di- and/or oligosaccharide, the cell comprising a pathways for production thereof, wherein the cell is genetically modified for expression and/or overexpression of at least one set of multiple coding DNA sequences (at least 2), wherein the multiple coding DNA sequences within one set: differ in nucleotide sequence, and each encode a polypeptide, wherein the polypeptides have the same function and/or activity of interest (being functional variants), wherein the cell comprises a modification for reduced production of acetate.
MPEP 2163(1):
35 U.S.C. 112(a) and the first paragraph of pre-AIA 35 U.S.C. 112 require that the "specification shall contain a written description of the invention ...." This requirement is separate and distinct from the enablement requirement. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1340, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010) (en bane); Vas-Gath, Inc. v. Mahurkar, 935 F.2d 1555, 1560, 19 USPQ2d 1111, 1114 (Fed. Cir. 1991); see also Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920-23, 69 USPQ2d 1886, 1890-93 (Fed. Cir. 2004) (discussing the history and purpose of the written description requirement); In re Curtis, 354 F.3d 1347, 1357, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004) ("conclusive evidence of a claim's enablement is not equally conclusive of that claim's satisfactory written description"). The written description requirement has several policy objectives. "[T]he 'essential goal' of the description of the invention requirement is to clearly convey the information that an applicant [inventor] has invented the subject matter which is claimed." In re Barker, 559 F.2d 588, 592 n.4, 194 USPQ 470, 473 n.4 (CCPA 1977). Another objective is to convey to the public what the applicant claims as the invention. See Regents of the Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 1566, 43 USPQ2d 1398, 1404 (Fed. Cir. 1997), cert. denied, 523 U.S. 1089 (1998). "The 'written description' requirement implements the principle that a patent must describe the technology that is sought to be patented; the requirement serves both to satisfy the inventor's obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee [inventor] was in possession of the invention that is claimed." Capon v. Eshhar, 418 F.3d 1349, 1357, 76 USPQ2d 1078, 1084 (Fed. Cir. 2005). Further, the written description requirement promotes the progress of the useful arts by ensuring that patentees adequately describe their inventions in their patent specifications in exchange for the right to exclude others from practicing the invention for the duration of the patent's term.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Gath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. However, a showing of possession alone does not cure the lack of a written description. Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 969-70, 63 USPQ2d 1609, 1617 (Fed. Cir. 2002). For example, it is now well accepted that a satisfactory description may be found in originally-filed claims or any other portion of the originally-filed specification. See In re Koller, 613 F.2d 819, 204 USPQ 702 (CCPA 1980); In re Gardner, 475 F.2d 1389, 177 USPQ 396 (CCPA 1973); In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). However, that does not mean that all originally-filed claims have adequate written support. The specification must still be examined to assess whether an originally-filed claim has adequate support in the written disclosure and/or the drawings.
9. The claims are drawn to a cell for producing a di- and/or oligosaccharide, the cell comprising a pathways for production thereof, wherein the cell is genetically modified for expression and/or overexpression of at least one set of multiple coding DNA sequences (at least 2), wherein the multiple coding DNA sequences within one set: differ in nucleotide sequence, and each encode a polypeptide, wherein the polypeptides have the same function and/or activity of interest (being functional variants), wherein the cell comprises a modification for reduced production of acetate. The variability in DNA sequences encoding polypeptides involved in some capacity of producing di- and/or oligosaccharides is enormous, considering the production of di- and/or oligosaccharides is a central part of cellular metabolism. Additionally, the variability in polypeptide function and/or activity of the proteins involved in these complex pathways is inherently diverse and covers a multitude of possibilities, such as the enzymes involved, the sugars involved, the ability for the pathway to be fed substrates, location in the cell, and even the cell type; the manner to which a bacterium accomplishes the production of saccharides is going to vary greatly from that of an animal cell. The specification does not describe every polypeptide of every type of metabolic pathway in the production of di- and/or oligosaccharides that can be found in any cell. At most the specification describes the production of 6’-SL or 3’-SL with a modified E. coli, utilizing constitutive transcriptional units with two different coding DNA sequences selected from the group consisting of SEQ ID NOs: 1-57 (Examples 4-7 and partially Example 11). However, this single group of enzymes with galactoside beta-1,3-N-acetylglucosaminylrnasferase activity is not inclusive to all of the different functions and/or activities Here the specification is incomplete and it mandates that those skilled in the art must then figure out how to manufacture the aimed invention. Thus, the claims do not find adequate support in any place in the specification to show that possession of a cell comprising the ability to produce di- and/or oligosaccharides by expressing at least one set of multiple coding DNA sequences (at least 2), wherein the multiple coding DNA sequences within one set: differ in nucleotide sequence, and each encode a polypeptide, wherein the polypeptides have the same function and/or activity of interest. The courts have established:
Novozymes A/S v. DuPont Nutrition Biosciences APS, 723 F.3d 1336 (Fed. Cir. 2013):
A patent, however, "is not a reward for the search, but compensation for its successful conclusion." Ariad, 598 F.3d at 1353 (quoting University of Rochester, 358 F.3d at 930 n.10). For that reason, the written description requirement prohibits a patentee from "leaving it to the ... industry to complete an ufinished invention.” Id.
Enablement:
10. Claims 80-90, 97-98, 100-103, 107-110, 112, and 115-119 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the production of 6’-SL or 3’-SL with a modified E. coli with an enzyme encoded by SEQ ID NOs: 1-57, it does not reasonably provide enablement for all of the possibilities of nucleic acid sequences that could possibly be involved in the creation di- and/or oligonucleotides. Additionally, the claims do not provide enablement for the production of any or all di- and/or oligosaccharides as generically claimed. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims without significant undue experimentation.
The factors to be considered in determining whether undue experimentation is required are summarized In re Wands 858 F.2d 731, 8 USPQ2nd 1400 (Fed. Cir, 1988). The court in Wands states:
"Enablement is not precluded by the necessity for some experimentation such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is 'undue,' not 'experimentation.' " (Wands, 8 USPQ2d 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. "Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations." (Wands, 8 USPQ2d 1404). The factors to be considered in determining whether undue experimentation is required include: (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.
The claims in their broadest are drawn to a cell for producing a di- and/or oligosaccharide, the cell comprising a pathways for production thereof, wherein the cell is genetically modified for expression and/or overexpression of at least one set of multiple coding DNA sequences (at least 2), wherein the multiple coding DNA sequences within one set: differ in nucleotide sequence, and each encode a polypeptide, wherein the polypeptides have the same function and/or activity of interest (being functional variants), wherein the cell comprises a modification for reduced production of acetate. The direction and guidance coupled with the working examples of the application, however, are drawn only to the production of 3’-SL and 6’-SL with a modified E. coli expressing at least nucleic acid sequences selected from the group consisting of SEQ ID NO: 1-57. The quantity experimentation would be considerable because, while the relative skill level in the art is high (PhD or MD), they would be required to ascertain which enzymes or combination of enzymes to use from any protein or enzyme involved in the production of a di- and/or oligosaccharide in any type of cell. It would be extremely difficult to be able to discern which disclosed combinations of sequences in which cells would give rise to each of the disclosed di- and/or oligosaccharides, resulting in an excessive trial and error to produce the disclosed cell comprising a pathway and/or ability to produce any di- and/or oligosaccharide. It would be almost impossible to reliably predict such a cell without knowing the substrates, enzymes, and/or cell type involved.
Claim Rejections - 35 USC § 112(b)
11. 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.
12. Claims 80-91, 94, 97-98, and 100-119 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.
13. Claim 80 recites “polypeptides have the same function and/or activity of interest,” which renders the claim indefinite because there is no specific or even general function or activity claimed in the claim or the specification, and further, the activity or function is only described as “the same” not in any functional manner, i.e. a large class of enzymes such as “glycosyltransferase activity” or the like. Claims 81-91, 94, 97-98, and 100-119 are included in the instant rejection, since they do not mitigate this issue.
14. Claim 82 recites the limitation "wherein multiple is…" in line 1. There is insufficient antecedent basis for this limitation in the claim, since this limitation lacks “the,” which would properly establish antecedent basis from claim 80, which recites both “at least one set of multiple coding DNA sequences” and subsequently “the multiple coding DNA sequences.” The claim should be amended to “wherein the multiple coding DNA sequences” to properly establish antecedent basis in regards to the “the multiple coding DNA sequences” recited in claim 80.
15. Claim 97 recites the limitation "the cultivation medium" in line 3. There is insufficient antecedent basis for this limitation in the claim. Claim 80 does not recite any cultivation medium.
16. The term “enhanced production and/or supply of PEP” in claim 102 renders the claim indefinite. There is no comparison to which “enhanced” is compared, i.e. enhancement of PEP over a wildtype unmodified cell.
17. Claim 104 recites the limitation "a polypeptide comprising a peptide having 80% or more sequence identity to the full-length peptide" in (i) part 6. It is unclear if the polypeptide comprising a peptide is the same or different polypeptide/peptide. Additionally, there is insufficient antecedent basis for “the full-length peptide,” since the claim on recites “a peptide” before this limitation. It is suggested to amend the claim to recite “a polypeptide having 80% or more sequence identity to any one of the polypeptides selected from the group consisting of” to increase clarity.
18. The term “reduced production of acetate” in claim 107 renders the claim indefinite. There is no comparison to which “reduced” is compared, i.e. reduced production of acetate compared to a wildtype, unmodified cell.
19. The term “reduced production of acetate” in claim 107 renders the claim indefinite. There is no comparison to which “reduced” is compared, i.e. reduced production of acetate compared to a wildtype, unmodified cell.
20. The term “is at least partially inactivated” in claim 109 is a relative term which renders the claim indefinite. It is unclear as to what the partially inactivated catabolic pathway is compared to initially, i.e. the wildtype or the catabolic pathway found in an unmodified cell.
21. The term “a fraction or substantially” in claim 110 is a relative term which renders the claim indefinite. It is unclear what constitutes a fraction or substantially all of the di- and/or oligosaccharide. To clarify the claim, it is recommended to give a range or an “at least percentage.”
22. Claim 111 recites the limitation "the whole broth and/or supernatant" in lines 2, 3, and 4-5. There is insufficient antecedent basis for this limitation in the claim. Claim 111 does not recite a whole broth or supernatant. Additionally, claim 80 does not recite a whole broth or supernatant.
23. The term “reduced or abolished synthesis” in claim 113 is a relative term which renders the claim indefinite. It is unclear what constitutes reduced or abolished synthesis of the recited products is compared to initially, i.e. the wildtype or the synthesis of the products in an unmodified cell.
24. The term “resists a phenomenon” in claim 114 is a relative term which renders the claim indefinite. It is unclear what constitutes resisting the phenomenon, i.e. the wildtype or the unmodified cell’s ability to resist the phenomenon.
Claim Rejections - 35 USC § 112(d)
25. 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.
26. Claim 88 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 88 fails to further limit the independent claim 80 because claim 80 includes both recited limitations, i.e. genetically modified (at line 3) and the production of di- and/or oligosaccharides (line 2). 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 § 102
27. 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.
28. 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.
29. Claims 80, 84-106, 110, 112, and 114-119 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Merighi et al (Merighi et al., 2020, US 2020/0190548 A1—cited herein), as evidenced by PubChem (“PubChem,” 2026, downloaded and provided herein as a PDF from < https://pubchem.ncbi.nlm.nih.gov/compound/Phosphoenolpyruvate >--cited herein). Regarding claim 80, drawn to a cell, wherein the cell is a bacteria (claim 112) for producing a di- and/or oligosaccharide, wherein the oligosaccharide mixture is mammalian milk oligosaccharides (claims 100 and 115-119), wherein the production is genetically modified (claim 88), the cell comprising a pathway for production of the di- and/or oligosaccharide, such as N-acetylglucosaminylation pathway (claim 101), wherein the pathway is genetically modified (claim 89) wherein the cell is genetically modified for expression and/or overexpression, via a plasmid (claim 84), within a biosynthetic gene cluster (claim 85), wherein said DNA sequences are in a co-expression module (claim 86), wherein said DNA sequences are regulated by a promoter (claim 87) of at least one set of multiple coding DNA sequences, wherein the multiple coding DNA sequences within one set: differ in nucleotide sequence, and each encode a polypeptide, wherein the polypeptides have the same function and/or activity of interest, wherein said polypeptides are involved in the pathway for the di- and/or oligosaccharide production (claim 90) by exhibiting a glycosyltransferase activity (claim 91), wherein the polypeptides are acetylglucosylaminyltransferases (SEQ ID NO: 80; claim 104) and N-acetylgalactosaminyltransferases (claim 94), Merighi et al. teaches the engineering of bacteria, specifically E. coli, to produce sialylated and N-acetylglucosamine-containing oligosaccharides (abstract), specifically human milk oligosaccharide lacto-N-neotetraose (LNnT), or a combination of milk oligosaccharides (Fig. 8, paragraph 0052), by utilizing a plasmid (Fig. 6) for the expression of the UDP-GlcNac:Galα/β-R β 3-N-acetylglucosaminyltransferases encoded by the LgtA gene from N. meningitides, (SEQ ID NO: 16, sharing 100% sequence identity with SEQ ID NO: 80 of the instant claims; See supplemental file: ) and an exogenous β-1,4-galactosyltransferase gene from E. coli (paragraph 0017), wherein the two polypeptides share the same function of a glycosyltransferase and encode a N-acetylglucosaminylation pathway. Regarding claims 97-98, drawn to the cell using at least one precursor for producing the di- and/or oligosaccharide precursors being fed to the cell from the cultivation medium or being produced by the cell, Merighi et al. teaches the feeding of cells substrates, such as lactose and glucose from the culture medium and substrates, such as ManNAc and ManNAc-6-P from the cell (Figs 1 and 3). Regarding claim 102, drawn to the cell production of phosphoenolpyruvate (PEP), Merighi et al. teaches the utilization of a RpoS+ E. coli as a host, and as such, the production of oligosaccharides enhances the production of phosphoenoylpyruvate, which is utilized in the transferring of sugars across the membrane, glycolysis, and gluconeogenesis, as evidenced by PubChem (p. 1). Regarding claim 110, drawn to the di- and/or oligosaccharide being produced inside the cell and subsequently being retained and/or excreted, Merighi et al. teaches the intracellular production and accumulation of the oligosaccharide, 6SL (paragraph 105).
Claim Rejections - 35 USC § 103
30. 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.
31. Claims 107-109 are rejected under 35 U.S.C. 103 as being unpatentable over Merighi et al (Merighi et al., 2020, US 2020/0190548 A1—cited herein), as evidenced by PubChem (“PubChem,” 2026, downloaded and provided herein as a PDF from <https://pubchem.ncbi.nlm.nih.gov/compound/Phosphoenolpyruvate >–cited herein) as applied to claims 80, 84-106, 110, 112, and 114-119 above, and further in view of Jantama et al (Jantama et al., 2008, Biotechnology and Bioengineering—cited herein).
The teachings of Merighi et al. as evidenced by PubChem are discussed above and incorporated into the instant rejection. Merighi et al. does not teach a reduction of acetate (claim 107), deletion of the phosphate acetyltransferase (claim 108), or the partial inactivation of mono-, di-, or oligosaccharides (claim 109). Jantama et al. teaches the reduction of acetate by the deletion of pflB, tdcD, tdcE, and adhE were removed to reduce acetate, and additionally, the phosphate acetyltransferase, pta, was deleted to further reduce the production of acetate, reducing the production of saccharides reliant CoA containing enzymes (p. 891, Conclusion, paragraph 2).
Therefore, it 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 combine the teachings of Merighi et al. as evidenced by PubChem and Jantama et al. to reduce acetate formation in E. coli to decrease the production of side products as taught by Jantama et al. One would be motivated to combine these teachings to arrive at the instant claims to increase the yield of desired products by the use of “white biotechnology,” the production of renewable chemicals by microbial and enzymatic routes, as taught by Jantama et al. There would be a reasonable expectation of success, yielding no surprising results when combining the teachings of Merighi et al. as evidenced by PubChem and Jantama et al., since Jantama et al. decreased acetate in E. coli by deleting the phosphate acetyltransferase.
Double Patenting
32. 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 conflicting claims 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); 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.
33. Claim 80-91, 94, 97-103, 107-119 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 52-58, 60, 62-66, 69-70-78 of copending Application No. 18/041,137 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘137 claims would anticipate the instant claims. The instant claims in their broadest are drawn to a cell, wherein the cell is a bacteria for producing a di- and/or oligosaccharide, wherein the oligosaccharide mixture is mammalian milk oligosaccharides, wherein the production is genetically modified, the cell comprising a pathway for production of the di- and/or oligosaccharide, such as N-acetylglucosaminylation pathway, wherein the pathway is genetically modified wherein the cell is genetically modified for expression and/or overexpression, via a plasmid, within a biosynthetic gene cluster, wherein said DNA sequences are in a co-expression module, wherein said DNA sequences are regulated by a promoter of at least one set of multiple coding DNA sequences, wherein the multiple coding DNA sequences within one set: differ in nucleotide sequence, and each encode a polypeptide, wherein the polypeptides have the same function and/or activity of interest, wherein said polypeptides are involved in the pathway for the di- and/or oligosaccharide production by exhibiting a glycosyltransferase activity.
The ‘137 claims are drawn to Aacell that is metabolically engineered for production of a sialylated disaccharide and/or sialylated oligosaccharide, the cell comprising a pathway for production of the sialylated disaccharide and/or sialylated oligosaccharide, wherein the cell is modified for expression and/or overexpression of multiple coding DNA sequences via integration of the multiple coding DNA sequences into the cell's genome and/or into at least one vector that is stably transformed in the cell, wherein the multiple coding DNA sequences are heterologous to the cell and encode one or more proteins that catalyze a same chemical reaction, and wherein the multiple coding DNA sequences comprise at least two (2) coding DNA sequences, and wherein the multiple coding DNA sequences comprise one or more of: (a) at least two different coding DNA sequences that differ in nucleotide sequence from one another and encode the same protein; and (b) at least two coding DNA sequences encoding at least two different isoproteins that catalyze the same chemical reaction.
The only difference between the two claim sets is the requirement of the ‘137 claims is the requirement for a production of sialylated disaccharide or oligosaccharide. However, the ‘137 claims would still anticipate the instant claims, since the instant claims’ broad limitation of di- and/or oligosaccharide would include that of sialylated di- and/or oligosaccharides. Therefore, the ‘137 claims would still anticipate the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
34. All claims are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CIARA A MCKNIGHT whose telephone number is (703)756-4791. The examiner can normally be reached M-F 8:00am-4:30pm.
Examiner interviews are available via telephone, in-person, and 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) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath 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.
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.
/CIARA A MCKNIGHT/Examiner, Art Unit 1656
/MANJUNATH N RAO/Supervisory Patent Examiner, Art Unit 1656
Prosecution Insights