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 .
Notice of Pre-AIA or AIA Status
DETAILED ACTION
Status of the Claims
Claim 2, 3, 13, 16, and 19-21 are cancelled. Claim 26 is new. Claims 1, 4-12, 14, 15, 17-18 and 22-26 are pending and under examination.
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 .
Priority
This application is a national stage entry of PCT/EP2022/074095 filed on 8/30/2022, which claims priority from European applications EP22169108.2 filed on 4/20/2022 and EP21193811.3 filed on 8/30/2021.
Information Disclosure Statement
The information disclosure statement filed on 02/29/2024 has been considered by the examiner.
Objections/Rejections Withdrawn
The objection over claims 11, 12 and 14 for using other periods in the claim is withdrawn per applicant’s correction.
The objection over claim 11 for improper capitals in the claim is withdrawn per applicant’s amendments to the claims.
The objection over claim 12 is withdrawn per applicant’s amendment to the claim.
The objection over claim 25 is withdrawn per applicant’s addition of “further” in the claim.
The rejection under USC 112(a) for scope of enablement of the proteins in the claim is withdraw as applicant has provided SEQIDs to proteins used by applicant.
The rejection under USC 112(b) for indefiniteness of claim 8 is withdrawn per applicant’s amendment to provide the macromolecular complex has a mass.
The rejection under USC 112(b) over claim 2 is withdrawn per cancellation of claim 2.
The rejection under USC 112(b) over claim 11 for “the host cell culture” is withdrawn per applicant’s amendments.
The rejection under USC 112(b) over claims 14 and 15 are withdrawn for “the SlyB nanodisc particles” not referring back particular to “the one or more SlyB nanodisc particles” is withdrawn per applicant’s amendments to these claims.
The rejection under USC 112(b) over claims 1, 2, 11, and 13 and dependent claims 3-10, 12, 14-15, 17-18, and 22-25 is withdrawn per applicant’s amendment.
The rejection under USC 102 over Chen as evidenced by Janssens is withdrawn per applicant’s amendment and arguments.
As these rejections are withdrawn, applicant’s arguments toward these rejections are now moot.
Maintained Rejection – Modified As Necessitated by Amendment
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 4-10, 22-24 and 26 rejected under 35 U.S.C. 101 because the claim is to a product of nature that is indicated as “isolated SlyB nanodisc” in the claim. However, the claim provides for the naturally occurring structure of a SlyB nanodomain as characterized by Janssens et al (Nature, December 2023, volume 626, pages 617-625). Janssens teaches that SlyB encapsulates outer membrane proteins (polypeptides) in stress-induced lipid nanodomains (title and abstract). Figure 4 teaches the lipid nanodomains that are formed with two SlyB proteins (tan color) surrounding phospholipid bilayer (blue color), lipid anchor (pink) with BamA outer membrane protein (a macromolecule) in the lipid bilayer (green), and Lipopolysaccharides around the outer portion of the SlyB proteins of the structure (in yellow). The figure legend of figure 4 provides that there is SlyB protomer (page 622). Jannsens was using cryo-EM structures in order to characterize the natural structure (page 621). Part e of figure 4 shows one LPS per one SlyB protomer (1:1 ratio). The first column on page 622 provides for BamA being enclosed in the lumen and Sly B oligomer. Note that figure 4 shows the shape of a disc for the nanodomain. Additionally, see part h of Figure 5 with how the nanodomains would occur in the lipid outer membrane of the cell. Janssens teaches conserved domains of SlyB protomer in gram negative bacteria (page 622). Since Janssens provides the structure of the claims and having SlyB and LPS, it would be immunogenic. Janssens teaches the structures in a cell membrane, and thus, are comprised in a cell that could be considered a host cell. Regarding claim 24, endogenous expression of SlyB can be affected naturally in a cell as are other proteins to reduce or raise it. Note that isolation here is not changing the natural structure or natural composition of the nanodomain. Additionally, teachings of Plesa et al (Res Microbiol, 2006, volume 157, pages 582-592) teach SlyB as a lipoprotein in the bacteria Burkholderia multivorans (abstract) and that SlyB mutants were identified (abstract). Figure 1 of Plesa provides for SlyB sequences from different bacteria. In regard to the size of the nanodiscs, Liu et al (Bioactive Materials, 2022, volume 14, pages 169-181) teaches that outer membrane vesicles of gram negative bacteria usually range from 20-250 nm (section 2.1) but also provides some vesicles from E coli were 15-100 nm (section 2.1). As outer membrane vesicles naturally occur and are capable of carrying components of the outer membrane, the SlyB nanodomains will be part of such vesicles. In regard to water solubility, Boldog et al (Methods in Enzymology, 2007, volume 423, pages 317-335) teaches that nanodiscs are soluble, nanoscale (about 10 nm in diameter) particles of lipid bilayer surrounded by an annulus of amphipathic protein (page 318 and abstract of Boldog). Thus, water solubility is a property of the protein nanodisc. See MPEP 2106.04 – “See Myriad Genetics, Inc., 569 U.S. at 590-91, 106 USPQ2d at 1979 (claims to isolated DNA held ineligible because they "claim naturally occurring phenomena" and are "squarely within the law of nature exception"); Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130, 76 USPQ 280, 281 (1948) (claims to bacterial mixtures held ineligible as "manifestations of laws of nature" and "phenomena of nature"). Step 2A of the Office’s eligibility analysis uses the terms "law of nature" and "natural phenomenon" as inclusive of "products of nature".” Also in MPEP 2106.04 “It is important to keep in mind that product of nature exceptions include both naturally occurring products and non-naturally occurring products that lack markedly different characteristics from any naturally occurring counterpart. See, e.g., Ambry Genetics, 774 F.3d at 760, 113 USPQ2d at 1244 ("Contrary to Myriad's argument, it makes no difference that the identified gene sequences are synthetically replicated. As the Supreme Court made clear, neither naturally occurring compositions of matter, nor synthetically created compositions that are structurally identical to the naturally occurring compositions, are patent eligible."). Thus, a synthetic, artificial, or non-naturally occurring product such as a cloned organism or a human-made hybrid plant is not automatically eligible because it was created by human ingenuity or intervention. See, e.g., In re Roslin Institute (Edinburgh), 750 F.3d 1333, 1337, 110 USPQ2d 1668, 1671-72 (Fed. Cir. 2014) (cloned sheep); cf. J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred Int’l, Inc., 534 U.S. 130-132, 60 USPQ2d 1868-69 (2001) (hybrid plant). Instead, the key to the eligibility of all non-naturally occurring products is whether they possess markedly different characteristics from any naturally occurring counterpart.” Boldog does provide that “Thus, the Nanodisc‐inserted protein is in an environment that approximates its native state” (abstract of Boldog). Additionally, as the structure of the nanodisc exist at sizes of about 10 nm, they also are found in such a size.
Response to Arguments over the Rejection under USC 101
Applicant argues that the nanodiscs being under 40 nm in diameter and being soluble are different than what would be found naturally, however, nanodisc structures are recognized to be less than 40 nm and even less than 20 nm. Additionally, it is recognized these nanodisc structures are water soluble due to their structure. The rejection has been updated to further address the water soluble nature of the protein containing nanodiscs. Note that isolating or purifying natural molecules or structures does not necessarily make them patent eligible (Myriad, Funk Bros, see MPEP 2106.04). This is further addressed above.
New Rejection – As Necessitated by New Claim Limitation
Claim Rejections - 35 USC § 112(a) – Written Description – New Matter
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 26 is 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. Applicant cites paragraphs 8 and 9 of the specification to provide for “solubility in an aqueous solution”, however, these paragraphs support detergent solubility (detergent soluble). Thus, indicating the nanodiscs are soluble in an aqueous solution where no detergent may be present constitutes new matter.
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 11-12, 14-15 and 18 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.
Maintained/Modified Rejections – Modified As Necessitated by Amendments
Claim 11 recites the limitation "the isolated SlyB nanodisc particles" in part c) of the claim with a first recitation in claim 11 being “one or more SlyB nanodisc particles”. There is insufficient antecedent basis for this limitation in the claim. Applicant may amend the claim to indicate these as “the one or more SlyB nanodisc particles”.
Claims 12 and 14-15 are rejected as being dependent on an indefinite claim.
Claim 18 recites the limitation "the macromolecule” in the claims with a first recitation in claim 25 (after the change in dependency) being “at least one macromolecule”. There is insufficient antecedent basis for this limitation in the claim. Applicant may amend the claim to indicate these as “the at least one macromolecule”. This rejection results from the change in dependency by amendment.
New Rejection – As Necessitated by Amendment to Claims 11 and 12
Claims 11 and 12 are indefinite for recitation of “SlyB protein comprises SEQ ID NO: 57-84 or a functional bacterial homologue with at least 80% identity of any one thereof functional in forming SlyB” because it is unclear if the SlyB protein will comprise all of SEQ ID NO: 57-84 due to “SlyB protein comprises SEQ ID NO: 57-84” or if applicant means to choose one of those sequences out of the group. Applicant may correct this by stating “SlyB protein comprises any one of SEQ ID NO: 57-84 or a functional bacterial homologue with at least 80% identity of any one thereof functional in forming SlyB”.
Claims 14 and 15 are rejected as being dependent on an indefinite claim.
Maintained Rejection – Modified As Necessitated by Amendments
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 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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 4-12, 14, 15, 17, 18, 22, 23 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al (Chemical Communications, June 2017, volume 53, pages 7569-7572, in applicant’s IDS) and Fischer US 20200108133A1 as evidenced by Janssens (previously cited).
Chen teaches multi-functional bacterial outer membrane vesicles and provides for E coli (title and abstract). Chen teaches “isolated” outer membrane vesicles that contain SlyB protein (figure 1). Chen teaches using PCR amplification of SlyB gene and introduction into a vector that can be overexpressed in cells (second column of page 7569). Chen teaches “Overexpression of either SlyB or SlyB-Nluc in whole-cell lysates and the membrane fraction was first demonstrated by Western blot (Fig. S1, ESI†). After collecting the resulting OMVs by ultracentrifugation, the presence of these proteins in OMVs was also confirmed by Western blot” (first column of page 7570). Chen teaches an average diameter of intact vesicles of 41 +/- 2 nm (39-43 nm) (first column, page 7571). Thus, vesicles can be below 40 nm in size. Chen teaches encapsulation of Nluc (a protein) inside OMVs with SlyB (this is within the lipid bilayer) (page 7571). Below Jannsens evidences the structure of the SlyB nanodomains/nanodiscs that form due to SlyB in the cell’s membrane. The SlyB-Nluc is a transgenic protein, and thus, is not a natural protein to the cell it is incorporated into making it heterologous. Figure 2 of Chen provides for the overexpression confirmation. Chen teaches “The native E. coli outer membrane lipoprotein SlyB was exploited as an anchor to target proteins to the interior of OMVs. SlyB is a 155 residues long protein that contributes to the integrity of the cell envelope,16 and is anchored to the periplasmic side of the outer membrane through its N-terminus lipid moiety.”
Janssens evidences the SlyB nanodomain (abstract). Janssens evidences that SlyB encapsulates outer membrane proteins (polypeptides) in stress-induced lipid nanodomains (title and abstract). Figure 4 evidences the lipid nanodomains that are formed with two SlyB proteins (tan color) surrounding phospholipid bilayer (blue color), lipid anchor (pink) with BamA outer membrane protein in the lipid bilayer (green), and Lipopolysaccharides around the outer portion of the SlyB proteins of the structure (in yellow). The figure legend of figure 4 provides that there is SlyB protomer (page 622). Jannsens was using cryo-EM structures in order to characterize the natural structure (page 621). Part e of figure 4 shows one LPS per one SlyB protomer (1:1 ratio). The first column on page 622 provides for BamA being enclosed in the lumen and Sly B oligomer. Note that figure 4 shows the shape of a disc for the nanodomain. Additionally, see part h of Figure 5 with how the nanodomains would occur in the lipid outer membrane of the cell. Janssens evidences conserved domains of SlyB protomer in gram negative bacteria (page 622). Since Janssens provides the structure of the claims and having SlyB and LPS, it would be immunogenic. Janssens evidences the structures in a cell membrane, and thus, are comprised in a cell that could be considered a host cell. Janssens also makes evident that outer membrane proteins of the cell will get incorporated into the nanodomains.
Thus, when overexpressing SlyB protein in bacterial cells, these nanostructures will form and when the nanovesicles are harvested, they will be isolated from the cell as evidenced by Jannsens. Before, cell production of nanovesicles, the nanodiscs will be part of the cell (comprised in the host cell).
Chen’s teachings are provided above. Chen also recognizes its OMVs for antigen binding (abstract) and that liposomes are frequently used for therapy and diagnosis as they are compatible for drug delivery and biosensing (page 7569). Here, Chen also teaches they have applications in vaccines. Thus, OMVs are seen as having utilities for drug/vaccine delivery to subjects.
Chen does not teach mixing isolated SlyB nanodisc particles with a macromolecule to allow encapsulation of the macromolecule with the SlyB nanodisc, below 20 nm, or the method of claim 17 for immunizing a subject.
Fischer teaches antigenic combinations for immunizing a host from infection (abstract). Fischer provides for a nanodisc structure with scaffold proteins as a belt structure, lipids/lipid bilayer, and LPS (lipopolysaccharide) (Figure 3 and paragraph 7) that is similar to the structure of Chen as evidenced by Janssens. Figure 3 of Fischer teaches combining the IgIC with the nanodisc structure which leads to IgIC being put into the lipid bilayer of the nanodisc structure (the lumen of the structure). Fischer teaches administering an effective amount of the immunogenic composition (paragraphs 361-362). Fischer teaches protein antigens (paragraph 204). Fischer teaches 5 to 25 nm or 3 to 6 nm for the nanolipoprotein with discoidal shape (paragraph 237).
One of ordinary skill in the art before the time of filing would have utilized lipopolysaccharide discoidal protein lipid bilayer containing SlyB by combined teachings of Chen and Fischer for the delivery of immunogenic compositions like antigens as both references recognize these types of protein-lipid nanosystems for that purpose of vaccine and drug delivery. Thus, there was a reasonable expectation of success in combining the teachings of the references to provide for SlyB nanodiscs and using them for successfully delivering vaccine antigens to subjects for immunization/vaccination. Fischer also allows for sizes of less than 20 nm as well as the mixing/combining step to include the antigen into the lipid bilayer of the nanodisc carrier.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Chen et al (Chemical Communications, June 2017, volume 53, pages 7569-7572, in applicant’s IDS) and Fischer US 20200108133A1 and Meuskens et al (Front Cell Infect Microbiol, 2017, volume 7, claims 1-13).
Chen and Fischer teaches the claims as discussed above.
Chen and Fischer does not teach using endogenous SlyB deficient cells for the overexpression/expression.
Meuskens teaches new strains for improved expression of outer membrane proteins (title and abstract). Meuskens teaches using deletion mutants of E coli designed for overexpression of outer membrane proteins (abstract). Meuskens teaches “These strains harbor deletions of four genes encoding abundant β-barrel proteins in the outer membrane (OmpA, OmpC, OmpF, and LamB), both single and in all combinations of double, triple, and quadruple knock-outs. The sequences encoding these outer membrane proteins were deleted completely, leaving only a minimal scar sequence, thus preventing the possibility of genetic reversion. (abstract). Meuskens teaches “As surface exposed molecules, outer membrane β-barrel proteins are also potential drug and vaccine targets” (abstract). Meuskens teaches “As the amount of competing OMPs is low, heterologous OMPs can be purified efficiently and simply with e.g., ion exchange chromatography, without the need to introduce affinity tags, which might compromise protein function. This applies even to transmembrane β-barrel proteins of eukaryotic origin, some of which have been produced in bacteria (page 11).
As SlyB is an outer membrane protein, one of ordinary skill in the art before the time of filing would also consider knocking it out in Chen in view of Fischer in order to improve overexpression of the recombinant form based on the teachings of Meuskens. There would be a reasonable expectation of success in making endogenous SlyB deficient cells and utilizing those cells for the overexpression of SlyB and other outer membrane proteins and getting improved overexpression particularly to use for isolation.
New Rejection – As Necessitated by New Claim 26
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Chen et al (Chemical Communications, June 2017, volume 53, pages 7569-7572, in applicant’s IDS); Fischer US 20200108133A1 and Boldog et al (Methods in Enzymology, 2007, volume 423, pages 317-335) as evidenced by Janssens (previously cited).
Chen and Fischer teach the claims as discussed above. Chen also teaches “The native E. coli outer membrane lipoprotein SlyB was exploited as an anchor to target proteins to the interior of OMVs. SlyB is a 155 residues long protein that contributes to the integrity of the cell envelope and is anchored to the periplasmic side of the outer membrane through its N-terminus lipid moiety.”
Chen and Fischer do not provide for water soluble nanodiscs.
Boldog teaches using nanodiscs to create water-soluble transmembrane chemoreceptors insert in lipid bilayers (title and abstract). Boldog teaches that nanodiscs are soluble, nanoscale particles (about 10 nm diameter) particles of lipid bilayer surrounded by an annulus of amphipathic protein (abstract). Boldog teaches this is an emerging technology for transmembrane proteins (abstract). Boldog teaches Nanodisc technology has great promise for improving isolation, purification, and characterization of the many membrane proteins that are
difficult to handle, become unstable, or lose native activity when surrounded by detergent instead of lipid bilayer. (abstract). Boldog teaches a procedure to prepare the nanodiscs (figure 2).
One of ordinary skill in the art before the time of filing would have utilized nanodisc technologies by teachings of Boldog so as not to lose stability or activity of the bound proteins and to create water-soluble versions of such proteins for use such as for an anchor. There would be a reasonable expectation of success in producing nanodiscs as another form of SlyB proteins for characterization by the combined teachings of the references. Boldog teaches procedures on how to obtain isolated nanodiscs with incorporated proteins, and thus, one of the ordinary skill in the art would use such known processes to obtain nanodiscs of transmembrane proteins having the advantages of stability and protein activity for proteins including SlyB proteins in the teachings of Chen.
Response to Applicant’s Arguments over the Rejections under USC 103
Applicant argues that although SlyB proteins were known in the art, applicant discovered that oligomers of SlyB appear as discoidal structures under conditions triggering PhoP-PhoQ stress regulon. Janssens, which was previously cited, provides the claimed structure associated with SlyB proteins and Chen recognizes SlyB proteins in its outer membrane vesicles (OMVs). Thus, this is a structure that occurs with SlyB expression in cells (particularly in the membranes) and it was a structure that Jannsens (a formerly cited evidentiary reference) had recognized due to presence of SlyB.
Applicant argues they were able to resolve the SlyB nanodiscs through their analysis technique. Again, this is toward applicant’s discovery that SlyB nanodiscs exist in a certain structure, but Chen as evidenced by Janssens recognizes SlyB nanodiscs are from cells and that they are known to have this type of structure in the membrane.
Applicant argues that Chen provides for outer membrane vesicles containing the SlyB proteins, but as evidenced, the cellular outer membrane vesicles of Chen will house the SlyB proteins in the structure they exist in the cells as evidenced by SlyB characterization of Janssens. The claims do not state that isolated SlyB nanodiscs in the structure as claimed cannot be part of a vesicle or isolated cell membrane.
Applicant argues that the isolated SlyB nanodiscs are soluble in aqueous solution and this would not be recognized in Chen’s formulation. This is a property of the SlyB nanodiscs as provided by Boldog. Claim 1 does not provide the isolated SlyB nanodiscs dissolved in an aqueous solution as a composition or indicate that the nanodiscs are in a water soluble form. In regard to new claim 26, which adds this limitation as a dependent claim, the examiner has included the teachings of Boldog which recognizes further separation/isolation of nanodiscs and their solubility in water/aqueous solution. Boldog recognizes advantages of having transmembrane proteins in the form of water-soluble nanodiscs such as better stability and protein activity. This provides further motivation to further isolate the proteins as nanodiscs and in doing so, obtaining this form known to be water soluble.
Applicant argues that their process does not involve an amphipathic protein such as MSP, but there is no limitation excluding the use of MSP or any product-by-process limitation in claim 1 to dictate how the nanodiscs are formulated or isolated as applicant is arguing if such a product by process limitation imparts structural differences beyond just size which the prior art recognizes through ranges within and overlapping with applicant’s claims.
Applicant argues that the structure of SlyB OMVs is very different from SlyB nanodiscs even though self-adjuvating properties are comparable (one structural noting the solubility in aqueous solution of the SlyB nanodiscs). This is noted, but only new claim 26 imparts that limitation to water-soluble. Prior art was added to address claim 26, but new matter was also noted. It is noted that this art addressing claim 26 further expands on transmembrane protein containing nanodiscs.
In regard to Chen, Fischer and Meuskens, this rejection is maintained as the rejection over Chen and Fischer is being maintained.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARK V STEVENS whose telephone number is (571)270-7080. The examiner can normally be reached M-F 9:00 am to 6:00 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian-Yong Kwon can be reached at (571)272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARK V STEVENS/Primary Examiner, Art Unit 1613
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