DETAILED ACTION
Status of the Application
Receipt is acknowledged of Applicants’ Amendments and Remarks, filed 13 March 2026, in the matter of Application N° 18/422,810. Said documents have been entered on the record. The Examiner further acknowledges the following:
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
No claims have been canceled. Claim 53 is newly added and is supported by the previously filed claims and originally-filed disclosure.
Claims 1, 8, 10-14, 16, and 18 have been amended. Of particular note is that claim 1 has stylized the previously recited nanolipoprotein particle as “cationic”, in addition to adding the language of “one or more” before each of the previously recited components. Also added to the claim is the molar concentration range that was previously (and still) recited by dependent claim 4 (see New Rejections). Lastly, the claim also now recites the functional limitation of the particle “being configured to bind a polynucleotide having at least 200 bases.”
The recitation of “ratio” has been clarified in claims 8, 10, 12-14, and 18 to be “molar ratio”. Claim 16 has been corrected to recite polysorbate 20. Claim 11 has been amended to remove the parenthetical apolipoprotein species.
No new matter has been added.
Thus, claims 1-20 and 53 now represent all claims currently under consideration.
Information Disclosure Statement
Two new Information Disclosure Statements (IDS) filed 26 March 2026 and 24 April 2026 are acknowledged and have been considered.
Withdrawn Objections/Rejections
Objection to the Specification
Applicants’ amendment to the specification adding “polysorbate 20” to the registered tradename “Tween 20” is persuasive in overcoming the previously raised objection. Said objection is withdrawn.
Rejection under 35 USC 112
Applicants’ amendments to claims 8, 10-14, 16, and 18, discussed above, are sufficient in overcoming the previously raised grounds of indefiniteness.
Applicants’ response to the indefiniteness rejection over claim 16 for reciting “Z3-14”, on its own, is not persuasive. However, consideration of the state of art, beyond the cited article, reveals that “Z3-14” is a zwitterionic detergent having a designation of “3-14” or “zwittergent 3-14”. PubChem CID 84705 defines it as follows:
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3-[dimethyl(tetradecyl)azaniumyl]propane-1-sulfonate (IUPAC)
Thus, in spite of Applicants’ response to the rejection, the rejection is withdrawn.
Rejection under Nonstatutory Double Patenting
Applicants’ submission of an electronic Terminal Disclaimer (eTD) over USPN 12,083,223 B2 is acknowledged. The eTD was approved upon submission and thus results in the withdrawal of the rejection.
Rejection under 35 USC 102
Applicants’ amendment to claim 1 rebranding the nanolipoprotein (NLP) particle as a “cationic” NLP is adequate in overcoming the previously raised anticipation rejection. Here, the Examiner notes that while cationic lipids are disclosed by the reference as conceded by Applicants, they are not disclosed with the requisite specificity to anticipate the broadly recited composition. Said rejection is withdrawn.
Maintained Rejections
The following rejections are maintained from the previous Office Correspondence dated 14 November 2025 since the art that was previously cited continues to read on the amended and previously recited limitations.
Claim Rejections - 35 USC §103
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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. Applicants are 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 1-3, 6, 7, 11, 16, 19, 20, and 53 are rejected under 35 U.S.C. 103 as being unpatentable over Luo et al. (US Pre-Grant Publication Nº 2013/0165636 A1). [emphasis added to reflect newly added claim]
The limitations of the instantly claimed invention are directed to a nanolipoprotein particle comprising:
a membrane forming lipid;
a cationic lipid; and
a scaffold protein;
wherein the membrane forming lipid and the cationic lipid are arranged in a membrane forming lipid bilayer stabilized by the scaffold protein.
Luo discloses a “nanodisc” comprising a membrane scaffold protein, a telodendrimer, and a lipid (see e.g., Abstract claim 1).
The “nanodisc” is considered to disclose the recited nanolipoprotein particle structure as defined in ¶[0003]. Therein, nanolipoprotein particles (or NLPs) are defined as being nanoscale (6-30 nm), discoidal patches of lipid bilayer stabilized by peripheral scaffold.
The lipid is further defined by the reference as being selected from such lipids as a phospholipid, a cholesterol, a phosphatidylcholine, and other lipids such as DPPC, DMPC, MPPC, DSPC, DSPE, DPPE, DSPG, DPPG, MPPG, and cholesterol (see e.g., claims 7-9 and ¶[0058]). Paragraphs [0059], [0060], and [0072] all teach that combinations of lipids may be used in the formation of the NLPs.
DMPC is disclosed in claim 9, thereby teaching the limitations of the recited species of membrane-forming lipid.
Paragraph [0059] additionally teaches that “[a]ny suitable combination of lipids can be used to provide the nanodiscs of the invention. The lipid compositions can be tailored to affect characteristics such as leakage rates, stability, particle size, zeta potential, protein binding, in vivo circulation, and/or accumulation in tissues or organs. For example, negatively or positively lipids, such as DSPG and/or DOTAP, can be included to affect the surface charge of a nanodisc. The lipid compositions can include about ten or fewer types of lipids, or about five or fewer types of lipids, or about three or fewer types of lipids. In some embodiments, the lipid includes at least two different lipids. The molar percentage (mol %) of a specific type of lipid present can be from about 0% to about 10%, from about 10% to about 30%, from about 30% to about 50%, from about 50% to about 70%, from about 70% to about 90%, or from about 90% to 100% of the total lipid present in a nanodisc.” [emphases added]
The membrane scaffold protein is defined by claim 2 as being apolipoprotein. Apolipoproteins are further defined in ¶[0052] as being selected from apolipoproteins A (including, for example, apo A-1 and apo A-2), B, C, D, E, and H.
The telodendrimers are disclosed a being present in the composition in a 9:1 (w/w) of lipid to telodendrimer (see e.g., claim 15). Thus, the telodendrimer is taught as being present in an amount of up to 10% of the total lipid component of the composition.
Based on the combined teachings of the references, the Examiner submits that a person of ordinary skill in the art would have had a reasonable expectation of success at producing the instantly claimed composition. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, and absent a clear showing of evidence to the contrary.
Response to Arguments
Applicants’ arguments with regard to the rejection of claims 1-3, 6, 7, 11, 16, 19, 20, and 53 under 35 USC 103(a) as being unpatentable over the combined teachings of Luo et al. have been fully considered, but they are not persuasive.
Applicants traverse the rejection on the grounds that the Examiner is picking and choosing from “billions, if not trillions, of possible theoretical formulations explicitly permitted by Luo” and that picking this exact combination out of the trillions of possibilities is not routine optimization, but instead hindsight reconstruction.
In response to Applicants’ argument that the Examiner’s conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
In the instant case, the Examiner respectfully submits that Applicants’ remarks affirm the obviousness rejection insomuch as pointing out the presence of the constituent elements in the practiced invention. Paragraph [0059] of the reference (cited by Applicants on pp. 20-21 of the response) points out that “[a]ny suitable combination of lipids can be used to provide the nanodiscs of the invention.” The passage also states that positively charged lipids such as DOTAP can be included to affect the surface charge of a nanodisc. Mol percentages of said lipid are disclosed further within the passage and overlap with the previously recited and instantly amended range. MPEP §2144.05(I) states that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” “Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close.” Such is the case in this instance whereby the reference teaches and suggests that the practiced nanodiscs may comprise positively charged (cationic) lipids for affecting a positive charge on the nanodiscs and that said lipids may be present in a mol% which reads on the recited range.
Applicants’ arguments, for the above reasons, are found unpersuasive. Said rejection is therefore maintained and extended to include newly added claim 53 in view of the foregoing teachings of apolipoprotein species (i.e., Apo A-1, Apo A-2, etc.).
Claims 1-8, 11, 16, 17, and 53 are rejected under 35 U.S.C. 103 as being unpatentable over Blanchette et al. (WO 2017/035326 A1). [emphasis added to reflect newly added claim]
The limitations of the instantly claimed invention are directed to a nanolipoprotein particle comprising:
membrane forming lipid;
a cationic lipid; and
a scaffold protein;
wherein the membrane forming lipid and the cationic lipid are arranged in a membrane forming lipid bilayer stabilized by the scaffold protein.
Claim 5 recites that the total lipid to scaffold protein molar percent ratio is 80:1. Claim 8 recites that the ratio of membrane forming lipid to cationic lipid to scaffold protein is the range of 19:1:1 to 96:144:1. [emphases added] The Examiner notes that the claim, like claim 4, recites a total lipid to scaffold protein ratio range of 20:1 to 240:1.
Claim 6 recites additional species for the cationic (polymerizable) lipid component.
Claim 11 further defines the scaffold protein as being selected from different apolipoproteins (i.e., apoA1, apoE4, etc.). Claim 16 recites that the particle will further comprise one or more additives such as cholesterol. Claim 17 recites that the one or more additives will be present in a molar ratio ranging from about 1:99 to 3:2.
The teachings of Blanchette are discussed above.
Blanchette discloses a nanolipoprotein particle comprising:
a membrane forming lipid;
a “polymerized” lipid; and
a scaffold protein.
The membrane forming lipid and the polymerized lipid are arranged in a membrane forming lipid bilayer stabilized by the scaffold protein and by the polymerized lipid (see e.g., claim 1).
Regarding the “polymerized” lipid, the Examiner submits that Blanchette provides compositional disclosure whereby the polymerized lipid reads on the instantly claimed “one or more” cationic lipid. [emphasis added] Claims 7 and 22 of the reference provide increasingly narrowed definitions for the “polymerized” lipid, which are considered to teach the instantly claimed cationic lipids of claims 6 and 7.
Claim 22, for instance discloses the following core formula for the one or more polymerized lipids as being:
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Here, R1, R2, m, n, o, Y, and R21 all read on the variables as instantly recited by claim 7. The phosphate group (PO4-) reads on variable ‘Q’ recited by instant claim 7. Cationic polymers such as DMPC and DOPE are considered to be read on by the foregoing core formula and definitions.
Additional lipids that are taught as being used to form membrane forming lipids include: 1,2-dioleoyl-3-trimethyl ammonium-propane (DOTAP), 1,2-di-O-octadecenyl-3-trimethyl-ammonium propane (DOTMA). See ¶[0083].
Claim 2 of the reference discloses that the polymerizable (cationic) lipid is present in a molar concentration of about 5 to about 40 mol%. This reads directly on the limitations of instant claims 2 and 3.
Claim 4 of the reference discloses that the total lipid to scaffold protein molar percent ratio ranges from 20:1 to 240:1. This reads directly on the limitations of instant claim 4. The same disclosure is also considered to encompass, and therefore teach the narrower range of 80:1 as recited by claim 5.
Regarding claim 8, the Examiner submits that given the definition of the practiced “total lipid” as defined by claims 1 and 4-6 of Blanchette, that the ratio range of the membrane forming and cationic lipids is met. Therein, the total lipid is composed of the membrane and polymerizable (cationic) lipids. Per claim 5, the membrane forming lipid is present in a range of 60-95 mol% of the total lipid while the polymerizable (cationic) lipid is present in a range of 5-40 mol% of the total lipid. When considered with respect to the 20:1 to 240:1 total lipid to scaffold protein molar percent ratio ranges disclosed by claim 4, the Examiner submits that the limitations of claim 8 are expressly met.
The apolipoprotein limitations of claim 11 are taught by the reference as being a definition for the scaffold protein component. Therein, ¶[0036]-¶[0037] define the term “apolipoprotein” as an amphipathic protein species of scaffold protein which includes: Apolipoproteins A (apo A-I, apo A-II, apo A-IV, and apo A-V), Apolipoproteins B (apo B48 and apo B100), Apolipoproteins C (apo C-I, apo C-II, apo C-III, and apo C-IV), Apolipoproteins D, Apolipoproteins E (e.g., ApoE4), and Apolipoproteins H. See also ¶[0073].
The limitations of claims 16 and 17 are considered to be met by such disclosures as cholesterol and cholesterol modified oligonucleotides. See ¶[0037] and ¶[0115]. In the case of the latter, the cholesterol modified oligonucleotides are taught as being an amphipathic compound that is less lipid like and that a lower mol% (e.g., 0.1-10 mol%) is needed for successful NLP (nanolipoprotein particle) assembly. Such is considered to disclose the recited lower mol% amount of claim 17.
Based on the combined teachings of Blanchette, the Examiner submits that a person of ordinary skill in the art would have had a reasonable expectation of success at producing the instantly claimed nanolipoprotein particles. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, and absent a clear showing of evidence to the contrary.
Response to Arguments
Applicants’ arguments with regard to the rejection of claims 1-8, 11, 16, 17, and 53 under 35 USC 103(a) as being unpatentable over the combined teachings of Blanchette et al. have been fully considered, but they are not persuasive.
Applicants traverse the rejection on the grounds that Figures 6, 9, and 10 each provide evidence of unexpected results for ‘high-throughput testing of exemplary cationic-NLPs, RNA migration with respect to different bulk lipid percentages, and Zeta potential distributions, respectively. It appears that Applicants’ argue that in view of the data, the claimed invention possesses a critical showing that stable, fully-assembled nanodiscs (aka discoidal nanoparticles) are formed when using cationic lipids up to 40[mol]%.
Applicants assert that even following the line of reasoning of the action in connection with the reference, that the amended composition would be a result at least unexpected in view of such cited documents as Blanchette.
The Examiner respectfully disagrees noting that the overall disclosure of Blanchette is directed to producing stable nanolipoprotein particles (see e.g., Title, Abstract) and that the key distinction between the disclosed and claimed compositions is that the former is more generically taught as having a polymerized lipid component whereas the latter defines the lipid as being cationic. Blanchette further defines the polymerizable lipid as including species that are cationic as instantly defined.
Pursuant to Applicants request, those passages relied upon by the Examiner to disclose the instantly amended compositions are already provided in the above maintained rejections. Having considered the evidence provided, the Examiner respectfully advances that it is not commensurate in scope with the increased breadth of the amended composition.
Applicants’ arguments, for the above reasons, are found unpersuasive. Said rejection is therefore maintained and extended to include the limitations of newly presented claim 53, the limitations of which are also already presented in the above rejection (see e.g., ¶[0036]- ¶[0037]).
Nonstatutory 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 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.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of Blanchette et al. (USPN 12,226,529 B2; IDS reference). Although the claims at issue are not identical, they are not patentably distinct from each other.
Claim 1 of Blanchette discloses:
A nanolipoprotein particle comprising: a membrane forming lipid, a polymerized lipid and a scaffold protein, the membrane forming lipid and the polymerized lipid arranged in a membrane forming lipid bilayer stabilized by the scaffold protein and by the polymerized lipid.
The limitations of instant claim 1 recite:
a cationic nanolipoprotein particle comprising: one or more membrane forming lipids; one or more cationic lipids; and one or more scaffold proteins; wherein the one or more membrane forming lipids and the one or more cationic lipids are arranged in a membrane forming lipid bilayer stabilized by the one or more scaffold proteins.
The Examiner notes that the key difference between the two compositions is the identity of the “polymerized” lipid versus the “cationic” lipid. However, while styled differently, the Examiner submits that in view of such disclosures as claim 6 of Blanchette, they are considered to read on one another. Claim 6 discloses Formula (I):
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Here, each of variables R1, R2, n, o, m, R21, and Y (typographical of ‘Z’) read on the instantly claimed variables. The phosphate group (PO4-) reads on Formula (V) for variable ‘Q’ as instantly claimed. Variable ‘Z’, formula (V) reads on instantly claimed ‘Z’ Formula (II).
The foregoing is considered to disclose the cationic lipid limitations of instant claims 6 and 7.
Two such lipids that read on the above formulation, though not expressly disclosed in the claims are: dimyristoylphosphatidylcholine (DMPC) and dioleoylphosphoethanolamine (DOPE). DMPC has the following structure:
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DOPE has the following structure:
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Disclosure of the polymerized (cationic) lipid being present in an amount ranging from about 5 mol% to about 40 mol% in claims 1 and 2 read on the limitations of the cationic lipid recited by instant claims 2 and 3.
The limitations of claim 3 of the reference read on the limitations of instant claims 4 and 5.
The limitations disclosed by claims 4 and 5 of the reference are considered to teach the limitations of instant claim 8.
Based on the foregoing disclosures provided by Blanchette, were the practiced ‘529 patent available as prior art, it would be considered to teach and suggest the instantly claimed composition, where it does not anticipate it.
Claims 1-7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 49-57 of copending Application No. 19/015,536 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Claim 49 of the reference application discloses a composition comprising a nanolipoprotein particle comprising:
a cross-linked membrane lipid bilayer confined in a discoidal configuration by a scaffold protein, the cross-linked membrane lipid bilayer comprising one or more polymerized lipids and one or more membrane forming lipids wherein the nanolipoprotein particle, further comprises one or more functional molecules selected from a functional molecule embedded in the membrane lipid bilayer, a functional molecule conjugated to a lipophilic anchor compound inserted into the membrane lipid bilayer and a functional molecule conjugated through binding of a functional group with a corresponding functional group presented on functionalized membrane forming lipid of the membrane lipid bilayer.
The foregoing is considered to teach the limitations of instant claim 1, whereby the “one or more polymerizable lipids” reads on the instantly claimed cationic lipid.
Reference claim 56 is considered to disclose the limitations of instant claims 6 and 7.
Reference claims 50 and 51 disclose the limitations of instant claims 2 and 3.
Reference claim 52 reads directly on instant claim 4 and encompasses the 80:1 total lipid to scaffold protein molar percent ratio recited by instant claim 5.
Thus, while the disclosure of the reference application does not expressly meet the instantly recited composition, it does teach the instantly recited nanolipoprotein particle and its constituent lipids and scaffold protein. As such, were the reference application available as prior art, the Examiner submits that a person of ordinary skill in the arts would have found it to render the instant composition prima facie obvious.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicants’ filed responses to the rejections of claims 1-8 on the grounds of nonstatutory double patenting over the patented teachings of Blanchette et al. and copending Application No. 19/015,536, have been fully considered, but are not persuasive.
Applicants traverses both rejections on the basis of the remarks provided in traversal of the obviousness rejection made over WO 2017/035326 (the WO publication of the reference patent). Applicants’ also cite MPEP §804(II)(B)(1) stating that “…the disclosure of the patent may not be used as prior art.”
Here, the Examiner submits that subject matter relied upon in support of the rejections is in fact, disclosed in the claims. The Examiner also cites the same passage section which states that
“[i]n construing the claims of the reference patent or application, a determination is made as to whether a portion of the specification, including the drawings and claims, is directed to subject matter that is within the scope of a reference claim. For example, assume that the claim in a reference patent is directed to a genus of compounds, and the application being examined is directed to a species within the reference patent genus. If the reference patent discloses several species within the scope of the reference genus claim, that portion of the disclosure should be analyzed to properly construe the reference patent claim and determine whether it anticipates or renders obvious the claim in the application being examined. Because that portion of the disclosure of the reference patent is an embodiment of the reference patent claim, it may be helpful in determining the full scope and obvious variations of the reference patent claim.” MPEP §804(II)(B)(1), fifth paragraph.
Thus, the remaining double patenting rejections of record are maintained.
New Rejections
Applicants’ amendments have necessitated the following ground(s) of rejection:
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 1-3, 6-9, 11-15, 18 and 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
As amended, claim 1 recites the limitations “one or more membrane forming lipids,” “one or more cationic lipids,” and “one or more scaffold forming proteins”.
The recitation of “the scaffold protein” in line 6 of claim 1, as a result of the above amendment lacks sufficient antecedent basis in the claim.
Claims 8, and 11-15 also each recite the limitation “the scaffold protein”. There is insufficient antecedent basis for this limitation in each of these claims.
Claims 2, 3, 6, 7, 9, 12-15, 18, and 20 each recite the limitation “the cationic lipid”. There is insufficient antecedent basis for this limitation in each of these claims.
Claims 8, 9, 12-15, 18, and 20 each recite the limitation “the membrane forming lipid”. There is insufficient antecedent basis for this limitation in each of these claims.
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 3 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.
As amended, claim 1 now recites the limitation wherein the “one or more cationic lipids in a molar concentration of 5 mol% to 40 mol% of a total lipid component.
Claim 3, which depends directly from claim 1, continues to recite wherein the [at least one] cationic lipid is in molar concentration of about 5 to about 40 mol%. The claim fails to further limit the amended recitation of claim 1 and the recitation of “about” appears to improperly broaden the claim.
Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
Allowable Subject Matter
Claims 9, 10, 12-15 and 18 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding the aforementioned claims, the Examiner’s consideration of the parent application 15/969,311 (allowed as USPN 12,083,223 B2) reveals that the limitations recited therein are each free of the prior art, but remain subject to the rejection of instant claim 1 as discussed above.
All claims have been rejected; no claims are allowed.
Conclusion
Applicants’ amendments 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 extension fee 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.
Correspondence
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Jeffrey T. Palenik whose telephone number is (571) 270-1966. The Examiner can normally be reached on 9:30 am - 7:00 pm; M-F (EST).
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Robert A. Wax can be reached on (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jeffrey T. Palenik/
Primary Examiner, Art Unit 1615
Prosecution Insights