DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This is the first Office action on the merits of the claims.
All citations to the Manual of Patent Examining Procedure (MPEP) refer to Revision 01.2024, which was released in November 2024.
Status of the Claims
In the Preliminary Amendment filed 19 October 2023, Applicant amended claims 9-11. Claims 1-11 are pending.
Claim Objections
Claims 9-11 are objected to because of the following informalities:
Regarding claim 9, there is inconsistency within the preamble. The examiner recommends either (i) replacing “antibacterial” with “antiviral” or (ii) simply deleting “antibacterial.”
Regarding claim 10, in the preamble, the word “a” is missing between the word “treating” and the phrase “viral infection.”
Regarding claim 11, there is inconsistency between the preamble and the process steps. Specifically, the process steps do not concern an “optimized nanodisc structure composition.” Rather, they concern a polymer nanodisc. For this reason, the preamble of the claim must be amended to read as follows: “A method for screening a polymer nanodisc for antiviral activity.”
In further regard to claim 11, the step identifiers “(a)” and “(b)” need to be relocated to the beginning of their respective phrases.
Appropriate corrections are required.
Claim Rejections - 35 U.S.C. 112(a)
The following is a quotation of 35 U.S.C. 112(a):
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.
Claim 10 is rejected under 35 U.S.C. 112(a) for lack of enablement.
The test of enablement is whether one skilled in the art could make and use the claimed invention from the disclosures in the specification coupled with information known in the art without undue experimentation (United States v. Telectronics, 8 USPQ2d 1217 (Fed. Cir. 1988)). MPEP § 2164.01. Whether undue experimentation is needed is not based upon a single factor but rather is a conclusion reached by weighing many factors. MPEP § 2164.01(a). These factors were outlined in In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988) and include the following: (1) the breadth of the claims; (2) the nature of the invention; (3) the state of the prior art; (4) the level of one of ordinary skill; (5) the level of predictability in the art; (6) the amount of direction provided by the inventor; (7) the existence of any working examples; and (8) the quantity of experimentation necessary needed to practice the claimed invention based on the content of the disclosure. MPEP § 2164.01(a).
There is no requirement in claim 10 that an effective amount of the polymer nanodisc is administered to the subject. Applicant’s specification does not reasonably provide enablement for treating or preventing a viral infection by administering a negligible or otherwise ineffective amount of the polymer nanodisc. In sum, a person having ordinary skill in the art could not practice the full scope of Applicant’s invention, as recited in claim 10, without first engaging in undue experimentation.
Claim Rejections - 35 U.S.C. 112(b)
The following is a quotation of 35 U.S.C. 112(b):
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.
Claims 4 and 6-8 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter that the inventors regard as the invention.
Regarding claim 4, the following abbreviation is not defined: C13PC. It is unclear which chemical compound (amphiphilic lipid) corresponds to C13PC.
Regarding claim 6, is the viral envelope a required element of the claim? More specifically, is the presence of a viral envelope being perforated by the polymer nanodisc required to satisfy claim 6? Alternatively, does the claim introduce a functional limitation relating to the polymer nanodisc — i.e., the nanodisc is capable of perforating the lipid bilayer envelope of a virus? Even if it is the latter, it is nevertheless unclear how the functional limitation further defines the structure (configuration) or compositional profile of the nanodisc. MPEP § 2173.05(g) (“the use of functional language in a claim may fail ‘to provide a clear-cut indication of the scope of the subject matter embraced by the claim’ and thus be indefinite”). This lack of clarity renders claim 6 and the claims depending thereon (claims 7-8) indefinite.
Claim Rejections - 35 U.S.C. 102(a)
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102(a) that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless
(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; or
(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-11 are rejected under 35 U.S.C. 102(a)(1) and/or 35 U.S.C. 102(a)(2) as being anticipated by Kweon (US 2019/0255145 A1).
The specification of the present application, as originally filed on 19 October 2023, states in relevant part:
As used herein, the term "polymer" refers to a compound containing a molecule in which one or more structural units (monomers) are polymerized and linked to each other through a large number of chemical bonds. Depending on the structure of the polymer, the polymer is classified into a linear polymer, a branched polymer, and a networked polymer. A polymer including two or more different monomers is called a "copolymer" and a polymer including one monomer is referred to as "a homopolymer". In the present invention, among these polymers, an amphiphilic polymer is used.
Page 16 at para. [49].
In accordance with Applicant’s definition, the examiner notes that a membrane scaffold protein (MSP), which is a polypeptide, qualifies as a polymer. MPEP § 2111.01(I) (“the best source for determining the meaning of a claim term is the specification - the greatest clarity is obtained when the specification serves as a glossary for the claim terms”). With this in mind, the examiner turns to Kweon, which is directed to a “nanoperforator for preventing or treating viral infectious diseases.” Title.
Kweon discloses “a nano-perforator comprising a lipid bilayer nanodisc and a membrane scaffold protein surrounding an outer circumferential surface of the nanodisc.” (Emphasis added) Claim 1. The general configuration of the nano-perforator is shown in Figure 1 of Kweon, which is reproduced below:
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Kweon discloses that “the membrane scaffold protein is an amphipathic protein having a helix structure.” (Emphasis added) Claim 4; see also para. [0025] (“The term ‘membrane scaffold protein’ as used herein refers to an amphipathic helical protein and means a protein capable of constituting the shape of the nano-perforator including a lipid bilayer according to the present invention by surrounding the outer circumferential surface of the lipid bilayer.”).
In paragraph [0025], Kweon further discloses:
In the present invention, the membrane scaffold protein surrounding the outer circumferential surface of the lipid bilayer may be an amphipathic protein including a hydrophobic region and a hydrophilic region. The nano-perforator may be formed such that the hydrophobic region (e.g., hydrophobic amino acid) of the membrane scaffold protein binds to a hydrophobic region (e.g., lipid) of the lipid bilayer nanodisc, and the hydrophilic region (e.g., hydrophilic amino acid) of the membrane scaffold protein is exposed to the outside. For example, the membrane scaffold protein may be an amphipathic protein having a helical structure.
On the basis of the foregoing disclosure, claims 1 and 2 of the present application are anticipated by Kweon.
Regarding claim 3, Applicant is referred to claim 3 and paragraph [0021] of Kweon. See also Examples 1-1 and 1-2 (paras. [0100]-[0101]).
Regarding claim 4, Applicant is referred to paragraphs [0022], [0100], and [0101] of Kweon.
Regarding claim 5, Kweon discloses ratios of lipid to membrane scaffold protein (MSP) of “preferably 50:1 to 150:1, and may be, for example, 65:1 or 125:1.” Those exemplary ratios, along with Example 1-1 (para. [0100]), satisfy the range recited in claim 5. MPEP § 2131.03(I) (“‘If the prior art discloses a point within the claimed range, the prior art anticipates the claim.’”), quoting UCB, Inc. v. Actavis Labs UT, Inc., 65 F.4th 679, 687 (Fed. Cir. 2023). In the alternative, this rejection is supported by MPEP § 2131.03(II) (“prior art that teaches a range overlapping or touching the claimed range anticipates if the prior art range discloses the claimed range with ‘sufficient specificity’”).
Regarding claim 6, Applicant is referred to claim 2 of Kweon.
Regarding claim 7, Applicant is referred to claim 10 of Kweon.
Regarding claim 8, Applicant is referred to paragraph [0061] of Kweon.
Regarding claim 9, Applicant is referred to claim 11 of Kweon.
Regarding claim 10, Applicant is referred to claim 12 of Kweon.
Regarding claim 11, Applicant is referred to claim 14 of Kweon.
Claim Rejections - Double Patenting (Non-Statutory)
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 obviousness-type 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); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR1.321(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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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 eTerminalDisclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/ eTD-info-I.jsp.
Claims 1-11 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-10 of Patent No. 11,541,100.
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following: Conflicting claims 1 and 5-6 of the ’100 Patent collectively disclose the nanodisc configuration required by claims 1-2 of the present application, which is a disc-shaped lipid bilayer surrounded by an amphiphilic polymer. Conflicting claims 1-3 respectively disclose the ability to perforate a viral envelope and treat viral infections. Therefore, the present claims are not patentably distinguishable over conflicting claims 1-10 of the ’100 Patent.
Claims 1-9 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-16 of co-pending Application No. 18/839,970 (as preliminarily amended on 20 August 2024).
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following: Conflicting claims 1-2, 5, and 13 of the ’970 Application collectively disclose the nanodisc configuration required by claims 1-2 of the present application, which is a disc-shaped lipid bilayer surrounded by an amphiphilic polymer. Conflicting claims 3-4 and 11-12 respectively disclose the various species of phospholipid recited in present claims. Therefore, present claims 1-9 are not patentably distinguishable over conflicting claims 1-16 of the ’970 Application. This is a provisional rejection because the conflicting claims have not been patented.
Claims 1-11 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-18 of co-pending Application No. 18/881,554 (as originally filed on 13 February 2025).
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following: Conflicting claims 1, 4, 6, 9, 12, and 15 of the ’554 Application collectively disclose the nanodisc configuration required by claims 1-2 of the present application, which is a disc-shaped lipid bilayer surrounded by an amphiphilic polymer. Conflicting claims 2-3, 7-8, and 13-14 respectively disclose the various species of phospholipid recited in the present claims. Conflicting claims 17-18 disclose that the nanodisc functions as an antiviral. Therefore, the present claims are not patentably distinguishable over conflicting claims 1-16 of the ’554 Application. This is a provisional rejection because the conflicting claims have not been patented.
Conclusion
Claims 1-11 are rejected.
Claims 9-11 are also objected to.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER ANTHOPOLOS whose telephone number is 571-270-5989. The examiner can normally be reached on Monday – Friday (9:00 am – 5:00 pm). If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany P. Barham, can be reached on Monday – Friday (9:00 am – 5:00 pm) at 571-272-6175. The fax number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P.A./
30 March 2026
/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
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