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 second 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 Reply filed 02 August 2026, Applicant amended claims 1, 6, and 9-11. Additionally, Applicant cancelled claim 4. Claims 1-3 and 5-11 are pending.
Status of the Rejections and Objections
The objections to claims 9-11 are withdrawn in view of Applicant’s amendments thereto.
The rejection of claim 10 under 35 U.S.C. 112(a) for lack of enablement is withdrawn in view of Applicant’s amendment thereto.
The rejection of claim 9 under 35 U.S.C. 112(a) for failing to comply with the written description requirement is new and has been necessitated by Applicant’s recent amendment.
The rejection of claims 4 and 6-8 under 35 U.S.C. 112(b) has been modified in view of Applicant’s recent amendments.
The rejection of claims 1-11 under 35 U.S.C. 102(a)(1) and/or 35 U.S.C. 102(a)(2) as being anticipated by Kweon (US 2019/0255145 A1) is withdrawn in view of Applicant’s narrowing amendment to claim 1.
The rejection of claims 1-3 and 5-9 under 35 U.S.C. 102(a)(1) and/or 35 U.S.C. 102(a)(2) as being anticipated by Tanaka (“Preparation and characterization of reconstituted lipid–synthetic polymer discoidal particles.” Langmuir 31.46 (2015): 12719-12726) is new and has been necessitated by Applicant’s narrowing amendment to claim 1.
The rejection of claims 1-3 and 5-11 under 35 U.S.C. 103 as being unpatentable over Kweon (US 2019/0255145 A1) in view of Tanaka (“Preparation and characterization of reconstituted lipid–synthetic polymer discoidal particles.” Langmuir 31.46 (2015): 12719-12726) is new and has been necessitated by Applicant’s narrowing amendment to claim 1.
All three rejections on the ground of non-statutory double patenting set forth in the previous Office action (02 April 2026) are withdrawn in view of Applicant’s narrowing amendment to claim 1.
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 9 is rejected under 35 U.S.C. 112(a) for failing to comply with the written description requirement.
Claim 9, as recently amended, now contains subject matter that was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventors, at the time the application was filed, had possession of the invention, as now claimed.
Specifically, the specification of the present application, as originally filed 19 October 2023, provides insufficient support for the following intended use now recited in the preamble of claim 9: “for preventing or treating a bacterial infection.” Emphasis added.
Paragraph [24] of the specification states: “In accordance with another aspect of the present invention, provided is an antibacterial composition for preventing or treating a viral infection containing the polymer nanodisc.” (Emphasis added) Page 11.
Paragraph [69] of the specification states: “In another aspect, the present invention is directed to an antibacterial composition for preventing or treating a viral infection containing the polymer nanodisc.” (Emphasis added) Page 23.
There is no other relevant disclosure in the specification. The present application is directed to the treatment or prevention of viral infections, not bacterial infections. See, e.g., Specification at Title and at paras. [4], [6], [8], [14], [71], [80], [84], and [156]-[158]. This is why the examiner recommended (i) replacing “antibacterial” with “antiviral” or (ii) simply deleting “antibacterial,” in the objection to claim 9 set forth in the previous Office action (02 April 2026).
Given that none of Applicant’s claims, as originally filed, compensates for the deficiency in the specification identified above, the present application does not reasonably convey to persons skilled in the art that the inventors, at the time the application was filed, had possession of the following limitation: “for preventing or treating a bacterial infection.” Thus, claim 9 recites new matter. 35 U.S.C. 132(a) (“No amendment shall introduce new matter into the disclosure of the invention.”); see also MPEP § 608.04. Accordingly, it is appropriate to reject claim 9 under 35 U.S.C. 112(a).
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 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.
Claim 6, as recently amended, states: “The polymer nanodisc according to claim 1, wherein the polymer nanodisc is configured to perforate a lipid bilayer envelope of a virus.” It is unclear whether (and if so how) the foregoing functional limitation further defines the structure (configuration) or compositional profile of the nanodisc of claim 1. The specification does not provide guidance on distinguishing between (i) nanodiscs capable of perforating a virus and (ii) nanodiscs that do not have that capability. 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”). Query: Is the nanodisc, as defined in claim 1, incapable of perforating the lipid bilayer envelope of a virus? In sum, claim 6 and the claims depending thereon (claims 7-8) remain 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 1-3 and 5-9 are rejected under 35 U.S.C. 102(a)(1) and/or 35 U.S.C. 102(a)(2) as being anticipated by Tanaka (“Preparation and characterization of reconstituted lipid–synthetic polymer discoidal particles.” Langmuir 31.46 (2015): 12719-12726).
Tanaka is directed to lipid-synthetic polymer discoidal particles.
The figure set forth in the abstract of Tanaka (reproduced below) is considered especially relevant to Applicant’s claims:
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Referring to claim 1 of the present application, the foregoing figure discloses a “polymer nanodisc having a configuration in which an amphipathic polymer is bound to a lipid bilayer including hydrophobic moieties of amphiphilic lipids contacting each other.”
Tanaka identifies the polymer that forms the belt around the lipid bilayer as the hydrolyzed acid form of styrene–maleic anhydride copolymer (SMAaf). Abstract; see also page 12720 at Section 2.1. The examiner notes that SMAaf satisfies the following claim 1 limitation: “styrene-maleic acid (SMA).”
Tanaka discloses: “The combination of a hydrophobic styrene moiety and charged maleic acid moiety provides the amphiphilic nature of SMAaf.” (Emphasis added) Page 12724 at Section 4.2.
Tanaka identifies dimyristoyl phosphatidylcholine, which is referred to also as “DMPC,” as a constituent of the lipid bilayer. Abstract; see also page 12720 at Section 2.1 and pages 12721-22 at Section 3.1. The specification of the present application, as originally filed 19 October 2023, defines DMPC as a phosphatidylcholine. Page 8 at para. [55].
On the basis of the foregoing disclosure, claims 1-3 of the present application are anticipated by Tanaka.
Regarding claims 6-8, although Tanaka is silent as to whether the discoidal particles are capable of perforating a lipid bilayer envelope of a virus, it is important to acknowledge that “if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” MPEP § 2112.01(II), citing In re Spada, 911 F.2d 705, 709 (Fed. Cir. 1990). Applicant’s discovery of that anti-viral property does not render the claimed invention patentable, even if that property is advantageous. MPEP § 2112(I) (“‘[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.’”), quoting Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347 (Fed. Cir. 1999). Applicant is reminded that “[t]here is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference.” MPEP § 2112(II) (emphasis in original), citing Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377 (Fed. Cir. 2003).
Regarding claim 9, the intended result recited in the preamble (i.e., “for preventing or treating a bacterial infection”) is not afforded patentable weight. MPEP § 2111.02(II) (“If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.”).
Claim Rejections - 35 U.S.C. 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(a) 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.
Claims 1-3 and 5-11 are rejected under 35 U.S.C. 103 as being unpatentable over Kweon (US 2019/0255145 A1) in view of Tanaka (“Preparation and characterization of reconstituted lipid–synthetic polymer discoidal particles.” Langmuir 31.46 (2015): 12719-12726).
Kweon 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 on the next page:
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Kweon discloses that “the membrane scaffold protein [(MSP)] 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 [(MSP)] 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.
Although Kweon discloses that an amphiphilic helical protein (MSP) can serve as the belt of the nanodisc, Kweon is silent as to whether any of the four amphiphilic synthetic polymers now recited in claim 1 of the present application are suitable for that role. Consequently, Kweon does not satisfy claim 1. As explained below, Tanaka compensates for this deficiency.
Tanaka is discussed above in the rejection under 35 U.S.C. 102. That discussion is incorporated by reference into this rejection under 35 U.S.C. 103.
Tanaka additionally teaches: “In particular, discoidal nanoparticles, termed Nanodiscs, consisting of membrane scaffold protein (MSP) are widely used for studies of membrane proteins. Because MSP has been designed on the basis of the human apoA-I sequence, Nanodiscs are essentially identical to nascent HDL. In addition, the apoA-I mimetic peptide has been shown to form discoidal particles that can stabilize membrane proteins.” (Emphasis added) Page 12719, right column.
Tanaka additionally teaches: “Initially, we sought to make use of discoidal HDL composed of apolipoproteins or their mimetic peptides for bioimaging applications. However, there are some limitations for clinical application of such discoidal nanoparticles, particularly in terms of productivity because proteins or peptides are expensive, and regarding the safety because apolipoproteins are usually obtained from plasma or Escherichia coli. Recently, it has been revealed that a synthetic polymer, styrene–maleic acid, forms discoidal nanoparticles similar to those of reconstituted HDL (rHDL). HDL-mimicking lipid particles composed of styrene–maleic acid instead of apolipoproteins are referred to as SMALPs and are commercially available as Lipodisq. Styrene–maleic acid polymer is biocompatible; consequently, its lipid complexes can be used clinically.” (Emphasis added) Page 12720, left column.
Before the effective filing date of the claimed invention, the foregoing teachings of Tanaka would have motivated a person having ordinary skill in the art to modify the nanodisc of Kweon by substituting SMAaf (styrene-maleic acid) for the MSP, in an effort to reduce costs and improve safety. Therefore, claims 1 and 2 are prima facie obvious.
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 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. Alternatively, the intended result recited in the preamble (i.e., “for preventing or treating a bacterial infection”) is not afforded patentable weight. MPEP § 2111.02(II) (“If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.”).
Regarding claim 10, Applicant is referred to claim 12 of Kweon.
Regarding claim 11, Applicant is referred to claim 14 of Kweon.
Conclusion
Claims 1-3 and 5-11 are rejected.
No claim is 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 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./
24 September 2026
/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
