DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/4/25 has been entered.
Priority
The instant application, filed 09/22/2022 and having one RCE, is a Continuation of 16427493, filed 05/31/2019, now U.S. Patent # 11485759
16427493 is a Continuation of 15490351, filed 04/18/2017, now U.S. Patent # 10351603
15490351 is a Divisional of 14930792, filed 11/03/2015, now U.S. Patent # 9630994
14930792 Claims Priority from Provisional Application 62074167, filed 11/03/2014.
Information Disclosure Statement
The Examiner has considered the reference(s) provided in the 12/11/24, 7/16/25, and 7/23/25 Information Disclosure Statements, and provides a signed and dated copy of each herewith.
Claim Status
Claims 21-28 and 30-57 are pending.
Claims 1-20, 29 and 58-60 are cancelled.
Claims 21-28 and 30-57 are rejected.
Claim Interpretation
The claim limitations are given their broadest reasonable interpretation (BRI) consistent with the specification, MPEP 2111, and under the BRI, words of the claim must be given their plain meaning, unless such meaning is inconsistent with the specification, MPEP 2111.01.
The specification, page 3, lines 9-10 states, “Each I53 material comprises 12 identical pentamers (dark grey) and 20 identical trimers (light grey),”. Claim 24, depending from claim 21 via claim 23, is directed to the nanostructure of claim 23, “wherein the trimeric components and the pentameric components form an I53 icosahedral architecture.” “I53” is interpreted to mean that each of the respective trimeric components and pentameric components are identical, each trimeric component has identical sequence to every other trimeric component, each pentameric component has identical sequence to every other pentameric component, as distinguished from the claim 21 and 23 nanostructures, which by claim differentiation could comprise different, non-identical sequences when comparing one or more of the trimeric components or pentameric components in those icosahedral protein nanostructures.
The examiner acknowledges applicant’s 9/21/24 amendment of claim 24 following the above interpretation, albeit per Remarks of 9/21/24, page 7, without acquiescence to this claim construction.
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.
Response to Arguments
Applicant's arguments filed 1/14/25 have been fully considered but they are not persuasive.
It is the examiner’s understanding of the MPEP that it proper to make and maintain the NSDP rejection that is set forth below.
Claims 21-60 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 6 and 7 of U.S. Patent No. 11192926. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent claims are directed to administering to a subject in need thereof a nanostructure genera or subgenera from which the instant claims’ subgenera (or species) are at once envisaged, as explained in the table below:
Instant claim(s)
Relevant reference patent claim(s)
Discussion/explanation
21
1, 2, 6 and 7
All sequences of instant claim 1 are set forth in these reference patent claims, as well as additional limitations regarding particular virus proteins’ inclusion in the structure, claimed combinations to form the nanostructure is reinforced in reference patent claims 2 and 6. AT 100% SEQUENCE IDENTITY OF THE FIRST AND SECOND POLYPEPTIDES THAT FORM THE ADMINISTERED NANOSTRUCTURES, ENCOMPASSED IN THE REFERENCE CLAIMS, THE IDENTITY AT THE PARTICULARLY RECITED INTERFACE AMINO ACID POSITIONS OF THE INSTANT CLAIMS ARE AT ONCE ENVISAGED AND NECESSARILY MET. THIS APPLIES ALSO TO ALL DEPENDENT CLAIMS SET FORTH BELOW.
22
1, 2, 6 and 7
As above, and 90% identity is at once envisaged from reference patent claims 1 and 2 at least 75% and narrower identities as a closer match to the listed sequences
23
1, 2, 6 and 7
As above, and 95% identity is at once envisaged from reference patent claims 1 and 2 at least 75% and narrower identities as a closer match to the listed sequences
24
1, 2, 6 and 7
This rejection is based on “I53” requiring 12 identical pentamers and 20 identical trimers, and this would have been obvious by selection of a single sequence for each from the listing in reference patent claim 1 or claim 6 at least because there is no indication in these claims to mix sequences for the first or the second polypeptides
25
1, 2, 6 and 7
This combination is specifically listed in reference patent claim 6
26
1, 2, 6 and 7
This combination is specifically listed in reference patent claim 6
27
1, 2, 6 and 7
This combination is specifically listed in reference patent claim 6
28
1, 2, 6 and 7
This combination is specifically listed in reference patent claim 6
30
1, 2, 6 and 7
This combination is specifically listed in reference patent claim 6
31
1, 2, 6 and 7
This combination is specifically listed in reference patent claim 6
32
1, 2, 6 and 7
This combination is specifically listed in reference patent claim 6
33
1, 2, 6 and 7
This combination is specifically listed in reference patent claim 6
34
1, 2, 6 and 7
This combination is specifically listed in reference patent claim 6
35
1, 2, 6 and 7
This combination is specifically listed in reference patent claim 6
36
1, 2, 6 and 7
This combination is specifically listed in reference patent claim 6
37
1, 2, 6 and 7
This combination is specifically listed in reference patent claim 6
38
1, 2, 6 and 7
This combination is specifically listed in reference patent claim 6
39
1, 2, 6 and 7
This combination is specifically listed in reference patent claim 6
40
1, 2, 6 and 7
This combination is specifically listed in reference patent claim 6
41
1, 2, 6 and 7
This combination is specifically listed in reference patent claim 6
42-49
1, 2, 6 and 7
As above for claim 21, and 95% identity is at once envisaged from reference patent claim’s at least 75% and narrower identities
50-57
1, 2, 6 and 7
As above for claim 21, and the exact sequence as set forth in instant claims 50-57 is at once envisaged from reference patent claims 1 and 6 that list these sequences
Claims 21-60 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 4, 25 and 26 of U.S. Patent No. 11732011. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent claims are directed to a nanostructure genera or subgenera from which the instant claims’ subgenera (or species) are at once envisaged, as explained in the table below:
Instant claim(s)
Relevant reference patent claim(s)
Discussion/explanation
21
1, 3, 4, 25 and 26
All sequences of instant claim 1 are set forth in these reference patent claims, directed to administering a nanostructure formed from these sequences, as well as additional limitations regarding particular virus proteins’ inclusion in the structure, the former is reinforced in reference patent claims 2 and 6. AT 100% SEQUENCE IDENTITY OF THE FIRST AND SECOND POLYPEPTIDES OF THE NANOSTRUCTURE, ENCOMPASSED IN THE REFERENCE CLAIMS, THE IDENTITY AT THE PARTICULARLY RECITED INTERFACE AMINO ACID POSITIONS OF THE INSTANT CLAIMS ARE AT ONCE ENVISAGED AND NECESSARILY MET. THIS APPLIES ALSO TO ALL DEPENDENT CLAIMS SET FORTH BELOW.
22
1, 3, 4, 25 and 26
As above, and 90% identity is at once envisaged from reference patent claims 1 and 3 at least 75% and narrower identities as a closer match to the listed sequences
23
1, 3, 4, 25 and 26
As above, and 95% identity is at once envisaged from reference patent claims 1 and 3 at least 75% and narrower identities as a closer match to the listed sequences
24
1, 3, 4, 25 and 26
This rejection is based on “I53” requiring 12 identical pentamers and 20 identical trimers, and this would have been obvious by selection of a single sequence for each from the listing in reference patent claim 1 or claim 3 at least because there is no indication in these claims to mix sequences for the first or the second polypeptides
25
1, 3, 4, 25 and 26
This combination is specifically listed in reference patent claim 6
26
1, 3, 4, 25 and 26
This combination is specifically listed in reference patent claim 6
27
1, 3, 4, 25 and 26
This combination is specifically listed in reference patent claim 6
28
1, 3, 4, 25 and 26
This combination is specifically listed in reference patent claim 6
30
1, 3, 4, 25 and 26
This combination is specifically listed in reference patent claim 6
31
1, 3, 4, 25 and 26
This combination is specifically listed in reference patent claim 6
32
1, 3, 4, 25 and 26
This combination is specifically listed in reference patent claim 6
33
1, 3, 4, 25 and 26
This combination is specifically listed in reference patent claim 6
34
1, 3, 4, 25 and 26
This combination is specifically listed in reference patent claim 6
35
1, 3, 4, 25 and 26
This combination is specifically listed in reference patent claim 6
36
1, 3, 4, 25 and 26
This combination is specifically listed in reference patent claim 6
37
1, 3, 4, 25 and 26
This combination is specifically listed in reference patent claim 6
38
1, 3, 4, 25 and 26
This combination is specifically listed in reference patent claim 6
39
1, 3, 4, 25 and 26
This combination is specifically listed in reference patent claim 6
40
1, 3, 4, 25 and 26
This combination is specifically listed in reference patent claim 6
41
1, 3, 4, 25 and 26
This combination is specifically listed in reference patent claim 6
42-49
1, 3, 4, 25 and 26
As above for claim 21, and 95% identity is at once envisaged from reference patent claim’s at least 75% and narrower identities
50-57
1, 3, 4, 25 and 26
As above for claim 21, and the exact sequence as set forth in instant claims 50-57 is at once envisaged from reference patent claims 1 and 6 that list these sequences
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH FISCHER whose telephone number is (571)270-7925. The examiner can normally be reached on Monday to Friday, 9:00 AM to 5:00 PM, however noting that the examiner will not normally be working on Wednesday-Friday and on Monday/Tuesday on alternating weeks, but will promptly answer messages upon his return to work.
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/JOSEPH FISCHER/Examiner, Art Unit 1658