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 .
Priority
This application claims priority to foreign application SE2150022-8, filed on 13 January 2021, and PCT application PCT/EP22/50663, filed on 13 January 2022. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. The effective filing date is 13 January 2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 29 April 2024 is being considered by the examiner.
Status of Application, Amendments, and/or Claims
Claims 1-31 are the original claims filed on 12 July 2023. In the preliminary amendment of 12 July 2023, claims 2-4, 11-15, 17, 19, 21-31 were amended. In response to the office action filed on 04 March 2026, claims 1-14, 17, 19-24, 27, 28 were cancelled, claims 15, 16, 18, 25, 26, 29, and 30 were amended, and claims 32-48 were added. Claims 15, 16, 18, 25, 26, and 29-48 are pending and the subject of this office action.
Withdrawn Objections/Rejections
In the office action of 04 March 2026, claims 3 and 21-24 were rejected under 35 U.S.C. 112(b) for failing to distinctly claim the subject matter, which the inventor(s) regard as the invention. These claims have been cancelled, rendering the rejection moots.
Claims 1-13, 15, 16, and 21-24 were rejected under 35 U.S.C. 101 for being directed to a product of nature. Claims 1-13 and 21-24 were cancelled rendering these rejections moot. Claims 15 and 16 were amended, so as to overcome the previous rejection.
Claims 1-13, 15, and 16 were rejected under 35 U.S.C. 102, as being anticipated by the prior art. Claims 1-13 were cancelled, rendering these rejection moot. Claims 15 and 16 were amended to include limitations from previous claim 17, which renders the previous rejection moot.
Claims 14, 17, 18, and 25-31 were rejected under 35 U.S.C. 103. Claims 14 and 17 have been cancelled rendering these rejections moot. In regard to claims 18 and 25-31, the previous rejections relied on a piece of prior art, Allergen Nomenclature allergen database, which taught an amino acid sequence tied to these claims. However, based on the applicant’s persuasive arguments, regarding the this reference not meeting 35 U.S.C. 102 requirements, this art will no longer be considered, and as such the corresponding rejections have been lifted.
Claims 1-26, and 29-31 were previously rejected on grounds of non-statutory double patenting over claims 1, 2, 15, 16, 20, 21, 26, 27, 30, 31, and 32 of U.S. Patent No. 12,539,330. Claims 1-14, 17, and 19-24 have been cancelled rendering these rejections moot. The applicant has chosen not address the remaining rejections, until there is an indication of otherwise allowable subject matter. Therefore, the previous double patenting rejections remains.
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 15, 16, 18, 25, 26, and 29-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 16, 18, 19, 20, 21, 26, 27, 30, 31, 32 of U.S. Patent No. 12539330 (herein ‘330). Although the claims at issue are not identical, they are not patentably distinct from each other.
‘330 is drawn to an isolated allergen protein, derived from the Cup s 7 allergen, comprising the amino acid sequence disclosed in SEQ ID NO: 4. In claims 1 and 2 of the referenced patent, the applicant limits the required sequence identity to at least 85 % (claim 1) or at least 90 % (claim 2). The amino acid sequence referenced in claims 1 and 2 of the instant application, SEQ ID NO: 53, shares 98.41 % sequence identity with SEQ ID NO:4 of the reference sequence and exceeds the minimum allowable sequence identity established in the reference claims 1 and 2 (85 % or 90 %, respectively), as shown below:
Instant SEQ ID NO:53 AQIDCDKECNRRCSKASAHDRCIKYCGICCEKCHCVPPGTAGNEDVCPCYANLKNSKGGH 60
Ref SEQ ID NO:4 AQIDCDKECNRRCSKASAHDRCLKYCGICCEKCHCVPPGTAGNEDVCPCYANLKNSKGGH 60
**********************:*************************************
Instant SEQ ID NO:53 KCP 63 (98.41 % Sequence Identity)
Ref SEQ ID NO:4 KCP 63
***
The subsequent claims limiting the amino acid substitutions of the allergenic protein in the current application (claims 33-43) allow for amino acid substitutions in set positions, however all of them are bound to the same sequence identity limitations established in claim 15 and are encroaching on the claimed invention of ‘330 (see claims 1 and 2 of the referenced patent). Reference claim 18 refers to an expression vector comprising a nucleic acid (SEQ ID NO: 10) (relevant to instant claim 16), that encodes the amino acid described in claim 1 (SEQ ID NO: 4). This claim directly overlaps with instant claim 15, for the reasons discussed above. Essentially, because ‘330 allows for up to 15% sequence variation within the amino acid corresponding to SEQ ID NO:4 and there are no limitations, regarding the identity of the amino acid at position 23, it is easily conceivable that the expression vector of reference claim 18 could express a protein meeting the limitations established in instant claim 15 (i.e. having an isoleucine residue at position 23).
In regard to claims 18, 25, 26, 29, 30, and 31, the claims of the instant application and their counterparts in ‘330, claims 19, 26, 27, 30, 31, and 32 respectively, are effectively describing the same invention as they have overlapping limitations.
In regard to claims 15, 16, the applicant is claiming an expression vector comprising an isolated nucleic acid molecule encoding a protein sharing at least 85% sequence identity with SEQ ID NO: 53. As described above, the encoded protein encroaches on claim 18 of ‘330. Additionally, the sequence referenced in instant claim 16, SEQ ID NO: 10, is nearly identical to the sequence referenced in claim 17 of ‘330, see below. The only variations act to define the possible nucleic acid limitations at the corresponding positions. However, there is significant overlap between the allowed nucleic acids, and as such the possible nucleic acid molecules defined by these are sequences could encode proteins of identical amino acid sequences, and as such are not patentably distinct.
Instant gcncanathgaytgygayaargartgyaaymgnmgntgywsnaargcnwsnnyncaygay 60
Reference gcncanathgaytgygayaargartgyaaymgnmgntgywsnaargcnwsnbyncaygay 60
*************************************************** ********
Instant mgntgyhtnaartaytgyggnathtgytgyraraartgymaytgygtnccnccnggnacn 120
Reference mgntgyytnaartaytgyggnathtgytgyraraartgymaytgygtnccnccnggnacn 120
****** *****************************************************
Instant kmnggnaaygargaydbntgyccntgytaygcnmayytnaaraaywsnaarggnggncay 180
Reference kmnggnaaygargaydbntgyccntgytaygcnmayytnaaraaywsnaarggnggncay 180
************************************************************
Instant aartgyccn 189
Reference aartgyccn 189
*********
Claims 46-48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 26 of U.S. Patent No. Patent No. 12539330 (herein ‘330) in view of Tuppo L, et al. (2019) Isolation of cypress gibberellin-regulated protein: Analysis of its structural features and IgE binding competition with homologous allergens. Mol Immunol. 2019 Oct;114:189-195 (herein Tuppo).
As discussed for the non-statutory double patenting rejections of claims 15, 16, 18, 25, 26, and 29-44, the cited claims of ‘330 are not patentably distinct from the those previously cited from the current application. The cited set of claims are silent in regard to the nature of the Type 1 allergy identified by the method referenced in instant claim 25 or reference claim 26. Tuppo teaches that these limitations would be inherent to the protein, corresponding to SEQ ID NO: 53 (Current application) or SEQ ID NO:4 (‘330), encoded by the expression vector referenced in the independent claims from both the current application (claim 25) and ‘330 () .
Tuppo teaches that Cupressaceae pollen, more specifically a GRP isolated from the pollen and later referred to as Cup s 7, shares common IgE epitopes with allergenic GRPs found in several fruits, such as peach and pomegranate (Discussion, Results: Direct IgE binding, and Results: IgE inhibition experiments). These teachings help discern the link between pollen and fruit as they relate to PFAS. Essentially, the shared IgE reactivity/epitopes of the homologous allergenic GRP proteins found in certain fruit and pollen makes for natural immunologic cross-reactivity between GRPs from different sources (i.e. fruit, nuts, and pollen). The shared limitations established in instant claims 46-48 (Type 1 allergy caused by Cupressaceae pollen and associated with pollen food-associated syndrome) are inherent to the allergen described in instant claim 15 (SEQ ID NO:53) and claims 1 and 18 of ‘330.
Allowable Subject Matter
Claims 44 and 45 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.
Conclusion
No claims allowed.
THIS ACTION IS MADE FINAL. 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 MATTHEW CURRAN METCALF whose telephone number is (571)272-5520. The examiner can normally be reached 7:30AM-5:00PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Hama, can be reached at (571)272-2911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW CURRAN METCALF/Examiner, Art Unit 1647 /JOANNE HAMA/Supervisory Patent Examiner, Art Unit 1647
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