DETAILED ACTION
Applicant’s amendment and response received on 11/21/05 has been entered. Claims 9-10, 16-23, 27-31, 34-67, 69-70, 73-78 are now canceled, and new claims 84-86 have been added.
Claims 1-8, 11-15, 24-26, 32-33, 68, 71-72, 74, and 79-86 are currently pending in this application. Applicant’s election without traverse of Group I, and the following species: an Fc domain as the species of serum half-life enhancer, a mammalian sialidase as the species of sialidase, and a single sialidase mutation which is a substitution of a proline residue at a position corresponding to position 62 of wild-type human Neu2 (P62), is acknowledged.
Claims 11-12, 14-15, and 74, previously withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention or species, there being no allowable generic or linking claim, is withdrawn in view of applicant’s amendments to the claims. Claims 11-12, 14-15, and 74 are hereby rejoined.
Claims 1-8, 11-15, 24-26, 32-33, 68, 71-72, 74, and 79-86 are therefore currently under examination based on the elected species of a serum half-life enhancer which is an Fc.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . An action on the merits follows.
Claim Rejections - 35 USC § 102
The rejection of previously pending claims 1-8, 13, 16-18, and 20 under 35 U.S.C. 102(a)(2) as being anticipated by U.S. Patent Application Publication 2025/0049846 (2025), hereafter referred to as Alkhateeb et al., with an effective filing date of 1/3/19, is withdrawn in view of applicant's invocation of the exception under 35 USC 102(b)(2)(C) which states that the instant application and that of Alkhateeb et al. have a common assignee and were jointly owned by Palleon Pharmaceuticals Inc. no later than the effective filing date of the claimed invention.
Claim Rejections - 35 USC § 103
The rejection of previously pending claims 1-8, 13, 16-18, 20, 24-26, 32-33, 68, 71-72, and 79-83 are rejected under 35 U.S.C. 103 as being obvious over U.S. Patent Application Publication 2025/0049846 (2025), hereafter referred to as Alkhateeb et al., with an effective filing date of 1/3/19, in view of US Patent Application Publication 2020/00339968 (2020), hereafter referred to as Peng et al., with an effective filing date of 1/3/18, Petrick et al. (1994) Clin. Exp. Metastasis, Vol. 12, 108-116, and Johansson et al. (2003) J. Biochem., Vol. 134, 345-352, is withdrawn in view of applicant's invocation of the exception under 35 USC 102(b)(2)(C) for each of Alkhateeb et l. and Peng et al. separately, which states that the instant application and that of Alkhateeb et al. OR Peng et al. have a common assignee and were jointly owned by Palleon Pharmaceuticals Inc. no later than the effective filing date of the claimed invention.
Applicant’s amendments to the claims has necessitated the following new grounds 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 14-15 are newly 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.
Claim 14 depends on claim 1 and reacts that the sialidase comprises a combination of substitutions selected from a specific group of substitutions. However, the claim has been amended such that the groups of substitutions no longer comprise a P62G substitution as required by amended claim 1. Claim 15 depends on claim 14 and thus is included in this rejection. As such, claim 14 conflicts with claim 1 such that the metes and bounds of the claim cannot be determined. It is suggested that claim 14 be amended to recite where the sialidase of claim 1 “further” comprises a combination of substitutions selected from the group consisting of etc.
Double Patenting
The provisional rejection of previously pending claims 1-8, 13, 16-18, 20, 24-26, 32-33, 68, 71-72, and 79-83 on the ground of no statutory double patenting as being unpatentable over 1) claims 1-4, 8, 12-14, 16, 21, 25, 27, 29-33, 44-45, 47, 55-57, 59, 61, and 63-67 of cop ending Application No.17/624,118, hereafter referred to as the ‘118 application, OR 2) claims 1-3, 5-14, 18, 21-22, 24-29, 38-39, 46-50, and 55 of copending Application 17/624,121, hereafter referred to as the ‘121 application, OR 3) claims 1-4, 7, 11, 15-20, 24, 27-28, 30, 32-36, 45-46, and 53-57 of copending Application 18/003,234, hereafter referred to as the ‘234 application, is withdrawn or maintained as follows:
1) the rejection over the ‘121 application is withdrawn in view of applicant’s submission of a terminal disclaimer filed on 7/15/26 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of application 17/624,121 has been reviewed, is accepted, and has been recorded;
2) the rejection over the ‘118 application is maintained over currently pending claims 1-8, 13, 24-26, 32-33, 68, 71-72, and 79-86. Applicant’s amendments and arguments have been fully considered but have not been found persuasive in overcoming the rejection for reasons discussed in detail below;
3) the rejection over the ‘234 application is maintained over currently pending claims 1-8, 13, 24-26, 32-33, 68, 71-72, and 79-86. Applicant’s amendments and arguments have been fully considered but have not been found persuasive in overcoming the rejection for reasons discussed in detail below.
In regards to the ‘118 application, the applicant argues that the claims in the ‘118 application have been amended and no longer recite that the sialidase is a human Neu2 sialidase with a P62G substitution and no longer comprise a sequence with this substitution such hat the claims of the ‘118 application are patentably distinct from the instant claims. In response, while the claims in the ‘118 application has been amended to delete the previous specific recitations to a P62G substitution in human Neu2, the currently pending claims in the ‘118 application continue to encompass this species. See for examples claims 12-14 of the ‘118 application. Claim 12 recites that the sialidase is a mutant human Neu2 sialidase comprising a number of substitutions. Thus, even though the ‘118 application claim 14 has deleted that the substitution is P62G, this embodiment, continues to be encompassed by the claims. As such, the ’118 patent claims, while broader in their current form than the instant claims, continue to render obvious species in which a P62G substitution is present.
In regards to the ‘234 application, the applicant argues that as the ‘234 application has a later filing date that non-statutory obviousness type double patenting (obvious-type double patenting) should not have been applied, referring to a PTAB decision from 2024. In response, examination of this application follows the current Manual of Patent Examining Procedure (MPEP) which was revised in November 2024 [R-01.2024]. The following section is reproduced from MPEP 804(I)(B)(1)(b) is dispositive:
(b) Provisional nonstatutory double patenting rejection is the only rejection remaining in a utility or plant application
Subsections (i)-(iv) below discuss examination procedures when two or more utility or plant patent applications, filed on or after June 8, 1995, contain provisional nonstatutory double patenting rejections over each of the other application(s). The explanations refer to pairs of applications, but also apply when more than two applications are involved.
(i) Application under examination has the earlier patent term filing date
If a provisional nonstatutory double patenting rejection is the only rejection remaining in an application having the earlier patent term filing date, the examiner should withdraw the rejection in the application having the earlier patent term filing date and permit that application to issue as a patent, thereby converting the provisional nonstatutory double patenting rejection in the other application into a nonstatutory double patenting rejection upon issuance of the patent.
(ii) Application under examination has the same patent term filing date
If both the application under examination and the reference application have the same patent term filing date, the provisional nonstatutory double patenting rejection made in each application should be maintained until it is overcome. Provisional nonstatutory double patenting rejections are subject to the requirements of 37 CFR 1.111(b). Thus, applicant can overcome a provisional nonstatutory double patenting rejection by filing a reply that either shows that the claims subject to the rejection are patentably distinct from the claims of the reference application, or includes a compliant terminal disclaimer under 37 CFR 1.321 that obviates the rejection. If the reply is sufficient, the examiner will withdraw the nonstatutory double patenting rejection in the application in which it was submitted.
(iii) Application under examination has the later patent term filing date
If a provisional nonstatutory double patenting rejection is the only rejection remaining in an application, and that application has the later patent term filing date, the rejection should be maintained until applicant overcomes the rejection. Replies to overcome the rejection are discussed in subsection (ii) above.
From the above, it is clear that the MPEP sanctions provisional nonstatutory double patenting rejection between the claims of an application under examination and a later filed pending application. As set forth in MPEP 804, “[a] double patenting issue may arise between two or more pending applications, or between one or more pending applications and a patent”. There is no discrimination between whether copending application has an earlier or a later filing date. MPEP 804(I)(B)(1)(b)(iii), cited above, “if a provisional nonstatutory double patenting rejection is the only rejection remaining in an application, and that application has the later patent term filing date, the rejection should be maintained until applicant overcomes the rejection”. Currently, the rejection over the copending ‘243 patent is not the only rejection remaining in the application, as the instant claims remain rejected over a number of other copending applications. As such, applicant’s arguments are not found persuasive and the provisional rejection stands.
The provisional rejection of previously pending claims 1, 3-8, 13, 16-18, 20, 24-26, 32-33, 68, and 71-72 on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5, 9, 11, 15, 17, 19, 21-23, 25-26, 35-37, 48-52, 60, 65-66, and 68 of copending Application No.18,260,383, hereafter referred to as the ‘383 application, is maintained over currently pending claims 1-8, 13, 24-26, 32-33, 68, 71-72, and 79-86.
The applicant argues that as the ‘383 application has a later filing date that non-statutory obviousness type double patenting (obvious-type double patenting) should not have been applied, referring to a PTAB decision from 2024. In response, examination of this application follows the current Manual of Patent Examining Procedure (MPEP) which was revised in November 2024 [R-01.2024]. The following section is reproduced from MPEP 804(I)(B)(1)(b) is dispositive:
(b) Provisional nonstatutory double patenting rejection is the only rejection remaining in a utility or plant application
Subsections (i)-(iv) below discuss examination procedures when two or more utility or plant patent applications, filed on or after June 8, 1995, contain provisional nonstatutory double patenting rejections over each of the other application(s). The explanations refer to pairs of applications, but also apply when more than two applications are involved.
(i) Application under examination has the earlier patent term filing date
If a provisional nonstatutory double patenting rejection is the only rejection remaining in an application having the earlier patent term filing date, the examiner should withdraw the rejection in the application having the earlier patent term filing date and permit that application to issue as a patent, thereby converting the provisional nonstatutory double patenting rejection in the other application into a nonstatutory double patenting rejection upon issuance of the patent.
(ii) Application under examination has the same patent term filing date
If both the application under examination and the reference application have the same patent term filing date, the provisional nonstatutory double patenting rejection made in each application should be maintained until it is overcome. Provisional nonstatutory double patenting rejections are subject to the requirements of 37 CFR 1.111(b). Thus, applicant can overcome a provisional nonstatutory double patenting rejection by filing a reply that either shows that the claims subject to the rejection are patentably distinct from the claims of the reference application, or includes a compliant terminal disclaimer under 37 CFR 1.321 that obviates the rejection. If the reply is sufficient, the examiner will withdraw the nonstatutory double patenting rejection in the application in which it was submitted.
(iii) Application under examination has the later patent term filing date
If a provisional nonstatutory double patenting rejection is the only rejection remaining in an application, and that application has the later patent term filing date, the rejection should be maintained until applicant overcomes the rejection. Replies to overcome the rejection are discussed in subsection (ii) above.
From the above, it is clear that the MPEP sanctions provisional nonstatutory double patenting rejection between the claims of an application under examination and a later filed pending application. As set forth in MPEP 804, “[a] double patenting issue may arise between two or more pending applications, or between one or more pending applications and a patent”. There is no discrimination between whether copending application has an earlier or a later filing date. MPEP 804(I)(B)(1)(b)(iii), cited above, “if a provisional nonstatutory double patenting rejection is the only rejection remaining in an application, and that application has the later patent term filing date, the rejection should be maintained until applicant overcomes the rejection”. Currently, the rejection over the copending ‘383 patent is not the only rejection remaining in the application, as the instant claims remain rejected over a number of other copending applications. As such, applicant’s arguments are not found persuasive and the provisional rejection stands.
The provisional rejection of previously pending claims 1, 3-8, 13, 16-18, 20, 24-26, 32-33, 68, and 71-72 on the ground of nonstatutory double patenting as being unpatentable over 1) claims 1-4, 8, 12-14, 16, 21, 25, 27, 29-33, 35, 44-46, and 60-64 of copending Application No.17/624,116, hereafter referred to as the ‘116 application, OR 2) claims 1-6, 10-13, 15-18, 21, 25, 27, 29, 31, 33-34, 43-45, and 54-58 of copending Application No. 18/260,364, hereafter referred to as the ‘364 application, OR 3) claims 1, 3-6, 9, 13, 15, 17, 19-21, 23-24, 33-35, and 44-48 of copending Application No. 18/260,378, hereafter referred to as the ‘378 application, is withdrawn or maintained as follows:
1) the rejection over the ‘116 application claims is withdrawn in view of the abandonment of this application;
2) the rejection over the ‘364 application claims is maintained over currently pending claims 1-8, 13, 24-26, 32-33, 68, 71-72, and 79-86, applicant’s amendments and arguments have been fully considered but have not been found persuasive in overcoming the rejection for reasons discussed in detail below;
3) the rejection over the ‘378 application claims is maintained over currently pending claims 1-8, 13, 24-26, 32-33, 68, 71-72, and 79-86, applicant’s amendments and arguments have been fully considered but have not been found persuasive in overcoming the rejection for reasons discussed in detail below.
In regards to the rejection over the ‘364 application claims and the rejection over the ‘378 application claims, the applicant argues that each of these applications has a later filing date that non-statutory obviousness type double patenting (obvious-type double patenting) should not have been applied, referring to a PTAB decision from 2024. In response, examination of this application follows the current Manual of Patent Examining Procedure (MPEP) which was revised in November 2024 [R-01.2024]. The following section is reproduced from MPEP 804(I)(B)(1)(b) is dispositive:
(b) Provisional nonstatutory double patenting rejection is the only rejection remaining in a utility or plant application
Subsections (i)-(iv) below discuss examination procedures when two or more utility or plant patent applications, filed on or after June 8, 1995, contain provisional nonstatutory double patenting rejections over each of the other application(s). The explanations refer to pairs of applications, but also apply when more than two applications are involved.
(i) Application under examination has the earlier patent term filing date
If a provisional nonstatutory double patenting rejection is the only rejection remaining in an application having the earlier patent term filing date, the examiner should withdraw the rejection in the application having the earlier patent term filing date and permit that application to issue as a patent, thereby converting the provisional nonstatutory double patenting rejection in the other application into a nonstatutory double patenting rejection upon issuance of the patent.
(ii) Application under examination has the same patent term filing date
If both the application under examination and the reference application have the same patent term filing date, the provisional nonstatutory double patenting rejection made in each application should be maintained until it is overcome. Provisional nonstatutory double patenting rejections are subject to the requirements of 37 CFR 1.111(b). Thus, applicant can overcome a provisional nonstatutory double patenting rejection by filing a reply that either shows that the claims subject to the rejection are patentably distinct from the claims of the reference application, or includes a compliant terminal disclaimer under 37 CFR 1.321 that obviates the rejection. If the reply is sufficient, the examiner will withdraw the nonstatutory double patenting rejection in the application in which it was submitted.
(iii) Application under examination has the later patent term filing date
If a provisional nonstatutory double patenting rejection is the only rejection remaining in an application, and that application has the later patent term filing date, the rejection should be maintained until applicant overcomes the rejection. Replies to overcome the rejection are discussed in subsection (ii) above.
From the above, it is clear that the MPEP sanctions provisional nonstatutory double patenting rejection between the claims of an application under examination and a later filed pending application. As set forth in MPEP 804, “[a] double patenting issue may arise between two or more pending applications, or between one or more pending applications and a patent”. There is no discrimination between whether copending application has an earlier or a later filing date. MPEP 804(I)(B)(1)(b)(iii), cited above, “if a provisional nonstatutory double patenting rejection is the only rejection remaining in an application, and that application has the later patent term filing date, the rejection should be maintained until applicant overcomes the rejection”. Currently, the rejection over the copending ‘364 application OR over the ‘378 application is not the only rejection remaining in the application, as the instant claims remain rejected over a number of other copending applications. As such, applicant’s arguments are not found persuasive and the provisional rejections stand.
It is noted that nonstatutory double patenting has not been raised at this time in regards to U.S. Patent 11,965,188, hereafter referred to as the ‘188 patent, or to U.S. Patent 12,686,858, hereafter referred to as the ‘858 patent. The claims of the ‘188 patent and the claims of the ‘858 patent, while reciting similar products and methods comprising a fusion protein comprising a sialidase with a substitution and an Fc domain, recite that the substitution is the substitution residues other than substitution of a proline at position 62, or more specifically, a P62G substitution. It is also noted that the specifications of these earlier filed patents do not disclose this particular substitution.
No claims are 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 from the examiner should be directed to Anne Marie S. Wehbé, Ph.D., whose telephone number is (571) 272-0737. If the examiner is not available, the examiner’s supervisor, Maria Leavitt, can be reached at (571) 272-1085. For all official communications, the technology center fax number is (571) 273-8300. Please note that all official communications and responses sent by fax must be directed to the technology center fax number. For informal, non-official communications only, the examiner’s direct fax number is (571) 273-0737. For any inquiry of a general nature, please call (571) 272-0547.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Dr. A.M.S. Wehbé
/ANNE MARIE S WEHBE/Primary Examiner, Art Unit 1634
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