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 .
Detailed Action
This application is a national stage application of PCT/CN2022/143387, filed December 29, 2022. Claims 1-15 are pending in this application and examined on the merits herein. Applicant’s preliminary amendment submitted June 13, 2024 is acknowledged wherein claims 3-9, 11, and 13-15 are amended.
Drawings
The drawings are objected to because all of figures 1-27 are of sufficiently low resolution that the text appearing in the figures is not legible. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities: The chemical formulae at the top of p. 3 are of low resolution and are illegible. The chemical structures given in example 3 on p. 109 and step 4 on p. 117 are similarly illegible.
Appropriate correction is required.
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 1-16 are 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 1 includes a limitation defining n as an integer from 1 to 20. However this limitation is immediately followed by the additional proviso “preferably an integer from …” as well as “e.g.” These optional narrower limitations create confusion as to whether the narrower limitations appearing after the initial statement of the limitation are required or merely exemplary, rendering the claim indefinite.
Additionally the structures D-1-1 to D-1-8 pictured in claim 1 are at such a low resolution that the identity of the R-groups in these structures cannot be determined, rendering the structures indefinite.
Claim 1 further describes the variable L1 as “includes but not limited to,” three structures, creating confusion as to the full scope of L1.
Claim 1 further defines the variables s and t as integers from 1 to 20, “such as” a listing of specific integers, rendering the true scope of these variables unclear.
Claim 6 similarly defines the ratio of n to m as “from 1 to 20, preferably from …, such as …”
Claim 9 defines E as “recognizable for viral surface antigens,” but then follows this proviso with “such as” a number of specific antigens, rendering this claim indefinite.
Claim 15 defines the viral infection as caused by an influenza or parainfluenza virus. However, the claim then recites several additional provisos headed by the word “preferably,” and defining narrower scopes of viruses or subjects. Claim 16 similarly defines a broad method of preventing a secondary infection, and then recites a number of narrower provisos containing the word “preferably.”
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 11 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 11 depends from claim 1, but claims a structure I-1 which differs from I-1 in that is does not contain a variable (e) and further includes a variable L3 which is not a subset of L2 recited in claim 1. Therefore claim 11 does not include all of the limitations of claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(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.
Claim 1-4 and 6-16 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Balkovec et al. (US pre-grant publication 2022/0257787, cited in PTO-892)
Independent claim 1 is directed to a conjugate I-1 comprising a Fc fragment E attached to two copies of a Drug compound D1 and D2 by a linker comprising sections L1 and L2. Balkovec et al. discloses a conjugate containing two groups E and two groups A1 and A2 connected by a linker L. (p. 1 paragraph 7) A1 and A2 include for example, embodiments A-I and A-II equivalent to structures D-1-1 and D-1-2 in present claim 1. Each E is an Fc domain monomer having a formula which is Seq ID No: 1-68. (p. 18 paragraph 12) These sequences, recited on pp. 535-588, are the same as Seq ID NO: 1-68 in the present application. In a separate embodiment Balkovec et al. discloses a conjugate of formula (3) having only 1 E variable group, which is equivalent to formula I-1 in present claim 1 wherein m is 1. (pp. 22-30) Embodiments of L are described including ones on pp. 199-202 which include embodiments of L1 and L2 as recited in present claim 1, for example the last structure on p. 199 which contains
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236
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for L1. Regarding the presence of a triazole in structure L2 in present claim 1, Balkovec et al. describes conjugates wherein the linker is attached to an alkyne, (e.g. table 1 on pp. 63-110) which is described as reacting with an azide in the Fc component in order to produce a triazole-containing linker. (See e.g. fig. 43 conjugate 6, which is the same as for example linker L2-1 in claims 1 wherein t is 3, s is 4, and y is 0, or fig. 61 conjugate 33 wherein t is 4, s is 4, and y is 0) For these reasons Balkovec et al., particularly figures 43 and 61, anticipate present claim 1.
Dependent claims 2-4, 6, and 8 claim narrower structures which still encompass the aforementioned conjugates described by Balkovec et al. Regarding claim 7, pp. 248-252 paragraphs 429-471 describe the claimed DAR ratios. Regarding claim 9, p. 239 paragraph 324 of Balkovec describes these particular viral surface antigens.
Regarding present claims 11 and 12, the aforementioned alkyne intermediates in table 1 of Balkovec would anticipate the intermediates recited in these claims. See e.g. int-9 on p. 66 of Balkovec and structure C-inter-28 in present claim 12.
Regarding present claim 13, p. 351 paragraph 714 of Balkovec describes pharmaceutical compositions containing these conjugates. Regarding claims 14-15, p. 351 paragraphs 708-713 of Balkovec describe methods of treating or preventing viral infections including influenza or parainfluenza. Regarding present claim 16, p. 267 paragraph 599 of Balkovec describes secondary bacterial infections as one consequence of influenza.
For these reasons Balkovec et al. anticipates the present claims.
Claim Rejections - 35 USC § 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.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Balkovec et al. (US pre-grant publication 2022/0257787, cited in PTO-892)
The disclosure of Balkovec et al. is discussed above. Balkovec et al. does not disclose any of the specific structures recited in present claim 5. In particular formula C-28 differs from figures 43 and 61 of Balkovec in that the group corresponding to “Y” is a 2-oxyacetamido linkage rather than a carbamoyl linkage as described in the specific embodiments of Balkovec. However, Balkovec et al. additionally describes that the disclosed conjugates can be prepared having the 2-oxyacetamido linkage at this position as well. (see e.g. p. 155 paragraph 112) It would therefore have been obvious to one of ordinary skill in the art at the time of the invention to modify the specific preferred lead structures recited in the figures of Balkovec so as to arrive at conjugates having these alternate linkages at position Y. Doing so would have been obvious because one of ordinary skill in the art would have seen the broad disclosure of Balkovec as suggesting any of these linkages.
Therefore the invention taken as a whole is prima facie obvious.
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 1-10 and 13-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9-14, and 19-22 of copending Application No. 19/497259 (reference application, unpublished, cited in PTO-892, herein referred to as ‘259). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘259 anticipate the present claims.
Specifically, claim 1 of ‘259 claims a conjugate of two of the claimed antiviral moieties with a Fc domain as recited in the present claims. Furthermore dependent claim 9 of ‘259 claims one of a number of specific embodiments of these conjugates that would anticipate the specific structures in present claims 1-5 and 10. Regarding present claims 5-9 and 13-16, claims 10-13, 19-20, and 22 of ‘259 recite the same limitations as these claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed in this action.
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/ANDREA OLSON/ Primary Examiner, Art Unit 1693 8/4/2026
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