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 .
Claim Status
Claims 1-2, 4-6, 8, 10-11, 13, 18, 20-23, 26-31 are currently pending.
Election/Restrictions
Applicant's election with traverse of Group II and the species of fusion protein having the amino acid sequence of SEQ ID NO:15 in the reply filed on 17 June 2026 is acknowledged. The traversal is on the ground(s) that Farzan et al. does not disclose or suggest the particular variant ACE2 domains defined relative to a specific full-length wildtype ACE2 (SEQ ID NO:1) nor the specific fusion proteins have the amino acid sequences of SEQ ID NO:7, 9, 11, 13, 15-19 or 21. This is not found persuasive because claim 1 does not require that the variant ACE2 domains be defined relative to a specific full-length wildtype ACE2 (SEQ ID NO:1). Rather, claim 1 administers a fusion protein that comprises a variant ACE2 domain, wherein the variant ACE2 domain comprises deletions relative to a full-length wildtype ACE2 having a SEQ ID NO:1. Therefore, the only comparison to the wildtype ACE2 is made in relation to the deletions and not to the specific amino acid sequence. The specific amino acid sequences in claim 2 are not a unifying feature as they are not recited in claim 1 or claim 26. Therefore, Applicant’s arguments are not persuasive.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-2, 4-6, 8, 10-11, 13, 18 and 20-23 (and fusion protein species of SEQ ID NO:7, 9, 11, 13, 16-19 and 21) are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention and/or species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 17 June 2026.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
The information disclosure statement (IDS) submitted on 28 March 2023 has been considered by the examiner. It is noted that a copy of the WO2018140456A1 document has not been submitted, therefore, the citation has been lined through.
Drawings
The drawings are objected to because do not comply with 37 CFR 1.84(a)(1) and (l) which requires the use of black ink and that all drawings be made by a process which will give them satisfactory reproduction characteristics; every line number, and letter must be durable, clean, black, sufficiently dense and dark and uniformly thick and well-defined. See screenshot example below:
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Figures 15-17 do not comply with 37 CFR 1.84(u)(1) which requires the use of capital letters when referring to partial views intended to form one complete view (Figure requires a number followed by a capital letter). Once the Figures are correctly labeled, the Brief Description of the Drawings should also be amended to reflect the corrections made to the Figures.
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.
Nucleotide and/or Amino Acid Sequence Disclosures
MPEP 2412.06 states that pursuant to 37 CFR 1.83(a), sequences that are included in the “Sequence Listing XML” should not be duplicated in the drawings. However, in certain instances, a significant sequence characteristic may not be readily conveyed by the sequence-associated data of the "Sequence Listing XML" and may need to be depicted in a figure. For example, in view of the fact that the representation of double stranded nucleic acids is not permitted in the "Sequence Listing XML," many significant nucleic acid features, such as "sticky ends" and the like, may only be shown effectively by reference to a drawing figure.
Figure 1B is the sequence of the SI-F019 fusion protein. Neither the Figure nor the Brief Description of the Drawings includes the Sequence identifier for this sequence (the sequence identifier is required). However, as the sequence is one that should be included in the Sequence Listing, it is not proper for this sequence to be duplicated in the drawings. The various elements in FIG.1B could be expressed in the disclosure, such as the location of glycosylation sites, the location of the N-terminal signal sequence, the hinge and the location and identification of the null mutations (all listed in the annotations).
Specification
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
The abstract of the disclosure is objected to because it refers to speculative applications such as methods of prevention. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because of the following informalities: the specification at page 15 (under “Example 4”, line 4) appears to disclose an amino acid sequence with no Sequence identifier (YVADAPK). If this is indeed an amino acid sequence, it must be included in the Sequence listing and be referenced by the Sequence identifier. If this is not an amino acid sequence, explanation of what this recitation is will be required.
Appropriate correction is required.
The use of the term GraphPad Prism (see page 17 under Example 7), which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
The use of the term ACROBiosystems (see page 22, second paragraph), which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
The use of the term Sino Biological (see page 22, second paragraph), which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 26-31 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The instant claims are directed to a liquid composition comprising a fusion protein, wherein the fusion protein comprises a variant angiotensin converting enzyme 2 (ACE2) domain covalently fused to a Fc domain, wherein the variant ACE2 domain comprises a N-terminal deletion, a C-terminal deletion, or both, relative to a full-length wild-type ACE2 having a SEQ ID NO:1, wherein the variant ACE2 domain has ACE2 activity. Claim 29 recites that the ACE2 domain comprises an amino acid sequence having at least 98% sequence identity to SEQ ID NO:3; claim 30 recites that the Fc domain comprises an amino acid sequence having at least 98% sequence identity to SEQ ID NO:6; claim 31 recites that the fusion protein comprises an amino acid sequence having at least 98% sequence identity to SEQ ID NO: 7, 9, 11, 13, 15-19 or 21.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. V. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. V. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116.
In analyzing whether the written description requirement is met for genus claims, it is first determined whether a representative number of species have been described by their complete structure. In the instant case, the specification merely gives working examples of six fusion protein combinations comprising two ACE2 variants (with various truncated sequence length identical to SEQ ID NO's: 1 & 3), and the Fc domain comprising IgG1 null, IgG4, IgGA1, IgGA2 according to SEQ ID NO's: 7, 9, 11, 13, 25, 15-19, 21 as disclosed on page 20, Sequence Listing, and are the only species whose complete structure is disclosed. Only the fusion protein SI-F019 (according to SEQ ID NO: 15) was tested for binding affinity to spikes, Fc receptors, and C1q, as shown in Tables 2 and 3, and only to SARS-CoV-2 and human FcyRs, C1q, and FcRn. While the genus encompasses a large number of variants that have ACE2 activity, the specification does not describe the complete structure of a representative number of species of the large genus of ACE2 variants or provide guidance on what variations could/should be made to the ACE2 domain and still retain ACE2 activity as required by the claims.
Next, then, it is determined whether a representative number of species have been sufficiently described by other relevant identifying characteristics (i.e., other than nucleotide sequence or amino acid sequence), specific features and functional attributes that would distinguish different members of the claimed genus. In the instant case, the only other identifying characteristic of a 'variant' of ACE2, is that the ACE2 domain has ACE2 activity.
Applicant's attention is directed to the Guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112(a) or Pre-AIA 35 U.S.C. 112, first paragraph, "Written Description" Requirement (MPEP2163).
In conclusion, Applicant's disclosure of the species of fusion proteins comprising an ACE 2 variant domain covalently fused to a Fc domain of the claimed broad genus is not sufficient to reasonably convey to one skilled in the art that Applicant was in possession of the claimed broad genus at the time the application was filed. Thus, it is concluded that the written description requirement is not satisfied for the claimed genus.
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.
Claim 27 is 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 27 recites “having the fusion protein content from about 100 mg to about 10,000 mg per dose”. However, the metes and bounds of claim 27 are unclear because the recitation of a “dose” implies a specific amount of a therapeutic drug or a measured quantity of a therapeutic agent to be taken at one time. A “dose” will vary based on what condition is to be treated and therefore, the metes and bounds of “per dose” are unclear. The liquid composition could have as much or as little protein in it as can be made. A dose would seem to be an aliquot of liquid composition which is removed or contained in a container with the intent of administering said dose to a subject for a given purpose, therefore, the current limitation does not make sense in the context of the liquid composition of claim 26 as currently drafted.
The term “about” in claim 27 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore, one of ordinary skill would not be apprised of the range of “about 100 mg to about 10,000 mg”.
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)(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.
(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(s) 26, and 29-31 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2018/140456 A1 (Batlle et al.).
Batlle et al. teach a fusion protein comprising a variant angiotensin converting enzyme 2 (ACE2) domain covalently fused to a Fc domain, wherein the variant ACE2 domain comprises a N-terminal deletion, a C- terminal deletion, or both, relative to a full-length wildtype ACE2 having a SEQ ID NO: 1 that has 100% sequence identity to instant SEQ ID NO's: 1 & 3, wherein the variant ACE2 domain has ACE2 activity (see [0066] [0067], [0072], [0074]) and compositions thereof (see [0080]). Batlle et al. teach an Fc portion (SEQ ID NO:6) which has 98.4% amino acid sequence identity to SEQ ID NO:6 of the instant application (see alignment below).
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While [0080] does not explicitly recite a liquid composition, [0083] indicates that the pharmaceutical composition is administered intravenously, subcutaneously or pulmonarily which indicates that the composition would be in a liquid form. Therefore, Batlle et al. anticipate the instant claims.
Claim(s) 26, 29-31 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by WO 2021/183404 A1 (Wycoff et al.).
Wycoff et al. teach an ACE2-Fc fusion protein of SEQ ID NO:5 (see Figure 2B). This protein has at least 98% amino acid sequence identity to the instant fusion protein of SEQ ID NO:15 (elected species) (see alignment below).
Query Match 98.9%; Score 4454.5; Length 828;
Best Local Similarity 99.3%;
Matches 823; Conservative 1; Mismatches 4; Indels 1; Gaps 1;
Qy 2 STIEEQAKTFLDKFNHEAEDLFYQSSLASWNYNTNITEENVQNMNNAGDKWSAFLKEQST 61
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Db 1 STIEEQAKTFLDKFNSEAEDLFYQSSLASWNYNTNITEENVQNMNNAGDKWSAFLKEQST 60
Qy 62 LAQMYPLQEIQNLTVKLQLQALQQNGSSVLSEDKSKRLNTILNTMSTIYSTGKVCNPDNP 121
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Db 61 LAQMYPLQEIQNLTVKLQLQALQQNGSSVLSEDKSKRLNTILNTMSTIYSTGKVCNPDNP 120
Qy 122 QECLLLEPGLNEIMANSLDYNERLWAWESWRSEVGKQLRPLYEEYVVLKNEMARANHYED 181
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Db 121 QECLLLEPGLNEIMANSLDYNERLWAWESWRSEVGKQLRPLYEEYVVLKNEMARANHYED 180
Qy 182 YGDYWRGDYEVNGVDGYDYSRGQLIEDVEHTFEEIKPLYEHLHAYVRAKLMNAYPSYISP 241
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Db 181 YGDYWRGDYEVNGVDGYDYSRGQLIEDVEHTFEEIKPLYEHLHAYVRAKLMNAYPSYISP 240
Qy 242 IGCLPAHLLGDMWGRFWTNLYSLTVPFGQKPNIDVTDAMVDQAWDAQRIFKEAEKFFVSV 301
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Db 241 IGCLPAHLLGDMWGRFWTNLYSLTVPFGQKPNIDVTDAMVDQAWDAQRIFKEAEKFFVSV 300
Qy 302 GLPNMTQGFWENSMLTDPGNVQKAVCHPTAWDLGKGDFRILMCTKVTMDDFLTAHHEMGH 361
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Db 301 GLPNMTQGFWENSMLTDPGNVQKAVCHPTAWDLGKGDFRILMCTKVTMDDFLTAHHEMGH 360
Qy 362 IQYDMAYAAQPFLLRNGANEGFHEAVGEIMSLSAATPKHLKSIGLLSPDFQEDNETEINF 421
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Db 361 IQYDMAYAAQPFLLRNGANEGFHEAVGEIMSLSAATPKHLKSIGLLSPDFQEDNETEINF 420
Qy 422 LLKQALTIVGTLPFTYMLEKWRWMVFKGEIPKDQWMKKWWEMKREIVGVVEPVPHDETYC 481
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Db 421 LLKQALTIVGTLPFTYMLEKWRWMVFKGEIPKDQWMKKWWEMKREIVGVVEPVPHDETYC 480
Qy 482 DPASLFHVSNDYSFIRYYTRTLYQFQFQEALCQAAKHEGPLHKCDISNSTEAGQKLFNML 541
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Db 481 DPASLFHVSNDYSFIRYYTRTLYQFQFQEALCQAAKHEGPLHKCDISNSTEAGQKLFNML 540
Qy 542 RLGKSEPWTLALENVVGAKNMNVRPLLNYFEPLFTWLKDQNKNSFVGWSTDWSPYADEPK 601
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Db 541 RLGKSEPWTLALENVVGAKNMNVRPLLNYFEPLFTWLKDQNKNSFVGWSTDWSPYA-EPK 599
Qy 602 SSDKTHTCPPCPAPEAAGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWY 661
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Db 600 SADKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWY 659
Qy 662 VDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCAVSNKALPAPIEKTISK 721
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Db 660 VDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISK 719
Qy 722 AKGQPREPQVYTLPPSRDELTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVL 781
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Db 720 AKGQPREPQVYTLPPSRDELTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVL 779
Qy 782 DSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK 830
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Db 780 DSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK 828
Wycoff et al. teach pharmaceutical compositions comprising the ACE2-Fc fusion protein (see [0309] and claim 53) as well as the ACE2-Fc fusion in a buffer solution (0.6-25 mg/ml; meeting the 0.5%-1% by weight limitation of instant claim 28). Therefore, Wycoff et al. anticipates the instant 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(s) 26-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over either WO 2018/140456 A1 (Batlle et al.) or WO 2021/183404 A1 (Wycoff et al.) in view of Haschke et al. (Clin. Pharmacokinet.52: 783-792, 2013).
The disclosures of Batlle et al. and Wycoff et al. are provided above. Neither disclosure teaches a liquid composition of fusion protein comprising an ACE2 domain and an Fc domain wherein the liquid composition has a fusion protein content of from about 100 mg to about 10,000 mg per dose.
Haschke et al. teach the administration of ACE2 in healthy subjects. Haschke et al. administered recombinant ACE2 intravenously to human subjects at doses of 100-1200 µg/kg. Such doses were found to be safe and well tolerated. Haschke et al. also disclose that recombinant ACE2 has been administered to non-human primates, rodents and piglets at doses of up to 40 mg/kg without any tolerability issues.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to include a fusion protein content of about 100 mg or more in the compositions of Batlle et al. and/or Wycoff et al. because such amounts would be consistent with amounts which are safe and tolerated for administration. It additionally would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a fusion protein content of any amount, including up to about 10,000 mg per dose in order to create a concentrated liquid composition for use experimentally or as a depot from which diluted formulations could be prepared. One of ordinary skill in the art would have been motivated to include any amount in the liquid composition because the composition could be used for a number of different purposes which would require different amounts depending on the particular use (therapeutic, diagnostic, in vitro experimentation, etc.). Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
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 26-31 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 5, 8, 9-10, 17 and 28 of copending Application No. 17/772,646 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of both the instant application and ‘646 are directed to compositions comprising identical ACE2-Fc fusion proteins. The instant claims recite a liquid composition while the claims of ‘646 recite a pharmaceutical composition and a pharmaceutically acceptable carrier. While limitations from the specification are not read into the claims, the claims are read in light of the specification. Administration of the compositions includes intravenous, subcutaneous and pulmonary administration which would necessarily include liquid formulations. While ‘646 does not explicitly recite a fusion protein content of about 100 mg to about 10,000 mg per dose or a concentration from about 0.5% to about 1% by weight, such amounts do not distinguish the claimed compositions from one another because it would have been obvious to formulate the compositions in any particular amount that would be useful for any desired use, such as in vivo administration, in vitro application or as a drug depot formula from which the composition could be further diluted for alternate uses. Therefore, the instant claims are not patentably distinct from those of ‘646, absent evidence to the contrary.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Christine J Saoud whose telephone number is (571)272-0891. The examiner can normally be reached M-F, 8am-4pm.
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/Christine J Saoud/Primary Examiner, Art Unit 1645
Prosecution Insights