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 .
Response to Election/Restriction filed on July 01, 2025 is acknowledged.
Claims 53-54 and 58-67 have been cancelled.
Claims 50-52 and 55-57 are pending in this application.
Information Disclosure Statement
5. It is noted that Applicants have not filed an information disclosure statementunder § 1.97(c). Applicant is reminded of 37 CFR § 1.56, which details Applicants dutyto disclose all information known to be material to patentability.
Restriction
6. Applicant’s election without traverse of the following species: (1) SEQ ID NO: 4 as the modified human hormone receptor antagonist, (2) a PEG that is a 4.5 kDa branched PEG, (3) an anticancer composition that is an antitumor antibiotic, wherein the antitumor antibiotic is doxorubicin, (4) breast cancer as the species of cancer, and (5) further comprising an amino acid substitution of H18D in the reply filed on July 1, 2025 is acknowledged. Restriction is deemed to be proper and is made FINAL in this office action. Applicant cancelled claims 53-54 and 58-67. Claims 50-52 and 55-57 are examined on the merits in this office action.
Objections
7. The use of the trademark SOMAVERT® has been noted in this application at paragraph [0006] of instant specification US 2024/0082362. The use of the trademark dPEG® has been noted in this application at paragraph [0040] of instant specification. These should be capitalized wherever it appears and be accompanied by the generic terminology.
Although the use of trademarks is 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 trademarks.
Please note, the specification has not been checked to the extent necessary to determine the presence of all possible error. Applicant's cooperation is required in correcting any errors of which applicant may become aware in the specification. MPEP § 608.01.
Rejections
DOUBLE PATENTING
8. 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.
9. Claims 50-52 and 55-57 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 8 of U.S. Patent No. 11,857,602. Although the claims at issue are not identical, they are not patentably distinct from each other because if one of ordinary skill in the art practiced the claimed invention of instant application, one would necessarily achieve the claimed invention of US Patent claims, and vice versa.
Please note: instant application is a DIV of US Patent No. 11857602 and CIP of US Patent No. 11,452,763. The DIV filing is incorrect in view of the previous restriction requirement applied to US Application No 17/411497. In the Election/Restriction requirement dated 3/17/2023, the groups were restricted as follows:
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. In the response to Election/Restriction for SN 17/411497, Applicant elected without traverse of Group 1 (claims 1-17 and 19-33). Therefore, the double patenting rejection set forth herein is proper.
10. Instant claims are drawn to:
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.
11. US Patent claims are drawn to:
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.
12. The scope of the instant claims and US Patent claims are similar. Therefore, if one of ordinary skill in the art practiced the claimed invention of instant claims would necessarily lead to US Patent claims, and vice versa.
ART OF INTEREST
13. Brody patent (US Patent No. 10874717) teaches a human growth hormone receptor antagonist comprising (a) a human growth hormone receptor antagonist G120K having a DNA sequence of SEQ ID NO: 3 and an amino acid sequence of SEQ ID NO: 4, wherein two amino acids of human growth hormone receptor antagonist G120K have been mutated to cysteine, wherein the two amino acids mutated cysteine are T142 and H151; and (b) a polyethylene glycol molecule conjugated to each substituted cysteine in the human growth hormone receptor antagonist G120K mutant (see claims 1-3). SEQ ID NO: 24 is same as instant SEQ ID NO: 4, and SEQ ID NO: 23 is the same as instant SEQ ID NO: 3.
14. Cho et al (US Patent No. 8778880) teach covalent attachment of PEG to growth hormone molecules in order to increase water solubility, bioavailability, serum half-life, therapeutic half-life, etc. (see column 3, lines 50-67). Cho et al teach that PEG molecules are frequently linked to biologically active molecules through reactive chemical functionalities such as cysteine (see column 4, lines 1-3). Cho et al further teach a substitution at position 120 of growth hormone results in a growth hormone antagonist (see column 19, lines 35-40). Cho et al do not teach substitution of cysteine residues at positions 142 and 151 in order to covalently attach a PEG molecule.
15. Cox et al (US Patent No. 7399839) teach addition of PEG molecules to growth hormone proteins by addition of a cysteine residue. Cox et al teach a number of amino acid positions which would be suitable for substitution with cysteine, including T142 and H151 (see column 27, line 1). Cox et al teach PEGylation using a cysteine-reactive PEG-maleimide reagent (see Example 11, column 32).
16. Neither Cho et al or Cox et al teach instant SEQ ID NO: 4 as the human growth hormone receptor antagonist G120K protein having the T142C-H151C substitutions.
17. Muller et al (The Journal of Clinical Endocrinology & Metabolism, 2004, 89(4): 1503-1511) teach PEG-hGH G120K, also known as pegvisomant as the generic name, and is currently available in the US for the treatment of acromegaly (its tradename is SOMAVERT®) (see p. 1504, right column). As evidenced by DrugBank online (https://go.drugbank.com/drugs/DB00082, pp. 1-13, enclosed), pegvisomant has the sequence:
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(see p. 2 of 13). The PEG-hGH G120K (pegvisomant) does not have Cys at positions 142 and 151.
CONCLUSION
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIE HA whose telephone number is (571)272-5982. The examiner can normally be reached Monday-Thursday 5:00 am- 6:30 pm EST.
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/JULIE HA/Primary Examiner, Art Unit 1654
9/28/2025