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 5-6 were canceled.
Claims 9-10 were added.
Claims 1-4 and 7-10 are pending and under consideration.
Withdrawn Rejections
Objection of claims 1 and 5-6 is withdrawn. Applicant amended the claim 1 and canceled claims 5-6, thereby obviating this rejection/objection.
Rejection of Claims 5-6 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn.
Rejection of Claim(s) 5-6 under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter is withdrawn.
Applicant canceled the claim(s) 5-6 and therefore these rejections are moot.
Rejection of Claim(s) 1-4 and 7-8 under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Forrest et al (WO2020/097141) is withdrawn. Applicant amended the claim 1, thereby obviating this rejection/objection.
NEW - Claim Rejections - 35 USC § 112
(necessitated by amendments)
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 1-4 and 7-10 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.
Claims 1 and 9-10 contain the trademark/trade name “TergitolTM”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name.
Claims 1 and 9-10 recite “(Branched secondary alcohol ethoxylate with 8 EO units)” and “(Secondary alcohol ethoxylate with 15 EO units)” which are exemplary claim languages and it is unclear the content in parenthesis is limiting or merely exemplary.
Claims 2-4 and 7-8 depend from claim 1 and do not resolve these issues.
NEW - Claim Rejections - 35 USC § 102
(necessitated by amendments)
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.
Claim(s) 1-4 and 7-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fattom et al (WO2018/204669; PTO-892).
Regarding claims 1-3, Fattom teaches a pharmaceutical composition comprising human antibodies and a pharmaceutically acceptable carrier (claim 1). Fattom teaches that the pharmaceutical composition further comprises surfactant (claim 18). Fattom teaches that the surfactant is selected from the group consisting of … Tergitol Type TMN-6 (claim 38(f)).
Regarding claims 4 and 7-8, Fattom teaches “the non-ionic surfactant is present in a concentration of about 0.05% to about 10%, about 0.05% to about 7.0%, about 0.1% to about 7%, or about 0.5% to about 4%” (claim 40(f)). 0.05% taught by Fattom corresponds to 0.05 g/100mL = 50 mg/100 mL = 0.5 mg/mL which is less than 1 mg/mL as recited by claims 4 and 7-8.
Regarding claim 9, because Fattom teaches a pharmaceutical composition comprising antibody and surfactant TMN-6, the pharmaceutical composition of Fattom must have been prepared by adding TMN-6 into the composition. Therefore, the active process step “adding TMN-6 into the composition” is the inherent characteristics of the pharmaceutical composition of Fattom.
Regarding claim 10, the active process step of claim 10 is also adding TMN-6 into the composition. The claim limitation “for stabilizing a protein and preventing formation of visible particles in a liquid pharmaceutical composition comprising said protein, upon storage” is the expected result of the active process step. Because same active process step will bring the same result, claim 10 is also taught by Fattom.
Conclusion
No claim is 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.
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/CHEOM-GIL CHEONG/Examiner, Art Unit 1645
/DANIEL E KOLKER/Supervisory Patent Examiner, Art Unit 1645