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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 5/26/2026 has been entered.
Claim Status
Claims 2 and 5-7 were canceled.
Claims 11-16 were added.
Claims 1, 3-4 and 8-16 are pending and under consideration.
MAINTAINED - 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, 3-4 and 8-16 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.
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.
Dependent claims are also rejected because they depend from independent claims and do not resolve these issues.
Response to Arguments
In the response filed on 5/26/2026, Applicant argued at page 4,
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In contrast to Applicant’s argument, the recitations of trademarks and parenthesis are still in the independent claims.
MAINTAINED - 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.
Claim(s) 1, 3-4 and 8-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fattom et al (WO2018/204669).
Regarding claims 1, 3 and 11, 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(iii)). Fattom teaches that the surfactant is selected from the group consisting of … Tergitol Type TMN-6 (claim 38(f)).
Regarding claims 4, 8 and 12-13, 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 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 claimed active process step. Because same active process step will result in the same result, claim 10 is also taught by Fattom.
Response to Arguments
In the response filed on 5/26/2026, Applicant argued “applicant's invention is concerned with finding a suitable surfactant having suitable qualities for use in pharmaceutical formulations, rather than development of an effective vaccine against RSV infection. The two problems require completely different sets of considerations and solutions” at page 5-6.
Applicant's arguments have been fully considered but they are not persuasive. Whether the claimed composition is used for a pharmaceutical composition or vaccine composition, the composition taught by Fattom anticipates instant invention because the composition taught by Fattom comprises same composition comprising antibody and surfactant TMN-6. Intended use does not have patentable weight. Furthermore, vaccine composition is a type of a pharmaceutical composition.
Applicant further argued at page 7, “Applicant submits that there is no anticipation of the claimed subject matter, because Fattom requires combining multiple distinct embodiments, examples, or list selections within the reference”.
Applicant's arguments have been fully considered but they are not persuasive. Although claim 38 of Fattom encompasses many species of surfactants, TMN-6 is clearly among the species encompassed by claim 38 of Fattom. Therefore, the composition comprising protein and TMN-6 which encompassed by instant claim 1 is taught by Fattom.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHEOM-GIL CHEONG whose telephone number is (571)272-6251. The examiner can normally be reached Monday - Friday 9:00 am - 5:00 pm.
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/CHEOM-GIL CHEONG/Examiner, Art Unit 1645
/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641
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