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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 22 December 2025 has been entered.
Status of Application, Amendments and/or Claims
The amendment and Applicant’s arguments, filed 09 December 2025, have been entered in full. Claims 12, 14 and 15 are withdrawn from consideration as being drawn to a non-elected invention. Claims 2, 3, 5, 13, 16 and 17 are canceled. Claims 1, 20-22 are amended. Claims 1, 4, 6-11, 18-22 are under examination.
Withdrawn Objections And/Or Rejections
The rejection to claims 1, 4, 6-11, 18-20 under 35 U.S.C. 102(a1) and 35 U.S.C. 102(a2) as being anticipated by Walters (Pfizer Inc. WO 2017/055966; published 06 April 2017) as evidenced by de Villiers et al. (The Dissolution and Complexing Properties of Ibuprofen and Ketoprofen when Mixed with N- Methylglucamine. Drug Development and Industrial Pharmacy, 25(8), 967-972; 1999), as set at pages 3-5 of the previous Office Action (15 October 2025) is withdrawn in view of Applicant’s arguments regarding the teaching of using meglumine in the recited method (09 December 2025).
Claim Rejections-35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1, 4, 6-11, 18-20 and 22 remain rejected under 35 U.S.C. 102(a1) and 35 U.S.C. 102(a2) as being anticipated by Larson et al. (US 2015/0071925; published 12 March 2015) as evidenced by de Villiers et al. (Drug Development and Industrial Pharmacy, 25(8), 967-972; 1999).
The basis for this rejection is set forth at pages 5-6 of the previous Office Action (15 October 2025)
APPLICANT’S ARGUMENTS: Applicant submits that the Office Action is not following the appropriate test for anticipation. Applicant argues that the law of anticipation has been phrased by the Federal Circuit as follows: "to anticipate, every element and limitation of the claimed invention must be found in a single prior art reference, arranged as in the claim." Applicant cites the following: Karsten Mfg. Corp. v. Cleveland Golf Co., 58 USPQ2d 1286 (Fed. Cir. 2001). Anticipation under 35 U.S.C. §102 requires that "[e]very element of the claim must be literally present, arranged as in the claim" (emphasis added), see, e.g., Richardson v. Suzuki Motor Co., 9 USPQ2d 1913 (Fed. Cir. 1989); and MPEP §2131. In re Arkley, 172 USPQ 524 (CCPA 1972), stating: "the reference ... must clearly and unequivocally disclose the claimed compound or direct those skilled in the art to the compound without any need for picking, choosing, and combining various disclosures not directly related to each other by the teachings of the cited reference".
Applicant states that N-methylglutamine (a.k.a. meglumine) appears exactly once in the disclosure buried in the lists of potential ingredients. Applicant submits that this is not the type of disclosure that satisfies anticipation, and not even obviousness as nothing further is taught or suggested regarding making a choice for N-methylglutamine as an ingredient from the extensive lists of potential ingredients containing at least hundreds of options.
Regarding carnitine, Applicant argues that it is correct that it’s cited in Table 8. Applicant, however, maintains that nothing in the reference teaches or even suggests that the concentration with a viscosity-reducing effect is such that a viscosity reduction is achieved that is greater than the sum of the actions of the camphorsulfonic acid and the at least one cationic excipient, and nor is there any teaching or suggestion that such an effect could be achieved.
Applicant’s arguments have been fully considered but are not found persuasive for the following reasons.
1. MPEP 2131 (Application of 35 U.S.C. 102) teaches: A claimed invention may be rejected under 35 U.S.C. 102 when the invention is anticipated (or is "not novel") over a disclosure that is available as prior art. To reject a claim as anticipated by a reference, the disclosure must teach every element required by the claim under its broadest reasonable interpretation. See, e.g., MPEP § 2114, subsections II and IV. "A claim is anticipated only if each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior art reference." Verdegaal Bros. v. Union Oil Co. of California, 814 F.2d 628, 631, 2 USPQ2d 1051, 1053 (Fed. Cir. 1987). "When a claim covers several structures or compositions, either generically or as alternatives, the claim is deemed anticipated if any of the structures or compositions within the scope of the claim is known in the prior art." Brown v. 3M, 265 F.3d 1349, 1351, 60 USPQ2d 1375, 1376 (Fed. Cir. 2001) (claim to a system for setting a computer clock to an offset time to address the Year 2000 (Y2K) problem, applicable to records with year date data in "at least one of two-digit, three-digit, or four-digit" representations, was held anticipated by a system that offsets year dates in only two-digit formats). See also MPEP § 2131.02. "The identical invention must be shown in as complete detail as is contained in the ... claim." Richardson v. Suzuki Motor Co., 868 F.2d 1226, 1236, 9 USPQ2d 1913, 1920 (Fed. Cir. 1989). The elements must be arranged as required by the claim, but this is not an ipsissimis verbis test, i.e., identity of terminology is not required. In re Bond, 910 F.2d 831, 15 USPQ2d 1566 (Fed. Cir. 1990). Note that, in some circumstances, it is permissible to use multiple references in a 35 U.S.C. 102 rejection. See MPEP § 2131.01.
In the instant case, the Larson reference teaches every limitation recited in each claim.
2. MPEP 2131.02 teaches: A genus does not always anticipate a claim to a species within the genus. However, when the species is clearly named, the species claim is anticipated no matter how many other species are additionally named. See Ex parte A, 17 USPQ2d 1716 (Bd. Pat. App. & Inter. 1990) (The claimed compound was named in a reference which also disclosed 45 other compounds. The Board held that the comprehensiveness of the listing did not negate the fact that the compound claimed was specifically taught. The Board compared the facts to the situation in which the compound was found in the Merck Index, saying that "the tenth edition of the Merck Index lists ten thousand compounds. In our view, each and every one of those compounds is ‘described’ as that term is used in [pre-AIA ] 35 U.S.C. 102(a), in that publication."). Id. at 1718. See also In re Sivaramakrishnan, 673 F.2d 1383, 213 USPQ 441 (CCPA 1982) (The claims were directed to polycarbonate containing cadmium laurate as an additive. The court upheld the Board’s finding that a reference specifically naming cadmium laurate as an additive amongst a list of many suitable salts in polycarbonate resin anticipated the claims. The applicant had argued that cadmium laurate was only disclosed as representative of the salts and was expected to have the same properties as the other salts listed while, as shown in the application, cadmium laurate had unexpected properties. The court held that it did not matter that the salt was not disclosed as being preferred, the reference still anticipated the claims and because the claim was anticipated, the unexpected properties were immaterial.).
In the instant case, Larson et al. clearly teach a method for reducing the viscosity of a liquid composition comprising an antibody in a concentration in the range of at least 50 mg/ml up to 300 mg/ml comprising the step of combining the liquid composition with at least camphorsulfonic acid. Larson et al. clearly teach meglumine and carnitine as viscosity-lowering agents that can be added to a liquid composition comprising an antibody and camphorsulfonic acid to reduce the viscosity of the liquid composition.
3. Applicant’s arguments that nothing in the reference teaches or even suggests that the concentration with a viscosity-reducing effect is such that a viscosity reduction is achieved that is greater than the sum of the actions of the camphorsulfonic acid and the at least one cationic excipient, and nor is there any teaching or suggestion that such an effect could be achieved, is not found persuasive.
The Examiner notes that the following limitations (also currently recited in the claims) are not positive active steps of the claimed method:
“wherein the viscosity reduction is achieved that is greater than the sum of the action of the camphorsulfonic acid and the at least one cationic excipient”
“wherein viscosity rejection is achieved that is greater than the sum of the actions of the camphorsulfonic acid and the meglumine”
“wherein viscosity reduction is achieved that is greater than the sum of the actions of the camphorsulfonic aid and the carnitine”
The recited limitations are functional language that describes a property of combining a protein in the range of at least 50 mg/ml up to 300 mg/ml with a liquid composition with camphorsulfonic acid and at least one cationic excipient selected from the group consisting of meglumine, ornithine and carnitine.
The instant claims do not recite a particular “concentration with a viscosity-reducing effect” for meglumine, ornithine and carnitine. Because Larson et al. teach the methods steps recited in claims 1, 4, 6-11, 18-20 and 22, those recited functional effects would be inherent to the method teaching the recited steps.
The Examiner also notes that arguments regarding unexpected results have no bearing in an anticipatory/102 rejection.
The scientific reasoning and evidence as a whole indicates that the rejection should be maintained.
Claims 1, 4, 6-11, 18-22 remain rejected under 35 U.S.C. 102(a2) as being anticipated by Shenoy (US 2018/0333493; published 22 November 2018, priority date 16 May 2017) as evidenced by de Villiers et al. (Drug Development and Industrial Pharmacy, 25(8), 967-972; 1999).
The basis for this rejection is set forth at pages 6-7 of the previous Office Action (15 October 2025).
APPLICANT’S ARGUMENTS: Applicant argues that Shenoy merely teaches huge lists of potential viscosity-reducing agents without any teaching or suggestion to any one of the agents in the claims, let alone a combination thereof, and let alone a combination that is at a concentration that leads to more than additive effect. Applicant argues that none of the viscosity reducing agents recited in the claims are taught or suggested in an example and not in a combination with each other and also not in a concentration as recited that achieves more than additive effect.
Applicant’s arguments have been fully considered but are not found persuasive for the following reasons:
1. As was stated above, a genus does not always anticipate a claim to a species within the genus. But when the species is clearly named, the species claim is anticipated no matter how many other species are additionally named (MPEP 2131.02).
In the instant case, Shenoy clearly teaches a method for reducing the viscosity of a liquid composition comprising an antibody in a concentration in the range of at least 50 mg/ml up to 300 mg/ml with a viscosity-reducing agent. Shenoy teaches viscosity of a high concentration protein formulation can be reduced using one or more viscosity-reducing agents such as camphorsulfonic acid, meglumine, ornithine and/or carnitine.
2. As was stated above, the instant claims do not recite a particular “concentration with a viscosity-reducing effect” for meglumine, ornithine and carnitine. Because Shenoy teaches the methods steps recited in claims 1, 4, 6-11, 18-22, those recited effects would be inherent to the method teaching the recited steps.
The Examiner also notes that arguments regarding unexpected results have no bearing in an anticipatory/102 rejection.
3. Applicant’s argument that none of the viscosity reducing agents recited in the claims are taught or suggested in an Example is not found persuasive because MPEP 2123 teaches: disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or non-preferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). “A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use.” In re Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994). MPEP 2141.02 teaches: the prior art's mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed. In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004).
The scientific reasoning and evidence as a whole indicates that the rejection should be maintained.
Conclusion
No claims are allowed.
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/R.M.D/Examiner, Art Unit 1647 2/2/2026
/BRIDGET E BUNNER/Primary Examiner, Art Unit 1647