Ex parte Lamicq

• Docket Number: 2023-0028061[1],Application 16/469,277,Technology Center 1600
• Decision Date: 28 December 2023
• Parties: Ex parte ELIA CECILIA BRAVO LAMICQ and JUANA EDITH ZARATE RODRIGUEZ
• Court: Patent Trial and Appeal Board

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Ex parte ELIA CECILIA BRAVO LAMICQ and JUANA EDITH ZARATE RODRIGUEZ No. 2023-0028061^[1]

Application 16/469,277

Technology Center 1600

United States Patent and Trademark Office, Patent Trial and Appeal Board

December 28, 2023

FILING DATE 06/13/2019

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Before RICHARD M. LEBOVITZ, ULRIKE W. JENKS, and CYNTHIA M. HARDMAN, Administrative Patent Judges.

DECISION ON APPEAL

HARDMAN, Administrative Patent Judge.

This is an appeal under 35 U.S.C. § 134(a) involving claims related to a method of treating neuropathic pain using pregabalin and alpha-lipoic acid. The Examiner rejected the claims under 35 U.S.C. § 112(a) for lack of adequate written description and under 35 U.S.C. § 103 as obvious. We have jurisdiction under 35 U.S.C. § 6(b).

We REVERSE.

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CLAIMED SUBJECT MATTER

Claims 16, 18, 21, and 23 are pending. Final Act.^[2] 2. Claim 16 illustrates the claimed subject matter and reads:

16. A method of treating neuropathic pain in a human subject in need thereof comprising orally administering to the subject a therapeutic composition consisting of two active ingredients that are

a. pregabalin; and

b. alpha-lipoic acid

wherein pregabalin and alpha lipoic acid are administered in a ratio of 1:5 by weight; and wherein pregabalin is administered in an amount from 40 mg to 80 mg and alpha lipoic acid is administered in an amount from 200 mg to 400 mg, and a same dosage of pregabalin and alpha lipoic acid is maintained while treating the neuropathic pain in a human subject in need thereof.

Appeal Br.^[3] 43 (Claims App'x).

REFERENCES

The Examiner relies on the following references to reject the claims:

Name	Reference
He	J. He, Therapeutic Effects of α-Lipoic Acid Combined with Pregabalin on Diabetic Peripheral Neuropathy, 21 Chin. J. Prew. Contr. Chron. Dis. 1-14 (April 2013) (English translation of Chinese article)
Vasudevan	D. Vasudevan et al., Efficacy and safety of methylcobalamin, alpha lipoic acid and pregabalin combination versus pregabalin monotherapy in improving pain and nerve conduction velocity in type 2 diabetes associated impaired peripheral neuropathic condition. [MAINTAIN]: Results of a pilot study, 17 Ann. Indian Acad. Neurol. 19-24 (Jan.-Mar. 2014)

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Patel N. Patel et al., A study of the use of carbamazepine, pregabalin and alpha lipoic acid in patients of diabetic neuropathy, 13 J. Diabetes & Metabolic Disorders 1-7 (2014)

REJECTIONS

The Examiner maintains the following rejections:

Claim(s) Rejected	35 U.S.C. §	Reference(s)/ Basis
16, 18, 21, 23	112(a)	Written description
16, 18, 21, 23	103	He, Vasudevan, Patel

Final Act. 2, 4.

OPINION

Written Description Rejection

The Examiner asserts that claims 16, 18, 21, and 23 lack adequate written description support for the recitation of administering a dose of pregabalin "in an amount from 40 mg to 80 mg." Final Act. 3. The Examiner acknowledges that the Specification discloses two dosage ranges for pregabalin, namely "an amount from 40 mg to 160 mg" and "an amount from 65 to 150 mg," but asserts that "the addition of specific percentages after a broader original disclosure constitutes new matter," and here there is no disclosure of "pregabalin at 80 mg." Id. (citing Spec.^[4] 5:7-12).

Appellant disagrees, arguing that "80 mg is an endpoint clearly falling within and contemplated by the explicitly disclosed ranges." Appeal Br. 41.

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The Examiner essentially finds that because the Specification does not make expressly disclose an 80 mg dose of pregabalin, there is inadequate written description support for that endpoint. See Final Act. 3. We disagree with the Examiner. A lack of express disclosure of an 80 mg dose of pregabalin is not dispositive of whether the Specification provides adequate written description support for the claimed dose, because a specification need not recite the claimed invention in haec verba. See Ariad Pharms., Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1352 (Fed. Cir. 2010) (en banc).

We also disagree with Appellant's assertion that the written description requirement is satisfied because "80 mg is an endpoint clearly falling within and contemplated by the explicitly disclosed ranges." Appeal Br. 41. In some cases, a broader disclosed range can be used to support a narrower claimed range. For example, in Wertheim, the appellants' parent application disclosed a range of "25 to 60% solid matter," together with examples showing solid contents of 36% and 50%. See In re Wertheim, 541 F.2d 257, 262 (CCPA 1976). The court found that the specification adequately supported a later claim to a solids content of "between 35% and 60%." See id. at 264. In making its finding, the Wertheim court observed that "the question is whether, on the facts, the PTO has presented sufficient reason to doubt that the broader described range also describes the somewhat narrower claimed range." Wertheim, 541 F.2d at 264. The court stated:

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We note that there is no evidence, and the PTO does not contend otherwise, that there is in fact any distinction, in terms of the operability of appellants' process or of the achieving of any desired result, between the claimed lower limit of solids content and that disclosed in the [parent] application.... Where it is clear . . . that the broad described range pertains to a different invention than the narrower (and subsumed) claimed range, then the broader range does not describe the narrower range.

Id. at 264-65 (citation omitted); cf. Gen. Hosp. Corp. v. Sienna Biopharms., Inc., 888 F.3d 1368, 1372 (Fed. Cir. 2018) ("[t]he disclosure of a broad range of values does not by itself provide written description support for a particular value within that range.").

Wertheim made clear that "[t]he burden of showing that the claimed invention is not described in the specification rests on the PTO in the first instance, and it is up to the PTO to give reasons why a description not in ipsis verbis is insufficient." Id. at 265. Here, as in Wertheim, the Examiner "has done nothing more than to argue lack of literal support" for the 80 mg...