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 .
Formal Matters
Applicant’s amendments and arguments in the reply filed on 22 December 2025 are acknowledged and have been fully considered. Claims 1-2, 7-8, and 10-17 are pending. Claims 1-2, 7-8, 10, 13, and 17 are under consideration in the instant office action. Claims 11-12 and 14-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and/or species, there being no allowable generic or linking claims. Claims 3-6 and 9 are cancelled. Claim 17 is newly added. Applicant’s claim amendments and arguments did not overcome the rejections under 35 USC 103 for reasons set forth in the previous office action and herein below.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 10 December 2025 is noted and the submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the examiner has considered the information disclosure statement. A signed copy is herein attached.
Withdrawn Objections/Rejections
Rejections and/or objections not reiterated from the previous office actions are hereby withdrawn as are those rejections and/or objections expressly stated to be withdrawn.
Rejections Maintained
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 7-8, 10, 13, and 17 remain rejected under 35 U.S.C. 103 as being unpatentable over Bartholomaeus et al. (WO 03/035053, machine English Translation is attached) in view of FDA Guidance for Industry on Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation (herein after “FDA Guidance”, March 2013)
Applicant Claims
Applicant claims a scored tablet comprising the ingredients as recited. Dependent claims thereof recite different features that further defines the independent claim.
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
Bartholomaeus et al. teach a pharmaceutical formulation which is characterized by delayed release of the active ingredient. Said formulation contains 3-(3-dimethylamino-1-ethyl-2-methyl-propyl)phenol (which the examiner notes is tapentadol) or one of its pharmaceutically acceptable salts in a matrix with delayed release of the active ingredient. Said matrix contains between 1 and 80 wt. % of at least one hydrophilic or hydrophobic polymer as a pharmaceutically acceptable matrix forming agent and exhibits, in vitro, the following dissolution speed: between 3 and 35 wt. % (in relation to 100 wt. % of active ingredient) of 3-(3-dimethylamino-1-ethyl-2-methyl-propyl)phenol is released after half an hour, between 5 and 50 wt. % of 3-(3-dimethylamino-1-ethyl-2-methyl-propyl)phenol is released after one hour, between 10 and 75 wt. % of 3-(3-dimethylamino-1-ethyl-2-methyl-propyl)phenol is released after two hours, between 15 and 82 wt. % of 3-(3-dimethylamino-1-ethyl-2-methyl-propyl)phenol is released after three hours, between 30 and 97 wt. % of 3-(3-dimethylamino-1-ethyl-2-methyl-propyl)phenol is released after six hours, more than 50 wt. % of 3-(3-dimethylamino-1-ethyl-2-methyl-propyl)phenol is released after twelve hours, more than 70 wt. % of 3-(3-dimethylamino-1-ethyl-2-methyl-propyl)phenol is released after eighteen hours, and more than 80 wt. % of 3-(3-dimethylamino-1-ethyl-2-methyl-propyl)phenol is released after twenty-four hours (see abstract). Bartholomaeus et al. teach a prolonged-release pharmaceutical formulation comprising 3-(3-dimethylamino-1-ethyl-2-methyl-propyl)phenol or one of its pharmaceutically acceptable salts (e.g. hydrochloride) embedded in a hydrophilic or hydrophobic polymer matrix specifically hydroxypropylmethylcellulose (HPMC) as a preferred matrix-forming agent with a viscosity of 3,000 to 150,000 mP.s (preferably 100,000 mP.s) at 1-80 wt% (preferably 5-80)(claims 1-6; p.3 lines 14-28; p. 4, lines 1-10; Examples 1-3, 5-7, 9-11). The prolonged release matrix comprises microcrystalline cellulose (MCC, Avicel) as a filler at up to 80wt% (preferably 5-65%), with specific amounts of 23-213 mg MCC per tablet in examples (p.3, lines 29-32; p. 4, lines 11-15; examples 1-3, 5-7, 9-11). The pharmaceutical formulations according to the invention may also contain as further constituents pharmaceutically customary auxiliaries such as fillers, for example lactose, microcrystalline cellulose (MCC) or calcium hydrogenphosphate, as well as lubricants, lubricants and flow regulators, for example talc, magnesium stearate, stearic acid and or fumed silica whose total content in the tablet is between 0 and 80% by weight, preferably between 5 and 65% by weight. The tablet has a total weight in the claimed range (e.g., example 1:500 mg total including 116.5 mg tapentadol HCl, 350 mg HPMC, and 33.5 mg other excipients) (examples 1-2). The tablet is scored with a site of mechanical weakness (break score or “Bruchkerbe”) allowing manual breaking into two separate halves, specifically in oblong forms (e.g., 6x 15 mm) designed for divisibility (example 8; p. 5, lines 1-5). In vitro release profiles are provided for the whole tablet (e.g., 3-35% release after 0.5 h, greater than 80% after 24 h, via Ph. Eur. Paddle method at pH 6.8), with pH-independent sustained release over 12-24 hours (p.2, lines 20-30; and examples). Example 1 for instance teaches as follows:
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Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
Bartholomaeus et al. do not teach that the in vitro release profile of the scored tablet essentially corresponds to the in vitro release profile of each of the two separate halves. These deficiencies are cured by the teachings of FDA Guidance.
The FDA Guidance teach that for scored modified release (extended-release) solid oral dosage forms using matrix technology, dissolution profiles of whole versus split tablet portions must meet similarity criteria (e.g., f2≥50), with data generated on at least 12 split portions (split both by hand and mechanically) to ensure the scoring does not compromise controlled release (sections III.A.3, III.A.5.a-b). Modified release products where splitting could alter release should not be scored (section III.A.3).
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the instant invention to modify the scored prolonged-release HPMC matrix tablet of Bartholomaeus et al. such that the in vitro release profile of the whole tablet essentially corresponds to that of each half, as taught by the FDA Guidance, because Bartholomaeus et al. already provides a scored ER matrix tablet for divisibility, and the FDA Guidance establishes this is as standard regulatory requirement for such formulations to ensure safe and effective dosing when split. One of ordinary skill in the art would have been motivated to meet this criterion to obtain regulatory approval for the scored tablet with a reasonable expectation of success, as uniform matrix tablets like those in Bartholomaeus et al. 9homogenously embedding the active in HPMC/MCC) are routinely designed to maintain similar release kinetics upon splitting, per established pharmaceutical practice as demonstrated by the FDA Guidance. The selection of a known material and its amounts based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) (Claims to a printing ink comprising a solvent having the vapor pressure characteristics of butyl carbitol so that the ink would not dry at room temperature but would dry quickly upon heating were held invalid over a reference teaching a printing ink made with a different solvent that was nonvolatile at room temperature but highly volatile when heated in view of an article which taught the desired boiling point and vapor pressure characteristics of a solvent for printing inks and a catalog teaching the boiling point and vapor pressure characteristics of butyl carbitol.) Furthermore, in the case where the claimed ranges for amounts of ingredients and actives “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). Furthermore, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Thus, an ordinary skilled artisan would have had a reasonable expectation of success upon combination of the Bartholomaeus et al. and the FDA Guidance because both references teach preparation of scored tablets. In addition to the above explanations with respect to the pharmacokinetic release profile of the scored tablet including the new recitation in new claim 17, "[I]nherency may supply a missing claim limitation in an obviousness analysis." PAR, 773 F.3d at 1194-1195 ; see also Endo Pharms. Sols., Inc. v. Custopharm Inc., 894 F.3d 1374 , 1381 , 127 U.S.P.Q.2D (BNA) 1409 (Fed. Cir. 2018) ("An inherent characteristic of a formulation can be part of the prior art in an obviousness analysis even if the inherent characteristic was unrecognized or unappreciated by a skilled artisan."). It is long settled that in the context of obviousness, the "mere recitation of a newly discovered function or property, inherently possessed by things in the prior art, does not distinguish a claim drawn to those things from the prior art." In re Oelrich, 666 F.2d 578 , 581 (C.C.P.A. 1981). The Supreme Court explained long ago that "[i]t is not invention to perceive that the product which others had discovered had qualities they failed to detect." Gen. Elec. Co. v. Jewel Incandescent Lamp Co., 326 U.S. 242 , 249 , 66 S. Ct. 81 , 90 L. Ed. 43 , 1946 Dec. Comm'r Pat. 611 (1945).
We too have previously explained that "an obvious formulation cannot become nonobvious simply by administering it to a patient and claiming the resulting serum concentrations," because "[t]o hold otherwise would allow any formulation—no matter how obvious—to become patentable merely by testing and claiming an inherent property." Santarus, Inc. v. Par Pharm., Inc., 694 F.3d 1344 , 1354 (Fed. Cir. 2012). In In re Kao, we found that the claimed controlled-release oxymorphone formulation was obvious because an inherent pharmacokinetic property of oxymorphone that was present in controlled-release oxymorphone "add[ed] nothing of patentable consequence." In re Huai-Hung Kao, 639 F.3d 1057 , 1070 , 98 U.S.P.Q.2D (BNA) 1799 (Fed. Cir. 2011). In In re Kubin, we found an inherent property obvious, explaining that "[e]ven if no prior art of record explicitly discusses the [limitation], the . . . application itself instructs that [the limitation] is not an additional requirement imposed by the claims on the [claimed protein], but rather a property necessarily present in [the claimed protein]." In re Kubin, 561 F.3d 1351 , 1357 , 90 U.S.P.Q.2D (BNA) 1417 (Fed. Cir. 2009). Our predecessor court similarly concluded that it "is not the law" that "a structure suggested by the prior art, and, hence, potentially in the possession of the public, is patentable . . . because it also possesses an [i]nherent, but hitherto unknown, function which [the patentees] claim to have discovered." In re [*1191] Wiseman, 596 F.2d 1019 , 1023 (C.C.P.A. 1979).
Inherency, however, is a "high standard," that is "carefully circumscribed in the context of obviousness." PAR, 773 F.3d at 1195 . Inherency "may not be established by probabilities or possibilities," and "[t]he mere fact that a certain thing may result from a given set of circumstances is not sufficient." Oelrich, 666 F.2d at 581 (emphasis added) (quoting Hansgirg v. Kemmer, 102 F.2d 212 , 214 , 26 C.C.P.A. 937 , 1939 Dec. Comm'r Pat. 327 (C.C.P.A. 1939); see also In re Rijckaert, 9 F.3d 1531 , 1533-1534 (Fed. Cir. 1993). Rather, inherency renders a claimed limitation obvious only if the limitation is "necessarily present," or is "the natural result of the combination of elements explicitly disclosed by the prior art." PAR, 773 F.3d at 119511 -96; see also Alcon Research, Ltd. v. Apotex Inc., 687 F.3d 1362 , 1369 (Fed. Cir. 2012) (relying on inherency where the claims recited "a property that is necessarily present" in the prior art). "If . . . the disclosure is sufficient to show that the natural result flowing from the operation as taught would result in the performance of the questioned function, it seems to be well settled that the disclosure should be regarded as sufficient" to render the function inherent. Oelrich, 666 F.2d at 581 (quoting Hansgirg v. Kemmer, 102 F.2d 212 , 214 , 26 C.C.P.A. 937 , 1939 Dec. Comm'r Pat. 327 (C.C.P.A. 1939)).
On appeal, Persion contends that the district court erred in applying the inherency doctrine in its obviousness analysis because Devane does not teach administering its hydrocodone-only formulation to patients with mild or moderate hepatic impairment. Thus, Persion asserts, "'the natural result flowing from the operation as taught' in Devane cannot be the claimed [pharmacokinetic] values for [hepatically impaired] patients." Appellant's Br. 37 (quoting Oelrich, 666 F.2d at 581 ); Reply Br. 19.
To the extent Persion contends that inherency can only satisfy a claim limitation when all other limitations are taught in a single reference, that position is contrary to our prior recognition that "inherency may supply a missing claim limitation in an obviousness analysis" where the limitation at issue is "the natural result of the combination of prior art elements." PAR, 773 F.3d at 1194-1195 (emphasis added, internal quotations omitted). Here, the district court specifically found that Devane, together with Jain, the state of the prior art at the time of invention, and the Vicodin and Lortab labels, taught the combination of elements that inherently result in the claimed pharmacokinetic parameters. The district court found that a person of ordinary skill in the art would have been motivated, with reasonable expectation of success, to administer an unadjusted dose of the Devane formulation to hepatically impaired patients. There was also no dispute that the Devane formulation, which was identical to the Zohydro ER formulation described in the patents in suit, necessarily exhibited the claimed parameters under these conditions. Pernix, 323 F. Supp. 3d at 607 , 610 . In this context, the district court did not err by finding that the pharmacokinetic limitations of the asserted claims were inherent and added no patentable weight to the pharmacokinetic claims.
With regard to the recitation “which has been preferably prepared by dry granulation” in claims 3-6 and 8-9 the recitation is a product-by-process recitation."[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted) (Claim was directed to a novolac color developer. The process of making the developer was allowed. The difference between the inventive process and the prior art was the addition of metal oxide and carboxylic acid as separate ingredients instead of adding the more expensive pre-reacted metal carboxylate. The product-by-process claim was rejected because the end product, in both the prior art and the allowed process, ends up containing metal carboxylate. The fact that the metal carboxylate is not directly added, but is instead produced in-situ does not change the end product.). Furthermore, "[b]ecause validity is determined based on the requirements of patentability, a patent is invalid if a product made by the process recited in a product-by-process claim is anticipated by or obvious from prior art products, even if those prior art products are made by different processes." Amgen Inc. v. F. Hoffmann-La Roche Ltd., 580 F.3d 1340, 1370 n. 14, 92 USPQ2d 1289, 1312, n. 14 (Fed. Cir. 2009). See also Biogen MA Inc. v. EMD Serono, Inc., 976 F.3d 1326, 1334, 2020 USPQ2d 11129 (Fed. Cir. 2020) ("Biogen is certainly correct that the scope of composition and method of treatment claims is generally subject to distinctly different analyses. But where, as here, the novelty of the method of administration rests wholly on the novelty of the composition administered, which in turn rests on the novelty of the source limitation, the Amgen analysis will necessarily result in the same conclusion on anticipation for both forms of claims."); United Therapeutics Corp. v Liquidia Techs., Inc., 74 F.4th 1360, 1373, 2023 USPQ2d 862 (Fed. Cir. 2023) (the court held that product-by-process claims were properly rejected as "anticipated by a disclosure of the same product irrespective of the processes by which they are made."); and Purdue Pharma v. Epic Pharma, 811 F.3d 1345, 117 USPQ2d 1733 (Fed. Cir. 2016). However, in the context of an infringement analysis, a product-by-process claim is only infringed by a product made by the process recited in the claim. Id. at 1370 ("a product in the prior art made by a different process can anticipate a product-by-process claim, but an accused product made by a different process cannot infringe a product-by-process claim").
In light of the forgoing discussion, one of ordinary skill in the art would have concluded that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed 22 December 2025 have been fully considered but they are not persuasive.
Applicant argues the FDA Guidance only sets forth a target that a scored tablet must meet in order to obtain approval for marketing from the FDA. The FDA Guidance does not, however, contain any directions for making and, therefore, does not actually enable persons skilled in the art how to make any scored tablet that meet this target. In re Stepan Co., 123 USPQ2d 1838 (Fed. Cir. 2017), stands for the proposition that a prima facie case against a claim reciting a functional limitation must: (1) show the obviousness of the claimed subject matter including that functional limitation; and (2) explain how the prior art reveals to persons skilled in the art that they would have had a reasonable expectation of success in achieving the claimed subject matter including that functional limitation. Both the suggestion and the reasonable expectation of success must be present in the cited prior art in order for prima facie obviousness to lie. Applicant argues the Examiner has not shown exactly how the FDA Guidance enables persons skilled in the art, starting with Bartholomaeus, to make a scored tablet meeting the release profile requirements of the instant claims and, thus, reveals to persons skilled in the art the requisite reasonable expectation of success in that endeavor. In the absence of such a showing, no prima facie case of obviousness has been made out. See, e.g., In re Morsa, 713 F.3d 104, 110, 106 USPQ2d 1327, 1332 (Fed. Cir. 2013) ("[A]n examiner must determine if prior art is enabling by asking whether a person of ordinary skill in the art could make or use the claimed invention without undue experimentation based on the disclosure of that particular document (emphasis in original)."); and MPEP § 2121 ("Where a reference appears to not be enabling on its face, however, an applicant may successfully challenge the cited prior art for lack of enablement by argument without supporting evidence."). Applicant further argues based on the teachings provided in the specification paragraphs in [0009], [0012], [0013], and [0015] for references disclosed in information disclosure statement filed December 10, 2025; and the references discussed in paragraphs [0008], [0010], [0011], and [0014] were cited in the information disclosure statement filed September 14, 2022.) who teach splitting of scored tablets is generally not expected to maintain the release profile of the intact tablet.
The above assertions are not found persuasive because first Applicant incorrectly characterizes the FDA Guidance as merely setting a post-approval target without enabling teachings or relevance to obviousness. This misapprehends both the FDA Guidance and the obviousness law. The FDA scoring guidance expressly addresses modified release (prolonged release) matrix tablets and provides detailed recommendations for designing and evaluating scored versions to ensure the split halves perform equivalently to the whole tablet. For modified release products using matrix technology (precisely the technology in Bartholomaeus and the instant claims: dissolution on whole versus split tablet portions should meet the similarity factor (f2) criteria (I.e., the in vitro release profiles do not differ significantly). Additional criteria include uniformity of dosage units, loss of mass <3%, friability, stability of split portions, and testing at hardness range extremes. Data must be generated on a minimum of 12 individual split tablet portions. These are not vague aspirations. The FDA Guidance teach that for scored modified release (extended-release) solid oral dosage forms using matrix technology, dissolution profiles of whole versus split tablet portions must meet similarity criteria (e.g., f2≥50), with data generated on at least 12 split portions (split both by hand and mechanically) to ensure the scoring does not compromise controlled release (sections III.A.3, III.A.5.a-b). Modified release products where splitting could alter release should not be scored (section III.A.3). The guidance details the data to generate, tests to perform, and acceptance criteria that one of ordinary skill in the art would follow to make a functional scored prolonged release matrix tablet. It directly teaches that scored modified release matrix tablets are desirable for dose flexibility provided the release control is persevered upon splitting which is achieved through proper form formulation design, scoring, and verification. One of ordinary skill in the art reading Bartholomaeus who already teaches scored prolonged release tapentadol matrix tablets with HPMC and MCC would have been motivated to ensure the scoring meets regulatory expectations for approvability and patient safety /usability by following the FDA scoring guidance. The combination is nothing but a classic example of using a secondary reference to optimize or verify a known feature in the primary reference. There is no requirement that the FDA Guidance itself make the tablet in isolation. The FDA guidance itself provides the explicit motivation and roadmap for achieving the claimed functional result when combined with Bartholomaeus enabling matrix teachings. When the reference relied on expressly anticipates or makes obvious all of the elements of the claimed invention, the reference is presumed to be operable. Once such a reference is found, the burden is on applicant to rebut the presumption of operability. In re Sasse, 629 F.2d 675, 207 USPQ 107 (CCPA 1980). See also MPEP § 716.07. See also In re Antor Media Corp., 689 F.3d 1282, 103 USPQ2d 1555 (Fed. Cir. 2012). Specifically, in In re Antor Media Corp., the court stated: "Consistent with the statutory framework and our precedent, we therefore hold that, during patent prosecution, an examiner is entitled to reject claims as anticipated by a prior art publication or patent without conducting an inquiry into whether or not that prior art reference is enabling. As long as an examiner makes a proper prima facie case of anticipation by giving adequate notice under § 132, the burden shifts to the applicant to submit rebuttal evidence of nonenablement." In re Antor Media Corp., 689 F.3d at 1289, 103 USPQ2d at 1559. The examiner takes the position that Applicant’s reliance on In re Stepan Co., 123 USPQ2d 1838 (Fed. Cir. 2017) is misplaced as the recited functional limitation is rendered obvious by the combination teachings of the references with reasonable expectation of success. In In re Stepan Co., 123 USPQ2d 1838 (Fed. Cir. 2017), the court held that a prima facie case for a claim with functional limitation requires showing that the prior art renders the functional limitation obvious, including a reasonable expectation of success in achieving it. The combination teachings of Bartholomaeus and the FDA Guidance fully satisfy the stated standard contrary to Applicant’s assertions. The evidence is provided within the references. Bartholomaeus already provides scored tablets for its prolonged release tapentadol formulation. The FDA Guidance supplies additional motivation to optimize/verify the scoring so that the split halves maintain the prolonged release profile (f2 similarity) addressing known regulatory and practical needs for dose flexibility in controlled substances like tapentadol. The prior art combination provides concrete, enabling directions for both how to make and use tapentadol containing scored tablet. Bartholomaeus enables the matrix formulation including HPMC and MCC and scoring. The FDA Guidance details precisely how to test and achieve non-significant differences in release profiles upon splitting (f2 similarity for matrix systems). One of ordinary skill in the art routinely design and validate scored matrix tablets to meet such criteria. It should be noticed that reasonable success is not unpredictable guesswork but follows established pharmaceutical development principles. The teachings by Bartholomaeus the amounts of HPMC/MCC within the claimed ranges along with routine optimization supports expectation of success. No failure data or unpredictability is alleged here unlike In re Stepan Co., 123 USPQ2d 1838 (Fed. Cir. 2017). Therefore, it is the examiner’s position the functional limitation “ the in vitro release profile of the scored tablet does not differ significantly from….each of the two separate halves” is expressly contemplated and enabled by the combination. Applicant has not demonstrated unexpected results or criticality that would rebut the prima facie case.
Furthermore, in addition to the above explanations with respect to the pharmacokinetic release profile of the scored tablet including the new recitation in new claim 17, "[I]nherency may supply a missing claim limitation in an obviousness analysis." PAR, 773 F.3d at 1194-1195 ; see also Endo Pharms. Sols., Inc. v. Custopharm Inc., 894 F.3d 1374 , 1381 , 127 U.S.P.Q.2D (BNA) 1409 (Fed. Cir. 2018) ("An inherent characteristic of a formulation can be part of the prior art in an obviousness analysis even if the inherent characteristic was unrecognized or unappreciated by a skilled artisan."). It is long settled that in the context of obviousness, the "mere recitation of a newly discovered function or property, inherently possessed by things in the prior art, does not distinguish a claim drawn to those things from the prior art." In re Oelrich, 666 F.2d 578 , 581 (C.C.P.A. 1981). The Supreme Court explained long ago that "[i]t is not invention to perceive that the product which others had discovered had qualities they failed to detect." Gen. Elec. Co. v. Jewel Incandescent Lamp Co., 326 U.S. 242 , 249 , 66 S. Ct. 81 , 90 L. Ed. 43 , 1946 Dec. Comm'r Pat. 611 (1945).
We too have previously explained that "an obvious formulation cannot become nonobvious simply by administering it to a patient and claiming the resulting serum concentrations," because "[t]o hold otherwise would allow any formulation—no matter how obvious—to become patentable merely by testing and claiming an inherent property." Santarus, Inc. v. Par Pharm., Inc., 694 F.3d 1344 , 1354 (Fed. Cir. 2012). In In re Kao, we found that the claimed controlled-release oxymorphone formulation was obvious because an inherent pharmacokinetic property of oxymorphone that was present in controlled-release oxymorphone "add[ed] nothing of patentable consequence." In re Huai-Hung Kao, 639 F.3d 1057 , 1070 , 98 U.S.P.Q.2D (BNA) 1799 (Fed. Cir. 2011). In In re Kubin, we found an inherent property obvious, explaining that "[e]ven if no prior art of record explicitly discusses the [limitation], the . . . application itself instructs that [the limitation] is not an additional requirement imposed by the claims on the [claimed protein], but rather a property necessarily present in [the claimed protein]." In re Kubin, 561 F.3d 1351 , 1357 , 90 U.S.P.Q.2D (BNA) 1417 (Fed. Cir. 2009). Our predecessor court similarly concluded that it "is not the law" that "a structure suggested by the prior art, and, hence, potentially in the possession of the public, is patentable . . . because it also possesses an [i]nherent, but hitherto unknown, function which [the patentees] claim to have discovered." In re [*1191] Wiseman, 596 F.2d 1019 , 1023 (C.C.P.A. 1979).
Inherency, however, is a "high standard," that is "carefully circumscribed in the context of obviousness." PAR, 773 F.3d at 1195 . Inherency "may not be established by probabilities or possibilities," and "[t]he mere fact that a certain thing may result from a given set of circumstances is not sufficient." Oelrich, 666 F.2d at 581 (emphasis added) (quoting Hansgirg v. Kemmer, 102 F.2d 212 , 214 , 26 C.C.P.A. 937 , 1939 Dec. Comm'r Pat. 327 (C.C.P.A. 1939); see also In re Rijckaert, 9 F.3d 1531 , 1533-1534 (Fed. Cir. 1993). Rather, inherency renders a claimed limitation obvious only if the limitation is "necessarily present," or is "the natural result of the combination of elements explicitly disclosed by the prior art." PAR, 773 F.3d at 119511 -96; see also Alcon Research, Ltd. v. Apotex Inc., 687 F.3d 1362 , 1369 (Fed. Cir. 2012) (relying on inherency where the claims recited "a property that is necessarily present" in the prior art). "If . . . the disclosure is sufficient to show that the natural result flowing from the operation as taught would result in the performance of the questioned function, it seems to be well settled that the disclosure should be regarded as sufficient" to render the function inherent. Oelrich, 666 F.2d at 581 (quoting Hansgirg v. Kemmer, 102 F.2d 212 , 214 , 26 C.C.P.A. 937 , 1939 Dec. Comm'r Pat. 327 (C.C.P.A. 1939)).
On appeal, Persion contends that the district court erred in applying the inherency doctrine in its obviousness analysis because Devane does not teach administering its hydrocodone-only formulation to patients with mild or moderate hepatic impairment. Thus, Persion asserts, "'the natural result flowing from the operation as taught' in Devane cannot be the claimed [pharmacokinetic] values for [hepatically impaired] patients." Appellant's Br. 37 (quoting Oelrich, 666 F.2d at 581 ); Reply Br. 19.
To the extent Persion contends that inherency can only satisfy a claim limitation when all other limitations are taught in a single reference, that position is contrary to our prior recognition that "inherency may supply a missing claim limitation in an obviousness analysis" where the limitation at issue is "the natural result of the combination of prior art elements." PAR, 773 F.3d at 1194-1195 (emphasis added, internal quotations omitted). Here, the district court specifically found that Devane, together with Jain, the state of the prior art at the time of invention, and the Vicodin and Lortab labels, taught the combination of elements that inherently result in the claimed pharmacokinetic parameters. The district court found that a person of ordinary skill in the art would have been motivated, with reasonable expectation of success, to administer an unadjusted dose of the Devane formulation to hepatically impaired patients. There was also no dispute that the Devane formulation, which was identical to the Zohydro ER formulation described in the patents in suit, necessarily exhibited the claimed parameters under these conditions. Pernix, 323 F. Supp. 3d at 607 , 610 . In this context, the district court did not err by finding that the pharmacokinetic limitations of the asserted claims were inherent and added no patentable weight to the pharmacokinetic claims.
Conclusion
No claims are allowed.
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Primary Examiner, Art Unit 1619
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