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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 November 13, 2025 has been entered.
Formal Matters
Applicant’s claim amendments and arguments in the reply filed on November 13, 2025 are acknowledged and have been fully considered due to the entered request for continued examination. Claims 1, 3 and 7-26 are pending. Claims 1, 3, and 7-26 are under consideration in the instant office action. Claims 2 and 4-6 are cancelled. Applicant’s claim amendments necessitated a new ground of objections and/or rejections under 35 USC 112 as set forth below.
Withdrawn Objections/Rejections
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn as are those rejections and/or objections expressly stated to be withdrawn.
New Objections/Rejections-Necessitated by Amendments
Claim 1 is objected to because of the following informalities: Instant claim 1 recites “a viscosity of 1,000 about 3000 mPa.s”. Applicant placed a comma when reciting 1,000 but not when reciting 3000. Applicant is requested to be consistent in using punctuation when reciting numerical values. Appropriate correction is required.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 3 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 1 recites “A hydroxypropyl cellulose having a molar substitution of from 3.4 to 3.8, a weight average molecular weight of from 1,000,000 to 1,500,000 Daltons, a volume average particle size of less than 100 mm, and a viscosity of 1,000 about 3000 mPa.s in a 1% aqueous solution at 25ºC.” However, claim 3 recites “The hydroxypropyl cellulose of claim 1, wherein the molar substitution is of from about 3.4 to about 3.7.” The recitation in claim 3 “from about 3.4 to about 3.7” does not further limit the recitation in the base claim 1 of from 3.4 to 3.8. It actually broadens the scope of the limitation. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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, 3, and 7-26 remain rejected under 35 U.S.C. 103 as being unpatentable over ROSENBERG et al. (CA 2211671) in view of Durig et al. (Pharmaceutical Technology Report, According to the report the work was presented at the annual meeting of the American Association of Pharmaceutical Scientists, November 7-11, 2004 in Baltimore, Maryland and the report was revised in November 2011).
Applicants’ claims
Applicant claims a hydroxypropyl cellulose having a molar substitution of from 3.4 to 3.8, a weight average molecular weight of from 1,000,000 to 1,500,000 Daltons, a volume average particle size of less than 100 mm, and a viscosity of 1,000 about 3000 mPa.s in a 1% aqueous solution at 25ºC. Claim 7 recites a modified release formulation comprising hydroxypropyl cellulose having a molar substitution of from 3.0 to 3.9, a weight average molecular weight of from 700,000 to 2,000,000 Daltons, and a volume average particle size of less than 100 mm. Dependent claims thereof recite features further limit the limitations of claim 7.
Determination of the Scope and Content of the Prior Art
(MPEP 2141.01)
ROSENBERG et al. teach preparations containing active agents obtainable by the melt extrusion of A) a water-soluble thermoplastic hydroxypropyl cellulose, B) one or more active agents, C) if desired, pharmaceutical auxiliaries, in which the proportion of A) is 10 to 30 % wt. in relation to the entire preparation (see abstract). The component A) used according to the invention is a water-soluble thermoplastic hydroxypropyl cellulose which preferably has a molar degree of substitution of from 3.0 to 4.4. "Molar degree of substitution" refers to the average number of moles of propylene oxide which have reacted per glucose unit in the cellulose (see page 2, lines 24-28). The hydroxypropyl cellulose can have melt viscosities measured by the DIN 53735 method in the range from 0.075 to 54.8 g/10 min (see page 2, lines 30-31). The molecular weight of the hydroxypropyl cellulose can vary with-in wide limits depending on whether slower or faster release of active ingredient is desired. Hydroxypropyl cellulose with molecular weights in the range from 200,000 to 1,500,000 is suitable in particular for producing drug forms in which slow release of active ingredients is desired, since the polymers of higher molecular weight dissolve less well, and only with swelling, in water. If, however, it is intended to produce drug forms with faster release of active ingredient, it is advisable to use polymers of lower molecular weight which are readily soluble in water, it being possible in this case to use hydroxypropyl cellulose with a molecular weight of from 60,000 to 200,000, preferably 60,000 to 100, 000 (see page 2, lines 33-46). The content of hydroxypropyl cellulose in the composition is from 10 to 30%, preferably 20 to 30%, of the total weight thereof (see page 3, lines 4-5). Suitable as component B) in the compositions are active ingredients or mixtures of active ingredients which are thermally stable under the processing conditions. Examples of suitable active ingredients according to the invention are: acebutolol, acetylcysteine, acetylsalicylic acid, aciclovir, alprazolam, albumin, alfacalcidol, allantoin, allopurinol, ambroxol, amikacin, amiloride, aminoacetic acid, amiodarone, ami-triptyline, amlodipine, amoxicillin, ampicillin, ascorbic acid, aspartame, astemizole, atenolol, beclometasone, benserazide, benzalkonium hydroxide, benzocaine, benzoic acid, betametasone, 20 bezafibrate, biotin, biperiden, bisoprolol, bromazepan, bromhex-ine, bromocriptine, budesonide, bufexamac, buflomedil, buspirone; caffeine, camphor, captopril, carbamazepine, carbidopa, carbopla-tin, ~-carotene and other carotenoids, cefachlor, cefalexin, cefa-droxil, cefazolin, cefixime, cefotaxime, ceftazidine, ceftriaxone, cefuroxime axetil, chloramphenicol, chlorhexidine, chlorpheniramine, chlortalidone, choline, ciclosporin, cilastatin, cime-tidine, ciprofloxacin, cisapride, cisplatin, clarithromycin, cla-vulanic acid, clomipramine, clonazepam, clonidine, clotrimazole, clozapine, codeine, colestyramine, cromoglicic acid, cyanocobalamin, cyproterone desogestrel, dexamethasone, dexpanthenol dextro-methorphan, dextropropoxiphene, diazepam, diclofenac, digoxin, dihydrocodeine, dihydroergotamine, diltiazem, diphenhydramine, dipyridamole, dipyrone, disopyramide, domperidone, dopamine, en-alapril, ephedrine, epinephrine, ergocalciferol, ergotamine, erythromycin, estradiol, ethinylestradiol, etoposide, Eucalyptusglobulus, fam-otidine, felodipine, fenofibrate, fenoterol, fenta-nyl, flavin mononucleotide, fluconazole, flunarizine, fluoroura-cil, fluoxetine, flurbiprofen, furosemide, gemfibrozil, gentami-cin, Ginkgo biloba, glibenclamide, glipizide, Glycyrrhiza glabra, guaifenesin, haloperidol, heparin, hyaluronic acid, hydrochloro-thiazide, hydrocodone, hydrocortisone, hydromorphon, ipratropium hydroxide, ibuprofen, imipenem, indomethacin, iohexol, iopamidol, isosorbide dinitrate, isosorbide mononitrate, isotretinoin, keto-tifen, ketoconazole, ketoprofen, ketorolac, labetalol, lactulose, lecithin, levocarnitine, levodopa, levoglutamide, levonorgestrel, levothyroxine, lidocaine, lipase, lisinopril, loperamide, loraze-pam, lovastatin, medroxyprogesterone, menthol, methotrexate, methyldopa, methylprednisolone, metoclopramide, metoprolol, miconazole, midazolam, minocycline, minoxidil, misoprostol, morphine, multivitamins and minerals, nystatin, N-methyl-ephedrine, naftidrofuril, naproxen, neomycin, nicardipine, nicergoline, nicotinamide, nicotine, nicotinic acid, nifedipine, nimodipine, nitrendi-pine, nizatidine, norethisterone, norfloxacin, norgestrel, nor-triptlyine, ofloxacin, omeprazole, ondansetron, pancreatin, pan-thenol, pantothenic acid, paracetamol, penicillin G, penicillin V, phenobarbital, pentoxifylline, phenylephrine, phenylpropanolamine, phenytoin, piroxicam, polymyxin B, povidone-iodine, pravas-tatin, prazosin, prednisolone, propafenone, propranolol, pseudo-ephedrine, pyridoxine, quinidine, ramipril, ranitidine, reser-pine, retinol, riboflavin, rifampicin, rutoside, saccharin, sal-butamol, salcatonin, salicylic acid, selegiline, simvastatin, somatotropin, sotalol, spironolactone, sucralfate, sulbactam, sul-famethoxazole, sulpiride, tamoxifen, tegafur, teprenone, terazosin, terbutaline, terfenadine, theophylline, thiamine, ticlopidine, timolol, tranexamic acid, tretinoin, triamcinolone aceto-nide, triamterene, trimethoprim, troxerutin, uracil, valproic acid, vancomycin, verapamil, vitamin E, folinic acid, zidovudine. Crop protection agents are also suitable as active ingredients (see page 3, lines 7-47 to page 4, lines 1-24). The amount of active ingredient component B) in the complete composition may vary within wide limits depending on the activity. Thus, the content of B) can be from 0.1 to 90% of the total weight of the composition (see page 4, lines 25-28). The compositions according to the invention can furthermore contain as components C) conventional pharmaceutical ancillary substances as long as they are thermally stable under the processing conditions, eg. fillers or extenders, lubricants, plasticizers, stabilizers, dyes or pigments, disintegrants, preservatives or flavorings. Examples of suitable fillers are organic compounds such as lactose or mannitol or inorganic substances such as silica or silicates, oxides of magnesium, aluminium or titanium. Fillers which are readily soluble in water, such as lactose or mannitol, are suitable, for example, for producing compositions with an increased rate of release of active ingredient. The content of fillers in the composition depends on the dosage of active ingredient. In the case of active ingredients with low dosage, it is possible according to the invention to achieve, by higher filler contents, a higher tablet weight without adversely affecting the melt processability. In the case of active ingredients requiring very low doses, the amount of filler can be up to about 90% by weight. The examiner notes that lactose also is considered as a binder as recited in claim 24. Examples of lubricants which may be mentioned are stearates of aluminum or calcium, and talc and silicones, the amount thereof being about 0.1 to 5, preferably 0.1 to 3, % by weight (see page 4, lines 30-46 and page 5, lines 1-25). The compositions according to the invention are used as drugs in the form of tablets or granules or employed as pellets in capsule (see page 6, lines 5-7).
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP 2141.02)
ROSENBERG et al. do not specifically teach the volume average particle size and viscosity of the hydroxypropyl cellulose as recited in claims 1 and 13-14. These deficiencies are cured by the teachings of Durig et al.
Durig et al. teach in the introduction section as follows:
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Finding of Prima Facie Obviousness Rational and Motivation
(MPEP 2142-2143)
It would have been prima facie obvious to a person of ordinary skill before the effective filing date of the instant invention to modify the teachings of ROSENBERG et al. by utilizing HPC with average particle size of less than 100 mm and with viscosity values as recited in claims 1 and 13-14 because Durig et al. teach in the introduction section as follows:
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One of ordinary skill in the art would have been motivated to utilize HPC with average particle size and viscosity values as recited because Durig et al. teach the advantages of having fine particle sizes, molecular weight, and their correlated viscosity values at different grades that can be used to slow or modified release of active agents.
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As clearly shown above Durig et al. teach typical mean particle size between 80 and 100 mm. The selection of a known material 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. "Reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle." 325 U.S. at 335, 65 USPQ at 301.).
A person of ordinary skill in the art would have had a reasonable expectation of success in combining the teachings of ROSENBERG et al. and Durig et al. because both references teach slow or modified release compositions utilizing HPC. Furthermore, in the case where the claimed molecular weights, particles sizes, amounts of ingredients, viscosity of polymer "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). Furthermore, differences in concentration, molecular weight, particle size, viscosity etc., 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).
The molecular weight of the hydroxypropyl cellulose can vary with-in wide limits depending on whether slower or faster release of active ingredient is desired. Hydroxypropyl cellulose with molecular weights in the range from 200,000 to 1,500,000 is suitable in particular for producing drug forms in which slow release of active ingredients is desired, since the polymers of higher molecular weight dissolve less well, and only with swelling, in water. The examiner reminds Applicant that both the molar degree of substitution, molecular weights, and particle sizes are overlapping in scope.
Furthermore, with respect to the volume average particle size and viscosity of the hydroxypropyl cellulose, the examiner also reminds Applicant that "[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.
In light of the forgoing discussion, the Examiner concludes 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 was 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 argues Rosenberg describes preparations containing active agents that can be produced through melt extrusion of A) a water-soluble thermoplastic hydroxypropyl cellulase, B) one or more active agents, and C) optionally, pharmaceutical auxiliaries. The proportion of A) is 10 to 30% by weight of the entire preparation (see Abstract).The current application does not disclose the preparation of HPC using the melt extrusion process. Durig discloses the general state of the art, describing various grades of HPC along with physical characteristics data, but it does not mention problems and solutions as in the current application. Furthermore, HPC grade HFX, which is described in Durig et al., has been referenced in the current application as a comparative example (example 5) and analyzed in relation to inventive HPC samples.
The above assertions are not found persuasive because as Applicant is claiming a composition of matter the examiner showed in the rejection how the claimed structure is met by the combination teachings of Rosenberg and Durig. Applicant in their arguments to the rejections set forth in the previous office action under 35 USC 103 failed to explain and show how structurally the claimed composition is different from the structure taught by the combination teachings of Rosenberg and Durig. Applicant is claiming a product claim not a method of making the product. The process in which the product is made is not a recited limitation in the current claims. Therefore, the process in which Rosenberg and Durig make the HPC is not considered a point of difference. Furthermore, the final product HPC is the same or substantially similar as clearly described above. Regarding a comparative HPC, the closest prior art is Rosenberg et al. who teach the molar substitution values in overlapping manner. It is very clear in comparative example 5 it is the molar substitution values which are different. The examiner reminds Applicant that Klucel HXF is available in the market with different varieties. The examiner herein for instance provides solely to rebut Applicant’s arguments, Sasa et al. (European journal of pharmaceutical sciences 27 (2006) 375–383) who teach hydroxypropyl cellulose (HPC, Klucel 99-HXF, Aqualon, Hercules; ≅ 1,150,000, molar substitution ≅ 3.7) (see page 376, materials and methods section).
In response to applicant's argument that the claimed HPC exhibits several superior properties, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). It should be noticed that Rosenberg teaches HPC with which preferably has a molar degree of substitution of from 3.0 to 4.4. "Molar degree of substitution" refers to the average number of moles of propylene oxide which have reacted per glucose unit in the cellulose (see page 2, lines 24-28). The hydroxypropyl cellulose can have melt viscosities measured by the DIN 53735 method in the range from 0.075 to 54.8 g/10 min (see page 2, lines 30-31). The molecular weight of the hydroxypropyl cellulose can vary with-in wide limits depending on whether slower or faster release of active ingredient is desired. Hydroxypropyl cellulose with molecular weights in the range from 200,000 to 1,500,000 is suitable in particular for producing drug forms in which slow release of active ingredients is desired, since the polymers of higher molecular weight dissolve less well, and only with swelling, in water. The examiner reminds Applicant that both the molar degree of substitution and molecular weights are overlapping in scope. ROSENBERG et al. is silent with respect to the volume average particle size and viscosity of the hydroxypropyl cellulose. These deficiencies are cured by the teachings of Durig et al. It would have been prima facie obvious to a person of ordinary skill before the effective filing date of the instant invention to modify the teachings of ROSENBERG et al. by utilizing HPC with average particle size of less than 100 mm and with viscosity values as recited in claims 6 and 13-14 because Durig et al. teach in the introduction section as follows:
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One of ordinary skill in the art would have been motivated to utilize HPC with average particle size and viscosity values as recited because Durig et al. teach the advantages of having fine particle sizes, molecular weight, and their correlated viscosity values at different grades that can be used to slow or modified release of active agents.
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The selection of a known material 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. "Reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle." 325 U.S. at 335, 65 USPQ at 301.).
A person of ordinary skill in the art would have had a reasonable expectation of success in combining the teachings of ROSENBERG et al. and Durig et al. because both references teach slow or modified release compositions utilizing HPC. Furthermore, in the case where the claimed molecular weights, particles sizes, amounts of ingredients, viscosity of polymer "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). Furthermore, differences in concentration, molecular weight, particle size, viscosity etc., 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). Applicants did not point out what are the supposed errors of the combination.
Furthermore, with regard to the argument “the invention exhibits superior properties listed in the arguments section” Any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986) (differences in sedative and anticholinergic effects between prior art and claimed antidepressants were not unexpected). In In re Waymouth, 499 F.2d 1273, 1276, 182 USPQ 290, 293 (CCPA 1974), the court held that unexpected results for a claimed range as compared with the range disclosed in the prior art had been shown by a demonstration of "a marked improvement, over the results achieved under other ratios, as to be classified as a difference in kind, rather than one of degree." Compare In re Wagner, 371 F.2d 877, 884, 152 USPQ 552, 560 (CCPA 1967) (differences in properties cannot be disregarded on the ground they are differences in degree rather than in kind); Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992) ("we generally consider a discussion of results in terms of ‘differences in degree’ as compared to ‘differences in kind’ . . . to have very little meaning in a relevant legal sense"). See also UCB, Inc. v. Actavis Labs, UT, Inc., 65 F.4th 679, 693, 2023 USPQ2d 448 (Fed. Cir. 2023) ("A difference of degree is not as persuasive as a difference in kind – i.e., if the range produces ‘"a new property dissimilar to the known property,’" rather than producing a predictable result but to an unexpected extent."). The examiner contends that given the structural similarity of the HPC taught by Rosenberg and Durig with the claimed HPC, the alleged unexpected results is not unexpected results. Additionally, the evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992) (Mere conclusions in appellants’ brief that the claimed polymer had an unexpectedly increased impact strength "are not entitled to the weight of conclusions accompanying the evidence, either in the specification or in a declaration."); Ex parte C, 27 USPQ2d 1492 (Bd. Pat. App. & Inter. 1992) (Applicant alleged unexpected results with regard to the claimed soybean plant, however there was no basis for judging the practical significance of data with regard to maturity date, flowering date, flower color, or height of the plant.). See also In re Nolan, 553 F.2d 1261, 1267, 193 USPQ 641, 645 (CCPA 1977) and In re Eli Lilly, 902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir. 1990) as discussed in MPEP § 716.02(c). Even furthermore, whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980) (Claims were directed to a process for removing corrosion at "elevated temperatures" using a certain ion exchange resin (with the exception of claim 8 which recited a temperature in excess of 100°C). Appellant demonstrated unexpected results via comparative tests with the prior art ion exchange resin at 110°C and 130°C. The court affirmed the rejection of claims 1-7 and 9-10 because the term "elevated temperatures" encompassed temperatures as low as 60°C where the prior art ion exchange resin was known to perform well. The rejection of claim 8, directed to a temperature in excess of 100°C, was reversed.). See also In re Peterson, 315 F.3d 1325, 1329-31, 65 USPQ2d 1379, 1382-85 (Fed. Cir. 2003) (data showing improved alloy strength with the addition of 2% rhenium did not evidence unexpected results for the entire claimed range of about 1-3% rhenium); In re Grasselli, 713 F.2d 731, 741, 218 USPQ 769, 777 (Fed. Cir. 1983) (Claims were directed to certain catalysts containing an alkali metal. Evidence presented to rebut an obviousness rejection compared catalysts containing sodium with the prior art. The court held this evidence insufficient to rebut the prima facie case because experiments limited to sodium were not commensurate in scope with the claims.).
Conclusion
No claims are allowed.
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/TIGABU KASSA/Primary Examiner, Art Unit 1619