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 .1
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 August 14, 2026 has been entered.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Status of Claims
Claims 1-3 and 6-10 are pending. Examination is proceeding based on the elected without traverse, the species, (lactose as diluent, povidone, aka PVP as the binder, isopropyl alcohol as the solvent and the lubricant magnesium stearate).
Response to Arguments
Applicant’s arguments, filed Aug 11, 2026 with respect to the obviousness rejection of Claims 1-3 and 6-10 over WO 2014/147526 (WO 526) in view of Martin 2014 have been fully considered and are not persuasive.
The rejection of claims 1-3 and 6-10 is maintained. See below rejection of claims 1-3 and 6-10 and response to Attorney arguments.
Specification
The disclosure is objected to because of the following informalities:
At page 2, line 25: a registration mark “®” is missing between “XELJANZ” and “XR.”
At page 2, line 26: a registration mark “®” is missing after “XELJANZ”.
At page 3, line 1: a registration mark “®” is missing between “XELJANZ” and “XR.”
At page 6, line 10: the specification recites “Xeljanz” instead of “XELJANZ”.
At page 13, line 30: the specification recites “Xeljanz®” instead of “XELJANZ®”.
At page 14, line 10: the specification recites “Xeljanz” instead of “XELJANZ®”.
Specification page 14, line 12: Please delete “Xeljanz” and replace it with “XELJANZ®”. Appropriate correction is required.
Claim Rejections - 35 USC § 112 (Scope of Enablement)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-3 and 6-10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for extended-release tablets as detailed by Examples 4 and 5 (evidenced by the Dissolution Data of Table 6) of the specification, does not reasonably provide enablement for extended-release compositions as claimed. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
Claims 1-3 and 6-10 are directed to ALL extended-release compositions of tofacitinib with the claimed mixture of a first and second PEO in the claimed ratio as recited therein.
Applicant’s attention is drawn to In re Wands, 8 USPQ2d 1400 (CAFC1988) at 1404 where the court set eight forth factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors: (1) the nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
The predictability or unpredictability of the art
The instant claimed invention is highly unpredictable since a person having ordinary skill in the art (PHOSITA) recognizes the unpredictability of formulating extended-release tofacitinib compositions, including tablets, beyond the scope of Applicant’s extended-release tablets of Examples 4 and 5 and noted by the Examples of the Background of the Invention, in particular, the extended-release extrudable core system (ECS) relying on a particular proprietary osmotic delivery system.2
The specification admits the current lack of approved tofacitinib extended-release tablets, where it states,
The commercially available product for Tofacitinib extended-release tablet is in the form of osmotic delivery system. The said tablets having (sic) drilled hole at one end of the tablet. The tablets with osmotic drug delivery is costly, complex and also problems of Gastro intestinal obstruction, serious gastrointestinal reaction, Dose dumping, size of drilled hole is critical, Retrieval therapy is not possible in the case of unexpected adverse events. Also the product known in the prior art for Tofacitinib extended-release tablet contain polyethylene oxide and they are in the form of osmotic drug delivery system and have drilled hole at one end of the tablet. See Background of the Invention, page 4, lines 18-25.
Accordingly, the unpredictability in the art is a Wands factor against enablement of the full scope of the claims.
The breadth of the claims
The claims are broadly directed to any extended-release composition and includes the composition in the form of a tablet, a capsule, a sachet, granules, beads, pellets or a powder. See claim 6. The broad scope is a Wands factor against enablement of the full scope of the claims.
The amount of direction or guidance presented, and the presence or absence of working examples
It has been established that “the amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art.” In re Fisher, 427 F.2d 833, 839 166 USPQ 18, 24 (CCPA 1970).
The enabled tablets, as per the specification, are disclosed to be the specific tablets of Examples 4 and 5 of the specification, as supported by dissolution data of Table 6.
There is no working example, either in vivo or in vitro to enable the full scope of formulations, beyond the particular tablets of Examples 4 and 5. The lack of working examples is a Wands factor against enablement of the full scope of the claims.
Therefore, in view of the Wands factors, Applicant fails to provide information sufficient to practice the full scope of the claimed invention.
Claim Rejections - 35 USC § 112 (Written Description)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-3 and 6-10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The instant claims are broadly directed to any extended-release composition, and includes the forms of a tablet, a capsule, a sachet, granules, beads, pellets or a powder. See claim 6.
Dependent claims 2-3 and 6-10 are similarly rejected as their scope is not supported by the specification.
The specification does not teach or disclose the full scope of the rejected compound claims to demonstrate that the inventors had possession of the clamed method.
At best, Examples 4-5 of Tables 4-5 and dissolution data of Table 6 support the claimed extended-release composition as a tablet, and not the broader claimed scope of any formulation, or those particular compositions (excepting a tablet) of claim 6.
Applicant’s disclosure of Examples 4-5, is not a sufficient representation of the full scope of any claimed extended-release compositions. Other than Examples 4-5, Applicant has not reasonably described a scientific or “systematic” approach to synthesize the full scope of claim 1 and claims dependent. See MPEP 2163.02, the standard for determining compliance with the written description.3 Applicant has not provided reasonably provided a description the support the broader scope of claimed extended-release formulations.
Accordingly, Applicants have not adequately described the invention for the breadth that is claimed. It thus appears that Applicants were not in possession of the claimed invention at the time the application was filed. Accordingly, Applicants have not adequately described the invention for the breadth that is claimed. It thus appears that Applicants were not in possession of the claimed invention at the time the application was filed, and the claimed species of the Examples of the specification do not support the broader claimed genus of extended-release formulations.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-3 and 6-10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1, bullet point b) recites the first and second PEO are present in a ratio 1:4 to 1:5, without reference of how the ratio is to be represented. It is commonly understood in the art that when amounts of compounds, etc. are represented by a ratio, a type of unit of measurement is to be stated, such as weight, volume, molar amounts, etc. No such reference is stated by the claims. An amendment of the claims to recite a “w/w” ratio will overcome this rejection. This amendment is supported by reference to Tables 4-5 of Examples 4-5 where quantities of PEO 900000 to PEO 2000000 are noted to be 20.00 mg : to 80.00 mg and 20.00 mg to 100.00 mg.
New Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 6-10 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2014/147526 (WO 526) in view of Martin 2014, aka Martin, L.M., Rajabi-Siahboomi, A.R. (2014). Applications of Polyethylene Oxide (POLYOX) in Hydrophilic Matrices. [Chapter 5] In: Timmins, P., Pygall, S., Melia, C. (eds) Hydrophilic Matrix Tablets for Oral Controlled Release. AAPS Advances in the Pharmaceutical Sciences Series, vol 16. Springer, New York, NY.
In terms of claim interpretation, the specification states the invention is directed to a “non-osmotic an extended-release composition of Tofacitinib or salt thereof is used in the treatment of Rheumatoid Arthritis. . . . “ See abstract. The specification states “there is need in the art to provide a simple cost effective commercial feasible non[-]osmotic extended-release [oral] tablet of Tofacitinib and which also avoids, minimizes problems associated with osmotic drug delivery system [sic] like Gastrointestinal obstruction. . . . [etc.]” See page 4, 4th full paragraph. “Osmotic drug delivery devices are composed of an osmotically active drug core, which is surrounded by a rate controlling semipermeable membrane.” See page 7, last paragraph.
Similar to the goals of the claimed invention, WO 526 is directed to achieve the goal of treating Rheumatoid arthritis with a sustained release oral composition of tofacitinib, with a desirable sustained pharmacokinetic release profile as defined therein. See paragraph 1, page 1. See also abstract and claim 1.
Note that the art recognized terms, polyethylene oxide, poly (ethylene oxide), PEO and POLYOX will be used interchangeably throughout this office action.
Currently amended claim 1 is directed to an extended-release composition comprising
a) tofacitinib or a pharmaceutically acceptable salt thereof;
b) a mixture comprising a first polyethylene oxide (PEO) having a molecular weight of 900,000 g/mol and a PEO having a molecular weight of 2,000,000 g/mol wherein the first and the second PEO are present in a ratio of 1:4 to 1:5.
c) one or more pharmaceutically acceptable excipients.
Regarding claim 1 WO 526 discloses a once daily pharmaceutical dosage form comprising tofacitinib, or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable carrier, wherein said dosage form is a sustained release dosage form, and when administered to a subject has a mean area under the plasma
concentration versus time curve following administration defined therein. See claim 1.
WO 526 teaches a sustained release pharmaceutical dosage form of its claim 1, wherein said tofacitinib is embedded in a matrix which releases tofacitinib by eroding. See claim 48. Note, like the claimed invention, that disclaims an osmotic drug delivery system, this particular embodiment of WO 526 of claim 48, is distinguished from the osmotic drug delivery systems of WO 526’s claims 28-47.
Regarding the limitation of claim 1 and polyethylene oxide, WO 526 teaches sustained release pharmaceutical dosage form of claim 48, wherein the matrix of the dosage form comprises poly (ethylene oxide) aka PEO. See claim 50. Note that WO 526 teaches an equivalent interchangeable substitute to polyethylene oxide polymer matrix is a hydroxypropyl methylcellulose (HPMC) matrix, see claim 49, as both PEO and HPMC can be used interchangeably with WO 526 composition of claim 48.
Regarding the limitation of claim 1 and polyethylene oxide, WO 526 teaches sustained release pharmaceutical dosage form of claim 48, wherein the matrix of the dosage form comprises poly (ethylene oxide) aka PEO. See claim 50. Note that WO 526 teaches an equivalent interchangeable substitute to polyethylene oxide polymer matrix is a hydroxypropyl methylcellulose (HPMC) matrix, see claim 49, as both PEO and HPMC can be used interchangeably with WO 526 composition of claim 48.
See also page 16, first paragraph that notes “release modifying agents which can optionally be formulated into the matrix include water-soluble polymers such as . . . hydroxypropyl methyl cellulose (HPMC) . . . methyl cellulose [ aka METHOCEL] [and its equivalents] poly (N-vinyl-2- pyrrolidinone) (PVP) [aka povidone], [and] poly(ethylene oxide) (PEO) [aka POLYOX]. . . .” See page 16, first paragraph.
As required by claim 1 and the suggestion of two or more polyethylene oxides, WO 526 teaches that for its sustained release matrix systems, a mixture of tofacitinib with one or more excipients selected to form a matrix capable of limiting the dissolution rate of the tofacitinib into a medium. See bottom page 15 bridging to top of page 16. As required by claim 1 such matrix materials include multiple polymers, such as poly (ethylene oxide) (PEO). See page 16, middle of page. The mixture of polymers of WO 526 suggests a mixture of two more PEOs as claimed. Also note that WO 526 teaches its extended-release compositions, where such water swellable polymer is PEO as claimed. See page 15, line 16 and page 36, lines 1-18.
As required by claim 1, WO 526 teaches a “one or more” additional pharmaceutically acceptable excipient, i.e., “polyacrylic acid.” See claim 51. See also Table 11, page 81, where a hydrophilic matrix tablet composition formulation comprising tofacitinib citrate and the following additional pharmaceutically acceptable excipients: the PEO equivalent Methocel (methyl cellulose) as matrix polymer, lactose monohydrate and magnesium stearate(s), is taught.
While WO 526 teaches the claimed tofacitinib comprising polyethylene oxide as a matrix and at least one additional pharmaceutically acceptable carrier, it does not teach polyethylene oxide excipients with the claimed MW weight ranges from 900000 g/mol to 2000000 g/mol, or the claimed weight ratio.
To address this Martin and Rajabi - Siahboomi 4 (aka Martin 2014), teaches that polyethylene oxide (PEO, aka POLYOX) is an alternative to HPMC in hydrophilic matrices, where the physical and chemical properties make it a suitable candidate for use on its own or in combination with other polymers in hydrophilic matrix formulations. See Section 5.1 Introduction, page 12. With regard to the particular range MW range of 20000 to 10000000 g/mol of PEO, Martin 2014 teaches PEO, aka POLYOX compounds in weights that overlap the claimed range.5 See Tables 5.2 pages 124 bottom of page, reproduced below.
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Also note Figure 5.4 on top of page 130 noting different release profile for different weights of POLYOX (900000 MW, 40000000 MW, 7000000MW) providing a suggestion to a PHOSITA to mix and match various polyethylene oxides, to order to achieve desirable drug releases over time.
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In fact, Fig 5.4, with its varying drug release profiles suggests to a person having ordinary skill in the art (PHOSITA), that mixtures of PEO combined would result in adjustments of release profiles as each PEO of Fig. 5.4 has a unique profile, see WSR 1105 vs WSR-303.
Prior to the filing of the present patent application, it would have been prima facie obvious to a PHOSITA following the teachings of WO 526 to modify tofacitinib extended-release formulations with combinations of polyethylene oxide matrices and other excipients with Martin 2014 in order to arrive at a formulation having the instantly claimed PEO, or POLYOX, molecular weights.
Regarding claim 1 and the limitation of a range where the two PEO mixture is from 1:4 to 1:5 ratio range, while such range is not explicitly recited in WO 526, given that there would be only two PEO mixtures, it would be routine to optimize choices of PEO in terms of choice and weight ratio as claimed as WO teaches a choice of PEO and amount of PEO based on where the PEO makes a bulk of the tofacitinib containing composition. Specifically, WO 526 teaches choice of molecular weight of the PEO depends upon whether the PEO makes a bulk of the non-tofacitinib portion of the tofacitinib containing composition. See page 32, lines 14-19. As per Figure 5.4, a mixture of PEO combined would guide a PHOSITA to adjust amounts of each PEO to arrive at an optimal ratio as claimed.
A PHOSITA would routinely optimize two PEO mixtures in concentration ratio between to adjust the ratio as claimed, especially where Martin 2014 teaches particular PEOs with particular weight ratios as claimed. The PHOSITA would have had a reasonable expectation of success because the cited prior art note the necessity of formulating extended release tablet formulations of tofacitinib to treat rheumatoid arthritis (RA), in non-osmotic forms, with interchangeable polymer matrix systems of PEO mixtures in the MW weight ranges that overlap with the range of MW claimed, to optimize to arrive at the claimed w/w ratio range, where choice of PEO in varying weight ratios as claimed is suggested by WO 526 and Martin 2014.
Regarding claim 2, WO 526 discloses a non-osmotic drug delivery system, see above.
As required by claim 3 where dose is to 11mg or 22 mg, WO 526 discloses: wherein the dosage is 11 mg of tofacitinib (see claim 23) and wherein the dose is 22 mg of tofacitinib (see claim 25). See also Table 11 disclosing a 22 mg tofacitinib tablet.
Regarding claim 6 and the limitations of dosage forms claimed therein, WO 526 discloses its sustained release formulations are meant to include tablets, capsules, multiparticulates or beads. See page 11, first full paragraph. See also Table 11 on page 81 disclosing a 22 mg tofacitinib tablet.
Regarding claim 7 and the disclosed dissolution profile claimed therein, as the claimed composition is taught by the prior art, such dissolution profile is necessarily present. See MPEP 2112.01 II. 6
As required by claims 8-9 and the limitations of a diluent (lactose, microcrystalline cellulose, mannitol); binder (povidone aka polyvinylpyrrolidone aka PVP, hydroxy propyl cellulose (aka HPC)) solvent (isopropyl alcohol or water) and magnesium stearate as lubricant, these are taught in WO 526 as follows. Table 11 at page 81 of WO 526, teaches a tablet formulation relying on Methocel (PEO equivalent as a gel former providing controlled release), lactose as a filler and magnesium stearate as lubricant. WO 526 teaches solvents such as water and isopropanol at page 17, first paragraph, last line. WO 526 teaches binders including PVP and HPC. See page 35, 3rd paragraph.
As required by claim 10’s limitations of techniques, WO 526 teaches tofacitinib multiparticulates can be formed by techniques known in the art (said to be previously discussed with reservoir systems but NOT limited to) such as extrusion and spheronization, wet granulation and fluid bed (dry) granulation. See page 61, last paragraph.
RESPONSE TO ATTORNEY ARGUMENTS:
The Attorney response states that a PHOSITA would not have reasonably selected polyethylene oxide having molecular weight of 900,000 g/mol together with polyethylene oxide having molecular weight of 2000,000 g/mol in the presently claimed ratio ranging from 1 :4 to 1 :5, requesting the obviousness rejection be withdrawn with regard to claim 1, as well as dependent claims 2-3 and 6-10. While Applicant stated claim 2 has been canceled, it nonetheless remains pending in the latest set of claims. See below.
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As detailed above, the prima facie case of obviousness has been established. It is noted that the specific embodiments of Example 4, Table 4 and Example 5, Table 5 note specific tablet formulations as detailed below.
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These working examples appear to recite unexpected results as demonstrated by Table 6, where Examples 4-5, as non-osmotic drug delivery systems, possess similar extended-release dissolution data/release profiles similar to a proven and FDA approved osmotic drug delivery system. See Table 6 comparing Examples 4-5 to the Reference Product .
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Amendment of the claims to be limited to the formulations of Examples 4-5, as supported by Table 6, will likely overcome the prima facie case.
Conclusion and Correspondence
No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM LEE whose telephone number is (571)270-3876. The examiner can normally be reached M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam C. Milligan can be reached at (571) 270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/WILLIAM Y LEE/Examiner, Art Unit 1623
/GEORGE W KOSTURKO/Primary Examiner, Art Unit 1621
1 CONTINUING DATA
This application is a 371 of PCT/IB2021/054195 05/17/2021
FOREIGN APPLICATIONS
INDIA 202021020825 05/18/2020
This application has published as US 20230172934
2 See Lamba et al. “Extended-Release Once-Daily Formulation of Tofacitinib: Evaluation of Pharmacokinetics Compared With Immediate-Release Tofacitinib and Impact of Food" Journal of clinical pharmacology 2016 10 Nov; 56( 11 ): 1362-1371.
Further, per the Background of the Invention of the specification, see also other sustained/extended-release formulations of CN CN110787145, CN 108066319, US20140271842, WO2014174073 and WO2017029587.
3 Whenever the issue arises, the fundamental factual inquiry is whether the specification conveys with reasonable clarity to those skilled in the art that, as of the filing date sought, inventor was in possession of the invention as now claimed. See, e.g., Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991). An applicant shows that the inventor was in possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997). Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was "ready for patenting" such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the inventor was in possession of the claimed invention. See, e.g., Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 68,119 S.Ct. 304,312, 48 USPQ2d 1641, 1647 (1998); Regents of the Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997); Amgen, Inc. v. Chugai Pharm., 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compound by "whatever characteristics sufficiently distinguish it"
4 Martin, L.M., Rajabi-Siahboomi, A.R. (2014). Applications of Polyethylene Oxide (POLYOX) in Hydrophilic Matrices. In: Timmins, P., Pygall, S., Melia, C. (eds) Hydrophilic Matrix Tablets for Oral Controlled Release. AAPS Advances in the Pharmaceutical Sciences Series, vol 16. Springer, New York, NY. https://doi.org/10.1007/978-1-4939-1519-4_5
5 See MPEP 2144.05 with regard to prima facie obviousness with overlapping ranges.
6 II. COMPOSITION CLAIMS — IF THE COMPOSITION IS PHYSICALLY THE SAME, IT MUST HAVE THE SAME PROPERTIES
"Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. (Applicant argued that the claimed composition was a pressure sensitive adhesive containing a tacky polymer while the product of the reference was hard and abrasion resistant. "The Board correctly found that the virtual identity of monomers and procedures sufficed to support a prima facie case of unpatentability of Spada’s polymer latexes for lack of novelty.").
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