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 claim amendments and arguments in the reply filed 31 October 2025 are acknowledged and have been fully considered. Claims 1, 10-13, 15-17, and 24-33 are pending. Claims 1, 10-13, 15-17, and 24-33 are under consideration in the instant office action. Claims 2-9,14, and 18-23 are canceled. Claims 26-33 are newly added. Applicant’s claim amendments and arguments did not overcome the rejections under 35 USC 103 for reasons set forth below.
Withdrawn Objections/Rejections
Rejections and/or objections not reiterated from the previous office actions are hereby withdrawn as are those rejections and/or objections expressly stated to be withdrawn.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, 10-11, 13, 15-17, 24-25, and newly added claims 26-33 are rejected under 35 U.S.C. 103 as being unpatentable over Santi et al. (WO 01/92255) in view of Kooner et al. (Invest New Drugs. 2012 December ; 30(6): 2294–2302)
Applicants’ claims
Applicants claim a liposome composition comprising Utidelone, a phospholipid, and optionally a sterol. Dependent claims thereof further define other limitations such as types of phospholipids and sterols and other features.
Determination of the Scope and Content of the Prior Art
(MPEP 2141.01)
Santi et al. in Example 32 teach liposomal compositions containing 9-oxo epothilone. A mixture of lipids and 9-oxo-epothilone D are dissolved in ethanol and the solution is dried as a thin film by rotation under reduced pressure. The resultant lipid film is hydrated by addition of the aqueous phase and the particle size of the epothilone-derivative containing liposomes is adjusted to the desired range. The Examiner notes that Epothilone D is another name of Utidelone. Preferably, the mean particle diameter is less than 10 microns, preferably from about 0.5 to about 4 microns. The particle size may be reduced to the desired level, for example, by using mills (e.g., air-jet mill, ball mill, or vibrator mill), microprecipitation, spray-drying, lyophillization, high-pressure homogenization, recrystrytallization from supercritical media, or by extruding an aqueous suspension of the liposomes through a series- of membranes (e.g., polycarbonate membranes) having a selected uniform pore size. In one embodiment, the liposomal composition comprises: an inventive compound (1.00 mg); phosphatidylcholine (16.25 mg); cholesterol (3.75 mg); polyethyleneglycol derivatized distearyl phosphatidylethanolamine (5.00 mg); lactose (80.00 mg); citric acid (4.20 mg); tartaric acid (6.00 mg); NaOH (5.44 mg); water (up to 1 mL). In another embodiment, the liposomal composition comprises: an inventive compound (1.00 mg); phosphatidylcholine (19.80 mg); cholesterol (3.75 mg); distearyl phosphatidylcholine (1.45 mg); lactose (80.00 mg); citric acid (4.20 mg); tartaric acid (6.00 mg); NaOH (5.44 mg); water (up to 1 mL). In yet another embodiment, the liposomal composition comprises: an inventive compound (1.00 mg); l-palmitoyl-2-oleyl-sn-glycero-3-phosphocholine (17.50 mg); l-palmitoyl-2-oleyl-sn- glycero-3-phosphoglycerol, Na (7.50 mg); lactose (80.mg); citric acid (4.20 mg); tartaric acid (6.00 mg); NaOH (5.44 mg); water (up to 1 mL). Liposomal compositions containing other compounds of the present invention are prepared using conditions similar to those described above. Santi et al. also teach that the inventive methods can be used with epothilones C and D (which the examiner notes epothilone D is Utidelone) and with any other naturally occurring epothilone compounds having a double bond (see pages 17-18). In one embodiment, the compounds and compositions of the present invention are used in combination with another anti-cancer agent or procedure. Illustrative examples of other anti-cancer agents include but are not limited to: (i) alkylating drugs such as mechlorethamine, chlorambucil, Cyclophosphamide, Melphalan, Ifosfamide; (ii) antimetabolites such as methotrexate; (iii) microtubule stabilizing agents such as vinblastin, paclitaxel, docetaxel, and discodermolide; (iv) angiogenesis inhibitors; (v) and cytotoxic antibiotics such as doxorubicon (adriamycin), bleomycin, and mitomycin. Illustrative examples of other anti-cancer procedures include: (i) surgery; (ii) radiotherapy; and (iii) photodynamic therapy (see page 40). The amount of active ingredient that may be combined with the carrier materials to produce a single dosage form will vary depending upon the subject treated and the particular mode of administration. For example, a formulation for intravenous use comprises an amount of the inventive compound ranging from about 1 mg/mL to about 25 mg/mL, preferably from about 5 mg/mL to 15 mg/mL, and more preferably about 10 mg/mL. Intravenous formulations are typically diluted between about 2 fold and about 30 fold with normal saline or 5% dextrose solution prior to use (pages 38-39). Illustrative formulations for intravenous use and pretreatment regiments are described by Examples 35 and 36 respectively (see page 40).
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP 2141.02)
Although Santi et al. teach a derivative of Utidelone which is 9-oxo-epothilone D, Santi et al. do not specifically teach or exemplify Utidelone. These deficiencies are cured by the teachings of Konner et al.
Konner et al. teach agents that target microtubules have potent cytotoxic effects, and are among the most commonly prescribed anti-cancer therapies. The taxanes (paclitaxel and docetaxel) bind and stabilize tubulin, preventing depolymerization of microtubules, resulting in G2/M phase arrest and induction of apoptosis. Taxanes have well-documented activity in several malignancies including breast, ovarian, and lung cancer. Despite this activity, acquired drug resistance is frequently encountered through over-expression of drug efflux protein P- glycoprotein or mutation of β-tubulin . In addition, many tumor types are inherently resistant to taxanes (see introduction, page 2). Epothilone D (KOS-862) (Figure 1), is a more potent microtubule stabilizer in vitro than epothilone A or B. In vitro, KOS-862 (Epothilone D) has shown potent cytotoxicity in a panel of human tumor cell lines, with similar potency to paclitaxel. It also showed a definite advantage over paclitaxel in drug-resistant cell lines, and retained its cytotoxicity against a multidrug resistant cell line over-expressing P-glycoprotein. In vivo, antitumor efficacy has been observed in both paclitaxel-sensitive and -resistant xenografts, as well as certain multidrug resistant xenografts including a doxorubin-resistant CCRF-CEM leukemic cell xenograft (see introduction, page 2).
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 Santi et al. by incorporating or utilizing Utidelone because Konner et al. teach agents that target microtubules have potent cytotoxic effects, and are among the most commonly prescribed anti-cancer therapies. The taxanes (paclitaxel and docetaxel) bind and stabilize tubulin, preventing depolymerization of microtubules, resulting in G2/M phase arrest and induction of apoptosis. Taxanes have well-documented activity in several malignancies including breast, ovarian, and lung cancer. Despite this activity, acquired drug resistance is frequently encountered through over-expression of drug efflux protein P- glycoprotein or mutation of β-tubulin . In addition, many tumor types are inherently resistant to taxanes (see introduction, page 2). One of ordinary skill in the art would have been motivated to do so because Kooner et al. teach that Epothilone D (KOS-862) which is Utidelone (Figure 1), is a more potent microtubule stabilizer in vitro than epothilone A or B. In vitro, KOS-862 (Epothilone D) has shown potent cytotoxicity in a panel of human tumor cell lines, with similar potency to paclitaxel. It also showed a definite advantage over paclitaxel in drug-resistant cell lines, and retained its cytotoxicity against a multidrug resistant cell line over-expressing P-glycoprotein. In vivo, antitumor efficacy has been observed in both paclitaxel-sensitive and -resistant xenografts, as well as certain multidrug resistant xenografts including a doxorubin-resistant CCRF-CEM leukemic cell xenograft (see introduction, page 2). Furthermore, it must be noticed that Santi et al. clearly teach that the inventive methods can be used with epothilones C and D (which the examiner notes epothilone D is Utidelone) and with any other naturally occurring epothilone compounds having a double bond (see pages 17-18). In one embodiment, the compounds and compositions of the present invention are used in combination with another anti-cancer agent or procedure. Illustrative examples of other anti-cancer agents include but are not limited to: (i) alkylating drugs such as mechlorethamine, chlorambucil, Cyclophosphamide, Melphalan, Ifosfamide; (ii) antimetabolites such as methotrexate; (iii) microtubule stabilizing agents such as vinblastin, paclitaxel, docetaxel, and discodermolide; (iv) angiogenesis inhibitors; (v) and cytotoxic antibiotics such as doxorubicon (adriamycin), bleomycin, and mitomycin. Illustrative examples of other anti-cancer procedures include: (i) surgery; (ii) radiotherapy; and (iii) photodynamic therapy (see page 40).
The particle size and amount of active and other ingredients is a result effective parameter as demonstrated by Santi et al. above and it is within the purview of one of ordinary skill in the art to tune the particle size of the granules. In the case where particle size and amount of active and other ingredients "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 or particle size or density 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). One of ordinary skill in the art would have had a reasonable expectation of success in combining the teachings of Santi et al., and Kooner et al. because both references are drawn to compositions containing epothilone D.
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.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Santi et al. (WO 01/92255) in view of Kooner et al. (Invest New Drugs. 2012 December ; 30(6): 2294–2302) as applied to claims 1, 10-11, 13, 15-17, and 24-33 above, and further in view of Danaei et al. (Pharmaceutics, 10, 57, 1-17, 2018).
Applicants’ claims
Applicants claim a liposome composition comprising Utidelone, a phospholipid, and optionally a sterol. Dependent claims thereof further define other limitations such as types of phospholipids and sterols and other features.
Determination of the Scope and Content of the Prior Art
(MPEP 2141.01)
The teachings of Santi et al. and Kooner et al. are described above in detail and are incorporated by reference herein.
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP 2141.02)
Santi et al. and Kooner et al. do not specifically teach that the liposome composition have an average polydispersity index (PDI) of less than 0.25. This deficiency is cured by the teachings of Danaei et al.
Danaei et al. teach Lipid-based drug delivery systems, or lipidic carriers, are being extensively employed to enhance the bioavailability of poorly-soluble drugs. They have the ability to incorporate both lipophilic and hydrophilic molecules and protecting them against degradation in vitro and in vivo. There is a number of physical attributes of lipid-based nanocarriers that determine their safety, stability, efficacy, as well as their in vitro and in vivo behaviour. These include average particle size/diameter and the polydispersity index (PDI), which is an indication of their quality with respect to the size distribution. The suitability of nanocarrier formulations for a particular route of drug administration depends on their average diameter, PDI and size stability, among other parameters. Controlling and validating these parameters are of key importance for the effective clinical applications of nanocarrier formulations. This review highlights the significance of size and PDI in the successful design, formulation and development of nanosystems for pharmaceutical, nutraceutical and other applications. Liposomes, nanoliposomes, vesicular phospholipid gels, solid lipid nanoparticles, transfersomes and tocosomes are presented as frequently-used lipidic drug carriers. The advantages and limitations of a range of available analytical techniques used to characterize lipidic nanocarrier formulations are also covered (see abstract). PDI is basically a representation of the distribution of size populations within a given sample. The numerical value of PDI ranges from 0.0 (for a perfectly uniform sample with respect to the particle size) to 1.0 (for a highly polydisperse sample with multiple particle size populations). Values of 0.2 and below are most commonly deemed acceptable in practice for polymer-based nanoparticle materials. In drug delivery applications using lipid-based carriers, such as liposome and nanoliposome formulations, a PDI of 0.3 and below is considered to be acceptable and indicates a homogenous population of phospholipid vesicles (see page 8).
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 Santi et al. and Kooner et al. by preparing the liposome compositions with an average polydispersity index (PDI) of less than 0.25 because Danaei et al. teach Lipid-based drug delivery systems, or lipidic carriers, are being extensively employed to enhance the bioavailability of poorly-soluble drugs. They have the ability to incorporate both lipophilic and hydrophilic molecules and protecting them against degradation in vitro and in vivo. There is a number of physical attributes of lipid-based nanocarriers that determine their safety, stability, efficacy, as well as their in vitro and in vivo behaviour. These include average particle size/diameter and the polydispersity index (PDI), which is an indication of their quality with respect to the size distribution. The suitability of nanocarrier formulations for a particular route of drug administration depends on their average diameter, PDI and size stability, among other parameters. Controlling and validating these parameters are of key importance for the effective clinical applications of nanocarrier formulations. This review highlights the significance of size and PDI in the successful design, formulation and development of nanosystems for pharmaceutical, nutraceutical and other applications. Liposomes, nanoliposomes, vesicular phospholipid gels, solid lipid nanoparticles, transfersomes and tocosomes are presented as frequently-used lipidic drug carriers. The advantages and limitations of a range of available analytical techniques used to characterize lipidic nanocarrier formulations are also covered (see abstract). One of ordinary skill in the art would have been motivated to do so because Danaei et al. teach that PDI is basically a representation of the distribution of size populations within a given sample. The numerical value of PDI ranges from 0.0 (for a perfectly uniform sample with respect to the particle size) to 1.0 (for a highly polydisperse sample with multiple particle size populations). Values of 0.2 and below are most commonly deemed acceptable in practice for polymer-based nanoparticle materials. In drug delivery applications using lipid-based carriers, such as liposome and nanoliposome formulations, a PDI of 0.3 and below is considered to be acceptable and indicates a homogenous population of phospholipid vesicles (see page 8). The particle size, amount of active and other ingredients, and polydispersity index (PDI) are result effective parameters. In the case where particle size, amount of active and other ingredients, and polydispersity index (PDI), etc., "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 or particle size or PDI 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). One of ordinary skill in the art would have had a reasonable expectation of success in combining the teachings of Santi et al., Kooner et al., and Danaei et al. because Santi et al. and Danaei et al. are drawn to liposome compositions for the delivery of actives while Kooner is drawn to the type of active Utidelone.
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's arguments filed 31 October 2025 have been fully considered but they are not persuasive.
Applicant argues Santi does not disclose or suggest a solution to this problem as Santi fails to teach or exemplify Utidelone. Therefore, one skilled in the art would not have had a motivation or a reasonable expectation of success to arrive at the liposome composition comprising Utidelone of amended claim 1 in view of Santi. Consequently, amended claim 1 is patentable over Santi. Kooner does not cure the deficiencies of Santi. Kooner discloses that Epothilone D (KOS-862) is a more potent microtubule stabilizer in vitro than epothilone A or B. In vivo, Epothilone D shows significant in vivo antitumor efficacy in both paclitaxel-sensitive and paclitaxel-resistant xenograft models. Kooner does not disclose or suggest any liposomal composition of Utidelone, let alone how to obtain a stable Utidelone liposome composition with high encapsulation efficiency. A discussion of the unexpected results and encapsulation efficiency occurs below in Section I (ii). Therefore, one skilled in the art would not have had a motivation or a reasonable expectation of success to arrive at the liposome composition comprising Utidelone of amended claim 1 in view of Santi or Kooner. Consequently, amended claim 1 is patentable over Santi or Kooner. See the Declaration paragraph 10. On page 14, the Office Action states "Santi et al. also teach that the inventive methods can be used with epothilones C and D (which the examiner notes epothilone D is Utidelone) and any other naturally occurring epothiolone compounds having a double bond." Applicant presents that in light of pages 16-19 of Santi, the inventive methods refer to the methods for obtaining epothilones C and D as starting materials as opposed to liposome compositions comprising Utidelone. Since the considerations for synthesizing a compound and preparing its liposomal formulation are distinct, such teachings would not enable a person skilled in the art to directly apply the method for preparing 9-oxo epothilone D liposomes to the preparation of epothilone D liposomes. See the Declaration paragraph 11. Therefore, although Example 32 of Santi generally describes liposomal compositions containing 9-oxo-epothilone D, it does not reveal whether the resulting liposomes are stable and possess high encapsulation efficiency. A person skilled in the art, upon repeating the experiment in Santi would find that the resulting liposomes are not stable and thus lack practical significance, see unexpected results below. Consequently, there would be no motivation for the person skilled in the art to substitute epothilone D for 9-oxo-epothilone D and reasonably expect that the resulting epothilone D liposomal composition would be a stable liposome with high encapsulation efficiency. Kooner does not involve liposomes at all and thus cannot provide any technical teaching regarding how to obtain a stable epothilone D liposomal composition with high encapsulation efficiency. See the Declaration paragraph 12. Example 2, table 1 of the present application as filed demonstrates that the Utidelone liposomes prepared according to the present application have extremely high stability with a drug content close to 100% for up to two months, when stored at 2-8 °C. Moreover, Examples 3, 4, 6, and 8-16 of the application as filed all disclose Utidelone liposomes with more than 90% encapsulation efficiency. See the Declaration paragraph 13. In contrast, Example 32 of Santi generically describes the preparation process of liposomal compositions containing a 9-oxo epothilone D. It remains uncertain whether this method ultimately yields a stable, high-encapsulation-efficiency liposomal composition. To verify this, the inventors prepared a 9-oxo-epothilone D liposomal composition following the method described in Santi, with the specific steps as follows: 10.4 mg of 9-oxo-epothilone D, 190.4 mg of EPC, 37.8 mg of cholesterol, and 44.4 mg DSPE-PEG were weighed, charged into a flask, then dissolved in 4 ml of anhydrous ethanol, and formed a lipid film by removing the ethanol using rotatory evaporation (IKA, RV10) at 40°C. The lipid film was hydrated with a hydrating solvent (8% lactose in a pH 5.23 citrate-tartrate buffer, 10 ml) at 45-50°C. After hydration, the hydrated solution was extruded using an extruder (Avanti) with a 100-nm extrusion film. However, the extrusion process was difficult and ultimately unsuccessful, with visible precipitate observed by the naked eye. Obviously, the 9-oxo-epothilone D liposomal composition as prepared has poor stability. This experiment demonstrates that there is no predictability regarding the formation of stable liposomes for a given active ingredient. See the Declaration paragraph 7. Further, the inventors prepared a liposomal composition using 9-oxo epothilone D according to the method described in Example 14 of the present application as filed, with the specific steps as follows: 12.2 mg of 9-oxo epothilone D, 192.1 mg of EPC, 37.8 mg of DSPE-PEG, and 14.2 mg of cholesterol were weighed, charged into a flask, then dissolved by addition of 2 ml of organic solvents (chloroform, methanol and water in a ratio of 95:4:1), and formed a lipid film by removing the organic solvents using rotatory evaporation (IKA, RV10) at 40°C. The lipid film was hydrated with a hydrating solvent (10% sucrose solution, 3 ml) at 25-35°C. After the hydration, the hydrated solution was extruded 10-15 times using an extruder (Avanti) with a 100-nm extrusion film. After the extrusion was completed, precipitate was visibly observed by the naked eye. The liposome solution was filtered using a 0.22-µm polyethersulfone filter membrane. The hydrated particle size of the liposomes was determined by using dynamic light scattering (DLS) to be 127.24 nm, with a polydispersity index (PDI) of 0.082. The encapsulation efficiency was less than 70%. In contrast, the Utidelone liposomes prepared in Example 14 of the present application have more than 90% encapsulation efficiency. This clearly demonstrates that the structure of the encapsulated drug significantly impacts the stability and encapsulation efficiency of the resulting liposomes. See the Declaration paragraph 8. Applicant presents that it is not possible for a skilled person to predict whether Utidelone and 9-oxo epothilone D will have similar performance with regard to liposome encapsulation ability and liposome stability, based on the chemical structures alone. See the Declaration paragraphs 9 and 14. Danaei does not disclose or suggest any liposomal composition of Utidelone, let alone how to obtain a stable Utidelone liposome composition with high encapsulation efficiency.
The above assertions are not found persuasive because Example 2, table 1 and Examples 3, 4, 6, and 8-16 show specific compositions with specific amounts of active and ingredients while claim 1 is broader in scope. 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.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/TIGABU KASSA/Primary Examiner, Art Unit 1619
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