DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/13/2025 has been entered.
Response to Amendments
Applicant's amendments filed 11/13/2025 to claims 1, 46, 49, and 50 have been entered. Claims 5, 12-29, and 31-42 have been canceled. Claims 1-4, 6-11, 30, and 43-50 remain pending, and are being considered on their merits. References not included with this Office action can be found in a prior action.
The instant amendments to claims 46 and 50 have overcome the 35 U.S.C. § 112(a) rejections of record, which are withdrawn.
Any other rejections of record not particularly addressed below are withdrawn in light of the claim amendments and/or applicant’s comments.
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.
Claims 1-4, 6-8, 10, 11, 30, 44, and 45 are rejected under 35 U.S.C. 103 as being unpatentable over Faris et al. (WO 2015/148742), Miyabayashi et al. (US 8,883,504), Miller et al. (US 2004/0122101), and Phelps (WO 2017/106783; provided in the ISR dated 9/13/2023).
Faris teaches a cell culture sustained release composition (Abstract). Faris teaches a tableted composition comprising glucose (a carbohydrate), dibutyl sebacate (a plasticizer), and ethyl cellulose (a binder) (Example 1), reading in-part on claim 1. Faris teaches further adding amino acids, salts, metals, sugars, lipids, nucleic acids, hormones, vitamins, fatty acids, proteins, buffering salts, or combinations thereof ([0017] and [0063]), reading on claim 1. Faris teaches CaCl2, KCl, MgCl2, MgSO4, NaCl, NaHCO3, Na2HPO4, and NaH2PO4 H20 ([0066]), reading on those embodiments of salts for claim 1 and claim 6 element (c). Faris teaches amino acids comprising L-alanine, L-arginine, L-asparagine, L-aspartic acid, L-cystine, L-cysteine, L-glutamic acid, L-glutamine, glycine; L-histidine, L-isoleucine, L-leucine, L-lysine, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L- tryptophan, L-tyrosine, and L-valine ({0064]), reading in-part on claim 1 and on claim 6 element (b). Faris teaches vitamin B12 and D2 ([0065]), reading on those embodiments of claim 1 and claim 6 element (d). Faris teaches trace elements comprising copper, nickel, manganese, zinc, chromium, molybdenum, selenium, fluorine/fluoride, and vanadium ([0067]), reading on those embodiments of claim 1 and claim 6 element (e). Faris teaches vitamin B12 and D2 ([0065]), reading on those embodiments of claim 1 and claim 6 element (d). Faris teaches trace elements comprising copper, nickel, manganese, zinc, chromium, molybdenum, selenium, fluorine/fluoride, and vanadium ([0067]), reading on those embodiments of claim 1 and claim 6 element (e). Faris teaches a working example comprising 2 wt% mg stearate (Example 8), reading on claim 1. Faris teaches that the tableted composition starts to dissolve 30 minutes after placement in a diluent comprising cell culture media (Figure 2 and [0089]), reading on claim 2. Faris teaches a tablet comprising 55% by weight of glucose (Example 8), reading on claim 4. Faris teaches the composition formulated as a powder ([0030]), reading on claim 7. Faris teaches a working example of making the tablets by first preparing an uncoated core tablet by combining D(+) glucose with ethyl cellulose, dibutyl sebacate (a plasticizer), and 1,4-dioxane (a solvent), aliquoting the mixture, and then evaporating the solvent to form tablets (Example 1), then coating the tablets (Example 3), reading in-part on claim 8. Faris teaches a tablet mass of 1.12-5.12 g (Fig. 3 and [0089]), reading on claim 10 and reading in-part on claims 44 and 45. Faris teaches diluting the tablet composition in an Erlenmeyer flask and with (aqueous) DMEM media (Fig.2 and [0089]), reading on the diluent and receptacle of claim 30.
Regarding claim 8, product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. See M.P.E.P. § 2113 (III). Once a product appearing to be substantially identical is found and an art rejection made, the burden shifts to the applicant to show an unobvious difference. In this case, the burden is shifted to Applicant to show that the manufacturing process steps of the product-by-process claim imparts any non-obvious structural characteristics to the claimed product as compared to the substantially similar composition taught by Faris and made by the different method as set forth above.
Regarding claim 11, claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. See M.P.E.P. § 2111.02 and 2111.04. In this case, the limitations of claim 11 are only a statement of intended outcome and so the composition of Faris is reasonably construed as being capable of meeting the claim limitations absent any showing to the contrary.
Regarding claims 44 and 45, optimization within prior art conditions or through routine experimentation will generally not support patentability absent a showing of criticality of the claimed range to the contrary. See M.P.E.P. § 2144.05, particularly subsections II and III. In this case, teaches that the tablet mass is result-effective to release more glucose (see Fig. 3), and so any differences between the mass of claimed tablets and the tablets of Faris must be optimization within prior art conditions or through routine experimentation absent any showing of criticality of the claimed range to the contrary.
Regarding claim 1, it would have been obvious to a person of ordinary skill in the art before the invention was filed to combine the working example of Faris comprising glucose with the exemplary embodiments of Faris comprising amino acids, salts, metals, sugars, lipids, nucleic acids, hormones, vitamins, fatty acids, proteins, buffering salts, or combinations thereof of Faris. A person of ordinary skill in the art would have had a reasonable expectation of success to do so and the skilled artisan would have been motivated to do so because Faris expressly considers the combination; combining prior art elements according to known methods would then predictably yield a tableted composition comprising amino acids, salts, metals, sugars, lipids, nucleic acids, hormones, vitamins, fatty acids, proteins, buffering salts, or combinations thereof as envisioned by Faris. See M.P.E.P. § 2143 (I)(A).
Regarding claim 1, Faris does not teach a composition comprising 20-80% by mass amino acids, 2-10% by mass of salts, 1-10 percent by mass of vitamins, 0.01-1 percent by mass of trace elements, 1-10% by mass of vitamins, and 1-5 percent by mass of croscarmellose sodium. Regarding claim 6, Faris does not teach a composition comprising 20-65% by mass of the embodiment of glucose, 20-40% by mass of amino acids, 2-10% by mass of salts, 1-5 percent by mass of vitamins, 0.01-0.05 percent by mass of trace elements and 1-5 percent by mass of croscarmellose sodium. Regarding claim 30, Faris does not teach a kit. Regarding claim 30, Faris does not teach instructions for use.
Miyabayashi teaches methods of stem cell culture (Abstract and Col. 1, lines 16-23). Miyabayashi teaches croscarmellose sodium as an exemplary disintegrator and pharmaceutically acceptable carrier (Col. 34, lines 21-27 and lines 39-42), reading in-part on claim 1.
Miller teaches a pharmaceutical composition comprising croscarmellose sodium and magnesium stearate ([0023]). Miller teaches 5-15% by weight croscarmellose sodium as a disintegrant and 0.1-5% by weight magnesium stearate as a lubricant ([0224]), reading on claim 1.
Phelps teaches dry cell culture media compositions (Abstract), formulated as tablets (([0069]). Phelps teaches 40% amino acids, 20-65% binders, 1-5% vitamins, 2-10% salts, 0.01-0.05% trace components ([0026]), reading on claims 1 and 6. Phelps teaches the pellet compositions comprises one or more of 31-32% amino acids, 59-60% binders, 25% vitamins, 6-7% salts, 0.01-0.05% trace components and the binder is D-glucose ([0026]), reading on claims 1 and 6. Phelps teaches calcium, magnesium, and ammonium as exemplary salts and iron, manganese, copper, and zinc as exemplary trace elements ([0023]), reading on claims 1 and 6. Phelps teaches dry cell culture media compositions formulated as a kit in a first container/package and with instructions for use (Abstract; [0033]), and formulated as tablets (([0069]), reading on the kit and package of claim 30.
Regarding claims 1 and 6, it would have been obvious to a person of ordinary skill in the art before the invention was filed to add the croscarmellose sodium of Miyabayashi at the concentration range taught by Miller to the composition of Faris. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because Miyabayashi and Faris are directed towards cell culture compositions, and because Miyabayashi, Faris, and Miller are all in-part directed towards solid compositions comprising carriers (binders, disintegrants, etc.) The skilled artisan would have been motivated to do so Faris further teaches dissolving the tablet composition in a diluent, and so the addition would then predictably yield a tablet composition comprising a disintegrator that then facilitates disintegration of the tableted composition when placed into an aqueous solution.
Regarding the croscarmellose sodium concentration of claims 1 and 6, Regarding optimization within prior art conditions or through routine experimentation will generally not support patentability absent a showing of criticality of the claimed range to the contrary. See M.P.E.P. § 2144.05, particularly subsections II and III. In this case, Miller teaches that 5-15% by weight of croscarmellose sodium is result effective as a disintegrator, and so any further modification of Miller’s concentration range must be held as optimization within prior art conditions or through routine experimentation absent any showing of criticality of the claimed range to the contrary.
Regarding claims 1 and 6, it would have been obvious to a person of ordinary skill in the art before the invention was filed to formulate the tableted cell culture media composition of Faris according to the ranges of Phelps. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because both Faris and Phelps are directed towards dry cell culture media compositions formulated as tablets. The skilled artisan would have been motivated to do so because formulation would predictably yield a tableted cell culture media composition at specific concentration ranges for the further culturing of cells as taught by Faris.
Regarding claim 30, it would have been obvious to a person of ordinary skill in the art before the invention was filed to combine the tablet composition, diluent, and receptacle of Faris with the first container/package and instructions of Phelps. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because both Faris and Phelps are directed towards dry and tableted cell culture media compositions. The skilled artisan would have been motivated to do so because the combination would predictably yield packaging for the tablets of Faris and instructions for their downstream use of the composition of Faris. See M.P.E.P. § 2143 (I))(A).
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Claims 9 and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Faris, Miyabayashi, Miller, and Phelps as applied to claim 1 above, and further in view of Natoli et al. (Ch. 33 in Developing Solid Oral Dosage Forms (2017), p917-951) and Verwijs (US 2013/0186801).
The teachings of Faris, Miyabayashi, Miller, and Phelps are relied upon as set forth above.
Regarding claim 9, Faris, Miyabayashi, Miller, and Phelps do not teach a tableted medium having a hardness of about 18-22 kp. Regarding claim 9, Faris, Miyabayashi, Miller, and Phelps do not teach a tableted medium having a hardness of about 10-30 kp.
Natoli teaches methods of compressing pharmaceutical tablets (Introduction on p917), Natoli teaches that the working length of the punches affects the hardness of the tablet (“Tooling Inspection” on p936), reading in-part on claim 9. Natoli teaches exemplary hardness of either 24.4 kp or 36.2 kp with Avicel (an exemplary plasticizer) dependent upon the diameter of the roller used. (Table 33.5 and 33.6), reading in part on claims 9 and 43.
Verwijs teaches a pharmaceutical composition for treating cystic fibrosis (Abstract). Verwijs a tablet composition having a hardness range of 5-20 kp ([0291]), reading on claims 9 and 43. Verwijs further teaches methods of cell culture ([0485]), reading in-part on claims 9 and 43
It would have been obvious to a person of ordinary skill in the art before the invention was filed to further formulate the tablets of Faris at 5-20 kp hardness in view of Verwijs and Natoli. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because Natoli as a whole teaches detailed methods of formulating tablets and that hardness is results effective to the working length of the punches of the diameter of the roller used, because Verwijs teaches that 5-20 kp hardness was known in this art, and because Verwijs is analogous art being further directed towards methods of cell culture. The skilled artisan would have been motivated to do so because combination would predictably yield a tablet with a hardness range of 5-20 kp; see M.P.E.P. § 2143 (I)(A).
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Claims 46-48 are rejected under 35 U.S.C. 103 as being unpatentable over Faris, Miyabayashi, Miller, and Phelps as applied to claim 1 above, and further in view of von Hagen (WO 2018/019812; Reference N).
The teachings of Faris, Miyabayashi, Miller, and Phelps are relied upon as set forth above. Faris further teaches a tablet comprising sodium bicarbonate particle size of 50 microns or less (¶0097), reading in-part on claim 47.
Regarding claims 46-48, Faris, Miyabayashi, Miller, and Phelps do not teach a powder with a homogeneous particle size distribution. Regarding claim 48, Faris, Miyabayashi, Miller, and Phelps do not teach any product-by-process limitations to producing the particles by milling.
von Hagen teaches methods of improving the solubility or dissolution behavior of components of an aqueous solution (Abstract), such as a cell culture medium (p4, lines 10-29). von Hagen teaches uniform particle sizes less than 500 µm or 200 µm produced by milling (p9, line 27 through p10, line 18; p9, lines 1-3), which are advantageous to better mix poorly soluble components (p9, lines 12-25), wherein the poorly soluble components include leucine, valine, isoleucine, and phenylalanine (p6, lines 7-8), reading on claims 46-48 and reading on the particle size range of claim 47. von Hagen teaches formulating dry powder mixtures as tablets (p8, lines 8-19), reading in-part on claims 46-48.
Regarding claims 46-48, it would have been obvious to a person of ordinary skill in the art before the invention was filed to substitute the dry media particles of Faris with the uniform dry media particles having a size less than 500 microns or less than 200 microns and made by milling of von Hagen in Faris’ dry media tablet composition. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because both Faris and von Hagen are directed in-part towards dry media tablet composition, and because von Hagen teaches methods of producing the particle size range by milling. The skilled artisan would have been motivated to do so because von Hagen teaches that uniform dry media particles having a size less than 500 microns or less than 200 microns are predictably advantageous to better mix poorly soluble components comprising leucine, valine, isoleucine, and phenylalanine and so would improve solubility of these amino acids in Faris’ dry media tablet composition when said composition is dissolve in an aqueous solution to prepare aqueous media for cell culture.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Claim 49 is rejected under 35 U.S.C. 103 as being unpatentable over Faris et al. (WO 2015/148742), Miyabayashi et al. (US 8,883,504), Miller et al. (US 2004/0122101), Phelps (WO 2017/106783; provided in the ISR dated 9/13/2023), Natoli et al. (Ch. 33 in Developing Solid Oral Dosage Forms (2017), p917-951) and Verwijs (US 2013/0186801).
Faris teaches a cell culture sustained release composition (Abstract). Faris teaches a tableted composition comprising glucose (a carbohydrate), dibutyl sebacate (a plasticizer), and ethyl cellulose (a binder) (Example 1), reading in-part on claim 49. Faris teaches further adding amino acids, salts, metals, sugars, lipids, nucleic acids, hormones, vitamins, fatty acids, proteins, buffering salts, or combinations thereof ([0017] and [0063]), reading on claim 49. Faris teaches CaCl2, KCl, MgCl2, MgSO4, NaCl, NaHCO3, Na2HPO4, and NaH2PO4 H20 ([0066]), reading on those embodiments of salts for claim 49. Faris teaches amino acids comprising L-alanine, L-arginine, L-asparagine, L-aspartic acid, L-cystine, L-cysteine, L-glutamic acid, L-glutamine, glycine; L-histidine, L-isoleucine, L-leucine, L-lysine, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L- tryptophan, L-tyrosine, and L-valine ({0064]), reading in-part on claim 49. Faris teaches vitamin B12 and D2 ([0065]), reading on those embodiments of claim 49. Faris teaches trace elements comprising copper, nickel, manganese, zinc, chromium, molybdenum, selenium, fluorine/fluoride, and vanadium ([0067]), reading on those embodiments of claim 49. Faris teaches vitamin B12 and D2 ([0065]), reading on those embodiments of claim 49. Faris teaches trace elements comprising copper, nickel, manganese, zinc, chromium, molybdenum, selenium, fluorine/fluoride, and vanadium ([0067]), reading on those embodiments of claim 49. Faris teaches a working example comprising 2 wt% mg stearate (Example 8), reading on the lubricant of claim 49. Faris teaches a tablet comprising 55% by weight of glucose (Example 8), reading on claim 49.
Regarding claim 49, Faris does not teach a composition comprising 20-80% by mass amino acids, 2-10% by mass of salts, 1-10 percent by mass of vitamins, 0.01-1 percent by mass of trace elements, 1-10% by mass of vitamins, and 1-5 percent by mass of croscarmellose sodium as a species of disintegrant. Regarding claim 49, Faris does not teach a tableted medium having a hardness of about 10-30 kp.
Miyabayashi teaches methods of stem cell culture (Abstract and Col. 1, lines 16-23). Miyabayashi teaches croscarmellose sodium as an exemplary disintegrator and pharmaceutically acceptable carrier (Col. 34, lines 21-27 and lines 39-42), reading in-part on claim 49.
Miller teaches a pharmaceutical composition comprising croscarmellose sodium and magnesium stearate ([0023]). Miller teaches 5-15% by weight croscarmellose sodium as a disintegrant and 0.1-5% by weight magnesium stearate as a lubricant ([0224]), reading on claim 49.
Phelps teaches dry cell culture media compositions (Abstract), formulated as tablets (([0069]). Phelps teaches 40% amino acids, 20-65% binders, 1-5% vitamins, 2-10% salts, 0.01-0.05% trace components ([0026]), reading on claims 1 and 6. Phelps teaches the pellet compositions comprises one or more of 31-32% amino acids, 59-60% binders, 25% vitamins, 6-7% salts, 0.01-0.05% trace components and the binder is D-glucose ([0026]), reading on claim 49. Phelps teaches calcium, magnesium, and ammonium as exemplary salts and iron, manganese, copper, and zinc as exemplary trace elements ([0023]), reading on claim 49.
Natoli teaches methods of compressing pharmaceutical tablets (Introduction on p917), Natoli teaches that the working length of the punches affects the hardness of the tablet (“Tooling Inspection” on p936), reading in-part on claim 9. Natoli teaches exemplary hardness of either 24.4 kp or 36.2 kp with Avicel (an exemplary plasticizer) dependent upon the diameter of the roller used. (Table 33.5 and 33.6), reading in part on claim 49.
Verwijs teaches a pharmaceutical composition for treating cystic fibrosis (Abstract). Verwijs a tablet composition having a hardness range of 5-20 kp ([0291]), reading on claims 9 and 43. Verwijs further teaches methods of cell culture ([0485]), reading in-part on claim 49.
It would have been obvious to a person of ordinary skill in the art before the invention was filed to add the croscarmellose sodium of Miyabayashi at the concentration range taught by Miller to the composition of Faris. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because Miyabayashi and Faris are directed towards cell culture compositions, and because Miyabayashi, Faris, and Miller are all in-part directed towards solid compositions comprising carriers (binders, disintegrants, etc.) The skilled artisan would have been motivated to do so Faris further teaches dissolving the tablet composition in a diluent, and so the addition would then predictably yield a tablet composition comprising a disintegrator that then facilitates disintegration of the tableted composition when placed into an aqueous solution.
Regarding the croscarmellose sodium concentration, optimization within prior art conditions or through routine experimentation will generally not support patentability absent a showing of criticality of the claimed range to the contrary. See M.P.E.P. § 2144.05, particularly subsections II and III. In this case, Miller teaches that 5-15% by weight of croscarmellose sodium is result effective as a disintegrator, and so any further modification of Miller’s concentration range must be held as optimization within prior art conditions or through routine experimentation absent any showing of criticality of the claimed range to the contrary.
It would have been obvious to a person of ordinary skill in the art before the invention was filed to formulate the tableted cell culture media composition of Faris according to the ranges of Phelps. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because both Faris and Phelps are directed towards dry cell culture media compositions formulated as tablets. The skilled artisan would have been motivated to do so because formulation would predictably yield a tableted cell culture media composition at specific concentration ranges for the further culturing of cells as taught by Faris.
It would have been obvious to a person of ordinary skill in the art before the invention was filed to further formulate the tablets of Faris at 5-20 kp hardness in view of Verwijs and Natoli. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because Natoli as a whole teaches detailed methods of formulating tablets and that hardness is results effective to the working length of the punches of the diameter of the roller used, because Verwijs teaches that 5-20 kp hardness was known in this art, and because Verwijs is analogous art being further directed towards methods of cell culture. The skilled artisan would have been motivated to do so because combination would predictably yield a tablet with a hardness range of 5-20 kp; see M.P.E.P. § 2143 (I)(A).
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Claim 50 is rejected under 35 U.S.C. 103 as being unpatentable over Faris, Miyabayashi, Miller, Phelps, Natoli, and Verwijs as applied to claim 49 above, and further in view of von Hagen (WO 2018/019812).
The teachings of Faris, Miyabayashi, Miller, Phelps, Natoli, and Verwijs are relied upon as set forth above.
Regarding claim 50, Faris, Miyabayashi, Miller, Phelps, Natoli, and Verwijs do not teach a powder with a homogeneous particle size distribution.
von Hagen teaches methods of improving the solubility or dissolution behavior of components of an aqueous solution (Abstract), such as a cell culture medium (p4, lines 10-29). von Hagen teaches uniform particle sizes less than 500 µm or 200 µm produced by milling (p9, line 27 through p10, line 18; p9, lines 1-3), which are advantageous to better mix poorly soluble components (p9, lines 12-25), wherein the poorly soluble components include leucine, valine, isoleucine, and phenylalanine (p6, lines 7-8), reading on claim 50. von Hagen teaches formulating dry powder mixtures as tablets (p8, lines 8-19), reading in-part on claim 50.
It would have been obvious to a person of ordinary skill in the art before the invention was filed to substitute the dry media particles of Faris with the uniform dry media particles having a size less than 500 microns or less than 200 microns and made by milling of von Hagen in Faris’ dry media tablet composition. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because both Faris and von Hagen are directed in-part towards dry media tablet composition, and because von Hagen teaches methods of producing the particle size range by milling. The skilled artisan would have been motivated to do so because von Hagen teaches that uniform dry media particles having a size less than 500 microns or less than 200 microns are predictably advantageous to better mix poorly soluble components comprising leucine, valine, isoleucine, and phenylalanine and so would improve solubility of these amino acids in Faris’ dry media tablet composition when said composition is dissolve in an aqueous solution to prepare aqueous media for cell culture.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Response to Arguments
Applicant's arguments on pages 6-10 of the reply have been fully considered, but not found persuasive of error for the reasons given below.
In response to applicant's argument on pages 6-8 of the reply that Miller (of record) is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Miller is in Applicant’s field of endeavor by being directed in-part towards solid compositions comprising carriers such as binders and disintegrants, and Miller is reasonably pertinent to the Inventor’s problem by teaching 5-15% croscarmellose sodium as a disintegrant in solid compositions comprising carriers such as a disintegrant. Applicant’s arguments rely on the intended use of the claimed composition, which is not persuasive because “where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation”; see M.P.E.P. § 2111.02 (II). In this case, independent claim 1 sets forth a structurally complete invention and while the claimed composition would be capable of use as cell culture medium by dissolving the claimed solid composition in water and the primary teachings of Faris as cited in the last Office Action addresses the intended use of the claimed composition, the broadest reasonable interpretation of the scope of claim 1 does not afford patentable weight to the intended use of the preamble and so broadens the analogous prior art available for consideration under 35 U.S.C. § 103.
It is noted that while Applicant traverses the assertion that Miller is both in the same field of endeavor and is not reasonably pertinent to the particular problem with which the inventor was concerned, Applicant has not provided any additional evidence to the contrary, see M.P.E.P. § 716.01(d)
On pages 8-9 of the reply, Applicant alleges that Miller does not teach the claimed excipient ranges. This is not found persuasive as the assertion is factually incorrect as the magnesium stearate and croscarmellose sodium ranges of Miller overlap with the claimed ranges, Applicant has not addressed the specific rationale to combine Miller and Miyabayashi with Faris as cited above, and none of Applicant’s arguments address that where the claimed ranges overlap or lie inside ranges disclosed by the prior art a prima facie case of obviousness exists; See M.P.E.P. § 2144.05.
Conclusion
No claims are allowed. No claims are free of the art.
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/Sean C. Barron/Primary Examiner, Art Unit 1653