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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 January 2nd, 2026, has been entered.
Response to Arguments
Applicant's arguments in view of the amendments filed December 4th, 2025, have been fully considered but they are not persuasive.
Applicant argues the skilled person would not have considered Semen in order to teach the compression temperature below 37⁰C as there is no indication in Semen that this temperature range does also function in a solvent-free compaction. Examiner respectfully disagrees. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., solvent-free compaction) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See MPEP 2145 (VI).
Applicant argues Semen does not address polymers stabilized with these tablets exhibit a decent melt flow index (MFI) and a low yellowness index. Examiner respectfully disagrees. 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 MPEP 2145 (II). These features are not recited by the claims. Furthermore, the prior art rejections are based on a combination of Ingo, Semen and Guha, wherein the combination teaches the claimed invention. The courts have held that "Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established." See MPEP 2112.01. As such, the combination of Ingo, Semen and Guha is expected to produce a product with the recited properties.
Applicant argues there would have been no reason for the ordinary skill artisan to combine the teachings of Ingo, Semen and Guha as they are nonanalogous art. Examiner respectfully disagrees. 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 MPEP 2141.01(a). In this case, Ingo, Semen and Guha are all considered to be analogous to the claimed invention because they are in the field of compressing to form polymer tablets.
Applicant argues amended claim 1 is demonstrably inventive since none of the cited documents describes solvent-free compaction, whereas amended claim 1 specifies that the starting material is neither liquid nor gaseous, nor contains any substance that is liquid or gaseous. Examiner respectfully disagrees. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the starting material does not contain any substance that is liquid or gaseous) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See MPEP 2145 (VI). Furthermore, Semen teaches cold compaction of a starting material disclosed as a paste into tablets ([0036-0037]). The paste of Semen is not considered a liquid or a gas as a paste is a semi-solid that is capable of retaining its shape. As such, the paste is not excluded from the solid form of the starting material claimed. Examiner also notes that the specification of the instant application states in page 5, lines 8-11 that an auxiliary component, such as a solvent, may be present in the starting material. From applicant’s own disclosure, one of ordinary skill in the art can recognize that the inclusion of a solvent as an auxiliary component does not change the classification of the starting material from a solid to a liquid or gas.
Claim Interpretation
Claim 2 recites the limitation “at which in case a corner is present, each corner possesses only angles directed to the inner side of the tablet above 90⁰ or each corner is convexly rounded, and at which in case of an edge is present, each edge possesses only angles directed to the inner side of the tablet above 90⁰ or each edge is convexly rounded, except in case a corner or an edge originates from an embossed groove” in lines 2-6. This limitation as recited is a conditional limitation under broadest reasonable interpretation and are not required to be performed. Therefore, this limitation is not required to be taught by the prior art in the prior art rejections below.
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.
Claims 1, 2, 9 and 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Ingo et al. (US 20170087789 A1; hereafter Ingo), in view of Semen (US 20030193041 A1) and Guha et al. (US 20220142928 A1; hereafter Guha).
Regarding claim 1, Ingo discloses a method for manufacturing a tablet (Fig. 1; [0021]; producing tablets using rotary tablet press), which comprises the steps of:
(A) filling a starting material ([0021]; filling with filling material), which is in a solid form ([0009]; filling material is powdered), in a first open cavity (Fig. 1; [0019, 0021]; an empty hole of a plurality of holes 12 in die plate 10), which is formed by a first punch (Fig. 1; [0019, 0021]; lower punch 16) and a die (Fig. 1; [0019, 0021]; die plate 10), to obtain a second open cavity ([0021]; a filled hole of a plurality of holes 12), which is filled at least partly with the starting material ([0021]; filling material to be pressed is added to holes 12),
Wherein solid form of the starting material excludes that the starting material is a liquid or a gas ([0009]; filling material is powdered),
(B) closing the second open cavity by a second punch (Fig. 1; [0019, 0021]; upper punch 14) to obtain a first closed cavity (Fig. 1; [0019, 0021]; upper punch 14 pressing down closes filled hole),
(C) compressing the starting material by moving at least one out of the first punch and the second punch to obtain a second closed cavity (Fig. 1; [0019, 0021]; pressing the filling material using upper punch 14 and lower punch 16), which has a smaller volume than the first closed cavity (Fig. 1; [0019, 0021]; upper punch 14 and lower punch 16 press in opposite directions, resulting in a smaller hole when pressing the filling material), which results in formation of a trapped tablet of the starting material in the second closed cavity (Fig. 1; [0021]; pressing the filling material produces the tablets 44),
(D) removing the trapped tablet to obtain the tablet (Fig. 1; [0021]; the produced tablets 44 are ejected by the lower punches 16),
wherein the steps (A), (B), (C) and (D) are conducted in a tablet press (Fig. 1; [0019, 0021]; operation of the rotary tablet press).
Ingo does not explicitly disclose a compression temperature below 37⁰C, a tablet temperature below 37⁰C directly after removal, the starting material is solid at 37⁰C and 101.32 KPa and comprises (i) 60 to 100 wt.% of a first polymer stabilizer, which is selected from the list provided in instant claim 1, (ii) 0 to 40 wt.% of a second polymer stabilizer, which is zinc stearate, calcium stearate, magnesium stearate or a mixture thereof, (iii) 0 to 34 wt.% of a third polymer stabilizer, which is zinc oxide, hydrotalcite, sodium benzoate or a mixture thereof, (iv) 0 to 20 wt.% of a further ingredient, which is different to the first polymer stabilizer, the second polymer stabilizer and the third polymer stabilizer, wherein the sum of components (i), (ii), (iii) and (iv) is 100 wt.%, and wherein the tablet has a weight above 20 mg and below 330 mg and a cross-section dimension above 3 mm and below 18 mm.
However, Semen teaches a method of manufacturing a tablet ([0036-0037]; making granules which can comprise a tablet shape) comprising compressing a starting material ([0036-0037]; polymer additive composition) below 37⁰C ([0107]; compression at die temperature in the range of from about ambient room temperature (e.g., about 20⁰C) up to about 5⁰C below the boiling temperature of the processing solvent being used; In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists, see MPEP 2144.05), wherein the tablet has a temperature below 37⁰C directly after removal ([0107]; the polymer additive composition compressed into the tablet would have the die temperature in the range of from about ambient room temperature (e.g., about 20⁰C) up to about 5⁰C below the boiling temperature of the processing solvent being used; In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists, see MPEP 2144.05), the starting material comprises (i) 60 to 100 wt.% ([0112]; components can be used in an (a):(b) weight ratio as high as about 99.9:0.1; In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists, see MPEP 2144.05) of a first polymer stabilizer ([0038, 0056]; compound a can be tetrakis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionyl-oxymethyl]methane), which is tetrakis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionyl-oxymethyl]methane ([0056]), (ii) 0 to 40 wt.% of a second polymer stabilizer, which is zinc stearate, calcium stearate, magnesium stearate or a mixture thereof ([0131]; polymer additive composition may or may not include metal stearate salts (e.g., calcium stearate, magnesium stearate, zinc stearate, etc.)), (iii) 0 to 34 wt.% ([0112]; components can be used in an (a):(b) weight ratio as high as about 99.9:0.1; In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists, see MPEP 2144.05) of a third polymer stabilizer, which is zinc oxide ([0087]), hydrotalcite ([0087]), sodium benzoate ([0085]) or a mixture thereof, (iv) 0 to 20 wt.% of a further ingredient ([0103]; about 3 to about 20 parts by weight of solvent), which is different to the first polymer stabilizer, the second polymer stabilizer and the third polymer stabilizer ([0103]; the solvent is different from the additives in the polymer additive composition), wherein the sum of components (i), (ii), (iii) and (iv) is 100 wt.% ([0103]; total parts by weight is 100), and wherein the tablet has a cross-section dimension above 3 mm and below 18 mm ([0104]; the cross sectional area be in the range of from about 1 to about 75 square millimeters; In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists, see MPEP 2144.05). While Semen does not explicitly recite the starting material is solid at 37⁰C and 101.32 KPa, the courts have stated that 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. "Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established." See MPEP 2112.01 (II).
Ingo and Semen are both considered to be analogous to the claimed invention because they are in the field of compressing to form tablets. Therefore, it would have been obvious to the person in the ordinary skill in the art before the effective filing date of the invention to modify Ingo with the teachings of Semen to provide a compression temperature below 37⁰C, a tablet temperature below 37⁰C directly after removal, the starting material is solid at 37⁰C and 101.32 KPa and comprises (i) 60 to 100 wt.% of a first polymer stabilizer, which is selected from the list provided in instant claim 1, (ii) 0 to 40 wt.% of a second polymer stabilizer, which is zinc stearate, calcium stearate, magnesium stearate or a mixture thereof, (iii) 0 to 34 wt.% of a third polymer stabilizer, which is zinc oxide, hydrotalcite, sodium benzoate or a mixture thereof, (iv) 0 to 20 wt.% of a further ingredient, which is different to the first polymer stabilizer, the second polymer stabilizer and the third polymer stabilizer, wherein the sum of components (i), (ii), (iii) and (iv) is 100 wt.%, and wherein the tablet has a cross-section dimension above 3 mm and below 18 mm. Doing so would allow for the manufacture of tablets with extremely low dust-forming characteristics, and therefore reduce the need for sieving/filtering (Semen [0106]).
Ingo, in view of Semen, does not explicitly disclose the tablet has a weight above 20 mg and below 330 mg.
However, Guha teaches a method of manufacturing a polymer tablet ([0074]; producing compressed polymer tablets) comprising compressing stabilizers ([0058-0059]; compressing a matrix comprising stabilizers), wherein the tablet has a weight above 20 mg and below 330 mg ([0062]; the weight of the compressed tablet may be from 50 to 2000 mg; In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists, see MPEP 2144.05).
Ingo and Guha are both considered to be analogous to the claimed invention because they are in the field of compressing to form tablets. Therefore, it would have been obvious to the person in the ordinary skill in the art before the effective filing date of the invention to modify Ingo, in view of Semen, with the teachings of Guha to provide the tablet has a weight above 20 mg and below 330 mg. Doing so would allow for the manufacture of a greater variety of tablets with different weights.
Regarding claim 2, modified Ingo discloses the method for manufacturing a tablet according to claim 1, wherein the tablet has a geometric form (Ingo Fig. 1; tablets 44 have a geometric form shown in the figure).
Regarding claim 9, modified Ingo discloses the method for manufacturing a tablet according to claim 1, wherein Guha further teaches the tablet has a weight above 55 mg and below 200 mg ([0062]; the weight of the compressed tablet may be from 50 to 2000 mg; In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists, see MPEP 2144.05) and Semen further teaches the tablet has a cross-section dimension above 4 mm and below 15 mm ([0104]; the cross sectional area be in the range of from about 1 to about 75 square millimeters; In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists, see MPEP 2144.05).
Regarding claim 14, modified Ingo discloses the method for manufacturing a tablet according to claim 1, wherein Semen further teaches the steps for compression molding to form the tablet are conducted at a temperature below 37⁰C ([0107]; compression at die temperature in the range of from about ambient room temperature (e.g., about 20⁰C) up to about 5⁰C below the boiling temperature of the processing solvent being used; In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists, see MPEP 2144.05).
Regarding claim 15, modified Ingo discloses the method for manufacturing a tablet according to claim 1, wherein Semen further teaches the compression temperature is below 32⁰C ([0107]; compression at die temperature in the range of from about ambient room temperature (e.g., about 20⁰C) up to about 5⁰C below the boiling temperature of the processing solvent being used; In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists, see MPEP 2144.05) and the tablet temperature is below 32⁰C ([0107]; the polymer additive composition compressed into the tablet would have the die temperature in the range of from about ambient room temperature (e.g., about 20⁰C) up to about 5⁰C below the boiling temperature of the processing solvent being used; In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists, see MPEP 2144.05).
Regarding claim 16, modified Ingo discloses the method for manufacturing a tablet according to claim 1, wherein the tablet or a plurality of tablets is not sieved (Ingo; no recitation that a sieve is used in forming the tablets).
Regarding claim 17, modified Ingo discloses the method for manufacturing a tablet according to claim 1, wherein the tablet press is a rotary tablet press (Ingo Fig. 1; [0019, 0021]; rotary tablet press).
Claims 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Ingo et al. (US 20170087789 A1; hereafter Ingo), in view of Semen (US 20030193041 A1) and Guha et al. (US 20220142928 A1; hereafter Guha) as applied to claim 1, and further in view of Madsen et al. (US 20090081289 A1; hereafter Madsen).
Regarding claim 11, modified Ingo discloses the method for manufacturing a tablet according to claim 1.
Modified Ingo does not explicitly disclose the starting material has a mean particle size above 15 um and below 1000 um as determined by light scattering.
However, Madsen teaches a method of manufacturing a tablet ([0001]) comprising compressing a starting material ([0046]; compressing particles), wherein the starting material has a mean particle size above 15 um and below 1000 um ([0049]; the particles are of a mean diameter of 70 um, suitably 10 um, or above; In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists, see MPEP 2144.05).
Ingo and Madsen are both considered to be analogous to the claimed invention because they are in the field of compressing to form tablets. Therefore, it would have been obvious to the person in the ordinary skill in the art before the effective filing date of the invention to modify modified Ingo with the teachings of Madsen to provide the starting material has a mean particle size above 15 um and below 1000 um. Doing so would allow for the use of higher compression forces when manufacturing the tablets, and therefore producing tablets with a higher coherence of the starting material particles (Madsen [0049]).
Regarding claim 12, modified Ingo discloses the method for manufacturing a tablet according to claim 1.
Modified Ingo does not explicitly disclose the starting material has a bulk density above 300 g / L and below 950 g / L as determined by DIN EN ISO 17892-3.
However, the bulk density of the starting material depends on the particle size of the starting material. Semen further teaches the starting material can have any particle size to form the tablet as desired ([0036]), and as such teaches the bulk density can be selected to form the tablet as desired. The starting material of the instant claim has a mean particle size above 15 um and below 1000 um as determined by light scattering (instant specification pg. 8, 3rd ¶).
Madsen teaches a method of manufacturing a tablet ([0001]) comprising compressing a starting material ([0046]; compressing particles), wherein the starting material has a mean particle size above 15 um and below 1000 um ([0049]; the particles are of a mean diameter of 70 um, suitably 10 um, or above; In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists, see MPEP 2144.05).
Ingo and Madsen are both considered to be analogous to the claimed invention because they are in the field of compressing to form tablets. Therefore, it would have been obvious to the person in the ordinary skill in the art before the effective filing date of the invention to modify modified Ingo with the teachings of Madsen to provide the starting material has a mean particle size above 15 um and below 1000 um. Doing so would allow for the use of higher compression forces when manufacturing the tablets, and therefore producing tablets with a higher coherence of the starting material particles (Madsen [0049]).
The courts have stated that 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. As modified Ingo discloses the same starting material with the same particle size, it is expected the starting material of modified Ingo has a bulk density above 300 g / L and below 950 g / L as determined by DIN EN ISO 17892-3. "Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established." See MPEP 2112.01 (II).
Regarding claim 13, modified Ingo discloses the method for manufacturing a tablet according to claim 1.
Modified Ingo does not explicitly disclose the compressing at step (C) takes place with a compression pressure above 90 MPa and below 600 MPa.
However, Madsen teaches a method of manufacturing a tablet ([0001]) comprising compressing a starting material ([0046]; compressing particles), wherein the compressing takes place with a compression pressure above 90 MPa and below 600 MPa ([0049]; compression pressure in the range of 40 to 400 MPa; In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists, see MPEP 2144.05).
Ingo and Madsen are both considered to be analogous to the claimed invention because they are in the field of compressing to form tablets. Therefore, it would have been obvious to the person in the ordinary skill in the art before the effective filing date of the invention to modify modified Ingo with the teachings of Madsen to provide the compressing at step (C) takes place with a compression pressure above 90 MPa and below 600 MPa. Doing so would allow for the use of higher compression forces when manufacturing the tablets, and therefore producing tablets with a higher coherence of the starting material particles (Madsen [0049]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Vipul Malik whose telephone number is (571)272-0976. The examiner can normally be reached M-F.
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/V.M./Examiner, Art Unit 1754 /SUSAN D LEONG/ Supervisory Patent Examiner, Art Unit 1754