DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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.
2. Claims 1-3, 6-7, 13-21 are rejected under 35 U.S.C. 103 as being unpatentable over Kawasaki et al (US 5,908,893).
3. Kawasaki et al discloses a process for removing protein from natural rubber latex, including surgical gloves (Abstract, col. 1, lines 40-42) and the deproteinized articles produced by such process (Abstract, as to instant claims 20-21), the process comprising:
1) first step of washing the latex in a solution of an enzyme and a surfactant in water (col. 2, lines 5-12);
2) a second step of washing (col. 4, lines 56-60) in a solution of an inorganic salt including sodium carbonate using centrifugation for 60 minutes (col. 2, lines 3-50; col. 5, lines 7-12), followed by
3) further washing the latex repeatedly (col. 4, lines 56-60),
wherein said process is conducted at a temperature of 5-90⁰C, or 20-60⁰C (col. 4, lines 35-38), and
wherein the total process may be carried out from several minutes to about a week (col. 4, lines 30-35).
4. Since the process of Kawasaki et al is cited as being conducted at a temperature of 5-90⁰C, or 20-60⁰C, therefore, it would have been obvious to a one of ordinary skill in the art to conduct all washings steps 1)-3) in the process of Kawasaki et al at a temperature of 5-90⁰C, or 20-60⁰C, and specifically 60⁰C as well (as to instant claims 2-3, 6-7, since it would be obvious to choose the temperature for such treatment as taught in the art.
5. Further, since i) Kawasaki et al teaches that the total process may be carried out from several minutes to about a week (col. 4, lines 30-35), ii) the timing necessary for said treatment will intrinsically and necessarily depend on the initial amount of protein in the natural rubber latex such as gloves, and further on the desired final concentration of said protein, and iii) the longer treatment/washing in each of the steps will intrinsically and necessarily lead to more protein being removed from said natural latex gloves and the final product being free from any residual chemicals, therefore, it would be obvious to a one of ordinary skill in the art to make variations and optimize the specific time necessary to first washing in the step 1), in the final repeated washings, including at least 2 times in the step 3), using the time range from several minutes to a week as taught by Kawasaki et al, including 10-30 minutes during the steps 1) and 3), and further to choose and use the duration of 60 minute for the treatment using sodium carbonate in the step 2) of the process of Kawasaki et al, thereby arriving at the present invention (as to instant claims 1, 7, 10).
The key to supporting any rejection under 35 USC 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 USC 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "‘[R]ejections on obviousness cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.’" KSR, 550 U.S. at 418, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include:
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(A) Combining prior art elements according to known methods to yield predictable results;
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(B) Simple substitution of one known element for another to obtain predictable results;
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(C) Use of known technique to improve similar devices (methods, or products) in the same way;
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(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
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(E) "Obvious to try" – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
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(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention. MPEP 2141
"[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).
6. Since the process of Kawasaki et al is substantially the same as that claimed in instant invention, i.e. includes treating the natural rubber latex gloves with sodium carbonate solution at a temperature of 60⁰C, and the process of Kawasaki et al is specified as being conducted for a period of time from several minutes to about a week, including pre-wash and final repeated washings after the treatment, therefore, the process of Kawasaki et al would be reasonably expected to lead to producing said rubber glove having the residual concentration of the protein after said treatment in the ranges as claimed in instant invention as well (as to instant claims 13-18). 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. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). MPEP 2112.01(I). Since PTO cannot conduct experiments the proof of burden is shifted to the applicants to establish an unobviousness difference, see In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977). See MPEP § 2112.01.
7. It is further noted that instant specification does not provide sufficient evidence of criticality in conducting the process at specific time periods as claimed in instant invention, i.e. heating the rubber glove for specifically 10-30 minutes, heating the rubber glove in sodium carbonate solution for specifically 50-70 minutes and washing the rubber glove at least 2 times in washing water for specifically 10-30 minutes.
Thus, inventive examples presented in instant specification show the process comprising i) heating the gloves at 65⁰C for specifically 20 minutes; ii) heating the gloves in the 0.1%wt solution of sodium carbonate for 60 minutes at 65⁰C in a rotatable drum, and iii) two time- washing for 20 minutes at 65⁰C (pp. 7-8 of instant specification). No other temperatures or duration of treatment were presented. Comparative Samples were the gloves having protein removed by conventional chlorination.
Therefore, there is no evidence of criticality in conducting treatment for the periods of time as claimed in instant invention. However, Kawasaki et al teaches that the total process of treatment may be carried out from several minutes to about a week (col. 4, lines 30-35), wherein the timing necessary for said treatment will intrinsically and necessarily depend on the initial amount of protein in the natural rubber latex such as gloves, and further on the desired final concentration of said protein, and the longer treatment will intrinsically and necessarily lead to more protein being removed from said natural latex gloves.
8. Claims 1-3, 5-21 are rejected under 35 U.S.C. 103 as being unpatentable over Kawasaki et al (US 5,908,893) in view of Elvig (US 2002/0066975) and Huynh et al (US 6,790,933).
9. The discussion with respect to Kawasaki et al (US 5,908,893), set forth in paragraphs 2-7 above, is incorporated here by reference.
10. Kawasaki et al does not explicitly recite the concentration of the sodium carbonate in the treatment solution, and the process being carried after the rubber glove has been stripped.
11. However,
1) Elvig discloses a method for reducing the protein in a natural latex device, including surgical gloves ([0027]) comprising treating a cured article with a leaching solution comprising an alkali metal carbonate salt, wherein alkali metal being sodium ([0048]-[0049]), wherein the leaching solution comprises 0.01-1%wt of said salt, or 0.1%wt ([0051], as to instant claim 5, 10).
2) Huynh et al discloses a process for producing natural latex gloves with very low levels of protein without being subjected to halogenation, wherein said process comprises after stripping the article from a former (Abstract, as to instant claim 9, 12), contacting said article with a rinse aqueous solution comprising ionic species of a disassociated metal salt (Abstract), wherein the metal salt includes metal of Group I, i.e. alkali metal salt (col. 2, lines 40-45), the concentration of the metal salt in the solution is 0.1-1.5%wt salt (col. 7, lines 4-10, col. 6, lines 60-67, as to instant claims 5, 10). The process includes the steps of pre-rinse and further rinsing, and further drying (col. 8, lines 32-40, as to instant claims 8, 11). The step of immersing the gloves in the rinse solution may be conducted for a long enough period of time to cause the protein levels to drop to acceptable levels (col. 2, lines 35-40).
12. Since Kawasaki et al, Elvig and Huynh et al are related to processes for removing protein from natural rubber gloves by treatment those with solutions comprising alkali metal salts including sodium carbonate, and thereby belong to the same field of endeavor, wherein Elvig recites said sodium carbonate being used at a concentration of 0.01-1%wt, or 0.1%wt, and Huynh et al recites such salts being used at the concentration of 0.1-1.5%wt and further such process being conducted after the glove has been stripped, therefore, it would have been obvious to a one of ordinary skill in the art to combine the teachings of Kawasaki et al, Elvig and Huynh et al, and to use, or obvious to try to use the solution of sodium carbonate in the process of Kawasaki et al at a concentration of 0.01-1%wt, or 0.1%wt, as taught by Elvig and Huynh et al, and further conduct such treatment after the gloves were stripped, since such conditions for said treatment are taught in the art and it would be obvious to choose those based on their suitability. Case law holds that the selection of a known material based on its suitability for its intended use supports prima facie obviousness. Sinclair & Carroll Co vs. Interchemical Corp., 325 US 327, 65 USPQ 297 (1045). The key to supporting any rejection under 35 USC 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 USC 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "‘[R]ejections on obviousness cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.’" KSR, 550 U.S. at 418, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include:
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(A) Combining prior art elements according to known methods to yield predictable results;
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(B) Simple substitution of one known element for another to obtain predictable results;
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(C) Use of known technique to improve similar devices (methods, or products) in the same way;
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(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
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(E) "Obvious to try" – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
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(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention. MPEP 2141
13. Since the process of Kawasaki et al in view of Elvig and Huynh et al is substantially the same as that claimed in instant invention, i.e. includes treating the natural rubber latex gloves with 0.1%wt sodium carbonate solution at a temperature of 60⁰C, and the process of Kawasaki et al in view of Elvig and Huynh et al is specified as being conducted for a period of time from several minutes to about a week, including pre-wash and final repeated washings after the treatment, therefore, the process of Kawasaki et al in view of Elvig and Huynh et al would be reasonably expected to lead to producing said rubber glove having the residual concentration of the protein after said treatment in the ranges as claimed in instant invention as well (as to instant claims 13-18). 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. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). MPEP 2112.01(I). Since PTO cannot conduct experiments the proof of burden is shifted to the applicants to establish an unobviousness difference, see In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977). See MPEP § 2112.01.
14. It is further noted that instant specification does not provide sufficient evidence of criticality in conducting the process at specific time periods as claimed in instant invention, i.e. heating the rubber glove for specifically 10-30 minutes, heating the rubber glove in sodium carbonate solution for specifically 50-70 minutes and washing the rubber glove at least 2 times in washing water.
Thus, inventive examples presented in instant specification show the process comprising i) heating the gloves at 65⁰C for specifically 20 minutes; ii) heating the gloves in the 0.1%wt solution of sodium carbonate for 60 minutes at 65⁰C in a rotatable drum, and iii) two times washing for 20 minutes at 65⁰C (pp. 7-8 of instant specification). No other temperatures or duration of treatment were presented. Comparative Samples were the gloves having protein removed by conventional chlorination.
Therefore, there is no evidence of criticality in conducting treatment as claimed in instant invention. However, Kawasaki et al teaches that the total process of treatment may be carried out from several minutes to about a week (col. 4, lines 30-35), wherein the timing necessary for said treatment will intrinsically and necessarily depend on the initial amount of protein in the natural rubber latex such as gloves, and further on the desired final concentration of said protein, and the longer treatment will intrinsically and necessarily lead to more protein being removed from said natural latex gloves.
15. Claims 1-3, 6-8, 13-21 are rejected under 35 U.S.C. 103 as being unpatentable over Tabor et al (WO 2009/061311) in view of Rosholm et al (US 6,107,455).
16. Tabor et al discloses a method for reducing the protein content in natural rubber latex articles ([0023]), including gloves ([0022]) and the natural rubber latex articles produced by said process ([0022]), the process comprising the steps of:
1) exposing the article to a first clean water bath;
2) exposing the article to a leach batch comprising a surfactant and a potentiator comprising non-chlorinating salt ([0016]), wherein the non-chlorinating salt comprises a water-soluble metal carbonate ([0042]);
3) exposing the article to a second clean water bath,
wherein the temperatures of first clean water bath, the leach batch and the second clean bath are about 70⁰C or lower, preferably 60⁰C ([0017]).
Thus, all steps in the process of Tabor et al are conducted at a temperature of 60-70⁰C (as to instant claims 2-3, 6, 10).
17. Though Tabor et al does not explicitly recite the duration of treatment in each of the steps 1)-3),
Rosholm et al discloses a process for lowering the protein content in natural rubber latex articles, including natural rubber gloves (col. 3, lines 62-63) comprising washing the article/gloves in a solution of soluble silicate further comprising a sodium carbonate (col. 3, lines 30-32),
wherein comprises the following steps:
1) a pre-wash with water for specifically 15 minutes (col. 4, lines 1-5; col. 3, lines 43-45),
2) washing with said solution at 20-70⁰C for 1-60 minutes (col. 3, lines 36-40), or at specific temperature of 50⁰C (col. 4, lines 9-14, 55-57),
3) rinsing with water (col. 4, lines 17-20; col. 3, lines 43045) and
4) drying the article/gloves (col. 4, lines 22-25, as to instant claims 8, 11).
18. Since Tabor et al and Rosholm et al are related to processes for removing protein from natural rubber gloves by treatment those with solutions comprising metal carbonates including sodium carbonate, and thereby belong to the same field of endeavor, wherein Rosholm et al explicitly teaches the prewash step being conducted for 15 minutes, washing with sodium carbonate-containing solution for 60 minutes, and further teaches rinsing the gloves, therefore, it would have been obvious to a one of ordinary skill in the art to combine the teachings of Tabor et al and Rosholm et al and to use, or obvious to try to conduct the re-wash step in the process of Tabor et al for 15 minutes and wash with sodium carbonate-containing solution for 60 minutes, as taught by Rosholm et al, since such durations of deproteinization treatment are taught in the art and it would have been obvious to apply those.
Further, since i) the timing necessary for said treatment in the step 2) will intrinsically and necessarily depend on the initial amount of protein in the natural rubber latex such as gloves, and further on the desired final concentration of said protein, ii) rinsing in the step 3) leads to removing all chemicals left in the gloves during and after said treatment in the step 2), and iii) the longer duration of rinsing and the increased number of rinsings will intrinsically and necessarily lead to more thorough removal of all chemicals from the gloves, therefore, it would be obvious to a one of ordinary skill in the art to make variations and optimize the specific time necessary to rinse the gloves in the step 3) after said treatment in the step 2), including conducting said rinsing for at least 10 minutes, or 10-30 minutes, and for multiple repetitions, such as at least two times, so to produce the final deproteinized natural rubber gloves having substantially no residual chemicals, and desired cleanliness, given such is desired, thereby arriving at the present invention. The key to supporting any rejection under 35 USC 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 USC 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "‘[R]ejections on obviousness cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.’" KSR, 550 U.S. at 418, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include:
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(A) Combining prior art elements according to known methods to yield predictable results;
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(B) Simple substitution of one known element for another to obtain predictable results;
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(C) Use of known technique to improve similar devices (methods, or products) in the same way;
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(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
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(E) "Obvious to try" – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
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(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention. MPEP 2141
19. Since the process of Tabor et al in view of Rosholm et al is substantially the same as that claimed in instant invention, i.e. includes treating the natural rubber latex gloves with sodium carbonate solution at a temperature of 60⁰C for 60 minutes, including pre-wash and further rinsing after said treatments, therefore, the process of Tabor et al in view of Rosholm et al would be reasonably expected to lead to producing said rubber glove having the residual concentration of the protein after said treatment in the ranges as claimed in instant invention as well (as to instant claims 13-18). 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. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). MPEP 2112.01(I). Since PTO cannot conduct experiments the proof of burden is shifted to the applicants to establish an unobviousness difference, see In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977). See MPEP § 2112.01.
20. It is further noted that instant specification does not provide sufficient evidence of criticality in conducting the process at specific time periods as claimed in instant invention, i.e. heating the rubber glove for specifically 10-30 minutes, heating the rubber glove in sodium carbonate solution for specifically 50-70 minutes and washing the rubber glove at least 2 times in washing water.
Thus, inventive examples presented in instant specification show the process comprising i) heating the gloves at 65⁰C for specifically 20 minutes; ii) heating the gloves in the 0.1%wt solution of sodium carbonate for 60 minutes at 65⁰C in a rotatable drum, and iii) two times washing for 20 minutes at 65⁰C (pp. 7-8 of instant specification). No other temperatures or duration of treatment were presented. Comparative Samples were the gloves having protein removed by conventional chlorination.
Therefore, there is no evidence of criticality in conducting treatment in the periods of time as claimed in instant invention.
21. Claims 1-3, 5-21 are rejected under 35 U.S.C. 103 as being unpatentable over Tabor et al (WO 2009/061311) in view of Rosholm et al (US 6,107,455), in further view of Elvig (US 2002/0066975) and Huynh et al (US 6,790,933).
22 The discussion with respect to Tabor et al (WO 2009/061311) in view of Rosholm et al (US 6,107,455), set forth in paragraphs 15-20 above, is incorporated here by reference.
23. Tabor et al in view of Rosholm et al do not explicitly recite the concentration of the sodium carbonate in the treatment solution, and the process being carried after the rubber glove has been stripped.
24. However,
1) Elvig discloses a method for reducing the protein in a natural latex device, including surgical gloves ([0027]) comprising treating a cured article with a leaching solution comprising an alkali metal carbonate salt, with alkali metal being sodium ([0048]-[0049]), wherein the leaching solution comprises 0.01-1%wt of said salt, or 0.1%wt ([0051], as to instant claim 5, 10).
2) Huynh et al discloses a process for producing natural latex gloves with very low levels of protein without being subjected to halogenation, wherein said process comprises after stripping the article from a former (Abstract, as to instant claim 9, 12), contacting said article with a rinse aqueous solution comprising ionic species of a disassociated metal salt (Abstract), wherein the metal salt includes metal of Group I, i.e. alkali metal salt (col. 2, lines 40-45), the concentration of the metal salt in the solution is 0.1-1.5%wt salt (col. 7, lines 4-10, col. 6, lines 60-67, as to instant claims 5, 10). The process includes the steps of pre-rinse and further rinsing, and further drying (col. 8, lines 32-40, as to instant claims 8, 11). The step of immersing the gloves in the rinse solution may be conducted for a long enough period of time to cause the protein levels to drop to acceptable levels (col. 2, lines 35-40).
25. Since Tabor et al in view of Rosholm et al, Elvig and Huynh et al are related to processes for removing protein from natural rubber gloves by treatment those with solutions comprising alkali metal salts including sodium carbonate, and thereby belong to the same field of endeavor, wherein Elvig recites said sodium carbonate being used at a concentration of 0.01-1%wt, or 0.1%wt, and Huynh et al recites such salts being used at the concentration of 0.1-1.5%wt and further such process being conducted after the glove has been stripped, therefore, it would have been obvious to a one of ordinary skill in the art to combine the teachings of Tabor et al in view of Rosholm et al, Elvig and Huynh et al, and to use, or obvious to try to use the solution of sodium carbonate in the process of Tabor et al in view of Rosholm et al at a concentration of 0.01-1%wt, or 0.1%wt, as taught by Elvig and Huynh et al, and further conduct such treatment after the gloves were stripped, since it would be obvious to choose material based on its suitability. Case law holds that the selection of a known material based on its suitability for its intended use supports prima facie obviousness. Sinclair & Carroll Co vs. Interchemical Corp., 325 US 327, 65 USPQ 297 (1045). The key to supporting any rejection under 35 USC 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 USC 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "‘[R]ejections on obviousness cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.’" KSR, 550 U.S. at 418, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include:
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(A) Combining prior art elements according to known methods to yield predictable results;
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(B) Simple substitution of one known element for another to obtain predictable results;
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(C) Use of known technique to improve similar devices (methods, or products) in the same way;
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(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
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(E) "Obvious to try" – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
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(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention. MPEP 2141
26. Since the process of Tabor et al in view of Rosholm et al, Elvig and Huynh et al is substantially the same as that claimed in instant invention, i.e. includes treating the natural rubber latex gloves with 0.1%wt sodium carbonate solution at a temperature of 60⁰C for 60 minutes, including pre-wash and further rinsing after said treatment, therefore, and the process , therefore, the process of Tabor et al in view of Rosholm et al, Elvig and Huynh et al would be reasonably expected to lead to producing said rubber glove having the residual concentration of the protein after said treatment in the ranges as claimed in instant invention as well (as to instant claims 13-18). 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. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). MPEP 2112.01(I). Since PTO cannot conduct experiments the proof of burden is shifted to the applicants to establish an unobviousness difference, see In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977). See MPEP § 2112.01.
27. It is further noted that instant specification does not provide sufficient evidence of criticality in conducting the process at specific time periods as claimed in instant invention, i.e. heating the rubber glove for specifically 10-30 minutes, heating the rubber glove in sodium carbonate solution for specifically 50-70 minutes and washing the rubber glove at least 2 times in washing water.
Thus, inventive examples presented in instant specification show the process comprising i) heating the gloves at 65⁰C for specifically 20 minutes; ii) heating the gloves in the 0.1%wt solution of sodium carbonate for 60 minutes at 65⁰C in a rotatable drum, and iii) two times washing for 20 minutes at 65⁰C (pp. 7-8 of instant specification). No other temperatures or duration of treatment were presented. Comparative Samples were the gloves having protein removed by conventional chlorination.
Therefore, there is no evidence of criticality in conducting treatment as claimed in instant invention.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IRINA KRYLOVA whose telephone number is (571)270-7349. The examiner can normally be reached 9am-5pm EST M-F.
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/IRINA KRYLOVA/Primary Examiner, Art Unit 1764
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