Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claim 1-4, 6-12 and 14-17 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Montgomery et al. (US5338312) in view of Lee et al. (US5753234).
Regarding claims 1-4 and 9, Montgomery teaches coating the interior surface of a glass syringe barrel (col. 3, lines 16-27) by spraying (col. 3, lines 47-54) with a silicone oil composition wherein the silicone oil is thereafter plasma treated with RF plasma energy (col. 3, line 55 through col. 4, line 3). Montgomery is generally vague as to the possible uses of his syringes. However, Lee teaches that syringes are known to provide medical compositions for the purpose of injecting them (see Test Example 3). Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to combine the medical composition of Lee and the syringe of Montgomery as a simple combining of a prior art syringe and medication deliverable by a syringe combinable using known vaccination methods wherein the vaccine and syringe each function separately and the same as they would have on the own in the respective cited prior arts and are merely combined herein in a non-unique manner, consistent with general vaccine usage in the medical field using syringes injection. Further the references would be combined in order to make the composition of Lee useful as it is seemingly intended to be injected. Further in general this could also be viewed as a simple substitution of the syringe of Lee with the syringe of Montgomery, wherein the substitution would be been predictable especially based upon the teachings of Lee that syringes are useful for the injection of medical compositions. Further it is noted that because the barrel, silicone oil and silicone oil treatment steps of Montgomery are the same as those of the current claims, it would logically be expected that the syringe of Montgomery would function to release particles in the exact same manner claimed herein, especially as relates to the use of Lee which further shows that use of a combination of PBS and Tween 80 is part of the vaccine described and further described as being used in the current specification and in current claim 4 in particular. The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). See MPEP 2112. A reference which is silent about a claimed invention’s features is inherently anticipatory if the missing feature is necessarily present in that which is described in the reference. In re Robertson, 49 USPQ2d 1949 (1999).
Regarding claims 2-3, similar it is noted that as in the rejection of claim 1 above, the prior art syringe would be expected to have the same claimed properties as claimed in the current claims and therefore properly meets the claim limitations. Further it is noted that how the particle level is measured in these two claims is largely irrelevant because the claim does not actively require a step of measuring the particles but rather states “when measured” the results would be as claimed. This is not the equivalent of requiring measurement as part of the claim. Additionally the current claim it a product claim wherein is not a requirement of the product that the exact steps of use are followed so long as the prior art product is at least capable of the operation claimed. It is further noted however, that the current claims is not view as a “product-by-process” claim because the current claims do not require the active step of measuring as stated above. However, if it were required it should be noted that, “Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F. 2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Regarding claim 6, Montgomery further teaches coating thicknesses in the range claimed (col. 4, lines 18-29).
Regarding claim 7, because the silicone oil, stopper and barrel of Montgomery are the same as those claimed it is logical that the syringe of Montgomery in use would function in the same way claimed. The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). See MPEP 2112. A reference which is silent about a claimed invention’s features is inherently anticipatory if the missing feature is necessarily present in that which is described in the reference. In re Robertson, 49 USPQ2d 1949 (1999).
Regrading claims 8 and 11, the teachings of Montgomery are as shown above. Montgomery fails to teach the exact viscosity range of the current claimed but rather teaches an overlapping range (col. 3, lines 38-46). However, those of ordinary skill in the art would readily recognize that the viscosity of the lubricant provided would directly affect the lubricity of the final coating. Therefore, in the absence of criticality of the specific range of the current claims, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the viscosity of the lubricating material employed in order to optimize the lubricity of the final plasma treated product. Discovery of optimum value of result effective variable in known process is ordinarily within skill of art. In re Boesch, CCPA 1980, 617 F.2d 272, 205 USPQ215. It is noted further that it is factors such as gliding force that relate to the lubricity of Montgomery wherein when the examiner states that the lubricity of Montgomery would be optimized that includes measurements directly related to lubricity such as gliding force. Therefore, in the absence of criticality of the specific range of the current claims, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the viscosity of the lubricating material employed in order to optimize the lubricity of the final plasma treated product in order to control factors such a gliding force.
Regarding claim 10, Montgomery further teaches the use of PDMS (col. 2, lines 1-7).
Regarding claim 12, Montgomery further teaches providing an internal volume equivalent to that claimed (col. 3, lines 1-8) but is silent as to the diameter of the syringe provided. However, the Court has long held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. See In Gardnerv.TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit.
Regarding claim 14, the teachings of Montgomery in view of Lee are as shown above. Montgomery in view of Lee is silent as to the weight of coating material present. However, it is noted that the overall weight of the coating present is a function of the thickness of the coating provided, the type of coating used and the area over which is it is provided, all of which are directly taught by Montgomery or addressed in the rejections of claims 1-4 and 6-12 above. Logically any modification in any one of these factors for any reason would directly affect the weight of overall coating used. Therefore as stated above, changes to the relative dimensions of the device to be coated are considered to be obvious by the Court and thereby also changing the mass of coating provided for a given coated thickness due to a change in the size of the device to be coated would also reasonably be obvious outside of a new and unexpected result arising from the particular coating mass claimed. Therefore, in the absence of criticality of the specific coating mass claimed, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the size of the syringe barrel coated as described above and thereby optimize the coating mass of coating simultaneously in order to provide a matching coating mass for the size of syringe barrel chosen thereby allowing the coating of Montgomery to function as originally desired as the size of the barrel of Montgomery is changed.
Regarding claim 15, the current claims describes why a step was taken. However, the reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006).
Regarding claim 16, the composition of Lee is a vaccine ( see Title).
Regarding claim 17, because the silicone oil, stopper and barrel of Montgomery are the same as those claimed it is logical that the syringe of Montgomery would cause the same effect claimed in the same way. The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). See MPEP 2112. A reference which is silent about a claimed invention’s features is inherently anticipatory if the missing feature is necessarily present in that which is described in the reference. In re Robertson, 49 USPQ2d 1949 (1999).
Claim 13 and 18-20 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Montgomery et al. (US5338312) in view of Lee et al. (US5753234) as applied to claims 1-4, 6-12 and 14-17 and further in view of Strowe et al. (US4838857).
Regarding claims 13, Montgomery teaches coating the interior surface of a glass syringe barrel (col. 3, lines 16-27) by spraying (col. 3, lines 47-54) with a silicone oil composition wherein the silicone oil is thereafter plasma treated with RF plasma energy (col. 3, line 55 through col. 4, line 3). Montgomery is generally vague as to the possible uses of his syringes. However, Lee teaches that syringes are known to provide medical compositions for the purpose of injecting them (see Test Example 3). Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to combine the medical composition of Lee and the syringe of Montgomery as a simple combining of a prior art syringe and medication deliverable by a syringe combinable using known vaccination methods wherein the vaccine and syringe each function separately and the same as they would have on the own in the respective cited prior arts and are merely combined herein in a non-unique manner, consistent with general vaccine usage in the medical field using syringes injection. Further the references would be combined in order to make the composition of Lee useful as it is seemingly intended to be injected. Further in general this could also be viewed as a simple substitution of the syringe of Lee with the syringe of Montgomery, wherein the substitution would be been predictable especially based upon the teachings of Lee that syringes are useful for the injection of medical compositions. Further it is noted that because the barrel, silicone oil and silicone oil treatment steps of Montgomery are the same as those of the current claims, it would logically be expected that the syringe of Montgomery would function to release particles in the exact same manner claimed herein, especially as relates to the use of Lee which further shows that use of a combination of PBS and Tween 80 is part of the vaccine described and further described as being used in the current specification and in current claim 4 in particular. The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). See MPEP 2112. A reference which is silent about a claimed invention’s features is inherently anticipatory if the missing feature is necessarily present in that which is described in the reference. In re Robertson, 49 USPQ2d 1949 (1999). The teachings of Montgomery in view of Lee are as shown above. Montgomery in view of Lee fails to teach the exact viscosity range of the current claimed but rather teaches an overlapping range (col. 3, lines 38-46). However, those of ordinary skill in the art would readily recognize that the viscosity of the lubricant provided would directly affect the lubricity of the final coating. Therefore, in the absence of criticality of the specific range of the current claims, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the viscosity of the lubricating material employed in order to optimize the lubricity of the final plasma treated product. Discovery of optimum value of result effective variable in known process is ordinarily within skill of art. In re Boesch, CCPA 1980, 617 F.2d 272, 205 USPQ215. It is noted further that it is factors such as gliding force that relate to the lubricity of Montgomery wherein when the examiner states that the lubricity of Montgomery would be optimized that includes measurements directly related to lubricity such as gliding force. Therefore, in the absence of criticality of the specific range of the current claims, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the viscosity of the lubricating material employed in order to optimize the lubricity of the final plasma treated product in order to control factors such a gliding force. The teachings of Montgomery in view of Lee are as shown above. Montgomery in view of Lee fails to teach wherein the needle comprises a finger flange or a needle although Montgomery does teach that finger pressure is applied to the body of the syringe (see background of invention). However, Strowe teaches that syringes commonly are provided with finger flanges for use manually with fingers or for use with syringe pumps (see. Fig. 1) as a means to assist in holding the syringe in the pump mount (col. 3, lines 30-42). Therefore it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to provide the syringes of Montgomery with finger flanges for manual use or for use with pumps as guided above. Further, Montgomery further teaches coating thicknesses in the range claimed (col. 4, lines 18-29). Further, because the silicone oil, stopper and barrel of Montgomery are the same as those claimed it is logical that the syringe of Montgomery in use would function in the same way claimed. The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). See MPEP 2112. A reference which is silent about a claimed invention’s features is inherently anticipatory if the missing feature is necessarily present in that which is described in the reference. In re Robertson, 49 USPQ2d 1949 (1999). Further as relates to the relative dimensions of the syringe, the Court has long held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. See In Gardnerv.TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit.
Regarding claims 18, Montgomery teaches coating the interior surface of a glass syringe barrel (col. 3, lines 16-27) by spraying (col. 3, lines 47-54) with a silicone oil composition wherein the silicone oil is thereafter plasma treated with RF plasma energy (col. 3, line 55 through col. 4, line 3). Montgomery is generally vague as to the possible uses of his syringes. However, Lee teaches that syringes are known to provide medical compositions for the purpose of injecting them (see Test Example 3). Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to combine the medical composition of Lee and the syringe of Montgomery as a simple combining of a prior art syringe and medication deliverable by a syringe combinable using known vaccination methods wherein the vaccine and syringe each function separately and the same as they would have on the own in the respective cited prior arts and are merely combined herein in a non-unique manner, consistent with general vaccine usage in the medical field using syringes injection. Further the references would be combined in order to make the composition of Lee useful as it is seemingly intended to be injected. Further in general this could also be viewed as a simple substitution of the syringe of Lee with the syringe of Montgomery, wherein the substitution would be been predictable especially based upon the teachings of Lee that syringes are useful for the injection of medical compositions. Further it is noted that because the barrel, silicone oil and silicone oil treatment steps of Montgomery are the same as those of the current claims, it would logically be expected that the syringe of Montgomery would function to release particles in the exact same manner claimed herein, especially as relates to the use of Lee which further shows that use of a combination of PBS and Tween 80 is part of the vaccine described and further described as being used in the current specification and in current claim 4 in particular. The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). See MPEP 2112. A reference which is silent about a claimed invention’s features is inherently anticipatory if the missing feature is necessarily present in that which is described in the reference. In re Robertson, 49 USPQ2d 1949 (1999). The teachings of Montgomery in view of Lee are as shown above. Montgomery in view of Lee fails to teach the exact viscosity range of the current claimed but rather teaches an overlapping range (col. 3, lines 38-46). However, those of ordinary skill in the art would readily recognize that the viscosity of the lubricant provided would directly affect the lubricity of the final coating. Therefore, in the absence of criticality of the specific range of the current claims, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the viscosity of the lubricating material employed in order to optimize the lubricity of the final plasma treated product. Discovery of optimum value of result effective variable in known process is ordinarily within skill of art. In re Boesch, CCPA 1980, 617 F.2d 272, 205 USPQ215. It is noted further that it is factors such as gliding force that relate to the lubricity of Montgomery wherein when the examiner states that the lubricity of Montgomery would be optimized that includes measurements directly related to lubricity such as gliding force. Therefore, in the absence of criticality of the specific range of the current claims, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the viscosity of the lubricating material employed in order to optimize the lubricity of the final plasma treated product in order to control factors such a gliding force. The teachings of Montgomery in view of Lee are as shown above. Montgomery in view of Lee fails to teach wherein the needle comprises a finger flange or a needle although Montgomery does teach that finger pressure is applied to the body of the syringe (see background of invention). However, Strowe teaches that syringes commonly are provided with finger flanges for use manually with fingers or for use with syringe pumps (see. Fig. 1) as a means to assist in holding the syringe in the pump mount (col. 3, lines 30-42). Therefore it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to provide the syringes of Montgomery with finger flanges for manual use or for use with pumps as guided above. Further, Montgomery further teaches coating thicknesses in the range claimed (col. 4, lines 18-29). Further, because the silicone oil, stopper and barrel of Montgomery are the same as those claimed it is logical that the syringe of Montgomery in use would function in the same way claimed. The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). See MPEP 2112. A reference which is silent about a claimed invention’s features is inherently anticipatory if the missing feature is necessarily present in that which is described in the reference. In re Robertson, 49 USPQ2d 1949 (1999). Further as relates to the relative dimensions of the syringe, the Court has long held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. See In Gardnerv.TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit.
Regrading claim 19, Montgomery teaches coating the interior of the barrel in general reasonably implying that the entire surface of the barrel portion of the syringe would be coated.
Regarding claim 20, the teachings of Montgomery in view of Lee and Strowe are as shown above. Montgomery in view of Lee and Strowe fail to teach the step of the current claims. However, first it is noted that it is not a requirement of the prior art that the step of the current claims be performed because the current claims are product claims. It is noted that claim 20 is a product-by-process claim. “Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F. 2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). As otherwise described the product of Montgomery in view of Lee and Strowe is as claimed and therefore meets the claim limitations.
Claim 5 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Montgomery et al. (US5338312) in view of Lee et al. (US5753234) as applied to claims 1-4, 6-12 and 14-17 above and further in view of Williams et al. (US54767414).
Regarding claim 5, the teachings of Williams in view of Lee are as shown above. Williams in view of Lee fails to teach coating the plunger/stopper necessarily. However, Williams teaches that it is known to coat stoppers with silicone oil (PDMS) in order to reduce breakout forces associated with their use in syringes (see Example). Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to coat the plunger/stoppers of Montgomery in view of Lee as guided by Williams in order to prevent breakout forces in the syringes of Williams in view of Lee in the same way.
Conclusion
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/ANDREW J BOWMAN/Examiner, Art Unit 1717
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