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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 13 June 2023 has been considered and made of record. It should be noted that the document number of the cited U.S. Patent Application Publications 2003230521, 2012184033, 2013274929, 2016122798, 2019292507 appear to be incomplete/incorrect document numbers.
Claim Objections
Claims 2-23 are objected to because of the following informalities: Regarding claims 2-14, “A bioprocess system as defined in claim” should read “The bioprocess system as defined in claim.” Regarding claims 16-23, “A process as defined in claim” should read “The process as defined in claim.” Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-24 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the internal diameter being greater than about 260 mm" in line 7. The limitation “greater than about 260 mm” renders the claim indefinite. The language of the claim is such that one of ordinary skill in the art could not interpret the meets and bounds of the claim. In particular, it is not clear as to what range is covered by the term "greater than about.” Claims 2-14 are included in this rejection by virtue of their dependency upon a rejected base claim.
Claim 2 recites the limitation "a material that is sufficiently rigid and malleable" in line 2. However, the claim is unclear. It is unclear how rigid or malleable the material need to be to meet the limitation. Further, it is unclear how the material is rigid and malleable at the same time. Further clarification is requested and appropriate correction is required.
Claim 5 recites the limitation "a width of greater than about 0.5 mm" in lines 2-3. The limitation “greater than about 0.5 mm” renders the claim indefinite. The language of the claim is such that one of ordinary skill in the art could not interpret the meets and bounds of the claim. In particular, it is not clear as to what range is covered by the term "greater than about.”
Claim 5 recites the limitation “less than about 3 mm" in line 4. The limitation “less than about 3 mm” renders the claim indefinite. The language of the claim is such that one of ordinary skill in the art could not interpret the meets and bounds of the claim. In particular, it is not clear as to what range is covered by the term " less than about 3 mm.”
Claim 15 recites the limitation "a material that is sufficiently rigid and malleable" in line 13. However, the claim is unclear. It is unclear how rigid or malleable the material need to be to meet the limitation. Further, it is unclear how the material is rigid and malleable at the same time. Further clarification is requested and appropriate correction is required. Claims 16-23 are included in this rejection by virtue of their dependency upon a rejected base claim.
Claim 24 recites the limitation "a material that is sufficiently rigid and malleable" in line 11. However, the claim is unclear. It is unclear how rigid or malleable the material need to be to meet the limitation. Further, it is unclear how the material is rigid and malleable at the same time. Further clarification is requested and appropriate correction is required.
Appropriate correction is required.
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 1-2, 5-6, 10-15, 18-22 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Hlavinka et al. (US 5,520,218; hereinafter “Hlavinka”).
Regarding claim 1, Hlavinka discloses a bioprocess system comprising: a first bioprocess device (FIG.7; col. 3, ll. 40-48); a second bioprocess device (FIG. 7; col. 3, ll. 40-48); a bioprocess tube in fluid communication with the first bioprocess device and the
second bioprocess device (FIG. 7: tube 10), the bioprocess tube comprising a thermoplastic elastomer (col. 4, ll. 3-5), the bioprocess tube defining a hollow passageway and having an internal diameter, an external diameter, and an external surface (FIGS.7-10); and a separating collar for facilitating cutting the bioprocess tube for disconnecting the first bioprocess device from the second bioprocess device (sleeve 12’, 12”; FIGS. 7-10; col. 4, ll. 24-51), the separating collar being slidably mounted on the exterior surface of the bioprocess tube (sleeve (12’,12”) includes slits that facilitate sliding of the sleeve over the bioprocess tube), the separating collar having a cylindrical shape and having a length that extends from a first end to a second and opposite end (FIGS.7-10), the separating collar defining at least one pair of adjacent separating edges that extend over the length of the collar, the pair of adjacent separating edges allowing the separating collar to be installed and removed from a bioprocess tube (sleeve (12’,12”) defines a slit (20); see FIG. 1). Hlavinka discloses the claimed invention except for the claimed internal dimeter of the bioprocess tube being greater than about 260 mm. However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the dimension of bioprocess tube of Hlavinka to have any dimension including the claimed dimension, since such a modification would involve only a mere change in size of a component. Scaling up or down of an element which merely requires a change in size is generally considered as being within the ordinary skill in the art (See MPEP 2144.04 IV. A.). One would have been motivated to scale the size of bioprocess tube to have the claimed size in order to process desired volume of fluid. Furthermore, it’s noted that the courts have held 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 (In Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777). See MPEP 2144.04 IV. A.
Furthermore, it is noted that the recitation of functional language "e.g., for facilitating cutting the bioprocess tube for disconnecting the first bioprocess device from the second bioprocess device" is drawn to intended use of the claimed invention. It is noted that a recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform. Apparatus claims must distinguish from the prior art in terms of structure rather than function (see MPEP 2114). The prior art discloses all of the structural features of the claimed system and thus since the structure is the same, the claimed functions are apparent.
Regarding claim 2, modified Hlavinka further discloses wherein the separating collar is made from a material that is sufficiently rigid and malleable such that when the separating collar is cut with a cutting tool to form cut ends, the cut ends of the separating collar maintain cut ends of the bioprocess tube in a closed configuration (FIGS. 1-6; col. 4, ll. 39-64).
Regarding claim 5, modified Hlavinka discloses wherein the pair of adjacent separating edges define a slit (sleeve (12’,12”) defines a slit (20); see FIG. 1), but does not explicitly disclose wherein the slit has a width of greater than about 0.5 mm and less than about 3 mm. However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the dimension of slit of modified Hlavinka to have any dimension including the claimed dimension, since such a modification would involve only a mere change in size of a component. Scaling up or down of an element which merely requires a change in size is generally considered as being within the ordinary skill in the art (See MPEP 2144.04 IV. A.). One would have been motivated to scale the size of slit to have the claimed size in order to complement the seize of the bioprocess tube being used. Furthermore, it’s noted that the courts have held 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 (In Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777). See MPEP 2144.04 IV. A.
Regarding claim 6, modified Hlavinka discloses wherein the pair of adjacent separating edges define a slit (sleeve (12’,12”) defines a slit (20); see FIG. 1), but does not explicitly disclose wherein the slit has a width of greater than about 3 mm and less than about 100 mm. However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the dimension of slit of modified Hlavinka to have any dimension including the claimed dimension, since such a modification would involve only a mere change in size of a component. Scaling up or down of an element which merely requires a change in size is generally considered as being within the ordinary skill in the art (See MPEP 2144.04 IV. A.). One would have been motivated to scale the size of slit to have the claimed size in order to complement the seize of the bioprocess tube being used. Furthermore, it’s noted that the courts have held 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 (In Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777). See MPEP 2144.04 IV. A.
Regarding claim 10, modified Hlavinka does not explicitly disclose wherein the separating collar has a length of from about 600 mm to about 10,000 mm. However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the dimension of separating collar of modified Hlavinka to have any dimension including the claimed dimension, since such a modification would involve only a mere change in size of a component. Scaling up or down of an element which merely requires a change in size is generally considered as being within the ordinary skill in the art (See MPEP 2144.04 IV. A.). Furthermore, it’s noted that the courts have held 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 (In Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777). See MPEP 2144.04 IV. A.
Regarding claim 11, modified Hlavinka does not explicitly disclose wherein the first bioprocess device comprises a chromatography device. However, modified Hlavinka does disclose wherein the system can be employed with various devices including filtration devices that process materials (Hlavinka at col. 3, ll. 40-47). Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the first bioprocess device of modified Hlavinka with a chromatography device to arrive at the claimed invention with a reasonable expectation of success. One of ordinary skill in the art would have made said modification because said modification would been the simple substitution of one known separation device for another for the predictable result of separating material.
Regarding claim 12, modified Hlavinka further discloses wherein the second bioprocess device comprises a filtration device (Hlavinka at col. 3, ll. 40-47).
Regarding claim 13, modified Hlavinka further discloses wherein the second bioprocess device comprises a filtration device (Hlavinka at col. 3, ll. 40-47). Modified Hlavinka does not explicitly disclose wherein the first bioprocess device comprises a chromatography device. However, modified Hlavinka does disclose wherein the system can be employed with various devices (Hlavinka at col. 3, ll. 40-47). Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the first bioprocess device of modified Hlavinka with a chromatography device to arrive at the claimed invention with a reasonable expectation of success. One of ordinary skill in the art would have made said modification because said modification would been the simple substitution of one known device for another for the predictable result of separating material.
Regarding claim 14, modified Hlavinka further discloses wherein the first bioprocess
device comprises a filtration device (Hlavinka at col. 3, ll. 40-47)and wherein the second bioprocess device comprises a bioprocess bag (reservoir; Hlavinka at col. 3, ll. 40-47).
Regarding claim 15, Hlavinka discloses a method for disconnecting two bioprocess devices comprising; placing a separating collar on an exterior surface of a bioprocess tube (sleeve 12’, 12”; FIGS. 7-10; col. 4, line 24 to col. 5, line 7), the bioprocess
tube being made from a thermoplastic elastomer (col. 4, ll. 3-5), the bioprocess tube defining a hollow passageway and having an internal diameter and an external diameter (FIGS. 7-10), the separating collar being slidably mounted on the exterior surface of the bioprocess tube, the separating collar having a cylindrical shape and having a length that extends from a first end to a second end (sleeve 12’, 12”; FIGS. 7-10; col. 4, ll. 24-51), the separating collar defining at least one pair of adjacent separating edges that extend over the length of the collar that permits placement of the separating collar on the exterior surface of the bioprocess tube (sleeve (12’,12”) defines a slit (20); see col. 4, ll. 24-34; FIG. 1); and cutting through the separating collar and bioprocess tube to produce a first free end
and a second free end, wherein during cutting, the separating collar and underlying bioprocess
tube are deformed (col. 4, line 46 to col. 5, line 7), compressing the walls of the bioprocess tube together, the separating collar being made from a material with sufficient rigidity and malleability to maintain the free ends of the bioprocess tube in a compressed condition after cutting (FIGS. 2-5; col. 4, line 46 to col. 5, line 7). Hlavinka discloses the claimed invention except for the claimed internal dimeter of the bioprocess tube being greater than about 260 mm. However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the dimension of bioprocess tube of Hlavinka to have any dimension including the claimed dimension, since such a modification would involve only a mere change in size of a component. Scaling up or down of an element which merely requires a change in size is generally considered as being within the ordinary skill in the art (See MPEP 2144.04 IV. A.). One would have been motivated to scale the size of bioprocess tube to have the claimed size in order to process desired volume of fluid. Furthermore, it’s noted that the courts have held 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 (In Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777). See MPEP 2144.04 IV. A.
Regarding claim 18, modified Hlavinka further discloses wherein, after transferring a bioprocess composition through the bioprocess tube from a first bioprocess device to a second bioprocess device, the separating collar and bioprocess tube are cut (col. 4, ll. 54-61; col. 5, ll. 24-28).
Regarding claim 19, modified Hlavinka does not explicitly disclose wherein the first bioprocess device comprises a chromatography device. However, modified Lofving does disclose wherein the system can be employed with various devices including filtration devices that process materials (Hlavinka at col. 3, ll. 40-47). Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the first bioprocess device of modified Hlavinka with a chromatography device to arrive at the claimed invention with a reasonable expectation of success. One of ordinary skill in the art would have made said modification because said modification would been the simple substitution of one known separation device for another for the predictable result of separating material.
Regarding claim 20, modified Hlavinka further discloses wherein the second bioprocess device comprises a filtration device (Hlavinka at col. 3, ll. 40-47).
Regarding claim 21, modified Hlavinka does not explicitly disclose wherein the first bioprocess device comprises a ultrafiltration device. However, modified Hlavinka does disclose wherein the system can be employed with various devices including filtration devices that process materials (Hlavinka at col. 3, ll. 40-47). Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the first bioprocess device of modified Hlavinka with a ultrafiltration device to arrive at the claimed invention with a reasonable expectation of success. One of ordinary skill in the art would have made said modification because said modification would been the simple substitution of one known separation device for another for the predictable result of separating material. Modified Hlavinka does disclose wherein the filtration device filters a bioprocess composition, the filtered composition being fed through the bioprocess tube prior to cutting the tube with the separating device (Hlavinka does disclose wherein flow of material to filtration device is interrupted after filtration (col. 4, ll. 56-60; col. 5, ll. 24-26).
Regarding claim 22, modified Hlavinka further discloses wherein at least one of the first bioprocess device or the second bioprocess device is connected to the bioprocess tube comprises a bioprocess bag (reservoir; Hlavinka at col. 3, ll. 40-47).
Regarding claim 24, Hlavinka discloses apparatus for conveying a bioprocess fluid comprising: a bioprocess tube made from a thermoplastic elastomer (FIG. 7: tube 10; col. 4, ll. 3-5), the bioprocess tube defining a
hollow passageway and having an internal diameter, an external diameter and an external
surface (FIGS. 7-10); and a separating collar removably mounted on the external surface of the bioprocess tube (sleeve 12’, 12”; FIGS. 7-10; col. 4, ll. 24-51), the separating collar being mounted such that the separating collar is slidable along the external surface of the bioprocess tube (sleeve (12’,12”) includes slits that facilitate sliding of the sleeve over the bioprocess tube), the separating collar having a cylindrical shape and having a length that extends from a first end to a second end (FIGS.7-10), the separating collar defining at least one pair of adjacent separating edges that extend over the length of the collar, the pair of adjacent separating edges allowing the separating collar to be installed and removed from a bioprocess tube (sleeve (12’,12”) defines a slit (20); see FIG. 1), the separating collar being made from a rigid and malleable material that, when a cut is made through the separating collar and the underlying bioprocess tube, the separating collar compresses and maintains cut ends of the bioprocess tube in a closed state after cutting (FIGS. 1-6; col. 4, ll. 39-64).
Hlavinka discloses the claimed invention except for the claimed internal dimeter of the bioprocess tube being greater than about 260 mm. However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the dimension of bioprocess tube of Hlavinka to have any dimension including the claimed dimension, since such a modification would involve only a mere change in size of a component. Scaling up or down of an element which merely requires a change in size is generally considered as being within the ordinary skill in the art (See MPEP 2144.04 IV. A.). One would have been motivated to scale the size of bioprocess tube to have the claimed size in order to process desired volume of fluid. Furthermore, it’s noted that the courts have held 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 (In Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777). See MPEP 2144.04 IV. A.
Furthermore, it is noted that the recitation of functional language "e.g., for facilitating cutting the bioprocess tube for disconnecting the first bioprocess device from the second bioprocess device" is drawn to intended use of the claimed invention. It is noted that a recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform. Apparatus claims must distinguish from the prior art in terms of structure rather than function (see MPEP 2114). The prior art discloses all of the structural features of the claimed system and thus since the structure is the same, the claimed functions are apparent.
Claims 1 and 7-10 are rejected under 35 U.S.C. 103 as being unpatentable over Lofving et al. (US 8,056,583; hereinafter “Lofving”) in view of Zumbrum (US 2011/0155274).
Regarding claim 1, Lofving discloses a bioprocess system comprising: a first bioprocess device (process vessel (not shown); col. 11, ll. 34-36); a second bioprocess device (collection vessel (not shown); col. 11, ll. 34-36); a bioprocess tube in fluid communication with the first bioprocess device and the
second bioprocess device (FIG. 1c: hose 2), the bioprocess tube defining a hollow passageway and having an internal diameter (FIG. 1c), an external diameter (FIG. 1c), and an external surface (FIG. 1c); and a separating collar for facilitating cutting the bioprocess tube for disconnecting the first bioprocess device from the second bioprocess device (FIG. 1c: deformable sleeve (4,4’)), the separating collar being slidably mounted on the exterior surface of the bioprocess tube (see FIG. 1c), the separating collar having a cylindrical shape and having a length that extends from a first end to a second and opposite end (FIG. 1c), the separating collar defining at least one pair of adjacent separating edges that extend over the length of the collar, the pair of adjacent separating edges allowing the separating collar to be installed and removed from a bioprocess tube (FIG. 1c; deformable sleeve (4,4’) includes two separating edges). Lofving does not explicitly disclose wherein the bioprocess tube comprising a thermoplastic elastomer. However, Lofving does disclose wherein the bioprocess tube can be made of desired material including plastics (col. 11, ll. 30-33). Zumbrum, in the same field of endeavor, discloses a system comprising a thermoplastic tubing and a deformable sleeve arranged on the thermoplastic tubing ([0025]). In view of Zumbrum, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the material of the bioprocess tube of Lofving with the thermoplastic material of Zumbrum to arrive at the claimed invention. One of ordinary skill in the art would have made said modification because Lofving discloses that the bioprocess tube can be made of any desired material including plastics (Lofving at col. 11, ll. 30-33). Further, the selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. See In re Leshin, 125 USPQ 416 (CCPA 1960) (see MPEP § 2144.07). Lofving discloses wherein the bioprocess tube has an internal diameter but does not explicitly disclose wherein the internal diameter being greater than about 260 mm. However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the dimension of bioprocess tube of Lofving to have any dimension including the claimed dimension, since such a modification would involve only a mere change in size of a component. Scaling up or down of an element which merely requires a change in size is generally considered as being within the ordinary skill in the art (See MPEP 2144.04 IV. A.). One would have been motivated to scale the size of bioprocess tube to have the claimed size in order to process desired volume of fluid. Furthermore, it’s noted that the courts have held 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 (In Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777). See MPEP 2144.04 IV. A.
Furthermore, it is noted that the recitation of functional language "e.g., for facilitating cutting the bioprocess tube for disconnecting the first bioprocess device from the second bioprocess device" is drawn to intended use of the claimed invention. It is noted that a recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform. Apparatus claims must distinguish from the prior art in terms of structure rather than function (see MPEP 2114). The prior art discloses all of the structural features of the claimed system and thus since the structure is the same, the claimed functions are apparent.
Regarding claim 7, modified Lofving further discloses wherein the pair of adjacent separating edges on the separating collar comprise opposing free edges and wherein the free edges overlap along the length of the separating collar (Lofving at FIG. 1c).
Regarding claim 8, modified Lofving further discloses wherein the separating collar comprises a first collar member and a separate second collar member, the first and second collar members cooperating together to form the cylindrical shape (Lofving FIG. 1c: deformable sleeve (4,4’); col. 11, ll. 15-21).
Regarding claim 9, modified Lofving further discloses wherein the separating collar
forms two pair of adjacent separating edges where the first collar member intersects the
second collar member (Lofving FIG. 1c: deformable sleeve (4,4’); col. 11, ll. 15-21).
Regarding claim 10, modified Lofving does not explicitly disclose wherein the separating collar has a length of from about 600 mm to about 10,000 mm. However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the dimension of separating collar of modified Lofving to have any dimension including the claimed dimension, since such a modification would involve only a mere change in size of a component. Scaling up or down of an element which merely requires a change in size is generally considered as being within the ordinary skill in the art (See MPEP 2144.04 IV. A.). Furthermore, it’s noted that the courts have held 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 (In Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777). See MPEP 2144.04 IV. A.
Claims 3-4 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Hlavinka as applied to claims 1 and 15 above, and further in view of Lofving (US 8,056,583).
Regarding claims 3 and 16, modified Hlavinka discloses the bioprocess system according to claims 1 and 15 as set forth above. Modified Hlavinka does not explicitly wherein the separating collar is made from a metal. Lofving further discloses wherein separating collar can be formed of any suitable material including plastic or metal (col. 13, ll. 61-64). In view of Lofving, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the material of the separating collar of modified Hlavinka with the material of Lofving to arrive at the claimed invention with a reasonable expectation of success. One of ordinary skill in the art would have made said modification because said modification would have been the simple substitution of one known material for another as disclosed by Lofving (col. 13, ll. 61-64). Further, the selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. See In re Leshin, 125 USPQ 416 (CCPA 1960) (see MPEP § 2144.07).
Regarding claims 4 and 17, modified Hlavinka further discloses wherein the metal comprises Aluminum (Lofving at col. 13, ll. 61-64).
Claims 23 is rejected under 35 U.S.C. 103 as being unpatentable over Hlavinka as applied to claim 15 above, and further in view of Tomasetti (US 7,722,733).
Regarding claim 23, modified Hlavinka discloses the bioprocess system according to claim 15 as set forth above. Modified Hlavinka does not explicitly disclose wherein, prior to cutting the bioprocess tube, the process includes blocking flow of fluids through the bioprocess tube upstream of the separating device using a flow stop device and blocking flow of fluids through the bioprocess tube downstream of the separating device using a flow stop device. Tomasetti discloses the use of two stop device coupled to a tubing prior to cutting (FIG. 1: clamps (9,11 and 13,15) coupled toa tubing; col. 5, ll. 28-62).
In view of Tomasetti, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have employed the flow stop devices of Tomasetti with the bioprocess tube of modified Hlavinka in order to stop flow of material through the bioprocess tube. One of ordinary skill in the art would have made said modification for the purpose of preventing accidental spillage of material from the bioprocess tube during cutting process.
Conclusion
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/LIBAN M HASSAN/Primary Examiner, Art Unit 1799