Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Status
Claims 1-9, 11-21 are pending. Claims 7 and 20 are withdrawn. Claims 10 and 22 are cancelled.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-6, 8, 11-14, 16-19, and 21 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent No. 5938333 by Kearney (Kearney) in view of U.S. Patent No. 6733730 by Griffiths et al. (Griffiths), further in view of Characterization of the effect of surface roughness and texture on fluid flow by Taylor et al. (Taylor) as evidenced by BioPharm International (BioPharm).
In regard to claim 1, Kearney teaches a fluid distributor unit (abstract; Figures 2-3; C1/L6-8; C2/L15 to C3/L11; C5/L1-12; C6/L11-31). Kearney teahces a stereolithographic construction (C8/L46-64). Kearney teaches a packed column comprising a one-piece channel system where one or more inlet channels starting on an inlet side of the distributor unit branch out successively into several channels ending on the other side of the distributor unit, the outlet side (abstract; Figures 2-3; C1/L6-8; C2/L15 to C3/L11; C5/L1-12; C6/L11-31). Kearney teaches the channel system comprises curved channels that form a tree structure (abstract; Figures 2-3; C1/L6-8; C2/L15 to C3/L11; C5/L1-12; C6/L11-31; C6/L46-56). Kearney teaches smooth conduits as an alternative to 90 degree corners (C6/L57-62); reading on without joints or corners and curved along a length.
Kearney does not teach the fluid distributor unit is sanitary, used for processing biomacromolecules, or provided in one single body.
Griffiths teaches a sanitary fluid distributor system (Figures 15-16; C16/L8-25) comprising a channel system (Figures 15-16; C16/L11-14) with one inlet channel on an inlet side (Figure 15; C16/L8-25) branching into several channels ending on the outlet side in a three-dimensional tortuous structure (Figure 15; C16/L8-25). Griffiths teaches the distributor is one single body formed by free form fabrication and is devoid of any joints and interconnections (C6/L38-45). Griffiths teaches curved channels which are curved along a length (Figure 15; C16/L8-25). Griffiths teaches the fluid distributor is sanitary and used to process biomacromolecules (C1/L51-63; C4/L31-44; C7/22-39; C16/L8-25).
It would be obvious to one of ordinary skill in the art at the time the invention was filed to process biomacromolecules in a sanitary fluid distributor, as taught by Griffiths, in the apparatus of Kearney since lithographic fluid distributor systems are known to be used for biological separations.
Regarding limitations recited in claim 1, which are directed to method of making said sanitary fluid distributor unit (e.g. “by free form fabrication”) it is noted that said limitations are not given patentable weight in the product claims. Even though a product-by-process is defined by the process steps by which the product is made, determination of patentability is based on the product itself and does not depend on its method of production. In re Thorpe, 777 F.2d 695, 227 USPQ 964 (Fed. Cir. 1985). As the court stated in Thorpe, 777 F.2d at 697, 227 USPQ at 966 (The patentability of a product does not depend on its method of production. In re Pilkington, 411 F.2d 1345, 1348, 162 USPQ 145, 147 (CCPA 1969). If the product in a product-by-process claim is the same or obvious as the product of the prior art, the claim is unpatentable even though the prior art product was made by a different process.). See MPEP 2113 and 2114.
Regarding limitations recited in the claims which are directed to a manner of operating disclosed sanitary fluid distributor unit, it is noted that neither the manner of operating a disclosed device nor material or article worked upon further limit an apparatus claim. Said limitations do not differentiate apparatus claims from prior art. See MPEP § 2114 and 2115. "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). Claim analysis is highly fact-dependent. A claim is only limited by positively recited elements. Thus, "[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims." In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963); see also In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935). This applies to the following limitations: “for processing of biomacromolecules”.
Modified Kearney does not teach the surface of the three-dimensional tortuous channel system has a roughness average Ra of less than 5 microns.
Taylor teaches it is well known in the art at the time of invention that surface roughness has an effect on fluid flow especially at the mini and micro levels (abstract). Taylor teaches the surface texture will determine the surface behavior and performance, as well as control of the process (section 2.2). Surface roughness plays a role on friction through the conduit (section 2.3). Additionally, for mini channel and micro channels the roughness profile becomes significant in terms of recirculation, flow separation, and pressure drop. Therefore, the surface roughness is a variable that can be modified among others and would have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. As such, without showing unexpected results, the claimed surface roughness cannot be considered critical. Accordingly, one of ordinary skill in the art at the time the invention was made would have optimized, by routine experimentation, the surface roughness in the process of modified Kearney to obtain the desired balance between pressure drop, recirculation, and flow separation (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
In regard to claim 2, Kearney teaches the channel system has two or more generations of branching (abstract; Figures 2-3; C1/L6-8; C2/L15 to C3/L11; C5/L1-12; C6/L11-31).
In regard to claim 3, Griffiths teaches the maximum angle of curvature of the channels is more than 20 degrees (C4/L31-45).
In regard to claim 4, Griffiths teaches the average radius of curvature of the channels is less than 5 channel diameters and/or the minimum radius of curvature is about 0.25 channel diameters (C12/L60-65).
In regard to claim 5, Griffiths teaches the unit comprises tapered channel segments (Figure 15; C16/L8-25).
In regard to claim 6, Griffiths teaches the channel diameter decreases from the inlet side of the unit (Figures 15-16; C16/L8-25).
In regard to claim 8, regarding limitations recited in the claims which are directed to a manner of operating disclosed fluid distributor unit, it is noted that neither the manner of operating a disclosed device nor material or article worked upon further limit an apparatus claim. Said limitations do not differentiate apparatus claims from prior art. See MPEP § 2114 and 2115. "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). Claim analysis is highly fact-dependent. A claim is only limited by positively recited elements. Thus, "[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims." In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963); see also In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935). This applies to the following limitations: “all pathways from the inlet side to the outlet side have the same flow resistance”.
In regard to claims 11-12, Modified Kearney does not explicitly teach the three dimensional tortuous channel system is constructed from a material that generates less than 1 mg/l leachables in an extraction fluid.
Griffiths teaches materials used for such devices include PMMA, TEFLON, PVC, and PDMS (C6/L45-53). Griffths further teaches these fluid distribution devices are used for processes such as DNA sequencing, immunochromatography, identification of explosives, identification of chemical and biological warfare agents, and synthesis of chemicals and drugs (C1/L59-63).
BioPharm teaches that processing systems, specifically process streams, can release extractables into a process stream (pg. 1). BioPharm further teaches that interactions between packaging and process streams with drugs are crucial considerations for drug manufacturing, especially during increased regulation (pg. 1). Further, BioPharm teaches that the tested materials for extractables based on USP Class VI for toxicology (pg. 3). BioPharm further teaches that TEFLON is expected to meet the test criteria, which includes USP VI standard testing (pg. 8).
In regard to claim 13, Griffiths teaches integral sealing the channel tops and bottoms (C6/L53-62). Griffiths teaches an elastomer (C6/L35-62).
In regard to claim 14, Griffiths teaches a chromatography column equipped with a fluid distributor unit according to claim 1 (C4/L57-64).
In regard to claims 16-17, Kearney teaches a method to prepare a fluid distributor unit (abstract; Figures 2-3; C1/L6-8; C2/L15 to C3/L11; C5/L1-12; C6/L11-31). Kearney teahces a stereolithographic construction (C8/L46-64). Kearney teaches a packed column comprising a one-piece channel system where one or more inlet channels starting on an inlet side of the distributor unit branch out successively into several channels ending on the other side of the distributor unit, the outlet side (abstract; Figures 2-3; C1/L6-8; C2/L15 to C3/L11; C5/L1-12; C6/L11-31). Kearney teaches the channel system comprises curved channels that form a tree structure (abstract; Figures 2-3; C1/L6-8; C2/L15 to C3/L11; C5/L1-12; C6/L11-31; C6/L46-56). Kearney teaches smooth conduits as an alternative to 90 degree corners (C6/L57-62); reading on without joints or corners.
Kearney does not teach the fluid distributor unit is sanitary, used for processing biomacromolecules, or provided in one single body.
Griffiths teaches a method to prepare a sanitary fluid distributor system (Figures 15-16; C16/L8-25) comprising a channel system (Figures 15-16; C16/L11-14) with one inlet channel on an inlet side (Figure 15; C16/L8-25) branching into several channels ending on the outlet side in a three-dimensional tortuous structure (Figure 15; C16/L8-25). Griffiths teaches the distributor is one single body formed by free form fabrication and is devoid of any joints and interconnections (C6/L38-45). Griffiths teaches curbed channels (Figure 15; C16/L8-25). Griffiths teaches the fluid distributor is sanitary and used to process biomacromolecules (C1/L51-63; C4/L31-44; C7/22-39; C16/L8-25).
It would be obvious to one of ordinary skill in the art at the time the invention was filed to process biomacromolecules in a sanitary fluid distributor, as taught by Griffiths, in the apparatus of Kearney since lithographic fluid distributor systems are known to be used for biological separations.
Modified Kearney does not teach the surface of the three-dimensional tortuous channel system has a roughness average Ra of less than 5 microns.
Taylor teaches it is well known in the art at the time of invention that surface roughness has an effect on fluid flow especially at the mini and micro levels (abstract). Taylor teaches the surface texture will determine the surface behavior and performance, as well as control of the process (section 2.2). Surface roughness plays a role on friction through the conduit (section 2.3). Additionally, for mini channel and micro channels the roughness profile becomes significant in terms of recirculation, flow separation, and pressure drop. Therefore, the surface roughness is a variable that can be modified among others and would have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. As such, without showing unexpected results, the claimed surface roughness cannot be considered critical. Accordingly, one of ordinary skill in the art at the time the invention was made would have optimized, by routine experimentation, the surface roughness in the process of modified Kearney to obtain the desired balance between pressure drop, recirculation, and flow separation (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
In regard to claim 18, Griffiths teaches modifying the channel surfaces (C7/L49-51).
In regard to claim 19, Griffiths teaches modifying the channel surfaces comprising applying a coating on the channel surfaces (C7/L49-51).
In regard to claim 21, Kearney teaches a method to prepare a fluid distributor unit according to claim 16, further comprising communicating a design filed from a computer assisted design (CAD) system to a computer controlled free form fabrication system (C8/L46 to C9/L7).
Claim 9 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent No. 5938333 by Kearney (Kearney) in view of U.S. Patent No. 6733730 by Griffiths et al. (Griffiths), further in view of Characterization of the effect of surface roughness and texture on fluid flow by Taylor et al. (Taylor) as evidenced by BioPharm International (BioPharm), as noted above, further in view U.S. Patent Publication 2009/0014360 by Toner et al. (Toner).
In regard to claim 9, modified Kearney teaches the limitations as noted above. Modified Kearney does not teach an integral filter having average pore diameter below 30 microns.
Toner teaches separation for biomedical applications ([0020]). Toner teaches a filter can be provide to prevent clogging in the channels and facilitate collection of particles ([0186]-[0187]; [0229]). Toner teaches the filtering 4.5 and 3 micrometer particles from one another ([0229]).
It would be obvious to one of ordinary skill in the art at the time the invention was filed to incorporate a filter, as taught by Toner, in the system of modified Kearney in order to remove unwanted contamination in biomedical applications.
Claim 15 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent No. 5938333 by Kearney (Kearney) in view of U.S. Patent No. 6733730 by Griffiths et al. (Griffiths), further in view of Characterization of the effect of surface roughness and texture on fluid flow by Taylor et al. (Taylor) as evidenced by BioPharm International (BioPharm), as noted above, further in view U.S. Patent Publication No. 2007/0092960 by Hansen et al. (Hansen).
In regard to claim 15, Modified Kearney teahces all the limitations as noted above. Modified Kearney does not teach the column bed diameter is larger than 5cm.
Hansen teaches separating biomolecules in chromatography columns (abstract). Hansen teaches column bed diameters are typically at least 20 cm ([0055]).
It would be obvious to one of ordinary skill in the art at the time the invention was effectively filed that the column diameter is at least 20 cm as it is known in the field that columns are typically that size for biomolecule separations.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-5, 8-9, 11-12, and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 and 11 of U.S. Patent No. 11143636. Although the claims at issue are not identical, they are not patentably distinct from each other because they are directed towards the same fluid distributor unit with the same required components.
Claim 1 of ‘636 reads on claims 1, 5, and 9 of ‘230; Claim 2 of ‘636 reads on claim 2 of ‘230; Claim 3 of ‘636 reads on claim 3 of ‘230; Claim 4 of ‘636 reads on claim 4 of ‘230; Claim 5 of ‘636 reads on claim 8 of ‘230; Claim 6 of ‘636 reads on claim 11 of ‘230; Claim 7 of ‘636 reads on claim 12 of ‘230; Claim 11 of ‘636 reads on claim 14 of ‘230.
Response to Arguments
Applicant's arguments filed 1/12/2026 have been fully considered but they are not persuasive.
In regard to the Applicant’s argument that Kearney and Griffiths do not disclose a fluid distributor unit comprising a one piece channel system where a roughness average Ra of the channel surface is less than 5 microns; arriving at an average roughness is not a matter of routine optimization; no reasoning has been provided; the surface roughness is entirely irrelevant to optimizing fluid flow; Taylor is silent regarding the relevance of surface roughness to sanitation; the Examiner does not find this persuasive.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Kearney and Griffiths are not used to teach average roughness.
As noted above: Taylor teaches it is well known in the art at the time of invention that surface roughness has an effect on fluid flow especially at the mini and micro levels (abstract). Taylor teaches the surface texture will determine the surface behavior and performance, as well as control of the process (section 2.2). Surface roughness plays a role on friction through the conduit (section 2.3). Additionally, for mini channel and micro channels the roughness profile becomes significant in terms of recirculation, flow separation, and pressure drop. Therefore, the surface roughness is a variable that can be modified among others and would have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. As such, without showing unexpected results, the claimed surface roughness cannot be considered critical. Accordingly, one of ordinary skill in the art at the time the invention was made would have optimized, by routine experimentation, the surface roughness in the process of modified Kearney to obtain the desired balance between pressure drop, recirculation, and flow separation (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
The Examiner does not state that surface roughness has an impact on sanitation. Further, In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., sanitation) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARA M PEO whose telephone number is (571)272-9958. The examiner can normally be reached 9 to 5:30.
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/KARA M PEO/Primary Examiner, Art Unit 1777