OFFICE ACTION
This application has been assigned or remains assigned to Technology Center 1700, Art Unit 1774 and the following will apply for this application:
Please direct all written correspondence with the correct application serial number for this application to Art Unit 1774.
Telephone inquiries regarding this application should be directed to the Electronic Business Center (EBC) at http://www.uspto.gov/ebc/index.html or 1-866-217-9197 or to the Examiner at (571) 272-1139. All official facsimiles should be transmitted to the centralized fax receiving number (571)-273-8300.
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 .
Priority
Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d). All of the CERTIFIED copies of the priority documents have been received in this national stage application from the International Bureau (PCT Rule 17.2(a)).
Drawings
The drawings are objected to under 37 CFR § 1.84 in view of the following deficiencies that require correction:
The reference characters and lines forming the Figures are of poor quality (not uniformly thick and well-defined - 37 CFR 1.84(l): All drawings must be made by a process which will give them satisfactory reproduction characteristics. Every line, number, and letter must be durable, clean, black (except for color drawings), sufficiently dense and dark, and uniformly thick and well-defined. The weight of all lines and letters must be heavy enough to permit adequate reproduction. This requirement applies to all lines however fine, to shading, and to lines representing cut surfaces in sectional views. Note the drawings provided in the priority document of record are MUCH CLEARER than the drawing Figures filed in the US application in the representative Figures on sheet number (7):
INSTANT US APPLICATION:
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PRIORITY APPLICATION:
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Although clearer in line quality, note the drawings immediately above include improper foreign language for the Figure legends and some reference characters are still illegible such as “311” ?? in Figure 8e.
Applicant should review the specification and drawing Figures to ensure a proper one-to-one correspondence between the specification and drawings in accordance with MPEP 608.01(g) and 37 CFR 1.84(f). The brief description of the drawings and the descriptive portion of the specification may require revision in accordance with any drawing objections listed herein or those noticed by Applicant during said review.
From MPEP 608.01(g): The reference characters must be properly applied, no single reference character being used for two different parts or for a given part and a modification of such part. See 37 CFR 1.84(p). Every feature specified in the claims must be illustrated, but there should be no superfluous illustrations.
INFORMATION ON HOW TO EFFECT DRAWING CHANGES
Replacement Drawing Sheets
Drawing changes must be made by presenting replacement figures which incorporate the desired changes and which comply with 37 CFR 1.84. An explanation of the changes made must be presented either in the drawing amendments, or remarks, section of the amendment. Any replacement drawing sheet must be identified in the top margin as “Replacement Sheet” (37 CFR 1.121(d)) and include all of the figures appearing on the immediate prior version of the sheet, even though only one figure may be amended. The figure or figure number of the amended drawing(s) must not be labeled as “amended.” If the changes to the drawing figure(s) are not accepted by the examiner, applicant will be notified of any required corrective action in the next Office action. No further drawing submission will be required, unless applicant is notified.
Identifying indicia, if provided, should include the title of the invention, inventor’s name, and application number, or docket number (if any) if an application number has not been assigned to the application. If this information is provided, it must be placed on the front of each sheet and centered within the top margin.
Annotated Drawing Sheets
A marked-up copy of any amended drawing figure, including annotations indicating the changes made, may be submitted or required by the examiner. The annotated drawing sheets must be clearly labeled as “Annotated Marked-up Drawings” and accompany the replacement sheets.
Timing of Corrections
Applicant is required to submit acceptable corrected drawings within the time period set in the Office action. See 37 CFR 1.85(a). Failure to take corrective action within the set period will result in ABANDONMENT of the application.
If corrected drawings are required in a Notice of Allowability (PTOL-37), the new drawings MUST be filed within the THREE MONTH shortened statutory period set for reply in the “Notice of Allowability.” Extensions of time may NOT be obtained under the provisions of 37 CFR 1.136 for filing the corrected drawings after the mailing of a Notice of Allowability.
Information Disclosure Statement
Note the attached PTO-1449 form(s) submitted with the Information Disclosure Statement filed 14 APR 2023.
Specification
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant's cooperation is requested in correcting any errors of which applicant may become aware in the specification.
The Abstract of the Disclosure is objected to because:
a. the extraneous text "Figure 1" at the end of the abstract should be deleted.
b. the recitation of " The present invention" in line 1 is an improper implied phrase.
c. “piston arm (300)” should be --piston rod (300)--, note claim 1.
Correction is required. See MPEP § 608.01(b).
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed (MPEP 606.01).
Claim Rejections - 35 U.S.C. § 112(b)
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.
The inquiry during examination is patentability of the invention as the inventor or a joint inventor regards such invention. If the claims do not particularly point out and distinctly claim that which the inventor or a joint inventor regards as his or her invention, the appropriate action by the examiner is to reject the claims under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. In re Zletz, 893 F.2d 319, 13 USPQ2d 1320 (Fed. Cir. 1989).
Claims 1-22 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 joint inventor regards as the invention.
Claim 1, line 10: the “at least one mixing throat” is provided in what element?; in line 12, it appears “in the first axis” should be --along the first axis-- for accuracy and clarity.
Claim 6, line 2: “the piston arm” lacks antecedent basis.
Claim 17: “the second body and the first body” lacks antecedent basis.
Claims 18 and 19 are worded in an awkward and unclear manner - it is not known what is being claimed in these two claims. In line 3 of claim 18, “thereof” is inferential and refers to what element?
Claim 19: “the first body” lacks antecedent basis.
Claim 20, line 11: “the support element” lacks antecedent basis and “the second piston body” lacks antecedent basis; in line 12, “the mixture” lacks antecedent basis.
Claim 21 depends from itself. The quotation marks (“) in lines 1 and 2 are extraneous are should be removed.
Claim 22: The quotation marks (“) in lines 1 and 3 are extraneous are should be removed. In line 3, the “passing of substances” passes the substances through which element(s)?
Claim Rejections - 35 USC § 102
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 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 terms used in this respect are given their broadest reasonable interpretation in their ordinary usage in context as they would be understood by one of ordinary skill in the art, in light of the written description in the specification, including the drawings, without reading into the claim any disclosed limitation or particular embodiment. See, e.g., In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004); In re Hyatt, 211 F.3d 1367, 1372 (Fed. Cir. 2000); In re Morris, 127 F.3d 1048, 1054-55 (Fed. Cir. 1997); In re Zletz, 893 F.2d 319, 321-22 (Fed. Cir. 1989).
The Examiner interprets claims as broadly as reasonable in view of the specification, but does not read limitations from the specification into a claim. Elekta Instr. S.A.v.O.U.R. Sci. Int'l, Inc., 214 F.3d 1302, 1307 (Fed. Cir. 2000). "A claim is anticipated only if each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior art reference." Verdegaal Bros. Inc. v. Union Oil Co. of California, 814 F.2d 628, 631 (Fed. Cir. 1987).
The express, implicit, and inherent disclosures of a prior art reference may be relied upon in the rejection of claims under 35 U.S.C. 102 or 103. "The inherent teaching of a prior art reference, a question of fact, arises both in the context of anticipation and obviousness." In re Napier, 55 F.3d 610, 613, 34 USPQ2d 1782, 1784 (Fed. Cir. 1995) (affirmed a 35 U.S.C. 103 rejection based in part on inherent disclosure in one of the references). See also In re Grasselli, 713 F.2d 731, 739, 218 USPQ 769, 775 (Fed. Cir. 1983). See MPEP 2112.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless—
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3, 4, 8, 9, 12, 13, 14, 15, 16, 17, 18, and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by HUANG (US 2007/0242562 A1).
HUANG ‘562 discloses a mixing device for mixing substances comprising a mixing chamber 1 with an upper wall and a lower wall connected via side walls to define a mixing volume proximate 5 - Figure 5; a piston disposed in the mixing volume including piston bodies 4 spaced along the axis of the mixing volume between the upper and lower walls; a piston rod 3 to move the piston bodies 4 within the mixing volume along the axis; at least one mixing throat 42 or 43;
a drive element 30 is associated with the piston to provide movement of the piston at a speed value;
wherein a temperature control chamber 2 is located about the sidewall and has a form encircling the side walls of mixing chamber 1 - Figure 5;
transfer ports 13, 14;
wherein the piston rod 3 comprises the piston bodies 4;
wherein the upper wall comprises a first piston opening proximate 11;
wherein the lower wall comprise a second piston opening proximate 12;
drive element 30;
lower wall delimiter 12;
and a support element 31 at the lower part of the piston rod 3.
Claims 1, 3, 4, 5, 11, 15, and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by VAN ROSSEM et al. (US 1998692).
VAN ROSSEM et al. discloses a mixing device for mixing substances comprising a mixing chamber 1 with a removable upper wall 3 and a removable lower wall 2 selectively secured to the mixing chamber 1; the upper and lower walls being connected via side walls 14 to define a mixing volume proximate 13 - Figure 1; a piston disposed in the mixing volume including piston bodies 7, 8 located along the axis of the mixing volume between the upper and lower walls; the edges of the piston bodies 7, 8 are sealed with side walls 14 (Figure 1); a piston rod 10 to move the piston bodies 7, 8 within the mixing volume along the axis; at least one mixing throat 11 or 12;
a drive element 17 is associated with the piston to provide movement of the piston at a speed value;
wherein the piston rod 10 comprises the piston bodies 7, 8;
wherein the upper wall comprises a first piston opening proximate 3;
and a drive element 17.
Claims 1, 2, 3, 4, 5, 6, 14, 15, and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by DellaContrada et al. (US 2016/0227960 A1).
DellaContrada et al. discloses a mixing device for mixing substances comprising a mixing chamber 20 with an upper wall and a lower wall connected via side walls to define a mixing volume proximate 24 - Figure 3A; a piston disposed in the mixing volume including piston bodies 12 spaced along the axis of the mixing volume between the upper and lower walls; the edges of the piston bodies 12 are sealed with side walls 14 (Figures 3A-3C); a piston rod 10 to move the piston bodies 12 within the mixing volume along the axis; at least one mixing throat 42 of about 400 microns in size (¶ [0052]);
a drive element 16 is associated with the piston to provide movement of the piston at a speed value;
wherein the piston rod 10 comprises the piston bodies 12;
and wherein the upper wall comprises a first piston opening proximate 14;
With regard to the above rejections, the manner in which the recited mixing device is operated (such as the piston speed, the entry or exit of the piston bodies to enter or exit the mixing chamber, and the like) recites no further structure of the device and as held in In re Casey, 370 F.2d 576, 152 USPQ 235 (CCPA 1967), "the manner or method in which such machine is to be utilized is not germane to the issue of patentability of the machine itself." See MPEP 2115. Nevertheless, the prior art above discloses all of the recited structure irrespective of the manner in which said structure is
APPARATUS CLAIMS MUST BE STRUCTURALLY DISTINGUISHABLE FROM THE PRIOR ART
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While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997) (The absence of a disclosure in a prior art reference relating to function did not defeat the Board’s finding of anticipation of claimed apparatus because the limitations at issue were found to be inherent in the prior art reference); see also In re Swinehart, 439 F.2d 210, 212-13, 169 USPQ 226, 228-29 (CCPA 1971);In re Danly, 263 F.2d 844, 847, 120 USPQ 528, 531 (CCPA 1959). “[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).
Applicant should further note that “[e]xpressions relating the apparatus to contents thereof during an intended operation are of no significance in determining patentability of the apparatus claim.” Ex parte Thibault, 164 USPQ 666, 667 (Bd. App. 1969). Furthermore, “[i]nclusion of material or article worked upon by a structure being claimed does not impart patentability to the claims.” In re Young, 75 F.2d 966, 25 USPQ 69 (CCPA 1935) (as restated in In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963)). Accordingly, the recited oil and water (e.g., see claim 6) are merely the contents of the mixing device during an intended operation and are thus of no patentable significance in the pending apparatus claims.
Claim Rejections - 35 USC § 103
The terms used in this respect are given their broadest reasonable interpretation in their ordinary usage in context as they would be understood by one of ordinary skill in the art, in light of the written description in the specification, including the drawings, without reading into the claim any disclosed limitation or particular embodiment. See, e.g., In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004); In re Hyatt, 211 F.3d 1367, 1372 (Fed. Cir. 2000); In re Morris, 127 F.3d 1048, 1054-55 (Fed. Cir. 1997); In re Zletz, 893 F.2d 319, 321-22 (Fed. Cir. 1989). The Examiner interprets claims as broadly as reasonable in view of the specification, but does not read limitations from the specification into a claim. Elekta Instr. S.A.v.O.U.R. Sci. Int'l, Inc., 214 F.3d 1302, 1307 (Fed. Cir. 2000).
To determine whether subject matter would have been obvious, "the scope and content of the prior art are to be determined; differences between the prior art and the claims at issue are to be ascertained; and the level of ordinary skill in the pertinent art resolved .... Such secondary considerations as commercial success, long felt but unsolved needs, failure of others, etc., might be utilized to give light to the circumstances surrounding the origin of the subject matter sought to be patented." Graham v. John Deere Co. of Kansas City, 383 U.S. 1, 17-18 (1966).
The Supreme Court has noted:
Often, it will be necessary for a court to look to interrelated teachings of multiple patents; the effects of demands known to the design community or present in the marketplace; and the background knowledge possessed by a person having ordinary skill in the art, all in order to determine whether there was an apparent reason to combine the known elements in the fashion claimed by the patent at issue.
KSR Int'l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1740-41 (2007). "Under the correct analysis, any need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed." (Id. at 1742).
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 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 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 instant office action conforms to the policies articulated in the Federal Register notice titled “Updated Guidance for Making a Proper Determination of Obviousness” at 89 Fed. Reg. 14449, February 27, 2024, wherein the Supreme Court’s directive to employ a flexible approach to understanding the scope of prior art is reflected in the frequently quoted sentence, ‘‘A person of ordinary skill is also a person of ordinary creativity, not an automaton.’’ Id. at 421, 127 S. Ct. at 1742. In this section of the KSR decision, the Supreme Court instructed the Federal Circuit that persons having ordinary skill in the art (PHOSITAs) also have common sense, which may be used to glean suggestions from the prior art that go beyond the primary purpose for which that prior art was produced. Id. at 421–22, 127 S. Ct. at 1742. Thus, the Supreme Court taught that a proper understanding of the prior art extends to all that the art reasonably suggests, and is not limited to its articulated teachings regarding how to solve the particular technological problem with which the art was primarily concerned. Id. at 418, 127 S. Ct. at 1741 (‘‘As our precedents make clear, however, the analysis need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.’’). ‘‘The obviousness analysis cannot be confined . . . by overemphasis on the importance of published articles and the explicit content of issued patents.’’ Id. at 419, 127 S. Ct. at 1741. Federal Circuit case law since KSR follows the mandate of the Supreme Court to understand the prior art— including combinations of the prior art—in a flexible manner that credits the common sense and common knowledge of a PHOSITA. The Federal Circuit has made it clear that a narrow or rigid reading of prior art that does not recognize reasonable inferences that a PHOSITA would have drawn is inappropriate. An argument that the prior art lacks a specific teaching will not be sufficient to overcome an obviousness rejection when the allegedly missing teaching would have been understood by a PHOSITA—by way of common sense, common knowledge generally, or common knowledge in the relevant art. For example, in Randall Mfg. v. Rea, 733 F.3d 1355 (Fed. Cir. 2013), the Federal Circuit vacated a determination of nonobviousness by the Patent Trial and Appeal Board (PTAB or Board) because it had not properly considered a PHOSITA’s perspective on the prior art. Id. at 1364. The Randall court recalled KSR’s criticism of an overly rigid approach to obviousness that has ‘‘little recourse to the knowledge, creativity, and common sense that an ordinarily skilled artisan would have brought to bear when considering combinations or modifications.’’ Id. at 1362, citing KSR, 550 U.S. at 415–22, 127 S. Ct. at 1727. In reaching its decision to vacate, the Federal Circuit stated that by ignoring evidence showing ‘‘the knowledge and perspective of one of ordinary skill in the art, the Board failed to account for critical background information that could easily explain why an ordinarily skilled artisan would have been motivated to combine or modify the cited references to arrive at the claimed inventions.’’ Id.
From Norgren Inc. v. Int’l Trade Comm’n, 699 F.3d 1317, 1322 (Fed. Cir. 2012) (‘‘A flexible teaching, suggestion, or motivation test can be useful to prevent hindsight when determining whether a combination of elements known in the art would have been obvious.’’); Outdry Techs. Corp. v. Geox S.p.A., 859 F.3d 1364, 1370–71 (Fed. Cir. 2017) (‘‘Any motivation to combine references, whether articulated in the references themselves or supported by evidence of the knowledge of a skilled artisan, is sufficient to combine those references to arrive at the claimed process.’’). In keeping with this flexible approach to providing a rationale for obviousness, the Federal Circuit has echoed KSR in identifying numerous possible sources that may, either implicitly or explicitly, provide reasons to combine or modify the prior art to determine that a claimed invention would have been obvious. These include ‘‘market forces; design incentives; the ‘interrelated teachings of multiple patents’; ‘any need or problem known in the field of endeavor at the time of invention and addressed by the patent’; and the background knowledge, creativity, and common sense of the person of ordinary skill.’’ Plantronics, Inc. v. Aliph, Inc., 724 F.3d 1343, 1354 (Fed. Cir. 2013), quoting KSR, 550 U.S. at 418–21, 127 S. Ct. at 1741–42.
The Federal Circuit has also clarified that a proposed reason to combine the teachings of prior art disclosures may be proper, even when the problem addressed by the combination might have been more advantageously addressed in another way. PAR Pharm., Inc. v. TWI Pharms., Inc., 773 F.3d 1186, 1197–98 (Fed. Cir. 2014) (‘‘Our precedent, however, does not require that the motivation be the best option, only that it be a suitable option from which the prior art did not teach away.’’) (emphasis in original). One aspect of the flexible approach to explaining a reason to modify the prior art is demonstrated in the Federal Circuit’s decision in Intel Corp. v. Qualcomm Inc., 21 F.4th 784, 796 (Fed. Cir. 2021), which confirms that a proposed reason is not insufficient simply because it has broad applicability. Patent challenger Intel had argued in an inter partes review before the Board that some of Qualcomm’s claims were unpatentable because a PHOSITA would have been able to modify the prior art, with a reasonable expectation of success, for the purpose of increasing energy efficiency. Id. at 796–97. The Federal Circuit explained that ‘‘[s]uch a rationale is not inherently suspect merely because it’s generic in the sense of having broad applicability or appeal.’’ Id. The Federal Circuit further pointed out its pre-KSR holding ‘‘that because such improvements are ‘technology independent,’ ‘universal,’ and ‘even common-sensical,’ ‘there exists in these situations a motivation to combine prior art references even absent any hint of suggestion in the references themselves.’ ’’ Id., quoting DyStar Textilfarben GmbH v. C.H. Patrick Co., 464 F.3d 1356, 1368 (Fed. Cir. 2006) (emphasis added by the Federal Circuit in Intel). When formulating an obviousness rejection, the PTO may use any clearly articulated line of reasoning that would have allowed a PHOSITA to draw the conclusion that a claimed invention would have been obvious in view of the facts. MPEP 2143, subsection I, and MPEP 2144. Acknowledging that, in view of KSR, there are ‘‘many potential rationales that could make a modification or combination of prior art references obvious to a skilled artisan,’’ the Federal Circuit has also pointed to MPEP 2143, which provides several examples of rationales gleaned from KSR. Unwired Planet, 841 F.3d at 1003.
When considering the prior art in its entirety, note Allied Erecting v. Genesis Attachments, 825 F.3d 1373, 1381, 119 USPQ2d 1132, 1138 (Fed. Cir. 2016) ("Although modification of the movable blades may impede the quick change functionality disclosed by Caterpillar, ‘[a] given course of action often has simultaneous advantages and disadvantages, and this does not necessarily obviate motivation to combine.’" (quoting Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1165, 77 USPQ2d 1865, 1870 (Fed Cir. 2006) (citation omitted))). However, "the prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed…." In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over the prior art to HUANG ‘562, VAN ROSSEM et al., or Della Contrada et al. in view of BROWN (US 6354729 B1) .
Said prior art to HUANG ‘562, VAN ROSSEM et al., or Della Contrada et al. do not disclose the geometry of the mixing throat. Brown discloses a mixing device with mixing bodies 4, 7 having channels/throats 5, 8 therein that include a collecting cavity provided mutually on both faces of the bodies and which have a diameter which narrows and a center mixing opening with a fixed diameter provided in a manner hydraulically connecting opposite sides of the bodies 4, 7 (see 18 in Figure 3d reproduced below).
It would have been obvious to one skilled in the art before the effective filing date of the invention to have provided the mixing throats of said prior art with the recited geometry as taught by BROWN for the purpose of imposing a greater resistance to flow in one direction than in the other (col. 5, lines 56-59).
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Claims 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over the prior art to HUANG ‘562, VAN ROSSEM et al., or Della Contrada et al. in view of LEE et al. (US 2012/0177533 A1).
Said prior art to HUANG ‘562, VAN ROSSEM et al., or Della Contrada et al. do not disclose the recited temperature control arrangement of claims 8-10. LEE et al. discloses a mixing device with a mixing chamber for heating fluids but can also be used for mixing and/or cooling fluids. The systems can be used for heating and/or mixing other biological or non-biological fluids for other purposes such as sterilization or fluid processing.
Depicted in FIG. 1 is one embodiment of an inventive fluid heating system 10 incorporating features of the present invention. In general, fluid heating system 10 comprises a mixing tank assembly 12, a container assembly 16 that is disposed within and supported by tank assembly 12, and a drive shaft 18 (FIG. 2) that extends between tank assembly 12 and container assembly 16. Container assembly 16 houses the fluid or solution that is heated and can also be mixed and/or cooled. The various components of fluid heating system 10 will now be discussed in greater detail.
Continuing with FIG. 1, tank assembly 12 comprises a tank body 102 having a lid 104 hingedly coupled thereto. Tank body 102 comprises a substantially cylindrical sidewall 106 having an interior surface 108 that extends between an upper end 110 and an opposing lower end 112. As depicted in FIG. 2, tank body 102 also includes a floor 114 located at lower end 112 with a drain opening 116 extending therethrough. Interior surface 108 of sidewall 106 and floor 114 bound a chamber 118. As discussed below, chamber 118 is configured to receive container assembly 16 so that container assembly 16 is supported therein. A substantially C-shaped lip 120 is formed at upper end 110 of sidewall 106 and partially bounds an access opening 122 to chamber 118. A pair of spaced apart slots 124A and B are recessed on lip 120 and, as will be discussed below in greater detail, provide channels through which fluid lines can pass out of chamber 118 when lid 104 is closed.
In general, tank body 102 has a front face 126 and an opposing back face 128. As best shown in FIG. 1, an enlarged notch 130 is formed on front face 126 at upper end 110 and extends through sidewall 106 and lip 120. Disposed within notch 130 so as to communicate with chamber 118 is a drive motor assembly 132. As will be discussed below in greater detail, drive motor assembly 132 is used to rotate drive shaft 18 (FIG. 2) which in turn mixes the fluid within container assembly 16. Although not required, drive motor assembly 132 is typically fitted so that notch 130 is sealed closed. A generally U-shaped flange 134 having a top surface 136 extends between opposing sides of notch 130 along an inside face of drive motor assembly 132. Top surface 136 at opposing ends of flange 134 is flush with lip 120 so that lip 120 and flange 134 combine to form sealing surface 137 that bounds access opening 122 of chamber 118.
TEMPERATURE CONTROL MEANS WITH HEAT EXCHANGER: Means are provided for controlling the temperature of the fluid that is contained within container assembly 16 when container assembly 16 is disposed within chamber 118 of tank assembly 12. By way of example and not by limitation, tank body 102 and lid 104 can both be jacketed so as to bound one or more fluid channels through which heated or cooled fluid can pass. In turn, heat from the heated fluid flowing through tank assembly 12 radiates to the fluid within container assembly 16 for heating the fluid therein. Alternatively, chilled fluid flowing through tank assembly 12 draws heat from the fluid within container assembly 16 for cooling the fluid therein. For example, as shown in FIG. 2, sidewall 106 comprises an inside wall 162 and an outside wall 164 that bound a fluid channel 166 therebetween; floor 114 comprises an inside wall 168 and an outside wall 170 that bound a fluid channel 172 therebetween; and lid 104 comprises an inside wall 174 and an outside wall 176 that bound a fluid channel 178 therebetween. If desired an insulation layer 179 can be positioned between each outside wall 164, 170, and 176 and the corresponding fluid channel.
Turning to FIG. 3, outside wall 176 of lid 104 has an inlet port 180 and an outlet port 182 formed thereon and communicating with fluid channel 178 (FIG. 2). A hose coupling 181 is coupled with inlet port 180. Hose coupling 181 is designed to couple with a fluid line that extends from a thermal control unit (TCU) 197 or some other source for generating or providing a heated or cooled fluid so that the fluid can be pumped into fluid channel 178 at a desired temperature and flow rate. The fluid can be water, propylene glycol, or other types of fluids commonly used in this type of heating or cooling. In one embodiment, the TCU 197 can comprise a boiler 198 [liquid tank] fluid coupled with a pump 199 [pump] which delivers the fluid to house coupling 181. A chiller and other components can also be used.
Outside wall 162 of sidewall 106 has an inlet port 184 and an outlet port 186 formed thereon and communicating with fluid channel 166 (FIG. 2). A fluid line 188 extends from outlet port 182 on lid 104 to inlet port 184 of sidewall 106 so that after the heated fluid passes through fluid channel 178 in lid 104 it can then pass through fluid channel 166 in sidewall 162. In turn, outside wall 170 of floor 114 has an inlet port 190 and an outlet port 192 formed thereon and communicating with fluid channel 172 (FIG. 2). A fluid line 194 extends from outlet port 186 on sidewall 106 to inlet port 190 of floor 114 so that after the heated fluid passes through fluid channel 166 in sidewall 162 it can then pass through fluid channel 172 in floor 114.
Finally, a hose coupling 196 is coupled with outlet port 192 of floor 114 so that a fluid line [liquid pipes] can be coupled therewith and extend back to TCU 197 where the fluid is then heated or cooled back to the desired temperature before repeating the cycle. The fluid flow system can thus be a close loop, recirculating system. It is appreciated that partitions or other structures can be formed within fluid channels 166, 172, and 178 to optimize fluid flow throughout so that tank body 102 and lid 104 apply a substantially uniform and continuous heat or cooling around all sides of container assembly 16 when container assembly 16 is disposed within tank assembly 12.
In alternative embodiments, it is appreciated that the heated or cooled fluid can enter through hose coupling 190 on floor 114 and then exit out through hose coupling 181 on lid 104. In still other embodiments, separate recirculating systems can be coupled with each of lid 104, sidewall 106 and/or floor 114. In contrast to using a heated liquid fluid, heated gas or steam can be used. Alternatively, the means for controlling the temperature can comprise electrical heating elements placed on the exterior surfaces of inside walls 162, 168, and 174. Other conventional heating or cooling systems can also be used. The means for controlling the temperature can be used to heat the fluid within container assembly 16 to a temperature in a desired range.
As shown in FIG. 1, tank assembly 12 is typically mounted on a platform 212. If desired, one or more load cells can be incorporated into platform 212 so that the quantity of fluid delivered to container assembly 12 when disposed within tank assembly 12 can be accurately measured. FIG. 1 also shows an electrical controller 214. Controller 214 can be used for measuring and controlling operational parameters such as the heat and flow rate of fluid through the fluid channels, as discussed above, tracking the time and temperature that the fluid within container assembly 12 is heated, measuring the weight of fluid entering container assembly 12 and controlling mixing of the fluid within container assembly 12 as will be discussed below in greater detail.
It is appreciated that container 18 can be manufactured to have virtually any desired size, shape, and configuration. For example, container 18 can be formed having a compartment sized to 10 liters, 30 liters, 100 liters, 250 liters, 500 liters, 750 liters, 1,000 liters, 1,500 liters, 3,000 liters, 5,000 liters, 10,000 liters or other desired volumes and thus can be in a range between any of the above volumes. Although container 18 can be any shape, in one embodiment container 18 is specifically configured to be complementary or substantially complementary to chamber 118 of tank body 102, as discussed above.
By inserting a temperature probe 210 within receiver 276, temperature probe 210 can measure the temperature of the fluid within container 18 through the wall of receiver 276. Receiver 276 protects temperature probe 210 from directly contacting the fluid within container 18. As such, there is no risk of temperature probe 210 contaminating the fluid and temperature probe 210 can be reused without sterilization or other cleaning. Furthermore, temperature probe 210 is rigidly held in position at a distance spaced apart from sidewall 162. As such, temperatures probe 210 give a more accurate reading of the temperature of the fluid than if it was positioned adjacent to sidewall 162. Temperatures probe 210 is also held at a constant location independent of whether fluid is being added or removed from container 18.
Impeller 64 comprises a central hub 66 having a plurality of fins 68 radially outwardly projecting therefrom. It is appreciated that a variety of different numbers and configurations of fins 68 can be mounted on hub 66. Hub 66 has a first end 70 with a blind socket 72 formed thereat. Socket 72 typically has a non-circular transverse cross section, such as polygonal, so that it can engage a driver portion of drive shaft 362. Accordingly, as will be discussed below in greater detail, when a driver portion is received within socket 72, the driver portion engages with impeller 64 such that rotation of drive shaft 362 facilities rotation of impeller 64.
In one embodiment, hub 66 and fins 68 of impeller 64 are molded from a polymeric material. In alternative embodiments, hub and fins 68 can be made of metal, composite, or a variety of other materials. If desired, an annular insert can be positioned within socket 72 to help reinforce hub 66. For example, the insert can be comprised of metal or other material having a strength property greater than the material from which hub 66 is comprised.
As depicted in FIG. 10, impeller assembly 40 is used in conjunction with drive shaft 362. In general drive shaft 362 comprises a head section 364 and a shaft section 366 that can be coupled together by threaded connection or other techniques. Alternatively, draft shaft 362 can be formed as a single piece member or from a plurality of attachable sections. Drive shaft 362 has a first end 368 and an opposing second end 370. Formed at first end 368 is a frustoconical engaging portion 372 that terminates at a circular plate 374. Notches 376 are formed on the perimeter edge of circular plate 374 and are used for engaging drive shaft 362 with drive motor assembly 132 as will be discussed below.
Formed at second end 370 of drive shaft 362 is a driver portion 378. Driver portion 378 has a non-circular transverse cross section so that it can facilitate locking engagement within hub 66 of impeller 64. In the embodiment depicted, driver portion 378 has a polygonal transverse cross section. However, other non-circular shapes can also be used. A driver portion 380 is also formed along drive shaft 362 toward first end 368. Driver portion 380 also has a non-circular transverse cross section and is positioned so that it can facilitate locking engagement within the interior surface of hub 54 of rotational assembly 48.
One embodiment of the present invention includes means for mixing the fluid within container 18. One example of such means comprises impeller assembly 40, draft shaft 362 and drive motor assembly 132. In alternative embodiments of the means for mixing, impeller assembly 40 can be replaced with a drive shaft that extends through a dynamic seal on container 18 and has an impeller mounted on the end thereof within container 18. In yet other embodiments, the means for mixing can comprise a stir bar, impeller or other form of mixer disposed within container 18 and a magnetic mixer disposed outside of container 18 that can rotate the mixer within container 18 through the use of a magnetic force. Other conventional mixers can also be used.
One typical example of how the inventive fluid heating system 10 can be used will now be provided. Initially, container assembly 16 is fabricated at a plant so that it is collapsed and sterilized as a complete assembly. Either just prior to or after placement of container assembly 16 within compartment 28 of tank assembly 12, container assembly 16 is partially filled with a gas through gas filter 244 (FIG. 6). By so doing, container assembly 16 expands enabling it to be easily positioned within and coupled to tank assembly 12. Specifically, as shown in FIG. 5, drain line 310 is passed out through drain opening 116 in floor 114 and support plate 314 is fitted within drain opening 116; temperature port assembly 215 is coupled with retainer 204 of tank assembly 12 and rotational assembly 48 of container assembly 16 is coupled with drive motor assembly 132 of tank assembly 12 each has previously discussed. At different stages, more gas can be injected into container assembly 16 to ensure proper placement and coupling of container assembly 16 and to avoid any potential risk of kinking container 18 as it is filled with liquid.
Once container assembly 16 is properly positioned, fluid line 232A is coupled with a fluid source while fluid line 232B is coupled with a gas outlet line. These couplings are made aseptically so as to ensure no breach and sterility. The desired fluid is then dispensed into container 18 through fluid line 232A while the displace gas is passed out through fluid line 232B. As desired, the fluid and components thereof can be delivered in different stages. For example, container assembly 16 can initially be substantially filled with media followed by delivering a culture of cells or microorganisms. During this fluid filling and gas evacuation process, fluid lines 232A and 232B can pass out of tank assembly 12 through slots 124A and B on lip 120. This ensures that if lid 104 is closed, that the fluid lines are not damaged. At some stage, temperature probe 210 is secured within probe adaptor 254 as discussed above. The electrical wires extending from temperature probe 210 can likewise pass out through a slot 320 formed on lip 120 of tank assembly 12 as shown in FIG. 1, so as to avoid any damage thereto when lid 104 is closed.
With rotational assembly 48 secured to drive motor assembly 132, drive shaft 362 is passed down through drive motor assembly 132 and into impeller assembly 40 where it couples with impeller 64. Once all of the attachments and couplings are complete and container 18 is filled with the desired fluid, clamps 238 are closed on fluid lines 232A and 232B (FIG. 6) so as to close off any further communications through the lines. Fluid lines 232A and 232B can then be disconnected from the fluid source and the gas outlet line after which the entire fluid lines 232A and 232B can be coiled and placed on top of container 18 within tank assembly 12. Lid 104 is then closed and locked in place using fastener 156.
Either before or after closing lid 104, drive motor assembly 132 is activated to begin mixing fluid within container assembly 16. This mixing of the fluid is not always required by helps to ensure that all of the fluid is uniformly heated within container 18. Furthermore, the mixing helps to ensure that the fluid is homogeneous when it is dispensed for subsequent use. Heated fluid is pumped through the jacket of tank assembly 12 so that fluid within container 18 is heated. The heating can be started at any stage, i.e., before or after disconnecting fluid line 232A from the fluid source. By having lid 104 closed and all sides of tank assembly 12 heated, along with the fluid in container 18 being mixed, the fluid can be uniformly and accurately heated with precision. The fluid is typically heated to a desired temperature after which that temperature is maintained for desired period of time to achieve desired results.
For example, the temperature and the time for maintaining the temperature can vary depending on the desired processing. Furthermore, the temperature may be raised or lowered at different stages. Likewise, in contrast to using tank assembly 12 for heating, it is also appreciated that chilled fluid can be passed through the jacket of tank assembly 12 for chilling the fluid within container assembly 16.
To ensure that all of the fluid in container assembly 16 is properly heated, an electrical heating element 322, as shown in FIG. 5, can be wrapped around the portion of drain line 310 extending between contain 18 and clamp 238. Electrical heating element 322 can heat the fluid within drain line 310 to the same temperature as the fluid within container 18. This ensure proper heating of the fluid within drain line 310. Clamp 238 is not opened until after all of the fluid has been properly heated.
Once the fluid within container assembly 16 has been properly processed, the heating can be discontinued. Drain line 310 can then be coupled in a sterile manner with a container or further line for draining fluid from container 18. If desired, mixing of the fluid within container 18 may continue to ensure that the fluid is homogeneous as it is dispensed.
When the processing is complete, drive shaft 362 is removed and rotational assembly 48 is separated from drive motor assembly 132. Container assembly 16 can then be separated from tank assembly 12 and disposed of. A second container assembly 16 can then be couple with tank assembly 12 in the same manner as discussed above and the process repeated.
Accordingly, it would have been obvious to one skilled in the art before the effective filing date of the invention to have provided said prior art with the recited temperature control arrangement of claims 8-10 as taught by LEE et al. for the purpose of providing heat exchange (heating or cooling) to a desired degree of the substances being mixed in the mixing chamber as outlined above.
Conclusion
Claims 20-22 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHARLES COOLEY whose telephone number is (571) 272-1139. The examiner can normally be reached M-F 9:30 AM - 6:00 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CLAIRE X. WANG can be reached at 571-272-1700. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHARLES COOLEY/
Examiner, Art Unit 1774
DATED: 27 SEP 2025