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)).
Information Disclosure Statement
Note the attached PTO-1449 forms submitted with the Information Disclosure Statements.
Drawings
The replacement sheets of drawings filed on 18 JAN 2024 are approved by the examiner, with the exception(s) noted below.
The drawings are objected to under 37 CFR § 1.84 in view of the following deficiencies that require correction:
The drawings contain improper sectional views. The plane upon which a sectional view is taken should be indicated on the view from which the section is cut by a broken line. The ends of the broken line should be designated by Arabic or Roman numerals corresponding to the view number of the sectional view, and should have arrows to indicate the direction of sight (37 CFR 1.84(h)(3)). For example, Figures 4A, 4B, and 4C should each be a sectional view taken along line --4A, 4B, 4C - 4A, 4B,4C-- in Figure 3 (not sectional line A-A”). All sectional views should be corrected in accordance with 37 CFR 1.84(h)(3).
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 will require revision in accordance with any drawing objections listed herein (such as the sectional line designations)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.
Applicant should thus verify that (1) all reference characters in the drawings are described in the detailed description portion of the specification and (2) all reference characters mentioned in the specification are included in the appropriate drawing Figure(s) as required by 37 CFR 1.84(p)(5).
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.
Specification
The substitute specification is approved for entry but 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 substitute abstract is acceptable.
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) by mentioning the different sized fins removably attached to the core.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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).
In view of the guidance above, claims 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over MERINO et al. (US2011/0136648 A1) in view of JP 2017-131873 A.
MERINO et al. discloses a centrifuge rotor (cylindrical rotor assembly 2) for a centrifuge 100 with a drive device D for driving the rotor assembly into rotation per ¶ [0069] that discloses with reference to FIG. 1, the centrifuge 100 includes a tank assembly 1 within which is housed a drive turbine and a rotor assembly 2 and the drive turbine D is used to spin rotor assembly 2 at high speeds; the rotor assembly 2 typically includes an outer rotor housing 5, two end caps 7, 8 and a core 6 therein; a lift assembly 3 is provided to raise both drive turbine D and the rotor assembly 2 from tank assembly 1 as shown in FIG. 1; a console assembly 4 is provided which connects to tank assembly 1 and controls the critical functions of centrifuge 100 such as, for example, time and speed; a sample line 3 (and see Figure 4 showing sample flow through the rotor assembly); a column-shaped core body (inner cylinder 110) and a plurality of fins (fins 13) with which the core body is equipped so that the fins project radially from the outer circumferential surface of the core body 110; and describes a rotatable rotor comprising a core 6 within a cylindrical rotor body (rotor housing 5a) surrounding the core, wherein the rotor is configured such that a sample is passed through the core body and the rotor body between both ends in the rotation axis direction (Figure 4); wherein the volume of the centrifugal separation space defined between the core body and the rotor body is changed by changing the size of the fin to the circumferential width of the portion protruding radially outward relative to the outer circumferential surface of the core body per ¶ [0025], [0029], [0038], [0058], 0093], [0096].
MERINO et al. does not disclose the fins being removably attached and detached from the core via mounting grooves. However, JP 2017-131873 A discloses an analogous centrifuge with a rotor including a rotor housing 11, a core body 21 with fins 22 being provided in the rotor of the centrifugal machine 200, and the fin 22 is detachable to and from the core body. It would have been obvious to one skilled in the art before the effective filing date of the invention to have utilized the teachings of JP ‘873 in the centrifuge of MERINO et al. for the purposes of enabling the fins to be detachably attached and thus removable from the core, to prevent sticking between the core and the outer housing (per the machine translation), and therefore to enable fins of different sizes to be readily attached and removed from the core when changing the size of the fin as described in MERINO et al.
JP ‘873 describes a configuration including a fin mounting groove 21C. Moreover, it would have been obvious to adopt the fin mounting groove described in JP ‘873 to the core described in MERINO et al. thus making the width in the circumferential direction of the protruding portion of the fin larger than the width of the fin mounting groove, and making the area of the outer circumferential surface of the fin larger than the opening area of the fin mounting groove.
MERINO et al. discloses in ¶ [0094] and Fig. 4 a configuration in which the sample to be centrifugally separated is injected into the rotor body from one side in the rotation axis direction during the rotation of the rotor, and is discharged from the other side, Furthermore, MERINO et al. in [0038]) describes that the fin and the core main body can be removed from the rotor body.
The radial distance recited in claim 5 is seen in the Figures of MERINO et al. and JP ‘873.
MERINO et al. discloses in [0070] that the core 6 is a synthetic resin or a metal. Rotor assembly 2 includes an outer rotor housing 5 and a core 6 which is adapted to be disposed within outer rotor housing 5. Outer rotor housing 5 may be made of any material suitable in the centrifugation art, preferably titanium. Core 6 may be made of any material or blend of materials suitable in the centrifugation art, such as, for example, a thermoplastic resin, titanium and polyetheretherketone (PEEK). In a preferred embodiment, core 6 may be formed from a polymeric material such as, for example, a polyphenylene ether, or a blend of more than one polymeric material. A preferred polyphenylene ether is available commercially from the General Electric Company and is sold under the trademark NORYL. Core 6 is substantially cylindrical, but may be configured into any shape that can withstand the stress of centrifugation. Moreover, the specific gravity and density of the core body and the fins can be set as appropriate by a person skilled in the art.
The protruding portion of the fin in MERINO et al. has an arc surface (Figs. 2A-4) having an outer diameter substantially equal to the inner diameter of the rotor body, and the inner surface of the protruding portion is formed by an arc surface in contact with the outer surface of the core body. Furthermore, the density of the core body and the fin can be set as appropriate by a person skilled in the art.
With regard to the recited materials, densities, and specific gravities of the elements of the rotor such as the core body and fins, it would have been obvious to one having ordinary skill in the art to have formed the rotor from the recited materials, densities, and specific gravities since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416; Sinclair & Carroll Co., Inc. v. Interchemical Corp., 65 USPQ 297 (1945).
It is observed that artisans must be presumed to know something about the art apart from what the references disclose (see In re Jacoby, 309 F.2d 513, 135 USPQ 317 (CCPA 1962)). Moreover, skill is presumed on the part of those practicing in the art. See In re Sovish, 769 F.2d 738, 226 USPQ 771 (Fed. Cir. 1985). Therefore, it is concluded that the selection of desired materials known in the art such as the recited materials would have been obvious to one of ordinary skill in this art, if for no other reason than to achieve the advantage of using a more modern material or a lower cost or more easily fabricated material.
This exemplifies the Supreme Court's analysis in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 [82 USPQ2d 1385] (2007). “When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation, §103 likely bars its patentability. For the same reason, if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill.” Id. at 417. As further emphasis on the substitution of one material for another, there is the venerable case of Hotchkiss v. Greenwood, 52 U.S. (11 How.) 248 (1851), cited approvingly in KSR Int'l Co. v. Teleflex Inc., supra, 550 U.S. at 406, 415, which denied patentability to an invention consisting of the substitution of a clay or porcelain knob for a metallic or wood knob in a doorknob (the doorknob itself, as distinct from the knob on the end of it, being an assemblage of knob, shank, and spindle). Other substitution cases in which patentability was denied on grounds of obviousness include Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530, 1535–38 [218 USPQ 871] (Fed. Cir. 1983); Brunswick Corp. v. Champion Spark Plug Co., 689 F.2d 740, 749-50 [216 USPQ 1] (7th Cir. 1982), and Lyle/Carlstrom Associates, Inc. v. Manhattan Store Interiors, Inc., 635 F.Supp. 1371, 1381-83 [230 USPQ 278] (E.D.N.Y. 1986), aff'd, 824 F.2d 977 (Fed. Cir. 1987).
Among the inventions that the law deems obvious are those modest, routine, everyday, incremental improvements of an existing product or process that confer commercial value (otherwise they would not be undertaken) but do not involve sufficient inventiveness to merit patent protection. This class of inventions is well illustrated by efforts at routine experimentation with different standard grades of a material used in a product—standard in the sense that their properties, composition, and method of creation are well known, making successful results of the experimentation predictable. Ritchie v. Vast Resources Inc., 90 USPQ2d 1668 (Fed. Cir. 2009). Accordingly, it is well settled that a predictable substitution of one material for another is well within the grasp of 35 U.S.C 103(a) and common sense. A rejection to overcome an obviousness rejection will not be withdrawn when the allegedly missing teaching of the rejection would have been understood by a PHOSITA—by way of common sense, common knowledge generally, or common knowledge in the relevant art. Randall Mfg. v. Rea, supra. Choosing an appropriate material for a specific application or structural member can unquestionably be determined by a PHOSITA by innate common sense, the common knowledge generally, or the common knowledge in the relevant art.
Allowable Subject Matter
No claims stand allowed.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The cited prior art discloses centrifuge rotors with a core assembly therein.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. New USPTO policy limits time for interviews to one per new application or RCE (utility), when during prosecution, the examiner conducts an interview. More than one interview and additional time will only be granted if it is ensured “that the interviews are being used to advance prosecution”.
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: 24 JUNE 2026