DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-11) in the reply filed on June 01, 2026 is acknowledged. The examiner does not recommend canceling Group II (claims 12-16) as the examiner will consider rejoinder of Group II upon the allowance of Group I.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “160” has been used to designate both “plate member” and “plate mover” (see para [0038] of applicant’s specification).
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
i. “deck module” in claims 1, 6 and 9 has been interpreted by the examiner as corresponding to a tray that includes an open volume capable of receiving a filter plate as disclosed in para [0026] of applicant’s corresponding US 2024/0103025 (hereinafter ‘025) or structural equivalences thereof;
ii. “agitating member” in claims 1, 2 and 11 has been interpreted by the examiner as corresponding to a vortex plate as disclosed in para [0027] of ‘025 or structural equivalences thereof;
iii. “liquid handling member” in claims 1, 4 and 5 has been interpreted by the examiner as corresponding to a robotic arm and six pipettes as disclosed in para [0029] of ‘025 or structural equivalences thereof.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
In the patentability analysis of system claims, aspects or limitations the examiner interprets as functional are generally italicized whereas aspects interpreted as structural components are normally bolded. The bold font and italics are shown when the structure and function are initially introduced though not necessarily repeated, particularly in dependent claims. Examiner applies this formatting for both the examiner and applicant’s convenience. However, absent the referenced typestyles, the patentability analysis will still be clear regarding which limitations the examiner interprets as structural versus functional.
The claims are apparatus/device/system claims requiring only the recited structural components, although structured with physical features that can perform the stated functions or the intended uses. Functional limitations state either an intended use or operation, a manner of operating a device, apparatus or system, or what the apparatus/system does. Apparatus 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). Also, 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).
Of course, in the patentability analysis of these system claims, functional features are not ignored and Applicant can and should employ such language where appropriate and helpful. However, if a prior art structure is capable of performing the intended use, or if such apparatus can operate in the manner described, then it meets the claim limitation (MPEP §§ 2114, 2173.05(g)). Choosing to define an element functionally, i.e., by what it does, carries with a risk as stated in Swinehart, 439 F.2d at 213: “where the Patent Office has reason to believe that a functional limitation asserted to be critical for establishing novelty in the claimed subject matter may, in fact, be an inherent characteristic of the prior art, it possesses the authority to require the applicant to prove that the subject matter shown to be in the prior art does no possess the characteristic relied on.”
In summary, while features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus should 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).
Examiner's referral to Applicant's specification will generally pertain to the corresponding PG published application, if available, otherwise the original specification. The below patentability analysis provides one or more interpretations and claim mappings of the claimed structures and/or limitations although other interpretations may be possible. In the patentability analysis, the Office applies the broadest reasonable interpretation (BRI) consistent with the specification. However, specific limitations from the specification are not read into the claims. See MPEP §§2111, 2173.01 I.
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 (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-11 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Lapham et al., (US 2017/0045542; hereinafter “Lapham”).
Regarding claim 1, Lapham teaches a drug processing system comprising:
a workstation 1;
at least one deck module (platform 2) movably positionable within the workstation;
at least one filter plate 9 or 190 operably coupled with the at least one deck module, the at least one filter plate having a plurality of wells to receive a fluid therein (see Fig. 19 and para [0113] et seq.);
an agitating member adapted to move the at least one filter plate according to an agitation system (platform may be configured to perform one or more function(s) with regard to a plate supported thereon, such as, but not limited to, shaking, heating, and/or cooling”, see para [0079] et seq.- note that the agitation system is not positively recited and therefore does not limit the claimed system); and
a liquid handler member 150 adapted to selectively add a fluid to at least one of the plurality of wells and/or remove a fluid from the at least one of the plurality of wells according to a liquid handling system) note that the liquid handling system is not positively recited and therefore does not limit the claimed system);
wherein the agitating member is adapted to move the at least one filter plate while the liquid handler member selectively adds and/or removes the fluid from the at least one of the plurality of wells.
Also note when the preamble in the context of the entire claim, the recitation “drug processing system” is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention’s limitations. Thus, the preamble of the claim(s) is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02.
Regarding claim 2, Lapham teaches the agitating member comprises a vortex plate (shaking device) adapted to move at a selectable speed (see para [0078] et seq.)
Regarding claim 3, the vortex plate is adapted to move between approximately 25 revolutions per minute and approximately 300 revolutions per minute. This limitation does not limit the system structurally.
Regarding claim 4, Lapham teaches the liquid handling member comprises a first robotic arm 8 movable between a plurality of positions within the workstation (see Fig. 1).
Regarding claim 5, Lapham teaches the liquid handling member further comprises at least six tip members 170 adapted to simultaneously add and/or remove the fluid from six wells of the filter plate (see para [0112] et seq.)
Regarding claims 6 and 7, Lapham teaches a plate mover comprising a second robotic arm (planar surface gantry 7) adapted to move the at least one filter plate and/or the at least one deck module to a plurality of positions within the workstation (see para [0130] et seq.).
Regarding claim 8, Lapham teaches an adapter bracket 3 adapted to operably couple with at least a portion of the at least one filter plate, the adapter bracket including a sidewall member and at least one groove formed on at least a portion of the sidewall member (see groove along the perimeter of the plate in Fig. 2), wherein the at least one groove is adapted to be engaged by the plate mover during movement thereof within the workstation.
Regarding claim 9, Lapham teaches comprising a visual identification member (bar code) disposed on at least one of the at least one deck module or the at least one filter plate (see para [0072] et seq.)
Regarding claim 10, Lapham teaches a memory adapted to store non-transitory computer executable instructions; and a processor adapted to interface with the memory, wherein upon receiving a command to initiate the liquid handling system, the processor is adapted to execute the non-transitory computer executable instructions to cause the processor to automatically activate the agitation system and selectively add the fluid to at least one of the plurality of wells and/or remove the fluid from the at least one of the plurality of wells (see para [0134] et seq.)
Regarding claim 11, this is considered a functional/process limitation which does not limit the system (wherein the agitating member is adapted to move the at least one filter plate in a circular motion while the liquid handler member selectively adds and/or removes the fluid from the at least one of the plurality of wells).
Citations to art
In the above citations to documents in the art, an effort has been made to specifically cite representative passages, however rejections are in reference to the entirety of each document relied upon. Other passages, not specifically cited, may apply as well.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure include:
a. Johnson et al., (US 4,952,518) which teach a machine for transferring liquids to and from the wells of assay trays in a controlled, automated manner and a solid phase assay tray for use with the machine. The machine includes a horizontally translatable table (15) that holds the tray (46), a plurality of liquid dispensing manifolds (54) for dispensing liquids into the tray wells (50) and an aspirating manifold (65) for aspirating liquid from the well. The dispensing and aspirating manifolds are mounted on a vertically translatable head (16) above the table.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to P. Kathryn Wright whose telephone number is (571)272-2374. The examiner can normally be reached between 9:30am-7pm EST.
Examiner interviews are available via telephone 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.
E-mail communication Authorization
Per updated USPTO Internet usage policies, Applicant and/or applicant’s representative is encouraged to authorize the USPTO examiner to discuss any subject matter concerning the above application via Internet e-mail communications. See MPEP 502.03. To approve such communications, Applicant must provide written authorization for e-mail communication by submitting the following statement via EFS Web (using PTO/SB/439) or Central Fax (571-273-8300):
Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.
Written authorizations submitted to the Examiner via e-mail are NOT proper. Written authorizations must be submitted via EFS-Web (using PTO/SB/439) or Central Fax (571-273-8300). A paper copy of e-mail correspondence will be placed in the patent application when appropriate. E-mails from the USPTO are for the sole use of the intended recipient, and may contain information subject to the confidentiality requirement set forth in 35 USC § 122. See also MPEP 502.03.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached on 571-270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P. Kathryn Wright/Primary Examiner, Art Unit 1798
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