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 .
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: “quality control system”, “harvester”, “robotic system”, “tracker”, “particle counter”, “air flow system”, “isolator”, “conduit configured to prevent back splashing”, “system for determining cell number or cell confluency”, “sterilizer for sterilizing” and “system configured for tilting” as found throughout the claims.
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 apparatus claims 1-20, aspects or limitations examiner interprets as functional/process/intended use language and/or not positively recited as part the claimed apparatus have been generally italicized whereas aspects interpreted as positively recited 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. The 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/process/intended use and not positively recited structure. Also, note that it has been held that recitations in which an element is "adapted to/for", “configured to/for”, “positionable”, “moveable/immovable”, etc., only requires the ability to so perform (i.e., functional/process/intended use). The functional/process/intended use recitation(s) and/or element(s) not positively recited as part of the apparatus do not constitute a limitation in any patentable sense with respect to the prior art. Please note these recitations have not been ignored by the examiner. All of the recitations in applicant’s claims 1-20 have been considered by the examiner and afforded the appropriate amount of patentable weight. In certain instances during prosecution, the examiner’s current interpretation(s) regarding the patentable weight of these limitation(s) might change based on the facts of the case.
The examiner's below patentability analysis provides one or more interpretations and claim mappings of the claimed structures and steps although other interpretations may be possible. In the patentability analysis, the Office applies the broadest reasonable interpretation (BRI) consistent with the specification and specific limitations from the specification have not been read into the claims.
See MPEP at least §2111.02, 2173.01 I 2114, and 2173.05(g).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1-17 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 1 recites a plurality of batches. The batches (first batch, second batch) are not positively recited (not required). It is unclear whether applicant intends the plurality of batches to be considered required in the claim since the CPU process recites the first batch and the second batch are within the enclosure at the same time, without cross contamination from the other of the first batch and the second batch, wherein, while operational, the enclosure is only accessible from outside of the system through the at least one isolation chamber has not received patentable weight. This logic applies to the “at least one instrument” in claim 1. Further, “while operational” is conditional and thus not required. Also, it is not clear what application means by “while operational”. What process is associated with “operational”.
Claim 8 recites “at a location remote from the center of the closed enclosure”. The term “remote” is vague and indefinite. It is not clear from the claim or the specification what distance between the center of closed enclosure applicant considers remote. Furthermore, the center of the closed enclosure lacks antecedent basis. That is, the center of the enclosure has not been established, nor has the “closed” enclosure.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 5-7, 10, 14 and 17 are rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Parent claim 2 is written using alternative language. That is, the system comprising one or more, only requires single element. Thus, claims 5-7, 10, and 14 do not further limit the subject matter of the claim 2 upon which it depends and have not been considered. Similar logic is applied to claim 17, which depends on alternatively recited claim 15. Note: if a Markush like claim (or any other claim that sets forth alternatives) is rejected with respect to any one of the alternatives, a second action may be made final provided that any new ground of rejection in the action is either necessitated by Applicant's amendment (including elimination of unpatentable alternatives) or is based on information submitted in an IDS in compliance with 37 CFR 1.97(c). See MPEP 803.02.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 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 1-17 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as anticipated by Okano et al., (US 2013/0130361; hereinafter “Okano”-already of record).
As to claim 1, Okano teaches a system for automated processing of a plurality of batches, each batch being derived from one biological sample, the system comprising:
an enclosure (reads on modules 11-14) comprising an enclosure access port (FIG. 1 is a plan view of an embodiment of a processing system for cell cultures of the present invention. Reference numeral 1a of FIG. 1 denotes the embodiment of the processing system for cell cultures, 11 denotes a conveyance module, 12 denotes a dispensing module, 13 denotes a homothermal module, 14 denotes a cell-sheet stacking module. These modules 11 to 14 are shown as examples and may be modules having other functions. More modules may be connected thereto, see para [0047] et seq.);
at least one isolation chamber 15 comprising a first access port of the at least one isolation chamber and a second access port of the at least one isolation chamber, wherein the enclosure and the at least one isolation chamber are connected by an opening through the enclosure access port and the first access port of the at least one isolation chamber (e.g., module 15 denotes a carry-out/in module of, for example, a culturing plate);
wherein a first gate 16 operably opens and closes the opening between the enclosure access port and the first access port of the at least one isolation chamber (Attaching/detaching means 16 are provided at lateral surfaces of the hexagonal conveyance module 11 at the center of the drawing. The attaching/detaching means 16 detachably connect the conveyance module 11 with the modules represented by 12 to 15. The conveyance module 11 and the other modules 12 to 15 (also referred to as processing devices) are provided with closed spaces (for example, chamber or housing) which shut off outside air. After the conveyance module and the other modules are mutually connected, one closed space or sealed space can be formed as a whole system, alternatively, a closed space or a sealed space, which is completely sealed, separated by an openable/closable door can be formed in each module unit, see para [0048] et seq.);
at least one chamber 12-14 which is outside of but accessible from inside the enclosure through at least one auxiliary gate that connect(s) the enclosure to the at least one chamber outside of the enclosure (other modules 12 to 14 referred to as processing devices) are provided with closed spaces (for example, chamber or housing) which shut off from the outside air. After the conveyance module and the other modules are mutually connected, one closed space or sealed space can be formed as a whole system, alternatively, a closed space or a sealed space, which is completely sealed, separated by an openable/closable door can be formed in each module unit);
a control unit (CU 70) communicatively coupled to at least one instrument located in the at least one chamber located outside of but accessible from inside the enclosure, the at least one auxiliary gate that connect(s) the enclosure to the at least one chamber outside of the enclosure (instruments are not positively recited), and
the first gate that operably opens and closes the opening between the enclosure access port and the first access port of the at least one isolation chamber, wherein the plurality of batches comprises a first batch and a second batch, the system being configured to receive the second batch into the enclosure before the first batch is transported out of the enclosure,
wherein the CU is configured to automatically process the first batch and the second batch within the enclosure at the same time, without cross contamination from the other of the first batch and the second batch, wherein, while operational, the enclosure is only accessible from outside of the system through the at least one isolation chamber (note that the batches are not positively recite, however Okano does teach using the processing system for cell cultures of the present invention, cells derived from one or plural patients may be subjected to cell culturing and processing operations simultaneously and parallelly. Even in the case of the cells derived from a single patient, the cells of plural types having different culturing steps may be handled simultaneously and parallelly. An embodiment of a case in which cells derived from plural patients are subjected to cell culturing and processing operations simultaneously and parallelly by using the processing system for cell cultures, see para [0054] et seq.); and
wherein the CU controls opening of the first gate and the at least one auxiliary gate that connect(s) the enclosure to the at least one chamber outside of the enclosure, wherein the CU is configured to ensure that only one gate that connects the enclosure to an open space outside of the enclosure can be opened at a time (see para [0097] et seq.)
Regarding claim 2, the use of alternative language (at least one of) merely requires the system of Okano comprise one element to meet the limitation of the claim. Okano teaches a robotic arm (see Fig. 4) within the enclosure, configured for at least one of transporting the one or more cell processing containers.
Regarding claim 3, the enclosure is at least a class 100 environment or at least a class 10 environment.
Regarding claim 4, Okano teaches the enclosure 11 is defined at least in part by a top wall, a first side wall and a second side wall extending opposite the first side wall, and a bottom wall;
the enclosure has an air inlet port 35b defined in one or more of the top wall, the first side wall, the second side wall and the bottom wall (see Fig. 3 and para [0070] et seq.);
the enclosure has an air outlet port 37 disposed in one or more of the top wall, the first side wall, the second side wall and the bottom wall (see para ,
the one or more impellers (reads on fan 29) are configured to direct air flow into the enclosure via the air inlet port and air flow out of the enclosure via the air outlet port, and an air flow within the enclosure is laminar.
Regarding claims 5-7, 10, 14 and 17, these claims have not been applied with respect to the prior for the reasons delineated above. However, the examiner believes the structural element in these claims are taught by Okano.
Regarding claim 8, Okano teaches the enclosure is fluidly connected to a waste receptacle by a conduit 92 at a relocation remote from the center of the closed enclosu, see para [0179] et seq.)
Regarding claim 9, is implicit that the conduit slopes at some point (i.e., curved) that is angled in relation to an opening of the waste receptacle to prevent backsplashing of waste material deposited into the conduit for disposal into the waste receptacle.
Regarding claim 11, Okano teaches a plate reader (i.e., measurement/analysis modules, see para [0099] et seq.)
Regarding claim 12, this a functional/process claim and thus does not structurally limit the system, an air pressure inside the enclosure is greater than an air pressure in the at least one isolation chamber and an air pressure inside the at least one isolation chamber is greater than an air pressure adjacent to the at least one isolation chamber in a direction other than the enclosure, or an ambient air pressure outside the system.
As to claim 13, Okano teaches a biological safety cabinet (no specific structure has been read into the BSC, thus, any of the modules 12-17 reads on the BSC). Note: the isolator 15 in Okano is selectively fluidly connected to the BSC (air passage), and objects from outside the system are received into the isolator via the BSC, and objects from inside the enclosure are passed out of the system by passing from the enclosure to the isolator and from the isolator to the BSC via the isolator.
Regarding claim 15, Okano teaches an incubator for incubating cells (homothermal module, see para [0129] et seq.)
Regarding claim 16, Okano teaches a liquid fill system (see para [0177] et seq.) housed inside the enclosure and configured for direct filling of liquid from a supply container disposed inside or outside the enclosure into a cell processing container disposed inside the enclosure.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,796,552 and 1-17 of U.S. Patent No. 11,125,767. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘552 and ‘767 patents disclose the same elements or structural equivalent of the elements recited in the instant claims such that the scope of the instant claims are encompassed by those of the ‘552 and ‘767 patents.
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.
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
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 between9:30am-7:30 pm 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) 270-36383638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/P. Kathryn Wright/Primary Examiner, Art Unit 1798
Prosecution Insights