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 .
Response to Arguments
Applicant’s argument filed with respect to the non-statutory double patenting rejection has been fully considered, but is not persuasive and the rejection will not be held in abeyance. The rejection is recited again below.
Applicant’s arguments with respect to the prior art rejections have been considered but are not persuasive. Examiner reminds Applicant that “"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987) (The preamble of claim 1 recited that the apparatus was "for mixing flowing developer material" and the body of the claim recited "means for mixing ..., said mixing means being stationary and completely submerged in the developer material." The claim was rejected over a reference which taught all the structural limitations of the claim for the intended use of mixing flowing developer. However, the mixer was only partially submerged in the developer material. The Board held that the amount of submersion is immaterial to the structure of the mixer and thus the claim was properly rejected.).”. Accordingly, arguments pertaining to differences in operation between Bauer and Applicant’s claimed invention are not found persuasive. Regarding Applicant’s arguments that fans and nozzles are not pumps, Examiner notes that injecting via a nozzle is indicative of an upstream pump, and further notes that a fan is a device that transfers fluid by suction, pressure, or both (see attached definition for pump) and thus can broadly be considered a pump. Regarding the external refrigeration system, Examiner notes that the reference refers to “The apparatus (100) comprises a cooling chamber (102), a cooling device (104) comprising means configured to cool an interior of the cooling chamber (102), wherein the cooling device (104) further comprises cooling tubes (146) that are separate from the means configured to cool the interior of the cooling chamber (102) and that are arranged within the cooling chamber (102), wherein the cooling device (104) is configured to provide a flow of refrigerant through the cooling tubes (146)”, which appears to correspond to the corresponding structure for external refrigeration system in Applicant’s disclosure (see claim interpretation, below). Even if the refrigeration system of Bauer is open loop, this is not currently disclaimed by Applicant’s structural limitations, which do not require “re-circulation of the heat exchange fluid”. Accordingly, the rejections are maintained below. Applicant is encouraged to either amend to reflect the structural limitations pertaining to Applicant’s operation arguments or present arguments as to how the structure claimed differs from that mapped to the Bauer reference. If Applicant believes discussion would aid in advancing prosecution, Applicant is encouraged to contact the Examiner using the information below to schedule an interview.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 8 of U.S. Patent No. 12,458,037. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claim 1, US 12,458,037 discloses an apparatus for preserving consumable products by freezing the consumable products, the apparatus comprising an inner housing arranged within a tank,
wherein walls of the inner housing define a compartment for receiving consumable products, said walls comprising
an inlet wall for inflow of a heat exchange fluid into the compartment;
an opposed outlet wall for outflow of the heat exchange fluid out of the compartment; side walls; and
a base, the side walls and the base adjoining the inlet wall to the outlet wall, wherein insulation is provided in walls of the tank, and wherein the tank comprises:
an inlet side corresponding to the inlet wall of the inner housing and defining a cavity between the inlet side and the inlet wall; and
an outlet side corresponding to the outlet wall of the inner housing and defining an opposing cavity between the outlet side and the outlet wall,
wherein the inlet wall and outlet wall each include a series of apertures to accommodate a continuous heat exchange fluid flow through the apparatus such that, in operation, consumable products received in the compartment of the inner housing are immersed in the heat exchange fluid to exchange heat with the heat exchange fluid,
wherein the inlet side includes at least one inlet communicating from an outside of the tank into the cavity,
wherein the outlet side includes at least one outlet communicating from the opposing cavity to the outside of the tank,
wherein the apparatus further comprises a pump for pumping the heat exchange fluid into the tank through the at least one inlet,
wherein, in operation, the heat exchange fluid is introduced into the tank via the at least one inlet and removed from the tank via the at least one outlet, (Claim 1) and
wherein the apparatus is configured to be connected to an external refrigeration system whereby the heat exchange fluid that is removed from the tank exchanges heat with a refrigerant in the refrigeration system to continuously cool the heat exchange fluid. (Claim 8)
US 12,458,037 does not disclose biological products, instead disclosing consumable products (see Claim 1, lines 1, 4, and 17-18).
However, it is noted that the material or article worked upon does not limit apparatus claims (see MPEP 2115), and thus the biological or consumable product(s) claimed are not indicative of a patentable distinction.
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: “external refrigeration system” in claim 8.
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.
In the case of the “external refrigeration system”, the corresponding structure can be found in par 0067: “The refrigeration system includes a heat exchanger”.
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.
The limitation "structure" in claims 3-4 has NOT been interpreted as invoking 35 U.S.C. 112(f) since the "structure" is modified by structural limitations.
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.
Claim(s) 1-3, and 6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bauer et al. (WO 2017/137552: cited by Applicant).
Regarding claim 1, Bauer et al. shows an apparatus for use in cryopreservation of biological products (see at least #100), the apparatus comprising an inner housing (see at least inner casing #108) arranged within a tank (see at least outer casing #110),
wherein walls of the inner housing define a compartment for receiving biological products (see at least cooling chamber #102), said walls comprising:
an inlet wall for inflow of a heat exchange fluid into the compartment (see at least lower side wall #122);
an opposed outlet wall for outflow of the heat exchange fluid out of the compartment (see at least top side wall #124);
side walls (see at least left/right walls of #108); and
a base, the side walls and the base adjoining the inlet wall to the outlet wall (see at least wall #130: side walls of #108 and the base wall define in part the space between inlet/outlet walls),
wherein insulation is provided in walls of the tank (see at least fluid gap between #110/#112/#108), and wherein the tank the outer housing comprises:
an inlet side corresponding to the inlet wall of the inner housing and defining a cavity between the inlet side and the inlet wall (see at least region between #122/#130); and
an outlet side corresponding to the outlet wall of the inner housing and defining an opposing cavity between the outlet side and the outlet wall (see at least region between #124/#132), and
wherein the inlet wall and outlet wall each include a series of apertures to accommodate a continuous heat exchange fluid flow through the apparatus such that, in operation, biological products received in the compartment of the inner housing are immersed in the heat exchange fluid to exchange heat with the heat exchange fluid (see at least walls #122/#124 both include apertures #126 for the flow of heat transfer fluid),
wherein the inlet side includes at least one inlet communicating from an outside of the tank into the cavity (see at least #152),
wherein the outlet side includes at least one outlet communicating from the opposing cavity to the outside of the tank (see at least #140),
wherein the apparatus further comprises a pump for pumping the heat exchange fluid into the tank through the at least one inlet (injecting via nozzles #150 is indicative of pump; alternatively fan #144 is a form of pump), and
wherein, in operation, the heat exchange fluid is introduced into the tank via the at least one inlet (see at least via nozzles #150) and removed from the tank via the at least one outlet (see at least via fan #144), and
wherein the apparatus is configured to be connected to an external refrigeration system,
whereby the heat exchange fluid that is removed from the tank exchanges heat with a refrigerant in the refrigeration system to continuously cool the heat exchange fluid (see at least cooling device #104 which provides refrigerant to both tubes #146 and nozzles #150 and, thus, continuously exchanges heat with the fluid in chamber #102).
Regarding claim 2, Bauer et al. further shows wherein the base includes a series of apertures (see at least #130 includes a series of at least one aperture #134).
Regarding claim 3, Bauer et al. further shows wherein the apparatus is configured to receive a structure in the compartment for holding the biological products, wherein the structure is one or more of a tray, a rack and a basket (see at least support #106 which meets tray/rack).
Regarding claim 6, Bauer et al. further shows wherein the cavity and the opposing cavity are fluidly connected (see at least via chamber #102).
Claim Rejections - 35 USC § 103
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.
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.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bauer et al. as applied to claim 3 above, and further in view of Caveney (US-20160288999-A1: previously cited).
Regarding claim 4, Bauer et al. does not disclose wherein the apparatus is configured to allow the structure to be suspended from a lid of the apparatus.
Caveney teaches another apparatus for cryogenic storage (Caveney, Fig 1 cryogenic storage device #100) wherein the apparatus is configured to receive a structure (Caveney Fig 10 sample storage rack #480) in the compartment for holding the biological products (Caveney Fig 10 freezer #120), wherein the structure is one or more of a tray, a rack and a basket (Caveney Fig 4 and Fig 10, sample storage rack #480 and shelves #481), wherein the apparatus is configured to allow the structure to be suspended from a lid of the apparatus (Caveney Fig 10 sample storage rack #480 is suspended from freezer cover #121 via retrieval module #110).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to provide the system of Bauer et al. with wherein the apparatus is configured to receive a structure in the compartment for holding the biological products, wherein the structure is one or more of a tray, a rack and a basket, wherein the apparatus is configured to allow the structure to be suspended from a lid of the apparatus, as taught by Caveney, as doing so would improve the system of Bauer et al. by having a structure that is capable of holding multiple samples or samples in small tubes that need to be accommodated in a tray or holder and that can facilitate access to the samples and improve the uniform distribution of heat around the sample.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bauer et al. as applied to claim 1 above, and further in view of Kulkarni (US-9448006-B2: previously cited).
Regarding claim 7, Bauer et al. is silent regarding wherein the at least one inlet and the at least one outlet are 80 mm in diameter.
However, the size of inlets and outlets that are used for introduction or removal of a heat exchange fluid are a results effective variable, as recognized by Kulkarni (see Kulkarni col 6 lines 49-65 and col 7 lines 1-7: the diameter/size of the inlet or outlet of the apertures can vary to optimize the flow rate of a heat exchange fluid that passes through).
It would, therefore, have been obvious to one having ordinary skill in the art before the effective filing date of the invention to provide the system of Bauer et al. with wherein the at least one inlet and the at least one outlet are 80 mm in diameter, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or working ranges involves only routine skill in the art (see In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977)).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAVIA SULLENS whose telephone number is (571)272-3749. The examiner can normally be reached M-R 6:30-4:30 Eastern.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jianying Atkisson can be reached at 571-270-7740. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TAVIA SULLENS/Primary Examiner, Art Unit 3763