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 with traverse of Group I, claims 1-9, in the reply filed on April 20, 20206 is acknowledged. The traversal is on the ground(s) that “[t]he claims of Groups I-II are directed to a product and process of use of said product under 37 C.F.R. $1.475(b)(2). In particular, Group I is directed to an apparatus for preserving biological material (see, e.g., claim 1) and Group II is directed to a method of preserving biological material including cooling the sample in the apparatus of claim 1 (see, e.g., claim 10(e)). As set forth in 37 C.F.R. $1.475(b)(2), a national stage application will be considered to have unity of invention if the claims are drawn to a product and a process of use of said product. Thus, the claims of at least Groups I-II have unity of invention.” This is not found persuasive because as set forth in the restriction requirement, the inventions listed as Groups I and II do not relate to a single general inventive concept under PCT Rule 13.1 because they do not relate to one invention only, or to a group of inventions so linked so as to form a single inventive concept. Further, Applicants’ attention is drawn to the fact that the search for method claims requires the identification of processing steps, while the search for apparatus claims requires the identification of structural elements. Further, the inventions of Groups I and II do fall within a proper category of combination of inventions which is permitted by 37 C.F.R. § 1.475(b); however, these inventions lack unity of invention because even though the inventions of these groups require the technical feature of adjusting flow of heat exchange over a biological material, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Cameron et al. (WO 2020/102854).
The requirement is still deemed proper and is therefore made FINAL.Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, (i) a tube arrangement for conveying the heat transfer fluid from the pump to the compartment (claim 3), (ii) the inlet communicating from an outside of the outer insulated tank into the compartment in use, and the outlet communicating from the compartment to an outside of the outer insulated tank in use, wherein, in operation, said heat exchange fluid is introduced into the tank via said at least one inlet and removed from the tank via said at least one outlet (Claim 9), must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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 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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the heat exchange fluid" in line 4. There is insufficient antecedent basis for this limitation in the claim. Claims 2-9 are included in this rejection by virtue of their dependency upon a rejected base claim.
The term “substantially” in claim 3 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Regarding claim 3, the term "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the term are part of the claimed invention. See MPEP § 2173.05(d).
Claim 5 recites the limitation "inflow of a heat exchange fluid into the compartment from the outer insulated tank is at or adjacent one face of the insert, and outflow of the heat exchange fluid out of the compartment to the outer insulated tank is at or adjacent said face of the insert." However, the claim does not positively recite the insulated tank, yet the claim requires the container to be in a specific structural relationship with other recited claim elements. Therefore, the metes and bounds of the claim is unclear.
Claim 5 recites the limitation "a heat exchange fluid" in line 1. However, the claim already recites a heat exchange fluid earlier in the claim. Therefore, it is unclear whether the heat exchange fluid is referring to the heat exchange fluid recited earlier in the claim or is an additional element.
Claim 8 recites the limitation "said structures" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "said face" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
(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 and 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Steen et al. (US 2012/0184024; hereinafter “Steen”).
Regarding claim 1, Steen discloses an apparatus for preserving biological material, comprising an insert configured to be arranged within an outer insulated tank (FIG. 1: insert (12); [0049]), the insert defining a compartment for receiving biological material (FIG. 1), such that, in operation, biological material in the compartment is immersed in the heat exchange fluid to exchange heat with the heat exchange fluid for freezing of said biological material (the insert of Steen is structurally the same as the instant insert, and thus can be immersed in the heat exchange fluid to exchange heat with the heat exchange fluid for freezing of said biological material), the apparatus further comprising a pump that is operable to adjust a flow of heat exchange fluid over the biological material in the compartment, the pump being operable to cool the biological material at one or more different stages of cooling (abstract; claim 1; the pump of Steen is structurally the same as the instant pump, and thus fully capable “to adjust a flow of heat exchange fluid over the biological material in the compartment, the pump being operable to cool the biological material at one or more different stages of cooling”).
Furthermore, it is noted that the recitations of functional language "e.g., for preserving biological material; to be arranged within an outer insulated tank; to adjust a flow of heat exchange fluid over the biological material in the compartment, the pump being operable to cool the biological material at one or more different stages of cooling" are drawn to intended use of the claimed invention. It is noted that a recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform. Apparatus claims must distinguish from the prior art in terms of structure rather than function (see MPEP 2114). The prior art discloses all of the structural features of the claimed apparatus and thus since the structure is the same, the claimed functions are apparent.
Regarding claim 6, Steen further discloses wherein the insert comprises a baffle configured to direct flow of the heat exchange fluid through the compartment along one or more specific pathways.(FIGS. 1 and 4-5: ridge/protuberance extending from bottom of the compartment and comprising slit (21)).
Therefore, Steen meets and anticipates the limitations set forth in claims 1 and 6.
Claims 1, 5 and 7 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Cameron et al. (already of record, WO 2020/102854; hereinafter “Cameron”).
The applied reference has a common assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Regarding claim 1, it is noted that while the invention contains an insulated tank, the insulated tank is not positively recited in the instant claims.
Cameron discloses an apparatus for preserving biological material, comprising an insert configured to be arranged within an outer insulated tank (FIG. 2: inner housing (10); [0025]), the insert defining a compartment for receiving biological material (FIG. 2; [0024]), such that, in operation, biological material in the compartment is immersed in the heat exchange fluid to exchange heat with the heat exchange fluid for freezing of said biological material ([0024], [0030]), the apparatus further comprising a pump that is operable to adjust a flow of heat exchange fluid over the biological material in the compartment, the pump being operable to cool the biological material at one or more different stages of cooling (see [0030], [0033]-[0034]; the pump of Cameron is structurally the same as the instant pump and thus fully capable of performing the recited function). Furthermore, it is noted that the recitations of functional language "e.g., for preserving biological material; to be arranged within an outer insulated tank" are drawn to intended use of the claimed invention. It is noted that a recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform. Apparatus claims must distinguish from the prior art in terms of structure rather than function (see MPEP 2114). The prior art discloses all of the structural features of the claimed apparatus and thus since the structure is the same, the claimed functions are apparent.
Regarding claim 5, Cameron further discloses wherein inflow of a heat exchange fluid into the compartment from the outer insulated tank is at or adjacent one face of the insert, and outflow of the heat exchange fluid out of the compartment to the outer insulated tank is at or adjacent said face of the insert (insert includes a series of apertures (FIG. 2: apertures 11) to accommodate a continuous heat exchange fluid flow through the apparatus; [0018], [0025]). Again, Application is remined that the insulated tank is not positively recited in the instant claims.
Regarding claim 7, Cameron further discloses wherein a structure receivable in the
compartment for holding the biological material, wherein the structure is one or more of a tray, a rack and a basket ([0022]).
Therefore, Cameron meets and anticipates the limitations set forth in claims 1, 5 and 7.
Claims 1 and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by He et al. (CN110432260-A; hereinafter “He”).
Regarding claim 1, He discloses an apparatus for preserving biological material, comprising an insert configured to be arranged within an outer insulated tank (FIGS. 5-7: organ compartment (2) within water bath compartment (10); the water bath compartment is intrinsically insulated; [0060]), the insert defining a compartment for receiving biological material ([0060]), such that, in operation, biological material in the compartment is immersed in the heat exchange fluid to exchange heat with the heat exchange fluid for freezing of said biological material ([0062],[0074], [0080]), the apparatus further comprising a pump that is operable to adjust a flow of heat exchange fluid over the biological material in the compartment, the pump being operable to cool the biological material at one or more different stages of cooling (see FIGS. 5-6: pump (71); [0062]). Furthermore, it is noted that the recitation of functional language "e.g., to adjust a flow of heat exchange fluid over the biological material in the compartment, the pump being operable to cool the biological material at one or more different stages of cooling" is drawn to intended use of the claimed invention. It is noted that a recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform. Apparatus claims must distinguish from the prior art in terms of structure rather than function (see MPEP 2114). The prior art discloses all of the structural features of the claimed apparatus and thus since the structure is the same, the claimed functions are apparent.
Regarding claim 7, He further discloses wherein a structure receivable in the
compartment for holding the biological material, wherein the structure is one or more of a tray, a rack and a basket (FIGS. 4 and 7: compartment shelf 58; [0033], [0062]).
Therefore, He meets and anticipates the limitations set forth in claims 1 and 7.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 2, 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over He as applied to claims 1 and 7 above.
Regarding claim 2, He discloses the apparatus according to claim 1 as set forth above. He discloses wherein the pump has a pumping capacity, but does not explicitly disclose wherein the pumping capacity is of at least 50L/min, at least 60L/min, at least 70L/min, at least about 80L/min, and/or preferably up to about lO0L/min, preferably up to 120L/min, preferably up to about 150 L/min. However, it would therefore have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pumping capacity of He to have any pumping capacity including the claimed pumping capacity. One of ordinary skill in the art would have made said modification in order to optimize the cooling of the biological material according to need.
Regarding claim 8, He discloses the apparatus according to claim 7 as set forth above. He discloses the claimed compartment and structure but does not explicitly disclose wherein the compartment comprises a plurality of internal dividers defining a plurality of sub-compartments, each sub-compartment configured to receive one of said structures. However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus of He to comprise a plurality of internal dividers defining a plurality of sub-compartments for the purpose of accommodating a plurality of biological material individually and separately, and thereby enhance the throughput of the apparatus.
Regarding claim 9, He discloses the apparatus according to claim 1 as set forth above. He discloses disclose wherein the outer insulated tank comprises: at least one inlet and at least one outlet (see FIGS. 6 and 8: inlet and outlet coupled the outer tank for circulating heat exchange fluid in the outer tank; [0062[, [0076], [0080]), the inlet communicating from an outside of the outer insulated tank into the compartment in use (i.e., the compartment is in thermal communication with the inlet providing heat exchange fluid), and the outlet communicating from the compartment to an outside of the outer insulated tank in use (i.e., the compartment is in thermal communication with the outlet removing heat exchange fluid), wherein, in operation, said heat exchange fluid is introduced into the tank via said at least one inlet and removed from the tank via said at least one outlet ([0062], [0076], [0080]). He does not explicitly disclose wherein the outer tank comprises one side adjacent a face of the insert when the insert is arranged within the outer insulated tank, said side comprising at least one inlet and at least one outlet. However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have rearranged the inlet and outlet of the outer insulated tank to a one side adjacent a face of the insert when the insert is arranged within the outer insulated tank, since it has been held that a mere rearrangement of element without modification of the operation of the device involves only routine skill in the art (see MPEP § 2144.04 VI. C.).
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Steen as applied to claim 1 above.
Regarding claim 3, Steen discloses the apparatus according to claim 1 as set forth above. Steen further discloses a tube arrangement, the tube arrangement including a substantially linear elongate tube portion leading into the compartment (see, e.g., FIG. 5: tube (39) which includes substantially linear elongate tube portion). Steen does not explicitly disclose wherein the elongate tube portion has a length of at least about 0.2 m, preferably at least about 0.4 m, and further preferably at least about 0.5 m. However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the length of the of the elongate tube portion of Steen to comprise any length including the claimed length, since such a modification would involve only a mere change in size of a component. Scaling up or down of an element which merely requires a change in size is generally considered as being within the ordinary skill in the art (see MPEP 2144.04 IV. A.). Furthermore, it’s noted that the courts have held where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. Furthermore, it is noted that the recitation of functional language “e.g., for conveying the heat transfer fluid from the pump to the compartment" is not given patentable weight in an apparatus claim. Apparatus claims must distinguish from the prior art in terms of structure rather than function (see MPEP 2114).
Regarding claim 4, modified Steen discloses wherein the elongate tube portion has a diameter (FIG. 5), but does not explicitly disclose wherein the elongate tube portion has a diameter of about 1 inch, about 0.5 inches, or up to about 1.5 inches. However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the diameter of the of the elongate tube portion of Steen to comprise any diameter including the claimed diameter, since such a modification would involve only a mere change in size of a component. Scaling up or down of an element which merely requires a change in size is generally considered as being within the ordinary skill in the art (see MPEP 2144.04 IV. A.). Furthermore, it’s noted that the courts have held where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Bassler (US 2007/0169489) discloses a device comprising an insert within an outer tank.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LIBAN M HASSAN whose telephone number is (571)270-7636. The examiner can normally be reached on 8:30 AM - 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached on 5712721374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LIBAN M HASSAN/Primary Examiner, Art Unit 1799
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