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 . 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.
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994)
The disclosure of the prior-filed application, U.S. Provisional Application No. 61/779,371, fails (see below) to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. More specifically, this application fails to disclose the new limitations in the independent claims.
The Examiner notes that support for the instant claims has been found in PCT/US2014/026547. As such, the Examiner will be taking the priority date for the instant application for the purposes of examination as 3/13/2014, this being the filing date of PCT/US2014/026547.
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, the ‘trapezoidal ports’ and the ‘head space’ 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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 170-176, 180-182, and 184-188 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 170 and 181 recite the limitations “wherein the inlet port and outlet port are substantially trapezoidal” and “wherein the head space at the first end is greater in cross-sectional area than the fluid channel”. However, there does not appear to be sufficient support for this claim language in the specification. Appropriate correction is required.
It should be noted that all other cited claims have been rejected for being dependent upon a rejected base claim.
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 170-176, 180-182, and 184-188 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-35 of U.S. Patent No. 10,368,937. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims anticipate the claims of the application. Accordingly, the application claims are not patentably distinct from the patent claims. Here, the more specific patent claims encompass the broader application claims. Following the rationale in In re Goodman cited in the preceding paragraph, where applicant has once been granted a patent containing a claim for the specific narrow invention, applicant may not obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
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.
Claims 170, 172-173, 175, and 180 is/are rejected under 35 U.S.C. 103 as being unpatentable over Machold, U.S. 2012/0095536 (hereinafter Machold) in view of Ford, U.S. 5,381,510 (hereinafter Ford).
Regarding claim 170, Machold discloses (note figs. 9-11B; as best understood by Examiner) a heat exchanger cartridge comprising: a thermally conductive surface (502 – note paragraphs 139-142) coupled to a ‘cover’ (500) having ‘structure’ (i.e. a surface) necessarily ‘defining’ a fluid channel (504); and a ‘biasing mechanism’ (one of the ‘detent/depression’ locking arrangements described in paragraph 154); wherein the cartridge includes an inlet port (junction between ‘452’ and inflow catheter tube) ‘positioned on’ a first side (could necessarily be described in this manner since it’s closer to the surface of the cartridge that faces into the page – see fig. 10B) of the heat exchanger cartridge and configured to connect to a fluid supply line (i.e., inflow catheter tube) at a first end of the inlet port, wherein a second end of the inlet port is ‘integrally connected’ to (i.e., in fluid communication with) a ‘first end’ of the fluid channel (near ‘462’ – see fig. 10B), and an outlet port (junction between ‘452’ and outflow catheter tube) ‘positioned on’ a second side (could necessarily be described in this manner since it’s closer to the opposite surface of the cartridge that faces out of the page – see fig. 10B) of the heat exchanger cartridge and configured to connect to a fluid outlet line (i.e., outflow catheter tube) at a first end of the outlet port, wherein a second end of the outlet port is ‘integrally connected’ to (i.e., in fluid communication with) a ‘second end’ of the fluid channel (see fig. 10B); and wherein the fluid channel is necessarily dimensioned for the fluid to exit at a temperature within the claimed range (note paragraph 186). However, Machold fails to explicitly disclose that the inlet/outlet port has a sloped/trapezoidal profile with a height/area at the first end of the port being greater than a height/area of the second end of the port (i.e., at the fluid channel). Ford teaches (note figs. 1, 2, and 7) a similar system comprising a heat exchanger cartridge having a fluid channel (308) with an inlet port (112) and an outlet port (122), wherein the ports have a sloped/trapezoidal profile (as best understood) with a height/area at a first end (adjacent an inflow/outflow tube) of the ports being greater than a height/area of a second end (adjacent the fluid channel) of the ports (as best understood). It is well known in the art that these different fluid port configurations are widely considered to be interchangeable. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed, to have modified Machold to comprise an inlet/outlet port having a sloped/trapezoidal profile with a height/area at the first end of the port being greater than a height/area of the second end of the port. This is because this modification would have merely comprised a simple substitution of interchangeable fluid port configurations in order to produce a predictable result (see MPEP 2143). It should be noted that the claimed “head space” limitation would necessarily be met by this combination of references (as best understood). Furthermore, it should be noted that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claims 172-173, Machold discloses (see above) a heat exchanger cartridge that is capable of being configured in a convex manner when disengaged from a cooling device (note fig. 11B), and a substantially flat manner when engaged with the cooling device (note fig. 11A).
Regarding claim 175, Machold discloses (see above) a heat exchanger cartridge comprising a thermally-conductive first plate (502) coupled to a second plate (500), wherein the first plate has the claimed thickness (note paragraph 142) and the second plate comprises the cover.
Regarding claim 180, Machold discloses (see above) a heat exchanger cartridge wherein at least one side of the cartridge includes structure defining a ‘notch’ (622) configured to align with a ‘key’ (i.e., detent) formed on a surface of the cooling device for automatic alignment and biasing of the cartridge when engaged to the cooling device (i.e., this notch/key arrangement has been interpreted as the other of the ‘detent/depression’ locking arrangements described in paragraph 154).
Claim(s) 171 is/are rejected under 35 U.S.C. 103 as being unpatentable over Machold in view of Ford as applied to claims 170, 172-173, 175, and 180 above, and further in view of Smisson, U.S. 7,975,491 (hereinafter Smisson) and Bouthillier, U.S. 2009/0125014 (hereinafter Bouthillier).
Regarding claim 171, Machold discloses (see above) a heat exchanger cartridge and a cooling device (404) that are removably coupled to each other via a biasing mechanism. However, Machold fails to explicitly disclose the specifically-claimed biasing mechanism. Smisson teaches (note fig. 2d) a similar device comprising a cooling device (250) and a heat exchanger cartridge (100) that are removably coupled to each other via a biasing mechanism, wherein the biasing mechanism comprises a pair of corresponding components (‘210’ and ‘290’) at each opposing end (along the perimeter) of the cartridge. It is well known in the art that these different biasing/engaging configurations (along with a wide variety of other configurations; e.g., a configuration using magnetic components as in paragraph 35 of Bouthillier) are widely considered to be interchangeable. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed, to have further modified the system in accordance with the claim. This is because this modification would have merely comprised a simple substitution of interchangeable biasing/engaging configurations in order to produce a predictable result (see MPEP 2143).
Claim(s) 174 is/are rejected under 35 U.S.C. 103 as being unpatentable over Machold in view of Ford as applied to claims 170, 172-173, 175, and 180 above, and further in view of Bouthillier.
Regarding claim 174, Machold discloses (see above) a heat exchanger cartridge and a cooling device (404) that are removably coupled to each other via a biasing mechanism. However, Machold fails to explicitly disclose the specifically-claimed biasing mechanism. Bouthillier teaches a similar system that can utilize a wide variety of mechanisms (including magnets) for biasing comparable components against each other (paragraph 35). It is well known in the art (as can be seen in Bouthillier) that these different biasing mechanisms are widely considered to be interchangeable. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed, to have modified the biasing mechanism of Machold to comprise a plurality of magnets. This is because this modification would have merely comprised a simple substitution of interchangeable biasing mechanisms in order to produce a predictable result (see MPEP 2143).
Claim(s) 176 is/are rejected under 35 U.S.C. 103 as being unpatentable over Machold in view of Ford as applied to claims 170, 172-173, 175, and 180 above, and further in view of Streeter, U.S. 4,919,134 (hereinafter Streeter).
Regarding claim 176, Machold discloses (see above) a cartridge made up of multiple ‘plates’ having a fluid channel therebetween, wherein the first plate includes a thermally conductive surface and the second plate comprises an insulation ‘cover’ (note paragraph 140). However, Machold fails to explicitly disclose a second plate that includes a groove defining a portion of the fluid channel. Streeter teaches (note fig. 2; abstract) a similar cartridge made up of multiple plates having a fluid channel therebetween, wherein the first plate includes a thermally conductive surface and the second plate includes a groove defining the fluid channel. It is well known in the art that these different cartridge-channel configurations (i.e., channel between surfaces vs channel recessed into one surface and covered by another) are widely considered to be interchangeable. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed, to have further modified the cartridge to comprise a second plate that includes a groove defining a portion of the fluid channel. This is because this modification would have merely comprised a simple substitution of interchangeable cartridge-channel configurations in order to produce a predictable result (see MPEP 2143).
Claims 181 and 184-188 is/are rejected under 35 U.S.C. 103 as being unpatentable over Machold in view of Streeter and Ford.
Regarding claim 181, Machold discloses (note figs. 9-11B; as best understood by Examiner) a heat exchanger cartridge comprising: a plate having a thermally conductive surface (502 – note paragraphs 139-142), and a cover (500) capable of being constructed via thermoforming (‘patentability does not depend on its method of production’ - MPEP 2113), wherein the cover is coupled to the conductive surface thereby defining a fluid channel (504) therebetween; wherein the cartridge is removably couplable to a cooling device (404) in the claimed manner; and wherein the cartridge includes a first port (junction between ‘452’ and inflow catheter tube) ‘positioned on’ a first side (could necessarily be described in this manner since it’s closer to the surface of the cartridge that faces into the page – see fig. 10B) of the cartridge ‘integrally connected’ to and in fluid communication with (see above) a ‘first end’ of the fluid channel (near ‘462’ – see fig. 10B), the first port being configured to connect to a fluid supply line (i.e., inflow catheter tube) at a first end of the first port, and a second port (junction between ‘452’ and outflow catheter tube) ‘positioned on’ a second side (could necessarily be described in this manner since it’s closer to the opposite surface of the cartridge that faces out of the page – see fig. 10B) of the cartridge ‘integrally connected’ to and in fluid communication with (see above) a ‘second end’ of the fluid channel (see fig. 10B), the second port being configured to connect to a fluid outlet line (i.e., outflow catheter tube) at a first end of the second port, the ports being configured to connect to respective fluid lines along axes that are parallel to the fluid channel at the first end (note fig. 10B). However, Machold fails to explicitly disclose a cover that includes a groove defining the fluid channel (in conjunction with the thermally conductive surface). Streeter teaches (note fig. 2; abstract) a similar cartridge made up of multiple plates having a fluid channel therebetween, wherein the first plate includes a thermally conductive surface and the second plate includes a groove defining the fluid channel. It is well known in the art that these different cartridge-channel configurations (i.e., channel between surfaces vs channel recessed into one surface and covered by another) are widely considered to be interchangeable. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed, to have modified the cartridge to comprise a cover that includes a groove defining the fluid channel. This is because this modification would have merely comprised a simple substitution of interchangeable cartridge-channel configurations in order to produce a predictable result (see MPEP 2143).
Machold further fails to explicitly disclose that the first/second port has a sloped/trapezoidal profile with a height/area at the first end (adjacent the catheter tube) being greater than a height/area of the second end (at the fluid channel). Ford teaches (note figs. 1, 2, and 7) a similar system comprising a heat exchanger cartridge having a fluid channel (308) with an inlet port (112) and an outlet port (122), wherein the ports have a sloped/trapezoidal profile (as best understood) with a height/area at a first end (adjacent an inflow/outflow tube) being greater than a height/area of a second end (adjacent the fluid channel; as best understood). It is well known in the art that these different fluid port configurations are widely considered to be interchangeable. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed, to have further modified Machold to comprise a first/second port (connecting the ‘parallel’ fluid lines and the planar fluid channel) having a sloped/trapezoidal profile with a height/area at the first end being greater than a height/area of the second end. This is because this modification would have merely comprised a simple substitution of interchangeable fluid port configurations in order to produce a predictable result (see MPEP 2143). It should be noted that the claimed “head space” limitation would necessarily be met by this combination of references (as best understood). Furthermore, it should be noted that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claims 184-185, Machold discloses (see above) a heat exchanger cartridge that is capable of being configured in a convex manner when disengaged from a cooling device (note fig. 11B), and a substantially flat manner (as best understood by Examiner) when engaged with the cooling device (note fig. 11A).
Regarding claim 186, Machold discloses (see above) a heat exchanger cartridge wherein the plate including the thermally-conductive surface has the claimed thickness (note paragraph 142).
Regarding claim 187, Machold discloses (see above) a heat exchanger cartridge further comprising a fluid reservoir (474 – note paragraph 134) contained therein.
Regarding claim 188, Machold discloses (see above) a heat exchanger cartridge wherein at least one side of the cartridge includes structure defining a ‘notch’ (622) configured to align with a ‘key’ (i.e., detent) formed on a surface of the cooling device for automatic alignment and biasing of the cartridge when engaged to the cooling device (note paragraph 154).
Claim 182 is/are rejected under 35 U.S.C. 103 as being unpatentable over Machold in view of Streeter and Ford as applied to claims 181 and 184-188 above, and further in view of Bouthillier.
Regarding claim 182, Machold discloses (see above) a heat exchanger cartridge and a cooling device (404) that are removably coupled to each other via a ‘biasing mechanism’ (see ‘locking arrangement’ in paragraph 154). However, Machold fails to explicitly disclose the specifically-claimed biasing mechanism. Bouthillier teaches a similar system that can utilize a wide variety of mechanisms (including magnets) for biasing comparable components against each other (paragraph 35). It is well known in the art (as can be seen in Bouthillier) that these different biasing mechanisms are widely considered to be interchangeable. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed, to have modified the biasing mechanism of Machold to comprise a plurality of magnets. This is because this modification would have merely comprised a simple substitution of interchangeable biasing mechanisms in order to produce a predictable result (see MPEP 2143).
Response to Arguments
Applicant's arguments filed March 25, 2025 have been fully considered but they are not persuasive. Regarding Applicant’s arguments that the claims have not been met by the cited references, Examiner respectfully disagrees. More specifically, Examiner maintains that the claims have been met as they are currently written (and as best understood), due to the breadth of limitations such as “integrally”, “substantially trapezoidal”, and “head space” (see updated interpretation above).
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., ports having a different cross-sectional area – this is different from the claim language, which recites different heights, a sloped profile, and a head space having a different area than the fluid channel) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Regarding Applicant’s arguments concerning the use of Streeter, it should be noted that this reference was merely relied upon for its cited teachings. It was never intended to remedy all of the deficiencies of the base reference. Therefore, Examiner asserts that the claims are still met in view of the cited references, as they are currently written (as best understood).
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 THOMAS ANTHONY GIULIANI whose telephone number is (571)270-3202. The examiner can normally be reached Mon - Fri 9:00-5:00.
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/THOMAS A GIULIANI/Primary Examiner, Art Unit 3794