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 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.
Claim 9 is 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 9 has been amended to depend on cancelled claim 8.
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)(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.
Claim(s) 1-3, 10-20 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by
Ang et al. (US 2012/0063973A1).
Ang discloses in reference to claim:
1. (Currently Amended) A flexible heater 122, comprising: a first conformable substrate 106 forming one a first side of a medical fluid bag 102; a second conformable substrate 106 forming a second side of the medical fluid bag; and a plurality of inks printed onto a substantially planar faces of each of the at least one first and second substrates to form first and second flexible heaters [FIG. 1 shows a perspective view of a flexible fluid storage and warming bag including an electrical heating element printed on one flexible main wall of the bag ] each comprising: at least one conductive layer 116 capable of conducting current flow from at least one power source [the power supply may include a battery or may be directly connected to the power supply mains. For example, the power supply may be a lithium polymer battery configured to yield an overall voltage of about 12 Vdc to about 15 Vdc rated at 3 amp-hour or a normal AC-DC adapter yielding preferably about 30 W rating], and communicative with a control circuit [The hanger and power supply device 132 also may include a temperature controller 142 so as to control the amount of power supplied to the electrical heating element 104 or electrically conductive strip 124 so as to increase or decrease the amount of heat supplied to the fluid 108 stored in the bag 102.]; at least one resistive layer 124 electrically associated with the at least one conductive layer 116 and comprising a plurality of heating elements 104 capable of generating heat upon receipt of the current flow; and at least one dielectric layer [ In an embodiment, the thermal conduction and electrical insulation layer may include a material selected from a group consisting of a thermally conductive epoxy, a thermally conductive adhesive, and a thermally conductive resin for example.] capable of at least partially insulating the at least one resistive layer.
2. The flexible heater of claim 1, wherein the substrate comprises an inorganic substrate.
Ang discloses In an embodiment, the thermal conduction and electrical insulation layer may include a material selected from a group consisting of a thermally conductive epoxy, a thermally conductive adhesive, and a thermally conductive resin for example. n an embodiment, the base layer may include a material selected from a group consisting of a polyethylene terephthalate (PET) substrate and a polyethylene naphthalate (PEN) substrate, for example. The base layer may be of a relatively rigid material so as to act as a base for subsequent deposition of materials.
3. The flexible heater of claim 1, wherein the substrate comprises one of PET, flexible PVC, and polyether polyurethane.
Ang discloses an embodiment, the base layer may include a material selected from a group consisting of a polyethylene terephthalate (PET) substrate and a polyethylene naphthalate (PEN) substrate, for example. The base layer may be of a relatively rigid material so as to act as a base for subsequent deposition of materials.
10. The flexible heater of claim 1, wherein the control circuit 142 comprises an attachable cartridge 132.
Ang discloses Further, the hanger and power supply device 132 may include a display 140 to display the temperature of the fluid 108 stored within the bag 102. The hanger and power supply device 132 also may include a temperature controller 142 so as to control the amount of power supplied to the electrical heating element 104 or electrically conductive strip 124 so as to increase or decrease the amount of heat supplied to the fluid 108 stored in the bag 102.
11. The flexible heater of claim 10, wherein the control circuit particularly controls an amount of heat delivered by the heating elements.
In an embodiment, a device for warming of a physiological fluid before introduction into a patient may be provided. The device may include a flexible substrate conformable to the shape of the fluid bag, or fluid containing products; a thermal conductive ink printed on at least one side of the flexible substrate; a power source connected to the conductive ink, wherein power supplied causes the conductive ink to radiate heat; and a temperature controller coupled to the power source and the conductive ink, the temperature controller is adapted to control the voltage delivered to the conductive ink.
15. The flexible heater of claim 11, further comprising at least one power source connectively associated particularly with the control circuit. The connection of a power source to a control unit is plainly obvious to a skilled artisan and is suggested by Ang. In an embodiment, the power supply may include a DC power supply voltage and/or a battery which is chargeable for portability. The temperature sensor may be able to measure temperature range between about 0.degree. C. to about 80.degree. C. The solid state relay may include a relay with a control voltage between about 3 VDC to about 32 VDC and a load voltage of about 3 VDC to about 36 VDC. The current is about 3 A.
[0104] In an embodiment, the battery may include a voltage rating of between 12 V to 15 V. The battery may provide a current of about 2 A to about 3 A, a power of about 30 watts and 2.3 Ah.
16. The flexible heater of claim 15, wherein the power source comprises one of a rechargeable battery and a power outlet plug.
In an embodiment, the power supply may include a DC power supply voltage and/or a battery which is chargeable for portability. The temperature sensor may be able to measure temperature range between about 0.degree. C. to about 80.degree. C. The solid state relay may include a relay with a control voltage between about 3 VDC to about 32 VDC and a load voltage of about 3 VDC to about 36 VDC. The current is about 3 A.
[0104] In an embodiment, the battery may include a voltage rating of between 12 V to 15 V. The battery may provide a current of about 2 A to about 3 A, a power of about 30 watts and 2.3 Ah.
17. The flexible heater of claim 11, wherein the attachable cartridge comprises repeatedly removable connections. See figures 13a, 13b showing cartridge 132 having a removable connection clip engaging with the hanger 176.
18. The flexible heater of claim 17, wherein the removable connections comprise at least one of clips, snaps, latches and Velcro. See figures 13a, 13b showing cartridge 132 having a removable connection clip engaging with the hanger 176.
19. The flexible heater of claim 1, wherein the dielectric layer insulates ones of the plurality of heating elements from shorting onto one another due to the conformability of the conformable substrate. Note Fig. 3b and 6b suggesting that the dielectric substrate insulates one of the plurality of heating elements from shorting onto one another due to the conformability of the conformable substrate.
20. The flexible heater of claim 1, wherein the dielectric layer insulates heat produced by the heating elements to avoid localized overheating. Note the dielectric layer is noted as a thermal insulating layer as well therefore the dielectric layer insulates heat produced by the heating elements to avoid localized overheating.
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.
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.
The Supreme Court in KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper “functional approach” to the determination of obviousness as laid down in Graham. The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit.
EXEMPLARY RATIONALES
Exemplary rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Claim(s) 12-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ang et al. (US 2012/0063973A1) in view of Scarpaci et al (US2013/0165847).
Ang discloses the claimed invention as discussed above except in reference to claim:
12. The flexible heater of claim 11, wherein the control circuit comprises a wireless receiver.
13. The flexible heater of claim 12, wherein the wireless receiver comprises at least one of a Bluetooth, WiFi, NFC, cellular and RF receiver.
14. The flexible heater of claim 13, wherein a wirelessly linked remote portion of the control circuit comprises a mobile device app.
Scarparci et al discloses a wireless receiver such as Bluetooth, wifi, nfc, cellular, RF receiver, and wirelessly linked remote portion is a mobile device app (para. 0472-0473). It would have been obvious to one of ordinary skill before the effective filing date of the invention to have included a wireless receiver such as Bluetooth, wifi, nfc, cellular, RF receiver, and wirelessly linked remote portion is a mobile device app as disclosed by Scarpaci et al in the heater of Ang et al because, a wireless receiver such as Bluetooth, wifi, nfc, cellular, RF receiver, and wirelessly linked remote portion is a mobile device app allows heater to be more portable.
Claim(s) 4, 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ang et al. (US 2012/0063973A1).
Ang discloses the claimed invention except specifically in reference to claim:
4. The flexible heater of claim 3, wherein the substrate comprises a thickness in the range of 6 mm and 10 mm.
Ang discloses a flexible substrate for use in a blood bag as is claimed, since a change in size or thickness of a component is generally considered within the ordinary skill of the artisan, a skilled artisan would have found such a modification of the Ang device to be obvious
6. The flexible heater of claim 1, wherein the printed inks in the ink set comprise at least one positive temperature coefficient ink.
It is generally known in the art of electrical heating to provide printed ink heaters having a positive temperature coefficient, as previously evidenced by Lazanja. Lazanja discloses preferably, the second electrically functional layer may be made of PTC ink, for example, DuPont 7282 family of inks.
Claim(s) 21-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ang et al. (US 2012/0063973A1).
Ang discloses the claimed invention except specifically in reference to claim:
21. (New) The flexible heater of claim 1, wherein the first and second flexible heaters are connected in series. It is noted that the electrical connection of multiple heating elements either in series or in parallel is well known in the art and the artisan having routine creativity and common sense would find it obvious to connect the heating elements in series or in parallel depending on the well known and predictable performance based on such a connection.
22. (New) The flexible heater of claim 1, wherein the first and second flexible heaters are connected in parallel. It is noted that the electrical connection of multiple heating elements either in series or in parallel is well known in the art and the artisan having routine creativity and common sense would find it obvious to connect the heating elements in series or in parallel depending on the well known and predictable performance based on such a connection.
23. (New) The flexible heater of claim 1, wherein each ink of the plurality of inks is matched to preclude detrimental interactions between the printed inks of each of the at least one conductive, resistive and dielectric layers, and to preclude detrimental interactions with the at least one conformable substrate, based on one or more of a compatibility of the substrate and printed inks, a compatibility between the printed inks, receptivity of the substrate, a surface energy of the substrate, compositions of the inks employed, conductivity of the printed inks, fineness of the printed traces used, pitch of the printed traces used, density of the printed inks, consistency of the printed inks, a type of printing performed, thickness of the printed layers.
Note that the ordinary artisan when contemplating combinations and modifications would find it obvious to ensure that that the materials used for the substrate, inks and other components are matched so as to preclude detrimental interactions therebetween. Given the industry focus on safety and reliability in the medical field one of skill in the art would seek to preclude detrimental interactions between materials used in the production of the device of Ang.
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.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,633,549 in view of Ang et al. (US 2012/0063973A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are merely broader in scope by not requiring “a cartridge physically and electrically associated with the at least one conductive layer” and further that the at least one substrate and associated structure is two substrate structures. Note that it would have been obvious to modify the 11,633,549 patent in view of Ang to provide the double substrate structure as claimed.
US 11633549 recites claim:
1. A flexible heater formed on at least one conformable substrate of a medical fluid bag, comprising: a matched function ink set, printed onto at least one substantially planar face of the at least one substrate to form at least: at least one conductive layer capable of receiving current flow from at least one power source, having a cartridge physically and electrically associated with the at least one conductive layer; at least one resistive layer electrically associated with the at least one conductive layer and comprising a plurality of heating elements capable of generating heat upon receipt of the current flow; and at least one dielectric layer capable of at least partially insulating the at least one resistive layer; wherein the matched ink set is matched to preclude detrimental interactions between the printed inks of each of the at least one conductive, resistive and dielectric layers, and to preclude detrimental interactions with the at least one conformable substrate.
Instant claim 1 recites:
1. A flexible heater, comprising: a conformable substrate forming one side of a fluid bag; a set of inks printed onto a substantially planar face of the at least one substrate to form: at least one conductive layer capable of conducting current flow from at least one power source, and communicative with a control circuit; at least one resistive layer electrically associated with the at least one conductive layer and comprising a plurality of heating elements capable of generating heat upon receipt of the current flow; and at least one dielectric layer capable of at least partially insulating the at least one resistive layer; wherein each ink in the set of inks is matched to preclude detrimental interactions between the printed inks of each of the at least one conductive, resistive and dielectric layers, and to preclude detrimental interactions with the at least one conformable substrate.
Instant claims 2-6, 9-20 track with claims 2-20 of 11633549.
Response to Arguments
Applicant's arguments filed 04/01/2026 have been fully considered but they are not persuasive. Applicant’s arguments with respect to the pending claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 THOR S CAMPBELL whose telephone number is (571)272-4776. The examiner can normally be reached M,W-F 6:30-10:30, 12-4.
Examiner interviews are available via telephone, in-person, 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.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ibrahime Abraham can be reached at 5712705569. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THOR S CAMPBELL/
Primary Examiner
Art Unit 3761
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