DETAILED ACTION
Applicant’s preliminary amendment, filed April 10, 2025, is fully acknowledged by the Examiner. Currently, claims 1-20 are pending and originally filed, with claims 21-51 cancelled. The following is a complete response to the April 10, 2025 communication.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 1-3, 5-14 and 16-18 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Spence et al. (US Pat. Pub. 2014/0222121 A1).
Regarding claim 1, Spence provides for a treatment system for cooling subcutaneous lipid-rich cells in a subject, comprising an applicator configured to be in thermal communication with skin of the subject (20), and a control unit having a cooling state and a heating state (222), the control unit including an applicator circulation circuit including a supply end in fluid communication with the applicator (214) and a return end in fluid communication with the applicator (216), the applicator circulation circuit defining a flow path extending between the supply end and the return end and along which coolant flows to deliver coolant to the applicator (via the flow path defined through 214/216/222), a chiller apparatus configured to chill coolant from the applicator circulation circuit (see figure 20A with the reservoir 342 functioning as in [0099] and having a chiller construction as disclosed, for example, in [0074]), the chiller apparatus is configured to deliver chilled coolant to the applicator circulation circuit to reduce a temperature of coolant in the applicator circulation circuit when the control unit is in the cooling state (via the reservoir capable of providing chilled fluid through the valve 362), and a heater apparatus configured to deliver heated coolant to the applicator circulation circuit to raise the temperature of the coolant in the applicator circulation circuit when the control unit is in the heating state (reservoir 344 with the heater 312).
Regarding claim 2, Spence provides that the chiller apparatus includes a chiller fluidic circuit configured to hold a volume of chilled coolant and deliver chilled coolant to the applicator circulation circuit to reduce the temperature of coolant that is delivered to the applicator by at least about 20°C in less than about 5 minutes (via the reservoir 342 as noted in the rejection of claim 1 above configured to provide a chilled fluid as in at least [0100]).
Regarding claim 3, Spence provides that the chiller apparatus includes a chiller fluidic circuit that receives coolant from the applicator circulation circuit and delivers chilled coolant to the applicator circulation circuit while coolant flows continuously along the flow path of the applicator circulation circuit (the circuit including the reservoir 342 along with the “cold out” and “cold return” paths).
Regarding claim 5, Spence provides that the chiller apparatus includes a chilled reservoir and a cooling device, wherein the chilled reservoir receives coolant from the applicator circulation circuit, and the cooling device removes heat from coolant contained in the chilled reservoir (see the rejection of claim 1 above with the reservoir 342 with a cooling device as in [0074]).
Regarding claim 6, Spence provides that the applicator circulation circuit defines a primary loop (loop between valves 362/364 and to the garment 218), a chiller fluidic circuit of the chiller apparatus defines a first secondary loop (with the “cold out” and “cold return” lines and to the reservoir 342), and a heater fluidic circuit of the heater apparatus defines a second secondary loop (with the “hot out” and “hot return” lines and to the reservoir 344).
Regarding claim 7, Spence provides that the chiller apparatus and the heater apparatus are configured to independently deliver the chilled coolant and heated coolant, respectively, to the applicator circulation circuit (via the ability to independent supply fluid from each of 342 and 344 through the valve 362).
Regarding claims 8 and 9, Spence provides for a passive fluid leveling element that delivers coolant from the applicator circulation circuit to the chiller apparatus (See [0098] providing for an alternative arrangement of the reservoirs with an opening at 308). Spence further provides that the passive fluid leveling element allows coolant to flow from the applicator circulation circuit to the chiller apparatus when a volume of the coolant in the applicator circulation circuit is at or above a limit volume (via the ability for the coolant to pass over the opening at 308)
Regarding claim 10, Spence provides the applicator circulation circuit includes a mixing reservoir, and wherein the passive fluid leveling element includes a spillway that allows coolant to flow from the mixing reservoir to the chiller apparatus (container 300 with the spillway above the wall 300; see also [0098] providing for an alternative arrangement of the reservoirs).
Regarding claim 11, Spence provides that the applicator circulation circuit includes a mixing reservoir (300), wherein the chiller apparatus includes a chilled coolant reservoir (306), and the passive fluid leveling element includes a conduit with one end fluidically coupled to the mixing reservoir and another end fluidically coupled to the chilled coolant reservoir (conduit at 308 coupled between 304 and 306).
Regarding claim 12, Spence provides that the conduit allows a level of chilled coolant in the chilled reservoir to generally equilibrate with a level of coolant in the mixing reservoir (308 would allow fluid to equilibrate between each of 304/306).
Regarding claim 13, Spence provides that the applicator circulation circuit includes a mixing reservoir configured to accept chilled coolant from the chiller apparatus and warm coolant from the applicator (300), a return conduit fluidically coupling an outlet of the applicator to the mixing reservoir (see the conduit from the applicator that connects through valve 364), and a delivery conduit fluidically coupling the mixing reservoir to an inlet of the applicator (see the conduit that connects from 362 to the applicator).
Regarding claim 14, Spence provides for a controller in communication with the chiller apparatus and the heater apparatus (See [0074] providing for the “associated controls” set forth therein to control the flow of fluid as well as the valves and controls as in the embodiment for figure 20A), the controller containing instructions that, when executed, causes the controller to:
command the chiller apparatus to deliver the chilled coolant to the applicator circulation circuit to lower a temperature of the coolant delivered to the applicator (in view of the embodiment in figure 20A with the control of the valve 362 to provide for chilled fluid to the applicator), and
command the heater apparatus to deliver the heated coolant to the applicator circulation circuit to raise a temperature of the coolant delivered to the applicator (via the control of the valve 364 to provide for heated fluid to the applicator).
Regarding claim 16, Spence provides that the applicator has a heat exchanger element configured to transfer heat from the subcutaneous lipid-rich cells of the subject to coolant in the applicator to affect the subcutaneous lipid-rich cells (see, for example, the structure as in figures 8A and B for exchanging heat).
Regarding claim 17, Spence provides for a temperature monitoring device (See [0160] and [0161]) and a controller communicatively coupled to the temperature monitoring device, the controller containing instructions for commanding the chiller apparatus to deliver chilled coolant the applicator circulation circuit based, at least in part, on one or more signals from the temperature monitoring device (in view of the automated design as in [0160]-[0169] to provide for the delivery of chilled fluid in response to sensor feedback).
Regarding claim 18, Spence provides for a temperature monitoring device (See [0160] and [0161]) and a controller communicatively coupled to the temperature monitoring device, the controller contains containing instructions for commanding the heater apparatus to deliver heated coolant into the applicator circulation circuit based, at least in part, on one or more signals from the temperature monitoring device (in view of the automated design as in [0160]-[0169] to provide for the delivery of heated fluid in response to sensor feedback).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claim 15 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Spence et al. (US Pat. Pub. 2014/0222121 A1).
Regarding claim 15, Spence provides for an embodiment that includes a cold pump with the chiller apparatus wherein the cold pump operative to direct the chilled coolant into the applicator circulation circuit (see figure 19A with the pump at 220), and also provides for a warm pump with the heater apparatus wherein the warm pump is operative to direct the heated coolant into the applicator circulation circuit (see figure 19B with the pump at 220). Spence also provides for a single embodiment where the system includes two pumps to provide desired fluid flow to the system (See figure 20D with pumps 220 and 220a). Spence fails, however, to provide for a single embodiment that has a cold pump and a warm pump as required by the claim. However, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of the invention was made to have utilized a cold pump for directing chilled coolant into the applicator circulation circuit as well as a warm pump for directed the heated coolant into the applicator circulation circuit as required by claim 15. Specifically, Spence already contemplates the use of a pump for individually providing both cooled and warmed fluid to the applicator circuit (as in figures 19A and 19B, respectively), further contemplates the interchangeability of reservoirs, lines, valves and pumps to provide for desired fluid flow within the system, and contemplates for the inclusion of more than one pump in a desired system (see figure 20D). Therefore, it is the Examiner’s position that it would have been an obvious consideration to one of ordinary skill to have utilize a cold pump and warm pump to provide for the requisite chilled and warmed fluid flow through the system to provide for a desired amount of each fluid to the applicator circuit. This, in combination with the disclosed control and fluid mixing would provide for the controlled delivery along with the valving of a desired temperature of fluid during use of the device.
Claims 4 and 20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Spence et al. (US Pat. Pub. 2014/0222121 A1) as applied to claim 1 above, and further in view of Levinson (US Pat. Pub. 2008/0077202 A1).
Regarding claims 4 and 20, while Spence provides that the chiller apparatus is configured to deliver the chilled coolant to the applicator circulation circuit to reduce the temperature of the coolant in the applicator circulation circuit from room temperature to a lower temperature, Spence only provides that the temperature is about 2°C. Thus, Spence fails to provide that the lower temperature less than about 0°C while the chilled coolant in the chiller apparatus is maintained at a temperature less than about 0°C as in claim 4, or that the control unit is configured to deliver the coolant at a temperature lower than the subject's skin temperature when the subject's skin temperature is equal to or lower than about -5°C as in claim 20.
Levinson discloses a similar device as that of Spence, and specifically provides for the delivering of a coolant with a temperature of less than 0°C and -5°C (see [0059]). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time the invention was made to have utilized a fluid temperature level as in Levinson for the cooling fluid temperature control of Spence. Such would allow for the system to deliver lower temperature chilled fluids to the applicator circuit thereby allowing for a wider range of treatment temperatures by the system.
Claim 19 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Spence et al. (US Pat. Pub. 2014/0222121 A1) as applied to claim 1 above, and further in view of Augustine et al. (US Pat. No. 5,807,332).
Regarding claim 19, while Spence provides for the heater apparatus, Spence fails to specifically contemplate that such includes a heat exchanger that heats coolant from the applicator circulation circuit by extracting heat from air. Augustine contemplates an exemplary manner of heating a fluid utilizing a heat exchanger that heats coolant via extracting heat from air (See figures 1, 2 and 6 with the fluid heater functioning to heat fluid via hot air blowing over the fluid line).
Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized an air-based heated as in Augustine as at least a portion of the heating apparatus of Spence to provide for an exemplary manner of heating a fluid in the art. Augustine readily provides that such a heater arrangement is sufficient to provide for warming a fluid to be supplied to a patient (or to a cooling/warming applicator as in col. 13; 14-28).
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 1-29 of U.S. Patent No. 9,844,460 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding instant independent claim 1, it is clear that all the elements of instant claim 1 are to be found in one of patented claims 1, 22 and 28. The difference between the instant claim and each of the patented claims lie in the fact that each patented claim includes many more elements and is thus much more specific. Thus the invention of set forth in each of the patented claims is in effect a “species” of the “generic” invention of instant claim 1. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since instant claim 1 is anticipated by each of the listed patented claims, it is not patentably distinct from any of the listed patented claims.
With respect to instant dependent claims 2-20, the various features set forth therein can readily be found in one or more of the patented claims 1-29.
Conclusion
The instant application is a continuation of applicant's earlier Application No. 17/843,898. All claims are identical to, patentably indistinct from, or have unity of invention with the invention claimed in the earlier application (that is, restriction (including lack of unity) would not be proper) and could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the earlier application. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action in this case. See MPEP § 706.07(b). 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 RONALD HUPCZEY, JR whose telephone number is (571)270-5534. The examiner can normally be reached Monday - Friday; 8 am - 4 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at (571) 272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794
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