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 .
Priority
The instant application is a continuation of US application 17/188,359 (now US 11,938,188) filed 1 March 2021 which is a continuation of US application 15/505,042 filed 17 February 2017 which is a national stage entry of PCT/US15/47301 filed 27 August 2015. Acknowledgement is made of the Applicant’s claim of domestic priority to provisional US applications 62/121,329 filed 26 February 2015, 61/121,472 filed 26 February 2015, and 62/042,979 filed 28 August 2014. A review of the priority documents reveals support for a priority date of 26 February 2015. Claims 24-44 are given the priority date of 27 August 2015.
Examiner’s Note
Applicant's amendments and arguments filed 24 March 2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. In the Applicant’s response, filed 24 March 2026, it is noted that claims 24, 27, 31, 33, 37, and 41 have been amended and claim 44 newly added. Support can be found in specification at (pg 46, lns 20-27). No new matter has been added.
Status of the Claims
Claims 24-44 are pending.
Claims 24-44 are rejected.
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.
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 24-44 are rejected under 35 U.S.C. 103 as being unpatentable over Becker et al. (US 2005/0203598) in view of Kasza et al. (US 2007/0056313) as evidenced by Metzger et al. (Neurology Research International, Volume 2021, Article ID 4776610, 13 pages).
Becker teaches using saline slurries in methods of cooling subcutaneous, intravascular, intraperitoneal, gastrointestinal, and lung human tissues [0010]. Becker notes that the location of injection depends on the desired target for cooling [0026]. For example, a slurry of ice particles is delivered through a subcutaneous injection to, for example, cool the brain and the heart, by way of injection into the soft tissue of the neck [0024, 0026] and delivered to the lungs in order to first cool the lungs and secondarily cool the heart nearby [0030]. In one example, the slurry comprises 0.9% saline (sodium chloride) which as a temperature of -0.3 ºC and serves as a freezing point depressant [0055]. In one model, the ice slurry injection is held in contact with the lungs and maintained at 0 ºC for about 28.4 minutes to lower the tissue temperature from 37 º to 25 ºC [0103]. The brain edges can be cooled in about 10 minutes [0095] and other locations of the body from 10-40 minutes (Table 1). The slurry for human use comprises about 50% ice and 50% water [0055]. Table 1 of Becker further shows cooling rates, per minute, for various body tissues (Table 1). Becker specifically teaches that the slurry does not cause tissue damage [0057].
Becker does not teach wherein the ice slurry is left for a period to melt.
Kasza teaches a method of producing ice slurries for medical cooling applications including for targeting organs such as the brain, heart, and lungs (Abstract). Kasza teaches that once fully melted in the body, the slurry resembles medical grade saline that comprises 0.9% salt [0003].
Metzger evidences that myelination is present around parts of the left ventricle nerve bundle fibers (abstract).
It would have been prima facie obvious to inject an ice slurry comprising 0.9% saline (sodium chloride) into or around a human tissue, such as the heart, that comprises myelination (i.e. myelin sheathes) based on the teaches of Becker. In doing so, the skilled artisan is effectively targeting said heart (cardiac) tissue. Becker also renders obvious administration of the slurry to any desired target location and exemplifies administration directly to the lungs or the intraperitoneal cavity. The injection is held at -0.3 ºC and can be kept around the tissue for at least 28.4 minutes to achieve a heat loss of at least 12 ºC. Lipids are present throughout the entire body including in adipose tissue. Since Becker teaches injections can be done subcutaneous, which is directly under the skin and into the fat and muscle tissue, the ice slurry would necessarily be in contact with lipids. Upon holding the ice slurry in place at -0.3 ºC, such as around the heart tissue, the lipids present would necessarily be crystalized, as required in instant claims 24-30.
Regarding claims 31-36 and 44, the ice slurry of Becker can be held in place for a period of time that is exemplified as 28.4 minutes. Kasza teaches that allowing the solution to melt in the body results in medical grade saline, which is harmless to the patient. Becker further teaches that no damage is done to the tissue by the slurry. Thus it would have been obvious to follow the guidance of Becker and treat a body tissue with the ice slurry by holding the slurry in the desired location for a period of time, thus resulting in a reduction of temperature of the target tissue without tissue damage. Lipids in contact with the slurry would necessarily be crystallized by the sub-freezing temperature of the slurry. The ice slurry could then be left in place to melt since Kasza teaches that it would turn into medical-grade saline.
Regarding claims 27, 33, and 40, while Becker does not teach cooling body tissue to 0 ºC or lower, various rates of cooling are taught. As such, the skilled artisan would have been able to calculate the amount of time necessary based on said rates to cool the desired tissue to any value including 0 ºC, since the ice slurry itself is held at -0.3 ºC. That being said and in lieu of objective evidence of unexpected results, the temperature can be viewed as a variable which achieves the recognized result of successfully treating a specific patient. The optimum or workable range of cooling temperature can be accordingly characterized as routine optimization and experimentation (see MPEP 2144.05 (II)B). “[Discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” In re Boesch, 617 F.2d 272, 276 (CCPA 1980). Appellants provide no evidence of any secondary consideration such as unexpected results that would render the optimized level of temperature. Since Becker teaches administration by various means including subcutaneous, it would have been obvious to use the method to cool any tissue under the skin including adipose and organ tissue.
The resulting method of the prior art renders obvious instant claims 24-44.
Response to Arguments
Applicant's arguments filed 24 March 2026 have been fully considered but they are not persuasive. The Applicant argues, on page 8-9 of their remarks, that Becker does not disclose or suggest a method of crystallizing one or more lipids in a target tissue comprising locally administering a cold slurry to the target tissue. Applicant argues that Becker is rather towards indirect cooling of target organs. The Applicant further argues that Becker teaches target zones and that the temperature ranges disclosed in Becker are well above the temperatures taught by the instant application. The Applicant further argues, on pages 11-13 of their remarks, that Becker does not recognize the need for higher resolution and specificity in targeting selected tissues while avoiding harm to non-selected tissues.
In response, Becker teaches using saline slurries in methods of cooling subcutaneous, intravascular, intraperitoneal, gastrointestinal, and lung human tissues. As such, it would have been obvious to inject the slurry into a target tissue, such as intravascular or lung tissue, and cool said tissue with the slurry, which can be considered local adminstration. Becker exemplifies treating lung issue by injecting the ice slurry in contact with the lungs (local to the lungs) and maintaining at 0 ºC for about 28.4 minutes to lower the tissue temperature from 37 º to 25 ºC, thus crystallizing lipids at the lung tissue in which the slurry was injected. Even though the heart tissue is a target for cooling indirectly, the initial cooling target is the lungs to which the slurry is locally administered.
The Applicant argues, on pages 10-11, that neither Kasza nor Metzger disclose crystallizing one or more lipids in a target tissue.
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).
The Applicant argues, on pages 14-15 of their remarks, that a POSA would not have had any reasonable expectation of success to arrive at the claimed invention. The Applicant argues that Becker requires a large volume of slurry over 30 minutes to achieve that the instant claims have achieved in only a few minutes of activetime.
In response, Becker teaches that the brain edges can be cooled in about 10 minutes and other locations of the body from 10-40 minutes. Table 1 of Becker further shows cooling rates, per minute, for various body tissues (Table 1). The instant independent claims are not specific as to the time it takes to achieve target cooling. Therefore, the prior art applies regardless of the time being 10 minutes or 30 minutes.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW S ROSENTHAL whose telephone number is (571)272-6276. The examiner can normally be reached M-F 8-5pm EST.
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/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613
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