DETAILED ACTION
This action is responsive to the amendment filed 7/8/25.
Claims 1-9 are finally rejected.
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.
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 § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 5-7 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
In the instant case, claim 1 had been amended to include the limitations of claims 5-7, therefore, these claims fail to further limit the independent claim. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 negatived by the manner in which the invention was made.
Claim 1 and 4-9 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kulstad et al. (US 20100217361, “Kulstad”) in view of Pearce et al. "Perioperative Hypothermia in the pediatric Population: Prevalence, Risk Factors and Outcomes".
Regarding claim 1, Kulstad teaches a method for maintaining normothermia in a subject (Pars. 10-13, 46, 60, 185, 315) in a surgical suite with an ambient temperature of about 23˚C, or less, (Par. 184, ‘To further simulate the hypothermia inducing conditions of the operating room, the swine was left exposed to the ambient temperature of the room (22˚C.)’), comprising: performing anesthesia on the subject in the surgical suite (Par. 184, ‘To further simulate the hypothermia inducing conditions of the operating room, the swine was […] continuously anesthetized with inhalational anesthesia ’); orally or nasally inserting an esophageal heat transfer device into the subject (Par. 46, ‘inserting the distal end of the heat transfer device nasally or orally’), the esophageal heat transfer device including a heat transfer region (Par. 47, ‘a heat transfer region configured for contacting esophageal epithelium of a patient’) and a gastric access tube (Par. 47, ‘The heat transfer device can also comprise a hollow tube having a distal end configured to extend into the patient's stomach’); positioning the heat transfer device such that at least a portion of the heat transfer region is in an esophagus of the subject and a distal end of the gastric access tube is in a stomach of the subject (Par. 47, ‘(b) a heat transfer region configured for contacting esophageal epithelium of a patient […] The heat transfer device can also comprise a hollow tube having a distal end configured to extend into the patient's stomach’); suctioning contents of the stomach of the subject via the gastric access tube of the heat transfer device (Par. 105, ‘The gastric tube 228 may allow the patient's health care provider to insert, for example, a nasogastric tube that allows for suctioning of the gastric contents.’); contacting the heat transfer region with esophageal tissue of the esophagus of the subject (Par. 47, ‘a heat transfer region configured for contacting esophageal epithelium of a patient’); causing fluid to flow through a fluid path defined by one or more lumens of the heat transfer device (Pars. 94, 102, ‘In operation, the coolant enters the input port 208 and flows through the lumen of the coolant supply tube 224 to the distal end 202 of the heat transfer device 200, which may be positioned in, for example, the esophagus of a patient. The coolant then flows through the lumen of the coolant return tube 226 to the output port 210.’; par. 36, ‘initiating flow of a heat transfer medium along the fluid path; and circulating the medium along the fluid path for a time sufficient to control core body temperature in a subject’); and transferring heat between the esophageal heat transfer device and the esophageal tissue via the heat transfer region (Par. 62, ‘Certain embodiments of the present technology provide for controlling patient temperature through esophageal warming or cooling’) to facilitate normothermia of the subject (Par. 60, ‘The present technology provides devices and methods for treating patients suffering from various diseases and disorders by […] maintaining normothermia (target temperature: about 37˚ C.).’).
Kulstad fails to explicitly teach that the subject is a pediatric subject, wherein the pediatric subject is less than about 26 kg.
Pearce provides an observational cohort study which tracks perioperative hypothermia in pediatric subjects undergoing general anesthesia (Abstract) including pediatric subjects less than 26 kg (Table 1, weight: 28.3 kg ± 23). Pearce teaches that infants and neonates have been shown to be at an increased risk for perioperative hypothermia since they have less effective thermoregulatory capacity with greater heat loss due to an increased surface area to body weight ratio and less subcutaneous fat (Introduction, par. 2). Pearce further identified several areas for improvement including improved use of warming techniques on pediatric subjects in a perioperative setting (Discussion, last paragraph).
In view of Pearce, it would have been obvious to POSITA at the time that the invention was made to modify Kulstad by utilizing the disclosed warming techniques on pediatric subjects, including those less than 26 kg, in order to reduce perioperative hypothermia and improve outcomes in these patients, as taught by Pearce.
Regarding claim 4, Kulstad, as modified, teaches wherein, to increase heat transfer between the heat transfer region and the esophageal tissue, the gastric access tube suctions the contents of the stomach to improve contact between the heat transfer region and the esophageal tissue (Par. 105, ‘The gastric tube 228 may allow the patient's health care provider to insert, for example, a nasogastric tube that allows for suctioning of the gastric contents.’).
Kulstad, as modified, fails to teach that the suctioning takes place before the heat transfer region contacts the esophageal tissue.
The examiner maintains, however, that it would have been obvious to POSITA at the time that the invention was made to perform the suctioning step prior to the contact step, since it has been held that selection of any order of performing process steps is prima facie obvious absent of new or unexpected results. In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946).
Regarding claim 5, Kulstad, as modified, further teaches wherein the pediatric subject is less than about 26 kg (Kulstad has previously been modified in view of Pearce to treat pediatric subjects which can include those in this weight range; See Pearce, table 1, weight: 28.3 kg ± 23).
Regarding claim 6, Kulstad, as modified, further teaches wherein the cooling-biased environment includes a surgical suit with an ambient temperature of about 23° C or less (Par. 184).
Regarding claim 7, Kulstad, as modified, further teaches causing fluid to flow through a fluid path define by one or more lumens of the heat transfer device (Par. 36, ‘initiating flow of a heat transfer medium along the fluid path; and circulating the medium along the fluid path for a time sufficient to control core body temperature in a subject’).
Regarding claim 8, Kulstad, as modified, further teaches wherein flowing the fluid through the fluid path enables the transfer of heat between the heat transfer region and esophageal tissue (Par. 36, ‘circulating the medium along the fluid path for a time sufficient to control core body temperature in a subject.’).
Regarding claim 9, Kulstad, as modified, further teaches controlling the fluid flowing through the fluid path via a PID controller to control the transfer of heat between the heat transfer region and esophageal tissue (See Kulstad, Pars. 81-82, ‘The heat transfer fluid circulates in heat exchanger, so the Heat Transfer Fluid PID essentially controls the temperature of the heat transfer fluid. In this way, the control scheme is able to automatically achieve a specified target based on input from sensors placed on the patient and the logic built into the controller.’).
Claim 2 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kulstad in view of Pearce, as applied to claim 1 and 4-9 above, and further in view of Kordis et al. (US 20020077665, “Kordis”).
Regarding claim 2, Kulstad, as modified, fails to teach covering the pediatric subject with a blanket to further facilitate normothermia of the pediatric subject.
Kordis teaches that often times external body heating approaches such as blankets are combined with internal body heating approaches in order to shorten the time needed to bring a patient to normothermia (Par. 9).
In view of Kordis, it would have been obvious to POSITA to combine the esophageal body warming means with an external body warming means in order to shorten the time needed to bring a patient to normothermia, as taught by Kordis.
Claim 3 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kulstad in view of Pearce and Kordis, as applied to claim 2 above, and further in view of Ellis et al. (US 20020019654, “Ellis”).
Regarding claim 3, Kulstad, as modified, teaches assisting in the maintenance of normothermia by using an external heating blanket (See Kordis, par. 9), but fails to teach pre-warming the blanket prior to covering the pediatric subject with the blanket to further facilitate normothermia of the pediatric subject.
However, Ellis teaches that pre-warming a heating blanket is a conventional method of preventing intraoperative temperature decline in surgical patients (Par. 5).
In view of Ellis, it would have been obvious to POSITA at the time that the invention was made to further modify Kulstad by prewarming the external blanket, as taught by Ellis, in order to prevent intraoperative temperature decline in surgical patients, as taught by Ellis.
Response to Arguments
Applicant's arguments filed 7/8/25 have been fully considered but they are not persuasive.
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 the instant case, applicant argues that Kulstad does not recognize the risk of perioperative hypothermia in pediatric patients. However, applicant does not address Pearce, which is relied upon to demonstrate the obviousness of using warming to reduce the risk of perioperative hypothermia in pediatric patients. Therefore, applicant’s argument is unpersuasive since it only addresses Kulstad and not the combination of Kulstad in view of Pearce.
Conclusion
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 ADAM JOSEPH AVIGAN whose telephone number is (571)270-3953. The examiner can normally be reached Monday-Friday 9am-5pm.
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ADAM JOSEPH. AVIGAN
Examiner
Art Unit 3739
/ADAM J AVIGAN/Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794