DETAILED ACTION
Claim Objections
Claims 9 and 16 are objected to because of the following informalities: there appears to be a grammatical error on the second line. Appropriate correction is required.
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.
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.
Claim(s) 1-4, 7, 8, 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over West (US 5172683 A) in view of St. Etienne (US 20100126492 A1) and Yang (CN 102302364 A).
Regarding claim 1, West discloses a stethoscope warming system comprising:
a warmer (Fig. 3, 36) having an exothermic warming composition (col. 4, lines 50-56);
at least one stethoscope (Fig. 3, 14) configured to attach to a patient's body to detect signals, wherein the at least one stethoscope is thermally connected to the warmer (see “Field of the Invention”);
an insert (Fig. 2, 28) positioned between the at least one stethoscope and the warmer, wherein the at least one stethoscope is removably connected to the insert; and
a barrier (Fig. 3, 33) configured to separate the exothermic warming composition from a reactant composition, wherein the barrier is breakable by a user to allow the reactant composition to contact the exothermic warming composition and wherein contact between the reactant composition and the exothermic warming composition causes the exothermic warming composition to release heat (col. 4, lines 50-56).
West fails to disclose:
where the warmer is bonded to the insert with an adhesive, and
where the stethoscope is an ECG electrode.
West discloses that the warmer (36) may be integrally connected to the pouch (20) (col. 5, lines 19-25), but does not state how it is integrally connected to the pouch. St. Etienne teaches a warmer having an exothermic warming composition, wherein the warmer has an adhesive that is configured to integrally connect the warmer to a baby bottle (abstract).
It would have been obvious to a person skilled in the art at the time of effective filing of the application to modify West where the warmer (West, 36) is bonded to the insert (West, 28) of the pouch (West, 20) with an adhesive, since this provides a means for integrally connecting the warmer with the pouch. Moreover, it would have been obvious to apply the adhesive between the insert and the warmer, rather than between the warmer and the casing (West, 26) of the pouch, because it would provide good thermal conductive contact between the warmer and the insert, resulting in more efficient heat transfer to the stethoscope.
Yang teaches an ECG electrode warmer (para. 3); however, the drawback of this design is that it is bulky (Fig. 3). It would have been obvious to a person skilled in the art at the time of effective filing of the application to take the concept of using a compact chemical warming system for warming a medical instrument, as taught by West, and apply it to other medical instruments that would benefit from being warmed before use. Yang teaches an ECG electrode warmer but the design is bulky and not easily transportable; therefore, it would be an advantage to warm the ECG electrode using the slim and portable warming system of West.
Regarding claim 2, modified West discloses the ECG electrode warming system of claim 1, except wherein the warmer is configured to warm the at least one ECG electrode to at least a selected temperature within five minutes and maintain the at least one ECG electrode at or above the selected temperature for at least 45 minutes.
However, this limitation is a matter of optimization. A short time to reach the selected temperature is important so that the ECG electrode can be warmed on demand. It would be inconvenient for the doctor and patient if they have to wait for the electrode to heat up. Furthermore, maintaining the temperature of the electrode is important so that there is sufficient time for the electrode to be warm during use.
Regarding claim 3, modified West discloses the ECG electrode warming system of claim 2, except wherein the selected temperature is 120 degrees Fahrenheit. However, this limitation is a matter of optimization. The optimal temperature is one where the electrode is warm and comfortable on the patient, but not too hot.
Regarding claim 4, modified West discloses the ECG electrode warming system of claim 1, except wherein the exothermic warming composition is packaged within a fabric with a weight of at least 50 grams per square meter. However, this limitation is a matter of optimization. The optimal weight is one where the system is strong and durable, but not too heavy.
Regarding claim 7, modified West discloses the ECG electrode warming system of claim 5, wherein the warmer is bonded to the insert (see St. Etienne and the rejection of claim 1).
Regarding claim 8, modified West discloses the ECG electrode warming system of claim 7, wherein the warmer is bonded to the insert with an adhesive (see St. Etienne and the rejection of claim 1).
Regarding claim 18, modified West discloses the ECG electrode warming system of claim 13, further comprising an insert positioned between the at least one ECG electrode and the warmer, wherein the at least one ECG electrode is removably connected to the insert and the warmer is bonded to the insert (see rejection of claim 1).
Claim(s) 5, 6, 9-17, 19, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over West (US 5172683 A) in view of Yang (CN 102302364 A).
Regarding claim 5, West in view of Yang discloses (see rejection of claim 1 for citations) an electrocardiogram (ECG) electrode warming system comprising:
a warmer having an exothermic warming composition;
at least one ECG electrode configured to attach to a patient's body to detect electric signals, wherein the at least one ECG electrode is thermally connected to the warmer; and
a barrier configured to separate the exothermic warming composition from a reactant composition, wherein the barrier is breakable by a user to allow the reactant composition to contact the exothermic warming composition and wherein contact between the reactant composition and the exothermic warming composition causes the exothermic warming composition to release heat.
Regarding claim 6, modified West discloses the ECG electrode warming system of claim 5, further comprising an insert positioned between the at least one ECG electrode and the warmer, wherein the at least one ECG electrode is removably connected to the insert (see rejection of claim 1).
Regarding claim 9, modified West discloses the ECG electrode warming system of claim 5, wherein the barrier is an envelope configured to encase the warmer and the reactant composition is ambient air (West, Fig. 3). Note: the bolded phrase appears to be a grammatical mistake. The bolded phrase is examined to mean “the reactant composition from ambient air”.
Regarding claim 10, modified West discloses the ECG electrode warming system of claim 5, except wherein the warmer is configured to warm the at least one ECG electrode to at least a selected temperature within five minutes and maintain the at least one ECG electrode at or above the selected temperature for at least 45 minutes.
However, this limitation is a matter of optimization. A short time to reach the selected temperature is important so that the ECG electrode can be warmed on demand. It would be inconvenient for the doctor and patient if they have to wait for the electrode to heat up. Furthermore, maintaining the temperature of the electrode is important so that there is sufficient time for the electrode to be warm during use.
Regarding claim 11, modified West discloses the ECG electrode warming system of claim 10, except wherein the selected temperature is 120 degrees Fahrenheit. However, this limitation is a matter of optimization. The optimal temperature is one where the electrode is warm and comfortable on the patient, but not too hot.
Regarding claim 12, modified West discloses the ECG electrode warming system of claim 5, except wherein the exothermic warming composition is packaged within a fabric with a weight of at least 50 grams per square meter. However, this limitation is a matter of optimization. The optimal weight is one where the system is strong and durable, but not too heavy.
Regarding claim 13, West in view of Yang discloses (see rejection of claim 1 for citations) an electrocardiogram (ECG) electrode warming system comprising: a warmer having an exothermic warming composition; and at least one ECG electrode configured to attach to a patient's body to detect electric signals, wherein the at least one ECG electrode is removably and thermally connected to the warmer.
Regarding claim 14, modified West discloses the ECG electrode warming system of claim 13, wherein the exothermic warming composition is air-activated (col. 4, line 7 of West cites Yasuki, US Pat. 4,649,895, as a suitable composition, and this composition is air-activated, as stated in col. 1, lines 32-33 of Yasuki).
Regarding claim 15, modified West discloses the ECG electrode warming system of claim 13, further comprising a barrier configured to separate the exothermic warming composition from a reactant composition, wherein the barrier is breakable by a user to allow the reactant composition to contact the exothermic warming composition (see rejection of claim 1).
Regarding claim 16, modified West discloses the ECG electrode warming system of claim 15, wherein the barrier is an envelope configured to encase the warmer and the reactant composition is ambient air (see rejection of claim 9).
Regarding claim 17, modified West discloses the ECG electrode warming system of claim 13, wherein contact between a reactant composition and the exothermic warming composition causes the exothermic warming composition to release heat (see rejection of claim 1)
Regarding claim 19, modified West discloses the ECG electrode warming system of claim 13, wherein the warmer is configured to warm the at least one ECG electrode to at least a selected temperature within five minutes.
However, this limitation is a matter of optimization. A short time to reach the selected temperature is important so that the ECG electrode can be warmed on demand. It would be inconvenient for the doctor and patient if they have to wait for the electrode to heat up.
Regarding claim 20, modified West discloses the ECG electrode warming system of claim 13, wherein the warmer is configured to maintain the at least one ECG electrode at or above a selected temperature for at least 45 minutes.
However, this limitation is a matter of optimization. It is important to maintain the temperature of the electrode so that there is sufficient time for the electrode to be warm during use.
Conclusion
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/JASON LAU/Primary Examiner, Art Unit 3762