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 .
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 04/11/2025 is/are acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner. See attached copy of PTO-1449.
Response to Restriction
Applicants' election without traverse of Group I (claims 1-13) and has further withdrawn claims 14-20 in the reply filed on 04/06/2026 is acknowledged.
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 non-obviousness.
Claims 1-2 and 4-13 are rejected under 35 U.S.C. 103 as being unpatentable over Baker et al. (Baker et al. Physiological mechanisms determining eccrine sweat composition. European Journal of Applied Physiology (2020) 120:719–752) in view of Quinton (Quinton, Effects of Some Ion Transport Inhibitors on Secretion and Reabsorption in Intact and Perfused Single Human Sweat Glands. Pfugers Arch, 391:309- 313. 1981).
Claims 1 and 12-13,
Baker et al. teach the major sweat electrolytes (sodium, chloride, and potassium), other micronutrients (e.g., calcium, magnesium, iron, copper, zinc, vitamins), metabolites (e.g., glucose, lactate, ammonia, urea, bicarbonate, amino acids, ethanol), and other compounds (e.g., cytokines and cortisol). Ion membrane transport mechanisms for sodium and chloride are well established, that include secretion and/or reabsorption for most other sweat solutes. Final sweat composition is influenced by extracellular solute concentrations, and also mechanisms of secretion and/or reabsorption, sweat flow rate, byproducts of sweat gland metabolism, skin surface contamination, and sebum secretions, among other factors related to methodology. (Abs). Taken together, the ions Na+ and Cl− of final sweat are determined primarily by the rate of ion reabsorption in the duct relative to the rate of ion secretion in the clear cells of the secretory coil. (pg. 729, left col., 2nd par.). Baker et al. do not teach inhibiting a rate of ion reabsorption of a sweat duct.
Quinton teaches each sweat gland is composed of only one secretory unit and one reabsorptive duct. (pg. 309, left col., 2nd last par.). Amiloride blocked Na reabsorption in the sweat duct. (Abs).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to use inhibitors like Amiloride to block sodium reabsorption in the sweat duct, taught by Quinton, since the ions Na+ and Cl− of final sweat are determined primarily by the rate of ion reabsorption in the duct relative to the rate of ion secretion in the clear cells of the secretory coil, taught by Baker et al., so inhibiting sodium reabsorption in the sweat duct would enhance a rate of sodium excretion through a surface of skin in a subject.
With regard to claim 2,
Quinton teaches amiloride was used to inhibit Na uptake by blocking the Na entry channel. Pg. 309, right col., 1st par.).
With regard to claims 4-7
Baker et al. teach upon stimulation clear cells of the secretory coil secrete primary sweat. Briefly, secretion of sweat by the clear cells occurs primarily in response to increases in body temperature, which is sensed by central and skin thermoreceptors. In turn, this information is processed by the preoptic area of the hypothalamus to initiate the sudomotor response-mediated
predominately by sympathetic cholinergic stimulation and to a lesser extent (~ 10%) by adrenergic stimulation. Eccrine glands also secrete sweat in response to non-thermal stimuli (separate from changes in skin or body temperature) associated with exercise, such
as central command, muscle metabo-/mechanoreceptors, osmoreceptors, and possibly baroreceptors. (pg. 721, left col., 2nd par.). Heat acclimation results in a significant
enhancement in the rate of sweat secretion by eccrine glands. (pg. 738, left col., last par.).
Sweat secretion is stimulated: by passive and active methods. Passive sweating occurs while the participant is at rest and can be induced by pharmacological manipulation or by increasing
the temperature of the surrounding air (e.g., dry heat or sauna bathing). Active sweating refers to exercise-induced sweat secretion. Pharmacologically induced sweating involves the use of a small electrical current (iontophoresis) to propel charged cholinergic agonists (e.g., pilocarpine or methacholine) transdermally to stimulate the muscarinic receptors on the sweat glands, (pg. 736, right col., last par.). The percentage of secreted Na+ that was reabsorbed in the duct decreased with a rise in sweating rate. (pg. 729, right col., 1st par.). The precursor fluid to primary sweat is the water and dissolved solutes in the interstitial fluid space. Water and solutes can cross the lipid bilayer membrane of clear cells and into the lumen of the secretory coil: (pg. 726, right col., last par.). They produce copious salt-water secretions which empty directly onto the skin surface. (pg. 721, right col., 1st par.).
With regard to claims 8-9,
Baker et al. teach final sweat composition is not only influenced by extracellular solute concentrations, but also mechanisms of secretion and/or reabsorption, sweat flow rate, byproducts of sweat gland metabolism, skin surface contamination from desquamated epidermal cells, and sebum secretions, among other factors. Some solutes are relatively dilute in sweat because of reabsorption in the duct (Na+, Cl−, bicarbonate), others because of limitations in transport across/between cells of the eccrine gland (glucose, cytokines, cortisol). (pg. 742, Conclusions). Much like Na+ and Cl−, bicarbonate reabsorption is inversely
related to sweating rate. Thus, lower sweat flow rates are associated with a lower bicarbonate concentration and lower pH of final sweat. It seems most likely that sweat pH is an artifact of a reabsorptive duct function. (pg. 734, left col., 2nd last par.). In the opposite thus, higher sweat flow rates are associated with a higher bicarbonate concentration and higher pH of final sweat. It would have been obvious to one of ordinary skill in the art to have negative ions like bicarbonate on the skin surface, to have bicarbonate absorbed by the sweat duct, to have a higher bicarbonate concentration and higher pH, and have higher sweat flow rate.
With regard to claim 10,
Baker et al. teach glucose flux in sweat has been shown to change with the modulation of tight junctions in the sweat gland epithelium Using citrate, a calcium chelator, Jajack et al. (2018) were able to modify paracellular pathways and found a > 10-fold increase in sweat glucose flux. (pg. 731, right col., 1st par.). Since a calcium chelator is available to move glucose, so it would have been obvious to one of ordinary skill in the art to have a chelator on the skin surface, to attract other ions, to increase excretion and so does Na+ from the sweat duct, toward the surface of the skin for excretion.
With regard to claim 11,
Baker et al. teach a bicarbonate/Cl− exchanger termed pendrin (SLC26a4) in isolated secretory cells of murine footpad sweat glands. This anion protein may play a role in bicarbonate secretion. (pg. 734, left col., 1st par.). Paracellular movement of solutes against concentration gradients can also occur with the help of ion transporters (e.g., Na+– K+- ATPase) via active or energy-requiring processes (Yang and Hinner 2015). Larger polar molecules and charged
ions or molecules move paracellularly during the process of sweat secretion (Heikenfeld et al. 2019). Pg. 727, left col., 1st par.) that these larger polar molecules can be polyanions.
Quinton teaches Some Ion Transport Inhibitors on Secretion and Reabsorption in Intact and Perfused Single Human Sweat Glands. (Title). Amiloride was used to inhibit Na uptake by blocking the Na entry channel, and furosemide was used as a potential inhibitor of anion transport. (pg. 1981, right col., 1st par.). It would have been obvious to one of ordinary skill in the art to administer a polyanion down a channel of a sweat duck to facilitate the sodium excretion.
Claims 1 and 3 are rejected under 35 U.S.C. 102(a)(1) as being unpatentable over Baker et al. (Baker et al. Physiological mechanisms determining eccrine sweat composition. European Journal of Applied Physiology (2020) 120:719–752) in view of Quinton (Quinton, Effects of Some Ion Transport Inhibitors on Secretion and Reabsorption in Intact and Perfused Single Human Sweat Glands. Pfugers Arch, 391:309- 313. 1981), further in view of Heran et al. (Heran et al., Blood pressure lowering e icacy of potassium-sparing diuretics (that block the epithelial sodium channel) for primary hypertension (Review). Cochrane Database of Systematic Reviews 2012, Issue 11. Art. No.: CD008167).
Claim 3,
The teachings of Baker et al. and Quinton are described in claim 1 above.
Baker et al. and Quinton do not teach blocking the ion channel involves administering a potassium sparing diuretic to the subject.
Heran et al. teach potassium-sparing diuretics, which block the epithelial sodium channel (ENaC). (Abs, pg. 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to use inhibitors like Amiloride to block sodium reabsorption in the sweat duct, taught by Quinton, since the ions Na+ and Cl− of final sweat are determined primarily by the rate of ion reabsorption in the duct relative to the rate of ion secretion in the clear cells of the secretory coil, taught by Baker et al., and to block ion channel by potassium sparing diuretic, taught by Heran et al., so inhibiting sodium reabsorption in the sweat duct would enhance a rate of sodium excretion through a surface of skin in a subject.
Conclusion
No claim is allowed.
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/NGOC-ANH THI NGUYEN/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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