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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 9 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 9 recites the limitation " heating wires" in line 3. There is insufficient antecedent basis for this limitation in the claim.
NOTE: Claim 9 depends from claim 4, which does not disclose “heating wires” but does disclose the “pocket for holding the power supply”. However, claim 7 does disclose “the heating wires” but does not disclose a “pocket for holding the power supply”. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3 and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kirkland (US 20020077689 A1).
As to claim 1, Kirkland discloses a base garment (suit; Figures 1-3; Abstract) with inner pockets positioned, sized, and made of material suitable to hold TENS unit electrodes (Abstract) in place while in use for pain relief ([0006-0008]); a power supply (TENS Unit; [0008-0009, 0019, 0021]; Figures 1-2), and conductive wires ([0008-0009, 0019, 00021]; Figures 1-2).
As to claim 2, Kirkland discloses the power supply is a standard power supply for a TENS unit ([0002, 0008-0009, 0019, 0021]; Figures 1-2).
As to claim 3, Kirkland discloses the garment is a pair of pants or a shirt ([0018]; Figures 1-3).
As to claim 7, Kirkland discloses “wires configured to connect to the power supply” ([0008-0009, 0019, 0021]; Figures 1-2). In absence of any recitation of additional heat source or heating element in connection to the wiring, the examiner considers the wires of Kirkland to be considered “heating wires”. As such, Kirkland discloses “heating wires configured to connect to the power supply”.
Claims 1-5 and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Axelgaard et al. (US 20020138125 A1).
As to claim 1, Axelgaard et al. discloses a base garment (Figures 1-2, [0028-0030]) with inner pockets positioned, sized, and made of material suitable to hold TENS unit ([0003]) electrodes (medical electrodes, depicted as 40 in Figure 2; [0031-0034]) in place while in use for pain relief ([0003, 0032]); a power supply ([0003, 0032]; Figures 1-2), and conductive wires (embedded wires, depicted as 44 in Figure 2; [0032]).
As to claim 2, Axelgaard et al. discloses the power supply is a standard power supply for a TENS unit ([0003, 0005, 0032]).
As to claim 3, Axelgaard et al. discloses the garment is a pair of pants ([0028-0030]; Figures 1-2).
As to claim 4, Axelgaard et al. discloses a pocket for holding the power supply (depicted as 34 in Figure 2; [0032]).
As to claim 5, Axelgaard et al. discloses the inner pockets are configured to be closed using hook and loop fasteners ([0033]), such that the electrodes can be held securely within the pockets while connected electrically to the power supply ([0030-0034]).
As to claim 7, Axelgaard et al. discloses “wires configured to connect to the power supply” ([0008-0009, 00019, 00021]; Figures 1-2). In absence of any recitation of additional heat source or heating element in connection to the wiring, the examiner considers the wires of Axelgaard et al. to be considered “heating wires”. As such, Axelgaard et al. discloses “heating wires configured to connect to the power supply”.
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.
Claims 4-5 and 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Kirkland (US 20020077689 A1) in view of Axelgaard et al. (US 20020138125 A1).
As to claim 4, Kirkland discloses the invention substantially as claimed with pockets for holding the electrodes but does not explicitly disclose a pocket for holding the power supply. Axelgaard et al. discloses and electrode garment with retaining pockets for electrodes as well as the power supply (Figure 2; [0032-0033]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the garment of Kirkland to include an additional pocket to retain the power supply as disclosed by Axelgaard et al. in order to provide the predictable results of enhanced ambulatory use of the garment. Furthermore, such a modification would enable the patient to be unencumbered by loose or visible wires connecting to the garment.
As to claims 5 and 8-9, the modified Kirkland disclose the invention substantially as claimed with inner pockets for retaining the electrodes and power supply, but does not explicitly disclose they are both secured with hook and loop fasteners. Axelgaard et al. disclose hook and loop fasteners for securing the electrodes within the flap or pocket ([0032-0034]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the inner pockets for retaining the electrodes and power supply of the modified Kirkland to include hook and loop fasteners closures as disclosed by Axelgaard et al. ([0032-0034]) in order to provide the predictable results of providing the electrodes and power supply are securely retained on the garment. Furthermore, such a modification would provide the predictable results of preventing accident dislodgement or separation of the electrodes or power supply by ensuring it is sufficiently retained within the pocket.
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Axelgaard et al. (US 20020138125 A1).
As to claims 8-9, Axelgaard et al. discloses the invention substantially as claimed with flaps or pockets using hook and loop fasteners to retain electrodes ([0032-0034]), but does not explicitly disclose using hook and loop fasteners for the pocket that retains the power supply (Figure 2). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the power supply pocket of Axelgaard et al. to also include hook and loop fasteners present in the electrode flabs or pockets of Axelgaard et al. in order to provide the predictable results of providing the power supply is securely retained on the garment. Furthermore, such a modification would provide the predictable results of preventing accident dislodgement or separation of the power supply by ensuring it is sufficiently retained within the pocket.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Kirkland (US 20020077689 A1) in view of Yamazaki et al. (US 6,453,203 B1).
Kirkland discloses the invention substantially as claimed but does not explicitly disclose washing instructions or the ability to remove the electrical componentry prior to washing. Yamazaki et al. discloses a garment that is machine-washable after removing the power supply, conductive wires, and electrical contacts (electrodes) in col. 5, lines 21-28 (Figures 10-12). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the garment of Kirkland to be washable with the removal of the power supply, conductive wires, and electrical contacts as disclosed by Yamazaki et al. in order to provide the predictable results of ensuring a hygienic and clean garment. Furthermore, modifying the device so it can be wash, particularly machine-washable, would enhance the usefulness of the garment and optimize long term usage to meet specific patient therapeutic needs and requirements.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Axelgaard et al. (US 20020138125 A1) in view of Yamazaki et al. (US 6,453,203 B1).
Axelgaard discloses the invention substantially as claimed but does not explicitly disclose washing instructions or the ability to remove the electrical componentry prior to washing. Yamazaki et al. discloses a garment that is machine-washable after removing the power supply, conductive wires, and electrical contacts (electrodes) in col. 5, lines 21-28 (Figures 10-12). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the garment of Axelgaard to be washable with the removal of the power supply, conductive wires, and electrical contacts as disclosed by Yamazaki et al. in order to provide the predictable results of ensuring a hygienic and clean garment. Furthermore, modifying the device so it can be wash, particularly machine-washable, would enhance the usefulness of the garment and optimize long term usage to meet specific patient therapeutic needs and requirements.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALYSSA M ALTER whose telephone number is (571)272-4939. The examiner can normally be reached M-F 8am-4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David E Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALYSSA M ALTER/Primary Examiner, Art Unit 3796