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 .
Election/Restrictions
Applicant’s election without traverse of claims 7-15 in the reply filed on 12/08/2025 is acknowledged.
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 14 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 14 recites the limitation of “the neutral position”; it is unclear what is being considered to be the neutral position. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 101
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 7-15 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 7 recites “one or more connector disposed on [] adjacent to a treatment area”. As recited the “treatment area” is being positively recited. The recommended language would include “configured to”, “designed for”, etc. Dependent claims 8-15 are rejected for depending on rejected claim 7, and inheriting the same deficiency.
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.
Claim(s) 7 and 8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CN109224290A to Shi.
Regarding claim 7. (Original) Shi discloses a garment for delivering TTFields to a treatment area on or in a body of a subject (abstract, Description; it is noted that “delivering TTFields to a treatment area” is not given any patentable weight, as it does not positively recite the limitation – see MPEP 2111), comprising: a supporting layer (Description, “the front fixing belt and a rear fixing belt”); one or more connector disposed on a skin-facing surface of the supporting layer adjacent to a treatment area (Description, “wires”, “electrode tip 3 is connected to the electric pulse generator 4 by a wire”); and an inflatable component comprising one or more bladder (Description “elastic bladder 6”, fig. 1) and supported by the supporting layer at a location associated with the treatment area (Description “the elastic bladder 6 can be integrated in the wearing device 5”), the one or more bladder biased to a neutral position and configured to expand to an inflated position or contract to a deflated position based in part on one or more predetermined pressure (Description; the mesh elastic bladder 6 is filled with water or inflated, and after being expanded, the elastic bladder 6 presses the front fixing belt 1 and the rear fixing belt 2 respectively).
Regarding claim 8. (Original) Shi discloses the garment of claim 7, wherein the one or more connector (description “electrode tip 3 is connected to the electric pulse generator 4 by a wire”) is configured to attach a transducer array to a skin-facing surface of the supporting layer (Description, “the electrode tip is fixed at the acupuncture point”, “the front fixing belt and the rear fixing belt are respectively provided with three columns of the electrode heads”, “a plurality of electrode heads 3”).
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claim(s) 11, 12, 13 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shi in view of US Pub No. 20180154140 A1 to Bouton et al. (hereinafter “Bouton” – on IDS).
Regarding claim 11. (Original) Shi discloses the garment of claim 7, configured to selectively provide a fluid at one or more predetermined pressure (Description, “filled with water or inflated”;), and a tube configured to provide fluid communication between the pump and the inflatable component (Description” inflation port or a water filling port”).
But fails to explicitly disclose having a pump. Shi discloses an elastic bladder, inflation port, filling port, etc.,
Bouton, from a similar field of endeavor, teaches providing a pneumatic pump can be used to fill the bladders (Para 0116, 0127). It would have been obvious to one of ordinary skills in the art prior to the effective filing date of the claimed invention to modify the disclosure of Shi with the teachings of Bouton, to provide the predictable result of providing the means to inflate the elastic bladder.
Regarding claim 12. (Original) Shi as modified by Bouton renders obvious the garment of claim 11, wherein the tube comprises one or more hose surrounding one or more fluid pathway, each of the one or more fluid pathway configured to provide fluid communication between the pump and a particular bladder of the one or more bladder (Description” inflation port or a water filling port”; it is noted that the claim only requires one of each (i.e., hose and fluid pathway)).
Regarding claim 13. (Original) Shi as modified by Bouton renders obvious the garment of claim 11, wherein the one or more bladder is one or more first bladder, the tube is a first tube, and further comprising one or more second bladder, the first tube configured to provide fluid communication between the pump and the one or more first bladder, and further comprising a second tube configured to provide fluid communication between the pump and the one or more second bladder (Bouton, para 0116, 0127). Additionally, the court has held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. See In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Regarding claim 15. (Original) Shi as modified by Bouton renders obvious the garment of claim 11, wherein the pump is part of an electronic apparatus, the electronic apparatus having circuitry to cause the pump to provide the fluid at one or more elevated pressure during a period of time in which a measured impedance is above a predetermined threshold (Bouton, para 0116 “pneumatic pump”; it is understood that the pneumatic pump would include circuitry as claimed).
Claim(s) 9, 10 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shi in view of CN111481823A to Hongjie (on IDS).
Regarding claim 9. (Original) Shi discloses the garment of claim 7, wherein the one or more connector is one or more first connector (see rejection of claim 7), but fails to disclose further comprising two or more transducer arrays configured to deliver TTFields to the treatment area, each of the two or more transducer arrays comprising one or more second connector, the one or more second connector configured to attach to the one or more first connector.
Hongjie, from a similar field of endeavor, teaches having a plurality of patches associated with a plurality of cloth pieces to allow for providing field energy electrode patch is close to the human body and adapted to the position of the tumor (Description, fig 3). It would have been obvious to one of ordinary skills in the art prior to the effective filing date of the claimed invention to modify the disclosure of Shi with the teachings of Hongjie, because doing so would allow for providing additional patches, providing the predictable result of providing field energy electrode adapted to the position of the tumor. Additionally, the court has held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. See In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Regarding claim 10. (Original) Shi discloses the garment of claim 7, wherein the inflatable component is a first inflatable component, the one or more bladder is one or more first bladder, the location is a first location (see rejection of claim 7), but fails to disclose the garment further comprising: a second inflatable component comprising one or more second bladder supported by the supporting layer at a second location associated with the treatment area, the one or more second bladder biased to a neutral position and configured to expand to an inflated position or contract to a deflated position based in part on the one or more predetermined pressure.
Hongjie, from a similar field of endeavor, teaches having a plurality of patches associated with a plurality of cloth pieces to allow for providing field energy electrode patch is close to the human body and adapted to the position of the tumor (Description, fig 3). It would have been obvious to one of ordinary skills in the art prior to the effective filing date of the claimed invention to modify the disclosure of Shi with the teachings of Hongjie, because doing so would allow for providing additional patches, providing the predictable result of providing field energy electrode adapted to the position of the tumor.
Shi as modified by Hongjie, would render obvious providing additional inflatable components associated with the additional plurality of cloths pieces/patches to provide a biasing force to press the electrodes to the body (Shi, Description). Additionally, the court has held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. See In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Regarding claim 14. (Original) Shi as modified by Hongjie renders obvious the garment of claim 9, wherein each of the one or more bladder comprises a biasing material such that the one or more bladder in the neutral position provides an initial biasing pressure against a particular transducer array of the two or more transducer arrays (Shi, Description, elastic bladder provided on the belt is understood to provide at biasing force).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SANA SAHAND whose telephone number is (571)272-6842. The examiner can normally be reached M-Th 8:30 am -5:30 pm; F 9 am-3 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer S McDonald can be reached at (571) 270- 3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SANA SAHAND/Examiner, Art Unit 3796