DETAILED ACTION
Response to Amendment
The Amendment filed 6/26/26 has been entered. Claims 1 and 4-8 remain pending in the application. Claim(s) 7-8 has/have been withdrawn. Claim(s) 2-3 has/have been canceled. New claim(s) 9 has/have been added. Applicant's amendments to the claims have overcome the 112(a)&(b) rejections previously set forth in the Non-Final Rejection mailed 4/7/26.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 4/7/26 has been considered by the examiner.
Claim Rejections - 35 USC § 112
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 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.
Claim 9 is rejected under 35 U.S.C. 112(a), as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 9 contains the limitation “wherein cutting of the laminated magnetostrictive material in the predetermined direction is performed while maintaining an internal strain generated by the additive manufacturing.” The instant specification does not provide proper antecedent basis for the claimed subject matter, i.e., “wherein cutting of the laminated magnetostrictive material in the predetermined direction is performed while maintaining an internal strain generated by the additive manufacturing.”
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Language from the reference(s) is shown in quotations. Limitations from the claims are shown in quotations within parenthesis. Examiner explanations are shown in italics.
Claims 1, 4, and 9 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Price (US 20220361810 A1).
Regarding claim 1, Price teaches “a personal wireless digital device for supporting a patient in receipt of medication treatment, more particularly for improving a healthcare outcome of the patient, through improved medication adherence and reduced medication error; a method for the manufacture thereof” (which reads upon “a method for producing”, as recited in the instant claim; paragraph [0002]). Price teaches that “an EHU comprises a smart material or smart system comprising a combination of materials which is responsive to a stimulus of the patient or the patient's environment by a response comprising a reversible material property change, more particularly which is ferroelectric, piezoelectric, triboelectric, thermoelectric, pyroelectric, photovoltaic, magnetostrictive, electromagnetic or the like” (which reads upon “a magnetostrictive material”, as recited in the instant claim; paragraph [0038]). Price teaches that “A method for manufacture of the device or a module therefor herein suitably comprises providing or forming an AU about a MAMU and OU, or individual units or parts thereof as hereindefined, for example by extrusion, 3D and/or 4D printing or moulding such as injection moulding. 3D and 4D printing techniques include extrusion such as fused deposition modelling, vat photopolymerisation such as stereolithography, powder bed fusion, digital light projection, material or binder jetting, multi jet modelling, selective laser sintering, electron beam melting, sheet lamination, directed energy deposition or combinations thereof” (which reads upon “comprising melting raw material powder for a magnetostrictive material by a directed energy deposition method to perform additive manufacturing, the melting being performed by a laser or electron beam using a metal 3D additive manufacturing machine”, as recited in the instant claim; paragraph [0266]). Price teaches that “a plurality of same or different devices and/or modules may be manufactured on or in form of a web, reel or spool thereof e.g. for efficient manufacture and convenient handling, with subsequent separation into discrete devices or modules” (which reads upon “cutting an unannealed laminated magnetostrictive material in a predetermined direction”, as recited in the instant claim; paragraph [0266]). Price teaches that “preferably an AS is a smart sensor such as a piezoelectric or magnetostrictive sensor” (which reads upon “to obtain a magnetic anisotropy”, as recited in the instant claim; paragraph [0174]; one of ordinary skill in the art would understand that magnetostrictive sensors are anisotropic). Price is silent regarding any annealing steps.
Regarding claim 4, Price teaches the method of claim 1 as stated above. Price teaches that “magnetostrictive material includes magnetic materials such as e.g ferromagnetic such as iron, nickel or cobalt and combinations thereof and their alloys including crystalline or amorphous alloys with metals including Galfenol (Ga, Fe alloy) and Alfenol (Fe, Al alloy), including alloys with rare earth metals, such as Terfenol-D (Terbium, Iron, Dysprosium alloy), and amorphous or crystalline alloys including Metglas (Fe, Si, B, C alloy) and cobalt ferrite (Co Fe alloy)” (paragraph [0136]).
Regarding claim 9, Price teaches the method of claim 1 as stated above. Price teaches that “a plurality of same or different devices and/or modules may be manufactured on or in form of a web, reel or spool thereof e.g. for efficient manufacture and convenient handling, with subsequent separation into discrete devices or modules” (paragraph [0266]). Price teaches that “the variation of materials' magnetization due to the applied magnetic field changes a magnetostrictive strain until reaching a saturation value” (paragraph [0133]). Price is silent regarding any annealing steps or reducing internal strain generated by the additive manufacturing.
Claim Rejections - 35 USC § 103
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Price (US 20220361810 A1), as applied to claim 1 above
Regarding claims 5-6, Price teaches the method of claim 1 as stated above. Price teaches that “a device herein is sized and shaped to be worn about the person of a patient” (paragraph [0077]). Price teaches that “a flexible, e.g. conformable or deformable or resiliently deformable AU is configured to conform to a shape of e.g. to loosely or closely contact, a contacted patient member or body part, suitably the AU or part thereof comprises a flexible, and/or adhesive, material” (paragraph [0085]). Price teaches that “a smart system or material may comprise one or more shaped component(s), such as membrane, foil, sheet, block, foam, film such as thin film, fibre, rod, bar, wire, electrode, cylinder, tube or nanotube, metamaterial or the like or a combination thereof including 2D and 3D arrays or matrices, bicomponent shaped materials such as bilayers or laminates, woven, knitted, braided, spaced or non-woven textiles of any combination of the foregoing” (paragraph [0134]). Price teaches that “a smart material may be profiled such as curved or coiled or straight, nanostructured or nanotextured” (paragraph [0134]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the magnetostrictive material of Smith to have a honeycomb shape, as such modification would involve a mere change in configuration. It has been held that a change in configuration of shape of a device is obvious, absent persuasive evidence that a particular configuration is significant. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). Here, one would be motivated to use a honeycomb structure to reduce weight and increase breathability, while maintaining structural integrity thus improving the comfort of the patient wearing the device.
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Price (US 20220361810 A1), as applied to claim 1 above, and further in view of Niu et al., Modeling and optimization of magnetostrictive actuator amplified by compliant mechanism, 2017, Smart Mater. Struct. 26 095029.
Regarding claims 5-6, Price teaches the method of claim 1 as stated above. Price teaches that “non limiting examples of a stimulus include mechanical, such as force, pressure, strain” (paragraph [0124]). Price teaches that “the variation of materials' magnetization due to the applied magnetic field changes a magnetostrictive strain until reaching a saturation value” (paragraph [0133]).
Price is silent regarding a honeycomb structure.
Niu is similarly concerned with magnetostrictive materials (page 1). Niu teaches that “magnetostriction is a property of ferromagnetic materials that their shape or dimensions will change during the process of magnetization when a magnetic field is imposed on them” (page 1). Niu teaches that “taking advantage of the property, magnetostrictive actuator is a kind of strain actuator with large actuation force, quick response, high resolution and broad response band [1], and has been applied to servo-valves [2–4], biosensors [5, 6], injectors [7], bending type design [8], tunable springs [9] and vibration control platforms” (page 1). Niu teaches that “Therefore, they are suitable to make mechanical amplifiers for strain actuators, and various topologies have been developed including V-shaped amplifier [12], honeycomb link amplifier [13] and buckling mechanism amplifier” (pages 1-2). Niu teaches that “the amplification gains range from several times to several dozens” (page 2).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the shape of the magnetostrictive material of Price to include a honeycomb structure, as taught by Niu to improve its performance as a strain actuator in a biosensor.
Response to Arguments
Applicant’s arguments, see Remarks, pages 6-7, filed 6/26/26, with respect to the rejection(s) of claim(s) 1 and 4-6 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Price (US 20220361810 A1).
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 extension fee 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 date of this final action.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA JANSSEN whose telephone number is (571)272-5434. The examiner can normally be reached on Mon-Thurs 10-7 and alternating Fri 10-6.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. The Examiner requests that interviews not be scheduled during the last week of each fiscal quarter or the last half of September, which is the end of the fiscal year. Q4: 9/21-9/30/26; Q1: 1/4-1/8/27.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Hendricks can be reached on (571)272-1401. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REBECCA JANSSEN/Primary Examiner, Art Unit 1733
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