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 .
Response to Amendment
The amendments to the claims and specification filed 04/13/2026 have been entered. Claims 1-11, 13-18 are pending in the application. Applicant’s amendments have overcome every objection and 112(b) rejection previously set forth in the Non-final Office Action mailed 01/13/2026.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are: “control mechanism module” and sensing module” in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 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 1-4, 8-11, 13-18 are rejected under 35 U.S.C. 103 as being unpatentable over Estes (US 2009/0069784) in view of Yudovsky (US 2011/0105955).
Regarding Claim 1, Estes discloses a skin patch drug infusion system (10, Fig 2), comprising: an infusion mechanism module (100, Fig 1) comprising: a reservoir (120, Fig 1), for accommodating a drug (126, Fig 1) to be infused, and provided with a drug inlet (125, Fig 1) and a drug outlet (121, Fig 1); an infusion needle (149, Fig 6), wherein one end of the infusion needle is communicated with the drug outlet of the reservoir, and another end of the infusion needle is configured to be delivered subcutaneously to realize drug infusion (Para 0046); a control mechanism module (200, Fig 1), connected with the infusion mechanism module to control the drug infusion; a sensing module (249, Fig 15), operatively connected to the control mechanism module and used to sense or recognize body movements, wherein the body movements respectively represent different functional instructions and according to the body movements sensed or recognized by the sensing module, the control mechanism module controls the infusion mechanism module to execute a functional instruction (Para 0032); and an adhesive patch, for attaching the infusion mechanism module, the control mechanism module and the sensing module, in part or in whole, to the skin surface (Para 0048; See Fig 8)
Estes is silent regarding wherein the body movements include a movement repeated several times or a combination of a first movement and a second movement in sequence, the second movement is different from the first movement.
Yudovsky teaches an analogous drug infusion system comprising a sensing module (310, 312, 314, Fig 3), operatively connected to the control mechanism module (316, 318, Fig 3) (Para 0034) and used to sense or recognize body movements, wherein the body movements respectively represent different functional instructions, and according to the body movements sensed or recognized by the sensing module, the control mechanism module controls the infusion mechanism module to execute a functional instruction, the body movements include a movement repeated several times or a combination of a first movement and a second movement in sequence, the second movement is different from the first movement (“sequence of movements”, Para 0082).
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 sensing module and control mechanism module to be configured to recognize body movement including repeated movements or a combination of movements as taught by Yudovsky in order to facilitate quicker and simplified usage of a device (Para 0083).
Regarding Claim 2, the modified invention of Estes and Yudovsky discloses the skin patch drug infusion system of wherein the functional instruction includes infusing drug or stopping infusing drug, priming the infusion needle, inserting or retracting the infusion needle, adjusting an infusion speed or an infusion mode, adjusting an amount of drug infusion, turning on or off an alarm, connecting or disconnecting a remote device, switching a physical state, or starting an event (Para 0083 -Yudovsky).
Regarding Claim 3, the modified invention of Estes and Yudovsky discloses the sensing module (310, 312, 314, Fig 3 -Yudovsky) is provided with one or more of an acceleration sensor, an inclination sensor, a vibration sensor and a rotation sensor (Para 0041 -Yudovsky).
Regarding Claim 4, the modified invention of Estes and Yudovsky discloses the body movements include one or a combination of jumping, squatting, leg movements, arm movements, taps on the sensing module, bending over and torso twist (Para 0082 -Yudovsky).
Regarding Claim 8, the modified invention of Estes and Yudovsky discloses the sensing module (310, 312, 314, Fig 3 -Yudovsky) is integrated in the infusion mechanism module or the control mechanism module (Para 0030 -Estes; Para 0033 -Yudovsky).
Regarding Claim 9, the modified invention of Estes and Yudovsky discloses the sensing module, the control mechanism module and the infusion mechanism module are arranged in one device (Para 0027, 0030 -Estes; the sensing, control, and infusion modules are all arranged in infusion pump device 10).
Regarding Claim 10, the modified invention of Estes and Yudovsky discloses the infusion mechanism module and the control mechanism module are detachable to each other (Para 0029, 0039; See Fig 4 -Estes).
Regarding Claim 11, the modified invention of Estes and Yudovsky discloses the infusion mechanism module and the control mechanism module are disposed in one housing (110, 220, Fig 2 -Estes; a housing can be formed of multiple parts positioned together during use), discarded together after a single use (This is an intended use. Estes device meets this limitation as there is nothing preventing a user from discarding both the infusion and control mechanism after a single use).
Regarding Claim 13, the modified invention of Estes and Yudovsky discloses the control mechanism module is provided with first electrical contacts (218, Fig 4 -Estes) exposed on a surface of the control mechanism module, the infusion mechanism module is provided with second electrical contacts (118, Fig 5 -Estes) corresponding to the first electrical contacts, the first electrical contacts and the corresponding second electrical contacts are pressed against each other, thereby electrically connecting the control mechanism module and the infusion mechanism module (Para 0036 -Estes).
Regarding Claim 14, the modified invention of Estes and Yudovsky discloses one of the first electrical contacts or the second electrical contacts is a rigid metal pin (“pins”,Para 0036 -Estes) or an elastic conductive member.
Regarding Claim 15, the modified invention of Estes and Yudovsky discloses first engaging portions (214a-b, Fig 4 -Estes) are provided on the control mechanism module, and second engaging portions (114a-b, Fig 1 -Estes) engaged with the first engaging portions are provided on the infusion mechanism module (Para 0040 -Estes).
Regarding Claim 16, the modified invention of Estes and Yudovsky discloses the first engaging portions and the second engaging portions include hooks, blocks, holes, or slots (Para 0040 -Estes; the guide channels can be interpreted as slots and the rails can be interpreted as blocks).
Regarding Claim 17, the modified invention of Estes and Yudovsky discloses the infusion mechanism module and the control mechanism module are detachable to each other (Para 0029, 0039; See Fig 4 -Estes).
Regarding Claim 18, the modified invention of Estes and Yudovsky discloses the infusion mechanism module and the control mechanism module are disposed in one housing (110, 220, Fig 2 -Estes; a housing can be formed of multiple parts positioned together during use), discarded together after a single use (This is an intended use. Estes device meets this limitation as there is nothing preventing a user from discarding both the infusion and control mechanism after a single use).
Claims 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Estes (US 2009/0069784) in view of Yudovsky (US 2011/0105955) and further in view of Vleugels (US 2020/0135320).
Regarding Claim 5, the modified invention of Estes and Yudovsky discloses all of the elements of the invention as discussed above, however, is silent regarding the body movement sensed or recognized by the sensing module within a fixed time period t is recognized as a valid body movement, and beyond the fixed time period t, the body movement is recognized as an invalid body movement.
Vleugels teaches an analogous system having a sensing module (“sensors”), operatively connected to the control mechanism module and used to sense or recognize body movements (Para 0037), wherein the body movements respectively represent different functional instructions, wherein the body movement sensed or recognized by the sensing module within a fixed time period t is recognized as a valid body movement, and beyond the fixed time period t, the body movement is recognized as an invalid body movement (Para 0378).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify sensing module to determine valid body movement based on the body movement being within a fixed time period as taught by Vleugels in order to have a classifier that has improved performance (Para 0399).
Regarding Claim 6, the modified invention of Estes, Yudovsky, and Vleugels discloses a fixed time period (Para 0378 -Vleugels), however, is silent regarding the fixed time period t is 0.5s-5s.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the fixed time period to be between 0.5-5s since Vleugels provides examples of time periods of gestures from 1.9s - 3.9s (See Fig 9) and teaches that the fixed time periods are based on the time it takes to perform corresponding gesture and the person performing the gesture (Para 0378, 0399). It has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding Claim 7, the modified invention of Estes, Yudovsky, and Vleugels discloses a fixed time period (Para 0378 -Vleugels), however, is silent regarding the fixed time period t is 1s.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the fixed time period to be 1s since Vleugels provides many examples of time periods for varying gestures (See Fig 9) and teaches that the fixed time periods are based on the time it takes to perform corresponding gesture and the person performing the gesture (Para 0378, 0399). It has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Response to Arguments
Applicant’s arguments filed 04/13/2026, on pages 11-14, regarding Vleugels failing to teach the amended limitations have been fully considered but are moot in view of the current rejection that relies on Estes and Yudovsky to teach all of the limitations of the independent claim. Vleugels is now only relied on to teach elements of the dependent claims regarding fixed time periods as detailed in the rejections of claims 5-7 above.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANTARIUS S DANIEL whose telephone number is (571)272-8074. The examiner can normally be reached M-F 7:00am to 4:30pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at 571-272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANTARIUS S DANIEL/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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