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 .
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.
Specification
35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, requires the specification to be written in “full, clear, concise, and exact terms.” The specification is replete with terms which are not clear, concise and exact. The specification should be revised carefully in order to comply with 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112. Examples of some unclear, inexact or verbose terms used in the specification are:
in general, articles and particles are missing throughout; there are numerous grammatical errors;
the Brief Description of Figs. 1b-1e should indicate four, not three, embodiments; cf. pg. 6, lines 6-8; and
pg. 6,
the third full paragraph does not identify where patch 150 can be seen in the figures; and
fourth para., line 2, “Fig. 54f” is incorrect
Claim Objections
Claims 1, 2, 4, and 13 objected to because of the following informalities.
Claim 1, line 7, “delivered subcutaneously” implies that the term is a step of a method, and should instead include “configured to be,” which is how the term has been treated.
Claim 2, line 3, “puncturing” is the wrong word, and should be “inserting” or the like, being the verb which describes the action on the needle, which is how the term has been treated.
Claim 4, line 3, the list of movements needs the word “and” before the last element of the list.
Claim 13, penultimate line, “presses” should be “pressed.”
Appropriate correction is required.
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.
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 limitation(s) is/are:
in Claim 1, “control mechanism module” and ”sensing module;” and
in Claim 12, “verification module.”
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 § 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.
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.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], 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.
Claims 1-18 are 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.
In Claim 1, lines 11-12, the clause “wherein the body movements which are different” renders the scope of the claim indefinite, because: (a) “the body movements which are different” lacks a positive antecedent basis; and (b) the clause demands the question, “Different from what?” The clause has been treated as instead stating “wherein body movements which are different represent different functional instructions” as originally recited.
In Claim 4, last line, “special way of walking” renders the scope of the claim indefinite, because the clause relies on an entirely subjective evaluation of the walk of a person, i.e., whether it is “special” or not, and thus its scope cannot be determined. The term has been read out of the claim.
The balance of the claims depend from Claim 1, inherit and do not cure its deficiency, and therefore are also rejected.
The claim limitation “verification module” in Claim 12 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function.
More specifically, the specification, including the explanation beginning at pg. 9 concerning the “verification module,” only discusses the result which the inventors hope that the module produces, to wit, “confirms whether the movement meets the requirements or the standard,” but not how that verification or confirmation is performed.
Therefore, Claim 12 is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claims 10 and 17 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Both Claims 10 and 17 recite, “wherein the infusion mechanism module and the control mechanism module are designed separately, and the control mechanism module is reusable.” Both of the clauses in the claims do not further limit the scope of the claim from which it depends, because: (a) when or how the modules are designed by an engineer does not impose any structural or functional limitation on the modules; and (b) whether or not a module is “reusable” relates only to a non-structural, non-functional intended use of the module.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-12, 17, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent App. Pub. No. 2020/0135320, by Vleugels (“Vleugels”) in view of U.S. Patent App. Pub. No. 2009/0069784, by Estes et al. (“Estes”).
Vleugels describes a device substantially as claimed by Applicant, as follows.
Claim 1: A skin patch drug infusion system, comprising:
a control mechanism module (Fig. 1, generally; Abstract), connected with an infusion mechanism module to control the drug infusion ([0427]);
a sensing module (gesture envelope detector, passim, 1018, 1125, 1238, 1349, 1459), operatively connected to the control mechanism module (Fig. 8, showing the detector subsystem within the overall control mechanism) and used to sense or recognize body movements ([0343], describing the function of the gesture envelope detector), wherein the body movements which are different represent different functional instructions (id.), and according to the body movement sensed or recognized by the sensing module, the control mechanism module controls the infusion mechanism module to execute a corresponding functional instruction of the functional instructions (passim, e.g., Abstract: “The medication administration message might comprise a signal to an input of an insulin management system or an input of a meal-aware artificial pancreas. The events might also include a drinking event, a smoking event, a personal hygiene event, and/or a medication related event.”).
While Vleugels describes its gesture control schemes in great detail, it does not describe the details of its medication infusion components, and thus does not describe:
an infusion mechanism module comprising:
a reservoir, for accommodating a drug to be infused, and provided with a drug inlet and a drug outlet; [sic: and]
an infusion needle, wherein one end of the infusion needle is communicated with the drug outlet of the reservoir, and an other end of the infusion needle is delivered subcutaneously to realize drug infusion; or
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.
Estes relates to wearable, computer-controlled, gesture-evaluating insulin infusion devices and is therefore from an art which is the same as, or very closely analogous to, those of Applicant' s claims. Estes is representative of a large number of wearable, computer-controlled insulin infusion devices in the prior art, and teaches that such devices can be constructed to include the following features, in order to provide a wearable infusion device as is standard in the industry and the prior art:
an infusion mechanism module (100, Fig. 1) comprising:
a reservoir (120), for accommodating a drug to be infused (126), and provided with a drug inlet (at piston 125) and a drug outlet (at 121);
an infusion needle (149), wherein one end of the infusion needle is communicated with the drug outlet of the reservoir (via septum 121), and an other end of the infusion needle is delivered subcutaneously (see treatment above) to realize drug infusion ([0046]); or
an adhesive patch ([0048] and Fig. 8), for attaching the infusion mechanism module, the control mechanism module and the sensing module, in part or in whole, to the skin surface (id.).
It 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, to construct Vleugels’s insulin delivery device to include the foregoing additional features, because Estes teaches doing so in a closely related infusion device, exemplary of a vast number of such devices, in order to provide an industry and prior art standard portable infusion device.
Claim 2: (A skin patch drug infusion system of claim 1,) wherein, the functional instructions include infusing drug or stopping infusing drug (Title, Abstract, [0002]), priming the infusion needle, puncturing (see treatment above) or retracting the infusion needle, adjusting an infusion speed or an infusion mode, adjusting an amount of drug infusion, a turning on or off an alarm, connecting or disconnecting a remote device, switching physical state, or starting an event.
Claim 3: (A skin patch drug infusion system of claim 1,) wherein, the sensing module is provided with one or more of an acceleration sensor (gyroscope 755), an inclination sensor, a vibration sensor and a rotation sensor.
Claim 4: (A skin patch drug infusion system of claim 1,) wherein, the body movements include one or a combination of jumping, squatting, leg movements, arm movements ([0034]), taps on the sensing module, bending over, torso twist, special way of walking.
Claim 5: (A skin patch drug infusion system of claim 4,) 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 (Vleugels, [0377], “As described herein, improved methods frame temporal problems with a variable time envelope, so that information tied to the overall variable time envelope or to segments thereof can be extracted and included in the feature set used to train the classifier.”- the logic therefore differentiates between valid and invalid body movements in order to ‘extract’ data within certain variable time envelopes for further use in the logic).
Claim 6: (A skin patch drug infusion system of claim 5,) wherein, the fixed time period t is 0.5s-5.0s (Vleugels Fig. 9, ID 1, time envelope is 3.5s).
Regarding Claim 7, Vleugels and Estes together disclose the invention essentially as claimed; see above. Vleugels also discloses the use of variable time envelopes to accept/reject motion data for further use in its logic (see discussion of Claim 6, above), including envelopes as short as 1.9s (Fig. 9, Gesture ID3); however, it does not expressly disclose a gesture time envelope of 1s.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to construct the device of Vleugels and Estes to have a gesture time envelope of 1s, since it has been held that, “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 1345 (Fed. Cir. 1984), cert. denied, 469 U.S. 830 (1984); see also In re Chu, 66 F.3d 292, 298-99 (Fed. Cir. 1995) (“design choice” is appropriate where the applicant fails to set forth any reasons why the differences between the claimed invention and the prior art would result in a different function). In the instant case, the device of Vleugels and Estes would not operate differently with the claimed time envelope and, as its device is to be used with numerous people, numerous gestures, and the resulting large number of permutations of useful time envelopes for all of the gesture time periods, the device would function appropriately having the claimed 1s time envelope. Further, Applicant assigns no criticality on the 1s time period claimed, indicating simply that the “the fixed time period t can be set to any time within 0.5s~5s according to the habits of users. Preferably, t=1s” (Specification @ pg. 8, third full paragraph).
Claim 8: (A skin patch drug infusion system of claim 1,) wherein, the sensing module is integrated in the infusion mechanism module or the control mechanism module (Fig. 7, sensors 754-759 in module 770).
Claim 9: (A skin patch drug infusion system of claim 1,) wherein, the sensing module, the control mechanism module and the infusion mechanism module are arranged in one device (Estes, Figs. 2, 3).
Claim 10: (A skin patch drug infusion system of claim 8, wherein, the infusion mechanism module and the control mechanism module are designed separately, and the control mechanism module is reusable (see treatment above; rejected for the same reasons as Claim 8).
Claim 11: (A skin patch drug infusion system of claim 8, wherein, the infusion mechanism module and the control mechanism module are disposed in one housing, discarded together after a single use (see treatment above; one housing, as shown in Figs. 2 and 3, as a complete device; a housing can be formed of multiple parts positioned together during use).
Claim 12: (A skin patch drug infusion system of claim 1,) further comprising a body movement verification module which is connected to the sensing module ([0355], logic labels some gestures as NEGATIVE, “indicating it does not correspond to any labels of interest.”).
Claim 17: (A skin patch drug infusion system of claim 9,) wherein, the infusion mechanism module and the control mechanism module are designed separately, and the control mechanism module is reusable (see treatment above; rejected for the same reasons as Claim 9).
Claim 18: (A skin patch drug infusion system of claim 9,) wherein, the infusion mechanism module and the control mechanism module are disposed in one housing (one housing, as shown in Figs. 2 and 3, as a complete device; a housing can be formed of multiple parts positioned together during use), discarded together after a single use (see treatment above).
Claims 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Vleugels and Estes.
Vleugels and Estes describe a device substantially as claimed by Applicant; see above concerning Claim 10. Vleugels does not, however, describe that:
the control mechanism module is provided with first electrical contacts exposed on a surface of the control mechanism module, the infusion mechanism module is provided with second electrical contacts corresponding to the first electrical contacts, the first electrical contacts and the corresponding second electrical contacts are presses [sic: pressed] against each other, thereby electrically connecting the control mechanism module and the infusion mechanism module (Claim 13);
one of the first electrical contacts or the second electrical contacts is a rigid metal pin or an elastic conductive member (Claim 14);
first engaging portions are provided on the control mechanism module, and second engaging portions engaged with the first engaging portions are provided on the infusion mechanism module (Claim 15); or
the first engaging portions and the second engaging portions include one or more of hooks, blocks, holes, or slots (Claim 16).
As indicated above, Estes relates to portable (insulin) infusion devices that rely on a motion sensor to control some of its function and is therefore from an art which is the same as, or very closely analogous to, those of Applicant’s claims. Estes teaches that such device can be constructed, for the purposes of securing the two portions of the device together in a correct orientation, easily reloading the device and disposing of an empty portion of the device (see Fig. 12 and accompanying text), such that:
the control mechanism module is provided with first electrical contacts (218 in Fig. 4; see [0036]) exposed on a surface of the control mechanism module (id.), the infusion mechanism module is provided with second electrical contacts corresponding to the first electrical contacts (118 in Fig. 5; [0036]), the first electrical contacts and the corresponding second electrical contacts are presses [sic: pressed] against each other ([0036]), thereby electrically connecting the control mechanism module and the infusion mechanism module (id.) (Claim 13);
one of the first electrical contacts or the second electrical contacts is a rigid metal pin ([0036], pin) or an elastic conductive member (Claim 14);
first engaging portions are provided on the control mechanism module (guide channel 214a-b, Fig. 4), and second engaging portions (segmented rails 114a-b, Fig. 1) engaged with the first engaging portions are provided on the infusion mechanism module (Claim 15); or
the first engaging portions and the second engaging portions include one or more of hooks, blocks, holes, or slots (slots formed by the rails above) (Claim 16).
It 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, to construct a Vleugels-Petisce device to include the foregoing features of Claims 13-16, because Estes teaches doing so in a closely-related infusion device, in order to more easily connect the two portions of the device together securely in a correct orientation, reload the device, and dispose of an empty portion of the device.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
U.S. Patent App. Pub. No. 2013/0120106 describes sensed gestures.
U.S. Patent App. Pub. No. 2014/0099237 describes movement of a phone translated into functions.
U.S. Patent App. Pub. No. 2016/0367202 describes movement of sensors translated into the control of an insulin pump at [0139]
The balance of the documents cited with this Office Action relate generally to medication delivery pumps and their controllers.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Adam J. Cermak whose telephone number is 571.272.0135. The Examiner can normally be reached M-F 7:30-4:00 Eastern Time.
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.
If attempts to reach the examiner by telephone are unsuccessful, the Examiner’s supervisor, Bhisma Mehta, can be reached on 571.272.3383. The fax phone number for the organization where this application or proceeding is assigned is 571.273.8300.
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/ADAM J. CERMAK/
Assistant Patent Examiner
Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 01/10/2026