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 Objections
Claims 2-14 are objected to because of the following informalities:
As to claim 2, line 3 should be amended to read “the alarm is one or a combination of a lighting alarm…” for grammar.
Claims 3-14 are objected to by virtue of their dependency on claim 2.
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.
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 limitation(s) is/are: “control mechanism module” and “infusion mechanism 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 § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
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.
Claims 1-17 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.
As to claim 1, the wording of “an alarm, non-closed arranged in the control mechanism module…” is unclear as to whether the alarm itself is “non-closed” or whether the applicant is intending to say that the alarm is not enclosed within the control mechanism module. It will be assumed this language is synonymous with saying that the alarm is not enclosed within the control mechanism module.
Claims 2-17 are rejected by virtue of their dependency on claim 1.
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 of this title, 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.
Claim(s) 1-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Flaherty (US 2002/0169439 A1), hereafter “Flaherty”, in view of Fifield et al. (US 2017/0332980), hereafter “Fifield”).
As to claim 1, Flaherty discloses a skin patch drug infusion device (10; see Figs. 1, 3), comprising:
a control mechanism module (700) provided with multiple first engaging portions (703, 703a) and a first electrical connection (720 or 730) exposed on a surface of the control mechanism module (see para 0067, 0071, Fig. 3); and
an infusion mechanism module (800) including a case (802), with a second electrical connection (820 or 830) exposed on a surface of the case and second engaging portions (804, 804a) engaged with the first engaging portions (see at least para 0050-0053, clear that Fig. 3 shows alternate forms of projections/holes seen in other Figures), wherein when the control mechanism module and the infusion mechanism module are assembled with each other, the first engaging portions and the second engaging portions are engaged, the first electrical connection and the second electrical connection are electrically connected to each other, thereby the control mechanism module and the infusion mechanism module are electrically connected to each other (para 0067, 0071); and
an alarm (para 0123).
Flaherty does not expressly recite the alarm being non-closed arranged in the control mechanism module.
Fifield disclose an alarm (316), the alarm being non-closed arranged in a control mechanism module (202) (see para 0115 teaching “an audio aperture 214 (which can be referred to as a buzzer port) through which sound from an audio speaker 316 inside the housing 202 can pass”).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Flaherty such that the alarm was non-closed arranged in the control mechanism module, such as by including an aperture in the housing 702 of the control mechanism module 700. One would have been motivated to do so in order to allow sound from the alarm to pass from inside the control mechanism module to the outside (see para 0115 of Fifield).
As to claim 2, Flaherty in view of Fifield discloses a skin patch drug infusion device of claim 1, wherein the alarm is one or a combination of lighting alarm, audio alarm and vibration alarm, or an alarm with multiple alarm signals of light, sound, or vibration (see para 0123 of Flaherty, also see para 0115 of Fifield).
As to claim 3, Flaherty in view of Fifield discloses a skin patch drug infusion device of claim 2 as described above. Flaherty is silent to wherein the alarm is a buzzer, however, Fifield discloses that the alarm can be a buzzer (para 0115). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, when modifying Flaherty, to further do so such that the alarm is a buzzer. One would have been motivated to do so as a possible form for the alarm, which is capable of alerting a user (see para 0115 of Fifield). As to claim 4, Flaherty in view of Fifield discloses a skin patch drug infusion device of claim 3, wherein at least a non-closed area is provided on a housing of the control mechanism module (see rejection of claim 1 above which added an aperture to the housing 702).
As to claim 5, Flaherty in view of Fifield discloses a skin patch drug infusion device of claim 4, wherein the non-closed area is a sound-permeable outlet (see rejections above and para 0115 of Fifield).
Claim(s) 6-8 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Flaherty in view of Fifield as applied to claim 5 above, and further in view of Agard et al. (US 2014/0296787 A1), hereafter “Agard”.
As to claim 6, Flaherty in view of Fifield discloses a skin patch drug infusion device of claim 5 as described above, but does not expressly recite wherein the housing of the control mechanism module includes an upper housing and a lower housing, the sound-permeable outlet is arranged on the lower housing.
Agard however discloses a housing 2012 and teaches “The housing 2012 may take any number of configurations and be facilitated by any number of components, such as a single-body or multi-component housing 2012” (para 0102).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Flaherty (as already modified above) such that the housing of the control mechanism module includes an upper housing and a lower housing based off of Agard (see para 0102; the examiner notes that the claim does not point out what the housings are “upper” and “lower” relative to and argues that a multi-body housing could be interpreted as having lower and upper housings depend on an orientation of the device). Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have positioned the sound-permeable outlet on the lower housing. The examiner notes that the claimed additional housings and/or the location of the sound-permeable outlet would constitute only a mere duplication and/or rearrangement of known parts with no change in their respective functions, and therefore would have been obvious to one having ordinary skill in the art to construct.
As to claim 7, Flaherty in view of Fifield and Agard teaches a skin patch drug infusion device of claim 6 as described above. While Flaherty is silent to wherein a waterproof sound-permeable membrane is disposed between the sound-permeable outlet and the buzzer, Fifield further teaches “the audio aperture 124 can include an air-permeable water-sealed membrane, adhered to an inner side of the audio aperture 214, to improve ingress protection of the audio aperture 214” (para 0115). It therefore would have been further obvious to one having ordinary skill in the art, when modifying Flaherty, to do so such that a waterproof sound-permeable membrane is disposed between the sound-permeable outlet and the buzzer, for the motivation of improving ingress protection of the outlet (para 0115 of Agard).
As to claim 8, Flaherty in view of Fifield and Agard teaches a skin patch drug infusion device of claim 7 as described above. Flaherty further discloses wherein the first engaging portions include some of at least one hook, at least one block, at least one hole and at least one slot, and the second engaging portions include some of at least one hook, at least one block, at least one hole and at least one slot, the first engaging portions and the second engaging portions are engaged with each other (see at least para 0050-0053).
As to claim 15, Flaherty in view of Fifield discloses a skin patch drug infusion device of claim 1 as described above, but does not expressly recite wherein the case includes an upper case and a lower case.
Agard however discloses a case (housing 2012) and teaches “The housing 2012 may take any number of configurations and be facilitated by any number of components, such as a single-body or multi-component housing 2012” (para 0102).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Flaherty (as already modified above) such that the case includes an upper case and a lower case based off of Agard (see para 0102; the examiner notes that the claim does not point out what the cases are “upper” and “lower” relative to and argues that a multi-body housing could be interpreted as having lower and upper cases depend on an orientation of the device). The examiner also notes that the claimed additional cases would constitute only a mere duplication and/or rearrangement of known parts with no change in their respective functions, and therefore would have been obvious to one having ordinary skill in the art to construct.
Claim(s) 9-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Flaherty in view of Fifield and Agard as applied to claim 8 above, and further in view of Donnay et al. (US 2011/0319729 A1, hereafter “Donnay”).
As to claims 9-11, Flaherty in view of Fifield and Agard teaches a skin patch drug infusion device of claim 8 as described above, but is silent to wherein the first engaging portions and the second engaging portions are first electrical contacts and second electrical contacts, wherein one of the first electrical contacts is a rigid metal pin or an elastic conductive member, or one of the second electrical contacts is a rigid metal pin or an elastic conductive member, and wherein the elastic conductive member includes a conductive spring, a conductive leaf spring, a conductive rubber, or a conductive silica gel.
Donnay teaches “on body housing 4200 includes housing unit 4220 and sensor hub 4222 as illustrated in FIG. 159. The sensor may be insert molded with mechanical contacts. The PCB in the housing unit 4220 may include leaf spring contacts 4230. The sensor hub 4222 may be mechanically attached to the housing unit 4220, e.g., the electrical contacts may function as mechanical snaps” (para 0275; also see Fig. 159).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Flaherty further (as already modified above) such that the first engaging portions and the second engaging portions are first electrical contacts and second electrical contacts, and further wherein one of the first electrical contacts an elastic conductive member, or one of the second electrical contacts is an elastic conductive member, and wherein the elastic conductive member includes a conductive leaf spring, based off of Donnay. One would have been motivated to do so based off of Donnay, for the purpose of providing a combined snap and electrical contact means (see para 0275 of Tieck).
Allowable Subject Matter
Claims 12-14 and 16-17 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
As to claim 12, while Flaherty in view of Fifield, Agard and Donnay teaches a skin patch drug infusion device of claim 11 as described above, each are silent to wherein one of the first electrical contacts is a rigid metal pin while one of the second electrical contacts is a conductive spring, and a groove, within which a sealing element is provided, is disposed around an area where the second electrical contacts are disposed in combination with the limitations of claim 11 (which includes the claims from which claim 11 depends).
Claims 13-14 depend from claim 12.
As to claim 16, while Flaherty in view of Fifield and Agard teaches a skin patch infusion device of claim 15 described above, each are silent to wherein the lower case further includes an outward extending portion, and a block is provided on an outside of the outward extending portion in combination with the limitations of claim 15.
Claim 17 depends from claim 16.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to James D Ponton whose telephone number is (571)272-1001. The examiner can normally be reached M-F 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/James D Ponton/Primary Examiner, Art Unit 3783