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 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: “a driving unit, driving the driving wheel to rotate”, “a power unit… to offer power for the driving unit” 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 1-20 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 “a driving wheel, connected with the screw, driving the screw to push the piston forward by rotation” is unclear as to which component(s) must rotate (i.e. the driving wheel, the screw, and/or the piston).
Claim 1 recites “a driving unit” in line 8 which is unclear because the claim previously introduced a driving unit in line 6, and it is not apparent whether the applicant intends to introduce a different driving unit. The examiner will assume that line 8 intends to refer to the same driving unit as line 6.
Claim 4 recites “the at least one protective film” in line 2. There is a lack of antecedent basis for this limitation. Claim 4 was perhaps intended to depend from claim 2 which does give antecedent basis.
Claim 8 recites “the protective film” in line 3. This is inconsistent with every previous recitation of protective films, and therefore lacks a proper antecedent basis.
As to claim 8, the wording of “…is conformal to each other” is not proper grammatically and leads to a lack of clarity.
Claim 13 recites “the tape” in line 2. Based on the language in claim 1, it is unclear if claim 13 is referring to each individual layer of tape or different layers added together.
Claim 14 recites “the protective film” in line 2. This is inconsistent with claim 2 which introduced “at least one protective film”, leading to a lack of clarity.
Claim 15 recites “the protective film” in line 1. There is a lack of antecedent basis for this limitation in the claim.
Claim 17 recites “the patch drug infusion device” in line 3. There is a lack of antecedent basis for this limitation in the claim.
Claim 17 recites “the driving unit” in line 4, which is unclear because claim 1 introduced two different driving units.
The preambles of each of claims 17-20 are inconsistent with claim 1. It is not clear if “The patch drug infusion device of claim [x]” is intended to further limit any of these claims.
Claim 20 is a device claim but recites “wherein the infusion mechanism module and the control mechanism module are … discarded together after a single-use”, which constitutes a method step. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. (see MPEP 2173.05(P))
Claims 2-20 are rejected as they depend from a rejected claim.
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, 2, 9, 10, 17, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith (US 2016/0089491) in view of Frey et al. (US 2016/0135747 A1, hereafter “Frey”).
As to claim 1, Smith discloses a drug infusion device (100; see Figs. 1A-7), comprising:
a reservoir (336), used for accommodating a drug to be infused, provided with a piston (335) and a screw (334);
a driving wheel (333), connected with the screw, driving the screw to push the piston forward by rotation (para 0031, 0050);
a driving unit (331 and/or gear train 332), driving the driving wheel to rotate (para 0050);
a power unit (221), connected with the driving unit, to offer power for the driving unit (para 0031, 0048);
a case (302 and 202 forming parts of a case), for accommodating the reservoir, the driving wheel, a driving unit and the power unit (see Figs. 1A-1B); and
an adhesive patch (“adhesive backing”), for attaching the drug infusion device to a skin (see para 0005, 0034, 0050, 0059-0060),
Smith is silent to wherein the adhesive patch includes at least two layers of tape, a first side of a first layer of the at least two layers of the tape is fixedly connected with a bottom of the case, and a second side opposite to the first side of the first layer of the at least two layers of the tape is coated with an adhesive material.
Frey discloses an adhesive patch (plaster kit 16) that includes at least two layers of tape (22, 24, 26), a first side of a first layer (22) of the at least two layers of the tape is fixedly connected with a bottom of a case (22 connected to bottom of 12; see para 0031), and a second side opposite to the first side of the first layer of the at least two layers of the tape is coated with an adhesive material (para 0031, 0033-0035).
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 the adhesive patch of Smith to include at least two layers of tape, a first side of a first layer of the at least two layers of the tape is fixedly connected with a bottom of the case, and a second side opposite to the first side of the first layer of the at least two layers of the tape is coated with an adhesive material similar to Frey. One would have been motivated to do so for the purpose of increasing the potential wearing time of the device/patch (see abstract, para 0006, 0033 of Frey).
As to claim 2, Smith in view of Frey discloses the drug infusion device of claim 1, and further wherein the adhesive patch further-further includes at least one protective film (“adhesive liner” – see para 0056 & 0059 of Smith; also see para 0032, 0038, & claim 4 of Frey teaching liners which can be used to cover adhesive and/or separate different layers).
As to claim 9, Smith in view of Frey discloses the drug infusion device of claim 1 as described above. While Smith is not explicit to the limitations of claim 9, Frey further discloses wherein the at least two layers of tape comprises an outer layer (24 or alternatively, 26) and an inner layer (22), the outer layer completely covers the inner layer (24/26 completely cover a peripheral surface of 22; see Figs. 1-2). Therefore, when modifying Smith, it would have been further obvious to one having ordinary skill in the art to do so such that the at least two layers of tape comprises an outer layer and an inner layer, the outer layer completely covers the inner layer, for the purpose of increasing the potential wearing time of the device/patch (see abstract, para 0006, 0033 of Frey).
As to claim 10, Smith in view of Frey discloses the drug infusion device of claim 1 as described above. While Smith is not explicit to the limitations of claim 10, Frey further discloses wherein the at least two layers of tape comprises an outer layer (26) and an inner layer (24), the outer layer at least partially covers the inner layer (see Figs. 1-3, 9, para 0035). Therefore, when modifying Smith, it would have been further obvious to one having ordinary skill in the art to do so such that the at least two layers of tape comprises an outer layer and an inner layer, the outer layer at least partially covers the inner layer, for the purpose of increasing the potential wearing time of the device/patch (see abstract, para 0006, 0033 of Frey).
As to claim 17, Smith in view of Frey teaches the patch drug infusion device of claim 1 as described above, and further wherein the patch drug infusion device includes an infusion mechanism module (350) and a control mechanism module (200), the reservoir (336), the drive wheel (333), the driving unit (331 and/or gear train 332), the power unit (221) and the case are arranged on the infusion mechanism module (all specified components arranged on 350 when assembled – see Fig. 1A-1B).
As to claim 18, Smith in view Frey teaches the patch drug infusion device of claim 17, wherein the infusion mechanism module and the control mechanism module are detachable, and the control mechanism module is reusable (see para 0034, 0048).
Claim(s) 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith in view of Frey as applied to claim 2 above, and further in view of Gyrn (US 2011/0152778 A1).
As to claim 11, Smith in view of Frey teaches drug infusion device of claim 2 as described above, but is silent to wherein the at least one protective film is provided with at least one tearing portion.
Gyrn teaches including at least one tearing portion (score lines 4) within at least one protective film (“release liner”, which includes at least 3a, 3b; see Figs. 2-9, 11a, 11b).
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 Smith (as already modified above) further such that the at least one protective film is provided with at least one tearing portion. One would have been motivated to do so in order to provide an easy yet reliable removal of the at least one protective film with a predetermined patten (see abstract, para 0005, 0007, 0036 of Gyrn).
As to claim 12, Smith in view of Frey teaches drug infusion device of claim 2 as described above, but is silent to wherein at least one tearing portion is provided on an inner protective film of the at least one protective film.
Gyrn teaches including at least one tearing portion (score lines 4) within at least one protective film (“release liner”, which includes at least 3a, 3b; see Figs. 2-9, 11a, 11b).
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 Smith (as already modified above) further such that at least one tearing portion is provided on an inner protective film of the at least one protective film for the purpose of easy yet reliable removal of the at least one protective film with a predetermined patten (see abstract, para 0005, 0007, 0036 of Gyrn).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith in view of Frey as applied to claim 1 above, and further in view of Sonoda et al. (US 2008/0015624 A1, hereafter “Sonoda”).
As to claim 13, Smith in view of Frey teaches the drug infusion device of claim 1 as described above, but is silent to wherein a thickness of the tape is 1µm-500µm.
Sonoda discloses a thickness of a tape (adhesive film 54) being around 1 micron to 30 microns, but it should be noted that even an adhesive film having thickness of more than 30 microns can be applied thereto (see para 0402, 0442).
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 Smith further (as already modified above) such that a thickness of the tape is 1µm-500µm. One would have been motivated to do so as it taught by Sonoda that tapes can effectively apply devices to skin with thicknesses in the specified range (para 0402, 0442 of Sonoda), and further because the specific range of 1µm-500µm has not been specified as critical (see MPEP 2144.05).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith in view of Frey as applied to claim 2 above, and further in view of Blott et al. (US 2007/0167926 A1, hereafter “Blott”).
As to claim 14, Smith in view of Frey teaches the drug infusion device of claim 2 as described above, but is silent to wherein a thickness of the protective film is 10µm~500µm.
Blott teaches a protective layer “often with a (generally uniform) thickness of up to 100 micron, preferably up to 50 micron, more preferably up to 25 micron, and of 10 micron minimum thickness” (para 0073).
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 Smith (as already modified above) to include a protective film having a thickness of 10µm~500µm. One would have been motivated to do so as Blott teaches a backing having a thickness in the specified range as being capable of providing a fluid-tight seal (see para 0029, 0070, 0073 of Blott), and further because the specific range of 10µm-500µm has not been specified as critical (see MPEP 2144.05).
Claim(s) 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith in view of Frey as applied to claim 1 above, and further in view of Taub (US 2009/0088614 A1).
As to claim 15, Smith in view of Frey teaches the drug infusion device of claim 1 as described above, but is silent to wherein the protective film is one of polycarbonate, polyamide, polyformaldehyde, polyphenyl ether, polyester, polyphenylene sulfide and polyaryl-ester.
Taub discloses a protective film (“peelable release liner”) wherein the protective film is polyester (see para 0085 of Taub).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modfied Frey to use a protective film and/or modify the existing protective film (see para 0056 & 0059 of Smith; also see para 0032, 0038, & claim 4 of Frey) such that the protective film is polyester because Taub teaches Polyester as a suitable material for protective films and further because it has been held that the selection of a known material based on its suitability for its intended use is prima facie obvious (see MPEP 2144.07)
As to claim 16, Smith in view of Frey teaches the drug infusion device of claim 1 as described above, but is silent to wherein before the adhesive patch is pasted on a surface of the skin, the second side of the first layer of the tape is covered with at least one layer of release paper.
Taub discloses an adhesive patch including tape, wherein before the adhesive patch is pasted on a surface of the skin, a second side of the tape is covered with at least one layer of release paper (see para 0075, 0085 disclosing that a release liner made of silizonized paper can be removed from an adhesive layer before placement on skin).
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 Frey such that before the adhesive patch is pasted on a surface of the skin, the second side of the first layer of the tape is covered with at least one layer of release paper. One would have been motivated to do so in order to maintain integrity of the adhesive prior to placement on skin (see para 0085 of Taub).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith in view of Frey as applied to claim 1 above, and further in view of Flaherty (US 2002/0169439 A1), hereafter “Flaherty ‘439”.
As to claim 19, Smith in view of Frey teaches the patch drug infusion device of claim 18 as described above, but are silent to wherein the infusion mechanism module and the control mechanism module are electrically connected to each other by a plurality of electrical contacts.
Flaherty ‘439 discloses various ways of organizing infusion mechanism modules (800, throughout figures) and control mechanism modules (700, throughout figures) and teaches wherein the infusion mechanism module and the control mechanism module are electrically connected to each other by a plurality of electrical contacts (see para 0067, 0085, Claim 11).
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 Smith (as already modified above) to organize the infusion mechanism module and the control mechanism module in any of various manners, and to have done so such that the infusion mechanism module and the control mechanism module are electrically connected to each other by a plurality of electrical contacts. One would have been motivated to do so as a means of providing electrical connection between the infusion mechanism module and the control mechanism module (see para 0067, 0085, Claim 11 of Flaherty ‘439).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith in view of Frey as applied to claim 17 above, and further in view of Flaherty (US 2002/0072733) hereafter “Flaherty ‘733”.
As to claim 20, Smith in view of Frey teaches the patch drug infusion device of claim 17 as described above, but is silent to wherein the infusion mechanism module and the control mechanism module are disposed in one housing, and discarded together after a single-use.
Flaherty ‘733 teaches placement of different modules (e.g. see Figs. 3-3b showing a dispensing module including dispenser 40 and reservoir module comprising 30 and 33 and 34) disposed within one housing, and discarded together after a single-use (see para 0011).
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 Smith (as already modified above) such that the infusion mechanism module and the control mechanism module are disposed in one housing, and discarded together after a single-use. One would have been motivated to do so based off Flaherty ‘733, for the purpose of cost reduction and making the entire device disposable in nature (see para 0011 of Flaherty ‘733).
Allowable Subject Matter
Claims 3-8 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 examiner notes that any amendments made to address the rejection(s) under 35 U.S.C. 112(b) may affect the prior art considerations.
The following is a statement of reasons for the indication of allowable subject matter:
As to claim 3, while Smith in view of Frey teaches the drug infusion device of claim 2 as described above, each are silent to wherein among the at least two layers of the tape and the at least one protective film, except for the first layer of the tape, the other layer(s) of the tape and the protective film(s) are annular, and laminated and sleeved on the drug infusion device in combination with the limitations of claims 1-2.
Claims 6-8 depend from claim 3.
As to claim 4, while Smith in view of Frey teaches the drug infusion device of claim 2 (it is assumed that claim 4 is intended to depend from claim 2 based on antecedent basis issues) as described above, each are silent to wherein a rockwell hardness of the at least one protective film is higher than that of the at least two layers of the tape in combination with the limitations of claims 1-2.
Claim 5 depends from claim 4.
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