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 biasing arrangement configured to bias the rupturing element into the initial position” in claim 19, and “a locking mechanism associated with the rupturing element, and is configured such that in a locked condition of the locking mechanism, the rupturing element is prevented from being moveable to rupture the fluid reservoir, and in an unlocked condition of the locking mechanism, the rupturing element is moveable to be able to rupture the fluid reservoir” of claim 29.
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 § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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.
Claim(s) 16-18, 20, 26-28 and 33 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dunmire (US 2,696,212).
As to claim 16, Dunmire discloses a patch (1; see Figs. 1-6) for placement on skin and for use with an injector device (“for use with” represents an intended use and is not a positive recitation of any particular injector device), the patch comprising:
a first layer (2; or alternatively, 22) on a first side of the patch;
a second layer (4) on a second side of the patch opposite to the first side;
a sealed fluid reservoir (interior of 1 defined by 2, 3, 4) between the first and second layers (see Fig. 2); a fluid contained within the fluid reservoir (para beginning line 22 col. 4); a moveable rupturing element (10) configured to be movable so as to pierce and rupture the fluid reservoir to allow release of the fluid out of the fluid reservoir (see para beginning line 68 col. 3 and para beginning line 62 col. 4); and
an aperture (33 or either of 25/26) extending at least partially through the patch, and configured to receive an injection needle of the injector device (the examiner notes that the claim makes no mention of any particular size of the injection needle or capacity in which it is used therefore this limitation is purely functional and thus the specified apertures are considered to be capable of receiving injection needles, depending on a relative size of the needle).
As to claim 17, Dunmire discloses the patch according to claim 16, wherein the fluid reservoir is defined by the first and second layers (see Fig. 2).
As to claim 18, Dunmire discloses the patch according to claim 16, wherein the rupturing element is moveable between an initial position (position seen in Fig. 2) and an activated position in which the rupturing element ruptures the fluid reservoir (see at least lines 62-65 col. 4 and lines 4-9 col. 5).
As to claim 20, Dunmire discloses the patch according to claim 16, wherein the rupturing element is disposed within the fluid reservoir (Fig. 2).
As to claim 26, Dunmire discloses the patch according to claim 16, wherein the first layer comprises a pierceable membrane which can be pierced by the rupturing element to rupture the fluid reservoir (see para beginning line 68 col. 3 and para beginning line 62 col. 4).
As to claim 27, Dunmire discloses the patch according to claim 26, wherein the pierceable membrane includes one or more regions of weakness (45) at which the pierceable membrane is more easily ruptured than at other regions of the pierceable membrane (see Fig. 5 & lines 71-75 col. 5).
As to claim 28, Dunmire discloses the patch according to claim 27, wherein at least one region in the one or more regions of weakness comprises a region of reduced thickness in the pierceable membrane (see Fig. 5 & lines 71-75 col. 5).
As to claim 33, Dunmire discloses a method comprising:
moving a moveable rupturing element (10) of a patch (1; see Figs. 1-6) to rupture a fluid reservoir (interior of 1 defined by 2, 3, 4) of the patch to allow release of fluid out of the fluid reservoir (see para beginning line 68 col. 3 and para beginning line 62 col. 4),
wherein the patch comprises a first layer (2; or alternatively, 22) on a first side of the patch, a second layer (4) on a second side of the patch opposite to the first side, the fluid reservoir that is sealed and is in between the first and second layers (see Fig. 2), the fluid contained within the fluid reservoir (see Fig. 2), the moveable rupturing element configured to be movable so as to pierce and rupture the fluid reservoir (see para beginning line 68 col. 3 and para beginning line 62 col. 4), and an aperture (33 or either of 25/26) extending at least partially through the patch to receive an injection needle of an injector device (the examiner notes that the claim makes no mention of any particular size of the injection needle or capacity in which it is used therefore this limitation is purely functional and thus the specified apertures are considered to be capable of receiving injection needles, depending on a relative size of the needle).
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) 16, 18, 19, 21, 24 and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gertsek et al. (US 6,656,147 B1, hereafter “Gertsek”) in view of Shantha et al. (US 2009/0312706 A1, hereafter “Shantha”)
As to claim 16, Gertsek discloses a patch (100; see Figs. 7-9) for placement on skin (118; see para beginning line 24 col. 9) and for use with an injector device (“for use with” represents an intended use an is not a positive recitation of any particular injector device), the patch comprising:
a first layer (22; or alternatively the first layer can be interpreted as the material of the bladder 16’) on a first side of the patch;
a second layer (34) on a second side of the patch opposite to the first side;
a sealed fluid reservoir (16’) between the first and second layers; a fluid contained within the fluid reservoir (lines 34-39 col. 3, lines 30-34 col. 9); a moveable rupturing element (102) configured to be movable so as to pierce and rupture the fluid reservoir to allow release of the fluid out of the fluid reservoir (see line 61 col. 8 through line 33 col. 9; the cannula 104 can be an integral part of 102, and the arms 112 must move in order for piercing to occur).
Gertsek is silent to an aperture extending at least partially through the patch, and configured to receive an injection needle of the injector device.
Shantha discloses a patch (10) including an aperture (11) extending at least partially through the patch (see Figs. 1, 3), and configured to receive an injection needle of the injector device (see Fig. 2).
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 Gertsek to include an aperture extending at least partially through the patch, and configured to receive an injection needle of the injector device. One would have been motivated to do so in order to permit injections through the patch (see Figs. 1-3 and para 0020 of Shantha).
As to claim 18, Gertsek in view of Shantha discloses the patch according to claim 16, wherein the rupturing element is moveable between an initial position (“normal position” – see Fig. 7 and para beginning line 32 col. 9 of Gertsek) and an activated position (position of Fig. 9) in which the rupturing element ruptures the fluid reservoir (see para beginning line 25 col. 9 of Gertsek).
As to claim 19, Gertsek in view of Shantha discloses the patch according to claim 18, further comprising a biasing arrangement (material of arms 112) configured to bias the rupturing element into the initial position (see Fig. 7 and para beginning line 32 col. 9 of Gertsek).
As to claim 21, Gertsek in view of Shantha discloses the patch according to claim 16, wherein the patch comprises a support member (22’) that supports the rupturing element (Figs. 7, 9 of Gertsek).
As to claim 24, Gertsek in view of Shantha discloses the patch according to claim 16, wherein the rupturing element is disposed outside the fluid reservoir (Figs. 7, 9 of Gertsek).
As to claim 26, Gertsek in view of Shantha discloses the patch according to claim 16, wherein the first layer comprises a pierceable membrane which can be pierced by the rupturing element to rupture the fluid reservoir (this is true under the second interpretation of the first layer mentioned above – see Figs. 7-9).
Claim(s) 31-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gertsek in view of Ulrich et al. (US 2014/0324021 A1, cited previously and hereafter “Ulrich”).
As to claim 31, Gertsek discloses a system comprising:
a patch (100; see Figs. 7-9) for placement on skin (118; see para beginning line 24 col. 9); and
wherein the patch comprises
a first layer (22; or alternatively the first layer can be interpreted as the material of the bladder 16’) on a first side of the patch,
a second layer (34) on a second side of the patch opposite to the first side,
a sealed fluid reservoir (16’) between the first and second layers,
a fluid contained within the fluid reservoir (lines 34-39 col. 3, lines 30-34 col. 9),
a moveable rupturing element (102) configured to be movable so as to pierce and rupture the fluid reservoir to allow release of the fluid out of the fluid reservoir (see line 61 col. 8 through line 33 col. 9; the cannula 104 can be an integral part of 102, and the arms 112 must move in order for piercing to occur).
Gertsek is silent to an injector device for use with the patch, wherein the injector device comprises a housing configured to receive a container of medicament and an aperture extending at least partially through the patch, and configured to receive an injection needle of the injector device.
Ulrich discloses an injector device (18; see Figs. 1 & 4-8) for use with a patch (14), wherein the injector device comprises a housing (230) configured to receive a container (240) of medicament, and the patch comprises an aperture (205) specifically configured to receive an injection needle of the injector device (needle not numbered but depicted in Figs. 7-8; also see para 0038, 0054, 0055).
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 system of Gertsek to include an injector device for use with the patch, wherein the injector device comprises a housing configured to receive a container of medicament, and include an aperture specifically configured to receive an injection needle of the injector device. One would have been motivated to do so based off of Ulrich, for the motivation of being able to provide different substances via the patch and injector device (e.g. a substance for pain management or an anti-inflammatory and a medication for a specific condition of the patient – see para 0007, 0009, 0031, 0036, 0052).
As to claim 32, Gertsek in view of Ulrich teaches the system of claim 31 as described above. When modifying Gertsek, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further do so such that the injector device comprises the container of medicament received within the housing, based off of Ulrich, for the motivation of providing the substance injected by the injector device (see abstract, para 0007, 0009, 0031, 0035, of Ulrich).
As to claim 33, Gertsek disclose a method comprising:
moving a moveable rupturing element (102) of a patch (100; see Figs. 7-9) to rupture a fluid reservoir (16’) of the patch to allow release of fluid out of the fluid reservoir (see line 61 col. 8 through line 33 col. 9; the cannula 104 can be an integral part of 102, and the arms 112 must move in order for piercing to occur),
wherein the patch comprises a first layer (22; or alternatively the first layer can be interpreted as the material of the bladder 16’) on a first side of the patch, a second layer (34) on a second side of the patch opposite to the first side, the fluid reservoir that is sealed and is in between the first and second layers, the fluid contained within the fluid reservoir, the moveable rupturing element configured to be movable so as to pierce and rupture the fluid reservoir (see Figs. 7-9 and line 61 col. 8 through line 33 col. 9; the cannula 104 can be an integral part of 102, and the arms 112 must move in order for piercing to occur).
Gertsek is silent to an aperture extending at least partially through the patch to receive an injection needle of an injector device.
Ulrich disclose a patch (14) including an aperture (205) extending at least partially through the patch to receive an injection needle of an injector device (18; see Figs. 1 & 4-8).
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 method of Gertsek to include an aperture extending at least partially through the patch to receive an injection needle of an injector device. One would have been motivated to do so based off of Ulrich, for the motivation of being able to provide different substances via the patch and injector device (e.g. a substance for pain management or an anti-inflammatory and a medication for a specific condition of the patient – see para 0007, 0009, 0031, 0036, 0052).
As to claim 34, Gertsek in view of Ulrich teaches the method according to claim 33 as described above, and further comprising placing the patch on skin of a patient (lines 24-27 col. 9 of Gertsek).
Allowable Subject Matter
Claims 22, 23, 25, 29, 30, 35 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including 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:
Each of the claims listed above, which are dependent claims, requires a combination of limitations that are not taught or made obvious by any of Dunmire, Gertsek, or Ulrich, either alone or in combination. Therefore, the specified claims are considered non-obvious over the prior art.
Response to Arguments
Applicant’s Remarks submitted 12/22/25 have been considered. While the arguments regarding the previously-cited Genosar reference are persuasive, the amendments prompted new rejections using the art specified 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 James D Ponton whose telephone number is (571)272-1001. The examiner can normally be reached M-F 9am-5pm.
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/James D Ponton/Primary Examiner, Art Unit 3783