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 .
Claims 1, 3, 5, 7-9 and 11-14 are currently amended
Claims 2, 4 and 15 are cancelled.
Claim Rejections - 35 USC § 112
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 the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claim 14 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
The claim contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The claim recites “a force-applying application device”, however, the specification fails to provide the structure, material or acts to support the claim. The specification merely recites “a microneedle device to be applied using an in particular force-applying application device” (refer to page 2). As such, the claim recites a function that has no limits and covers every conceivable means and/or device that can be used to apply force. Thus, the specification fails to provide a written description that supports the claim.
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 use the word “means,” and
thus are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitations use a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are: “by means of a force-applying application device” in claim 14.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
Regarding claim 14, the limitation “by means of a force-applying application device” 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. The disclosure is devoid of any structure that performs the function in the claim
If applicant does not intend to have this limitation interpreted under 35 U.S.C. 112(f)
or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 103
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, 3, 5-14 are rejected under 35 U.S.C. 103 as being unpatentable over YuWei Zhuhai Biotechnology Co Ltd (CN 108744261 A, herein, Zhuhai). in view of Brandwein et al. (US 20080208146 A1, herein, Brandwein).
Regarding claim 1, Zhuhai discloses a microneedle device (1 – Fig.1) comprising:
a microneedle array (12 – Fig.1); and
a sensor device connected to the microneedle array (122 – Fig.1),
the sensor device being configured to detect at least one force acting on the microneedle array (“force of use when pressed”, 1222 – Fig.2).
Zhuhai does not appear to expressly disclose wherein the sensor device comprises two force sensors,
wherein one of the force sensors is configured to detect an application force applied on the microneedle array during application of the microneedle array into the skin, and
wherein the other one of the force sensors is configured to detect a counterforce acting from the skin on the microneedle array.
Brandwein teaches wherein the sensor device comprises two force sensors (“one or more sensors are provided on the tool for sensing forces between the tool and a surface (such as a target skin surface)”, see para [0036]),
wherein one of the force sensors (58 – Fig.6) is configured to detect an application force applied on the microneedle array during application of the microneedle array into the skin (“sensor 58 is capable of sensing applied mechanical forces”, see para [0044]), and
wherein the other one of the force sensors (80 – Fig.6) is configured to detect a counterforce acting from the skin on the microneedle array (“a sensor arranged relative to any of locations 80A-80C will sense forces applied to the collar 40”, see para [0050]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Brandwein with the disclosure of Zhuhai so that the sensor device comprises two force sensors in order to further “permit detection of an orientation of the device relative to the skin surface” (Brandwein, Para [0053]).
Regarding claim 3, Zhuhai discloses the microneedle device as recited above, wherein the sensor device comprises at least one piezoelectric force sensor (under broadest reasonable interpretation, examiner interprets the sensor device to comprise at least one force sensor (“pressure sensor 1222 for receiving a pressing force”), 1222 – Fig.2).
Regarding claim 5, Zhuhai discloses the microneedle device as recited above, wherein the sensor device comprises a cylindrical support structure (11 – Fig.1).
Regarding claim 6, Zhuhai discloses the microneedle device as recited above, wherein the sensor device comprises a cylindrical support structure (11 – Fig.1).
Zhuhai does not appear to expressly disclose that two opposing force sensors are connected to the support structure.
However, Brandwein teaches wherein two opposing force sensors are connected to the support structure (sensor regions 108 and 110, See Fig.7A and Para [0064]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Brandwein with the disclosure of Zhuhai so that the support structure comprises two opposing force sensors in order to further “permit detection of an orientation of the device relative to the skin surface” (Brandwein, Para [0053]).
Regarding claim 7, Zhuhai discloses the microneedle device as recited above, wherein the sensor device is connected two-dimensionally to the rear side of the microneedle array (122 – Fig.3).
Regarding claim 8, Zhuhai discloses the microneedle device as recited above, wherein further comprising a processing device for the evaluation of the at least one detected force (“a processor disposed in the main body casing”, 112 – Fig.3).
Regarding claim 9, Zhuhai discloses the microneedle device as recited above, wherein the processing device is configured to compare the at least one detected force with a target force and/or to detect the period of force application (“when passing the pressure sensor 1222 the administration pressure value is obtained, and when the administration pressure value reaches the preset pressure threshold, the blue light flashes”).
Regarding claim 10, Zhuhai discloses the microneedle device as recited above, wherein the processing device is configured to provide a person with a feedback on an application of the microneedle array performed using the microneedle device (“pressure indicator light 114 includes red and blue capable of switching between two colours”).
Regarding claim 11, Zhuhai discloses the microneedle device as recited above, further comprising an acoustic and/or optical and/or haptic feedback device (“pressure indicator light 114 includes red and blue capable of switching between two colours”).
Regarding claim 12, Zhuhai discloses the microneedle device as recited above, further comprising a finger application surface for the manual application of the microneedle array by at least one finger of a user (“the main body assembly 11 can be provided in the form of a hand-held device, and is provided with a hand-held grip to make the user more convenient to press during use”).
Regarding claim 13, Zhuhai discloses a method for detecting at least one force acting on the microneedle array according to claim 1 by means of the sensor device connected to the microneedle array (1 and 122 – Fig.1).
Regarding claim 14, Zhuhai discloses a method for applying a microneedle array, the method comprising the steps of:
applying the microneedle array, the application being performed manually or by means of a force-applying application device (main body assembly 11 “is provided with a hand-held grip to make the user more convenient to press during use”);
detecting, at least one force acting on the microneedle array using the method according to claim 13 (“the pressure sensor 1222 (Pressure Transducer) is a device or device capable of sensing a pressure signal”); and
evaluating the at least one detected force and/or outputting a feedback on the at least one detected force (“pressure indicator light is used for feedback according to pressure data collected by the pressure sensor”).
Response to Arguments
Applicants arguments filed 08/07/2026 have been fully considered.
In regards to Applicants argument:
“Regarding the claim interpretation issues raised on pages 3-6 of the current Office Action, it is believed that use of the "means" language in any of the pending claims is clear and able to be adequately defined in scope due to the disclosure contained in the as-filed specification.”
This argument is not persuasive, and the claim interpretation is maintained.
In regards to Applicants argument:
“Claim 14 has been rejected under 35 U.S.C. § 112(a) for failing to comply with the written description requirement due to the use of the claim element "an application device". Given the disclosure contained in the as-filed specification, claim 14 has been amended to recite "a force-applying application device". As noted by the Examiner, support for this element is contained in the as-filed application. Thus, given this amendment to claim 14, it is believed that the 35 U.S.C. § 112(a) rejection of claim 14 has been rendered moot and withdrawal thereof is believed due and is respectfully requested.”
This argument is not persuasive because the specification fails to provide the structure, material or acts to support the claim. As such, the claim recites a function that has no limits and covers every conceivable means and/or device that can be used to apply force. Thus, the 35 U.S.C. § 112(a) rejection is maintained.
In regards to Applicants argument:
“Claims 1-12 and 14 have been rejected under 35 U.S.C. § 112(b) as indefinite. Given this, all of the occurrences of "in particular" and "preferably" have been removed from the pending claim set. As such, it is believed that the 35 U.S.C. § 112(b) rejection of claims 1-12 and 14 has been rendered moot and withdrawal thereof is believed due and is respectfully requested.”
This argument is persuasive and the 35 U.S.C. § 112(b) rejections has been withdrawn.
In regards to Applicants argument:
“Given the above, it is clear that while Brandwein discloses two or more force sensors, such two or more force sensor are only concerned with obtaining feedback as to the orientation of patch (52) relative to target application site (54), which then can only be used to predict and characterize patch application path (78) (emphasis supplied).
Thus, for at least the reasons stated above, it is clear that Brandwein fails to disclose teach, or suggest utilizing two force sensors in a manner such that one of the force sensors is configured to detect an application force applied on the microneedle array during application of the microneedle array into the skin and the other force sensor is configured to detect a counterforce acting from the skin on the microneedle array (emphasis supplied).”
This argument is persuasive and the 35 U.S.C. § 102 rejection for claim 1 has been withdrawn, however, upon further consideration, a new ground of rejection is made in view of Brandwein et al. (US 20080208146 A1) for the following reasons:
The amended claims only require two force sensors. Brandwein teaches “one or more sensors are provided on the tool for sensing forces between the tool and a surface (such as a target skin surface)”, see para [0036]. Examiner interprets this to be equivalent to the two force sensors. Furthermore, Brandwein does not appear to explicitly limit the use of the two force sensors solely for patch application path and teaches that the feedback sensor “is capable of generating an output corresponding to forces between the target skin location and the microneedle application device”, see Abstract.
In response to applicant's argument that “one of the force sensors is configured to detect an application force applied on the microneedle array during application of the microneedle array into the skin and the other force sensor is configured to detect a counterforce acting from the skin on the microneedle array”, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Additionally, according to the laws of physics every force has an equal and opposite counterforce, hence Examiner interprets the force from the application tool as one force and the force of the user’s skin in return as the counterforce, “for sensing forces between the tool and a surface (such as a target skin surface), see para [0036].” Therefore, the rejection as recited above is maintained.
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.
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/T.M.A./
Examiner, Art Unit 3783
/CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
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