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 1-18 are cancelled.
Claims 19-38 are new.
Claims 19-38 are being examined in this Office Action.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 98 and 108 in Fig. 1. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
Page 15 Lines 29-30, flexible antenna is given the reference numeral 51 when in previous and later iterations it is given the reference numeral 501.
Reference numeral 120 is referred to both as a user interface module and an electronic module.
Appropriate correction is required.
Claim Objections
Claims 29 and 34 are objected to because of the following informalities:
Claim 29 line 3 should contain a period at the end of the sentence.
Claim 34 line 4 should contain a period at the end of the sentence.
Appropriate correction is required.
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.
Claims 28, 30, and 32-34 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.
Claims 28, 30, and 32-34 recites the limitation "the arrangement" in the preamble. There is insufficient antecedent basis for this limitation in the claim. Examiner interprets “the arrangement” to be the previously recited apparatus of claim 19.
Claim Rejections - 35 USC § 102
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.
The following is a quotation of the appropriate paragraphs of 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) 19, 21, 22, 26, 29, 31, 32, and 35-38 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hammen et al. (Pub. No. US 20190388619 A1, herein Hammen).
Regarding Claim 19, Hammen discloses an apparatus for a drug delivery device (Fig. 1A), the apparatus comprising:
at least one electronic circuit (128);
an antenna for wireless communication (130, Paragraph [0032]);
and a body (106),
wherein the antenna is operatively connected to the electronic circuit (Paragraphs [0032]- [0033]),
wherein the antenna is flexible (Paragraph [0033]), and
wherein the antenna is adapted to follow a contour defined by the body (Fig. 1A).
Regarding Claim 21, Hammen discloses the apparatus of claim 19, wherein a curvature of the antenna follows a curvature that is defined by the body (Fig. 1A, antenna 130 having a flexible structure forming around 106).
Regarding Claim 22, Hammen discloses the apparatus of claim 19, wherein the antenna is arranged on a flexible carrier substrate (antenna 130 arranged on flexible smart label 104 in Fig. 1A), and
wherein the flexible carrier substrate is part of a circuit board (104 including foil 122b where components are connected, Paragraph [0026]) of the electronic circuit (128 connected to 104 in Fig. 1A).
Regarding Claim 26, Hammen discloses the apparatus of claim 19, wherein the antenna is arranged and configured for at least one of the following features:
being arranged within a region between at least one distal electronic circuit and at least one proximal electronic circuit (“A plurality of flexible components can be attached to the carrier layer/foil 122b. The flexible components can include printed electronics generated using functional inks for printing the electronics defining the flexible smart label 104. The plurality of flexible components includes light emitting diodes (LEDS) 124a and 124b, photodiodes 126a and 126b” – Paragraph [0026]). Antenna 130 arranged between proximal photodiode 126b and distal photodiode 126b which are connected via 122b.
Regarding Claim 29, Hammen discloses the apparatus of claim 19,
wherein the apparatus comprises a longitudinal axis (axis that runs from 111 to 113 in Fig. 1A), and
wherein a main direction of extension of the antenna is along the longitudinal axis (130 extending along longitudinal axis in Fig. 1A).
Regarding Claim 31, Hammen discloses the apparatus of claim 19, comprising:
an electrical impedance matching network (“the impedance connected to the antenna 130 may be periodically modulated by an electronic code generator circuit 133 within the smart label 104,” – Paragraph [0035]),
wherein the antenna is connected to the electrical impedance matching network (“the impedance connected to the antenna 130 may be periodically modulated by an electronic code generator circuit 133 within the smart label 104,” – Paragraph [0035]), and
wherein the electrical impedance matching network comprises at least two passive electronic components that are discrete electronic components (130, 133, 142, 146, 148, 162, or 166, Paragraph [0035]).
Regarding Claim 32, Hammen discloses the arrangement of claim 19, wherein a first attachment region is formed adjacent to a free end of the antenna on a carrier substrate of the antenna (examiner interprets attachment region to be the portion of the flexible smart label 104, adjacent to antenna 130, that is affixed to the cartridge), and
wherein the first attachment region is configured to position the antenna relative to the body (Paragraphs [0020], [0022], [0024]).
Regarding Claim 35, Hammen discloses a drug delivery device (Fig. 1A) comprising:
an apparatus (104) comprising:
at least one electronic circuit (128);
an antenna for wireless communication (130, Paragraph [0032]);
and a body (106),
wherein the antenna is operatively connected to the electronic circuit (Paragraphs [0032]- [0033]),
wherein the antenna is flexible (Paragraph [0033]), and
wherein the antenna is adapted to follow a contour defined by the body (Fig. 1A)
and
at least one of:
a medicament container (106, Paragraph [0021]),
a medicament container holding part (115, “The injection device 102 can include the housing 110 and contains the cartridge 106, to which a needle assembly 115 that includes a needle 113 can be affixed” – Paragraph [0020]), and
a piston rod which is adapted to be inserted into the medicament container during injection (108, Paragraph [0022]).
Regarding Claim 36, Hammen discloses the drug delivery device of claim 35, wherein the medicament container holding part (115) is made as a separate part of the drug delivery device (115 attaching to 106 in Fig. 1A) compared to a main housing (110).
Regarding Claim 37, Hammen discloses a user interface module (Fig. 1A) comprising:
an apparatus (104) for a drug delivery device (102), the apparatus comprising at least one electronic circuit (128), an antenna for wireless communication (130), and a body (106), wherein the antenna is operatively connected to the electronic circuit (Paragraphs [0032]- [0033]), the antenna is flexible (Paragraph [0033]), and the antenna is adapted to follow a contour defined by the body (Fig. 1A),
wherein the user interface module comprises at least one of the following:
at least one sensor that is configured to detect a movement or a rotation of an element of the drug delivery device during injection of a medicament or during adjustment of a dose of a medicament to be injected (“The carrier layer/foil 122b can include electronic components such as LEDs and photodiodes that can be used to sense characteristics of the injection device 102 such as the stopper position and/or amount of medicament in the cartridge 106.”- Paragraph [0022]), or
at least one mechanical interface that is configured to be connected to the drug delivery device (111, Fig. 1A).
Regarding Claim 38, Hammen discloses the user interface module of claim 37, wherein the user interface module is a rotatable dose adjusting knob (“A dose of the contained medicament can be ejected from the injection device 102 by turning the dosage knob 112” – Paragraph [0021]).
Claim Rejections - 35 USC § 103
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.
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.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hammen in view of Rolsted et al. (Pub. No. US 20170338864 A1, herein Rolsted).
Regarding Claim 20, Hammen discloses the apparatus of claim 19, wherein the antenna is arranged on a flexible carrier substrate (104, Fig. 1A, Paragraph [0024]),
wherein the flexible carrier substrate is part of a circuit board (104 including foil 122b where components are connected, Paragraph [0026]) of the electronic circuit (128 connected to 104 in Fig. 1A).
Hammen does not expressly disclose wherein the antenna comprises a main portion and a connecting portion which are oriented in different directions,
wherein the connecting portion is arranged between the main portion and the electronic circuit, wherein the connecting portion is arranged at an angle relative to the main portion of the antenna, wherein the angle allows a winding of the antenna in a plane perpendicular to a longitudinal axis of the body, and
wherein a main part of the circuit board is arranged in a plane which is perpendicular to the longitudinal axis of the body.
However, Hammen discloses where the smart label can be configured to be attached to a variety of surface geometries (Paragraph [0024]).
Rolsted teaches wherein the antenna (105) is arranged on a flexible carrier substrate (107),
wherein the flexible carrier substrate is part of a circuit board (111) of the electronic circuit (Paragraph [0009], Fig. 2),
wherein the antenna comprises a main portion (105) and a connecting portion (107d) which are oriented in different directions (Fig. 2, Paragraph [0024]),
wherein the connecting portion is arranged between the main portion and the electronic circuit (Fig. 2), wherein the connecting portion is arranged at an angle relative to the main portion of the antenna (Fig. 2), and
wherein a main part of the circuit board is arranged in a plane which is perpendicular to the longitudinal axis of the body (electronics circuit assembly 111 oriented perpendicular to central axis 122 in Fig. 1).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus disclosed by Hammen wherein the antenna comprises a main portion and a connecting portion which are oriented in different directions, wherein the connecting portion is arranged between the main portion and the electronic circuit, wherein the connecting portion is arranged at an angle relative to the main portion of the antenna, wherein the angle allows a winding of the antenna in a plane perpendicular to a longitudinal axis of the body, and wherein a main part of the circuit board is arranged in a plane which is perpendicular to the longitudinal axis of the body as taught by Rolsted so that the flexible carrier member may be able to contain various electronic and mechanical components and be folded to fit inside of a data communication module (Rolsted, Paragraph [0024]).
Rolsted does not expressly disclose wherein the angle allows a winding of the antenna in a plane perpendicular to a longitudinal axis of the body.
However, Rolsted teaches where the flexible printed circuit board may possess numerous different structures, including various components integrally formed (Paragraph [0009]) and can be made of separate flexible printed circuit board pieces (Paragraph [0024]).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus disclosed by modified Hammen in view of Rolsted wherein the angle allows a winding of the antenna in a plane perpendicular to a longitudinal axis of the body as taught by Rolsted so that the flexible circuit board, which holds the flexible antenna, is able to wind around the body (Rolsted, Paragraph [0009]).
Regarding Claim 23, Hammen discloses the apparatus of claim 22, wherein the antenna is wrapped around the body (130 wrapped around 106 in Fig. 1A).
Hammen does not expressly disclose the electronic circuit is arranged within the body.
Rolsted teaches the electronic circuit (111) is arranged within the body (Fig. 1).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus disclosed by Hammen wherein the electronic circuit is arranged within the body as taught by Rolsted so that the antenna is protected from EMI noise generated from the electronic circuit (Rolsted, Paragraph [0027]).
Regarding Claim 24, Hammen discloses the apparatus of claim 22.
Hammen does not expressly disclose wherein the antenna comprises a main portion and a connecting portion which are oriented in different directions,
wherein the connecting portion is arranged at an angle relative to the main portion of the antenna,
wherein the angle allows a winding of the antenna in a plane perpendicular to a longitudinal axis of the body, and
wherein a main part of the circuit board is arranged in a further plane which is perpendicular to the longitudinal axis of the body.
Rolsted teaches wherein the antenna comprises a main portion (105) and a connecting portion (107d) which are oriented in different directions (Fig. 2),
wherein the connecting portion is arranged at an angle relative to the main portion of the antenna (Fig. 2), and
wherein a main part of the circuit board is arranged in a further plane which is perpendicular to the longitudinal axis of the body (111 arranged perpendicular to central axis 122 in Fig. 1).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus disclosed by Hammen wherein the antenna comprises a main portion and a connecting portion which are oriented in different directions, wherein the connecting portion is arranged at an angle relative to the main portion of the antenna, wherein the angle allows a winding of the antenna in a plane perpendicular to a longitudinal axis of the body, and wherein a main part of the circuit board is arranged in a further plane which is perpendicular to the longitudinal axis of the body.
Rolsted does not expressly disclose wherein the angle allows a winding of the antenna in a plane perpendicular to a longitudinal axis of the body.
However, Rolsted teaches where the flexible printed circuit board may possess numerous different structures, including various components integrally formed (Paragraph [0009]) and can be made of separate flexible printed circuit board pieces (Paragraph [0024]).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus disclosed by modified Hammen in view of Rolsted wherein the angle allows a winding of the antenna in a plane perpendicular to a longitudinal axis of the body as taught by Rolsted so that the flexible circuit board, which holds the flexible antenna, is able to wind around the body (Rolsted, Paragraph [0009]).
Regarding Claim 30, Hammen discloses the arrangement of claim 19.
Hammen does not expressly disclose wherein the antenna comprises a main portion and a connecting portion which are oriented in different directions, and
wherein the connecting portion is arranged between the main portion and the electronic circuit.
Rolsted teaches wherein the antenna comprises a main portion (105) and a connecting portion (107d) which are oriented in different directions (Fig. 2), and
wherein the connecting portion is arranged between the main portion and the electronic circuit (Fig. 2).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus disclosed by Hammen wherein the antenna comprises a main portion and a connecting portion which are oriented in different directions, and wherein the connecting portion is arranged between the main portion and the electronic circuit as taught by Rolsted so that the apparatus may be folded into its folded structure (Rolsted, Paragraph [0024]).
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hammen in view of Kube et al. (Pub. No. US 20170172701 A1, herein Kube).
Regarding Claim 25, Hammen discloses the apparatus of claim 19,
Hammen does not expressly disclose wherein the antenna is a monopole antenna or a dipole antenna.
Kube teaches wherein the antenna is a dipole antenna (4, Fig. 2, Paragraph [0020]).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus disclosed by Hammen wherein the antenna is a dipole antenna as taught by Kube so that an entire area of the printed circuit board can be used to house an antenna (Paragraph [0020]).
Claim(s) 27 and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hammen.
Regarding Claim 27, Hammen discloses the apparatus of claim 19, wherein the apparatus comprises a longitudinal axis (axis that runs from 111 to 113 in Fig. 1A) and wherein a main portion of the antenna extends around the longitudinal axis (130 extending around longitudinal axis in Fig. 1A).
Hammen does not expressly disclose wherein an angular extension of the antenna is at least 180 degrees.
However, Hammen discloses that the antenna has a flexible structure and can be made from a conductive and transparent material configured to maintain the elasticity of the flexible smart label (Paragraph [0033]) and the flexible smart label can be configured to attach to a variety of surface geometries, including curved (Paragraph [0024)
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus disclosed by Hammen wherein an angular extension of the antenna is at least 180 degrees since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or working ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. See MPEP 2144.05. II.
Regarding Claim 28, modified Hammen discloses the arrangement of claim 27, wherein a main direction of extension of the antenna is in an angular direction (Examiner interprets that the antenna would extend around cartridge 106 as smart label 104 demonstrates in Fig. 1A).
Claim(s) 33 and 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hammen in view of Klemm et al. (Pub. No. US 20180093042 A1, herein Klemm).
Regarding Claim 33, Hammen discloses the arrangement of claim 19.
Hammen does not expressly disclose wherein the apparatus comprises a guide structure to define a path of the antenna along the contour of the body.
Klemm teaches the apparatus (Fig. 12) comprises a guide structure (322, 323, and 352) to define a path of the antenna along the contour of the body (Paragraph 0214, communication zone 14 of foil 11 following path created by fastening elements and printed circuit board 352 running along distal housing 320 in Fig. 12).
Therefore, it would be obvious to one of ordinary skill of the art before the effective filing date of the claimed invention to modify the apparatus disclosed by Hammen wherein the apparatus comprises a guide structure to define a path of the antenna along the contour of the body as taught by Klemm so that the antenna may be releasably fastened to the housing (Klemm, Paragraph [0214]).
Regarding Claim 34, Hammen discloses the arrangement of claim 19.
Hammen does not expressly disclose wherein the body comprises at least one attachment element that is configured to interact with at least one attachment region of the apparatus in order to prevent relative movement of the antenna and the body along a main extension direction of the antenna.
Klemm teaches wherein the body (304) comprises at least one attachment element (305) that is configured to interact with at least one attachment region of the apparatus in order to prevent relative movement of the antenna and the body along a main extension direction of the antenna (Paragraph [0211], Figs. 12-13).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus disclosed by Hammen wherein the body comprises at least one attachment element that is configured to interact with at least one attachment region of the apparatus in order to prevent relative movement of the antenna and the body along a main extension direction of the antenna as disclosed by Klemm so that that the antenna may be releasably fastened to the housing (Klemm, Paragraph [0214]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Frazier et al. (Pub. No. US 20210283339 A1) is considered relevant prior art with regards to an apparatus comprising an electronic circuit, an antenna, a body, a connecting portion, a medicament container, a piston rod, and a drive spring.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mark Golovan whose telephone number is (571)272-2119. The examiner can normally be reached Monday - Friday 7:30am-4:30pm Alt. Fri off.
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, 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MARK GOLOVAN/ Patent Examiner, Art Unit 3783
/CHELSEA E STINSON/ Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights