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 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 19-39 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.
In claim 19, Applicant requires “a transition region is formed between facing surfaces of elements of the drug delivery device, at least one of these elements being an element of the component” (emphasis added). Yet the beginning of the claim, “A component for a drug delivery device”, indicates the component needs to be usable with a/the drug delivery device, but only the component is required by the claim. The limitation cited above with emphasis, however, above makes it unclear how the component and drug delivery device are different. Claims 36 and 39 have this issue as well.
Claim 20 is dependent on cancelled claim 1. It is treated as if it depends from claim 19. Claim 27 has the same issue and is treated similarly.
In claims 19, 27-30, 36 and 39, Applicant refers to “the functional element”, while this is treated as if referring to “at least one functional element”, it is unclear if “the functional element” refers to only one functional element when there are a plurality of functional elements or all of the functional elements.
In claim 28, Applicant requires “two transition regions are formed”. It is unclear if this is in addition to “a transition region” in claim 19, or the transition region in claim 19 comprises one of the two transition regions in claim 28.
Claim Rejections - 35 USC § 102
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.
Claim(s) 19-28 and 30-39 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Granziti (US 2018/0250473).
Regarding claim 19, Granziti discloses a component 118 for a drug delivery device (Granziti shows one in fig 3, but the drug delivery device is only claimed as intended use; this is important because while Granziti needs to be capable of use as claimed, any structure drawn to the drug delivery is minimally limiting), the component configured to be connected to an arrangement of the drug delivery device (capable of such) and comprising: at least one functional element (350; or the enlarged end of the button/component 118); wherein at least when the component is connected to the arrangement (fig 3), a transition region (152; while structure 152 meets the limitations for the transition region, a transition region does not have to be an actual structure but an area formed by other structures) is formed between facing surfaces of elements of the drug delivery device (capable of such; regardless, see fig 3), at least one of these elements being an element of the component (see 112 issue above as this limitation makes it unclear how the component and drug delivery device are different; for purposes of rejection, the component is capable of such; also/alternatively, the gap between the component and collar/grip 114 in fig 114 can be considered the transition region); wherein the transition region reaches from an exterior of the component to an interior of the component (capable of such; regardless see fig 3), and wherein the transition region is designed such that a risk of fluid reaching from the exterior into the interior of the component via the transition region is reduced in order to protect the functional element (capable of such; regardless see fig 3 and the gap between 114 and 152, which will reduce chance of fluid reaching from exterior to interior as opposed to a larger gap).
Regarding claim 20, wherein the transition region is a fluid path transition region in which the facing surfaces are spaced from each other so that a fluid path along which fluid can travel extends between the facing surfaces, and wherein the transition region is designed such that, inside the transition region, the fluid path comprises two sections which extend in different axial directions (capable of such, as discussed above the transition region relies on structure of the drug delivery device, which is only required as part of intended use).
Regarding claim 21, wherein inside the transition region, the fluid path comprises at least one coil and/or is a tortuous path (capable of such; alternatively see fig 3 and structures such as 111/360/123).
Regarding claim 22, wherein the component is configured to be axially moved relative to at least one element of the arrangement during usage of the drug delivery device, and wherein the length of the fluid path inside the transition region is configured to change during movement of the component (capable of such; ¶27 – component is a button which is moved with respect to drug delivery device and changes length of transition region to trigger fluid delivery).
Regarding claim 23, wherein the transition region is formed between elements of both the component and the arrangement (capable of such, regardless see fig 3).
Regarding claim 24, wherein the transition region is formed between a distal section of the element of the component and a proximal section of an element of the arrangement, and wherein when the component is connected to the arrangement, the distal section of the element of the component and the proximal section of the element of the arrangement axially overlap and are offset from each other in radial direction (capable of such, regardless see fig 3).
Regarding claim 25, wherein the transition region is a fluid tight transition region in which the facing surfaces are tightly fitted to each other so that no fluid can pass through the transition region (capable of such).
Regarding claim 26, wherein the transition region is formed between elements of the component (fig 3, between proximal and distal ends of component).
Regarding claim 27, wherein the functional element is axially and/or radially offset from the transition region (fig 3).
Regarding claim 28, at least when the component is connected to the arrangement, two transition regions are formed, wherein one transition region of the two transition regions is a fluid path transition region and the other transition region of the two transition regions is a tight transition region, and wherein the functional element is axially arranged between the fluid path transition region and the tight transition region (capable of such).
Regarding claim 30, wherein the functional element is associated with an electronic functionality of the component, and wherein the functional element is an optical sensor, electro-mechanical switch, circuit board, battery, or LED (¶25).
Regarding claim 31, wherein the component is a user interface member configured to be touched by a user in order to operate the user interface member when the component is connected to the arrangement (fig 3, ¶25).
Regarding claim 33, wherein the transition region reaches from an outer surface of the component to an inner surface of the component (fig 3).
Regarding claim 34, wherein the inner surface of the component adjoins the interior of the component (fig 3).
Regarding claim 35, wherein the transition region is a fluid path transition region in which the facing surfaces are spaced from each other so that a fluid path extends between the surfaces along which fluid can travel (capable of such).
Regarding claim 36, Granziti discloses a drug delivery device comprising: an arrangement 102/104/114 comprising a container holder 104 for holding a drug container 106; and a component 118 configured to be connected to the arrangement (fig 1) and comprising: at least one functional element 350; wherein at least when the component is connected to the arrangement (figs 1 and 3), a transition region (region/space between 114 and 152 in fig 3) formed between facing surfaces of elements of the drug delivery device, at least one of these elements being an element of the component (fig 3; also see 112 issue as it is unclear how “at least one of these elements” can be part of the component, but also separate, different structure that is the drug delivery device); wherein the transition region reaches from an exterior of the component to an interior of the component (fig 3); and wherein the transition region is designed such that a risk of fluid reaching from the exterior into the interior of the component via the transition region is reduced in order to protect the functional element (fig 3; the gap between 114 and 152, which will reduce chance of fluid reaching from exterior to interior as opposed to a larger gap; also structures such as 360 will decrease amount of fluid that can enter by decreasing the volume available for fluid to enter).
Regarding claim 37, wherein the component is a user interface member configured to be operated by a user in order to perform a dose dial and/or a dose delivery process, and wherein the component is configured to be rotated and/or axially moved relative to the container holder when operated by the user (fig 3, component is a button which is used for delivery; ¶45).
Regarding claim 38, wherein the drug container comprises a drug (¶21).
Regarding claim 39, Granziti discloses a method of delivering a drug from a drug delivery device, the method comprising: operating a drug delivery device (¶23 – setting dose; ¶24 – pushing button to deliver dose), the drug delivery device comprising: an arrangement 102/104/114 comprising a container holder 104 for holding a drug container 106; and a component 118 configured to be connected to the arrangement (fig 1) and comprising: at least one functional element 350; wherein at least when the component is connected to the arrangement (figs 1 and 3), a transition region (region/space between 114 and 152 in fig 3) formed between facing surfaces of elements of the drug delivery device, at least one of these elements being an element of the component (fig 3; also see 112 issue as it is unclear how “at least one of these elements” can be part of the component, but also separate, different structure that is the drug delivery device); wherein the transition region reaches from an exterior of the component to an interior of the component (fig 3); and wherein the transition region is designed such that a risk of fluid reaching from the exterior into the interior of the component via the transition region is reduced in order to protect the functional element (fig 3; the gap between 114 and 152, which will reduce chance of fluid reaching from exterior to interior as opposed to a larger gap; also structures such as 360 will decrease amount of fluid that can enter by decreasing the volume available for fluid to enter).
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.
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Granziti (US 2018/0250473) in view of Castellano (US 2002/0099329).
Regarding claim 29, while Granziti substantially discloses the invention as claimed, it does not disclose wherein a surface of the component in the vicinity of the transition region is formed of a hydrophobic material.
Castellano discloses materials for an activator button 2029 including polycarbonate and metals (¶81). Polycarbonate is hydrophobic due to its aromatic rings and ether linkages, both of which are non-polar. Metal is also hydrophobic.
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Granziti such that the component is made of a hydrophobic material (and thus a surfaces of the component in the vicinity of the transition region is formed of a hydrophobic material) as taught by Castellano since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 227 F.2d 197. 125 USPQ 416 (CCPA 1960).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRADLEY JAMES OSINSKI whose telephone number is (571)270-3640. The examiner can normally be reached Monday to Thursday 9AM to 5PM.
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, Michael Tsai can be reached at (571)270-5246. 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.
/BRADLEY J OSINSKI/Primary Examiner, Art Unit 3783
Prosecution Insights