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.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: “a touch input means for providing inputs” in claim 15.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends 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 remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
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) 15-24, 28-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pletcher et al. (WO 2019/191222A1, IDS dated 2/9/23) in view of Madsen (WO 2019/001919 A1, IDS dated 2/9/23) and in further view of Ho (JP 2014-13777, citations taken from English translation attached).
With regard to claim 15, 24, 30, Pletcher discloses A system comprising: a drug injection device (Fig. 1, element 100) comprising a distal end (towards 102, invention uses the terms distal and proximal opposite to its normal use) and a proximal end (towards 106) that comprises a drug delivery body (104) for injecting a drug into a patient's body (via 106); an electronic module (102) for wirelessly exchanging data related to a usage of the drug injection device with a device paired with the electronic module ([0030], [0106]), the electronic module being attached to or integrated in the distal end of the drug injection device (as shown in Fig. 1); a computing device (200, Fig. 2) configurable for a pairing with the electronic module for wireless exchange of the data and comprising a touch interface (see Fig. 2, screen 202); and a computer program comprising instructions for execution by a processor of the computing device to configure the computing device for the pairing with the electronic module based on the inputs received via the touch interface ([0051]-[0056]).
However, Pletcher does not explicitly disclose the drug injection device includes a syringe.
Madsen teaches a similar pen-type drug delivery device having a distal end (fig. 2a and 2b, distal end being 290), a proximal end that includes a syringe (210) for injecting drug into a patient’s body and an electronic module (300) that assists in pairing the drug injection device to a computing device.
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Pletcher with the syringe as taught by Madsen for delivery of a drug (Col 14, line 21-30) because doing so would serve the same purpose as that of Pletcher is a well-known way to delivery drugs in the art (Col 14, lines 21-30).
However, Pletcher/Madsen do not teach the touch input means at the proximal end of the drug injection device.
Ho teaches a pen-type device (Fig. 1 and 6) having a cap or proximal end (at 110) that further includes a touch input means (112) for providing inputs on the touch interface ([0024]-[0028]). This type of touch input means can be placed on the cap of the pen injection device of Pletcher which covers the proximal end prior to injection.
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Pletcher/Madsen with the touch input means as taught by Ho for the purpose of authorizing signals when contacting the touchscreen ([0024]).
With regard to claim 16 and 31, Pletcher discloses wherein the touch interface comprises a touch screen (202), wherein the pairing comprises touching a pairing button (204) with the touch input means (shown in Fig. 2), and wherein the pairing button is displayed on the touch screen and is configured by the computer program (Fig. 2).
With regard to claim 17 and 32, Pletcher discloses wherein the touching of the pairing button with the touch input means comprises receiving and processing the touching by the computer program to switch a radio communication module of the computing device into a scan mode for detecting the electronic module within a predetermined area of the computing device for a certain time span ([0050]-[0056], after the injection pen is touched to the screen at 204 the computing device detects the electronic module 102 of the injection pen and can confirm a pairing as shown in Fig. 2. The phrase “certain time span” is broad and does not provide any specific parameters for how long the time span lasts, therefore it is considered inherent that the computing device will allow for pairing within a length of time and this is considered to read on the claims as currently recited)
With regard to claim 18 and 33, Pletcher discloses wherein the pairing with the electronic module is detected within the certain time span (as described above the phrase certain time span does not provide any specific boundaries on how long the time span would last. Therefore it is inherent that a certain length of time is provided for the pairing option and thus would be considered to be part of a “certain time span” [0050]-[0056]).
With regard to claim 19 and 34, Pletcher discloses wherein the pairing comprises touching of the pairing button (204) with the touch input (end surface of 102) means until the electronic module and the computing device are paired ([[0051], [0052]).
With regard to claim 20, Pletcher discloses wherein the drug injection device comprises a visual indicator for signaling an availability for the pairing with the computing device (Injection pen includes lights 114 that are used to communicate with the computing device).
With regard to claim 21, Pletcher discloses wherein the visual indicator is located at the distal end of the drug injection device (112, see Fig .1).
With regard to claim 22, Pletcher discloses wherein the visual indicator (112) is controlled by the electronic module such that when the electronic module is switched into a pairing mode, the visual indicator is controlled to signal the pairing mode ([0030]), and/or wherein the visual indicator is configured to signal the availability for pairing by a predetermined light sequence ([0030]).
With regard to claim 23 and 29, Pletcher discloses wherein the drug injection device has a pen-like shape (see Fig. 1, element 100).
With regard to claim 28, Pletcher discloses wherein the touch input means is configured for usage with capacitive touch screens (“configured to” language implies functional limitation, therefore only the structure of the touch input means (end surface of 102) needs to be taught and is capable of being used with capacitive touch screens ([0051], most smartphone touch screens are capacitive touch screens).
Claim(s) 25-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pletcher et al. (WO 2019/191222A1, IDS dated 2/9/23) in view of Madsen (WO 2019/001919 A1, IDS dated 2/9/23) in further view of Ho (JP 2014-13777, citations taken from English translation attached) and Radmer et al. (US 2017/055468 A1).
With regard to claim 25, Pletcher/Madsen/Ho teach the claimed invention except for a cap.
Radmer teaches a similar pen-type injection device that further includes a cap (Fig. 1a and 1b, element 120). Radmer further teaches that in an alternative to replace the standard cap, a electronic cap (200, Fig.2) can be used in order to provide the same electronic circuitry as an electronic add-on device. Thus the electronic module, which includes the touch input means, of Pletcher could be incorporated into a cap as shown in Radmer as an alternative way to include the electronics while also protecting the syringe/needle end of the drug injection device (p. 9, line 34- p.10, line 5).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Pletcher/Madsen/Ho with the cap as taught by Radmer for the purpose of combining the electronic module with needle protection device eliminating the need for a separate electronic module (p. 9, line 34 to p. 10, line 5; p.9, line 4-24).
With regard to claim 26, Pletcher discloses wherein the touch input means comprises a touch pen tip ([0034]).
With regard to claim 27, Pletcher discloses wherein the touch pen tip ([0034]) is shaped like a ballpoint/pencil/spherical tip ([0034], also see Fig. 1) and wherein the touch pen tip comprises at least a part of an elastic surface for entering touch inputs ([0034], touch sensitive rubber material or opaque material).
Response to Arguments
Applicant’s arguments with respect to claim(s) 15-34 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 LAUREN P FARRAR whose telephone number is (571)270-1496. The examiner can normally be reached Monday - Friday 9am - 5pm.
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/Lauren P Farrar/ Primary Examiner, Art Unit 3783