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 .
Information Disclosure Statement
The information disclosure statement (IDS), submitted on 11/01/2024, has been considered by the examiner.
Claim Objections
Claim 35 is objected to because of the following informalities: The term “the basis,” in the 3rd line of the claim, should be changed to “a basis.” Appropriate correction is required.
Claim 35 is objected to because of the following informalities: The term “the selected touch signal profile,” in the 9th and 10th lines of the claim, should be changed to “a selected touch signal profile.” 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 21-38 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 21, 37, and 38] The claims recite the limitation of “the basis of the temporal variation.” There is a lack of antecedent basis for this limitation in the claims. Further, the examiner is unable to determine the metes and bounds of the claims, since it is unclear if this refers to variation of a single signal of a single segment, a variation of multiple signals of a single segment, a variation of a single signal of multiple segments, or a variation of multiple signals of multiple segments. For purposes of examination, it is interpreted that any of the above interpretations meets the limitations of the claims.
[Claim 23] The claim recites the limitation of “an electric touch signal” in the 2nd line of the claim. The examiner is unable to determine the metes and bounds of the claim, since it is unclear if this is intended to be the same or different “electric touch signal” introduced in claim 21. For purposes of examination, it is interpreted that the limitation refers to the same “electric touch signal” introduced in claim 21.
[Claims 31, 32, and 35] The claims recite the term “numerous” relative to the “electric touch signals” and “touch sensitive sensor segments.” The term “numerous” in claims 31, 32, and 35, is a relative term which renders the claim indefinite. The term “numerous” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As such, the number of “electric touch signals” and “touch sensitive sensor segments” has been rendered indefinite, as it is unclear if a mere plurality is required (more than one), or if a higher number of each limitation is required. For purposes of examination, the term “numerous” is interpreted as simply a plurality.
[Claim 34] The claim recites the limitation of “the data” in the 3rd line of the claim. There is a lack of antecedent basis for this limitation in the claim. Further, the examiner is unable to determine the metes and bounds of the claim, since it is unclear if this refers to the previously recited “use related data,” or if an additional limitation is being introduced into the claim language. For purposes of examination, it is interpreted that the limitation refers to the previously recited “use related data.”
[Claim 34] The claim recites the limitation of “the duration” in the 4th line of the claim. There is a lack of antecedent basis for this limitation in the claim. Further, the examiner is unable to determine the metes and bounds of the claim, since it is unclear if “the duration” refers to continuous or non-continuous segments of time. For purposes of examination, it is interpreted that either scenario meets the limitations of the claim.
[Claim 34] The claim recites the limitation of “the medicament set of injected” in the 4th and 5th lines of the claim. There is a lack of antecedent basis for this limitation in the claim. Further, the examiner is unable to determine the metes and bounds of the claim, since it is unclear if this is a grammatical error in the claim, or if the phrase was meant to indicate “a size of a dose of a medicament injected by the injection device.” For purposes of examination, it is interpreted that the limitation should recite “a size of a dose of a medicament injected by the injection device.”
[Claim 35] The term “best” in claim 35 is a relative term which renders the claim indefinite. The term “best” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As such, what qualifies as a “match” is rendered indefinite. For purposes of examination, it is interpreted that any selected “touch signal profile” meets the limitation of the claim.
[Claim 35] The claim recites the limitation of “the specific operation” in the 9th line of the claim. There is a lack of antecedent basis for this limitation in the claim. Further, the examiner is unable to determine the metes and bounds of the claim, since it is unclear if this limitation refers to the previously recited “operation,” or if additional “operations” are being introduced into the claim language. For purposes of examination, it is interpreted that either scenario meets the limitations of the claim.
[Claim 38] The claim recites the limitation of “the body” in the 2nd line of the claim. There is a lack of antecedent basis for this limitation in the claim. Further, the examiner is unable to determine the metes and bounds of the claim, since it is unclear if this limitation refers to the previous recited “device body,” or if a new structure is being introduced into the claim language. For purposes of examination, it is interpreted that the limitation refers to the previously recited “device body.”
[Claims 22-36] The claims are rejected based upon their dependency from independent claim 21.
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.
Claims 21-31, 33, 34, and 36-38, are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Helmer et al. (WO 2021/037844 A1).
[Claims 21, 23, and 37] Helmer teaches an injection device (figure 1, item 100) for injecting a dose of a medicament (page 9, lines 5-7), the injection device comprising:
a body (figure 1, item 102) to accommodate a drive mechanism operable to withdraw or to expel the medicament from a medicament container (the examiner notes the “drive mechanism,” “medicament,” and “medicament container,” are only functionally recited),
at least one of a dose dial and a trigger (“release button”) actuatable by a user for injecting the dose (the examiner notes figure 5 shows an unlabeled trigger; furthermore, Helmer describes the “drug delivery device” as an autoinjector; page 1, lines 21-23, page 2, lines 1-3) and
a sensor assembly (figure 1, item 104 and figure 6, item 134) attached to or integrated into at least one of the body (figure 1, item 102), the dose dial and the trigger, the sensor assembly (figure 1, item 104 and figure 6, item 134) comprising:
a sensor element (figure 1, item 104) attachable to the injection device and comprising a sensing surface (figure 3, item 112), the sensing surface (figure 3, item 112) comprising a number of touch sensitive sensor segments (figures 3 and 4, items 116/118), the touch sensitive sensor segments (figures 3 and 4, items 116/118) being operable to generate (or to modify) an electric touch signal when touched by a body part of a user (figure 4; page 27, lines 21-31; page 28, lines 1-3 and 19-25; page 29, lines 4-7), and
a processor (figure 6, item 144) connectable to the sensor element (figure 1, item 104), operable to detect a variation of the electric touch signals over time and to recognize an operation of the injection device at least partially on the basis of the temporal variation (see 112b interpretation above) of the electric touch signals (figure 4; page 27, lines 21-31; page 28, lines 1-3 and lines 19-25; page 29, lines 4-7).
[Claim 38] Helmer teaches an add-on device (figure 1, items 104/110/112) configured for fastening to an injection device (figure 1, item 102), the add-on device (figure 1, items 104/110/112) comprising a device body (figure 1, item 104) and a fastener (figure 1, item 110) for fastening the body (see 112b interpretation above) to at least one of a body, a dose dial and a trigger of the injection device (the examiner notes the “injection device” and associated structures are only functionally recited), wherein the add-on device (figure 1, items 104/110/112) comprises a sensor assembly (figure 1, item 112 and figure 6, item 134), comprising:
a sensor element (figure 1, item 112) attachable to the injection device (figure 1, item 102) and comprising a sensing surface (figure 3), the sensing surface comprising a number of touch sensitive sensor segments (figures 3 and 4, items 116/118), the touch sensitive sensor segments (figures 3 and 4, items 116/118) being operable to generate an electric touch signal when touched by a body part of a user (figure 4; page 27, lines 21-31; page 28, lines 1-3 and 19-25; page 29, lines 4-7), and
a processor (figure 6, item 144) connectable to the sensor element (figure 1, item 112), operable to detect a variation of the electric touch signals over time and to recognize an operation of the injection device (figure 1, item 102) at least partially on the basis of the temporal variation (see 112b interpretation above) of the electric touch signals (figure 4; page 27, lines 21-31; page 28, lines 1-3 and lines 19-25; page 29, lines 4-7).
[Claim 22] Helmer teaches the limitations of claim 21, upon which claim 22 depends. In addition, Helmer discloses at least one of the touch sensitive sensor segments (figures 3 and 4, items 116/118) is operable to generate different electric touch signals in response to a variation of a pressure applied to the touch sensitive sensor segment (page 4, lines 4-8; page 27, lines 21-31; page 28, lines 1-3) (The examiner notes that a “variation in pressure” could simply be interpreted as contact vs. no contact. The examiner further notes that the “touch sensitive sensor segments” have not been defined in terms of size, orientation, or number; as such, the “sensing surface” taught by Helmer could be divided into different “sensor segments” which vary in size, thereby producing different electric touch signals.)
[Claims 24-27] Helmer teaches the limitations of claim 21, upon which claims 24-27 depend. Helmer further discloses the processor (figure 6, item 144) is operable to process electric touch signals of a number of touch sensitive sensor segments (figures 3 and 4, items 116/118) to ascertain a sensing area of the sensing surface being touched by the body part (figures 4 and 5; page 30, lines 14-31; page 31, lines 1-9);
wherein the processor (figure 6, item 144) is operable to detect a movement, variation in size, and a variation of a geometry or orientation, of the sensing area on the sensing surface (figures 4 and 5; page 27, lines 21-31; page 28, lines 1-3).
[Claims 28-30] Helmer teaches the limitations of claim 21, upon which claims 28-30 depend. Helmer also teaches the sensor element (figure 1, item 104) comprises
a planar sensing surface configured for fastening to an end face of a trigger of the injection device (figures 3 and 4); and
a tubular shaped sensing surface (flexible sheet) configured for wrapping around the tubular member of the injection device (figure 5).
[Claim 31] Helmer teaches the limitations of claim 21, upon which claim 31 depends. Helmer further discloses the processor (figure 6, item 144) is operable to detect at least one of a dose setting operation of the injection device, a dose dispensing operation of the injection device and an end of dose holding operation (the examiner notes an “end of dose holding operation” has not been defined; as such, the signals created by a user “holding” the device could be interpreted as meeting this limitation) of the injection device by processing numerous electric touch signals (see 112b interpretation above) of numerous touch sensitive sensor segments (see 112b interpretation above) (figures 3 and 4, items 116/118) over time when the sensor element (figure 1, item 104) is attached to the injection device (figures 4 and 5; page 27, lines 21-31; page 28, lines 1-3).
[Claim 33] Helmer teaches the limitations of claim 21, upon which claim 33 depends. In addition, Helmer teaches a clock (figure 6, item 142) connected to the processor (figure 6, item 144), wherein the processor (figure 6, item 144) is operable to detect or to measure at least one of a point of time, at which a user operates the injection device and a duration during which a user operates the injection device (page 29, lines 11-18).
[Claim 34] Helmer teaches the limitations of claim 21, upon which claim 34 depends. Helmer also teaches a memory (figure 6, item 140) connected to the processor (figure 6, item 144), wherein the processor (figure 6, item 144) is operable to store use related data in the memory (figure 6, item 140), wherein the data (see 112b interpretation above) contains at least one of: a point of time at which the injection device was operated, the duration (see 112b interpretation above) during which the device was operated, a size of a dose of the medicament set of injected by the injection device (see 112b interpretation above) (page 29, lines 10-18; page 30, lines 14-27).
[Claim 36] Helmer teaches the limitations of claim 21, upon which claim 36 depends. Helmer further discloses a clock (figure 6, item 142) and a memory (figure 6, item 140) connected to the processor (figure 6, item 144), wherein the processor (figure 6, item 144) is operable:
to monitor a temporal variation of electric touch signals during a specific operation of the injection device (page 27, lines 21-31; page 28, lines 1-3 and lines 19-25), and
to store the temporal variation of the electric touch signals as a touch signal profile in the memory (page 29, lines 10-18; page 30 lines 14-27) and
to assign the touch signal profile with the specific operation of the injection device (page 6, lines 21-25; page 7, lines 1-8; page 30, lines 14-31; page 31, lines 1-9).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 21, 23, and 37, are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21 and 35 of copending Application No. 18/862422 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because all of the elements of the recited instant application claims are found in the recited copending application claims. For example, all of the elements of claim 21 of the instant application can be found in claim 21 of the copending application. The difference between claim 21 of the instant application and claim 21 of the copending application lies in the fact that the copending application claim includes more elements and is thus more specific. Thus, the invention of claim 21 of the copending application is in effect a “species” of the "generic” invention of claim 21 of the instant application. It has been held that the generic invention is anticipated by the species. See In re Goodman , 29
USPQ2d 2010 (Fed. Cir. 1993). Since claim 21 of the instant application is anticipated by claim 21 of the copending application, it is not patentably distinct from claim 21 of the copending application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
Claims 32 and 35 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JASON E FLICK whose telephone number is (571)270-7024. The examiner can normally be reached M-F 7 a.m.-3 p.m. Eastern Time.
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, Bhisma Mehta can be reached at 571-272-3383. 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.
/JASON E FLICK/Primary Examiner, Art Unit 3783 09/24/2026
Prosecution Insights