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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because of the following:
reference character “32” has been used to designate both “radial direction” and “transversal direction.”
Corrected drawing sheets in compliance with 37 CFR 1.121(d) 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
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
The abstract of the disclosure is objected to because the abstract is not within the range of 50 to 150 words in length. Currently the abstract is 40 words in length.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because of the following informalities:
Page 10, line 26 should be amended to recite “fig. 4. Here, the guide protrusion 11 is at the initial proximal part of the guiding” to correct the structure referring to reference numeral 11.
Page 11, lines 3 – 4 should be amended to recite “structure movement enables for a transversal force to be applied by the guide protrusion 11 on the rotator 13 so that the rotator 13 rotates” to correct the structure referring to reference numeral 11.
Page 12, line 3 should be amended to recite “axis 102 of the medicament delivery device 1” to correct the structure referring to reference numeral 102.
Page 12, line 18 should be amended to recite “housing [[5]] 3. In other words, as the cover structure 7 was moved to the extended position” to correct the reference numeral for the housing.
Page 13, line 4 should be amended to recite “housing [[5]] 3 to flex radially outwards” to correct the reference numeral for the housing.
Page 13, line 17 should be amended to recite “protrusion 23 of the flexible member [[5]] 10 and prevents further distal motion of” to correct the reference numeral for the flexible member.
Page 14, line 14 should be amended to recite “203, a rear cap [[203]] 204, a rotator 206, and a cover structure 207. The cover” to correct the reference numeral for the rear cap.
Appropriate correction is required.
Claim Objections
Claims 17, 22 – 25, and 29 are objected to because of the following informalities:
Claim 17 recites “a radial direction” twice. It is unclear if the second recitation of “a radial direction” was intended to refer to the first recitation of “a radial direction” or alternatively if these radial directions are separate radial directions.
Claim 22 recites “the flexible portion.” The Examiner suggests amending this to recite “the at least one flexible portion” to provide proper antecedent basis for this claim limitation.
Claim 23 recites “the flexible portion” twice. The Examiner suggests amending each of these recitations to recite “the at least one flexible portion” to provide proper antecedent basis for these claim limitations.
Claim 24 recites “the flexible portion” twice. The Examiner suggests amending each of these recitations to recite “the at least one flexible portion” to provide proper antecedent basis for these claim limitations.
Claim 25 recites “the flexible portion.” The Examiner suggests amending this to recite “the at least one flexible portion” to provide proper antecedent basis for this claim limitation.
Claim 29 recites “the flexible portion.” The Examiner suggests amending this to recite “the at least one flexible portion” to provide proper antecedent basis for this claim limitation.
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.
Claim(s) 2, 3, 20, 27, 28, and 30 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.
The Claims recite “Claims 1 – 16 (cancelled).” However, the Claims include a “Claim 2” and a “Claim 3.” The Examiner believes these were intended to be “Claim 18” and “Claim 19” respectively. The Examiner finds the claim numbering to be confusing because Claims 2 and 3 are recited to be cancelled but are recited later within the claim language. Therefore, Claims 2 and 3 are rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 20 is rejected under 35 U.S.C. § 112(b) for the same rationale because of its dependency upon Claim 3.
Under the interpretation that Claim 3 was intended to be Claim 19, Claim 20 recites “comprising two guiding ribs for each flexible member.” Claim 20 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention because it cannot be determined if the recited “two guiding ribs” further limit the “at least one guiding rib” recited in Claim 3.
Claim 27 recites “the at least one flexible member of the cover structure.” Claim 27 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention because the “flexible member of the cover structure” has never been referred to as “the at least one flexible member.” Claim 17, upon which Claim 27 depends from, only recites “the cover structure comprising a flexible member.” Therefore, the language “the at least one flexible member of the cover structure” is unclear because it cannot be determined whether to interpret the flexible member of the cover structure to be “the flexible member” or “the at least one flexible member” of the cover structure.
Claim 28 is rejected under 35 U.S.C. § 112(b) for the same rationale because of its dependency upon Claim 27.
Claim 30 recites “the cover structure comprises two flexible members.” Claim 30 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or joint inventor regards as the invention because it cannot be determined how many flexible members are recited in Claim 30. Claim 17, upon which Claim 30 depends, recites “the cover structure comprising a flexible member.” Claim 30 does not recite whether the “two flexible members” further limit the “flexible member” recited in Claim 17 or if they are separate flexible members.
Allowable Subject Matter
Claims 2, 3, 17, and 20 – 32 would be allowable if rewritten to overcome the claim objections and rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Reasons for Allowance
The following is an examiner’s statement of reasons for allowance:
Claim 17 recites:
A subassembly of a medicament delivery device for expelling medicament from a medicament container, the subassembly comprising:
a housing having a proximal end and a distal end, the housing comprising at least one flexible portion adapted to flex in a radial direction;
a cover structure configured to surround a medicament delivery member at a proximal end of the medicament delivery device, the cover structure is movable inside the housing in an axial direction of the housing between a retracted position in which the medicament delivery member is exposed at the proximal end of the cover structure, and an extended position in which the medicament delivery member is covered by the cover structure,
the cover structure comprising a flexible member at a distal end of the cover structure, the flexible member is adapted to flex in a radial direction and comprises a guide protrusion protruding radially inwards and a locking protrusion protruding radially outwards;
a rotator arranged radially inside and coaxially with the cover structure and comprising a guiding track configured to receive the guide protrusion, the guiding track being adapted so that when the cover structure is moved towards the retracted position, the guide protrusion interacts with and slides in the guiding track from an initial position corresponding to the extended position of the cover structure to an intermediate position corresponding to the retracted position of the cover structure while causing the rotator to rotate about a longitudinal axis of the medicament delivery device, wherein once in the intermediate position, the guide protrusion reaches a locking position in a locking portion of the rotator when the cover structure is moved from the retracted position to the extended position, wherein,
in the locking portion, the rotator comprises a ramp surface adapted to interact with the guide protrusion to push the flexible member radially outwards so that the locking protrusion encounters the at least one flexible portion of the housing so that the cover structure is prevented to move towards the retracted position.
The closest prior art to disclose, teach, or suggest the invention of Claim 1 is the following:
Daniel (US 10,751,481 B2), Karlsson (US 2012/0041368 A1), Karlsson (US 8,858,510 B2), Karlsson (US 2015/0032058 A1), Karlsson (US 2013/0053790 A1), Maxfield (US 2017/0080153 A1), Holmqvist (US 2017/0119972 A1), Daniel et al. (US 2017/0246395 A1), Stefanov et al. (US 2017/0246400 A1), Renstad et al. (US 2017/0304538 A1), Bauss et al. (US 2017/0304541 A1), Olson et al. (US 2017/0368259 A1), Hautaviita et al. (US 2018/0008773 A1), Hautaviita et al. (US 2018/0008779 A1), Maxfield (US 2018/0036491 A1), Boström (US 2018/0104415 A1), Bostöm (US 10,881,797 B2), Stewart (US 2018/0154083 A1), Gylleby et al. (US 2018/0243511 A1), Steffanov (US 2018/0296773 A1), Daniel (US 2018/0315345 A1), Daniel (US 11,087,640 B2), Säll et al. (US 2018/0361082 A1), Säll et al. (US 10,881,813 B2), Daniel (US 2019/0001065 A1), Carlsson et al. (US 2019/0022320 A1), Frost et al. (US 2019/0022327 A1), Holmqvist (US 2019/0240409 A1), Keller (US 2020/0038593 A1), Keler (US 11,246,992 B2), Säll et al. (US 2021/0170108 A1), Frost et al. (US 2021/0187205 A1), Boström (US 2021/0220564 A1), Boström (US 2021/0268202 A1), Chen (US 2022/0347393 A1), Wang et al. (US 2022/0387719 A1), Chen (US 2022/0387730 A1), Joseph (US 2023/0098277 A1), Frost et al. (US 2023/0166046 A1), Boström (US 2023/0173192 A1), Dasbach et al. (US 2023/0270942 A1), Dasbach et al. (US 2023/0285673 A1), Boström (US 2023/0338662 A1), Huang et al. (US 2024/0307623 A1), Yin et al. (US 2024/0350737 A1), Yin (US 2024/0408317 A1), Alexandersson et al. (US 2025/0009989 A1), Carlsson et al. (US 2025/0025633 A1), Wiklund et al. (US 2025/0144319 A1), Alexandersson et al. (US 2025/0195785 A1), Stewart et al. (US 2025/0295866 A1), Wiklund et al. (US 2026/0151571 A1).
However, none of the aforementioned prior art discloses, teaches, or suggests “the housing comprising at least one flexible portion adapted to flex in a radial direction” and “in the locking portion, the rotator comprises a ramp surface adapted to interact with the guide protrusion to push the flexible member radially outwards so that the locking protrusion encounters the at least one flexible portion of the housing so that the cover structure is prevented to move towards the retracted position” in addition to the other limitations of Claim 17. Therefore, Claim 17 is allowable.
Claims 2, 3, and 20 – 32 are dependent upon or incorporate all of Claim 17 and are therefore allowable for the same rationale as Claim 17.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT F ALLEN whose telephone number is (571)272-6232. The examiner can normally be reached Monday-Friday 8:00 AM - 4:30 PM ET.
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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.
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/ROBERT F ALLEN/Examiner, Art Unit 3783
/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783
06/24/2026
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