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 1-20 of the claim set received 9/28/2023 are pending.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “the dose adjustment dial being tubular in shape” of claims 5, 12, and 17, “the injector button being positioned on the top surface of the dose adjustment dial” of claims 5, 12, and 17, “the dose adjustment dial slidably engaging with the inner surface of the outer casing” of claims 7, 14, and 19 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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.
Claim Objections
Claim 1 is objected to because of the following informalities: “the distal end” should be written “a distal end”.
Claim 3 is objected to because of the following informalities: “the proximal end” should be written “a proximal end”.
Claim 5 is objected to because of the following informalities: “the top surface” should be written “a top surface”.
Claim 6 is objected to because of the following informalities: “the outer surface at the proximal end” should be written “an outer surface at the proximal end” and “the proximal end of the dosage window” should be written “a proximal end of the dosage window”.
Claim 7 is objected because of the following informalities: “the outer surface” should be written “an outer surface”.
Claim 10 is objected to because of the following informalities: “the distal end” should be written “a distal end”.
Claim 10 is objected to because of the following informalities: “the proximal end” should be written “a proximal end”.
Claim 13 is objected to because of the following informalities: “the outer surface at the proximal end” should be written “an outer surface at the proximal end” and “the proximal end of the dosage window” should be written “a proximal end of the dosage window”.
Claim 17 is objected to because of the following informalities: “the distal end” should be written “a distal end”.
Claim 17 is objected to because of the following informalities: “the proximal end” should be written “a proximal end”.
Claim 17 is objected because of the following informalities: “the top surface” should be written “a top surface”.
Claim 18 is objected to because of the following informalities: “the outer surface at the proximal end” should be written “an outer surface at the proximal end” and “the proximal end of the dosage window” should be written “a proximal end of the dosage window”.
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 9, 16, and 20 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 9, 16, and 20 each recite the injector button being mechanically connected to the pen body while the base claim recites “the pen body comprising an outer casing, a dose adjustment dial and an injector button.” The injector button is defined as a portion of the pen body such that it is unclear what is required of the injector button mechanically connected to a body that includes itself.
Appropriate correction is required.
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.
Claims 1-4 and 10-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cronenberg (US 2019/0209782).
Regarding Claim 1, Cronenberg discloses in Figs. 5-7, an insulin self-injection pen comprising:
a needle 151;
a medication cartridge 4;
a pen body 2+3+6+10;
the medication cartridge 4 comprising a dose adjustor 44 ;
the pen body comprising an outer casing 2+3, a dose adjustment dial 6 and an injector button 10;
the needle 151 securing to the distal end 45 of the medication cartridge 4 (read para. 0091);
the medication cartridge 4 being positioned within the pen body 2+3+6+10 (see figure);
the pen body 2+3+6+10 encompassing around the medication cartridge 4 and needle 151 (when the needle pierces the distal end 45 as described in para. 0091, the pen body encompasses the needle in the same way shown by the instant application figures); and
the needle 151 extending outwards from the pen body 2+3+6+10.
Regarding Claim 2, Cronenberg discloses in Figs. 5-7, the needle 151 being a long slender cylindrical shape; and the needle 151 transferring a liquid medication into the body of a user (essential function of an insulin pen).
Regarding Claim 3, Cronenberg discloses in Figs. 5-7, the proximal end of the medication cartridge 4 being attached to the pen body 2+3+6+10; the medication cartridge 4 being interchangeable within the pen body 2+3+6+10 (read para. 0110); and the medication cartridge 4 being secured within the pen body 2+3+6+10.
Regarding Claim 4, Cronenberg discloses in Figs. 5-7, the dose adjustor 44 mechanically adjusting the quantity of medication being injected into the body of the user; and the dose adjustor 44 being mechanically connected and controlled by the dose adjustment dial 6 (read para. 0109).
Regarding Claim 10, Cronenberg discloses in Figs. 5-7, an insulin self-injection pen comprising: a needle 151; a medication cartridge 4; a pen body 2+3+6+10; the medication cartridge 4 comprising a dose adjustor 44; the pen body comprising an outer casing 2+3, a dose adjustment dial 6 and an injector button 10; the needle 151 securing to the distal end 45 of the medication cartridge 4 (read para. 0091); the medication cartridge 4 being positioned within the pen body 2+3+6+10; the pen body 2+3+6+10 encompassing around the medication cartridge 4 and needle 151 (when the needle pierces the distal end 45 as described in para. 0091, the pen body encompasses the needle in the same way shown by the instant application figures); the needle 151 extending outwards from the pen body 2+3+6+10; the needle 151 being a long slender cylindrical shape; the needle 151 transferring a liquid medication into the body of a user (essential function of an insulin pen); the proximal end of the medication cartridge 4 being attached to the pen body 2+3+6+10; the medication cartridge 4 being interchangeable within the pen body (read para. 0110); and the medication cartridge 4 being secured within the pen body 2+3+6+10.
Regarding Claim 11, Cronenberg discloses in Figs. 5-7, the dose adjustor 44 mechanically adjusting the quantity of medication being injected into the body of the user; and the dose adjustor 44 being mechanically connected and controlled by the dose adjustment dial 6 (read para. 0109).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 5-7, 9, 12-14, 16-18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Cronenberg (US 2019/0209782) in view of Zhang Li (CN209033383).
Regarding Claims 5 and 12, Cronenberg teaches the claimed invention as discussed above. Cronenberg further discloses in Figs. 5-7, the outer casing 2+3 being tubular in shape; the outer casing further comprising a dosage window 8; the dose adjustment dial 6 being tubular in shape; the dose adjustment dial 6 further comprising a plurality of numbers (also see 17); and the injector button 10 being positioned on the top surface of the dose adjustment dial 6.
Cronenberg does not disclose the outer casing comprising an LED light.
Zhang Li discloses in Fig. 3, an outer casing 1 comprising a dosage window 1a showing a dosage numbers, similar to Cronenberg. Zhang Li teaches the outer casing 1 comprises an LED light 6 (read para. 0040).
It would have been obvious to one of ordinary skill in the art at the time of filing to have modified Cronenberg to include the LED light taught by Zhang Li in order to illuminate to window for better visibility of the dosage (Zhang Li para. 0043).
Regarding Claims 6 and 13, Cronenberg in view of Zhang Li teaches the claimed invention as discussed above. Cronenberg further discloses in Figs. 5-7, the dosage window 8 creating a cutout 7 on the outer surface (of the outer casing 2+3) at the proximal end of the outer casing 2+3; the dosage window revealing one of the plurality of numbers of the dose adjustment dial (read para. 0073). Zhang Li teaches the LED light of the combination including as shown in Fig. 3, the LED light 6 being secured along the proximal end of the dosage window 1a; and the LED light illuminating one of the plurality of numbers of the dose adjustment dial 3.
Regarding Claims 7 and 14, Cronenberg in view of Zhang Li teaches the claimed invention as discussed above. Cronenberg further discloses in Figs. 5-7, the dose adjustment dial 6 rotating about the central axis of the dose adjustment dial (read para. 0073); the dose adjustment dial rotating to mechanically move the dose adjustor 44 (read para. 0109); the plurality of numbers being scribed along the outer surface of the dose adjustment dial 6 that traverse longitudinally (see threads 36 which move the dial 6 longitudinally when rotated and how the numbers which can be viewed through the window travel from the top to the bottom of surface 29; shown better in Fig. 17); and the dose adjustment dial slidably engaging with the inner surface of the outer casing (a function of the threads 36, the threads 36 of the dial 6 engaged with the internal threads 51 of the body as discussed at para. 0093).
Regarding Claims 9 and 16, Cronenberg in view of Zhang Li teaches the claimed invention as discussed above. Cronenberg further discloses in Figs. 5-7, the injector button 10 being mechanically connected to the pen body 2+3+6+10 (it is a portion of the pen body); the injector button 10 compressing when receiving an external surface force (read, e.g. para. 0073); and the injector button releasing the liquid medication from the medication cartridge when the injector button is compressed (read e.g. para. 0073).
Regarding Claim 17, Cronenberg discloses in Figs. 5-7, more detailed explanations found in the rejections of the same limitations found above, an insulin self-injection pen comprising: a needle 151; a medication cartridge 4; a pen body 2+3+6+10; the medication cartridge 4 comprising a dose adjustor 44; the pen body comprising an outer casing 2+3, a dose adjustment dial 6 and an injector button 10; the needle 151 securing to the distal end 45 of the medication cartridge 151; the medication cartridge 4 being positioned within the pen body 2+3+6+10; the pen body 2+3+6+10 encompassing around the medication cartridge 4 and needle 151 (when the needle pierces the distal end 45 as described in para. 0091, the pen body encompasses the needle in the same way shown by the instant application figures); the needle 151 extending outwards from the pen body 2+3+6+10; the needle 151 being a long slender cylindrical shape; the needle 151 transferring a liquid medication into the body of a user; the proximal end of the medication cartridge 4 being attached to the pen body 2+3+6+10; the medication cartridge 4 being interchangeable within the pen body; the medication cartridge 4 being secured within the pen body 2+3+6+10; the dose adjustor 44 mechanically adjusting the quantity of medication being injected into the body of the user; the dose adjustor 44 being mechanically connected and controlled by the dose adjustment dial 6; the outer casing 2+3 being tubular in shape; the outer casing further comprising a dosage window 8; the dose adjustment dial 6 being tubular in shape; the dose adjustment dial 6 further comprising a plurality of numbers; and the injector button 10 being positioned on the top surface of the dose adjustment dial 6.
Cronenberg does not disclose the outer casing comprising an LED light.
Zhang Li discloses in Fig. 3, an outer casing 1 comprising a dosage window 1a showing a dosage numbers, similar to Cronenberg. Zhang Li teaches the outer casing 1 comprises an LED light 6 (read para. 0040).
It would have been obvious to one of ordinary skill in the art at the time of filing to have modified Cronenberg to include the LED light taught by Zhang Li in order to illuminate to window for better visibility of the dosage (Zhang Li para. 0043).
Regarding Claim 18, Cronenberg in view of Zhang Li teaches the claimed invention as discussed above. Cronenberg further discloses in Figs. 5-7, the dosage window 8 creating a cutout 7 on the outer surface (of the outer casing 2+3) at the proximal end of the outer casing 2+3; the dosage window revealing one of the plurality of numbers of the dose adjustment dial (read para. 0073). Zhang Li teaches the LED light of the combination including as shown in Fig. 3, the LED light 6 being secured along the proximal end of the dosage window 1a; and the LED light illuminating one of the plurality of numbers of the dose adjustment dial 3.
Regarding Claim 20, Cronenberg in view of Zhang Li teaches the claimed invention as discussed above. Cronenberg further discloses in Figs. 5-7, the injector button 10 being mechanically connected to the pen body 2+3+6+10 (it is a portion of the pen body); the injector button 10 compressing when receiving an external surface force (read, e.g. para. 0073); and the injector button releasing the liquid medication from the medication cartridge when the injector button is compressed (read e.g. para. 0073).
Claims 8, 15, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Cronenberg (US 2019/0209782) in view of Zhang Li (CN209033383) as applied above, and further in view of Hirano (US 2003/0103418).
Regarding Claims 8 and 15, Cronenberg in view of Zhang Li teaches the claimed invention as discussed above. Cronenberg in view of Zang Li does not disclose the plurality of numbers containing a phosphor substance; and the plurality of numbers glowing in low light conditions.
Hirano discloses in Fig. 1, a dial 12 having a plurality of indicia 19 for a user to read and an associated LED light 20. Hirano teaches in Fig. 1 the LED light 20 emitting ultraviolet rays lighting the indicia (as read at para. 0068) the indicia 19 containing a phosphor substance (as read at para. 0067), the plurality of indicia glowing in low light conditions (emit light as read at para. 0068).
It would have been obvious to one of ordinary skill in the art at the time of filing to have modified Cronenberg in view of Zhang Li further such that the LED light emits ultraviolet rays and the indicia, i.e. the dosage numbers of Cronenberg, contain a phosphor substance as taught by Hirano in order to improve visibility and emit colored light whenever a user desires (read e.g. Hirano para. 0073).
Regarding Claim 19, Cronenberg in view of Zhang Li teaches the claimed invention as discussed above. Cronenberg further discloses in Figs. 5-7, the dose adjustment dial 6 rotating about the central axis of the dose adjustment dial (read para. 0073); the dose adjustment dial rotating to mechanically move the dose adjustor 44 (read para. 0109); the plurality of numbers being scribed along the outer surface of the dose adjustment dial 6 that traverse longitudinally (see threads 36 which move the dial 6 longitudinally when rotated and how the numbers which can be viewed through the window travel from the top to the bottom of surface 29; shown better in Fig. 17); and the dose adjustment dial slidably engaging with the inner surface of the outer casing (a function of the threads 36, the threads 36 of the dial 6 engaged with the internal threads 51 of the body as discussed at para. 0093).
Cronenberg in view of Zang Li does not disclose the plurality of numbers containing a phosphor substance; and the plurality of numbers glowing in low light conditions.
Hirano discloses in Fig. 1, a dial 12 having a plurality of indicia 19 for a user to read and an associated LED light 20. Hirano teaches in Fig. 1 the LED light 20 emitting ultraviolet rays lighting the indicia (as read at para. 0068) the indicia 19 containing a phosphor substance (as read at para. 0067), the plurality of indicia glowing in low light conditions (emit light as read at para. 0068).
It would have been obvious to one of ordinary skill in the art at the time of filing to have modified Cronenberg in view of Zhang Li further such that the LED light emits ultraviolet rays and the indicia, i.e. the dosage numbers of Cronenberg, contain a phosphor substance as taught by Hirano in order to improve visibility and emit colored light whenever a user desires (read e.g. Hirano para. 0073).
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure can be found in the attached Notice of References Cited.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RENE D FORD whose telephone number is (571)272-8140. The examiner can normally be reached on M-F 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Phutthiwat Wongwian can be reached on (571) 270-5426. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/R.D.F/Examiner, Art Unit 3741
/PHUTTHIWAT WONGWIAN/Supervisory Patent Examiner, Art Unit 3741