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 .
Election/Restrictions
Applicant's election with traverse of species 1) figures 1-4, claims 1-4, 6-7, and 10-15 in the reply filed on 01/06/2026 is acknowledged. The traversal is on the ground(s) that
1) As explained in MPEP 1893.03(d), "when making a lack of unity of invention requirement, the Examiner must (1) list the different groups of claims; and (2) explain why each group lacks unity with each other group (i.e., why there is no single general inventive concept) specifically describing the unique special technical feature in each group". The Office Action fails to show that the claims lack a special technical feature. According to MPEP 1893.03(d), "a group of inventions is considered linked to form a single general inventive concept where there is a technical relationship among the inventions that involves at least one common or corresponding special technical feature. The expression special technical features is defined as meaning those technical features that define the contribution which each claimed invention, considered as a whole, makes over the prior art."; and
2) In this case, independent claims 1, 10, and 15, as well as the remaining dependent claims, all require a retaining ring positioned between the proximal end portion of the cartridge and the distal end portion of the brake tower. Pala, Harms, and Lilley, whether considered individually or in combination, fail to teach or suggest such a retaining ring.
These arguments are not found fully persuasive as explained below.
With respect to 1), the reasons for an election of species are described herein below.
Species 1. Figures 1-4: claims 1-4, 6, 7, and 10-15; a medical injection device with a brake tower, spring washer component is positioned within the interior of the distal end of the brake tower 5, and retaining ring the retaining ring 18 is also positioned within the interior of the distal end portion of the brake tower.
Species 2. Figures 5-10: claims 1, 8, 9, and 15-17: a medical injection device including a brake tower with only retaining ring 21 positioned within the interior of the distal end portion of the brake tower 5.
Species 3. Figures 1, 2, 12, and 13: claims 1, 5, 10-14: a medical injection device including a brake tower with a retaining ring the spring washer component 11 is positioned against the distal end of the brake tower 5 rather than being positioned within the interior of the distal end of the brake tower 5 as shown in FIGS. 3 and 4.
With respect to 2),
Regarding claim 1, the examiner disagrees. Arguments with respect to Pala are narrower than the claim. Pala discloses a retaining ring 140 positioned between the proximal end portion of the cartridge and the distal end portion of the brake tower. The claim does not have any description about the retaining ring. Therefore, Pala discloses this technical feature as element 140.
Regarding claim 10, the examiner agrees. However, the claim has been found allowable due to the combination of the spring washer component and the retaining ring as claimed.
Regarding claim 15, the examiner agrees. However, the technical feature of the retaining ring is not novel as the new grounds of rejection below.
The requirement is still deemed proper and is therefore made FINAL.
Claims 5, 8-9, 16-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 01/06/2026.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description:
Reference numeral 59 [0030] is not shown in the drawings.
The drawings are objected to because:
Figures 1 and 5 show the orientation of the assembly in the incorrect order of the device. Some of the element’s orientation are incorrect in the assembly. For example, element number 5 should be rotated in the opposite direction like it is shown in figures 3, 4, 10-13.
In figure 11, the lead line of reference numerals 6 and 4 are pointing out to the same element.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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.
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.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pala (US 20140094765 A1).
As per claim 1, PALA discloses a medical injection device (injection device 100; figure 1; paragraph [0031]) comprising:
a housing having a distal end and a proximal end (pen body 108 having a distal end at cap 104 and proximal end at body 108; figure 1: paragraph [0031));
a brake tower (brake tower 144; figures 2, 9; paragraph [0038]) having a proximal end portion (a plurality of ratchet teeth 216 disposed on a proximal portion thereof; figure 9; paragraph [0039)), a distal end portion (base portion 220 disposed at a distal end thereof; figure 9; paragraph [0039]), and a sidewall therebetween defining a longitudinal axis (as shown;
figure 9);
a cartridge 132 received within the housing distally of the brake tower and holding a composition therein (medicament cartridge 132 is disposed within the injection device 100 distally of the break tower 144; figure 2; paragraph [0032]), wherein a proximal end portion of the cartridge is configured to extend at least partially within the distal end portion of the brake tower along the longitudinal axis (as shown; figure 2); and
a retaining ring 140 positioned between the proximal end portion of the cartridge 132 and the distal end portion of the brake tower 144 (the wave spring clip 140 supports the medicament cartridge 132 and biases the medicament cartridge 132 distally, thus retaining the cartridge in a desired position; figure 4; paragraph [0032]).
Claims 1 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kohlbrenner et al (US 20190022332 A1).
As per claim 1, Kohlbrenner discloses a medical injection device (figures 1-21) comprising:
a housing 10,20 having a distal end and a proximal end;
a brake tower 120 (figs 4- 6) having a proximal end portion (ribs 122) disposed on a proximal portion thereof [0079], a distal end portion at 140 disposed at a distal end thereof; and a sidewall 121 therebetween defining a longitudinal axis;
a cartridge 40 received within the housing 10 distally of the brake tower and holding a composition therein, wherein a proximal end portion of the cartridge is configured to extend at least partially within the distal end portion of the brake tower along the longitudinal axis [0083,0086] (via carpule sleeve 30); and
a retaining ring 140 positioned between the proximal end portion of the cartridge 40 and the distal end portion of the brake tower 120.
As per claim 15, Kohlbrenner discloses medical injection device (figs 1-21 comprising:
a housing 10,20 having a distal end and a proximal end;
a brake tower 120 (figs 4-6) having a proximal end portion (ribs 122) disposed on a proximal portion thereof [0079], a distal end portion at 140 disposed at a distal end thereof; and a sidewall 121 therebetween defining a longitudinal axis;
a cartridge 40 received within the housing distally of the brake tower 120 and holding a composition therein; wherein a proximal end portion of the cartridge is configured to extend at least partially within the distal end portion of the brake tower along the longitudinal axis ([0083,0086] (via carpule sleeve 30);
a cartridge housing 30 received within the housing distally of the brake tower and configured to hold the cartridge therein;
an injection needle 32 at a distal end of the housing (fig 2) and in fluid communication with the cartridge 40;
an actuation member at a proximal end of the housing (button 80, figure 2), the actuation member configured to actuate the medical injection device to deliver the composition through the injection needle; and
a retaining ring 140 positioned between the proximal end portion of the cartridge and the distal end portion of the brake tower; wherein the retaining ring is press-fittingly secured to an interior surface of the distal end portion of the brake tower (figs 4-6).
Allowable Subject Matter
Claims 2-4, 6, 7 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 10-14 are allowed.
The following is a statement of reasons for the indication of allowable subject matter: Regarding claim 10, the art of record does not teach or render obvious a medical injection device comprising:
a spring washer component, wherein the spring washer component is positioned within the distal end portion of the brake tower; and
a retaining ring positioned between the proximal end portion of the cartridge and the distal end portion of the brake tower, wherein the retaining ring is secured to an interior surface of the distal end portion of the brake tower to hold the spring washer component within the distal end portion of the brake tower, in combination with the elements set forth in claim 10.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 form.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Cris L Rodriguez whose telephone number is (571)272-4964. The examiner can normally be reached Monday-Thursday 8am- 2pm..
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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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/Cris L. Rodriguez/
Primary Patent Examiner
Art Unit 3783