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 .
Response to Amendment
This office action is responsive to the amendment filed on 01/12/2026. As directed by the amendment: claims 1, 12, 16, 18 have been amended; claims 8, 17 have been canceled; and no new claims have been added. Thus, claims 1-7, 9-16, 18-19 are presently pending in this application.
Response to Arguments
Applicant’s argument pages 6-8 of the remarks filed 01/12/2026 that the current interpretation of Plumptre fails to disclose or teach the amended limitation of claim 1. Applicant’s argument has been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection (with different interpretation of Plumptre) has been made, as seen below.
Applicant’s argument pages 8-10 of the remarks filed 01/12/2026 that Schrul fails to disclose “a distal end of the extension portion is non-coplanar with the body”. Applicant’s argument has been fully considered and are not persuasive. Schrul discloses a biasing member (14a/14b) comprising a body (14a) as a section or a sector of a circular ring (see fig. 5). The curvature portion of the body 14a is curved inwardly into the open space between the two elements 14a and this portion is not in the same plane as the extension portion 14b. Therefore, a distal end of Schrul extension portion is non-coplanar with the curvature portion of Schrul body.
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Applicant’s argument pages 10-12 of the remarks filed 01/12/2026 that Pala fails to disclose “a biasing member” with a first end and a second end. Pala only discloses element 140 with a ring/oval shaped body. Since a ring/oval shaped body is a closed loop body, element 140 does not have an end. Applicant’s argument has been fully considered and are not persuasive. As shown in fig. 10, element 140 comprises two recesses for two elements 232 being positioned within. Therefore, element 140 comprises a first end and a second end that are opposite to each other (see fig. 10).
Applicant’s argument pages 11-13 of the remarks filed 01/12/2026 that Pala fails to disclose “a pocket defined by the brake member wherein the pocket is located within an interior portion of the brake member”. Applicant’s argument has been fully considered and are not persuasive. Pala discloses a pocket 236/228 as a recessed portion of the brake member 144 and the recessed portion is located within an interior portion of 144 with respect to element 224 of 144.
Claim Objections
Claim(s) 1, 12 is/are objected to because of the following informalities:
Claim 1, line 4, “the first end and second end”. It should be amended as “the first end and the second end”.
Claim 1, line 5, “the first end and second end”. It should be amended as “the first end and the second end”.
Claim 12, line 9, “the first end and second end”. It should be amended as “the first end and the second end”.
Claim 12, line 10, “the first end and second end”. It should be amended as “the first end and the second end”.
Appropriate correction is required.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-4 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Plumptre et al. (US 2018/0080592).
Regarding claim 1, Plumptre discloses
A biasing member (300, figs. 6-7 and pars. 0051-0060) for a medical injection device having a housing, a brake member, a cartridge, and an injection needle (Examiner notes: the limitations “a medical injection device”, “a housing”, “a brake member”, “a cartridge”, “an injection needle” are not positively recited in claim 1. See fig. 1A for the medical injection device 100), the biasing member (300) comprising:
a body (body of 300 comprising 302, figs. 6-7) having a first end (outer end of 300, see annotated fig. 6 below), a second end (inner end of 300, see annotated fig. 6 below) positioned opposite the first end (see annotated fig. 6 below), a top surface (see annotated fig. 6 below) adjacent to the first end and second end (see annotated fig. 6 below), and a bottom surface (see annotated fig. 6 below) positioned opposite the top surface that is also adjacent to the first end and second end (see annotated fig. 6 below); and
an extension portion (304) extending from the body (body of 300, see annotated fig. 6 below) in a direction extending from the top surface of the body to the bottom surface of the body (see annotated fig. 6 below), wherein the extension portion (304) is resilient (see figs. 6-7 and pars. 0051-0060 for 304 being inwardly spring arm), and further wherein a distal end of the extension portion (308) is non-coplanar with the body (see fig. 6 for 308 being outwardly with respect to the body of 300).
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Regarding claim 2, Plumptre discloses
The biasing member of claim 1, wherein the extension portion (304) extends from the bottom surface of the body (see annotated fig. 6 above).
Regarding claim 3, Plumptre discloses
The biasing member of claim 1, wherein the body (body of 300) is arcuate (see figs. 6-7 for 300 having a tubular shape).
Regarding claim 4, Plumptre discloses
The biasing member of claim 1, wherein the extension portion (304) is wavy (see figs. 6-7).
Claim(s) 1-2, 6-7, 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schrul et al. (WO 2020/164910).
Regarding claim 1, Schrul discloses
A biasing member (14a/14b, fig. 5) for a medical injection device having a housing, a brake member, a cartridge, and an injection needle (Examiner notes: the limitations “a medical injection device”, “a housing”, “a brake member”, “a cartridge”, “an injection needle” are not positively recited in claim 1. See fig. 1 for the medical injection device), the biasing member (14a/14b) comprising:
a body (14a) having a first end (first end of 14a – one free end of 14a that is not directly connected to 14b), a second end (second end of 14a – another free end of 14a that is not directly connected to 14b) positioned opposite the first end (see annotated fig. 5 below), a top surface (top surface of 14a that is not directly connected to 14b) adjacent to the fist end and second end (see annotated fig. 5 below), and a bottom surface (bottom surface of 14a that is directly connected to 14b) positioned opposite the top surface that is also adjacent to the first end and second end (see annotated fig. 5 below); and
an extension portion (14b) extending from the body (14a) in a direction extending from the top surface of the body to the bottom surface of the body (see fig. 5), wherein the extension portion is resilient (see abstract for 14 with 14a/14b being radially deflectable element), and further wherein a distal end of the extension portion is non-coplanar with the body (Examiner notes: 14a is a section or a sector of a circular ring. The curvature portion of 14a is curved inwardly into the open space between the two elements 14a and this portion is not in the same plan as 14b, see annotated fig. 5 below. Therefore, a distal end of 14b is non-coplanar with the curvature portion of 14a).
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Regarding claim 2, Schrul discloses
The biasing member of claim 1, wherein the extension portion (14b) extends from the bottom surface of the body (see annotated fig. 5 above).
Regarding claim 6, Schrul discloses
The biasing member of claim 1, wherein the biasing member is T-shaped (see fig. 5).
Regarding claim 7, Schrul discloses
The biasing member of claim 1, wherein the extension portion (14b) extends from the body (body of 14a) at an equidistant point between the first and second ends of the body (see annotated fig. 5 above).
Regarding claim 10, Schrul discloses
The biasing member of claim 1, wherein the body (14a) is integrally formed with the extension portion (14b, see fig. 5)
Claim(s) 12-16, 18-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pala (US 2014/0094765).
Regarding claim 12, Pala discloses
A medical injection device (100, figs. 1-18 and pars. 0031-0052) comprising:
a housing (108, figs. 1-2) having a distal end (distal end of 108, figs. 1-2) and a proximal end (proximal end of 108, figs. 1-2);
a brake member (144, fig. 2) received within the housing (see fig. 9 and pars. 0039);
a cartridge (132, fig. 2) received within the housing (108, see pars. 0032-0033 for 132 is positioned within 128 and 128 is coupled to 108), the cartridge configured to receive a medicament (par. 0048);
a cartridge housing (128, fig. 2) received within the housing (108, par. 0033) distally of the brake member (144) and configured to hold the cartridge (132, par. 0032);
a biasing member (140, fig. 10) comprising a body (ring/oval shaped body, see fig. 10) having a first end (one end of 140 comprising one element 232), a second end (the other end of 140 comprising the other element 232 since there are two elements 232 on 140) positioned opposite the first end (see fig. 10), a top surface (the surface on top – facing upward, see fig. 10) adjacent to the first end and second end (see fig. 10), and a bottom surface (the surface on bottom, see fig. 10) positioned opposite the top surface that is also adjacent to the first end and second end (see fig. 10); and an extension portion (232) extending from the body (body of 140) in a direction extending from the top surface of the body to the bottom surface of the body (see fig. 10), wherein the extension portion is resilient (see pars. 0032 and 0039), and further wherein a distal end of the extension portion is non-coplanar with the body (see fig. 10 for distal end of 232 being positioned outwardly from the plane defined by 140);
the biasing member (140) received within the housing (108, see fig. 2) and positioned between the brake member (144) and the cartridge (132, see fig. 2);
an injection needle (needle in par. 0045) at the distal end of the housing (see fig. 2 for the connector of 128 configured to receive the needle) and in fluid communication with the cartridge (see par. 0045); and
an actuation member (116) configured to actuate the medical injection device to deliver the composition through the injection needle (see pars. 0045-0048).
Regarding claim 13, Pala discloses
The medical injection device of claim 12, wherein the biasing member (140) is received within a pocket (236/228) defined by the brake member (144, see fig. 9).
Regarding claim 14, Pala discloses
The medical injection device of claim 13, wherein the pocket (236/228) is defined by a radially extending protrusion of the brake member (see fig. 9).
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Regarding claim 15, Pala discloses
The medical injection device of claim 12, wherein the biasing member (140, fig. 10) comprises first and second biasing members (see fig. 10 for 2 elements 232).
Regarding claim 16, Pala discloses
A medical injection device (100, figs. 1-18 and pars. 0031-0052) comprising:
a housing (108, figs. 1-2) having a distal end (distal end of 108, figs. 1-2) and a proximal end (proximal end of 108, figs. 1-2);
a brake member (144, fig. 2) received within the housing (see fig. 9 and pars. 0039);
a cartridge (132, fig. 2) received within the housing (108, see pars. 0032-0033 for 132 is positioned within 128 and 128 is coupled to 108), the cartridge configured to receive a medicament (par. 0048);
a cartridge housing (128, fig. 2) received within the housing (108, par. 0033) distally of the brake member (144) and configured to hold the cartridge (132, par. 0032);
a biasing member (140, figs. 2 and 10) received within the housing (108, see fig. 2) and positioned between the brake member (144) and the cartridge (132, see fig. 2), the biasing member (140) comprising a compression spring (par. 0032)m wherein the biasing member (140) is received within a pocket (236/228) defined by the brake member (144, see fig. 9), wherein the pocket (236/228) is located within an interior portion of the brake member (Examiner notes: see fig. 9 for 236/228 as a recessed portion of the brake member 144 and the recessed portion is located within an interior portion of 144 with respect to element 224 of 144);
an injection needle (needle in par. 0045) at the distal end of the housing (see fig. 2 for the connector of 128 configured to receive the needle) and in fluid communication with the cartridge (see par. 0045); and
an actuation member (116) configured to actuate the medical injection device to deliver the composition through the injection needle (see pars. 0045-0048).
Regarding claim 18, Pala discloses
The medical injection device of claim 16, wherein the pocket (236/228) is defined by a shoulder portion of the brake member (shoulder portion of 144, see fig. 9), the shoulder portion extending radially outward from a body of the brake member (see fig. 9).
Regarding claim 19, Pala discloses
The medical injection device of claim 18, wherein the shoulder portion (should portion of 144) comprises a protrusion extending radially inward into the pocket (see annotated fig. 9 above), the protrusion engaging a portion of the biasing member (232) to retain the biasing member (140) within the pocket (see par. 0039).
Claim Rejections - 35 USC § 103
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 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) 5, 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Plumptre et (US 2018/0080592).
Regarding claim 5, Plumptre discloses the biasing member of claim 1, wherein the body (body of 300, see figs. 6-7) defines a width extending from the first end of the body to the second end of the body (see fig. 6)
Plumptre also discloses the extension portion (304) with a width (see figs. 6-7).
Plumptre is silent about wherein the extension portion (304) has a width less than the width of the body.
There is no evidence of record that establishes that changing the width of the extension portion would result in a difference in function of Plumptre device. Further, a person having ordinary skill in the art, being faced with modifying the extension portion, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed width.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify the extension portion to have a width less than the width of the body, as an obvious matter of design choice within the skill of the art.
Regarding claim 11, Plumptre discloses the biasing member of claim 1, as set forth above, except for wherein the body and the extension portion are equal in thickness.
Plumptre only discloses the body and the extension portion are molded together (par. 0053).
There is no evidence of record that establishes that changing the thickness of the body and the extension portion would result in a difference in function of Plumptre device. Further, a person having ordinary skill in the art, being faced with modifying the biasing member of Plumptre, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed thickness.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify the thickness of Plumptre to have the body and the extension portion equal in thickness as an obvious matter of design choice within the skill of the art.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Plumptre et al. (US 2018/0080592) in view of Eich et al. (US 2011/0054412).
Regarding claim 9, Plumptre discloses the biasing member of claim 1, as set forth above, except for wherein the biasing member comprises a metallic material.
However, Eich teaches a biasing member comprising a metallic material (par. 0025).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify Plumptre’s biasing member comprising a metallic material, as taught by Eich, for the purpose of providing sufficient structure to allow the biasing member to perform its function (par. 0025 of Eich).
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 DUNG T ULSH whose telephone number is (571)272-9894. The examiner can normally be reached Monday-Friday 9am-6pm.
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/DUNG T ULSH/Primary Examiner, Art Unit 3783 023