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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on November 24, 2025 has been entered.
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.
Claim(s) 44, 47, 53, 54, 67-69, 73-80, is/are rejected under 35 U.S.C. 103 as being unpatentable over Shang et al. (US 2013/0079718 A1) in view of Nguyen (US 2017/0157332 A1), Fourt et al. (US 2017/0259008 A1), Edwards et al. (US 2007/0239114 A1) and Hamazaki (US 2007/0184717 A1).
With regard to claims 44, 67-69, 76, 77, 79, and 80, Shang et al. teach a therapeutic agent delivery device, comprising: a housing including a distal end, a proximal end, and a lumen extending between the distal end and the proximal end (Fig. 1A member 12), wherein an outer surface of the housing includes a first opening for visualization int the housing (Figs. 1A and 2, member 130); and a cap configured to engage the proximal end of the housing, wherein the cap includes a central longitudinal axis, a distal end having a first cross-sectional dimension, a proximal end having a second cross-sectional dimension, and a sidewall extending from the distal end to the proximal end, wherein the sidewall includes an external surface, and wherein a proximal most surface of the cap includes a circular cross-section (Figs. 1A-2, cap 24), wherein the cap further includes a recess, the recess extending partially into a thickness of the cap and including a surface defining the depth of the recess, the recess including a distal width larger than the proximal width (Figs. 1A and 2, recess of the cap surrounding 130, the distal end is wider).
Shang et al. do not disclose the second cross-sectional dimension is large than the first. However, Nguyen teaches a proximal portion of the cap having a larger cross-sectional dimension which is beneficial for providing better finger gripping, especially for those who may be disable, and it allows the device to rest on a flat surface (Fig. 1108 and 106, [0047]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use larger proximal end in Shang et la. as Nguyen teaches this is beneficial for providing better finger gripping, especially for those who may be disable, and it allows the device to rest on a flat surface.
Shang et al. do not explicitly disclose the recess to have surfaces and to be enclosed by a ledge with an acute angle and a portion to be arrow-shaped as recited. However, Edwards et al. teach an injection device in which the cap has a recess enclosed by a ledge to indicate the direction in which the cap should be removed to provide visual and tactile instructions to the user (Figs. 8 and 10 member 3850, recess is the area within the raised ledge, [0073]). Hamazaki further teaches equivalently using a projection or an inset recess with an arrow shape to provide directional indicia for use ([0062], Fig.7 34a). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to additionally use an arrow-shaped indicia in the cap of Shang et al. as in Edwards et al. as this would provide instructions to the user for use and would aid in assisting those with visual impairment and enhance safety and further to provide this as a recess as in Hamazaki as Hamzaki teach this is equivalent to a projection. As provided by Hamzaki the recess would necessarily include a first radially outermost surface and a second surface disposed radially offset from the first surface and closer to the central longitudinal axis, the second surface defining a surface of a recess, extending partially into a thickness of the cap, wherein the recess is enclosed by a continuous ledge surrounding the second surface, and wherein the continuous ledge defines a depth of the recess. The angle of the arrow is not explicitly disclosed. Further, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use an acute angle as the angle would either be acute, right, or obtuse. As there are a limited number of options for the user to try for the angle one of ordinary skill in the art would reasonably select an acute angle. Additionally, it would have been an obvious matter of design choice to a person of ordinary skill in the art before the effective filing date of the claimed invention to use an acute angle because Applicant has not disclosed that such an angle provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected the Applicant's invention to perform equally well with the arrow shape of Edwards et al. as it provides an art effective means for indicating direction, the angle of the arrow would not change the ability of the user to discern the appropriate direction.
Shang et al. do not disclose a plurality of protrusions as recited. However, Fourt et al. teach using longitudinally extending rectangular protrusions to provide easier gripping. The protrusions are equally spaced about the cap and indicia is placed between adjacent protrusions (Fig. 16 106 between 104, [0047]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to place the arrows between protrusions in Shang et al. as Fourt et al. teach this is beneficial for easier gripping. One of ordinary skill would have a limited number of options for spacing about the cap and would be able to determine the necessary placement of the arrows and number of protrusions to achieve desired visibility and gripping.
With regard to claim 47, Shang et al. do not disclose specific dimensions but discloses the window may be sized as needed for the purpose of viewing ([0079], [0112], [00114]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to size the window as claimed as Shang et al. teach one or ordinary skill in the art would be able to select dimensions as desired for purpose. Further, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. Additionally, Applicant has not disclosed that such dimensions provide an advantage, are used for a particular purpose, or solver a stated problem. One of ordinary skill would except the invention to perform equally well with the window of Shang et al.
With regard to claims 53 and 54, see Fig. 1B syringe 50 ([0079]).
With regard to claim 55, Shang et al. teach using multiple windows/configurations spaced about the surface which may be diametrically opposite (Shang et al. [0079]).
With regard to claim 73, the proximal facing rim of the cap has a flat configuration (Fig. 2).
With regard to claims 74 and 75, the inner surface of the opening is flush with the outer surface of the housing.
With regard to claim 78, Shang et al. as combined do not disclose a plurality of recesses. However, it would have been obvious to a person of ordinary skill in the art at the time the invention was made to add an additional, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art, St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. Further, this would beneficial in allowing the recess to be easily viewed from various angles to enhance the ease of use.
Claim(s) 50 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shang et al. (US 2013/0079718 A1), Nguyen (US 2017/0157332 A1), Fourt et al. (US 2017/0259008 A1), Edwards et al. (US 2007/0239114 A1), and Hamazaki (US 2007/0184717 A1) as applied to claim 44 above, and further in view of Kemp et al. (US 2018/0133407 A1).
With regard to claim 50, Shang et al. teach a device substantially as claimed but Shang et al. do not disclose the autoinjector to contain dupilumab. However, Kemp et al. teach an autoinjector which can contain a drug including dupilumab ([0082], [0097]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to deliver dupilumab with the injector of Shang et al. as Kemp et al. teach such is an effective substance for treatment that can be delivered with an autoinjector.
Claim(s) 56 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shang et al. (US 2013/0079718 A1), Nguyen (US 2017/0157332 A1), Fourt et al. (US 2017/0259008 A1), Edwards et al. (US 2007/0239114 A1), and Hamazaki (US 2007/0184717 A1) as applied to claim 55 above, and further in view of Saussaye et al. (FR 3 043 562 US 2018/0311442 A1 used as translation).
With regard to claim 56, Shang et al. teach using multiple windows/configurations spaced about the surface (Shang et al. [0079]). Shang et al. do not explicitly disclose using different shapes. However, Saussaye et al. teach using multiple windows/configurations spaced about the surface Saussaye et al. [0052]). Saussaye et al. teach different windows on the device may have different shapes (see Figs. 10 and 11). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use windows with different shapes in Shang et al. as Saussaye et al. teach this is effective for visualization. One window may have a circular or oval opening as in Shang et al. and a second window may be shaped with an arrowhead as in Saussaye et al. This would yield the same predictable result regardless of the window shape.
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Jakob et al. (US 2015/0032062 A1) which discloses various embodiments of a syringe cap with gripping and indicia.
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/EMILY L SCHMIDT/Primary Examiner, Art Unit 3783