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 claim amendments filed on 1/30/2026. As directed by the amendment: claims 1, 6-8, and 10-11 have been amended; and no claims have been added. Thus, claims 1-11 are presently pending in this application.
Response to Arguments
Applicant's arguments filed 1/30/2026 are not found persuasive. Applicant argues beginning on pg. 5 “The Office Action at pages 9-11……Bosshardt fails to disclose the longitudinal protection [sic] 24 having a recessed lateral edge”. Examiner notes the claim as written does not require the lateral edge to have a recess. Therefore, Applicant’s argument is not found persuasive. Applicant is reminded that although claims are read in light of the specification, limitations are not imported from the specification. The limitation as now amended “the least one longitudinal bump having a rounded shape and defining recessed lateral edges”. The edges themselves are required to be recessed which as pointed out in the prior rejection under US 9,717,855 B2 to Bosshardt et al does teach. Examiner agrees Bosshardt does not teach the lateral edge surface having a recess. Applicant further argues “Bosshardt fails to disclose the guide window includes a rounded shape and lateral edges”. Examiner notes this limitation is not within the claim and considers this argument to on the bases of the limitation “at least one complementarily shaped guiding window”. For the same reasons as the first argument this argument is not found persuasive.
Applicant argues “Bosshardt fails to disclose the guiding means are configured to prevent a rotation of the adaptor relative to the distal tip”. Applicant’s argument is not found persuasive as Bosshardt teaches col 8 line 65 to col 9 line 10 “in the absence of a significant turning torque applied on the collar 30 as will be described later, the collar 30, and thus the adaptor 100, is further blocked or at least limited in rotation with respect to the end-piece 21,”. Examiner notes comprising language used within the claim and Bosshardt's teaching is considered to read upon the limitation under BRI.
Applicant argues on page 7 Bosshardt does not teach a snap-fit connection stating “Figure 11 illustrates (see arrows D) that the adapter is deflected radially outwardly”. Examiner does not find this argument persuasive. Applicant’s claim requires a snap-fit connection and the teaching of Bosshardt is one type of snap-fit connection. The adapter flexes outwardly and snaps back to the original position after clearing element 23.
Election/Restrictions
Newly submitted claim 11 is directed to an invention that lacks unity with the invention originally claimed for the following reasons: Although claim 11 at the presentation of these amendments share the technical features of claims 1, 7, and 10 these shared features are not special technical features. See MPEP 1893.03(d) “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.”.
Claim 11 listed above does not relate to a single general inventive concept under PCT Rule 13.1 with claims 1-10 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
In view of US 9,717,855 B2 to Bosshardt et al.:
Claim 1: A medical container (Fig. 1) forming a reservoir (Fig. 1 element 20) for containing a medical product (abstract “An adapter for use with a drug delivery device having a reservoir for containing a product”) and having a longitudinal distal tip (Fig. 1 element 21) extending along a longitudinal axis (Fig. 1 element 21), the distal tip defining a passageway in fluid communication with said reservoir (Col 7:13-17 “The end-piece 21 has a longitudinal axis A and defines a channel 22 providing a passageway for the transfer of the product from the reservoir 20.”), wherein the distal tip comprises - a fitting portion configured to fit with a connector (see annotated Fig. 3 below, considered configured to fit with a connector due to Fig. 2 element 40 “connector” connecting to elements 21 and threads of 31b); and - a mounting portion (see annotated Fig. 3 below) proximally located relative to said fitting portion (see annotated Fig. 3 below, proximal portion of element 21 from element 23b to 20a) and configured to slidably connect an adaptor to said distal tip (Fig. 2 element 100 mounted upon elements 24 of “fitting portion”. Further demonstrated by Figs. 9-11 specifically interactions between elements 24 and 37 “longitudinal grooves” of element 100), wherein said mounting portion is configured to allow a free longitudinal movement of the adaptor relative to the distal tip when the adaptor is connected to the distal tip (Col 8:49-56 “The collar 30, and thus the adaptor 100, is blocked, or at least limited, in translation with respect to the longitudinal axis A both in the proximal direction, by virtue of the proximal end of the collar 30 coming in abutment against the distal wall 20a of the reservoir 20, and in the distal direction, by virtue of the abutment surface 36 coming in contact with the radial proximal face 23b of the annular ridge 23 of the end-piece 21”(emphasis added) adapter (100) considered to freely move between the abutments of elements 23b and 20a when pushed as the grooves 37 allow limited longitudinal movement between abutments 23b and 20a as taught by Col 8:49-56 above. Rejection made in light of Applicants definition of “free longitudinal movement”.), wherein the mounting portion comprises guiding means (Fig. 3 elements 24) configured to guide a translational movement of the adaptor (Fig. 3 element 100) relative to the distal tip (col 8:49-56 “The collar 30, and thus the adaptor 100, is blocked, or at least limited, in translation with respect to the longitudinal axis A both in the proximal direction, by virtue of the proximal end of the collar 30 coming in abutment against the distal wall 20a of the reservoir 20, and in the distal direction, by virtue of the abutment surface 36 coming in contact with the radial proximal face 23b of the annular ridge” (emphasis added)) and to prevent a rotation of the adaptor relative to the distal tip (col 8:65-col 9:6 “FIGS. 2 and 9, wherein the collar 30 is engaged with the end-piece 21, and in the absence of a significant turning torque applied on the collar 30 as will be described later, the collar 30, and thus the adaptor 100, is further blocked or at least limited in rotation with respect to the end-piece 21, by virtue of the longitudinal projections 24 engaged in the longitudinal grooves 37 or in the longitudinal slots 33 as shown on FIG. 10” (emphasis added)), the guiding means comprising at least one longitudinal bump (Fig. 1 element 24), configured to engage at least one complementarily shaped guiding window (Fig. 10 elements 33. Considered a guiding window as it is a window from exterior of element 100 to the interior of element 100 that functions in the same manner as elements 37 (longitudinal grooves) when the at least one longitudinal bumps element 24 are aligned with the window elements 33. Examiner further notes fig. 12 elements 33 are present in the position of four of the longitudinal grooves as seen in Fig. 12) of a mounting ring of the adaptor (Figs. 10 through 12 elements 24 considered fully capable of engaging with the windows due to their corresponding rectangular shapes.), and the least one longitudinal bump has a rounded shape (see annotated Fig. 10 below) and defining recessed lateral edges (see annotated Fig. 10 below, considered to have a recessed lateral edge relative to the outermost longitudinal edge plane (labeled plane edge recessed from)) configured to receive lateral edges of said at least one guiding window (considered fully capable of receiving lateral edges of said at least one guiding window elements 33 as elements 24 are show to be capable of interacting with the lateral edges of elements 37 (see annotated Fig. 10) that make up at least a portion of the lateral edges of window element 33 as shown in annotated Fig. 10 below), thereby allowing a snap-fit connection between the adaptor and the mounting portion of the distal tip (Fig. 9 element 30 “snap fit” on element 20 past abutment element 23b. Considered a snap fit due to col 7:60-65 “ the skirt pieces 32 are flexible and capable of being radially outwardly deflected under the effect of a outwardly radial force exerted on their inner wall 32a. Moreover, each skirt piece 32 has two lateral sides forming radial walls 32b.” allowing skirt elements 32, of element 100, to expand around element 23b and snap fit to element 20. Col 8:32-46 “the adaptor 100 before engagement of the collar 30 on the end-piece 21 as shown on FIG. 1. The user then grasps the reservoir 20 in one hand and the collar 30 in the other hand and approaches the proximal region 30a towards the distal end of the end-piece 21 along the direction of the longitudinal axis A. The inner wall 32a of the skirt pieces 32 of the proximal region 30a of the collar 30 slides along the outer wall of the end-piece 21 until it reaches the slanted face 23a of the annular ridge 23 of the end-piece 21. Thanks to the capability of the skirt pieces 32 to be radially and outwardly deflected, the skirt pieces 32 deflect in the outward direction, overcome the annular ridge 23 and come back to their rest state, in which they face the longitudinal projections 24 of the proximal region of the end-piece 21.”).
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Claim 7: An adaptor (Fig. 1 element 100) for connecting the medical container according to claim 1 (Examiner notes this recitation is not considered to be positively reciting the structure of claim 1 but the capability of the adapter to connect to a medical container meeting the limitation of claim 1. Fig. 2 element 100 considered fully capable of connecting to a medical container as described due to col 9:44-50 “FIG. 2 is shown the drug delivery device 1 of the invention, with the collar 30 of the adaptor 100 engaged with the end-piece 21, and a connector 40 intended to be connected to the end-piece 21 of the drug delivery device 1”.), said adaptor (Fig. 1 element 100) having connecting means (fig. 2 element 31 col 10:8-9 “thread 31 of the collar 30”) configured to cooperate with complementary connecting means provided on a connector (col 10:6-10 “The user approaches the proximal end 42a of the thread 42 of the connector 40 to the distal end 31b of the thread 31 of the collar 30 and he begins to screw the connector 40 within the collar 30.”), and a mounting ring for mounting the adaptor onto the distal tip of the medical container (Fig. 7 element 30, and “skirt” elements 32), said mounting ring being configured to slidably engage the mounting portion of the distal tip (col 8:32-46 “the adaptor 100 before engagement of the collar 30 on the end-piece 21 as shown on FIG. 1. The user then grasps the reservoir 20 in one hand and the collar 30 in the other hand and approaches the proximal region 30a towards the distal end of the end-piece 21 along the direction of the longitudinal axis A. The inner wall 32a of the skirt pieces 32 of the proximal region 30a of the collar 30 slides along the outer wall of the end-piece 21 until it reaches the slanted face 23a of the annular ridge 23 of the end-piece 21. Thanks to the capability of the skirt pieces 32 to be radially and outwardly deflected, the skirt pieces 32 deflect in the outward direction, overcome the annular ridge 23 and come back to their rest state, in which they face the longitudinal projections 24 of the proximal region of the end-piece 21.”), wherein the mounting ring comprises at least one guiding window (Fig. 10 elements 33) configured to engage an at least one complementarily shaped longitudinal bump of said mounting portion (Fig. 10 elements 33. Considered a guiding window as it is a window from exterior of element 100 to the interior of element 100 that functions in the same manner as elements 37 (longitudinal grooves) when the at least one longitudinal bumps element 24 are aligned with the window elements 33. Examiner further notes fig. 12 elements 33 are present in the position of four of the longitudinal grooves as seen in Fig. 12) in order to guide the sliding movement of the adaptor relative to the tip and to block any rotation of the adaptor relative to said tip (Col 8:67 to Col 9:6 “in the absence of a significant turning torque applied on the collar 30 as will be described later, the collar 30, and thus the adaptor 100, is further blocked or at least limited in rotation with respect to the end-piece 21, by virtue of the longitudinal projections 24 engaged in the longitudinal grooves 37 or in the longitudinal slots 33 as shown on FIG. 10” (emphasis added)), and wherein this at least one window has lateral edges configured to engage corresponding lateral edges of the at least one longitudinal bump having a rounded shape (See annotated Fig. 10 below, col 9:4-6 “by virtue of the longitudinal projections 24 engaged in the longitudinal grooves 37 or in the longitudinal slots 33 as shown on FIG. 10”), said lateral edges forming snap-fitting means for connecting the adaptor to the mounting portion (Fig. 9 element 30 “snap fit” on element 20 past abutment element 23b. Considered a snap fit due to col 7:60-65 “ the skirt pieces 32 are flexible and capable of being radially outwardly deflected under the effect of a outwardly radial force exerted on their inner wall 32a. Moreover, each skirt piece 32 has two lateral sides forming radial walls 32b.” allowing skirt elements 32, of element 100, to expand around element 23b and snap fit to element 20. Col 8:32-46 “the adaptor 100 before engagement of the collar 30 on the end-piece 21 as shown on FIG. 1. The user then grasps the reservoir 20 in one hand and the collar 30 in the other hand and approaches the proximal region 30a towards the distal end of the end-piece 21 along the direction of the longitudinal axis A. The inner wall 32a of the skirt pieces 32 of the proximal region 30a of the collar 30 slides along the outer wall of the end-piece 21 until it reaches the slanted face 23a of the annular ridge 23 of the end-piece 21. Thanks to the capability of the skirt pieces 32 to be radially and outwardly deflected, the skirt pieces 32 deflect in the outward direction, overcome the annular ridge 23 and come back to their rest state, in which they face the longitudinal projections 24 of the proximal region of the end-piece 21.”).
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Claim 10: A drug delivery device comprising the medical container according to claim 7, wherein the adaptor is slidably mounted onto the mounting portion of the distal tip (Fig. 2).
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 11 is withdrawn from consideration as being directed to a nonelected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim Interpretation
Free longitudinal movement is understood in light of Applicant’s definition as disclosed in originally filed specification page 4 sixth paragraph, “By free longitudinal movement it is meant that the adaptor slides along the tip as soon as the adaptor is simply pushed proximally or distally in the axial direction.”
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are:
Guiding means in claims 1-11, claim 1 recites sufficient structure to perform the function. Claim 1 line 15 “the guiding means comprising at least one longitudinal bump”;
Blocking means in claims 4 and 5. claim 4 recites sufficient structure to perform the function. Claim 4 line 2 “the blocking means comprises a distal abutment surface”;
Snap-fitting means in claims 7-11, claim 7 recites sufficient structure to perform the function. Claim 7 lines 9-12 “at least one window has lateral edges… …said lateral edges forming snap-fitting means”.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
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.
(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) 1-5 and 7-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 9,717,855 B2 to Bosshardt et al.
In regard to claim 1:
A medical container (Fig. 1) forming a reservoir (Fig. 1 element 20) for containing a medical product (abstract “An adapter for use with a drug delivery device having a reservoir for containing a product”) and having a longitudinal distal tip (Fig. 1 element 21) extending along a longitudinal axis (Fig. 1 element 21), the distal tip defining a passageway in fluid communication with said reservoir (Col 7:13-17 “The end-piece 21 has a longitudinal axis A and defines a channel 22 providing a passageway for the transfer of the product from the reservoir 20.”), wherein the distal tip comprises - a fitting portion configured to fit with a connector (see annotated Fig. 3 below, considered configured to fit with a connector due to Fig. 2 element 40 “connector” connecting to elements 21 and threads of 31b); and - a mounting portion (see annotated Fig. 3 below) proximally located relative to said fitting portion (see annotated Fig. 3 below, proximal portion of element 21 from element 23b to 20a) and configured to slidably connect an adaptor to said distal tip (Fig. 2 element 100 mounted upon elements 24 of “fitting portion”. Further demonstrated by Figs. 9-11 specifically interactions between elements 24 and 37 “longitudinal grooves” of element 100), wherein said mounting portion is configured to allow a free longitudinal movement of the adaptor relative to the distal tip when the adaptor is connected to the distal tip (Col 8:49-56 “The collar 30, and thus the adaptor 100, is blocked, or at least limited, in translation with respect to the longitudinal axis A both in the proximal direction, by virtue of the proximal end of the collar 30 coming in abutment against the distal wall 20a of the reservoir 20, and in the distal direction, by virtue of the abutment surface 36 coming in contact with the radial proximal face 23b of the annular ridge 23 of the end-piece 21”(emphasis added) adapter (100) considered to freely move between the abutments of elements 23b and 20a when pushed as the grooves 37 allow limited longitudinal movement between abutments 23b and 20a as taught by Col 8:49-56 above. Rejection made in light of Applicants definition of “free longitudinal movement”.), wherein the mounting portion comprises guiding means (Fig. 3 elements 24) configured to guide a translational movement of the adaptor (Fig. 3 element 100) relative to the distal tip (col 8:49-56 “The collar 30, and thus the adaptor 100, is blocked, or at least limited, in translation with respect to the longitudinal axis A both in the proximal direction, by virtue of the proximal end of the collar 30 coming in abutment against the distal wall 20a of the reservoir 20, and in the distal direction, by virtue of the abutment surface 36 coming in contact with the radial proximal face 23b of the annular ridge” (emphasis added)) and to prevent a rotation of the adaptor relative to the distal tip (col 8:65-col 9:6 “FIGS. 2 and 9, wherein the collar 30 is engaged with the end-piece 21, and in the absence of a significant turning torque applied on the collar 30 as will be described later, the collar 30, and thus the adaptor 100, is further blocked or at least limited in rotation with respect to the end-piece 21, by virtue of the longitudinal projections 24 engaged in the longitudinal grooves 37 or in the longitudinal slots 33 as shown on FIG. 10” (emphasis added)), the guiding means comprising at least one longitudinal bump (Fig. 1 element 24), configured to engage at least one complementarily shaped guiding window (Fig. 10 elements 33. Considered a guiding window as it is a window from exterior of element 100 to the interior of element 100 that functions in the same manner as elements 37 (longitudinal grooves) when the at least one longitudinal bumps element 24 are aligned with the window elements 33. Examiner further notes fig. 12 elements 33 are present in the position of four of the longitudinal grooves as seen in Fig. 12) of a mounting ring of the adaptor (Figs. 10 through 12 elements 24 considered fully capable of engaging with the windows due to their corresponding rectangular shapes.), and the least one longitudinal bump has a rounded shape (see annotated Fig. 10 below) and defining recessed lateral edges (see annotated Fig. 10 below, considered to have a recessed lateral edge relative to the outermost longitudinal edge plane (labeled plane edge recessed from)) configured to receive lateral edges of said at least one guiding window (considered fully capable of receiving lateral edges of said at least one guiding window elements 33 as elements 24 are show to be capable of interacting with the lateral edges of elements 37 (see annotated Fig. 10) that make up at least a portion of the lateral edges of window element 33 as shown in annotated Fig. 10 below), thereby allowing a snap-fit connection between the adaptor and the mounting portion of the distal tip (Fig. 9 element 30 “snap fit” on element 20 past abutment element 23b. Considered a snap fit due to col 7:60-65 “ the skirt pieces 32 are flexible and capable of being radially outwardly deflected under the effect of a outwardly radial force exerted on their inner wall 32a. Moreover, each skirt piece 32 has two lateral sides forming radial walls 32b.” allowing skirt elements 32, of element 100, to expand around element 23b and snap fit to element 20. Col 8:32-46 “the adaptor 100 before engagement of the collar 30 on the end-piece 21 as shown on FIG. 1. The user then grasps the reservoir 20 in one hand and the collar 30 in the other hand and approaches the proximal region 30a towards the distal end of the end-piece 21 along the direction of the longitudinal axis A. The inner wall 32a of the skirt pieces 32 of the proximal region 30a of the collar 30 slides along the outer wall of the end-piece 21 until it reaches the slanted face 23a of the annular ridge 23 of the end-piece 21. Thanks to the capability of the skirt pieces 32 to be radially and outwardly deflected, the skirt pieces 32 deflect in the outward direction, overcome the annular ridge 23 and come back to their rest state, in which they face the longitudinal projections 24 of the proximal region of the end-piece 21.”).
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In regard to claim 2:
The medical container according to claim 1, wherein the mounting portion has a cylindrical shape (Fig. 10 element 21 cylindrical cross section demonstrates cylindrical shape).
In regard to claim 3:
The medical container according to claims 1, comprising blocking means configured to limit the free longitudinal movement of the adaptor relative to the distal tip (Fig. 3, 4, and 9 elements 23b and 20a. Col 8:49-56 “the adaptor 100, is blocked, or at least limited, in translation with respect to the longitudinal axis A both in the proximal direction, by virtue of the proximal end of the collar 30 coming in abutment against the distal wall 20a of the reservoir 20, and in the distal direction, by virtue of the abutment surface 36 coming in contact with the radial proximal face 23b of the annular ridge 23 of the end-piece 21”).
In regard to claim 4:
The medical container according to claim 3, wherein the blocking means comprises a distal abutment surface (Figs. 3, 4, and 9 element 23a) and a proximal abutment (Fig. 3, 4, and 9 element 20a) surface (Fig. 3, 4, and 9 elements 23b and 20a. Col 8:49-56 “the adaptor 100, is blocked, or at least limited, in translation with respect to the longitudinal axis A both in the proximal direction, by virtue of the proximal end of the collar 30 coming in abutment against the distal wall 20a of the reservoir 20, and in the distal direction, by virtue of the abutment surface 36 coming in contact with the radial proximal face 23b of the annular ridge 23 of the end-piece 21”).
In regard to claim 5:
The medical container according to claim 4, wherein the distal abutment surface (Fig. 3, 4, and 9 element 23b) and the proximal abutment surface (Fig. 3, 4, and 9 element 20a) are respectively provided on a bump (considered to be provided on a bump as elements 23b and 20a are provided on either end of element 24 (bump)).
In regard to claim 7:
An adaptor (Fig. 1 element 100) for connecting the medical container according to claim 1 (Examiner notes this recitation is not considered to be positively reciting the structure of claim 1 but the capability of the adapter to connect to a medical container meeting the limitation of claim 1. Fig. 2 element 100 considered fully capable of connecting to a medical container as described due to col 9:44-50 “FIG. 2 is shown the drug delivery device 1 of the invention, with the collar 30 of the adaptor 100 engaged with the end-piece 21, and a connector 40 intended to be connected to the end-piece 21 of the drug delivery device 1”.), said adaptor (Fig. 1 element 100) having connecting means (fig. 2 element 31 col 10:8-9 “thread 31 of the collar 30”) configured to cooperate with complementary connecting means provided on a connector (col 10:6-10 “The user approaches the proximal end 42a of the thread 42 of the connector 40 to the distal end 31b of the thread 31 of the collar 30 and he begins to screw the connector 40 within the collar 30.”), and a mounting ring for mounting the adaptor onto the distal tip of the medical container (Fig. 7 element 30, and “skirt” elements 32), said mounting ring being configured to slidably engage the mounting portion of the distal tip (col 8:32-46 “the adaptor 100 before engagement of the collar 30 on the end-piece 21 as shown on FIG. 1. The user then grasps the reservoir 20 in one hand and the collar 30 in the other hand and approaches the proximal region 30a towards the distal end of the end-piece 21 along the direction of the longitudinal axis A. The inner wall 32a of the skirt pieces 32 of the proximal region 30a of the collar 30 slides along the outer wall of the end-piece 21 until it reaches the slanted face 23a of the annular ridge 23 of the end-piece 21. Thanks to the capability of the skirt pieces 32 to be radially and outwardly deflected, the skirt pieces 32 deflect in the outward direction, overcome the annular ridge 23 and come back to their rest state, in which they face the longitudinal projections 24 of the proximal region of the end-piece 21.”), wherein the mounting ring comprises at least one guiding window (Fig. 10 elements 33) configured to engage an at least one complementarily shaped longitudinal bump of said mounting portion (Fig. 10 elements 33. Considered a guiding window as it is a window from exterior of element 100 to the interior of element 100 that functions in the same manner as elements 37 (longitudinal grooves) when the at least one longitudinal bumps element 24 are aligned with the window elements 33. Examiner further notes fig. 12 elements 33 are present in the position of four of the longitudinal grooves as seen in Fig. 12) in order to guide the sliding movement of the adaptor relative to the tip and to block any rotation of the adaptor relative to said tip (Col 8:67 to Col 9:6 “in the absence of a significant turning torque applied on the collar 30 as will be described later, the collar 30, and thus the adaptor 100, is further blocked or at least limited in rotation with respect to the end-piece 21, by virtue of the longitudinal projections 24 engaged in the longitudinal grooves 37 or in the longitudinal slots 33 as shown on FIG. 10” (emphasis added)), and wherein this at least one window has lateral edges configured to engage corresponding lateral edges of the at least one longitudinal bump having a rounded shape (See annotated Fig. 10 below, col 9:4-6 “by virtue of the longitudinal projections 24 engaged in the longitudinal grooves 37 or in the longitudinal slots 33 as shown on FIG. 10”), said lateral edges forming snap-fitting means for connecting the adaptor to the mounting portion (Fig. 9 element 30 “snap fit” on element 20 past abutment element 23b. Considered a snap fit due to col 7:60-65 “ the skirt pieces 32 are flexible and capable of being radially outwardly deflected under the effect of a outwardly radial force exerted on their inner wall 32a. Moreover, each skirt piece 32 has two lateral sides forming radial walls 32b.” allowing skirt elements 32, of element 100, to expand around element 23b and snap fit to element 20. Col 8:32-46 “the adaptor 100 before engagement of the collar 30 on the end-piece 21 as shown on FIG. 1. The user then grasps the reservoir 20 in one hand and the collar 30 in the other hand and approaches the proximal region 30a towards the distal end of the end-piece 21 along the direction of the longitudinal axis A. The inner wall 32a of the skirt pieces 32 of the proximal region 30a of the collar 30 slides along the outer wall of the end-piece 21 until it reaches the slanted face 23a of the annular ridge 23 of the end-piece 21. Thanks to the capability of the skirt pieces 32 to be radially and outwardly deflected, the skirt pieces 32 deflect in the outward direction, overcome the annular ridge 23 and come back to their rest state, in which they face the longitudinal projections 24 of the proximal region of the end-piece 21.”).
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Annotated Fig. 10
In regard to claim 8:
The adaptor according to claim 7, wherein the mounting ring defines a through opening (Fig. 6 element 30 through opening in the center, see annotated Fig. 8 below.), whose diameter is at least equal to an outer diameter of the mounting portion of the distal tip (See annotated Fig. 8 below through hole diameter considered at rigid portion of element 30. Considered to be greater than the outer diameter of the mounting portion as seen in annotated Fig. 9 below. Greater than is considered to within the range of at least equal to)
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Annotated Fig. 8
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Annotated Fig. 9
In regard to claim 9:
The adaptor according to claim 7, wherein the mounting ring is in the form of a frustoconical disc (Fig. 9 element 30. Considered a frustoconical disc under broadest reasonable interpretation due to Merriam-webster definition frustoconical: of the shape of a frustum of a cone. Merriam-webster definition frustum: the basal part of a solid cone or pyramid formed by cutting off the top by a plane parallel to the base. As element 30 is shown to be a tapered cone with the top portion cut of it is considered to be a frustoconical disc.)
In regard to claim 10:
A drug delivery device comprising the medical container according to claim 7, wherein the adaptor is slidably mounted onto the mounting portion of the distal tip (Fig. 2).
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 9,717,855 B2 to Bosshardt et al.
In regard to claim 6:
The medical container according to claim 3, taught by Bosshardt as described in parent claim rejection above.
Bosshardt teaches the blocking means (Figs. 3 and 4 elements 23b and 20a).
Bosshardt does not expressly disclose an amplitude of the adaptor free longitudinal movement is comprised between 0.9 mm and 1.3 mm. It would have been obvious to one of ordinary skill in the art, prior to the effective date of filing, to cause the device of Bosshardt to have an amplitude of the adaptor free longitudinal movement is comprised between 0.9 mm and 1.3 mm, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Bosshardt would not operate differently with the claimed amplitude of the adaptor free longitudinal movement is comprised between 0.9 mm and 1.3 mm, and since the device of Bosshardt would function appropriately having the claimed amplitude of the adapter free longitudinal movement.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/M.A.I./
Examiner, Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
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