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 12/24/2025. As directed by the amendment: claims 16, 21, 23-24, 28, and 43 have been amended, claims 22, 27, 29, and 31 have been cancelled, and claims 45-47 have been added. Thus, claims 16-21, 23-26, 28, 30, and 32-47 are presently pending in this application, with claims 33-35 being withdrawn from consideration. Applicant’s amendments to the claims have overcome each and every 112 rejection set forth in the Non-Final Office Action mailed on 08/26/2025. The 112(f) interpretation is being maintained.
Response to Arguments
Examiner notes that in response to applicant’s statement on p.1 of “Remarks”, filed 12/24/2025, stating “Examiner Turkowski indicated that amendments to claim 16 introducing the bifurcation from dependent claim 27 appear to overcome the present rejections under 103”, and the examiner wishes the clarify that this does not reflect the examiner’s summary of the interview. As stated in the Examiner’s Interview Summary filed 11/26/2025, the examiner stated “examiner pointed to the limitations of claim 27 after the term “or” which discuss an optical bifurcation in which examiner did not apply art to this optional limitation.” Thus, examiner clarifies that no conclusion was reached with regards to the limitation of claim 27 overcoming the rejection of record. As discussed below in the new grounds of rejection of claim 16, Garfield discloses the bifurcation from which the first fixing portion and the second fixing portion extend into the retaining space. Therefore, applicant’s arguments are not persuasive.
Applicant’s arguments, see p.3 of “Remarks”, filed 12/24/2025, with respect to the 103 rejection of claim 22 have been fully considered and are persuasive. Therefore, the 103 rejection of 08/26/2025 over this subject matter has been withdrawn.
Claim Objections
Claim 45 is objected to because of the following informalities:
Regarding claim 45, the phrase “wherein the container retaining member comprises a cartridge” in line 2 should read “further comprising the container retained by the container retaining member” as this reads more clearly to positively recite the container and maintains antecedent basis with claim 16,
Appropriate correction is required.
Claim Interpretation
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 do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
Fixing member in claim 1
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
Regarding the fixing member in claim 1, the specification is referenced for the corresponding structure. Page 9, lines 4-7 disclose the fixing member functions to prevent proximal and or distal movement of the container and is disclosed throughout the specification with several exemplary structures such as comprising a plate-like, finger, wedge, or trapezoidal shape. Examiner is interpreting the fixing member as a protrusion extending from the retaining member body that functions to prevent proximal or distal movement of the container.
If applicant does not intend 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 avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claim 45-46 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.
Claim 46 recites the limitation "the acute angle" in line 36. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 45, the phrase “the container retaining member comprising a cartridge” in line 2 renders the claim indefinite because it is unclear. It is unclear, in light of claim 16 which functionally recites “a container”, if the cartridge is to be interpreted as the same structure as the container or if this a different structure. Examiner is interpreting it as the same structure of claim 16 now being positively recited.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 42-43 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Examiner notes claims 42-43 are dependent upon claim 27 which is a cancelled claim, and thus fail to include all the limitations of the claim upon which they depend. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claim(s) 16-20, 25-26, 30, 32, 36-44, and 47 are rejected under 35 U.S.C. 103 as being unpatentable over Garfield et al. (U.S Patent Pub. No. 20180263848 A1, “Garfield”) in view of Fowles et al. (U.S Patent Pub. No. 20040199139 A1, “Fowles”) in view of Aneas (U.S Patent Pub. No. 20180169339 A1).
Regarding claim 16, Garfield discloses the limitations of (Claim 16) a container retaining member (120 in Fig. 6-7), comprising:
a retaining member body (120a) comprising an inner surface that limits a retaining space for a container (V, see Fig. 4 and 6 and para. 0088-0089 – vial collar 120 comprises annular body 120a with an inner surface limiting a retaining space for vial “V”), wherein the retaining member body (120a) has a length such that the retaining member body is configured to cover at least a percent of a length of the container (V, see Fig. 4 and 6), wherein the retaining member body (120a) has an insertion opening through which a distal portion of the container (V) is insertable into a distal portion of the retaining space (see Fig. 6), wherein the container (V) is configured to provide a suitable chamber for storage of one or more drugs see para. 0081 – vial “V” is a container holding liquid); and
at least one fixing member (121, examiner is interpreting a fixing member under 112(f) as a protrusion extending from the retaining member body that functions to prevent proximal or distal movement of the container, see Fig. 4 and 7 and para. 0089 – via collar 120 comprises retainers 121 for engages with the neck of vial “V” to prevent proximal movement) comprising:
a connecting portion that is connected to the inner surface and extends inwardly from the inner surface of the retaining member body (120a, see annotated Garfield drawing 1 below – retainers 121 comprise a portion at their base extending inwardly from the inner surface of body 120a interpreted as the connecting portion);
a first fixing portion that extends from the connecting portion into the retaining space and comprises a first free end of the at least one fixing member (121, see annotated Garfield drawing 1 below); and
a second fixing portion that extends from the connecting portion and comprises a second free end of the at least one fixing member (121, see annotated Garfield drawing 1 below);
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wherein the first fixing portion and the second fixing portion are arranged and configured to engage the container (V) in order to secure the container (V) within the container retaining member (120, see Fig. 6 and para. 0089 – retainer 121 including ledge 121a and the projection from ledge 121a engage with the neck of vial “V” to securely connect the vial “V” within the collar 120),
wherein the first free end of the at least one fixing member (121) is arranged closer to the insertion opening than the second free end of the at least one fixing member (121, see Fig. 6 and annotated Garfield drawing 1 above – the first free end of is arranged closer to the bottom opening than the second free end),
a first state (see Fig. 7) and a second state (see Fig. 9 and para. 0086 – the first state is being interpreted as the vial “V” not inserted into the vial collar 120 as shown in Fig. 7 and the second state as the vial “V” inserted into the vial collar 120 as shown in Fig. 9);
wherein the first fixing portion is directly connected to the connecting portion and the second fixing portion is directly connected to the connecting portion and wherein there is a bifurcation from which the first fixing portion and the second fixing portion extend into the retaining space in the second state and wherein the first free end of the at least one fixing member (121) and the second free end of the at least one fixing member (121) are arranged to prevent each from the losing contact to the container (V) in the second state (see annotated Garfield drawing 1 above and para. 0089 – the shape of each retainer 121 including the first fixing portion and second fixing portion engage the neck of the vial V and thus are configured to be arranged to prevent each from losing contact with the Vial V when it is inserted).
However, Garfield fails to disclose the limitation (Claim 16) wherein the retaining member body has a length such that the retaining member body is configured to cover at least 50 percent of a length of the container; and wherein for switching between a first state and a second state the first free end and the second free end are movable relative to the retaining member body. Examiner notes Garfield discloses the retainers 121 being snap-fit onto the neck of the vial which indicates a degree of flexibility to the retainers (see para. 0045), but Garfield is silent to the retainers of vial collar explicitly being movable during insertion of the vial.
Fowles discloses a reconstitution connector comprising a gripper assembly for retaining a vial within the connector. Fowles teaches (Claim 16) wherein for switching between a first state and a second state at least one fixing member (104) is movable relative to the retaining member body (92, see Fig. 1 and 5 and para. 0128-0131 – gripper assembly 28 comprises tabs 104 which have a first state as seen in Fig. 1 where no vial 14 is inserted and a second state as seen in Fig. 5 where the vial 14 is inserted, wherein when switching between the two states as the vial 14 is inserted, the tabs 104 flex relative to the body of the finger assembly 92 to accommodate the vial 14).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the retainers taught by Garfield to be resiliently flexible as taught by the tabs of Fowles in order to allow the tabs to flex radially outward while inserting varying diameter vial closures (see para. 0131). In combination, the at least one fixing member (121) of Garfield would be modified to deflect during insertion of the container (V) and thus both free ends of the at least one fixing member (121) would be movable relative to the body (120a).
However, modified Garfield fails to disclose the limitation (Claim 16) wherein the retaining member body has a length such that the retaining member body is configured to cover at least 50 percent of a length of the container.
Aneas discloses a container retaining housing assembly for an injection device, wherein Aneas teaches (Claim 16) wherein the retaining member body (32) has a length such that the retaining member body (32) is configured to cover at least 50 percent of a length of the container (20, see Fig. 4 and 8 and para. 0054).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the retaining member body taught by modified Garfield to have a length that is configured to cover at least 50 percent of a length of the container as taught Aneas. This modification is motivated to provide effective protection of the container particularly when it involves a cartridge such that the housing extends over its entire length (see para. 0011). In combination, the body (120a) of modified Garfield would be modified to extend over at least 50 percent of a length of the container (V) to provide increased protection to the container (V) as taught by Aneas.
Regarding claim 17, modified Garfield discloses the member of claim 16, as discussed above. In modified Garfield, Fowles discloses (Claim 17) wherein the connecting portion is movably connected to the inner surface (inner surface of 92) of the retaining member body (92, see annotated Fowles drawing 1 below for connecting portion);
wherein the at least one fixing member (104) is configured such that for switching between the first state (see Fig. 1) and the second state (see Fig. 5) the at least one fixing member (104) move(s) axially relative to an insertion axis that is arranged crosswise or perpendicular to the insertion opening (96, see annotated Fowles drawing 1 below for axis and para. 0119 and 0131 – as the vial 14 is inserted into the gripper assembly 28 through the insertion opening 96 and along the insertion axis, the tabs 104 flex to accommodate the diameter of the crimp ring 22 of the vial closure 14 such that the tab 104 would move at least partially axially as the crimp ring 22 pushes on the tab 104 during insertion);
wherein in the first state (see Fig. 1) no container (14) is inserted within the container retaining member (28, see Fig.1); and
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wherein in the second state (see Fig. 5) the container (14) is held within the container retaining member (see Fig. 5).
In combination, the at least one fixing member (121) of Garfield are modified to have their connecting portion be resiliently flexible such that the connecting portion and thus both free ends of the at least one fixing member (121) would deflect at least partially axially relative to the insertion axis during insertion of the container (V) as taught by Fowles.
Regarding claim 18, modified Garfield discloses the member of claim 16, as discussed above. In modified Garfield, Fowles discloses (Claim 18) wherein for the switching between the first state (see Fig. 1) and the second state (see Fig. 5) the at least one fixing member (104) moves away from the insertion opening (96, see annotated Fowles drawing 1 above for axis and see para. 0127 and 0131- as the vial 14 is inserted into the gripper assembly 28 through the insertion opening 96 and along the insertion axis, the tabs 104 flex to accommodate the diameter of the crimp ring 22 of the vial closure 14 such that the tab 104 would move away from the central opening 96 as the crimp ring 22 pushes on the tab 104 during insertion).
In combination, the at least one fixing member (121) of Garfield are modified to deflect during insertion of the container (V) and thus both free ends of the at least one fixing member (121) would move away from the insertion opening during insertion of the container (V) as taught by Fowles.
Regarding claim 19, modified Garfield discloses the member of claim 16, as discussed above. In modified Garfield, Garfield discloses (Claim 19) wherein the at least one fixing member (121) is configured such that in the second state (see Fig. 9) the second fixing portion extends axially relative to an insertion axis and/or that in the second state (see Fig. 9) the second fixing portion is arranged at a radial position relative to the insertion axis, wherein this radial position is radially inwardly offset from the inner surface of the retaining member body (120a, see annotated Garfield drawing 2 below and para. 0086-0089 – in the second state where vial “V” is inserted into the vial collar 120, the second fixing portion of retainers 121 as annotated below extends axially relative to the insertion axis and is positioned radially outward from the insertion axis
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while being radially inward from the inner surface of body 120a).
Regarding claim 20, modified Garfield discloses the member of claim 16, as discussed above. In modified Garfield, Garfield discloses (Claim 20) wherein the at least one fixing member (121) is configured such that in the second state (see Fig. 9) the second fixing portion is arranged between the container (V) and the inner surface of the retaining member body (120a, see annotated Garfield drawing 2 above and Fig. 9).
Regarding claim 25, modified Garfield discloses the retaining member of claim 16, as discussed above. In modified Garfield, Garfield discloses (Claim 25) wherein at least one of the first free end of the at least one fixing member (121) or the second free end of the at least one fixing member (121) has a shape of a long edge (see Garfield drawing 1 above – the second free end is a long edge) or wherein at least one of the first free end of the at least one fixing member (121) or the second free end of the at least one fixing member (121) has a round shape (see Garfield drawing 1 above – the first free end has a rounded shape).
Regarding claim 26, modified Garfield discloses the retaining member of claim 16, as discussed above. In modified Garfield, Garfield discloses the limitations of (Claim 26) wherein the container (V) comprises a container main body and a container cap (S, see Fig. 1 and para. 0080 – the container is medical vial V which comprises a main body and a stopper S),
wherein the container main body comprises glass and the container cap comprises metal (examiner notes the container is functional limitation and the vial collar 120 is capable of being used with a vial V having a glass main body and stopper S with a metal crimp).
Regarding claim 30, modified Garfield discloses the retaining member of claim 16, as discussed above. In modified Garfield, Garfield discloses (Claim 30) wherein the retaining member body (120a) is an elongated retaining member body (see Fig. 4), and wherein the at least one fixing member (121) is formed unitarily with the elongated retaining member body (see Fig. 7 for unitarily limitation).
Regarding claim 32, modified Garfield discloses the retaining member of claim 16, as discussed above. In modified Garfield, Garfield discloses (Claim 32) wherein the container retaining member (120) comprises three fixing members of the at least one fixing member (121) or at least four fixing members of the at least one fixing member (121, see para. 0017 – the vial collar may include two pairs of diametrically opposed retainers 121 indicating four retainers 121).
Regarding claim 36, modified Garfield discloses the retaining member of claim 16, as discussed above. In modified Garfield, Garfield discloses the limitations of (Claim 36) wherein in the second state (see Fig. 9), the first free end of the at least one fixing member (121) is arranged within a neck portion of the container (V, see annotated Garfield drawing 1 above for first free end and see Fig. 9 – the first free end is arranged in the neck of vial V when vial V is inserted into the vial collar 120), and
wherein in the second state (see Fig. 9), the second free end of the at least one fixing member (121) is arranged lateral of a metal cap (S) of the container (V, see annotated Garfield drawing 1 above for second free end and see Fig. 9 – the second free end of the axial protrusion of retainer 121 is arranged laterally of the stopper S of vial V, examiner notes the container is functional limitation and the vial collar 120 is capable of being used with a vial V having a stopper S with a metal crimp).
Regarding claim 37, modified Garfield discloses neck limitation of claim 36, as discussed above. In modified Garfield, Garfield discloses the limitations of (Claim 37) wherein the second free end of the at least one fixing member (121) contacts the cap (S) of the container (V) laterally (see annotated Garfield drawing 1 above for second free end and see Fig. 9 – the second free end of the axial protrusion of retainer 121 contacts the stopper S of vial V laterally, examiner notes the container is a functional limitation and the vial collar 120 is capable of being used with a vial V having a stopper S with a metal crimp).
Regarding claim 38, modified Garfield discloses the lateral contact of the cap of claim 37, as discussed above. In modified Garfield, Garfield discloses (Claim 38) wherein the first free end of the at least one fixing member (121) and the second free end of the at least one fixing member (121) are arranged in a cross section along a longitudinal axis of the retaining member body (120a);
wherein the cross section comprises the longitudinal axis of the retaining member body (120a); and
wherein the first free end of the at least one fixing member (121) and the second free end of the at least one fixing member (121) are arranged within the cross section at the same side relative to the longitudinal axis of the retaining member body (120a, see annotated Garfield drawing 3 below – the drawing below illustrates a cross-section of the vial collar body 120a with the first and second free ends of the retainer 121 being arranged in the cross section along the longitudinal axis and on the same side laterally relative to the longitudinal axis).
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Regarding claim 39, modified Garfield discloses the retaining member of claim 16, as discussed above. In modified Garfield, Garfield discloses (Claim 39) wherein the at least one fixing member (121) has a distal part which forms a larger inner diameter of the insertion opening in the second state compared to an inner diameter of a more proximal part of the insertion opening in the second state (see annotated Garfield
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drawing 4 below and Fig. 9 for second state).
Regarding claim 40, modified Garfield discloses the retaining member of claim 16, as discussed above. In modified Garfield, Garfield discloses (Claim 40) wherein the retaining member body (120a) is formed integrally with the at least one fixing member (121, see Fig. 7 and para. 0089).
Regarding claim 41, modified Garfield discloses the retaining member of claim 40, as discussed above. Examiner notes the limitation “wherein the retaining member body and the at least one fixing member are formed as one part in a same mold during an injection molding process” of claim 41 is considered a product-by-process limitation. It is noted by the examiner that even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself and does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 227 USPQ 964. Therefore, as the step of “in a same mold during an injection molded process” does not impart a physical limitation which differentiates over the prior art, the integrally formed fixing members (120) and body (120a) of modified Garfield are considered as reading on the limitation above.
Regarding claim 42, in light of the 112(d) rejection above, examiner is interpreting claim 42 as dependent upon claim 16 which was amended to incorporate the limitations of cancelled claim 27. In modified Garfield, Garfield discloses (Claim 42) wherein the connecting portion is integrally connected to the inner surface of the retaining member body (120a, see annotated Garfield drawing 1 above and see Fig. 7).
Regarding claim 43, in light of the 112(d) rejection above, examiner is interpreting claim 42 as dependent upon claim 16 which was amended to incorporate the limitations of cancelled claim 27. In modified Garfield, Garfield discloses wherein the second fixing portion has an axial length (see annotated Garfield drawing 1 above for second fixing portion and see Fig. 9 for axial lengths of the second fixing portion and the cap (S) of vial (V)). Examiner notes that the container and thus its cap are functional limitations of claim 16, and thus the second fixing portion of modified Garfield would be capable of being configured for use with a cap of a container that has an axial length equal to or smaller than the second fixing portion.
Regarding claim 44, modified Garfield discloses the retaining member of claim 16, as discussed above. In modified Garfield, Garfield discloses (Claim 44) wherein in the second state the first free end of the at least one fixing member (121) and the second free end of the at least one fixing member (121) are arranged at different axial positions in a cross section along a longitudinal axis of the retaining member body (120a, see annotated Garfield drawing 3 above and Fig. 7).
Regarding claim 47, modified Garfield discloses the retaining member of claim 16, as discussed above. In modified Garfield, Aneas discloses (Claim 47) wherein the container retaining member (32) is configured to cover the length of the container (20) completely (see Fig. 4 and 8 and para. 0054).
Claim(s) 16 is rejected under 35 U.S.C. 103 as being unpatentable over Avery et al. (U.S Patent Pub. No. 20130253432 A1, “Avery”) in view of Aneas in view of Garfield in view of Fowles.
Regarding claim 16, Avery discloses (Claim 16) a container retaining member (200 in Fig. 3-7), comprising:
a retaining member body (202 in Fig. 3) comprising an inner surface (219 in Fig. 4) that limits a retaining space for a container (320 in Fig. 6-7, see para. 0074), wherein the retaining member body (202) has an insertion opening (204 in Fig. 3) through which a distal portion of the container (320) is insertable into a distal portion of the retaining space (see Fig. 6-7 and para. 0074), wherein the container (320) is configured to provide a suitable chamber for storage of one or more drugs (see para. 0059); and at least one fixing member (214 in Fig. 3-7, examiner is interpreting a fixing member under 112(f) as a protrusion extending from the retaining member body that functions to prevent proximal or distal movement of the container, para. 0067-0068 – flange 214 is a protrusion extending from the retaining member body 202 that prevents movement of the container 320 in both directions).
However, Avery fails to disclose (Claim 16) wherein the retaining member body has a length such that the retaining member body is configured to cover at least 50 percent of a length of the container, and at least one fixing member comprising: a connecting portion that is connected to the inner surface and extends inwardly from the inner surface of the retaining member body; a first fixing portion that extends from the connecting portion into the retaining space and comprises a first free end of the at least one fixing member; and a second fixing portion that extends from the connecting portion and/or from the first fixing portion into the retaining space and comprises a second free end of the at least one fixing member; where in the first fixing portion and the second fixing portion are arranged and configured to engage the container in order to secure the container within the container retaining member; wherein the first free end of the at least one fixing member is arranged closer to the insertion opening than the second free end of the at least one fixing member; and wherein for switching between a first state and a second state the first free end and the second free end are movable relative to the retaining member body; wherein the first fixing portion is directly connected to the connecting portion and the second fixing portion is directly connected to the connecting portion and wherein there is a bifurcation from which the first fixing portion and the second fixing portion extend into the retaining space in the second state and wherein the first free end of the at least one fixing member and the second free end of the at least one fixing member are arranged to prevent each other from losing contact to the container in the second state.
Aneas discloses a container retaining housing assembly for an injection device, wherein Aneas teaches (Claim 16) wherein the retaining member body (32) has a length such that the retaining member body (32) is configured to cover at least 50 percent of a length of the container (20, see Fig. 4 and 8 and para. 0054).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the retaining member body taught by Avery to have a length that is configured to cover at least 50 percent of a length of the container as taught Aneas. This modification is motivated to provide effective protection of the container particularly when it involves a cartridge such that the housing extends over its entire length (see para. 0011). In combination, the body (202 in Fig. 3) of Avery would be modified to extend over at least 50 percent of a length of the container (320) to provide increased protection to the container (320) as taught by Aneas.
Garfield discloses an assembly for retaining a medical vial (V in Fig. 1) using a container retaining member (120 in Fig. 1), wherein Garfield teaches (Claim 16) the container retaining member (120 in Fig. 6-7), comprising:
at least one fixing member (121, examiner is interpreting a fixing member under 112(f) as a protrusion extending from the retaining member body that functions to prevent proximal or distal movement of the container, see Fig. 4 and 7 and para. 0089 – via collar 120 comprises retainers 121 for engages with the neck of vial “V” to prevent proximal movement) comprising:
a connecting portion that is connected to the inner surface and extends inwardly from the inner surface of the retaining member body (120a, see annotated Garfield drawing 1 below – retainers 121 comprise a portion at their base extending inwardly from the inner surface of body 120a interpreted as the connecting portion);
a first fixing portion that extends from the connecting portion into the retaining space and comprises a first free end of the at least one fixing member (121, see annotated Garfield drawing 1 below); and
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a second fixing portion that extends from the connecting portion and comprises a second free end of the at least one fixing member (121, see annotated Garfield drawing 1 below);
wherein the first fixing portion and the second fixing portion are arranged and configured to engage the container (V) in order to secure the container (V) within the container retaining member (120, see Fig. 6 and para. 0089 – retainer 121 including ledge 121a and the projection from ledge 121a engage with the neck of vial “V” to securely connect the vial “V” within the collar 120),
wherein the first free end of the at least one fixing member (121) is arranged closer to the insertion opening than the second free end of the at least one fixing member (121, see Fig. 6 and annotated Garfield drawing 1 above – the first free end of is arranged closer to the bottom opening than the second free end),
a first state (see Fig. 7) and a second state (see Fig. 9 and para. 0086 – the first state is being interpreted as the vial “V” not inserted into the vial collar 120 as shown in Fig. 7 and the second state as the vial “V” inserted into the vial collar 120 as shown in Fig. 9);
wherein the first fixing portion is directly connected to the connecting portion and the second fixing portion is directly connected to the connecting portion and wherein there is a bifurcation from which the first fixing portion and the second fixing portion extend into the retaining space in the second state and wherein the first free end of the at least one fixing member (121) and the second free end of the at least one fixing member (121) are arranged to prevent each from the losing contact to the container (V) in the second state (see annotated Garfield drawing 1 above and para. 0089 – the shape of each retainer 121 including the first fixing portion and second fixing portion engage the neck of the vial V and thus are configured to be arranged to prevent each from losing contact with the Vial V when it is inserted).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the at least one fixing member taught by modified Avery to be the at least one fixing member taught by Garfield. Garfield provides that the collar comprising the retainers having the shape discussed above allows each retainer to snap-fit into engagement with the neck of the vial and provides both radial engagement under the neck of the vial and axial engagement on the side of the ferrule (see Fig. 9 and para. 0034). Such a configuration allows for guidance of the ferrule into the engagement with the collar and a more secure engagement in both axial and radial directions. In combination, the flange (214) of modified Avery is being substituted for the retainers (121) of the collar (120) of Garfield such that the locking mechanism (200) of modified Avery would have at least one retainer (121) disposed circumferentially thereon.
While Garfield discloses the at least one fixing member (121) being snap-fit onto the neck of the container (V) which indicates a degree of flexibility (see para. 0045), Garfield is silent to the at least one fixing member (121) explicitly being movable during insertion of the container (V).
Fowles discloses a reconstitution connector comprising a gripper assembly for retaining a vial within the connector. Fowles teaches (Claim 16) wherein for switching between a first state and a second state at least one fixing member (104) is movable relative to the retaining member body (92, see Fig. 1 and 5 and para. 0128-0131 – gripper assembly 28 comprises tabs 104 which have a first state as seen in Fig. 1 where no vial 14 is inserted and a second state as seen in Fig. 5 where the vial 14 is inserted, wherein when switching between the two states as the vial 14 is inserted, the tabs 104 flex relative to the body of the finger assembly 92 to accommodate the vial 14).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the at least one fixing member taught by modified Avery to be resiliently flexible as taught by the tabs of Fowles in order to allow the tabs to flex radially outward while inserting varying diameter vial closures (see para. 0131). In combination, the at least one fixing member (121) of modified Avery would be modified to deflect during insertion of the container and thus both free ends would be movable relative to the retaining member body.
Claim(s) 45 is rejected under 35 U.S.C. 103 as being unpatentable Avery in view of Aneas in view of Garfield in view of Fowles as applied to claim 16 above, and further in view of Hemmann (U.S Patent Pub. No. 20130140208 A1).
Regarding claim 45, modified Avery discloses the container retaining member of claim 16, as discussed above.
In modified Avery, Avery discloses (Claim 45) wherein the container retaining member (200) comprises the container (320) in the form of a cartridge (examiner notes the cartridge is being interpreted as the same structure as the container of claim 16, see Fig. 6-7, para. 0059 and 0074 – the container 320 is a cartridge which is used in a drug delivery device 100 shown in Fig. 1 with container 120, examiner notes the container 320 is identical the container 120); wherein the cartridge (320) comprises a piston (128 in Fig. 1-2, see para. 0063); and wherein the piston (128) is configured to be driven by a piston rod (109 in Fig. 1) for the delivery of a medicament comprised within the cartridge (320, see para. 0063).
However, modified Avery fails to explicitly disclose (Claim 45) wherein the cartridge has a maximal outer diameter within a range of 7 mm to 12 mm.
Hemmann discloses medicament cartridge’s and their dimensions as used in drug delivery devices (see abstract), wherein Hemmann teaches (Claim 45) a cartridge (120 in Fig. 1-2), wherein the cartridge (120) has a maximal outer diameter (D in Fig. 2) within a range of 7 mm to 12 mm (see para. 0017-0018 and 0040).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the maximal outer diameter of the cartridge taught by modified Avery to be within a range of 7 mm to 12 mm as taught by Hemmann. Hemmann teaches the dimensions for a “standard cartridge” under ISO 11608-2:2000A which are known to those skilled din the art of drug delivery devices, wherein the maximal outer diameter of the cartridge is 8 mm (see para. 0017-0018).
Allowable Subject Matter
Claims 21, 23-24, and 28 are allowed.
The following is an examiner’s statement of reasons for allowance:
The closest prior art is Garfield et al. (U.S Patent Pub. No. 20180263848 A1, “Garfield”) and Fowles et al. (U.S Patent Pub. No. 20180169339 A1, “Fowles”).
Garfield discloses a container retaining member (120 in Fig. 6-7) comprising a retaining member body (120a), at least one fixing member (121) in the form of a protruding retainer (see Fig. 4 and 7 and para. 0089), wherein each fixing member (121) comprises a first fixing portion directly connected to a connecting portion and a second fixing portion directly connected to the connecting portion (see annotated drawing below), and each fixing portion comprising a free end. Further, the first fixing portion comprises a first surface facing distally relative to insertion axis, and the second fixing portion comprises a second surface facing radially inwardly relative to the insertion axis (see annotated drawing below). There is a bifurcation from the first fixing and second fixing portions extend into the retaining space in the second state with the vial (V) inserted into the retaining member (120), and the bifurcation forms an angle therebetween. While Garfield discloses that the fixing members (121) are snap-fit engaged with the neck of the vial (V, see para. 0034), Garfield does not explicitly disclose the movement of the first and second free ends being movable relative to the retaining member body during the switching between the vial (V) being free from the retaining member body (120a) and inserted into the retaining member body (120a).
Fowles teaches a container retaining member (see Fig. 5) for retaining a vial (14) within it, wherein a retaining member body (92) comprises at least one fixing member (104) in the form of flexible tabs that are movable relative to the retaining member body (92) during switching between the vial (14) being free from the retaining member body (92) and inserted therein (see para. 0128-0131).
However, Garfield in view of Fowles fail to disclose the acute angle of claims 21 and 28. While Garfield illustrates an angle formed by the bifurcation, Garfield does not explicitly disclose the angle is acute nor a range of dimensions for the angle. While Fowles does illustrate an angle that is formed by the fixing member (104), this angle is not an equivalent angle formed between the two claimed surfaces of the fixing portions of claims 21 and 28. Further, even if the angle was equivalent there is no motivation provided by Fowles to modify Garfield to have such an angle.
Therefore, there is no reference that teaches or discloses the container retaining member having the at least one fixing member as claimed in claims 21 and 28.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
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.
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/KAYLA M. TURKOWSKI/Examiner, Art Unit 3783
/COURTNEY B FREDRICKSON/Primary Examiner, Art Unit 3783