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 .
Acknowledgments
In the reply, filed on April 13, 2026, Applicant amended claims 82-84, 86-87, 90, 99, 101, and 104.
Applicant cancelled claim 102.
Applicant added new claims 105-107.
In the non-final rejection of January 14, 2026, Examiner noted that the listing of references in the specification is not a proper information disclosure statement. Applicant submitted information disclosure statements on April 24, 2026, with some of the indicated references; however, Applicant did not cite all of the indicated references. Concern is maintained.
Examiner objected to claims 82, 84, 87, 90, and 102. Applicant amended claims 82, 84, 87, and 90, and cancelled claim 102. Objection is withdrawn.
Examiner rejected claims 86, 99, 102, and 104 under 35 U.S.C. 112(b). Applicant amended claims 86, 99, and 104, and cancelled claim 102. Rejection is withdrawn.
Currently, claims 82-101 and 103-107 are under examination.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered:
WO 2020/2404170 (paragraph [00157])
The information disclosure statement filed April 24, 2026 (27 pages), fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because:
The citation for US 20180043107 has been provided with the incorrect name of patentee of Standley et al. The correct name of patentee for US 20180043107 is Hooven et al. Thus, it unclear whether Applicant is intending to cite US 20180043107 or another document to Standley et al
The citation for US 20200338257 has been provided with the incorrect name of patentee of Standley et al. The correct name of patentee for US 20200338257 is Hooven et al. Thus, it unclear whether Applicant is intending to cite US 20200338257 or another document to Standley et al
It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
The information disclosure statements filed April 24, 2026, fail to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
Copies of foreign patent documents with lined-through citations have not been provided
A copy of the non-patent literature document with the lined-through citation has not been provided
Applicant should note that the large number of references in the attached IDSs have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.05(b). Applicant is requested to point out any particular references in the IDSs which they believe may be of particular relevance to the instant claimed invention in response to this office action.
It is desirable to avoid the submission of long lists of documents if it can be avoided. Clearly irrelevant and marginally pertinent cumulative information should be eliminated. If a long list is submitted, those documents which have been specifically brought to applicant's attention and/or are known to be of most significance should be highlighted. See Penn Yan Boats, Inc. v. Sea Lark Boats, Inc., 359 F. Supp. 948, 175 USPQ 260 (S.D. Fla. 1972), affd, 479 F.2d 1338, 178 USPQ 577 (5th Cir. 1973), cert. denied, 414 U.S. 874 (1974). But cf. Molins PLC v. Textron Inc., 48 F.3d 1172, 33 USPQ2d 1823 (Fed. Cir. 1995). See MPEP 2004.
Applicant's duty of disclosure of material and information is not satisfied by presenting a patent examiner with "a mountain of largely irrelevant [material] from which he is presumed to have been able, with his expertise and with adequate time, to have found the critical [material]. It ignores the real world conditions under which examiners work. Applicant has a duty not just to disclose pertinent prior art references but to make a disclosure in such way as not to "bury" it within other disclosures of less relevant prior art; See Golden Valley Microwave Foods Inc. v. Weaver Popcorn Co. Inc., 24 USPQ2d 1801 (N.D. Ind. 1992); Molins PLC v. Textron Inc., 26 USPQ2d 1889, at 1899 (D.Del 1992); Penn Yan Boats, Inc. v. Sea Lark Boats, Inc. et al., 175 USPQ 260, at 272 (S.D. F1. 1972).
The examiner is not afforded the time to thoroughly review each reference of the IDSs of April 24, 2026, given the number of references cited. By initialing each of the cited references on the accompanying 1449 form(s), the examiner is merely acknowledging the submission of the cited references and indicating that only a cursory review was made of the cited references.
Claim Objections
Claim 83 is objected to because of the following informalities:
In regards to claim 83, line 3, “in the first position” should be changed to “wherein in the first position”.
Appropriate correction is required.
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.
Claims 87-101 and 103-107 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.
In regards to claim 87, line 26 recites “the syringe coupler”. There is insufficient antecedent basis for this limitation in the claim. Claims 88-101 and 103-107 are rejected by virtue of being dependent upon claim 87.
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.
Claims 82-101, 103-105, and 107 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sherman et al (US 2022/0331523).
In regards to claim 82, Sherman et al teaches a syringe coupler (Figures 13-17B, syringe coupler 156) configured to couple to a first syringe and a second syringe (Figure 13), the syringe coupler comprising:
a valve assembly having a first portion (168) and a second portion (158) that are displaceable relative to one another between at least a first position (Figure 17A) and a second position (Figure 17B), wherein the first portion and the second portion comprise respective internal flow ports (202/162) and syringe receiving portions (166/162), wherein the internal flow port (202) of the first portion is configured to couple to the first syringe (Figures 17A-17B) and the internal flow port (162) of the second portion is configured to couple to the second syringe (Figures 17A-17B), wherein the second portion comprises a sealing element (164) that is displaceable with and in fixed relative position to the second syringe (Figures 17A-17B), wherein the sealing element comprises a main body portion (labeled in Figure 17A below) and an upstanding portion (labeled in Figure 17A below, comprising septum, first sealed area, and second sealed area) that is formed to project from the main body portion, wherein the upstanding portion projects towards the first portion of the valve assembly and defines a septum (labeled in Figure 17A below), a first sealed area (labeled in Figure 17A below) that is aligned with the internal flow port of the second portion, and a second sealed area (labeled in Figure 17A below) that is separated from the first sealed area by the septum
wherein in the first position of the valve assembly:
the internal flow port of the second portion and the first sealed area are offset from the internal flow port of the first portion (Figure 17A)
the second sealed area is aligned with the internal flow port of the first portion (Figure 17A)
wherein in the second position of the valve assembly:
the internal flow port of the second portion and the first sealed area are aligned or substantially aligned with and in fluid communication with the internal flow port of the first portion (Figure 17B)
wherein the upstanding portion of the sealing element provides a contact seal against the first portion in both the first position of the valve assembly (Figure 17A) and the second position of the valve assembly (Figure 17B)
PNG
media_image1.png
430
610
media_image1.png
Greyscale
In regards to claim 83, Sherman et al teaches
in the first position of the valve assembly, the second sealed area is aligned with the internal flow port of the first portion (Figure 17A)
wherein in the second position of the valve assembly, the second sealed area is offset from the internal flow port of the first portion (Figure 17B)
In regards to claim 84, Sherman et al teaches wherein in the first position of the valve assembly, the upstanding portion of the sealing element is configured to prevent:
travel of fluid between the internal flow port of the first portion and the internal flow port of the second portion (Figure 17A)
leakage of fluid from either or both of the first syringe and the second syringe through the syringe coupler (Figure 17A)
In regards to claim 85, Sherman et al teaches wherein the valve assembly comprises a user interface (160) operable to receive a force from a user and transmit the force to the sealing element.
In regards to claim 86, Sherman et al teaches wherein the first portion of the valve assembly comprises a rotatable member (166) that is free to rotate when the valve assembly is in the second position (Figure 17B), wherein the rotatable member is configured to engage the first syringe (Figures 17A-17B).
In regards to claim 87, Sherman et al teaches a syringe-to-syringe mixing system (Figures 13-17B, mixing syringe system 150) comprising:
a first syringe (152)
a second syringe (154)
a valve assembly having a first portion (168) and a second portion (158) that are displaceable relative to one another between at least a first position (Figure 17A) and a second position (Figure 17B), wherein the first portion and the second portion comprise respective internal flow ports (202/162) and syringe receiving portions (166/162), wherein the internal flow port (202) of the first portion is coupled to the first syringe (Figures 17A-17B) and the internal flow port (162) of the second portion is coupled to the second syringe (Figures 17A-17B), wherein the second portion comprises a sealing element (164) that is displaceable with and in fixed relative position to the second syringe (Figures 17A-17B), wherein the sealing element comprises a main body portion (labeled in Figure 17A above) and an upstanding portion (labeled in Figure 17A above, comprising septum, first sealed area, and second sealed area) that is formed to project from the main body portion, wherein the upstanding portion projects towards the first portion of the valve assembly and defines a first sealed area (labeled in Figure 17A above) that is aligned with the internal flow port of the second portion, and wherein the upstanding portion of the sealing element provides a contact seal against the first portion in both the first position of the valve assembly (Figure 17A) and the second position of the valve assembly (Figure 17B)
wherein in the first position of the valve assembly:
the internal flow port of the second portion and the first sealed area are offset from the internal flow port of the first portion (Figure 17A)
the contact seal formed between the upstanding portion and the first portion is configured to prevent:
travel of fluid between the internal flow port of the first portion and the internal flow port of the second portion (Figure 17A)
leakage of fluid from either or both of the first syringe and the second syringe through the syringe coupler (Figure 17A)
wherein in the second position of the valve assembly:
the internal flow port of the second portion and the first sealed area are aligned or substantially aligned with and in fluid communication with the internal flow port of the first portion to permit mixing of contents of the first syringe and the second syringe (Figure 17B)
In regards to claim 88, Sherman et al teaches wherein at least one of the first syringe or the second syringe contains a liquid component (paragraph [0094]).
In regards to claim 89, Sherman et al teaches wherein one of the first syringe or the second syringe contains a liquid component, and wherein the other of the first syringe or the second syringe contains a lyophilized component (paragraph [0094]).
In regards to claim 90, Sherman et al teaches wherein the first syringe and the second syringe each contain a liquid component (paragraph [0111]).
In regards to claim 91, Sherman et al teaches wherein at least one of the first syringe or the second syringe contains a Gonadotropin Releasing Hormone (GnRH) agonist or antagonist (paragraph [0113]).
In regards to claim 92, Sherman et al teaches wherein the GnRH agonist comprises leuprolide or a pharmaceutically acceptable salt thereof (paragraph [0094]).
In regards to claim 93, Sherman et al teaches wherein the GnRH agonist comprises leuprolide acetate (paragraph [0094]).
In regards to claim 94, Sherman et al teaches wherein the GnRH agonist is provided in a lyophilized or liquid component (paragraph [0094]).
In regards to claim 95, Sherman et al teaches wherein the GnRH agonist comprises leuprolide or a pharmaceutically acceptable salt thereof (paragraph [0094]).
In regards to claim 96, Sherman et al teaches wherein the GnRH agonist comprises leuprolide acetate (paragraph [0094]).
In regards to claim 97, Sherman et al teaches wherein the first syringe and the second syringe each contain a GnRH agonist or antagonist (paragraph [0094] states “the second syringe 154 may comprise lyophilizate such as, but not limited to, lyophilized leuprolide acetate”, which is a GnRH agonist, and paragraph [0108] states “Mixing of contents is thus enabled, wherein plunger rods (not shown in FIGS. 17A-17B) associated with the first and second syringes are operable to force contents between the syringes”, from which it is understood that the GnRH agonist of the second syringe would travel into the first syringe; thus, the first syringe and the second syringe each contain the GnRH agonist).
In regards to claim 98, Sherman et al teaches wherein the GnRH agonist or antagonist contained within the first syringe is provided in a liquid component (paragraph [0094] states “The first and second syringes are contemplated as initially comprising solid or liquid contents. For example, the first syringe 152 may house or comprise a polymer-solvent system such as, but not limited to, a biodegradable polymer dissolved in NMP and the second syringe 154 may comprise lyophilizate such as, but not limited to, lyophilized leuprolide acetate”, from which it is understood that the first syringe contains a liquid of a biodegradable polymer dissolved in NMP and the second syringe contains leuprolide acetate, which is a GnRH agonist, and paragraph [0108] states “Mixing of contents is thus enabled, wherein plunger rods (not shown in FIGS. 17A-17B) associated with the first and second syringes are operable to force contents between the syringes”, from which it is understood that the GnRH agonist of the second syringe would travel into the first syringe and mix with the liquid of the first syringe; thus, the GnRH agonist would be provided in a liquid component in the first syringe).
In regards to claim 99, Sherman et al teaches wherein the liquid component contained within the first syringe is a first liquid component, and wherein the GnRH agonist or antagonist contained within the second syringe is provided in a second liquid component (paragraph [0094] states “The first and second syringes are contemplated as initially comprising solid or liquid contents. For example, the first syringe 152 may house or comprise a polymer-solvent system such as, but not limited to, a biodegradable polymer dissolved in NMP and the second syringe 154 may comprise lyophilizate such as, but not limited to, lyophilized leuprolide acetate”, from which it is understood that the first syringe contains a liquid of a biodegradable polymer dissolved in NMP and the second syringe contains leuprolide acetate, which is a GnRH agonist, and paragraph [0108] states “Mixing of contents is thus enabled, wherein plunger rods (not shown in FIGS. 17A-17B) associated with the first and second syringes are operable to force contents between the syringes”, from which it is understood that the GnRH agonist of the second syringe would travel into the first syringe and mix with the liquid of the first syringe; thus, the GnRH agonist would be provided in a first liquid component in the first syringe; and then the mixed liquid/GnRH agonist of the first syringe would travel into the second syringe; thus, the GnRH agonist would be provided in a second liquid component in the second syringe).
In regards to claim 100, Sherman et al teaches wherein the first syringe and the second syringe each contain leuprolide or a pharmaceutically acceptable salt thereof (paragraph [0094] states “the second syringe 154 may comprise lyophilizate such as, but not limited to, lyophilized leuprolide acetate”, and paragraph [0108] states “Mixing of contents is thus enabled, wherein plunger rods (not shown in FIGS. 17A-17B) associated with the first and second syringes are operable to force contents between the syringes”, from which it is understood that leuprolide acetate of the second syringe would travel into the first syringe; thus, the first syringe and the second syringe each contain leuprolide acetate).
In regards to claim 101, Sherman et al teaches wherein the upstanding portion of the sealing element comprises a septum (labeled in Figure 17A above), and wherein the upstanding portion of the sealing element defines a second sealed area (labeled in Figure 17A above) that is separated from the first sealed area by the septum (labeled in Figure 17A above)
wherein in the first position of the valve assembly, the second sealed area is aligned with the internal flow port of the first portion (Figure 17A)
wherein in the second position of the valve assembly, the second sealed area is offset from the internal flow port of the first portion (Figure 17B)
In regards to claim 103, Sherman et al teaches wherein the valve assembly comprises a user interface (160) operable to receive a force from a user and transmit the force to the sealing element of the valve assembly.
In regards to claim 104, Sherman et al teaches wherein the first portion of the valve assembly comprises a rotatable member (166) that is free to rotate when the valve assembly is in the second position (Figure 17B), wherein the rotatable member engages the first syringe (Figures 17A-17B).
In regards to claim 105, Sherman et al teaches wherein in the first position of the valve assembly, the upstanding portion of the sealing element is configured to provide a simultaneous seal to both the first syringe and the second syringe (Figure 17A).
In regards to claim 107, Sherman et al teaches wherein the second syringe further comprises N-methyl-2-pyrrolidone (NMP), and the leuprolide acetate is dissolved in the NMP (paragraph [0094] states “the first syringe 152 may house or comprise a polymer-solvent system such as, but not limited to, a biodegradable polymer dissolved in NMP and the second syringe 154 may comprise lyophilizate such as, but not limited to, lyophilized leuprolide acetate”, and paragraph [0108] states “Mixing of contents is thus enabled, wherein plunger rods (not shown in FIGS. 17A-17B) associated with the first and second syringes are operable to force contents between the syringes”, from which it is understood that the NMP of the first syringe would travel into the second syringe; thus, the second syringe would contain NMP, and the leuprolide acetate of the second syringe would dissolve in the NMP).
Response to Arguments
Applicant's arguments filed April 13, 2026, have been fully considered but they are not persuasive:
In regards to claim 82, Applicant argued: Claim 82, as amended, recites structural features of the sealing element that are not disclosed in Sherman. Specifically, claim 82 now recites that the sealing element comprises "a main body portion and an upstanding portion that is formed to project from the main body portion, wherein the upstanding portion projects towards the first portion of the valve assembly and defines a septum, a first sealed area . .. and a second sealed area that is separated from the first sealed area by the septum." Sherman's sealing element 164 is described as "a rectilinear member" that "nests within recessed area 159 of a displaceable member 158." See Sherman, paragraph [0096]; FIG. 13 (reproduced below). Sherman's sealing element 164 is a uniform, flat member; it does not have two distinct structural regions, i.e., a main body portion serving as a base and a separate upstanding portion that "is formed to project from the main body portion" and "projects towards the first portion of the valve assembly" as recited by claim 82. Sherman does not disclose a sealing element having a main body portion and an upstanding portion that is formed to project from the main body portion. Sherman's sealing element 164 does not have an upstanding portion that projects towards the first portion and defines a septum separating two discrete sealed areas… Moreover, Sherman's sealing element 164 "nests within recessed area 159 of a displaceable member 158" (Sherman, paragraph [0096]) and is "moved from a first position characterized by a channel of the sealing element 164 being offset from and preventing flow between inlets and outlets of interconnected syringes and a second position characterized by the channel of the sealing element 164 being provided in axial alignment with the syringe outlets and inlets" (Sherman, paragraph [0103]). Sherman's sealing element sits passively within a recess of the displaceable member; it does not have a portion that projects outwardly towards the guide member 168 (the first portion). The amended claims recite that the upstanding portion "is formed to project from the main body portion" and "projects towards the first portion of the valve assembly," a directional, three- dimensional structural relationship that is absent from Sherman's flat rectilinear seal. The Office's annotated Figure 17A labels a "first sealed area," "second sealed area," and "septum" on Sherman's sealing element 164, but these labels are not supported by Sherman's disclosure. Across all relevant paragraphs, including paragraph [0096] (describing the sealing element as "a rectilinear member"), paragraph [0103] (describing the sealing element being moved between offset and aligned positions), and paragraph [0107] (describing the first position where the sealing element is offset from the central axis), Sherman never uses the terms "sealed area," "septum," "upstanding portion," "main body portion," or any equivalent terminology. Sherman describes a single aperture in a flat member, not two discrete sealed areas separated by a septum. The features the Office labels as "sealed areas" on the annotated figure appear to be simply the solid portions of the rectilinear member on either side of the single aperture. Labeling these solid portions as "sealed areas" does not establish that Sherman's sealing element defines two discrete sealed areas in the manner claimed. The amended claims recite areas defined by an upstanding portion and separated by a septum, where each area has a specific functional role of alternating alignment with the first portion's flow port between the first and second positions. The septum recited by the amended claims is a raised ridge or wall within the upstanding portion that physically divides the first sealed area from the second sealed area; it is a distinct structural feature, not merely an arbitrary designation of a region on a flat surface. Applicant's specification describes a sealing element 256 that "comprises a main body portion and an embossed and/or upstanding portion 260" that "is raised above the main body portion and generally forms two discrete areas 262, 265 surrounded by a raised seal or gasket" with a septum 261 dividing the first and second areas. See As-Filed Specification, paragraphs [00162] and [00168]; FIG. 22A (reproduced below). This structural configuration, a projecting structure that forms two sealed areas separated by a septum, does not exist in Sherman. The upstanding portion structure provides specific functions that distinguish the claimed device from Sherman. First, as described in the specification, "[t]he upstanding portion 260 is sized and operable to provide a simultaneous seal to the first and second syringes in at least a stored or pre-mixing position." See As-Filed Specification, paragraph [00162]. Second, "[t]he upstanding portion 260 also encompasses the second, smaller area 265, which is operable to surround a flow path of an adjacent component and fully occlude and segregate fluid from flowing to or through the offset first area 262." Id. These functions, simultaneous sealing of both syringes and full occlusion and segregation of fluid, enable preventing premature mixing or contamination during storage, and are provided by the three-dimensional projecting structure that Sherman's flat rectilinear sealing element cannot provide (Remarks, pages 13-16). Examiner disagrees. First, Sherman et al teaches wherein the sealing element (164) comprises a main body portion (labeled in Figure 17A above) and an upstanding portion (labeled in Figure 17A above, comprising septum, first sealed area, and second sealed area) that is formed to project from the main body portion, wherein the upstanding portion projects towards the first portion (168) of the valve assembly and defines a septum (labeled in Figure 17A above), a first sealed area (labeled in Figure 17A above) that is aligned with the internal flow port (162) of the second portion (158), and a second sealed area (labeled in Figure 17A above) that is separated from the first sealed area by the septum. Second, whether or not Sherman et al states the terms “sealed area”, “septum”, “upstanding portion”, or “main body portion”, Figures 17A-17B show these claim elements. Third, the claim does not require the septum to be “a raised ridge or wall within the upstanding portion that physically divides the first sealed area from the second sealed area”, as argued by Applicant. Fourth, the claim does not require an “embossed” upstanding portion that is “raised above the main body portion and generally forms two discrete areas 262, 265 surrounded by a raised seal or gasket”, as argued by Applicant. Fifth, the claim does not require “simultaneous sealing of both syringes and full occlusion and segregation of fluid, enable preventing premature mixing or contamination during storage”, as argued by Applicant.
In regards to claim 82, Applicant argued: Claim 82 also recites that in the first position, "the second sealed area is aligned with the internal flow port of the first portion." This further distinguishes over Sherman because Sherman's sealing element does not define two discrete sealed areas that alternate alignment with the first portion's flow port between the first and second positions. As recited by claim 82, the upstanding portion defines two discrete sealed areas separated by a septum, and these areas alternate alignment with the first portion's flow port: in the first position, the second sealed area aligns with the first portion's flow port to seal it, while the first sealed area is offset; in the second position, the first sealed area aligns with the first portion's flow port to enable fluid communication, while the second sealed area moves to an offset position. This dual-sealed-area alternating mechanism differs from Sherman's single-aperture offset/align mechanism, in which a single aperture in a flat member is simply slid between an offset position and an aligned position (Remarks, pages 16-17). Examiner disagrees. First, Sherman et al teaches wherein in the first position of the valve assembly: the internal flow port (162) of the second portion (158) and the first sealed area (labeled in Figure 17A above) are offset from the internal flow port (202) of the first portion (168) (Figure 17A), and the second sealed area (labeled in Figure 17A above) is aligned with the internal flow port of the first portion (Figure 17A), and wherein in the second position of the valve assembly: the internal flow port of the second portion and the first sealed area are aligned or substantially aligned with and in fluid communication with the internal flow port of the first portion (Figure 17B).
In regards to claim 87, Applicant argued: Claim 87 further recites that in the first position, "the contact seal formed between the upstanding portion and the first portion is configured to prevent: travel of fluid between the internal flow port of the first portion and the internal flow port of the second portion; and leakage of fluid from either or both of the first syringe and the second syringe through the syringe coupler." This recites two distinct forms of sealing in the first position: (1) prevention of fluid travel between the flow ports, AND (2) prevention of leakage from the syringes through the syringe coupler. Both forms of sealing are provided by the upstanding portion that projects from the main body portion, a structure that does not exist in Sherman (Remarks, page 17). Examiner disagrees. Sherman et al teaches wherein in the first position of the valve assembly: the contact seal formed between the upstanding portion (labeled in Figure 17A above, comprising septum, first sealed area, and second sealed area) and the first portion (168) is configured to prevent: travel of fluid between the internal flow port (202) of the first portion and the internal flow port (162) of the second portion (158) (Figure 17A), and leakage of fluid from either or both of the first syringe (152) and the second syringe (154) through the syringe coupler (Figure 17A).
In regards to claim 87, Applicant argued: Sherman's sealing element 164 does not have a main body portion with an upstanding portion that projects therefrom and provides these two distinct forms of sealing. Sherman's sealing element is a flat rectilinear member with an aperture that simply slides between offset and aligned positions. In Sherman, sealing in the first position is achieved primarily through offset positioning of the flow paths, where the sealing element's aperture is simply offset from the rotatable member's passageway. This differs from the dual-mode sealing provided by the projecting upstanding portion recited by claim 87 (Remarks, page 18). Sherman et al teaches wherein the sealing element (164) comprises a main body portion (labeled in Figure 17A above) and an upstanding portion (labeled in Figure 17A above, comprising septum, first sealed area, and second sealed area) that is formed to project from the main body portion.
In regards to claim 107, Applicant argued: New claim 107 further distinguishes over Sherman by reciting that "the second syringe further comprises N-methyl-2-pyrrolidone (NMP), and the leuprolide acetate is dissolved in the NMP." Sherman's syringe coupler was specifically designed for liquid-solid mixing, where the second syringe contains "lyophilizate such as, but not limited to, lyophilized leuprolide acetate." See Sherman, paragraph [0094]. Sherman does not disclose or suggest a liquid-liquid formulation where the leuprolide acetate is dissolved in NMP in the second syringe. Claim 107 is therefore patentable over Sherman for this additional reason (Remarks, page 18). Examiner disagrees. First, Sherman et al teaches wherein the second syringe (154) further comprises N-methyl-2-pyrrolidone (NMP), and the leuprolide acetate is dissolved in the NMP (paragraph [0094] states “the first syringe 152 may house or comprise a polymer-solvent system such as, but not limited to, a biodegradable polymer dissolved in NMP and the second syringe 154 may comprise lyophilizate such as, but not limited to, lyophilized leuprolide acetate”, and paragraph [0108] states “Mixing of contents is thus enabled, wherein plunger rods (not shown in FIGS. 17A-17B) associated with the first and second syringes are operable to force contents between the syringes”, from which it is understood that the NMP of the first syringe would travel into the second syringe; thus, the second syringe would contain NMP, and the leuprolide acetate of the second syringe would dissolve in the NMP). Second, the claim does not require “a liquid-liquid formulation” where the leuprolide acetate is dissolved in NMP “in the second syringe”, as argued by Applicant.
Allowable Subject Matter
Claim 106 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
In regards to dependent claim 106, the prior art of record does not disclose or render obvious before the effective filing date of the claimed invention the combination of a syringe-to-syringe mixing system, as claimed, specifically including wherein the upstanding portion of the sealing element comprises: a second semi-annular projection that cooperates with the septum to define the second sealed area.
Sherman et al teaches wherein the upstanding portion (labeled in Figure 17A above, comprising septum, first sealed area, and second sealed area) of the sealing element (164) comprises: a first semi-annular projection (Figure 13) that cooperates with the septum (labeled in Figure 17A above) to define the first sealed area (labeled in Figure 17A above).
However, Sherman et al does not teach wherein the upstanding portion of the sealing element comprises: a second semi-annular projection that cooperates with the septum to define the second sealed area.
Thus, dependent claim 106 is objected to as being dependent upon a rejected base claim 87, but would be allowable if rewritten in independent form including all of the limitations of the base claim 87 and intervening claims 101 and 105.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHEFALI D PATEL whose telephone number is (571)270-3645. The examiner can normally be reached Monday-Friday 8:30am-4:30pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin C Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SHEFALI D PATEL/Primary Examiner, Art Unit 3783
Prosecution Insights