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 .
Information Disclosure Statement
The information disclosure statement(s) filed on the record are in compliance with the content requirements of 37 CFR 1.97 and 37 CFR 1.98 and have been considered.
Election/Restrictions
Claims 19-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/17/2025.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “plurality of springs and a plurality of engaging members distributed rotationally about the actuatable assembly interface” (claim 16) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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:
“a fluid shutoff mechanism to reversibly shut off fluid communication between the first fluid reservoir and the second fluid reservoir” (claim 1) and “a keyed locking mechanism configured to allow attachment and removal of the actuatable assembly interface to and from the actuatable assembly only when the fluid communication between the first and second fluid reservoirs is shut off’ (claim 18).
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.
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 § 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 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.
Claims 1-13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Alvarez et al (U.S. Pub. 2016/0000982 A1, hereinafter “Alvarez’”) in view of Shekalim (U.S. Pub. 2008/0281276 A1, hereinafter “Shekalim”).
Regarding claim 1, Alvarez discloses an apparatus for expression of breast milk from a breast, the apparatus comprising:
a breast interface, e.g., 2210 (Fig. 22) configured to receive and fluidly seal against the breast, the breast interface comprising a first fluid reservoir (the space within the breast interface 2210 in which fluid 2220 is located; see Fig. 22 and para [0018]);
an actuatable assembly interface 2300 (Fig. 22) configured to removably couple to an actuatable assembly 2205 (Fig. 22), the actuatable assembly interface comprising a second fluid reservoir, e.g., the space within the interface 2300 in which fluid 2220 is located (Fig. 22; see also para [0018]); and
a tube, 2215 (Fig. 22) having a first end coupled to the breast interface and a second end coupled to the actuatable assembly interface, such that the first fluid reservoir and the second fluid reservoir are in fluid communication (Fig. 22), and
wherein the first fluid reservoir, the second fluid reservoir, and the tube are filled with a driving fluid 2220 (Fig. 22; see also para [0055] describing the driving fluid).
It is noted that Alvarez does not appear to disclose that the actuatable assembly interface comprises a fluid shutoff mechanism to reversibly shut off fluid communication between the first fluid reservoir and the second fluid reservoir.
Shekalim discloses an actuatable assembly interface (i.e. an infusion set; Figs. 3 and 5-7) for fluid communication between two areas (i.e., the infusion set 500 and the skin), comprising a fluid shutoff mechanism (a spring, which is a combination of 7 or 10 along with member 5; see Figs. 4 and 5, respectively; the “fluid shutoff mechanism” is being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph to be a material spring (see Applicant’s published specification at para [0077])) to reversibly shut off fluid communication between a first fluid reservoir (such as flexible tubing connected to the infusion set; Fig. 5) and a second reservoir (Such as a cannula 3; Fig. 7). Specifically, when the actuatable assembly is removed from the interface, the member 7 or 10 releases the member 5 into a position to pinch a tubing and shut off fluid communication between the reservoirs (Figs. 4B or 7). When the actuatable assembly is placed back on the interface, the member 7 or 10 is compressed such that the member 5 moves out of the pinching configuration to enable fluid communication between the reservoirs (Figs. 4A or 6). In this way, the fluid shutoff mechanism can shut off fluid communication reversibly.
A skilled artisan would have found it obvious at the time of the invention to modify the actuatable assembly interface of Alvarez to include a fluid shutoff mechanism as taught in Shekalim, in order to prevent fluid leakage in the event of an intentional or unintentional (e.g., caused by a malfunction) removal of the actuatable assembly interface from the area which is to receive the fluid (see Shekalim at paras [001 7]- [0018]).
Regarding claims 2 and 3, Alvarez discloses that the driving fluid has a density higher than that of air, and is an incompressible fluid (i.e., the fluid is hydraulic fluid which is known to those of ordinary skill in the art to be denser than air and substantially or completely incompressible in order to generate a hydraulic force; para [0055]).
Regarding claim 4, Alvarez discloses that the breast interface comprises a first housing (shown to be the cup-shaped member in Fig. 22) and a distal membrane 2210 (Fig. 22) coupled thereto to form the first fluid reservoir therebetween (see Fig. 22), wherein the actuatable assembly interface comprises a second housing 2225 (Fig. 23) and a proximal membrane 2230 (Fig. 22) coupled thereto to form the second fluid reservoir therebetween, and wherein the distal and proximal membranes are flexible to allow movement of the driving fluid into or out of the first and second fluid reservoirs (para [0079)]).
Regarding claim 5, Alvarez discloses that the proximal membrane is configured to seal against an actuatable assembly membrane when the actuatable assembly interface is coupled to the actuatable assembly, wherein the actuatable assembly membrane is coupled with a driver mechanism of the actuatable assembly, such that movement of the actuatable assembly membrane in response to actuation of the driver mechanism causes corresponding movement of the proximal membrane (para [0012]).
Regarding claim 6, Alvarez discloses that the proximal membrane comprises a structure configured to allow air trapped between the proximal membrane and the actuatable assembly membrane to exit (para [0013]), but does not disclose that the structure is a sealing flap (Alvarez discloses that the structure is a “one-way valve”: para [0013]).
However, Alvarez teaches the use of valves that are formed as sealing flaps (see, e.g., para [0053] describing a flap valve, which is interpreted to be a valve formed as a sealing flap).
A skilled artisan would have found it obvious at the time of the invention to modify the one-way valve of Alvarez to be a sealing flap, since Alvarez suggests that sealing flaps are well-known in the art for forming valves, and would result in a reasonable expectation of success in performing the functions of a one-way valve.
Regarding claim 7, Alvarez discloses that the second housing of the actuatable assembly interface comprises a tube receiving member 2305 (Fig. 23) configured to couple to the second end of the tube, the tube receiving member defining a bore that is in fluid communication with the second fluid reservoir through an opening in the second housing (i.e., the tubing 2215 is inserted into the bore; see Fig. 23).
Regarding claim 8, Alvarez does not appear to disclose that the tube receiving member comprises a barbed region configured to receive the tube thereover and form a fluid seal thereagainst.
However, in another part of the device, Alvarez discloses a barbed region configured to receive a member and form a fluid seal thereagainst (i.e., a drain port 1906 with associated seal 1904 is depicted as a barbed member which receives a milk collecting vessel 275; see Figs. 3 and 19 and paras [0054] and [0074]).
Accordingly, a skilled artisan would have found it obvious at the time of the invention to modify the tube receiving member of Alvarez to comprise a barbed region, based on the teaching in Alvarez of such a structure being expected to provide a sealing function to prevent leakage of fluid (para [0074]).
Regarding claim 9, Alvarez does not appear to disclose that the actuatable assembly interface further comprises a barbed adaptor configured to fit within and fluidly seal against the bore of the tube receiving member, the barbed adaptor comprising a barbed region configured to receive the tube thereover and form a fluid seal thereagainst.
However, in another part of the device, Alvarez discloses a barbed region configured to receive a member and form a fluid seal thereagainst (i.e., a drain port 1906 with associated seal 1904 is depicted as a barbed member which receives a milk collecting vessel 275; see Figs. 3 and 19 and paras [0054] and [0074]).
Accordingly, a skilled artisan would have found it obvious at the time of the invention to modify the actuatable assembly interface to comprise a barbed adaptor to fit within and fluidly seal against the bore of the tube receiving member, based on the teaching in Alvarez of such a structure being expected to provide a sealing function to prevent leakage of fluid (para [0074]).
Regarding claim 10, it is noted that Alvarez does not disclose that the shutoff mechanism (as described in Shekalim) is configured to shut off fluid communication between the first and second fluid reservoirs in response to detachment of the actuatable assembly interface from the actuatable assembly and re-open the fluid communication in response to attachment of the actuatable assembly interface to the actuatable assembly.
However, provided that the shutoff mechanism in Shekalim is designed specifically to shut off fluid communication between the first and second fluid reservoirs in response to the actuatable assembly's interface detachment from another area (e.g., the skin surface; see Fig. 7), and to re-open the fluid communication in response to attachment of the actuatable assembly interface to the area (Figs. 5-6), a skilled artisan would have found it obvious at the time of the invention to modify the combination so that the shutoff mechanism is configured to shut off and re-open fluid communication in response to detachment and attachment, respectively, of the actuatable assembly interface to the actuatable assembly, for the purpose of preventing fluid leakage in the event of a failure of the arrangement coupling the actuatable assembly interface to the actuatable assembly (see Shekalim at paras [0017]-[0018] describing the advantage of the shutoff mechanism as responding to at least partial failure of a retention arrangement retaining the infusion set to the skin surface).
Regarding claim 11, a skilled artisan would understand that the combination of Alvarez and Shekalim would produce the fluid shutoff mechanism being configured to simultaneously secure coupling of the actuatable assembly interface to the actuatable assembly and release pinching of the tube to open the tube and to simultaneously release coupling of the actuatable assembly interface to the actuatable assembly and pinch the tube closed. Specifically, when the actuatable assembly interface is secured to the actuatable assembly, the shutoff mechanism would expectedly be in its position shown in Figs. 4A and 6 where the member 7 or 10 is compressed and the member 5 releases pinching of the tube; and when the actuatable assembly interface is decoupled from the actuatable assembly, the shutoff mechanism would expectedly move into its position shown in Figs. 4B and 8 whereby the expansion of the member 7 or 10 causes the member 5 to pinch the tube closed.
Regarding claim 12, it is noted that the combination of Alvarez and Shekalim does not appear to disclose the fluid shutoff mechanism is configured to secure or release the coupling of the actuatable assembly interface to the actuatable assembly and simultaneously release or pinch the tube via rotational movement of the actuatable assembly interface with respect to the actuatable assembly.
However, Shekalim discloses that an adhesive may be provided on the underside of the infusion set to secure the infusion set to the area to which fluid is to be delivered (paras [0008], [0054], [0068]). At the time that the adhesive would expectedly secure and release the coupling of the actuatable assembly, the member 5 would expectedly be moved into the position to pinch the tube closed (as shown in Figs. 5-6).
Accordingly, a skilled artisan would have found it obvious at the time of the invention to modify the combination of Alvarez and Shekalim accordingly, e.g., by adding an adhesive between the actuatable assembly interface and the actuatable
assembly, in order to retain the interface and assembly together (see Shekalim at para [0054]).
Regarding claim 13, the combination of Alvarez and Shekalim discloses that the fluid shutoff mechanism (described in Shekalim) comprises one or more springs 7 or 10 (Figs. 4B and 5-7, respectively) and one or more engaging members 5 (Figs. 4B and 5- 7) configured to engage the one or more springs in a first configuration (Fig. 7) and a second configuration (Figs. 5-6). Based on the explanation above with respect to claims 10 and 11 above, a skilled artisan would understand that the first configuration would correspond to the actuatable assembly interface attached to the actuatable assembly, and the second configuration would correspond to the actuatable assembly interface detached from the actuatable assembly.
Regarding claim 15, the combination of Alvarez and Shekalim discloses the apparatus as in claim 13, wherein the one or more springs are configured such that a greater force is required to disengage the one or more engaging members from the one or more springs in the first configuration than in the second configuration (when in the second configuration, the actuatable assembly interface is detached from the actuatable assembly so that no force is required to disengage the one or more engaging members from the one or more springs; and in the first configuration, there exists some force required to disengage the one or more engaging members from the one or more springs).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-13 and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over respective claims 1-14 of U.S. Patent No. 11,583,616, hereinafter “the ‘616 patent”. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent include all the limitations of the present claims (i.e., the present claims are broader than the patent claims and thus anticipate the pending claims).
Further, claims 1-9 and 11-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over respective claims 1-12 of U.S. Patent No. 10,610,625, hereinafter “the ‘625 patent”. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent include all the limitations of the present claims.
Further, claims 10, 11 and 14 are rejected for not being patentably distinct from claim 1 of the ‘625 patent (i.e., claim 1 of the ‘625 patent includes all the subject matter of instant claims 10, 11 and 14).
Further, claim 15 is rejected for not being patentably distinct from claim 11 of the ‘625 patent (i.e., claim 11 of the ‘625 patent includes all the subject matter of instant claim 15).
Further, claim 16 is rejected for not being patentably distinct from claim 12 of the ‘625 patent (i.e., claim 12 of the ‘625 patent includes all the subject matter of instant claim 16).
Further, claim 17 is rejected for not being patentably distinct from claim 13 of the ‘625 patent (i.e., claim 12 of the ‘625 patent includes all the subject matter of instant claim 17).
Further, claim 18 is rejected for not being patentably distinct from claim 14 of the ‘625 patent (i.e., claim 13 of the ‘625 patent includes all the subject matter of instant claim 15).
Allowable Subject Matter
Claim 14, 16, 17 and 18 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 and pending resolution of the double patenting rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SCOTT J MEDWAY whose telephone number is (571)270-3656. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 PM.
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/SCOTT J MEDWAY/ Primary Examiner, Art Unit 3783
11/26/2025