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 .
Priority
This application is a continuation of U.S. Patent Application No. 17/806,223 filed June 9, 2022, which is a continuation of U.S. Patent Application No. 16/734,406 filed January 6, 2020 (now U.S. Patent No. 11,399,823).
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 loader control” in claims 10, 18 and 19.
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 § 102
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 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.
Claim(s) 1-8 and 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Baril et al. (US 2017/0360431, which is cited in the Information Disclosure Statement filed July 9, 2024, hereinafter “Baril”).
As to claim 1, Baril discloses a loader system 2000 (Figs. 3-5; para. [0028. Figs. 3 and 5 are reproduced below]) configured to load a shuttle (examiner notes that applicant use the term “shuttle” for needle 14 as shown in Figs. 5A-5B, 11A-11C and 15C17C of the present application. Needle 104 of Baril has been interpreted as “a shuttle”; Fig. 3-5; para. [0028]) into a suture device 100 (Figs. 1-2), the loader system 2000 comprising: a body 2010 (Figs. 3-5; para [0028]) and the shuttle 104, wherein when the suture device 120 is attached to the body, the shuttle 104 is in a different position when the shuttle is in a non-loaded position than when the shuttle is in a loaded position (the loaded position has been interpreted as the needle 104 is attached to one of the jaw 130 as shown in Fig. 5. In alternative, a loaded position can be interpreted as when the needle tips are in the jaws 130 and 132 of the suture device and the loader 2000 is no longer attached to the suture device. The non-loaded position is the position in which the needle 104 is in the channel 2038 or track 2038 (para. [0031]) and the tip of the needle is also outside of the jaw 130. Examiner notes that the user can move the shuttle 2040 and needle 104 in the channel/track 2038 because of spring 2044).
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As to claim 2, Baril discloses the loader system of claim 1, wherein the body 2010 has a shuttle track 2038 (Fig. 3; para. [0031]), and wherein less of the shuttle (needle 104) is in the shuttle track 2038 when the shuttle is in the loaded position than when the shuttle is in the non-loaded position (Figs. 3 and 5 show when a portion of needle tip is inside jaw 130 while the rest of the body of the needle is still located inside shuttle track 2038 ).
As to claim 3, Baril discloses the loader system of claim 1, wherein the body 2010 has a shuttle track 2038 (Fig. 3; para. [0031]) having a first end (near lead line 132, Fig. 5) and a second end (near lead line 130, Fig. 5), and wherein the shuttle 104 is farther from the first end 132 when the shuttle is in the loaded position than when the shuttle is in the non-loaded position (Fig. 5) (the loaded position has been interpreted as the needle 104 is attached to one of the jaws 130 or 132 as shown in Fig. 5 (see rejection of claim 1 for alternative interpretation of loaded position). The non-loaded position is the position in which the needle 104 is in the channel 2038 or track 2038 and at a position that the entire length of the needle is outside of the jaw 130).
As to claim 4, Baril discloses the loader system of claim 1, wherein the body 2010 has a shuttle track 2038 (Fig. 5), and wherein the suture device 120 is the same distance from the shuttle track 2038 when the shuttle 104 is in the non-loaded position and when the shuttle is in the loaded position (Fig. 5 shows the outer surface of each of the jaws 130, 132 is abutting again peripheral guides 2032, 2034, 2034a (Fig. 3; para [0030]) and protrusion 2016 of the loader is received in a hole or an aperture in support member 122 of the suture device (para [0029]). Thus, in the configuration as shown in Fig. 5 the jaws 130 and 132 of suture device 120 are stationary with respect to the suture track 2038).
As to claim 5, Baril discloses the loader system of claim 1, wherein a first end of the shuttle (needle 104) and a second end of the shuttle are in a jaw of the suture device when the shuttle is in the loaded position (Baril discloses the central guide 2036 is used to prevent the jaws 130 and 132 from moving in the distal direction. Fig. 5 shows that the user can close the jaws after the needle is loaded into the bottom jaw 130).
As to claim 6, Baril discloses the loader system of claim 5, wherein the first end of the shuttle (needle 104) and the second end of the shuttle are outside the jaw of the suture device when the shuttle is in the non-loaded position (the non-loaded position has been interpreted as the needle 104 is still in the track and the entire length of the needle is still outside of the jaw 130 as shown in Fig. 5).
As to claim 7, Baril discloses the loader system of claim 1, wherein when the suture device 120 is attached to the body, the suture device is in the same position relative to the body when the shuttle is in the non-loaded position and when the shuttle is in the loaded position (Fig. 5 shows the outer surface of each of the jaws 130, 132 is abutting again peripheral guides 2032, 2034, 2034a (Fig. 3; para. [0030]) and protrusion 2016 (Fig. 3) is received and align with an hole or aperture in support member 122 of suture device 120 (para. [0029]). Thus, in the configuration as shown in Fig. 5 the suture device 120 is stationary with respect to the body 2010).
As to claim 8, Baril discloses the loader system of claim 1, wherein the suture device 120 comprises a first jaw 130 (Figs. 2 and 5) and a second jaw 132, and wherein when the suture device is attached to the body 2010 of the loader 2000, the first jaw and the second jaw are the same distance apart when the shuttle is in the non-loaded position and when the shuttle is in the loaded position (Fig. 5 shows the outer surface of each of the jaws 130, 132 is abutting again peripheral guides 2032, 2034, 2034a (Fig. 3; para. [0030]) and protrusion 2016 (Fig. 3) is received and align with a hole or an aperture in support member 122 of suture device 120 (para [0029]). Thus, in the configuration as shown in Fig. 5 the jaws of the suture device 120 are the same distance apart in the loaded position and non-loaded position).
As to claim 10, Baril discloses the loader system of claim 1, further comprising a loader control (shuttle 2040 as shown in Figs. 3 and 5; para. [0031]), wherein the shuttle 104 is moveable from the non-loaded position to the loaded position via the loader control (Baril discloses needle 104 is attached to shuttle 2040 (para. [0031]) and the shuttle can be moved in the track 2038 from an non-loaded position, which is a position of the entire length of the needle 104 is located outside of the jaw, to a loaded position, which is a position of a tip of the needle is located inside the jaw as shown in Fig. 5).
Claim(s) 12-17 and 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schweizer (US 3,901,244, which is cited in the Information Disclosure Statement filed July 9, 2024, hereinafter “Schweizer”).
As to claim 12, Schweizer discloses a loader system (cartridge 72 as shown in Fig. 7) configured to load a suture 68 (Figs. 1-4 and 7) into a suture device 10 (Figs. 1-5), the loader system comprising: a body (cartridge 72 as shown in Fig. 7) and the suture 68, wherein when the suture device 10 is attached to the body, the suture 68 is under less tension when the suture is in a non-loaded position (Fig. 3 shows distal portion of suture 68 is not inside jaw 14 of the suture device 10) than when the suture is in a loaded position (Fig. 4 shows the distal portion of suture 68 is inside jaw 14 of the suture device 10 and serrated face 64 in jaw 14 is engaged with suture 68).
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As to claim 13, Schweizer discloses the loader system of claim 12, wherein the body 72 has a suture track (the potion from lead line 108, which includes bobbin 70, to lead line 96 as shown in Fig. 7 has been interpreted as suture track), and wherein more of the suture is in the suture track when the suture is in the non-loaded position than when the suture is in the loaded position (when the tip of needle push the suture 68 out of slot 98 the length of suture in the suture track is shorten by an amount equal to the amount that being pushed out of slot 98 as shown in Fig. 4. Figs. 4 and 7 are reproduced above).
As to claim 14, Schweizer discloses the loader system of claim 12, wherein the body 72 has a suture track (the potion from lead line 108, which includes bobbin 70, to lead line 96 as shown in Fig. 7), and wherein the suture device 10 is the same distance from the suture track when the suture is in the non-loaded position and when the suture is in the loaded position (Fig. 3 shows cartridge 72 and suture device 10 are coupled to each other and cartridge 72 is stationary with respect to the suture device 10).
As to claim 16, Schweizer discloses the loader system of claim 12, wherein when the suture device 10 is attached to the body (cartridge 72), an end of the suture 68 is movable into the suture device such that the end of the suture is in a different position relative to the body when the suture is in the non-loaded position (Figs. 3 and 7) than when the suture is in the loaded position (Fig. 4)(attention is directed to Figs. 3-4 and 7 of Schweizer’s drawings. The figures show a distal portion of suture 68 is grasped and pushed by needle 56 to load the suture into lower jaw 14. Thus, the distal end portion of suture 68 is in a different position relative to the body (cartridge 72) when the suture is in a loaded position).
As to claim 17, Schweizer discloses the loader system of claim 16, wherein the end of the suture 68 comprises a terminal end of the suture (Fig. 4).
As to claim 19, Schweizer discloses a method of loading a suture device 10 comprising: moving a shuttle (needle 56 as shown in Figs. 2-4) and a suture 68 from a non-loaded configuration (Fig. 3 shows distal portion of suture 68 is not inside jaw 14 of the suture device 10) to a loaded configuration (Fig. 4 shows the distal portion of suture 68 is inside jaw 14 of the suture device 10 and serrated face 64 in jaw 14 is engaged with suture 68) via a loader control (handle 22 and rod 48 as shown in Fig. 3. Rod 48 is attached to the shuttle 56 (needle 56) as shown in Figs. 3-4) when the suture device is attached to a loader (suture cartridge 72 is interpreted as a loader).
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 and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 19, respectively, of U.S. Patent No. 11,399,823 (hereinafter “the patent”). Although the claims at issue are not identical, they are not patentably distinct from each other because all limitations in claims 1 and 19 can be found in claims 1 and 19, respectively, of the patent. Claims 1 and 19 of the patent are more specific than claims 1 and 19 of the patent application. The specific anticipates that broader.
The claims match-up with respect to one another as listed below:
U.S. Patent Application No. 18/767,797
U.S. Patent No. 11,399,823
Claim 1. A loader system configured to load a shuttle into a suture device, the loader system comprising:
a body and the shuttle, wherein when the suture device is attached to the body, the shuttle is in a different position when the shuttle is in a non-loaded position than when the shuttle is in a loaded position.
Claim 1. A suture device loader comprising:
a body having a device space; a loader control; and a shuttle moveable from a shuttle first position (non-loaded position as required in claim 1 of the patent application) to a shuttle second position (loaded position as required in claim 1 of the patent application), wherein the shuttle is moveable from the shuttle first position to the shuttle second position via the loader control, wherein when the shuttle is in the shuttle first position, a suture device is positionable in the device space, wherein when the suture device is positioned in the device space, the shuttle is moveable from the shuttle first position to the shuttle second position, wherein when the shuttle is in the shuttle first position, the shuttle is outside the suture device, and wherein when the shuttle is in the shuttle second position, the shuttle is inside the suture device.
Claim 19. A method of loading a suture device comprising:
moving a shuttle and a suture from a non-loaded configuration to a loaded configuration via a loader control when the suture device is attached to a loader.
19. A method of loading a suture device, comprising:
removably attaching the suture device to a loader, wherein the loader has a loader control, a suture, and a shuttle; and loading, via the loader control, the shuttle and the suture into the suture device, wherein loading comprises moving, via the loader control, the shuttle and the suture from a non-loaded configuration to a loaded configuration by moving the loader control from a loader control first position to a loader control second position, wherein when the loader control is in the loader control first position, the shuttle and the suture are in the non-loaded configuration, and wherein when the loader control is in the loader control second position, the shuttle and the suture are in the loaded configuration.
Allowable Subject Matter
Claims 9, 11, 15, 18 and 20 are 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 a Terminal Disclaimer is required to overcome the non-statutory double patenting rejection set forth in this Office action.
Conclusion
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/TUAN V NGUYEN/Primary Examiner, Art Unit 3771