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 .
Claim Objections
Claims 1 and 17 are objected to because of the following informalities: “configured to receive a portion of second material” in the paragraph beginning with “a second slot” should instead recite - - configured to receive a portion of a second material - - to be grammatically correct. 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 6 and 17 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 6 recites “the first ferrule receiving passage the proximal to a distal end”. It is unclear what “the proximal” and “a distal end” is in reference to as there were various proximal ends and distal ends introduced in claim 1. For examination purposes and as best understood by the Examiner in light of the specification, the Examiner will interpret claim 6 as - - the first ferrule receiving passage extends from the proximal end of the first ferrule receiving passage to a distal end of the first ferrule receiving passage - -.
Claim 17 recites in its last paragraph “as the needle displaces from the second needle position to the second needle position. It is unclear how the needle is displaced if it is displaced from the same position to the same position. For examination purposes and as best understood by the Examiner in light of the specification, the Examiner will interpret claim 17 as – as the needle displaces from the second needle position to the first needle position - -.
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.
Claim(s) 1, 5-14 and 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sauer (US 2007/0255296).
Sauer discloses the following limitations:
Claim 1. A suturing device (10) comprising:
a housing (22+24);
an actuator (64) coupled to a first portion (22D+24D) of the housing such that the actuator is displaceable between a first actuator position (Fig. 13A; not squeezed towards grip 22) and a second actuator position (Fig. 13C; squeezed towards grip 22) ([0094]-[0096]);
a shaft (34) extending from a proximal end (end towards user) to a distal end (end towards treatment site) along a shaft axis, wherein the shaft defines an interior portion that extends from the proximal end of the shaft to the distal end of the shaft ([0094], Fig. 2), and wherein the proximal end of the shaft is coupled to a second portion (22B+24B) of the housing ([0097]);
a needle (56) extending from a proximal end to a distal end along a longitudinal axis that is parallel to or coaxially aligned with the shaft axis (Figs. 2-4), wherein the proximal end of the needle is coupled to a portion (at slot 64C) of the actuator ([0096]) and at least a portion of the needle extends through the interior portion of the shaft ([0094]), wherein as the actuator is displaced from the first actuator position (Fig. 13A) to the second actuator position (Fig. 13C), the distal end of the needle is displaced along the longitudinal axis from a first needle position (Fig. 13A, retracted position) to a second needle position (Fig. 13C, extended position) ([0113]), and wherein as the actuator is displaced from the second actuator position to the first actuator position, the distal end of the needle is displaced along the longitudinal axis from the second needle position to the first needle position (Fig. 13D; [0114]); and
a guide tip (32) coupled to the distal end of the shaft, the guide tip comprising:
a proximal portion (see annotated figure below);
a transition portion (see annotated figure below) coupled to the proximal portion, wherein a transition passage extends through the transition portion from a proximal end of the transition portion to a distal end of the transition portion;
a distal portion coupled to the transition portion (see annotated figure below), the distal portion having a first ferrule receiving passage (32F), wherein a first ferrule receiving aperture (proximal opening into ferrule compartment 32F) is disposed at a proximal end of the first ferrule receiving passage, and wherein at least a portion of the first ferrule receiving passage is configured to hold a first ferrule (52A) secured to a first portion of suture (52C) ([0102], [0106]);
a first slot (see annotated figure below) defined between a distal end of the proximal portion and the proximal end of the transition portion, the first slot defining an area capable of being a cuff receiving area configured to receive a portion of a first material; and
a second slot (see annotated figure below) defined between the distal end of the transition portion and a proximal end of the distal portion, the second slot defining an area capable of being a tissue bite area configured to receive a portion of a second material,
wherein in the first needle position (Fig. 13A), the distal end of the needle is disposed proximal to the distal end of the proximal portion ([0113], “FIGS. 13A shows the lever 64 fully forward with the needles 56 (not visible) fully retracted”) and in the second needle position (Fig. 13C) the distal end of the needle is disposed adjacent to the first ferrule receiving aperture of the distal portion such that the distal end of the needle is configured to operatively engage the first ferrule secured to the first portion of suture ([0113]; “FIG. 13C shows the lever 64 fully rotated back and the needles 56 fully forward through the tissue jaw 32R to fully engage both suture ferrules 52A (not visible)”, and
wherein as the needle displaces from the first needle position to the second needle position, the distal end of the needle displaces through a portion of the cuff receiving area, the transition passage, a portion of the tissue bite area, and a proximal portion of the first ferrule receiving passage (these areas and passages form a linear pathway for the needle as seen in the annotated figure below and as illustrated by movement of the needle through Figs. 13A-13C; [0113]), and
as the needle displaces from the second needle position to the second needle position, the distal end of the needle is configured to retain the first ferrule secured to the first portion of suture as the distal end of the needle displaces through the proximal portion of the first ferrule receiving passage, the portion of the tissue bite area, the transition passage, and the portion of the cuff receiving area (Fig. 13D; [0114]).
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Claim 5. The suturing device of claim 1, wherein in the second needle position, the distal end of the needle is disposed at or adjacent to the distal end of the distal portion of the guide tip (Fig. 13C).
Claim 6. The suturing device of claim 1, wherein the transition passage extends through the transition portion of the guide tip from the proximal end of the transition portion to the distal end of the transition portion along the longitudinal axis (see annotated figure from claim 1), and the first ferrule receiving passage extends from the proximal end of the first ferrule receiving passage to a distal end of the first ferrule receiving passage along the longitudinal axis (Fig. 7B).
Claim 7. The suturing device of claim 1, wherein the first slot is aligned with the longitudinal axis and the second slot is aligned with the longitudinal axis (see annotated figure from claim 1).
Claim 8. The suturing device of claim 1, wherein a portion of the housing defines a grip portion (22), and wherein in the first actuator position (Fig. 13A; not squeezed position), a lever portion (64) of the actuator is in a first position (further from the grip portion) relative to the grip portion of the housing and in the second actuator position (Fig. 13C; squeezed position), the lever portion of the actuator is in a second position (closer to the grip portion) relative to the grip portion of the housing.
Claim 9. The suturing device of claim 1, wherein the distal end of the needle is displaced linearly from the first needle position to the second needle position (Figs. 13A-13D).
Claim 10. The suturing device of claim 1, wherein the actuator is pivotably coupled to the first portion of the housing such that the actuator is pivotably displaceable between the first actuator position (Fig. 13A) and the second actuator position (Fig. 13C; [0095]).
Claim 11. The suturing device of claim 1, wherein the portion of the first ferrule receiving passage configured to hold the first ferrule secured to the first portion of suture is disposed distally to the proximal portion of the first ferrule receiving passage (Fig. 7B).
Claim 12. The suturing device of claim 1, further comprising:
a second needle (56) extending from a proximal end to a distal end along a second longitudinal axis that is parallel to the longitudinal axis (Figs. 2-3; [0094]), wherein the proximal end of the second needle is coupled to a second portion of the actuator (at the other one of slot 64C; [0096]) and at least a portion of the second needle extends through the interior portion of the shaft, wherein as the actuator is displaced from the first actuator position to the second actuator position, the distal end of the second needle is displaced along the second longitudinal axis from a third needle position (Fig. 13A) to a fourth needle position (Fig. 13C; [0113]), and wherein as the actuator is displaced from the second actuator position to the first actuator position, the distal end of the second needle is displaced along the second longitudinal axis from the fourth needle position to the third needle position (Fig. 13D; [0114]).
Claim 13. The suturing device of claim 1, wherein the proximal portion of the guide tip is coupled to the transition portion of the guide tip by a cuff support (see annotated figure from claim 1) that extends parallel to the longitudinal axis from the distal end of the proximal portion to the proximal end of the transition portion, wherein a surface of the cuff support at least partially defines the first slot.
Claim 14. The suturing device of claim 13, wherein the distal portion of the guide tip is coupled to the transition portion of the guide tip by a connector portion (see annotated figure from claim 1), the connector portion extending from a lateral end of the distal portion to a lateral end of the transition portion (the connector portion extends along both and across the left and right lateral sides and is therefore considered extending from a lateral end of the distal portion to a lateral end of the transition portion).
Claim 17. A method of assembling a suturing device (10), the method comprising:
coupling an actuator (64) to a first portion (22D+24D) of a housing (22+24) such that the actuator is displaceable between a first actuator position (Fig. 13A; not squeezed towards grip 22) and a second actuator position (Fig. 13C; squeezed towards grip 22) ([0094]-[0096]);
coupling a proximal end (end towards user) of a shaft (34) to a second portion (22B+24B) of the housing ([0097]), wherein the shaft extends from the proximal end to a distal end (end towards treatment site) along a shaft axis, and wherein the shaft defines an interior portion that extends from the proximal end of the shaft to the distal end of the shaft ([0094], Fig. 2);
coupling a proximal end of a needle (46) to a portion (64C) of the actuator (64) such that at least a portion of the needle extends through the interior portion of the shaft ([0094], [0096]), the needle extending from the proximal end to a distal end along a longitudinal axis that is parallel to or coaxially aligned with the shaft axis (Figs. 2-4_, wherein as the actuator is displaced from the first actuator position (Fig. 13A) to the second actuator position (Fig. 13C), the distal end of the needle is displaced along the longitudinal axis from a first needle position (Fig. 13A, retracted position) to a second needle position (Fig. 13C, extended position) ([0113]), and wherein as the actuator is displaced from the second actuator position to the first actuator position, the distal end of the needle is displaced along the longitudinal axis from the second needle position to the first needle position (Fig. 13D; [0114]); and
coupling a guide tip (32) to the distal end of the shaft, the guide tip comprising:
a proximal portion (see annotated figure from claim 1);
a transition portion (see annotated figure from claim 1) coupled to the proximal portion, wherein a transition passage extends through the transition portion from a proximal end of the transition portion to a distal end of the transition portion;
a distal portion coupled to the transition portion (see annotated figure from claim 1), the distal portion having a first ferrule receiving passage (32F), wherein a first ferrule receiving aperture (proximal opening into ferrule compartment 32F) is disposed at a proximal end of the first ferrule receiving passage, and wherein at least a portion of the first ferrule receiving passage is configured to hold a first ferrule (52A) secured to a first portion of suture (52C) ([0102], [0106]);
a first slot (see annotated figure from claim 1) defined between a distal end of the proximal portion and the proximal end of the transition portion, the first slot defining an area capable of being a cuff receiving area configured to receive a portion of a first material; and
a second slot (see annotated figure from claim 1) defined between the distal end of the transition portion and a proximal end of the distal portion, the second slot defining an area capable of being a tissue bite area configured to receive a portion of a second material,
wherein in the first needle position (Fig. 13A), the distal end of the needle is disposed proximal to the distal end of the proximal portion ([0113], “FIGS. 13A shows the lever 64 fully forward with the needles 56 (not visible) fully retracted”) and in the second needle position (Fig. 13C) the distal end of the needle is disposed adjacent to the first ferrule receiving aperture of the distal portion such that the distal end of the needle is configured to operatively engage the first ferrule secured to the first portion of suture ([0113]; “FIG. 13C shows the lever 64 fully rotated back and the needles 56 fully forward through the tissue jaw 32R to fully engage both suture ferrules 52A (not visible)”, and
wherein as the needle displaces from the first needle position to the second needle position, the distal end of the needle displaces through a portion of the cuff receiving area, the transition passage, a portion of the tissue bite area, and a proximal portion of the first ferrule receiving passage (these areas and passages form a linear pathway for the needle as seen in the annotated figure below and as illustrated by movement of the needle through Figs. 13A-13C; [0113]), and
as the needle displaces from the second needle position to the second needle position, the distal end of the needle is configured to retain the first ferrule secured to the first portion of suture as the distal end of the needle displaces through the proximal portion of the first ferrule receiving passage, the portion of the tissue bite area, the transition passage, and the portion of the cuff receiving area (Fig. 13D; [0114]).
Statutory Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claim 2 is/are rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 21 of prior U.S. Patent No. 12070205.
Claim 3 is/are rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 18 of prior U.S. Patent No. 12070205.
Claim 4 is/are rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 19 of prior U.S. Patent No. 12070205.
Claim 15 is/are rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 20 of prior U.S. Patent No. 12070205.
These are statutory double patenting rejections.
Nonstatutory 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 1-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 12070205.
Although the claims at issue are not identical, they are not patentably distinct from each other because the elements of claims1-17 of the instant application are to be found in claims 1-17 of the patent. Thus the difference between claims 1-17 of the instant application and claims 1-17 of the patent lies in the fact that the patent claims include many more elements and is thus much more specific. Thus, the invention of claims 1-17 of the patent is in effect a “species” of the “generic” invention of claims 1-17 of the instant application. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claims 1-17 are anticipated by claims 1-17 of the patent, it is not patentably distinct from claims 1-17 of the patent.
The limitations of the instant claims can be found in the corresponding claims of the patent as follows:
Instant claims
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Allowable Subject Matter
Claim 16 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 if the above double patenting rejections are obviated. Claim 15, from which claim 16 is dependent upon, even though not taught by prior art is not considered allowable as there is a statutory double patenting against claim 20 of US Patent 12070205 as indicated above.
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art of record, Sauer, discloses the invention substantially as claimed above. In regards to independent claim 16, the prior art of record does not disclose or fairly suggest either singly or combination the claimed suturing device comprising, inter alia, the connector portion is disposed on a first side of the first plane, and the first plane bisects the cuff support.
Therefore, in view of the prior art and its deficiencies, Applicant’s invention is rendered novel and non-obvious, and thus, is allowable as claimed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE M SHI whose telephone number is (571)270-5620. The examiner can normally be reached Mon-Thurs, 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached on (571)272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE M SHI/Primary Examiner, Art Unit 3771
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