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 .
Election/Restrictions
Applicant’s election of Group I, claims 1-17, in the reply filed on 3/19/2024 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 18-20 are withdrawn.
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 “needle comprises four projections at a distal end of the needle” of claim 12 must be shown or the feature(s) canceled from the claim(s). While Fig. 4A shows needle (502) with four projections (504). It does not show the needle with four projections in addition to the at least one barb recited in claim 1 (therefore totaling 5 or more barbs/projections). Instead, Fig. 4A only shows the at least one barb of claim 1 comprising four barbs/projections in total at the distal end of the needle. 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 Objections
Claim 16 is objected to because of the following informalities: “a connection member attached to proximal end” should recite - - a connection member attached to a proximal end - - 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 7, 16 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 7 recites “the needle comprises a plurality of barbs on at least two sides of the needle”. However, claim 1, from which claim 7 is dependent upon, recites “a needle with at least one barb”. It is unclear in claim 7 if 1) the at least one barb of claim 1 comprises a plurality of barbs on at least two sides of the needle, or 2) needle comprises a plurality of barbs on at least two sides of the needle in addition to the at least one barb of claim 1. For examination purposes and as best understood by the Examiner in light of the specification, the Examiner will interpret claim 7 as interpretation 1) above.
Claim 16 recites the limitation "the first end and the second end of the second attachment member are coupled to the biasing member". There is insufficient antecedent basis for this limitation in the claim for all three of those terms. A first and second end has only been defined for a connection member. For examination purposes and as best understood by the Examiner in light of the specification, the Examiner will interpret claim 16 as - - the first end and the second end of the connection member are coupled to the biasing member - -.
Claim(s) 17 is/are rejected as being dependent on, and failing to cure the deficiencies of, their rejected respective parent claims.
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) 1-3, 8, 10, 11, 14 and 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kondo (JP 2005-103107; wherein the English machine translation is cited below).
Kondo discloses the following limitations:
Claim 1. A medical device (100) (Fig. 7) comprising:
a connection member (see boxed portion in annotated figure below) capable of connecting a homeostasis clip to the medical device (p. 6, discussion regarding embodiment 3; a homeostasis clip can be clipped onto claws 102a or 102b of grasping member 102);
a biasing member (101), wherein the biasing member biases the medical device toward a compressed configuration (page 4, last paragraph to page 5, first paragraph; “the connecting member 101 can be configured using an elastic body such as a rubber or a spring having a predetermined length having an urging force that the pair of gripping members 102 and 102 are attracted to each other,” the compressed configuration is considered the resting non-elongated/non-stretched configuration of elastic body 101);
a needle (701) with at least one barb (702), wherein
the connection member is connected to the biasing member such that, with the needle inserted into tissue past the at least one barb and the biasing member pulled toward a tensioned configuration by the homeostasis clip connected to the connection member, the needle and the at least one barb pull the tissue in a direction parallel to a direction of tension placed on the biasing member (page 4, last paragraph to page 5, first paragraph; “the connecting member 101 can be configured using an elastic body such as a rubber or a spring having a predetermined length having an urging force that the pair of gripping members 102 and 102 are attracted to each other,” page 5 paragraph 6 to page 6, paragraph 2) .
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Claim 2. The medical device of claim 1, wherein the medical device includes a longitudinal axis (along biasing member 101) and the biasing member applies tension along the longitudinal axis when pulled by the connection member (Fig. 5; page 4, last paragraph to page 5, first paragraph; “the connecting member 101 can be configured using an elastic body such as a rubber or a spring having a predetermined length having an urging force that the pair of gripping members 102 and 102 are attracted to each other,”
Claim 3. The medical device of claim 1, further comprising a base member (see annotated figure from claim 1, wherein the base member is integrally formed with the connection member), wherein the base member is coupled to the connection member and the biasing member.
Claim 8. The medical device of claim 1, wherein the at least one barb comprises one or more projections that extend at an angle that is not parallel to a longitudinal axis of the needle (Fig. 7; longitudinal axis of the needle defined by the needle base member and as seen with the dashed horizontal line in the annotated figure from claim 1, the angle the barb 702 extends at is indicated by a thicker dashed line).
Claim 10. The medical device of claim 1, wherein the connection member is capable of being removably coupled to a subject's anatomy with a homeostasis clip (a homeostasis clip can be clipped onto claws 102a or 102b of grasping member 102 and also sandwiching tissue in the clip as well to couple to a subject’s anatomy).
Claim 11. The medical device of claim 1, wherein the biasing member (101) comprises stainless steel (page 5, paragraph 3).
Claim 14. The medical device of claim 1, wherein the connection member is capable of being cut by an end effector of one or more medical device systems to sever the connection member (cutting is possible with an appropriate device).
Claim 16. A tissue traction device (100) (Figs. 9-1, 9-2), comprising:
a biasing member (101) comprising a compliant or semi-compliant material biasing the tissue traction device toward a compressed configuration (page 4, last paragraph to page 5, first paragraph; “the connecting member 101 can be configured using an elastic body such as a rubber or a spring having a predetermined length having an urging force that the pair of gripping members 102 and 102 are attracted to each other,” the compressed configuration is considered the resting non-elongated/non-stretched configuration of elastic body 101);
a needle (901) attached to a distal end (end towards treatment site) of the biasing member (Fig. 9-1);
a connection member (102) attached to proximal end (end towards user) of the biasing member, wherein
the needle comprises one or more projections (901a-901n) at a distal end of the needle that are angled away from a longitudinal axis (see dashed horizonal line in annotated figure below) of the needle so as to impede removal of the needle from tissue (Fig. 9-2; page 7, discussion regarding embodiment 5), and
the connection member comprises a first end and a second end (ends of claws 102a and 102b) and the first end and the second end of the connection member are coupled to the biasing member (see annotated figure below).
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Claim(s) 1-8, 12, 14, 16 and 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sharma (US 2021/0205006).
Sharma discloses the following limitations:
Claim 1. A medical device (800 with 1102C; Figs. 8 and 11), comprising:
a connection member (hook 802 on the right side of Fig. 8) capable of connecting a homeostasis clip to the medical device (a homeostasis clip can clip onto the body of hook 802);
a biasing member (804), wherein the biasing member biases the medical device toward a compressed configuration (Fig. 8; [0009], [0016]);
a needle (hook 802 on the left side of Fig. 8) with at least one barb ([0085]; hooks can be configured as the options seen in Fig. 11, including hook 1102c with barbs 1106c), wherein
the connection member is connected to the biasing member such that, with the needle inserted into tissue past the at least one barb and the biasing member pulled toward a tensioned configuration by the homeostasis clip connected to the connection member, the needle and the at least one barb pull the tissue in a direction parallel to a direction of tension placed on the biasing member (step 226 in Figs. 2A, 2B; [0073]).
Claim 2. The medical device of claim 1, wherein the medical device includes a longitudinal axis (central axis extending through central portion 804) and the biasing member applies tension along the longitudinal axis when pulled by the connection member (step 226 in Figs. 2A, 2B; [0073]).
Claim 3. The medical device of claim 1, further comprising a base member (1708), wherein the base member is coupled to the connection member and the biasing member (Fig. 17; [0091]).
Claim 4. The medical device of claim 3, wherein the base member comprises a disc (1708o) having two holes for connecting the connection member to the disc (Fig. 17; [0091]; the button clasps 1708o as seen in Fig. 17 has two holes)
Claim 5. The medical device of claim 3, wherein the base member is a flat circular plate (17080 is a button which is by definition a flat circular plate and as seen in Fig. 17) that includes one or more connection portions for connecting to the connection member ([0091]).
Claim 6. The medical device of claim 5, further comprising a needle base member (1708) that couples the biasing member and the needle (the needle 802 is a hook on the left side of the medical device, each hook can have a connector 1708, therefore any one of connectors 1708a-1708x as discussed in [0091] can be considered a needle base member).
Claim 7. The medical device of claim 1, wherein the needle (1102c) comprises a plurality of barbs on at least two sides of the needle (see single barb on top side and three barbs on bottom side of needle in Fig. 11).
Claim 8. The medical device of claim 1, wherein the at least one barb comprises one or more projections (1106c) that extend at an angle that is not parallel to a longitudinal axis of the needle (Fig. 11).
Claim 12. The medical device of claim 1, wherein the needle (1102c) comprises four projections at a distal end of the needle (Fig. 11).
Claim 14. The medical device of claim 1, wherein the connection member is capable of being cut by an end effector of one or more medical device systems to sever the connection member (cutting is possible with appropriate device).
Claim 16. A tissue traction device (800 with 1102C; Figs. 8 and 11), comprising:
a biasing member (804) comprising a compliant or semi-compliant material biasing the tissue traction device toward a compressed configuration (Fig. 8; [0009], [0016]);
a needle (hook 802 on the left side of Fig. 8) attached to a distal end (left side) of the biasing member;
a connection member (1708i or 1708p) (Fig. 17) attached to proximal end (right side) of the biasing member, wherein
the needle comprises one or more projections ([0085]; hooks can be configured as the options seen in Fig. 11, including hook 1102c with barbs 1106c) at a distal end of the needle that are angled away from a longitudinal axis of the needle so as to impede removal of the needle from tissue, and
the connection member comprises a first end and a second end (ends of the hinged clip in 1708i or ends of the snap lock in 1708p) and the first end and the second end of the second attachment member are coupled to the biasing member ([0091]).
Claim 17. The tissue traction device of claim 16, further comprising a needle base member (one of connectors 1708 used for connecting right hook 802) that couples the biasing member and the needle (Fig. 17; [0091]).
Claim Rejections - 35 USC § 103
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.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sharma.
Claim 13. Sharma discloses the invention substantially as claimed above, but fails to disclose the projections at the distal end of the needle are of equivalent size.
The instant disclosure describes this parameter as one option and does not describe it as contributing any unexpected result to the tissue traction device. For example, the projections may be any size and may each be of an equivalent size or different size ([0034] of the published application). Sharma further discloses the shape and size of the barbs may be of various configurations, wherein the barbs (1106c) may be substantially similar in size (Fig. 11; [0085]). As such this parameter is deemed a matter of design choice (lacking in any criticality) and well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results.
Allowable Subject Matter
Claims 9 and 15 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.
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art of record, Kondo and Sharma, each discloses the invention substantially as claimed above. T
In regards to claim 9, the prior art of record does not disclose or fairly suggest either singly or in combination the claimed medical device comprising, inter alia, the connection member comprises a loop made from one or more of nylon and linear low density polyethylene. The connection member of Kondo is a stainless-steel clip and the connection member of Sharma is a needle, neither of which would have been obvious to one of ordinary skill in the art to modify to a loop made from one or more of nylon and linear low density polyethylene.
In regards to claim 15, the prior art of record does not disclose or fairly suggest either singly or in combination the claimed medical device comprising, inter alia, the connection member is formed from one or more of nylon and linear low density polyethylene. The connection member of Kondo is a stainless-steel clip and the connection member of Sharma is a needle, neither of which would have been obvious to one of ordinary skill in the art to modify to a loop made from one or more of nylon and linear low density polyethylene.
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 at (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