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
This application contains claims directed to the following patentably distinct species:
Species a: fig. 1-14: a ligating clip with first and second arms, a locking device with a hook portion and fitting portion;
Species b: fig. 15-16: a ligating clip with inner and outer clips.
The species are independent or distinct because claims to the different species recite the mutually exclusive characteristics of such species. In addition, these species are not obvious variants of each other based on the current record.
Applicant is required under 35 U.S.C. 121 to elect a single disclosed species, or a single grouping of patentably indistinct species, for prosecution on the merits to which the claims shall be restricted if no generic claim is finally held to be allowable. Currently, claims 1-4 are generic.
There is a serious search and/or examination burden for the patentably distinct species as set forth above because at least the following reason(s) apply:
(a) the inventions have acquired a separate status in the art due to their recognized divergent subject matter;
(b) the inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries);
(c) the prior art applicable to one invention would not likely be applicable to another invention.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of a species to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected species or grouping of patentably indistinct species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered nonresponsive unless accompanied by an election.
The election may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the election of species requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected species or grouping of patentably indistinct species.
Should applicant traverse on the ground that the species, or groupings of patentably indistinct species from which election is required, are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing them to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the species unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other species.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which depend from or otherwise require all the limitations of an allowable generic claim as provided by 37 CFR 1.141.
During a telephone conversation with Feng Shan on 02/10/2026 a provisional election was made without traverse to prosecute the invention of species a, claims 1-14. Affirmation of this election must be made by applicant in replying to this Office action. Claims 15-20 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1 and 4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Smith (US 4,646,741).
Regarding claim 1 Smith discloses a ligating clip, made from an absorbable biomedical polymer material (see col. 2 ln. 19-22), the absorbable biomedical polymer material comprising a first polymer (lactide/glycolide) and a second polymer (poly(p-dioxanone), see col. 3 ln. 29-32), and wherein:
with a sum of weight percentages being 100%,
a weight ratio of the first polymer is 2.5 wt% to 60 wt% (lactide/glycolide copolymer, see col. 3 ln. 56-59 which discloses a range of >50-75), and a weight ratio of the second polymer is 40 wt% to 97.5 wt% (poly(p-dioxanone), see col. 3 ln. 56-59 which discloses a range of 25-<50);
wherein the first polymer is composed of poly-L-lactide with a weight ratio of 50 wt% to 100 wt% (see col. 3 ln. 33-36) and polyglycolide with a weight ratio of 0 wt% to 50 wt% (see col. 3 ln. 33-36);
the second polymer is poly-p-dioxanone (see col. 3 ln. 56-59).
Regarding claim 4 Smith further discloses the first polymer is composed of the poly-L-lactide with the weight ratio of 70 wt% to 100 wt% (see col. 3 ln. 33-36) and the polyglycolide with the weight ratio of 0 wt% to 30 wt% (see col. 3 ln. 33-36).
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.
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Smith.
Regarding claim 2, Smith discloses the claimed invention substantially as claimed, as set forth above for claim 1. Smith further discloses the weight ratio of the first polymer is just over 50 wt% (see col. 3 ln. 33-36), and the weight ratio of the second polymer is just under 50 wt% (see col. 3 ln. 33-36).
Smith does not expressly disclose the weight ratio of the first polymer is 2.5 wt% to 50 wt%, and the weight ratio of the second polymer is 50 wt% to 97.5 wt%.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to adjust the wt% of Smith to be the first polymer is 2.5 wt% to 50 wt%, and the weight ratio of the second polymer is 50 wt% to 97.5 wt% as applicant appears to have placed no criticality on the claimed range (the specification lists numerous alternative ranges [0012]-[0025]) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 3, Smith discloses the claimed invention substantially as claimed, as set forth above for claim 2. Smith further discloses the weight ratio of the first polymer is just over 50 wt% (see col. 3 ln. 33-36), and the weight ratio of the second polymer is just under 50 wt% (see col. 3 ln. 33-36).
Smith fails to expressly disclose the weight ratio of the first polymer is 2.5 wt% to 40 wt%, and the weight ratio of the second polymer is 60 wt% to 97.5 wt%.
Before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person of ordinary skill in the art to have the weight ratio of the first polymer is 2.5 wt% to 40 wt%, and the weight ratio of the second polymer is 60 wt% to 97.5 wt% because as applicant appears to have placed no criticality on the claimed range (the specification lists numerous alternative ranges [0012]-[0025]). One of ordinary skill in the art, furthermore, would have expected Smith’s clip, and applicant’s invention, to perform equally well with either the wt% taught by Smith or the claimed wt% because values allow one to form a clip that can be used for ligating.
Therefore, it would have been prima facie obvious to modify Smith to obtain the invention as specified in claim 3 because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Smith.
Claims 5-7 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Smith in view of Patel et al. (US 20200008810 A1).
Regarding claim 5, Smith discloses the claimed invention substantially as claimed, as set forth above for claim 1. Smith further discloses (fig. 4-9) a ligating clip, made from a same material as the ligating clip according to claim 1 (see col. 3 ln. 29-59, col. 5 ln. 16-21, and claim 1 above), wherein the ligating clip 40 comprises: a ligating clip body; the ligating clip body comprising a clip and a locking device (46+47) for keeping the clip closed (see col. 5 ln. 22-36); the clip having a first clip arm 41 and a second clip arm 42 connected in a V-shape (see fig. 4), the first clip arm 41 and the second clip arm 42 being in a straight structure (see fig. 4); the locking device comprising a hook portion 46 arranged at a distal end of the first clip arm 41 (see fig. 4 and and col. 5 ln. 22-36) a fitting portion 47 arranged at a distal end of the second clip arm 42 and adapted to the hook portion (see fig. 4 and col. 5 ln. 22-36), the hook portion 46 being provided with an acute-angle cutting structure 49 (see fig. 4 and col. 5 ln. 33-36).
Smith is silent regarding two limit blocks, the two limit blocks being oppositely arranged at the distal end of the second clip arm; and the hook portion being engaged with the two limit blocks and limited between the two limit blocks.
However Patel, in the same filed of endeavor, teaches (fig. 1A-2, 6A, and 11A) a clip comprising a first arm 105 with a hook portion 155 at the distal end thereof (see fig. 1A and [0074]) and a second arm 110 with a fitting portion 160 at a distal end thereof (see fig. 1A and [0074]), two limit blocks (910, 912, see fig. 6A and [0105]), the two limit blocks (910, 912) being oppositely arranged at the distal end of the second clip arm 110 (fig. 6A and [0105]); and the hook portion being engaged with the two limit blocks and limited between the two limit blocks (see fig. 11A and [0121]).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Smith to have two limit blocks, the two limit blocks being oppositely arranged at the distal end of the second clip arm; and the hook portion being engaged with the two limit blocks and limited between the two limit blocks as taught by Patel, for the purpose of proving a guiding aperture for the hook and providing counter-traction of the tissue as the hook advances through the (see Patel [0121]).
Regarding claim 6, Smith as modified discloses the claimed invention substantially as claimed, as set forth above for claim 5. Smith further discloses (fig. 4-9) in accordance with a determination that the first clip arm and the second clip arm are in the curved arc structure with the same direction; a connection between the first clip arm and the second clip arm is provided with a hollow groove; and an inner side of the hook portion is provided with a reinforcing rib (since the curved clip structure is introduced in the alternative in claim 5 and is not the option used to reject claim 5, this limitation is not required for the art to read on the claim).
Regarding claim 7, Smith as modified discloses the claimed invention substantially as claimed, as set forth above for claim 5. Smith further discloses (fig. 4-9) the clip 40 is provided with a clamping device (53+54); the clamping device comprises a first clamping column 53 arranged on left and right sides of the distal end of the first clip arm 41 along a width direction of the clip (see fig. 4, 7, and col. 5 ln. 40-46); and a second clamping column 54 arranged on left and right sides of the distal end of the second clip arm 42 along the width direction of the clip (see fig. 4 and col. 5 ln. 40-46).
Regarding claim 9, Smith as modified discloses the claimed invention substantially as claimed, as set forth above for claim 5. Smith further discloses (fig. 4-9) the locking device is provided with a penetrating device configured to cut a tissue when the clip begins to close; the penetrating device comprises a pointed cutting head provided at an outer end of the hook portion; when the clip begins to close, the pointed cutting head cooperates with an inclined surface on the fitting portion to cut the tissue.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Smith in view of Patel as applied to claim 5 above, and further in view of Cerwin et al. (US 4,498,476).
Regarding claim 8, Smith as modified discloses the claimed invention substantially as claimed, as set forth above for claim 5. Smith as modified is silent regarding the clip is provided with a positioning device; the positioning device comprises a first positioning groove provided on an inner side of the distal end of the first clip arm and a first positioning protrusion provided on an inner side of the second clip arm and adapted to the first positioning groove.
However Cerwin, in the same filed of endeavor, teaches (fig. 2) a clip comprising a first arm 31 with a hook portion 34 at the distal end thereof (see fig. 2 and col. 5 ln. 29-30) and a second arm 32 with a fitting portion 37 at a distal end thereof (see fig. 2 and col. 5 ln. 31-45); the clip is provided with a positioning device; the positioning device comprises a first positioning groove 35 provided on an inner side of the distal end of the first clip arm 31 (see fig. 2 and col. 5 ln. 31-45) and a first positioning protrusion 38 provided on an inner side of the second clip arm 32 and adapted to the first positioning groove 35 (see fig. 2 and col. 5 ln. 31-45).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Smith as modified to have the clip is provided with a positioning device; the positioning device comprises a first positioning groove provided on an inner side of the distal end of the first clip arm and a first positioning protrusion provided on an inner side of the second clip arm and adapted to the first positioning groove as taught by Cerwin, for the purpose of preventing lateral movement of the clip faces (see Cerwin col. 5 ln. 31-45).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Smith in view of Patel as applied to claim 5 above, and further in view of Mandel et al. (US 20020177863 A1) and Weadock (US 20030065345 A1).
Regarding claim 10, Smith as modified discloses the claimed invention substantially as claimed, as set forth above for claim 5. Smith as modified is silent regarding a surface of the ligating clip body is attached with an antibacterial layer, the antibacterial layer comprises an antibacterial agent, and a weight of the antibacterial agent is 0.1 wt% to 3 wt% of a total weight of the ligating clip body; or the ligating clip body is uniformly dispersed with an antibacterial agent, a weight of the antibacterial agent is 0.1 wt% to 10 wt% of a total weight of the ligating clip body.
However Mandel, in the same field of endeavor, teaches of a ligating clip comprising a surface of the ligating clip body is attached with an antibacterial layer, the antibacterial layer comprises an antibacterial agent (see [0028]-[0029], [0034]).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Smith as modified to have a surface of the ligating clip body is attached with an antibacterial layer, the antibacterial layer comprises an antibacterial agent as taught by Mandel, for the purpose of resist harboring infectious organisms and to kill infectious organisms (see Mandel [0028]).
Weadock, in the analogous art of coatings for medical devices, teaches a weight of the coating is 0.1 wt% to 3 wt% of a total weight of the medical device (see [0099]).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Smith as modified to have a weight of the coating is 0.1 wt% to 3 wt% of a total weight of the medical device as taught by Weadock, for the purpose of having a sufficient layer of coating to provide a pharmacological affect (see Weadock [0099]).
Claims 11 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Smith in view of Patel, Mandel, and Weadock as applied to claim 10 above, and further in view of O’Brien et al. (US 20080114469 A1).
Regarding claim 11, Smith as modified discloses the claimed invention substantially as claimed, as set forth above for claim 10. Smith as modified is silent regarding the antibacterial agent is one or more of a halogenated hydroxy ether, an acyloxy diphenyl ether, a vanillin, an ethyl vanillin compound, an acyl aniline, an imidazole, a thiazole, an isothiazolone derivative, a quaternary ammonium salt, a biguanide, and a phenol.
However O’Brien, in the analogous art of coatings for medical devices, teaches a coating with an antibacterial agent that is a biguanide (see [0047]).
Therefore, the substitution of one known antibacterial agent (biguanide as taught in O’Brien) for another (silver ions as taught in Smith as modified) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention since O’Brien teaches that a biguanide is a suitable antibacterial agent and the substitution of the biguanide as taught in O’Brien would have yielded predictable results, namely, a coating of Smith as modified that would resist and kill infectious organisms. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding claim 13, Smith as modified discloses the claimed invention substantially as claimed, as set forth above for claim 10. Smith as modified is silent regarding the antibacterial agent is one or more of a tetracycline hydrochloride, a neomycin sulfate, a chloramphenicol, a streptomycin sulfate, a penicillin potassium, an oxytetracycline hydrochloride, a gentamicin sulfate, a cephalothin sodium, a furanone, a rifamycin, a benzalkonium chloride, an oxacillin sodium, a dihydrostreptomycin sulfate, a carbenicillin disodium, and a nitrofurantoin sodium.
However O’Brien, in the analogous art of coatings for medical devices, teaches a coating with an antibacterial agent that is a chloramphenicol (see [0047]).
Therefore, the substitution of one known antibacterial agent (chloramphenicol as taught in O’Brien) for another (silver ions as taught in Smith as modified) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention since O’Brien teaches that a chloramphenicol is a suitable antibacterial agent and the substitution of the chloramphenicol as taught in O’Brien would have yielded predictable results, namely, a coating of Smith as modified that would resist and kill infectious organisms. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Smith in view of Patel, Mandel, and Weadock as applied to claim 10 above, and further in view of Hester et al. (US 20110112513 A1).
Regarding claim 12, Smith as modified discloses the claimed invention substantially as claimed, as set forth above for claim 10. Smith as modified further teaches the antibacterial agent is a silver ion (see Mandel [0034]).
Smith as modified is silent the silver ion is a nanoparticle.
However Hester, in the analogous art of coatings for medical devices, teaches silver ions used as antibacterial agents can be nanoparticles (see [0115]).
Therefore, the substitution of one known antibacterial agent (silver ion nanoparticle as taught in Hester) for another (silver ions as taught in Smith as modified) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention since the substitution of the silver ion nanoparticle as taught in Hester would have yielded predictable results, namely, a coating of Smith as modified that would resist and kill infectious organisms. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Smith in view of Patel, Mandel, and Weadock as applied to claim 10 above, and further in view of Deng et al. (US 20110152927 A1).
Regarding claim 14, Smith as modified discloses the claimed invention substantially as claimed, as set forth above for claim 10. Smith as modified is silent regarding the antibacterial agent is 2,4,4'-trichloro-2'-hydroxydiphenyl ether.
However Deng, in the analogous art of coatings for medical devices, teaches a coating with an antibacterial agent that is a 2,4,4'-trichloro-2'-hydroxydiphenyl ether (see [0020]).
Therefore, the substitution of one known antibacterial agent (2,4,4'-trichloro-2'-hydroxydiphenyl ether as taught in Deng) for another (silver ions as taught in Smith as modified) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention since Deng teaches that a 2,4,4'-trichloro-2'-hydroxydiphenyl ether is a suitable antibacterial agent and the substitution of the 2,4,4'-trichloro-2'-hydroxydiphenyl ether as taught in Deng would have yielded predictable results, namely, a coating of Smith as modified that would resist and kill infectious organisms. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE H SCHWIKER whose telephone number is (571)272-9503. The examiner can normally be reached Monday - Friday 7:30 am-4:00 pm.
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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 H SCHWIKER/Primary Examiner, Art Unit 3771