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 .
Claims 16-35 are pending.
Claims 1-15 have been canceled by the applicants.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 16-25, 30, and 32-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over MATSUTANI (JPS63-294845A, see IDS) in view of FAULKNER (US 2003/0094735 A1).
Re 16, MATSUTANI teaches of a process for manufacturing a surgical assembly (suture needle, see abstract, see Figs. 1-5 ), the process (see Figs. 6-10) comprising the step of forming a third element (resin layer 6, see page [0001] of english translated section, page 1) on a distal end portion of a first element and a proximal end portion of a second element (see first and second elements that corresponds to sutural needle main body 2 having an end being projection 23 and thread main body 3 with an end 31, see Figs. 6, 7, 9 and 10) by injection overmolding (see Fig. 7 of the manufacturing process which is via injection molding, with resin that is injected from runner 54 to the cavity 53 between mold dies 51, 52, see English translation section, pages 1 and 2) such that the distal end portion of the first element and the proximal end portion of the second element is joined to each other via the third element (see Figs. 5-10), and the third element (6) covers the distal end portion of the first element and the proximal end portion of the second element and is attached to the distal end portion of the first element and the proximal end portion of the second element (see Fig. 7).
Wherein, the MATSUTANI reference does not teach of an ultrasonic injection overmolding, instead MATSUTANI only teaches of injection overmolding.
Wherein, the teaching of FAULKNER includes teaching of joining of polymer to a solid material to produce a solid article, see [0007], application in ultrasonic injection molding method, see [0014, 0021], Fig. 1. This is applicable to the teaching of overmolding in MATSUTANI of molding a polymer to overmold to form a solid article. Further, FAULKNER teaches of the utilization of ultrasonic energy to improve bonding particularly for the interface between the solid material and liquid polymeric material, [0007].
It would have been obvious for one of ordinary skill in the art to have modified the injection overmolding process of MATSUTANI with ultrasonic injection as taught by FAULKNER whereby it allows for improved joining to form a solid article, see FAULKNER [0007].
Re 17 (upon 16), wherein the step of forming the third element is carried out by applying a molten material transversally with respect to a longitudinal axis L of the first element on the distal end portion of the first element such that the distal end portion of the first element is drawn in a direction of the second element, in particular such that either the distal end portion of the first element and the proximal end portion of the second element abut against each other or are spaced apart from each other at a defined distance.
Wherein, see teaching by MATSUTANI of Fig. 7 of the molding, and see arrangement of the elements with the ends abutting each other, see Figs. 6 and 9.
Regarding claims 18-23, FAULKNER teaches in [0037] of parameters of the ultrasonic energy application, which is relevant to the teaching regarding the injection overmolding of MATSUTANI, particularly in regards to the parameters of the ultrasonic energy provided as it can depend upon the size and composition of the liquid polymeric material and solid material used to form the article.
Re 18 (upon 16), wherein the ultrasonic injection overmolding is carried out by applying an ultrasonic frequency of 20 kHz to 60 kHz.
See in [0037] and claim 8 of FAULKNER, of frequency between 10 and 100 kHz, and especially 20-50 kHz.
Re 19 (upon 16), wherein the ultrasonic injection overmolding is carried out by applying an ultrasonic frequency of 25 kHz to 35 kHz.
See in [0037] and claim 8 of FAULKNER, of frequency between 10 and 100 kHz, and especially 20-50 kHz.
Re 20 (upon 16), wherein the ultrasonic injection overmolding is carried out by applying an ultrasonic frequency of 29 kHz to 31 kHz.
See in [0037] and claim 8 of FAULKNER, of frequency between 10 and 100 kHz, and especially 20-50 kHz.
Re 21 (upon 16), wherein the ultrasonic injection overmolding is carried out over a time period of 0.1 s to 30 s.
See in [0037] and claim 8 of FAULKNER, of duration of 0.5-60 seconds, and wherein the time can be adjusted based upon the size and material.
Re 22 (upon 16), wherein the ultrasonic injection overmolding is carried out over a time period of 1 s to 10 s.
See in [0037] and claim 8 of FAULKNER, of duration of 0.5-60 seconds, and wherein the time can be adjusted based upon the size and material.
Re 23 (upon 16), wherein the ultrasonic injection overmolding is carried out over a time period of 4 s to 6 s.
See in [0037] and claim 8 of FAULKNER, of duration of 0.5-60 seconds, and wherein the time can be adjusted based upon the size and material.
Re 24 (upon 16), wherein the third element comprises a meltable material.
See teaching by MATSUTANI of molten resin that enters through runner 54 into the cavity 53 between mold dies 51, 52 to form the resin body 6, see Fig. 7.
Re 25 (upon 24), wherein the meltable material is an injection-moldable material.
See MATSUTANI teaching of the injection molding of the resin, see Fig. 7.
Re 30 (upon 16), wherein the distal end portion of the first element and the proximal end portion of the second element directly abut against each other.
See MATSUTANI, see Figs. 6, 7, and 9, see abutment of elements 22, 31.
Re 32 (upon 16), wherein the third element comprises a mantle.
It would have been obvious for one of ordinary skill in the art to have recognize the teaching by MATSUTANI of the third element as being a mantle in surrounding the elements.
Re 33 (upon 16), wherein at least the distal end portion of the first element comprises a heat labile material.
See MATSUTANI teaches of heat shrinkable resin or UV shrinkable resin being used, see also teaching of the protrusions of the thread body that are made of heat-shrinkable material, see page 3 of English translation document from IDS.
Claim(s) 29 and 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over MATSUTANI in view of FAULKNER as applied to claim 16 above, and further in view of BOGART (US 8517073 B2).
Re 29 (upon 16), wherein the proximal end portion of the second element has a first cross-section, and the distal end portion of the first element has a second cross-section, the first cross-section being equal to or up to 30 % larger than the second cross-section.
Wherein, this is seen as change in size of the elements in MATSUTANI. Further, as seen in BOGART, see teaching in Fig. 2A, see elements 10, 30 with the different sized cross-sections, see also Col. 3, line 60 to Col. 4, line 11. While the BOGART reference does not of the particular specific cross section differences, the differing sizes and of the variable teaching allows for one skilled in the art to recognize in change of size of the elements for the desired cross-section difference of the desired product shape.
It would have been obvious for one of ordinary skill in the art to have further modify the process of the modified MATSUTANI with the cross section differences of the elements as taught by BOGART as a known variation of the construction of the devices, see KSR rationale, MPEP2143, as combining prior art elements according to known methods to yield predictable results.
Re 31 (upon 16), wherein the distal end portion of the first element and the proximal end portion of the second element are not directly joined to each other via the third element and the third element is additionally formed between the distal end portion of the first element and the proximal end portion of the second element.
Wherein, MATSUTANI does not specifically teach of the elements not directly joined. However, this manner of arrangement between the two elements in an overmolded structure is known in the art, see teaching by BOGART, which is in the same field of endeavor of overmolded medical devices which would be applicable to the MATSUTANI reference. Here, the teaching can be seen in BOGART, see Figs. 2, 2A, 2B, 2C, 2E, see elements 10, 30 and the space between the ends and in which the third element would be formed between the ends, see Col. 3, line 34 to Col. 4, line 65.
It would have been obvious for one of ordinary skill in the art to have further modify the process of the modified MATSUTANI with the relation between the ends of the elements as taught by BOGART as a known variation of the construction of the devices, see KSR rationale, MPEP2143, as combining prior art elements according to known methods to yield predictable results.
Claim(s) 26-28 and 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over MATSUTANI in view of FAULKNER as applied to claims 25 and 33 above, and further in view of OPFERMANN (US 2020/0121360 A1).
Re 26 (upon 25), wherein the injection-moldable material is selected from the group consisting of polyolefins, polyvinyl alcohols, polyamides, polyimides, polyesters, polyurethanes, polyhydroxyalkanoates, copolymers of at least two of the afore-said polymers, and mixtures of at least two of the afore-said polymers.
MATSUTANI teaches of molten resin, which is a broad teaching of the injectable moldable material for plastic resin.
Wherein, in the tools used in the surgery arts, the materials used to form devices are known as seen in OPFERMANN with teaching of a variety of materials that include polyamide, polyimide, polyurethane, that can be formed in various techniques including the use of injection molding, see [0109].
It would have been obvious for one of ordinary skill in the art to have modified the process of MATSUTANI with the particular use of resin materials used in injection molding as taught by OPFERMANN as known materials used in forming surgical devices, see KSR rationale, MPEP2143, as combining prior art elements according to known methods to yield predictable results.
Re 27 (upon 26), wherein the injection-moldable material comprises a thermoplastic polyurethane.
See teaching by OPFERMANN [0109] of polyurethane.
Re 28 (upon 26), wherein the injection-moldable material comprises a synthetic polymer.
See teaching by OPFERMANN [0109] of various resins that encompasses the claimed synthetic polymer.
Re 34 (upon 33), see limitation similar to that of claim 26.
Claim(s) 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over MATSUTANI in view of FAULKNER as applied to claim 16 above, and further in view of YOSHIMI (US 2019/0059882 A1).
Re 35 (upon 16), wherein MATSUTANI does not specifically teach of at least the proximal end portion of the second element comprises a metallic material.
See teaching by MATSUTANI that includes use of suture needle body for one end, and in which one skilled in the art would recognize the use of suture needles can be made from metallic material.
Further, YOSHIMI teaches of a known suture needle configuration, see Fig. 1, see suture needle 1 with suture thread 90 that are connected via connector 2, see also [0035], further, that the needle body can be of a metal or shape memory alloy, see [0009-0012]. Whereby, it is known in the art for the needle body to be made from a metallic material, and thus it would have been obvious for one of ordinary skill in the art to have further modify the process of the modified MATSUTANI with the metallic material as taught by YOSHIMI as a known material for the suture needle body, see KSR rationale, MPEP2143, as combining prior art elements according to known methods to yield predictable results.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See attached PTO-892 form, of particular note:
HONMA (US 2008/0143006 A1) teaches in [0014] regarding injection that utilizes ultrasonic vibrator at 1 kHz to 10 kHz to enhance the flow of resin.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMMANUEL S LUK whose telephone number is (571)272-1134. The examiner can normally be reached Monday-Friday 9 to 5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Xiao S Zhao can be reached at 571-270-5343. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EMMANUEL S LUK/Primary Examiner, Art Unit 1744
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