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
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in the French Republic on 9/19/2023. It is noted, however, that applicant has not filed a certified copy of the FR 2309922 application as required by 37 CFR 1.55.
Claim Objections
Claims 1, 5, 7, and 10 are objected to because of the following informalities:
Regarding claim 1, both instances of “said body” should be corrected to “said cylindrical body” for claim language consistency.
Regarding claim 5, “the thread” should be corrected to “the reinforcing thread” for claim language consistency.
Regarding claim 7, “pultruding at least one” should be corrected to “pultruding the at least one” for claim language consistency.
Regarding claim 10, the first instance of “an injection needle” should be corrected to “a needle” and the second instance of “an injection needle” should be corrected to “the needle” for claim language consistency. Additionally, the Examiner suggests including the limitation of a needle according to any of the preceding claims before a pump body equipped with an end fitting for adjusting an injection needle for clarity.
Appropriate correction is required.
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 thread comprising a rigidified portion and a flexible portion, subject matter of claim 5, must be shown or the feature(s) canceled from the claim(s). 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 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.
Claim 7 is 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 limitation “the polyaryletherketone polymer” in line 3. There is insufficient antecedent basis for this limitation in the claim.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 and 6-9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Clancy (US 20150099995 A1).
Regarding claim 1, Clancy discloses a needle (abstract) comprising a cylindrical body extending along a longitudinal axis (polymer body 100, abstract and [0025] & Fig. 1), at least one end of which is beveled ([0033]), said body being formed at least from a polymer ([0022]), said needle being characterized in that it comprises at least one reinforcing thread adapted to stiffen said body (wires 100, [0025]-[0026] & Fig. 1), said reinforcing thread being formed at least from a shape-memory material ([0028]).
Regarding claim 6, Clancy discloses all the limitations of claim 1. Clancy further discloses the needle characterized in that the reinforcing thread is arranged inside the needle body ([0025] & Fig. 1).
Regarding claim 7, Clancy discloses all the limitations of claim 6. The limitation of “is obtained according to a method comprising a first step of extruding the polyaryletherketone polymer simultaneously with a step of pultruding at least one reinforcing thread within said extruded polyaryletherketone polymer” is considered to be a product-by-process limitation. A product-by-process limitation adds no patentable distinction to the claim, and is unpatentable if the claimed product is the same as a product of the prior art. In the instant case, the claimed needle is the same as the needle of Clancy. Clancy discloses the “the polymer body may comprise polyimide, polyethylene, polyurethane, and any other polymer that can be extruded.”([0022]).
The applicant is advised that patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process MPEP 2113.
Regarding claim 8, Clancy discloses all the limitations of claim 6. The limitation of “is obtained according to a method comprising a first step of additive printing of the body from a spool of polyaryletherketone polymer thread around the at least one reinforcing thread” is considered to be a product-by-process limitation. A product-by-process limitation adds no patentable distinction to the claim, and is unpatentable if the claimed product is the same as a product of the prior art. In the instant case, the claimed needle is the same as the needle of Clancy.
The applicant is advised that patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process MPEP 2113.
Regarding claim 9, Clancy discloses all the limitations of claim 6. The limitation of “is obtained by a method comprising a first step of subtractive printing of the body in a polyaryletherketone polymer block wherein the at least one reinforcing thread is arranged” is considered to be a product-by-process limitation. A product-by-process limitation adds no patentable distinction to the claim, and is unpatentable if the claimed product is the same as a product of the prior art. In the instant case, the claimed needle is the same as the needle of Clancy.
The applicant is advised that patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process MPEP 2113.
Claim(s) 1, 3-4, and 6-9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Geliebter (US 20070179455 A1).
Regarding claim 1, Geliebter discloses a needle (abstract) comprising a cylindrical body extending along a longitudinal axis (barrel, [002] & Fig. 1), at least one end of which is beveled ([0024]-[0025] & Fig. 1), said body being formed at least from a polymer ([0027]), said needle being characterized in that it comprises at least one reinforcing thread adapted to stiffen said body (“the transparent or translucent portion is molded around or otherwise attached to or supported by a scaffold, e.g., of metal. Exemplary shapes of scaffolds include a spiral, a mesh, e.g., random, square grid, or hexagonal, or other continuous, near-continuous, or non-continuous patterns, e.g., multiple vertical or horizontal strands/bars/threads, crisscross, wavy, or zig-zag pattern.”, [0030]; see [0033] & Fig. 2; “By "scaffold" is meant any supporting structure”, [0017]; the scaffold is configured to support, or stiffen, the barrel), said reinforcing thread being formed at least from a shape-memory material (“the transparent or translucent portion is molded around or otherwise attached to or supported by a scaffold, e.g., of metal. “, [0030]; “In addition to the transparent or translucent portion, needles may contain other materials. Suitable materials include metals (e.g., stainless steel, titanium, chrome, shape memory alloy, e.g., nitinol, platinum, or nickel), ceramics, and opaque plastics.”, [0028]).
Regarding claim 3, Geliebter discloses all the limitations of claim 1. Geliebter further discloses the needle characterized in that the reinforcing thread has at least one portion in the form of a spiral about said longitudinal axis ([0030] & Fig. 2).
Regarding claim 4, Geliebter discloses all the limitations of claim 1. Geliebter further discloses the needle characterized in that it comprises a plurality of reinforcing threads forming a mesh (“the transparent or translucent portion is molded around or otherwise attached to or supported by a scaffold, e.g., of metal. Exemplary shapes of scaffolds include a spiral, a mesh…”, [0030]).
Regarding claim 6, Geliebter discloses all the limitations of claim 1. Geliebter further discloses the needle characterized in that the reinforcing thread is arranged inside the needle body ([0030] & Fig. 2).
Regarding claim 7, Geliebter discloses all the limitations of claim 6. The limitation of “is obtained according to a method comprising a first step of extruding the polyaryletherketone polymer simultaneously with a step of pultruding at least one reinforcing thread within said extruded polyaryletherketone polymer” is considered to be a product-by-process limitation. A product-by-process limitation adds no patentable distinction to the claim, and is unpatentable if the claimed product is the same as a product of the prior art. In the instant case, the claimed needle is the same as the needle of Geliebter. Geliebter discloses the “transparent, translucent, or other portion of a needle may be formed by any suitable method. Exemplary methods include molding, photocuring, and machining” ([0030]).
The applicant is advised that patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process MPEP 2113.
Regarding claim 8, Geliebter discloses all the limitations of claim 6. The limitation of “is obtained according to a method comprising a first step of additive printing of the body from a spool of polyaryletherketone polymer thread around the at least one reinforcing thread” is considered to be a product-by-process limitation. A product-by-process limitation adds no patentable distinction to the claim, and is unpatentable if the claimed product is the same as a product of the prior art. In the instant case, the claimed needle is the same as the needle of Geliebter. Geliebter discloses the “transparent, translucent, or other portion of a needle may be formed by any suitable method. Exemplary methods include molding, photocuring, and machining” ([0030]).
The applicant is advised that patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process MPEP 2113.
Regarding claim 9, Geliebter discloses all the limitations of claim 6. The limitation of “is obtained by a method comprising a first step of subtractive printing of the body in a polyaryletherketone polymer block wherein the at least one reinforcing thread is arranged” is considered to be a product-by-process limitation. A product-by-process limitation adds no patentable distinction to the claim, and is unpatentable if the claimed product is the same as a product of the prior art. In the instant case, the claimed needle is the same as the needle of Geliebter. Geliebter discloses the “transparent, translucent, or other portion of a needle may be formed by any suitable method. Exemplary methods include molding, photocuring, and machining” ([0030]).
The applicant is advised that patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process MPEP 2113.
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.
Claim(s) 1-3 and 5-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zambaux (US 20070073249 A1) in view of Zhao (US 20230364329 A1).
Regarding claims 1-3, Zambaux discloses a needle (abstract) comprising a cylindrical body extending along a longitudinal axis (hollow cylindrical body 1, [0040] & Fig. 1), at least one end of which is beveled ([0041] & Fig. 1), said body being formed at least from a polymer, characterized in that the polymer is oxy-1,4-phenylene-oxy-1,4-phenylene-carbonyl-1 ,4-phenylene (abstract and [0043]), said needle being characterized in that it comprises at least one reinforcing thread (reinforcement wires 3, 4, and 5, [0051] & Fig. 1-3) adapted to stiffen said body (reinforcement wires configured to reinforce the needle, see [0051] and [0061]).
However, Zambaux fails to explicitly disclose said reinforcing thread being formed at least from a shape-memory material, and the needle characterized in that the reinforcing thread has at least one portion in the form of a spiral about said longitudinal axis.
However, Zhao teaches a needle (abstract) comprising reinforcing thread being formed at least from a shape-memory material, and the needle characterized in that the reinforcing thread has at least one portion in the form of a spiral about said longitudinal axis (instrument 920 contains “activatable elements that may be activated to cause the instrument to become more rigid. The activatable elements take the form of shape memory alloy (SMA) wires… In this instrument 920, A SMA wire 922 is helically wrapped over the length of the cylindrical body 924.”, [0055]-[0058] & Fig. 9A-9B).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the reinforcing threads of Zambaux with Zhao to include the reinforcing thread being formed at least from a shape-memory material, and the needle characterized in that the reinforcing thread has at least one portion in the form of a spiral about said longitudinal axis, since Zhao teaches a shape-memory material to be an art effective material for threads configured to stiffen the body of a needle and would yield predictable results pertaining to increased needle body rigidity ([0036]). The modification would provide structure to actively control the rigidity, or stiffness, of the needle ([0055]-[0058]). Zhao teaches a helically wrapped SMA wire over the length of the needle body to be an equivalent embodiment to pairs of SMA wires 902 “distributed evenly around the circumference and length of the exterior of the instrument” (see [0055] & Fig. 9A of Zhao), a configuration synonymous to the longitudinal reinforcing wires of Zambaux.
As combined, reinforcing wires 3, 4, and 5 of Zambaux would be modified to substantially adopt the configuration and properties of wire(s) 922 of Zhao.
Regarding claim 5, Zambaux, as modified, discloses all the limitations of claim 1. Zambaux, as modified, further disclose the needle characterized in that the thread comprises a rigidified portion (as modified, wire 922 is configured to stiffen upon application of voltage, [0055]-[0058] of Zhao) but fails to explicitly disclose a flexible portion.
However, Zhao further teaches the needle (abstract) characterized in that the thread comprises a rigidified portion and a flexible portion (instrument 900 comprises a SMA wire(s) 922 and shunts 904, [0056]-[0058] & Fig. 9A-9B; “An electrical shunt 904 may be provided for each pair of SMA wires. The shape memory alloy wires 902 stiffen upon the application of a sufficient voltage to the SMA wires 902. The electrical shunts 904 may be made of non-shape memory alloy so that they do not stiffen upon application of electricity to the wires 902.”, [0055]; “electrical shunts 904 may be formed if warranted, depending on the configuration of the SMA wire(s) 902, 922.”, [0057]; shunts 904 may be provided with wire(s) 922).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the reinforcing thread of Zambaux with Zhao to include a flexible portion since such a modification would provide structure to divert current and prevent overcurrent. As modified, shunt 904 is being interpreted as the flexible portion as shunts 904 do not stiffen upon application of electricity.
Regarding claim 6, Zambaux, as modified, discloses all the limitations of claim 1. Zambaux further discloses the needle characterized in that the reinforcing thread is arranged inside the needle body (the reinforcing wires “embedded in the walls made of polyarylethercetone polymer of the formula (1)”, [0052] and claim 1 of Zambaux; “The SMA wire(s) 902, 922 may be embedded in or molded in the material of the cylindrical body 908, 924.”, [0057] of Zhao).
Regarding claim 7, Zambaux, as modified, discloses all the limitations of claim 6. The limitation of “is obtained according to a method comprising a first step of extruding the polyaryletherketone polymer simultaneously with a step of pultruding at least one reinforcing thread within said extruded polyaryletherketone polymer” is considered to be a product-by-process limitation. A product-by-process limitation adds no patentable distinction to the claim, and is unpatentable if the claimed product is the same as a product of the prior art. In the instant case, the claimed needle is the same as the needle of Zambaux. Zambaux discloses the “needle, the syringe and the connector of the invention may be made by any process known to a specialist, such as a process of injection molding, an extrusion process or an extrusion under tension process called the pultrusion process whereby the reinforcement wires are held under tension during their passage, and that of the polymer matrix, in the extrusion die.”([0079]).
The applicant is advised that patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process MPEP 2113.
Regarding claim 8, Zambaux, as modified, discloses all the limitations of claim 6. The limitation of “is obtained according to a method comprising a first step of additive printing of the body from a spool of polyaryletherketone polymer thread around the at least one reinforcing thread” is considered to be a product-by-process limitation. A product-by-process limitation adds no patentable distinction to the claim, and is unpatentable if the claimed product is the same as a product of the prior art. In the instant case, the claimed needle is the same as the needle of Zambaux.
The applicant is advised that patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process MPEP 2113.
Regarding claim 9, Zambaux, as modified, discloses all the limitations of claim 6. The limitation of “is obtained by a method comprising a first step of subtractive printing of the body in a polyaryletherketone polymer block wherein the at least one reinforcing thread is arranged” is considered to be a product-by-process limitation. A product-by-process limitation adds no patentable distinction to the claim, and is unpatentable if the claimed product is the same as a product of the prior art. In the instant case, the claimed needle is the same as the needle of Zambaux.
The applicant is advised that patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process MPEP 2113.
Regarding claim 10, Zambaux, as modified, discloses an injection syringe comprising:
- A plunger;
- A pump body equipped with an end fitting for adjusting an injection needle (“Another object of the invention is an injection syringe made up of a piston (considered as the recited plunger above), a pump body equipped with an end-fitting for fitting of an injection needle, characterized in that it is equipped with a needle according to the invention.”, [0027] and [0059] and claim 8 & Fig. 4);
- An injection needle according to any of the preceding claims (see claim 1 above).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARTIN ADAM RADOMSKI whose telephone number is (571)272-2703. The examiner can normally be reached Monday-Friday: 7:30-4:30 CT.
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, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARTIN A RADOMSKI/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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