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 .
Information Disclosure Statement
The information disclosure statement(s) filed on the record are in compliance with the content requirements of 37 CFR 1.97 and 37 CFR 1.98 and have been considered.
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 subject matter of claims 6-9 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 Objections
Claim 6 is objected to for containing a grammatical error: “the first group of slots are [sic] aligned on the same side of the shaft, and the second group of slots are [sic] aligned on an opposing side of the shaft.”
The claim should be corrected to recite “the first group of slots is aligned on the same side of the shaft, and the second group of slots is aligned on an opposing side of the shaft.”
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, 7 and 8 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.
Regarding claim 6, the limitation “the first group of slots are aligned on the same side of the shaft, and the second group of slots are aligned on an opposing side of the shaft” is unclear because only one first group of slots, and one second group of slots, has been claimed. Therefore, it is not known with what, specifically, the first group of slots is aligned; and it is also not known with what, specifically, the second group of slots is aligned.
Regarding claim 7, the limitation “the first group of slots are spaced apart from one another” and “the second group of slots are spaced apart from one another at regular intervals” is unclear because only one first group of slots, and one second group of slots, has been claimed. Therefore, it is not clear how “the first group of slots” could be “spaced apart from one another” and “the second group of slots” could be “spaced apart from one another”.
Regarding claim 8, the limitation “each of the first group of slots is diametrically opposed to a corresponding slot of the second group of slots” is unclear because only one first group of slots has been claimed, and so it is not clear what is meant by “each of the first group of slots”.
For examination purposes, claim 6 will be interpreted to require that the first group of slots comprises at least two slots, every slot of the first group of slots being aligned, and the second group of slots comprises at least two slots, every slot of the second group of slots being aligned.
For examination purposes, claim 7 will be interpreted to require that the first group of slots comprises at least two slots, each slot of the first group of slots being spaced at a regular interval, and the second group of slots comprises at least two slots, each slot of the second group of slots being spaced at a regular interval.
For examination purposes, claim 8 will be interpreted to require that the first group of slots consists of two slots diametrically opposed to one another; and the second group of slots consists of two slots diametrically opposed to one another.
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.
Claims 1-4 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Silverman et al (U.S. Pat. 5,478,328, hereinafter “Silverman”).
Regarding claim 1, Silverman discloses an injection needle 1 (see Fig. 3p), comprising:
a shaft extending between a hub end (adjacent to a hub/shaft junction shown in Fig. 9a), an injection end (adjacent to the beveled end 2; see Fig. 3p), and a lumen (combination of passages 4 and 16; see Fig. 3p) forming an opening (see “opening” in annotated Fig. 3p, below) that extends through the shaft from the hub end to the injection end (see Fig. 3p);
the injection end includes at least one bevel (the tapered end 2) having a point and a heel (see Fig. 3p), with the opening formed by the lumen passing through the bevel (see Fig. 3p); and
at least one slot formed within the shaft proximal to the injection end (see “slots” 1, 2 and 3 in annotated Fig. 3p, below).
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Silverman, Fig.3p, annotated
Regarding claims 2 and 3, Silverman discloses that the at least one slot includes a first slot (“slot 1” in annotated Fig. 3p) and a second slot (“slot 2” in annotated Fig. 3p), with the first and second slots being located on different sides of the shaft, and as per claim 3, wherein the first and second slots are diametrically opposed (see annotated Fig. 3p).
Regarding claim 4, Silverman disclose that the at least one slot is elliptical (see “slots” 1, 2 and 3, all of which are elliptical).
Regarding claim 10, Silverman discloses that the at least one slot is formed on the shaft at a location where a circumference of the shaft includes a portion of the bevel (see “slot 3” in annotated Fig. 3p).
Claims 1-3 and 5-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by De Sausmarez Lintell (U.S. Pat. 8,747,365, hereinafter “De Sausmarez Lintell”).
Regarding claim 1, De Sausmarez Lintell discloses an injection needle (see Abstract disclosing a “needle cannula”), comprising:
a shaft 400 (shown in Figs. 4a-4b) extending between a hub end (adjacent to a module 500 shown in Fig. 5), an injection end (406 in Fig. 4a), and a lumen (shown in Figs. 4a-3b) forming an opening 404 (see Fig. 4a) that extends through the shaft from the hub end to the injection end (see Fig. 4a);
the injection end includes at least one bevel (see Fig. 4a) having a point and a heel (see Fig. 4a), with the opening formed by the lumen passing through the bevel (see Fig. 4a); and
at least one slot 408, 410, 412 and 414 formed within the shaft proximal to the injection end (see Fig. 4a).
Regarding claim 2, De Sausmarez Lintell discloses that the at least one slot includes a first slot 412 (see Fig. 4a) and a second slot 408 (see Fig. 4a), with the first and second slots being located on different sides of the shaft.
Regarding claim 3, De Sausmarez Lintell discloses that the first and second slots 412 and 408 are diametrically opposed (see Fig. 4a).
Regarding claim 5, De Sausmarez Lintell discloses that the at least one slot includes a first group of slots (consisting of slots 412 and 414) formed on one side of the shaft and a second group of slots (consisting of slots 408 and 410) formed on an opposing side of the shaft (see Fig. 4a).
Regarding claim 6 (see interpretation above under the 35 U.S.C. 112(b) rejection), De Sausmarez Lintell discloses that every slot in the first group of slots is aligned on the same side of the shaft (slots 412 and 414 are on the same side of the shaft and aligned parallel to the longitudinal axis of the needle, as shown in Fig. 4a), and every slot in the second group of slots are aligned on an opposing side of the shaft (slots 408 and 410 are on the same side of the shaft and aligned parallel to the longitudinal axis of the needle, as shown in Fig. 4a).
Regarding claim 7 (see interpretation above under the 35 U.S.C. 112(b) rejection), De Sausmarez Lintell discloses the that first group of slots comprises at least two slots, each slot of the first group of slots being spaced at a regular interval slots 412 and 414 are evenly spaced from one another), and the second group of slots comprises at least two slots, each slot of the second group of slots being spaced at a regular interval (slots 408 and 410 are evenly spaced from one another).
Regarding claim 8 (see interpretation above under the 35 U.S.C. 112(b) rejection), De Sausmarez Lintell discloses an alternative in which the first group of slots are slots 412 and 408 and are diametrically opposed to one another; and the second group of slots are 414 and 410 and are diametrically opposed to one another.
Regarding claim 9, De Sausmarez Lintell discloses that the first group of slots (slots 412 and 414) and the second group of slots (slots 408 and 410) are formed in an “alternating pattern” on opposing sides of the shaft (i.e., the first group of slots opposes the second group of slots, and the claim does not require how many times the alternating pattern must be repeated).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See Notice of References Cited.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SCOTT J MEDWAY whose telephone number is (571)270-3656. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 PM.
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/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783 09/30/2025