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 .
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 “the silicone and the retention plug do not come into substantial contact with one another and the retention plug has improved adherence to the non-siliconized surface of the needle bore compared to the surface being coated with silicone” of claims 1 and 27 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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-9, 11-23, 25 and 27 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Applicant has not pointed out where the amended claims 1 and 27 is supported, nor does there appear to be a written description of the claim limitation “the silicone and the retention plug do not come into substantial contact with one another and the retention plug has improved adherence to the non-siliconized surface of the needle bore compared to the surface being coated with silicone” in the application as filed. The specification does not indicate that the “silicone” does not come into contact with the retention plug, and the figures do not show the structures in a complete manner to indicate that the “silicone” and the “retention plug” do not come into “substantial contact with one another”. This limitation was not found in the original claims. For these reasons the amendment is not supported by the original disclosure and is rejected as new matter.
Claims 1-9, 11-23, 25 and 27 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
MPEP 2164.01 refers to In re Wands in which it was stated that “The test of enablement is whether one reasonably skilled in the art could make or use the invention from the disclosures in the patent coupled with information known in the art without undue experimentation”. Furthermore, MPEP 2164.04 states “In order to make a rejection, the examiner has the initial burden to establish a reasonable basis to question the enablement provided for the claimed invention. In re Wright”.
The examiner has considered the factors noted in In re Wands such as the breadth of the claims, the state of the prior art, and the level of ordinary skill in the art, and has found that there is a reasonable basis to question the enablement of the invention as required by claims 1 and 27 since the instant specification lacks significant disclosure about how “the silicone and the retention plug do not come into substantial contact with one another”. While instant paragraph [0103-0104] describes that the retention plug and silicone do not come into ‘substantial contact with one another’ it is unclear what the metes and bounds of ‘substantial contact’ are. It would take a level of undue experimentation to know what level of od ‘contact would be considered within the bounds of ‘do not come into substantial contact’. Especially since [0103] teaches that spray coating is one method of applying the silicone to the needle to avoid the contact of the silicone and the retention plug, but then in [0104] there is disclosure that the silicone may be applied to both an external surface and an internal surface of the bevel. It is unclear what level of application would still provide an ‘unsubstantial amount of contact’ between the silicone and the retention plug’ when there are multiple application methods being disclosed.
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 1-9, 11-23, 25 and 27 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 1 recites “the lumen is substantially non-siliconized” in lines 13-14. The term “substantially” is indefinite. The term “substantially” is not defined in the claim, and there is no definition for the term “substantially” in the specification. The term “substantially” makes it unclear the degree how much silicone could be in the lumen before it is considered “substantially non-siliconized”. One of ordinary skill in the art would not be reasonably apprised for the scope of the invention.
Claims 1 and 27 recite “the silicone” line 14 and line 17 (respectively). There is a lack of antecedent basis for this limitation. It is unclear if “the silicone” is referring to a separate silicone component, the siliconized external surface or the non-siliconized lumen.
Claims 1 and 27 recite “the silicone and the retention plug do not come into substantial contact with one another”. The term “substantial” is indefinite. The term “substantial” is not defined in the claim, and there is no definition for the term “substantial” in the specification. The term “substantially” makes it unclear whether the silicone comes into contact with the retention plug or if the silicone does not come into contact with the retention plug. One of ordinary skill in the art would not be reasonably apprised for the scope of the invention.
Claims 2-9, 11-23, 25 are rejected due to their dependency on claim 1.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 27 have been considered but are moot because the new ground of rejection (112 rejections) take into consideration the amendments filed 5/18/2026.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Lubock (US 20030233101) teaches a plugged distal tip delivery tube for marker placement.
Eaton (US 20140221970) teaches an external silicone needle sleeve attached to the device.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NEERAJA GOLLAMUDI whose telephone number is (571)272-6449. The examiner can normally be reached Mon-Fri 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NEERAJA GOLLAMUDI/Examiner, Art Unit 3783
/WESLEY G HARRIS/Examiner, Art Unit 3783
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