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 because
Reference numerals in figures 1A-7 are too small. Numbers, letters, and reference characters must measure at least .32 cm. (1/8 inch) in height.
See MPEP 608.02(V), 37 CFR 1.84(p)(3).
Character of lines and shades in Figures 1A-7 are poor. See MPEP 608.02(V), 37 CFR 1.84(l).
(l) Character of lines, numbers, and letters. All drawings must be made by a process which will give them satisfactory reproduction characteristics. Every line, number, and letter must be durable, clean, black (except for color drawings), sufficiently dense and dark, and uniformly thick and well-defined. The weight of all lines and letters must be heavy enough to permit adequate reproduction. This requirement applies to all lines however fine, to shading, and to lines representing cut surfaces in sectional views. Lines and strokes of different thicknesses may be used in the same drawing where different thicknesses have a different meaning.
In figures, 1a-2c, 4a-6a, and 7, the longitudinal axis A is too thick that the needle 4 cannot be distinguished in the drawings.
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.
Specification
The abstract of the disclosure is objected to because “Fig. 1A” in the last line of the abstract should be deleted. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The incorporation by reference of the international patent application PCT/EP2021/082896 filed 11/24/2021 and of the Belgium patent application BE2020/5851 filed 11/25/2020 is ineffective as it was added on the date of entry into the national phase, which is after the filing date of the instant application. The filing date of this national stage application is the filing date of associated PCT, in this case 11/24/2021, see MPEP 1893.03(b). Therefore, the specification amendment of 11/25/2020 to include the incorporation by reference is new matter, per MPEP 608.01(p).
Information Disclosure Statement
The information disclosure statement filed 9/12/2025 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because there is no translation for JP 3119859, JP 49103487, and KR 20170046017. It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
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 3, 4, 8-10, 14-16, 19, 21, 23, 29, and 31 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.
Claims 3, 4, 8, 23, 29, and 31 are indefinite because the scope of the claims is not clear. The claims include “preferably” and/or further “in particular” which encompasses a broad limitation followed by the narrow limitation making the scope unclear what applicant intends to claim. The claims must be amended to the broad or narrow limitation. For example, in claim 3 applicant set forth the broad limitation “includes a sleeve” followed by the narrow limitation “preferably a tubular sleeve device”. The claim must be amended to the broad or narrow limitation.
In claims 14 and 15, there is no antecedent basis for “the sleeve”.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 32 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 32 depends from canceled claim 28. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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, 2, 4, 6, 8, 13, 19, 21, 23, 25, 27, 32 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Raines et al (US 4014797 A).
Regarding claim 1, Raines discloses a filter needle comprising:
a hub 10 having a proximal end arranged for removable connection to a syringe body, and having a distal end in which a needle 14 is mounted,
the hub provided with a channel (fig 2) between the proximal end and the distal end, for when the syringe body is connected, establishing a fluid connection between the syringe body and the needle,
wherein a filter unit 32,24 is mounted in the channel of the hub, the filter unit further including a sheet of woven filter material 32 (col 4, lines 14-18), wherein the sheet of woven filter material is fixated to a surrounding material, wherein the surrounding material protrudes through the sheet of woven filter material (col 4, lines 1-13).
Regarding claim 2, wherein the surrounding material is a hub material (col 4, lines 1-13).
Regarding claim 4, wherein an outer edge of the sheet of woven filter material is fixated to the surrounding material (col 4, lines 1-2), wherein the surrounding material protrudes through the meshes of the outer edge of the sheet of filter material.
Regarding claim 6, wherein the sheet of woven filter material is disc-shaped (fig 4).
Regarding claim 8, wherein the surrounding material, is of a thermoplastic material such as polypropylene (col. 4 lines 14-15).
Regarding claim 13, wherein the surrounding material is integrated to the sheet of woven filter material by locally melting of the surrounding material (col. 4 lines 1-2).
Regarding claim 19, wherein the filter unit is fitted into the channel of the hub by means of press-fitting (col 4 lines 59-68).
Regarding claim 21, wherein the filter unit is mounted in the channel of the hub adjacent the distal end of the hub towards a needle opening (col 4 lines 59-68).
Regarding claim 23, wherein in the channel of the hub a locking element 26,27 is provided for locking the filter unit in the channel.
Regarding claim 25, wherein a mesh size of the woven filter material is between 2 pm and 150 m (57; fig 9; (col. 5 lines 41-43).
Regarding claim 27, Raines discloses an assembly of a needle hub 10 having a proximal end arranged for removable connection to a syringe body, and having a distal end to which a needle 14 is mounted, the hub provided with a channel (fig 2) between the proximal end and the distal end, for when the syringe body is connected, establishing a fluid connection between the syringe body and the needle, wherein in the channel a filter unit 32,24 is provided,
wherein the filter unit comprises a tubular sleeve 24 and a sheet of woven filter material 32 fixated in a tubular sleeve wherein material of the sleeve protrudes through an outer edge of the sheet of wove filter material, wherein the filter unit is positioned in the channel (fig 2).
Regarding claim 32, Raines discloses a kit of a filter unit and of a needle hub (fig 1) having a proximal end arranged for removable connection to a syringe body, and having a distal end to which a needle 14 is mounted, the hub provided with a channel (fig 2) between the proximal end and the distal end.
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.
Claims 3, and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Raines et al.
Regarding claim 3, Raines discloses the filter unit 24,32 further includes a sleeve 24 wherein the surrounding material is a material of the sleeve. The surrounding material at 31 (fig 2) of the hub is made out of plastic such as polypropylene. The insert 24 is made out of plastic such as nylon or the like (col 4, lines 14-18).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Raines by providing both elements (sleeve and hub surrounding material) as being the same plastic material since it is deemed matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results.
Regarding claims 9-10, Raines discloses the surrounding hub material being a thermoplastic polypropylene. However, it is moot to the thermoplastic having a Shore A hardness of between 85 and 105, measured according to standard ISO 868; and
having a Melt Flow Rate between 15 and 20 g/10min measured according to standard ISO 1133 at 230°C and 2.16 kg.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Raines with the limitations of claims 9-10 since such limitations are deemed matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results.
Claims 11 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Raines in view of Meyer et al (US 4596561 A).
Regarding claim 11, Reines discloses a woven filter 32 made out of nylon, but can be made out of other materials (col 4 lines 14-17). However, it fails to disclose Meyer disclose the sheet of woven filter material is woven from a polyamide or polyester or polypropylene yarn.
Meyer teaches a sheet of filter made out of polyamide or polypropylene (col. 4 lines 56-63). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Raines woven filter material with the teachings of Meyer since such modification is taught old and well known in the art.
Regarding claim 26, Reines discloses the invention substantially as claimed. However, it fails to disclose a syringe with Reines filter needle.
Meyer teaches a syringe 10 using a filter needle12,15. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Reines with the Meyer’s teaching of using a filter needle with a syringe since it is taught old and well known in the art as an obvious alternative use.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Raines in view of Uesugi et al (EP 3167914 A1).
Regarding claim 12, Raines discloses the invention substantially as claimed. However, it fails to disclose the sheet of woven filter material is a twill weave filter.
Uesugi teaches a mesh filter made out of twill weave [0067]. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Raines woven filter with Uesugi’s twill weave filter since such modification is well known in the art to select a different type of weave to control particles being filtered as being design choice.
Allowable Subject Matter
Claims 14-16, 29, 31 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 form.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Cris L Rodriguez whose telephone number is (571)272-4964. The examiner can normally be reached Mon-Thur 8am- 2pm..
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, Chelsea Stinson can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Cris L. Rodriguez/
Primary Patent Examiner
Art Unit 3783