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 .
Election/Restrictions
Applicant’s election without traverse of group I in the reply filed on 12/23/2025 is acknowledged.
Claims 10, 16, 18, and 20-27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/23/2025.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 11/6/2024 and 12/23/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Drawings
The drawings are objected to because on page 26/28 of the drawings the figure is labeled 12G. Paragraph [00128] of the specification describes figure 13G, not figure 12G. No brief description has been included for figure 12G. It appears a typo has been made and figure 12G should be figure 13G. 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.
New corrected drawing in compliance with 37 CFR 1.121(d) are required in this application. Figure 7 contains improper shading and it is unclear/difficult to tell which structures item 706, 703, 712, 707, 711, and 708 point to. Figure 8A-8B, 9A-9C, 10, 11A-11E, 13A-13F, 12G, and 13H-13I also contain improper shading which may affect clarity once reproduced. Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
Specification
The abstract of the disclosure is objected to because:
Line 4 recites “the sterile withdrawal”. As the sterile withdrawal has not previously been introduced, Examiner suggests replacing “the sterile withdrawal” in line 4 of the abstract with “a sterile withdrawal” to put the abstract in clearer form.
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 disclosure is objected to because of the following informalities:
This application is a 371 of PCT/US2021/071787 filed 10/8/2021 which claims priority to provisional application 63/089,335 filed 10/8/2020. Examiner suggests inserting a heading before the field of the invention titled “Cross-references to Related Applications” and adding the continuity data for this application.
Appropriate correction is required.
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 1-9 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.
In regard to claim 1,
Line 2 recites “a distal end”. It is unclear if the distal end is of the syringe barrel, syringe reservoir, or of the sterile plunger syringe. For examination purposes Examiner construes the distal end to be a distal end of the syringe barrel. Examiner suggests replacing “a distal end” in line 2 of claim 1 with “a distal end of the syringe barrel”.
Line 3 recites “a proximal end”. It is unclear if the proximal end is of the syringe barrel, syringe reservoir, or of the sterile plunger syringe. For examination purposes Examiner construes the proximal end to be a proximal end of the syringe barrel. Examiner suggests replacing “a proximal end” in line 3 of claim 1 with “a proximal end of the syringe barrel”.
Examiner notes claims 2-9 are similarly rejected by virtue of their dependency on claim 1.
In regard to claim 7,
Line 2 recites “the proximal end of the syringe reservoir”. It is unclear if antecedent basis is provided for “the proximal end of the syringe reservoir”. As noted in regard to claim 1 above, it is unclear if the proximal end of claim 1 is of the syringe barrel, syringe reservoir, or of the sterile plunger syringe. If claim 1 is amended to state “a proximal end of the syringe barrel” as suggested by Examiner, line 2 of claim 7 should be amended to state “a proximal end of the syringe reservoir” or “the proximal end of the syringe barrel”.
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)(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.
Claims 1-3 and 6-9 are rejected under 35 U.S.C. 102 (a)(2) as being anticipated by Mato Sabat (U.S. PG publication 20200345940).
In regard to claim 1,
[AltContent: textbox (Syringe plunger sealing device )][AltContent: arrow][AltContent: textbox (Gasket )][AltContent: arrow][AltContent: textbox (Reservoir face)][AltContent: textbox (Plunger rod )][AltContent: arrow][AltContent: arrow][AltContent: arrow][AltContent: textbox (Syringe barrel flange)][AltContent: textbox (Interconnect )][AltContent: arrow]
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Mato Sabat discloses a sterile plunger syringe (figure 4C, item 400-c; paragraph [0008]-[0009]; see also paragraph [0032] wherein the features not described are similar to those described in figure 1A and 1B) comprising:
a syringe barrel (figure 4C, item 401) defining a syringe reservoir (figure 4C, item 408) and having an interconnect (see figure 4C above) at a distal end (see end which interconnect is at) and an opening (see opening of barrel that item 403 is received within) surrounded by a syringe barrel flange (see figure 4C above) at a proximal end (see figure 4C above wherein the proximal end is the end closest to the syringe barrel flange);
a syringe plunger (figure 4C, item 403) including a syringe plunger rod flange (figure 4C, item 406), a plunger rod (see figure 4C above), and a reservoir face (see figure 4C above);
a gasket (see figure 4C above; paragraph [0032] wherein the features not described are similar to those described in figure 1A and 1B and paragraph [0026]; Examiner notes the gasket is construed as the sliding seal which is labeled as item 10 in figure 1A) disposed over the reservoir face (see figure 4C and paragraph [0026]) and configured to provide a seal between the reservoir face and the syringe reservoir when the syringe plunger is seated within the syringe barrel (paragraph [0026]; see figure 4C above); and
a syringe plunger sealing device (see figure 4C above; paragraph [0032] wherein the features not described are similar to those described in figure 1A and 1B and paragraph [0026]; Examiner notes the syringe plunger sealing device is construed as the non-sliding seal which is labeled as item 7 in figure 1A. As shown in figure 4C, filters 409 are not positioned on the syringe plunger sealing device; paragraph [0026] describes the syringe plunger sealing device/non-sliding seal as forming a seal) secured to the syringe barrel (see figure 4C) and configured to provide a syringe plunger seal (paragraph [0026] describes the syringe plunger sealing device/non-sliding seal as forming a syringe plunger seal).
In regard to claim 2,
Mato Sabat discloses the sterile plunger syringe of claim 1, wherein the syringe plunger sealing device is secured to a proximal portion of the syringe barrel (see figure 4C; Examiner notes the proximal portion is construed as the portion of the syringe barrel which includes the syringe barrel flange).
In regard to claim 3,
Mato Sabat discloses the sterile plunger syringe of claim 1, wherein the syringe plunger sealing device is secured to the syringe barrel flange (see figure 4C).
In regard to claim 6,
Mato Sabat discloses the sterile plunger syringe of claim 1, wherein the syringe plunger sealing device includes a plurality of accordion folds (see figure 4C and paragraph [0026]. Examiner notes paragraph [0062] of the instant disclosure also states “The syringe plunger sealing device 709 may be a tube, bag, balloon, sock-like structure, accordion fold structure, or any other structure sufficient to enclose the proximal end of the sterile plunger syringe 700 and the syringe plunger 703”. It is noted that although Mato Sabat does disclose the plurality of accordion folds, it appears that a plurality of other structures besides an accordion fold could be equivalently used and that a plurality of accordion folds is a design choice).
In regard to claim 7,
Mato Sabat discloses the sterile plunger syringe of claim 1, wherein the syringe plunger sealing device seals the opening at the proximal end of the syringe reservoir (see figure 4C; paragraph [0026]).
In regard to claim 8,
Mato Sabat discloses the sterile plunger syringe of claim 1, wherein the syringe plunger seal (see seal formed by the syringe plunger sealing device/non-sliding seal) is substantially fluid-tight (see figure 4C; paragraph [0026] and [0008]).
In regard to claim 9,
Mato Sabat discloses the sterile plunger syringe of claim 8, wherein the syringe plunger seal (see seal formed by the syringe plunger sealing device/non-sliding seal) is substantially gas-tight (see figure 4C; paragraph [0026], [0013] and [0032]; As shown in figure 4C, filters 409 are located on the barrel, not the syringe plunger seal). It is noted that paragraph [0066] and [0077] of the instant disclosure supports that the syringe plunger seal can also not be substantially gas-tight.
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.
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 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Mato Sabat (U.S. PG publication 20200345940) further in view of Gruenberg (U.S. PG publication 20030097115).
In regard to claim 4,
Mato Sabat discloses the sterile plunger syringe of claim 1.
Mato Sabat is silent as to wherein the syringe plunger sealing device is secured via an adhesive, a heat bonding, a chemical bonding, or a sonic welding.
Gruenberg teaches wherein the syringe plunger sealing device (figure 1, item 18) is secured via an adhesive, a heat bonding, a chemical bonding, or a sonic welding (adhesive; paragraph [0025]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Mato Sabat to substitute an adhesive to secure the syringe plunger sealing device in place of the attachment type used to secure the syringe plunger sealing device of Mato Sabat, as taught by Gruenberg, because the substitution is a simple substitution that would yield the same predictable result of securing the syringe plunger sealing device and allowing a sterile environment to be maintained (paragraph [0026] and [0006] of Mato Sabat and paragraph [0025] of Gruenberg). Furthermore, Mato Sabat discloses modifications can be made (paragraph [0035] of Mato Sabat). Examiner notes paragraph [0063] of the instant disclosure supports that any suitable means can be used to secure the syringe plunger sealing device equivalently.
In regard to claim 5,
Mato Sabat discloses the sterile plunger syringe of claim 1.
Mato Sabat is silent as to wherein the syringe plunger sealing device is removably secured via clamping.
Gruenberg teaches wherein the syringe plunger sealing device (figure 1, item 18) is removably secured via clamping (paragraph [0025]; Examiner notes the syringe plunger sealing device is secured via a clamp which can be removed via opening the clamp or breaking the clamp for example).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Mato Sabat to substitute a clamp to secure the syringe plunger sealing device in place of the attachment type used to secure the syringe plunger sealing device of Mato Sabat, as taught by Gruenberg, because the substitution is a simple substitution that would yield the same predictable result of securing the syringe plunger sealing device and allowing a sterile environment to be maintained (paragraph [0026] and [0006] of Mato Sabat and paragraph [0025] of Gruenberg). Furthermore, Mato Sabat discloses modifications can be made (paragraph [0035] of Mato Sabat). Examiner notes paragraph [0063] of the instant disclosure supports that any suitable means can be used to secure the syringe plunger sealing device equivalently.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDRA ELIZABETH LALONDE whose telephone number is (313)446-6594. The examiner can normally be reached M-F 8-5 EST.
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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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/ALEXANDRA LALONDE/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783