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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on February 4, 2026, has been entered.
Acknowledgments
In the reply, filed on February 4, 2026, Applicant amended claims 1, 4-5, and 8.
Applicant added new claims 21-23.
In the final rejection of November 5, 2025, Examiner noted that the listing of references in the specification is not a proper information disclosure statement. Applicant did not address this concern in the reply. Concern is maintained.
Examiner noted that the information disclosure statement filed February 3, 2025, fails to comply with 37 CFR 1.98(a)(3)(i). Applicant did not address this concern in the reply. Concern is maintained.
Examiner objected to the Abstract. Applicant amended the Abstract. Objection is withdrawn.
Examiner objected to claim 1. Applicant amended claim 1. Objection is withdrawn.
Examiner rejected claims 1-8 under 35 U.S.C. 112(a). Applicant amended claim 1. Rejection is withdrawn.
Currently, claims 1-8 and 21-23 are under examination.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
U.S. patent application Ser. Nos. 14/696,342, 14/543,787, 14/321,706, 62/416,102, 62/431,382, and 62/480,276 (paragraphs [0005][0011][0047][0059][0071][0084])
The information disclosure statement filed February 3, 2025, fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. It has been placed in the application file, but the information referred to therein has not been considered.
No English translation has been provided for understanding of non patent literature documents 3 and 4
The information disclosure statement filed February 17, 2026, fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. It has been placed in the application file, but the information referred to therein has not been considered.
No English translation has been provided for understanding of foreign patent document 1
Claim Objections
Claims 1 and 23 are objected to because of the following informalities:
In regards to claim 1, lines 17-18, “the plurality of radially inwardly extending threated sections” should be changed to “the plurality of radially inwardly extending threaded sections”.
In regards to claim 23, line 2, “pressure” should be changed to “the pressure”.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 1-8 and 21-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jentzen (US 6,224,588).
In regards to claim 1, Jentzen teaches an injection system (Figure 7), comprising:
a molded polymer body member (syringe barrel 402)(column 3, lines 46-48: These items may be made of any material using common techniques such as injection molding of some form of fairly rigid plastic, such as nylon)(column 6, line 36: plastic) having a body connection member (thread cage 403) at a distal end of the molded polymer body member, wherein the body connection member defines a plurality of radially inwardly extending threaded sections (threads with crest 201) and a corresponding plurality of radially inwardly directed smooth surfaces (root 202), each radially inwardly directed smooth surface of the plurality of radially inwardly directed smooth surfaces disposed adjacent a respective radially inwardly extending threaded section of the plurality of radially inwardly extending threaded sections (Figure 7)
a needle hub assembly (hub 401, needle 400, flexible finger 103) coupled to the body connection member of the molded polymer body member, wherein the needle hub assembly comprises
a needle hub (401) coupled to the body connection member
a needle (400) coupled to the needle hub
a braking member (103) at least partially radially outwardly extending from the needle hub and configured to minimize inadvertent removal of the needle hub assembly from the body connection member (column 2, lines 49-52: during disengagement movements of the members, the finger is flexed in the opposite direction by the ridge for resistance to the disengagement movements)
wherein the braking member is configured to grip a radially inwardly extending threaded section (one of threads with crest 201) of the plurality of radially inwardly extending threated sections (Figures 2B-2D)
In regards to claim 2, Jentzen teaches wherein the braking member comprises a braking tab (103).
In regards to claim 3, Jentzen teaches wherein the needle hub defines a space in which the braking tab is disposed (Figure 7).
In regards to claim 4, Jentzen teaches wherein the braking tab has an unlocked position, in which the braking tab is configured to allow rotation of the needle hub assembly in a first direction relative to the molded polymer body member to couple the needle hub assembly to the molded polymer body member (Figure 2A), and a locked position, in which the braking tab is configured to prevent rotation of the needle hub assembly in a second direction relative to the molded polymer body member to remove the needle hub assembly from the molded polymer body member (Figure 2B), wherein the second direction (arrow 302 in Figure 2D) is opposite of the first direction (arrow 302 in Figures 2A-2B).
In regards to claim 5, Jentzen teaches wherein the coupling of the needle hub assembly to the molded polymer body member transforms the braking tab from the unlocked position to the locked position (Figure 2A to Figure 2B).
In regards to claim 6, Jentzen teaches wherein the first direction is clockwise when viewed toward a proximal direction (arrow 302 in Figures 2A-2B), and wherein the second direction is counterclockwise when viewed toward the proximal direction (arrow 302 in Figure 2D).
In regards to claim 7, Jentzen teaches wherein the braking member comprises a plurality of braking tabs (crests 101, flexible finger 103), including the braking tab (103).
In regards to claim 8, Jentzen teaches wherein when the needle hub assembly is coupled to the molded polymer body member, the braking tab expands due to pressure from the molded polymer body member and grips the plurality of radially inwardly directed smooth surfaces and the plurality of radially inwardly extending threaded sections (Figure 2B-2D).
In regards to claim 21, Jentzen teaches wherein the braking member is configured to contact a distal surface of the radially inwardly extending threaded section to grip the radially inwardly extending threaded section (Figure 2D) to prevent removal of the needle hub assembly from the molded polymer body member (column 4, lines 54-57: Finger 103 comes into contact with projection 203. The reverse angle of finger 103 imparted during assembly now becomes an impediment to disassembly, jamming against projection 203).
In regards to claim 22, Jentzen teaches wherein the braking member is configured to expand due to pressure from the molded polymer body member to grip the radially inwardly extending threaded section (Figure 2D) to prevent removal of the needle hub assembly from the molded polymer body member (column 4, lines 54-57: Finger 103 comes into contact with projection 203. The reverse angle of finger 103 imparted during assembly now becomes an impediment to disassembly, jamming against projection 203).
In regards to claim 23, Jentzen teaches wherein the braking member expanding due to pressure from the molded polymer body member to grip the radially inwardly extending threaded section prevents rotation of the needle hub assembly relative to the molded polymer body member to remove the needle hub assembly from the molded polymer body member (column 4, lines 54-57: Finger 103 comes into contact with projection 203. The reverse angle of finger 103 imparted during assembly now becomes an impediment to disassembly, jamming against projection 203).
Response to Arguments
Applicant's arguments filed February 4, 2026, have been fully considered but they are not persuasive:
In regards to claim 1, Applicant argued: Jentzen does not disclose "wherein the braking member is configured to grip a radially inwardly extending threaded section of the plurality of radially inwardly extending threated sections," as required by amended claim 1 (Remarks, page 8). Examiner disagrees. Jentzen teaches wherein the braking member (103) is configured to grip a radially inwardly extending threaded section (one of threads with crest 201) of the plurality of radially inwardly extending threated sections (201) (Figures 2B-2D).
In regards to claims 21-23, Applicant argued: In addition, the new claims are independently patentable because Jentzen does not disclose at least the following limitations. Claim 21 - "wherein the braking member is configured to contact a distal surface of the radially inwardly extending threaded section to grip the radially inwardly extending threaded section to prevent removal of the needle hub assembly from the molded polymer body member". Claim 22 - "wherein the braking member is configured to expand due to pressure from the molded polymer body member to grip the radially inwardly extending threaded section to prevent removal of the needle hub assembly from the molded polymer body member". Claim 23 - "wherein the braking member expanding due to pressure from the molded polymer body member to grip the radially inwardly extending threaded section prevents rotation of the needle hub assembly relative to the molded polymer body member to remove the needle hub assembly from the molded polymer body member" (Remarks, pages 8-9). Examiner disagrees. Jentzen teaches wherein the braking member (103) is configured to contact a distal surface of the radially inwardly extending threaded section (one of threads with crest 201) to grip the radially inwardly extending threaded section (Figure 2D) to prevent removal of the needle hub assembly (401/400/103) from the molded polymer body member (402) (column 4, lines 54-57: Finger 103 comes into contact with projection 203. The reverse angle of finger 103 imparted during assembly now becomes an impediment to disassembly, jamming against projection 203), wherein the braking member is configured to expand due to pressure from the molded polymer body member to grip the radially inwardly extending threaded section (Figure 2D) to prevent removal of the needle hub assembly from the molded polymer body member (column 4, lines 54-57: Finger 103 comes into contact with projection 203. The reverse angle of finger 103 imparted during assembly now becomes an impediment to disassembly, jamming against projection 203), and wherein the braking member expanding due to pressure from the molded polymer body member to grip the radially inwardly extending threaded section prevents rotation of the needle hub assembly relative to the molded polymer body member to remove the needle hub assembly from the molded polymer body member (column 4, lines 54-57: Finger 103 comes into contact with projection 203. The reverse angle of finger 103 imparted during assembly now becomes an impediment to disassembly, jamming against projection 203).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHEFALI D PATEL whose telephone number is (571)270-3645. The examiner can normally be reached Monday-Friday 8:30am-4:30pm EST.
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 C 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SHEFALI D PATEL/Primary Examiner, Art Unit 3783