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 .
Acknowledgments
In the reply, filed on June 8, 2026, Applicant amended claims 1 and 21-23.
In the non-final rejection of March 6, 2026, 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 noted that the information disclosure statement filed February 17, 2026, 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 claims 1 and 23. Applicant amended claims 1 and 23. Objection is withdrawn.
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
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, “a block” (claim 1, line 15) 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
Claims 1 and 22 are objected to because of the following informalities:
In regards to claim 1, lines 16-17, “the molded polymer body member the braking member” should be changed to “the molded polymer body member, the braking member”.
In regards to claim 22, line 2, “the molded polymer body member the braking member” should be changed to “the molded polymer body member, the braking member”.
Appropriate correction is required.
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 1-8 and 21-23 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.
In regards to claim 1, line 15 recites: “a block disposed proximal of the braking member”; however, such is new matter not described in the Specification. Claims 2-8 and 21-23 are rejected by virtue of being dependent upon claim 1.
In regards to claim 1, lines 16-19 recite: wherein when the needle hub assembly is rotated onto the molded polymer body member the braking member is configured to expand and grip a radially inwardly extending threaded section of the plurality of radially inwardly extending threaded sections “between the braking member and the block in an axial direction”; however, such is new matter not described in the Specification. Claims 2-8 and 21-23 are rejected by virtue of being dependent upon claim 1.
In regards to claim 21, lines 1-6 recite: wherein the braking member is configured to contact a distal surface of the radially inwardly extending threaded section “and the block is configured to contact a proximal surface of the radially inwardly extending threaded section” to grip the radially inwardly extending threaded section “between the braking member and the block in the axial direction” to prevent removal of the needle hub assembly from the molded polymer body member; however, such is new matter not described in the Specification.
In regards to claim 22, lines 1-5 recite: wherein when the needle hub assembly is rotated onto the molded polymer body member the braking member is configured to expand due to pressure from the molded polymer body member to grip the radially inwardly extending threaded section “between the braking member and the block in the axial direction” to prevent removal of the needle hub assembly from the molded polymer body member; however, such is new matter not described in the Specification. Claim 23 is rejected by virtue of being dependent upon claim 22.
In regards to claim 23, lines 1-5 recite: wherein the braking member expanding due to the pressure from the molded polymer body member to grip the radially inwardly extending threaded section “between the braking member and the block in the axial direction” 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; however, such is new matter not described in the Specification.
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)
a block (labeled in Figure 7 below) disposed proximal of the braking member
wherein when the needle hub assembly is rotated onto the molded polymer body member the braking member is configured to expand and grip a radially inwardly extending threaded section (one of threads with crest 201) of the plurality of radially inwardly extending threaded sections between the braking member and the block in an axial direction (Figure 7)(Figures 2B-2D)
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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 and the block is configured to contact a proximal surface of the radially inwardly extending threaded section to grip the radially inwardly extending threaded section (Figure 2D) between the braking member and the block in the axial direction (Figure 7) 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 when the needle hub assembly is rotated onto the molded polymer body member 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) between the braking member and the block in the axial direction (Figure 7) 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 the pressure from the molded polymer body member to grip the radially inwardly extending threaded section between the braking member and the block in the axial direction (Figure 7) 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 June 8, 2026, have been fully considered but they are not persuasive:
In regards to claim 1, Applicant argued: Jentzen does not disclose "wherein when the needle hub assembly is rotated onto the molded polymer body member the braking member is configured to expand and grip a radially inwardly extending threaded section of the plurality of radially inwardly extending threated sections between the braking member and the block in an axial direction," as required by amended claim 1 (Remarks, page 7). Examiner disagrees. Jentzen teaches wherein when the needle hub assembly (401/400/103) is rotated onto the molded polymer body member (402) the braking member (103) is configured to expand and grip a radially inwardly extending threaded section (one of threads with crest 201) of the plurality of radially inwardly extending threaded sections (threads with crest 201) between the braking member and the block (labeled in Figure 7 above) in an axial direction (Figure 7)(Figures 2B-2D).
In regards to claims 21-23, Applicant argued: Amended dependent claims 21-23 are also 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 and the block is configured to contact a proximal surface of the radially inwardly extending threaded section to grip the radially inwardly extending threaded section between the braking member and the block in the axial direction to prevent removal of the needle hub assembly from the molded polymer body member". Claim 22 - "wherein when the needle hub assembly is rotated onto the molded polymer body member the braking member is configured to expand due to pressure from the molded polymer body member to grip the radially inwardly extending threaded section between the braking member and the block in the axial direction to prevent removal of the needle hub assembly from the molded polymer body member". Claim 23 - "wherein the braking member expanding due to the pressure from the molded polymer body member to grip the radially inwardly extending threaded section between the braking member and the block in the axial direction 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 7-8). 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) and the block (labeled in Figure 7 above) is configured to contact a proximal surface of the radially inwardly extending threaded section to grip the radially inwardly extending threaded section (Figure 2D) between the braking member and the block in the axial direction (Figure 7) 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 when the needle hub assembly is rotated onto the molded polymer body member 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) between the braking member and the block in the axial direction (Figure 7) 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 the pressure from the molded polymer body member to grip the radially inwardly extending threaded section between the braking member and the block in the axial direction (Figure 7) 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
THIS ACTION IS MADE FINAL. 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.
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/SHEFALI D PATEL/Primary Examiner, Art Unit 3783
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