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 .
Response to Amendment
This office action is responsive to the amendment filed on 06/16/2026. As directed by the amendment: claims 1-3, 11-13, 20, and 23 have been amended, claim 21 has been cancelled, and claim 26 has been added. Thus, claims 1-20 and 22-26 are presently pending in this application, with claims 13-20 and 22-25 being withdrawn from consideration. Applicant’s amendments to the claims have overcome each 112(b) rejection, except a 112(b) rejection of claim 1, and each objection, except an objection of claim 10, set forth in the Non-Final Office Action mailed on 04/20/2026. Examiner notes the 112(b) rejection of claim 1 and the objection of claim 10 have been maintained.
Claim Objections
Claim 10 is objected to because of the following informalities:
Regarding claim 10, the phrase “the at least one concentrating feature” in lines 1-2 should read “the at least one force concentrating feature” for proper antecedent basis,
Regarding claim 10, the phrase “an outer diameter of the stopper” in line 4 should read “the outer diameter of the stopper” for proper antecedent basis,
Appropriate correction is required.
Response to Arguments
(i) Applicant's arguments on p.9-10 of “Remarks”, filed 06/16/2026, have been fully considered but they are not persuasive. In response to the applicant’s argument that Larose fails to disclose or teach an insertion pin that does not contact the distal region of the plunger rod engaging cavity, the examiner respectfully disagrees. The applicant argues “a portion of LaRose’s insertion pin will contact the plunger rod engaging cavity, regardless of whether the stopper has began, as the length L1 and diameter D1 of the tip end 910 is approximately the depth of the diameter of the cavity, respectively.” This argument is not persuasive because the examiner’s the statement on p.9 from the Non-Final Office Action mailed on 04/20/2026, the examiner stated “the pin tip end 910 is positioned on the a proximal end of the stopper 300 and thus does not contact the cavity 306 before guiding of the stopper 300 begins)” is clarified to indicate that the method does not require that the positioning of the insertion pin on the stopper requires direct contact between the insertion pin and the stopper. This is further bolstered by the next step of the method stating “contacting the proximal end of the stopper with the shoulder of the insertion pin.” Thus, LaRose discloses the limitation of claim 1 such that the pin tip end (910) of the insertion pin of LaRose is positioned on the proximal end of the stopper (300) before guiding of the stopper (300) begins such that it is aligned but not inserted therein. The rejection of claim 1 is maintained.
(ii) Applicant’s arguments, see p.10-11 of “Remarks”, filed 06/16/2026, with respect to the 103 rejection of newly amended claim 1 have been fully considered and are persuasive. The 103 rejection of claim 1 of 04/20/2026 has been withdrawn.
(iii) Applicant's arguments on p.12-13 of “Remarks”, filed 06/16/2026, have been fully considered but they are not persuasive. In response to the applicant’s argument that Kubo fails to disclose or teach the force concentrating features that bias the force towards an outer diameter of the stopper, the examiner respectfully disagrees. The applicant argues “At most, any contact (if at all) between LaRose’s alleged shoulder and Kubo’s projections 32 would more reasonable add interface therebetween that cause outward deformation of the stopper and increase frictional forces, rather than provide the claimed force path biased toward the outer diameter to reduce stopper deformation during insertion”. This argument is not persuasive because LaRose does explicitly disclose the shoulder (912) of the insertion pin (900) contacting the proximal end of the stopper (300, see para. 0076 – “The flat surface 912 is designed to push against the distal end of a stopper to provide straightness and stability during insertion of the stopper into the syringe barrel”). Thus, modifying in the force concentrators of Kubo onto the proximal end of the stopper (300) and the shoulder (912) of the insertion pin (900) of modified LaRose (as claimed in claim 26) would thus cause the force application from the shoulder of the insertion pin on the force concentrators to be transferred to the force concentrators on the proximal end of the stopper. Being that the force concentrators (namely the recess 31) of Kubo are on spaced around the outer diameter of the stopper (see Fig. 2), said force application would bias toward the outer diameter of the stopper.
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 1-12 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 limitation "the proximal end of the insertion pin" in line 14. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 1, the phrase “the body of the stopper tends to expand” in line 16 renders the claim indefinite because it is unclear. The term “tends” is defined by Merriam Webster as to exhibit an inclination or tendency. Thus, it is unclear whether the method requires the body of the stopper to expand since this expansion is claimed as only tending to occur. Examiner is interpreting this limitation as the body of the stopper expands.
Regarding claim 11, the phrase “compared to a conventional translation method” in lines 4-5 renders the claim indefinite because it is unclear. The examiner is unable to ascertain the scope of a conventional translation method. The specification references conventional translation methods such as in para. 000102-000103 and 000132, but the specification does not provide any characteristics of a conventional translation method. It is unclear whether this requires a certain degree of force, a certain structure, or other means.
Regarding claim 12, the phrase “compared to a conventional translation method” in line 3 renders the claim indefinite for the aforementioned reasons above.
Regarding claims 2-10, these claims are rejected due to their dependency upon an indefinite base claim.
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.
Claim(s) 26 is rejected under 35 U.S.C. 103 as being unpatentable over LaRose (U.S Patent Pub. No. 20170203046 A1) in view of Abrams et al. (W.O Patent Pub. No. 2020118275 A1, “Abrams”) in view of Xing et al. (C.N Patent No. 111359058 A, “Xing”) in view of Kubo (U.S Patent Pub. No. 20160193418 A1).
Regarding claim 26, LaRose discloses the limitations of (Claim 26) a method (see para. 0073) comprising:
placing a distal end of a stopper (300 in Fig. 3A) on a proximal end (1012 in Fig. 10A) of an insertion tube (1000 in Fig. 10A-10B, see para. 0074 – to insert the stopper 300 into the syringe barrel 104 in Fig. 1, the stopper 300 must first be placed on the proximal end 1012 of the insertion tube 1000 before it is pushed inside), the insertion tube (1000) and the stopper (300) being silicone lubricant free (see para. 0033 – the stopper insertion method is free from silicone oil and thus the insertion tube and stopper are both free from silicone lubricant), the stopper (300) including a plunger rod engaging cavity (306 in Fig. 3A) and a sealing region having a length spaced from a proximal end of the stopper (300) by a sealing location length (see annotated LaRose Drawing 1 below for sealing region and see para. 0049 for plunger rod engaging cavity), the sealing region having at least one rib (304 in Fig. 3A, see para. 0049-0050 – at least one ribs 304 form a region for sealing the stopper 300 with the inside of syringe barrel 104);
PNG
media_image1.png
722
901
media_image1.png
Greyscale
positioning an insertion pin (900 in Fig. 9A-9B) on the proximal end of the stopper (300) without contacting a distal region of the plunger rod engaging cavity (306, see para. 0073 and 0075-0076 – examiner notes the embodiment of Fig. 9A-9B has a reverse labelling of the proximal and distal directions with respect to the instant application, the pin tip end 910 is positioned on the a proximal end of the stopper 300 and thus does not contact the cavity 306 before guiding of the stopper 300 begins), wherein the insertion pin (900) has a cylindrical body (902 in Fig. 9A) that includes a distal end (906 in Fig. 9A) having a shoulder (912 in Fig. 9A) and a pin tip end (910 in Fig. 9A) that has a diameter smaller than a diameter of the plunger rod engaging cavity (306, see para. 0077 – pin tip end 910 has a width that allows tip end 910 to be inserted into cavity 306 and thus must have a diameter smaller than the diameter of cavity 306);
contacting the proximal end of the stopper (300) with the shoulder (912) of the insertion pin (900, see para. 0076 – examiner notes the embodiment of Fig. 9A-9B has a reverse labelling of the proximal and distal directions with respect to the instant application, shoulder 912 is designed to push against proximal end of stopper);
and applying a force on the proximal end (908 in Fig. 9A) of the insertion pin (900, see para. 0075-0076).
However, LaRose fails to disclose (Claim 26) the sealing region having at least one rib, each of the at least one ribs including at least one microgroove in a polymer barrier, the at least one microgroove having an initial width, the proximal end of the stopper including at least one force concentrating feature including an annular structure extending from the proximal end of the stopper, and applying a force to the at least one force concentrating feature such that the force applied to the stopper is applied to the annular surface such that the force is biased towards an outer diameter of the stopper.
Abrams discloses a gasket (14 in Fig. 1-3B) for use in syringe and plunger systems (see Fig. 1 and Abstract), wherein the gasket (14) comprises (Claim 26) the sealing region having at least one rib, the at least one rib including at least one microgroove (20 in Fig. 3B) in a polymer barrier (16 in Fig. 3A-3B, see annotated Abrams drawing 1 below for sealing region and rib, see para. 0018 and 0031 – film 16 may be made of a polymer and forms a barrier around the gasket core 18, see para. 0036 – the channel in the film 16 present on at least one rib may have a depth in the micron range indicating it is a microgroove), the at least one microgroove (20) having an initial width (see Fig. 3B for initial width).
PNG
media_image2.png
484
809
media_image2.png
Greyscale
Since LaRose discloses the method of placing the stopper into the syringe barrel using the insertion pin and insertion tube, and Abrams discloses an improved syringe stopper, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the stopper taught by LaRose to incorporate the at least one rib including at least one microgroove in a polymer barrier as taught by Abrams. Abrams provides that the one or more channels in the film on the surface of the gasket provides an improved structure for superior container closure integrity and sealability with minimal liquid/gas leakage (see para. 0013).
While Abrams illustrates that a singular rib may have a microgroove (20) and that there may be a plurality of microgrooves axially spaced on the gasket (14, see para. 0035), modified LaRose fails to disclose each of the at least one ribs including at least one microgroove.
Xing discloses a syringe (see Fig. 1-2) comprising a piston (2 in Fig. 2) having a plurality of sealing rings (5 in Fig. 3-4) in the form of ribs which interference fit with the barrel (1) wall (see para. 067-069). Xing teaches that the sealing rings (5 in Fig. 5-6) may each have an annular groove (6) formed on the outer peripheral surface of each sealing ring (5, see para. 070).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the stopper having at least one rib having at least one microgroove taught by modified LaRose to have said microgroove on each rib as taught by Xing. Xing provides that the annular grooves (6) reduces the contact area, reduces the pressure, and thus the friction between the piston (2) and the inner wall of the syringe (1, see para. 070).
Kubo discloses a syringe assembly (see Fig. 6) comprising a stopper (1 in Fig. 1-2) and a plunger rod (4 in Fig. 3-4), wherein the proximal end of the stopper (1) includes an annular structure (21) extending from the proximal end of the stopper (1) and comprising four recesses (31) having a flat surface as seen in Fig. 1 configured to engage the plunger rod (see para. 0024 and 0028 - Examiner notes the annular structure 21 and four recesses 31 are interpreted as the at least one force concentrating feature as they are engagement structures that are capable of being configured to concentrate force from the plunger rod 4 to the stopper 1). Kubo further teaches wherein the at least one concentrating feature (21, 31 in Fig. 3-4) is configured such that the force applied to the stopper (1) is applied to the at least one force concentrating feature (21, 31) such that the force applied to the stopper (1) is applied to the annular surface (21) such that the force is biased towards an outer diameter of the stopper (1, see para. 0022 and 0028 – a force is applied to the proximal end of plunger rod 4 which is transferred to the stopper 1 to translate the stopper 1 through the syringe barrel 8, the plunger rod 4 transfers said force to the proximal end of the stopper 1 through contact such as which protrusions 32 to the annular surface 21 of the stopper 1 which is located at an outer diameter of the proximal end of the stopper and thus at least a portion of said force is biased towards the outer diameter of the stopper).
Since modified LaRose discloses a syringe assembly comprising the stopper (300) having a proximal end that is engaged with the insertion rod (900) for applying a force to the proximal end of the stopper (300), and Kubo discloses a syringe assembly comprising a stopper (1) having an annular structure (21) and four recesses (31) wherein the plunger rod (4) applies a force to the proximal end of the stopper (1) by contacting the proximal end of the stopper (1) including the four recesses (31), it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the proximal end of the stopper taught by modified LaRose to incorporate the at least one force concentrating feature as taught by Kubo. Kubo teaches that the projections on the plunger rod and corresponding recesses on the stopper form a looseness prevention mechanism to prevent unscrewing of the plunger from the stopper and loosening (see para. 0024 and 0026). Thus, LaRose which discloses an insertion pin that applies a force to the proximal end of the stopper to translate said stopper would be modified such that the insertion pin comprises the projections taught by Kubo and the stopper comprises the recesses taught by Kubo such that loosening between the insertion pin and the stopper during assembly can be prevented. Examiner notes that the operation of the plunger rod of Kubo would have been pertinent to one of ordinary skill in the art when solving the problem of translating a stopper during assembly in a similar manner for translating a stopper during drug dispensing.
Allowable Subject Matter
Claims 1-12 would be allowable if rewritten or amended 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.
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art is LaRose (U.S Patent Pub. No. 20170203046 A1) in view of Abrams et al. (W.O Patent Pub. No. 2020118275 A1, “Abrams”) in view of Xing et al. (C.N Patent No. 111359058 A, “Xing”) and Kubo (U.S Patent Pub. No. 20160193418 A1).
LaRose discloses a method (see para. 0073) for assembling a syringe using an insertion pin and vent tube (see para. 0073), wherein the method comprises placing a distal end of a stopper (300 in Fig. 3A) on a proximal end (1012 in Fig. 10A) of an insertion tube (1000 in Fig. 10A-10B, see para. 0074), the insertion tube (1000) and the stopper (300) being silicone lubricant free (see para. 0033), the stopper (300) including a plunger rod engaging cavity (306 in Fig. 3A) and a sealing region having a length spaced from a proximal end of the stopper (300) by a sealing location length (see annotated LaRose drawing 1 below and para. 0049), wherein the sealing region has at least one rib (304 in Fig. 3A, see para. 0049-500), positioning an insertion pin (900 in Fig. 9A-9B) on a proximal end of the stopper (300) without contacting a distal region of the plunger rod engaging cavity (306) before guiding of the stopper (300) begins (see para. 0073 and 0075-0076). The insertion pin (900) has a cylindrical body (902 in Fig. 9A) that includes a distal end (906 in Fig. 9A) having a shoulder (912 in Fig. 9A) and a pin tip end (910 in Fig. 9A) that has a diameter smaller than a diameter of the plunger rod engaging cavity (306, see para. 0077). The method further comprises contacting the proximal end of the stopper (300) with the shoulder (912) of the insertion pin (900) and applying a force on the proximal end (908) of the insertion pin (900) to the proximal end of the stopper (300, see para. 0075-0076). However, LaRose fails to disclose each of the at least one ribs comprising at least one microgroove in a polymer barrier nor does LaRose disclose that applying the force on the proximal end of the insertion pin to the proximal end of the stopper cause the force to be biased towards an outer diameter of the stopper such that the body of the stopper tends to expand into the plunger rod engaging cavity under the force in order to reduce a normal force otherwise applied between the polymer barrier and the insertion tube.
Abrams discloses a gasket (14 in Fig. 1-3B) for use in a syringe (see abstract), wherein the gasket (14) comprises the sealing region having at least one rib including at least one microgroove (20 in Fig. 3B) in a polymer barrier (16 in Fig. 3B, see para. 0018 and 0031). Since LaRose discloses the method of placing the stopper into the syringe barrel using the insertion pin and an insertion tube, and Abrams discloses an improved syringe stopper, it would have been obvious to have modified the stopper taught by LaRose to have the microgroove in the polymer barrier of Abrams.
Xing discloses a syringe (see Fig. 1-2) comprising a piston (2 in Fig. 2) having a plurality of sealing rings (5 in Fig. 3-4) in the form of ribs which interference fit with the barrel (1) wall (see para. 067-069). Xing teaches that the sealing rings (5 in Fig. 5-6) may each have an annular groove (6) formed on the outer peripheral surface of each sealing ring (5, see para. 070). Thus, modified LaRose can be further modified such that each rib includes a microgroove as taught by Xing.
However, modified LaRose still fails to disclose the method step of applying the force on the proximal end of the insertion pin to the proximal end of the stopper such that the force is applied to the stopper as claimed in claim 1. While the limitation “the force is biased towards an outer diameter of the stopper such that…” in lines 15-18 of claim 1 recite the result or effect of the method, modified LaRose fails to disclose the terms of this recited step and the structure, specifically, the stopper expansion into the plunger rod engaging cavity, in order to result in the desired and recited effect.
Kubo discloses a syringe assembly (see Fig. 6) comprising a stopper (1 in Fig. 1-2) and a plunger rod (4 in Fig. 3-4) wherein the plunger rod (4) comprises a shoulder (51 in Fig. 3) for contacting the proximal end of the stopper (1, see para. 0024). Kubo further discloses that the proximal end of the stopper (1) includes an annular structure (21 in Fig. 1-2) extending from the proximal end of the stopper (1) and four recesses (31 in Fig. 1) which together with the annular structure (21) form the at least one force concentrating feature as they are engagement structures on the stopper (1) capable of being configured to concentrating force from the plunger rod (4) to the stopper (1, see para. 0024 and 0029). However, Kubo does not explicitly disclose the how an application of force onto the proximal end of the stopper (1) effects the structure of the stopper (1), and thus fails to disclose the method step of claim 1 requiring that this application of force results in the force being biased towards the outer diameter of the stopper such that the body of the stopper tends to expand into the plunger rod engaging cavity.
Therefore, there is no reference that discloses or teaches the method of claim 1 where the application of force on the proximal end of the stopper causes the stopper to expand into the plunger rod engaging cavity which reduces the normal force applied between the polymer barrier and the insertion tube.
Conclusion
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 KAYLA MARIE TURKOWSKI whose telephone number is (703)756-4680. The examiner can normally be reached Mon – Thurs, 7:00 AM – 4:00 PM 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, Bhisma Mehta can be reached at 571-272-3383. 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.
/KAYLA M. TURKOWSKI/Examiner, Art Unit 3783 /COURTNEY FREDRICKSON/ Primary Examiner, Art Unit 3783
Prosecution Insights