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 .
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.
Claims 3-4, 8-9, 18-20, 22, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Okihara et al. (U.S. PGPub 2015/0190578, cited in IDS) in view of Abrams et al. (WO2020118275, with reference to U.S. PGPub 2022/0040412 as a U.S. equivalent).
Claim 3: Okihara et al. discloses a method for feeding a syringe gasket (112) into a medical barrel (106), the method comprising: a. providing a gasket (112) configured for insertion into a medical barrel (106 – paragraph 46), the gasket comprising a main body (generally 112), the gasket having a distal nose cone (113 – paragraph 46) configured to face a product (110) stored within the medical barrel when inserted into the medical barrel (e.g. Fig. 1) and a circumferential surface portion (outer periphery including 120/122) extending proximally from the nose cone (Fig. 3), at least a portion of the circumferential surface portion being configured to contact an interior sidewall of the medical barrel in compressive engagement (paragraph 47); b. providing a tube (52/60 – see second embodiment in Figs. 5-7c) for retaining the gasket and then feeding the gasket into the medical barrel (paragraphs 95-96; 104), the tube comprising an elongate hollow tubular body (60) comprising an internal lumen (64 – paragraph 95), the lumen having an inner wall which consists of a contact surface configured to contact a portion of the circumferential surface portion of the gasket (implied by its diameter being “almost equal to or slightly smaller than the diameter (outer diameter) of the gasket 112” – Id.) and a non-contact surface occupying the remainder of the inner wall (implied by the presence of grooves 71 – paragraph 99); c. placing the gasket into the tube such that, along a selected plane perpendicular to a central axis of the tube (vertical axis), a first part of the circumferential surface portion of the gasket contacts and is in compressive engagement with the contact surface while a second part of the circumferential surface portion of the gasket either: (i) is not in contact with the non-contact portion; or (ii) is in contact with the non-contact portion but with less compression against the non-contact portion than exists between the first part of the circumferential surface portion of the gasket and the contact surface (the gasket would contact the inner surface (between grooves 71) due to the smaller inner diameter of the tube as cited above, the grooves forming a gap 70 of non-contact); d. aligning the tube with a proximal open end of the medical barrel (e.g. paragraphs 112-113; Fig. 6A); e. sliding the gasket through the tube (paragraphs 116-117; Figs. 7A-7C), wherein contact and compression between the circumferential surface portion of the gasket and the inner wall of the lumen as recited in step (c) is maintained as the gasket slides through the tube (implied since the grooves 71 have a length along the axis of the tube); and f. transferring the gasket from the tube into the medical barrel (as shown and described above).
The material of the main gasket body is not explicitly recited. However, Abrams et al. teaches that a syringe gasket is made of an elastic material (e.g. paragraphs 54-55). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the gasket from elastic material, as is standard for gaskets, in order to have provided the requisite compliance for sealing.
The tube 60 of Okihara has a central axis (e.g. paragraph 102), but the contact surface is not necessarily inwardly rounded towards the central axis and thus convex along a selected plane perpendicular to the central axis. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have shaped the contact surface in this manner since it has been held that the configuration of a claimed product is a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed product is significant. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). Please note that in the instant application, e.g. paragraphs 15 and 57, Applicant has not disclosed any criticality for this feature.
Claim 4: Okihara et al. discloses a method for feeding a syringe gasket (112) into a medical barrel (106), the method comprising: a. providing a gasket (112) configured for insertion into a medical barrel (106 – paragraph 46), the gasket comprising a main body (generally 112), the gasket having a distal nose cone (113 – paragraph 46) configured to face a product (110) stored within the medical barrel when inserted into the medical barrel (e.g. Fig. 1) and a circumferential surface portion (outer periphery including 120/122) extending proximally from the nose cone (Fig. 3), at least a portion of the circumferential surface portion being configured to contact an interior sidewall of the medical barrel in compressive engagement (paragraph 47); b. providing a tube (52/60 – see second embodiment in Figs. 5-7c) for retaining the gasket and then feeding the gasket into the medical barrel (paragraphs 95-96; 104), the tube comprising an elongate hollow tubular body (60) comprising an internal lumen (64 – paragraph 95), the lumen having an inner wall which consists of a contact surface configured to contact a portion of the circumferential surface portion of the gasket (implied by its diameter being “almost equal to or slightly smaller than the diameter (outer diameter) of the gasket 112” – Id.) and a non-contact surface occupying the remainder of the inner wall (implied by the presence of grooves 71 – paragraph 99), the contact surface comprising two or more guide rails extending axially along the lumen (the rails would be effectively defined by the vertically running contact surface portions between the grooves 71); c. placing the gasket into the tube such that, along a selected plane perpendicular to a central axis of the tube (central axis mentioned in paragraph 102), a first part of the circumferential surface portion of the gasket contacts and is in compressive engagement with the two or more guide rails (contact surfaces between grooves 71) while a second part of the circumferential surface portion of the gasket either: (i) is not in contact with the non-contact portion; or (ii) is in contact with the non-contact portion but with less compression against the non-contact portion than exists between the first part of the circumferential surface portion of the gasket and the two or more guide rails (the gasket would contact the inner surface (between grooves 71) due to the smaller inner diameter of the tube as cited above, the grooves forming a gap 70 of non-contact); d. aligning the tube with a proximal open end of the medical barrel (e.g. paragraphs 112-113; Fig. 6A); e. sliding the gasket through the tube (paragraphs 116-117; Figs. 7A-7C), wherein contact and compression between the circumferential surface portion of the gasket and the inner wall of the lumen as recited in step (c) is maintained as the gasket slides through the tube (implied since the grooves 71 have a length along the axis of the tube); and f. transferring the gasket from the tube into the medical barrel (as shown and described above).
The material of the main gasket body is not explicitly recited. However, Abrams et al. teaches that a syringe gasket is made of an elastic material (e.g. paragraphs 54-55). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the gasket from elastic material, as is standard for gaskets, in order to have provided the requisite compliance for sealing.
The guiderails are not necessarily inwardly rounded towards the central axis and thus convex along the selected plane. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have shaped the guiderails in this manner since it has been held that the configuration of a claimed product is a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed product is significant. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). Please note that in the instant application, e.g. paragraphs 15 and 57, Applicant has not disclosed any criticality for this feature.
Claim 8: Okihara discloses two to eight guiderails (defined between two to eight grooves 71 – paragraph 99).
Claim 9: Okihara contemplates an even number of guiderails (two to eight). Okihara does not explicitly disclose wherein each guiderail opposes another guiderail located 180 degrees from it around the lumen, though such would be the case for any even number of guiderails if they were simply spaced evenly bout the circumference. The cross-section of Fig. 5 suggests two grooves (and thus guiderails between them) spaced 180 degrees apart, i.e. directly opposed. Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have spaced the guiderails as claimed since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950). Please note that in the instant application, paragraph 9, Applicant has not disclosed any criticality for the number or spacing of the guiderails.
Claim 18: Okihara further discloses the circumferential surface portion of the gasket comprising one or more ribs (120, 122) that protrude radially outward and are configured to engage and provide a seal between the gasket and a medical barrel into which the gasket is disposed (paragraph 47). Okihara does not disclose wherein at least one of the one or more ribs comprises a channel or channels running along at least a portion of the circumference of the at least one of the one or more ribs. However, Abrams further teaches a similar gasket wherein at least one of the one or more ribs comprises a channel or channels (20 – one or more being contemplated, see paragraphs 44 and 60) running along at least a portion of the circumference of the at least one of the one or more ribs. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the channel(s) as taught by Abrams since it/they provide improved prevention of liquid or gas leakage (paragraphs 12-13).
Claim 19: Further referring to Abrams, the one or more ribs comprises a distal rib adjacent to the nose cone (e.g. Fig. 3A), the channel or channels being provided on the distal rib (as shown).
Claim 20: Further referring to Abrams, the channel or channels are laser cut (e.g. paragraphs 45 and 60), though it is noted that this amounts to a product-by-process limitation which does not necessarily limit the channel (see MPEP 2113), where the channel(s) have a depth measured from a rib surface adjacent to the channel down to a lowest point in a trough of the channel, the laser cut depth being from 30-60 microns (paragraph 61).
Claim 22: Okihara further discloses a film residing on at least a part of the circumferential outer portion of the gasket (paragraph 47).
Claim 25: Okihara discloses that there is no flowable lubricant in the tube (paragraph 48).
Claims 11, 15, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Okihara et al. and Abrams et al. as applied to claim 4 above, and further in view of Zarins et al. (U.S. PGPub 2022/0203084.
Claim 11 and 15: Okihara and Abrams teach a method substantially as claimed except for wherein the contact surface comprises a surface coating having low surface energy, specifically a fluorinated polymer which is a member selected from the group consisting of: fluorinated ethylene propylene (FEP), ethylene tetrafluoroethylene (ETFE), polytetrafluoroethylene (PTFE), polychlorotrifluoroethylene (PCTFE) and perfluoroalkoxy (PFA) (Okihara is silent regarding the material of the tube or its contact surface). However, Zarins teaches a tool (400) comprising a tube (404) for guiding a workpiece therethrough for installation into another tube (paragraph 80) wherein an internal contact surface of the tube comprises a surface coating having low surface energy, specifically a fluorinated polymer such as PTFE (paragraph 79). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have coated the contact surface of Okihara with such a material in order to have reduced friction (Id.). It further would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used any of the claimed materials since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960). Please note that in the instant application, paragraph 61, Applicant has not disclosed any criticality for the coating material other than to be low friction as also guided by Zarins.
Claim 16: For the same purpose as discussed above, Zarins alternatively or additionally teaches that the tube is composed of polyoxymethylene homopolymer, polytetrafluoroethylene or a melt blend of the two (paragraph 79). It further would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used any of the claimed materials since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960). Please note that in the instant application, paragraphs 52-53, Applicant has not disclosed any criticality for the coating material other than to be low friction as also guided by Zarins.
Claims 21, 23, 24, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Okihara et al. and Abrams et al. as applied to claims 4 and 18 above, and further in view of Tanaka et al. (U.S. Patent 5,586,975).
Claim 21: Okihara and Abrams teach a method substantially as claimed except for wherein the channel or channels are non-continuous. However, Tanaka et al. teaches a syringe gasket with non-continuous channels (G - Fig. 6). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided non-continuous channels since they help to minimize the amount of injection liquid which remains unused (column 7, lines 1-4).
Claim 23: Okihara further discloses a. the main body comprising an internal cavity (124), the cavity being defined by an inner surface portion of the gasket and being open-ended at one end (Fig. 3); and b. a film residing on at least a part of the circumferential surface portion of the gasket (paragraph 47). Abrams further teaches c. a plurality of channels (20 – one or more being contemplated, see paragraphs 44 and 60) in or through the film (Id.) being approximately parallel to the other channels (e.g. paragraph 60), each channel of the plurality of channels extending around the circumferential outer surface of the gasket (Id.). Okihara and Abrams do not teach that the channels are non-continuous and each channel having a non-channel portion interrupting the non-continuous channel, wherein the non-channel portion of each non-continuous channel is positioned along the circumferential outer surface portion of the gasket such that it is not aligned with the non-channel portion of the immediately adjacent non-continuous channel. However, Tanaka et al. teaches a syringe gasket with non-continuous channels (G - Fig. 6). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided non-continuous channels since they help to minimize the amount of injection liquid which remains unused (column 7, lines 1-4). In this case, at least one non-channel portion (31) interrupting the non-continuous channel is positioned along the circumferential outer surface portion of the gasket such that it is not aligned with a non-channel portion (one of several for each channel, such as one on the opposing circumferential side) of the immediately adjacent non-continuous channel. Additionally, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have arranged the non-channel portions as claimed since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950). Please note that in the instant application, e.g. paragraph 76, Applicant has not disclosed any criticality for the alignment of the non-channel portions.
Claims 24 and 26: Turning to Abrams, the plurality of (non-continuous as modified by Tanaka) channels are provided on a rib of the gasket, and the rib is a distal rib adjacent to the nose cone (see Fig. 3A).
Response to Arguments
Applicant's arguments filed 1/20/2026 have been fully considered.
With regard to the alleged ambiguity of Okihara as relating to the nature of the grooves 71, the examiner disagrees with Applicant’s interpretation that “the gap 70 and grooves 71 are depicted in the drawings as conduits recessed behind a wall” which is allegedly “supported by a plain visual inspection of the drawing figures and the similarity of the drawing figures' structural depiction of the grooves 71 to the vent 66, which is clearly an enclosed conduit rather than an open channel along a surface.”
To start, a “groove” would typically be understood as being open on one side rather than a closed, “internal channel” as suggested by Applicant. For example, referring to Dictionary.com, a groove is defined as “1. a long, narrow cut or indentation in a surface, as the cut in a board to receive the tongue of another board tongue-and-groove joint, a furrow, or a natural indentation on an organism.”
Fig. 5 of Okihara appears to show the groove 71 as not having a defined edge facing the inner volume of the body 60, which further implies it is open toward the inner surface or wall of the body 60.
The fact that the gap 70, formed by the groove 71, is formed between the inner wall of the body 60 and the gasket also suggests it is not an internal channel, otherwise it would be disclosed as being formed between the inner wall of the body and some other portion of the body. Additionally, the grooves could not be “formed on the inner wall of the jig body 60” [0099] if they were instead enclosed and internal to the inner wall structure of 60.
One of ordinary skill would have understood what was meant by the “inner wall” of the body 60, even if it was not specifically labeled, since the inner wall of a cylindrical tube is simple to understand and requires no further explanation. That wall also has a diameter, which is similarly simple to understand. That same wall has grooves defined therein, which are shown and described sufficiently in view of the understanding of a “groove”. While the examiner understands that the bottoms of the grooves might be said to effectively define a second (i.e. larger) diameter of the inner wall of the tube, the reference need not express this for the overall structure to be sufficiently clear. If one were to form vertical grooves along the inner wall of a tube, it is implicit that the structure between those grooves would be defined by the original inner diameter of the tube and that structure would contact the gasket while the gaps 70 defined by the grooves 71 would provide less or no such contact.
Regarding Applicant’s comparison to the vent 66, notably 66 is described as a “vent” whereas the “grooves” 71 are specifically described as such, as discussed above, so they are not necessarily the same structure.
Applicant argues the following with regard to the new limitations:
Further, even if Okihara did teach grooves 71 and a gap 70 of non-contact as the Examiner asserts (which Applicant contests), Okihara most certainly does not teach or suggest a contact surface that is convex, as the amended claims require. Convex contact surfaces could not be formed from "follow[ing] the inwardly rounded circumference of the tube inner wall," as the Examiner asserts on p. 7 of the Office Action with respect to now cancelled claim 7. Convex contact surfaces would advantageously minimize contact surface area while still stabilizing the gasket within the tube for smooth feeding of the gasket into the medical barrel.
The above amounts to speculatory benefits and arguments of counsel unsupported by evidence. There is no evidence of record that a convex surface is any better than a concave one in this regard, and the instant application contemplates both apparently equally (e.g. paragraph 57).
Okihara (per the Examiner's interpretation) would need to be fundamentally reconstructed to create convex contact surfaces in the tube for the gasket.
Okihara is silent to how portion 60 is manufactured. Merely changing the shape of the wall surface between grooves to be convex could be a trivial change in geometry formed by any of various common methods such as casting, 3D printing, machining, etc.
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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW P TRAVERS whose telephone number is (571)272-3218. The examiner can normally be reached 10:00AM-6:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sunil K. Singh can be reached at 571-272-3460. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Matthew P Travers/ Primary Examiner, Art Unit 3726