DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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
2. This is an office action in response to Applicant's arguments and remarks filed on 07/10/2026. Claims 1-2, 53-57, and 60-65 are pending in the application and are being examined herein.
Status of Objections and Rejections
3. All 35 U.S.C. 102(a)(1) rejections from the previous office action are withdrawn in view of Applicant's amendment.
New grounds of rejection under 35 U.S.C. 103 are necessitated by the amendments.
Response to Arguments
4. In the arguments presented on p.5 of the amendment, the Applicant argues that the modification of Rose (US 5965086 A, cited in prior office action) with Mermet (US 20200398041 A1, cited in prior office action) is incompatible because the modification ignores the difference in purposes of the devices disclosed in Rose (creating a sterile connection) and Mermet (pinch clamp for tube connection to a pump).
The Examiner does not find this argument persuasive. Mermet was brought in as a secondary reference as a known/conventional clamping means for its conduit. While Rose does teach a clamping means, the clamping means is not the structure that claim 1 recites, and thus, an alternative clamping means is substituted to achieve the same intended purpose of clamping a conduit/tubing. The nexus between the two references is the fact that both references are directed towards clamping means for a conduit/tubing. Per MPEP 2144.07, the selection of a known material based on its suitability for its intended use (i.e., clamping a tubing/conduit) supports a prima facie obviousness determination.
In the arguments presented on p.6 of the amendment, the Applicant argues that the Examiner’s assertion regarding the amended claim 1 limitation (original claim 59) of “critical zone” is misunderstood. Specifically, the mapped critical zone of Mermet is a hand-drawn zone in the pertinent Fig. 2 drawing provided in the prior office action and is not the same as the critical zone of the present application (i.e., a space between the clamp and the insulated portion of the insert that is not sufficiently heated during inductive sterilization).
The Examiner does not find this argument persuasive. Mermet does not need to disclose an insert because Rose does. The clamp setup of Rose is substituted with Mermet’s pinch clamp for the sole rationale that the clamping means of Rose and Mermet are interchangeable. Because the instant claim language does not sufficiently define what the critical zone is, the Examiner believes that any zone/area that may be subjectively “critical” would satisfy the term “critical zone” (hence the Mermet’s drawing annotations). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Even if there is nothing in Mermet that suggests that the pinch clamp disclosed therein can facilitate sterilization of a connection between two sections of tubing or conduit, or that there is a critical zone that does not get adequately sterilized by inductive heating, Applicant arguments do not take the place of evidence. The Examiner can only evaluate the capability of the structural substitution of Rose’s clamp with Mermet’s. Because Rose and Mermet both disclose the aforementioned zones (see claim 1 rejection drawing below), the aim was to show that one of ordinary skill would predictably find that the specific zones would also exist in the instant combination. There are no positively recited structural limitations in amended claim 1 that render the instant combination insufficient. It is important to note that the Applicant’s recitation of the clamp/critical/insulated zones are embedded in functional language of the collar. Because Mermet’s clamp assembly and Rose’s clamp assembly can have a critical zone, clamp zone, and insulated zone, the Rose/Mermet combination is fully capable of having a collar configured to make contact only with said critical zone located between a clamp zone directly adjacent to the clamp and an insulated zone formed by an overlap of the insert and the conduit.
Claim Rejections - 35 USC § 103
5. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
6. Claims 1-2, 53, and 60-64 are rejected under 35 U.S.C. 103 as being unpatentable over Rose et al. (US 5965086 A), further in view of Mermet (US 20200398041 A1).
Regarding claim 1, Rose teaches a system (Fig. 2A-2E) comprising an insert (metal tube 30, Fig. 2E) for connecting a conduit (16A and B, Fig. 2C) having an outer surface and an inner surface (outer and inner surface of tubing 16A and B, Fig. 2C), the insert comprising:
a body (metal tube 30, Fig. 2E) having an inner surface and an outer surface (inner tube surface and outer tube surface of metal tube 30, Fig. 2E), the body configured to connect with the conduit having the outer surface and the inner surface (Fig. 2E),
wherein the outer surface of the body of the insert is configured to engage with the inner surface of the conduit (outer surface of metal tube 30 engages with inner surface of tubing 16A/B, Fig. 2E),
wherein the body is configured for inductive heating of a connection of the insert and the conduit to a sterilizing temperature (col. 4, lines 43-46),
wherein the body is configured for inductive heating for a duration of time (col. 4, lines 43-46), and
wherein an interior of the connection of the insert and the conduit is sterilized as a result of the inductive heating (col. 4, lines 43-46); and
a clamp (22A and 22B, Fig. 2E), wherein the clamp (22A/B, Fig. 2E) comprises a base (22A/B, Fig. 2E).
Regarding the limitation of “a clamp configured to transmit inductive heat to the conduit”, this limitation is directed to the function of the apparatus. All the structural limitations of the claim has been disclosed by Rose and the apparatus of Rose is capable of transmitting inductive heat to the conduit. As such, it is deemed that the claimed apparatus is not differentiated from the applicant' s invention (see MPEP §2114).
NOTE: this is a recitation of intended use / functional language, and so long as the prior art structure reads on the instant claimed structure, this limitation would be met because the same structure would be capable of the same function; in this case, the clamp is a hemostat clamp (col. 4, 2nd paragraph), which are metallic in nature and are heat-conductive.
Per MPEP 2114,II, claims cover what a device is, not what a device does. A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim.
However, Rose fails to teach wherein the clamp comprises a base and a collar extending beyond the base, wherein the collar is configured to make contact only with a portion of the conduit in a critical zone located between a clamp zone directly adjacent to the clamp and an insulated zone formed by an overlap of the insert and the conduit, and wherein the collar transmits inductive heat to the critical zone.
Mermet teaches a clamp (Fig. 1-2), having a base (2, Fig. 1-2) and a collar (3, Fig. 1-2), for the same purpose as Rose’s clamps of closing/compressing/pinching a tube held by the clamp (Fig. 2 showing closed position, Fig. 1 showing open of conduit 4).
Rose and Mermet are both considered to be analogous to the claimed invention because they are in the same field of clamp-based sealing/closing of a tube/conduit it holds.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the clamps of Rose each with the clamp assembly of Mermet, because the substitution of this feature yields the predictable result of closing/compressing/pinching a tube held by the clamp (Mermet, Fig. 2 showing closed position, Fig. 1 showing open).
The limitation of “wherein the collar is configured to make contact only with a portion of the conduit in a critical zone located between a clamp zone directly adjacent to the clamp and an insulated zone formed by an overlap of the insert and the conduit” is directed to the function of the apparatus and/or the manner of operating the apparatus. All the structural limitations of the claim has been disclosed by the Rose/Mermet combination and the apparatus of the Rose/Mermet combination is capable of having a collar configured to make contact only with said critical zone located between a clamp zone directly adjacent to the clamp and an insulated zone formed by an overlap of the insert and the conduit. As such, it is deemed that the claimed apparatus is not differentiated from the applicant' s invention (see MPEP §2114).
NOTE: this is a recitation of intended use / functional language, and so long as the prior art structure reads on the instant claimed structure, this limitation would be met because the same structure would be capable of the same function; in this case, Rose teaches a clamp zone (conduit portions of 16A and B clamped by clamps 22A and 22B, Fig. 2E), an insulated zone formed by an overlap of the insert and the conduit (overlap of insert 30 and conduit portions 16A and B, Fig. 2E), and a critical zone (conduit portions 16A and B between said insulated and clamp zones, Fig. 2E). Mermet teaches its clamp collar in direct contact with its tubing. Mermet’s clamp assembly being substituted for Rose’s clamping having said zones would correlate to Mermet’s mapped respective zones (see drawing below). Thus, Mermet’s collar is fully capable of only making contact with said critical zone.
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The instant combination would further teach wherein the collar (Mermet, 3, Fig. 2) transmits inductive heat (Rose, heat generated by induction coil 32, Fig. 3) to the critical zone (heat will conduct through the collar to Rose’s tubing/insert because Mermet’s collar is in direct contact with its tubing, see drawing above).
Regarding claim 2, modified Rose teaches wherein the sterilizing temperature is between about 160°C and about 350°C (400°F ≈ 204°C).
Regarding the limitation of “the duration of time is between about 60 seconds and about 300 seconds”, this limitation is directed to the function of the apparatus. All the structural limitations of the claim has been disclosed by Rose and the metal tubing/body of Rose is capable of being heated to such a temperature from 60 to 300 seconds. As such, it is deemed that the claimed apparatus is not differentiated from the applicant' s invention (see MPEP §2114).
NOTE: this is a recitation of intended use / functional language, and so long as the prior art structure reads on the instant claimed structure, this limitation would be met because the same structure would be capable of the same function; in this case, the entire recited structure of claim 1 including the body is taught by Rose. Rose mentions that “the induction heating to sterilization temperatures occurs within such a short period of time that little softening or melting, if any, of the tubing material occurs” (col.5, lines 37-39); in view of the similar recited structure of claim 1, the material makeup of each of the individual components are configured to endure high temperatures during an inductive heating sterilization cycle (such as 204°C), and thus Rose’s system is fully capable of being induction heated from 60 to 300 seconds.
Regarding claim 53, the limitation of “wherein the body is configured for inductive heating for the duration of time of about 100 seconds” is directed to the function of the apparatus. All the structural limitations of the claim has been disclosed by modified Rose and the metal tubing/body of modified Rose is capable of being heated to such a temperature from 60 to 300 seconds. As such, it is deemed that the claimed apparatus is not differentiated from the applicant' s invention (see MPEP §2114).
NOTE: this is a recitation of intended use / functional language, and so long as the prior art structure reads on the instant claimed structure, this limitation would be met because the same structure would be capable of the same function; in this case, the entire recited structure of claim 1 including the body is taught by modified Rose. Modified Rose mentions that “the induction heating to sterilization temperatures occurs within such a short period of time that little softening or melting, if any, of the tubing material occurs” (col.5, lines 37-39); in view of the similar recited structure of claim 1, the material makeup of each of the individual components are configured to endure high temperatures during an inductive heating sterilization cycle (such as 204°C), and thus modified Rose’s system is fully capable of being induction heated from 60 to 300 seconds.
Regarding claim 60, Rose in view of Mermet teaches wherein the collar has a frustoconical shape (Mermet, flexible fingers 7 being part of the second part 3 and having a frustoconical shape, Fig. 2).
Regarding claim 61, Rose in view of Mermet teaches wherein the collar (3, Fig. 2) has an inwardly facing surface (flexible fingers 7, Fig. 2) configured to substantially conform with an outer surface of the clamped conduit (flexible fingers 7 conform to tube 4 shape, Fig. 2).
Regarding claim 62, modified Rose teaches an apparatus (coils 32, Fig. 2E and 3).
Regarding the limitation of “configured to make contact with the insert and the clamp and to deliver energy from an external energy source to the insert and the clamp in order to generate inductive heat in the insert and the clamp”, this limitation is directed to the function of the apparatus. All the structural limitations of the claim have been disclosed by modified Rose and the coils of modified Rose are capable of making contact with the insert and the clamp and delivering energy from an external energy source to the insert and the clamp in order to generate inductive heat in the insert and the clamp. As such, it is deemed that the claimed apparatus is not differentiated from the applicant' s invention (see MPEP §2114).
NOTE: this is a recitation of intended use / functional language, and so long as the prior art structure reads on the instant claimed structure, this limitation would be met because the same structure would be capable of the same function; in this case, modified Rose teaches an external energy source (“source of alternating current”, col.7, line 5) in order to generate inductive heat in the insert and the clamp (col. 4, lines 43-46) along with the recited structure of instant claim 1.
Regarding claim 63, modified Rose teaches an apparatus (coils 32, Fig. 2E and 3).
Regarding the limitation of “configured to accommodate or hold the conduit, the insert, and the clamp during the generation of the inductive heat”, this limitation is directed to the function of the apparatus. All the structural limitations of the claim have been disclosed by modified Rose and the coils of modified Rose are capable of holding/supporting the conduit, insert, and the clamp during inductive heat generation. As such, it is deemed that the claimed apparatus is not differentiated from the applicant' s invention (see MPEP §2114).
NOTE: this is a recitation of intended use / functional language, and so long as the prior art structure reads on the instant claimed structure, this limitation would be met because the same structure would be capable of the same function; in this case, modified Rose teaches an external energy source (“source of alternating current”, col.7, line 5) in order to generate inductive heat in the insert and the clamp (col. 4, lines 43-46) along with the recited structure of instant claim 1, where Fig. 3 displays the supporting of the coil relative to the apparatus of claim 1.
Regarding claim 64, modified Rose teaches an induction controller (AC current source, col.4, lines 48-53) configured to control provision of energy (turning the AC current source on/off is a control of the provision of energy) to the apparatus (coils 32, Fig. 2E and 3) to heat the insert and the clamp (heat radiating from the coils 32 would reach the clamp and insert), which transfer heat to sterilize the conduit (tubing 16A and 16B (not labeled, but shown) in connection with metal tube 30, Fig. 3).
7. Claim 54 is rejected under 35 U.S.C. 103 as being unpatentable over Rose et al. (US 5965086 A), further in view of Mermet (US 20200398041 A1), as applied to claim 1 above, and further in view of Smith (US 4443215 A, cited in prior office action).
Regarding claim 54, Rose teaches a conduit with a predetermined diameter (16A/B, Fig. 2E, col.6, lines 62-67), but fails to teach wherein the conduit has an outer diameter of between about 0.125 inches and about 1.25 inches.
Smith teaches a sterile docking process utilizing a metal tube (needle 20, Fig. 2) sealed at the ends by a conduit (11, 12, Fig. 2) utilizing induction heating (col.5, lines 45-46) to sterilize the metal tube and conduit assembly (col. 1, lines 7-9), wherein the conduit has an outer diameter of between about 0.125 inches and about 1.25 inches (4.2mm ≈ 0.165in, col. 6, lines 17-20), the outer diameter mentioned as a “conventional” value within the art.
Rose and Smith are both considered to be analogous to the claimed invention because they are in the same field of sterilizing connections between fluid conduit tubes, tubes which are in fluid connection to biological cell samples (Smith cites blood in col.1, lines 20-24, where Rose cites animal cells in col. 1, last paragraph).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the outer diameter of the conduit tubes of Rose to be 4.2mm/0.165in as taught by Smith, citing the diameter as a “conventional” value in the context of sterilizing connections between conduits in connection to animal cells (Smith cites blood in col.1, lines 20-24, where Rose cites animal cells in col. 1, last paragraph).
8. Claims 55-57 are rejected under 35 U.S.C. 103 as being unpatentable over Rose et al. (US 5965086 A), further in view of Mermet (US 20200398041 A1), as applied to claim 1 above, and further in view of Lathus et al. (US 20060081617 A1, cited in prior office action).
Regarding claim 55, Rose teaches an outer surface of the insert body (outer surface of metal tubing 30, Fig. 2E) in connection to an inner surface of a conduit (tubing 16A/B, Fig. 2E), but fails to teach wherein the outer surface of the body comprises at least one rib.
Lathus teaches an inductive heating apparatus (Fig. 1-2) for the decontamination of fluid connections between tubes (10, Fig. 2) and a connector (12, Fig. 2), where a plurality of V-shaped notches are present on the outer surface of the connector/insert (skirt 28, Fig. 2A) in order to “produce a hermetic engagement… with the inner layer… of the tube” ([0070]).
Rose and Lathus are both considered to be analogous to the claimed invention because they are in the same field of sterilizing connections between fluid conduit tubes and a connector/insert.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the outer surface of the metal tube/insert of Rose by incorporating a plurality of V-shaped notches as taught by Lathus in order to “produce a hermetic engagement… with the inner layer… of the tube” (Lathus, [0070]).
Regarding claim 56, Rose in view of Lathus teaches wherein the at least one rib comprises 3 ribs at each end of the insert (Lathus, three V-shaped notches on end of outer surface of connector 12, Fig. 2A), for the same modification purpose as stated in claim 55 rejection above.
Regarding claim 57, Rose in view of Lathus wherein each of the 3 ribs (Lathus, 3 V-shaped notches on connector 12, Fig. 2A) comprises a radially extending ridge (V-shaped notches are radially extending ridges, Fig. 2A) forming an engagement surface configured for engagement with the inner surface of the conduit (Lathus, [0070]).
9. Claim 65 is rejected under 35 U.S.C. 103 as being unpatentable over Rose et al. (US 5965086 A), further in view of Mermet (US 20200398041 A1), as applied to claim 1 above, and further in view of Sun et al. (CN 208713743 U, cited in prior office action)
Regarding claim 65, Rose teaches a clamp (22A/B, Fig. 2E), but fails to teach wherein the clamp comprises carbon steel.
Sun teaches a clamp (100, Fig. 1) similar in structure and function to Rose’s clamps, further mentioning “wherein, clamp is made of… carbon steel” (p.2, last paragraph of English translation).
Rose and Sun are both considered to be analogous to the claimed invention because they are in the same field of clamps for holding tubes.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the clamps of Rose by incorporating a clamp material makeup of carbon steel as suggested by Sun, because the selection of a known material based on its suitability for its intended use (i.e., clamping tubes) supports a prima facie obviousness determination (MPEP 2144.07).
Conclusion
10. 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.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Aham Lee whose telephone number is (703)756-5622. The examiner can normally be reached Monday to Thursday, 10:00 AM - 8:00 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris R. Kessel can be reached at (571) 270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Aham Lee/Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758
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