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 .
Election/Restrictions
2. Claims 17, 19, 21, 23-29, 31, 33, 34, 37-39 and 52 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/11/2026.
Applicant’s election without traverse of Group I in the reply filed on 02/11/2026 is acknowledged.
Claim Rejections - 35 USC § 102
3. 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.
4. Claims 1-2, 53, and 62-64 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rose et al. (US 5965086 A, provided in Applicant’s IDS filed 09/21/2023).
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).
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.
Regarding claim 2, 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 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 62, 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 Rose and the coils of 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, 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, 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 Rose and the coils of 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, 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, 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).
Claim Rejections - 35 USC § 103
5. 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.
6. Claim 54 is rejected under 35 U.S.C. 103 as being unpatentable over Rose et al. (US 5965086 A) as applied to claim 1 above, and further in view of Smith (US 4443215 A, provided in Applicant’s IDS filed 09/21/2023).
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).
7. Claims 55-57 are rejected under 35 U.S.C. 103 as being unpatentable over Rose et al. (US 5965086 A) as applied to claim 1 above, and further in view of Lathus et al. (US 20060081617 A1, provided in Applicant’s IDS filed 09/21/2023).
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]).
8. Claims 58-61 are rejected under 35 U.S.C. 103 as being unpatentable over Rose et al. (US 5965086 A) as applied to claim 1 above, and further in view of Mermet (US 20200398041 A1).
Regarding claim 58, Rose teaches wherein the clamp (22A/B, Fig. 2E) comprises a base (22A/B, Fig. 2E), but fails to teach a clamp collar extending beyond the base.
Mermet teaches a clamp (Fig. 1-2), having a base (2, Fig. 1-2) and a collar (3, Fig. 1-2), for the purpose 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 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).
Regarding claim 59, Rose in view of Mermet teaches wherein the collar (Mermet, 3, Fig. 2) is configured to make contact with a portion of the conduit (4, Fig. 2) in a critical zone (see drawing below) located between a clamp zone directly adjacent to the clamp (see drawing below) and an insulated zone formed by an overlap of the insert and the conduit (Rose teaches the insulated zone of the insert and the conduit, Fig. 2E, but in view of the clamping substitution modification, the insulated zone would thus include said insert/conduit interface portion of Rose, see drawing below), for the same modification purpose as stated in claim 58 rejection above..
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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), for the same modification purpose as stated in claim 58 rejection above.
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).
9. Claim 65 is rejected under 35 U.S.C. 103 as being unpatentable over Rose et al. (US 5965086 A) as applied to claim 1 above, and further in view of Sun et al. (CN 208713743 U)
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. 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