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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 01/16/2026 is acknowledged.
Claims 34-59 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 01/16/2026.
Claim Objections
Claim 20 is objected to because the language “surrounded by a wall ends in an opening” requires correction. It is suggested to amend the language to read “surrounded by a wall ending in an opening”.
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 21, 23-26, and 28-30 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 21 recites the limitation “wherein the free connection opening and the opening of the wall have a minimum distance of at least or exactly 10 mm from each other.” Since the term “minimum distance” implies a range, it is unclear how the minimum distance between the two walls can be exactly 10 mm. A minimum distance of at least 10 mm is any distance of 10 mm or greater, and a minimum distance of exactly 10 mm is also any distance of 10 mm or greater.
Claim 23 recites the limitation "the front end" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claims 24-26 recite the limitation “wherein the part or portion of the cross-section of the rib structure which the recesses make up or receive in a cross-section of the connector by or across the rib structure is between … of the cross-section of the connector” which is unclear. For the purposes of compact prosecution, these limitations are interpreted as the percentage of the cross-sectional area of the connector that is recesses.
Claim 28 recites the limitation "some ribs" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 28 recites the limitation "the front end" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 29 recites the limitation "ribs" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 30 is also rejected based on its dependency on Claim 29.
Claim 30 recites the limitation “a connector” which is also recited in Claim 20. It is unclear if this recitation of “a connector” is intended to refer to the same connector or a different connector as the connector in Claim 20. For the purpose of compact prosecution, these limitations are interpreted as referring to the same connector.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 20-26 and 31-33 are rejected under 35 U.S.C. 103 as being unpatentable over Choksi (US 5176415) in view of Tanner et al (US 8215492).
Regarding Claims 20 and 21, Choksi discloses a disposable (Fig. 2) comprising:
a fluid line (30, Fig. 2) and a connector (male unit 25, Fig. 2) with a connector lumen (interior of first tubular member 27, Fig. 2) for fluidically connecting the fluid line (30, Fig. 2) with a first lumen (interior of second tubular member 28, Fig. 2) of a first fluid guide (second tubular member 28, Fig. 2) of a port (26, Fig. 2) of a medical treatment apparatus (Fig. 2), wherein the port (26, Fig. 2) further comprises a second lumen (lumen between skirt 34 and tube 28, Fig. 2) for receiving a section of the connector (25, Fig. 2), wherein the connector (25, Fig. 2) comprises a touch-protection cover (skirt 33, Fig. 2) with a free connection opening (as seen in Fig. 2, the left side of skirt 33 has an opening), wherein inside the touch-protection cover (33, Fig. 2) the connector lumen (interior of 27, Fig. 2) is surrounded by a wall (27a, Fig. 2) ending in an opening (27b, Fig. 2), wherein the free connection opening and the opening (27b, Fig. 2) of the wall (27a, Fig. 2) have a minimum distance from each other (as seen in Fig. 2, there is a spaced distance between the two ends; Col. 3 lines 12-27 describes how the skirts should be long enough to prevent inadvertent touching of surface 27b).
Choksi is silent whether the free connection opening and the opening of the wall have a minimum distance of at least 5 mm from each other, or at least 10 mm from each other.
Tanner teaches a cartridge for water treatment, thus being in the same field of endeavor of fluid management devices that have ports/tubes that should not be touched during use, with a distance (L6, Fig. 9) between a free connection opening (opening of 30, Fig. 9) and the opening of the wall (28, Fig. 9) is in the range of 0 mm to 10 mm (Col. 8 lines 3-6). This helps prevent the user from touching the opening of the wall 28 and contaminating the surface (Col. 7 lines 27-39).
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 minimum distance between the free connection opening and the opening of the wall of Choksi to have a minimum distance of 0 mm to 10 mm, as taught by Tanner, to prevent the user from touching the opening of the wall and contaminating the surface (as motivated by Tanner Col. 7 lines 27-39).
Choksi/Tanner discloses a minimum distance of 0 mm to 10 mm.
However, Choksi/Tanner does not explicitly disclose the minimum distance is at least 10 mm.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the minimum distance of Choksi/Tanner to be from 0 mm to 10 mm to at least 10 mm as applicant appears to have placed no criticality on the claimed range (see ¶ [0076] of Applicant’s published specification indicating the minimum distance is “preferably” within the claimed range) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding Claim 22, Choksi further discloses the connector (25, Fig. 2) comprises a rib structure (threading 57, Fig. 2) on an outside thereof, and wherein the rib structure (57, Fig. 2) is arranged to be introduced in sections into the second lumen (lumen between skirt 34 and tube 28, Fig. 2; Fig. 2a shows the threading placed within the second lumen) of the port (26, Fig. 2) when the connector (25, Fig. 2) is connected to the medical treatment apparatus (as seen in Fig. 2a).
Regarding Claim 23, Choksi further discloses the rib structure (57, Fig. 2) extends up to the front end (40, Fig. 2) of the connector (25, Fig. 2).
Regarding Claims 24-26, Choksi further discloses the rib structure (57, Fig. 2) comprises adjacent ribs which delimit recess that are arranged between them (as seen in Fig. 2).
Choksi/Tanner is silent whether the recesses make up between 5 and 15%, 10% and 12%, or more than 12% of the cross-sectional area of the connector.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Choksi/Tanner to have the recesses make up between 5 and 15%, between 10% and 12%, or more than 12% of the cross-sectional area of the connector since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Choksi/Tanner would not operate differently with any of the claimed recess area percentages the device would function appropriately as a threaded connector. Further, applicant places no criticality on the range claimed, indicating simply that the recess area is for example within the claimed ranges (¶ [0070] of Applicant’s published specification).
Regarding Claims 31-33, Choksi/Tanner is silent whether the rib structure comprises at least 16 ribs distributed over the circumference of the touch-protection cover, at least 18 ribs distributed over the circumference of the touch-protection cover, or at least 20 ribs distributed over the circumference of the touch-protection cover.
However, it would have been obvious to one of ordinary skill in the art to modify the number of threads, and therefore the number of ribs, distributed over the circumference of the touch-protection cover, to allow the connector to mate with various other sizes of connectors. Therefore, it would have been obvious to have the rib structure comprise at least 20 ribs distributed over the circumference of the touch-protection cover to allow the connector to mate with a connector with at least 20 recesses.
Claim(s) 20 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Szpara et al (US 2017/0319768) in view of Tanner et al (US 8215492).
Regarding Claims 20 and 21, Szpara discloses a disposable (Fig. 3D) comprising:
a fluid line and a connector with a connector lumen for fluidically connecting the fluid line with a first lumen of a first fluid guide of a port of a medical treatment apparatus, wherein the port further comprises a second lumen for receiving a section of the connector, wherein the connector comprises a touch-protection cover with a free connection opening, wherein inside the touch-protection cover the connector lumen is surrounded by a wall ending in an opening, wherein the free connection opening and the opening of the wall have a minimum distance (D, Fig. 3D) from each other (see Image 1).
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Image 1: Annotated Fig. 3D of Szpara
Szpara is silent whether the free connection opening and the opening of the wall have a minimum distance of at least 5 mm from each other, or at least 10 mm from each other.
Tanner teaches a cartridge for water treatment, thus being in the same field of endeavor of fluid management devices that have ports/tubes that should not be touched during use, with a distance (L6, Fig. 9) between a free connection opening (opening of 30, Fig. 9) and the opening of the wall (28, Fig. 9) is in the range of 0 mm to 10 mm (Col. 8 lines 3-6). This helps prevent the user from touching the opening of the wall 28 and contaminating the surface (Col. 7 lines 27-39).
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 minimum distance between the free connection opening and the opening of the wall of Szpara to have a minimum distance of 0 mm to 10 mm, as taught by Tanner, to prevent the user from touching the opening of the wall and contaminating the surface (as motivated by Tanner Col. 7 lines 27-39).
Szpara/Tanner discloses a minimum distance of 0 mm to 10 mm.
However, Szpara/Tanner does not explicitly disclose the minimum distance is at least 10 mm.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the minimum distance of Szpara/Tanner to be from 0 mm to 10 mm to at least 10 mm as applicant appears to have placed no criticality on the claimed range (see ¶ [0076] of Applicant’s published specification indicating the minimum distance is “preferably” within the claimed range) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Claim(s) 22-33 are rejected under 35 U.S.C. 103 as being unpatentable over Szpara et al (US 2017/0319768) in view of Tanner et al (US 8215492) further in view of Ryan (US 5066286).
Regarding Claims 22, 23, 27, and 28, Szpara/Tanner is silent whether the connector comprises a rib structure on an outside thereof, and wherein the rib structure is arranged to be introduced in sections into the second lumen of the port when the connector is connected to the medical treatment apparatus, wherein the rib structure extends up to the free connection opening or to the front end of the disposable or of the connector, wherein the rib structure comprises ribs having at least or precisely two lengths that differ from each other, and wherein some ribs of the rib structure extend to the connection opening or to the front end of the disposable or of the connector, however, others do not.
Ryan teaches a medical connector, thus being in the same field of endeavor, with a connector (312, Fig. 1a) comprising a rib structure (ribs 337, Fig. 1a) on an outside (334, Fig. 1a) thereof, wherein the rib structure (337, Fig. 1a) extends up to the free connection opening (leftmost edge of 334, Fig. 1a), wherein the rib structure comprises ribs (337, Fig. 1a) having two lengths (as seen in Fig. 1a) that differ from each other, wherein some ribs of the rib structure (337, Fig. 1a) extend to the connection opening (leftmost edge of 334, Fig. 1a) however others do not (as seen in Fig. 1a), to allow the user to more easily grip the assembly during mating (Col. 3 lines 46-50).
Therefore, it would have been obvious to modify the outside of the connector of Szpara/Tanner to include a rib structure extending up to the free connection opening, wherein the rib structure comprises ribs having at least or precisely two lengths that differ from each other, and wherein some ribs of the rib structure extend to the connection opening or to the front end of the disposable or of the connector, however, others do not, as taught by Ryan, to allow the user to more easily grip the connector during mating (as motivated by Ryan Col. 3 lines 46-50). The combination of Szpara/Tanner/Ryan would have the rib structure arranged to be introduced in sections into the second lumen of the port when the connector is connected to the medical treatment apparatus (see Image 1).
Regarding Claims 24-26, Szpara/Tanner/Ryan further discloses the rib structure comprises adjacent ribs which delimit recess that are arranged between them (as seen in Fig. 1a of Ryan).
Szpara/Tanner/Ryan is silent whether the recesses make up between 5 and 15%, 10% and 12%, or more than 12% of the cross-sectional area of the connector.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Szpara/Tanner/Ryan to have the recesses make up between 5 and 15%, between 10% and 12%, or more than 12% of the cross-sectional area of the connector since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Szpara/Tanner/Ryan would not operate differently with any of the claimed recess area percentages the device would function appropriately as a connector with ribs for enhanced grasp. Further, applicant places no criticality on the range claimed, indicating simply that the recess area is for example within the claimed ranges (¶ [0070] of Applicant’s published specification).
Regarding Claims 29 and 30, Szpara further discloses the connector comprises a drip disc and a disc structure (see Image 1), and ribs that extend between the drip disc and the disc structure (as seen in Fig. 3C). These ribs can be considered as part of the “rib structure” of the device of Szpara/Tanner/Ryan, and therefore ribs of the rib structure are arranged between the drip disc and the disc structure. Additionally, the drip disc and the disc structure extend at an angle between 75 and 105 to a flow-through lumen of the connector as both extend at a 90 degree angle from the connector.
Regarding Claims 31-33, Szpara/Tanner/Ryan is silent whether the rib structure comprises at least 16 ribs distributed over the circumference of the touch-protection cover, at least 18 ribs distributed over the circumference of the touch-protection cover, or at least 20 ribs distributed over the circumference of the touch-protection cover.
However, it would have been obvious to one of ordinary skill in the art to modify the number of ribs distributed over the circumference of the touch-protection cover, to increase the surface area of the touch-protection cover and therefore increase the manipulability of the connector. Therefore, it would have been obvious to have the rib structure comprise at least 20 ribs distributed over the circumference of the touch-protection cover to allow the connector to mate with a connector with at least 20 recesses.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 20-23 and 27-31 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 7, and 8 of copending Application No. 17/495,254 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending application claims are merely narrower than the instant claims. Since it has been held that the species anticipates the genus, the copending claims anticipate the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/JESSICA ARBLE/ Primary Examiner, Art Unit 3781
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