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 Species A and C, readable on claims 1-4, 6-20 in the reply filed on 7/28/2026 is acknowledged.
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 9 and 10 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 9 recites the limitation "the valve actuator" in Line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation “a triangular protrusion comprising two channels” in Line 2, wherein it’s unclear how the two channels of the triangular protrusion correspond to the container outlet and container inlet previously recited in claim 1. For example, it’s unclear if these features are being redundantly recited or if the two channels are distinct from the container outlet and container inlet. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 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.
Claims 1-4, 7, 8, 11-17 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cronk et al. (US Patent No. 4,870,975, hereinafter Cronk).
In regard to claim 1, Cronk discloses a sampling system (Fig. 1) for the use with an endoscope having a suction channel and a suction connector in communication with said suction channel, the suction connector being a male connector with a longitudinal axis (the sampling system is capable of use with an endoscope as claimed), the sampling system comprising:
a sample container (11) including an opening (Fig. 1); and
a sampling device (12,14) including:
an inlet (41) configured to be connected to the suction connector of the endoscope (Fig. 1, the inlet is capable of connection with a suction connector of the endoscope);
an outlet vacuum connector (38) configured to be connected to a vacuum source separate from the endoscope, the vacuum source creating suction, through the outlet vacuum connector, at the inlet, and through the inlet at the suction channel of the endoscope (Fig. 1, the outlet vacuum connector is capable of functioning as claimed);
a container outlet (36) configured to be inserted through the opening of the sample container (Fig. 1);
a container inlet (35) configured to be inserted through the opening of the sample container (Fig. 1);
wherein said sampling device is sized and configured to form a rigid connection with said endoscope when connected to the suction connector thereof (the end of tube (41) is capable of forming a rigid connection with the suction connector of an endoscope),
wherein the sampling device comprises a female connector configured to engage the suction connector of the endoscope (via end of tube (41) is a female connector capable of connection with a suction connector of an endoscope),
wherein an insertion direction extends along the longitudinal axis, and wherein the sampling device is configured to engage the suction connector of the endoscope in the insertion direction (the end of tube (41) is capable of engaging the suction connector of an endoscope in the insertion direction).
In regard to claim 2, Cronk teaches wherein the container outlet and the container inlet comprise longitudinal protrusions (35, 36) that extend in parallel with the insertion direction and are configured to engage the sample container by insertion, in the insertion direction, into the opening of the sample container (Fig. 1, the protrusions are capable of engaging the sample container by insertion in the insertion direction depending on the positioning of the endoscope).
In regard to claim 3, Cronk teaches wherein the sampling device comprises a valve (17) configured to divert the suction through the sample container, and wherein the valve comprises a rotatable shaft having a longitudinal axis that is perpendicular to the insertion direction (Col. 3, Line 64 – Col. 4, Line 17).
In regard to claim 4, Cronk teaches wherein the female connector of the sampling device is adapted to receive the suction connector of the endoscope to form said rigid connection, and the sampling device is furthermore configured to engage the endoscope in a manner preventing rotation around the suction connector (via friction fit between the end of tube (41) and the suction connector of the endoscope).
In regard to claim 7, Cronk teaches wherein the sampling device comprises a valve (17) configured to divert the suction through the sample container (Fig. 1).
In regard to claim 8, Cronk teaches wherein the valve comprises a valve actuator configured to change a state of the valve and divert the suction through the sampling device (Col. 3, Line 64 – Col. 4, Line 17).
In regard to claim 11, Cronk teaches wherein the sampling device comprises a
sample container connector adapted for connecting the sample container (via flange portion (30), Fig. 1).
In regard to claim 12, Cronk teaches wherein the sample container connector extends in a direction parallel to or coincident with said insertion direction (Fig. 1, the container is capable of extending in a direction parallel with the insertion direction depending on the positioning of the endoscope).
In regard to claim 13, Cronk teaches wherein the sample container connector is adapted to penetrate at least one seal of the sample container (Col. 4, Lines 18-30).
In regard to claim 14, Cronk teaches wherein the sample container comprises a self-sealing membrane covering the opening (Col. 4, Lines 18-30).
In regard to claim 15, Cronk teaches wherein the sampling device further comprises a suction reduction valve fluidly coupled between the inlet and the outlet (via valve means (17) adjusting flow between the sampling device and the sample container).
In regard to claim 16, Cronk teaches wherein the sampling device further comprises a suction reduction valve fluidly coupled between the inlet and the outlet (via valve means (17) adjusting flow between the sampling device and the sample container), and wherein the sampling device further comprises a pressure indicator fluidly coupled between the inlet and the outlet (via a pressure within stockette (13) can visually observed via expansion of the stockette as it’s filled with solid matter).
In regard to claim 17, ‘298 teaches the system further comprising the endoscope, wherein the sampling system is arranged in a kit (the sampling system is used with a medical device and is capable of being used as a kit).
In regard to claim 20, Cronk teaches wherein the outlet vacuum connector is a male connector configured to receive a hose from the vacuum source which is configured to be connected to the male connector when the sampling device is not used (Fig. 1), and wherein the outlet vacuum connector has a longitudinal axis that is not parallel to the insertion direction (the outlet vacuum connector is capable of being non-parallel to the insertion direction depending on positioning of the endoscope).
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 1-4, 6-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 12,161,298 (hereinafter ‘298). Although the claims at issue are not identical, they are not patentably distinct from each other as shown in the claim mappings below.
In regard to claim 1, ‘298 discloses a sampling system for the use with an endoscope having a suction channel and a suction connector in communication with said suction channel, the suction connector being a male connector with a longitudinal axis (see Claim 1), the sampling system comprising:
a sample container including an opening (see Claim 1); and
a sampling device including:
an inlet configured to be connected to the suction connector of the endoscope (see Claim 1);
an outlet vacuum connector configured to be connected to a vacuum source separate from the endoscope, the vacuum source creating suction, through the outlet vacuum connector, at the inlet, and through the inlet at the suction channel of the endoscope (see Claim 1);
a container outlet configured to be inserted through the opening of the sample container (see Claim 1)
a container inlet configured to be inserted through the opening of the sample container (see Claim 1);
wherein said sampling device is sized and configured to form a rigid connection with said endoscope when connected to the suction connector thereof (see Claim 1),
wherein the sampling device comprises a female connector configured to engage the suction connector of the endoscope (see Claim 1),
wherein an insertion direction extends along the longitudinal axis (see Claim 1), and
wherein the sampling device is configured to engage the suction connector of the endoscope in the insertion direction (see Claim 1).
In regard to claim 2, ‘298 teaches wherein the container outlet and the container inlet comprise longitudinal protrusions that extend in parallel with the insertion direction and are configured to engage the sample container by insertion, in the insertion direction, into the opening of the sample container (see Claim 2).
In regard to claim 3, ‘298 teaches wherein the sampling device comprises a valve configured to divert the suction through the sample container, and wherein the valve comprises a rotatable shaft having a longitudinal axis that is perpendicular to the insertion direction (see Claim 4).
In regard to claim 4, ‘298 teaches wherein the female connector of the sampling device is adapted to receive the suction connector of the endoscope to form said rigid connection, and the sampling device is furthermore configured to engage the endoscope in a manner preventing rotation around the suction connector (see Claim 2).
In regard to claim 6, ‘298 teaches wherein the sampling device comprises a valve configured to divert the suction through the sample container, wherein the valve comprises a valve actuator configured to change a state of the valve, wherein the valve actuator is positioned less than 3 cm from a handle of the endoscope, wherein the valve actuator comprises a rotatable shaft having a longitudinal axis that is perpendicular to the insertion direction, and wherein the valve actuator is sized and configured to be accessible and operable using a single finger of a hand of an operator gripping the endoscope with said hand (see Claim 6).
In regard to claim 7, ‘298 teaches wherein the sampling device comprises a valve configured to divert the suction through the sample container (see Claim 4).
In regard to claim 8, ‘298 teaches wherein the valve comprises a valve actuator configured to change a state of the valve and divert the suction through the sampling device (see Claim 5).
In regard to claim 9, ‘298 teaches wherein the valve actuator is sized and configured to be operated using a single finger of a hand of an operator gripping the endoscope and is located in a position on said sampling device which, when the rigid connection is formed between the sampling device and the endoscope, is accessible and operable by the finger of the hand of the operator (see Claim 6).
In regard to claim 10, ‘298 teaches wherein the sampling device comprises a triangular protrusion comprising two channels, and wherein the sample container comprises a complementary triangular receptacle configured to receive the triangular protrusion and the two channels (Claim 26).
In regard to claim 11, ‘298 teaches wherein the sampling device comprises a
sample container connector adapted for connecting the sample container (Claim 7).
In regard to claim 12, ‘298 teaches wherein the sample container connector extends in a direction parallel to or coincident with said insertion direction (see Claim 8).
In regard to claim 13, ‘298 teaches wherein the sample container connector is adapted to penetrate at least one seal of the sample container (see Claim 9).
In regard to claim 14, ‘298 teaches wherein the sample container comprises a self-sealing membrane covering the opening (see Claim 10).
In regard to claim 15, ‘298 teaches wherein the sampling device further comprises a suction reduction valve fluidly coupled between the inlet and the outlet (see claim 14).
In regard to claim 16, ‘298 teaches wherein the sampling device further comprises a suction reduction valve fluidly coupled between the inlet and the outlet, and wherein the sampling device further comprises a pressure indicator fluidly coupled between the inlet and the outlet (see claim 15).
In regard to claim 17, ‘298 teaches the system further comprising the endoscope, wherein the sampling system is arranged in a kit (see Claim 19).
In regard to claim 18, ‘298 teaches wherein the sampling device comprises a valve configured to divert the suction through the sample container, wherein the valve comprises a rotatable shaft having a longitudinal axis that is perpendicular to the insertion direction, wherein the sampling device comprises a housing supporting the rotatable shaft, the inlet, and the outlet vacuum connector, and wherein the housing comprises a flange configured to snap into engagement with the endoscope to further secure the rigid connection against rotation, wherein the sampling device further comprises, coupled between the inlet and the outlet, a suction reduction valve and a pressure indicator (see Claims 6,14,15).
In regard to claim 19, ‘298 teaches wherein the sampling device comprises a valve configured to divert the suction through the sample container, wherein the valve comprises a rotatable shaft having a longitudinal axis that is perpendicular to the insertion direction, wherein the sampling device comprises a housing supporting the rotatable shaft, the inlet, and the outlet vacuum connector, and wherein the housing comprises a flange configured to snap into engagement with the endoscope to further secure the rigid connection against rotation (see Claim 6).
In regard to claim 20, ‘298 teaches wherein the outlet vacuum connector is a male connector configured to receive a hose from the vacuum source which is configured to be connected to the male connector when the sampling device is not used, and wherein the outlet vacuum connector has a longitudinal axis that is not parallel to the insertion direction (see Claim 24).
Allowable Subject Matter
Claims 6, 18 and 19 would be allowable if a terminal disclaimer were filed to overcome the double patenting rejections.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RYAN N HENDERSON whose telephone number is (571)270-1430. The examiner can normally be reached Monday-Friday 6am-5pm (PST).
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, Anhtuan Nguyen can be reached at 571-272-4963. 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.
/RYAN N HENDERSON/Primary Examiner, Art Unit 3795 August 22, 2026
Prosecution Insights