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 .
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.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/853,094 in view of Toth (Pub. No.: US 2021/0369937 A1).
This is a provisional nonstatutory double patenting rejection.
Claim 1 of copending Application No. 18/853,094 recites all the limitations of instant claim 1 except for the step of combining a derivatizing agent and at least a portion of the fluid stream; and analyzing at least a portion of the fluid stream via a visual test.
Toth teaches (1-3, 7) a method of assessing wound exudate (abstract) and thus in the same field of endeavor, comprising the steps of: removing via at least one suction line (wound drain 7) medical waste to generate a fluid stream in the at least one suction line (¶ 0035); and combining a derivatizing agent (biomarkers 50) and at least a portion of the fluid stream (fig. 7); and analyzing the at least one portion of the fluid stream via a visual test to (¶ 0114-¶ 0115), wherein such derivatizing agent interacts with the exudate and such visual test is useful for detecting the presence or absence of certain biological materials (¶ 0115).
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 method of claim 1 of copending Application No. 18/853,094 such that it comprises combining a derivatizing agent and at least a portion of the fluid stream and analyzing the at least a portion of the fluid stream via a visual test, as taught by Toth, in order to detect the presence or absence of certain biological materials (Toth, ¶ 0115).
Claim 2 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of copending Application No. 18/853,094 (reference application) in view of Toth.
Claim 3 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of copending Application No. 18/853,094 (reference application) in view of Toth.
Claim 4 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of copending Application No. 18/853,094 (reference application) in view of Toth.
Claim 3 of copending Application No. 18/853,094 (reference application) in view of Toth fail to disclose wherein the target material contained within the fluid stream is indicated via illumination.
Toth teaches wherein the target material contained within the fluid stream is indicated via illumination (Toth, ¶ 0114-¶ 0115), wherein such illumination allows the test to be read (¶ 0115).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Claim 3 of copending Application No. 18/853,094 (reference application) in view of Toth such that the target material contained within the fluid stream is indicated via illumination, as taught by Toth, in order to allow the test to be read (Toth, ¶ 0115).
Claim 5 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of copending Application No. 18/853,094 (reference application) in view of Toth.
As discussed above in claim 4, claim 3 of copending Application No. 18/853,094 (reference application) in view of Toth disclose wherein the target material contained in the fluid stream is indicated via illumination. Toth further teaches wherein the illumination is via a release of fluoresce or luminescent (¶ 0115).
Claim 6 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of copending Application No. 18/853,094 (reference application) in view of Toth.
Claim 7 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of copending Application No. 18/853,094 (reference application) in view of Toth.
Claim 8 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of copending Application No. 18/853,094 (reference application) in view of Toth.
Claim 9 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of copending Application No. 18/853,094 (reference application) in view of Toth.
Claim 10 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 8 of copending Application No. 18/853,094 (reference application) in view of Toth.
Claim 11 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 9 of copending Application No. 18/853,094 (reference application) in view of Toth.
Claim 12 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10 of copending Application No. 18/853,094 (reference application) in view of Toth.
Claim 13 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/853,094 (reference application) in view of Toth.
Claim 1 of copending Application No. 18/853,094 (reference application) in view of Toth fail to disclose wherein the visual test is performed by a user or a detection device.
Toth further teaches wherein the visual test is performed by a user or a detection device (¶ 0034, ¶ 0039), in order to allow the visual test to be analyzed (¶ 0039).
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 visual test of Claim 1 of copending Application No. 18/853,094 (reference application) in view of Toth such that it is performed by a user or a detection device, as taught by Toth, in order to allow the visual test to be analyzed (Toth ¶ 0039).
Claim 14 (corresponding to claim 11 “A system for performing the steps of claim 1” is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11 of copending Application No. 18/853,094 (reference application).
Claim Objections
Claim 13 is objected to because of the following informalities:
Claim 13, ln. 1 should read ---wherein the visual test is performed by a user---
Appropriate correction is required.
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 1-14 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 1 recites “steps of: (c) combing a derivatizing agent and at least a portion of the fluid stream; (c) analyzing the at least a portion of the fluid stream via a visual test to generate a result based on a predetermined criteria”. Claim 1 recites two step (c)’s. Appropriate correction is required.
Claims 2-14 are rejected due to dependency on claim 1.
The claims recite “11. The method of claim 9, wherein the visual indication is a symbol on the visual test.” and “11. A system for performing the steps of claim 1.” The second claim 11 will be interpreted as claim 14, “14. A system for performing the steps of claim 1.”
Claim Rejections - 35 USC § 103
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) 1-11, 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Locke et al. (Pub. No.: US 2022/0280712 A1) in view of Toth (Pub. No.: US 2021/0369937 A1).
Regarding claim 1, Locke discloses (fig. 1) a method of performing lavage (instillation therapy, abstract, ¶ 0004) comprising steps of:
Providing an irrigation fluid (solution source 145) to a surgical area (¶ 0003, ¶ 0024);
Removing via at least one suction line (fig. 1, see fluid connection from dressing 110 to negative-pressure source 105) the irrigation fluid and medical waste at the surgical area to generate a fluid stream in the at least one suction line (¶ 0026, ¶ 0053);
analyzing at least a portion of the fluid stream (see portion comprising diagnostic module 160) via a test to generate a result based on a predetermined criteria (fig. 5, steps 506, 508, 510, ¶ 0072-¶ 0073);
generating a feedback signal based on the result, wherein the feedback signal indicates whether the lavage has achieved the predetermined criteria (step 510, ¶ 0073); and
based on the outcome, either (1) if the predetermined criteria has not been achieved, repeating steps (a) through (d) until the lavage has achieved the predetermined criteria (step 516, ¶ 0074), or (2) if the predetermined criteria has been achieved, ending the lavage procedure (step 512, step 514, ¶ 0073).
Locke fails to disclose the step of: combining a derivatizing agent and at least a portion of the fluid stream and analyzing the at least a portion of the fluid stream via a visual test.
Toth teaches (1-3, 7) a method of assessing wound exudate (abstract) and thus in the same field of endeavor, comprising the steps of: removing via at least one suction line (wound drain 7) medical waste to generate a fluid stream in the at least one suction line (¶ 0035); and combining a derivatizing agent (biomarkers 50) and at least a portion of the fluid stream (fig. 7); and analyzing the at least one portion of the fluid stream via a visual test to (¶ 0114-¶ 0115), wherein such derivatizing agent interacts with the exudate and such visual test is useful for detecting the presence or absence of certain biological materials (¶ 0115).
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 method of Locke such that it comprises combining a derivatizing agent and at least a portion of the fluid stream and analyzing the at least a portion of the fluid stream via a visual test, as taught by Toth, in order to detect the presence or absence of certain biological materials (Toth, ¶ 0115).
Regarding claim 2, as discussed above in claim 1, 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 method of Locke such that it includes the visual test of Toth. Locke in view of Toth further disclose wherein the visual test is configured to test for a target material contained within the fluid stream (Toth, ¶ 0115).
Regarding claim 3, Locke in view of Toth further disclose wherein the target material includes at least one of a microorganism (¶ 0116), debris or non-endogenous protein.
Regarding claim 4, Locke in view of Toth disclose wherein the target material contained within the fluid stream is indicated via illumination (Toth, ¶ 0114-¶ 0115).
Regarding claim 5, Locke in view of Toth disclose wherein the illumination is via a release of fluoresce or luminescent (Toth, ¶ 0114-¶ 0115).
Regarding claim 6, Locke discloses wherein the test is performed in-line on the at least one suction line (¶ 0044).
Regarding claim 7, Locke discloses wherein the test is continuously performed on the fluid stream (¶ 0066).
Regarding claim 8, Locke discloses wherein the test is performed at least once and, if necessary, periodically thereafter on the fluid Stream (¶ 0066).
Regarding claim 9, Locke discloses wherein the feedback triggers a visual indication to a user (step 518, ¶ 0074).
Regarding claim 10, Locke in view of Toth fail to disclose wherein the visual indication is a light source.
Toth further teaches a visual indication that is a light source (¶ 0108) wherein such light is a suitable visual indicator (¶ 0108).
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 visual indicator of Locke in view of Toth such that it is a light source, as taught by Toth, as such light is a suitable visual indicator (Toth ¶ 0108).
Regarding claim 12, Locke in view of Toth fail to disclose wherein the visual test is performed remotely by obtaining a sample from the fluid stream.
Toth teaches (fig. 19) wherein the visual test is performed remotely by obtaining a sample from the fluid stream (¶ 0055), in order to prevent interrupting flow through the at least one suction line (¶ 0055).
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 method of Locke in view of Toth such that the visual test is performed remotely by obtaining a sample from the fluid stream, as taught by Toth, in order to prevent interrupting flow through the at least one suction line (Toth ¶ 0055).
Regarding claim 13, Locke discloses wherein the test is performed by a user or a detection device (¶ 0060).
Regarding claim 14, Locke in view of Toth disclose a system for performing the steps of claim 1 (Locke, fig. 1, Toth, fig. 7).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Locke in view of Toth, as applied to claim 9 above, and further in view of Rodrigues (Pub. No.: US 2022/0168491 A1).
Regarding claim 11, Locke in view of Toth fail to disclose wherein the visual indicator is a symbol on the visual test.
Rodrigues teaches a method including removing via at least one suction line medical waste (abstract) and thus in the same field of endeavor, comprising: a visual indicator that is a symbol (¶ 0122), wherein such symbol is suitable for indicating a condition (¶ 0122).
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 visual indication of Locke in view of Toth such that it is a symbol, as taught by Rodrigues, on the visual test, as symbols are suitable for indicating a condition (Rodrigues, ¶ 0122).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Marvin, III et al. (Pub. No.: US 2024/0115113 A1) discloses a method of performing lavage.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEAGAN NGO whose telephone number is (571)270-1586. The examiner can normally be reached M - TH 8:00 - 4:00 PT.
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, Sarah Al-Hashimi can be reached at (571) 272-7159. 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.
/MEAGAN NGO/Examiner, Art Unit 3781
/ANDREW J MENSH/Primary Examiner, Art Unit 3781
Prosecution Insights