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 .
Status of Claims
2. This action is responsive to the “RESPONSE TO RESTRICTION REQUIREMENT” filed on 12/05/2025. Claims 1-32 are pending in the application. However, for the reasons noted below (Election/Restriction), claims 16-32 are withdrawn from consideration. As such, claims 1-15 have been examined on the merits.
Election/Restriction
3. Applicant’s election without traverse of Group I (claims 1-15) in the reply filed on 12/05/2025 is acknowledged. Claims 16-32 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim.
Claim Rejections - 35 USC § 101
4. 35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
5. Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
6. Claims 1-15 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
7. Independent claim 1 recites the limitation “the measurement lumen including an outlet at a distal end thereof through which the electrically-conductive fluid exits the measurement lumen and contacts an intestinal tissue of a subject to provide electrical coupling between the measurement electrode and the intestinal tissue” (emphasis added) in lines 8-11. As such, because claim 1 positively recites (and requires) contact with an intestinal tissue, claim 1 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as encompassing a human organism, and as therefore being directed to non-statutory subject matter.
To obviate the rejection, Examiner suggests reciting “is configured to contact an intestinal tissue” or “is adapted to contact an intestinal tissue.”
8. Claims 2-15 are rejected as ultimately depending from a claim (claim 1) rejected under 35 U.S.C. § 101.
9. Claim 14 recites the limitation “wherein intestinal tissue comprises epithelial intestinal tissue of the small intestine of the subject” in lines 1-2. As such, because claim 14 positively recites (and requires) a tissue, claim 14 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as encompassing a human organism, and as therefore being directed to non-statutory subject matter. It is also noted that that this limitation also fails to further limit any of the recited structural elements of the system of claim 1.
Claim Rejections - 35 USC § 112
10. 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.
11. Claims 7-10 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
12. Claim 7 recites the limitation “the reference tube” in line 3. There is insufficient antecedent basis for this recitation in the claim.
13. Claims 8-10 are rejected as ultimately depending from a claim (claim 7) rejected under 35 U.S.C. 112(b).
Claim Rejections - 35 USC § 103
14. 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.
15. The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
16. Claims 1, 6-9, & 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over WO 88/06860 to Højgaard et al. (“Højgaard”) [made of record in Applicant’s 12/18/24 IDS] in view of U.S. Patent No. 5,551,425 to Essen-Moller ("Essen-Moller").
17. Regarding claim 1, Højgaard teaches a system for determining intestinal potential difference, comprising:
a measurement probe comprising a measurement tube [electrolyte reservoir (26) - pg. 35, ll. 12-20; FIGS. 4-5] having a measurement lumen [reservoir (26) is shaped as a hollow cylinder - pg. 35, ll. 17-20] which houses a measurement electrode [PD measuring electrode (23) - pg. 35, line 8] therein [FIG. 5];
***
…an electrically-conductive fluid [PD measuring electrolyte (36) - pg. 35, ll. 32-35; FIGS. 4-5] [in] the measurement lumen [(26)] such that the electrically-conductive fluid [(36)] is electrically coupled to the measurement electrode [(23)] [pg. 36, ll. 1-4; FIGS. 4-5], and
the measurement lumen [(26)] including an outlet at a distal end thereof [pores of ceramic body (35) comprise an “outlet” - pg. 35, ll. 32-35; FIGS. 4, 7] through which the electrically-conductive fluid [(36)] exits the measurement lumen [(26)] and contacts an intestinal tissue of a subject [see FIG. 7] to provide electrical coupling between the measurement electrode and the intestinal tissue; [and]
a controller coupled to the measurement electrode [(23)] configured to measure a potential difference between the measurement electrode [(23)] and a reference electrode [reference electrode (53) - pg. 36, lines 5+; FIG. 6] electrically coupled to the subject [see, e.g., pg. 33, lines 8+; pg. 34, ll. 4-20; pg. 37, ll. 16-30 (computer 632)].
Measurement Fluid Delivery System
Højgaard teaches that electrolyte reservoir (26) is supplied detached from the measurement electrode (23) [e.g., pg. 34, ll. 24-47]. Højgaard further teaches that electrolyte reservoir (26) may be porous, or designed so as to provide a “controlled leak,” and may be of any suitable design [pg. 26, ll. 20-33; pg. 27, ll. 17-28].
Højgaard does not, however, teach the following emphasized claim limitations:
a measurement fluid delivery system in fluid communication with the measurement lumen,
the measurement fluid delivery system being configured to deliver an electrically-conductive fluid into the measurement lumen [(26)] such that the electrically-conductive fluid [(36)] is electrically coupled to the measurement electrode [(23)].
However, the use of a measurement fluid delivery system for delivering an electrically-conductive fluid into the measurement lumen of a measurement probe was well known in the art, before the effective filing date of the claimed invention.
As one example, Essen-Moller, in a similar field of endeavor, teaches a perfusion catheter for measuring potential difference across the gastrointestinal wall [e.g., Abstract]. More particularly, Essen-Moller teaches a system comprising a catheter (1) [measurement probe], and a perfusion pump (21) [measurement fluid delivery system] for providing a flow of perfused solution to lumen (3) of catheter (1) [via capillary (22)/tube (23)] [col. 2, ll. 53-64].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Højgaard to include a measurement fluid delivery system in fluid communication with the measurement lumen, the measurement fluid delivery system being configured to deliver an electrically-conductive fluid into the measurement lumen [(26)] such that the electrically-conductive fluid [(36)] is electrically coupled to the measurement electrode [(23)], since such a delivery technique for the provision of an electrically-conductive fluid was recognized as part of the ordinary capabilities of one skilled in the art (as demonstrated by Essen-Moller), and one of ordinary skill in the art would have been capable of applying this known technique to the known device of Højgaard, and the results (electrically-conductive fluid supply) would have been entirely predictable to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
18. Regarding claim 6, the combination of Højgaard and Essen-Moller teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Højgaard further teaches wherein the reference electrode [reference electrode (53)] is electrically coupled to a tissue of the subject [e.g., pg. 10, ll. 22-25; pg. 11, ll. 14-19; pg. 13, ll. 7-10; pg. 14, line 34 - pg. 15, line 8].
19. Regarding claim 7, the combination of Højgaard and Essen-Moller teaches all of the limitations of claim 6 for the reasons set forth in detail (above) in the Office Action.
Højgaard further teaches wherein the reference electrode [reference electrode (53)] is housed within a reference probe, wherein the reference tube comprises a reference lumen which houses the reference electrode therein [pg. 33, line 14 - pg. 34, line 3; pg. 34, line 32 - pg. 35, line 7; pg. 36, ll. 5-21; FIGS. 1, 3, 6].
20. Regarding claim 8, the combination of Højgaard and Essen-Moller teaches all of the limitations of claim 7 for the reasons set forth in detail (above) in the Office Action.
Højgaard further teaches wherein the reference probe further comprises a reference fluid delivery system [infusion reference system - pg. 33, lines 16+; FIG. 1] in communication with the reference lumen, wherein the reference fluid delivery system is configured to deliver an electrically-conductive fluid into the reference lumen [pg. 33, lines 18-20 (“The infusion reference system is filled with an infusion fluid 90, such as 0.15 M NaCl solution, functioning as the PD reference electrolyte”)] such that the electrically-conductive fluid is electrically coupled to the reference electrode [pg. 33, ll. 21-25], and
wherein the reference lumen includes an outlet at a distal end thereof through which the electrically-conductive fluid exits the reference lumen and contacts the tissue to provide electrical coupling between the reference electrode and the tissue [e.g., pg. 15, ll. 8-21 (“infusion of fluids”); FIG. 1].
21. Regarding claim 9, the combination of Højgaard and Essen-Moller teaches all of the limitations of claim 8 for the reasons set forth in detail (above) in the Office Action.
Højgaard further teaches wherein the reference probe further comprises at least one of a skin patch [pg. 16, ll. 1-7] or a needle fluidly coupled to the reference lumen by the electrically-conductive fluid, wherein the skin patch or needle is configured to contact the tissue such that the tissue is electrically coupled to the reference electrode by the electrically-conductive fluid [pg. 16, ll. 1-7].
22. Regarding claim 12, the combination of Højgaard and Essen-Moller teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Højgaard further teaches wherein the measurement electrode [PD measuring electrode (23)] comprises an Ag/AgCl electrode [pg. 35, line 9].
23. Regarding claim 13, the combination of Højgaard and Essen-Moller teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Højgaard was modified above (in the rejection of claim 1) to include the measurement fluid delivery system of Essen-Moller.
Essen-Moller further teaches wherein the measurement fluid delivery system comprises a perfusion pump [perfusion pump (21)] and perfusion tube [either capillary (22) or tube (23)] [see col. 2, ll. 53-64; and FIG. 1], and
wherein the electrically-conductive fluid comprises a saline solution [col. 1, ll. 57-58 (“a saline perfused exploring electrode catheter”)].
24. Regarding claim 14, the combination of Højgaard and Essen-Moller teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Højgaard further teaches wherein intestinal tissue comprises epithelial intestinal tissue of the small intestine of the subject [e.g., pg. 12, ll. 17-31].
25. Claims 2-5 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Højgaard and Essen-Moller, as applied to claim 1 above, and further in view of WO 2018/200440 to Tearney et al. ("Tearney").
26. Regarding claims 2-5, the combination of Højgaard and Essen-Moller teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
The combination of Højgaard and Essen-Moller does not, however, teach:
[claim 2] wherein the measurement probe further comprises a proximity sensor for determining a proximity of a distal end of the measurement tube to the intestinal tissue;
[claim 3] wherein the proximity sensor comprises an optical fiber disposed within the measurement tube, wherein a distal end of the optical fiber is configured to emit an electromagnetic radiation from the distal end of the measurement tube;
[claim 4] wherein the optical fiber of the proximity sensor comprises an optical coherence tomography (OCT) system, wherein the optical fiber comprises a sample arm of the OCT system, and wherein the OCT system further comprises a reference arm; nor
[claim 5] wherein the OCT system further comprises optics coupled to the distal end of the optical fiber for focusing light onto the intestinal tissue and receiving light backscattered from the intestinal tissue.
Tearney, in a similar field of endeavor, teaches apparatuses and methods for providing access transnasally to luminal gastrointestinal spaces in subjects [e.g., ¶[0002]].
More particularly, Tearney further teaches that:
[claim 2] it was known for a probe to include a proximity sensor [optical fiber] which can obtain location information (e.g., M-mode OCT images) for determining a proximity of a distal end of the measurement tube to the intestinal tissue [e.g., ¶[0085]];
[claim 3] wherein the proximity sensor comprises an optical fiber [¶[0085]] disposed within the measurement tube, wherein a distal end of the optical fiber is configured to emit an electromagnetic radiation from the distal end of the measurement tube [e.g., ¶’s [0071]-[0073], [0082], [0085]];
[claim 4] wherein the optical fiber of the proximity sensor comprises an optical coherence tomography (OCT) system [see ¶’s [0071], [0073], [0082], [0085] (“M-mode OCT images”)], wherein the optical fiber comprises a sample arm of the OCT system, and wherein the OCT system further comprises a reference arm [¶’s [0071]-[0073], [0082] & [0085]]; and
[claim 5] wherein the OCT system further comprises optics coupled to the distal end of the optical fiber for focusing light onto the intestinal tissue and receiving light backscattered from the intestinal tissue [e.g., ¶[0071]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Højgaard and Essen-Moller to include a proximity sensor for determining a proximity of a distal end of the measurement tube to the intestinal tissue, or, more particularly, wherein the proximity sensor comprises an optical fiber disposed within the measurement tube, wherein a distal end of the optical fiber is configured to emit an electromagnetic radiation from the distal end of the measurement tube, wherein the optical fiber of the proximity sensor comprises an optical coherence tomography (OCT) system, wherein the optical fiber comprises a sample arm of the OCT system, and wherein the OCT system further comprises a reference arm, & wherein the OCT system further comprises optics coupled to the distal end of the optical fiber for focusing light onto the intestinal tissue and receiving light backscattered from the intestinal tissue, all as taught by Tearney, since such a modification would help a physician ensure that the measurement probe of Højgaard & Essen-Moller is properly placed (i.e., in contact with the intestinal tissue) such that successful electrical coupling between the measurement electrode and the intestinal tissue can be achieved, thereby facilitating the procedure for the physician.
Still further, all the claimed elements were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results [proximity sensing through the acquisition of M-mode OCT images] to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
27. Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Højgaard and Essen-Moller, as applied to claim 1 above, and further in view of U.S. Patent Application Publication No. 2019/0365270 to Bachelder et al. ("Bachelder").
28. Regarding claim 10, the combination of Højgaard and Essen-Moller teaches all of the limitations of claim 9 for the reasons set forth in detail (above) in the Office Action.
The combination of Højgaard and Essen-Moller does not, however, teach:
wherein the skin patch comprises an abrasive substance to abrade an adjacent region of skin of the subject.
Bachelder, in a similar field of endeavor, teaches that it was known for a skin patch (electrode) to include an electrically conductive fluid or gel that is at least partially abrasive and/or includes abrasive elements to facilitate abrading the skin [see, e.g., ¶[0093] (“Examples of abrasive elements to be included in the electrically conductive fluid or gel may include particles of silica or silicon oxide, aluminum oxide, pumice, clay, lanolin, jojoba oil, to name a few”)].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Højgaard and Essen-Moller such that the skin patch comprises an abrasive substance to abrade an adjacent region of skin of the subject since such a modification would provide the benefits/advantages of reducing skin-electrode impedance and enhancing conductivity.
29. Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Højgaard and Essen-Moller, as applied to claim 1 above, and further in view of U.S. Patent Application Publication No. 2002/0193670 to Garfield et al. ("Garfield").
30. Regarding claim 11, the combination of Højgaard and Essen-Moller teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Højgaard further teaches wherein the controller is coupled to the measurement electrode and the reference electrode… for receiving electrical signals acquired by the measurement electrode and reference electrode, and wherein the controller comprises a processor configured to determine from the received signals the potential difference between the measurement electrode and the reference electrode [pg. 37, line 16 - pg. 38, line 7].
The combination of Højgaard and Essen-Moller does not, however, teach the following emphasized claim limitations:
wherein the controller is coupled to the measurement electrode and the reference electrode through an isolation head-stage and a bio-amplifier for receiving electrical signals…
Garfield, in a similar field of endeavor, teaches that it was well known in the art to utilize amplifiers, isolation head-stages, filters, etc. when processing electrical bio-signals acquired from a patient for the purposes of, e.g., noise elimination and signal amplification [e.g., ¶’s [0057]-[0059]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Højgaard and Essen-Moller to include well-known signal-processing components including, e.g., wherein the controller is coupled to the measurement electrode and the reference electrode through an isolation head-stage and a bio-amplifier, since all the claimed elements were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results [conventional signal processing] to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
31. Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Højgaard and Essen-Moller, as applied to claim 1 above, and further in view of U.S. Patent Application Publication No. 2021/0393954 to Pikov ("Pikov").
32. Regarding claim 15, the combination of Højgaard and Essen-Moller teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
While Højgaard teaches that the measurement probe may be inserted in a variety of manners, including endoscopes and plastic tubes [e.g., pg. 3, ll. 7-13; pg. 12, ll. 2-16; pg. 12, ll. 22-31]; the combination of Højgaard and Essen-Moller does not explicitly teach:
wherein the measurement probe is configured to be inserted into the subject using a trans-nasal introduction tube (TNIT).
Pikov, in a similar field of endeavor, teaches that it was known to introduce a device into, e.g., the duodenum using a trans-nasal catheter [see, e.g., ¶[0065] (“For example, the temporary signal delivery device may be attached to a trans-nasal or a trans-oral catheter to deliver intraluminal intestinal electrical stimulation (e.g., a screening stimulation signal). Methods of placing the temporary signal delivery device may comprise inserting a trans-nasal or trans-oral catheter with the temporary signal delivery device and advancing the distal end toward and into the duodenum. The non-surgical catheter insertion may be performed without anesthesia or under local anesthesia, and a hospital stay may not be required”)].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Højgaard and Essen-Moller such that the measurement probe is configured to be inserted into the subject using a trans-nasal introduction tube (TNIT) [trans-nasal catheter] since such a delivery technique was recognized as part of the ordinary capabilities of one skilled in the art (as demonstrated by Pikov), and one of ordinary skill in the art would have been capable of applying this known technique to the known device of Højgaard and Essen-Moller, and the results (delivery of the measurement probe via a trans-nasal device) would have been entirely predictable to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Still further, use of a trans-nasal approach provides the benefits/advantages of being able to be performed without anesthesia or under local anesthesia, and possibly without requiring a hospital stay [Pikov, ¶[0065]].
Conclusion
33. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Bradford C. Blaise whose telephone number is (571)272-5617. The examiner can normally be reached on Monday - Friday 8 AM-5 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Linda Dvorak can be reached on 571-272-4764. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Bradford C. Blaise/Examiner, Art Unit 3794