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 .
Status of Claims
In the present application, claims 1-20 are currently pending and examined below.
Claim Objections
Claims 6 and 9 are objected to because of the following informalities:
Claims 6 and 9 both recites a typo in the limitation “the reference waveform time-series change.” The limitation should be corrected to state, the reference waveform of time-series change.”
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 1-20 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 1 recites the limitation “while supplying gas into the stomach” in lines 4-5. However line 3 of claim 1 also recites the limitation of “supplying gas into the stomach.” Therefore it is unclear whether the limitation in lines 4-5 is supplying new and distinct gas or merely referencing the same supply of gas previously introduced in line 3. Claims 2-9 and 17-20 are also rejected because they are dependent on the rejected base claim 1. Appropriate correction is required.
Claim 1 recites the limitation "the internal pressure value" in line 6. There is insufficient antecedent basis for this limitation in the claim. It is suggested to amend the limitation to ‘an internal pressure value.” Claims 2-9 and 17-20 are also rejected because they are dependent on the rejected base claim 1. Appropriate correction is required.
Claim 3 recites the limitation "the reference waveform" in line 2. There is insufficient antecedent basis for this limitation in the claim. It is suggested to amend the limitation to state, “the reference waveform of time-series change.” Appropriate correction is required.
Claim 3 recites the limitation "the target waveform" in line 4. There is insufficient antecedent basis for this limitation in the claim. It is suggested to amend the limitation to state, “the target waveform of time-series change.” Appropriate correction is required.
Claim 3 recites the limitation “when gas is supplied into the stomach” in lines 2-3. However line 3 of claim 1 also recites the limitation of “supplying gas into the stomach.” Therefore it is unclear whether the limitation in lines 2-3 of claim 2 is supplying new and distinct gas or merely referencing the same supply of gas previously introduced in line 3. Claims 2-9 and 17-20 are also rejected because they are dependent on the rejected base claim 1. Appropriate correction is required.
Claim 4 recites the limitation "the reference waveform" in line 2. There is insufficient antecedent basis for this limitation in the claim. It is suggested to amend the limitation to state, “the reference waveform of time-series change.” Appropriate correction is required.
Claim 4 recites the limitation "the target waveform" in line 4. There is insufficient antecedent basis for this limitation in the claim. It is suggested to amend the limitation to state, “the target waveform of time-series change.” Appropriate correction is required.
Claim 4 recites the limitation “when gas is supplied into the stomach” in lines 2-3. However line 3 of claim 1 also recites the limitation of “supplying gas into the stomach.” Therefore it is unclear whether the limitation in lines 2-3 of claim 2 is supplying new and distinct gas or merely referencing the same supply of gas previously introduced in line 3 of claim 1. Claims 2-9 and 17-20 are also rejected because they are dependent on the rejected base claim 1. Appropriate correction is required.
Claim 4 recites the term “around” twice in lines 4 and 7, which is a relative term which renders the claim indefinite. The term “around” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore the amount that is considered to be “around the maximum value” is unclear, thus the claim is indefinite. Appropriate correction is required.
Claim 5 recites the limitation "the maximum value" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 5 recites the limitation "the threshold value" in line 3. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 6 recites the limitation "the maximum value" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 6 recites the limitation "the threshold value" in line 3. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 6 recites the term “around” in line 2, which is a relative term which renders the claim indefinite. The term “around” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore the amount that is considered to be “around the maximum value” is unclear, thus the claim is indefinite. Appropriate correction is required.
Claim 7 recites the limitation "the second waveform" in line 3. There is insufficient antecedent basis for this limitation in the claim. It is suggested to amend the limitation to state, “the second reference waveform of time-series change.” Appropriate correction is required.
Claim 7 recites the limitation “when gas is supplied into the stomach” in lines 4-5. However line 3 of claim 1 also recites the limitation of “supplying gas into the stomach.” Therefore it is unclear whether the limitation in lines 4-5 of claim 7 is supplying new and distinct gas or merely referencing the same supply of gas previously introduced in line 3 of claim 1. Appropriate correction is required.
Claim 7 recites the limitation "the first waveform of time-series change" in lines 5-6. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 8 recites the term “substantially” in line 2, which is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore it is unclear what exactly the degree of volume of gas is necessary that is substantially identical to a volume of gas which causes a person without GERD to have a body reflex of a closing cardia. Appropriate correction is required.
Claim 9 recites the limitation “the maximum value" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 9 recites the limitation "the threshold value" in line 3. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 9 recites the limitation "the second reference waveform of time-series change" in lines 5-6. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 10 recites the limitation "the internal pressure value" in line 6. There is insufficient antecedent basis for this limitation in the claim. Claims 11-15 are also rejected because of their dependence on the rejected base claim 10. Appropriate correction is required.
Claim 10 recites the term “around” in line 7, which is a relative term which renders the claim indefinite. The term “around” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore it is unclear to what degree the maximum value of internal pressure should be. Claims 11-15 are also rejected because of their dependence on the rejected base claim 10. Appropriate correction is required.
Claim 10 recites the limitation "the person" twice in lines 9 and 10-11. There is insufficient antecedent basis for this limitation in the claim. Claims 11-15 are also rejected because of their dependence on the rejected base claim 10. Appropriate correction is required.
Claim 11 recites the limitation "the person" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 11 recites the term “around” in line 3, which is a relative term which renders the claim indefinite. The term “around” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore it is unclear to what degree the maximum value should be. Appropriate correction is required.
Claim 12 recites the limitation "the person" in line 3. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 12 recites the limitation “when gas is supplied into the stomach” in line 4. However line 3 of claim 10 also recites the limitation of “supplying gas into the stomach.” Therefore it is unclear whether the limitation in line 4 of claim 12 is supplying new and distinct gas or merely referencing the same supply of gas previously introduced in line 3 of claim 10. Appropriate correction is required.
Claim 12 recites the limitation in line 5 stating “inserting an endoscope into a stomach of a subject.” However claim 12 depends on claim 10 and claim 10 recites the same limitation. Therefore it is unclear whether the limitation in claim 12 is a mere reference to claim 10 or introducing a separate and distinct endoscope, stomach, and subject. Appropriate correction is required.
Claim 12 recites the limitation "the internal pressure value" in line 6. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "the second waveform of time-series change" twice in line 3 and 5. There is insufficient antecedent basis for this limitation in the claim. It is suggested to amend the limitation to state, “the second reference waveform of time-series change.” Appropriate correction is required.
Claim 13 recites the limitation “when gas is supplied into the stomach” in lines 4-5. However line 3 of claim 1 also recites the limitation of “supplying gas into the stomach.” Therefore it is unclear whether the limitation in lines 4-5 of claim 7 is supplying new and distinct gas or merely referencing the same supply of gas previously introduced in line 3 of claim 1. Appropriate correction is required.
Claim 13 recites the limitation "the first waveform of time-series change" in lines 5-6. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 14 recites the term “substantially” in line 2, which is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore it is unclear what exactly the degree of volume of gas is necessary that is substantially identical to a volume of gas which causes a person without GERD to have a body reflex of a closing cardia. Appropriate correction is required.
Claim 15 recites the limitation "the second reference waveform of time-series change" in lines 5-6. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 16 recites the limitation "the first waveform of time-series change" in lines 5-6. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 16 recites the limitation “while supplying gas into the stomach” in lines 9-10. However line 8 of claim 16 also recites the limitation of “supplying gas into the stomach.” Therefore it is unclear whether the limitation in lines 9-10 is supplying new and distinct gas or merely referencing the same supply of gas previously introduced in line 8. Appropriate correction is required.
Claim 17 recites the limitation “while supplying gas into the stomach” in lines 2-3. However line 3 of claim 1 also recites the limitation of “supplying gas into the stomach.” Therefore it is unclear whether the limitation in lines 2-3 of claim 17 is supplying new and distinct gas or merely referencing the same supply of gas previously introduced in line 3 of claim 1. Appropriate correction is required.
Claim 17 recites the limitation "the maximum value" in line 4. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 17 recites the limitation "the internal pressure value" in line 5. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 18 recites the limitation “while supplying gas into the stomach” in line 2. However line 3 of claim 1 also recites the limitation of “supplying gas into the stomach.” Therefore it is unclear whether the limitation in line 2 of claim 18 is supplying new and distinct gas or merely referencing the same supply of gas previously introduced in line 3 of claim 1. Appropriate correction is required.
Claim 18 recites the limitation "the maximum value" in line 4. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 18 recites the limitation "the waveform" in line 5. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 18 recites the limitation "the internal pressure value" in line 5. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 19 recites the limitation "the maximum value" twice in lines 2 and 4. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 19 recites the limitation "the threshold value" twice in lines 2-3 and 5. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
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 1-13 and 15-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-7, and 15 of U.S. Patent No. 12,226,200. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-13 and 15-20 are anticipated by claims 1-3, 5-7, and 15 of the reference patent. Every limitation is recited in the conflicting reference patent claims, and the similarities between the claims are highlighted below with bold lettering.
Application 19/014376
US Patent No.12,226,200
Claim No.
Claim Text
Claim No.
Claim Text
1.
A method for diagnosing gastro esophageal reflux disease (GERD), comprising:
inserting an endoscope into a stomach of a subject;
supplying gas into the stomach of the subject;
measuring an internal pressure within the stomach of the subject while supplying gas into the stomach of the subject using the endoscope to obtain a waveform of time-series change of the internal pressure value of the subject;
obtaining a target waveform of time-series change of the internal pressure in the stomach of the subject; and
comparing at least the target waveform of time-series change to at least a reference waveform of time-series change of an internal pressure within a stomach of a person without GERD.
1.
A method for diagnosing gastro esophageal reflux disease (GERD), comprising:
identifying a threshold value of an internal pressure within a stomach of a person without GERD;
obtaining a first waveform of time-series change of the internal pressure within the stomach of the person without GERD, wherein the first waveform of time-series change increases to the threshold value when gas is supplied into the stomach;
obtaining a second waveform of time-series change of an internal pressure within a stomach of a person with GERD, wherein the second waveform of time-series change repeatedly increases and decreases within a pressure range when gas is supplied into the stomach and the second waveform of time-series change is flatter than the first waveform of time-series change;
inserting an endoscope into a stomach of a subject;
supplying a volume of gas substantially identical to a volume of gas which causes a person without GERD to have a body reflex of a closing cardia;
measuring an internal pressure only within the stomach of the subject while supplying gas into the stomach of the subject using the endoscope to obtain a waveform of time-series change of the internal pressure value of the subject, the internal pressure including a maximum value of the internal pressure in the stomach of the subject;
obtaining a third waveform of time-series change of the internal pressure value in the stomach of the subject;
comparing the maximum value of the subject to the threshold value of the person without GERD;
comparing the third waveform of time-series change to the first waveform of time-series change;
comparing the third waveform of time-series change to the second waveform of time-series change;
determining whether the subject has GERD based on the comparison of the maximum value of the subject to the threshold value of the person without GERD, the comparison of the third waveform of time-series change to the first waveform time-series change, and the comparison of the third waveform of time-series change to the second waveform of the time-series change.
2.
The method according to Claim 1, further comprising:
determining whether the subject has GERD based on the comparison of at least the target waveform of time-series change to at least the reference waveform time-series change.
1.
determining whether the subject has GERD based on the comparison of the maximum value of the subject to the threshold value of the person without GERD, the comparison of the third waveform of time-series change to the first waveform time-series change, and the comparison of the third waveform of time-series change to the second waveform of the time-series change.
3.
The method according to Claim 1, wherein:
the reference waveform increases to a threshold value when gas is supplied into the stomach;
the target waveform includes a maximum value of the internal pressure in the stomach of the subject; and
the method further comprises:
comparing the maximum value of the subject to the threshold value of the person without GERD.
1.
measuring an internal pressure only within the stomach of the subject while supplying gas into the stomach of the subject using the endoscope to obtain a waveform of time-series change of the internal pressure value of the subject,
the internal pressure including a maximum value of the internal pressure in the stomach of the subject;
comparing the maximum value of the subject to the threshold value of the person without GERD;
4.
The method according to Claim 1, wherein: the reference waveform increases to a threshold value when gas is supplied into the stomach;
the target waveform includes a maximum value of the internal pressure in the stomach of the subject; and
the method further comprises: comparing around the maximum value of the subject to the threshold value of the person without GERD.
1.
measuring an internal pressure only within the stomach of the subject while supplying gas into the stomach of the subject using the endoscope to obtain a waveform of time-series change of the internal pressure value of the subject,
the internal pressure including a maximum value of the internal pressure in the stomach of the subject;
comparing the maximum value of the subject to the threshold value of the person without GERD;
5.
The method according to Claim 1, further comprising:
determining whether the subject has GERD based on the comparison of the maximum value of the subject to the threshold value of an internal pressure within a stomach of a person without GERD and the comparison of at least the target waveform of time-series change to at least the reference waveform time-series change.
1.
determining whether the subject has GERD based on the comparison of the maximum value of the subject to the threshold value of the person without GERD, the comparison of the third waveform of time-series change to the first waveform time-series change, and the comparison of the third waveform of time-series change to the second waveform of the time-series change.
6.
The method according to Claim 1, further comprising:
determining whether the subject has GERD based on the comparison around of the maximum value of the subject to the threshold value of an internal pressure within a stomach of a person without GERD and the comparison of at least the target waveform of time-series change to at least the reference waveform time-series change.
1.
determining whether the subject has GERD based on the comparison of the maximum value of the subject to the threshold value of the person without GERD, the comparison of the third waveform of time-series change to the first waveform time-series change, and the comparison of the third waveform of time-series change to the second waveform of the time-series change.
7.
The method according to Claim 1, further comprising:
obtaining a second reference waveform of time-series change of an internal pressure within a stomach of a person with GERD, wherein the second waveform of time-series change repeatedly increases and decreases within a pressure range when gas is supplied into the stomach and the second reference waveform of time-series change is flatter than the first waveform of time-series change; and
comparing the target waveform of time-series change to the second reference waveform of time-series change.
1.
obtaining a second waveform of time-series change of an internal pressure within a stomach of a person with GERD, wherein the second waveform of time-series change repeatedly increases and decreases within a pressure range when gas is supplied into the stomach and the second waveform of time-series change is flatter than the first waveform of time-series change;
comparing the third waveform of time-series change to the second waveform of time-series change;
8.
The method according to Claim 1, further comprising:
supplying a volume of gas substantially identical to a volume of gas which causes a person without GERD to have a body reflex of a closing cardia.
1.
supplying a volume of gas substantially identical to a volume of gas which causes a person without GERD to have a body reflex of a closing cardia;
9.
The method according to Claim 1, further comprising:
determining whether the subject has GERD based on the comparison of the maximum value of the subject to the threshold value of the person without GERD, the comparison of the target waveform of time-series change to the reference waveform time-series change, and the comparison of the target waveform of time-series change to the second reference waveform of the time-series change.
1.
determining whether the subject has GERD based on the comparison of the maximum value of the subject to the threshold value of the person without GERD, the comparison of the third waveform of time-series change to the first waveform time-series change, and the comparison of the third waveform of time-series change to the second waveform of the time-series change.
10.
A method for diagnosing gastro esophageal reflux disease (GERD), comprising:
inserting an endoscope into a stomach of a subject;
supplying gas into the stomach of the subject;
measuring an internal pressure within the stomach of the subject while supplying gas into the stomach of the subject using the endoscope to obtain a waveform of time-series change of the internal pressure value of the subject, the waveform including a maximum value or around a maximum value of the internal pressure in the stomach of the subject; and
comparing the maximum value of the subject to a threshold value of an internal pressure within a stomach of the person without GERD, wherein the threshold value is defined by identifying an internal pressure of time-series change within a stomach of the person without GERD.
7.
A method for diagnosing gastro esophageal reflux disease (GERD), comprising:
identifying a threshold value of an internal pressure within a stomach of a person without GERD,
obtaining a first waveform of time-series change of the internal pressure within the stomach of the person without GERD, wherein the first waveform of time-series change increases to the threshold value when gas is supplied into the stomach
obtaining a second waveform of time-series change of an internal pressure within a stomach of a person with GERD, wherein the second wave form of time-series change repeatedly increases and decreases within a pressure range when gas is supplied into the stomach and the second waveform of time-series change is flatter than the first waveform of time-series change;
inserting an endoscope into a stomach of a subject;
supplying a volume of gas into the stomach using the endoscope;
measuring an internal pressure only within the stomach of the subject while supplying gas into the stomach using the endoscope to obtain a waveform of time-series change of the internal pressure value of the subject, the internal pressure including
a maximum value of the internal pressure in the stomach of the subject;
obtaining a third waveform of time-series change of the internal pressure value in the stomach of the subject;
comparing the maximum value of the subject to the threshold value of the person without GERD;
comparing the third waveform of time-series change to the first waveform of time-series change;
comparing the third waveform of time-series change to the second waveform of time-series change;
determining whether the subject has GERD based on the comparison of the maximum value of the subject to the threshold value of the person without GERD, the comparison of the third waveform of time-series change to the first waveform time-series change, and the comparison of the third waveform of time-series change to the second waveform of the time-series change.
11.
The method according to Claim 10, further comprising:
determining whether the subject has GERD based on the comparison of the maximum value or around the maximum value of the subject to the threshold value of the person without GERD.
7.
determining whether the subject has GERD based on the comparison of the maximum value of the subject to the threshold value of the person without GERD, the comparison of the third waveform of time-series change to the first waveform time-series change, and the comparison of the third waveform of time-series change to the second waveform of the time-series change.
12.
12. The method according to Claim 10, further comprising:
identifying a reference waveform of time-series change of the internal pressure within the stomach of the person without GERD, wherein the reference waveform of time-series change increases to the threshold value when gas is supplied into the stomach;
inserting an endoscope into a stomach of a subject;
obtaining a target waveform of time-series change of the internal pressure value in the stomach of the subject; and
comparing the target waveform of time-series change to the reference waveform of time-series change.
7.
obtaining a first waveform of time-series change of the internal pressure within the stomach of the person without GERD, wherein the first waveform of time-series change increases to the threshold value when gas is supplied into the stomach;
inserting an endoscope into a stomach of a subject;
obtaining a third waveform of time-series change of the internal pressure value in the stomach of the subject;
comparing the third waveform of time-series change to the first waveform of time-series change;
13.
The method according to Claim 10, further comprising:
obtaining a second reference waveform of time-series change of an internal pressure within a stomach of a person with GERD, wherein the second waveform of time-series change repeatedly increases and decreases within a pressure range when gas is supplied into the stomach and the second waveform of time-series change is flatter than the first waveform of time-series change;
comparing the target waveform of time-series change to the second reference waveform of time-series change.
7.
obtaining a second waveform of time-series change of an internal pressure within a stomach of a person with GERD, wherein the second wave form of time-series change repeatedly increases and decreases within a pressure range when gas is supplied into the stomach and the second waveform of time-series change is flatter than the first waveform of time-series change;
comparing the third waveform of time-series change to the second waveform of time-series change;
15.
The method according to Claim 10, further comprising:
determining whether the subject has GERD based on the comparison of the maximum value of the subject to the threshold value of the person without GERD, the comparison of the target waveform of time-series change to the reference waveform time-series change, and the comparison of the target waveform of time-series change to the second reference waveform of the time-series change.
7.
determining whether the subject has GERD based on the comparison of the maximum value of the subject to the threshold value of the person without GERD, the comparison of the third waveform of time-series change to the first waveform time-series change, and the comparison of the third waveform of time-series change to the second waveform of the time-series change.
16.
A method for diagnosing gastro esophageal reflux disease (GERD), comprising:
identifying a threshold value of an internal pressure within a stomach of a person without GERD;
identifying a reference waveform of time-series change of the internal pressure within the stomach of the person without GERD, wherein the first waveform of time-series change increases to the threshold value when gas is supplied into the stomach;
inserting an endoscope into a stomach of a subject;
supplying gas into the stomach of the subject;
measuring an internal pressure within the stomach of the subject while supplying gas into the stomach of the subject using the endoscope to obtain a waveform of time-series change of the internal pressure value of the subject, the internal pressure including a maximum value of the internal pressure in the stomach of the subject;
obtaining a target waveform of time-series change of the internal pressure value in the stomach of the subject;
comparing the maximum value of the subject to the threshold value of the person without GERD; and
comparing the target waveform of time-series change to the reference waveform of time-series change.
15.
A method for diagnosing gastro esophageal reflux disease (GERD), comprising:
identifying a threshold value of an internal pressure within a stomach of a person without GERD,
obtaining a first waveform of time-series change of the internal pressure within the stomach of the person without GERD, wherein the first waveform of time-series change increases to the threshold value when gas is supplied into the stomach,
obtaining a second waveform of time-series change of an internal pressure within a stomach of a person with GERD, wherein the second waveform of time-series change repeatedly increases and decreases within a pressure range when gas is supplied into the stomach and the second waveform of time-series change is flatter than the first waveform of time-series change;
inserting an endoscope into a stomach of a subject;
supplying a volume of gas substantially identical to a volume of gas which causes a person without GERD to have a body reflex of a closing cardia;
measuring an internal pressure only within the stomach of the subject while supplying gas into the stomach of the subject using the endoscope to obtain a waveform of time-series change of the internal pressure value of the subject, the internal pressure including a maximum value of the internal pressure in the stomach of the subject;
obtaining a third waveform of time-series change of the internal pressure value in the stomach of the subject;
comparing the maximum value of the subject to the threshold value of the person without GERD;
comparing the third waveform of time-series change to the first waveform of time-series change; and
determining whether the subject has GERD based on the comparison of the maximum value of the subject to the threshold value of the person without GERD, the comparison of the third waveform of time-series change to the first waveform time-series change, and the comparison of the third waveform of time-series change to the second waveform of the time-series change.
17.
The method for diagnosing GERD according to claim 1, further comprising:
observing a cardia of the subject by the endoscope while supplying gas into the stomach using the endoscope; and
determining whether the subject has GERD based on the maximum value of the internal pressure, the waveform of time-series change of the internal pressure value, and a result of a cardia observation.
2.
The method for diagnosing GERD according to claim 1, further comprising:
observing a cardia of the subject by the endoscope while supplying gas into the stomach using the endoscope; and
determining whether the subject has GERD based on the maximum value of the internal pressure, the waveform of time-series change of the internal pressure value, and a result of a cardia observation.
18.
The method for diagnosing GERD according to claim 1, further comprising:
obtaining a burp sound of the subject while supplying gas into the stomach using the endoscope; and
determining whether the subject has GERD based on the maximum value of the internal pressure, the waveform of the internal pressure value, and the burp sound.
3.
The method for diagnosing GERD according to claim 1, further comprising:
obtaining a burp sound of the subject while supplying gas into the stomach using the endoscope; and
determining whether the subject has GERD based on the maximum value of the internal pressure, the waveform of the internal pressure value, and the burp sound.
19.
The method for diagnosing GERD according to claim 1, further comprising:
comparing the maximum value of the internal pressure with the threshold value; and
determining that the subject has GERD when the maximum value of the internal pressure is below the threshold value.
5.
The method for diagnosing GERD according to claim 1, further comprising:
comparing the maximum value of the internal pressure with the threshold value; and
determining that the subject has GERD when the maximum value of the internal pressure is below the threshold value.
20.
The method for diagnosing GERD according to claim 1,
wherein determining whether the subject has GERD is based on a volume or length of a burp sound.
6.
The method for diagnosing GERD according to claim 1,
wherein determining whether the subject has GERD is based on a volume or length of a burp sound.
Allowable Subject Matter
Claims 1-20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten to overcome all the claim objections and claim rejections identified above.
The following is a statement of reasons for indication of allowable subject matter:
Regarding claim 1, Ganz et al. (US2004/0138586), Udaya Sankar Devanaboyina (US2017/0035318), alone or in obvious combination, teach the above except for measuring an internal pressure within the stomach of the subject while supplying gas into the stomach of the subject using the endoscope to obtain a waveform of time-series change of the internal pressure value of the subject; obtaining a target waveform of time-series change of the internal pressure in the stomach of the subject; and comparing at least the target waveform of time-series change to at least a reference waveform of time-series change of an internal pressure within a stomach of a person without GERD.
Regarding claim 10, Ganz et al. (US2004/0138586), Udaya Sankar Devanaboyina (US2017/0035318), alone or in obvious combination, teach the above except for measuring an internal pressure within the stomach of the subject while supplying gas into the stomach of the subject using the endoscope to obtain a waveform of time-series change of the internal pressure value of the subject, the waveform including a maximum value or around a maximum value of the internal pressure in the stomach of the subject; and comparing the maximum value of the subject to a threshold value of an internal pressure within a stomach of the person without GERD, wherein the threshold value is defined by identifying an internal pressure of time-series change within a stomach of the person without GERD.
Regarding claim 16, Ganz et al. (US2004/0138586), Udaya Sankar Devanaboyina (US2017/0035318), alone or in obvious combination, teach the above except for identifying a reference waveform of time-series change of the internal pressure within the stomach of the person without GERD, wherein the first waveform of time-series change increases to the threshold value when gas is supplied into the stomach; inserting an endoscope into a stomach of a subject; supplying gas into the stomach of the subject; measuring an internal pressure within the stomach of the subject while supplying gas into the stomach of the subject using the endoscope to obtain a waveform of time-series change of the internal pressure value of the subject, the internal pressure including a maximum value of the internal pressure in the stomach of the subject; obtaining a target waveform of time-series change of the internal pressure value in the stomach of the subject; comparing the maximum value of the subject to the threshold value of the person without GERD; and comparing the target waveform of time-series change to the reference waveform of time-series change.
There is not reason or suggestion provided in the prior art to modify the above prior art to have the additional features as claimed above, and the only reason to modify the references would be based on Applicant’s disclosure, which is impermissible hindsight reasoning.
Conclusion
The prior art made of record and not relied upon is considered pertinent to Applicant’s disclosure:
Michael O. Madsen (US7223247);
Goode et al. (US12465761);
Sharma et al. (US9616225);
Sharma et al. (US12343530).
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/MEGAN ELIZABETH MONAHAN/Examiner, Art Unit 3795
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