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
The amendment filed 11/11/2022 has been entered. Claims 1, 25-37 are pending in the application.
Claim Rejections - 35 USC § 112
Claim 25 is 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 25 reciters the limitation “the administration comprises does control with an administration controller” in lines 1-2. It is unclear if this a typo or a grammatical issue leading to the loss of a clear meaning in this phrase. For the sake of examination, the limitation will be interpreted as reciting “the administration comprises dose control with an administration controller”.
Claims 36 and 37 recite the limitation “a controlling unit” in line 2. It is unclear if this is the same or different controlling unit than the one recited in claim 34. For the sake of examination, the limitations will be interpreted as reciting “the controlling unit”.
Claim Rejections - 35 USC § 102
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 26 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Sutton (US 2021/0308181).
Regarding Claim 1, Sutton discloses a method for administering oxygen to a subject in need thereof, the method comprising: administering a pharmaceutical composition comprising a perfluorocarbon dissolving oxygen therein to the subject though oral administration, nasogastric administration, trans-fistula gastric administration, or administration into a large intestine (Para 0008, 0084).
Regarding Claim 26, Sutton discloses the pharmaceutical composition is administered into the large intestine through the rectum of the subject (“intrarectal”, Para 0048).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 27-29, 31-33 are rejected under 35 U.S.C. 103 as being unpatentable over Friedberg (US 2006/0263302) in view of Schmid (US 2015/0010644).
Regarding Claim 1, Friedberg discloses a method for administering oxygen to a subject in need thereof, the method comprising: administering a pharmaceutical composition comprising a perfluorocarbon dissolving oxygen therein to the subject though a catheter to the stomach (Col 0002, 0004-0005).
Friedberg is silent regarding the exact delivery route, such as oral administration, nasogastric administration, trans-fistula gastric administration, or administration into a large intestine.
Schmid teaches an analogous method of delivering a pharmaceutical composition comprising a perfluorocarbon to the subject though nasogastric administration (Para 0017).
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 to include nasogastric delivery of the pharmaceutical composition to the stomach as taught by Schmid in order to have a simple and effective method of delivery for the treatment (Para 0007).
Regarding Claim 27, the modified invention of Friedberg and Schmid discloses wherein the method treats hypoxemia (Para 0004-0005 -Friedberg).
Regarding Claim 28, the modified invention of Friedberg and Schmid discloses the subject has respiratory failure(Para 0004-0005 -Friedberg).
Regarding Claim 29, the modified invention of Friedberg and Schmid discloses the pharmaceutical composition is in the form of a gas (Para 0014 -Friedberg; the pharmaceutical composition is oxygen that has been forced into a perfluorocarbon liquid).
Regarding Claim 31, the modified invention of Friedberg and Schmid discloses the pharmaceutical composition is mixed with oxygen gas before administration (Para 0014 -Friedberg).
Regarding Claim 32, the modified invention of Friedberg and Schmid discloses the administrating is oral administration, nasogastric administration (Para 0017 -Schmid), or trans-fistula gastric administration.
Regarding Claim 33, Friedberg discloses a method of reducing blood carbon dioxide partial pressure in a subject in need thereof, the method comprising: administering a pharmaceutical composition comprising a perfluorocarbon dissolving oxygen therein to the subject though a catheter to the stomach (Col 0002, 0004-0005).
Friedberg is silent regarding the exact delivery route, such as oral administration, nasogastric administration, trans-fistula gastric administration, or administration into a large intestine.
Schmid teaches an analogous method of delivering a pharmaceutical composition comprising a perfluorocarbon to the subject though nasogastric administration (Para 0017).
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 to include nasogastric delivery of the pharmaceutical composition to the stomach as taught by Schmid in order to have a simple and effective method of delivery for the treatment (Para 0007).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Friedberg (US 2006/0263302) in view of Schmid (US 2015/0010644) and further in view of Kovacheva (US 2023/0010826).
Regarding Claim 25, the modified invention of Friedberg and Schmid discloses the administration comprises dose control with an administration controller (Roller Pump, Fig 1 -Friedberg), wherein the administration controller is suitable for administering a perfluorocarbon dissolving oxygen therein or oxygen, and wherein the administration controller comprises: a delivering unit (roller) configured to deliver the perfluorocarbon dissolving oxygen therein or oxygen to a tube; and a controlling unit configured to control a rate of delivery from the delivering unit (Para 0029 -Friedberg), however, is silent regarding controlling a rate of delivery from the delivering unit on the basis of blood oxygen saturation of the subject and/or intraintestinal pressure of a large intestine of the subject.
Kovacheva teaches a dose control with an administration controller (100, Fig 1) comprising a delivering unit (102, Fig 1) and a controlling unit (110, Fig 1) configured to control a rate of delivery from the delivering unit on the basis of blood oxygen saturation of the subject (Para 0025, 0012, 0016; oxygen saturation can be one of the patient parameters that is relied on to base the rate or dosage of delivery on).
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 to include dose control based on blood oxygen saturation of the subject as taught by Kovacheva in order to have more individualized dosages for a particular patient based on their unique parameters while alleviating the time-consuming and tedious process of monitoring parameters and adjusting medication (Para 0003).
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Friedberg (US 2006/0263302) in view of Schmid (US 2015/0010644) and further in view of McLeay (US 2021/0299258).
Regarding Claim 30, the modified invention of Friedberg and Schmid discloses all of the elements of the invention as discussed above, however, is silent regarding the pharmaceutical composition is administered into the large intestine to remove mucosa in the large intestine by coating thereof with the perfluorocarbon.
McLeay teaches an analogous method of administering oxygen to a subject in need thereof, the method comprising: administering a pharmaceutical composition comprising a perfluorocarbon dissolving oxygen therein to the subject though administration into a large intestine (Para 0010, 0067-0068), wherein the pharmaceutical composition is administered into the large intestine to remove mucosa in the large intestine by coating thereof with the perfluorocarbon (Para 0103).
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 to further include administering a perfluorocarbon dissolving oxygen to the large intestine to remove mucosa as taught by McLeay in order to smooth the surface of the mucosa to improve contact for removal and improve visualization (Para 0103).
Claim(s) 34, 35-37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Friedberg (US 2006/0263302) in view of Polizzotti (US 2016/0067276) and further in view of Kovacheva (US 2023/0010826) and further in view of Shtul (US 2012/0289910) as evidenced by Hindryckx (“Intrarectal administration of oxygenated perfluorodecalin promotes healing of murine colitis by targeting inflammatory hypoxia”).
Regarding Claim 34, Friedberg discloses an administration controller (Roller Pump, Fig 1) configured for gastric administration of a perfluorocarbon dissolving oxygen therein or oxygen (Col 0002, 0004-0005), the administration controller comprising: a delivering unit (roller) configured to deliver the perfluorocarbon dissolving oxygen therein or oxygen to a tube; and a controlling unit configured to control a rate of delivery from the delivering unit (Para 0029) on the basis of blood oxygen saturation of a subject and intraintestinal pressure of a large intestine of the subject.
Friedberg is silent regarding the administration controller configured for oral administration, nasogastric administration, trans-fistula gastric administration, or administration into a large intestine and controlling a rate of delivery from the delivering unit on the basis of blood oxygen saturation of the subject and intraintestinal pressure of a large intestine of the subject.
Polizzotti teaches an analogous method of administration supplemental oxygen to the gastric organs including the large intestine (Para 0222).
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 device to deliver the perfluorocarbon dissolving oxygen to the intestine to supplement oxygen as taught by Polizzotti in order to prevent or mitigate intestinal ischemia and decrease the burden of anaerobic bacteria in the bowel (Para 0222). Hindryckx further provides evidence that perfluorocarbon dissolving oxygen can be delivered to the large intestine specifically via the rectum (See paragraphs 1-2 on page 1275).
The modified invention of Friedberg and Polizzotti disclose all of the elements of the invention as discussed above, however, is silent regarding controlling a rate of delivery from the delivering unit on the basis of blood oxygen saturation of the subject and intraintestinal pressure of a large intestine of the subject.
Kovacheva teaches a dose control with an administration controller (100, Fig 1) comprising a delivering unit (102, Fig 1) and a controlling unit (110, Fig 1) configured to control a rate of delivery from the delivering unit on the basis of blood oxygen saturation of the subject (Para 0025, 0012, 0016; oxygen saturation can be one of the patient parameters that is relied on to base the rate or dosage of delivery on).
Shtul teaches a dose control with an administration controller comprising a controller unit configured to control a rate of delivery from the delivering unit on the basis of intraintestinal pressure of a large intestine (Para 0049-0056)
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 to include dose control based on blood oxygen saturation and intestinal pressure of the subject as taught by Kovacheva and Shtul in order to have more individualized dosages for a particular patient based on their unique parameters while alleviating the time-consuming and tedious process of monitoring parameters and adjusting medication (Para 0003 -Kovacheva) and to protect intestinal tissue from excessive pressure or dangerously low pressure (Para 0102-0104 -Shtul).
Regarding Claim 35, the modified invention of Friedberg, Polizzotti, Kovacheva, and Shtul discloses a receiving unit (108, Fig 1 -Kovacheva) configured to receive information on oxygen saturation from a blood oxygen monitor and intraintestinal pressure of a large intestine (Para 0018 -Kovacheva).
Regarding Claim 36, the modified invention of Friedberg, Polizzotti, Kovacheva, and Shtul discloses the controlling unit configured to control a rate of delivery from the delivering unit on the basis of blood oxygen saturation of the subject, wherein: (A) the controlling unit is configured to refer to information on oxygen saturation received by a receiving unit, and if the oxygen saturation has reached lower than a predetermined value or a predetermined value or lower, the controlling unit sends a signal to increase the rate of delivery to the delivering unit; and/or (B) the controlling unit is configured to refer to information on oxygen saturation received by a receiving unit, and if the oxygen saturation has reached a predetermined value or higher or higher than a predetermined value, the controlling unit sends a signal to decrease the rate of delivery to the delivering unit (Para 0025, 0012, 0016 -Kovacheva).
Regarding Claim 37, the modified invention of Friedberg, Polizzotti, Kovacheva, and Shtul discloses the controlling unit configured to control a rate of delivery from the delivering unit on the basis of intraintestinal pressure of a large intestine of the subject, wherein: (C) the controlling unit configured to refer to information on intraintestinal pressure of a large intestine received by a receiving unit, and if the intraintestinal pressure has reached lower than a predetermined value or a predetermined value or lower or if the intraintestinal pressure has increased during liquid delivery, the controlling unit stops sending a signal to increase the rate of delivery to the delivering unit, or sends a signal to decrease the rate of delivery to the delivering unit (Para 0049-0056, 0102-0104 -Shtul).
Conclusion
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/ANTARIUS S DANIEL/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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