DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Amendment after Non-final office action filed on 11/20/2025 is acknowledged.
3. Claim filed on 11/20/2025 is acknowledged.
4. Claims 1-48, 53-55 and 68-80 have been cancelled.
5. New claims 81-92 have been added.
6. Claims 49-52, 56-67 and 81-92 are pending in this application.
7. Claims 51, 52, 57, 58, 60, 61, 63, 65-67 and 81-92 remain/are withdrawn from consideration as being drawn to non-elected species.
Please note: as stated in the previous office action, during the search for the elected species, prior art was found for the non-elected species of subject recited in instant claim 62. Therefore, for the purpose of compact prosecution, claim 62 is examined in the current office action.
8. Applicant elected without traverse of Group 1 (claims 49-67) and elected AQGV (SEQ ID NO: 1) as species of peptide/peptides; severe trauma as species of subject; and reducing fluid intake as species of type of reducing use/intake in the reply filed on 5/1/2025.
Restriction requirement was deemed proper and made FINAL in the previous office action. The instant claims 49-52, 56-67 and 81-92 are drawn to a method of treating a subject receiving fluid therapy and in need of (a) maintaining or improving hemodynamic stability, (b) a reduction in adverse vascular permeability, and/or (c) a reduction in fluid retention, the method comprising: administering to the subject peptide(s) to maintain or improve hemodynamic stability, reduce adverse vascular permeability, and/or reduce fluid retention, wherein the peptide(s) is/are selected from the group of peptides consisting of SEQ ID NO:1, SEQ ID NO:2, SEQ ID NO:3, SEQ ID NO:4, SEQ ID NO:5,SEQ ID NO:6, SEQ ID NO:7, SEQ ID NO:8, SEQ ID NO:9, SEQ ID NO:10, SEQ ID NO:11, SEQ ID NO:12, SEQ ID NO:13, SEQ ID NO:14, SEQ ID NO:15, SEQ ID NO:16, SEQ ID NO:17, and any combination thereof. A search was conducted on the elected species; and prior art was found. Claims 51, 52, 57, 58, 60, 61, 63, 65-67 and 81-92 remain/are withdrawn from consideration as being drawn to non-elected species. Claims 49, 50, 56, 59, 62 and 64 are examined on the merits in this office action.
Non-compliant Amendment
9. The claim filed on 11/20/2025 is a non-compliant amendment. In the claim filed on 11/20/2025, claims 53-55 have been cancelled, and the texts of these claims have been crossed-out. However, as stated in MPEP: “A claim being canceled must be indicated as "canceled;" the text of the claim must not be presented.” (see MPEP § 714). Applicant is required to correct this error.
Claim Interpretations
10. With regards to the recited “in need of (a) maintaining or improving hemodynamic stability, (b) a reduction in adverse vascular permeability, and/or (c) a reduction in fluid retention”, in the broadest reasonable interpretation and for the purpose of this examination, the Examiner is interpretating such recitation as in need of any one of (a)-(c) and combination thereof. Such interpretation applies to all the rejections set forth below.
With regards to the recited “a subject receiving fluid therapy”, in the instant case, the instant specification fails to define the term “fluid therapy”. Based on Danigole (Drink Up: 10 Reasons Water is a Key Ingredient in Your Good Health, from https://www.lcmchealth.org/university-medical-center-new-orleans/blog/2018/may/drink-up-10-reasons-water-is-a-key-ingredient-in/, 2018, enclosed pages 1-3), water is essential and drinking water exhibits therapy effects such as flushing out toxins from the system (see for example, page 1). Therefore, in the broadest reasonable interpretation, a subject drinking water is “a subject receiving fluid therapy” recited in instant claim 49. Such interpretation applies to all the rejections set forth below.
Furthermore, the Examiner would like to point out that with regards to the recited a subject in need of maintaining hemodynamic stability, based on the Hemodynamics document (from https://my.clevelandclinic.org/health/body/24013-hemodynamics, 2022, enclosed pages 1-8), a subject in need of maintaining hemodynamic stability broadly includes every subject having blood flows through the blood vessels (see for example, pages 1-2. Section “What is hemodynamics?”; and pages 4-5, Section “What is hemodynamic instability?”).
Withdrawn Objections and Rejections
11. Objection to the specification is hereby withdrawn in view of Applicant’s amendments to the specification
12. Objection to the drawings is hereby withdrawn in view of Applicant’s amendments to the description of the drawings in the specification.
13. Rejection to claims 49-52, 56, 59, 62 and 64-66 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph (written description) is hereby withdrawn in view of Applicant’s amendment to the claim.
14. Rejections to instant claims on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims of co-pending Application Nos. 17/639018, 18/029174, 18/548845, 18/698512, 18/960532 and 18992888 are hereby withdrawn in view of Applicant’s amendment to the claim.
15. Rejection to instant claims on the ground of nonstatutory obviousness-type double patenting over claims of co-pending Application No. 18/310188 is hereby withdrawn in view of Applicant’s abandonment of Application No. 18/310188.
Maintained Objections
16. The abstract remains objected to for the following minor informality: The abstract recites the peptide AQGV. However, it is missing the sequence identifier. Applicant is required to amend the abstract to comply with 37 CFR 1.821(d).
Response to Applicant's Arguments
17. Applicant fails to add the sequence identifier to every recited peptide AQGV. Therefore, the objection is deemed proper and is hereby maintained.
New Objections
18. Claim 49 is objected to for the following minor informality: Applicant is suggested to amend claim 49 as “wherein the peptide(s) is/are selected from the group consisting of SEQ ID NOs:1-17, and any combination thereof”.
19. Claim 50 is objected to for the following minor informality: Applicant is suggested to amend claim 50 as “…wherein the method comprises administering to the subject the peptide of SEQ ID NO:1 and any combination thereof”.
Maintained/Revised Rejections
Claim Rejections - 35 U.S.C. § 102(a)(1)
20. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
21. (Revised due to Applicant’s amendment to the claim) Claims 49, 50, 56, 59 and 62 remain rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gueler et al (PLoS ONE, 2015, 10, pages 1-13, filed with IDS), and as evidenced by Danigole (Drink Up: 10 Reasons Water is a Key Ingredient in Your Good Health, 2018, from https://www.lcmchealth.org/university-medical-center-new-orleans/blog/2018/may/drink-up-10-reasons-water-is-a-key-ingredient-in/, enclosed pages 1-3).
The instant claims 49, 50, 56, 59 and 62 are drawn to a method of treating a subject receiving fluid therapy and in need of (a) maintaining or improving hemodynamic stability, (b) a reduction in adverse vascular permeability, and/or (c) a reduction in fluid retention, the method comprising: administering to the subject peptide(s) to maintain or improve hemodynamic stability, reduce adverse vascular permeability, and/or reduce fluid retention, wherein the peptide(s) is/are selected from the group of peptides consisting of SEQ ID NO:1, SEQ ID NO:2, SEQ ID NO:3, SEQ ID NO:4, SEQ ID NO:5,SEQ ID NO:6, SEQ ID NO:7, SEQ ID NO:8, SEQ ID NO:9, SEQ ID NO:10, SEQ ID NO:11, SEQ ID NO:12, SEQ ID NO:13, SEQ ID NO:14, SEQ ID NO:15, SEQ ID NO:16, SEQ ID NO:17, and any combination thereof.
Gueler et al, throughout the literature, teach ischemia reperfusion injury (IRI) causes acute kidney injury (AKI), and impaired renal blood flow is a critical event after IRI; and a method of treating a subject in need of maintaining or improving hemodynamic stability, wherein the method comprises administering to the subject the peptide AQGV (also named as EA-230, and identical to the peptide of instant SEQ ID NO: 1) to maintain or improve hemodynamic stability, wherein the subject has been subjected to surgery (a severe trauma) and has AKI, and wherein the subject receives drinking water, for example, Abstract; page 2, Introduction and Section “Animals”; page 3, Sections “Ischemia reperfusion injury to induce acute kidney injury (AKI)” and “EA-230 compound and treatment strategy”; and Figure 1C. And as evidenced by Danigole, drinking water exhibits therapy effects such as flushing out toxins from the system (see for example, page 1). Therefore, the subject in the method in Gueler et al is one receiving fluid therapy and in need of maintaining or improving hemodynamic stability. It reads on AQGV (SEQ ID NO: 1) as the elected species of peptide/peptides; and severe trauma as the elected species of subject. And it meets the limitations of instant claims 49, 50, 56, 59 and 62.
Since the reference teaches all the limitations of instant claims 49, 50, 56, 59 and 62; the reference anticipates instant claims 49, 50, 56, 59 and 62.
Response to Applicant's Arguments
22. Applicant argues that Gueler et al do not anticipate the method recited in instant claims 49, 50, 56, 59 and 62.
23. Applicant's arguments have been fully considered but have not been found persuasive.
Please note: in view of Applicant’s amendment to the claim, Danigole (Drink Up: 10 Reasons Water is a Key Ingredient in Your Good Health, enclosed pages 1-3, from https://www.lcmchealth.org/university-medical-center-new-orleans/blog/2018/may/drink-up-10-reasons-water-is-a-key-ingredient-in/, 2018) is cited as an evidentiary reference in instant rejection.
In response to Applicant’s arguments about instant rejection:
First, as stated in Section 21 above, Gueler et al explicitly teach ischemia reperfusion injury (IRI) causes acute kidney injury (AKI), and impaired renal blood flow is a critical event after IRI; and the subject in the method taught in Gueler et al receives drinking water. And as evidenced by Danigole, drinking water exhibits therapy effects such as flushing out toxins from the system (see for example, page 1). Furthermore, Gueler et al explicitly teach the treatment results in improved renal blood flow (see for example, Figure 1C). And based on the Hemodynamics document (2022, enclosed pages 1-8, from https://my.clevelandclinic.org/health/body/24013-hemodynamics), hemodynamics is how your blood flows through your blood vessels (see page 1). Therefore, the method in Gueler et al is the method recited in instant claims 49, 50, 56, 59 and 62.
Second, the Examiner understands that Gueler et al do not teach the peptides of instant SEQ ID NOs: 2-17 recited in instant claim 49. However, Gueler et al teach the elected species of peptide AQGV (instant SEQ ID NO: 1). And as stated in MPEP: “Following election, the Markush claim will be examined fully with respect to the elected species and further to the extent necessary to determine patentability. Note that where a claim reads on multiple species, only one species needs to be taught or suggested by the prior art in order for the claim to be anticipated or rendered obvious. See, e.g., Fresenius USA, Inc. v. Baxter Int’l, Inc., 582 F.3d 1288, 1298, 92 USPQ2d 1163, 1171 (Fed. Cir. 2009)(the entire element is disclosed by the prior art if one alternative in the Markush group is in the prior art).” And “If on examination the elected species is found to be anticipated or rendered obvious by prior art, the Markush claim and claims to the elected species will be rejected, and claims to the nonelected species will be held withdrawn from further consideration.” (see MPEP § 803.02 III A).
Third, as stated in Section 10 above, the Examiner would like to point out that with regards to the recited a subject in need of maintaining hemodynamic stability, based on the Hemodynamics document (2022, enclosed pages 1-8, from https://my.clevelandclinic.org/health/body/24013-hemodynamics), a subject in need of maintaining hemodynamic stability broadly includes every subject having blood flows through the blood vessels (see for example, pages 1-2. Section “What is hemodynamics?”; and pages 4-5, Section “What is hemodynamic instability?”).
Taken all these together, Gueler et al teach the method recited in instant claims 49, 50, 56, 59 and 62. And the rejection is still deemed proper and is hereby maintained.
The Hemodynamics document is cited only for the purpose of rebutting Applicant’s arguments, therefore, it is not cited as prior art reference.
Claim Rejections - 35 U.S.C. § 103
24. 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 of this title, 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.
25. 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.
26. (Revised due to Applicant’s amendment to the claim) Claims 49, 50, 56, 59, 62 and 64 remain rejected under 35 U.S.C. 103 as being unpatentable over Gueler et al (PLoS ONE, 2015, 10, pages 1-13, filed with IDS), and as evidenced by Danigole (Drink Up: 10 Reasons Water is a Key Ingredient in Your Good Health, 2018, from https://www.lcmchealth.org/university-medical-center-new-orleans/blog/2018/may/drink-up-10-reasons-water-is-a-key-ingredient-in/, enclosed pages 1-3), and in view of Wang et al (Critical Care, 2015, 19, pages 1-11, cited and enclosed in the previous office action).
The instant claims 49, 50, 56, 59, 62 and 64 are drawn to a method of treating a subject receiving fluid therapy and in need of (a) maintaining or improving hemodynamic stability, (b) a reduction in adverse vascular permeability, and/or (c) a reduction in fluid retention, the method comprising: administering to the subject peptide(s) to maintain or improve hemodynamic stability, reduce adverse vascular permeability, and/or reduce fluid retention, wherein the peptide(s) is/are selected from the group of peptides consisting of SEQ ID NO:1, SEQ ID NO:2, SEQ ID NO:3, SEQ ID NO:4, SEQ ID NO:5,SEQ ID NO:6, SEQ ID NO:7, SEQ ID NO:8, SEQ ID NO:9, SEQ ID NO:10, SEQ ID NO:11, SEQ ID NO:12, SEQ ID NO:13, SEQ ID NO:14, SEQ ID NO:15, SEQ ID NO:16, SEQ ID NO:17, and any combination thereof.
Gueler et al, throughout the literature, teach ischemia reperfusion injury (IRI) causes acute kidney injury (AKI), and impaired renal blood flow is a critical event after IRI; and a method of treating a subject in need of maintaining or improving hemodynamic stability, wherein the method comprises administering to the subject the peptide AQGV (also named as EA-230, and identical to the peptide of instant SEQ ID NO: 1) to maintain or improve hemodynamic stability, wherein the subject has been subjected to surgery (a severe trauma) and has AKI, and wherein the subject receives drinking water, for example, Abstract; page 2, Introduction and Section “Animals”; page 3, Sections “Ischemia reperfusion injury to induce acute kidney injury (AKI)” and “EA-230 compound and treatment strategy”; and Figure 1C. And as evidenced by Danigole, drinking water exhibits therapy effects such as flushing out toxins from the system (see for example, page 1). Therefore, the subject in the method in Gueler et al is one receiving fluid therapy and in need of maintaining or improving hemodynamic stability. It reads on AQGV (SEQ ID NO: 1) as the elected species of peptide/peptides; and severe trauma as the elected species of subject. And it meets the limitations of instant claims 49, 50, 56, 59 and 62.
The difference between the reference and instant claims 49, 50, 56, 59, 62 and 64 is that the reference does not explicilty teach reducing fluid intake as the elected species of type of reducing use/intake; and the limitation of instant claim 64.
However, Wang et al, throughout the literature, teach one important consequence of fluid administration is the risk of developing fluid overload (FO), which is associated with increased mortality in patients with acute kidney injury (AKI); and FO is an independent risk factor for the incidence of AKI and increases the severity of AKI, for example, page 1. Abstract; page 2, Introduction; and page 4, Sections “Fluid balance and the incidence of AKI” and “Fluid balance and the mortality of patients with AKI”.
Therefore, it would have been obvious to one of ordinary skilled in the art to combine the teachings of Gueler et al and Wang et al to develop a method of treating a subject receiving fluid therapy and in need of maintaining or improving hemodynamic stability, wherein the method comprises administering to the subject the peptide AQGV (also named as EA-230, and identical to the peptide of instant SEQ ID NO: 1) to maintain or improve hemodynamic stability, wherein the subject has been subjected to surgery (a severe trauma) and has AKI, and wherein the method further comprises reducing the subject’s water intake to avoid FO. It reads on reducing fluid intake as the elected species of type of reducing use/intake.
One of ordinary skilled in the art would have been motivated to combine the teachings of Gueler et al and Wang et al to develop a method of treating a subject receiving fluid therapy and in need of maintaining or improving hemodynamic stability, wherein the method comprises administering to the subject the peptide AQGV (also named as EA-230, and identical to the peptide of instant SEQ ID NO: 1) to maintain or improve hemodynamic stability, wherein the subject has been subjected to surgery (a severe trauma) and has AKI, and wherein the method further comprises reducing the subject’s water intake to avoid FO, because Wang et al, throughout the literature, teach one important consequence of fluid administration is the risk of developing fluid overload (FO), which is associated with increased mortality in patients with acute kidney injury (AKI); and FO is an independent risk factor for the incidence of AKI and increases the severity of AKI.
A person of ordinary skilled in the art would have reasonable expectation of success in combining the teachings of Gueler et al and Wang et al to develop a method of treating a subject receiving fluid therapy and in need of maintaining or improving hemodynamic stability, wherein the method comprises administering to the subject the peptide AQGV (also named as EA-230, and identical to the peptide of instant SEQ ID NO: 1) to maintain or improve hemodynamic stability, wherein the subject has been subjected to surgery (a severe trauma) and has AKI, and wherein the method further comprises reducing the subject’s water intake to avoid FO.
Response to Applicant's Arguments
27. Applicant argues that: 1. Neither Gueler nor Wang discloses the required patient population ("subject receiving fluid therapy"). 2. Neither teaches or suggests reducing fluid intake, preventing capillary leakage, or stabilizing hemodynamics via peptide therapy. Wang merely illustrates that in the current standard of care - when fluid administration has been deemed necessary, particularly in the acute phase - fluid overload may adversely compound post-operative organ function and surgical outcomes. Wang, however, nowhere teaches reducing fluid intake. 3. Wang provides no therapeutic teaching and in fact teaches away from reducing fluid administration. 4. No motivation to combine exists, and no reasonable expectation of success would have been present. 5. The amended claim is now tied to SEQ ID NOs:1-17, none of which is taught or suggested by Wang et al.
28. Applicant's arguments have been fully considered but have not been found persuasive.
Please note: in view of Applicant’s amendment to the claim, Danigole (Drink Up: 10 Reasons Water is a Key Ingredient in Your Good Health, enclosed pages 1-3, from https://www.lcmchealth.org/university-medical-center-new-orleans/blog/2018/may/drink-up-10-reasons-water-is-a-key-ingredient-in/, 2018) is cited as an evidentiary reference in instant rejection.
First, the Examiner would like to point out that instant claims 49, 50, 56, 59, 62 and 64 are rejected under 35 U.S.C. 103 (obviousness type); and the rejection is based on the combined teachings of Gueler et al and Wang et al. Therefore, it is not necessary for each of the cited prior art references to teach all the limitations of instant claims 49, 50, 56, 59, 62 and 64. Furthermore, the Examiner would like to point out that the MPEP states "One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references…" (see MPEP § 2145 IV).
In response to Applicant’s arguments that “1. Neither Gueler nor Wang discloses the required patient population ("subject receiving fluid therapy")”, these have been addressed in Section 23 above.
In responses to Applicant’s arguments that “2. Neither teaches or suggests reducing fluid intake, preventing capillary leakage, or stabilizing hemodynamics via peptide therapy” and “3. Wang provides no therapeutic teaching and in fact teaches away from reducing fluid administration”, the Examiner would like to point out that as stated in both Sections 21 and 23 above, Gueler et al teach each and every limitations of the method recited in instant claims 49. 50, 56, 59 and 62. And in the instant case, the subject in the method in Gueler et al is one that has been subjected to surgery (a severe trauma) and has AKI; and also one receiving fluid therapy and in need of maintaining or improving hemodynamic stability. And Wang et al teach that one important consequence of fluid administration is the risk of developing fluid overload (FO), which is associated with increased mortality in patients with acute kidney injury (AKI); and FO is an independent risk factor for the incidence of AKI and increases the severity of AKI. Furthermore, the Examiner would like to point out that reducing the subject’s fluid intake is not the same as completely removing the subject’s fluid intake; and positive fluid balance correlates with higher mortality taught in Wang et al is not the same as teaching away from reducing the subject’s fluid intake. In the instant case, the Examiner understands that Wang et al do not explicitly state reducing the subject’s fluid intake recited in instant claim 64. However, in view of the teachings of Wang et al as a whole, one of ordinary skilled in the art would understand and reasonably expect that reducing the subject’s water intake in the method taught in Gueler et al would avoid FO (achieve a fluid balance) and avoid increasing the severity of AKI.
In response to Applicant’s arguments that “4. No motivation to combine exists, and no reasonable expectation of success would have been present.”, in the instant case, the subjects in both Gueler et al and Wang et al are one having AKI. And in view of the teachings of Wang et al as set forth in Section 26 above, one of ordinary skilled in the art would be motivated to reduce the subject’s water intake in the method taught in Gueler et al to avoid FO (achieve a fluid balance) and avoid increasing the severity of AKI. Therefore, in the instant case, in view of the combined teachings of the cited prior art references as set forth in Section 26 above, one of ordinary skilled in the art would have been motivated to develop the method recited in instant claims 49, 50, 56, 59, 62 and 64. And a person of ordinary skilled in the art would have reasonable expectation of success in developing develop the method recited in instant claims 49, 50, 56, 59, 62 and 64. Furthermore, with regards to the expectation of success, the MPEP states: “Absolute predictability is not a necessary prerequisite to a case of obviousness. Rather, a degree of predictability that one of ordinary skill would have found to be reasonable is sufficient. The Federal Circuit concluded that “[g]ood science and useful contributions do not necessarily result in patentability.” Id. at 1364, 83 USPQ2d at 1304.” (see MPEP § 2145).
In response to Applicant’s arguments that “5. The amended claim is now tied to SEQ ID NOs:1-17, none of which is taught or suggested by Wang et al.”, as stated above, the rejection is based on the combined teachings of Gueler et al and Wang et al. Therefore, it is not necessary for each of the cited prior art references to teach all the limitations of instant claims 49, 50, 56, 59, 62 and 64. Furthermore, as stated in Section 23 above, Gueler et al teach the elected species of peptide AQGV (instant SEQ ID NO: 1). And as stated in MPEP: “Following election, the Markush claim will be examined fully with respect to the elected species and further to the extent necessary to determine patentability. Note that where a claim reads on multiple species, only one species needs to be taught or suggested by the prior art in order for the claim to be anticipated or rendered obvious. See, e.g., Fresenius USA, Inc. v. Baxter Int’l, Inc., 582 F.3d 1288, 1298, 92 USPQ2d 1163, 1171 (Fed. Cir. 2009)(the entire element is disclosed by the prior art if one alternative in the Markush group is in the prior art).” And “If on examination the elected species is found to be anticipated or rendered obvious by prior art, the Markush claim and claims to the elected species will be rejected, and claims to the nonelected species will be held withdrawn from further consideration.” (see MPEP § 803.02 III A).
In addition, as stated in Section 10 above, the Examiner would like to point out that with regards to the recited a subject in need of maintaining hemodynamic stability, based on the Hemodynamics document (2022, enclosed pages 1-8, from https://my.clevelandclinic.org/health/body/24013-hemodynamics), a subject in need of maintaining hemodynamic stability broadly includes every subject having blood flows through the blood vessels (see for example, pages 1-2. Section “What is hemodynamics?”; and pages 4-5, Section “What is hemodynamic instability?”).
Taken all these together, the rejection is still deemed proper and is hereby maintained.
The Hemodynamics document is cited only for the purpose of rebutting Applicant’s arguments, therefore, it is not cited as prior art reference.
Obviousness Double Patenting
29. 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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
30. (Revised due to Applicant’s amendment to the claim) Claims 49 and 50 remain rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-4 of US patent 7524820 B1, and as evidenced by Bennett et al (Journal of Neuroimmunology, 2010, 229, pages 180-191, cited and enclosed in the previous office action) and Danigole (Drink Up: 10 Reasons Water is a Key Ingredient in Your Good Health, 2018, from https://www.lcmchealth.org/university-medical-center-new-orleans/blog/2018/may/drink-up-10-reasons-water-is-a-key-ingredient-in/, enclosed pages 1-3).
31. Instant claims 49 and 50 are drawn to a method of treating a subject receiving fluid therapy and in need of (a) maintaining or improving hemodynamic stability, (b) a reduction in adverse vascular permeability, and/or (c) a reduction in fluid retention, the method comprising: administering to the subject peptide(s) to maintain or improve hemodynamic stability, reduce adverse vascular permeability, and/or reduce fluid retention, wherein the peptide(s) is/are selected from the group of peptides consisting of SEQ ID NO:1, SEQ ID NO:2, SEQ ID NO:3, SEQ ID NO:4, SEQ ID NO:5,SEQ ID NO:6, SEQ ID NO:7, SEQ ID NO:8, SEQ ID NO:9, SEQ ID NO:10, SEQ ID NO:11, SEQ ID NO:12, SEQ ID NO:13, SEQ ID NO:14, SEQ ID NO:15, SEQ ID NO:16, SEQ ID NO:17, and any combination thereof.
32. Claims 1-4 of US patent 7524820 B1 are drawn to a method for the treatment of exacerbations resulting from pro-inflammatory cytokine release in a subject having multiple sclerosis, said method comprising: administering to the subject, in an amount sufficient to reduce NF-kappaB mediated inflammatory cytokine release, a pharmaceutical composition comprising LQGV (SEQ ID NO: 1 ), MTR, MIRV (SEQ ID NO: 2), AQGV (SEQ ID NO: 3 ), LAGV (SEQ ID NO: 4), AQG, LQG, VLPALPQ (SEQ ID NO: 5), LAG, and/or VLPALP (SEQ ID NO: 6).
And as evidenced by Bennett et al, a subject having multiple sclerosis is a subject in need of a reduction in adverse vascular permeability (see for example, Title). And further as evidenced by Danigole, water is essential and drinking water exhibits therapy effects such as flushing out toxins from the system (see for example, page 1). Therefore, the subject recited in claims 1-4 of US patent 7524820 B1 is identical to the subject recited in instant claims 49 and 50.
Furthermore, the method recited in claims 1-4 of US patent 7524820 B1 comprises the same active method step, i.e., the same patient population, the same peptide and the same route of administration, therefore, administering the same peptide to the same patient population via the same route of administration would lead to the same effect, i.e., a reduction in adverse vascular permeability.
33. (Revised due to Applicant’s amendment to the claim) Claim 49 remains rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-6 of US patent 7662776 B2, and as evidenced by Danigole (Drink Up: 10 Reasons Water is a Key Ingredient in Your Good Health, from https://www.lcmchealth.org/university-medical-center-new-orleans/blog/2018/may/drink-up-10-reasons-water-is-a-key-ingredient-in/, 2018, enclosed pages 1-3).
34. Instant claim 49 is drawn to a method of treating a subject receiving fluid therapy and in need of (a) maintaining or improving hemodynamic stability, (b) a reduction in adverse vascular permeability, and/or (c) a reduction in fluid retention, the method comprising: administering to the subject peptide(s) to maintain or improve hemodynamic stability, reduce adverse vascular permeability, and/or reduce fluid retention, wherein the peptide(s) is/are selected from the group of peptides consisting of SEQ ID NO:1, SEQ ID NO:2, SEQ ID NO:3, SEQ ID NO:4, SEQ ID NO:5,SEQ ID NO:6, SEQ ID NO:7, SEQ ID NO:8, SEQ ID NO:9, SEQ ID NO:10, SEQ ID NO:11, SEQ ID NO:12, SEQ ID NO:13, SEQ ID NO:14, SEQ ID NO:15, SEQ ID NO:16, SEQ ID NO:17, and any combination thereof.
35. Claims 1-6 of US patent 7662776 B2 are drawn to a method of treating a subject suffering from lung cancer, said method comprising: providing the subject with repeated administrations of LQGV (SEQ ID NO: 1 ), or an acceptable salt thereof, wherein each repeated administration comprises a dose of at least 5 mg peptide/kg bodyweight of the subject, thus treating the subject suffering from lung cancer; and a method of treating a subject suffering from lung cancer, the method comprising: administering to the subject a peptide or acceptable salt of the peptide, wherein the peptide is SEQ ID NO: 1, thus treating the subject suffering from lung cancer.
The LQGV (SEQ ID NO: 1) recited in claims of US patent 7662776 B2 is identical to the peptide of instant SEQ ID NO: 4.
And as evidenced by instant claim 57, a subject suffering from lung cancer is a subject in need of maintaining or improving hemodynamic stability, a reduction in adverse vascular permeability, and/or a reduction in fluid retention recited in instant claim 49. And further as evidenced by Danigole, water is essential and drinking water exhibits therapy effects such as flushing out toxins from the system (see for example, page 1). Therefore, the subject recited in claims 1-6 of US patent 7662776 B2 is identical to the subject recited in instant claim 49.
Furthermore, the methods recited in claims 1-6 of US patent 7662776 B2 comprises the same active method step, i.e., the same patient population, the same peptide and the same route of administration, therefore, administering the same peptide to the same patient population via the same route of administration would lead to the same effect, i.e., maintaining or improving hemodynamic stability, a reduction in adverse vascular permeability, and/or a reduction in fluid retention.
36. (Revised due to Applicant’s amendment to the claim) Claims 49 and 50 remain provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 9 and 19-24 of co-pending Application No. 17/995692, and as evidenced by Danigole (Drink Up: 10 Reasons Water is a Key Ingredient in Your Good Health, from https://www.lcmchealth.org/university-medical-center-new-orleans/blog/2018/may/drink-up-10-reasons-water-is-a-key-ingredient-in/, 2018, enclosed pages 1-3).
37. Instant claims 49 and 50 are drawn to a method of treating a subject receiving fluid therapy and in need of (a) maintaining or improving hemodynamic stability, (b) a reduction in adverse vascular permeability, and/or (c) a reduction in fluid retention, the method comprising: administering to the subject peptide(s) to maintain or improve hemodynamic stability, reduce adverse vascular permeability, and/or reduce fluid retention, wherein the peptide(s) is/are selected from the group of peptides consisting of SEQ ID NO:1, SEQ ID NO:2, SEQ ID NO:3, SEQ ID NO:4, SEQ ID NO:5,SEQ ID NO:6, SEQ ID NO:7, SEQ ID NO:8, SEQ ID NO:9, SEQ ID NO:10, SEQ ID NO:11, SEQ ID NO:12, SEQ ID NO:13, SEQ ID NO:14, SEQ ID NO:15, SEQ ID NO:16, SEQ ID NO:17, and any combination thereof.
38. Claims 9 and 19-24 of co-pending Application No. 17/995692 are drawn to a method of treating a subject in need thereof suffering from an infection of COVID-19 or a mutant of COVID-19, the method comprising: providing to the endothelial layer of a blood vessel of the subject at a site of increased permeability due to the infection, a substance that reduces the ratio of angiopoietin-2 to angiopoietin-1, wherein the substance comprises a polypeptide selected from the group consisting of the amino acid sequence of SEQ ID NO:2, the amino acid sequence of SEQ ID NO:3, and a combination there of so as to reduce the increased permeability of the endothelial layer of the blood vessel due to the infection.
In the instant case, the method recited in claims 9 and 19-24 of co-pending Application No. 17/995692 is one that reduces the increased permeability of the endothelial layer of the blood vessel due to the infection (a reduction in adverse vascular permeability recited in instant claim 49), and the peptide of SEQ ID NO: 2 is identical to the peptide of instant SEQ ID NO: 1. Furthermore, as evidenced by Danigole, water is essential and drinking water exhibits therapy effects such as flushing out toxins from the system (see for example, page 1). Therefore, the subject recited in claims 9 and 19-24 of co-pending Application No. 17/995692 is identical to the subject recited in instant claims 49 and 50.
Furthermore, the methods recited in claims 9 and 19-24 of co-pending Application No. 17/995692 comprises the same active method step, i.e., the same patient population, the same peptide and the same route of administration, therefore, administering the same peptide to the same patient population via the same route of administration would lead to the same effect, i.e., maintaining or improving hemodynamic stability, a reduction in adverse vascular permeability, and/or a reduction in fluid retention.
This is a provisional obviousness-type double patenting rejections because the conflicting claims have not in fact been patented.
Response to Applicant's Arguments
39. For the ODP rejections over claims of the US patents, Applicant argues these patents are expired, and instant application and the reference patents are patentably distinct. Applicant further argues that co-pending Application No. 17/995692 and instant application are to different clinical indications, field of use and many others.
40. Applicant's arguments have been fully considered but have not been found persuasive.
Please note: in view of Applicant’s amendment to the claim, Danigole (Drink Up: 10 Reasons Water is a Key Ingredient in Your Good Health, enclosed pages 1-3, from https://www.lcmchealth.org/university-medical-center-new-orleans/blog/2018/may/drink-up-10-reasons-water-is-a-key-ingredient-in/, 2018) is cited as an evidentiary reference in instant rejections.
In response to Applicant’s arguments about the ODP rejections over claims of the US patents 7524820 B1 and 7662776 B2, the Examiner would like to point out that as stated in Sections 30-35 above, instant application and the reference patents are NOT patentably distinct. Furthermore, the Examiner understands that these patents are expired. However, in the instant case, Applicants have not pointed to any law, court case, or MPEP citation as to why expired patents cannot be the basis of a double patenting rejection.
In response to Applicant’s argument about the ODP rejection over claims 9 and 19-24 of co-pending Application No. 17/995692, in the instant case, the subject in claims 9 and 19-24 of co-pending Application No. 17/995692 is a subgroup of the subject recited in instant claims 49 and 50. Furthermore, the instant claimed method is one comprising administering to the subject peptide(s) is/are selected from the group consisting of instant SEQ ID NOs: 1-17, and any combination thereof. And with regards to the transitional phrase “comprising”, the MPEP states: “The transitional term "comprising", which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps.” (see MPEP § 2111.03). Therefore, the method recited in instant claims 49 and 50 is not patentably distinct from the method recited in claims 9 and 19-24 of co-pending Application No. 17/995692.
In addition, as stated in Section 10 above, the Examiner would like to point out that with regards to the recited a subject in need of maintaining hemodynamic stability, based on the Hemodynamics document (2022, enclosed pages 1-8, from https://my.clevelandclinic.org/health/body/24013-hemodynamics), a subject in need of maintaining hemodynamic stability broadly includes every subject having blood flows through the blood vessels (see for example, pages 1-2. Section “What is hemodynamics?”; and pages 4-5, Section “What is hemodynamic instability?”).
Therefore, until a proper terminal disclaimer is filed and approved by the Office, these double patenting rejections are hereby maintained.
The Hemodynamics document is cited only for the purpose of rebutting Applicant’s arguments, therefore, it is not cited as prior art reference.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
No claim is allowed.
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/LI N KOMATSU/Primary Examiner, Art Unit 1658