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 .
Election/Restrictions
Applicant’s election without traverse of the species hAM(1-52), [Ala-44]hAM(13-52), and 60 K PEG-AM in the reply filed on December 1, 2025, is acknowledged.
The species hAM(1-52) consists of SEQ ID NO: 1, amidated at the C-terminus and having a disulfide bond between the two cysteines in the sequence.
The species [Ala-44]hAM(13-52) consists of SEQ ID NO: 17, amidated at the C-terminus and having a disulfide bond between the two cysteines in the sequence.
The species 60K PEG-AM is an adrenomedullin derivative having a PEG group with a weight-average MW of 60 kDa
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These species read on claims 21-40. Prior art was found therefore the search was not extended further in accordance with MPEP 803.02.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Issues Relevant to Both Written Description and Enablement Presented Once for Brevity
1) Scope of the Claims
The claims are drawn to methods for preventing or treating a symptom or disorder due to a viral infection or a sequela after cure of a viral infection using adrenomedullin or a derivative thereof.
Scope of composition:
In claims 21-23 and 32-40, the term “adrenomedullin or derivative thereof” is defined at [0114]: native adrenomedullin or a peptide consisting of an amino acid sequence of adrenomedullin with a part thereof deleted, substituted, or added; a peptide consisting of an amino acid sequence of adrenomedullin or an adrenomedullin analog and having a disulfide bond formed by two cysteine residues in the amino acid sequence, or a peptide wherein the disulfide bond of that peptide is substituted with an ethylene group, or peptide attached to a modifying group by a linker. The extent of modification of the adrenomedullin is not structurally limited.
In claims 24-31, the term “adrenomedullin or derivative thereof” is still exceptionally broad. Although the claims recite various structural limitations, BRI the language “an amino acid sequence of” means includes full-length and all possible fragments of the recited peptides. In addition, there is no limit to the types of substitutions, additions, or modifications to the peptides.
Only those sequences meeting the structural and functional requirements of the genus are encompassed by the claim. Therefore, the claims encompasses all peptides meeting the structural and functional requirements above that are also able to prevent or treat a symptom or disorder due to a viral infection or a sequela after cure of a viral infection.
Scope of subject: Claims 21-32 and 35-40 due not limit the virus that causes the claimed symptoms or disorders or the type of infection or sequalae. According to [0095] the viral infection may be caused, but is not limited to, novel coronavirus (SARS-CoV-2), severe acute respiratory syndrome (SARS) coronavirus, Middle East respiratory syndrome (MERS) coronavirus, conventional human coronavirus (229E, NL63, OC43, and HKU1), influenza virus, dengue virus, RS virus, adenovirus, varicella-zoster virus, herpes simplex virus, measles virus, parainfluenza virus, enterovirus, rhinovirus, or human metapneumovirus. According to [0106] the viral infection may be viral pneumonia, viral myocarditis, viral encephalitis, viral hemorrhagic fever, viral nephropathy, viral gastroenteritis, viral vasculitis, viral stomatitis, viral keratitis, or viral neuritis, and the sequela after cure of the viral infection is dyspnea or shortness of breath remaining after cure of viral pneumonia. According to [0128] the symptom or disorder due to a viral infection may be, but is not limited to, viral pneumonia, organ dysfunctions, respiratory disorder (such as cough or dyspnea), fever, muscle aches, general malaise, septicemia, septic shock, and multi-organ failure (such as organ failure of the lung, kidney, liver, heart, blood vessels, or cerebral nerves); for viral myocarditis, myocarditis; for viral encephalitis, encephalitis; for viral hemorrhagic fever, hemorrhagic fever; for viral nephropathy, nephropathy; for viral gastroenteritis, gastroenteritis; for viral vasculitis, vasculitis; for viral stomatitis, stomatitis; for viral keratitis, keratitis; and for viral neuritis, neuritis. Claim 33 limits the form of the disorder but not the virus. Claim 34 recites a broad list of viruses.
2) Actual reduction to practice/Working examples
The instant specification includes a limited reduction to practice:
Example 1, Table 5, [0263]: gross lesion formation in the lung was significantly suppressed in the influenza virus- infected mice treated with hAM(1-52);
Example 2, Table 8, Table 9, [0276]: gross lesion formation in the lung and the virus concentration in the lung significantly decreased in the influenza virus- infected mice treated with hAM(1-52) and [Ala-44]hAM(13-52);
Example 3, Table 13, Table 14, [0289]: gross lesion formation in the lung and the virus concentration in the lung significantly decreased in the influenza virus- infected mice treated with 60K PEG-AM; and
Example 4, Table 16, [0329]-[0331]: evaluated patients with severe pneumonia and mechanical ventilation caused by COVID-19 treated with hAM(1-52).
The results for the clinical trial reported in Example 4 state in [0331]: “As described above, the present trial is randomized double-blind trial, and it is currently difficult to show a definite conclusion. However, reduction in blood pressure was observed for the cases with short-term mechanical ventilation in the early stage of administration (FIG. 2). This is inferred to be the effect of AM. In particular, case 10 (FIG. 2C) succeeded in early withdrawal from mechanical ventilation in spite of the high clinical severity and the high inflammatory reaction (i.e., high production of cytokine), and the subsequent progress was very good as well. These findings probably suggest the efficacy of AM in clinical situations. In addition, no adverse event directly caused by AM has been reported so far in patients subjected to dosing. Probably, this ensures the safety of AM.”
3) Predictability in the art
There is a high level of unpredictability and complexity associated with treat viral infection. The specification notes that only influenza and herpes virus have effective therapeutic agents, and that even with these agents, influenza leads to many deaths [0010].
In addition, there is a high level of unpredictability and complexity associated with the therapeutic use of adrenomedullin because of its side effects. The specification at [0014] states: “ from the viewpoint of management of blood pressure, it has been needed for long-term administration of AM to avoid administration at night, in which reduction in blood pressure is expected. In administering AM to patients with viral infections, excessively high rates of administration or excessive doses may cause reduction in blood pressure due to the excessive vasodilatory effect of AM, leading to a shock state.” Practice of the invention requires preventing and/or treating a symptom due to a viral infection in a subject with the viral infection, without causing any unwanted serious side effect.
4) Guidance in the specification/Structure-function correlation
The specification does not describe a general correlation between structure and function for the claimed genus. The role of each of the 52 amino acids of adrenomedullin on the ability to treat and prevent disorders and symptoms caused by viral infection as well as sequela after cure of the infection are not described. As a result, it is impossible to predict, based on the specification, how changing any position will affect the claimed function.
Claims 21-40 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
MPEP § 2163 states that the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus.
Only methods of treating infection caused by influenza and SARS-CoV2 with hAM(1-52), [Ala-44]hAM(13-52), and 60K PEG-AM were reduced to practice. As discussed above the claim scope is enormous given the breadth of structural limitations and complexity of functional limitations in the claims as well as the scope of viral infection. Therefore, one of ordinary skill in the art would not consider treating infection caused by influenza and SARS-CoV2 with hAM(1-52), [Ala-44]hAM(13-52), and 60K PEG-AM to be representative of the full scope of the claimed genus. Therefore, the instant specification has failed to meet the written description requirement by actual reduction to practice of a representative number of species alone.
The specification discloses the complete structure of hAM(1-52), [Ala-44]hAM(13-52), and 60K PEG-AM.
The data presented in the specification raise more questions about the physical properties of the genus than they answer. The data do not suggest the physical basis for the claimed activity and therefore do not describe which substitutions, deletions or additions could be made while preserving function. Understanding the physical basis for the claimed activity is critical to determining which of the sequences that meet the structural requirements of the genus also meet the functional requirements of the genus.
The specification does not describe a general correlation between structure and function for the claimed genus. The role of the 52 amino acids of adrenomedullin in ability to treat and prevent disorders and symptoms caused by viral infection as well as sequela after cure of the infection are not described. As a result, it is impossible to predict, based on the specification, how changing any position will affect the claimed functions.
As described above there is a high degree of unpredictability in the prior art with respect to adrenomedullin structure-function, the effect of adrenomedullin on blood pressure in viral patients, and the use of adrenomedullin to treat and prevent disorders and symptoms caused by viral infection as well as sequela after cure of the infection. For all of the reasons presented above, one of ordinary skill in the art would not know which of the countless peptides that meet the structural requirements of the claims would also be able to perform the complicated claimed functions. The specification does not make clear which peptides are in the genus and which are not because it does not describe the physical basis for the claimed activity. In other words, the specification does not describe which peptides to make.
For these reasons, the skilled artisan would not reasonably conclude that the inventor(s), at the time the application was filed, had possession of the full scope of the claimed invention. In conclusion, only treating infection caused by influenza and SARS-CoV2 with hAM(1-52), [Ala-44]hAM(13-52), and 60K PEG-AM dose meet the written description provision of 35 U.S.C. 112(a).
Claims 21-40 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating a symptom or a disorder in a subject having a viral infection caused by SARS-CoV-2 or influenza virus, comprising administering a therapeutically effective amount of adrenomedullin or a derivative thereof to the subject:
wherein the adrenomedullin or a derivative thereof is selected from the group consisting of:
1) hAM(1-52), which consists of the amino acid sequence of SEQ ID NO: 1, amidated at the C-terminus and having a disulfide bond between the two cysteines in the sequence;
2) [Ala-44]hAM(13-52), which consists of SEQ ID NO: 17, amidated at the C-terminus and having a disulfide bond between the two cysteines in the sequence; and
3) 60K PEG-AM, which is the structure
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wherein the PEG group has a weight-average molecular weight of 60 kDa, does not reasonably provide enablement for the treatment of any other conditions with these compositions or the use of any other compositions. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
To comply with the enablement requirements of 35 U.S.C. §112, first paragraph, a specification must adequately teach how to make and how to use a claimed invention throughout its scope, without undue experimentation. Plant Genetic Systems N.V. v. DeKalb Genetics Corp., 315 F.3d 1335, 1339, 65 USPQ2d 1452, 1455 (Fed. Cir. 2003). There are a variety of factors which may be considered in determining whether a disclosure would require undue experimentation. These factors include: (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims. In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
Factors (2)-(8) are discussed above.
The scope of the claimed compositions of adrenomedullin derivatives and therapeutic indications are extremely broad relative to the narrow reduction to practice in the specification. That fact combined with the level of unpredictability and complexity in the art, the relative skill in the art, and the lack of specific guidance in the specification, poses an undue burden of experimentation on one of ordinary skill in the art seeking to practice the claimed methods. The specification is an invitation to undertake a research program to identify additional compositions that could be used to carry out different embodiments of the claims. As such, the specification fails to meet the enablement provision of 35 U.S.C. 112(a).
Claim Rejections - 35 USC § 102
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 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.
Claims 21-27 and 32-36 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bevec et al. (US 2010/0184676 A1).
Bevec et al. teach a method for prophylaxis and treatment of infectious disease, including viral infection, in a subject comprising administering a therapeutically effective amount of adrenomedullin ([0007]). The adrenomedullin consists of instant SEQ ID NO: 1 and is amidated at the C-terminus ([0007]). Therefore, Bevec et al. satisfy all of the limitations of instant claims 21-22, 24-27, and 32.
Regarding claim 23, Bevec et al. teach pharmaceutical compositions comprising the adrenomedullin and a pharmaceutically-acceptable carrier ([0162]).
Regarding claim 33, Bevec et al. teach the treatment of viral pneumonia ([0044]).
Regarding claim 34, Bevec et al. teach treatment of viral infection caused by Dengue/Dengue fever or herpes simplex virus ([0041]).
Regarding claim 35, teaches a method of administering adrenomedullin to treat viral infection and also viral pneumonia but is silent as to the effect on dyspnea or shortness of breath remaining after cure. Because the prior art teaches all of the same active method steps as the claim, that is administering the same exact structure, to the same patients, in the same manner, the claimed effect of treating or preventing dyspnea or shortness of breath remaining after cure of the viral infection is inherent to the prior art method.
Regarding claim 36, Bevec et al. teach intravenous administration ([0215]).
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 pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 37-40 are rejected under 35 U.S.C. 103 as being unpatentable over Bevec et al. (US 2010/0184676 A1), as applied to claims 21-27 and 32-36 above, in view of Kita et al. (Safety, Tolerability, and Pharmacokinetics of Adrenomedullin in Healthy Males: A Randomized, Double-Blind, Phase 1 Clinical Trial. Drug Des Devel Ther. 2020;14:1-11).1
Determining the scope and contents of the prior art.
Bevec et al. teach a method for prophylaxis and treatment of infectious disease, including viral infection, in a subject comprising administering a therapeutically effective amount of adrenomedullin ([0007]). The adrenomedullin consists of instant SEQ ID NO: 1 and is amidated at the C-terminus ([0007]).
Ascertaining the differences between the prior art and the claims at issue.
Bevec et al. does not teach the dose.
Resolving the level of ordinary skill in the pertinent art.
Kita et al. teach a Phase 1 clinical trial for intravenous administration of adrenomedullin. Subjects received either a placebo, 3 ng/kg/min AM, 9 ng/ kg/min AM, or 15 ng/kg/min AM via continuous 12-h intravenous infusion. Other subjects received either placebo or 15 ng/kg/min AM for 8 h per day for 7 days (abstract).
Considering objective evidence present in the application indicating obviousness or nonobviousness.
The specification does not include evidence of unexpected results.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the dose taught by Kita et al. in the method taught by Bevec et al. The rationale for obviousness is combining prior art elements according to known methods to yield predictable results (MPEP § 2143.01(A)). The relevant findings for this rationale are as follows.
(1) The prior art included each element claimed, although not necessarily in a single prior art reference, with the only difference between the claimed invention and the prior art being the lack of actual combination of the elements in a single prior art reference. In the instant case, the only difference between the claimed invention and the primary reference Bevec et al. is the dose. This difference is found in the prior art of Kita et al. which teaches a Phase 1 clinical trial for intravenous administration of adrenomedullin. Subjects received either a placebo, 3 ng/kg/min AM, 9 ng/ kg/min AM, or 15 ng/kg/min AM via continuous 12-h intravenous infusion. Other subjects received either placebo or 15 ng/kg/min AM for 8 h per day for 7 days (abstract). Therefore, the only difference between the claimed invention and the prior art is the actual combination of elements in a single prior art reference.
(2) One of ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately. One of ordinary skill in the art could have combined the dose taught by Kita et al. with the method taught by Bevec et al. One of ordinary skill in the art would expect that the adrenomedullin performs the function of treating the viral infection in the combination, which is the same function it performs separate from the combination. Likewise, one of ordinary skill in the art would expect that the dose taught by Kita et al. performs the function of adrenomedullin activity in the combination, which is the same function it performs separate from the combination. Therefore, one of ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately.
(3) One of ordinary skill in the art would have recognized that the results of the combination were predictable. One of ordinary skill in the art would expect that the dose taught by Kita et al. would be effective because the Phase 1 clinical trial showed that the dose is safe and tolerable (abstract). Therefore, one of ordinary skill in the art would have recognized that the results of the combination were predictable.
(4) Whatever additional findings based on the Graham factual inquiries may be necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness. The specification does not include evidence of unexpected results.
The rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at 416, 82 USPQ2d at 1395; B/E Aerospace, Inc. v. C&D Zodiac, Inc., 962 F.3d 1373, 1379, 2020 USPQ2d 10706 (Fed. Cir. 2020); Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atl. & P. Tea Co. v. Supermarket Equip. Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950). "[I]t can be important to identify a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does." KSR, 550 U.S. at 418, 82 USPQ2d at 1396.
Regarding claim 37, the prior art doses 3 ng/kg/min AM, 9 ng/ kg/min AM, or 15 ng/kg/min AM via continuous 12-h intravenous infusion and 15 ng/kg/min AM for 8 h per day for 7 days (abstract) fall within the claimed range.
Regarding claim 39, the prior art dose 15 ng/kg/min AM for 8 h per day for 7 days (abstract) falls within the claimed range.
Regarding claims 38 and 40, it would have been routine optimization to arrive at the claimed invention because the claimed parameter the timing and duration of administration is recognized as a result-effective variable, i.e., a variable which achieves a recognized result. MPEP § 2144.05(II)(A)
Claims 21-36 are rejected under 35 U.S.C. 103 as being unpatentable over Bevec et al. (US 2010/0184676 A1) in view of Kitamura et al. (WO 2017/047788 A1, published March 23, 2017; citations are made to the English language equivalent US 2018/0264123 A1).
Determining the scope and contents of the prior art.
Bevec et al. teach a method for prophylaxis and treatment of infectious disease, including viral infection, in a subject comprising administering a therapeutically effective amount of adrenomedullin ([0007]). The adrenomedullin consists of instant SEQ ID NO: 1 and is amidated at the C-terminus ([0007]).
Ascertaining the differences between the prior art and the claims at issue.
Bevec et al. does not teach the elected species 60K PEG-AM is an adrenomedullin derivative having a PEG group with a weight-average MW of 60 kDa
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Resolving the level of ordinary skill in the pertinent art.
Kitamura et al. teaches 60K PEG-AM is an adrenomedullin derivative having a PEG group with a weight-average MW of 60 kDa
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. The species is prepared in Example 1-8 and reduced to practice in several therapeutic applications in Examples IV-2, IV-3, IV-5, and IV-9 through IV-14 and Figures 6-7, 9, and 11-21.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
The specification does not include evidence of unexpected results.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute Compound (8) of Kitamura et al. for the hAM(1-52) in the method of treating viral infection taught by Bevec et al. The rationale for obviousness is some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention (MPEP § 2143.01(G)). The relevant findings for this rationale are as follows.
(1) There was some teaching, suggestion, or motivation, either in the references themselves or in the knowledge generally available to one of ordinary skill in the art, to modify the reference or to combine reference teachings. In the instant case, Kitamura et al. teaches that Compound (8) is an adrenomedullin derivative sustainable for a long period which is capable of substantially suppressing unwanted side effects while maintaining pharmacological effects of adrenomedullin. In [0278] Kitamura et al. teaches: “As shown in FIG. 6, rapidly decreased blood pressure was observed in full-length AM (h.AM (1-52)) without a linked PEG group immediately after the administration. By contrast, the rapidly decreased blood pressure observed in h.AM (1- 52) immediately after the administration was not observed in the adrenomedullin derivatives (Compound (2), compound (4) and compound (8)) having the linked PEG group. Therefore, the adrenomedullin derivatives having the linked PEG group are presumed to be able to suppress unwanted side effects such as rapidly decreased blood pressure that may occur in the parent compound full-length AM.” Therefore, there was some teaching, suggestion, or motivation, either in the references themselves or in the knowledge generally available to one of ordinary skill in the art, to modify the reference or to combine reference teachings.
(2) There was reasonable expectation of success. One of ordinary skill in the art would predict that Compound (8) of Kitamura et al. would be superior to hAM(1-52) of Bevec et al. because Kitamura et al. provide a side by side comparison of these species in [0282]. Therefore, there was a reasonable expectation of success.
(3) Whatever additional findings based on the Graham factual inquiries may be necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness. The specification does not allege unexpected results.
The rationale to support a conclusion that the claim would have been obvious is that "a person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and whether there would have been a reasonable expectation of success in doing so." DyStar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464 F.3d 1356, 1360, 80 USPQ2d 1641, 1645 (Fed. Cir. 2006).
Therefore, claims 21-22 and 24-32 are obvious over the cited art.
Regarding claim 23, Kitamura et al. teach pharmaceutical compositions comprising the adrenomedullin and a pharmaceutically-acceptable carrier ([0049]).
Regarding claim 33, Bevec et al. teach the treatment of viral pneumonia ([0044]).
Regarding claim 34, Bevec et al. teach treatment of viral infection caused by Dengue/Dengue fever or herpes simplex virus ([0041]).
Regarding claim 35, teaches a method of administering adrenomedullin to treat viral infection and also viral pneumonia but is silent as to the effect on dyspnea or shortness of breath remaining after cure. Because the prior art teaches all of the same active method steps as the claim, that is administering the same exact structure, to the same patients, in the same manner, the claimed effect of treating or preventing dyspnea or shortness of breath remaining after cure of the viral infection is inherent to the prior art method.
Regarding claim 36, Kitamura et al. teach intravenous administration ([0202]).
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 21-28, 32-33 and 36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 and 11-25 of copending Application No. 17/916,062 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Reference claim 6 recites a peptide consisting of SEQ ID NO: 4 being amidated at the C-terminus thereof, and having a disulfide bond formed by cysteine residues at positions 4 and 9. SEQ ID NO: 4 is identical to instant SEQ ID NO: 17.
Reference claim 14 states that the peptide can be used in a method of treating or preventing viral infection comprising administering a therapeutically effect amount of the peptide.
Therefore, the reference claims satisfy all of the limitations of and anticipate instant claims 21-22, 24-28, and 32.
Regarding claim 23, reference claim 11 recites a pharmaceutical composition comprising the peptide and a pharmaceutically-acceptable carrier.
A claim to a method of using a composition is not patentably distinct from an earlier claim to the identical composition in a patent disclosing the identical use (Sun Pharmaceutical. Industries, Ltd. v. Eli Lilly & Co., 611 F.3d 1381 (Fed. Cir. 2010))
Regarding claim 33, the reference application discloses a method of treating or preventing viral infection caused by influenza virus, novel coronavirus (SARS-CoV-2), severe acute respiratory syndrome (hereinafter also described as "SARS") coronavirus, Middle East respiratory syndrome (hereinafter also described as "MERS") coronavirus, conventional human coronavirus (229E, NL63, OC43, and HKU1), RS virus, adenovirus, varicella-zoster virus, herpes simplex virus, measles virus, parainfluenza virus, enterovirus, rhinovirus, and human metapneumovirus, and, in particular, include one or more viruses selected from the group consisting of influenza virus and SARS-CoV-2 ([0057]).
Regarding claim 34, the reference application discloses a method of treating or preventing viral pneumonia, viral myocarditis, viral encephalitis, viral hemorrhagic fever, viral nephropathy, viral gastroenteritis, viral vasculitis, viral stomatitis, viral keratitis, and viral neuritis, in particular, viral pneumonia ([0057]).
Regarding claim 36, the reference application discloses a method of administering the peptide intravenously ([0062]).
Conclusion
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/CHRISTINA BRADLEY/Primary Examiner, Art Unit 1654
1 Applicant cannot rely upon the certified copy of the foreign priority application to overcome this rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.