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 the Claims
Claims 1-71 were originally filed June 14, 2022.
The amendment received December 5, 2022 canceled claims 1, 2, 4, 7-9, 13-22, 24, 25, 27-30, 32-38, 40-49, 54, 58-60, and 62-70 and amended claims 5, 6, 10-12, 23, 26, 31, 39, 50-53, 55-57, and 61.
Please note: claim 71 is missing from the December 5, 2022 amendment.
Claims 3, 5, 6, 10-12, 23, 26, 31, 39, 50-53, 55-57, and 61 are currently pending.
Claims 3, 10-12, 26, 31, 50-52, 57, and 61 are currently under consideration.
Election/Restrictions
Applicant's election with traverse of an individual diagnosed with having AHF utilizing a physical examination of symptoms, AHF associated with edema, synthetic WT acylated ghrelin which causes increased heart output, utilizing a physical examination to diagnose AHF and having an increased heart output, an ACE inhibitor, and parenteral administration over a day as the species in the reply filed on April 13, 2026 is acknowledged. The traversal is on the grounds that Brizzi et al. teach unacylated ghrelin, that the presently claimed acylated ghrelin is SEQ ID NO: 1, and applicant’s representative argues unexpected results. Applicant’s representative acknowledges that post-translationally modified acylated ghrelin is taught by Brizzi et al. (see page 4, third full paragraph of the response received April 13, 2026). This is not found persuasive because, as acknowledged by applicant’s representative, Brizzi et al. teaches post-translationally modified acylated ghrelin (see page 4, third full paragraph of the response received April 13, 2026) and treating cardiovascular disease including heart failure. Present SEQ ID NO: 1 and SEQ ID NO: 1 of Brizzi et al. are the same sequence (i.e. Gly-Ser-Ser-Phe-Leu-Ser-Pro-Glu-His-Gln-Arg-Val-Gln-Gln-Arg-Lys-Glu-Ser-Lys-Lys-Pro-Pro-Ala-Lys-Leu-Gln-Pro-Arg – see page 7 last full paragraph of Brizzi et al. and page 30 of the present originally filed specification). The octanoyl of the third amino acid (i.e. Ser) is wildtype ghrelin. Limitations from the specification should not be read into the claims. If applicant wishes to claim SEQ ID NO: 1 or a specific location and type of acylation, then SEQ ID NO:1 and/or the specific location and type of acylation should clearly be present in the claims. The present claims are drawn to any “acylated ghrelin molecule”. Unexpected results are not a reason to drop a Lack of Unity requirement. As long as the “least common denominator” for the claims is taught in the prior art, Lack of Unity is present.
The requirement is still deemed proper and is therefore made FINAL.
Claims 5, 6, 23, 39, 53, 55, and 56 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on April 13, 2026.
Priority
The present application is a 371 (National Stage) of PCT/EP2020/086960 filed December 18, 2020 which claims foreign priority to United Kingdom 1918853.1 filed December 19, 2019.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on May 3, 2023 and January 13, 2025 are being considered by the examiner.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency - This application fails to comply with the requirements of 37 CFR 1.821 - 1.825 because it does not contain a "Sequence Listing" as a separate part of the disclosure or a CRF of the “Sequence Listing.”.
See page 30 of the present specification (SEQ ID NO: 1).
Required response - Applicant must provide:
A "Sequence Listing" part of the disclosure; together with
An amendment specifically directing its entry into the application in accordance with 37 CFR 1.825(a)(2);
A statement that the "Sequence Listing" includes no new matter as required by 37 CFR 1.821(a)(4); and
A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825(a)(3).
If the "Sequence Listing" part of the disclosure is submitted according to item 1) a) or b) above, Applicant must also provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
If the "Sequence Listing" part of the disclosure is submitted according to item 1) c) or d) above, applicant must also provide:
A CRF in accordance with 37 CFR 1.821(e)(1) or 1.821(e)(2) as required by 1.825(a)(5); and
A statement according to item 2) a) or b) above.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
See page 64, line 6.
Claim Objections
Claim 3 is objected to because of the following informalities: “the individual” should read “the individual in need thereof” or “the individual with AHF” to form a nexus between the preamble and the body of the claim. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: “from the group comprising” should read “from the group consisting of”. Appropriate correction is required.
See also withdrawn claims 5, 23, and 39.
Claim 12 is objected to because of the following informalities: a single conjunction should be present in the Markush group. The following is required due to the selected from the group consisting of language: “and”. Applicants may wish to consider “and combinations thereof”. Appropriate correction is required.
See withdrawn claim 5 regarding utilization of “and”.
See withdrawn claims 23, 26, 39, and 56.
Claim 26 is objected to because of the following informalities: “the group comprising” should read “from the group consisting of”. Appropriate correction is required.
Claim 26 is objected to because of the following informalities: a single conjunction should be present in the Markush group. The following is required due to the selected from the group consisting of language: “and”. Applicants may wish to consider “and combinations thereof”. Appropriate correction is required.
Claim 26 is objected to because of the following informalities: “fainting (also known as syncope)” should read “fainting (syncope)”. Appropriate correction is required.
Claim 31 is objected to because of the following informalities: “the group comprising” should read “from the group consisting of”. Appropriate correction is required.
Claim 31 is objected to because of the following informalities: a single conjunction should be present in the Markush group. The following is required due to the selected from the group consisting of language: “and”. Applicants may wish to consider “and combinations thereof”. Appropriate correction is required.
Claim 50 is objected to because of the following informalities: “the group comprising” should read “from the group consisting of”. Appropriate correction is required.
Claim 50 is objected to because of the following informalities: a single conjunction should be present in the Markush group. The following is required due to the selected from the group consisting of language: “and”. Applicants may wish to consider “and combinations thereof”. Appropriate correction is required.
Claim 50 is objected to because of the following informalities: the claim contains both open comprising language and closed consisting of language. The Markush group should be clarified. Appropriate correction is required.
Claim 51 is objected to because of the following informalities: “the group comprising” should read “from the group consisting of”. Appropriate correction is required.
Claim 51 is objected to because of the following informalities: a single conjunction should be present in the Markush group. The following is required due to the selected from the group consisting of language: “and”. Applicants may wish to consider “and combinations thereof”. Appropriate correction is required.
Claim 51 is objected to because of the following informalities: the claim contains both open comprising language and closed consisting of language. The Markush group should be clarified. Appropriate correction is required.
Claim 52 is objected to because of the following informalities: all method steps should be recited as active, positive steps (i.e. “administered” should read “administering”; “wherein administering the acylated ghrelin molecule is once or more each day”). Appropriate correction is required.
See withdrawn claim 56.
Claim 57 is objected to because of the following informalities: all method steps should be recited as active, positive steps (i.e. “administered” should read “administering” or “further comprising administering one or more additional therapeutic agents”). Appropriate correction is required.
Claim 61 is objected to because of the following informalities: “selected from the group comprising” should read “selected from the group consisting of”. Appropriate correction is required.
Claim 61 is objected to because of the following informalities: a single conjunction should be present in the Markush group. The following is required due to the selected from the group consisting of language: “and”. Applicants may wish to consider “and combinations thereof”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3, 10-12, 26, 31, 50-52, 57, and 61 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. One of skill in the art would not be able to determine the scope of the present claims. For example, it is unclear what the scope of “acylated ghrelin molecule” is. Does “acylated ghrelin molecule” refer to WT acylated ghrelin (i.e. Gly-Ser-Ser(octanoyl)-Phe-Leu-Ser-Pro-Glu-His-Gln-Arg-Val-Gln-Gln-Arg-Lys-Glu-Ser-Lys-Lys-Pro-Pro-Ala-Lys-Leu-Gln-Pro-Arg), fragments, variants, etc.?
Claim 12 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 12 recites the limitation "the ghrelin molecule" in line 3. There is insufficient antecedent basis for this limitation in the claim. The following is suggested: “the acylated ghrelin molecule”.
See also withdrawn claim 53.
Claim 12 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. One of skill in the art would not be able to determine the scope of the present claims. For example, it is unclear if the claim requires additional method step(s) or not. The claim presently reads on the function of administering the acylated ghrelin molecule.
Claim 26 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.
Regarding claim 26, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). See lines 4, 7, 8, 10, 12, and 13.
See also withdrawn claim 23.
Claim 26 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.
Regarding claim 26, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). See line 15.
Claim 26 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. One of skill in the art would not be able to determine the scope of the present claims. For example, it is unclear if the claim requires additional method step(s) or not. The claim presently reads on symptoms of AHF. Is a method step of assessing the symptoms required or not?
Claim 31 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.
Regarding claim 31, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). See line 9.
Claim 31 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. One of skill in the art would not be able to determine the scope of the present claims. For example, it is unclear if the claim requires additional method step(s) or not. The present claim refers to the past tense (i.e. diagnosed), therefore, it is unclear if additional method steps are required or not. Active, positive method steps should be utilized when claiming additional method steps.
Claim 31 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. One of skill in the art would not be able to determine the scope of the present claims. For example, it is unclear if the claim requires additional method step(s) or not. See MPEP § 2173.05(q) regarding “use claims”.
Claim 50 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. One of skill in the art would not be able to determine the scope of the present claims. For example, it is unclear what modification, fusion, fragment, variant, or derivative would still have the function of treating AHF. In addition, one of skill in the art would assume that the acylated ghrelin of independent claim 3 may be wildtype ghrelin which is naturally acylated at the third amino acid residue (i.e. Ser(octanoyl)). Therefore, it is unclear how the limitation of wildtype ghrelin alters the acylated gherlin molecule of independent claim 3. Furthermore, it is unclear how administering a wildtype ghrelin molecule is different from the body naturally producing (i.e. administering) a ghrelin molecule.
Claim 51 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. One of skill in the art would not be able to determine the scope of the present claims. For example, it is unclear what the structural difference is between a synthetic ghrelin molecule, a recombinant ghrelin molecule, and an endogenous ghrelin molecule is. Furthermore, it is unclear how administering an endogenous ghrelin molecule is different from the body naturally producing (i.e. administering) a ghrelin molecule.
Claim 51 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 51 recites the limitation "the ghrelin molecule" in line 3. There is insufficient antecedent basis for this limitation in the claim. The following is suggested: “the acylated ghrelin molecule”.
Claim 52 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.
Regarding claim 52, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
See withdrawn claims 6 and 55.
Claim 52 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 52 recites the limitation "the ghrelin molecule" in line 3. There is insufficient antecedent basis for this limitation in the claim. The following is suggested: “the acylated ghrelin molecule”.
Claim 61 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.
Regarding claim 61, the phrase "in particular" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 61 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 61 contains the trademark/trade name Lanoxin™. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe digoxin and, accordingly, the identification/description is indefinite.
Applicant is respectfully requested to check all members of the Markush group for trademarks.
Claim 61 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.
Regarding claim 61, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). See lines 8, 9, and 10.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 12 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 12 depends on independent claim 3. Independent claim 3 requires a single method step of administering an acylated ghrelin molecule. Dependent claim 12 refers to various functions of administering the acylated ghrelin molecule. Therefore, claim 12 fails to further limit the reagents utilized or the method step of independent claim 3. Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
Claim 26 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 26 depends on independent claim 3. Independent claim 3 requires a single method step of administering an acylated ghrelin molecule. Dependent claim 26 refers to various symptoms of AHF. Therefore, claim 26 fails to further limit the reagents utilized or the method step of independent claim 3. The assessment of the symptoms includes metal steps (e.g. mental assessment of cough, breathing pattern, etc.). Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
Claim 31 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 31 is dependent on independent claim 3. Independent claim 3 requires a single method step of administering an acylated ghrelin molecule to an individual with acute heart failure. Dependent claim 31 refers to how the individual was diagnosed (i.e. prior to the administration step) including mental steps of diagnosing including the analysis of data, X-rays, blood tests, etc. Therefore, the mental steps of evaluating data and/or a preliminary method step of diagnosing via actually performing an MRI, etc. is not present and dependent claim 31 fails to further limit the administration steps of present independent claim 3. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim 50 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 50 depends on independent claim 3. Independent claim 3 requires an acylated ghrelin molecule. Dependent claim 50 appears to broaden the scope of the acylated ghrelin molecule to potentially exclude acylation and to include any modification, fusion, fragment, variant, or derivative which may not have the same function of treating AHF. In addition, one of skill in the art would assume that the acylated ghrelin of independent claim 3 may be wildtype ghrelin which is naturally acylated at the third amino acid residue (i.e. Ser(octanoyl)), therefore, that limitation also appears to fail to further limit independent claim 3. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim 51 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 51 depends on independent claim 3. Independent claim 3 requires an acylated ghrelin molecule. Dependent claim 51 appears to broaden the scope of the acylated ghrelin molecule to potentially exclude acylation and to include any synthetic or recombinant ghrelin molecule which may not have the same function of treating AHF. In addition, one of skill in the art would assume that the acylated ghrelin of independent claim 3 may be endogenous ghrelin which is naturally acylated at the third amino acid residue (i.e. Ser(octanoyl)), therefore, that limitation also appears to fail to further limit independent claim 3. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Please note: due to the myriad of claim objections and 35 USC 112 issues, applicants are respectfully requested to carefully review ALL claims for any additional issues.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 3, 10-12, 26, 31, 50-52, 57, and 61 are rejected under 35 U.S.C. 101 because the claimed invention is directed to naturally occurring ghrelin (Gly-Ser-Ser(octanoyl)-Phe-Leu-Ser-Pro-Glu-His-Gln-Arg-Val-Gln-Gln-Arg-Lys-Glu-Ser-Lys-Lys-Pro-Pro-Ala-Lys-Leu-Gln-Pro-Arg) without significantly more. The claims recite administering an acylated ghrelin molecule. Naturally occurring ghrelin is acylated (i.e. octanoyl on the third amino acid). This judicial exception is not integrated into a practical application because the administration step amounts to utilizing “apply it”. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims are drawn to a single method step as presently claimed and it is not clear how the addition of an additional therapeutic agent alters ghrelin (e.g. structural difference due to formulation, etc.) and co-therapies are well-understood, routine, and conventional in the art. Further exacerbating the 35 USC 101 issue is the recitation in claims 50 and 51 of wildtype ghrelin and endogenous ghrelin (e.g. “administering” could be the body making wildtype or endogenous ghrelin). See Kojima et al., 1999, Ghrelin is a growth-hormone-releasing acylated peptide from stomach, Nature, 402: 656-660.
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)(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 3, 12, 26, 31, and 50-52 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Huang et al., 2009, Ghrelin inhibits post-infarct myocardial remodeling and improves cardiac function through anti-inflammation effect, Peptides, 30: 2286-2291.
For present claims 3, 12, 26, 31, and 50-52, Huang et al. teach methods of administering ghrelin daily to individuals with acute heart failure (please refer to the entire reference particularly the abstract; Materials and Methods; Results; Table 2; Figures 1 and 4).
Therefore, the teachings of Huang et al. anticipate the presently claimed method.
Claims 3, 10-12, 26, 31, and 50-52 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kishimoto et al., 2012, Ghrelin and cardiovascular diseases, Journal of Cardiology, 59: 8-13.
For present claims 3, 10-12, 26, 31, and 50-52, Kishimoto et al. teach methods of administering ghrelin daily to individuals with acute heart failure (please refer to the entire reference particularly the abstract; Introduction; Octanoyl modification; Figure 1; Direct cardiovascular action; Cardiovascular actions of ghrelin; Ghrelin in cardiovascular diseases – Heart failure, Myocardial infarction, Myocardial ischemia/reperfusion injury, Pulmonary hypertension).
Therefore, the teachings of Kishimoto et al. anticipate the presently claimed method.
Claims 3, 10-12, 26, 31, 50-52, 57, and 61 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nagaya et al., 2004, Effects of Ghrelin Administration on Left Ventricular Function, Exercise Capacity, and Muscle Wasting in Patients with Chronic Heart Failure.
For present claims 3, 10-12, 26, 31, 50-52, 57, and 61, Nagaya et al. teach methods of administering ghrelin daily to individuals with heart failure wherein digoxin, ACE inhibitors, etc. were also utilized (please refer to the entire reference particularly the abstract; Introduction; Study Subjects; Table 1; Preparation of Human Ghrelin; Study Protocol; Effects of Ghrelin on Cardiac Structure and Function; Table 2; Figure 3; Discussion).
When the claim recites using an old composition or structure and the "use" is directed to a result or property of that composition or structure, then the claim is anticipated. See In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978) (Claims 1 and 6, directed to a method of effecting nonaddictive analgesia (pain reduction) in animals, were found to be anticipated by the applied prior art which disclosed the same compounds, as well as a method of using them for effecting analgesia but which was silent as to addiction. The court upheld the rejection and stated that the inventors had merely found a new property of the compound and such a discovery did not constitute a new use.
Therefore, the teachings of Nagaya et al. anticipate the presently claimed method.
Claims 3, 10-12, 26, 31, and 50-52 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mitacchione et al., 2014, The Gut Hormone Ghrelin Partially Reverses Energy Substrate Metabolic Alterations in the Failing Heart, Circ Heart Fail, 7(4): 643-651.
For present claims 3, 10-12, 26, 31, and 50-52, Mitacchione et al. teach methods of administering ghrelin daily to individuals with heart failure (please refer to the entire reference particularly the abstract; Methods; Results; Discussion; Figures 1-6; Tables 1-2).
When the claim recites using an old composition or structure and the "use" is directed to a result or property of that composition or structure, then the claim is anticipated. See In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978) (Claims 1 and 6, directed to a method of effecting nonaddictive analgesia (pain reduction) in animals, were found to be anticipated by the applied prior art which disclosed the same compounds, as well as a method of using them for effecting analgesia but which was silent as to addiction. The court upheld the rejection and stated that the inventors had merely found a new property of the compound and such a discovery did not constitute a new use.
Therefore, the teachings of Mitacchione et al. anticipate the presently claimed method.
Claims 3, 10-12, 26, 31, and 50-52 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shirai et al., 2015, Ghrelin Suppresses Sympathetic Hyperexcitation in Acute Heart Failure in Male Rats: Assessing Centrally and Peripherally Mediated Pathways, Endocrinology, 156(9): 3309-3316.
For present claims 3, 10-12, 26, 31, and 50-52, Shirai et al. teach methods of administering ghrelin daily to individuals with acute heart failure (please refer to the entire reference particularly the abstract; Introduction; Experimental protocol; Results; Figures 1-4).
Therefore, the teachings of Shirai et al. anticipate the presently claimed method.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Schwenke et al., 2008, Early Ghrelin Treatment after Myocardial Infarction Prevents an Increase in Cardiac Sympathetic Tone and Reduces Mortality, Endocrinology, 149(10): 5172-5176.
Schwenke et al., 2012, One Dose of Ghrelin Prevents the Acute and Sustained Increases in Cardiac Sympathetic Tone after Myocardial Infarction, Endocrinology, 153(5): 2436-2443.
Mao et al., 2014, One dose of oral hexarelin protects chronic cardiac function after myocardial infarction, Peptides, 56: 156-162.
WO 2003/097083
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