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 .
Priority
This application filed 02/05/2024 is a National Stage entry of PCT/US2022/039585 , International Filing Date: 08/05/2022; PCT/US2022/039585 Claims Priority from Provisional Application 63230503 , filed 08/06/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/08/2024 is in compliance with the
provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the
examiner.
Claim Status
The claim listing filed 09/10/2024 is pending. Claims 3, 5, 7, 10, 11, 15, 16, 19, 20, 24, 25 and 35 are currently amended. Claims 2, 6, 8, 9, 12, 13, 17, 21, 22, 26, 27, 30, 32-34, 36 are cancelled. Claims 1, 3-5, 7, 10-11, 14-16, 18- 20, 23-25, 28, 29, 31 and 35 are pending and under examination.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 3, 4, 5, 7, 10, 11, 23, 24, 25, 28, 29, are rejected under 35 U.S.C. 103 as being unpatentable over Edward T. Maggio, hereinafter Maggio‘014 (Maggio; US2010/0203014 A1; published Aug 12, 2010).
Regarding claim 1, Maggio’014 teaches glycine buffered pharmaceutical compositions including a therapeutically active peptide (see Abstract). Maggio’014 teaches GHRH therapeutic peptides for use in the composition ([0024] page 3, line 1).
Regarding claim 3, Maggio’014 teaches a therapeutically active peptide GHRH, an aqueous solution buffered with glycine, and an absorption enhancing amount of an alkyl saccharide (i.e. delivery enhancing agent) [0029].
Regarding claim 4, Maggio’014 teaches GHRH therapeutic peptides for use in the composition ([0024] page 3, line 1) and an absorption enhancing amount of an alkyl saccharide (i.e. delivery enhancing agent) [0029].
Regarding claim 5, Maggio’014 teaches alkyl saccharides [0034]. Maggio’014 teaches preferred alkyl glycosides including maltose, sucrose, ...([0035], line 7).
Regarding claim 7, embodiments of the specification disclose that -delivery enhancing agent comprises membrane penetration enhancing agents, such as a surfactant; a bile salt; a phospholipid
additive, mixed micelle, liposome, or carrier; an alcohol; an enamine; an NO donor compound; a long-chain amphipathic molecule; a small hydrophobic penetration enhancer; sodium or a salicylic acid derivative; a glycerol ester of acetoacetic acid; a cyclodextrin or beta-cyclodextrin derivative; a medium-chain fatty acid; a chelating agent; an amino acid or salt thereof; an N-acetylamino acid or salt thereof; an enzyme degradative to a selected membrane component; an inhibitor of fatty acid synthesis; an inhibitor of cholesterol synthesis; and any combination of the membrane penetration enhancing agents recited above.
Examiner interprets ‘any combination of …recited in (i)-(xx)’ as a combination comprising any choice of delivery enhancing agents and not all delivery enhancing agents. Examiner interprets the disjunctive conjunction ‘or’ as presenting alternatives. Eg: in line 3 of the instant claim, the claim recites a phospholipid additive ‘or’ mixed micelle ‘or’ liposome ‘or’ carrier. Accordingly, Maggio’014 teaches carriers [0041] (i.e. iv); glycine [0041] (i.e. xx); alcohol [0042] (i.e. v); amino acid [0041 (i.e. xv); beta methyl-cyclodextrin [0042] (i.e. xii); chelating agent [0041] (i.e. xiv); alkylsaccharide [0038] (i.e. surfactant ii).
Regarding claim 10, embodiments of the specification disclose that non-limiting examples of stimulatory agents include glycine, choline, arginine, ornithine, glycine, lysine, glutamine, or niacin (vitamin B3), and a combination of two or more thereof. In some compositions, the stimulatory agent comprises glycine [0065]. Maggio’014 teaches glycine (see Abstract) (i.e. stimulatory agent). The claim limitation “wherein the stimulatory agent..hormone” is interpreted as intended use. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention's limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children's Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020) (see MPEP § 2111. 02 (II)).
Regarding claim 11, Maggio’014 teaches glycine (see Abstract), excipients [0026].
Regarding claim 23, Maggio’014 teaches excipients [0026].
Regarding claim 24, Maggio’014 teaches glycine (see Abstract) (i.e. stimulatory agent).
Regarding claim 25, Maggio’014 teaches carriers [0041], glycine [0041], alcohol [0042], amino acid [0041], beta methyl-cyclodextrin [0042], chelating agent [0041], alkyl saccharide [0038] (i.e. penetration enhancing agents).
Regarding claim 28, Maggio’014 teaches GHRH therapeutic peptides for use in the composition ([0024] page 3, line 1).
Regarding claim 29, the scope of the claim is open-ended, ‘comprising’ the sequence of SEQ ID NO: 1 or SEQ ID NO: 2 with any N/C terminal additions. Accordingly, Maggio’014 teaches GHRH therapeutic peptides for use in the composition ([0024] page 3, line 1), which is 100 % identical to SEQ ID NO: 1.
Claim(s) 1, 14, 16, 18, 20, 31, 35 are rejected under 35 U.S.C. 103 as being unpatentable over Edward T. Maggio hereinafter Maggio’402 (Maggio; US10,265,402B2; date of patent April 23, 2019) in view of Edward T. Maggio, hereinafter Maggio‘014 (Maggio; US2010/0203014 A1; published Aug 12, 2010) evidenced by Seohyun Lee et al., hereinafter Lee (Seohyun Lee et al., Ginsenoside Rg3 Reduces Lipid Accumulation with AMP-Activated Protein Kinase (AMPK) Activation in HepG2 Cells, Int. J. Mol. Sci. 2012, 13, 5729-5739).
Regarding claim 14, Maggio’402 teaches GHRH (Col 12, line 13) and inhibitor of cholesterol synthesis (Col 27, line 20). Ginsenoside Rg3 (i.e. steroid), evidenced by Lee, inhibits cholesterol levels (page 5730, last line).
Maggio ‘402 teaches amino acids (Col 7, line 20) in the composition. Maggio does not teach the amino acid is glycine.
Teachings of Maggio’014 have been set forth above. Notably, Maggio’014 teaches that amino acid glycine is effective in buffering therapeutic peptide drug formulations in the pH range of from about 3.0 to 4.5, but does not significantly modify the normal pH of nasal mucosal secretions when used at low concentrations [0026].
Obviousness can be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so. In re
Kahn, 441 F.3d 977, 986, 78 USPQ2d 1329, 1335 (Fed. Cir. 2006) (discussing rationale underlying the motivation-suggestion-teaching test as a guard against using hindsight in an obviousness analysis).
Consequently, it would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to modify the composition of Maggio’014 comprising amino acid, and use the amino acid glycine as disclosed in Maggio’402. One motivated to do so, would have a reasonable expectation of success, as both references teach therapeutic compositions comprising GHRH. Thus, one would have recognized that applying the teaching of Maggio’402 to the teaching of Maggio’014 would have yielded predictable results and improved the composition, as glycine is effective in buffering therapeutic peptide drug formulations [0026] and since artificial and natural sweeteners are often added to drug formulations to increase palatability or mask unpleasant drug taste, the natural sweet taste of glycine makes it an exemplary buffer system [0028]. See MPEP §2143.
Regarding claim 16, Maggio’402 teaches GHRH (Col 12, line 13) and inhibitor of cholesterol synthesis (Col 27, line 20). Ginsenoside Rg3 (i.e. steroid), evidenced by Lee, inhibits cholesterol levels (page 5730, last line). Maggio ‘402 teaches amino acids (Col 7, line 20). The teachings of Maggio’014 have been set forth above in the obviousness rationale for the rejection of claim 14.
Regarding claim 18, Maggio’402 teaches vitamin (Col 24, line 11).
Regarding claim 20, the teachings of Maggio ‘014, and obviousness rationale have been set forth above. Maggio ‘402 teaches B12 (Col 24, line 11).
Regarding claim 31, Maggio ‘402 teaches oral tablet (Col 29, last paragraph, line 10).
Regarding claim 35, embodiments of the specification disclose ‘method of improving’, as comprising administering to the subject the composition. In some embodiments, the administration is oral. In some embodiments, the administration is sublingual or buccal [0016]. Maggio ‘402 teaches ocular, nasal, nasolacrimal, inhalation or pulmonary, oral cavity (sublingual or Buccal cell), or CSF delivery route than by traditional self-administration methods such as injection (Col 29, second paragraph).
Claim(s) 11, 15 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Edward T. Maggio hereinafter Maggio’402 (Maggio; US10,265,402B2; date of patent April 23, 2019).
Regarding claim 15, Maggio’402 teaches GHRH (Col 12, line 13), vitamin (Col 24, line 11), excipient (Col 19, 3rd paragraph, line 5).
Regarding claim 19, Maggio’402 teaches vitamin (Col 24, line 11).
Conclusion
No claim is allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARCHANA VARADARAJ whose telephone number is (571)272-2366. The examiner can normally be reached Monday-Friday 10:00am-5:00pm.
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/ARCHANA VARADARAJ/Examiner, Art Unit 1658
/Melissa L Fisher/Supervisory Patent Examiner, Art Unit 1658
Prosecution Insights