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 .
Response to Election/Restriction filed on June 27, 2025 is acknowledged.
Claims 1-20 are pending in this application.
Restriction
Applicant’s election without traverse of Group 1 (claims 1-13 and 15-19) and the election of SEQ ID NO: 2 as the species of the peptide, aspartic acid as the species of stabilizing agent, pH value 4.5 as the species of pH, 1-150 mOsm/kg as the species of osmolarity range, benzalkonium chloride as the species of preservative, and retinal neurodegenerative disease as the species of eye disease in the reply filed on June 27, 2025 is acknowledged. Restriction is deemed to be proper and is made FINAL in this office action. Claims 14 and 20 are withdrawn from consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected invention, there being no allowable generic or linking claim. Claims 1-13 and 15-19 are examined on the merits in this office action.
Objections
3. The abstract is objected to for the following minor informality:
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words. It is important that the abstract not exceed 150 words in length since the space provided for the abstract on the computer tape used by the printer is limited. The form and legal phraseology often used in patent claims, such as "means" and "said," should be avoided. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, "The disclosure concerns," "The disclosure defined by this invention," "The disclosure describes," etc.
In the instant case, the abstract recites, “The present invention relates to...” at line 1 of the abstract. Further, at line 3, the abstract recites, "The invention provides…..." Furthermore, at line 6, the abstract recites, "This further relates to..." Applicant should correct these informalities. See MPEP 608.01(b).
Please note, the specification has not been checked to the extent necessary to determine the presence of all possible error. Applicant's cooperation is required in correcting any errors of which applicant may become aware in the specification. MPEP § 608.01.
Rejections
U.S.C. 112(b)
4. 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.
5. Claim 5 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.
6. Claim 5 recites, “…(b) a peptide with an amino acid sequence having at least 85% identity degree with SEQ ID NO: 2…(c) a peptide with a sequence length up to 50 amino acids comprising an amino acid sequence having at least 85% of identity degree with SEQ ID NO 2…(d) a fragment of a peptide having at least 85% of identity degree with SEQ ID NO: 2 or a pharmaceutically acceptable salt thereof, provided that the fragment has an amino acid length from 14 to 49 amino acids and includes the N-terminal region.” It is unclear what is meant by “at least 85% identity degree”. The term is not clearly defined in the specification. Additionally, in part (d) of claim 5, it is unclear how a “fragment” can be a length from 14 to 49 amino acids when SEQ ID NO: 2 has 30 residues.
U.S.C. 103
7. 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.
8. 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.
9. 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.
10. 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.
11. Claim(s) 1-11, 13 and 15-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Simo Canonge et al (WO 2014/131815, filed with IDS) in view of Bossart et al (US 2017/0008944, filed with IDS) and Daniels et al (WO 2005/084635, filed with IDS).
12. Simo Canonge et al teach the exact same sequence of instant SEQ ID NO: 1 (see pp. 5 and 11, SEQ ID NO: 1, for example) and a 31 residue peptide sequence comprising instant SEQ ID NO: 2 (see SEQ ID NO: 2, p. 14). Simo Canonge et al teach that the peptide has a sequence with a length from 13 to 40 amino acids, and is for use in the topical treatment and/or prevention of retinal neurodegenerative disease (see p. 11, lines 11-13), meeting the limitation of instant claims 1-6, 9, 13 and 15-18, in part. Simo Canonge et al teach that the pharmaceutical topical composition for use in the topical treatment of retinal neurodegenerative diseases comprises at least one peptide as defined with excipients such as water, saline buffers, and mixtures of water in oil or oil in water and particular excipients are selected from preservatives, agglutinants, humectants, emollients and antioxidants (see p. 18, lines 10-19). Simo Canonge et al further teach that the pharmaceutical topical compositions are selected from the group consisting of solutions (e.g., eye drops), creams, lotions…(see p. 18, lines 21-25). Additionally, for a better understanding of how the examiner views the claims 17-18, it should be noted that the claim is to a product, and products are not limited or novel based on the product’s non-functional instructions on how to use the product by being in a kit. “Where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art.” In re Ngai, 367 F.3d 1336, 2004 WL 1068957 (Fed. Cir. May 13, 2004).
Simo Canonge et al do not teach wherein the pH value of the composition is between 4.0 and 4.8 and the osmolality ranges between 0.5 and 200 mOsm/kg, a preservative and a lyophilizate.
13. However, Bossart et al teach GLP-1/glucagon receptor agonists and their medical use (see paragraph [0001]). Bossart et al teach a 39 residues peptide comprising instant SEQ ID NO: 1 (see SEQ ID NO: 4, for example), and teach that the compound had high solubility in the presence of an antimicrobial preservative like phenol or m-cresol, e.g., at an acidity range from pH 4 to 5, especially pH 4.5 (see paragraph [0038] and has high stability when stored in solution in the presence of an antimicrobial preservative…in solution at an acidity range from pH 4 to 5, especially pH 5…(see paragraph [0039]). Bossart et al further teach that the pharmaceutical composition comprises carriers, buffers…preservatives, physical and chemical stabilizers, e.g., surfactants, antioxidants and other components…(see paragraph [0180]). Bossart et al further teach that carriers are selected from the group of buffers…co-solvents…tonicity adjusters…stabilizers (e.g., surfactant, antioxidants, amino acids) (see paragraph [0184]).
Regarding instant claim 10, the MPEP states the following: When the compound is not specifically named, but instead it is necessary to select potions of teachings within a reference and combine them, e.g., select various substituents from a list of alternatives given for placement at specific sites on a generic chemical formula to arrive at a specific composition, anticipation can only be found if the classes of substituents are sufficiently limited or well delineated. Ex parte A, 17 USPQ2d1716 (Bd. Pat. App. & Inter. 1990). If one of ordinary skill in the art is able to "at once envisage" the specific compound within the generic chemical formula, the compound is anticipated (See MPEP 2105). Since there are only twenty (20) naturally occurring amino acids, aspartic acid and glutamic acid is envisioned by Bossart et al.
14. Additionally, Daniels et al teach a pharmaceutical preparation in a form suitable for use in the eye, for example, in the form of a solution, cream, ointment or gel (see p. 13, lines 14-15), and further teach that the pH of the pharmaceutical preparation is appropriate for eye drops and may have a pH in the range of from 4.5 to 9.0, and osmolarity of eye drops is generally in the range from 100 to 350 mOsm, for example, from 120 to 320 mOsM…(see p.13, lines 21-27).
15. Therefore, it would have been obvious to one of ordinary skill in the art to combine the teachings of Simo Canonge et al, Bossart et al and Daniels et al for ophthalmic composition comprising instant SEQ ID NO: 1 and instant SEQ ID NO: 2 at pH between 4.0 and 4.8 and osmolarity between 0.5 and 200 mOsm/kg (elected species is 1 to 150 mOsm/kg), since Simo Canonge et al teach both instant SEQ ID NO 1 and 2, and Bossart et al teach instant SEQ ID NO: 1, and Daniels et al teach an eye drop at the pH and osmolarity. One of ordinary skill in the art would be motivated to combine with a reasonable expectation of success, since Bossart et al teach that the stability of the compound solution is increased at a pH of 4 to 5, and Bossart et al teach that the osmolarity of eye drop is generally in the range from 100 to 350 mOsm. The MPEP states that “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997).” One of ordinary skill in the art would be motivated to optimize the pH and osmolality to achieve the optimal ophthalmic pharmaceutical composition. Therefore, it is deemed that the combined art is prima facie obvious over instant claims 1-11, 13 and 15-18.
16. Claim(s) 1-13 and 15-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Simo Canonge et al (WO 2014/131815, filed with IDS) in view of Bossart et al (US 2017/0008944, filed with IDS) and Daniels et al (WO 2005/084635, filed with IDS), as applied to claims 1-11, 13 and 15-18 above, further in view Rostene et al (US Patent No. 9439981).
17. The teachings of Simo Canonge et al in view of Bossart et al and Daniels et al are described above. The difference between the references and instant claims is that the references do not teach preservative, benzalkonium chloride.
18. However, it is well known in the art that benzalkonium chloride is used in solution compositions for ocular administration (see for example, Rostene et al, abstract).
19. Therefore, it would have been obvious to one of ordinary skill in the art to combine the teachings of Simo Canonge et al, Bossart et al, Daniels et al and Rostene et al for ophthalmic composition comprising instant SEQ ID NO: 1 and instant SEQ ID NO: 2 at pH between 4.0 and 4.8 and osmolarity between 0.5 and 200 mOsm/kg (elected species is 1 to 150 mOsm/kg) and comprising benzalkonium as the preservative in the composition, since Simo Canonge et al teach both instant SEQ ID NO 1 and 2, and Bossart et al teach instant SEQ ID NO: 1, Daniels et al teach an eye drop at the pH and osmolarity, and Rostene et al teach that benzalkonium chloride is used in ocular composition/solution for ocular administration. One of ordinary skill in the art would be motivated to combine with a reasonable expectation of success, since Bossart et al teach that the stability of the compound solution is increased at a pH of 4 to 5, and Bossart et al teach that the osmolarity of eye drop is generally in the range from 100 to 350 mOsm. The MPEP states that “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997).” One of ordinary skill in the art would be motivated to optimize the pH and osmolality to achieve the optimal ophthalmic pharmaceutical composition.
Therefore, it is deemed that the combined art is prima facie obvious over instant claims 1-13 and 15-19.
CONCLUSION
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIE HA whose telephone number is (571)272-5982. The examiner can normally be reached Monday-Thursday 5:00 am- 6:30 pm EST.
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/JULIE HA/Primary Examiner, Art Unit 1654
9/16/2025