A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/10/2025 has been entered.
DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Amendment after Final office action filed on 10/10/2025 is acknowledged.
3. Claims 1-24, 28 and 29 have been cancelled.
4. Claims 25-27 and 30-52 are pending in this application.
5. Claims 45-52 remain withdrawn from consideration pursuant to 37 CFR 1.142(b), as being drawn to non-elected inventions, there being no allowable generic or linking claim. Claims 32, 33, 37, 38, 42 and 43 remain withdrawn from consideration as being drawn to non-elected species.
6. Applicant elected without traverse of Group 3 (claims 25-27 and 30-44) and elected without traverse of an ophthalmic pharmaceutical composition comprising L-alanyl-L-glutamine, sodium chloride as an osmotic agent, sodium hydroxide as a pH regulator, and without both a bacteriostatic or antimicrobial agent and a viscosity modifying agent as species of ophthalmic pharmaceutical composition in the reply filed on 8/19/2024.
Restriction requirement was deemed proper and made FINAL in the previous office actions. Group 3 is drawn to a method of relieving dry eye disease (DED) symptoms in a patient in need thereof, a method of improving dry eye disease (DED) in a patient in need thereof, and/or a method of treating dry eye disease (DED) in a patient in need thereof, the method comprising administering to the patient a pharmaceutical composition comprising L-Alanyl-L-Glutamine suspended or dissolved in an isoosmotic solution that is suitable for eyes. A search was conducted on the elected species; and prior art was found. Claims 32, 33, 37, 38, 42 and 43 remain withdrawn from consideration as being drawn to non-elected species. Claims 25-27, 30, 31, 34-36, 39-41 and 44 are examined on the merits in this office action.
Declaration under 37 C.F.R. 1.132
7. Declaration of Zuguo Liu under 37 CFR 1.132 has been filed on 10/10/2025. The Declaration is insufficient to overcome the rejection to instant claims 25-27, 30, 31, 34-36, 39-41 and 44 under 35 U.S.C. 103 as set forth in Section 10 below for the following reasons:
First, with regards to Applicant’s arguments about the non-equivalence of dipeptides and free amino acids, the Examiner understands that dipeptides and free amino acids are not the same. However, in the instant case, as stated in both previous office action and Section 10 below, Kinoshita et al explicilty teach a clinical trial comprising administering eye drops comprising Gln, Ala and Asn to patients with DED, wherein the eye drops are effective in treating DED (see pages 28-31, Example 3). Furthermore, Kinoshita et al explicilty teach that “In addition, peptides such as Lalanylglutamine, which are known to have the same effect on cells as the amino acids, which are active ingredients of the ophthalmic composition of the present invention, can also be used”. Therefore, in view of the teachings of Kinoshita et al as a whole, one of ordinary skilled in the art would understand and reasonably expect that similar to the eye drops comprising Gln, Ala and Asn in Example 3 of Kinoshita et al, an ophthalmic composition comprising Lalanylglutamine would be effective in treating DED.
Second, with regards to the unexpected superior results indicated by the additional data presented in the declaration, as explicitly stated in the declaration, it is well known in the art that “Free glutamine is notoriously unstable, degrading into pyroglutamate and ammonia, which complicates the formulation and shelf-life of an ophthalmic solution…The dipeptide form provides superior chemical stability, ensuring consistent potency and safety”. Therefore, in the instant case, considering the state of art regarding the stability issues of free glutamine, one of ordinary skilled in the art would understand and reasonably expect that a solution comprising the instant claimed dipeptide L-Alanyl-L-Glutamine would exhibit superior performance, in comparison to a solution comprising Ala and Gln. Thus, the additional data presented in the declaration is NOT unexpected. Furthermore, the Examiner would like to point out that as stated in MPEP: “An affidavit or declaration under 37 CFR 1.132 must compare the claimed subject matter with the closest prior art to be effective to rebut a prima facie case of obviousness.” (see MPEP § 716.02(e)). In the instant case, the closest prior art is the cited Kinoshita et al reference. And as stated in both Section 10 below and the paragraph above, Kinoshita et al explicilty teach that “In addition, peptides such as Lalanylglutamine, which are known to have the same effect on cells as the amino acids, which are active ingredients of the ophthalmic composition of the present invention, can also be used”.
Maintained Rejections
Claim Rejections - 35 U.S.C. § 103
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 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
9. The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
10. Claims 25-27, 30, 31, 34-36, 39-41 and 44 remain rejected under 35 U.S.C. 103 as being unpatentable over Kinoshita et al (WO 2010/107069 A1, filed with IDS, machine translation used and enclosed in the previous office actions, pages 1-32) in view of the Ophthalmic Preparations document (2016, pages 1-2, filed with IDS, from https://pharmlabs.unc.edu/labs/ophthalmics/isoosmo.htm).
The instant claims 25-27, 30, 31, 34-36, 39-41 and 44 are drawn to a method of relieving dry eye disease (DED) symptoms in a patient in need thereof, a method of improving dry eye disease (DED) in a patient in need thereof, and/or a method of treating dry eye disease (DED) in a patient in need thereof, the method comprising administering to the patient a pharmaceutical composition comprising L-Alanyl-L-Glutamine suspended or dissolved in an isoosmotic solution that is suitable for eyes.
Kinoshita et al, throughout the patent, teach a method of relieving dry eye disease (DED) symptoms in a patient in need thereof, a method of improving dry eye disease (DED) in a patient in need thereof, and/or a method of treating dry eye disease (DED) in a patient in need thereof, wherein the method comprises administering to the patient an ophthalmic composition comprising at least one amino acid selected from a group consisting of alanine, asparagine, glutamine and arginine, and wherein the pH of the ophthalmic composition is adjusted to 3-10, preferably 5-8; including a clinical trial comprising administering eye drops comprising Gln, Ala and Asn to patients with DED, for example, Abstract; page 4, paragraph [0001]; page 6, paragraphs [0007] and [0008]; page 10, paragraph [0025]; pages 28-31, Example 3; and claims 1-11. It meets the limitation of the patient population recited in instant claims 25-27; and the limitation of pH recited in instant claims 34, 39 and 44. Kinoshita et al also teach the ophthalmic composition further comprises isotonic agent such as sodium chloride and pH adjuster such as sodium hydroxide, for example, page 8, paragraph [0018]; and page 10, paragraph [0024]. It meets the limitations of osmotic agent and pH regulator recited in instant claims 31, 34, 36, 39, 41 and 44.
The difference between the reference and instant claims 25-27, 30, 31, 34-36, 39-41 and 44 is that the reference does not teach an ophthalmic pharmaceutical composition comprising L-alanyl-L-glutamine, sodium chloride as an osmotic agent, sodium hydroxide as a pH regulator, and without both a bacteriostatic or antimicrobial agent and a viscosity modifying agent as the elected species of ophthalmic pharmaceutical composition; the limitations of L-alanyl-L-glutamine and its concentration recited in instant claims 25-27, 30, 35 and 40; and the limitation of the concentration of osmotic agent recited in instant claims 31, 36 and 41.
However, Kinoshita et al teach that “In addition, peptides such as Lalanylglutamine, which are known to have the same effect on cells as the amino acids, which are active ingredients of the ophthalmic composition of the present invention, can also be used”, for example, page 7, paragraph [0011]. Kinoshita et al further teach the concentration of each effective amino acid is not particularly limited as long as the desired effect is exerted; and the dosage may vary depending on the dosage form, target disease, target animal species, age, sex, body weight, symptoms and so on, for example, page 7, paragraph [0012]; and page 10, paragraph [0029]. Therefore, in view of the teachings of Kinoshita et al as a whole, it would have been obvious to one of ordinary skilled in the art to develop a method of relieving dry eye disease (DED) symptoms in a patient in need thereof, a method of improving dry eye disease (DED) in a patient in need thereof, and/or a method of treating dry eye disease (DED) in a patient in need thereof, wherein the method comprises administering to the patient an ophthalmic composition comprising Lalanylglutamine, wherein the pH of the ophthalmic composition is 5-8, and wherein the ophthalmic composition further comprises sodium chloride as isotonic agent and sodium hydroxide as pH adjuster. It read on an ophthalmic pharmaceutical composition comprising L-alanyl-L-glutamine, sodium chloride as an osmotic agent, sodium hydroxide as a pH regulator, and without both a bacteriostatic or antimicrobial agent and a viscosity modifying agent as the elected species of ophthalmic pharmaceutical composition.
Furthermore, the Ophthalmic Preparations document teaches that iso-osmotic ophthalmic solutions do not damage tissue or produce pain when administered, for example, page 1, the 3rd paragraph in Section "Iso-osmoticity and Isotonicity". The Ophthalmic Preparations document further teaches a 0.9% solution of NaCl (normal saline) is iso-osmatic with blood and tears; the most widely used method to adjust isotonicity (a term used interchangeably with iso-osmoticity) of pharmaceutical composition is using sodium chloride; and how to calculate the amount of NaCl required to make an isotonic (a term used interchangeably with iso-osmotic) ophthalmic pharmaceutical composition, for example, page 1, the 2nd and 4th paragraphs in Section "Iso-osmoticity and Isotonicity"; and pages 1-2, Section "sample calculation". Therefore, in view of the combined teachings of Kinoshita et al and the Ophthalmic Preparations document, one of ordinary skilled in the art would have been motivated to optimize the dosage concentration of both L-alanyl-L-glutamine and osmotic agent in the ophthalmic composition comprising Lalanylglutamine, including Lalanylglutamine at a concentration of 0.1-10% (w/v) of the composition and osmotic agent at a concentration of 0.01-3% (w/v) of the composition. And the MPEP states the following: 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) (see MPEP § 2144.05 II A).
Therefore, it would have been obvious to one of ordinary skilled in the art to combine the teachings of Kinoshita et al and the Ophthalmic Preparations document with routine optimization to develop a method of relieving dry eye disease (DED) symptoms in a patient in need thereof, a method of improving dry eye disease (DED) in a patient in need thereof, and/or a method of treating dry eye disease (DED) in a patient in need thereof, wherein the method comprises administering to the patient an ophthalmic composition comprising Lalanylglutamine at a concentration of 0.1-10% (w/v), wherein the pH of the ophthalmic composition is 5-8, and wherein the ophthalmic composition is isotonic and comprises sodium chloride as isotonic agent at a concentration of 0.01-3% (w/v) and sodium hydroxide as pH adjuster.
One of ordinary skilled in the art would have been motivated to combine the teachings of Kinoshita et al and the Ophthalmic Preparations document with routine optimization to develop a method of relieving dry eye disease (DED) symptoms in a patient in need thereof, a method of improving dry eye disease (DED) in a patient in need thereof, and/or a method of treating dry eye disease (DED) in a patient in need thereof, wherein the method comprises administering to the patient an ophthalmic composition comprising Lalanylglutamine at a concentration of 0.1-10% (w/v), wherein the pH of the ophthalmic composition is 5-8, and wherein the ophthalmic composition is isotonic and comprises sodium chloride as isotonic agent at a concentration of 0.01-3% (w/v) and sodium hydroxide as pH adjuster, because Kinoshita et al teach that “In addition, peptides such as Lalanylglutamine, which are known to have the same effect on cells as the amino acids, which are active ingredients of the ophthalmic composition of the present invention, can also be used”. Kinoshita et al further teach the concentration of each effective amino acid is not particularly limited as long as the desired effect is exerted; and the dosage may vary depending on the dosage form, target disease, target animal species, age, sex, body weight, symptoms and so on. Therefore, in view of the teachings of Kinoshita et al as a whole, it would have been obvious to one of ordinary skilled in the art to develop a method of relieving dry eye disease (DED) symptoms in a patient in need thereof, a method of improving dry eye disease (DED) in a patient in need thereof, and/or a method of treating dry eye disease (DED) in a patient in need thereof, wherein the method comprises administering to the patient an ophthalmic composition comprising Lalanylglutamine, wherein the pH of the ophthalmic composition is 5-8, and wherein the ophthalmic composition further comprises sodium chloride as isotonic agent and sodium hydroxide as pH adjuster. The Ophthalmic Preparations document teaches that iso-osmotic ophthalmic solutions do not damage tissue or produce pain when administered. The Ophthalmic Preparations document further teaches a 0.9% solution of NaCl (normal saline) is iso-osmatic with blood and tears; the most widely used method to adjust isotonicity (a term used interchangeably with iso-osmoticity) of pharmaceutical composition is using sodium chloride; and how to calculate the amount of NaCl required to make an isotonic (a term used interchangeably with iso-osmotic) ophthalmic pharmaceutical composition. Therefore, in view of the combined teachings of Kinoshita et al and the Ophthalmic Preparations document, one of ordinary skilled in the art would have been motivated to optimize the dosage concentration of both L-alanyl-L-glutamine and osmotic agent in the ophthalmic composition comprising Lalanylglutamine, including Lalanylglutamine at a concentration of 0.1-10% (w/v) of the composition and osmotic agent at a concentration of 0.01-3% (w/v) of the composition. And the MPEP states the following: 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 (see MPEP § 2144.05 II A).
A person of ordinary skilled in the art would have reasonable expectation of success in combining the teachings of Kinoshita et al and the Ophthalmic Preparations document with routine optimization to develop a method of relieving dry eye disease (DED) symptoms in a patient in need thereof, a method of improving dry eye disease (DED) in a patient in need thereof, and/or a method of treating dry eye disease (DED) in a patient in need thereof, wherein the method comprises administering to the patient an ophthalmic composition comprising Lalanylglutamine at a concentration of 0.1-10% (w/v), wherein the pH of the ophthalmic composition is 5-8, and wherein the ophthalmic composition is isotonic and comprises sodium chloride as isotonic agent at a concentration of 0.01-3% (w/v) and sodium hydroxide as pH adjuster.
Response to Applicant's Arguments
11. Applicant presents the same arguments as those in the Declaration of Zuguo Liu under 37 CFR 1.132 filed on 10/10/2025. Applicant further discusses about the data presented in Exhibits A and B.
12. Applicant's arguments have been fully considered but have not been found persuasive.
In response to Applicant's arguments about instant rejection:
First, the arguments presented in the Declaration of Zuguo Liu under 37 CFR 1.132 filed on 10/10/2025 have been addressed in Section 7 above.
Second, the data presented in Exhibits A and B haven been discussed in the interview held with Applicant’s representatives on 4/10/2025 (see PTO-413 mailed on 4/15/2025).
Taken all these together, the rejection is deemed proper and is hereby maintained.
Obviousness Double Patenting
13. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
14. Claims 25-27, 30, 31, 34-36, 39-41 and 44 remain rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-15 of US patent 7163917 B2 in view of Kinoshita et al (WO 2010/107069 A1, filed with IDS, machine translation used and enclosed in the previous office actions, pages 1-32) and the Ophthalmic Preparations document (2016, pages 1-2, filed with IDS, from https://pharmlabs.unc.edu/labs/ophthalmics/isoosmo.htm).
15. Instant claims 25-27, 30, 31, 34-36, 39-41 and 44 are drawn to a method of relieving dry eye disease (DED) symptoms in a patient in need thereof, a method of improving dry eye disease (DED) in a patient in need thereof, and/or a method of treating dry eye disease (DED) in a patient in need thereof, the method comprising administering to the patient a pharmaceutical composition comprising L-Alanyl-L-Glutamine suspended or dissolved in an isoosmotic solution that is suitable for eyes.
16. Claims 1-15 of US patent 7163917 B2 are drawn to a method of synthesizing alanylglutamine.
Claims 1-15 of US patent 7163917 B2 are in possession of the alanylglutamine (synonym of L-alanyl-L-glutamine) recited in instant claims 25-27, 30, 31, 34-36, 39-41 and 44.
17. The difference between claims 1-15 of US patent 7163917 B2 and instant claims 25-27, 30, 31, 34-36, 39-41 and 44 is that claims 1-15 of US patent 7163917 B2 do not teach applying the alanylglutamine in a method recited in instant claims 25-27, 30, 31, 34-36, 39-41 and 44.
However, in view of the combined teachings of Kinoshita et al and the Ophthalmic Preparations document with routine optimization as set forth in Section 10 above, it would have been obvious to one of ordinary skilled in the art to use the alanylglutamine (synonym of L-alanyl-L-glutamine) prepared by the method recited in claims 1-15 of US patent 7163917 B2 and develop the method recited in instant claims 25-27, 30, 31, 34-36, 39-41 and 44.
Response to Applicant's Arguments
18. Applicant argues that “Kinoshita and the Ophthalmic Preparations document do not credibly teach or suggest using L-alanyl-L-glutamine in methods to relieve, improve, or treat symptoms of DED. As such, Kinoshita and the Ophthalmic Preparations document do not cure the deficiency of the '917 patent.”
19. Applicant's arguments have been fully considered but have not been found persuasive.
Applicant’s arguments related to the rejection under 35 U.S.C. 103 have been addressed in Section 7 above. Furthermore, as repeatedly stated in the office actions, Kinoshita et al explicilty teach a clinical trial comprising administering eye drops comprising Gln, Ala and Asn to patients with DED, wherein the eye drops are effective in treating DED (see pages 28-31, Example 3). Furthermore, Kinoshita et al explicilty teach that “In addition, peptides such as Lalanylglutamine, which are known to have the same effect on cells as the amino acids, which are active ingredients of the ophthalmic composition of the present invention, can also be used”. Therefore, in view of the teachings of Kinoshita et al as a whole, one of ordinary skilled in the art would understand and reasonably expect that similar to the eye drops comprising Gln, Ala and Asn in Example 3 of Kinoshita et al, an ophthalmic composition comprising Lalanylglutamine would be effective in treating DED. And in the instant case, other than statements/arguments, Applicant fails to provide any data and/or evidence to prove otherwise.
Taken all these together, the rejection is deemed proper. And until a proper terminal disclaimer is filed and approved by the Office, the double patenting rejection is hereby maintained.
New Rejections
Obviousness Double Patenting
20. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
21. Claims 25-27, 30, 31, 34-36, 39-41 and 44 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 25-28 of co-pending Application No. 18/715086 in view of Kinoshita et al (WO 2010/107069 A1, filed with IDS, machine translation used and enclosed in the previous office actions, pages 1-32) and the Ophthalmic Preparations document (2016, pages 1-2, filed with IDS, from https://pharmlabs.unc.edu/labs/ophthalmics/isoosmo.htm).
22. Instant claims 25-27, 30, 31, 34-36, 39-41 and 44 are drawn to a method of relieving dry eye disease (DED) symptoms in a patient in need thereof, a method of improving dry eye disease (DED) in a patient in need thereof, and/or a method of treating dry eye disease (DED) in a patient in need thereof, the method comprising administering to the patient a pharmaceutical composition comprising L-Alanyl-L-Glutamine suspended or dissolved in an isoosmotic solution that is suitable for eyes.
23. Claims 25-28 of co-pending Application No. 18/715086 are drawn to an ophthalmic composition comprising alanyl-glutamine and an ophthalmologically acceptable excipient, wherein the ophthalmic composition is in the form of eye drops, suspensions, gels, eye ointments, emulsions, eye pads, eye patches, eye masks, eye creams, sprays, injections or implants.
24. The difference between claims 25-28 of co-pending Application No. 18/715086 and instant claims 25-27, 30, 31, 34-36, 39-41 and 44 is that claims 25-28 of co-pending Application No. 18/715086 do not teach applying the ophthalmic composition comprising alanylglutamine in a method recited in instant claims 25-27, 30, 31, 34-36, 39-41 and 44.
However, in view of the combined teachings of Kinoshita et al and the Ophthalmic Preparations document with routine optimization as set forth in Section 10 above, it would have been obvious to one of ordinary skilled in the art to use the ophthalmic composition comprising alanylglutamine recited in claims 25-28 of co-pending Application No. 18/715086 and develop the method recited in instant claims 25-27, 30, 31, 34-36, 39-41 and 44.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Please note: in the instant case, co-pending Application No. 18/715086 shares the same Applicant (SEINDA PHARMACEUTICAL GUANGZHOU CORPORATION) as instant application.
Conclusion
No claim is allowed.
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/LI N KOMATSU/Primary Examiner, Art Unit 1658