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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 9/23/2025 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 9/23/2025 is acknowledged.
3. Claim 1-7, 9, 12, 13, 15 and 19 have been cancelled.
4. Claims 8, 10, 11, 14, 16-18, 20 and 21 are pending in this application.
5. Claims 11, 17 and 21 remain withdrawn from consideration as being not read on either the elected species or the non-elected species found in the prior art.
6. Applicant elected without traverse lung/pulmonary fibrosis as species of fibrosis in the reply filed on 7/3/2023.
Restriction requirement was deemed proper and made FINAL in the previous office actions. The instant claims 8, 10, 11, 14, 16-18, 20 and 21 are drawn to a method for treating fibrosis, comprising administering to the subject an effective amount of Cyclo-HisPro or a pharmaceutically acceptable salt thereof, wherein the fibrosis develops in any one or more selected from the group consisting of liver, lung, skin, heart, pancreas, genital system, sweat gland, brain, bone marrow, muscle, and joint; a method for reducing or inhibiting fibrosis in a subject whose fibrosis has already developed, comprising administering to the subject an effective amount of Cyclo-HisPro or a pharmaceutically acceptable salt thereof, wherein the fibrosis develops in any one or more selected from the group consisting of liver, lung, skin, heart, pancreas, genital system, sweat gland, brain, bone marrow, muscle, and joint; and a method of inducing anti-fibrotic activity in a subject in need thereof, comprising administering to the subject an effective amount of Cyclo-HisPro or a pharmaceutically acceptable salt thereof, wherein the anti-fibrotic activity is induced in any one or more selected from the group consisting of liver, lung, skin, heart, pancreas, genital system, sweat gland, brain, bone marrow, muscle, and joint, and wherein the anti-fibrotic activity is characterized by a decrease in expression of TGF-β gene. A search was conducted on the elected species; and prior art was found. Claims 11, 17 and 21 remain withdrawn from consideration as being not read on either the elected species or the non-elected species found in the prior art. Claims 8, 10, 14, 16, 18 and 20 are examined on the merits in this office action.
Please note: as stated in the previous office actions, for the purpose of this examination, the Examiner is interpreting lung/pulmonary fibrosis as the elected species of fibrosis includes any type of lung/pulmonary fibrosis.
Withdrawn Rejections
7. Rejection to claims 8, 14, 18 and 19 under 35 U.S.C. 102(a)(1) as being anticipated by Yoo et al (KR 20180008305 A, filed with IDS, published on 1/24/2018, machine translation used, pages 1-18, cited and enclosed in the previous office actions), and as evidenced by the Anatomy of the Urinary System document (from Johns Hopkins Medicine, accessed 2025, enclosed pages 1-6) is hereby withdrawn in view of Applicant’s amendment to the claim.
8. Rejection to claim 19 under 35 U.S.C. 112(d) or 35 U.S.C. 112 (pre-AIA ), 4th paragraph is hereby withdrawn in view of Applicant’s amendment to the claim.
9. Rejections to claims 8, 14, 18 and 19 on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-15 of US patent 11820834 B2, and as evidenced by the Anatomy of the Urinary System document (from Johns Hopkins Medicine, accessed 2025, enclosed pages 1-6); and claims 1-14 of US patent 11890317 B2 in view of Yoo et al (KR 20180008305 A, filed with IDS, machine translation used, pages 1-18, cited and enclosed in the previous office actions), and as evidenced by the Anatomy of the Urinary System document (from Johns Hopkins Medicine, accessed 2025, enclosed pages 1-6) are hereby withdrawn in view of Applicant’s amendment to the claim.
Maintained/Revised Rejections
Claim Rejections - 35 U.S.C. § 103
10. 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.
11. 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.
12. (Revised due to Applicant’s amendment to the claim) Claims 8, 10, 14, 16, 18 and 20 remain rejected under 35 U.S.C. 103 as being unpatentable over Grottelli et al (Int. J. Mol. Sci., 2016, 17, pages 1-14, filed with IDS) in view of Tsuburai et al (HUMAN GENE THERAPY, 2002, 13, pages 1945-1960, cited and enclosed in the previous office actions).
The instant claims 8, 10, 14, 16, 18 and 20 are drawn to a method for treating fibrosis, comprising administering to the subject an effective amount of Cyclo-HisPro or a pharmaceutically acceptable salt thereof, wherein the fibrosis develops in any one or more selected from the group consisting of liver, lung, skin, heart, pancreas, genital system, sweat gland, brain, bone marrow, muscle, and joint; a method for reducing or inhibiting fibrosis in a subject whose fibrosis has already developed, comprising administering to the subject an effective amount of Cyclo-HisPro or a pharmaceutically acceptable salt thereof, wherein the fibrosis develops in any one or more selected from the group consisting of liver, lung, skin, heart, pancreas, genital system, sweat gland, brain, bone marrow, muscle, and joint; and a method of inducing anti-fibrotic activity in a subject in need thereof, comprising administering to the subject an effective amount of Cyclo-HisPro or a pharmaceutically acceptable salt thereof, wherein the anti-fibrotic activity is induced in any one or more selected from the group consisting of liver, lung, skin, heart, pancreas, genital system, sweat gland, brain, bone marrow, muscle, and joint, and wherein the anti-fibrotic activity is characterized by a decrease in expression of TGF-β gene.
Grottelli et al teach Cyclo-HisPro as an anti-inflammatory agent increases heme oxygenase 1 (HO-1) expression, and is protective in the experimental model of pulmonary injury, for example, page 6, Section “4.1. Cyclo(His-Pro) Acts as an Anti-Inflammatory Agent”. It meets the limitation of Cyclo-HisPro recited in instant claims 8, 14 and 18.
The difference between the reference and instant claims 8, 10, 14, 16, 18 and 20 is that the reference does not explicitly teach lung/pulmonary fibrosis as the elected species of fibrosis; and the subject recited in instant claims 8, 10, 14, 16, 18 and 20.
However, Tsuburai et al, throughout the literature, teach overexpression of HO-1 provides therapeutic benefit in a murine model of bleomycin-induced pulmonary fibrosis; and using HO-1 overexpression to treat disorders due to chronic, profibrotic, inflammatory processes or apoptotic cell death, and such disorders include pulmonary fibrosis, emphysema, lung injury, liver cirrhosis, and nephrosclerosis, for example, Title; Abstract; Overview Summary; and Figures 1-11.
Therefore, it would have been obvious to one of ordinary skilled in the art to combine the teachings of Grottelli et al and Tsuburai et al and develop a method for treating pulmonary fibrosis, and/or reducing or inhibiting pulmonary fibrosis, and/or inducing anti-pulmonary fibrosis activity in a subject whose pulmonary fibrosis has already developed, comprising administering to the subject an effective amount of Cyclo-HisPro. It reads on lung/pulmonary fibrosis as the elected species of fibrosis.
With regards to the limitation “wherein the anti-fibrotic activity is characterized by a decrease in expression of TGF-β gene” recited in instant claim 18, first, this is a result-oriented limitation. In the instant case, the method developed from the combined teachings of Grottelli et al and Tsuburai et al above comprises administering the same Cyclo-HisPro to the same subject (a subject whose pulmonary fibrosis has already developed). Therefore, the method developed from the combined teachings of Grottelli et al and Tsuburai et al above would results in the same effect, in that the anti-fibrotic activity is characterized by a decrease in expression of TGF-β gene. Second, since Cyclo-HisPro in the method developed from the combined teachings of Grottelli et al and Tsuburai et al above is identical to Cyclo-HisPro in the method recited in instant claim 18, Cyclo-HisPro in the method developed from the combined teachings of Grottelli et al and Tsuburai et al above would necessarily have the same properties and functionalities of Cyclo-HisPro in the method recited in instant claim 18. Therefore, Cyclo-HisPro in the method developed from the combined teachings of Grottelli et al and Tsuburai et al above exhibits anti-fibrotic activity by decreasing expression of TGF-β gene. Furthermore, the MPEP states “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Claims were directed to a titanium alloy containing 0.2-0.4% Mo and 0.6-0.9% Ni having corrosion resistance. A Russian article disclosed a titanium alloy containing 0.25% Mo and 0.75% Ni but was silent as to corrosion resistance. The Federal Circuit held that the claim was anticipated because the percentages of Mo and Ni were squarely within the claimed ranges. The court went on to say that it was immaterial what properties the alloys had or who discovered the properties because the composition is the same and thus must necessarily exhibit the properties.).” (see MPEP § 2112.01 I). In addition, since the USPTO lacks the experimental facilities to make a further determination, the burden is on the Applicant to prove the otherwise.
One of ordinary skilled in the art would have been motivated to combine the teachings of Grottelli et al and Tsuburai et al and develop a method for treating pulmonary fibrosis, and/or reducing or inhibiting pulmonary fibrosis, and/or inducing anti-pulmonary fibrosis activity in a subject whose pulmonary fibrosis has already developed, comprising administering to the subject an effective amount of Cyclo-HisPro, because Tsuburai et al, throughout the literature, teach overexpression of HO-1 provides therapeutic benefit in a murine model of bleomycin-induced pulmonary fibrosis; and using HO-1 overexpression to treat disorders due to chronic, profibrotic, inflammatory processes or apoptotic cell death, and such disorders include pulmonary fibrosis, emphysema, lung injury, liver cirrhosis, and nephrosclerosis.
A person of ordinary skilled in the art would have reasonable expectation of success in combining the teachings of Grottelli et al and Tsuburai et al to develop a method for treating pulmonary fibrosis, and/or reducing or inhibiting pulmonary fibrosis, and/or inducing anti-pulmonary fibrosis activity in a subject whose pulmonary fibrosis has already developed, comprising administering to the subject an effective amount of Cyclo-HisPro.
Response to Applicant's Arguments
13. Applicant argues about each of the cited prior art references individually, in that the Examiner overextends the actual disclosure of Grottelli and its cited references; and one of ordinary skill in the art would not, without impermissible hindsight, interpret the general HO-1 discussion in Grottelli and its references as teaching or suggesting the use of CHP to treat pulmonary fibrosis or pulmonary injury; and the effect reported in Tsuburai is properly interpreted as suppression of early inflammation that prevents subsequent fibrosis, not as a direct anti-fibrotic (therapeutic) activity. Applicant further argues that instant application demonstrates a therapeutic anti-fibrotic effect independent of inflammation; CHP was administered after fibrosis had already been established; and the significant reductions in TGF-β and collagen III expression observed in the CHP-treated group confirm a genuine therapeutic anti-fibrotic effect. Applicant also argues that even when combined, Grottelli and Tsuburai would at most suggest that CHP may have HO-1-mediated anti-inflammatory or prophylactic effects, but they do not provide a motivation or reasonable expectation of success for using CHP to treat established pulmonary fibrosis or to reduce TGF-β-driven fibrotic markers.
14. Applicant's arguments have been fully considered but have not been found persuasive.
In response to Applicant’s arguments about instant rejection, the Examiner agrees that none of the cited references individually teaches or suggests the methods recited in instant claims 8, 10, 14, 16, 18 and 20; and none of the cited references anticipates the methods recited in instant claims 8, 10, 14, 16, 18 and 20. However, the Examiner would like to point out that instant claims 8, 10, 14, 16, 18 and 20 are rejected under 35 U.S.C. 103 (obviousness type); and the rejection is based on the combined teachings of Grottelli et al and Tsuburai et al. Therefore, it is not necessary for each of the cited references to teach all the limitations of instant claims. Furthermore, the Examiner would like to point out that the MPEP states "One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references…" (see MPEP § 2145 IV).
In response to Applicant’s arguments about instant rejection:
First, with regards to Applicant’s arguments about the cited Grottelli et al reference, the Examiner understands that references 75-78 cited in Grottelli et al do not teach Cyclo-HisPro is protective in the experimental model of pulmonary injury. However, the Examiner would like to point out that the reference is considered as a whole, instead of only one specific sentence in the cited reference. In the instant case, in view of the teachings of Grottelli et al as a whole, in particular, page 6, Section “4.1. Cyclo(His-Pro) Acts as an Anti-Inflammatory Agent” in Grottelli et al, one of ordinary skilled in the art would understand and reasonably expect Grottelli et al teach Cyclo-HisPro as an anti-inflammatory agent increases heme oxygenase 1 (HO-1) expression, and is protective in the experimental model of pulmonary injury.
Second, with regards to Applicant’s arguments about the cited Tsuburai et al reference, the Examiner understands that preventive effect is not the same as therapeutic effect. The Examiner also understands that data presented in Tsuburai et al are obtained from mice model pretreated with adenovirus vector encoding HO-1 before bleomycin challenge. However, in the instant case, as stated in Section 12 above, Tsuburai et al explicilty teach overexpression of HO-1 provides therapeutic benefit in a murine model of bleomycin-induced pulmonary fibrosis; and using HO-1 overexpression to treat disorders due to chronic, profibrotic, inflammatory processes or apoptotic cell death, and such disorders include pulmonary fibrosis, emphysema, lung injury, liver cirrhosis, and nephrosclerosis.
Third, with regards to Applicant’s arguments that instant application demonstrates a therapeutic anti-fibrotic effect independent of inflammation; CHP was administered after fibrosis had already been established; and the significant reductions in TGF-β and collagen III expression observed in the CHP-treated group confirm a genuine therapeutic anti-fibrotic effect, in the instant case, it appears to the Examiner that Applicant has identified latent properties of CHP as an anti-fibrotic agent. And the MPEP states: “Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention.” (see MPEP § 2145 II).
Fourth, with regards to Applicant’s arguments about impermissible hindsight, in the instant case, Applicant fails to point to any facet of instant rejection that is not found in the cited prior art references. It is unclear to the Examiner which part of the instant rejection is not based on the combined teachings of the cited references. Merely pointing out the differences between each of the cited references and instant claimed invention is not proof of hindsight reasoning. And, the MPEP states “"[a]ny judgment on obviousness is in a sense necessarily a reconstruction based on hindsight reasoning, but so long as it takes into account only knowledge which was within the level of ordinary skill in the art at the time the claimed invention was made and does not include knowledge gleaned only from applicant’s disclosure, such a reconstruction is proper." In re McLaughlin, 443 F.2d 1392, 1395, 170 USPQ 209, 212 (CCPA 1971).” (see MPEP § 2145).
Taken all these together, in view of the combined teachings of Grottelli et al and Tsuburai et al as set forth in Section 12 above, one of ordinary skilled in the art would have been motivated to develop the methods recited in instant claims; and a person of ordinary skilled in the art would have reasonable expectation of success to develop the methods recited in instant claims. Furthermore, with regards to the expectation of success, the MPEP states: “Absolute predictability is not a necessary prerequisite to a case of obviousness. Rather, a degree of predictability that one of ordinary skill would have found to be reasonable is sufficient. The Federal Circuit concluded that “[g]ood science and useful contributions do not necessarily result in patentability.” Id. at 1364, 83 USPQ2d at 1304.” (see MPEP § 2145).
Therefore, the rejection is deemed proper and is hereby maintained.
Obviousness Double Patenting
15. 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.
16. (Revised due to Applicant’s amendment to the claim) Claims 8, 10, 14, 16, 18 and 20 remain/are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 7-10 and 12-17 of co-pending application No. 18/377656, and in view of Grottelli et al (Int. J. Mol. Sci., 2016, 17, pages 1-14, filed with IDS) and Tsuburai et al (HUMAN GENE THERAPY, 2002, 13, pages 1945-1960, cited and enclosed in the previous office actions).
17. Instant claims 8, 10, 14, 16, 18 and 20 are drawn to a method for treating fibrosis, comprising administering to the subject an effective amount of Cyclo-HisPro or a pharmaceutically acceptable salt thereof, wherein the fibrosis develops in any one or more selected from the group consisting of liver, lung, skin, heart, pancreas, genital system, sweat gland, brain, bone marrow, muscle, and joint; a method for reducing or inhibiting fibrosis in a subject whose fibrosis has already developed, comprising administering to the subject an effective amount of Cyclo-HisPro or a pharmaceutically acceptable salt thereof, wherein the fibrosis develops in any one or more selected from the group consisting of liver, lung, skin, heart, pancreas, genital system, sweat gland, brain, bone marrow, muscle, and joint; and a method of inducing anti-fibrotic activity in a subject in need thereof, comprising administering to the subject an effective amount of Cyclo-HisPro or a pharmaceutically acceptable salt thereof, wherein the anti-fibrotic activity is induced in any one or more selected from the group consisting of liver, lung, skin, heart, pancreas, genital system, sweat gland, brain, bone marrow, muscle, and joint, and wherein the anti-fibrotic activity is characterized by a decrease in expression of TGF-β gene.
18. Claims 7-10 and 12-17 of co-pending application No. 18/377656 are drawn to a composition comprising a cyclo(-His-Pro) hydrate compound and a pharmaceutically acceptable carrier, said cyclo(-His-Pro) hydrate compound being characterized by an X-ray powder diffraction (XRPD) diffractogram comprising three or more peaks at 2θ values selected from the group consisting of 13.5o-13.9o, 16.9o-17.3o, 22.4o-22.6o, 24.1o-24.5o and 27.2o-27.5o.
19. The difference between instant claims 8, 10, 14, 16, 18 and 20 and claims 7-10 and 12-17 of co-pending application No. 18/377656 is that claims 7-10 and 12-17 of co-pending application No. 18/377656 do not teach apply the composition in the methods recited in instant claims 8, 10, 14, 16, 18 and 20.
However, in view of the combined teachings of Grottelli et al and Tsuburai et al as set forth in Section 12 above, it would have been obvious to one of ordinary skilled in the art to apply the composition recited in claims 7-10 and 12-17 of co-pending application No. 18/377656 and develop the methods recited in instant claims 8, 10, 14, 16, 18 and 20.
Furthermore, with regards to the limitation “wherein the anti-fibrotic activity is characterized by a decrease in expression of TGF-β gene” recited in instant claim 18, first, this is a result-oriented limitation. In the instant case, the method developed above comprises administering the same Cyclo-HisPro to the same subject (a subject whose pulmonary fibrosis has already developed). Therefore, the method developed above would results in the same effect, in that the anti-fibrotic activity is characterized by a decrease in expression of TGF-β gene. Second, since Cyclo-HisPro in the method developed above is identical to Cyclo-HisPro in the method recited in instant claim 18, Cyclo-HisPro in the method developed above would necessarily have the same properties and functionalities of Cyclo-HisPro in the method recited in instant claim 18. Therefore, Cyclo-HisPro in the method developed above exhibits anti-fibrotic activity by decreasing expression of TGF-β gene. In addition, the MPEP states “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Claims were directed to a titanium alloy containing 0.2-0.4% Mo and 0.6-0.9% Ni having corrosion resistance. A Russian article disclosed a titanium alloy containing 0.25% Mo and 0.75% Ni but was silent as to corrosion resistance. The Federal Circuit held that the claim was anticipated because the percentages of Mo and Ni were squarely within the claimed ranges. The court went on to say that it was immaterial what properties the alloys had or who discovered the properties because the composition is the same and thus must necessarily exhibit the properties.).” (see MPEP § 2112.01 I). And, since the USPTO lacks the experimental facilities to make a further determination, the burden is on the Applicant to prove the otherwise.
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. 18/377656 shares the same Applicant (NovMetaPharma Co., Ltd.) as instant application.
20. (Revised due to Applicant’s amendment to the claim) For the same and/or similar reasoning/rational as the rejection set forth in Sections 16-19 above, instant claims 8, 10, 14, 16, 18 and 20 remain/are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable claims 1-28 of US patent 10683300 B2, and in view of the combined teachings of Grottelli et al (Int. J. Mol. Sci., 2016, 17, pages 1-14, filed with IDS) and Tsuburai et al (HUMAN GENE THERAPY, 2002, 13, pages 1945-1960, cited and enclosed in the previous office actions) as set forth in Section 12 above.
Please note: in the instant case, US patent 10683300 B2 shares the same Applicant (NovMetaPharma Co., Ltd.) as instant application.
Response to Applicant's Arguments
21. Applicant argues that ”the term 'urinary system' has been deleted from base claims 8, 14, and 18, and claim 19 has been cancelled, rendering the rejections moot.”
22. Applicant's arguments have been fully considered but have not been found persuasive.
Please note: In view of Applicant’s amendment to the claim, Grottelli et al (Int. J. Mol. Sci., 2016, 17, pages 1-14, filed with IDS) and Tsuburai et al (HUMAN GENE THERAPY, 2002, 13, pages 1945-1960, cited and enclosed in the previous office actions) are cited as prior art references in instant rejections.
In the instant case, Applicant’s amendment to the claim fails to overcome the ODP rejections as set forth in Sections 16-20 above. Therefore, until a proper terminal disclaimer is filed and approved by the Office, these double patenting rejections are maintained.
New Objections
23. Claim 18 is objected to for the following minor informality: Claim 18 contains the acronym “TGF-β”. An acronym in the first instance of claims should be expanded upon/spelled out with the acronym indicated in parentheses, for example, transforming growth factor-beta (TGF-β). The abbreviation can be used thereafter.
New Rejections
Obviousness Double Patenting
24. 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.
25. Claims 8, 10, 14, 16, 18 and 20 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 23-29 of co-pending application No. 19/107159.
26. Instant claims 8, 10, 14, 16, 18 and 20 are drawn to a method for treating fibrosis, comprising administering to the subject an effective amount of Cyclo-HisPro or a pharmaceutically acceptable salt thereof, wherein the fibrosis develops in any one or more selected from the group consisting of liver, lung, skin, heart, pancreas, genital system, sweat gland, brain, bone marrow, muscle, and joint; a method for reducing or inhibiting fibrosis in a subject whose fibrosis has already developed, comprising administering to the subject an effective amount of Cyclo-HisPro or a pharmaceutically acceptable salt thereof, wherein the fibrosis develops in any one or more selected from the group consisting of liver, lung, skin, heart, pancreas, genital system, sweat gland, brain, bone marrow, muscle, and joint; and a method of inducing anti-fibrotic activity in a subject in need thereof, comprising administering to the subject an effective amount of Cyclo-HisPro or a pharmaceutically acceptable salt thereof, wherein the anti-fibrotic activity is induced in any one or more selected from the group consisting of liver, lung, skin, heart, pancreas, genital system, sweat gland, brain, bone marrow, muscle, and joint, and wherein the anti-fibrotic activity is characterized by a decrease in expression of TGF-β gene.
27. Claims 23-29 of co-pending application No. 19/107159 are drawn to a method for preventing, alleviating, or treating a respiratory disease, comprising administering an effective amount of a composition including: a zinc salt including a zinc cation and an anion; and cyclo-hispro or a pharmaceutically acceptable salt thereof, to an individual in need thereof.
In the instant case, in view of the combined teachings of claims 23-29 of co-pending application No. 19/107159, it would have been obvious to one of ordinary skilled in the art to develop a method for treating pulmonary fibrosis or cystic fibrosis, and/or reducing or inhibiting pulmonary fibrosis or cystic fibrosis, and/or inducing anti-pulmonary fibrosis or anti-cystic fibrosis activity in a subject whose pulmonary fibrosis or cystic fibrosis has already developed, comprising administering to said subject an effective amount of a composition including: a zinc salt including a zinc cation and an anion; and cyclo-hispro or a pharmaceutically acceptable salt thereof.
Furthermore, with regards to the limitation “wherein the anti-fibrotic activity is characterized by a decrease in expression of TGF-β gene” recited in instant claim 18, in the instant case, since Cyclo-HisPro in the method developed above is identical to Cyclo-HisPro in the method recited in instant claim 18, Cyclo-HisPro in the method developed above would necessarily have the same properties and functionalities of Cyclo-HisPro in the method recited in instant claim 18. Therefore, Cyclo-HisPro in the method developed above exhibits anti-fibrotic activity by decreasing expression of TGF-β gene. In addition, the MPEP states “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Claims were directed to a titanium alloy containing 0.2-0.4% Mo and 0.6-0.9% Ni having corrosion resistance. A Russian article disclosed a titanium alloy containing 0.25% Mo and 0.75% Ni but was silent as to corrosion resistance. The Federal Circuit held that the claim was anticipated because the percentages of Mo and Ni were squarely within the claimed ranges. The court went on to say that it was immaterial what properties the alloys had or who discovered the properties because the composition is the same and thus must necessarily exhibit the properties.).” (see MPEP § 2112.01 I). And, since the USPTO lacks the experimental facilities to make a further determination, the burden is on the Applicant to prove the otherwise.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Conclusion
No claim is allowed.
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/LI N KOMATSU/Primary Examiner, Art Unit 1658