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
Acknowledgments are made that this application claims the priority to the following:
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Information Disclosure Statement
Filed information disclosure statements (IDS) comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, they have been placed in the application file and the information therein has been considered as to the merits.
Response to Restriction
Applicant's response to restriction requirement and election of group I corresponding to claims 1-7, 16-19 and 25, without traverse, in the reply filed on 06/01/2026 is acknowledged.
The examiner also acknowledges applicants response to election of species and providing the following species for the claimed subject matter:
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Claims 1-7, 16-17 and 25 read applicants elected species.
Claims 10-11, 18-19, 26, 28, 30 and 32-34 are withdrawn from consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
The claims 1-7, 16-17 and 25 are examined, in light of elected species, on merits in this office action.
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 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 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.
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.
Claims 1-7, 16-17 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Bosukonda (US2014/0057831A1) in view of Ghazi-Khansari (J.Appl.Toxicol., 2007, Jul-Aug:27(4):342-9) ad Yang (Biochemical and Biophysical Research Communications 482, 2017 147-153).
For claim 1:
Bosukonda teaches a method of treating a subject having a disease or disorder characterized by fibrosis, comprising administering an effective amount of a peptide set forth in SEQ ID NOs: 1-77, thereby treating the subject, wherein fibrosis is idiopathic pulmonary fibrosis [see claim 1, paragraphs 0214-0217, Examples 5-7].
Bosukonda further teaches that methods of treating fibrosis can be combined with any other method of treating fibrosis known in the art [see 0215]. Steroidal anti-inflammatory compounds (e.g., prednisone) and ACE inhibitors (e.g., perindopril, captopril, enalapril) can be tested and used to treat fibrosis in combination with the peptides of the invention [see 0215]. Bosukonda exemplified a combination of peptide (THR-123, SEQ ID NO:1) with ACE inhibitor captopril [see 0403].
In the above, fibrosis reads applicants elected “tissue differentiated factor associated disease or disorder”, peptide SEQ ID NO:5 in SEQ ID NO:1-77 is identical to applicants elected SEQ ID NO:3, which reads applicants TDFRP, captopril reads applicants inhibitor of ACE.
Difference is that Bosukonda silent on exemplifying applicants elected treating idiopathic pulmonary fibrosis with elected SEQ ID NO:3 and elected enalapril.
However, Bosukonda provided enough guidance and description for treating diseases or disorders associated with fibrosis in their disclosure and pulmonary fibrosis is one of them. Further suggested that ACE inhibitors (e.g., perindopril, captopril, enalapril) can be tested and used to treat fibrosis in combination with the peptides of the invention and exemplified with their SEQ ID NO:1 in combination with captopril, wherein SEQ ID NO:1 is identical to applicants SEQ ID NO:1. Therefore a skilled person in the art would be motivated to extrapolate shown data to other fibrosis associated diseases and other inhibitors of ACE.
In addition, both captopril and enalapril are known to treat pulmonary fibrosis, as evidenced from the following art:
Ghazi-Khansari teaches that antifibrotic effect of captopril and enalapril on paraquat-induced lung fibrosis in rats [see abstract].
Based on above, both captopril and enalapril are equivalent and therefore, it is obvious to extrapolate shown data in the disclosure of Bosukonda to treat pulmonary fibrosis by administering applicants SEQ ID NO:3 in combination with enalapril.
For claims 2-3:
Since the active ingredients are identical, and so, these properties are expected, absent evidence to the contrary.
For claims 4-7:
See the provided reasoning in For claim 1 above.
For claim 16:
Since the elected sequence is identical to the sequence of Bosukonda, this limitation must be present in the sequence of Bosukonda.
For claim 17:
See For claim 1 above.
For claim 25:
Bosukonda silent on incorporation of anti-neoplastic agents in their method. However, anti-cancer drugs are known to treat pulmonary fibrosis. For example, Yang teaches that glaucocalyxin A, an anti-neoplastic agent, can effectively ameliorate pulmonary fibrosis [see abstract]. Generally, if it is known to use A, and known to use B for the same purpose, then it is obvious to use both A and B, In re Susi, 169 USPQ 423, 426; In re Kerkhoven, 205 USPQ 1069. Thus, combining them flows logically from their having been individually taught in the prior art.
Based on the above established facts from the cited prior art, it appears that all the claimed elements, i.e, applicants individual components and their utility in treating pulmonary fibrosis, were known in the prior art, and one skilled person in the art could have combined the elements as claimed by known relationships, with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art.
A combination of prior art references is only proper if a person of ordinary skill in the art (POSA) at the time of the invention, faced with the same problem, would have been motivated to combine their teachings with a reasonable expectation of success. See KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Here, the technical fields and problems addressed by the references are not distinct from that of the present invention.
The motivation to combine the art can arise from the expectation that the prior art elements will perform their expected functions to achieve their expected results when combined for their common known purpose. See MPEP 2144.07. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention by taking the advantage of the teaching of the above cited reference and to make the instantly claimed method with a reasonable expectation of success.
The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art or drawn from a convincing line of reasoning based on established scientific principles or legal precedent, that some advantage or expected beneficial result would have been produced by their combination. In re Sernaker, 702 F.2d 989, 994-95, 217 USPQ 1, 5-6 (Fed. Cir. 1983).
Nonstatutory Double Patenting Rejection
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.
Claims 1-7, 16-17 and 25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 19-20 of US copending application# 17/235,035.
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
Claims of instant application are drawn to a method of treating a tissue differentiation factor-associated disorder or disease, the method comprising: administering to a subject in need of treatment at least one tissue differentiation factor related polypeptide (TDFRP) in combination with an additional agent, wherein the additional agent is selected from the group consisting of: an inhibitor of angiotensin converting enzyme (ACE), a neprilysin inhibitor and an angiotensin receptor-neprilysin inhibitor, wherein the TDFRP and additional agent are administered in an amount effective to treat-or-prevent the tissue differentiation factor-associated disorder or disease in the subject.
Claims of copending application are drawn to a method of treating or preventing a disease or disorder associated with fibrosis in a subject, the method comprising administering to a subject in need of treatment at least one TDFRP in combination with an additional agent, wherein the additional agent is selected from the group consisting of: an inhibitor of angiotensin converting enzyme (ACE), a neprilysin inhibitor and an angiotensin receptor-neprilysin inhibitor, wherein the TDFRP and additional agent are administered in an amount effective to treat the fibrosis in the subject, wherein the fibrosis is selected from the group consisting of: pulmonary fibrosis, renal fibrosis and hepatic fibrosis.
Claimed subject matter of instant application is fully disclosed in the claims of copending application and is covered by its disclosure. Both the patents and instant application are claiming common subject matter of treating fibrotic disorders by administering the combination of TDFRP and inhibitor of ACE.
Difference is in scope of claimed subject matter. However, the scope overlaps in both cases, that means both are in the same field of use, differences are minor or routine, co-pending application suggests the same or similar properties of peptides, and there is no evidence of criticality or unexpected results in the claimed subject matter.
Accordingly, claims are obvious over the claims of US copending application.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not been patented yet.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUDHAKAR KATAKAM whose telephone number is (571)272-9929. The examiner can normally be reached 8:30 am to 5 pm.
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/SUDHAKAR KATAKAM/Primary Examiner, Art Unit 1658
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