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 .
Claims 1, 4, 6, 10-12, 14-15, 19, 21-24, 29, 32, 35-38, 43, and 72-77 are pending in the application. Preliminary amendment filed 18 July 2024.
Priority
This application is a 371 of PCT/US2022/029620 filed 05/17/2022. This application claims the benefit of 63189570 filed 05/17/2021. The parent application 63189570 to which priority is claimed is seen to provide adequate support under 35 U.S.C. 112 for claims 1, 4, 6, 10-12, 14-15, 19, 21-24, 29, 32, 35-38, 43, and 72-77 of this application. Priority accorded is 05/17/2021.
Claim Objections
Claims 4, 10, 22, 24 are objected to because of the following informalities: Claim 4 does not end with a period. Claim 4 is examined as ending with the definition for n at the last line. Claims 22-24 also do not end with a period. Applicant is requested to review all the claims and insert a period wherever it is missing. Claim 11 is drawn to the use of a compound of formula I-A in the method of claim 10. Formula I-A is recited in claim 10. Therefore, claim 11 is seen as a duplicate of claim 10. In claim 22, the methyl group that is located between the carbonyl group and the NH is shown using a line which represents a methyl group. However, the stereochemistry of the methyl group is not indicated properly. This also applies to the phosphorus and the oxygen bond of the phenoxy. Does applicant intend a stereoisomer in claim 22? In claim 24, in the first structural formula, citric acid is also recited. Claim 24 is examined as drawn to the citrate salt of the formula. It would clarify if the first structural formula in claim 24 is recited with a dot after it followed by the formula for citric acid. Applicant may also mention that it is the citrate salt that is claimed. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the fourth paragraph of 35 U.S.C. 112:
Subject to the [fifth paragraph of 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 11 is rejected under 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 11 is drawn to the method of claim 10 wherein the compound used is a compound of formula I-A. This same limitation is seen in claim 10. Therefore, claim 11 does not further limit parent claim 10.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claim(s) 1, 10-12, 14, 15, 19, 21, 24, 35, and 73 are rejected under 35 U.S.C. 103 as being unpatentable over Biswas et al (Frontiers in Genetics, 09 March 2021, 12, article 626642,1-19).
Biswas et al teaches conducting screening of drugs against non-structural proteins of severe acute respiratory syndrome coronavirus 2, SARS-CoV2 (Abstract; immune disorder other than HIV as in claims 1, 35 and 73). One of the drugs screened is Rovafovir which falls under the definition of the compound of formula (I) in claim 1, compound of formula I-A in claims 10-12, 21, 24 (page 12. Figure 6).
Even though Biswas does not expressly teach a method of treating an immune disorder other than HIV, in a patient via administration of a compound of formula (I), its teaching suggests to one of ordinary skill in the art that Rovafovir and the other derivatives as in the instant claims can be used in a method of treating an immune disorder.
MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.'" KSR, 550 U.S. at, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) " Obvious to try " choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
According to the rationale discussed in KSR above, the rationale in (G) above is seen to be applicable here since based on the prior art teachings, the compound rovafovir, which is a compound of instant formula (I) is a potential drug for use in treating an immune disorder. Thus, it is obvious to arrive at the claimed method in view of Biswas et al.
Thus, the claimed invention as a whole would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention over the combined teachings of the prior art. Method improvement is the motivation. One of ordinary skill in the art would use rovafovir in the claimed method of treatment since it has been identified by screening as an important drug for treating an immune disorder other than HIV. Even though Biswas does not provide in vitro or in vivo results one of ordinary skill in the art would administer rovafovir (compound of formula (I) as claimed) since it targets one of the non-structural proteins in SARS-CoV2 and is most likely to be effective in treating an immune disorder. In view of the teachings of Biswas the artisan would also administer the other compounds as in claims 1, 10, 11, 12, 14, 15, 19, 21, 22 and 24 in the claimed method.
One of ordinary skill in the art would have reasonably expected that the instant compounds, would have same or substantially similar beneficial therapeutic effects and usefulness in methods for treating an immune disorder, based on the reasonable expectation that structurally similar species usually have similar properties. See, e.g., Dillon, 919 F.2d at 693, 696, 16 USPQ2d at 1901, 1904. See also Deuel, 51 F.3d at 1558, 34 USPQ2d at 1214, and if the claimed invention and the structurally similar prior art species share any useful property, that will generally be sufficient to motivate an artisan of ordinary skill to make the claimed species. In fact, similar properties may normally be presumed when compounds are very close in structure. Dillon, 919 F.2d at 693, 696, 16 USPQ2d at 1901, 1904, as noted in MPEP 2144.
Claim 43 is rejected under 35 U.S.C. 103 as being unpatentable over Berg et al (Drugs of the Future, 2020, 45(7), 459-469).
Berg et al teaches the following compound (page 459, right col., page 463, Scheme 3; part of the limitations of claim 43):
PNG
media_image1.png
140
232
media_image1.png
Greyscale
Berg does not teach compounds of formula (II) having a fluorine substitution on the purinyl ring and the other recited substitutions for R1 and R2 as in claim 43.
MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.'" KSR, 550 U.S. at, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) " Obvious to try " choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
According to the rationale discussed in KSR above, the rationale in (G) above is seen to be applicable here since based on the prior art teachings, the compound GS 9131 (aka-rovafovir), which is a compound of instant formula (II) is known in the art have potent antiviral activity (page 467-see under sub-title: Antiviral Activity). Thus, it is obvious to arrive at the claimed compounds of formula (II) having all the other substitutions in view of Berg et al.
Thus, the claimed invention as a whole would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention over the combined teachings of the prior art.
One of ordinary skill in the art would have reasonably expected that the instant compounds of formula (II) having all the substitutions as in claim 43, would have same or substantially similar beneficial therapeutic effects and usefulness in methods for treating antiviral infection, based on the reasonable expectation that structurally similar species usually have similar properties. See, e.g., Dillon, 919 F.2d at 693, 696, 16 USPQ2d at 1901, 1904. See also Deuel, 51 F.3d at 1558, 34 USPQ2d at 1214, and if the claimed invention and the structurally similar prior art species share any useful property, that will generally be sufficient to motivate an artisan of ordinary skill to make the claimed species. In fact, similar properties may normally be presumed when compounds are very close in structure. Dillon, 919 F.2d at 693, 696, 16 USPQ2d at 1901, 1904, as noted in MPEP 2144.
Claim(s) 1, 4, 6, 10-12, 14, 15, 19, 21-24, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Ting et al (WO 2020142629 A1) in view of Otto et al (US 6,949,522 B2).
One aspect of Ting’s invention is a method of treating cancer in a subject in need thereof via administration of a reverse transcriptase blocking agent. The reverse transcriptase is HERV-K and LINE1 (page 1, lines 10-12; page 7, lines 29-30; claim 4 and 30 of Ting; method of treating cancer as in claim 1, method of inhibiting LINE1 as in claim 4, and method of inhibiting HERV-K as in claim 6). The cancers treated are pancreatic, prostate, renal, ovarian, lung, and colorectal cancers (page 3, lines 14-20; limitations of claim 29).
Ting does not teach the administration of the compound of formula I in claims 1, 4, 6, the compound of formula I-A as in claims 10-11, the substitutions as in claims 12, 14, 19, the compounds as in claims 21-24, and some of the cancers in claim 29.
Otto, drawn to halonucleosides, teaches compounds of formula (I)-(IV). These compounds are used in a method of treating cell proliferation (col. 9, line 7, through col. 10, line 50; col. 20, line 55 through col. 21, line 2; part of the limitations of claims 1, 4, and 6 for formula (I); part of the limitation of claims 11 for formula I-A; and part of the limitations of claims 21-24). Pharmaceutically acceptable salts including that of citric acid can be used (col. 27, lines 15-25; as in claim 24).
The difference between the compounds of Otto and the instant compounds is that in Otto’s compounds the fluorine substitution is at the 3’-position of the furan ring, and at the 4’ position of the furan ring it is a -CH2-OR1, whereas in the instant compounds the fluorine is at the 2’-position of the furan ring and at the 4’-position it is -O-CH2-P(=O)R1,R2.
However, it would have been obvious to one of ordinary skill in the art at the time of filing of the instant invention to arrive at the claimed methods using the compounds of formulas (I) and (I-A) as active agents with a reasonable expectation of success.
MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.'" KSR, 550 U.S. at, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) " Obvious to try " choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
According to the rationale discussed in KSR above, the rationale in (G) above is seen to be applicable here since based on the prior art teachings, a method of treating cancer in a subject in need thereof via administration of a reverse transcriptase blocking agent is known, wherein the reverse transcriptase is HERV-K and LINE1. Otto teaches compounds that are structurally close to the instant compounds, as active agents in a method of treating cancer. Therefore, it would be obvious to use the instant active agents, which are close structural analogs in the claimed method of treating cancer, and in a method of inhibiting LINE1 and HERV-K reverse transcriptase activity. The artisan can test the instant compounds for inhibition of LINE1 and HERV-K reverse transcriptase activity in view of Ting. The artisan would have a reasonable expectation of success in doing so. Structural similarity of the compounds of Otto with those of the instant compounds entails motivation to make and use the instant compounds in the claimed method of treatment of cancer and reverse transcriptase inhibiting activity.
One of ordinary skill in the art would have reasonably expected that the instant compounds having all the other substitutions, would have same or substantially similar beneficial therapeutic effects and usefulness in methods for treating cancer, and reverse transcriptase inhibiting activity, based on the reasonable expectation that structurally similar species usually have similar properties. See, e.g., Dillon, 919 F.2d at 693, 696, 16 USPQ2d at 1901, 1904. See also Deuel, 51 F.3d at 1558, 34 USPQ2d at 1214, and if the claimed invention and the structurally similar prior art species share any useful property, that will generally be sufficient to motivate an artisan of ordinary skill to make the claimed species. In fact, similar properties may normally be presumed when compounds are very close in structure. Dillon, 919 F.2d at 693, 696, 16 USPQ2d at 1901, 1904, as noted in MPEP 2144.
Claim(s) 1, 10-12, 14-15, 19, 21, 22-24, 32, 35, 37-38, 72 and 74-77 are rejected under 35 U.S.C. 103 as being unpatentable over Dolei et al (International Journal of Molecular Sciences, 29 July 2019, 20, 3706, 1-17) in view of Gamdzyk et al (Molecular Neurobiology, 2020, 57, 2600-2619) and further in view of Ting et al (WO 2020142629 A1) and Otto et al (US 6,949,522 B2).
Dolei et al teaches that several diseases have been attributed to one or more HERVs, particularly neurological diseases. HERVs contribute to diseases like multiple sclerosis, amyotrophic lateral sclerosis (Abstract; page 3, part 2 through page 7 part 3; neurodegenerative disorder as in claims 1, 37, 76, and the neurodegenerative disorders recited in claims 38 and 77).
Gamdzyk et al teaches that LINE1 activity is somatic tissues contributes to neurodegeneration. The use of a reverse transcriptase inhibitor decreased LINE1 DNA content, suggesting that it blocked the reverse transcription of LINE-1(page 2615, right col. last paragraph through page 2616, right col.).
Dolei and Gamdzyk do not teach a method of treating a neurodegenerative disorder via administration of a compound of formula (I). However, the teachings of Dolei and Gamdzyk indicate that a reverse transcriptase inhibitor like stavudine, which has an unsaturated furan ring and a base, can be used to block the activity of LINE 1 and HERV.
The teachings of Ting and Otto are set forth above.
It would have been obvious to one of ordinary skill in the art at the time of filing of the instant invention to arrive at the claimed method using the compounds of formulas (I) and (I-A) as active agents in a method of treating a neurodegenerative disorder with a reasonable expectation of success from the combined teachings of the prior art.
MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.'" KSR, 550 U.S. at, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) " Obvious to try " choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
According to the rationale discussed in KSR above, the rationale in (G) above is seen to be applicable here since based on the prior art teachings, a method of reverse transcriptase using blocking agent is known, wherein the reverse transcriptase is HERV-K and LINE1. Otto teaches compounds that are structurally close to the instant compounds, as active agents in a method of treating cancer. Therefore, it would be obvious to use the instant active agents, which are close structural analogs in a method of inhibiting LINE1 and HERV-K reverse transcriptase activity and thereby treat a neurodegenerative disease as instantly claimed. The artisan can test the instant compounds for inhibition of LINE1 and HERV-K reverse transcriptase activity in view of Ting. The artisan would have a reasonable expectation of success in doing so. Structural similarity of the compounds of Otto with those of the instant compounds entails motivation to make and use the instant compounds in the claimed method of reverse transcriptase inhibiting activity and treating a neurodegenerative disease in a subject.
One of ordinary skill in the art would have reasonably expected that the instant compounds having all the other substitutions, would have same or substantially similar beneficial therapeutic effects and usefulness in methods for treating a neurodegenerative disease, based on the reasonable expectation that structurally similar species usually have similar properties. See, e.g., Dillon, 919 F.2d at 693, 696, 16 USPQ2d at 1901, 1904. See also Deuel, 51 F.3d at 1558, 34 USPQ2d at 1214, and if the claimed invention and the structurally similar prior art species share any useful property, that will generally be sufficient to motivate an artisan of ordinary skill to make the claimed species. In fact, similar properties may normally be presumed when compounds are very close in structure. Dillon, 919 F.2d at 693, 696, 16 USPQ2d at 1901, 1904, as noted in MPEP 2144.
Claim(s) 1, 10-12, 14-15, 19, 21-24, 32, 36, 72, 74-75 are rejected under 35 U.S.C. 103 as being unpatentable over Moles et al (Retrovirology, 2009, 6(Suppl 2): P60) in view of Ting et al (WO 2020142629 A1) and further in view of Otto et al (US 6,949,522 B2) and Biswas et al (Frontiers in Genetics, 09 March 2021, 12, article 626642,1-19).
Moles et al teaches that increased retrovirus activity was detected in protein extracts from lesional psoriatic skin when compared to normal skin confirming that endogenous retroelements are active in psoriatic lesion (page 1; inflammatory disorder as in claim 1, and psoriasis as in claims 32, 36, 72, 74).
Moles does not teach the use of the compounds of formula (I) as in claims1, 22-24, the compound of formula (I-A) as in claim 10-11 and the compounds having the substitutions as in claims 12, 14, 15, 19, 21, and all the other inflammatory diseases as in claims 32, 36, 72, 73 and 75.
The teachings of Ting and Otto are set forth above.
The difference between the compounds of Otto and the instant compounds is that in Otto’s compounds the fluorine substitution is at the 3’-position of the furan ring, and at the 4’ position of the furan ring it is a -CH2-OR1, whereas in the instant compounds the fluorine is at the 2’-position of the furan ring and at the 4’-position it is -O-CH2-P(=O)R1,R2.
The teaching of Biswas as set forth above suggests that Rovafovir, which falls under formulas (I) and (I-A) can be used in a method of treating inflammatory disorders. This renders obvious the use of the compounds having the instant formulas and the other substitutions in a method of treating an inflammatory disorder.
It would have been obvious to one of ordinary skill in the art at the time of filing of the instant invention to arrive at the claimed method of treating an inflammatory disorder in a subject using the compounds of formulas (I) and (I-A) as active agents, and the compounds having all the substitutions as in claims 12, 14, 15, 19, 21 with a reasonable expectation of success. In view of the teachings of the cited prior art, the artisan would also extend the method to the treatment of all the other disorders as in claims 32 and 36, 72-75. Testing can be done as routine experimentation in view of Ting and Moles.
MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.'" KSR, 550 U.S. at, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) " Obvious to try " choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
According to the rationale discussed in KSR above, the rationale in (G) above is seen to be applicable here since based on the prior art teachings, a method of treating cancer in a subject in need thereof via administration of a reverse transcriptase blocking agent is known, wherein the reverse transcriptase is HERV-K and LINE1. Otto teaches compounds that are structurally close to the instant compounds, as active agents in a method of treating cancer. Moles teaches reverse transcriptase activity is involved in psoriasis. Therefore, it would be obvious to use the instant active agents, which are close structural analogs of Otto’s compounds in the claimed method of treating an inflammatory disorder as in claims 1, 32, 36, 72, 74 and 75. The artisan can test the instant compounds for inhibition of LINE1 and HERV-K reverse transcriptase activity in view of Ting and Moles. The artisan would have a reasonable expectation of success in doing so. Structural similarity of the compounds of Otto with those of the instant compounds entails motivation to make and use the instant compounds in the claimed method of treatment of an inflammatory disorder
One of ordinary skill in the art would have reasonably expected that the instant compounds having all the other substitutions, would have same or substantially similar beneficial therapeutic effects and usefulness in methods for treating inflammatory disorders, based on the reasonable expectation that structurally similar species usually have similar properties. See, e.g., Dillon, 919 F.2d at 693, 696, 16 USPQ2d at 1901, 1904. See also Deuel, 51 F.3d at 1558, 34 USPQ2d at 1214, and if the claimed invention and the structurally similar prior art species share any useful property, that will generally be sufficient to motivate an artisan of ordinary skill to make the claimed species. In fact, similar properties may normally be presumed when compounds are very close in structure. Dillon, 919 F.2d at 693, 696, 16 USPQ2d at 1901, 1904, as noted in MPEP 2144.
Conclusion
Pending claims 1, 4, 6, 10-12, 14-15, 19, 21-24, 29, 32, 35-38, 43, and 72-77 are rejected
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GANAPATHY KRISHNAN whose telephone number is (571)272-0654. The examiner can normally be reached M-F 8.30am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Goon can be reached at 571-270-5241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/GANAPATHY KRISHNAN/ Primary Examiner, Art Unit 1693