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
The instant application is a divisional of Application No. 16/936,705 filed on July 23, 2020 which claims priority to domestic Provisional Application No. 62/877,614 filed on July 23, 2019.
Status of Claims
Acknowledgement is made of previously presented (21-24, 26), amended (1), cancelled (2-8, 19-20, 25, 27), withdrawn (9-18), and new (28-29) claimed filed on June 3, 2026. Claims 1, 9-18, 21-24, 26, 28-29 are pending. Claims 1, 21-24, 26, 28-29 are presently examined.
Response to Arguments
The following rejections have been withdrawn:
I. The NSDP Rejection over U.S. Patent No. 8,168,621 B2. Upon further consideration, US’621 Claim 1 Formula R5 can’t be methyl or a longer alkyl chain such as in instant CAS#1227511-09-2. This would not be an obvious variant to instant claims.
II. The NSDP Rejection over U.S. Patent No. 9,422,324 B2. Upon further consideration, US’324 Claim 20 species lack a methyl and a methoxy or longer methoxy alkyl chain of instant CAS#1227511-09-2. This would not be an obvious variant to instant claims.
The following rejections are new:
I. 35 USC 112(b) rejection due to claim amendments.
II. 35 USC 102(a)(1) Rejection over WO 2015/143201 A2.
III. Non-Statutory Double Patenting Rejections over U.S. Patent Nos. 10,723,757; 10,174,070.
The following rejections are maintained/modified:
I. Non-Statutory Double Patenting Rejections 9,636,348; 9,422,324; 9,364,486; 8,629,130 and 8,168,621, all in view of WO’201, Gui, and Thakker.
Regarding Applicant’s argument that WO’201 does not teach the instant method (see 6/3/26 Remarks at p. 8), WO’201 may not specify the instantly claimed functional limitations, but the method taught by WO’201 encompasses the instantly claimed method because the instant method is a result of the active step of administering CAS# 1227511-09-2 which is taught by WO’201, whether the functional limitations were known at the time or not.
Regarding Applicant’s arguments over Gui or Thakker, these references are no longer relied upon in the rejections below.
Claim Interpretation
Regarding functional limitations, Applicant’s Examples (see instant specification at pp. 31-33) disclose that it is the cell contact with NDC-1308 (which is understood to be CAS Registry No. 1227511-09-2) that up-regulates LPL, which alters microglial or macrophage cells to M2-like phenotype. No additional or special steps are identified. Therefore, any prior art or patent document that discloses contacting a microglial or macrophage cell or administering CAS# 1227511-09-2 to a subject would consequently up-regulate LPL and alter microglial or macrophage cells to M2-like phenotype since it is a result of the active step of administering CAS# 1227511-09-2.
Regarding “microglial cell or macrophage cell”, exemplary reference Ginhoux et. al.1 teaches microglial cells are known in the art to be a type of macrophage cell (see Ginhoux at Abstract). Any art disclosing contacting a microglial cell is thus art disclosing contacting a macrophage cell.
New Rejections
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 21-24, 26, 28-29 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “capable of expressing lipoprotein lipase (LPL) and/or apolipoprotein C2 (ApoC2)” but the new limitation “wherein the contacting increases expression of LPL and ApoC2” contradicts the prior “capable” and “or”.
Claims 21-24, 26, 28-29 do not rectify the issue of indefiniteness and are thus included in the instant rejection.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 21-24, 26, 28-29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2015/143201 A22 to Yarger et. al.
Claim interpretation: The claim interpretations set forth in the “claim interpretation” section above are hereby incorporated into the instant rejection. Additional claim interpretations are set forth below.
Regarding claims 1, 21-24, 26, 28-29 and CAS# 1227511-09-2 and a method, WO’201 claims a method of treating Alzheimer’s Disease comprising administering a therapeutically effective amount of a compound of formula I to a patient, including CAS# 1227511-09-2 (see WO’201 at p. 16 Compound 21, claim 4 p. 37, and claim 5 at p. 38 “(6R,8R,9S,13S,14S)-6-(6-methoxyhexyl)-13-methyl-7,8,9,11,12,13,14,15,16,17-decahydro-6H-cyclopenta[a]phenanthrene-3,17-diol”).
WO’201’s “administering to a patient” reads on the instant limitation of “contacting a microglial or macrophage cell”, because it is understood that humans have microglial and macrophage cells, and administering to a human would result in contacting a microglial or macrophage cell in said human.
WO’201 also claims a method of up-regulating LPL and/or ApoC2 functional activity comprising administering a compound of formula:
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(see WO’201 claim 6), including instantly claimed CAS#1227511-09-2 (see WO’201 at claim 9 p. 42 and claim 10, “(6R,8R,9S,13S,14S)-6-(6-methoxyhexyl)-13-methyl-7,8,9,11,12,13,14,15,16,17-decahydro-6H-cyclopenta[a]phenanthrene-3,17-diol”) (see also WO’201 at p. 33 Table 1 compound 21). WO’201 teaches CAS#1227511-09-2 upregulated LPL and ApoC2 but not ApoC3 (see WO’201 at p. 33 Table 1).
The instantly claimed property of increasing LPL and ApoC2 by contacting with CAS#1227511-09-2 was known in the art.
Further regarding claim 23 and a down-regulated inflammatory gene and claim 24 and an upregulated reparative gene claim 28 and increasing LPL hydrolytic activity and claim 29 and reducing expression of iNOS and increasing expression of Arginase 1, these limitations do not require any alterations to the active step of contacting a compound of Formula I to a microglial cell or macrophage cell with a pro-inflammatory phenotype capable of expressing LPL and/or ApoC2, and are understood to be a result of performing said active step.
The functional limitations of the instant claims appear to be latent properties discovered by Applicant of the known compound CAS#1227511-09-2 (see MPEP § 2145(II)). By practicing a method of the prior art (administering a therapeutically effective amount of CAS#1227511-09-2 to an Alzheimer’s patient), an artisan would be practicing the method instantly claimed (switching/polarizing/altering an inflammatory phenotype by contacting a microglial or macrophage cell having a pro-inflammatory phenotype capable of expressing LPL or ApoC2 with an effective amount of CAS#1227511-09-2).
Double Patenting
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 conflicting claims 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) 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 www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 21-24, 26, 28-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 8,629,130 B23 in view of WO’201.
The applicable analysis for Nonstatutory Double Patenting is set forth in MPEP § 804(II), and specifically MPEP § 804(II)(B). MPEP § 804(II)(B)(2)-(3) identifies that a Nonstatutory Double Patenting Rejection may be appropriate based upon either an anticipation analysis or an obviousness analysis. The instant analysis is an obviousness analysis.
Claim interpretation: The claim interpretations set forth in the “claim interpretation” section above are hereby incorporated into the instant rejection. Additional claim interpretations are set forth below.
Regarding compounds of Formula I, US’130 claims compounds encompassed by instant Formula I (US’130 claim 1) including CAS# 1025495-78-6 (US’130 claim 4) (see below).
US’130 Claim 1
US’130 Claim 4
CAS# 1025495-78-6
WO’201 Compound 4
CAS# 1025495-78-6
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Instantly claimed compound CAS# 1227511-09-2 differs only by repeating -(CH2)- segments from US’130’s CAS# 1025495-78-6 (US’130 claims 4 and 5).
Regarding a method, US’130 claims methods of treating cancer (US’130 claims 1-4) including breast cancer (US’130 claim 2).
The patented claims differ from instant claims as follows: While US’130 claims structurally similar compounds for treating cancer, US’130 does not discuss contacting with CAS# 1227511-09-2.
However,
WO’201 which teaches the 6-substituted estradiol derivatives (see WO’201 pp. 14-17), including compounds 4 (CAS# 1025495-78-6, the same compound as US’130 claim 4) and 21 (CAS#1227511-09-2, the same compound as instant claims) which differ by repeating -(CH2)- units, up-regulate LPL and ApoC2 and not ApoC3 (see WO’201 at p. 33 Table 1). WO’201 teaches administering a therapeutically effective amount to a human to treat Alzheimer’s.
Therefore, it would have been obvious to one of ordinary skill in the art, based on the previous patent, to arrive at the instantly claimed invention in view of the prior art for at least the following reason(s):
It would have been obvious to an artisan to substitute CAS# 1025495-78-6 for CAS#1227511-09-2 in the method claimed by US’130 because WO’201 teaches CAS# 1025495-78-6 and CAS#1227511-09-2 are structurally and functionally similar. Accordingly, an artisan would arrive at a method that encompasses the instantly claimed method, because the artisan is administering CAS#1227511-09-2 to a subject, which reads on the active step of contacting a microglial or macrophage cell with CAS#1227511-09-2.
Accordingly, the claims are not patentably distinct.
Claims 1, 21-24, 26, 28-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 9,364,486 B24 in view of WO’201.
The applicable analysis for Nonstatutory Double Patenting is set forth in MPEP § 804(II), and specifically MPEP § 804(II)(B). MPEP § 804(II)(B)(2)-(3) identifies that a Nonstatutory Double Patenting Rejection may be appropriate based upon either an anticipation analysis or an obviousness analysis. The instant analysis is an obviousness analysis.
Claim interpretation: The claim interpretations set forth in the “claim interpretation” section above are hereby incorporated into the instant rejection. Additional claim interpretations are set forth below.
Regarding compounds of Formula I, US’486 claims compounds encompassed by instant Formula I (US’130 claim 1-3, 6, 7, 8) including CAS# 1025495-78-6 (US’130 claims 4, 5, 9, 10, 15-16 “(6R,8R,9S,13S,14S)-6-(methoxymethyl)-13-methyl-7,8,9,11,12,13,14,15,16,17-decahydro-6H-cyclopenta[a]phenanthrene-3,17-diol”).
Regarding a method, US’486 claims methods of treating demyelination in an axon of a nerve cell in need of remyelination (US’486 claim 1), including wherein the cells are glial cells (US’486 claim 17), and demyelinating disorders, including multiple sclerosis and Alzheimer’s (US’486 claims 11, 12, 13, 14).
WO’201 Compound 21
Instant Claim 1
CAS#1227511-09-2
US’486
Claims 4-5, 9-10, 15-16
CAS# 1025495-78-6
WO’201 Compound 4
CAS# 1025495-78-6
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The patented claims differ from instant claims as follows: While US’486 claims structurally similar compounds for treating demyelinating disorders, US’486 does not discuss contacting with CAS# 1227511-09-2.
However,
WO’201 which teaches the 6-substituted estradiol derivatives (see WO’201 pp. 14-17), including compounds 4 (CAS# 1025495-78-6, the same compound as US’486 claims 4-5, 9-10, 15-16) and 21 (CAS#1227511-09-2, the same compound as instant claims) which differ by repeating -(CH2)- units, up-regulate LPL and ApoC2 and not ApoC3 (see WO’201 at p. 33 Table 1). WO’201 teaches administering a therapeutically effective amount to a human to treat Alzheimer’s.
Therefore, it would have been obvious to one of ordinary skill in the art, based on the previous patent, to arrive at the instantly claimed invention in view of the prior art for at least the following reason(s):
It would have been obvious to an artisan to substitute CAS# 1025495-78-6 for CAS#1227511-09-2 in the method claimed by US’486 because WO’201 teaches CAS# 1025495-78-6 and CAS#1227511-09-2 are structurally and functionally similar. Accordingly, an artisan would arrive at a method that encompasses the instantly claimed method, because the artisan is administering CAS#1227511-09-2 to a subject, which reads on the active step of contacting a microglial or macrophage cell with CAS#1227511-09-2.
Accordingly, the claims are not patentably distinct.
Claims 1, 21-24, 26, 28-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 9,636,348 B25 in view of WO’201, Gui, and Thakker.
The applicable analysis for Nonstatutory Double Patenting is set forth in MPEP § 804(II), and specifically MPEP § 804(II)(B). MPEP § 804(II)(B)(2)-(3) identifies that a Nonstatutory Double Patenting Rejection may be appropriate based upon either an anticipation analysis or an obviousness analysis. The instant analysis is an obviousness analysis.
Claim interpretation: The claim interpretations set forth in the “claim interpretation” section above are hereby incorporated into the instant rejection. Additional claim interpretations are set forth below.
Regarding compounds of Formula I, US’348 claims compounds of Formula I (US’348 claims 1-10) including CAS# 1025495-78-6 (US’348 claims 5,6, 9,10) “(6R,8R,9S,13S,14S)-6-(methoxymethyl)-13-methyl-7,8,9,11,12,13,14,15,16,17-decahydro-6H-cyclopenta[a]phenanthrene-3,17-diol”).
US’348 Claims 5-6, 9-10
CAS# 1025495-78-6
WO’201 Compound 4
CAS# 1025495-78-6
WO’201 Compound 21
Instant Claim 1
CAS#1227511-09-2
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Instantly claimed compound CAS# 1227511-09-2 differs only by repeating –(CH2)- segments from US’348 CAS#1025495-78-6.
Regarding methods, US’348 claims methods of treating myelination in an axon of a nerve cell (US’486 claim 1), treating a demyelination disorder (US’348 claim 6), such as multiple sclerosis or Alzheimer’s (US’348 claims 11, 12, 13, 14).
The patented claims differ from instant claims as follows: While US’348 claims structurally similar compounds for treating demyelinating disorders, US’348 does not discuss contacting with CAS# 1227511-09-2.
However,
WO’201 which teaches the 6-substituted estradiol derivatives (see WO’201 pp. 14-17), including compounds 4 (CAS# 1025495-78-6, the same compound as US’348 claims 5-6, 9-10) and 21 (CAS#1227511-09-2, the same compound as instant claims) which differ by repeating -(CH2)- units, up-regulate LPL and ApoC2 and not ApoC3 (see WO’201 at p. 33 Table 1). WO’201 teaches administering a therapeutically effective amount to a human to treat Alzheimer’s.
Therefore, it would have been obvious to one of ordinary skill in the art, based on the previous patent, to arrive at the instantly claimed invention in view of the prior art for at least the following reason(s):
It would have been obvious to an artisan to substitute CAS# 1025495-78-6 for CAS# 1227511-09-2 in the method claimed by US’348 because WO’201 teaches CAS# 1025495-78-6 and CAS#1227511-09-2 are structurally and functionally similar. Accordingly, an artisan would arrive at a method that encompasses the instantly claimed method, because the artisan is administering CAS#1227511-09-2 to a subject, which reads on the active step of contacting a microglial or macrophage cell with CAS#1227511-09-2.
Accordingly, the claims are not patentably distinct.
Claims 1, 21-24, 26, 28-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 10,723,757 B26 in view of WO’201.
The applicable analysis for Nonstatutory Double Patenting is set forth in MPEP § 804(II), and specifically MPEP § 804(II)(B). MPEP § 804(II)(B)(2)-(3) identifies that a Nonstatutory Double Patenting Rejection may be appropriate based upon either an anticipation analysis or an obviousness analysis. The instant analysis is an obviousness analysis.
Claim interpretation: The claim interpretations set forth in the “claim interpretation” section above are hereby incorporated into the instant rejection. Additional claim interpretations are set forth below.
Regarding compounds of Formula I, US’757 claims compounds of Formula I (US’348 claims 1-19, 21-24) including instant CAS#1227511-09-2 (US’757 claims 20) “(6R,8R,9S,13S,14S)-6-(methoxyhexyl)-13-methyl-7,8,9,11,12,13,14,15,16,17-decahydro-6H-cyclopenta[a]phenanthrene-3,17-diol”).
US’757 Claim 20
WO’201 Compound 21
Instant Claim 1
CAS#1227511-09-2
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The patented claims differ from instant claims as follows: While US’757 claims the same compound, US’757 does not claim a method comprising CAS#1227511-09-2.
However,
WO’201 which teaches the 6-substituted estradiol derivatives (see WO’201 pp. 14-17), including compound 21 (CAS#1227511-09-2, the same compound as instant claims and US’757 claim 20) up-regulates LPL and ApoC2 and not ApoC3 (see WO’201 at p. 33 Table 1). WO’201 teaches administering a therapeutically effective amount to a human to treat Alzheimer’s.
Therefore, it would have been obvious to one of ordinary skill in the art, based on the previous patent, to arrive at the instantly claimed invention in view of the prior art for at least the following reason(s):
It would have been obvious to an artisan to use CAS# 1227511-09-2 as claimed by US’757 in the method taught by WO’201 because WO’201 teaches a method comprising the same compound. Accordingly, by practicing the method of WO’201 with the species claimed by US’757 and taught by WO’201, an artisan would be practicing the instantly claimed method, because the artisan is administering CAS#1227511-09-2 to a subject, which reads on the active step of contacting a microglial or macrophage cell with CAS#1227511-09-2.
Accordingly, the claims are not patentably distinct.
Claims 1, 21-24, 26, 28-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 10,174,070 B27 in view of WO’201.
The applicable analysis for Nonstatutory Double Patenting is set forth in MPEP § 804(II), and specifically MPEP § 804(II)(B). MPEP § 804(II)(B)(2)-(3) identifies that a Nonstatutory Double Patenting Rejection may be appropriate based upon either an anticipation analysis or an obviousness analysis. The instant analysis is an obviousness analysis.
Claim interpretation: The claim interpretations set forth in the “claim interpretation” section above are hereby incorporated into the instant rejection. Additional claim interpretations are set forth below.
Regarding compounds of Formula I, US’070 claims compounds of Formula I (US’348 claims 1-4) which encompass instant CAS# 1227511-09-2.
US’070 Claim 1
WO’201 Compound 21
Instant Claim 1
CAS#1227511-09-2
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The patented claims differ from instant claims as follows: While US’070 claims a small genus that encompasses the instantly claimed species, US’070 does not claim a method comprising CAS# 1227511-09-2.
However,
WO’201 which teaches 6-substituted estradiol derivatives (see WO’201 pp. 14-17), including compound 21 (CAS#1227511-09-2, the same compound as instant claims, and encompassed by the claims of US’070) up-regulates LPL and ApoC2 and not ApoC3 (see WO’201 at p. 33 Table 1). WO’201 teaches administering a therapeutically effective amount to a human to treat Alzheimer’s.
Therefore, it would have been obvious to one of ordinary skill in the art, based on the previous patent, to arrive at the instantly claimed invention in view of the prior art for at least the following reason(s):
It would have been obvious to an artisan to use CAS# 1227511-09-2, a species encompassed by the small genus of US’070 in the method taught by WO’201 because WO’201 teaches a method comprising a species that reads on US’070 Formula I. Accordingly, by practicing the method of WO’201 with the species encompassed by the claimed of US’070 and taught by WO’201, an artisan would be practicing the instantly claimed method, because the artisan is administering CAS#1227511-09-2 to a subject, which reads on the active step of contacting a microglial or macrophage cell with CAS#1227511-09-2.
Accordingly, the claims are not patentably distinct.
Conclusion
Claims 1, 21-24, 26, 28-29 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SOPHIA J REILLY whose telephone number is (703)756-5669. The examiner can normally be reached 9:00 am - 5:00 pm EST M-F.
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/S.R./Examiner, Art Unit 1627
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
1 Ginhoux et. al. "Origin and differentiation of microglia" Front. Cell. Neurosci. 2013, 7, 45, 1-14. DOI: 10.3389/fncel.2013.00045. Cited in previous Office Action.
2 Published September 24, 2015. Cited in previous Office Action. Hereinafter WO’201.
3 Filed April 30, 2012.
4 Filed March 21, 2012
5 Filed June 10, 2016
6 Patented July 28, 2020. Hereinafter US’757.
7 Patented January 8, 2019. Hereinafter US’070.
Prosecution Insights