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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 3/25/26 has been entered.
Claims Status
Claims 17-24,26 and 27 are pending in the application. Claims 22 and 24 are withdrawn from consideration.
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 17-21,23,26 and 27 are 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.
Claims 17-21,23,26 and 27 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second
paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted steps are: the administration of the compounds of formula (I) or formula (II).
Claim Rejections - 35 USC § 102
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 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 17-21,23 and 26 is/are rejected under 35 U.S.C. 102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Cheng et al. (US 2016/0326167A1) in view of Wang et al. (Vaccine 28 (2010) 8169-8174) and Bae et al. (Med Sci Monit, 2012; 18(12): CR698-705).
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Cheng et al. (US 2016/0326167A1) teaches of the method of treating or prophylaxis of hepatitis B virus (HBV infection) via the administration of the compounds
PNG
media_image1.png
118
180
media_image1.png
Greyscale
(title; abstract; p2, [0009-0010]; p23, [0761]; p24, [0774-0777]) wherein R1 is C1-6alkyl, C3-7cycloalkyl, haloC1-6alkyl, etc.; R2 is aryl or heteroaryl, etc.; R3 is hydrogen, C3-7cycloalkyl, haloC3-7alkyl, hydroxy, etc.; R4 is hydroxy, C1-6alkoxy, amino, etc.; R5 is C1-6alkyl, C3-7cycloalkyl, hydroxyl, amino, etc.; R6 is hydrogen, C1-6alkylcarbonyl, etc.; R7 is hydrogen or C1-6alkyloxycarbonyl, etc.; R8 is hydroxy or C1-6alkoxy; U,W and Z are independently selected from CH and N; one of X and Y is N and the other one is CH or N (p2, [0012-0029]; p4, [0050]-[0068]).
The method of treating an HBV infection anticipates the method of treating an HBV infection of the instant claims. The method of prophylaxis of HBV infection anticipates inhibiting the development of chronic HBV infection of the instant claim 20.
The compounds inhibit HBV DNA and the antiviral activity was calculated from the reduction in HBV DNA levels (p148, [1720]) and anticipates the reduction in infectiousness of a HBV infected person of the instant claim 20.
The compounds
PNG
media_image1.png
118
180
media_image1.png
Greyscale
anticipate the compounds of the instant claim 17-20 and of formula II
PNG
media_image2.png
138
222
media_image2.png
Greyscale
of the instant claim 21.
The R1 is C1-6alkyl, C3-7cycloalkyl, haloC1-6alkyl, etc. anticipates the R1 is C1-6alkyl, C3-7cycloalkyl, haloC1-6alkyl, etc. of the instant claim 21.
The R2 is aryl or heteroaryl, etc. anticipates the R2 is aryl or heteroaryl, etc. of the instant claim 21.
The R3 is hydrogen, C3-7cycloalkyl, haloC3-7alkyl, hydroxy, etc. anticipates R3 is hydrogen, C3-7cycloalkyl, haloC3-7alkyl, hydroxy, etc. of the instant claim 21.
The R4 is hydroxy, C1-6alkoxy, amino, etc. anticipates the hydroxy, C1-6alkoxy, amino, etc. of the instant claim 21.
The R5 is C1-6alkyl, C3-7cycloalkyl, hydroxyl, amino, etc. anticipates the R5 is C1-6alkyl, C3-7cycloalkyl,
hydroxyl, amino, etc. of the instant claim 21.
The R6 is hydrogen, C1-6alkylcarbonyl, etc. anticipates the R6 is hydrogen, C1-6alkylcarbonyl, etc.
of the instant claim 21.
The R7 is hydrogen or C1-6alkyloxycarbonyl, etc. anticipates the R7 is hydrogen or C1-6alkyloxycarbonyl, etc. of the instant claim 21.
The R8 is hydroxy or C1-6alkoxy anticipates the R8 is hydroxy or C1-6alkoxy of the instant claim 21.
The U,W and Z are independently selected from CH and N anticipates the U,W and Z are
independently selected from CH and N of the instant claim 21.
The one of X and Y is N and the other one is CH or N anticipates the one of X and Y is N and the other one is CH or N of the instant claim 21.
The compounds may be formulated as a pharmaceutical composition comprising a pharmaceutically acceptable carrier (p22, [0758]; p23, [0763]) that anticipates the pharmaceutical composition of the instant claims 23 and 26.
The pharmaceutical composition comprises an effective amount of the compound necessary to inhibit HBsAg production or secretion by 50% (p23, [0759],[0770-0771]; p146, [1718]) that anticipates the inhibitor reduces secretion of HBsAg of the instant claim 19.
The compounds anticipate the inhibitor small molecule of the instant claims as they have analogous structures and utility and therefore, have the same properties and are capable of the same functions, such as binding to PAPD5 and/or PAPD7 polypeptide, inhibiting expression and/or activity of PAPD5 and/or PAPD7 and reducing secretion of HBsAg and HBeAg.
"[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999).
Products of identical chemical composition can not have mutually exclusive properties. A chemical composition and its properties are inseparable. Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable and does not render the old composition patentably new to the discoverer. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Cheng et al. does not disclose reducing secretion of HBeAg.
Wang et al. (Vaccine 28 (2010) 8169-8174) discloses that there is a correlation between HBeAg-seroconversion and a decrease in serum HBsAg and HBV DNA (abstract; p8172, 3.3. Kinetic patterns of HBeAg sero-conversion, decrease of serum HBV DNA and ALT).
Bae et al. (Med Sci Monit, 2012; 18(12): CR698-705) discloses HBeAg seroconversion is defined by the loss of HBeAg and development of the corresponding antibody (anti-HBe) that is highly correlated with favorable long-term outcome (pCR699, Background, first paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the compounds of Han et al. reduce secretion of HBeAg as the compounds inhibit HBV DNA and reduce the HBV DNA levels which is correlated with HBeAg-seroconversion that is defined by the loss of HBeAg and is an important indication for the efficacy of a therapeutic vaccine (Wang et al. p8173, right column, first paragraph).
Claim(s) 17-20,23 and 27 is/are rejected under 35 U.S.C. 102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Han et al. (US 2015/0210682A1) in view of Wang et al. (Vaccine 28 (2010) 8169-8174) and Bae et al. (Med Sci Monit, 2012; 18(12): CR698-705).
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Han et al. (US 2015/0210682A1) teaches of the treatment and prophylaxis of hepatitis B virus
(HBV infection) via the administration of the compounds
PNG
media_image3.png
146
190
media_image3.png
Greyscale
(title; abstract; p2, [0026]; p18, [593]; p19, [604-605]) wherein R1 is hydrogen, halogen, C1-6alkyl, C1-6alkylamino, or alkoxy; R2 is hydrogen, halogen, C1-6alkyl, etc.; R3 is hydrogen, halogen, C1-6alkyl, etc.; R7 is hydrogen, C1-6alkyl, etc.; R4 is hydrogen, halogen, C1-6alkyl, etc.; R5 is hydrogen or C1-6alkyl; R6 is hydrogen, C1-6alkyl, etc. (p2, [0010-0025]).
The method of treating an HBV infection anticipates the method of treating an HBV infection of the instant claims. The method of prophylaxis of HBV infection anticipates inhibiting the development of chronic HBV infection of the instant claim 20.
The compounds inhibit HBV DNA and the antiviral activity was calculated from the reduction in HBV DNA levels (p19, [0602]) and anticipates the reduction in infectiousness of a HBV infected person of the instant claim 20.
The compounds
PNG
media_image3.png
146
190
media_image3.png
Greyscale
anticipate the compounds of formula I
PNG
media_image4.png
130
256
media_image4.png
Greyscale
of the instant claim 27.
The R1 is hydrogen, halogen, C1-6alkyl, C1-6alkylamino, or alkoxy anticipates R1 is hydrogen, halogen, C1-6alkyl, C1-6alkylamino, or alkoxy of the instant claim 27.
The R2 is hydrogen, halogen, C1-6alkyl, etc. anticipates R2 is hydrogen, halogen, C1-6alkyl, etc. of
the instant claim 27.
The R3 is hydrogen, halogen, C1-6alkyl, etc. anticipates R3 is hydrogen, halogen, C1-6alkyl, etc. of the instant claim 27.
The R7 is hydrogen, C1-6alkyl, etc. anticipates R7 is hydrogen, C1-6alkyl, etc. of the instant claim 27.
The R4 is hydrogen, halogen, C1-6alkyl, etc. anticipates R4 is hydrogen, halogen, C1-6alkyl, etc. of the instant claim 27.
The R5 is hydrogen or C1-6alkyl anticipates R5 is hydrogen or C1-6alkyl of the instant claim 27.
The R6 is hydrogen, C1-6alkyl, etc. anticipates R6 is hydrogen, C1-6alkyl, etc. of the instant claim 27.
The compounds are formulated as a pharmaceutical composition comprising a pharmaceutically acceptable carrier (p18, [0589],[594],[0596]]; claim 24).
The pharmaceutical composition comprises an effective amount of the compound necessary to inhibit HBsAg production or secretion by 50% (p2, [0026]; p19, [0601],[0608]; p178, [2122]; claim 25) that anticipates the inhibitor reduces secretion of HBsAg of the instant claim 19.
The compounds anticipate the inhibitor small molecule of the instant claims as they have analogous structures and utility and therefore, have the same properties and are capable of the same functions, such as binding to PAPD5 and/or PAPD7 polypeptide, inhibiting expression and/or activity of PAPD5 and/or PAPD7 and reducing secretion of HBsAg and HBeAg.
"[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947
(Fed. Cir. 1999).
Products of identical chemical composition can not have mutually exclusive properties. A chemical composition and its properties are inseparable. Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable and does not render the old composition patentably new to the discoverer. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Han et al. does not disclose reducing secretion of HBeAg.
Wang et al. (Vaccine 28 (2010) 8169-8174) discloses that there is a correlation between HBeAg-seroconversion and a decrease in serum HBsAg and HBV DNA (abstract; p8172, 3.3. Kinetic patterns of HBeAg sero-conversion, decrease of serum HBV DNA and ALT).
Bae et al. (Med Sci Monit, 2012; 18(12): CR698-705) discloses HBeAg seroconversion is defined by the loss of HBeAg and development of the corresponding antibody (anti-HBe) that is highly correlated with favorable long-term outcome (pCR699, Background, first paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the compounds of Han et al. reduce secretion of HBeAg as the compounds inhibit HBV DNA and reduce the HBV DNA levels which is correlated with HBeAg-seroconversion that is defined by the loss of HBeAg and is an important indication for the efficacy of a therapeutic vaccine (Wang et al. p8173, right column, first paragraph).
Response to Arguments
Applicant's arguments filed 3/16/26 have been fully considered but they are not persuasive.
Applicant’s assertions with regards to Yang are moot as the reference is not used in the instant rejection.
Applicant asserts that neither Cheng nor Han discloses that PAPD5 and PAPD7 play a role in HBV infection; moreover, they do not disclose reduction of expression of PAPD5 and PAPD7. The surprising findings that certain molecules are able to bind to and inhibit PAPD5 and/or PAPD7 could not have been predicted from the cited references and is precisely the fining that enables the present invention to
provide new HBV treatment options by targeting PAPD5 and/or PAPD7.
The instant claims are not drawn to a method of determining, analyzing or identifying PAPD5 and PAPD7 inhibition in HBV infection.
The instant claims do not require reduction of expression of PAPD5 and PAPD7 as the instant claims state the inhibitor a.) binds to PAPD5 and/or PAPD7 polypeptide; and/or b.) inhibits expression and/or activity of PAPD5 and/or PAPD7 wherein a.) and b.) are stated in the alternative.
Also, the instant claims state that the compounds of the invention inhibits expression of PAPD5 and/or PAPD7 which may be in the alternative and therefore, does not necessarily inhibits expression of both PAPD5 and PAPD7.
The compounds of Cheng and Han teach of the method of treating or prophylaxis of an HBV infection.
The compounds inhibit HBV DNA and the antiviral activity was calculated from the reduction in HBV DNA levels.
The pharmaceutical compositions comprises an effective amount of the compound necessary to inhibit HBsAg production or secretion by 50%.
The compounds anticipate the inhibitor small molecule of the instant claims as they have analogous structures and utility and therefore, have the same properties and are capable of the same functions, such as binding to PAPD5 and/or PAPD7 polypeptide and inhibiting expression and/or activity
of PAPD5 and/or PAPD7.
"[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably
new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947
(Fed. Cir. 1999).
Products of identical chemical composition can not have mutually exclusive properties. A chemical composition and its properties are inseparable. Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable and does not render the old composition patentably new to the discoverer. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
The arguments of counsel cannot take the place of evidence in the record. Examples of attorney statements are not evidence and must be supported by an appropriate affidavit or declaration include statements regarding unexpected results. MPEP § 716.01 (c).
Applicant asserts that the specification demonstrates that the inhibition of PAPD5 or PAPD7 leads to reduction in HBsAg and HBeAg of around 50% or 15%, respectively.
The references of Cheng and Han teach that the pharmaceutical compositions of the compounds comprise an effective amount of the compound necessary to inhibit HBsAg production or secretion by 50%.
The references of Cheng and Han teaches that the compounds inhibit HBV DNA and the antiviral activity was calculated from the reduction in HBV DNA levels
The reference of Wang et al. was used to teach that there is a correlation between HBeAg-seroconversion and a decrease in serum HBsAg and HBV DNA.
The reference of Bae et al. was used to teach that HBeAg seroconversion is defined by the loss of HBeAg.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the compounds of Cheng and Han reduce secretion of HBeAg as the compounds inhibit HBV DNA and reduce the HBV DNA levels which is correlated with HBeAg-seroconversion that is an important indication for the efficacy of a therapeutic vaccine. Therefore, it would have been predictable that reduction in HBV DNA levels correlates with HBeAg-seroconversion, decrease in serum HBsAg and is defined by the loss of HBeAg, not excluding 15%.
Applicant asserts a synergistic effect of targeting both PAPD5 and PAPD7. The specification discloses that “[s]imultaneous knock-down of PAPD5 and PAPD7 leads to a synergistic effect in reduction of secretion of HBsAg and HBeAg.
The instant claims do not require inhibition of expression of PAPD5 and PAPD7 as the instant claims state the inhibitor a.) binds to PAPD5 and/or PAPD7 polypeptide; and/or b.) inhibits expression
and/or activity of PAPD5 and/or PAPD7 wherein a.) and b.) are stated in the alternative.
The instant claims state that the compounds of the invention bind PAPD5 and/or PAPD7 which may be in the alternative and therefore, does not necessarily bind both PAPD5 and PAPD7.
Also, the instant claims state that the compounds of the invention inhibits expression of PAPD5 and/or PAPD7 which may be in the alternative and therefore, does not necessarily inhibits expression of both PAPD5 and PAPD7.
Synergy refers to an interaction of elements that produces an effect that is greater than the effect that would have resulted from simply adding up the effects of each individual element.
716.02(a) Evidence Must Show Unexpected Results [R-07.2022]
Evidence of a greater than expected result may also be shown by demonstrating an effect which is greater than the sum of each of the effects taken separately (i.e., demonstrating "synergism"). Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.).
Therefore, binding of an individual compound of the instant claims to both PAPD5 and PAPD7
does not provide synergy but is an inherent property of the compound.
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 17-20,23 and 27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 9,458,153B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the compounds
PNG
media_image5.png
130
212
media_image5.png
Greyscale
of U.S. Patent No. 9,458,153B2 have analogous structures to the compounds
PNG
media_image4.png
130
256
media_image4.png
Greyscale
used for the method of treating HBV of the instant claims when R3 is alkoxy.
The compounds of U.S. Patent No. 9,458,153B2 may be formulated as a pharmaceutical
composition with a therapeutically inert carrier and encompass the inhibitor small molecule of the instant claims as they have analogous structures, have the same properties and are capable of the same functions, such as binding to PAPD5 and/or PAPD7 polypeptide, inhibiting expression and/or activity of
PAPD5 and/or PAPD7, reduces secretion of HBsAg and HBeAg and inhibits development of chronic HBC infection and/or reduces the infectiousness of an HBV infected person.
"[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947
(Fed. Cir. 1999).
Products of identical chemical composition can not have mutually exclusive properties. A chemical composition and its properties are inseparable. Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable and does not render the old composition patentably new to the discoverer. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Claims 17-20,23 and 27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 9,637,485B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the compounds
PNG
media_image6.png
142
214
media_image6.png
Greyscale
, wherein W and X are bonds, of U.S. Patent No. 9,637,485B2 have analogous structures to the compounds
PNG
media_image4.png
130
256
media_image4.png
Greyscale
of the method of treating HBV of the instant claims.
The compounds of U.S. Patent No. 9,637,485B2 may be formulated as a pharmaceutical composition with a therapeutically inert carrier and encompass the inhibitor small molecule of the instant claims as they have analogous structures, have the same properties and are capable of the same functions, such as binding to PAPD5 and/or PAPD7 polypeptide, inhibiting expression and/or activity of
PAPD5 and/or PAPD7, reduces secretion of HBsAg and HBeAg and inhibits development of chronic HBC infection and/or reduces the infectiousness of an HBV infected person.
"[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947
(Fed. Cir. 1999).
Products of identical chemical composition can not have mutually exclusive properties. A chemical composition and its properties are inseparable. Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable and does not render the old composition patentably new to the discoverer. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Claims 17-20,23 and 27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 10,093,671B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the compounds
PNG
media_image7.png
126
210
media_image7.png
Greyscale
of U.S. Patent No. 10,093,671B2 have analogous structures to the compounds
PNG
media_image4.png
130
256
media_image4.png
Greyscale
, when R6 comprises phenyl, used for the method of treating HBV of the instant claims.
The method of treating HBV of the instant claims is analogous to the method for the treatment
of HBV and the method for the inhibition of HBsAg production or secretion of U.S. Patent No.
10,093,671B2.
The compounds of U.S. Patent No. 10,093,671B2 may be formulated as a pharmaceutical composition with a therapeutically inert carrier and encompass the inhibitor small molecule of the instant claims as they have analogous structures, have the same properties and are capable of the same functions, such as binding to PAPD5 and/or PAPD7 polypeptide, inhibiting expression and/or activity of
PAPD5 and/or PAPD7, reduces secretion of HBsAg and HBeAg and inhibits development of chronic HBC infection and/or reduces the infectiousness of an HBV infected person.
"[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947
(Fed. Cir. 1999).
Products of identical chemical composition can not have mutually exclusive properties. A chemical composition and its properties are inseparable. Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable and does not render the old composition patentably new to the discoverer. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Claims 17-21,23 and 26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of U.S. Patent No. 11,104,674B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the compounds
PNG
media_image8.png
130
236
media_image8.png
Greyscale
of U.S. Patent No. 11,104,674B2 have analogous structures to the compounds
PNG
media_image9.png
174
324
media_image9.png
Greyscale
used for the method of treating HBV of the instant claims.
The compounds of the instant claims and the compounds of U.S. Patent No. 11,104,674B2 are formulated as a pharmaceutical composition in a pharmaceutically acceptable carrier.
The method of treating HBV of the instant claims is analogous to the method for the treatment of HBV and the method for the inhibition of HBsAg production or secretion of U.S. Patent No. 11,104,674B2.
The compounds of U.S. Patent No. 11,104,674B2 may be formulated as a pharmaceutical composition with a therapeutically inert carrier and encompass the inhibitor small molecule of the instant claims as they have analogous structures, have the same properties and are capable of the same functions, such as binding to PAPD5 and/or PAPD7 polypeptide, inhibiting expression and/or activity of
PAPD5 and/or PAPD7, reduces secretion of HBsAg and HBeAg and inhibits development of chronic HBC infection and/or reduces the infectiousness of an HBV infected person.
"[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947
(Fed. Cir. 1999).
Products of identical chemical composition can not have mutually exclusive properties. A chemical composition and its properties are inseparable. Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable and does not render the old composition patentably new to the discoverer. In re Best, 562
F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Claims 17-20,23 and 27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 9,920,049B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the compounds
PNG
media_image10.png
125
218
media_image10.png
Greyscale
of U.S. Patent No. 9,920,049B2 wherein Y and X are bonds have analogous structures to the compounds
PNG
media_image4.png
130
256
media_image4.png
Greyscale
used for the method of treating HBV of the instant claims.
The compounds of U.S. Patent No. 9,920,049B2 may be formulated as a pharmaceutical composition with a therapeutically inert carrier and encompass the inhibitor small molecule of the instant claims as they have analogous structures, have the same properties and are capable of the same functions, such as binding to PAPD5 and/or PAPD7 polypeptide, inhibiting expression and/or activity of
PAPD5 and/or PAPD7, reduces secretion of HBsAg and HBeAg and inhibits development of chronic HBC infection and/or reduces the infectiousness of an HBV infected person.
"[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947
(Fed. Cir. 1999).
Products of identical chemical composition can not have mutually exclusive properties. A chemical composition and its properties are inseparable. Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable and does not render the old composition patentably new to the discoverer. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Claims 17-21,23 and 26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23,25,26 and 29-46 of U.S. Patent No. 9,845,322B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the compounds
PNG
media_image11.png
106
202
media_image11.png
Greyscale
of U.S. Patent No. 9,845,322B2 have analogous structures to the compounds
PNG
media_image9.png
174
324
media_image9.png
Greyscale
used for the method of treating HBV of the instant claims. The compounds of the instant claims and the compounds of U.S. Patent No. 9,845,322B2 are formulated as a pharmaceutical composition in a pharmaceutically acceptable carrier.
The method of treating HBV of the instant claims is analogous to the method for the treatment of HBV and the method for the inhibition of HBsAg production or secretion of U.S. Patent No. 9,845,322B2.
The compounds of U.S. Patent No. 9,845,322B2 may be formulated as a pharmaceutical composition with a therapeutically inert carrier and encompass the inhibitor small molecule of the instant claims as they have analogous structures, have the same properties and are capable of the same functions, such as binding to PAPD5 and/or PAPD7 polypeptide, inhibiting expression and/or activity of
PAPD5 and/or PAPD7, reduces secretion of HBsAg and HBeAg and inhibits development of chronic HBC infection and/or reduces the infectiousness of an HBV infected person.
"[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947
(Fed. Cir. 1999).
Products of identical chemical composition can not have mutually exclusive properties. A chemical composition and its properties are inseparable. Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable and does not render the old composition patentably new to the discoverer. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Claims 17-20,23 and 27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3-21 of U.S. Patent No. 9,949,966B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the method of treating HBV of the instant claims using the compounds
PNG
media_image4.png
130
256
media_image4.png
Greyscale
, wherein R3 is alkoxyl, have analogous structures to the compounds
PNG
media_image12.png
100
170
media_image12.png
Greyscale
of U.S. Patent No. 9,949,966B2 used for the methods of inhibiting HBsAg production or secretion and treatment of HBV infection.
The compounds of U.S. Patent No. 9,949,966B2 may be formulated as a pharmaceutical composition with a therapeutically inert carrier and encompass the inhibitor small molecule of the instant claims as they have analogous structures, have the same properties and are capable of the same functions, such as binding to PAPD5 and/or PAPD7 polypeptide, inhibiting expression and/or activity of
PAPD5 and/or PAPD7, reduces secretion of HBsAg and HBeAg and inhibits development of chronic HBC infection and/or reduces the infectiousness of an HBV infected person.
"[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably
new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947
(Fed. Cir. 1999).
Products of identical chemical composition can not have mutually exclusive properties. A chemical composition and its properties are inseparable. Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable and does not render the old composition patentably new to the discoverer. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Response to Arguments
Applicant's arguments filed 3/16/26 have been fully considered but they are not persuasive.
Applicant asserts that they will address the DP rejections once the claims are otherwise in condition for allowance.
The rejections are maintained.
Conclusion
No claims are allowed at this time.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA JEAN PERREIRA whose telephone number is (571)272-1354. The examiner can normally be reached M9-3, T9-3, W9-3, Th9-2, F9-2.
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,
Michael Hartley can be reached at 571-272-0616. 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.
/MELISSA J PERREIRA/Examiner, Art Unit 1618
Prosecution Insights