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 .
Status of the Claims
Claims 31-47 are pending in this application. Claims 1-30 have been cancelled by applicant. Claims 31-39 and 47 are under examination herein. Claims 40-46 have been withdrawn from consideration.
Claim Rejections - 35 USC § 103
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.
Claims 31-39 are rejected under 35 U.S.C. 103 as being unpatentable over Förster et al. (US 9,409,859 B2 – previously cited) (“Förster”).
Regarding claims 31-39, Förster discloses the elected compound of Formula IV-A3 (col. 22, line 25; and claim 2) for the treatment of cancers (abstract) and further discloses the use of their compounds as medicaments (col. 1, line 22-23). Förster also discloses their general Formula below, wherein X can be -C(O)-; R3, 6 can be H; R4 can be -N=N-N(Me)2; and R5 can be -OSO2OH, reading on the structure of instant compound IV-A, wherein Met’ is H (Förster’s claim 1).
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Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing date of the instant application to prepare a medicament comprising Förster’s compound above. One of ordinary skill would have been motivated to do so with a reasonable expectation of success because Förster discloses that their compounds are useful for the treatment of cancer; further because Förster discloses their medicaments may be suitable for administration as sprays, tablets, etc., comprising pharmaceutically acceptable auxiliaries (col. 23, last 4 para.; and col. 24, lines 20-24).
Further regarding the instant claims, Applicant is advised that a recitation of the intended use of the claimed invention, such as: (i) the use of the instantly claimed medicaments for the treatment of coronavirus and COVID-19 infections; or (ii) wherein the medicament provides prophylactic and/or therapeutic treatment of the viral disease; etc. in the instant application, must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Note: MPEP 2111.02.
Furthermore, Applicant is advised that "[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). 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. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). In In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004), the court held that the claimed promoter sequence obtained by sequencing a prior art plasmid that was not previously sequenced was anticipated by the prior art plasmid which necessarily possessed the same DNA sequence as the claimed oligonucleotides. The court stated that "just as the discovery of properties of a known material does not make it novel, the identification and characterization of a prior art material also does not make it novel." Id. See also MPEP § 2112.01 with regard to inherency and product-by-process claims and MPEP § 2141.02 with regard to inherency and rejections under 35 U.S.C. 103.
In the present case, Förster’s compound anticipates the structure of the active ingredient in the instant medicaments, therefore, the courts have held that products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Claim 47 is rejected under 35 U.S.C. 103 as being unpatentable over Förster et al. (US 9,409,859 B2 – previously cited) (“Förster”); as applied to claims 31-39; in view of Berk et al. (WO 2007/061978 A1 – previously cited) (“Berk”).
The teachings of Förster are disclosed above and incorporated herein.
Regarding claim 47, Förster teaches their compounds may be administered in combination with at least one further medicament, which is administered together with the chemotherapeutic agents during chemotherapy (col 23, lines 23-35). Förster points to Berk (starting on page 23, line 1) for examples of the additional chemotherapeutic agents.
Berk discloses combination therapies comprising anti-inflammatory agents, like aspirin and ibuprofen (page 26, lines 24-25).
Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing date of the instant application to administer a combination therapy comprising Förster’s compounds and Berk’s anti-inflammatory agents. One of ordinary skill would have been motivated to do so with a reasonable expectation of success in view of Förster’s disclosure of their compounds for use as medicaments for the treatment of cancers; and Berk’s disclosure of combination therapies comprising anti-inflammatory agents like aspirin or ibuprofen.
Response to Arguments
Drawings
Amendments to the drawings are acknowledged and have been entered. No new matter has been introduced.
Applicant’s arguments, see page 12, filed 02/13/2026, with respect to objections to the drawings have been fully considered and are persuasive. The objections of the drawings have been withdrawn.
Claims
Amendments to the claims are acknowledged and have been entered. No new matter has been introduced.
Claim Rejections - 35 USC § 103
Applicant's arguments filed 02/13/2026 have been fully considered but they are not persuasive.
Applicant argues the Office’s assessment that cervical and vaginal cancers are known to be caused by HPV does not hold true at all because Förster deals with treatment of cancers, and consequently a different pharmacological target (not viruses). Applicant argues the present invention is delimited by “the special medical indication” and that the special medical indication is also linked with a special preparation and application of the medicament. Applicant argues one of ordinary skill would have had to make a multitude selection in order to arrive at the instant compound, and states the teachings of Förster are not relevant to the claimed invention. Applicant cited MPEP 2143.03 to say the examiner must consider each and every feature of the claims. Applicant argues the missing elements cannot be provided under the doctrine of inherency since, “to establish inherency the extrinsic evidence must make clear that the missing descriptive matter is necessarily present in the thing described in the reference, and that Examiner must provide a basis in fact reasoning to support the determination of inherency.
Applicant argues that Berk is drawn to inhibitors of histone deacetylase, which is a completely different class of compounds and medical indication, and that one skilled in the art would not consider Berk as relevant to the claimed invention. Applicant further argues that Förster and Berk do not show every element of the claimed invention and the missing elements are not inherent, and that therefore, a prima facie case of obviousness has not been made.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In response to Applicant’s arguments that the Office’s assessment that cervical and vaginal cancers are known to be caused by HPV does not hold true at all because Förster deals with treatment of cancers, and consequently a different pharmacological target (not viruses) -- Applicant’s arguments rely on language solely recited in preamble recitations in the instant claim(s). When reading the preamble in the context of the entire claim, the recitations: (i) the use of the instantly claimed medicaments for the treatment of coronavirus and COVID-19 infections; or (ii) wherein the medicament provides prophylactic and/or therapeutic treatment of the viral disease; etc are not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention’s limitations. Thus, the preamble of the claim(s) is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02.
In response to Applicant’s argument that the present invention is delimited by “the special medical indication” and that the special medical indication is also linked with a special preparation and application of the medicament. The instant specification (page 38, para. 3) describes that the present medicaments can broadly comprise at least one diphenyl derivative together with a pharmaceutically acceptable carrier or excipient – no specific preparation requirements are mentioned for special medication indication or special preparation. Similarly, Förster discloses their medicaments may be suitable for administration as sprays, tablets, etc., comprising pharmaceutically acceptable auxiliaries, carriers, etc. (col. 23, last 4 para.; and col. 24, lines 20-24). Therefore, Förster’s compositions read on the instant compositions, because as stated in the 103 rejections of record, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In response to Applicant’s arguments that one of ordinary skill would have had to make a multitude selection in order to arrive at the instant compound, Förster discloses their compound, which anticipates the structure of the active ingredients in the instant medicaments. Therefore, the instant invention is obvious, given the fact that Förster teaches that their compounds may be used as medicaments.
In regards to Applicant’s argument that the examiner must consider each and every feature of the claims; every limiting feature of the claims has been considered by the Examiner. In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
In this case, Förster discloses the elected compound of Formula IV-A3 (col. 22, line 25; and claim 2) for the treatment of cancers (abstract) and further discloses the use of their compounds as medicaments (col. 1, line 22-23). Förster also discloses their general Formula below, wherein X can be -C(O)-; R3, 6 can be H; R4 can be -N=N-N(Me)2; and R5 can be -OSO2OH, reading on the structure of instant compound IV-A, wherein Met’ is H (Förster’s claim 1).
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Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing date of the instant application to prepare a medicament comprising Förster’s compound above. One of ordinary skill would have been motivated to do so with a reasonable expectation of success because Förster discloses that their compounds are useful for the treatment of cancer; further because Förster discloses their medicaments may be suitable for administration as sprays, tablets, etc., comprising pharmaceutically acceptable auxiliaries (col. 23, last 4 para.; and col. 24, lines 20-24). Applicant is reminded that a recitation of the intended use of the claimed invention, such as: (i) the use of the instantly claimed medicaments for the treatment of coronavirus and COVID-19 infections; or (ii) wherein the medicament provides prophylactic and/or therapeutic treatment of the viral disease; etc. in the instant application, must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In response to Applicant’s arguments that “to establish inherency the extrinsic evidence must make clear that the missing descriptive matter is necessarily present in the thing described in the reference, and that Examiner must provide a basis in fact reasoning to support the determination of inherency”; Per MPEP 2112 (II): ("[T]he fact that a characteristic is a necessary feature or result of a prior-art embodiment (that is itself sufficiently described and enabled) is enough for inherent anticipation, even if that fact was unknown at the time of the prior invention."); Abbott Labs v. Geneva Pharms., Inc., 182 F.3d 1315, 1319, 51 USPQ2d 1307, 1310 (Fed. Cir. 1999). Furthermore, MPEP 2112 (V) reads: "[T]he PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. 102, on ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same." In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977) (footnote and citation omitted). The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (citing Best, 562 F.2d at 1255).
Thus, in the present case, Förster’s compound anticipates the structure of the active ingredient in the instant medicaments, therefore, the courts have held that products of identical chemical composition cannot have mutually exclusive properties." And that a chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to “prove that subject matter shown to be in the prior art does not possess the characteristic relied on” (205 USPQ 594, second column, first full paragraph).
Therefore, the burden is on Applicant to prove that the instantly claimed medicament possesses “special” characteristics of application, preparation, etc. not possessed by Förster’s medicaments.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACKSON J HERNANDEZ whose telephone number is (571)272-5382. The examiner can normally be reached Mon - Thurs 7:30 to 5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney L. Klinkel can be reached at (571) 270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JACKSON J HERNANDEZ/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
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