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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 January 6, 2026 has been reviewed by the examiner and entered of record in the file.
3. Claim 1 is amended. No claim is canceled or added.
4. Claims 4-7 and 11-24 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
5. Claims 1-3 and 8-10 are under examination with the elected species and are the subject of this Office Action.
Information Disclosure Statement
6. The listing of references submitted with Applicant’s Amendment of April 30, 2025 is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) indicates that the list must be submitted in a separate paper. Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Previous Claim Rejections - 35 USC § 103
7. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
8. Claims 1-3 and 8-10 remain rejected under 35 U.S.C. 103 as being unpatentable over Bennink et al, U.S. 9,561,238 B2, in view of Dutman et al., European Urology Supplements 2017, (cited on Applicant’s IDS of August 24, 2023), and in view of Spitz et al., Research and Reports in Urology 2016, (cited on Applicant’s IDS of August 24, 2023).
Claim 1, as amended, is directed to a kit-of-parts, comprising:
(a) a first pharmaceutical composition comprising a GnRH agonist (more specifically, comprising leuprolide, adapted for intramuscular or subcutaneous administration (claims 2 and 3)), and
(b) a second pharmaceutical composition adapted for daily oral administration, comprising 40 to 80 mg estetrol, in the form of a once-daily oral unit dose (claim 8), (more specifically, 40 to 60 mg estetrol (claim 9)).
9. Bennink et al. disclose the oral administration of an estrogenic component, preferably estetrol (column 1, lines 18-22 and column 3, lines 20-24), and suggest that a Gonadotropin hormone releasing hormone (GnRH) composition may also be employed (column 9, lines 49-51), for the treatment of prostate cancer. Bennink et al. teach a pharmaceutical kit comprising one or more oral dosage unit(s) of said estrogenic compound (column 10, lines 60- column 11, lines 1-3).
10. Regarding the co-administration of estetrol and the GnRH composition, nonpreferred and alternative embodiments constitute prior art (MPEP 2123, II). Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). "A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use." In re Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994) (The invention was directed to an epoxy impregnated fiber-reinforced printed circuit material. The applied prior art reference taught a printed circuit material similar to that of the claims but impregnated with polyester-imide resin instead of epoxy. The reference, however, disclosed that epoxy was known for this use, but that epoxy impregnated circuit boards have "relatively acceptable dimensional stability" and "some degree of flexibility," but are inferior to circuit boards impregnated with polyester-imide resins. The court upheld the rejection concluding that applicant’s argument that the reference teaches away from using epoxy was insufficient to overcome the rejection since "Gurley asserted no discovery beyond what was known in the art." 27 F.3d at 554, 31 USPQ2d at 1132.). Furthermore, "[t]he prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed…." In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004).
11. Bennink et al. teach dosage of the estrogenic compound:
“particularly when used in humans, the estrogenic component is usually administered in an average dosage of at least 0.05 mg per day, preferably of at least 0.1 mg per day. The maximum dosage is normally kept below 40 mg per day,”
(column 7, last paragraph). A dose of about 40 mg/day or less overlaps the range of 40 mg to 80 mg required by instant claim 1. The prior art does not disclose the exact claimed weight values, but does overlap: in such instances even a slight overlap in range establishes a prima facie case of obviousness, In re Peterson. 65 USPQ2d 1379,1382 (Fed. Cir. 2003).
12. Bennink et al. teach a drug delivery system in the form of an oral dosage unit (column 10, lines 57-59). Thus, Bennink suggests an oral dosage unit intended for daily administration.
13. And, Dutman et al. teach that the oral administration of estetrol (E4) (first paragraph) at a dose of 20 mg, 40 mg, or 60 mg in healthy men resulted in a dose-dependent decrease in total and free testosterone levels, and suggest that:
“E4 may be suitable for the treatment of prostate cancer… as estrogen add-back during Androgen Deprivation Therapy (ADT),” [emphasis added], (see fourth paragraph).
A dose of 20 mg, 40 mg, or 60 mg is within the range of 40 mg to 80 mg, required by claim 1, and overlaps the range of “40-60 mg estetrol,” required by claim 9.
14. As such, Bennink et al. in view of Dutman et al. teach the treatment of prostate cancer in a patient in need thereof comprising co-administering estetrol and a GnRH composition, but do not teach the GnRH agonist leuprolide.
15. Yet, Spitz et al. teach that androgen deprivation therapy (ADT) with GnRH agonists is the most common and well-established treatment for prostate cancer (page 160, left column, 1-6), specifically wherein Leuprolide acetate (LA) is the most widely employed GnRH agonist, in the form of an intramuscular or subcutaneous formulation, (page 160, left column, second full paragraph).
16. Thus, one of ordinary skill in the art would have been guided by the prior art to combine a pharmaceutical composition comprising the GnRH agonist leuprolide acetate and a pharmaceutical composition comprising estetrol, packaged together in a kit, useful for the treatment of prostate cancer in a patient in need thereof. One skilled in the art would reasonably expect that the combined administration would result in decrease in total and free testosterone levels, as guided by Dutman et al.
17. And, the rationale to modify or combine the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art, established scientific principles, or legal precedent established by prior case law, please 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). See also In re Kotzab, 217 F.3d 1365, 1370, 55 USPQ2d 1313, 1317 (Fed. Cir. 2000) (setting forth test for implicit teachings); In re Eli Lilly & Co., 902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir. 1990) (discussion of reliance on legal precedent); In re Nilssen, 851 F.2d 1401, 1403, 7 USPQ2d 1500, 1502 (Fed. Cir. 1988) (references do not have to explicitly suggest combining teachings). Furthermore, MPEP 2144 teaches that the strongest rationale for combining references is a recognition, expressly or impliedly in the prior art or drawn from a convincing line of reasoning based on established scientific principles or legal precedent, that some advantage or expected beneficial result would have been produced by their combination.
18. In the instant case, two known compositions comprising compounds which individually demonstrate activity against prostate tumors could be packaged together in a kit in order to achieve an additive effect in the treatment of prostate cancer in a patient in need thereof.
Please refer to MPEP 2144.06 “I. COMBINING EQUIVALENTS KNOWN FOR THE SAME PURPOSE” wherein Kerkhoven is specifically referenced:
“It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); and Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious).
19. As stated by the Court in KSR International Co., v. Teleflex Inc., 127 US 1727 (2007), “when a patent ‘simply arranges old elements with each performing the same function it had been known to perform’ and yields no more than one would expect from such an arrangement, the combination is obvious” (quoting Sakraida v. AG Pro, Inc., 425 US 273 (1976); see also: Merck v. Biocraft (874 F.2d 804, 807 (Fed. Cir. 1989), indicating that it is a matter of obviousness for one of ordinary skill in the art to select a particular component from among many disclosed by the prior art as long as it is taught that the selection will result in the disclosed effect, even when the possible selections number 1200 or in the thousands; Sundance, Inc. v. DeMonte Fabricated, Ltd., 550 F.3d 1356 (Fed. Cir. 2008): a claimed invention is obvious is it is a combination of known prior art elements that would reasonably have been expected to maintain their respective properties or functions after they had been combined.
20. Both of the claimed elements were known in the prior art and it would have been obvious to one skilled in the art before the effective filing date of the claimed invention to combine the elements as claimed into a kit, for ease and efficiency of patient administration, with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 416, 82 USPQ2d 1385, 1395 (2007); Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atlantic & P. Tea Co. v. Supermarket Equip. Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950).
As such, claims 1-3, 8 and 9 are prima facie obvious.
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Claim 10 is drawn to claim 1, and limits wherein the kit comprises instructions for us in treating prostate cancer.
21. In this case, the recitation of the instructions is given no patentable weight for the following reasons: the printed matter on a label or package insert of a kit or container does not lend patentable weight as a limitation of the claimed product, composition, or article of manufacture, absent a functional relationship between the label or package insert of a kit and the product, composition, or article of manufacture of a kit or container.
22. See In re Haller 73 USPQ 403 (CCPA 1947), where it is held that application of printed matter to old article cannot render the article patentable. In the opinion text of In re Haller, it is stated that: Whether the statement of intended use appears merely in the claim or in label on the product is immaterial so far as the question of Patentability is concerned. . . In accordance with the patent statutes, an article or composition of matter, in order to patentable, must not only be useful and involve invention, but must also be new. If there is no novelty in an article or composition itself, then a patent cannot be properly granted on the article or composition, regardless of the use for which it is intended. The difficulty is not that there can never be invention in discovering a new process involving the use of an old article, but that the statutes make no provision for patenting of an article or composition which is not, in and of itself, new.
23. Also see In re Venezia 189 USPQ 49 (CCPA 1976), where kits are drawn to the structural attributes of interrelated component parts and not to activities that may or may not occur. Further, In re Miller 164 USPQ 46 (CCPA 1969) and In re Gulak (CAFC) 217 USPQ 401 relate to a mathematical device and to a measuring cup respectively as well as In re Ngai, 70 USPQ2d 1862 (CAFC 2004). In each of these cases, the printed matter is considered a patentable distinction because the function of the device depends upon the printed matter itself, which is a patentable distinction because the function of the device depends upon the printed matter itself, which is a part of the substrate; without the printed indicia or numbers, the substrates lose their function. Such is not the case with the instantly claimed product. The claimed product remains fully functional absent the printed instructions for use.
24. Thus the instructions for use included in a product/ kit or article manufacture constitute an “intended use” for that product/kit or article of manufacture. Intended use does not impart patentable weight to a product. See MPEP 2111.03: Intended use recitations and other types of functional language cannot be entirely disregarded. However, in apparatus, article and composition claims, intended use 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 a claim drawn to a process of making, the intended use must result in a manipulative difference as compared to the prior art. In re Casey, 370 F.2d 576, 152 USPQ 235 (CCPA 1967); In re Otto, 312 F.2d 937, 938, 136 USPQ 458, 459 (CCPA 1963).
25. As such, one skilled in the art before the effective filing date of the claimed invention would have been motivated to combine the elements as claimed into a kit, with printed instructions, for ease and efficiency of patient administration, with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art.
As such, claim 10 is prima facie obvious.
Response to Arguments
26. Applicant traverses the previous obviousness rejection of Bennink et al. in view of Dutman et al. and Spitz et al. Applicant has amended independent claim 1 to recite a kit-of- parts comprising: (a) a first pharmaceutical composition comprising a GnRH agonist; and (b) a second pharmaceutical composition adapted for daily oral administration, comprising 40 to 80 mg of estetrol, in a once-daily unit dose.
Applicant argues the following points:
(i) Applicant argues that Claim 1, as amended, does not embrace “any number of doses/ oral dosage units” that comprise up to "40 to 80mg of estetrol," as alleged by the examiner. Applicant argues that Bennink (and Dutman) fail to teach such a kit-of-parts. Applicant argues that while Bennink teaches that in principle, GnRH compositions, as outlined in U.S. Patents 5,340,584 and 5,340,585, could be used in the methods, "preferably, however, the present method does not employ such a GnRH composition." Id., col. 9, 11. 49-52. Applicant contends that none of Bennink's examples include GnRH compositions.
27. Applicant's arguments have been fully considered but they are not persuasive. Regarding Applicant’s argument that Bennink teaches away from the claimed invention, the examiner refers to MPEP 2141.02 VI, Allied Erecting v. Genesis Attachments, 825 F.3d 1373,1381,119 USPQ2d 1132,1138 (Fed. Cir. 2016) ("Although modification of the movable blades may impede the quick change functionality disclosed by Caterpillar, ‘[a] given course of action often has simultaneous advantages and disadvantages, and this does not necessarily obviate motivation to combine,’" (quoting Medichem, SA. v. Rolabo, S.L., 437 F.3d 1157,1165, 77 USPQ2d 1865,1870 (Fed Cir. 2006) (citation omitted)). Thus, "the prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed...." In re Fulton, 391 F.3d 1195,1201,73 USPQ2dii4i, 1146 (Fed. Cir. 2004).
28. A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use. In re Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994) (The invention was directed to an epoxy impregnated fiber-reinforced printed circuit material. The applied prior art reference taught a printed circuit material similar to that of the claims but impregnated with polyester-imide resin instead of epoxy. The reference, however, disclosed that epoxy was known for this use, but that epoxy impregnated circuit boards have "relatively acceptable dimensional stability" and "some degree of flexibility," but are inferior to circuit boards impregnated with polyester-imide resins. The court upheld the rejection concluding that applicant’s argument that the reference teaches away from using epoxy was insufficient to overcome the rejection since "Gurley asserted no discovery beyond what was known in the art." 27 F.3d at 554, 31 USPQ2d at 1132.). And, disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971).
29. While Bennink teaches a preferred oral dose of estetrol of less than 20 mg per day, Bennink also embraces a dose up to 40 mg or more: “[t]he maximum dosage is normally kept below 40 mg per day” (column 7, last paragraph). Bennink’s use of the modifier “normally” indicates that a precise amount is not required for operability. In other words, it is evident in view of the record that no criticality is associated with the amount of estetrol required by the claim. Rather, in view of the teaching of Bennink, one of skill in the art would have understood that any amount close to 40 mg would reasonably be expected to be effective. Therefore one skilled in the art would have chosen to formulate the oral estetrol composition of Bennink with an amount of 40 mg or more, as required by claims 1-3 and 8-10. And, "[t]he prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed…." In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004).
30. Additionally, Dutman is relied on for specifically disclosing the oral administration of estetrol (E4) at a dose of 20 mg, 40 mg, or 60 mg, which resulted in a dose-dependent decrease in total and free testosterone levels and is useful for estrogen add-back during Androgen Deprivation Therapy (ADT) in the treatment of prostate cancer. Therefore, one of skill in the art before the effective filing date of the claimed invention would have reasonably considered employing estetrol at a dose amount of 40 mg or 60 mg, as specifically taught by Dutman, in the kit recited in the instant claims.
(ii) Applicant argues that Dutman fails to teach or suggest a combination of GnRH and oral estetrol comprising 40 to 80 mg of estetrol. Applicant alleges that Dutman, reporting the results for groups receiving 20 mg or 40 mg per day, concluded that "the observed dose-response related decrease of total and free testosterone levels and the acceptable safety parameters suggest that E4 may be suitable for the treatment of prostate cancer, both as estrogen add-back during Androgen Deprivation Therapy (ADT) and as primary ADT." Id., Table 1 and Conclusions.
Applicant contends that Dutman's teaching of estetrol as primary ADT means that estetrol is used instead of a GnRH agonist or GnRH antagonist; not a combined use of estetrol and GnRH agonist. Applicant argues that Dutman's suggestion to use estetrol as estrogen add-back would not have been motivated to orally administer estetrol in a daily oral dose of 40 to 80 mg, because the aim of add-back estrogen is to prevent occurrence of symptoms of hypoestrogenism, and to achieve this end in males, daily oral estetrol dosages of substantially less than 40 mg are sufficient.1 Applicant alleges that Bennink advocates for keeping the maximum dosage "below 40 mg per day, preferably below 20 mg per day." Bennink, col. 7, 11. 66-67, and that "in the case of treatment or prevention of prostate cancer, the present estrogenic component is suitably administered in an amount effective to inhibit the endogenous production of androgens. "Id., col. 5, 11. 33-38.
31. Applicant's arguments have been fully considered but they are not persuasive. Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). Bennink discloses the oral administration of an estrogenic component that is preferably estetrol and teaches a pharmaceutical kit comprising one or more oral dosage unit(s) of said estrogenic compound. Bennink goes on to suggests that a GnRH composition may also be utilized for the treatment of prostate cancer. Dutman is relied upon for suggesting the use of estetrol as add-back during Androgen Deprivation Therapy (ADT) in the treatment of prostate cancer, wherein Spitz teaches that ADT with GnRH agonists (specifically Leuprolide acetate (LA)) is the most common and well-established treatment for prostate cancer. As such, the combined art of record teaches the use of a GnRH composition comprising leuprolide together with estetrol as add-back during Androgen Deprivation Therapy.
32. And, Guise et al. evidences that “Androgen deprivation therapy (ADT) is part of standard therapy for locally advanced or metastatic prostate cancer… wherein [t]he intended therapeutic effect of ADT is testosterone deficiency. Because estrogen is a normal metabolite of testosterone, ADT also results in estrogen deficiency. ADT has a variety of adverse effects, many of which are primarily related to estrogen deficiency… Hot flashes, gynecomastia, and breast tenderness are common side effects associated with ADT,” (see abstract). Guise et al. teach that ADT consists of treatment with a GnRH agonist, (page 168, left column, first paragraph), and suggest estrogen therapy: “[e]strogens appear to be efficacious in the treatment of hot flashes for men on ADT,” (page 172, middle column, first full paragraph). Therefore given the state of the art, one of skill in the art before the effective filing date of the claimed invention would have reasonably considered combining estetrol in a kit together with the GnRH agonist leuprolide, wherein the kit is intended for the treatment of prostate cancer.
(iii) Applicant argues that Spitz, which is cited for teaching leuprolide acetate, does not remedy the deficiencies of Bennink and Dutman, because, while Spitz mentions administering 30 mg or 45 mg intramuscular depot injections of leuprolide acetate (a GnRH agonist) microspheres, the reference does not teach combining it with 40 to 80 mg of estetrol, in a once-daily unit dose.
33. Applicant's arguments have been fully considered but they are not persuasive. 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).
Bennink discloses the oral administration of an estrogenic component that is preferably estetrol and teaches a pharmaceutical kit comprising one or more oral dosage unit(s) of said estrogenic compound, suggesting that a GnRH composition may also be utilized for the treatment of prostate cancer. Dutman is relied upon for suggesting the use of estetrol as add-back during Androgen Deprivation Therapy (ADT) in the treatment of prostate cancer, wherein Spitz teaches that ADT with GnRH agonists (specifically Leuprolide acetate (LA)) is the most common and well-established treatment for prostate cancer. As such, the combined art of record teaches the use of a GnRH composition comprising leuprolide together with estetrol as add-back during Androgen Deprivation Therapy. In response to Aplicant's argument that Spitz fails to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the combination of leuprolide with 40 to 80 mg of estetrol) are not recited in the rejected claim(s)). It is noted that claims 1 and 8-10 have not presently limited component (a) to the GnRH agonist leuprolide, i.e., claims 1 and 8-10 presently embrace a kit comprising any GnRH agonist.
Previous Double Patenting Rejections
34. Claims 1-3 and 8-10 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 11,771,705 B2.
35. Although the claims at issue are not identical, they are not patentably distinct from each other because Applicant’s instant claims recite the following:
Claim 1, as amended, recites a kit-of-parts, comprising:
(a) a first pharmaceutical composition comprising a GnRH agonist (more specifically leuprolide, adapted for intramuscular or subcutaneous administration (claims 2 and 3)), and
(b) a second pharmaceutical composition adapted for daily oral administration, comprising 40 to 80 mg estetrol, in the form of an oral dosage unit (claim 8), (more specifically, 40- 60 mg estetrol (claim 9)).
Claim 10 is drawn to claim 1, and limits wherein the kit comprises instructions for us in treating prostate cancer.
36. The claims of U.S. Pat. No. 11,771,705 are as follows:
1. A method of treating prostate cancer in a patient undergoing androgen deprivation therapy (ADT), comprising:
(i) administering to the patient a GnRH agonist selected from the group consisting of buserelin, goserelin, leuprolide, nafarelin, and triptorelin, or a GnRH antagonist selected from the group consisting of cetrorelix, ganirelix, abarelix, degarelix, elagolix, relugolix, KLH-2109 (linzagolix), and ASP-1707 (opigolix), and
(ii) orally co-administering estetrol in a daily dose of 20 mg to 60 mg for at least 4 weeks, wherein the co-administration causes a further decrease of free testosterone levels compared to administration of the GnRH agonist or the GnRH antagonist alone.
2. The method according to claim 1, wherein a GnRH agonist is administered.
3. The method according to claim 1, comprising orally administering a dosage unit comprising a GnRH antagonist and estetrol.
4. The method according to claim 1, wherein the estetrol is administered in a daily dose of no more than 60 mg.
37. As such, one of ordinary skill in the art would reasonably consider combining a pharmaceutical composition comprising the GnRH agonist leuprolide together with a pharmaceutical composition comprising estetrol in an oral unit dose of from 40 mg to 80 mg, in a kit with instructions, for ease and efficiency of administration for treating prostate cancer in a patient in need thereof. The dose of 20 mg- 60 mg estetrol overlaps the range of 40 mg to 80 mg required by instant claim 1. MPEP 2144.05 states that: In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Even a slight overlap in range establishes a prima facie case of obviousness. In re Peterson, 65 USPQ2d 1379, 1382 (Fed. Cir. 2003).
38. And, the rationale to modify or combine the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art, established scientific principles, or legal precedent established by prior case law, please 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). See also In re Kotzab, 217 F.3d 1365, 1370, 55 USPQ2d 1313, 1317 (Fed. Cir. 2000) (setting forth test for implicit teachings); In re Eli Lilly & Co., 902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir. 1990) (discussion of reliance on legal precedent); In re Nilssen, 851 F.2d 1401, 1403, 7 USPQ2d 1500, 1502 (Fed. Cir. 1988) (references do not have to explicitly suggest combining teachings). Furthermore, MPEP 2144 teaches that the strongest rationale for combining references is a recognition, expressly or impliedly in the prior art or drawn from a convincing line of reasoning based on established scientific principles or legal precedent, that some advantage or expected beneficial result would have been produced by their combination.
39. In the instant case, two known compositions comprising compounds which individually demonstrate activity against prostate tumors could be packaged together in a kit in order to achieve an additive effect in the treatment of prostate cancer in a patient in need thereof.
40. Please refer to MPEP 2144.06 “I. COMBINING EQUIVALENTS KNOWN FOR THE SAME PURPOSE” wherein Kerkhoven is specifically referenced:
“It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); and Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious).
41. As stated by the Court in KSR International Co., v. Teleflex Inc., 127 US 1727 (2007), “when a patent ‘simply arranges old elements with each performing the same function it had been known to perform’ and yields no more than one would expect from such an arrangement, the combination is obvious” (quoting Sakraida v. AG Pro, Inc., 425 US 273 (1976); see also: Merck v. Biocraft (874 F.2d 804, 807 (Fed. Cir. 1989), indicating that it is a matter of obviousness for one of ordinary skill in the art to select a particular component from among many disclosed by the prior art as long as it is taught that the selection will result in the disclosed effect, even when the possible selections number 1200 or in the thousands; Sundance, Inc. v. DeMonte Fabricated, Ltd., 550 F.3d 1356 (Fed. Cir. 2008): a claimed invention is obvious is it is a combination of known prior art elements that would reasonably have been expected to maintain their respective properties or functions after they had been combined.
42. Both of the claimed elements were recited by U.S. Pat. No. 11,771,705 and one skilled in the art could have combined the elements as claimed into a kit, with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 416, 82 USPQ2d 1385, 1395 (2007); Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atlantic & P. Tea Co. v. Supermarket Equip. Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950).
43. Regarding the recitation of the instructions for treating prostate cancer in claim 10, this limitation is given no patentable weight for the following reasons, the printed matter on a label or package insert of a kit or container does not lend patentable weight as a limitation of the claimed product, composition, or article of manufacture, absent a functional relationship between the label or package insert of a kit and the product, composition, or article of manufacture of a kit or container.
44. See In re Haller 73 USPQ 403 (CCPA 1947), where it is held that application of printed matter to old article cannot render the article patentable. In the opinion text of In re Haller, it is stated that: Whether the statement of intended use appears merely in the claim or in label on the product is immaterial so far as the question of Patentability is concerned. . . In accordance with the patent statutes, an article or composition of matter, in order to patentable, must not only be useful and involve invention, but must also be new. If there is no novelty in an article or composition itself, then a patent cannot be properly granted on the article or composition, regardless of the use for which it is intended. The difficulty is not that there can never be invention in discovering a new process involving the use of an old article, but that the statutes make no provision for patenting of an article or composition which is not, in and of itself, new.
45. Also see In re Venezia 189 USPQ 49 (CCPA 1976), where kits are drawn to the structural attributes of interrelated component parts and not to activities that may or may not occur. Further, In re Miller 164 USPQ 46 (CCPA 1969) and In re Gulak (CAFC) 217 USPQ 401 relate to a mathematical device and to a measuring cup respectively as well as In re Ngai, 70 USPQ2d 1862 (CAFC 2004). In each of these cases, the printed matter is considered a patentable distinction because the function of the device depends upon the printed matter itself, which is a patentable distinction because the function of the device depends upon the printed matter itself, which is a part of the substrate; without the printed indicia or numbers, the substrates lose their function. Such is not the case with the instantly claimed product. The claimed product remains fully functional absent the printed instructions for use.
As such, claims 1-3 and 8-10 are prima facie obvious over claims 1-4 of U.S. Pat. No. 11,771,705.
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Response to Arguments
46. Applicant requests that the nonstatutory obviousness-type double patenting rejection is held in abeyance until the claims at issue are deemed otherwise allowable.
47. Accordingly, the nonstatutory obviousness-type double patenting rejection of claims 1-3 and 8-10 is maintained.
Conclusion
48. Claims 1-24 are present in the application. Claims 4-7 and 11-24 are presently withdrawn from consideration. Claims 1-3 and 8-10 are rejected. No claim is currently allowable.
49. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JANET L COPPINS whose telephone number is (571)272-0680. The examiner can normally be reached Monday-Friday 8:30AM-5PM EST.
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/JANET L COPPINS/Examiner, Art Unit 1628
/AMY L CLARK/Supervisory Patent Examiner, Art Unit 1628