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 .
Response to Amendment
2. Applicant’s amendment and response, submitted November 20, 2025, has been reviewed by the examiner and entered of record in the file. Claims 2, 14, 16 and 18 are amended, and claim 13 is presently canceled. No claims are added.
3. Claims 2-9, 11, 12 and 14-18 are under examination and are the subject of this office action.
Drawings
4. The original drawings filed January 20, 2023 were previously objected to as stating a title that is inconsistent with the title of the instant application. Applicant has submitted a replacement set of drawings wherein the title has been removed. Therefore, the previous objection to the drawings is withdrawn.
Information Disclosure Statement
5. The information disclosure statement (IDS) submitted on March 16, 2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner, please refer to the signed copy of Applicant’s PTO-1449 form, submitted herewith.
Previous Claim Rejections - 35 USC § 112(b)
6. Claims 2-18 were previously 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.
7. (a) Claim 2 was previously rejected as being unclear regarding the recitation of “to be released over a period of weeks.” In view of Applicant’s amendment to delete the above recitation from the claim, the indefiniteness rejection is withdrawn.
(b) Claim 2 was previously rejected as being indefinite regarding the recitation of "can be administered" in line 14. In view of Applicant’s amendment to replace “can be” with “is,” the indefiniteness rejection is withdrawn.
(c) Claim 2 was previously rejected regarding the recitation of “days, weeks, or months after birth” (line 13) being indefinite because the claim does not define the duration of day(s), week(s) or month(s) of administration.
In view of Applicant’s persuasive argument that the plain meaning is understood that the administration is provided any time between birth and puberty, the previous indefiniteness rejection is withdrawn.
8. Claim 5 was previously rejected regarding the recitation of “days after birth” (line 3) being indefinite because the claim did not define the duration of day(s) of administration.
In view of Applicant’s persuasive argument that the plain meaning is understood that the administration is provided any time between birth and puberty, the previous indefiniteness rejection is withdrawn.
9. Claim 8 was previously rejected regarding the recitation of “weeks after birth” (line 3) as being indefinite because the claim did not define the duration of week(s) of administration, such that one of skill in the art would not know how to practice the claimed invention.
In view of Applicant’s persuasive argument that the plain meaning is understood that the administration is provided any time between birth and puberty, the previous indefiniteness rejection is withdrawn.
10. Claim 9 was previously rejected regarding the recitation of “months after birth” (line 3) as being indefinite because the claim did not define the duration of months of administration.
In view of Applicant’s persuasive argument that the plain meaning is understood that the administration is provided any time between birth and puberty, the previous indefiniteness rejection is withdrawn.
11. Claim 16 was previously rejected regarding the recitation of plurals, i.e. “…wherein the polymer comprises … polyanhydrides, …polyorthoesters, …polyglycolic copolymers (PLG)” since it is not clear what is included or excluded from the claim language, and the metes and bounds of said claims cannot be ascertained. In view of Applicant’s amendment to replace the plural terms with singular, i.e., : “…wherein the polymer comprises … a polyanhydride, … a polyorthoester, …a polyglycolic copolymer (PLG),” the previous indefiniteness rejection is withdrawn.
12. Claim 18 was previously rejected regarding the recitation of plurals, i.e. “…wherein the sustained release matrix comprises polyesters, hydrogels, polyactides, copolymers of L-glutamic acid and gamma ethyl-L-glutamate or ethylene vinyl acetate,” since it is not clear what is included or excluded from the claim language, and the metes and bounds of said claims cannot be ascertained. In view of Applicant’s amendment to replace the plural terms with singular, i.e., “…wherein the sustained release matrix comprises a polyester, a hydrogel, a polylactide, a copolymer of L-glutamic acid and gamma ethyl-L-glutamate or ethylene vinyl acetate,” the previous indefiniteness rejection is withdrawn.
New Claim Rejections – 35 USC 112(b)
13. 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.
14. Claims 3-9, 11, 12, and 14-18 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.
This rejection is newly applied as a result of Applicant’s amendment to claim 2.
15. Claim 3 depends from claim 2, and recites the limitation “wherein the estradiol, estradiol benzoate, estradiol dipropionate, estradiol valerate, estradiol cypionate, or a combination thereof is administered on the day of birth” [emphasis added]. However this limitation attempts to limit the time of administration to a concept that is not encompassed by the claim from which it depends, because claim 2, as amended, limits the administration to “days, weeks, or months after birth but prior to reaching puberty” (i.e., plural days) in the last two lines of the claim [emphasis added]. Thus, the limitation of “days after birth,” meaning at least two days (plural) following birth cannot embrace administration “on the day of birth,” as required by claim 3. Clarification is requested.
16. Claim 4 depends from claim 2, and recites the limitation “wherein the estradiol, estradiol benzoate, estradiol dipropionate, estradiol valerate, estradiol cypionate, or a combination thereof is administered on the day after birth” [emphasis added]. However this limitation attempts to limit the time of administration to a concept that is not encompassed by the claim from which it depends, because claim 2, as amended, limits the administration to, “days, weeks, or months after birth but prior to reaching puberty” in the last two lines of the claim [emphasis added]. Thus, the limitation of “days after birth,” meaning at least two days (plural) following birth cannot embrace administration “on the day after birth,” (i.e., only 1 day following birth) as required by claim 4.
Clarification is requested.
New Claim Rejections - 35 USC § 112(a)
17. The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
18. Claims 2-9, 11, 12, and 14-19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
19. In particular, support cannot be found for the full scope of estradiol extended-release formulations comprising an effective amount of estradiol, estradiol benzoate, estradiol dipropionate, estradiol valerate, estradiol cypionate, or a combination thereof, formulated in an extended-release formulation, wherein the extended-release formulation comprises a liposome, polymer, microparticle, nanoparticle, semipermeable polymer matrix or a sustained release matrix, as instantly recited in the claims.
20. The MPEP §2163 states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by him. In the case of chemical entities, Applicant's attention is further directed to Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559 (Fed. Cir. 1997), cert. denied, 523 U.S. 1089, 118 S. Ct. 1548 (1998), which notes that an adequate written description requires a precise definition, such as by structure, formula, chemical name, or physical properties, “not a mere wish or plan for obtaining the claimed chemical invention.” While the court recognizes that, “[i]n claims involving chemical materials, generic formulae usually indicate with specificity what the generic claims encompass” (Id.), it is also recognized that for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim and/or the genus must be sufficiently detailed to show that applicant was in possession of the claimed invention as a whole (see Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555 (Fed. Cir. 1991)). If a genus has substantial variance, the disclosure must present a sufficient number of representative species that encompass the genus in order to adequately describe the genus (i.e., the disclosure must describe a sufficient variety of species to reflect the variation within that genus). See MPEP § 2163. Otherwise, as stated by the court in Ariad Pharmaceuticals, Inc., v. Eli Lilly and Company (Fed. Cir. 2010), “a generic claim may define the boundaries of a vast genus of chemical compounds, and yet the question may still remain whether the specification, including original claim language, demonstrates that the Applicant has invented species sufficient to support a claim to a genus. The problem is especially acute with genus claims that use functional language to define the boundaries of a claimed genus. In such a case, the functional claim may simply claim a desired result, and may do so without describing species that achieve that result. But the specification must demonstrate that the Applicant has made a generic invention that achieves the claimed result and do so by showing that the Applicant has invented species sufficient to support a claim to the functionally-defined genus.” In other words, a claim term is functional when it recites a feature "by what it does rather than by what it is.” In the instant case, claim 2 employs the functional term “extended-release formulation” in line 8, which describes the intended release profile of the formulation, but the Specification fails to provide examples of said formulation.
21. It is evident that the genus of formulations embraced by the claims has substantial variance, i.e., a formulation comprising any estradiol compound selected from estradiol, estradiol benzoate, estradiol dipropionate, estradiol valerate, estradiol cypionate or a combination thereof, in any effective amount of from 1 mg/kg to about 100 mg/kg estradiol; and comprising any liposome, polymer, microparticle, nanoparticle, semipermeable polymer matrix or a sustained release matrix. Thus, the genus of “extended-release” formulations embraces hundreds of thousands of potential combinations of ingredients an alternatives that bear no structural resemblance to one another what-so-ever. Yet, the instant Specification discloses only three “iNeuter” estradiol formulations comprising 30 mg, 100 mg or 300 mg estradiol benzoate in corn oil and formulated in a silicone capsule, for implantation in rat pups (paragraph [0062]) and only two estradiol formulations comprising 3.0 mg or 9.0 mg estradiol benzoate in corn oil and formulated in a silicone capsule, for implantation in piglets (paragraph [0063]).
22. While the MPEP does not define what constitutes a sufficient number of representative species, the courts have indicated what does not constitute a representative number of species to adequately describe a broad generic. For example, in In re Gostelli, the courts determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872 F.2d 1008 (Fed. Cir. 1989). In the instant case, it is similarly determined that the disclosure of just five “iNeuter” estradiol formulations which each employ just one estradiol compound (i.e., estradiol benzoate) in corn oil encapsulated by one polymer (i.e., silicone) does not adequately describe a genus embracing hundreds of thousands of alternative combinations of ingredients in formulations that bear no structural relationship with the above estradiol benzoate formulation. That is, the Specification does not disclose a sufficient variety of species to reflect the extreme variance in the genus of estradiol formulations.
23. The description requirement of the patent statue requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736, F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does “little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate”). Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
As such, claims 2-9, 11, 12, and 14-19 are rejected.
24. Claims 2-9, 11, 12, and 14-18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of inducing permanent sterility in a mammal comprising subcutaneously administering to said mammal an effective amount of estradiol formulated in an extended-release “iNeuter” formulation comprising corn oil and the polymer silicone, wherein said effective amount of estradiol is 3.0 mg or 9.0 mg (paragraph [0063]), wherein the formulation is administered in a single dose, one time, on the day of birth or on the day following birth, does not reasonably provide enablement for a method of administering an effective amount of the full scope of any recited estradiol compound formulated in an extended-release formulation comprising any/ all liposome, polymer, microparticle, nanoparticle, semipermeable polymer matrix, or a sustained-release matrix polymer, any time after birth but prior to puberty, as instantly claimed. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
25. The standard for determining whether the Specification meets the enablement requirement was cast in the Supreme Court decision of Mineral Separation v. Hyde, 242 U.S. 261 (1916) which postured the question: is the experimentation needed to practice the invention undue or unreasonable? As recognized by the court in In re Wands, 858 F.2d 731 (Fed. Cir. 1988), that is still the standard to be applied, determined by consideration of the Wands factors (MPEP 2164.01(A)); namely, nature of the invention, breadth of the claims, guidance of the specification, the existence of working examples, state of the art, predictability of the art and the amount of experimentation necessary. All of the Wands factors have been considered, with the most relevant factors discussed below:
1) the quantity of experimentation necessary,
2) the amount of direction or guidance provided,
3) the presence or absence of working examples,
4) the nature of the invention,
5) the state of the prior art,
6) the relative skill of those in the art,
7) the predictability of the art, and
8) the breadth of the claims.
26. These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons.
27. Nature of the Invention: As stated in MPEP 2164.05(a), “[t]he initial inquiry” for determining whether the Specification is enabling “is into the nature of the invention, i.e., the subject matter to which the claimed invention pertains.”
In the instant case, the claims are drawn to a method for inducing permanent sterility in a mammal (wherein the mammal is a companion animal or livestock), comprising subcutaneously administering to said mammal an effective amount of estradiol, estradiol benzoate, estradiol dipropionate, estradiol valerate, estradiol cypionate or a combination thereof so as to render the mammal permanently sterile, wherein said effective amount of estradiol, estradiol benzoate, estradiol dipropionate, estradiol valerate, estradiol cypionate, or a combination thereof is 1 mg/kg to about 100 mg/kg, wherein the estradiol, estradiol benzoate, estradiol dipropionate, estradiol valerate, estradiol cypionate, or a combination thereof is formulated in an extended-release formulation, wherein the extended-release formulation comprises a liposome, polymer, microparticle, nanoparticle, semipermeable polymer matrix or a sustained release matrix,
wherein the estradiol, estradiol benzoate, estradiol dipropionate, estradiol valerate, estradiol cypionate, or a combination thereof is administered days, weeks, or months after birth but prior to reaching puberty, and wherein the administration is a single dose, one time, administration.
28. The state of the prior art, level of predictability and relative skill level: As stated in MPEP 2164.05(a), “[t]he state of the prior art is what one skilled in the art would have known, at the time the application was filed, about the subject matter to which the claimed invention pertains” and, as stated in MPEP 2164.05(b), “[t]he relative skill of those in the art refers to the skill of those in the art in relation to the subject matter to which the claimed invention pertains at the time the application was filed.”
As discussed above, the instantly claimed invention pertains to a method for inducing permanent sterility in a mammal that is a companion animal or livestock, comprising subcutaneously administering to said mammal an effective amount of estradiol, estradiol benzoate, estradiol dipropionate, estradiol valerate, estradiol cypionate or a combination thereof (wherein said effective amount is 1 mg/kg to about 100 mg/kg), so as to render the mammal permanently sterile, wherein the estradiol is formulated in an extended-release formulation, wherein the extended-release formulation comprises a liposome, polymer, microparticle, nanoparticle, semipermeable polymer matrix or a sustained release matrix,
wherein the estradiol is administered days, weeks, or months after birth but prior to reaching puberty, and wherein the administration is a single dose, one time, administration.
29. The relative skill of those in the art is high, that of an MD or PhD. That factor is outweighed, however, by the unpredictable nature of the art. As illustrative of the state of the art regarding the effects of estrogens on neonatal female mammals, MacLusky et al. teach that in the case of female neonatal rats, administration of estradiol or its 2- and 4- hydroxylated metabolites on days 1-5, at varying dose amounts, demonstrated markedly different effects at the estrogen receptor (ER), and resulted in different effects on reproductive mechanisms: “[a]ll three estrogens reduced the frequency of LH surges in response to estrogen and progesterone, their rank order of potency being 4-OHE2 > E2 > 2-OHE2. These results demonstrate that the catechol estrogens 2-OHE2 and 4-OHE2 produce effects on the development of the mechanisms controlling LH release which resemble those of their parent estrogen, E2. 4-OHE2 appears to be considerably more active in this regard than its 2-hydroxy isomer, rivalling the potency of E2 itself,” (see abstract).
30. The amount of direction or guidance provided and the presence or absence of working examples: The amount of direction provided by the Applicant is considered to be determined by the Specification and the working examples. In the instant case, the specification provides no direction or guidance for the use of the full scope of possible estradiol extended-release formulations intended for permanent sterilization purposes. In this case, the instant Specification discloses only three “iNeuter” estradiol formulations comprising 30 mg, 100 mg or 300 mg estradiol benzoate in corn oil and formulated in a silicone capsule, for implantation in rat pups (paragraph [0062]) and only two estradiol formulations comprising 3.0 mg or 9.0 mg estradiol benzoate in corn oil and formulated in a silicone capsule, for implantation in piglets (paragraph [0063]). All prepared formulations comprise just one form of estradiol: estradiol benzoate; in corn oil; and just one polymer: a silicone capsule.
No reasonably specific guidance is provided concerning useful therapeutic protocols for inducing permanent sterilization in mammal comprising administering any other estradiol formulations according to the claims.
31. The breadth of the claims: As stated in MPEP 2164.01(c), “[w]hen a compound or composition claim is limited by a particular use, enablement of that claim should be evaluated based on that limitation.” Thus, as stated in MPEP 2164.08, “[t]he focus of the examination inquiry is whether everything within the scope of the claim is enabled” (emphasis added). Indeed, the Federal Circuit has repeatedly held that “the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation’.” In re Wright, 999 F.2d 1557 (Fed. Cir. 1993) (emphasis added). At the same time, however, it is also recognized that not everything necessary to practice the invention need be disclosed. Nor is it necessary that an Applicant test all the embodiments of his invention. In re Angstadt, 537 F.2d 498 (CCPA 1976) (emphasis added). In fact, as stated by the court in In re Buchner, 929 F.2d 660 (Fed. Cir. 1991), a patent need not teach, and preferably omits, what is well known in the art.
32. Accordingly, for purposes of enablement, the relevant concern is whether the scope of enablement provided to one skilled in the art by the disclosure is commensurate in scope with the protection sought by the claims. Thus, while “a patent application is entitled to claim his invention generically” it is necessary that “he provide a disclosure sufficient to enable one skilled in the art to carry out the invention commensurate with the scope of his claims." Amgen, Inc., v. Chugai Pharmaceutical Co., Ltd. (Fed. Cir. 1991). As noted by the court in In re Fisher, 427 F.2d 833 (CCPA 1970), the scope of enablement must bear a “reasonable correlation” to the scope of the claims. See also Ak Steel Corp. v. Sollac, 344 F.3d 1234 (Fed. Cir. 2003) and In re Moore, 439 F.2d 1232 (CCPA 1971). As stated in MPEP 2164.08, resolution of this concern requires two stages of inquiry: “[t]he first is to determine how broad the claim is with respect to the disclosure. The entire claim must be considered. The second inquiry is to determine if one skilled in the art is enabled to make and use the entire scope of the claim without undue experimentation”.
33. As to the first inquiry, as discussed above it is evident that the genus of formulations embraced by the claims has substantial variance, i.e., a formulation comprising any estradiol compound selected from estradiol, estradiol benzoate, estradiol dipropionate, estradiol valerate, estradiol cypionate or a combination thereof, in any effective amount of from 1 mg/kg to about 100 mg/kg estradiol; and comprising any liposome, polymer, microparticle, nanoparticle, semipermeable polymer matrix or a sustained release matrix. Thus, the genus of “extended-release” formulations embraces hundreds of thousands of potential combinations of ingredients and alternatives that bear no structural resemblance to one another what-so-ever.
34. Considering that the scope of said formulations encompasses hundreds of thousands of possible combinations of ingredients, it is evident that the claims are broad. Yet, as discussed above, the instant Specification discloses only three “iNeuter” estradiol formulations comprising 30 mg, 100 mg or 300 mg estradiol benzoate in corn oil and formulated in a silicone capsule, for implantation in rat pups (paragraph [0062]) and only two estradiol formulations comprising 3.0 mg or 9.0 mg estradiol benzoate in corn oil and formulated in a silicone capsule, for implantation in piglets (paragraph [0063]). All prepared formulations comprise just one form of estradiol: estradiol benzoate; in corn oil; and just one polymer: a silicone capsule.
As such, the claim is extremely broad with respect to the disclosure. The second inquiry is discussed in detail below.
35. The amount of experimentation necessary: In view of all of the foregoing, at the time the invention was made, it would have required undue experimentation to practice the entire scope of the invention as claimed. As discussed above, the claims are drawn to a method of inducing permanent sterilization in a mammal, comprising administering an effective amount of any estradiol selected from estradiol, estradiol benzoate, estradiol dipropionate, estradiol valerate, estradiol cypionate or a combination thereof, in any effective amount of from 1 mg/kg to about 100 mg/kg estradiol to said mammal, in a single dose, one time administration, wherein said estradiol is formulated in an extended-release formulation comprising any liposome, polymer, microparticle, nanoparticle, semipermeable polymer matrix or a sustained release matrix, wherein the estradiol formulation is administered any time starting from birth up to reaching puberty.
36. Since identifying any hormone formulation which is capable of modulating the reproductive activity of a female mammal is complex, let alone permanently sterilizing said mammal, the nature of the instant invention considered to be one of extreme complexity. In the instant case, this complexity is exacerbated by the broadness of the scope of claim 2 with respect to the disclosure since the scope of possible formulations encompasses hundreds of thousands of alternatives, whereas the instant Specification discloses the administration of just one formulation in varying dosage amounts, exerting the desired activity when administered on the day of birth or the following day. Although the relative skill of those in the art to which the invention pertains is high, the state of the art and unpredictability within the art is such that even the most talented artisan could not reasonably predict which of the thousands of formulations encompassed by the claims would exert the alleged activity based on the limited disclosure. Thus, it is highly unpredictable whether administering any formulation within the scope encompassed by the claims, on any day from birth to puberty, based on the instant disclosure would, in fact, be usable. Whether the other formulations encompassed by the claims would be usable is even less predictable. As such, the only way to ascertain which of the thousands, and potentially hundreds of thousands of claimed formulations presently embraced by the claims are usable based on the limited disclosure would require undue experimentation. That is, the only way one skilled in the art is enabled to use the entire scope of the claim based on the instant disclosure entails undue experimentation.
To overcome this rejection, Applicant should narrow the scope of the claims such that they bear a reasonable correlation with the disclosure, i.e., limit the claims to the methods of administering the iNeuter formulations disclosed in paragraphs [0062]-[0063] of the Specification.
Previous Claim Rejections - 35 USC § 103
37. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
38. Claims 2, 5-6, 8, 9, 11, 12, 14 and 16-18 remain rejected under 35 U.S.C. 103 as being unpatentable over Gorksi, Am. J. Physiol. 1963, in view of the webpage printout of https://www.pharmtech.com/view/sustained-release-injectable-drug-delivery, Pharmaceutical Technology 2010, as evidenced by Ghasemi et al., EXCLI Journal 2021, and as evidenced by Hou and Protopopova, PLOS ONE 2022.
This rejection has been modified as a result of Applicant’s amendment to claim 2.
Claim 2, as amended, is drawn to a method for inducing permanent sterility in a mammal comprising subcutaneously administering to said mammal an effective amount of estradiol benzoate, so as to render the mammal permanently sterile, wherein said effective amount of estradiol benzoate is 1 mg/kg to about 100 mg/kg,
wherein the estradiol benzoate is formulated in an extended-release formulation, that is released over 15-20 days (claim 12),
wherein the extended-release formulation comprises a liposome, polymer, microparticle, nanoparticle, semipermeable polymer matrix, or a sustained release matrix (more specifically a polymer (claim 14), that is a microparticle (claim 17)),
wherein the mammal is a companion animal or livestock, and
wherein the estradiol, can be administered days, weeks, or even months after birth but prior to reaching puberty (more specifically 1 to 7 days after birth (claims 5 and 6)),
wherein the administration is a single dose, one time, administration and
wherein the administration of the estradiol inhibits/blocks maturation of sex organs/gonads (claim 11).
**In view of a broadest reasonable interpretation of claim 2, for the purpose of applying prior art, the limitation of “estradiol, estradiol benzoate, estradiol dipropionate, estradiol valerate, estradiol cypionate, or a combination thereof” in the preamble is construed to mean:
“wherein the estradiol, estradiol benzoate, estradiol dipropionate, estradiol valerate, estradiol cypionate, or a combination thereof is formulated in an extended-release formulation, wherein the extended-release formulation comprises a liposome, polymer, microparticle, nanoparticle, semipermeable polymer matrix or a sustained release matrix”; and
the limitation of “…is administered days, weeks, or months after birth but prior to reaching puberty, wherein the administration is a single dose, one time, administration” in the last two lines is construed to mean:
“…is administered in a single dose, one time, from the day of birth up to the day puberty is reached”.
Claim 16 is drawn to claim 14, and limits wherein the polymer comprises ethylene vinyl acetate, polyanhydrides, silicone, polyglycolic acid, collagen, polyorthoesters, polylactic acid or polylactic, polyglycolic copolymers (PLG)).
Claim 18 is drawn to claim 2, and limits wherein the sustained release matrix comprises polyesters, hydrogels, polylactides, copolymers of L-glutamic acid and gamma ethyl-L-glutamate or ethylene vinyl acetate.
39 Gorksi teaches that the treatment of postnatal female rats with estrogen causes permanent sterility in adulthood, and disclose a method of inducing sterility wherein a single dose of 100 mg estradiol benzoate to 5-day old female rats results in permanent sterility,” [emphasis added] (see abstract). Gorski teaches that the estradiol benzoate is administered subcutaneously in oil (page 842, right column, first paragraph). And, a dose of 100 mg per rat pup at day 5 of life is equivalent to a dose of about 10 mg/kg, assuming that a 5-day old female rat pup weighs about 10 g (100 mg/10 g rat pup is equivalent to 10 mg/kg), as evidenced by Ghasemi et al. (page 1438, left column under “Pre-maturity growth”). Thus the dose amount of 10 mg/kg taught by Gorski is within the range of 1 mg/kg to 100 mg/kg required by instant claim 2.
40. Gorski teaches that said neonatal estradiol administration results in anovulatory vaginal cycles (i.e., anestrus) as adults, which meets the limitation of inhibition of maturation of sex organs/gonads required by claim 11 (see abstract). And, it is clear as evidenced by Hou et al. that a rat is a companion animal.
41. Gorski teach that the estradiol is administered in oil (page 842, right column, first paragraph), but does not teach the limitation of an extended-release formulation comprising a liposome, polymer, microparticle, nanoparticle, semipermeable polymer matrix, or a sustained release matrix.
42. However, PharmTech teaches injectable sustained-release drug delivery systems including formulations that are useful for delivering hormone drugs, and specifically teaches an oil-based injection containing an estradiol compound (see page 7 under “Commercially available injectable sustained-release drugs”). PharmTech teaches that said oil-based injectable formulations are long-acting and can sustain the release for weeks (see page 3, under “Sustained-release properties of injectables” and under “Oil-based injectable solutions and injectable drug suspensions”).
43. PharmTech additionally teach a variety of polymers for injectable sustained release/ controlled drug delivery including:
“polylactides (PLA), polyglycolides (PGA), poly(lactide-co-glycolide) (PLGA), poly(ε-caprolactone) (PCL), polyglyconate, polyanhydrides, polyorthoesters, poly(dioxanone), and polyalkylcyanoacrylates. Among the various approaches to deliver macromolecules parenterally, injectable biodegradable microspheres are the most successful systems (30). Many microsphere research reports have demonstrated the usefulness of biodegradable polymers such as PLGA microspheres (31–38), PCL microspheres (39), polyanhydride microspheres (40), polyorthoesters microspheres (41), and polyalkylcyanoacrylate microspheres (42, 43),”
(see page 6 under “Polymers in injectable sustained release”).
44. Thus, one of skill in the art before the effective filing date of the claimed invention would have been motivated to modify the oil-based hormone (estradiol) formulation of Gorski by employing a polymer or polymer microparticle as guided by and specifically named by PharmTech, to prepare an improved estradiol formulation for sustained release when administered to a neonatal rat, in order to sterilize said rat.
45. In this case, the extended-release of Applicant’s recited formulation is considered an inherent property of the known injectable oil-based estradiol benzoate formulation and are not a distinguishing characteristic per se. "The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985) (The prior art taught combustion fluid analyzers which used labyrinth heaters to maintain the samples at a uniform temperature. Although appellant showed an unexpectedly shorter response time was obtained when a labyrinth heater was employed, the Board held this advantage would flow naturally from following the suggestion of the prior art.). See also Lantech Inc.v. Kaufman Co. of Ohio Inc., 878 F.2d 1446, 12 USPQ2d 1076, 1077 (Fed. Cir. 1989), cert. denied, 493 U.S. 1058 (1990) (unpublished -- not citable as precedent) ("The recitation of an additional advantage associated with doing what the prior art suggests does not lend patentability to an otherwise unpatentable invention."). Thus one of skill in the art would reasonably expect that upon administration, Applicant’s instant oil-based estradiol benzoate composition would demonstrate an extended release of estradiol over a period of two-three weeks.
46. One skilled in the art before the effective filing date of the claimed invention would have been motivated to modify the oil-based estradiol formulation of Gorski by employing a polymer or polymer microparticle for sustained release/ controlled drug delivery as guided by PharmTech, and administer said estradiol benzoate formulation to neonatal rats for inducing permanent sterility, with the expectation that injecting said oil-based formulation would result in delayed release of estradiol benzoate over a period of two to three weeks in said neonatal rat, which meets the limitation of claims 2 and 12.
As such, claims 2, 5, 6, 11 and 12 are prima facie obvious.
Claim 8 is drawn to claim 2, wherein the estradiol benzoate is administered weeks after birth.
47. PharmTech specifically teaches an oil-based injection containing an estradiol compound, wherein said oil-based injectable formulation is long-acting, such that “[t]he administration need for these long-acting formulations only takes place every few weeks or so,” (see page 3, first paragraph under “Oil-based injectable solutions and injectable drug suspensions” and (see page 7 under “Commercially available injectable sustained-release drugs”). And, dose regimen optimization is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize given the guidance of the prior art. Optimization of parameters such as timing of administration, as guided by PharmTech’s teaching of “every few weeks or so,” is a routine practice that would be obvious for a person of ordinary skill in the art to employ.
48. One of skill in the art would have been motivated to modify the method of Gorski, wherein estradiol benzoate is administered on day 5 after birth, by delaying the administration of estradiol benzoate by a few weeks, as suggested by PharmTech, which meets the limitation of being administered “at least 2 weeks after birth.” Therefore one of skill in the art before the effective filing date of the claimed invention would have been motivated to administer the estradiol benzoate at least two weeks after birth, with a reasonable expectation of success.
As such, claim 8 is prima facie obvious.
Claim 9 is drawn to claim 2, wherein the estradiol benzoate is administered months after birth.
49. PharmTech specifically teaches an oil-based injection containing an estradiol compound, wherein said oil-based injectable formulation is long-acting, such that “[t]he administration need for these long-acting formulations only takes place every few weeks or so,” (see page 3, first paragraph under “Oil-based injectable solutions and injectable drug suspensions”). PharmTech goes on to discuss parenteral long-acting formulations comprising hormones, including oil-based solutions and suspensions that are designed to be administered via injection monthly (see page 7 under “Commercially available injectable sustained-release drugs”). And, dose regimen optimization is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize given the guidance of the prior art. Optimization of parameters such as timing of administration, as guided by PharmTech’s teaching of every few weeks or monthly administration, is a routine practice that would be obvious for a person of ordinary skill in the art to employ.
50. One of skill in the art would have been motivated to modify the method suggested by PharmTech, wherein estradiol benzoate is administered after a few weeks, or after a month, by delaying the administration by a few months, which meets the limitation of being administered “months after birth.” Thus one of skill in the art before the effective filing date of the claimed invention would have been motivated to administer the estradiol benzoate at least two months after birth, with a reasonable expectation of success.
As such, claim 9 is prima facie obvious.
51. Claims 3, 4 and 7 remain rejected under 35 U.S.C. 103 as being unpatentable over Gorksi, Am. J. Physiol. 1963, in view of the webpage printout of https://www.pharmtech.com/view/sustained-release-injectable-drug-delivery, Pharmaceutical Technology 2010, as evidenced by Ghasemi et al., EXCLI Journal 2021, and as evidenced by Hou and Protopopova, PLOS ONE 2022, as applied to claims 2, 5-6, 8, 9, 11, 12, 14 and 16-18, above, and further in view of Doughty et al., J. Endocrinology 1975.
Claim 2 is addressed in detail, above.
Claim 3 is drawn to claim 2, and limits wherein the estradiol is administered on the day of birth.
Claim 4 is drawn to claim 2, and limits wherein the estradiol is administered on the day after birth.
Claim 7 is drawn to claim 5, and limits wherein the administration is 2 days after birth.
52. Gorksi in view of PharmTech as evidenced by Ghasemi and Hou suggest a method of inducing permanent sterility in a mammal, comprising administering an effective amount of an estradiol benzoate formulation to a neonatal rat, wherein the administration is a single dose, one time administration, but do not teach said administration on the day of birth, the day after birth, or 2 days after birth.
53. Yet, Doughty et al. teach a method of administering oestradiol benzoate (aka estradiol benzoate) to postnatal rats, subcutaneously in a corn oil formulation, on days 1-5 of life, (see page 420, Experiments 1 and 2). Doughty et al. teach that following administration of oestradiol benzoate on days 1-5 of life, 100% of rats were anovulatory, i.e., oestradiol benzoate injection achieved 100% inhibition of ovulation (page 421, see Table 2).
54. As such, one of skill in the art before the effective filing date of the claimed invention would have been motivated to modify the teaching of Gorski and administer estradiol benzoate to a postnatal rat on day 1, day 2, or day 3 after birth, as guided by Doughty and known to be effective in blocking estrous and ovulation in said rat, with a reasonable expectation of success. And, dose regimen optimization is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize given the guidance of the prior art. Optimization of parameters such as timing of dose administration is a routine practice that would be obvious for a person of ordinary skill in the art to employ. Discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art. See In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Thus, claims 3, 4 and 7, are prima facie obvious.
55. Claim 15 remains rejected under 35 U.S.C. 103 as being unpatentable over Gorksi, Am. J. Physiol. 1963, in view of the webpage printout of https://www.pharmtech.com/view/sustained-release-injectable-drug-delivery, Pharmaceutical Technology 2010, as evidenced by Ghasemi et al., EXCLI Journal 2021, and as evidenced by Hou and Protopopova, PLOS ONE 2022, as applied to claims 2, 5, 6, 8, 9, 11, 12, 14 and 16-18, above, and further in view of Reilly, Brian, Medical Device and Diagnositc Industry 2006.
Claims 2 and 14 are addressed in detail, above.
Claim 15 is drawn to claim 14, wherein the polymer comprises silicone.
56. Gorksi in view of PharmTech as evidenced by Ghasemi and Hou suggest a method of inducing permanent sterility in a mammal, comprising administering an effective amount of an estradiol benzoate formulation to a neonatal rat, wherein the administration is a single dose, one time, administration, wherein said estradiol benzoate formulation is an extended-release formulation comprising a polymer carrier, wherein the release of estradiol benzoate is extended over a period of two to three weeks in said neonatal rat, but do not teach said wherein the estradiol formulation comprises silicone.
57. Yet, PharmTech teaches the inclusion of polymers in injectable sustained release hormone containing formulations, and Reilly teaches the benefits of employing silicone polymers in drug delivery applications, i.e., the versatility of silicone and its ability to control the release rate of a pharmaceutical agents, (page 3, first paragraph and page 7, first paragraph). Reilly specifically teaches an estradiol formulation comprising silicone in Figure 8 (page 7).
58. As such, one of skill in the art before the effective filing date of the claimed invention would have been motivated to modify the teaching of Gorski in order to prepare an improved controlled release formulation comprising estradiol for inducing sterility in a neonatal rat, by incorporating silicone, as guided by Reilly, in order to optimize the extended-release properties of said formulation.
As such, claim 15 is prima facie obvious.
Response to Arguments
59. Applicant traverses the previous obviousness rejections over Gorski in view of PharmTech as evidenced by Ghasemi et al. and as evidenced by Hou and Protopopova, arguing the following points:
(i) Applicant argues that Gorski administers estradiol benzoate (EB) subcutaneously in oil (i.e., a conventional oil vehicle), not a sustained-release system comprising a liposome, polymer, microparticle, nanoparticle, semipermeable polymer matrix or a sustained release matrix.
Applicant argues that Gorski demonstrates estrous cycles in the treated rats, (Table 2), and that given that the estrous cycle is regulated by sex steroid hormones originating from the ovaries, this observation suggests that the ovaries of the EB-treated animals maintained normal hormone synthesis and secretion functions. This, in turn, indicates that the hypothalamic-pituitary axis regulating ovarian function remained intact, and therefore, complete functional infertility was not achieved. Applicant alleges that Gorski does not disclose or suggest permanent sterility, such as irreversible inhibition of gonadal development, which is maintained even after drug exposure.
Applicant argues that in contrast, the data provided in the instant specification demonstrates complete functional suppression of the hypothalamus-pituitary-ovary axis by delivering an estrogen compound at a defined time and over a defined period. This is evidenced by the cessation of the estrous cycle in rats administered EB via a sustained release formulation.
60. 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). In this case, Gorski is relied upon for disclosing that a single, one-time subcutaneous administration of a formulation comprising estradiol benzoate and oil to 5-day old female rats resulted in permanent anovulatory sterility in 93.4% of said rats. PharmTech is relied upon for teaching injectable sustained-release drug delivery systems including formulations that are useful for delivering hormone drugs, and for teaching the benefits of polymers in said formulations. Nothing unobvious is seen in one skilled in the art combining the teachings of Gorksi and PharmTech in order to prepare an improved sustained release estradiol benzoate formulation for injection.
Regarding Applicant’s argument that Gorski does not disclose or suggest permanent sterility in the rat model employed because said rats show estrous cycles, this teaching does not negate the fact that in the method taught by Gorski, i.e., a single injection of 100 mg of estradiol benzoate is administered to 5-day old neonatal rats, permanent anovulatory sterility is achieved in 93.4% of said rats (page 844, left column, third paragraph). And, Gorki specifically teaches that “although the estrogen-sterilized rats show vaginal cycles, the estrous stage predominates,” (page 842, right column, first paragraph under “Results”). As the preamble of instant claim 2 recites the limitation of “a method of inducing permanent sterility in a mammal,” the method taught by Gorksi, specifically wherein a single injection of 100 mg estradiol benzoate to a neonatal female rat results in permanent sterility (see abstract), meets the limitation of claim 2.
While Applicant argues that the recited method of administering estradiol benzoate results in not just permanent sterilization but irreversible inhibition of gonadal development and cessation of the estrous cycle in rats, these features are not recited in the rejected claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
(ii) Applicant argues that PharmTech provides a review of long acting injectables and general formulation strategies for sustained release. Applicant alleges that PharmTech's long acting injectables are designed for repeated administration, i.e., its estradiol examples (HRT) are dosed monthly to maintain fertility, the exact opposite of Applicants' one-time neonatal sterilization.
Applicant argues that Ghasemi (2021) (an evidentiary reference) is a review of animal age and developmental stage on study outcomes, and does not disclose neonatal administration of estrogenic compounds, sustained release formulations, dosing to induce sterility, or sterilization of companion/livestock mammals.
Applicant argues that Hou and Protopopova (an evidentiary reference) discloses sex steroids and aggression in dogs and other species. Applicant alleges that Hou and Protopopova also provide no disclosure of administration on the date of birth or within 1-7 after birth, dosage or formulation or inducing sterility in animals.
Applicant argues that Doughty administers estradiol benzoate (EB) subcutaneously in corn oil, not a sustained- release system. Doughty does not disclose a formulation comprising a liposome, polymer, microparticle, nanoparticle, semipermeable polymer matrix or a sustained release matrix (claim 2, as amended). Further, Doughty injects the rats once per day for 5 days. As such, Doughty actually teaches away from a single, one-time administration (claim 2, as amended). Thus, Doughty also does not disclose or suggest permanent sterility, such as irreversible inhibition of gonadal development after single drug exposure.
Applicant argues that Reilly discloses silicone drug materials for drug-delivery devices (e.g., Norplant@, Femring®). Similar to PharmTech and Doughtery, these drug materials/ delivery devices have to be repeatedly administered and Reilly also does not address neonatal administration or permanent sterility.
Applicant contends that there is no reasonable expectation of success and there is no motivation to combine the cited documents.
61. 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). In this case, Gorski is relied upon for disclosing that a single, one-time subcutaneous administration of a formulation comprising estradiol benzoate and oil to 5-day old female rats resulted in permanent anovulatory sterility in 93.4% of said rats. PharmTech is relied upon for teaching injectable sustained-release drug delivery systems including formulations that are useful for delivering hormone drugs, and for teaching the benefits of polymers in said formulations. Nothing unobvious is seen in one skilled in the art combining the teachings of Gorksi and PharmTech in order to prepare an improved sustained release estradiol benzoate formulation for injection.
Ghasemi and Hou are each merely evidentiary references, wherein Ghasemi discloses the weight of a 5-day old female rat pup and Hou evidences that a rat is a companion animal.
Doughty is relied upon for suggesting estradiol benzoate administration to neonatal rats, subcutaneously in a corn oil formulation, on postnatal days 1-5. Reilly is relied upon for disclosing an estradiol benzoate formulation comprising the polymer silicone. 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, one skill in the art would have been guided by the combined prior art of record, each of which is directed to known injectable estradiol formulations and/or their administration to neonatal rats, to arrive at Applicant’s claimed invention, with a reasonable expectation of success.
Previous Double Patenting Rejections
62. 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).
63. 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).
64. 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.
65. 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.
66. Claims 2-18 remain rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 11,135,229, as evidenced by Passantino, Annamaria, Companion Animals, Journal of Animal Law 2008.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of U.S. Patent No. 11,135,229 recite the following:
PNG
media_image1.png
208
370
media_image1.png
Greyscale
PNG
media_image2.png
587
755
media_image2.png
Greyscale
67. Applicant’s instant claims are described in detail above.
The only difference between the claims of U.S. Pat. No. 11,135,229 and Applicant’s instant claims is that the patented claims limit the animal to be treated to a dog or cat.
68. Yet, it is clear as evidenced by Passantino that a companion animal is defined as “a dog, cat, or any warm-blooded, domesticated non human animal,” (page 61, under “Animal-Companion Defined).
69. As such, Applicant’s instant claims fully embrace the method of inducing permanent sterility recited by U.S. Pat. No. 11,135,229.
Response to Arguments
70. Applicant notes that Upon a notice of allowable subject matter, Applicant will consider filing a terminal disclaimer. Therefore, the previous double patenting rejections are maintained.
Conclusion
71. In conclusion, claims 2-9, 11, 12, and 14-18 are pending in the application, and all claims are rejected. No claim is presently allowable.
72. 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.
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, Amy L Clark can be reached at 571-272-1310. 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.
/JANET L COPPINS/Examiner, Art Unit 1628
/AMY L CLARK/Supervisory Patent Examiner, Art Unit 1628