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
Applicant’s amendment and response, submitted August 12, 2025, has been reviewed by the examiner and entered of record in the file. Claims 1, 3, 8-12 are amended and claims 21-23 are newly added.
Election/Restrictions and
Status of the Claims
3. Claim 13 remains withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, with traverse, there being no allowable generic or linking claim.
4. The non-elected species (i.e., dairy ruminants other than bovine) remain withdrawn from consideration with traverse as directed to non-elected subject matter.
5. Claims 1-12 and 14-23 are under examination with the elected species and are the subject of this office action.
Previous Claim Rejections - 35 USC § 112
6. Claims 3 and 8-12 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. (This rejection is partially newly applied as a result of Applicant’s amendments to the claim).
7. Applicant amended claim 3 to delete “and/or” in line 2. Therefore, the previous indefiniteness rejection of claim 3 is withdrawn.
It is noted that claim 3, as amended, recites the limitation “wherein the composition is administered once one time or several times,” [emphasis added] (see claim objection, below).
8. Claims 8-12 were previously rejected for reciting a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation in the same claim.
(a) Applicant amended claim 8 to delete the recitation “preferably from 3 to 6 mg, and more specifically 5-6 mg,” therefore, the previous indefiniteness rejection of claim 8 is withdrawn.
(b) Applicant amended claim 9 to delete the recitation of “bovines, ovines, caprines, camelids or bovids” and replace with “a bovine, an ovine, a caprine, a camelid, or a bovid.” Therefore, the previous indefiniteness rejection of claim 9 is withdrawn.
(c) Applicant amended claim 10 to delete the recitation of “preferably dairy cows, sheep or goats, and more preferably dairy cows,” and to replace “ruminants” with “ruminant” and “mammals” with “mammal.” Therefore, the previous indefiniteness rejection of claim 10 is withdrawn.
(d) Applicant amended claim 11 to delete the phrase "especially within the next 12-24 hours following parturition." Therefore, the previous indefiniteness rejection of claim 11 is withdrawn.
(e) Applicant amended claim 12 to delete the recitation of “or preferably intramuscularly.” Therefore, the previous indefiniteness rejection of claim 12 is withdrawn.
Previous Claim Rejections - 35 USC § 103
9. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
10. Claims 1-11, 14-17, 19 and 20 remain rejected and claims 21-23 are newly rejected under 35 U.S.C. 103 as being unpatentable over Bach et al., Journal of Dairy Science (2015), as evidenced by Toghiani et al., Journal of Dairy Science (2023), and as evidenced by Oetzel, Gary, Merck Manual (2022), in view of Vanacker et al., Journal of Dairy Science (2017) and further in view of Lacasse et al., Animal (2019).
Claim 1, as amended, recites a method of preventing and/or reducing post-partum hypocalcemia in a dairy ruminant in need thereof, (more specifically, a milk-producing bovine that is a dairy cow (embraced by claims 9, 10 and 21)),
comprising administering a veterinary composition comprising cabergoline to the dairy ruminant during the dry period (more specifically, at dry-off (claim 14)), after the last milking (claim 4) (more specifically within the first 15-20 minutes after the last milking (claim 16 and embraced by the range recited in claims 5 and 17)),
wherein said composition is administered one time (claims 3 and 15), intramuscularly (claim 23) and wherein the administered amount of cabergoline is from 1 to 6 mg (claim 20 and embraced by the range recited in claims 7, 8, and 19), or between about 6 to 9 mg/kg (claim 18 and embraced by the range recited in claim 6).
Claim 2 is drawn to claim 1, and further limits wherein the administration of cabergoline to the dairy ruminant during the dry period reduces or anneals the risk of developing milk fever in a dairy ruminant.
Claim 11 is drawn to claim 1, and further limits wherein the administration of cabergoline to the dairy ruminant during the dry period reduces or anneals the risk of developing post-partum hypocalcemia. Claim 22 is drawn to claim 11, wherein the treatment reduces or anneals the risk of developing post-partum hypocalcemia within the next 12-24 hours following parturition.
11. Bach et al. discuss the challenges that lactating dairy cows endure at dry-off, including udder engorgement (leading to discomfort and pain), milk leakages, and lying behavior (page 7097, Abstract and right column, first paragraph under “Short Communication”). To mitigate or prevent said challenges, Bach et al. disclose a method of facilitating dry-off, comprising intramuscularly administering a composition comprising cabergoline to a dairy cow post-partum, at dry-off:
“All cows were dried-off abruptly. At drying time (right after the last milking), 99 cows received an i.m. injection of 5 mL of a solution containing 5.6 mg of cabergoline.”
(Page 7098, left column, first full paragraph).
The administration of “right after the last milking” taught by Bach et al. meets the limitation of “within the first 15-20 minutes after the last milking” required by claim 17, which time frame is also embraced by claims 4, 5 and 16. The dose amount of 5.6 mg of cabergoline taught by Bach et al. is within the scope of from 0.25 to 7 mg required by claim 7, and from 2 to 7 mg required by claim 8, and from 0.3 to 6 mg required by claim 19, and from 1 mg to 6 mg required by claim 20.
12. Regarding claims 6 and 18, as evidenced by Toghiani et al., the mean weight of dairy cows is 640.50 kg (see Table 1). Thus, the administered dose of 5.6 mg taught by Bach et al. is equivalent to a dosage amount of 8.74 mg/kg (5.6 mg = 5600 mg, divided by 640.50 kg). A dose amount of 8.74 mg/kg is within the range of between about 6 to 9 mg/kg, required by claim 18 (and within the range of between about 1 and 50 mg/kg or between 5 to 11 mg/kg, required by claim 6).
13. As such, Bach et al. disclose a method of intramuscularly administering a veterinary composition comprising 5.6 mg cabergoline to a dairy cow post-partum at dry-off, but do not teach the limitation of reducing or annealing the risk of developing milk fever or hypocalcemia.
14. Yet, it is clear as evidenced by Oetzel that milk fever, which is also known as hypocalcemia, and also known as parturient paresis, is defined as:
“a profound decrease in blood calcium concentration- typically below 5.5 mg/dL.” Oetzel teaches that dairy cows are at considerable risk for hypocalcemia/ milk fever at the onset of lactation, when daily calcium excretion suddenly increases from about 10 g to 30 g per day, stressing calcium homeostasis and potentially causing blood calcium concentrations to fall well below the normal range (Page 1, first paragraph, and the paragraph under “Etiology of Parturient Paresis in Cows”).
15. And, Vanacker et al. teach that the post-partum administration of the prolactin inhibitor quinagolide (QUIN) to dairy cows results in increased blood calcium concentrations, relative to control (CTL) cows:
“Blood concentrations of calcium increased during the first week of lactation (P < 0.001; Figure 3D) and were higher (P = 0.05) in the QUIN cows than in the CTL cows.”
(Page 5787, left column, second paragraph). The quinagolide was administered just after calving, which meets the limitation of post-partum (see Figure 2 and Figure 3 summary, page 5787).
15. Vanacker et al. conclude that in their present experiment,
“lower blood BHB concentrations, as well as higher blood glucose and calcium concentrations, were observed in the QUIN cows.”
(Page 5789, right column, last paragraph, first sentence).
16. As such, one of skill in the art would have had awareness that a lactating dairy cow is at risk for hypocalcemia/ milk fever, and therefore in need of an increase in blood calcium concentrations, i.e., meets the limitation of a cow in need thereof, such that it would have been obvious to one of skill in the art before the effective filing date of the claimed invention to administer the prolactin inhibitor quinagolide to said cow. One skilled in the art before the effective filing date of the claimed invention would have been motivated to administer quinagolide to said dairy cow in need thereof, and would have had had a reasonable expectation of success because by virtue of increasing blood calcium levels in a post-partum dairy cow, one is reducing the risk of developing milk fever or post-partum hypocalcemia (characterized by low blood calcium levels).
17. And, Lacasse et al. suggest the benefits of inhibiting prolactin (PRL) in post-partum dairy ruminants, wherein:
“the inhibition of PRL could be a strategy for facilitating drying-off, reducing metabolic stress during the postpartum period, and alleviating acute nutritional stress during illness without compromising the overall productivity of dairy ruminants,” (Abstract, last sentence).
In particular, Lacasse et al. discuss the prolactin inhibitors quinagolide and cabergoline in dairy ruminants:
“the inhibition of PRL secretion by the dopamine agonists quinagolide and cabergoline causes a sharp decline in milk production and could be useful in several critical periods… and both quinagolide and cabergoline induced more rapid changes in several markers of mammary gland involution after drying-off.”
(Abstract).
Lacasse et al. go on to teach that the prolactin inhibitor quinagolide decreased milk production within the first day of treatment (Abstract), (a rapid reduction in milk production would necessitate increased blood calcium concentrations), where the first day of treatment meets the limitation of 12-24 hours, required by claim 22.
18. Thus, it would have been obvious to one of skill in the art before the effective filing date of the claimed invention to modify Vanacker et al. and substitute the instantly recited prolactin inhibitor cabergoline for quinagolide in order to rapidly reduce milk production in a dairy cow during the post-partum period, thereby increasing blood calcium concentrations in said dairy cow, with a reasonable expectation of success. One of skill in the art would have been motivated before the effective filing date of the claimed invention to administer cabergoline to facilitate dry-off in a dairy cow to prevent the sharp decline in blood calcium concentration in said cow, thereby reducing the risk of developing hypocalcemia (milk fever), with a reasonable expectation of success. And, as noted by the court in In re Font, 675 F.2d 297 (CCPA 1982), an express suggestion to substitute one equivalent component (i.e., an equivalent prolactin inhibitor) for another is not necessary to render such substitution obvious. In the instant case, (1) the prior art element of Vanacker et al. performs the function specified in the claim with only insubstantial differences (i.e., reduces the risk of hypocalcemia and milk fever by increasing blood calcium concentrations); (2) the claimed component (i.e., cabergoline, a prolactin inhibitor) and its function was known in the art; (3) a person of ordinary skill in the art would have recognized the interchangeability of the elements and could have substituted one known element for another; and (4) the results of the substitution would have been predictable.
As such, claims 1-11, 14-17, and 19-23 are prima facie obvious.
New Claim Rejections - 35 USC § 103
19 Claim 12 is newly rejected under 35 U.S.C. 103 as being unpatentable over Bach et al., Journal of Dairy Science (2015), as evidenced by Toghiani et al., Journal of Dairy Science (2023), and as evidenced by Oetzel, Gary, Merck Manual (2022), in view of Vanacker et al., Journal of Dairy Science (2017) and in view of Lacasse et al., Animal (2019), as applied to claims 1-11, 14-17, and 19-23, above, and further in view of Isaka and Bertaim, U.S. Pub. No. 2014/0024670 A1.
(This rejection is newly applied as a result of Applicant’s amendment to claim 12).
Claim 1 is addressed in detail, above.
Claim 12 is drawn to claim 1, and limits wherein the composition is intramammary administered.
20. Bach et al. as evidenced by Toghiani et al. and as evidenced by Oetzel, in view of Vanacker et al. and in view of Lacasse et al. teach the administration of cabergoline to facilitate dry-off in a postpartum dairy cow, in order to prevent the sharp decline in blood calcium concentration in said cow, thereby reducing the risk of developing hypocalcemia, but do not teach intramammary administration.
21. Yet, Isaka teaches the administration of dopamine receptor agonist compounds that are prolactin inhibitors to milk-producing dairy ruminants, preferably dairy cows (paragraph [0056]) during the dry period (paragraph [0055]), specifically a veterinary composition comprising the prolactin inhibitor cabergoline (see Example 1 at page 5). Isaka teaches intramammary route of administration (paragraph [0057]).
22. Thus, in view of the combined prior art of record, it would have been obvious to one skilled in the art before the effective filing date of the claimed invention to administer a veterinary composition comprising cabergoline via intramammary route to a postpartum dairy cow in order to facilitate dry-off in said cow, thereby reducing the risk of developing hypocalcemia in said cow. One of skill in the art would have been motivated to administer a veterinary composition comprising cabergoline intramammarily during dry off to a dairy cow, in order to reduce hypocalcemia in said cow, and would had a reasonable expectation of success.
As such, claim 12 is prima facie obvious.
Response to Arguments
23. Applicant traverses the obviousness rejection, and argues the following points:
(i) Applicant argues that Bach et al. disclose intramuscular administration of cabergoline to dairy cows at dry-off "to mitigate or prevent udder engorgement, milk leakages, and discomfort" (p. 7097-7098). Applicant contends that Bach's animals are not selected for risk of post-partum hypocalcemia, and Bach is entirely silent on calcium homeostasis, blood calcium levels, or prevention of milk fever. Applicant alleges that there is no disclosure or suggestion that Bach's administration treats or prevents hypocalcemia in any subset of cows.
Applicant argues that Bach's disclosure addresses all cows at dry-off without regard to calcium status, and without recognition of the claimed condition, therefore it does not teach the claimed population "in need of” hypocalcemia prevention.
24. 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, Bach et al. teach a method of facilitating dry-off in order to mitigate the deleterious effects of prolactin secretion, comprising administering a composition comprising the anti-prolactin cabergoline to a dairy cow post-partum, at dry-off. Oetzel evidences that dairy cows are at considerable risk for hypocalcemia/ milk fever at the onset of lactation. Vanacker is relied upon for teaching that when a prolactin inhibitor is administered post-partum to dairy cows, an increase in blood calcium concentrations was observed, and Lacasse discuss the benefits of administering anti-prolactins including cabergoline at dry-off. As such, nothing unexpected is seen in administering a composition comprising the prolactin inhibitor cabergoline to a post-partum dairy cow, known to be at considerable risk for hypocalcemia, at dry off, wherein one of skill in the art would reasonably expect that said administration of a composition comprising cabergoline would result in an increase in blood calcium concentration, thus reducing the risk of hypocalcemia.
(ii) Applicant argues that Oetzel teaches that dairy cows are at considerable risk for hypocalcemia at the onset of lactation when calcium excretion increases. Applicant argues that Vanacker describes administering the prolactin inhibitor quinagolide post-partum, during the first week of lactation, which resulted in higher blood calcium concentrations relative to control. Applicant alleges that neither reference teaches, suggests, or motivates administering any prolactin inhibitor during the dry period, when lactation has ceased and calcium demands are physiologically different, for the purpose of preventing hypocalcemia after calving. In fact, Vanacker's results are linked specifically to the early lactation stage, a time of markedly different endocrine and metabolic profiles from the dry period.
Applicant argues that the Examiner's reasoning imports Vanacker's calcium effect (observed with quinagolide post-calving) into Bach's dry-off administration of cabergoline: “[t]his is hindsight reconstruction.”
25. Applicant's arguments have been fully considered but they are not persuasive. In response to Applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the Applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In this case, Bach et al. teach a method of facilitating dry-off in order to mitigate the deleterious effects of prolactin secretion, comprising administering a composition comprising the anti-prolactin cabergoline to a dairy cow post-partum, at dry-off. It is noted that Oetzel is relied upon as a factual reference, i.e., Oetzel evidences that dairy cows are at considerable risk for hypocalcemia/ milk fever at the onset of lactation. Vanacker is relied upon for teaching that when a prolactin inhibitor is administered post-partum to dairy cows, an increase in blood calcium concentrations was observed. Taken together, one of skill in the art would reasonably assume that administering a composition comprising the prolactin inhibitor cabergoline to a post-partum dairy cow at dry off (as taught by Bach et al.), wherein a post-partum lactating cow is known to be at considerable risk for hypocalcemia, one of skill in the art would reasonably expect that said administration would result in an increase in blood calcium concentration, thus reducing the risk of hypocalcemia in said cow.
(iii) Applicant argues that Lacasse mentions that prolactin inhibition (by quinagolide or cabergoline) can facilitate drying-off and reduce metabolic stress during the postpartum period, but does not disclose or suggest that cabergoline, when administered during the dry period, has any effect on post-partum calcium concentrations or hypocalcemia risk.
Applicant contends that the dry period is a non-lactating stage characterized by low calcium demand, mammary gland involution, and different hormonal balance from the early lactation period. Strategies effective post- partum cannot simply be transposed to the dry period with a reasonable expectation of success, because the calcium homeostasis challenge (and the physiological triggers thereof) are absent at dry-off. The art provides no teaching or suggestion that dry-period administration of cabergoline would have any effect on calcium levels or hypocalcemia risk after calving.
26. 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, the primary reference, Bach et al., teaches a method of facilitating dry-off in order to mitigate the deleterious effects of prolactin secretion, comprising administering a composition comprising the anti-prolactin cabergoline to a dairy cow post-partum, at dry-off (i.e., during the dry period). Oetzel evidences that dairy cows are at considerable risk for hypocalcemia/ milk fever at the onset of lactation. Vanacker is relied upon for teaching that when a prolactin inhibitor is administered post-partum to dairy cows, an increase in blood calcium concentrations was observed. Lacasse teaches the advantages of administering anti-prolactins including cabergoline at dry-off. In view of the combined prior art of record, nothing unexpected is seen in administering a composition comprising the prolactin inhibitor cabergoline to a post-partum dairy cow, known to be at considerable risk for hypocalcemia, at dry off. The timing of administration, during the dry period, is set forth by Bach et al. Thus, one of skill in the art would reasonably expect that administering said composition comprising cabergoline at dry-off would result in an increase in blood calcium concentration, thus reducing the risk of hypocalcemia.
Double Patenting
27. 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).
28. 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).
29. 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.
30. 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.
31. Claims 1-12 and 14-20 remain provisionally rejected and claim 21 is newly rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 17/793,324 (reference application), as evidenced by Oetzel, Gary, Merck Manual (2022).
32. 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 recites a method of preventing and/or reducing post-partum hypocalcemia in a dairy ruminant, (more specifically, a dairy cow (claims 9-10 and 21)), wherein the administration of cabergoline to the dairy ruminant during the dry period reduces or anneals the risk of developing milk fever in a dairy ruminant (claim 2),
comprising administering a veterinary composition comprising cabergoline to the dairy ruminant during the dry period (more specifically, at dry-off (claim 14)), after the last milking (claim 4) (more specifically within the first 15-20 minutes after the last milking (claim 16 and embraced by the range recited in claims 5 and 17)),
wherein said composition is administered once (claims 3 and 15), intramuscularly (claim 12) and wherein the administered amount of cabergoline is from 1 to 6 mg (claim 20 and embraced by the range recited in claims 7, 8, and 19), or between about 6 to 9 mg/kg (claim 18 and embraced by the range recited in claim 6).
Claim 11 is drawn to claim 1, and further limits wherein the administration of cabergoline to the dairy ruminant during the dry period reduces or anneals the risk of developing post-partum hypocalcemia, especially within the next 12-24 hours following parturition.
33. The claims of Application No. 17/793,324 recite the following composition and kit thereof:
1. A veterinary composition comprising cabergoline for use to reduce milk production of a dairy ruminant, wherein said composition is administered into said dairy ruminant by intramammary route.
2. The veterinary composition for use according to claim 1, wherein the composition is administered at the time of the implementation of the dry period.
3. The veterinary composition for use according to claim 1, wherein the composition is administered at the time of the dry-off, after the last milking, preferably within the first 5, first 4, or first 2 hours after the last milking.
4. The veterinary composition for use according to claim 1, wherein the therapeutic dose of cabergoline is between 1 and 50 μg/kg, or between 5 and 50 μg/kg, preferably about 5 to 11 μg/kg, and more preferably about 6 to 9 μg/kg.
5. The composition for use according to claim 1, wherein the composition is administered in one or more quarters of the mammary gland by introduction of the composition via infusion, implantation, injection, or a combination thereof.
6. The composition for use according to claim 1, wherein the composition is administered to all quarters of the mammary gland of the ruminant.
7. The composition for use according to claim 1, wherein the amount of cabergoline which is intramammary administered is from 0.25 to 7 mg, preferably from 0.3 to 6 mg, and more specifically 1-6 mg, per dairy ruminant.
8. The composition for use according to claim 1, wherein the amount of cabergoline which is intramammary administered is from 2 to 7 mg, preferably from 3 to 6 mg, and more specifically 5-6 mg, per dairy cow.
9. The composition for use according to claim 1, characterized in that the ruminants are herbivorous mammals selected from bovines, ovines, caprines, camelids or bovids.
10. The composition for use according to claim 1, wherein the ruminants are milk-producing ruminant mammals, preferably dairy cows, cheeps or goats, and more preferably dairy cows.
11. A kit for reducing milk production of a dairy ruminant, wherein said kit includes at least one compartment for a packaging including an effective therapeutic amount of cabergoline, for intramammary administration to ruminants.
12. The kit according to claim 11, which also includes the means enabling the administration of the cabergoline composition by intramammary route and/or instructions relating to the mode and time of administration of the veterinary compositions.
34. Instant claims 1-12 and 14-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Application No. 17/793,324. Although the claims at issue are not identical, they are not patentably distinct from each other because the Application No. 17/793,324 recites a veterinary composition comprising cabergoline, while the instant claims recite a method of using a veterinary composition comprising cabergoline to prevent or reduce the risk of developing post-partum hypocalcemia and milk fever. And, as evidenced by Oetzel, dairy cows are at considerable risk for hypocalcemia/ milk fever at the onset of lactation.
35. The instant claims simply claim the method of treatment that was disclosed in the specification of Application No. 17/793,324, i.e.:
“The compositions used according to the invention thus prevent from hypocalcemia or diminish the risk of developing hypocalcemia, especially within the first 24 hours after dry-off”
(Page 5, last paragraph).
36. In Sun Pharmaceutical Industries, Ltd, v. Eli Lilly And Company (2010), the district court followed the double patenting analysis of the Geneva line of cases, which address the situation in which an earlier patent claims a compound, disclosing the utility of that compound in the specification, and a later patent claims a method of using that compound for a particular use described in the specification of the earlier patent. See Pfizer, 518 F.3d at 1363; and Geneva, 349 F.3d at 1385.In both of these cases, the Federal Circuit found claims of a later patent invalid for obviousness-type double patenting where an earlier patent claimed a compound, disclosing its utility in the specification, and a later patent claimed a method of using the compound for a use described in the specification of the earlier patent.
As such, claims 1-12 and 14-21 are obvious over the claims of Application No. 17/793,324.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
37. Applicant traverses the double patenting rejection over copending application 17/793,324 in view of Oetzel.” Applicant argues that:
“Oetzel is also a primary reference in the 103 rejection, and Applicant has traversed that combination. The present claims are directed to a distinct inventive concept, the timing of cabergoline administration during the dry period for hypocalcemia prevention, which is not claimed in the reference application.”
(Applicant’s remarks, page 8).
Applicant requests withdrawal of the rejection or that the rejection be held in abeyance until scope of the claims in each application is determined.
38. Applicant's arguments have been fully considered but they are not persuasive. As an initial matter, it is noted that Oetzel is relied upon in both the 103 rejection and the double patenting rejection as an evidentiary reference, i.e., a reference cited to show a universal fact (aka a factual reference, not a primary reference). In this case, Oetzel evidences that dairy cows are at considerable risk for hypocalcemia/ milk fever at the onset of lactation.
39. As to “the timing of cabergoline administration during the dry period for hypocalcemia prevention,” the claims of Application No. 17/793,324 recite a cabergoline composition that is intended to be administered at the time of the implementation of the dry period. Applicant’s instant claims are directed to administering the same composition during the dry period. As the range of time “during the dry period” fully embraces “at the time of the implementation of the dry period,” nothing unobvious is seen in one skilled in the art employing the method of use previously disclosed in the Specification of Application No. 17/793,324, for administering the same composition recited by the claims of Application No. 17/793,324.
As such, the double patenting rejection is maintained.
Claim Objections
40. Claim 1 was previously objected to for failing to define a distinct patient population, i.e., a dairy ruminant in need thereof.
In view of Applicant’s amendment to claim 1 to incorporate the phrase “in need thereof,” the previous objection is withdrawn.
41. Claim 3, as amended, is objected to for reciting the limitation: “wherein the composition is administering once one time or several times,” [emphasis added]. It is recommended that the term “once” be deleted.
Conclusion
42. In conclusion, claims 1-23 are pending in the application. Claim 13 is presently withdrawn as directed to non-elected subject matter. Claims 1-12 and 14-23 are rejected. No claim is presently allowed.
43. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to 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 on 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