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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claimed in claims 1-12,24 and 25 in the reply filed on 7/13/26 is acknowledged. Election was made without traverse of 7 days before the dry-off day.
Claims 1-14 and 21-25 are pending.
Claims 3, 5, 9, 13-14 and 21-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim.
Claims 1-2, 4, 6-8, 10-12, and 24-25 read on the elected Group and elected species and are under consideration.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-2, 4, 6-8, 10-12 and 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Ruiz et al. (J. Dairy Sci. 100:3305-3317, 2017, cited on IDS) in view of Tucker et al. (Journal of Dairy Science, Vol. 92 (7) July 2009:3194-3203).
Ruiz et al. investigated the efficacy of pegbovigrastim (Imrestor) on health and production parameters in lactating dairy cows (Abstract). Ruiz et al. teach that treated cows received Imrestor approximately 7days before expected calving and again within 24 hours after calving (Abstract and p. 3307, “Dosing Regimen” para.). Ruiz et al. teach that administration of Imrestor reduced the incidence of mastitis by 25% (p. 3309, bottom of 1st col. and Table 1). Therefore, Ruiz et al. teach inhibiting mastitis in a cow in need thereof, wherein the method comprises administering pegbovigrastim.
Ruiz et al. does not teach the pegbovigrastim is administered to the cow during the last lactation stage, including 7 days before the dry-off day. However, the teachings of Tucker et al. cure this deficiency.
Tucker et al. teach intervention in dairy cows during late lactation stage and early dry period. Tucker studied the effects of two common dry-off management procedures, feed restriction and reduced milking frequence on the behavior and udder characteristics (Abstract). In particular, Tucker et al. teach intervention in the week before dry off (Table 2). Therefore, Tucker et al. specifically identifies the approximately 7 days before dry off day as an important day for intervention during the late lactation stage. Tucker et al. teach the effects of S. uberis intramammary infection.
Please note that 7 days before dry-off day falls within the late lactation stage. Therefore, Tucker et al. teach that the late lactation stage and particularly the week before dry-off day are important periods for intervention regarding udder health and intramammary infection.
With respect to claims 7-8, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to administer pegbovigrastim taught by Ruiz et al. during the late lactation/week before dry-off day as taught by Tucker et al. in order to more effectively inhibit mastitis. A person of ordinary skill in the art would have a motivation to modify the administration days of Ruiz et al. because Tucker et al. establishes that the week before dry-off day is a well know period for intervention affecting udder characteristics and intramammary infections. Furthermore, the delivery time of an active agent is a result-effective variable and the determination of the optimum or workable ranges of said variable maybe characterized by routine experimentation (Please see MPEP 2144 II-Optimization of Ranges). In the instant case, Ruiz et al. teach administering pegbovigrastim for mastitis before expected calving and Tucker et al. teach the late lactation stage, in particular the week before dry-off day are important intervention times for udder health and intramammary infections. It would have been obvious and routine experimentation to a person of ordinary skill in the art with a reasonable expectation of success to optimize when the pegbovigrastim is administered in order to more effectively treat mastitis in cows. There is a reasonable expectation of success given that Ruiz et al. teach that pegbovigrastim was effective in treating mastitis.
With respect to claim 10, Ruiz et al. does not teach administration of antibiotics.
With respect to claims 11-12, Ruiz et al. teach administration of 15 mg of pegbovigrastim (p. 3307, 1st col.,2nd para.). As evidenced by vetadvises.com (How Much Do Holstein Cows Weigh - Vet Advises accessed 8/19/26), the average Holstein cow weighs 635-680 kg). If 15 mg is administered to a cow weighing 635-680, the dose administered is 22.1-23.6 µg/kg, meeting the limitation of 20-40 µg/kg. Please not that MPEP 2131.01 states: that an extra reference or evidence can be used to show an inherent characteristic of the thing taught by the primary reference. In the instant case, the reference is relied on to determine the average weight of the cow.
With respect to claims 1-2 and 24-25, Ruiz et al. primarily discloses pegbovigrastim for reducing the incidence of mastitis. However, Ruiz et al. further teach beneficial effects in cows experiencing mastitis. In particular, Ruiz et al. teach that the treated cows produced more milk than control cows after treatment and treatment reduced the number of medical treatment required for mastitis by 6%. It would have been obvious to one of ordinary skill in the art to administer pegbovigrastim for treatment of mastitis in cows comprising reducing the severity of a symptom of mastitis, such as reduced milk production or shortening the duration of mastitis in the cow because Ruiz et al. demonstrated that cows treated with pegbovigrastim that had mastitis exhibited improved milk production. There is a reasonable expectation of success given that Ruiz et al. show improved outcomes in pegbovigrastim treated cows.
With respect to administering the pegbovigrastim to the cow during the late lactation stage, in particular administration 7 days before the dry off day, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to administer pegbovigrastim taught by Ruiz et al. during the late lactation/week before dry-off day as taught by Tucker et al. in order to more effectively treat mastitis. A person of ordinary skill in the art would have a motivation to modify the administration days of Ruiz et al. because Tucker et al. establishes that the week before dry-off day is a well know period for intervention affecting udder characteristics and intramammary infections. Furthermore, the delivery time of an active agent is a result-effective variable and the determination of the optimum or workable ranges of said variable maybe characterized by routine experimentation (Please see MPEP 2144 II-Optimization of Ranges). In the instant case, Ruiz et al. teach administering pegbovigrastim for mastitis before expected calving and Tucker et al. teach the late lactation stage, in particular the week before dry-off day are important intervention times for udder health and intramammary infections. It would have been obvious and routine experimentation to a person of ordinary skill in the art with a reasonable expectation of success to optimize when the pegbovigrastim is administered in order to more effectively treat mastitis in cows. There is a reasonable expectation of success given that Ruiz et al. teach that pegbovigrastim was effective in treating mastitis.
With respect to claim 4, Ruiz et al. does not teach administration of antibiotics.
With respect to claim 6, Ruiz et al. teach administration of 15 mg of pegbovigrastim (p. 3307, 1st col.,2nd para.). As evidenced by vetadvises.com (How Much Do Holstein Cows Weigh - Vet Advises), the average Holstein cow weighs 635-680 kg). If 15 mg is administered to a cow weighing 635-680, the dose administered is 22.1-23.6 µg/kg, meeting the limitation of 20-40 µg/kg. Please not that MPEP 2131.01 states: that an extra reference or evidence can be used to show an inherent characteristic of the thing taught by the primary reference. In the instant case, the reference is relied on to determine the average weight of the cow.
Claims 1-2, 4, 6-8, 10-12 and 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Hays Putnam et al.(US2019/0071482) in view of Tucker et al. (Journal of Dairy Science, Vol. 92 (7) July 2009:3194-3203).
Hays et al. teach and claim a method of treating and preventing mastitis in pegylated bovine with bg-SCF, which is pegbovigrastim (claims 68, 102, 104-116, [0080,0088] Examples 1-26).
Hays et al. does not teach administration to a cow during the late lactation stage, in particular 7 days before the dry-off day. However, the teachings of Tucker et al. cure this deficiency.
Tucker et al. teach intervention in dairy cows during late lactation stage and early dry period. Tucker studied the effects of two common dry-off management procedures, feed restriction and reduced milking frequence on the behavior and udder characteristics (Abstract). In particular, Tucker et al. teach intervention in the week before dry off (Table 2). Therefore, Tucker et al. specifically identifies the approximately 7 days before dry off day as an important day for intervention during the late lactation stage. Tucker et al. teach the effects of S. uberis intramammary infection.
Please note that 7 days before dry-off day falls within the late lactation stage. Therefore, Tucker et al. teach that the late lactation stage and particularly the week before dry-off day are important periods for intervention regarding udder health and intramammary infection.
With respect to claims 1-2 and 7-8, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to administer pegbovigrastim taught by Hays et al. during the late lactation/week before dry-off day as taught by Tucker et al. in order to more effectively treat or inhibit mastitis. A person of ordinary skill in the art would have a motivation to modify the administration days of Hays et al. because Tucker et al. establishes that the week before dry-off day is a well know period for intervention affecting udder characteristics and intramammary infections. Furthermore, the delivery time of an active agent is a result-effective variable and the determination of the optimum or workable ranges of said variable maybe characterized by routine experimentation (Please see MPEP 2144 II-Optimization of Ranges). In the instant case, Hays et al. teach and claim administering pegbovigrastim for mastitis treatment and Tucker et al. teach the late lactation stage, in particular the week before dry-off day are important intervention times for udder health and intramammary infections. It would have been obvious and routine experimentation to a person of ordinary skill in the art with a reasonable expectation of success to optimize when the pegbovigrastim is administered in order to more effectively treat mastitis in cows. There is a reasonable expectation of success given that Hays et al. teach and claim that pegbovigrastim was effective in treating mastitis.
With respect to claims 4 and 10, although Hays et al. teach antibiotics may be administered [0089, 0148], the reference does not require antibiotic administration. It would have been obvious to a person of ordinary skill in the art to administer pegbovigrastim without antibiotics because the reference teaches antibiotic administration is optional. There is a reasonable expectation of success given that Hays et al. teach treatment of mastitis.
With respect to claim 6 and 11-12, Hays et al. teach the PEGylated bG-CSF is administered at a dose of 1-60 µg/kg [0649].
With respect to claims 24 and 25, the composition (pegbovigrastim) from Hays et al. reference would inherently have all of the activities and properties of the composition of claims 1 and 7. The MPEP § 2112 states: “Once a reference teaching product appearing to be substantially identical is made the basis of a rejection, and the Examiner presents evidence or reasoning tending to show inherency, the burden shifts to the Applicant to show an unobvious difference ‘[t]he PTO can require an Applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on inherency’ under 35 U.S.C. 102, on prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same…[footnote omitted].” The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzqerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (quoting In re Best, 562 F.2d 1252, 1255, 195 USPQ 430,433- 34 (CCPA 1977)).” In other words, Hays et al. and Tucker et al. make obvious administering the same composition to the same patient population at the claimed timing, therefore the severity of symptoms would be reduced and the duration of mastitis would be shortened. Moreover, MPEP 2112.01 states: “Products of identical chemical composition cannot have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Importantly, MPEP 2112 states: “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer” and “There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2, 4, 6-8, 10-12 and 24-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 11,542,310 in view of Tucker et al.
The USPN claims treatment and prevention mastitis with bG-CSF linked to PEG in a non-human animal, wherein the non-human animal is bovine (claims 1-6). PEGylated bG-CSF is pegbovigrastim. The USPN does not claim antibiotic administration. The USPN claims administration of 40µg/kg.
The USPN does not claim administration in the late lactation stage or 7 days before dry-off. However, the teachings of Tucker cure this deficiency.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to administer pegbovigrastim taught by the USPN. during the late lactation/week before dry-off day as taught by Tucker et al. in order to more effectively treat or inhibit mastitis. A person of ordinary skill in the art would have a motivation to modify the administration days of USPN because Tucker et al. establishes that the week before dry-off day is a well know period for intervention affecting udder characteristics and intramammary infections. Furthermore, the delivery time of an active agent is a result-effective variable and the determination of the optimum or workable ranges of said variable maybe characterized by routine experimentation (Please see MPEP 2144 II-Optimization of Ranges). In the instant case, the USPN claims administering pegbovigrastim for mastitis treatment and prevention and Tucker et al. teach the late lactation stage, in particular the week before dry-off day are important intervention times for udder health and intramammary infections. It would have been obvious and routine experimentation to a person of ordinary skill in the art with a reasonable expectation of success to optimize when the pegbovigrastim is administered in order to more effectively treat mastitis in cows. There is a reasonable expectation of success given that the USPN teach and claim that pegbovigrastim for treatment of mastitis.
Conclusion
No claims are allowed.
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/TARA L MARTINEZ/ Primary Examiner, Art Unit 1654
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