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 .
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1 – 3 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more. The claims recite a composition for improving cow reproductive ability comprising p-cresol as an active ingredient, wherein the improving of the cow reproductive ability is to shorten a first return to estrous day after calving. P-cresol exists in nature, as a marker for estrus in the urine of agriculture animals.
Moreover, there is no indication in the specification that p-cresol within the composition has any characteristics (structural, functional, or otherwise) that are different from the naturally occurring component. Thus, p-cresol in the composition does not have markedly different characteristics from their natural counterparts in their natural state, and are “product of nature” exceptions. Accordingly, the claim is directed to a judicial exception. Furthermore, while claim 2 recites the inclusion of was where the wax is selected from paraffin wax, beeswax wax, wood wax and carnauba wax. All of the wax options recited in claim 2 are also natural products that are material indistinct from their versions found in nature. Thus the recitation of waxes in claim 2 still does not integrate or provide significantly more than the judicial exemption for the composition of claim 1.
This judicial exception is not integrated into a practical application because the claims do not recite any elements in addition to the naturally occurring products. Furthermore as stated above, the waxes listed in claim 2 are not material indistinct from their versions found in nature. As taught by the prior art, P-cresol is a natural metabolite realized in the urine of animal that go through an estrus cycle. Hence, the claims do not amount to significantly more because they do not recite any elements in addition to the naturally occurring products. The applicant is advised that in order to overcome the rejection, applicant could amend the claim 1 to include or require specific, non-natural ingredients in the composition or demonstrate that p-cresol does something markedly different than what the prior art teach.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Muniasamy et. al. ((2017), P-cresol and oleic acid as reliable biomarkers of estrus: evidence from synchronized Murrah buffaloes, Iranian Journal of Veterinary Research, 18, 124 – 127; cited on the ISR and IDS).
Regarding claim 1, Muniasamy et. al. teach that low reproduction potential of buffaloes has been a major concern for decades, which streamed towards a substantial economic loss to developing countries. See page 124 column 1 paragraph 1. Moreover, Muniasamy et. al. teach that poorly timed artificial insemination (AI) due to failure in estrus detection would lead to low rate of conception. See page 124 column 1 paragraph 1. Likewise, Muniasamy et. al. teach that pheromones present in the body fluids of female during estrus elicit behavioral changes in males. See page 124 column 1 paragraph 1. Thus Muniasamy et. al. teach a study to determine the bull’s reproductive behavior towards the urine of synchronized animals and (ii) to examine the urinary volatile compounds in synchronized buffaloes to confirm the presence of estrus-specific compounds ascertained during natural estrus. See page 124 column 1 paragraph 2 and column 2 paragraph 1. Muniasamy et. al. teach the collection of midstream urine samples from six healthy heifer Murrah buffalo at pre-estrus (days 1-9), estrus (days 11-12), and post-estrus (days 15-18) based on CIDR treatment protocol. See page 124 column 2 paragraph 1.
Specifically, Muniasamy et. al. teach that volatiles such as phenol, 3-propylphenol, 9-octadecenal, and 3-methylbutanol, that is p-cresol were found only in estrus urine. See page 126 column 2 paragraph 1. See claim 1 limitation for a composition comprising p-cresol. Specifically, Muniasamy et. al. teach that volatiles such as phenol, 3-propylphenol, 9-octadecenal, and 3-methylbutanol, that is p-cresol were found only in estrus urine. See page 126 column 2 paragraph 1.
Moreover, Muniasamy et. al. teach that estrus signaling compounds from urine was suggested to lead bulls to perform flehmen reaction, and later to more intense mounting behavior. See page 126 column 2 paragraph 2 and page 127 column 1 paragraph 1. Additionally, Muniasamy et. al. teach that the female buffalo could be hormonally regulated to exhibit estrus through synchronization process and the characteristic estrus-specific volatile compounds released during normal estrous cycle are also expressed in synchronized buffaloes. See page 127 column 1 paragraph 3.Thus, Muniasamy et. al. teach that the bulls displayed significant flehmen, and mounting behavior towards the compounds present during estrus urine in synchronized buffaloes. See page 127 column 1 paragraph 3. Furthermore, Muniasamy et. al. teach that based on behavioral observations p-cresol and oleic acid are the two volatile compounds of estrus phase involved in influencing the sexual arousal and reproductive behavior of bull. See page 127 column 1 paragraph 3. Hence, Muniasamy et. al. suggest the feasibility of influencing the sexual arousal and reproductive behavior of bulls towards cows through the presence of p-cresol. Thus, Muniasamy et. al. suggest the feasibility of influencing the sexual arousal and reproductive behavior of bulls towards cows thus increasing the chances of a reproductive event by increasing mounting behavior in bulls.
Even though preamble of claim 1 recites a composition for improving cow reproductive ability; the preamble does not provide any structural limitation to the composition as recited in claim 1. Thus the preamble, for improving cow reproductive ability, is a statement of purpose or use. Therefore, if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020). See MPEP 2111.02(II). Thus the estrus urine sample of Muniasamy et. al. which comprises p-cresol anticipates a composition comprising p-cresol.
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 2 – 6 are rejected under 35 U.S.C. 103 as being unpatentable over Muniasamy et. al. ((2017), P-cresol and oleic acid as reliable biomarkers of estrus: evidence from synchronized Murrah buffaloes, Iranian Journal of Veterinary Research, 18, 124 – 127; cited on the ISR and IDS) in view of Yapura et. al. ((2015), Formulation and testing of a non-steroidal aromatase inhibitor intravaginal device for the control of ovarian function in cattle, Animal Reproductive Science, 156, 91 – 102) and Ribeiro Junior et. al. ((2022), Chemistry, biological activities, and uses of carnauba wax. In Gums, resins and latexes of plant origin: Chemistry, biological activities and uses (pp. 1-23). Cham: Springer International Publishing).
Regarding claims 2 – 6, Muniasamy et. al. teach that low reproduction potential of buffaloes has been a major concern for decades, which streamed towards a substantial economic loss to developing countries. See page 124 column 1 paragraph 1. Moreover, Muniasamy et. al. teach that poorly timed artificial insemination (AI) due to failure in estrus detection would lead to low rate of conception. See page 124 column 1 paragraph 1. Likewise, Muniasamy et. al. teach that pheromones present in the body fluids of female during estrus elicit behavioral changes in males. See page 124 column 1 paragraph 1. Thus Muniasamy et. al. teach a study to determine the bull’s reproductive behavior towards the urine of synchronized animals and (ii) to examine the urinary volatile compounds in synchronized buffaloes to confirm the presence of estrus-specific compounds ascertained during natural estrus. See page 124 column 1 paragraph 2 and column 2 paragraph 1. Muniasamy et. al. teach the collection of midstream urine samples from six healthy heifer Murrah buffalo at pre-estrus (days 1-9), estrus (days 11-12), and post-estrus (days 15-18) based on CIDR treatment protocol. See page 124 column 2 paragraph 1.
Specifically, Muniasamy et. al. teach that volatiles such as phenol, 3-propylphenol, 9-octadecenal, and 3-methylbutanol, that is p-cresol were found only in estrus urine. See page 126 column 2 paragraph 1.
Moreover, Muniasamy et. al. teach that estrus signaling compounds from urine was suggested to lead bulls to perform flehmen reaction, and later to more intense mounting behavior. See page 126 column 2 paragraph 2 and page 127 column 1 paragraph 1. Additionally, Muniasamy et. al. teach that the female buffalo could be hormonally regulated to exhibit estrus through synchronization process and the characteristic estrus-specific volatile compounds released during normal estrous cycle are also expressed in synchronized buffaloes. See page 127 column 1 paragraph 3.Thus, Muniasamy et. al. teach that the bulls displayed significant flehmen, and mounting behavior towards the compounds present during estrus urine in synchronized buffaloes. See page 127 column 1 paragraph 3. Furthermore, Muniasamy et. al. teach that based on behavioral observations p-cresol and oleic acid are the two volatile compounds of estrus phase involved in influencing the sexual arousal and reproductive behavior of bull. See page 127 column 1 paragraph 3.
However, Muniasamy et. al. fail to teach a composition the includes at least one wax selected from the group consisting of paraffin wax, bees wax, wood wax, and carnauba wax. See claim 2. Moreover, Muniasamy et. al. fail to teach a composition where the p-cresol is included in an amount of 0.1 to 5 wt% based on the entire composition. See claim 3. Furthermore, while Muniasamy et. al. suggest a way to influence the sexual arousal and mounting behavior of cows, that is cow reproductive ability, through the presence of p-cresol; Muniasamy et. al. fail to teach a method comprising mixing p-cresol with at least one wax selected from the group consisting of paraffin wax, bees wax, wood wax, and carnauba wax. See claim 4. Moreover, Muniasamy et. al. fail to teach a method where the wax is in a liquid state. See claim 5. Furthermore, Muniasamy et. al. fail to teach a method where the composition comprising p-cresol is mixed with 95 to 99.9 wt% of the wax and 0.1 to 5 wt% of the p-cresol. See claim 6.
Nevertheless, Yapura et. al. teach that control of the estrous cycle in animal species of commercial interest, such as cattle, impacts the efficiency and economy of meat and milk production. See page 92 column 1 paragraph 1. Yapura et. al. teach that there are numerous treatments and protocols that have been used to control reproductive events in animals; however, many of these protocols involve the administration of exogenous hormones in food producing animals. See page 92 column 1 paragraph 1. Consequently, Yapura et. al. teach that reproductively active steroid hormones, such as estradiol, are perceived as having a particularly negative impact on consumer health leading to a ban on the use of steroid hormones in food producing animals in the European Union, New Zealand, and Australia. See page 92 column 1 paragraph 1. As such, Yapura et. al. teach the potential of nonsteroidal aromatase inhibitors as an alternative for controlling ovarian function in cattle. See page 92 column 1 paragraph 2. Specifically, Yapura et. al. teach that a wax-based formulation containing 10% letrozole, as ovarian controlling compound, 10% Phospholipon90 H; 5%cholesterol; 2%DOPE;and Suppocire D q.s.to 100% were prepared by heating to 65 ◦C and vertexing for a uniformed formulation. Thus, Yapura et. al. teach a composition comprising 10 % of an ovarian function modulator and 73 % of Suppocire D q.s. which is a wax. See page 93 column 2 paragraph 1. See claim 4 limitation for a method where the p-cresol and wax are mixed. See claim 5 limitation for a method where the wax is a liquid. Furthermore, Yapura et. al. teach that intravaginal delivery of the wax differentially affected ovarian function in cattle. See page 93 column 2 paragraph 1.
While the prior art of Yapura et. al. teach a composition of 10 % by weight of a reproduction controlling agent; claim 3 recites that p-cresol, as the reproductive controlling agent be in the amount of 0.1 to 5 wt % based on the entire composition. Given that the skill level of one of ordinary skill in the veterinary pharmaceutical arts is fairly high and giving the teaching of Yapura et. al. for a wax formulation it would have been within the purview of one of ordinary skill in the art to take the example formulation of Yapura et. al. and try to formulate a composition with p-cresol. Moreover, in the effort to try to optimize the composition it would have been obvious to one of ordinary skill in the art to make a composition comprising p-cresol at 0.1 to 5 wt %. Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). See MPEP 2144.05 (I).
Furthermore, while the prior art of Yapura et. al. teach a composition of 10 % by weight of a reproduction controlling agent with 10% Phospholipon90 H; 5%cholesterol; 2% 1.2-Dioleoyl-sn-Glycero-3-Phosphoethanolamine (DOPE);and Suppocire D (a wax) q.s.to 100%; claim 6 recites that p-cresol, as the reproductive controlling agent be in the amount of 0.1 to 5 wt % and that the wax is 95 – 99.9 wt% based on the entire composition. Given that the skill level of one of ordinary skill in the veterinary pharmaceutical arts is fairly high and giving the teaching of Yapura et. al. for a wax formulation it would have been within the purview of one of ordinary skill in the art to take the example formulation of Yapura et. al. and try to formulate a composition with p-cresol and a wax. Moreover, it the effort to try a optimize the composition it would have been obvious to one of ordinary skill in the art to make a composition comprising p-cresol at 0.1 to 5 wt % and a wax at 95 – 99.9 % wt. Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). See MPEP 2144.05 (I).
However, while Muniasamy et. al. does teach a composition comprising a wax; Muniasamy et. al. fail to teach a composition the includes at least one wax selected from the group consisting of paraffin wax, bees wax, wood wax, and carnauba wax. See claims 2 and 4.
Nevertheless, Ribeiro Junior et. al. teach that carnauba wax is a natural “vegetable” wax derived from the leaves of the carnauba palm (Copernicia prunifera (Miller) H. E. Moore) family – Arecaceae
(Fig. 1), a Brazilian plant found exclusively in the arid climate of the northeast caatingas under economic circumstances (scrublands). See page 3 paragraph 1. Furthermore, Ribeiro Junior et. al. teach that carnauba wax is extensively utilized in the chemical, pharmaceutical, food, cosmetic, computer, and automotive sectors because of its antioxidant, photoprotective, and stable characteristics due to its lipophilic and nonpolar nature. See page 3 paragraph 1 and page 4 paragraph 1. Additionally, Ribeiro Junior et. al. teach that carnauba wax is the strongest, with melting point (84 oC) of any commercialized natural wax, has a limited solubility (insoluble in water but is soluble in alcohols and oils), and is mostly composed of aliphatic esters and cinnamic acid diesters. See page 4 paragraph 3. Moreover, Ribeiro Junior et. al. teach that many waxes are utilized for ointments, creams, and lotions, including for the production of tablet formulations and tablet coatings by the pharmaceutical industry. See page 15 paragraph 1. In addition, Ribeiro Junior et. al. teach that carnauba wax is a great alternative to promote the prolonged release of mini-tablets and that it reduces the interaction of drug particles with dissolving medium and delays the disintegration medium with drug release rate. See page 15 paragraph 1.
Therefore, it would have been obvious before the effective filing date of the instant application to use the observation of Muniasamy et. al. that is for the presence of p-cresol as an estrus indicator in a method of improving cow reproductivity ability comprising increasing p-cresol presence on the cow in view of Muniasamy et. al., that is to formulate the p-cresol with wax in further view of Ribeiro Junior et. al., that is for the use of carnauba wax. One of ordinary skill in the art would have been motivated to make this modification to improve reproductive efficiency by improving the rate of successful copulation. One of ordinary skill in the art would have had a reasonable expectation for success because the natural presence of p-cresol in urine of estrus cows cause an increase in mounting behavior in males.
Claim 7 is are rejected under 35 U.S.C. 103 as being unpatentable over Muniasamy et. al. ((2017), P-cresol and oleic acid as reliable biomarkers of estrus: evidence from synchronized Murrah buffaloes, Iranian Journal of Veterinary Research, 18, 124 – 127; cited on the ISR and IDS).
Regarding claim 7, Muniasamy et. al. teach that low reproduction potential of buffaloes has been a major concern for decades, which streamed towards a substantial economic loss to developing countries. See page 124 column 1 paragraph 1. Moreover, Muniasamy et. al. teach that poorly timed artificial insemination (AI) due to failure in estrus detection would lead to low rate of conception. See page 124 column 1 paragraph 1. Likewise, Muniasamy et. al. teach that pheromones present in the body fluids of female during estrus elicit behavioral changes in males. See page 124 column 1 paragraph 1. Thus Muniasamy et. al. teach a study to determine the bull’s reproductive behavior towards the urine of synchronized animals and (ii) to examine the urinary volatile compounds in synchronized buffaloes to confirm the presence of estrus-specific compounds ascertained during natural estrus. See page 124 column 1 paragraph 2 and column 2 paragraph 1. Muniasamy et. al. teach the collection of midstream urine samples from six healthy heifer Murrah buffalo at pre-estrus (days 1-9), estrus (days 11-12), and post-estrus (days 15-18) based on CIDR treatment protocol. See page 124 column 2 paragraph 1.
Specifically, Muniasamy et. al. teach that volatiles such as phenol, 3-propylphenol, 9-octadecenal, and 3-methylbutanol, that is p-cresol were found only in estrus urine. See page 126 column 2 paragraph 1.
Moreover, Muniasamy et. al. teach that estrus signaling compounds from urine was suggested to lead bulls to perform flehmen reaction, and later to more intense mounting behavior. See page 126 column 2 paragraph 2 and page 127 column 1 paragraph 1. Additionally, Muniasamy et. al. teach that the female buffalo could be hormonally regulated to exhibit estrus through synchronization process and the characteristic estrus-specific volatile compounds released during normal estrous cycle are also expressed in synchronized buffaloes. See page 127 column 1 paragraph 3.Thus, Muniasamy et. al. teach that the bulls displayed significant flehmen, and mounting behavior towards the compounds present during estrus urine in synchronized buffaloes. See page 127 column 1 paragraph 3. Furthermore, Muniasamy et. al. teach that based on behavioral observations p-cresol and oleic acid are the two volatile compounds of estrus phase involved in influencing the sexual arousal and reproductive behavior of bull. See page 127 column 1 paragraph 3. Thus, Muniasamy et. al. suggest a method to influence the sexual arousal and mounting behavior of cows, that is cow reproductive ability, through the presence of p-cresol.
Therefore, it would have been obvious before the effective filing date of the instant application to use the observation of Muniasamy et. al. that is for the presence of p-cresol as an estrus indicator in a method of improving cow reproductivity ability comprising increasing p-cresol presence on the cow. One of ordinary skill in the art would have been motivated to make this modification to improve reproductive efficiency by improving the rate of successful copulation. One of ordinary skill in the art would have had a reasonable expectation for success because the natural presence of p-cresol in urine of estrus cows cause an increase in mounting behavior in males. With regards to claim 7 limitation for a method where the improving of the cow reproductive ability is to shorten a first return to estrous day after calving; this limitation is rendered obvious in view of the prior art of Muniasamy et. al. that is for the presence of p-cresol as an estrus indicator in a method of improving cow reproductivity ability comprising increasing p-cresol presence on the cow. As stated above, the shorten a first return to estrous day after calving would flow from the administration of p-cresol in a method for improving cow reproductivity ability.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1 – 2 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1 – 2 of copending Application No. 19/134446 to Yoon et. al. (reference application; Yoon’446). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented. Even though preamble of Yoon’446 direct to a composition for use in female livestock and the preamble of the examined claim 1 direct to a composition for use in a cow; these preambles do not provide any structural limitations to either copending claims. Thus both copending preambles are mere statements of purpose or use. Hence, if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020). See MPEP 2111.02(II).
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.
Claim 3 – 7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4, 6 – 8, and 10 of copending Application No. 19/134446 to Yoon et. al. (reference application; Yoon’446).
Although the claims at issue are not identical, they are not patentably distinct from each other because copending applications direct to compositions comprising p-cresol. Specifically, Yoon’446 recite the composition of (reference) claim 1, where the female livestock is a cow. See reference claim 5. See examined claim 3.
Specifically, Yoon’446 recite the composition of (reference) claim 1, where the p-cresol is comprised in an amount of 0.01 wt % to 30 wt % relative to the total composition. See reference claim 4. See examined claim 3. Even though examined claim 3 recites the amount of p-cresol as 0.1 to 5 wt% based on the entire composition the amount of 0.1 to 5 wt% lies within the range recited in reference claim 4. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). See MPEP 2144.05(I).
Moreover, Yoon’446 recite a method for preparing a composition for improving the reproductive performance of female livestock comprising mixing para-cresol (p-cresol) into one or more waxes selected from the group consisting of paraffin wax, beeswax, wood wax, and carnauba wax, wherein the improvement in reproductive performance is shortening the number of days to return to estrus, or inducing or promoting estrus. See reference claim 7. See examined claim 4. While Yoon’446 recites livestock as a broad genus; the examined claim 4 recites the livestock species of a cow.
Furthermore, Yoon’446 recite the method of (reference) claim 7, where the composition is a mixture of 70 wt % to 99.99 wt % of wax and 0.01 wt % to 30 wt % of p-cresol. See reference claim 8. See examined claim 6. Even though examined claim 6 recites the composition is a mixture of 70 wt % to 99.99 wt % of wax and 0.1 wt % to 5 wt % of p-cresol the amount of 70 wt % to 99.99 wt % of wax and 0.1 wt % to 5 wt % lies within the range recited in reference claim 7. Thus, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). See MPEP 2144.05(I).
Additionally, Yoon’446 recite a method for improving the reproductive performance of female livestock, comprising applying the composition of any one of claims 1 to 6 to a part of the body of the female livestock or a breeding place or spraying the same on the body, wherein the improvement in reproductive performance is shortening the number of days to return to estrus, or inducing or promoting estrus.. See reference claim 10. See examined claim 7. While Yoon’446 recites livestock as a broad genus; the examined claim 7 recites the livestock species of a cow.
Moreover, Yoon’446 recite the composition of (reference) claim 1, where the composition is a solid or liquid. See reference claim 6. See examined claim 5. While Yoon’446 recites the composition; examined claim 5 recites a method for preparing a composition where the wax is a liquid state. Both copending applications direct to compositions comprising p-cresol and wax where the wax is a liquid. Thus the composition of copending Yoon’446 where the wax is optionally a liquid renders obvious the method of examined claim 5 where the wax is a liquid.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1 – 7 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAWANNA S WHITE whose telephone number is (703)756-4687. The examiner can normally be reached 7:00 am - 5:00 pm [EST] M - Th.
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/DAWANNA SHAR-DAY WHITE/Examiner, Art Unit 1627
/JULIET C SWITZER/Primary Examiner, Art Unit 1682
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