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 Status
Claims 28 and 29 are new.
Claims 3, 8 and 24 are cancelled.
Claims 1, 2, 4-7, 9-23 and 25-29 are pending.1
Claims 22 and 23 are withdrawn.
Claims 1, 2, 4-7, 9-21 and 25-29 are under examination. Applicant’s amendments have necessitated modification of the existing rejections. Accordingly, this Action is FINAL.
Withdrawn rejections
Applicant's amendments and arguments filed 2/13/26 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below is herein withdrawn. Claim 14 was rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. Claim 21 was rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. Claim 26 was rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. Applicant has amended the claims to overcome these rejections.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Claim Rejections - 35 USC § 103
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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, 5, 7, 9-13, 17-21, 25 and 27-29 are rejected under 35 U.S.C. 103 as being unpatentable over Sakata et al. (JP2013184941; English translation provided) and Twose (Terminal Sterilization for Parenteral Drugs: Finding the Right CDMO Partner, [online]; retrieved on 10/17/25 from: https://www.pharmasalmanac.com/articles/terminal-sterilization-for-parenteral-drugs-finding-the-right-cdmo-partner; October 2018: 6 pages) and Monajjemzadeh et al. (Adv Pharm Bull, 2014, 4(4), 329-338) and Oamen et al. (J Dairy Sci. 1989; 72:614-619).
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103, the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103.
Applicant claims, for example:
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The Examiner notes that the components of (a) can be in the alternative.
Level of Ordinary Skill in the Art
(MPEP 2141.03)
MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The level of skill is that of a parenteral nutritionist research scientist, as is the case here, then one can assume comfortably that such an educated artisan will possess a thorough knowledge in calculating precise nutrient needs such as calories, protein, fluids, electrolytes, vitamins, minerals including carbohydrates such as dextrose, fats (lipids), amino acids, vitamins, minerals such as Na, K, Ca, Mg, P, trace elements, and water, formulating complex intravenous (IV) solutions with consideration for stability and compatibility of the components, understanding vascular access, recognizing and managing parenteral nutrition-related complications and monitoring patient response.
In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Regarding claims 1, Sakata et al. in infusion preparation for central venous administration for daily maintenance of electrolytes and vitamins for nutrition management (Abstract; page 2, paragraphs 1-2) and teach a container divided into a plurality of compartments with a sugar solution, an amino acid solution and a vitamin solution contained in different compartments where the vitamin solution contains one or more vitamins including vitamin B12 (Page 10; claims). Thus, in the embodiment with just a single vitamin B12, the vitamin B12 compartment does not contain glucose or amino acids or vitamin B1 or vitamin C or ascorbyl palmitate, hence is essentially free of those components, and in that at least one embodiment only contains vitamin B12 and the other compartments contain the other macronutrients.
Regarding claim 2, Sakata et al. teach a daily dose of 1300-1700 mL (Page 9, claims; see also the Example on page 7), which is reads on a multi-chamber container with a reconstituted volume of more than 100 mL.
Regarding claim 5, Sakata et al. teach an aqueous solution (Page 3, 4th paragraph from the bottom), and the daily dose is 1300-1700 mL (Claims) rendering an aqueous vitamin B12 solution formulation is obvious.
Regarding claim 7, Sakata et al. teach that vitamin B12 can be cyanocobalamin or hydroxycobalamin (Page 4, last line).
Regarding claim 9, Sakata et al. teach a separate embodiment that includes trace elements (Page 10, second to last paragraph), which means embodiments exist without trace elements.
Regarding claims 4, 12 and 25, Sakata et al. teach that the infusion preparation obtained was packaged with an oxygen-impermeable outer packaging material together with an oxygen scavenger (Page 8, top of page), where an oxygen scavenger reasonably reads on an oxygen absorber, and Sakata et al. teach a flexible container made from polyolefin and having a laminated gas barrier layer manufactured by fuse/melting (Page 7, 2nd through 4th paragraphs), thus without adhesives. Since oxygen is a gas, then Sakata et al. reasonable disclose container made of a flexible polymeric material that comprises an oxygen barrier film and an inner lining containing a polyolefin free of PVC, plasticizer, adhesives or latex. Since the gas barrier layer is a barrier to gas permeability, then it renders obvious no oxygen gas permeation which is less than 50 cc/m2/day.
Regarding claims 13 and 14, Sakata et al. teach adding one or more other B vitamins including B1, B2, niacin, pantothenic acid, B6, biotin and folic acid as well as vitamins A, E, D and K (Claims, page 9).
Regarding claims 18 and 28, Sakata et al. teach 4 ml of vitamin B12 formulation (Example on page 7, step (3)), which is within the claimed range of from 2-100 ml and touches the range of from 5 to 50 ml.
Regarding claim 19, Sakata et al. teach 4-6 µg vitamin B12 (Page 9, claims), which is within the range of 0.5-10 µg vitamin B12.
Regarding claims 20-21, Sakata et al. teach a container with 3 compartments (Page 2, 2nd paragraph; Example on page 7 step (4)) and the claims recite that the container is divided into a plurality of compartments with sugar (carbohydrate) solution, amino acid solution and vitamin solution contained in different compartments as well as 1 or 2 or more trace elements (Claims page 9), which means more compartments can be present.
Regarding claims 1 and 10-11, Twose teaches: “To ensure patient safety, parenteral/injectable drug products must be sterilized to destroy any potential microbial contaminants (fungi, bacteria).” (Page 2, Numerous Sterilization Methods). Thus, sterilization is compulsory for those products. Twose further teaches: “Terminal sterilization is the preferred method for drug products because, in this process, sterilization takes place after the product has been filled into the primary packaging. Because of this, there are no further opportunities for contamination due to human intervention. As mentioned above, terminal sterilization with moist heat (i.e., steam) is recommended by all pharmacopeias, typically with heating to 121 °C at 15 psi for 15 minutes.” (Page 3, 1st paragraph), which is superheated water sterilization.
Regarding claim 1, Oamen et al. teach: “Dissolved oxygen is a major factor in the destruction of vitamin B12” and that the dissolved oxygen influences loss of vitamin B12 where the presence of oxygen results in the rapid destruction of vitamin B12 (page 614, right, column 1st and 3rd paragraphs).
Regarding claims 1, 17, 27 and 29, Monajjemzadeh et al. teach that that it is well known that: “ Water-soluble vitamins are prone to degradation in solutions, particularly when exposed to light. B Vitamins are sensitive to factors such as: light, heat, moisture, oxidizing and reducing agents, acids and or bases. There is plenty of literature concerning the poor stability of vitamin B12 and it has been reported that the optimum pH for stability of this vitamin is 4-6.5 pH value. It is well known that aqueous solutions of cyanocobalamin are photolabile…” (Page 329, left column 1st paragraph). To overcome this sensitivity to degradation, Monajjemzadeh et al. teach the artisan that: “additives such as co solvents and tonicity adjusters, surfactants, antioxidants and chelating agents as well as buffer solutions, were used to improve the stability of the parenteral mixed formulations of B12… It is necessary to formulate vitamin B12 mixed parenteral solutions using proper phosphate buffers (pH=5.8)…”(Abstract), where a pH of 5.8 is within the claimed range of 5-7. 0.05% w/v EDTA, which is 0.05 g in 100 mL or 0.5 g/L, and 0.025M and 0.05M phosphate buffers are taught (Table 1, page 331), where 0.025M is equivalent to 25mM and no more than 0.5 mM.
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02) and Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
The difference between the instant application and Sakata et al. is that Sakata et al. do not expressly teach a terminally heat sterilized multi-chamber container wherein the terminal heat sterilization is carried out by superheated water sterilization and is performed at a temperature of from 100°C to 126°C for 10 min to 60 min. This deficiency in Sakata et al. is cured by the teachings of Twose.
It would have been obvious to one of ordinary skill in the art before to the effective filing date of the claimed invention to terminally heat sterilize the multi-chamber container of Sakata et al. wherein the terminal heat sterilization is carried out by superheated water sterilization and is performed at a temperature of from 100°C to 126°C for 10 min to 60 min, as suggested by Twose, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because the art of Twose teaches that it is mandatory for the artisan to terminal heat sterilize containers for parenteral administration and provides guidance on the time and temperature to use superheated water. Consequently, it is compulsory that the ordinary artisan terminally heat sterilize the multi-chamber container of Sakata et al. to destroy any potential microbial contaminants and produce a multi-chamber container with a vitamin B12 chamber with a reasonable expectation of success.
The difference between the instant application and Sakata et al. as modified by Twose is that Sakata et al. as modified by Twose do not expressly teach a terminally heat sterilized multi-chamber container wherein the vitamin B12 formulation has a pH value from 5.2 to 6.2, includes a stabilizing EDTA at a concentration of nor more than 0.1 g/L or monobasic sodium phosphate buffer at a concentration of no more than 0.5 mM, does not include an amount of dissolved oxygen more than 1.0 ppm and has a volume from 5 to 50 ml. This deficiency in Sakata et al. is cured by the teachings of Oamen et al. and Monajjemzadeh et al.
It would have been obvious to one of ordinary skill in the art before to the effective filing date of the claimed invention to modify the terminally heat sterilize the multi-chamber container of Sakata et al. as modified by Twose wherein the vitamin B12 formulation has a pH value from 5.2 to 6.2, includes a stabilizing EDTA at a concentration of no more than 0.1 g/L or monobasic sodium phosphate buffer at a concentration of no more than 0.5 mM, does not include an amount of dissolved oxygen more than 1.0 ppm and has a volume from 5 to 50 ml, as suggested by Twose, and produce the instant invention. One of ordinary skill in the art would have been motivated to do this because it is known through Oamen et al. that vitamin B12 is sensitive to oxygen degradation and therefore it is critical to keep all oxygen away from vitamin B12 to ensure stability of the product. Thus, having an amount of dissolved oxygen of no more than 1.0 ppm is obvious to the ordinary artisan. It is known through the teachings of Monajjemzadeh et al. that: “It is necessary to formulate vitamin B12 mixed parenteral solutions using proper phosphate buffers (pH=5.8)…”(Abstract), where a pH of 5.8 is within the claimed range of 5.2-6.2, 0.05% w/v EDTA, which is 0.05 g in 100 mL or 0.5 g/L, and 0.025M and 0.05M phosphate buffers are taught (Table 1, page 331), where 0.025M is equivalent to 25mM and no more than 0.5 mM. Consequently, a pH value of from 5.2 to 6.2 is obvious and adding EDTA and phosphate buffer to achieve that pH is also obvious. Selection of a monobasic sodium phosphate buffer of no more than 0.5 mM is at the discretion of the ordinary artisan because the same pH is achieved. Similarly, it requires no inventive skill to have a volume of 5 to 50 ml for the vitamin B12 formulation. While 0.5 g/L EDTA taught by Monajjemzadeh et al. is greater than the claimed value of no more than 0.1 g/L EDTA, it is the Examiner’s position that optimization of the chelating agent concentration to provide the desired stability of the vitamin B12 is well within the skill of the ordinary artisan. In this regard see MPEP 2144.05 (II) (A): “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)…see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.").
The difference between the instant application and Sakata et al. as modified by Twose, Oaman et al. and Monajjemzadeh et al. do not expressly teach third and fourth chambers wherein the third chamber comprises a trace element composition and a fourth chamber comprises an amino acid formulation and the macronutrient formulation of the first chamber comprises carbohydrates.
It would have been obvious to one of ordinary skill in the art before to the effective filing date of the claimed invention to modify the terminally heat sterilize the multi-chamber container of Sakata et al. as modified by Twose, Oaman et al. and Monajjemzadeh et al. to have third and fourth chambers wherein the third chamber comprises a trace element composition and a fourth chamber comprises an amino acid formulation and the macronutrient formulation of the first chamber comprises carbohydrates, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because Sakata et al. teach a container with 3 compartments (Page 2, 2nd paragraph; Example on page 7 step (4)) and the claims recite that the container is divided into a plurality of compartments (Claims page 9), which means more compartments can be present such as 4 compartments. As noted above, Sakata et al. teach compartments of sugar (carbohydrate macronutrient) solution, amino acid solution, vitamin solution contained in different compartments as well as 1 or 2 or more trace elements and the selection of which compartment contains the trace elements, amino acids and carbohydrates is well within the purview of the ordinary artisan in this art. It is then merely just judicious selection of which compartment holds which solution/material by the ordinary artisan with a reasonable expectation of success.
Claims 6, 14-16 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Sakata et al. (JP2013184941; English translation provided) and Twose (Terminal Sterilization for Parenteral Drugs: Finding the Right CDMO Partner, [online]; retrieved on 10/17/25 from: https://www.pharmasalmanac.com/articles/terminal-sterilization-for-parenteral-drugs-finding-the-right-cdmo-partner; October 2018: 6 pages) and Monajjemzadeh et al. (Adv Pharm Bull, 2014, 4(4), 329-338) and Oamen et al. (J Dairy Sci. 1989; 72:614-619), as applied to claims 1, 2, 4, 5, 7, 9-13, 17-21, 25 and 27-29 above, in further view of Trouilly et al. (US20070092579) and Fell et al. (American Society for Nutrition. Adv Nutr. 2015;6:600–10).
Applicant claims, for example:
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The references of Sakata et al., Twose, Oamen et al. and Monajjemzadeh et al. are discussed in detail above. Sakata et al. as modified by Twose et al., Oamen et al. and Monajjemzadeh et al. do not expressly teach wherein the vitamin B12 formulation is a lipid emulsion comprising an aqueous phase and from 1% to 20% by weight of an oil phase based on the total weight of the lipid emulsion, comprises at least one other vitamin of claim 14, the oil phase comprises or consists of a low peroxide level oil as in claim 15 and does not comprise ascorbyl palmitate. However, Trouilly et al. teach that (Examiner added emphasis): “Lipid emulsions are generally one component of a parenteral nutritional solution (PN). Ternary parenteral nutritional formulations are used to provide all the nutritional components required by a patient. These PN formulations include also a carbohydrate component, an amino acid component, vitamin, trace element and electrolytes components. Because of various incompatibilities, nutritional components of PN formulations are prime examples of medical solutions that cannot be stored long term as a mixture in a ready-to-use state.” [0008]. Trouilly et al. also teach that: “The lipid component can include an emulsion containing about 10% to about 30% of lipids such as fatty acids and/or triglycerides from plant, animal or synthetic sources such as, but not limited to olive oil, Medium Chain Triglyceride oil, soybean oil and fish oil.” Fell et al. teach lipid emulsions with soybean oil, safflower oil, olive oil, fish oil and coconut oil (Table 1, page 604). The range of about 10% to about 30% overlaps the claimed range of from 1% to 20 % by weight oil phase. With the combined references in hand, it would appear obvious to compose the vitamin B12 in a lipid emulsion with 1-20% by weight oil phase based on the total weight of the lipid emulsion made with the low peroxide of no more than 5 mEq O2/kg oils claimed where no ascorbyl palmitate is in the oil phase with a reasonable expectation of success. Additionally, Sakata et al. teach adding other components such as vitamin A, vitamin D, vitamin E and vitamin K (Claims) thus rendering obvious the combination of those vitamins with vitamin B12 in the lipid emulsion. The ordinary artisan would do so before to the effective filing date of the claimed invention with a reasonable expectation of success.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the combined references, especially in the absence of evidence to the contrary.
Response to Arguments:
Applicant’s arguments filed 2/13/26 have been carefully considered but are not persuasive.
On page 10 of remarks, Applicant asserts that: “The present claims recite, in part, that the "vitamin Bl2 formulation (a) is essentially free from amino acids, vitamin Bl, ascorbyl palmitate and/or vitamin C[.]" However, Sakata discloses "amino acids in the second chamber, and further filling vitamins as necessary" as well as a list of vitamins that may be included such as vitamin B12, vitamin C, and vitamin B1… Nothing in Sakata suggests that the amino acids and various vitamins listed in the claim should not be included in the same formulation.” Respectfully, the Examiner does not agree because Sakata expressly states that a sugar solution, an amino acid solution and a vitamin solution are contained in different compartments (Claims). The permissive term “may” and “as necessary” indicate that the other vitamins are not required in combination with vitamin B12. In one embodiment of Sakata, the compartment may simply just have vitamin B12 essentially free from amino acids, vitamin B1, ascorbyl palmitate and/or vitamin C and does not contain glucose.
On page 10 of remarks, Applicant argues: “The present claims recite, in part, that the "vitamin B12 formulation [ ... ] does not comprise glucose[.]" However, Sakata discloses a formulation including vitamin B12 and also discloses the benefits of glucose in central intravenous administration but does not disclose anything that would teach a skilled artisan that these ingredients must be administered separately.” Respectfully, the Examiner cannot agree because as Applicant is well aware, glucose is a simple monosaccharide sugar and Sakata expressly teaches that the sugar solution is in a separate compartment from the vitamin solution compartment as underlined by the Examiner below:
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On page 11 of remarks, Applicant asserts that Oamen is directed to milk processing and storage and the skilled artisan would not apply milk processing or storage methods to the methods for infusion preparation with a reasonable expectation of success. Respectfully, the Examiner has a different perspective. Oamen is not relied upon for milk processing/storage methods but rather is relied upon for teaching the concept: “Dissolved oxygen is a major factor in the destruction of vitamin B12” and that the dissolved oxygen influences loss of vitamin B12 where the presence of oxygen results in the rapid destruction of vitamin B12 (page 614, right, column 1st and 3rd paragraphs). The ordinary skilled artisan would be aware of vitamin B12’s instability in the presence of dissolved oxygen.
On page 11 of remarks, Applicant asserts new and unexpected/superior results including: “"the fact that especially a mildly acidic pH in the range of from 5.2 to 6.2 [ ... ] can contribute to long-term stability of vitamin B12 was a surprising finding."… Further, "it was found that, surprisingly, even though glucose seems to be a viable medium for vitamin B12 during sterilization, it cannot be used for hosting vitamin B12 in either form." ... Moreover, maintaining the amount of dissolved oxygen at or below 1.0 ppm made it "possible to stabilize vitamin B 12 in a way that surprisingly [] is less impacted by light and oxygen as it could be expected based on what is known about light sensitivity of the vitamin." Regarding the pH range, this cannot be considered new or unexpected because Monajjemzadeh et al. teach that that it is well known that: “There is plenty of literature concerning the poor stability of vitamin B12 and it has been reported that the optimum pH for stability of this vitamin is 4-6.5 pH value.” (Page 329, left column 1st paragraph). Monajjemzadeh et al. teach the artisan that: “additives such as co solvents and tonicity adjusters, surfactants, antioxidants and chelating agents as well as buffer solutions, were used to improve the stability of the parenteral mixed formulations of B12… It is necessary to formulate vitamin B12 mixed parenteral solutions using proper phosphate buffers (pH=5.8). (Abstract). Concerning the amount of dissolved oxygen, it is already well-known through the art of Oamen et al. teach: “Dissolved oxygen is a major factor in the destruction of vitamin B12” and that the dissolved oxygen influences loss of vitamin B12 where the presence of oxygen results in the rapid destruction of vitamin B12 (page 614, right, column 1st and 3rd paragraphs). So, that cannot be considered new or unexpected. Concerning housing vitamin B12 separately from glucose (sugar) solution, the art of Sakata already teaches that too. So, that is not new or unexpected. Respectfully, Applicant has not shown any evidence of new or unexpected results.
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, 4-7, 9-21 and 25-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of copending Application No. 18246234. Both the instant application and the copending application have the same assignee and common inventors. Although the claims at issue are not identical, they are not patentably distinct from each other because the copending is also directed to a medical product comprising a lipid emulsion with vitamin A and optionally vitamins D, E, K in a flexible container with no more than 1.5 ppm dissolved oxygen and a pH from 5-9 (Claim 1) and a low peroxide level oil (Claims 3-4 and 24) with a lipid concentration of 2-40% in the lipid emulsion (Claim 5), that is sterilized (Claim 14) and configured for parenteral administration (Claim 16) and does not contain macronutrients (Claims 15 and 28) but the lipid emulsion comprises vitamin B12 (Claim 9), which is cyanocobalamin, and can further comprise vitamin B2 and B5 (Claim 27), is protected from light (Claim 10) that is stable for at least 3 months at 1-50 °C (Claim 12). The flexible bag comprises an inner lining of polyolefin free of PVC, plasticizers and latex (Claim 11) and has at least 2, 3, 4, 5 or 6 chambers (Claim 17) with a first chamber containing a carbohydrate formulation, a second chamber containing an amino acid formulation, a third chamber containing a lipid formulation, and optionally comprises electrolytes and/or vitamins and/or trace elements in the first, second and/or third chamber (Claim 18), with the lipid emulsion in a fourth chamber (Claims 19-20). Claim 21 instructs the artisan to terminal heat sterilize with moist heat. The oil phase of the copending does not require ascorbyl palmitate as it is one of 4 different antioxidant agents including EDTA (Claim 25).
The copending does not expressly teach a reconstituted volume of more than 100 mL. However, the determination of volume reconstituted is at the discretion of the ordinary artisan.
The copending does not expressly teach superheated water sterilization at a temperature of from 100°C to 126°C for 10 min to 60 min. However, the ordinary artisan would adjust the temperature and time to sterilization the container with no undue experimentation involved.
The copending does not expressly teach a vitamin B12 formulation volume of 2-100 ml comprising 0.5-10 micrograms of vitamin B12. However, it is merely routine optimization of the concentration of vitamin B12 to deliver a therapeutic amount of the vitamin B12 with no undue experimentation by the ordinary artisan.
The copending does not expressly teach an oxygen barrier film with an oxygen permeability of less than 50 cc/m2/day. However, the copending teaches a dissolved oxygen concentration of less than 1.5 ppm (Claim 3), which renders obvious adding an oxygen barrier film with low oxygen permeability such as less than 50 cc/m2/day to prevent oxygen from contacting the contents of the container.
The copending does not expressly teach wherein the stabilizing agent is selected from EDT A at a concentration of no more than 0.1 g/L and/or monobasic sodium phosphate buffer at a concentration of no more than 0.5 mM. However, the copending does teach a pH within the claimed range and it teaches adding EDTA. Consequently, it is merely routine optimization to determine the amount of monobasic sodium phosphate buffer to obtain the desired pH and amount of EDTA to stabilize the composition without any undue experimentation.
Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the copending subject matter.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 2, 4-7, 9-21 and 25-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of US Patent no 12507721. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent is also directed to:
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The patent does not expressly teach adding monobasic sodium phosphate. However, the patent does teach a pH of 5-7 (Claim 1) and phosphate buffers that comprise monobasic sodium phosphate are an obvious choice to achieve that pH.
The patent does not expressly teach an oxygen barrier film with an oxygen permeability of less than 50 cc/m2/day. However, the patent teaches a dissolved oxygen concentration of less than 1.5 ppm (Claim 15), which renders obvious adding an oxygen barrier film with low oxygen permeability such as less than 50 cc/m2/day to prevent oxygen from contacting the contents of the container.
The patent does not expressly teach they types of oil to employ. However, the scope of the oils include soybean, olive, coconut and palm kernel oil, for example (Column 49, lines 13-27). See MPEP 804: “The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim.”
Accordingly, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the patented subject matter.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments:
Applicant respectfully submits that this stage in prosecution is premature for a terminal disclaimer because the instant claims are not identified as otherwise allowable, and thus the final version of these claims is not yet known. At such time when the present claims are otherwise allowable, Applicant will reconsider any remaining double patenting rejection. The rejections have been reviewed with regard to Applicant’s claim amendments and are maintained.
Conclusion
No claims are allowed.
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 ERNST V ARNOLD whose telephone number is (571)272-8509. The examiner can normally be reached M-F 7-3:30.
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/ERNST V ARNOLD/Primary Examiner, Art Unit 1613
1 Claim 6 deletes “any of” in line 2. However, this was already deleted in the previous amendment. In the interest of stakeholder interaction and compact prosecution, a non-compliant claim amendment is not being filed. Rather the Examiner is alerting Applicant to the issue in this Office Action.