DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
The listing of claims filed 22 August 2024, have been examined. Claims 1-15 are pending. Claims 1-15 are amended and are supported by the originally-filed disclosure.
Claim Objections
Claim 5 is objected to because of the following informalities:
Claim 5 recites “in the range of -15 and +15 mV”, which should use "to" instead of "and" for standard range recitation and be corrected to "in the range of -15 to +15 mV".
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. § 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. § 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-15 are rejected under 35 U.S.C. § 112(a) or 35 U.S.C. § 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claim 1 is rejected for failing to comply with the enablement requirement with respect to the full scope of the claim, specifically the "preventing" a bone disease limitation. Claim 1 recites, in relevant part: "A method for use in ... preventing and/or treating a bone disease in a subject comprising administering to a subject in need a complex coacervate comprising lactoferrin and osteopontin."
The claim broadly encompasses prevention of any bone disease in any subject by administration of the claimed complex coacervate. The term "preventing" includes prophylactic administration to a subject who does not yet have a bone disease but is at risk of developing one. The term "bone disease" is broadly defined in the specification to include "medical conditions which affect the bone, in particular related to the reduction of bone organic matrix," including low bone density, osteopenia, osteoporosis, osteomalacia, rickets, Paget's disease, hypophosphatasia, scurvy, and osteitis fibrosa cystica.
The “Wands factors” guide the enablement inquiry (see In re Wands, 858 F.2d 731, 736-37 (Fed. Cir. 1988)) to determine if the specification describes the invention in sufficient detail such that a person of ordinary skill in the art could make and use the claimed invention without undue experimentation, and accordingly have been applied as outlined below:
Breadth of the claims – Claim 1 is extremely broad, encompassing prevention of any bone disease in any subject. Claim 1 is not limited to any particular bone disease (encompasses at least low bone density, osteopenia, osteoporosis, rickets, osteomalacia, Paget's disease, hypophosphatasia, scurvy, osteitis fibrosa cystica; any particular subject population (encompasses infants, children, adolescents, adults, elderly, animals; any particular dosage or administration regimen (dosage ranges are provided in dependent claims but not in Claim 1); any particular duration of administration; or any particular endpoint or measure of prevention. The specification provides no working examples and minimal guidance for the vast majority of subject matter encompassed by the claim. The broad scope of the claim, combined with the lack of enabling disclosure, renders the claim invalid for lack of enablement.
Nature of the invention – The invention is complex and unpredictable in the context of prevention of bone disease. The invention involves administration of a complex coacervate of two proteins (lactoferrin and osteopontin) that are naturally present in human milk. The mechanism of action for bone effects is not fully elucidated (see ¶[0010]-[0012] citing literature on LF and OPN individually). The specification posits that the complex coacervate "may promote normal bone metabolism and homeostasis", but this is speculative. Prevention of bone disease is inherently more challenging to demonstrate than treatment or promotion because prevention requires long-term administration to at-risk subjects, bone diseases have multifactorial etiologies (genetic, nutritional, hormonal), the relationship between short-term biomarkers and long-term prevention outcomes is uncertain, and different bone diseases (e.g., osteoporosis vs. rickets) have different pathophysiologies. The unpredictable nature of the art weighs against enablement of the full breadth of the claim.
State of the prior art – The prior art does not provide a reliable foundation for predicting prevention of bone diseases from administration of an LF-OPN complex coacervate. The specification cites studies showing that lactoferrin promotes osteoblast proliferation and inhibits osteoclastogenesis, and that osteopontin is involved in bone metabolism. However, these studies are directed to the individual proteins, not the complex coacervate. The specification does not cite any prior art demonstrating that an LF-OPN coacervate prevents bone disease. Indeed, the specification states that prior attempts to form coacervates of LF and OPN "have been shown to be not successful," indicating that the claimed coacervate itself is a new composition. There is no prior art teaching or suggesting that administration of an LF-OPN coacervate would prevent bone disease. A person of skill in the art could not rely on the prior art to fill the gaps in the specification with respect to prevention.
Level of one of ordinary skill in the art – A person of ordinary skill in the art would have significant expertise, but not enough to practice the full scope of the claim without undue experimentation. A person of ordinary skill in the art would likely have a master's degree or Ph.D. in biochemistry, food science, or a related field, with experience in protein chemistry, nutritional formulations, and bone biology. However, even a skilled artisan would require extensive experimentation to determine whether the claimed method prevents any bone disease, which bone diseases are prevented, in which subjects, at what dosages, and over what duration. The specification provides no roadmap.
Level of predictability in the art – The art of preventing bone diseases via protein coacervate administration is highly unpredictable. Bone biology is complex, involving systemic hormones (PTH, calcitonin, vitamin D), local growth factors (BMPs, IGFs), and cellular interactions (osteoblasts, osteoclasts, osteocytes). The effect of a specific protein coacervate on the complex processes of bone remodeling and disease prevention cannot be reliably predicted from first principles. The specification itself acknowledges unpredictability by describing the results of the mouse study as showing that the coacervate "may promote normal bone metabolism" (using speculative language). The specification does not provide a mechanistic explanation for how the coacervate would prevent bone disease. The unpredictable nature of the art weighs against enablement.
Amount of direction or guidance provided by the inventor – The specification provides little to no direction or guidance for practicing the prevention aspect of the claim. The specification mentions "preventing" a bone disease. However, the specification provides no animal model demonstrating prevention of any bone disease, no human clinical trial data showing prevention of bone disease, no guidance on dosing regimens specifically for prevention (as opposed to treatment or promotion), no guidance on which subjects are at risk for which bone diseases, and how to select subjects for prophylactic administration, no guidance on how long the complex coacervate must be administered to achieve prevention, and no guidance on what endpoints would indicate successful prevention. The sole example administers the complex coacervate to healthy mice from post-natal day 2-28. This is a promotion study, not a prevention study. There is no teaching of how to adapt this protocol to prevent bone disease in at-risk subjects. The specification acknowledges that "[u]p to this date, attempts to form coacervates of lactoferrin and osteopontin have been shown to be not successful," indicating that the art is not well-developed. The specification does not provide any prophetic examples or detailed protocols for prevention studies. The amount of guidance is grossly insufficient.
Existence of working examples – The specification lacks any working example of preventing a bone disease. The specification contains one working example showing that administration of the complex coacervate to wild-type mice resulted in increased bone parameters compared to control groups. This is a promotion or enhancement of bone growth, not prevention of a bone disease. The specification does not contain any working example demonstrating that the complex coacervate prevents the onset, delays the progression, or reduces the incidence of any bone disease in any subject. The absence of any working example for the prevention aspect of the claim is significant because prevention of bone disease requires a different experimental paradigm (e.g., use of disease models, prophylactic administration prior to disease onset, long-term follow-up). The specification provides no guidance on how to conduct such studies and no data showing that the claimed method would be effective for prevention.
Quantity of experimentation needed – The specification provides a single working example of administration of the complex coacervate to wild-type healthy mice for a period of 26 days (post-natal days 2-28) and subsequent measurement of bone parameters at day 170. This example demonstrates an increase in bone parameters in healthy mice. It does not demonstrate prevention of any bone disease in a subject at risk of developing a bone disease. The example does not use any disease model (e.g., ovariectomized mice for osteoporosis, vitamin D-deficient diet for rickets/osteomalacia, or genetically modified mice with bone defects). To determine whether the claimed method prevents bone disease, a person of skill in the art would need to conduct numerous separate studies for each bone disease (e.g., osteoporosis prevention studies in ovariectomized animals, rickets prevention studies in vitamin D-deficient models, osteomalacia prevention studies), at different dosages, in different subject populations (infants, adolescents, adults, elderly), using different administration regimens, and over different durations (short-term vs. long-term prophylaxis). The specification provides no guidance on how to design such studies or what endpoints would demonstrate "prevention." This constitutes undue experimentation.
The specification enables a person of ordinary skill in the art to practice the claimed method for promoting bone development, growth, and strength in healthy subjects, as demonstrated by the mouse study. However, this is not the full scope of claim 1, which also includes prevention of bone disease.
The specification does not enable a person of ordinary skill in the art to practice the claimed method for preventing bone disease because there are no working examples or prophetic examples are provided, no disease models are described, no guidance is provided on how to adapt the promotion protocol to prevention, and the unpredictable nature of bone disease prevention requires specific enabling disclosure. Accordingly, the specification fails to teach a person of ordinary skill in the art how to use the claimed complex coacervate to prevent a bone disease without undue experimentation. The Wands factors collectively support this rejection.
Dependent claims 2-15 are included in this rejection because they do not cure the defect noted above.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. § 102(b)(2)(C) for any potential 35 U.S.C. § 102(a)(2) prior art against the later invention.
Claims 1, 11 and 12 are rejected under 35 U.S.C. § 103 as being unpatentable over Liu et al. (Assessment of bioactivities of the human milk lactoferrin-osteopontin complex in vitro. J Nutr Biochem. 2019 Jul;69:10-18; hereinafter “Liu”), in view of Cornish et al. (US-20030191193-A1, published 09 Oct 2003; hereinafter “Cornish”), and in further view of, Poundarik et al. (US-20180280570-A1, published 04 Oct 2018; hereinafter “Poundarik”).
Liu teaches the formation of a complex coacervate comprising lactoferrin (LF) and osteopontin (OPN). Liu explicitly states these two proteins form a complex driven by electrostatic forces (p. 10, Abstract; p. 10, col. 2, LF is a basic glycoprotein while OPN is an acidic phosphorylated glycoprotein; p. 11, section 2.1, “Preparation and identification of the LF-OPN complex”; p. 12, Fig. 1A, showing higher molecular weight bands indicating complex formation; and p. 16, col. 1, lines 3-4, LF and OPN coacervated the most to form the LF-OPN complex). Liu teaches that this complex is taken up by intestinal cells (Caco-2, HIEC) and promotes proliferation and differentiation and demonstrates oral administration intent (p. 10, Abstract; p. 11, section 2.4, “in vitro digestion” simulating oral/gastric conditions; p. 17, col. 1, discussing oral administration of LF and use as a potential substitute for human LF-OPN complex as an additive in infant formula). Liu further teaches that this complex resist in vitro digestion and that by forming a complex LF and OPN may protect each other and enhance proteolysis and enhance their individual bioactivities (Abstract, and p. 16, ¶4).
Liu states that both LF and OPN individually are known to have multiple bioactivities (p. 10, col. 2, last 2 lines), and cites reference 44 (p. 18) related to the role of lactoferrin in osteoblasts in the scientific journal Bone, however does not explicitly emphasize the use of the LF-OPN complex coacervate for bone development and treatment of bone disease.
Cornish explicitly teaches that a known bioactivity of lactoferrin administration is to promote bone development, growth, and can be used as a method of preventing and treating bone-related disorders (e.g., by stimulating skeletal growth and inhibiting bone resorption) in osteoporosis (a metabolic bone disorder) and rheumatoid or osteo-arthritis (Abstract, ¶[0004], ¶[0007], ¶[0009]). Poundarik explicitly states that osteopontin is included in compositions to promote bone formation, regeneration, healing, and repair, and to treat bone fractures and defects (Abstract, ¶[0003], ¶[0004]).
Hence, it was known in the art at the time of the instant invention that both lactoferrin and osteopontin play a role in bone development, growth, strength and/or healing in a subject, including a subject with bone disease (see also evidentiary reference Yamniuk et al., Thermodynamic characterization of the interactions between the immunoregulatory proteins osteopontin and lactoferrin. Mol Immunol. 2009 Jul;46(11-12):2395-402, p. 2395, right paragraph and p. 2395, first full paragraph on the left, teaches that both proteins are involved in bone metabolism/remodeling with high-affinity complexes forming at physiological pH driven by electrostatic complementary interaction of multiple cationic LF molecules binding to anionic OPN (Abstract)).
Thus, a person of ordinary skill in the art would have recognized that administering the LF-OPN complex would promote bone development, based on the known bone anabolic effects of LF and OPN individually and the enhanced stability and cellular uptake of the complex by Liu, a person of ordinary skill in the art would have had a reasonable expectation that the complex would increase bone growth and treat metabolic bone disorders.
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to administer the LF-OPN complex taught by Liu as a method to promote bone development, as taught by Cornish and Poundarik and as evidence by Yamniuk et al., and treat bone diseases by delivering both osteogenic proteins in a protected, bioavailable form. The motivation is to improve the stability, bioavailability, and delivery of LF and OPN for bone health by forming a complex coacervate that protects the proteins from digestion as taught by Liu.
Claims 1-10, and 13-15 are rejected under 35 U.S.C. § 103 as being unpatentable over Liu et al. (Assessment of bioactivities of the human milk lactoferrin-osteopontin complex in vitro. J Nutr Biochem. 2019 Jul;69:10-18; hereinafter “Liu”), in view of Cornish et al. (US-20030191193-A1, published 09 Oct 2003; hereinafter “Cornish”), and in further view of, Poundarik et al. (US-20180280570-A1, published 04 Oct 2018; hereinafter “Poundarik”), and Bovetto et al. (WO-2012045801-A1, published 12 Apr 2012; hereinafter “Bovetto”).
The limitations of instant claim 1 are taught by Liu in view of Cornish and Poundarik, as described above, however, Liu does not explicitly teach the limitations of instant claims , depending from instant claim 1.
Liu does not recite zeta potential nor a diameter of at least 500 nm and the specific formulation and dosing/concentration parameters of the instant claims.
Bovetto teaches that complex coacervates are well defined in the art (p. 3, lines 23-27) and can be formed between lactoferrin (LF) and oppositely charged proteins (p. 4, lines 18-24), wherein the complex coacervate has a diameter of at least 500 nm in the shortest dimension and a zeta potential in the range of -15 and +15 mV (p. 4, lines 28-30; Figure 1, showing zeta potential near zero at optimal pH for complexation). It would have been obvious to one of ordinary skill that the LF-OPN complex of Liu would have a similar size (≥500 nm) because it forms via the same electrostatic coacervation mechanism as that taught by the invention of Bovetto. Selecting a size within a known range and a known charge-neutral region zeta potential is routine optimization (see In re Peterson, 315 F.3d 1325 (Fed. Cir. 2003)).
One would have a reasonable expectation of success in preparing LF-OPN coacervates with the instant claimed diameters by adjusting protein concentration, pH, and mixing ratio as taught by Bovetto in Figure 4 and the associated text (see also evidentiary reference Zheng et al., Heteroprotein complex coacervation: Focus on experimental strategies to investigate structure formation as a function of intrinsic and external physicochemical parameters for food applications. Adv Colloid Interface Sci. 2020 Oct;284:102268, p. 15-16, discussing pH and mixing ratio effects on size and characterizing heteroprotein complexes using zeta potential measurement as standard in the art). It would have been obvious to measure the zeta potential of the Liu complex and to adjust pH as taught Bovetto to achieve the claimed range for optimal coacervate formation.
Bovetto teaches that the complex coacervate is administered as an edible composition for human or animal consumption (p. 4, line 31- p. 5, line 25) for use to incorporate into food products (p. 3, lines 4-6), which are orally administered to humans or pets (animals) as food compositions, pet food compositions, drinks, nutritional formulas or nutraceuticals (p. 10, lines 24-28).
Bovetto teaches that one advantage of his invention is that the complex coacervates are well suitable for all age groups (which includes adults) and may be to be administered to children and infants (i.e., children younger than 12 months) (p. 11, lines 3-8). Hence, infant nutritional formulas and food compositions are encompassed by the invention of Bovetto. Further, as mentioned above, Liu explicitly suggest use of LF-OPN complex coacervates as a potential substitute for human LF-OPN complex as an additive in infant formula (p. 17, col. 1).
Bovetto teaches, “In a particular embodiment wherein the composition contains a complex coacervate, the complex coacervate consisting of lactoferrin, at least one other protein with an isoelectric point lower than pH 7.0, and water. Preferably, the complex coacervate consists of a total protein concentration in the range from ca. 5 to 25 wt%, and the rest being water. The lactoferrin and the at least one other protein are present in a weight ration in the range of 5:1 to 1:5. Complex coacervates consisting of only proteins and water have the advantage that they are thermodynamically stable, are fully food-grade, modulate well the kinetics of the protein digestion and hence exert very well the desired nutritional benefits as described above. Those skilled in the art will understand that they can freely combine all features of the present invention described herein, without departing from the scope of the invention as disclosed. In particular, features described for the uses of the present invention may be applied to the composition of the present invention and vice versa.” (p. 11, lines 9-26).
In addition, Figure 5 and the corresponding description by Bovetto show a protein concentration in the coacervate phase of approximately 22.4% (estimated 5.6g in 25 mL), which result in a concentration factor of 11. Thus, Bovetto explicitly teaching a 5-25 wt.% total protein concentration range and a calculated 75-95 wt.% water range, as well as effectively teaching wherein complex coacervates consisting of only proteins and water at any protein concentration range to achieve the desired nutritional benefit may be used.
Further, Bovetto claim 6 teaches that the composition may be further subjected to a drying step, such as spray-drying or a freeze-drying, which one of skill in the art would recognize as effectively taking a 5-25 wt.% total protein concentration and reducing water to approximately 1-10 wt.%, thereby increasing the total protein concentration to 90-99 wt. %. One of skill in the art would also recognize that the resulting spray-dried or a freeze-dried powder may be reconstituted to reform complex coacervates under appropriate conditions (e.g., pH and ionic strength) by adding water at a specific ratio to achieve the desired protein and water concentration. Hence, arguably, the entire instant claimed water range is arguably encompassed by the teachings of Bovetto.
Evidentiary reference Zheng et al. (Heteroprotein complex coacervation: Focus on experimental strategies to investigate structure formation as a function of intrinsic and external physicochemical parameters for food applications. Adv Colloid Interface Sci. 2020 Oct;284:102268), further teaches that teaches that complex coacervates comprise concentrated protein-rich phases dispersed in water and routinely contain protein and water amounts overlapping the claimed ranges (p. 16, section 3.2 and Table 1). Optimization of relative protein and water content constitutes routine result-effective-variable optimization (see In re Aller, 220 F.2d 454 (CCPA 1955)).
Neither Liu or Bovetto explicitly teach a dose of 100-10000 mg/kg/day. However, Bovetto teaches total protein concentration ranges of 0.5-5 wt% in the composition (claim 5), which translates to ~5-50 g/L. A person of ordinary skill would have been able to determine an appropriate dose for a subject based on the protein concentration in the composition and typical consumption volumes (e.g., 1-2 L/day for infants). The claimed dose range (100-10000 mg/kg/day) is broad and encompasses doses that would deliver therapeutic amounts of LF and OPN based on their known concentrations in human milk described by Liu for LF as 1 g/L (mature milk) to 7 g/L (colostrum) in human milk and OPN at ~138 mg/L (p. 10, introduction, first paragraph). It would have been obvious that administering the complex at levels approximating or exceeding those found in human milk would be effective, and routine optimization would yield suitable doses.
In addition, evidentiary reference Belldegrun and Funt (US-20190388518-A1; published 26 Dec 2019) teaches Formulations 1-2 and 4 using 0.85 g/L LF and 0.13 g/L OPN, resulting in a calculated estimated daily intake for a 5 kg infant with a daily intake of 750 mL formula per day of 127.5 mg/kg/day LF and 19.5 mg/kg/day LF, totaling 147 mg/kg/day protein together and Formulation 7 teaches 1.5 g/L LF, resulting in a calculated estimated daily intake for a 5 kg infant with a daily intake of 750 mL formula per day of 225 mg/kg/day LF. Thus, suggesting that the routine and expected dosage in healthy infants for nutritional supplementation of combination of LF and OPN is ≥147 mg/kg/day, which is encompassed within the instant claimed range.
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to combine Liu’s LF-OPN complex with Bovetto’s formulation parameters (size, zeta potential, forms, concentrations) because it represents a simple application of known techniques to a known composition (see KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007)). It would have been obvious to formulate the LF-OPN complex of Liu into the food and nutritional compositions taught by Bovetto for oral delivery. The combination simply involves application of a known formulation technique of complex coacervation to a known interacting protein pair lactoferrin and osteopontin for the predictable purpose of delivering those proteins in nutritional compositions.
One of ordinary skill would have recognized that coacervates formed from LF and OPN by Liu would have similar protein/water proportions as other protein-protein coacervates, as in Bovetto, because coacervates are liquid-liquid phase separated systems with high protein concentration in the dense phase (see also Zheng et al., “highly concentrated protein in the droplet phase”). It would have been obvious to apply the known concentration ranges from Bovetto to the LF-OPN complex of Liu.
A person of ordinary skill in the art would have had a reasonable expectation of success because Liu already demonstrates that the LF-OPN complex forms spontaneously and is stable. Bovetto, also as evidence by Zheng et al., teaches that coacervates of oppositely charged proteins, including LF with other proteins, predictably exhibit diameters ≥500 nm, near-neutral zeta potential at optimal pH, and specific protein/water ratios. Both LF and OPN individually have established roles in bone formation as taught by Cornish and Poundarik, and their combination in a complex that resists proteolysis would be expected to at least maintain, if not enhance, those bone-related activities.
Claim Rejections – Nonstatutory 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).
Claims 1-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 13 of co-pending US Application No. 18/720,338 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons outlined below. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Co-pending claim 1 a lactoferrin/osteopontin complex coacervate, co-pending claims 2-5 have the same compositional parameters as the instant claims (protein content of 5-50% w/w; water content of 50-95% w/w; diameter of at least 500 nm; and zeta potential between -15 and +15 mV), and co-pending claim 13 claims administration of a lactoferrin/osteopontin complex for treatment/prevention of metabolic disorders (in which osteoarthritis may be classified). The co-pending specification discloses that the same lactoferrin/osteopontin complexes are useful for promoting bone development and treating bone disease (¶[0001]).
The co-pending claims already claim the identical complex coacervate comprising lactoferrin and osteopontin (claim 1) and administration of a lactoferrin/osteopontin complex to a subject for therapeutic purposes (claim 13), overlapping and encompassing the limitations of instant claim 1. The only substantive distinction is that the instant claim recites treatment of bone-related conditions whereas claim 13 recites treatment or prevention of metabolic disorders. However, the co-pending specification expressly identifies promotion of bone development, bone growth, bone strength, bone healing, and treatment of bone disease as intended therapeutic uses of the same lactoferrin/osteopontin complexes (¶[0001]).
Accordingly, one of ordinary skill in the art would have understood administration of the claimed lactoferrin/osteopontin complex for bone development or treatment of bone disease to be an obvious therapeutic use of the same composition already claimed and disclosed in the co-pending application. A newly claimed use of an old composition is not patentably distinct where the use would have been obvious from the earlier claimed invention and its disclosure. Therefore, instant claim 1 is not patentably distinct from co-pending claims 1 and 13.
Instant claim 2-5 limitations are identical to the limitations of co-pending claims 2-5. Accordingly, instant claims 2-5 are not merely obvious variants but encompass the same compositional features already claimed in the co-pending application and therefore are not patentably distinct.
Instant claims 6-10 recite administration of the same complex coacervate in compositions, including foods, infant formulas, supplements, nutraceuticals, oral dosage forms, and dosage ranges. The underlying active ingredient remains the same lactoferrin/osteopontin complex coacervate already claimed in the co-pending application. Selecting conventional dosage forms, food vehicles, oral administration routes, or routine dosage amounts for administration of an already-claimed therapeutic composition would have been obvious design choices to one of ordinary skill in the art. It would have been prima facie obvious to one of ordinary skill in the art that the complex coacervate claimed in the co-pending application for use in promoting bone development could be administered to a subject in need thereof. The "administering" step in the present claims is nothing more than the routine and conventional application of the co-pending claimed composition for its intended purpose. The co-pending application's specification at ¶[0125] expressly states: "The complex coacervate may be administered by any suitable route, for example by oral, enteral, or parenteral administration. In preferred embodiments, the complex coacervate is administered orally." and between 100-1000 mg/kg/day (¶[0126]). Thus, the method of administration is already disclosed and enabled. Therefore, instant claims 6-10 are not patentably distinct.
Instant claims 11-15 merely recite expected therapeutic outcomes (bone growth, bone strength), disease categories (metabolic bone disorder), and intended patient populations (infants, children, adults, animals). These limitations constitute either intended results of administering the same lactoferrin/osteopontin complex or routine selection of treatment populations. Such limitations would have been obvious in view of the therapeutic use of the same complex already disclosed and claimed in the co-pending application. Accordingly, instant claims 11-15 are not patentably distinct from the claims of the co-pending application.
In summary, the instant claims define no patentably distinct invention over claims 1-5 and 13 of the co-pending application. The instant claims merely recite administration and therapeutic use of the same lactoferrin/osteopontin complex coacervate already claimed in the co-pending application and expressly disclosed therein for bone development, bone growth, bone strength, bone healing, and treatment of bone disease. To overcome this rejection, the applicant my amend the claims to establish a patentable distinction or file a terminal disclaimer.
Conclusion
No claims are allowed.
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/RL Scotland/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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