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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination (RCE) under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12 November 2025 has been entered.
Status of the Claims
Claims 1, 3, 6-10, 13, and 16-19 are pending.
Claim 1 is amended.
Claims 2, 4, 5, 11, 12, 14, and 15 are cancelled.
Response to Amendments
Applicant’s amendments filed 12 November 2025 are acknowledged.
Claim Rejections - 35 USC § 103
Applicant’s amendment to claim 1 and cancellation of claims are sufficient to overcome the rejections of:
Claims 1, 4, 8, 10, 14, and 18 under 35 U.S.C. 103 as being unpatentable over Kim (KR1020200099737, published 25 August 2020, cited by applicants 16 February 2023, see machine translation), as evidenced by Haynes et al. (“CRC Handbook”, hereinafter Haynes), in view of Brill-Karniely et al. (“Triangular correlation (TrC) between cancer aggressiveness, cell uptake capability, and cell deformability”, 15 January 2020, Science Advances, Vol. 6, Pgs. 1-13, hereinafter Brill-Karniely);
Claims 3, 5-7, 13, and 15-17 under 35 U.S.C. 103 as being unpatentable over Kim (KR1020200099737, published 25 August 2020, cited by applicants 16 February 2023, see machine translation), as evidenced by Haynes et al. (“CRC Handbook”, hereinafter Haynes), in view of Brill-Karniely et al. (“Triangular correlation (TrC) between cancer aggressiveness, cell uptake capability, and cell deformability”, 15 January 2020, Science Advances, Vol. 6, Pgs. 1-13), as applied to claims 1, 4, 8, 10, 14, and 18 under 35 USC 103 above, in further view of Poradosu, (US20180071243, hereinafter Poradosu), as evidenced by USPC <711> Dissolution; and,
Claims 9 and 19 under 35 U.S.C. 103 as being unpatentable over Kim (KR1020200099737, published 25 August 2020, cited by applicants 16 February 2023, see machine translation), as evidenced by Haynes et al. (“CRC Handbook”, hereinafter Haynes), in view of Brill-Karniely et al. (“Triangular correlation (TrC) between cancer aggressiveness, cell uptake capability, and cell deformability”, 15 January 2020, Science Advances, Vol. 6, Pgs. 1-13), as applied to claims 1, 4, 8, 10, 14, and 18 under 35 USC 103 above, in further view of Chan et al. (US20090186939, hereinafter Chan).
Due to the amendment to claim 1 and cancellation of claims the above rejections are withdrawn and a new ground(s) of rejection is/are provided below.
Response to Arguments
Applicant’s arguments filed 12 November 2025 have been fully considered but they are not persuasive.
Applicant argues that Kim in view of Brill-Karniely, Poradosu, and Chan do not teach the limitations as recited in amended claim 1. These arguments have been considered but are not persuasive for the reasons set forth in the response to arguments below and in the new grounds of rejection below.
In response to applicant’s remarks filed 12 November 2025, it is noted that the paragraph citations to the “Present Specification” appear to be mistaken. For example, “paragraphs [0066] and [0068]” are interpreted as paragraphs [0069] and [0072]. It appears the publication of the instant specification, US20240034744, is relied upon for the citations in the remarks instead of the as filed instant specification.
In response to applicant’s remarks filed 12 November 2025, it is noted “that Kim is the Applicant's own reference. In fact, Kim and the present application shares the same inventor. Therefore, Applicant is very well-versed in the subject matter described in Kim.”
In response to applicant’s remarks filed 12 November 2025 with respect to Brill-Karniely the arguments have been considered but are moot because the new ground of rejection does not rely on Brill-Karniely applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
In response to applicant’s arguments on pages 6-7 of the remarks filed 12 November 2025 that (A) “the manufacturing process of Kim produces a complex that is different than that of claim 1” and the complex of Kim will not have the same dissolution rate at the temperatures as instantly claimed. It is noted:
The instant claims are drawn to a complex compound not to a process of making a complex compound;
The instant claims do not specify the amount of the compound that is dissolved; and,
The instant claims do not specify the amount of the compound that is dissolved within the given time frame.
“The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain”, see MPEP 2123.
As stated in the previous office action dated 14 August 2025 (hereinafter POA) on page 6, Kim teaches “the metal-organic acid salt metal-organic framework (MOF) compound finally obtained contains 0.1 to 20 wt% of metal ions, the iron is Fe2+, see Paras. [0003];[0013];[0015];[0049];[0059];[0084]-[0087]”. Kim teaches the complex compound contains iron within the 8.8 wt% to 12.7 wt% range as instantly claimed. As stated in the POA on pages 7-8 and 12-13, “Kim teaches a substantially identical chemical process for the synthesis of the Fe-cit MOF as detailed in the instant specification”. Since Kim teaches the identical claimed complex with iron within the range claimed, the complex is made by substantially the same identical process, and MPEP 2112 states a “chemical composition and its properties are inseparable”, it would have been obvious to a person or ordinary skill in the art at the time the invention was made that the complex of Kim will include the same formula as instantly claimed and will dissolve in water at the instantly claimed temperature ranges and time ranges.
In addition, “[t]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer” and “the claiming of a new use, new function or unknown property”, such as the dissolution time range, temperature range, and pH range of the complex compound of Kim, “which is inherently present in the prior art does not necessarily make the claim patentable”, see MPEP 2112 I.
For the reasons indicated above, applicant’s above arguments are not persuasive.
In response to applicant’s argument on pages 6 and 8 of the remarks filed 12 November 2025 that “(B) there is no motivation to combine” the cited references. The examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art, see In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In addition, “[a] reference is analogous art to the claimed invention if: (1) the reference is from the same field of endeavor as the claimed invention (even if it addresses a different problem); or (2) the reference is reasonably pertinent to the problem faced by the inventor (even if it is not in the same field of endeavor as the claimed invention)”, see MPEP 2141.01(a).
In this case, Kim teaches that when present in an environment where kidney cancer cells exist the metal-organic acid salt MOF, iron citrate, is designed with a particle size that will allow the MOF to penetrate into cancer cells and decompose within the cancer cells into metal ions and organic acid salts, to thereby increasing oxidative stress and osmotic stress in the cancer cells, which leads to cancer cell death and growth inhibition effects, see Kim, Paras. [0008];[0013];[0051]-[0053];[0056].
Poradosu is in the known prior art field of adjusting the solubility of iron citrate in aqueous environments, see Paras. [0117]-[0119] and USPC <711> Dissolution, in order to treat patients with cancer and anemia associated with chronic kidney disease, see Paras. [0002];[0070];[0086];[0088], and is applied to teach the problem to be solved of synthesizing an iron citrate of the desired molecular weight and surface area in order to adjust the solubility of the iron citrate, see Paras. [0114]-[0119]. Therefore, it would have been obvious for a person of ordinary skill in the art to modify Kim by relying upon Poradosu before the effective filing date of the claimed invention for knowledge generally available within the cancer and kidney disease treatment art regarding the molecular weight of soluble iron citrate, see MPEP 2143 B & G.
Chan is in the known prior art field of adjusting the solubility of ferric citrate and ferric or ferrous phosphates over a wide range of pH levels in aqueous environments, see Paras. [0016]-[0018];[0051];[0079], in order to treat patients with anemia associated with chronic kidney disease, see Paras. [0014];[0021], and is applied to teach the problem to be solved of maintaining the iron citrate in crystal form until the desired pH is reached for dissolution, see Paras. [0017]-[0018];[0051]. Therefore, it would have been obvious for a person of ordinary skill in the art to modify Kim by relying upon Chan before the effective filing date of the claimed invention for knowledge generally available within the kidney disease treatment art regarding the desirable pH in which the iron citrate will maintain crystalline structure, see MPEP 2143 B & G.
The rationale to support a conclusion that the claim would have been obvious is that “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense”, see MPEP 2143 I.E. Since patents are part of the literature of the prior art relevant for all they contain, see MPEP 2123, and Kim, Poradosu, and Chan all teach the use of iron citrate to treat patients with kidney diseases, a person of ordinary skill in the art has good reason to modify Kim by relying upon Poradosu and Chan before the effective filing date of the claimed invention for knowledge generally available within the kidney disease treatment art regarding the molecular weight of soluble iron citrate and the desirable pH in which the iron citrate will maintain crystalline structure, see MPEP 2143 B & G and 2141.
For the reasons indicated above, applicant’s above arguments are not persuasive.
New Grounds of Rejection based on the RCE filed on 12 November 2025
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1, 3, 6-10, 13, and 16-19 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 1 states “combined while forming the following chemical formula”. It is unclear as to whether the claim language is directed to a final product or to an intermediate. The rejection may be obviated by amending the claim to state “combined to form the following formula”. The claim language is herein interpreted and examined as a final product formed.
Claims 1, 6, 7, 16, and 17 state the complex compound is dissolved in water. Claim 1 is a product claim drawn to a “complex compound in which a citrate and an iron ion are combined”. It is unclear as to whether additional water is included in the complex compound combination, the water dissolution is a step in a process of the production of the complex compound or a differing compound, the water dissolution is an intended use of the complex compound, and/or the water dissolution implies a characteristic and/or property of the complex compound.
Claims 3, 8-10, 13, 18, and 19 depend from base claim 1 and are included in this rejection as they do not correct the informalities identified in base claim 1.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 3 and 13 are rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 3 and 13 state a lower limit for the molecular weight of the complex compound detailed in claim 1 as “440 g/mol”. As calculated by the examiner, the lowest molecular weight of the complex compound in claim 1 is when a is 1, b is 2, and n is 1 which equates to a molecular weight of 458.11 g/mol. As a result, claims 3 and 13 broaden the molecular weight of the complex compound in claim 1. Claims 3 and 13 fail to further limit the subject matter of the claim upon which they depend and fail to include all the limitations of the claim upon which they depend.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 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, 3, 6-8, 10, 13, and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Kim (KR1020200099737, published 25 August 2020, see machine translation), as evidenced by Haynes, (“CRC Handbook of Chemistry and Physics”, 2017, 97th Edition, CRC Press, Pgs. 2-47, 4-25), in view of Su (WO2007062561, published 07 June 2007, see machine translation) and Poradosu et al., (US20180071243, published 15 March 2018, hereinafter Poradosu), as evidenced by USPC <711> Dissolution (published 01 February 2012).
Regarding instant application claim 1, Kim teaches the known prior art of a complex compound used in a food composition in which a citrate and an iron ion are combined, see Paras. [0003];[0013];[0015], where the metal-organic acid salt metal-organic framework (MOF) compound finally obtained contains 0.1 to 20 wt% of metal ions and the iron is Fe2+ aka ferrous, see Paras. [0038];[0049];[0059];[0061];[0084]-[0087], meeting the complex compound and within the range of the iron content in instant application claim 1; and,
Kim teaches a three-dimensional structure formed by a metal ion bonded between organic acid salts, see Para. [0052], i.e., one metal between salts leads to a ratio of at least 1:2, meeting and within the range in instant application claim 1.
The synthesis of the Fe-cit MOF of Kim is performed in air, see Kim Paras. [0084]-[0087], which comprises 21% oxygen and at atmospheric pressure of 101.325 kPa or 1 atm, as evidenced by Haynes, Pg. 2-47 and Pg. 4-25. The synthesis in the instant specification Example 1 details the exact same synthesis procedure as Kim except oxygen is injected and instant specification Comparative Example 1 details a 1 atm pressure, see instant specification Paras. [0067]-[0072].
Kim is silent regarding [Chemical Formula 1] [Fea(H3·C6H5O7)b(H2O)]n in Chemical Formula 1 and n is an integer of 1 to 7. See MPEP 2112.01(I) stating “[w]here the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).” As stated above, Kim teaches a substantially identical chemical process for the synthesis of the Fe-cit MOF as detailed in the instant specification. Therefore, the Fe-cit MOF of Kim will inherently have [Chemical Formula 1] [Fea(H3·C6H5O7)b(H2O)]n in Chemical Formula 1, a ratio of a and b is 1:2 to 1:3, and n is an integer of 1 to 7, meeting the formula in instant application claim 1.
In regard to “in which a citrate and an iron ion are combined while forming the following chemical formula [Chemical Formula 1] [Fea(H3·C6H5O7)b(H2O)]n in Chemical Formula 1, a ratio of a and b is 1:2 to 1:3, and n is an integer of 1 to 7”. See MPEP 2113(I) stating ““even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted)” and “[t]he structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product”. As stated above, Kim teaches a complex compound comprising a citrate and an iron ion made by the substantially identical chemical process as instantly claimed and having the instantly claimed amount of iron, see Kim, Paras. [0049];[0059];[0084]-[0087]. Therefore, the process in which the complex compound is made in Kim is substantially the same as instantly claimed and the patentability of the complex product does not depend on its method of production; therefore, the limitation in instant application claim 1 may not be given patentable weight.
In addition, the instant application claim 1 language does not limit the claim to a particular structure, see MPEP 2111.04. In this case, the “wherein” clause drawn to the dissolution does not appear to give “meaning and purpose” to the particular structure, see MPEP 2111.04.
Regarding instant application claim 8, Kim teaches where the metal-organic acid salt metal-organic framework (MOF) compound finally obtained contains 0.1 to 20 wt% of metal ions and the iron is Fe2+, see Paras. [0049];[0059];[0061];[0084]-[0087], meeting the specific iron in instant application claim 8.
Regarding instant application claims 10 and 18, Kim teaches a complex compound used in a food composition in which a citrate and an iron ion are combined, see Paras. [0003];[0013];[0015], where the metal-organic acid salt metal-organic framework (MOF) compound finally obtained contains Fe2+, see Paras. [0038];[0059];[0061];[0084]-[0087], meeting:
The food composition in instant application claim 10; and,
The specific iron in instant application claim 18.
Kim teaches the complex can be characterized by having a size of 1 nm to 1,000 nm, see Paras. [0051]-[0052].
Kim does not specifically teach:
The instant application claim 1 limitations of Chemical Formula 1, the diameter, and the dissolution; and,
The limitations in instant application claims 6, 7, 16, and 17.
In reference to the instant application claims 1, 6, 7, 16, and 17 limitations of dissolution. See the MPEP 2113(I) product-by-process stating above, Kim teaches a complex compound comprising a citrate and an iron ion made by the substantially identical chemical process as instantly claimed and having the instantly claimed amount of iron, see Paras. [0049];[0059];[0084]-[0087]. Therefore, the process in which the complex compound is made in Kim is substantially the same as instantly claimed and the patentability of the complex product does not depend on its method of production, meeting the dissolving in instant application claim 6, in instant application claim 7, in instant application claim 16, and in instant application claim 17.
In reference to the instant application claims 1, 6, 7, 16, and 17 limitations of dissolution, Kim teaches the same instantly claimed complex compound comprising a citrate and an iron ion. As stated in MPEP 2112.01, ““[p]roducts of identical chemical composition cannot have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705,709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).” Therefore, the Fe-cit MOF complex compound of Kim will dissolve in 5 0C to 40 0C water within 5 minutes, meeting the dissolving in instant application claim 6, in instant application claim 7, in instant application claim 16, and in instant application claim 17.
Further, Su teaches the known prior art of improving the solubility of iron citrate in water, see Abstract.
Regarding instant application claim 1, Su teaches it is known in the prior art to obtain iron citrate with a diameter of less than 5 micron aka 5000 nm in order to obtain a suitable dissolution rate for use in the pharmaceutical industry, i.e., less than 5000 nanometers includes the range from 1300 nm to 3000 nm, see PDF, Pg. 21, Second Full Para.; PDF Pg. 22, Bottom, 1., such as dissolving particle sizes of less than 100 micron in water at a temperature of 20 ◦C in less than 1 minute, see PDF Pg. 21. Ninth Full Para.-Pg. 22, Table 1, Dissolution rate and PDF Pg. 25, Table 1, meeting the dissolution, within the temperature range, and within the diameter range in instant application claim 1.
Regarding instant application claims 6, 7, 16, and 17, Su teaches dissolving iron citrate particles in water at a temperature of 20 ◦C in less than 1 minute, see PDF Pg. 21-Pg. 22, Ninth Full Para. -Table 1, Dissolution rate and PDF Pg. 25, Table 1, meeting and within the temperature and time dissolution ranges in instant application claim 6, in instant application claim 7, in instant application claim 16, and in instant application claim 17.
Further, Poradosu teaches the known prior art of iron citrate dissolved at a percentage of 91% or more within 5 minutes using dissolution testing conducted on the iron citrate preparations in USP <711>, see Para. [0117], i.e., or more implies an upper limit of 100%, as evidenced by USPC <711> Dissolution, Pg. 1, Col. 1, Third Para.; Pg. 5, Procedure, Apparatus 1 and Apparatus 2, Immediate-Release Dosage Forms, the medium may be water and the temperature may be 37 0C or 20-25 0C, in order to treat patients with cancer and anemia associated with chronic kidney disease, see Paras. [0002];[0070];[0086];[0088].
Regarding instant application claim 1, Poradosu teaches the iron citrate used as described herein is known chemically as iron (+3), x (1, 2, 3-propanetricarboxylic acid, 2-hydroxy-), y (H2O)
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, where the ratio of a to b aka x to y is 0.7:1.9 and n is 1, see Paras. [0114];[0122], meeting Chemical Formula 1 and within the ranges in instant application claim 1.
Regarding instant application claims 3 and 13, Poradosu teaches iron citrate hydrate, see Abstract; Paras. [0114]-[0115];[0122]-[0123], wherein the complex compound tetraferric tricitrate decahydrate has a molecular weight, as calculated by the examiner, of 967.8 g/mol, see Paras. [0114]-[0115], meeting and within the range in instant application claim 3 and in instant application claim 13.
In reference to the above claims, since MPEP 2112 states a “chemical composition and its properties are inseparable”, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to reasonably predict the Kim teaching of the identical claimed complex with iron within the range claimed made by substantially the same identical process will include the same formula as instantly claimed and will dissolve in water at the instantly claimed temperature ranges and time ranges.
Further, in reference to the above claims, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Kim to obtain an iron citrate with the desired molecular weight, formula, and diameter for the optimal aqueous dissolution, see MPEP 2144.04 IV., 2144.05, 2144.08, and as taught by Su and Poradosu, with a reasonable predictability of success for the purpose of efficiently producing iron citrate with the optimal dissolution rate in aqueous environments, see Su, PDF, Pg. 21, Second Full Para.; PDF Pg. 22, Bottom, 1; Poradosu, Paras. [0002];[0070];[0086];[0088].
The rationale to support a conclusion that the claim would have been obvious is that “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense”, see MPEP 2143 I.E. Since patents are part of the literature of the prior art relevant for all they contain, see MPEP 2123, and Kim, Su, and Poradosu all teach the use of iron citrate in the pharmaceutical industry, a person of ordinary skill in the art has good reason to modify Kim by relying upon Su and Poradosu before the effective filing date of the claimed invention for knowledge generally available within the pharmaceutical art regarding the molecular weight of soluble iron citrate and the desirable pH in which the iron citrate will maintain crystalline structure, see MPEP 2143 B & G and 2141, for the benefit of efficiently producing iron citrate with the optimal dissolution rate in aqueous environments, see Su, PDF, Pg. 21, Second Full Para.; PDF Pg. 22, Bottom, 1; Poradosu, Paras. [0002];[0070];[0086];[0088]; and MPEP 2141.
Changes in configuration, shape, and/or size, such as the diameter of the particles and the molecular weight of the iron citrate, is a matter of choice which a person of ordinary skill in the art would have found obvious, such as finding the optimal size and surface area for the preferred dissolution rate, absent persuasive evidence that the particular configuration as claimed was significant, see MPEP 2144.04 IV.
As stated in Sakraida v. Ag Pro, Inc., 425 U.S. 273, 189 USPQ 449, reh’g denied,
426 U.S. 955 (1976), “[w]hen a work is available in one field of endeavor, design
incentives and other market forces can prompt variations of it, either in the same field
or a different one. If a person of ordinary skill can implement a predictable variation, §
103 likely bars its patentability. For the same reason, if a technique has been used to
improve one device, and a person of ordinary skill in the art would recognize that it
would improve similar devices in the same way, using the technique is obvious unless its
actual application is beyond his or her skill”, see MPEP 2141.
“The discovery of a previously unappreciated property of a prior art composition,” such as quantifying the dissolution rate of the iron complex of Kim, “or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer” and “the claiming of a new use, new function or unknown property”, such as the formula, molecular weight, dissolution rates at differing pH levels of the complex of Kim, “which is inherently present in the prior art does not necessarily make the claim patentable”, see MPEP 2112 I.
“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”, such as the % iron in the complex, “is the optimum combination of percentages.” In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969), see MPEP 2144.05.
Selection of a known material, such as Fe(II), based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945), see MPEP 2144.07.
“It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions,” such as molecular weight and values for a, b, x, y, etc., “or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions. In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929)”, see MPEP 2144.05.
In addition, “[w]here applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, the examiner may make a rejection under both 35 U.S.C. 102 and 103.”, see MPEP 2112 III. In this case, Kim teaches the same iron complex as currently claimed which will inherently also have the same formula, molecular weight, dissolution rates, chemical properties, and chemical characteristics.
Claims 9 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Kim (KR1020200099737, published 25 August 2020, see machine translation), as evidenced by Haynes, (“CRC Handbook of Chemistry and Physics”, 2017, 97th Edition, CRC Press, Pgs. 2-47, 4-25), in view of Su (WO2007062561, published 07 June 2007, see machine translation) and Poradosu et al., (US20180071243, published 15 March 2018, hereinafter Poradosu), as evidenced by USPC <711> Dissolution (published 01 February 2012), as applied to claims 1, 3, 6-8, 10, 13, and 16-18 in the 35 USC 103 rejection above, in further view of Chan et al. (US20090186939, published 23 July 2009, hereinafter Chan).
Kim does not specifically teach the limitations of instant application claims 9 and 19.
In reference to the instant application claims 9 and 19 functional claim limitations pertaining to “wherein the complex compound maintains a crystal structure at pH 2 to pH 4”, Kim teaches the same instantly claimed complex compound comprising a citrate and an iron ion. As stated in MPEP 2112.01, ““[p]roducts of identical chemical composition cannot have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705,709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).” Therefore, the Fe-cit MOF complex compound of Kim will maintain a crystal structure at pH 2 to pH 4, meeting instant application claim 9 and instant application claim 19.
Further, Chan teaches the known prior art of pharmaceutical-grade iron organic compounds having enhanced aqueous dissolution rates over a wide range of pH, such as iron citrate and ferric or ferrous phosphates, see Abstract; Paras. [0016];[0051];[0060]-[0061];[0076]-[0079], in order to treat patients with anemia associated with chronic kidney disease, see Paras. [0014];[0021].
Regarding instant application claims 9 and 19, Chan teaches Fe (III) is a Lewis acid and is chemically less soluble in the stomach at a pH below 5 than at intestinal pH normally above 7, see Paras. [0016]-[0018], and the iron organic compounds of the present invention can be more effective by being soluble in the small intestine, see Para. [0051], i.e., the solid crystal structure is maintained at a pH below 5, meeting and within the range in instant application claim 9 and in instant application claim 19.
In reference to the above claims, since MPEP 2112 states a “chemical composition and its properties are inseparable”, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to reasonably predict the Kim teaching of the identical claimed complex with iron within the range claimed made by substantially the same identical process will include the same formula as instantly claimed and will remain in crystal form at the instantly claimed pH ranges.
Further, in reference to the above claims, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Kim to obtain a ferrous iron citrate with the desired molecular weight, formula, and diameter for the optimal aqueous dissolution at the desired pH, see MPEP 2144.04 IV., 2144.05, 2144.08, and as taught by Chan, with a reasonable predictability of success for the purpose of efficiently producing iron citrate with the optimal dissolution rate at the desired pH in aqueous environments, see Chan, Paras. [0017]-[0018];[0051].
The rationale to support a conclusion that the claim would have been obvious is that “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense”, see MPEP 2143 I.E. Since patents are part of the literature of the prior art relevant for all they contain, see MPEP 2123, and both Kim and Chan teach the use of iron citrate to treat kidney disease, a person of ordinary skill in the art has good reason to modify Kim by relying upon Chan before the effective filing date of the claimed invention for knowledge generally available within the kidney disease treatment art regarding the desirable pH in which the iron citrate will maintain crystalline structure, see MPEP 2143 B & G and 2141, for the benefit of efficiently producing iron citrate with the optimal dissolution rate at the desired pH in aqueous environments, see Chan, Paras. [0017]-[0018];[0051] and MPEP 2141.
As stated in Sakraida v. Ag Pro, Inc., 425 U.S. 273, 189 USPQ 449, reh’g denied,
426 U.S. 955 (1976), “[w]hen a work is available in one field of endeavor, design
incentives and other market forces can prompt variations of it, either in the same field
or a different one. If a person of ordinary skill can implement a predictable variation, §
103 likely bars its patentability. For the same reason, if a technique has been used to
improve one device, and a person of ordinary skill in the art would recognize that it
would improve similar devices in the same way, using the technique is obvious unless its
actual application is beyond his or her skill”, see MPEP 2141.
“The discovery of a previously unappreciated property of a prior art composition,” such as quantifying the dissolution rate of the iron complex of Kim, “or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer” and “the claiming of a new use, new function or unknown property”, such as the formula, molecular weight, dissolution rates at differing pH levels of the complex of Kim, “which is inherently present in the prior art does not necessarily make the claim patentable”, see MPEP 2112 I.
In addition, “[w]here applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, the examiner may make a rejection under both 35 U.S.C. 102 and 103.”, see MPEP 2112 III. In this case, Kim teaches the same iron complex as currently claimed which will inherently also have the same formula, molecular weight, dissolution rates at differing pH, chemical properties, and chemical characteristics.
Conclusion
No claims are allowed.
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/YO/Examiner, Art Unit 1692
/FEREYDOUN G SAJJADI/Supervisory Patent Examiner, Art Unit 1699