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 .
DETAILED ACTION
Application Status
This application is a CON of PCT/US2024/046780, filed on 04/24/2025.
The Examiner is also acknowledging the filing of a Petition to make this patent application as a Track One under 37 CFR 1.102(e) filed on 04/6/08/2021, and the petition has been granted on 05/22/2025.
Claims 1-20 are currently pending in the instant patent application.
The preliminary amendment of claims filed on 08/21/2025, amending claims 5-8, and 18 is acknowledged.
Election/Restriction
Applicant's election without traverse of species “ore” in the response filed on 08/21/2025 is acknowledged.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-20 are present for examination.
Priority
Acknowledgement is made of applicants claim for priority of US Provisional applications 63/583,201, filed on 09/15/2023.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/23/2025 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are considered by the examiner. The signed copies of 1449 are enclosed herewith.
Drawings
Drawings submitted on 04/24/2025 are accepted by the Examiner.
Claim Objections
Claim 18 is objected to in the recitation “40 %”, which should be changed to “40%”. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 5-7 are rejected under 35 U.S.C. 112(b) or second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claims 5-7 are indefinite in the recitation “at least about 30%” in the context of sequence identity of gamma carbonic anhydrase enzyme. It is unclear whether applicant meant “at least 30%” or “about 30%”. However, “about 30%” is unclear and vague, as it is not clearly stated in the specification about what is the scope of “about 30%” mean? In addition, the combination of “at least about 30%” is ambiguous and confusing. Besides, the term “about” is a term of degree and the examiner has reviewed the specification and can find no examples or teachings that can be used for ascertaining the variance intended by the recited term of degree. Moreover, there is nothing in the specification or prior art of record to indicate that one of ordinary skill in the art could have ascertain the scope of the recited degree. It is suggested that applicant clarify the meaning of the claim. Similar explanation is applied for 112(b) issues recited in claims 6-7. Clarification is required.
Claim 5 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 5 is indefinite and vague in the recitation “sequence identity at least about 30% ---- with an amino acid sequence of a gamma carbonic anhydrase”, which are confusing because absent a reference to a protein sequence of a gamma carbonic anhydrase to which the amino acid identity refers? What is the protein sequence of gamma carbonic anhydrase? In the art, gamma carbonic anhydrase can be multiple forms derived from many unknown sources, and includes many mutants and variants thereof. Therefore, “sequence identity at least about 30% ---- with an amino acid sequence of a gamma carbonic anhydrase” is confusing. Besides, Applicants are advised to include sequence with SEQ ID NO: of said gamma carbonic anhydrase for searching DNA or protein databases to determine the patentability of said phrase accurately. For the examination purpose, the examiner would not consider such phrase as limitation (% identity). Clarification is required.
Claim 6 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 6 is indefinite and vague in the recitation “sequence identity at least about 30% ---- with an amino acid sequence of an enzyme --------- of Methanosarcina thermophila gamma carbonic anhydrase”, which is confusing because absent a reference to a protein sequence of Methanosarcina thermophila gamma carbonic anhydrase to which amino acid identity refers? What is the protein sequence of Methanosarcina thermophila gamma carbonic anhydrase? In the art, Methanosarcina thermophila gamma carbonic anhydrase can be multiple forms including many mutants, variants and fragments thereof. Therefore, “sequence identity at least about 30% ---- with an amino acid sequence of an enzyme --------- of Methanosarcina thermophila gamma carbonic anhydrase” is confusing. Similar explanation would also apply for other gamma carbonic anhydrase of different species recited in claim 6. For the examination purpose, the examiner would not consider such phrase as limitation (% identity). Clarification is required.
Claim 8 is rejected under 35 U.S.C. 112(b) or second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claim 8 are indefinite in the recitation “about 23 degrees” in the context of the temperature. It is unclear whether applicant meant “23 degrees” or something other than “23 degrees”, which are unknown rendering the metes and bounds of the term unclear and confusing, and furthermore, it is not clearly stated in the specification about what is the scope of “about 23 degrees” mean? Besides, the term “about” is a term of degree and the examiner has reviewed the specification and can find no examples or teachings that can be used for ascertaining the variance intended by the recited term of degree. Moreover, there is nothing in the specification or prior art of record to indicate that one of ordinary skill in the art could have ascertain the scope of the recited degree. It is suggested that applicant clarify the meaning of the claim. Clarification is required.
Claim 9 is rejected under 35 U.S.C. 112(b) or second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claim 9 is indefinite in the recitation “about 4” in the context of pH of reaction conditions. It is unclear whether applicant meant “4” or something other than “4”, which are unknown rendering the metes and bounds of the term unclear and confusing, and furthermore, it is unclear and vague, as it is not clearly stated in the specification about what is the scope of “about 4” mean? Besides, the term “about” is a term of degree and the examiner has reviewed the specification and can find no examples or teachings that can be used for ascertaining the variance intended by the recited term of degree. Moreover, there is nothing in the specification or prior art of record to indicate that one of ordinary skill in the art could have ascertain the scope of the recited degree. It is suggested that applicant clarify the meaning of the claim. Clarification is required.
Claim 16 is rejected under 35 U.S.C. 112(b) or second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claim 16 is indefinite in the recitation “about 80%” in the context of purity of metal. It is unclear whether applicant meant “80%” or something other than “80%”, which are unknown rendering the metes and bounds of the term unclear and confusing, and furthermore, it is unclear and vague, as it is not clearly stated in the specification about what is the scope of “about 80%” mean? Besides, the term “about” is a term of degree and the examiner has reviewed the specification and can find no examples or teachings that can be used for ascertaining the variance intended by the recited term of degree. Moreover, there is nothing in the specification or prior art of record to indicate that one of ordinary skill in the art could have ascertain the scope of the recited degree. It is suggested that applicant clarify the meaning of the claim. Clarification is required.
Claim 18 is rejected under 35 U.S.C. 112(b) or second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claim 18 is indefinite in the recitation “about 40%” in the context of ratio of rock to liquid. It is unclear whether applicant meant “40%” or something other than “40%”, which are unknown rendering the metes and bounds of the term unclear and confusing, and furthermore, it is unclear and vague, as it is not clearly stated in the specification about what is the scope of “about 40%” mean? Besides, the term “about” is a term of degree and the examiner has reviewed the specification and can find no examples or teachings that can be used for ascertaining the variance intended by the recited term of degree. Moreover, there is nothing in the specification or prior art of record to indicate that one of ordinary skill in the art could have ascertain the scope of the recited degree. It is suggested that applicant clarify the meaning of the claim. Clarification is required.
Claim 5 is rejected under 35 U.S.C. 112(b), second paragraph, as being indefinite and vague for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). Note the explanation given by the Board of Patent Appeals and Interferences in Ex parte Wu, 10 USPQ2d 2031, 2033 (Bd. Pat. App. & Inter. 1989), as to where broad language is followed by "such as" and then narrow language. The Board stated that this can render a claim indefinite by raising a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Note also, for example, the decisions of Ex parte Steigewald, 131 USPQ 74 (Bd. App. 1961); Ex parte Hall, 83 USPQ 38 (Bd. App. 1948); and Ex parte Hasche, 86 USPQ 481 (Bd. App. 1949). In the present instance, claim 5 recites the broad recitation 30%, and the claim also recites 90%, which is the narrower statement of the range/limitation.
Claim 6 is rejected under 35 U.S.C. 112(b), second paragraph, as being indefinite and vague for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). Note the explanation given by the Board of Patent Appeals and Interferences in Ex parte Wu, 10 USPQ2d 2031, 2033 (Bd. Pat. App. & Inter. 1989), as to where broad language is followed by "such as" and then narrow language. The Board stated that this can render a claim indefinite by raising a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Note also, for example, the decisions of Ex parte Steigewald, 131 USPQ 74 (Bd. App. 1961); Ex parte Hall, 83 USPQ 38 (Bd. App. 1948); and Ex parte Hasche, 86 USPQ 481 (Bd. App. 1949). In the present instance, claim 6 recites the broad recitation 30%, and the claim also recites 90%, which is the narrower statement of the range/limitation.
Claim 7 is rejected under 35 U.S.C. 112, second paragraph, as being indefinite and vague for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). Note the explanation given by the Board of Patent Appeals and Interferences in Ex parte Wu, 10 USPQ2d 2031, 2033 (Bd. Pat. App. & Inter. 1989), as to where broad language is followed by "such as" and then narrow language. The Board stated that this can render a claim indefinite by raising a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Note also, for example, the decisions of Ex parte Steigewald, 131 USPQ 74 (Bd. App. 1961); Ex parte Hall, 83 USPQ 38 (Bd. App. 1948); and Ex parte Hasche, 86 USPQ 481 (Bd. App. 1949). In the present instance, claim 7 recites the broad recitation 50%, and the claim also recites 99.9%, which is the narrower statement of the range/limitation.
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.
A. Written Description
Claims 1-19 and 20 are rejected under 35 U.S.C. 112(a), as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 is directed to a method of extracting a metal from a mineral material, the method comprising:(a) contacting the mineral material with an enzyme having silicase activity under reaction conditions such that the metal contained within the mineral material is solubilized and released; and (b) collecting the released metal, thereby extracting the metal from the mineral material.
The Court of Appeals for the Federal Circuit has held that a “written description of an invention involving a chemical genus, like a description of a chemical species, ‘requires a precise definition, such as by structure, formula [or] chemical name,’ of the claimed subject matter sufficient to distinguish it from other materials.” University of California v. Eli Lilly and Co., 1997 U.S. App. LEXIS 18221, at *23, quoting Fiers v. Revel, 25 USPQ2d 1601, 1606 (Fed. Cir. 1993). To fully describe a genus of genetic material, which is a chemical compound, applicants must (1) fully describe at least one species of the claimed genus sufficient to represent said genus whereby a skilled artisan, in view of the prior art, could predict the structure of other species encompassed by the claimed genus and (2) identify the common characteristics of the claimed molecules, e.g., structure, physical and/or chemical characteristics, functional characteristics when coupled with a known or disclosed correlation between function and structure, or a combination of these (paraphrased from Enzo Biochemical).
Thus, Claims are drawn to a method of extracting any metal from a mineral material, the method comprising:(a) contacting the mineral material with any enzyme derived from any sources having no structural feature having silicase activity under reaction conditions such that the metal contained within the mineral material is solubilized and released; and (b) collecting the released metal, thereby extracting the metal from the mineral material, i.e., any enzyme having silicase activity encompassing many enzymes derived from many unknown sources and many mutants, variants, and fragments thereof, i.e., No Structure-Function correlation, which is required to fulfill the Written Description requirement. Simar explanations are also applied for any enzyme having silicase activity, which is at least about 30% to 80% identity to any gamma carbonic anhydrase recited in claim 5, or at least about 30% to 80% identity to any gamma carbonic anhydrase recited in claim 6, or at least about 30% to 80% identity to any gamma carbonic anhydrase of SEQ ID NO: 1 recited in claim 7.
As discussed in the written description guidelines the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. A representative number of species means that the species, which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
Thus, Claims are drawn to any enzymes polypeptide having silicase activity for claim 1, which is at least 30% to 80% amino acid sequence identity to any protein for claim 5, any GCA protein from different species of claim 6, and any GCA protein of SEQ ID NO: 1-402 of claim 7 derived from many unknown sources having any structural feature having respective enzymatic activity, i.e., 70% to 20% non-identity that encompasses many enzymes having silicase activity or GCA activity and said enzymes or GCA derived from many unknown sources and many mutants, variants, and fragments thereof, which can have wide variety of unknown structures, whose structures are not fully described in the specification. No information, beyond the characterization of few polypeptides of enzymes silicase or GCA enzymes has been provided, which would indicate that applicants had possession of the claimed genus said enzymes.
Furthermore, the genus of genes and encoded polypeptides and functional homologs or variants required in the claimed invention is an extremely large structurally and functionally variable genus. While the argument can be made that the recited genus of polypeptides and encoding polynucleotides are adequately described by the disclosure of the structures of prior art, i.e., genes associated with the production of amino acids, since one could use structural homology to isolate those polypeptides and the encoding polynucleotide recited in the claims. However, the art clearly teaches the “Practical Limits of Function Prediction”: Whisstock et al., (2003) highlight the difficulties associated with “Prediction of protein function from protein sequence and structure”; “To reason from sequence and structure to function is to step onto much shakier ground”, closely related proteins can change function, either through divergence to a related function or by recruitment for a very different function, in such cases, assignment of function on the basis of homology, in the absence of direct experimental evidence, will give the wrong answer, it is difficult to state criteria for successful prediction of function, since function is in principle a fuzzy concept. Given three sequences, it is possible to decide which of the three possible pairs is most closely related. Given three structures, methods are also available to measure and compare similarity of the pairs. However, in many cases, given three protein functions, it would be more difficult to choose the pair with most similar function, although it is possible to define metrics for quantitative comparisons of different protein sequences and structures, this is more difficult for proteins of different functions, in families of closely related proteins, mutations usually conserve function but modulate specificity i.e., mutations tend to leave the backbone conformation of the pocket unchanged but to affect the shape and charge of its lining, altering specificity, although the hope is that highly similar proteins will share similar functions, substitutions of a single, critically placed amino acid in an active-site residue may be sufficient to alter a protein’s role fundamentally (see, whole document). This finding is reinforced in the following scientific teachings for specific proteins in the art that suggest, even highly structurally homologous polypeptides do not necessarily share the same function and many functionally similar proteins will have little or no structural homology to disclosed proteins. For example, proteins having similar structure have different activities (structure does not always correlate to function); Witkowski et al., (1999) teaches that one conservative amino acid substitution transforms a -ketoacyl synthase into a malonyl decarboxylase and completely eliminates -ketoacyl synthase activity. Similarly, the art also teaches that functionally similar molecules have different structures; Kisselev L., (2002) teach that polypeptide release factors in prokaryotes and eukaryotes have same function but different structures.
As stated, no information, beyond the characterization of few polypeptides of enzymes silicase or GCA enzymes has been provided, which would indicate that applicants had possession of the claimed genus. The specification does not contain sufficient disclosure of the structure with function of all the polypeptides of enzymes silicase or GCA enzymes or proteins within the scope of the claimed genus. The genus of polypeptides claimed is a large variable genus including many mutants, variant and fragments thereof, which can have wide variety of structures. Therefore, many structurally unrelated enzymes polypeptides having silicase activity or GCA enzymes within the scope of these claims. The specification discloses the structure of only few representative species of the claimed genus with mutations, which is insufficient to put one of skill in the art in possession of the attributes and features of all species within the claimed genus. Therefore, one skilled in the art cannot reasonably conclude that applicant had possession of the claimed invention at the time the instant application was filed.
Applicant is referred to the revised guidelines concerning compliance with the written description requirement of U.S.C. 112, first paragraph, published in the Official Gazette and also available at www.uspto.gov.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless -
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
MPEP-2131 Anticipation — Application of 35 U.S.C. 102 [R-08.2017]
A claimed invention may be rejected under 35 U.S.C. 102 when the invention is anticipated (or is "not novel") over a disclosure that is available as prior art. To reject a claim as anticipated by a reference, the disclosure must teach every element required by the claim under its broadest reasonable interpretation. See, e.g., MPEP § 2114, subsections II and IV.
"A claim is anticipated only if each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior art reference." Verdegaal Bros. v. Union Oil Co. of California, 814 F.2d 628, 631, 2 USPQ2d 1051, 1053 (Fed. Cir. 1987). "When a claim covers several structures or compositions, either generically or as alternatives, the claim is deemed anticipated if any of the structures or compositions within the scope of the claim is known in the prior art." Brown v. 3M, 265 F.3d 1349, 1351, 60 USPQ2d 1375, 1376 (Fed. Cir. 2001) Note that, in some circumstances, it is permissible to use multiple references in a 35 U.S.C. 102 rejection. See MPEP § 2131.01.
MPEP-2131.01 Multiple Reference 35 U.S.C. 102 Rejections [R-11.2013]
Normally, only one reference should be used in making a rejection under 35 U.S.C. 102. However, a 35 U.S.C. 102 rejection over multiple references has been held to be proper when the extra references are cited to:
(A) Prove the primary reference contains an "enabled disclosure;"
(B) Explain the meaning of a term used in the primary reference; or
(C) Show that a characteristic not disclosed in the reference is inherent.
Claims 1-11, 12, and 13-20 are rejected under 35 U.S.C. 102(a)(1) based upon a public use or sale or other public availability of the invention as anticipated by Toender et al. (Use of enzymes having silicase activity. WO 2010/070110 A2, publication 06/24/2010, see IDS).
The Broadest Reasonable Interpretation (BRI) of claim 1, which is drawn to a method of extracting a metal from a mineral material, the method comprising:(a) contacting the mineral material with an enzyme having silicase activity under reaction conditions such that the metal contained within the mineral material is solubilized and released; and (b) collecting the released metal, thereby extracting the metal from the mineral material.
Regarding claim 1-11, 12, 13-19 and 20, Toender et al. teach a recombinant enzyme having silicase activity derived from Methanosarcina thermophila, which is 100% identical to SEQ ID NO: 1 of the instant application (see, sequence alignment as shown below), and the enzyme is gamma-carbonic anhydrase (gCA), and mutants and variants thereof, wherein the gene encoding gamma-carbonic anhydrase is cloned in a vector and transformed Bacillus subtilis to produce gCA enzyme after culturing, and purified resuspended in sodium phosphate/Glycine buffer, a solution, with pH 7.0, and used ZincS04 as a cofactor for the hydrolysis of the silicate substrate including amorphous, crystalline silicate, with gCA enzyme at 50oC, and a method of use of said polypeptides having silicase activity for the modification or synthesis of silica, silicones and other silicium (IV) compounds, and use of polypeptides having silicase activity for the modification of glass, sand, asbestos, computer chips, glass wool, fiber glass, optical fibers and silicones, for the removal of sand from oil-sands, for the removal of asbestos, and for sandblasting. Toender et al. also teach that silicates are by far the largest and the most complicated class of minerals, where 30% of all minerals are silicates and some geologists estimate that 90% of the Earth's crust is made up of silicates, and the examples of silicate minerals are feldspar, asbestos, clay, hornblende, and zeolites, as well as the nesosilicates (also known as orthosilicates) present a range of precious stones such as olivine, topaz, and zircon, wherein the earth crust also inherently comprises aluminum, and iron (see, evidential reference: WORLD Economic Forum (Visualizing the abundance of the elements in the Earth’s crust. Dec 14, 2021 (see, attached PDF file) (see, title, abstract, pg 2, para 4-7, pg 3, para 4-5, pg 5, para 2-3, pg 6, para 2, pg 10, line 36-37, pg 11, para 1-5, Example 1-V, Table 1-3, and claims 1-15).
Besides, the limitations under wherein clause of claims 13, 14, 15, 16, 17, and 18, which are just an “intended result of a process step, and as per MPEP 2111.04, the court noted that a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step.’” Id.(quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)).
According to MPEP- 2111.04 “Adapted to,” “Adapted for,” “Wherein,” “Whereby,” and Contingent Clauses [R-08.2017]
I. "ADAPTED TO," "ADAPTED FOR," "WHEREIN," and "WHEREBY"
Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “adapted to” or “adapted for” clauses; (B) “wherein” clauses; and (C) “whereby” clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. See, e.g., Griffin v. Bertina, 283 F.3d 1029, 1034, 62 USPQ2d 1431 (Fed. Cir. 2002) (finding that a “wherein” clause limited a process claim where the clause gave “meaning and purpose to the manipulative step. In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “‘whereby’ clause states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted that a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’” Id.(quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)).
Because the mineral material containing metal including silicate, aluminum or iron of the claimed invention (for claim 12), and that of earth crust as a source of mineral material containing metals such as silicate, feldspar, asbestos, clay and zeolites as well as stones like olivine, topaz, and zircon metals of the reference is one and the same, Examiner takes the position that the earth crust as a source of mineral material containing metals as a source iron or aluminum inherently associated with the earth crust as a source of mineral material containing metals of the Toender et al. reference as evidenced by WORLD Economic Forum, Dec 14, 2021 (see, attached PDF file) as evidential reference. Since the Office does not have the facilities for examining and comparing applicants' iron or aluminum presence in the earth crust disclosed by the prior art, the burden is on the applicant to show a novel or unobvious difference between the claimed product, and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald et al., 205 USPQ 594.
RESULT 1
ADZ39253
ID ADZ39253 standard; protein; 247 AA.
AC ADZ39253;
XX
DT 15-JUN-2007 (revised)
DT 30-JUN-2005 (first entry)
XX
DE M.thermophila full length gamma carbonic anhydrase (GCA).
XX
KW Prion protein; fusion protein; protein engineering; vaccine;
KW prion infection; cerebroprotective; infection; prion disease;
KW degeneration; neurological disease;
KW transmissible spongiform encephalopathy; Creutzfeldt Jakob disease;
KW neuroprotective; BSE; scrapie; kuru; gamma carbonic anhydrase; enzyme;
KW BOND_PC; carbonic anhydrase; GO4089; GO8270; GO8415; GO16829; GO15977.
XX
OS Methanosarcina thermophila.
SQ Sequence 247 AA;
Query Match 100.0%; Score 1265; Length 247;
Best Local Similarity 100.0%;
Matches 247; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MMFNKQIFTILILSLSLALAGSGCISEGAEDNVAQEITVDEFSNIRENPVTPWNPEPSAP 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MMFNKQIFTILILSLSLALAGSGCISEGAEDNVAQEITVDEFSNIRENPVTPWNPEPSAP 60
Qy 61 VIDPTAYIDPQASVIGEVTIGANVMVSPMASIRSDEGMPIFVGDRSNVQDGVVLHALETI 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 VIDPTAYIDPQASVIGEVTIGANVMVSPMASIRSDEGMPIFVGDRSNVQDGVVLHALETI 120
Qy 121 NEEGEPIEDNIVEVDGKEYAVYIGNNVSLAHQSQVHGPAAVGDDTFIGMQAFVFKSKVGN 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 NEEGEPIEDNIVEVDGKEYAVYIGNNVSLAHQSQVHGPAAVGDDTFIGMQAFVFKSKVGN 180
Qy 181 NCVLEPRSAAIGVTIPDGRYIPAGMVVTSQAEADKLPEVTDDYAYSHTNEAVVYVNVHLA 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 NCVLEPRSAAIGVTIPDGRYIPAGMVVTSQAEADKLPEVTDDYAYSHTNEAVVYVNVHLA 240
Qy 241 EGYKETS 247
|||||||
Db 241 EGYKETS 247
Therefore, Toender et al. anticipate claims 1-11, 12, 13-19 and 20 of the instant application as written.
Claim Rejections - 35 U.S.C. § 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.
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.
According to MPEP 2143:
“Exemplary rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield
predictable results;
(B) Simple substitution of one known element for another to obtain predictable
results;
(C) Use of known technique to improve similar devices (methods, or products)
in the same way;
(D) Applying a known technique to a known device (method, or product) ready
for improvement to yield predictable results;
(E) “ Obvious to try ” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in
either the same field or a different one based on design incentives or other market
forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art
reference teachings to arrive at the claimed invention.
Note that the list of rationales provided is not intended to be an all-inclusive list. Other rationales to support a conclusion of obviousness may be relied upon by Office personnel.”
Claims 1-11, 12, 13-19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Toender et al. (Use of enzymes having silicase activity. WO 2010/070110 A2, publication 06/24/2010, see IDS) as applied to claims 1-11, 12, 13-19 and 20 above, and further in view of WORLD Economic Forum (Visualizing the abundance of the elements in the Earth’s crust. Dec 14, 2021 (see, attached PDF file).
The Broadest Reasonable Interpretation (BRI) of claim 1, which is drawn to a method of extracting a metal from a mineral material, the method comprising:(a) contacting the mineral material with an enzyme having silicase activity under reaction conditions such that the metal contained within the mineral material is solubilized and released; and (b) collecting the released metal, thereby extracting the metal from the mineral material.
Regarding claims 1-11, 12, 13-19 and 20, Toender et al. teach a recombinant enzyme having silicase activity derived from Methanosarcina thermophila, which is 100% identical to SEQ ID NO: 1 of the instant application (see, sequence alignment as shown below), and the enzyme is gamma-carbonic anhydrase (gCA), and mutants and variants thereof, wherein the gene encoding gamma-carbonic anhydrase is cloned in a vector and transformed Bacillus subtilis to produce gCA enzyme after culturing, and purified and resuspended in sodium phosphate/Glycine buffer, a solution, with pH 7.0, and used ZincS04 as a cofactor for the hydrolysis of the silicate substrate including amorphous, crystalline silicate, with gCA enzyme at 50oC, and a method of use of said polypeptides having silicase activity for the modification or synthesis of silica, silicones and other silicium (IV) compounds, and use of polypeptides having silicase activity for the modification of glass, sand, asbestos, computer chips, glass wool, fiber glass, optical fibers and silicones, for the removal of sand from oil-sands, for the removal of asbestos, and for sandblasting. Toender et al. also teach that silicates are by far the largest and the most complicated class of minerals, where 30% of all minerals are silicates and some geologists estimate that 90% of the Earth's crust is made up of silicates, and the examples of silicate minerals are feldspar, asbestos, clay, hornblende, and zeolites, as well as the nesosilicates (also known as orthosilicates) present a range of precious stones such as olivine, topaz, and zircon, wherein the Earth’s crust also inherently comprises aluminum, and iron (see, evidential reference: WORLD Economic Forum (Visualizing the abundance of the elements in the Earth’s crust. Dec 14, 2021 (see, attached PDF file) (see, title, abstract, pg 2, para 4-7, pg 3, para 3-5, pg 5, para 2-3, pg 6, para 2, pg 10, line 36-37, pg 11, para 1-5, Example 1-V, Table 1-3, and claims 1-15).
Besides, the limitations under wherein clause of claims 13, 14, 15, 16, 17, and 18, which are just an “intended result of a process step, and as per MPEP 2111.04, the court noted that a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step.’” Id.(quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)).
According to MPEP- 2111.04 “Adapted to,” “Adapted for,” “Wherein,” “Whereby,” and Contingent Clauses [R-08.2017]
I. "ADAPTED TO," "ADAPTED FOR," "WHEREIN," and "WHEREBY"
Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “adapted to” or “adapted for” clauses; (B) “wherein” clauses; and (C) “whereby” clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. See, e.g., Griffin v. Bertina, 283 F.3d 1029, 1034, 62 USPQ2d 1431 (Fed. Cir. 2002) (finding that a “wherein” clause limited a process claim where the clause gave “meaning and purpose to the manipulative step. In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “‘whereby’ clause states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted that a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’” Id.(quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)).
Because the mineral material containing metal including silicate, aluminum or iron of the claimed invention (for claim 12), and that of Earth’s as a source of mineral material containing metals such as silicate, feldspar, asbestos, clay and zeolites as well as stones like olivine, topaz, and zircon metals of the reference is one and the same, Examiner takes the position that the Earth’s crust as a source of mineral material containing metals as a source iron or aluminum inherently associated with the earth crust as a source of mineral material containing metals of the Toender et al. reference as evidenced by WORLD Economic Forum, Dec 14, 2021 (see, attached PDF file) as evidential reference. Since the Office does not have the facilities for examining and comparing applicants' iron or aluminum presence in the earth crust disclosed by the prior art, the burden is on the applicant to show a novel or unobvious difference between the claimed product, and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald et al., 205 USPQ 594.
RESULT 1
ADZ39253
ID ADZ39253 standard; protein; 247 AA.
AC ADZ39253;
XX
DT 15-JUN-2007 (revised)
DT 30-JUN-2005 (first entry)
XX
DE M.thermophila full length gamma carbonic anhydrase (GCA).
XX
KW Prion protein; fusion protein; protein engineering; vaccine;
KW prion infection; cerebroprotective; infection; prion disease;
KW degeneration; neurological disease;
KW transmissible spongiform encephalopathy; Creutzfeldt Jakob disease;
KW neuroprotective; BSE; scrapie; kuru; gamma carbonic anhydrase; enzyme;
KW BOND_PC; carbonic anhydrase; GO4089; GO8270; GO8415; GO16829; GO15977.
XX
OS Methanosarcina thermophila.
SQ Sequence 247 AA;
Query Match 100.0%; Score 1265; Length 247;
Best Local Similarity 100.0%;
Matches 247; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MMFNKQIFTILILSLSLALAGSGCISEGAEDNVAQEITVDEFSNIRENPVTPWNPEPSAP 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MMFNKQIFTILILSLSLALAGSGCISEGAEDNVAQEITVDEFSNIRENPVTPWNPEPSAP 60
Qy 61 VIDPTAYIDPQASVIGEVTIGANVMVSPMASIRSDEGMPIFVGDRSNVQDGVVLHALETI 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 VIDPTAYIDPQASVIGEVTIGANVMVSPMASIRSDEGMPIFVGDRSNVQDGVVLHALETI 120
Qy 121 NEEGEPIEDNIVEVDGKEYAVYIGNNVSLAHQSQVHGPAAVGDDTFIGMQAFVFKSKVGN 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 NEEGEPIEDNIVEVDGKEYAVYIGNNVSLAHQSQVHGPAAVGDDTFIGMQAFVFKSKVGN 180
Qy 181 NCVLEPRSAAIGVTIPDGRYIPAGMVVTSQAEADKLPEVTDDYAYSHTNEAVVYVNVHLA 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 NCVLEPRSAAIGVTIPDGRYIPAGMVVTSQAEADKLPEVTDDYAYSHTNEAVVYVNVHLA 240
Qy 241 EGYKETS 247
|||||||
Db 241 EGYKETS 247
Toender et al. do not teach the presence of iron and aluminum in the Earth’s crust as a mineral material containing metal.
However, WORLD Economic Forum teaches that Earth’s crust contains mineral material metals such as Silicon 28.2%, Aluminum 8.2%, Iron (Fe) 5.6%, and Titanium 0.5% (see, whole document, in particular Table).
WORLD Economic Forum clearly teaches that Earth’s crust contains mineral material metals such as Silicon 28.2%, Aluminum 8.2%, Iron (Fe) 5.6%, and Titanium 0.5% (see, whole document, in particular Table).
Therefore, it would have been obvious to one of ordinary skill in the art to arrive at the claimed invention as a whole at the time of the invention was made by combining the teachings of Toender et al. and WORLD Economic Forum to identify the presence of mineral material metals Aluminium or Iron along with Silicates or Silicon in the Earth’s crust as taught by WORLD Economic Forum and modify Toender et al. to extract, isolate and purify crude mineral material metals Aluminium or Iron along with Silicates or Silicon using an enzyme carbonic anhydrase having silicase activity as taught by Toender et al. to arrive the claimed invention.
One of ordinary skilled in the art would have been motivated to extract, isolate and purify crude mineral material metals Aluminium or Iron along with Silicates or Silicon, expensive metals to be used in the downstream product production, which is commercially, industrially and financially beneficial.
One of ordinary skilled in the art would have a reasonable expectation of success because Toender et al. could successfully extract, isolate and purify crude mineral material metals Aluminium or Iron along with Silicates or Silicon from abundant source, expensive metals to be used in the downstream product production
Thus, the above references render the claims prima facie obvious to one of ordinary skill in the art.
Conclusion
Status of the claims:
Claims 1-11, 12, 13-19 and 20 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IQBAL H CHOWDHURY whose telephone number is (571)272-8137. The examiner can normally be reached on M-F, at 9:00-5:00 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath N. Rao, can be reached on 571-272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
Iqbal H. Chowdhury, Primary Patent Examiner
Art Unit 1656 (Recombinant Enzymes and Protein Crystallography)
US Patent and Trademark Office
Ph. (571)-272-8137 and Fax (571)-273-8137
/IQBAL H CHOWDHURY/
Primary Examiner, Art Unit 1656