DETAILED ACTION
Applicant's response, filed 07/21/2025, has been fully considered. The following rejections and/or objections are either reiterated or newly applied. Herein, "the previous Office action" refers to the Non-Final Rejection of 04/21/2025.
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 .
Status of the Claims
Claims 35, 38-39 and 42-46 are examined; claims 1-34, 36-37 and 40-41 are canceled.
Priority
This application is a DIV of US Application No. 16/089,648 (03/07/2019), which is a 371 of PCT/JP2017/013124 (03/29/2017), which claims priority from Foreign Application No. JP2016-066684 (03/09/2016), and Foreign application No. JP2017-015821 (01/31/2017) as reflected in the filing receipt mailed on Dec. 20, 2021. The claims to the benefit of priority are acknowledged and the effective filing date of claims 35, 38-39 and 42-46 is 03/09/2016.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code in [0033]. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Withdrawal / Revision of Objections and/or Rejections
In view of the amendment and remarks from 07/21/2025, the objection to the drawings is hereby withdrawn in view of Applicant's amendments. In view of the amendment and remarks from 07/21/2025, the rejection of claims 39-41 under 35 U.S.C. § 102(a) is hereby withdrawn in view of Applicant's amendments, and persuasive argument directed to teachings not anticipated by the prior art, rendering the ground of rejection moot. In view of the amendment and remarks from 07/21/2025, the 35 U.S.C. § 103 rejection of claims 35-37 over He is withdrawn. The following rejections and/or objections are either maintained or newly applied for claims 35, 38-39 and 42-46. They constitute the complete set applied to the instant application.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 35, 38-39, and 42-46 are 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 35 and 39 recite “of at least one protein selected from the group consisting of proline-rich proteins (PRPs) and fibrinogens … the PRPs include PRB1, PRH1, PRH2, PRB2, PRB4, PRB3, PRPMP5, PRP2, splicing variants thereof and post-translationally modified variants thereof, and the fibrinogens include FGA, FGB, FGG, and splicing variants thereof” which is indefinite because it is unclear if one is selecting PRPs and thus selecting all of the proteins in that list of PRPs or one is selecting PRPs and then select one protein from the list of PRPs. Claims 35, 38, and 43-46 are similarly rejected because they are dependent on claim 39 and do not resolve the lack of clarity introduced by claims 35 and 39.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 35, 38-39 and 42-46 are rejected under 35 USC § 101 because the claimed inventions are directed to an abstract idea without significantly more. "Claims directed to nothing more than abstract ideas (such as a mathematical formula or equation), natural phenomena, and laws of nature are not eligible for patent protection" (MPEP 2106.04 § I). Abstract ideas include mathematical concepts, and procedures for evaluating, analyzing or organizing information, which are a type of mental process (MPEP 2106.04(a)(2)). The claims as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than the abstract idea of “evaluating the effect of the active ingredient based on the measurement value”.
MPEP 2106 organizes JE analysis into Steps 1, 2A (Prong One & Prong Two), and 2B as analyzed below.
Step 1: Are the claims directed to a process, machine, manufacture, or composition of matter (MPEP 2106.03)?
Step 2A, Prong One: Do the claims recite a judicially recognized exception, i.e., a law of nature, a natural phenomenon, or an abstract idea (MPEP 2106.04(a-c))?
Step 2A, Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application by an additional element (MPEP 2106.04(d))?
Step 2B: Do the claims recite a non-conventional arrangement of elements in addition to any identified judicial exception(s) (MPEP 2106.05)?
Step 1: Are the claims directed to a 101 process, machine, manufacture, or composition of matter (MPEP 2106.03)?
The instant claims are directed to a method (claims 39, 42 and 45-46), and a machine (claims 35, 38 and 43-44) which falls within one of the categories of statutory subject matter. [Step 1: Yes]
Step 2A, Prong One: Do the claims recite a judicially recognized exception, i.e., a law of nature, a natural phenomenon, or an abstract idea (MPEP 2106.04(a-c))?
With respect to Step 2A, Prong One, the claims recite judicial exceptions in the form of abstract ideas. MPEP § 2106.04(a)(2) further explains that abstract ideas are defined as:
• mathematical concepts (mathematical formulas or equations, mathematical relationships
and mathematical calculations) (MPEP 2106.04(a)(2)(I));
• certain methods of organizing human activity (fundamental economic principles or practices, managing personal behavior or relationships or interactions between people) (MPEP 2106.04(a)(2)(II)); and/or
• mental processes (concepts practically performed in the human mind, including observations, evaluations, judgments, and opinions) (MPEP 2106.04(a)(2)(III)).
Mental processes, defined as concepts or steps practically performed in the human mind such as steps of observations, evaluations, judgments, and opinions, include “compare/comparing the measurement value(s) of the treated specimen” (claims 35 and 39); “evaluating/evaluation of the effect of the active ingredient” (claims 35 and 39); and “determine/determining that the active ingredient is effective in the body when the measurement value of the treated specimen are lower than the measurement value of the untreated specimen” (claims 35 and 39). Under the BRI, the recited limitations are mental processes because a human mind is sufficiently capable of identifying and evaluating information, making a comparison giving a set of values; wherein a determination is made of which value is lower.
Dependent claims 38 and 42 recite further details about “the active ingredient”; dependent claims 43-46 recite further details about “evaluating the effect of the active ingredient based on the measurement value”; not reciting any additional non-abstract elements; all reciting further aspects of the information being analyzed, the manner in which that analysis is performed.
Hence, the claims explicitly recite numerous elements that, individually and in combination, constitute abstract ideas. The instant claims recite a natural correlation by correlating the measurement of an amount of a protein naturally found in the body with the effect of an active ingredient of a medication. (see MPEP 2106.04(b).I). The instant claims must therefore be examined further to determine whether they integrate that abstract idea into a practical application (MPEP 2106.04(d)). [Step 2A Prong One: Yes]
Step 2A, Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application by an additional element (MPEP 2106.04(d))?
Instant claims 35, 38-39 and 42-46 recite additional elements that are not abstract ideas: performing some claim steps by a “processor” (claim 35) and “obtain/obtaining a measurement value of at least one protein selected” (claims 35 and 39). The recited limitations in these claims are interpreted to require the use of a computer. The use of a computer is broadly interpreted and not actually described in the claims or specification. Hence, claims directed to “processor” use explicitly recite steps executed by computers and therefore can be described as computer functions. However the described claims do not describe any specific computational steps by which the computer performs or carries out the abstract idea, nor do they provide any details of how specific structures of the computer are used to implement these functions.
Claims directed to “obtain a measurement value relating to at least one protein selected” read on mere data gathering activity because the measurements are utilized to gather information that is used as input for a comparison made by a computer, being an insignificant extra-solution activity since this limitation merely serve to gather data that is utilized as input for the judicial exception. See MPEP 2106.05(g). Because the claims recite an abstract idea, and do not integrate that abstract idea into a practical application, the claims are directed to that abstract idea.
Claims that are directed to abstract ideas must be examined further to determine whether the additional elements besides the abstract idea render the claims significantly more than the abstract idea. Claims that are directed to abstract ideas and that raise a concern of preemption of those abstract ideas must be examined to determine what elements, if any, they recite besides the abstract idea, and whether these additional elements constitute inventive concepts that are sufficient to render the claims significantly more than the abstract idea (MPEP 2106.05). When the claims are considered as a whole, they do not integrate the abstract idea into a practical application; they do not confine the use of the abstract idea to a particular technology; they do not solve a problem rooted in or arising from the use of a particular technology; and they do not provide any limitations beyond generally linking the use of the abstract idea to a broad technological environment. [Step 2A Prong Two: No]
Step 2B: Do the claims recite a non-conventional arrangement of elements in addition to any identified judicial exception(s) (MPEP 2106.05)?
Claims found to be directed to a judicial exception are then further evaluated to determine if the claims recite an inventive concept that provides significantly more than the judicial exception itself. Step 2B of the 35 USC § 101 analysis determines whether the claims contain additional elements that amount to an inventive concept, and an inventive concept cannot be furnished by an abstract idea itself (MPEP 2106.05).
Claims 35 and 38-39 recite a computer or computer functions, interpreted as instructions to apply the abstract idea using a computer, where the computer does not impose meaningful limitations on the judicial exceptions; which can be performed without the use of a computer (MPEP 2106.04(d) § I; and MPEP 2106.05(f)). Additionally, claims directed to obtaining/receiving measurement data read on electronically outputting data on a computer which is a conventional computer function (Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 225, 110 USPQ2d 1984 (2014) MPEP 2106.05(d)). Thus, the recited additional elements, alone or in combination with the judicial exceptions, do not appear to provide an inventive concept. [Step 2B: No]
Conclusion: Instant claims are directed to non-statutory subject matter
For these reasons, the claims in this instant application, when the limitations are considered individually and as a whole, are directed to an abstract idea and lack an inventive concept. Hence, the claimed invention does not constitute significantly more than the abstract idea, so instant claims 35, 38-39 and 42-46 are rejected under 35 USC § 101 as being directed to non-statutory subject matter.
Response to applicant's remarks in regards of Claim Rejection 35 U.S.C. ~ 101
The Remarks of 07/21/2025 have been fully considered but are not persuasive for the reasons below:
The rejection of claims 35, 38-39 and 42 under 35 U.S.C. § 101 is maintained. Regarding the applicant’s remarks “Applicant respectfully submits that the above-noted features of amended claim 35 [amended claim recited] cannot be practically performed in the human mind, and as such, it is respectfully submitted that amended claim 35 is not drawn to a mental process. Accordingly, claim 35 is directed to statutory subject matter under 35 U.S.C. 101. Similar arguments apply for amended claim 39. In view of the above, it is respectfully requested that the rejection of pending claims 35, 38, 39, and 42 under 35 U.S.C. 101 be withdrawn”; the examiner recognizes the argument. However, as described in the Claim rejection above the recited “compare/comparing the measurement value(s) of the treated specimen” (claims 35 and 39); “evaluating/evaluation of the effect of the active ingredient” (claims 35 and 39); and “determine/determining that the active ingredient is effective in the body when the measurement value of the treated specimen are lower than the measurement value of the untreated specimen” (claims 35 and 39) – are steps defined as mental processes because, under the BRI, a human mind is sufficiently capable of identifying and evaluating information given a data set, making a comparison giving a set of values; wherein a determination is made of which value is lower. Furthermore, dependent claims 38 and 42 recite further details about “the active ingredient”; not reciting any additional non-abstract elements; all reciting further aspects of the information being analyzed, the manner in which that analysis is performed. Additionally, the presence of additional elements does not change the fact that the claims are directed to a mental process because those additional elements do not integrate the judicial exception into a practical application. See Claim rejections above for detailed explanation of the maintained 101 rejection.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 35 and 39 are rejected under 35 U.S.C. 103(a) as being unpatentable over He L. et. al. (He L. et. al. “Ginsenoside Rh2 inhibits osteoclastogenesis through down-regulation of NF-κB, NFATc1 and c-Fos” Bone 50:1207–1213 (2012) – referred to in the action as He) in view of Horton et. al. “Interaction of Osteopontin with Osteoclast Integrins” Ann N. Y. Acad. Sci. 760:190-200 (1995) – referred to in the action as Horton.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Independent claim 35 recites “a device for evaluating an effect, in the body, of an active ingredient that suppresses functional expression of Oscar protein, the device comprising: a memory for storing a program; an interface; and a processor, during execution of the program, configured to: obtain a measurement value of at least one protein selected from the group consisting of proline-rich proteins (PRPs) and fibrinogens contained in a treated specimen, and/or a measurement value of mRNA of the protein contained in the treated specimen collected from the subject; obtain a measurement value of the at least one protein selected from the group consisting of proline-rich proteins (PRPs) and fibrinogens contained in an untreated specimen, and/or a measurement value of mRNA of the at least one protein contained in the untreated specimen; compare the measurement value of the treated specimen with the corresponding to measurement value of the untreated specimen; and determine that the active ingredient is effective in the body when the measurement value of the treated specimen are lower than the measurement value of the untreated specimen, wherein the treated specimen is collected from the subject to which the active ingredient has been administered, the untreated specimen is collected from the subject, test tissue, or test cell to which the active ingredient has not been treated”.
Independent claim 39 recites “a method for supporting the evaluation of an effect, in the body, of an active ingredient that suppresses functional expression of Oscar protein, the method comprising the following steps: obtaining a measurement value of at least one protein selected from the group consisting of proline-rich proteins (PRPs) and fibrinogens contained in treated specimen, and/or a measurement value of mRNA of the at least one protein contained in the treated specimen collected from the subject; obtaining a measurement value of the at least one protein selected from the group consisting of proline-rich proteins (PRPs) and fibrinogens contained in an untreated specimen, and/or a measurement value of mRNA of the at least one protein contained in the untreated specimen; comparing the measurement value of the treated specimen with the corresponding to measurement value of the untreated specimen; and determining that the active ingredient is effective in the body when the measurement value of the treated specimen are lower than the measurement value of the untreated specimen, wherein the treated specimen is collected from the subject to which the active ingredient has been administered”.
He teaches a method that uses CFX96™ real-time quantitative PCR system with a programmed detector (i.e. reading on a device with a memory for storing a program; an interface; and a processor) (pg. 1209 col. 2 para. 2) to understand the inhibitory mechanism of ginsenoside Rh2 active component (pg. 1210 col. 2 para. 2); by measuring mRNA levels of expressed target genes associated with osteoclastogenesis (pg. 1211 Fig. 4) from mouse bone marrow macrophages samples (i.e. specimen collected from a subject) obtained and cultured with or without ginsenoside Rh2 (pg. 1208 col. 2 para. 1) (i.e. treated and untreated specimens); wherein ginsenoside Rh2 is one of the most active components of red ginseng, shown in the study to significantly reduced RANKL-induced expression of transcription factors, c-Fos and nuclear factor of activated T-cells (NFATc1), as well as osteoclast markers, TRAP and OSCAR (pg. 1207 para. 1) (i.e. an active ingredient that suppresses functional expression of Oscar protein); wherein OSCAR is defined as osteoclast-associated receptor and NFATc1 is a proline rich protein (pg. 1210); wherein the comparison of evaluated mRNA levels of expressed target genes associated with osteoclastogenesis between bone marrow macrophages cells treated and untreated (vehicle) with ginsenoside Rh2; wherein levels of mRNA for the treated samples are lower than the level for the untreated samples (pg. 1211 Fig. 4); wherein the cells treated with the Rh2 active component showed reduced expression of osteoclast-associated receptor (OSCAR) (i.e. determine that the active ingredient is effective in the body when the measurement value of the treated specimen are lower than the measurement value of the untreated specimen, wherein the treated specimen is collected from the subject to which the active ingredient has been administered, the untreated specimen is collected from the subject, test tissue, or test cell to which the active ingredient has not been treated) (pg. 1210 col. 2 para. 2); reading on the recited limitations in claims 35 and 39.
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
He does not explicitly teach “a device with a memory for storing a program ; an interface; and a processor”.
Regarding claims 35 and 39; He does not explicitly teach “at least one protein selected from the group consisting of proline-rich proteins (PRPs) and fibrinogens contained … the PRPs include PRB1, PRH1, PRH2, PRB2, PRB4, PRB3, PRPMP5, PRP2, splicing variants thereof and post-translationally modified variants thereof, and the fibrinogens include FGA, FGB, FGG, and splicing variants thereof”. However, Horton teaches assays of osteoclast adhesion to matrix proteins osteopontin via the analysis of fibrinogen peptides (pg. 190 para 2 to 191 para. 1); wherein KQAGD is a peptide from the H12 region from the fibrinogen y-chain (i.e. FGG fibrinogen derived – reading on at least one protein selected from the group consisting of praline-rich proteins (PRPs) and fibrinogens contained in an specimen) (pg. 196 para. 4) in specimens (pg. 192 Fig. 1); reading on the recited limitations in claims 35 and 39.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
Regarding claims 35 and 39; it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the use of a computer and automate to compare the measurement value(s) of the treated specimen with the measurement value(s) of the untreated specimen based on the teachings by He. MPEP 2144.04(III) discusses “automating a manual activity” which applies to the described claims directed to comparison of values. One of ordinary skill in the art would be motivated to apply the obvious to automate rationale to the teachings by He to improve the efficiency of the comparison process claimed by the invention.
Regarding claims 35 and 39; it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teachings by Horton to the method that measure mRNA levels of expressed target genes associated with osteoclastogenesis to investigate ginsenoside Rh2 OSCAR suppressing effects as taught by He to investigate FGG variant measurements in regards of OSCAR expression in any specimens – treated or untreated. One of ordinary skill in the art would be motivated to apply the teachings by Horton to the method by He to investigate fibrinogen peptides involvement in osteoclast adhesion (pg. 196 para. 4 Horton). One of ordinary skill in the art would be able to motivated to combine the teachings in these references with a reasonable expectation of success since the described teachings pertain to methods investigation of the Oscar protein.
Claims 38 and 42 are rejected under 35 U.S.C. 103(a) as being unpatentable over He and Horton as applied to claims 35 and 39 above further in view of Nemeth K. et. al. (Nemeth K. et. al. “The Role of Osteoclast-Associated Receptor in Osteoimmunology” The Journal of Immunology 186(1):13–18 (2011) – referred to in the action as Nemeth.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Dependent claim 38 recites “wherein the active ingredient is at least one member selected from the group consisting of antagonists of the Oscar protein; genome editing systems that target Oscar gene; at least one RNA molecule selected from the group consisting of siRNA, shRNA, and miRNA that target Oscar mRNA, or vectors capable of expressing the RNA molecule; and antibodies that specifically bind to the Oscar protein and suppress function of the Oscar”. Dependent claim 42 recites “wherein the active ingredient is at least one member selected from the group consisting of antagonists of the Oscar protein; genome editing systems that target Oscar gene; at least one RNA molecule selected from the group consisting of siRNA, shRNA, and miRNA that target Oscar mRNA, or vectors capable of expressing the RNA molecule; and antibodies that specifically bind to the Oscar protein and suppress function of the Oscar”.
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
Regarding claims 38 and 42, He and Horton are silent in regards to the described limitations. However, Nemeth teaches a list of OSCAR inhibitors that suppress the expression and consequently activity of the OSCAR protein (i.e. reading on “antagonists of the Oscar protein”) (Table 1 pg. 16); reading on the recited limitations in claims 38 and 42.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
Regarding claims 38 and 42; it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teachings by Nemeth to the method that measure mRNA levels of expressed target genes associated with osteoclastogenesis to investigate ginsenoside Rh2 OSCAR suppressing effects as taught by He and Horton to investigate antagonists of the Oscar protein. One of ordinary skill in the art would be motivated to apply the teachings by Nemeth to the method by He and Horton to investigate the dentification of the ligands of OSCAR and shed more light onto this molecule to foster a more detailed and complete understanding of this branch of regulation of bone metabolism and the immune system (pg. 17 col. 2 para. 2 Nemeth). One of ordinary skill in the art would be able to motivated to combine the teachings in these references with a reasonable expectation of success since the described teachings pertain to methods for investigation of the Oscar protein.
Claims 43 and 45 are rejected under 35 U.S.C. 103(a) as being unpatentable over He and Horton as applied to claims 35 and 39 above further in view of Takahashi et. al. “Vitamin D endocrine system and osteoclasts” Bonekey Rep. 3:495 (2014) – referred to in the action as Takahashi.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Dependent claims 43 and 45 recite “wherein the active ingredient is used for improving kidney function”.
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
Regarding claims 43 and 45, He and Horton are silent in regards to the described limitations. However, Takahashi teaches the use of Vitamin D as an active component to stimulate RANKL expression and in turn induce osteoclastogenesis (pg. 1 para. 1) as well as maintaining calcium homeostasis through the vitamin D receptor in the kidney (i.e. improving kidney function) (pg. 1 col. 1 para. 2); reading on claims 43 and 45.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
Regarding claims 43 and 45; it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teachings by Takahashi to the method that measure mRNA levels of expressed target genes associated with osteoclastogenesis to investigate ginsenoside Rh2 OSCAR suppressing effects as taught by He and Horton to pick an active ingredient that improves kidney function. One of ordinary skill in the art would be motivated to apply the teachings by Takahashi to the method by He and Horton to investigate the maintenance of calcium homeostasis and the connection with bone function (pg. 2 Fig. 1 Takahashi). One of ordinary skill in the art would be able to motivated to combine the teachings in these references with a reasonable expectation of success since the described teachings pertain to methods for investigation of osteoclastogenesis related processes.
Claims 44 and 46 are rejected under 35 U.S.C. 103(a) as being unpatentable over He and Horton as applied to claims 35 and 39 above further in view of Tabari et. al. “Salivary soluble receptor activator of nuclear factor kappa B ligand/osteoprotegerin ratio in periodontal disease and health” J Periodontal Implant Sci. 43:227-232 (2013) – referred to in the action as Tabari.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Dependent claims 44 and 46 recite “wherein the specimen is parotid glands or saliva.”.
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
Regarding claims 44 and 46, He and Horton are silent in regards to the described limitations. However, Tabari teaches the collection of saliva (pg. 229 col. 1 para. 1) for the investigation of soluble RANKL and osteoclastogenesis in periodontal disease (pg. 228 col. 1para. 4); reading on claims 44 and 46.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
Regarding claims 44 and 46; it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teachings by Tabari to the method that measure mRNA levels of expressed target genes associated with osteoclastogenesis to investigate ginsenoside Rh2 OSCAR suppressing effects as taught by He and Horton to pick saliva as a specimen. One of ordinary skill in the art would be motivated to apply the teachings by Tabari to the method by He and Horton to incorporate saliva samples to investigate inhibitors of osteoclast differentiation and activity (pg. 228 col. 1 para. 5 Tabari). One of ordinary skill in the art would be able to motivated to combine the teachings in these references with a reasonable expectation of success since the described teachings pertain to methods for investigation of osteoclastogenesis related processes.
Response to applicant's remarks in regards of Claim Rejection 35 U.S.C. ~ 103
The Remarks of 07/21/2025 have been fully considered but are not persuasive for the reasons below: The Remarks of 07/21/2025 have been fully considered but are not persuasive for the reasons below. The rejection of claims 38 and 42 under 35 U.S.C. § 103 is maintained.
Regarding the applicant’s remarks “Applicant respectfully submits that the above-noted features of claim 35 are not disclosed, suggested, or otherwise rendered obvious by He based on the following. On page 11 of the Office Action, the Examiner discloses the following: … However, Applicant respectfully submits that He fails to teach "obtain a measurement value of the at least one protein selected from the group consisting of praline-rich proteins (PRPs) and fibrinogens contained in an untreated specimen, and/or a measurement value of mRNA of the at least one protein contained in the untreated specimen," where "the treated specimen is collected from the subject to which the active ingredient has been administered," "the untreated specimen is collected from the subject, test tissue, or test cell to which the active ingredient has not been treated," "the PRPs include PRBl, PRHl, PRH2, PRB2, PRB4, PRB3, PRPMP5, PRP2, splicing variants thereof and post-translationally modified variants thereof," and "the fibrinogens include FGA, FGB, FGG, and splicing variants thereof," as required by the above-noted features of claim 35. In view of the above, Applicant respectfully submits that He fails to disclose, suggest, or otherwise render obvious the above-noted features of claim 35. Accordingly, claim 35 is patentable over He. Claim 39 recites features generally corresponding to the above-noted features of claim 35. Accordingly, Applicant respectfully submits that He fails to disclose, suggest, or otherwise render obvious these corresponding features of claim 39 for reasons similar to those discussed above with respect to claim 35, and as such, claim 39 is patentable over He” (pg. 9 para. 1 to pg. 10 para. 4); the examiner agrees that He fails to teach the above recited amended limitations in claims 35 and 39.
However, the applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. With that, Horton teaches assays of osteoclast adhesion to matrix proteins osteopontin via the analysis of fibrinogen peptides (pg. 190 para 2 to 191 para. 1); wherein KQAGD is a peptide from the H12 region from the fibrinogen y-chain (i.e. FGG fibrinogen derived – reading on at least one protein selected from the group consisting of praline-rich proteins (PRPs) and fibrinogens contained in an specimen) (pg. 196 para. 4) in specimens (pg. 192 Fig. 1). One of ordinary skill in the art would be able to motivated to combine the teachings in these references with a reasonable expectation of success since the described teachings pertain to methods investigation of the Oscar protein.
Regarding the applicant’s remarks “Claims 38 and 42 were rejected under 35 U.S.C. 103(a) as being unpatentable over He in view of Nemeth ("The Role of Osteoclast-Associated Receptor in Osteoimmunology"). Applicant respectfully submits that Nemeth fails to provide disclosure that would obviate the above-mentioned deficiencies of He. Accordingly, claims 38 and 42 are patentable over any combination of He and Nemeth based at least on their respective dependency from claims 35 and 39” (pg. 11 para. 1). The applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Claims 35 and 39 are rejected over He and Horton as described previously; which makes the rejection for claims 38 and 42 maintained as applied to He and Horton further in view of Nemeth. See Claim rejections above.
Regarding the applicant’s remarks “New claims 43-46 are patentable over any combination of He and Nemeth based at least on their respective dependency from claims 35 and 39” and “In view of the foregoing amendments and remarks, Applicant respectfully submits that claims 35, 38, 39, and 42-46 are clearly in condition for allowance. An early notice thereof is earnestly solicited” (pg. 11 para. 2-3); the examiner acknowledges the arguments but respectfully disagrees. In this instant application, the amendments support existing claim rejections, in which the recited limitations are all addressed. Claims 35, 38-39 and 42-46 are rejected in this instant application due to being taught or motivated by the prior art as described in the Claim rejection above.
The examiner clarifies 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). To clarify how the prior art discloses all of the required elements, the examiner has identified each evidence by page, column and paragraph.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/F.F.L./Examiner, Art Unit 1685
/OLIVIA M. WISE/Supervisory Patent Examiner, Art Unit 1685