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 Claims
Claims 1-20 are pending.
Priority
Claims 1-20 have priority to PRO 63/395,839 filed on August 7, 2022.
Claim Objections
Claim 8 is objected to for the following reasons:
Claim 8 recites “introduction into cells proteins capable of inducing dedifferentiation” should read as “introduction into cells with proteins capable of inducing dedifferentiation”.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Applicant is advised that should claim 1 be found allowable, claim 15 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claim 15 is directed to “said liquid media” that is concentrated and used for formulating a pharmaceutical. Claim 1 is directed to supernatant that is derived from stimulated cells, concentrated, and administering the supernatant concentration to a patient. Here, the supernatant is already being used as a pharmaceutical formulation. Thus, despite the difference in wording, these claims have substantially the same scope.
Applicant is advised that should claim 1 be found allowable, claim 18 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claim 18 is directed to administering exosomes derived from regenerative cells for the prevention and/or treatment of Orthopox viral infections. Claim 1 is directed to a supernatant that is derived from stimulated regenerative, and therefore, exosomes are inherently present in the supernatant derived from the stimulated regenerative cells. Thus, despite the difference in wording, these claims have substantially the same scope.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 uses the generic term “active ingredients” in relation to the supernatant being separated form a regenerative cell composition and then administered to a patient “in need” that has either been diagnosed or exposed to the Orthopox virus. The same generic scope of “active ingredients” is present in each of the dependent claims, i.e. 2-20.
The specification provides antecedent basis for “active ingredients” as it relates to the active ingredients being concentrated and then administered to a patient in need that has been exposed or diagnosed with Orthopox virus [¶ 0005].
Applicant’s specification states “collecting supernatant from said stimulated cells; d) concentrating active ingredients from said supernatant; and e) administering said concentrated supernatant” [¶ 0005]. The specification does not provide any further guidance as to what “active ingredients” are necessary outside of exosomes. In paragraph [00211], the specification only mentions growth factors related to culturing cells. In paragraph [00102], the specification states that regenerative cell populations are transfected to express one or more cytokines with immune modulatory activity. However, the specific cytokines are not listed. In paragraph [00224], the specification states mesenchymal stem cells or other stem cells can by cocultured with immature dendritic cells and/or cytokines to create in vivo factories for immune-modulatory exosomes. However, the specific cytokines are not listed. In paragraph [00228], the specification briefly mentions cytokines in reference to nanoexosomes that were generated from patients infected with Mpox. It is the same with micro-RNA, the specification only mentions generically the mR-155 and mR-287 are to be present [¶ 00193 & 00194]. However, Maumus et al., discussing mesenchymal stem cell-derived extracellular vesicles, disclose a host of extracellular vesicles with therapeutic potential. These include proteins, lipids, nucleic acids such as mRNA, micro-RNAs, long non-coding RNAs, DNA, and metabolites [Introduction, Mesenchymal stem cell-derived extracellular vesicles: opportunities and challenges for clinical translation, Front. Bioeng. Biotechnol, 2020]. The specification does not include or indicate which of these components are essential to the claimed invention, what concentrations or amounts are required, or how they contribute to the therapeutic effect against Orthopox viral infections. Additionally, there is no guidance how these “active ingredients” achieve the claimed prophylactic or therapeutic effect in a patient. Because of this, it would be difficult for a person of ordinary skill to determine the concentration levels and amounts of respective extracellular vesicles derived from regenerative cells in the claimed invention for the purpose of preventing or treating Orthopox viral infections in patients.
Given the generic term “active ingredients” as it relates to being derived from regenerative cells in a supernatant that is then concentrated, and the absence of teachings of what “active ingredients” are crucial or required to practice the claimed invention, an Artisan would not understand Applicant to be in possession of the generic claimed “active ingredients” as used in claim 1.
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 13 recites the generic phrase “ability to inhibit, alleviate, or resolve Orthopox Virus infection” as it relates to the method of claim 1 liquid media exhibiting a therapeutic property in the treatment of Orthopox virus.
Claims 1-12 and 14-20 are also rejected given the claims also encompass therapeutic properties that do not inhibit, alleviate, or resolve Orthopox viral infections.
The specification provides antecedent basis for “ability to inhibit, alleviate, or resolve Orthopox Virus…infection” as it relates to administering a concentrated media that is derived from regenerative cells [¶ 0089].
Applicant’s specification states “preferred methods include…therapeutic property endowed to said liquid media as ability to inhibit, alleviate, or resovle Orthopox Virus…infection” [Id.]. In paragraph [0005] summary, the specification states the preferred embodiments are directed at a method of providing a prophylactic and/or treatment for Orthopox viral infections. This is reiterated in paragraph [0098]. Paragraph [00100] states that an embodiment where regenerative cell derived exosomes are administered for treatment for Orthopox viral infections. In paragraph [00213], the specification discusses creating a medicament that includes culturing Wharton jelly mesenchymal stem cells in a serum free media for the treatment of Mpox where a therapeutic supernatant is collected for administering to a patient. In paragraph [00219] the conditioned media, e.g. concentrated supernatant, is used as the active ingredient in a pharmaceutical formulation for the prophylaxis and/or treatment of Orthopox virus infection. However, claim 13 depends from claim 1 where claim 1 recites a composition capable of treating Orthopox viral infections, i.e. a composition having a “therapeutic property” endowed to a liquid medium derived from regenerative cells. Therefore, the broad scope of claim 1 thus encompasses embodiments in which the claimed composition lacks any actual ability to inhibit or resolve Orthopox viral infections. If the composition fails to provide such an effect, the method itself will not perform what is being claimed in claim 1. Furthermore, the remaining broad claims also encompass therapeutic properties that do not inhibit, alleviate, or resolve Orthopox viral infections. Given this, it would mean the method of claim 1 would not treat or prevent Orthopox viral infections, and because Applicant has provided no examples of the claimed composition inhibiting, alleviating, or resolving Orthopox viral infections, a person of ordinary skill would not understand that Applicant was in possession of the claimed method that Applicant states is capable of acting as a prophylactic or method for treating Orthopox viral infections.
Given the generic statement that “ability to inhibit, alleviate, or resolve Orthopox Virus infection” as it relates to the method of claim 1 liquid media exhibiting a therapeutic property in the treatment of Orthopox virus, and the absence of showing that Applicant possessed a method for treating Orthopox viral infections per the method in claim 1 and that claim 1 encompasses therapeutic properties that do not inhibit, alleviate, or resolve Orthopox viral infections as stated in claim 13, the Artisan would not understand Applicant to be in possession of the claimed method for treating Orthopox viral infections as stated in claim 1 and remaining generic claims.
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.
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 1-20 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.
Claim 1 recites “a ligand for Toll-Like Receptors…by itself or with a receptor selected from the group consisting of a NOD-like Receptors…, and a RIG-I-Like Receptors”. Does stimulating the cell population with a ligand only apply to the Toll-Like Receptors, or is a ligand also used in activating the NOD-Like Receptors or RIG-I-Like Receptors?
Claim 1 recites the limitation "supernatant" in Line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites the limitation "said cellular population" in Line 1. There is insufficient antecedent basis for this limitation in the claim. As written, there are two cell populations in claim 1, i.e. the regenerative cell population obtained, and the stimulated cells that were exposed to ligands.
Claim 6 recites the limitation "said cellular population" in Line 1. There is insufficient antecedent basis for this limitation in the claim. As written, there are two cell populations in claim 1, i.e. the regenerative cell population obtained, and the stimulated cells that were exposed to ligands.
Claim 7 recites the limitation "said cellular population" in Line 1. There is insufficient antecedent basis for this limitation in the claim. As written, there are two cell populations in claim 1, i.e. the regenerative cell population obtained, and the stimulated cells that were exposed to ligands.
Claim 8 recites the limitation "said dedifferentiation" in Line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "said pluripotency" in Line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "said conditioned media" in Line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "said therapeutic property" in Line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "said liquid media" in Line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation "said liquid media" in Line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 15 recites the limitation "said liquid media" in Line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation "said formulation" in Line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation "said liquid media" in Line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 20 recites “express mR-155”. It is unclear what is meant by this. Exosomes do not express microRNA. Instead, microRNA is produced by a cell and is packaged into exosomes. As written, a person of ordinary skill would not understand by what is meant by “express mR-155”.
Claim Rejections - 35 USC § 112
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.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], 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.
Claim 17 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, 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. Claim 16 requires the administration of the liquid media of claim 1. Claim 1 is directed to administering the supernatant and not the cells. 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
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 2, 3, 4, 7, 11, 12, 13, 15, 16, 17, 18, and 19 are rejected under 35 U.S.C. 103 as being unpatentable by Glassberg et al. [WO 2020 247610 A1, 2020], in view of Zhou et al. [Generation of induced pluripotent stem cells using recombinant proteins, Cell Stem Cell, 2009], in view of Lin & Young (Hereinafter Lin) [Interferons: success in antiviral immunotherapy, Cytokine Growth Factor Rev., 2015], in view of Yin et al. [Exosomes from mesenchymal stem/stromal cells: a new therapeutic paradigm, Biomarker Research, 2019]
Regarding the claims, Glassberg et al. does not expressly state a treatment for Orthopox viral infections, it is well established in the art that regenerative cells, more specifically the various species of stem cells, possess immunomodulatory and regenerative properties that support the immune system. These same properties, that are present, would provide therapeutic benefit in the treatment of viral infections. Given that the structure and function of the regenerative cells are the same in the Glassberg et al. art reference and Applicant’s claim, it would have been prima facie obvious to a person of ordinary skill in the art prior to the filing of the claimed invention to apply the systems and methods of Glassberg et al. to treat viral infections, including those from Orthopox viruses, using unmodified mesenchymal stem cells, induced pluripotent stem cells, exosomes derived from said regenerative type cells, as well as other “active ingredients” where the infections compromise the immune system.
Regarding claim 1, Glassberg et al. teaches a method of treatment that includes both mesenchymal stem cells and exosomes, i.e. a regenerative cell population [¶ 0054], stimulating said regenerative cell population with a ligand for Toll-Like Receptors [¶ 0042], collecting supernatant from said stimulated cells [¶ 0074], concentrating the active ingredients [¶ 00321 and 00322], administering the concentrated supernatant to a patient in need [¶ 00215].
For claim 2 where the stem cells are mesenchymal stem cells, Glassberg et al. teaches the use of mesenchymal stem cells [Description ¶ 1].
For claim 3 where the mesenchymal stem cells are derived for sources such as bone marrow, etc., Glassberg et al. discloses mesenchymal stem cells derived from numerous locations within the body that include adipose tissue, etc. [¶ 0057].
For claim 4 where the mesenchymal stem cells express VEGF-receptor 2, Glassberg et al. discloses the presence of VEGF-receptor 2 through the use of VEGF growth factor given that VEGF only exerts biological effects through binding with specific receptors that include VEGFR-1 and VEGFR-2 [¶ 00248].
Here, it is prima facie obvious to a person of ordinary skill in the art prior to the filing of the claimed invention to modify the systems and methods as taught by Glassberg et al. that discloses the use of mesenchymal stem cells and their exosomes in the treatment of fibrotic diseases with the additional teachings of Glassberg et al. that include several steps to concentrate the supernatant from centrifuged mesenchymal stem cells given the immunomodulatory properties possessed. It is further prima facie obvious that VEGF-Receptor 2 was present given that Glassberg et al. used VEGF as a growth factor in the culturing media for the mesenchymal stem cells due to VEGF only exerts its biological effects through presence of the primary receptors VEGFR-1, VEGFR-2, and VEGFR-3. Given this, there is a reasonable expectation of success that a person of ordinary skill would consider Glassberg et al. as a starting point for developing a treatment derived from mesenchymal stem cell derived exosomes and other active ingredients given that stem cells and their extracellular vesicles are known in the art to exert immunomodulatory effects on the body in the presence of viral infections.
For claim 5 where the regenerative cell population is derived from monocytes, Zhou et al., discussing the generation of induced pluripotent stem cells, disclosed that murine somatic cells could be induced into pluripotent cells through the use of known expression factors [Main Text ¶ 1].
For claim 6 where the regenerative cell population is derived from thymic medullary epithelial cells, Zhou et al., discussing the generation of induced pluripotent stem cells, disclosed that murine somatic cells could be induced into pluripotent cells through the use of known expression factors [Main Text ¶ 1]. Given this, it would have been prima facie obvious to a person of ordinary skill to recognize the teachings of Zhou et al. prior to the filing of the claimed invention that somatic cells, including monocytes and thymic medullary epithelial cells, could be induced to express pluripotent factors.
For claim 7 where the regenerative cells are hematopoietic stem cells, Glassberg et al. discloses that hematopoietic stem cells can also be used [¶ 0057].
For claim 8 where the dedifferentiation is introduced into the cells proteins capable of inducing differentiation, Zhou et al. discloses the use of transient transfection to deliver reprogramming genes, and other methods that are capable exploiting endogenous gene expression in certain cell types [Para starting with “iPSCs (and especially patient specific ones)”].
For claim 9 where the regenerative cell from dedifferentiation expresses pluripotency markers, Glassberg et al. discloses pluripotent cells that are capable or have the ability to develop into multiple cell types, including all three embryonic lineages [¶ 00277].
For claim 10 where the pluripotent marker is TRA-1-60, Glassberg et al. discloses pluripotent cells given that TRA-1-60 is a conventional surface marker that is universally associated with pluripotent stem cells. Therefore, when producing pluripotent stem cells, one skilled in the art would reasonably expect such cells to inherently or necessarily express TRA-1-60, along with other standard pluripotency markers such as SSEA-4, OCT4, SOX2, and NANOG.
For claim 11 where it states the conditioned media is administered from allogeneic cells, Glassberg et al. discloses the use of allogeneic cells [¶ 00277].
For claim 12 where the regenerative cells are exposed to hypoxia, Glassberg et al. discloses that hypoxic preconditioning enhances mesenchymal stem cell recruitment and functional recovery [¶ 0093].
For claim 13 where a therapeutic property is “endowed” to the liquid media derived from the regenerative cells with the ability to inhibit, alleviate, or resolve Orthopox viral infections, these properties, that are present, would provide therapeutic benefit in the treatment of viral infections. Given that the structure and function of the regenerative cells are the same in the Glassberg et al. art reference and Applicant’s claim, it would have been prima facie obvious to a person of ordinary skill in the art prior to the filing of the claimed invention to apply the systems and methods of Glassberg et al. to treat viral infections, including those from Orthopox viruses, using unmodified mesenchymal stem cells, induced pluripotent stem cells, exosomes derived from said regenerative type cells, as well as other “active ingredients” where the infections compromise the immune system.
Claim 14 where the liquid media is combined with interferon-alpha, Lin, discussing the success of interferons in anti-viral immunotherapy, discloses that interferons are glycoproteins with strong antiviral activities and are classified in three distinct groups [Abstract]. Lin further teaches that interferon-alpha has been used for treating chronic HBV infections [2.4 IFN-a as a therapeutic agent for HBV infections].
Claim 15 where the liquid media is used in the formulation of a pharmaceutical, Glassberg et al. teaches a similar composition that has been combined with a pharmaceutically acceptable carrier to form a pharmaceutical formulation [Abstract].
Claim 16 where the method of administration of the liquid media includes any parenteral route, Glassberg et al. teaches the generic administration of the mesenchymal-derived exosomes through injection [¶ 0078 and 00338].
For claim 17 where the regenerative cells themselves are administered, Glassberg et al. teaches the use of mesenchymal stem cells being administered [¶ 0070 and 0078].
For claim 18 where the derived exosomes from the regenerative cells are administered, Glassberg et al. discloses administering exosomes derived from allogeneic mesenchymal stem cells for fibrotic diseases [Abstract].
For claim 19 where the derived exosomes from regenerative cells are administered to a patient in need, Glassberg et al. discloses administering mesenchymal stem cell derived exosomes to a patient in need [Abstract and ¶ 00215].
For claim 20 where the exosome expresses or contains mR-155, Yin et al., discussing exosomes derived from mesenchymal/stromal cells, teaches that many miRNAs are found within exosomes that includes miR-155 that are involved in epigenetic regulation and immunoregulation [Characteristics of MSC-derived exosomes ¶].
Here it would have been prima facie obvious to a person of ordinary skill in the art prior to the filing of claimed invention to modify the systems and methods of Glassberg et al. where the inventors used mesenchymal stem cells, the exosomes derived from the mesenchymal stem cells, and the concentration derived from the supernatant that contained high levels of specific chemokines responsible for guiding immune cells during inflammation with the further teachings of Zhou et al. that disclosed methods for inducing pluripotency in somatic cells, that include both monocytes and thymic medullary epithelial cells, with the additional teachings of Lin discussing the use of interferon-alpha and the antiviral effects it has with the teachings of Yin et al. that disclosed miR-155 is typically present in stem cell derived exosomes and plays a role in epigenetic regulation, as well as immunoregulation. Given this, there is a reasonable expectation of success that a person of ordinary skill in the art would combine the teachings of Glassberg et al. with the additional teachings of Zhou et al., Lin, and Yin et al. for a regenerative cell composition where either the supernatant, exosomes, or regenerative cells themselves could be administered through parenteral routes for the purpose of treating Orthopox viral infections given that antiviral properties are known to exist in mesenchymal stem cells and their derived exosomes coupled with the methods that can induce pluripotency in somatic cells to include both monocytes and thymic medullary epithelial cells, as well as mesenchymal stem cells and hematopoietic stem cells, with interferon-alpha that is known in the art to exhibit antiviral properties with the fact that stem cell-derived exosomes typically contain miR-155, as well as other beneficial micro-RNAs, that contribute to immunoregulation.
The Supreme court has acknowledged:
When 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 varition..103 likely bars its patentability…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 that person’s skill. A court must ask whether the improvement is more than the predictable use of prior-art elements according to their established functions…
…the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results (see KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 U.S. 2007) emphasis added.
In KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court reaffirmed "the conclusion that when a patent 'simply arranges old elements with each performing the same function it had been known to perform' and yields no more than one would expect from such an arrangement, the combination is obvious." Id. at 417 (quoting Sakraida v. Ag Pro, Inc., 425 U.S. 273,282 (1976)). The Supreme Court also emphasized a flexible approach to the obviousness question, stating that the analysis under 35 U.S.C. § 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418; see also id. at 421 ("A person of ordinary skill is... a person of ordinary creativity, not an automaton.").
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claims allowed.
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/JOHN DAVID MOORE/Examiner, Art Unit 1638
/ROBERT M KELLY/Primary Examiner, Art Unit 1638