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
1. Claims 1-20 are under consideration.
Information Disclosure Statement
2. It is noted that Applicants have not filed an information disclosure statement under § 1.97(c). Applicant is reminded of 37 CFR § 1.56, which details Applicant’s duty to disclose all information known to be material to patentability.
Drawings
3. The description of Figures 6 and 7 (¶ [0021] and [0022]) refer to color when the drawings are filed in black and white. Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Specification
4. The disclosure is objected to because of the following informalities: the Figure 4 description in
¶ [0019] references Figure 3 instead of Figure 4. Appropriate correction is required.
5. The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. 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. See ¶ [0074].
6. The use of the terms ‘MALDI-TOF’ in ¶ [0062] and ‘MassARRAY’ in ¶ [0063], which are a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Note that ‘MALDI-TOF’ and ‘MassARRAY’ are merely examples and all improper uses of trademarks in the specification should be identified by Applicant and properly addressed.
Claim Objections
7. Claims 5-6, 10, and 12 are objected to because of the following informalities:
In claim 5, the phrase “determining the expression level or activity in the sample of the thymidine phosphorylase” is repeated.
Claims 6, 10, and 12 all recite “the COVID-19” which is grammatically incorrect.
Appropriate correction is required.
Claim Interpretation
8. According to the instant specification, the terms ‘having’ and ‘including’ are considered to be open-ended terms unless the context suggests otherwise (¶ [0032]). Additionally, all numbers are considered to be approximations and are assumed to be modified by the term ‘about’ (¶ [0033]).
Claim Rejections - 35 USC § 112
9. 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.
10. Claims 1-9, 13-14, and 19-20 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.
The term ‘acuity’ in claims 1-2 and 19 is a relative term which renders the claim indefinite. The term ‘acuity’ is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claims 2-9, which depend on claim 1, are similarly rejected.
The term ‘measurable’ in claim 1 is a relative term which renders the claim indefinite. The term ‘measurable’ is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claims 2-9, which depend on claim 1, are similarly rejected.
Regarding claim 13: claim 10 on which it depends refers to a method to determine if treatment should be given, however claim 13 seems to imply that the administration of a therapeutic agent is not an optional step. Therefore, the claim limitation is unclear.
Claim 14, which depends on claim 13, is similarly rejected.
Regarding claim 19, it is unclear whether “an assay” is referring to a method or a product. For purposes of future examination, Examiner is interpreting this claim to intend a method due to its method steps.
The term ‘useful’ in claim 20 is a relative term which renders the claim indefinite. The term ‘useful’ is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
11. 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.
12. Claim 20 is 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.
When establishing a 35 U.S.C. 112(a) written description rejection, the burden is on the
Examiner to set forth a prima facie case providing reasons why the specification is deficient and thus the
claims that relies thereon are rejected. It is important to note that each claim is given its broadest
reasonable interpretation in light of and consistent with the written description (see MPEP 2111 and
2163(II)). Additionally, a full review of the application must be done to understand how the applicant
provides support for the claimed invention during each element and/or step, which includes the
specification, drawings, structural chemical formulas, etc. (see MPEP 2163(II)). Finally, a determination
as to whether the applicant was in possession of the claimed invention at the time of filing is made by
considering (see MPEP 2163(II)):
1) The variety of ways that that applicant may show possession,
2) The level of skill and knowledge in the art, and
3) The predictability in the art.
The claim is drawn to the possession of a method for screening for compounds useful for treating COVID-19. The specification does not provide a method of screening compounds, nor does it provide any working examples. Additionally, the supplemental information (e.g. the drawings), provide data for testing TYMP expression values and diagrams for SARS-CoV-2 infection. There was no indication that the inventors screened compounds for reducing the level of TYMP to treat COVID-19.
At the time of filing, methods of screening drug-gene interactions were known in the art, as seen by the drug-gene database used in Al-Ejeh (US 20240094217 A1; Provisional filed 25 Nov 2020) (See PTO-892: Notice of References Cited). Methods were also known to screen drugs to treat COVID-19, as seen in Shalek (WO 2022178312 A1; Provisional filed 18 Feb 2021) (See PTO-892: Notice of References Cited): “In another aspect, the present invention provides for a method of screening for agents capable of shifting epithelial cells from a SARS-CoV2 severe phenotype to a mild/moderate phenotype comprising: treating a sample comprising epithelial cells with a drug candidate; detecting modulation of any indicators of infection according to any of the preceding claims; and identifying the drug, wherein the one or more indicators shift towards a mild/moderate phenotype.” (¶ [0025]). However, while methods were known for screening drugs for COVID-19 efficacy, that does not indicate that there was possession of the invention.
In view of the fact that the examples provided do not demonstrate possession of a method for screening compounds, the application has not identified a method for screening compounds, and one of ordinary skill in the art at the time of filing would not have recognized the possession of a method for screening compounds, there is insufficient written description support for a method to screen compounds for treating COVID-19.
Claim Rejections - 35 USC § 101
13. 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.
14. Claims 1-7, 10-12, and 19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite “diagnosis or prognosis”, ’determining’, ‘selecting’, ‘analyzing’, and ‘comparing’. This judicial exception is not integrated into a practical application and the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons set forth below. See MPEP 2106 for analysis framework.
The instant claims are drawn to a method with steps to diagnose COVID-19 acuity or continue treatment by determining expression levels, comparing values, and making decisions. As such, the instant claims are drawn to a process, which is statutory category of matter (Step 1: Yes).
The instant claims are drawn to a judicial exception of an abstract idea, more specifically a mental process. The step of assessing could be performed by a human using mental steps or basic critical thinking, which are types of activities that have been found by the courts to represent abstract ideas (e.g., the mental comparison in Ambry Genetics, or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in Grams). Thus, the claim is directed to at least one exception, which may be termed as an abstract idea (Step 2A, Prong 1: Yes). The instant claims are drawn to a judicial exception which is not integrated into a practical application because the claimed invention is not used to provide a particular treatment or prophylaxis for a disease or medical condition. Further, the claimed invention does not apply or use the judicial exception in a meaningful way and there is no inventive concept in the claims. Generally linking the use of the judicial exception to a particular technological environment or field of use, such as COVID-19 diagnosis and treatment, is not indicative of integration into a practical application (see MPEP 2106.05(h) and Example 29, Claim 2 (Diagnosing and Treating Julitis) of the Subject Matter Eligibility Examples: Life Sciences found at https://www.uspto.gov/sites/default/files/documents/ieg-may-2016-ex.pdf)). Therefore, the instant claims do not recite any additional elements that integrate the exception into a practical application (Step 2A, Prong 2: No).
The instant claims are drawn to a judicial exception and do not recite any additional elements that amount to significantly more than the judicial exception (Step 2B: No).
In view of the foregoing, the instant claims do not constitute patent eligible subject matter under 35 U.S.C. § 101.
Claim Rejections - 35 USC § 102
15. 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)(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.
16. Claims 1-8, 15, and 19 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Al-Ejeh (US 20240094217 A1; Provisional filed 25 Nov 2020) (See PTO-892: Notice of References Cited).
Regarding claims 1 and 3, Al-Ejeh teaches “…provided herein are methods of analyzing a biological sample from a patient infected with and/or exposed to COVID-19 and identifying a protein signature that can predict COVID-19 infected patients at higher risk of developing severe complications. In some embodiments, the protein signature is a blood-based protein signature.” (¶ [0050]) and “In some embodiments, the subject comprises an at least 1.5-fold upregulation, independently, of one or more expressed proteins selected from […] TYMP […] as compared to a corresponding average protein expression from a control cohort of subjects not infected with SARS-CoV-2 or as compared to a corresponding average protein expression from a cohort of SARS-CoV-2 infected subjects with no symptoms or mild-moderate symptoms.” (¶ [0066] and page 10, table 6). In summary, Al-Ejeh analyzed many proteins, including thymidine phosphorylase (TYMP), in a blood sample from COVID-19 patients to assess the risk of complications by comparing them to their control levels, as claimed.
Regarding claim 2, Al-Ejeh teaches “Moreover, RNA-Seq profiles from nasopharyngeal swabs in this study found several enriched immune-modulatory functions in SARS-CoV-2 infected patients versus controls, such as inflammatory response, interferon alpha response, and IL6-JAK-STAT3 signaling, which were also identified in our study. Activation of the complement and coagulation cascades was also among the most enriched gene sets (4), an observation corroborated by our plasma protein profiling results.” (¶ [0104]).
Regarding claim 4, Al-Ejeh teaches “A “subject” or “individual” is a mammal, preferably a human.” (¶ [0043]).
Regarding claim 5, Al-Ejeh teaches “Besides Olink technology, mass spectroscopy was used in two studies to identify deregulated proteins in SARS-CoV-2 infected patients.” (¶ [0106]) and “Plasma samples were profiled in house using the proximity extension assays (PEA), 96-plex immunoassay developed by Olink Proteomics (Uppsala, Sweden) (16) following the standard protocol at Qatar Biomedical Research Institute's (QBRI) Olink certified proteomics core facility.” (¶ [0118]), indicating that both mass spectrometry and immunoassays were used.
Regarding claims 6 and 8, Al-Ejeh teaches “Also provided herein are methods of treating COVID-19 in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of a drug described herein.” (¶ [0012]) and “In some embodiments, the drug comprises […] fluorouracil…” (¶ [0014]). Fluorouracil being an effective drug against TYMP is supported in Figure 7.
Regarding claim 7, Al-Ejeh teaches “In some embodiments, the subject comprises a clinical score of at least 7, wherein the clinical score is calculated by the sum of scores for respiratory rate, whole blood cells count, glucose concentration, lymphocyte counts, Neutrophil counts, CRP level and Creatinine level as detailed in the 7-marker nomogram (FIG. 15).” (¶ [0075]).
Regarding claim 15, Al-Ejeh teaches “Also provided herein are methods of modulating a protein expression profile in a subject in need thereof, comprising administering to the subject an effective amount of a drug described herein, wherein the protein expression profile comprises expression of one or more proteins that are differentially expressed when either 1) compared to a subject currently infected with SARS-CoV-2 as compared to a subject not currently infected with SARS-CoV-2, or 2) compared to a subject currently having COVID-19 as compared to a subject not currently having COVID-19.” (¶ [0055]), which includes TYMP (see above in claim 1, ¶ [0066]). They also administer an effective amount of therapeutic agent that reduces TYMP (see above in claims 6 and 8, ¶ [0012] and [0014]).
Regarding claim 19, Al-Ejeh teaches that they detected TYMP in their patients as part of their protomeric analysis (see above in claim 1, ¶ [0066]). Furthermore, they teach “Plasma samples were profiled in house using the proximity extension assays (PEA), 96-plex immunoassay developed by Olink Proteomics (Uppsala, Sweden) (16) following the standard protocol at Qatar Biomedical Research Institute's (QBRI) Olink certified proteomics core facility.” (¶ [0118]), which is the same assay and dataset used in the instant application: “The database provided by the Massachusetts General Hospital (MGH) emergency department COVID-19 Cohort (Filbin, Goldberg, Hacohen) with Olink Proteomics was utilized, which includes four 384-plex panels focused on inflammation, oncology, cardiometabolic, and neurology proteins.” (see instant specification, ¶ [0087]).
Claim Rejections - 35 USC § 102/103
17. 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.
18. Claims 10-12 and 20 are rejected under 35 U.S.C. 102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Al-Ejeh (US 20240094217 A1; Provisional filed 25 Nov 2020) (See PTO-892: Notice of References Cited).
Regarding claims 10-12, Al-Ejeh teaches “…provided herein are methods of repeating the analysis of the patient exposed to and/or infected with COVID-19 and generating new molecular severity score and/or clinical risk score. This method may be repeated once, twice, or more than twice, across time, in a patient exposed to and/or infected with COVID-19.” (¶ [0053]), “…provided herein are methods of identifying effective methods of treatments based on the patient analysis (molecular and clinical identifiers/indicators) described herein.” (¶ [0054]), and “We hypothesized that the molecular severity score could be used to identify informative clinical parameters to triage SARS-CoV-2 infected patients into high or low risk for developing severe complications.” (¶ [0101]). Al-Ejeh does not teach TYMP as one of the proteins for the clinical risk score. However, they do teach that an increase in TYMP is associated with a COVID-19 infection when compared to a control, and higher values are associated with higher risk of complications (see section 16 above). Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to use TYMP in the calculation of the clinical risk score to aid in determining prophylaxis/therapy of COVID-19, as claimed. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A.).
A rationale to support a conclusion that a claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 (2007) (see MPEP §§ 2143, A. and 2143.02).
Regarding claims 11-12, Al-Ejeh teaches the limitations of claim 10, as seen above. Al-Ejeh also teaches, “In some embodiments, the subject comprises a clinical score of at least 7, wherein the clinical score is calculated by the sum of scores for respiratory rate, whole blood cells count, glucose concentration, lymphocyte counts, Neutrophil counts, CRP level and Creatinine level as detailed in the 7-marker nomogram (FIG. 15).” (¶ [0075]). The clinical risk score was used to determine prophylaxis of therapy of COVID-19, as seen above.
Regarding claim 20, Al-Ejeh teaches “FIG. 7: Protein-drug interaction network of 1.5- to 2-fold upregulated plasma proteins in severe COVID-19. Proteins with 1.5- to 2-fold upregulation in patients with severe complications versus mild-moderate disease were subjected to protein-drug interaction (PDI) using the Drug-Gene Interaction database (DGIdb, v4.2.0).” (¶ [0024]). Al-Ejeh does not teach an actual method for screening compounds useful for treating COVID-19. However, the substitution of manually testing each compound for using a database with known drug-gene interactions would have been obvious to one of ordinary skill in the art. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B.).
Claim Rejections - 35 USC § 103
19. 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.
20. Claims 6 and 8-9 are rejected under 35 U.S.C. 103 as being obvious over Al-Ejeh (US 20240094217 A1; Provisional filed 25 Nov 2020) (See PTO-892: Notice of References Cited) as applied in claims 1-8, 15, and 19 above and further in view of Li (US 20220226320 A1; Provisional filed 14 May 2019) (See PTO-892: Notice of References Cited).
The applied reference has a common inventor and assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
Regarding claims 6 and 8-9, Al-Ejeh teaches the limitations of claim 1, as seen above in section 16. Al-Ejeh also teaches that the treatment of COVID-19 based on the level of TYMP is obvious as seen above in section 18. However, Li also teaches that “Reducing the expression level or activity of thymidine phosphorylase as part of a method for treatment of obesity, atherosclerosis, and/or thrombosis can comprise administering to the subject an effective amount of a thymidine phosphorylase inhibitor. The thymidine phosphorylase inhibitor administered to the subject can be tipiracil…” (Abstract). Therefore, it would have been obvious to one of ordinary skill in the art to take the methods of Al-Ejeh and apply the treatment as discussed in Li. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A.).
A rationale to support a conclusion that a claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 (2007) (see MPEP §§ 2143, A. and 2143.02).
21. Claims 13-14 are rejected under 35 U.S.C. 103 as being obvious over Al-Ejeh (US 20240094217 A1; Provisional filed 25 Nov 2020) (See PTO-892: Notice of References Cited) as applied to claims 10-12 and 20 above and further in view of Li (US 20220226320 A1; Provisional filed 14 May 2019) (See PTO-892: Notice of References Cited).
The applied reference has a common inventor and assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
Regarding claims 13-14, Al-Ejeh teaches the limitations of claim 10, as seen above in section 18. Al-Ejeh also teaches that the treatment of COVID-19 based on the level of TYMP is obvious as seen above in section 18. However, Li also teaches that “The thymidine phosphorylase inhibitor administered to the subject can be tipiracil…” (Abstract). Therefore, it would have been obvious to one of ordinary skill in the art to take the methods of Al-Ejeh and apply the treatment as discussed in Li. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A.).
A rationale to support a conclusion that a claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 (2007) (see MPEP §§ 2143, A. and 2143.02).
22. Claims 16-18 are rejected under 35 U.S.C. 103 as being obvious over Al-Ejeh (US 20240094217 A1; Provisional filed 25 Nov 2020) (See PTO-892: Notice of References Cited) as applied to claim 15 above and further in view of Li (US 20220226320 A1; Provisional filed 14 May 2019) (See PTO-892: Notice of References Cited).
The applied reference has a common inventor and assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
Regarding claim 16-17, Al-Ejeh teaches the limitations of claim 15, as seen above in section 16. Al-Ejeh does not teach a thymidine phosphorylase inhibitor, tipiracil. However, Li teaches “The thymidine phosphorylase inhibitor administered to the subject can be tipiracil…” (Abstract). Therefore, it would have been obvious to one of ordinary skill in the art to take the methods of Al-Ejeh and apply tipiracil as the treatment. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A.).
A rationale to support a conclusion that a claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 (2007) (see MPEP §§ 2143, A. and 2143.02).
Regarding claim 18, Al-Ejeh teaches the limitations of claim 15, as seen above in section 16. Al-Ejeh does not teach that administering the therapeutic agent reduces inflammation or thrombosis. However, Li teaches “In some embodiments of the therapeutic methods for the treatment of thrombosis, administering the effective amount of the thymidine phosphorylase inhibitor reduces an amount of platelet activation and aggregation.” (¶ [0016]) and “As such, the term “effective amount” is used herein to refer to an amount of the therapeutic composition (e.g., a TYMP inhibitor and a pharmaceutically vehicle, carrier, or excipient) sufficient to produce a measurable biological response (e.g., a decrease in inflammation or body weight).” (¶ [0067]). Therefore, it would have been obvious to one of ordinary skill in the art to assume that the treatment of TYMP in Al-Ejeh would also reduce inflammation and thrombosis, as seen in Li. A rationale to support a conclusion that a claim would have been obvious is that there is some teaching, suggestion, or motivation in the prior art or in the knowledge generally available to one of ordinary skill in the art to modify the reference or combine reference teachings, and the modification or combination would have a reasonable expectation of success. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 (2007) (see MPEP §§ 2143, G. and 2143.02).
23. This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Conclusion
24. No claim is allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTINA E LY whose telephone number is (571)272-5169. The examiner can normally be reached Monday - Thursday, 8:00 am - 5:00 pm EST.
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/KRISTINA E. LY/Examiner, Art Unit 1671
/M FRANCO G SALVOZA/Primary Examiner, Art Unit 1672