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 .
Claims 1-4, 6, 8, 10, 12-19, 22, 26, 31-34, 36, 39-45 and 48 are pending in the application. Claims 5, 7, 9, 11, 20-21, 23-25, 27-30, 35, 37-38 and 46-47 have been canceled. Preliminary amendment filed 24 May 2024.
Priority
This application is a continuation of PCT/US22/24516 filed 04/13/2022, which claims the benefit of 63175160 filed 04/15/2021.
The parent application 63175160 to which priority is claimed is seen to provide adequate support under 35 U.S.C. 112 for claims 1-4, 6, 8, 10, 12-19, 22, 26, 31-34, 36, 39-45 and 48 of this application.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-3, 6, 8, 10, 12-13, 15-16, 19, 22, 26, 31-34, 36, and 39-43 are rejected under 35 U.S.C. 103 as being unpatentable over Sprenger et al (US 2019/0290668 A1) in view of Buck et al (US 2012/0171165 A1) and further in view of Wild et al (Research Square, April 8, 2021, pages 1-25; cited in IDS filed 11/07/2023).
Sprenger teaches a method of treating upper respiratory tract infections in a patient which are illnesses cause by acute infections. This infection is caused by viruses which includes coronavirus (COVID). The most common symptoms are cough, weakness (aka fatigue), headache, fever and pain (paras 0002, 0004-0005, 0007, 0054; part of the limitations of claim 1, and limitations of claim 13). The method comprises administration of at least one human milk oligosaccharide or several other HMO’s (para 0116; page 11, claim 10 of Sprenger; as in claim 1 and limitation of claim 4). Even though Sprenger does not exemplify reduction or improvement in at least one sign or symptom of long COVID in patient as in claim 1, it would be obvious to one of ordinary skill in the art to treat a patient having long COVID via administration of at least one HMO wherein such treatment reduces or improves at least one symptom as in claim 1 in view of the teaching of Sprenger. According to Sprenger the HMO’s that can be administered are recited at paras 0079 and 0082 (limitations of claims 2-3 and 8). The HMO can be acidic or neutral (para 0076). This renders obvious the use of a composition comprising the mixture as in claim 6.
Sprenger teaches that the HMO’s used in the method can be produced by enzyme-based fermentation technology or by chemical synthesis or microbial fermentation technology (para 0132). This is a suggestion that the composition administered is not a mammalian milk and is not derived from mammalian milk as in claim 10. The composition can contain from 0.1 to 10g of the HMO per 100g of composition on a dry weight basis (limitation of claim 12-10%). The percentage can also be adjusted to the other values recited in claim 12 for optimization. Since Sprenger teaches treating upper respiratory tract infection which can be accompanied by headache and pain, the method of Sprenger should also reduce or improve headache as in claim 19 and joint pain as in claim 22. The upper respiratory tract which can be caused by coronavirus can be acute (para 003; as in claim 31). Sprenger teaches treating a child (Abstract; para 002). This reads on the patient being less than 55 years as in claim 34.
In view of the above teachings of Sprenger the artisan would find it obvious to administer all the other HMO’s recited in claims 2-3, 8, treat all the other symptoms in claims 13, 19 and 22, treat the conditions and all the other patients as in claims 31-34, 36, 39-43.
Sprenger does not teach the limitations of claims 14-18, 26, 44-45 and 48.
Buck et al, drawn to gastrointestinal related conditions teaches that that the administration of HMO’ correct effects of gut dysbiosis (Abstract; paras 0002, 0099-0100 and 0173; limitation of claim 26). In view of this teaching and the teaching of Sprenger, the artisan would have a reasonable expectation of success that the administration of the HMO’s would improve gut microbiome dysbiosis as in claim 26.
Wild teaches that the experience of long COVID or brain fog relates to a combination of physical symptoms and cognitive deficits (Abstract; page 16, para 5). Wild discloses testing of 485 volunteers for their response to questions and two additional scores included overall performance across the cognitive task battery and average processing speed (page 4-Results through page 5 and page 15 last para). This teaching of Wild suggests that reduction in brain fog can be measured by the cognitive battery score as in claim 15 and reduction of a neurological sign or symptom as in claim16.
MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.'" KSR, 550 U.S. at, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) " Obvious to try " choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
According to the rationale discussed in KSR above, the rationale in (G) above is seen to be applicable here since based on the prior art teachings, HMO’s are known in the art to be administered to subjects having upper respiratory tract infections caused by coronavirus with symptoms as claimed. Thus, it is obvious to administer the HMO’s in a method for the treatment of long COVID in a patient as claimed.
Thus, the claimed invention as a whole would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention over the combined teachings of the prior art. The artisan would be motivated to administer HMO’s in the claimed method since Sprenger teaches that there is a need to deliver health benefits that does not involve classical pharmaceutical intervention and in a manner that does not induce side effects. The cost will also be reasonable and affordable (paras 0023-0025).
Claim(s) 1, 13, 14, 17-18 and 48 are rejected under 35 U.S.C. 103 as being unpatentable over Sprenger et al (US 2019/0290668 A1) in view of Machado et al (Health and Quality of Life Outcomes, 03 February 2021, vol. 19, article 40, pages 1-10; cited in IDS filed 11/07/2023) and further in view of Ferguson et al (International Journal of Environmental Research and Public Health, 2016, 13, 171, pages 1-11) and further in view of Kaida et al (Clinical Neurophysiology, 2006, 117, 1574-1581).
The teachings of Sprenger are set forth above, which covers the limitations of claims 1 and 13. Sprenger does not teach the limitations of claims 14, 17-18 and 48.
Machado et al teaches the use of Work Productivity and Activity Impairment (WAPI) Questionnaire to look at the impairment of functional limitations of subjects recovering from COVID (Abstract; page 2, left col., lines 6-11; page 3, left col: Sub-Title-Measures; page 4, Table 1; page 8-Conclusions; limitation of claim 48). Using this teaching, the artisan can assess the reduction and/or improvement of at least one sign or symptom in a patient affected by long COVID after administration of HMO’s.
Ferguson et al teaches the use of Samn-Perelli scale for fatigue assessment (Abstract; Introduction; Conclusions; limitation of claim 14-Samn-Perelli scale).
Kaida et al teaches the use of Karolinska sleepiness scale for evaluating subjects (Abstract; page 1576, parts 2.2-2.3; page 1580, right col. last para; limitation of claims 14 and 17).
Even though Ferguson and Kaida do not teach the use of the respective scales with respect to COVID, one of ordinary skill in the art will recognize that the two scales can also be used to measure the reduction of the various symptoms in the claimed method of treatment in view of Sprenger and Machado. In view of this the artisan can also use the clinical scales recited in claim 18 for checking reduction in dyspnea after administration of HMO.
MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.'" KSR, 550 U.S. at, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) " Obvious to try " choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
According to the rationale discussed in KSR above, the rationale in (G) above is seen to be applicable here since based on the prior art teachings, HMO’s are known in the art to be administered to subjects having upper respiratory tract infections caused by coronavirus with symptoms as claimed. The scales used for checking WAPI, fatigue, and sleepiness ae also known in the art (Machado, Ferguson and Kaida).
Thus, the claimed invention as a whole would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention over the combined teachings of the prior art. The artisan would be motivated to administer HMO’s in the claimed method since Sprenger teaches that there is a need to deliver health benefits that does not involve classical pharmaceutical intervention and in a manner that does not induce side effects. The cost will also be reasonable and affordable (paras 0023-0025). Machado teaches that its scale can be easily used is a major advantage and captures symptom intensity in one meaningful scale (Conclusion). The artisan would also use the other scales in combination with these to ascertain the reduction in symptoms.
Claim(s) 1, 44 and 45 are rejected under 35 U.S.C. 103 as being unpatentable over Sprenger et al (US 2019/0290668 A1) in view of Amit et al (The Lancet, 18 February 2021, 397, No. 10277, pages 876-877; cited in IDS filed 11/07/2023).
The teachings of Sprenger are set forth above, which covers the limitations of claims 1 and 13. Sprenger does not teach the limitations of claims 44 and 45.
Amit teaches reductions in SARS-CoV-2 and COVID-19 infection rates in vaccinated subjects versus unvaccinated subjects (page 876, left col., paras 1-2; limitations of claims 44-45).
In view of this teaching of Amit and that of Sprenger it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to administer the HMO’s as taught by Sprenger to patients that were vaccinated and those that were not vaccinated as in claims 44 and 45.
MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.'" KSR, 550 U.S. at, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) " Obvious to try " choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
According to the rationale discussed in KSR above, the rationale in (G) above is seen to be applicable here since based on the prior art teachings, HMO’s are known in the art to be administered to subjects having upper respiratory tract infections caused by coronavirus with symptoms as claimed.
Thus, the claimed invention as a whole would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention over the combined teachings of the prior art. The artisan would be motivated to administer HMO’s to both vaccinated and unvaccinated patients in the claimed method since Sprenger teaches that there is a need to deliver health benefits that does not involve classical pharmaceutical intervention and in a manner that does not induce side effects. The cost will also be reasonable and affordable (paras 0023-0025). Administering HMO’s to vaccinated patients would have an additive effect of the vaccine and HMO’s. Administering the HMO’s to unvaccinated subjects would still provide the beneficial effects of the HMO’s.
Conclusion
1. Pending Claims 1-4, 6, 8, 10, 12-19, 22, 26, 31-34, 36, 39-45 and 48 are rejected.
2. Claims 5, 7, 9, 11, 20-21, 23-25, 27-30, 35, 37-38 and 46-47 have been canceled.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GANAPATHY KRISHNAN whose telephone number is (571)272-0654. The examiner can normally be reached M-F 8.30am-5pm.
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/GANAPATHY KRISHNAN/Primary Examiner, Art Unit 1693