DETAILED ACTION
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 .
This application is the national stage entry of PCT/US2022/045490, filed 03 Oct 2022; claims benefit of provisional application 63/275,933, filed 04 Nov 2021; and claims benefit of provisional application 63/252,140, filed 04 Oct 2021.
Claims 1-3, 6, 26-28, 30-32, and 77-78 are pending in the current application and are examined on the merits herein.
Claim Objections
Claim 6 is objected to because of the following informalities: claim 6 does not appear to end in a period. Appropriate correction is required.
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 1-3, 6, 26-28, 30-32, and 77-78 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for methods of treating an inflammatory lung disease or disorder in a subject comprising administering to the gastrointestinal tract of the subject an effective amount of specific oligosaccharide compositions, does not reasonably provide enablement for the full scope of preventing an inflammatory lung disease or disorder in a subject or the full scope of oligosaccharide compositions administered. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The Applicant’s attention is drawn to In re Wands, 8 USPQ2d 1400 (CAFC1988) at 1404 where the court set forth eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors:
(1) The nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
Nature of the invention: A method of treating and/or preventing an inflammatory lung disease or disorder in a subject, the method comprising administering to the gastrointestinal tract of the subject an effective amount of an oligosaccharide composition.
The state of the prior art: Lawrence et al. (WO 2021/222660 A1, published 04 Nov 2021, filed 29 April 2021, provided by Applicant in IDS filed 20 Aug 2025) provides evidence of the state of the art before the effective filing date of the claimed invention. Lawrence et al. teaches methods of using oligosaccharide compositions as microbiome metabolic therapies for treating respiratory viral illnesses, such as COVID-19 (abstract). Lawrence et al. teaches different oligosaccharides, such as FOS, maltodextrin, and the oligosaccharide composition of the invention, have different effects on different bacteria (figures 5-7 and 9; page 28, paragraphs 59-63; example 8 at page 96, paragraph 265 to page 97, paragraph 271).
Boehm et al. (WO 2006/022542 A1, published 02 March 2006, cited in PTO-892) teaches a method and composition for the treatment and/or prevention of respiratory tract infection and/or respiratory tract infection disease, said method comprising orally administering a composition to a mammal, said composition comprising a galactose containing indigestible oligosaccharide and at least 5 wt.% digestible galactose saccharide (abstract). The invention is particularly surprising because until now, it was believed that a low lactose content was essential for the prevention of respiratory disorder in infants (page 2, line 30). Boehm et al. discloses the working example of the effectiveness of transgalactooligsaccharides in standard infant formulas for prevention of respiratory tract infections in infants (page 16, line 15 to page 17, line 5).
The relative skill of those in the art: The relative skill of those in the art is high.
The predictability or unpredictability of the art: The prior art suggests that different oligosaccharides have different biological activities, meaning that one skilled in the art cannot predict the usefulness for all possible oligosaccharides. For example, Boehm et al. teaches that it was believed that a low lactose content was essential for the prevention of respiratory disorder in infants, and suggests it was not expected that transgalactooligsaccharides are effective for such purpose. Therefore the claimed invention is unpredictable.
The Breadth of the claims: The scope of the claims is infinite. Any possible chemical structure within the scope of the oligosaccharide having an average degree of polymerization of 5-20 and comprising glucose, galactose, and mannose having any connectivity could potentially be used as the oligosaccharide composition.
The amount of direction or guidance presented and The presence or absence of working examples: The only working examples provided in examples 6-7 and 14-16 for the activity of specific oligosaccharide compositions. Working example 7 describes treatment of COVID-19 using specific oligosaccharide compositions as measured by resolution of symptoms. Working example 16 describes a reduction of RSV lung viral load or for influenza a reduction of infiltrating neutrophils.
Note that lack of working examples is a critical factor to be considered, especially in a case involving an unpredictable art such as the biological activity of oligosaccharides. See MPEP 2164.
The quantity of experimentation necessary: In order to practice the invention with the full range of all possible oligosaccharide compositions beyond those known in the art, (such as the oligosaccharides of Lawrence et al. or the transgalactooligsaccharides of Boehm et al.) one skilled in the art would undertake a novel and extensive research program into the biological activity of different oligosaccharides having different chemical composition. Because this research would have to be exhaustive, and because it would involve such a wide and unpredictable scope of chemical compounds, or scope of inflammatory lung disease or disorder prevented, it would constitute an undue and unpredictable experimental burden.
Genentech, 108 F.3d 1361 at 1366, states that, “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion.” And “patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable.”
Therefore, in view of the Wands factors, as discussed above, particularly the breadth of the claims, Applicants fail to provide information sufficient to practice the claimed invention for all possible oligosaccharide compositions or for prevention of the full scope of inflammatory lung disease or disorder.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 30-32, and 77-78 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Boehm et al. (WO 2006/022542 A1, published 02 March 2006, cited in PTO-892).
Boehm et al. discloses method and composition for the treatment and/or prevention of respiratory tract infection and/or respiratory tract infection disease, said method comprising orally administering a composition to a mammal, said composition comprising a galactose containing indigestible oligosaccharide and at least 5 wt.% digestible galactose saccharide (abstract). Recently it has been described that administration of infant formula enriched with prebiotics (galactooligosaccharides), probiotics, nucleotides and LC-PUFA and with a low level of lactose is useful for infants suffering from respiratory infections (page 2, line 10-15). The present inventors have now surprisingly found that enteral administration of a combination of: a) a galactose containing indigestible oligosaccharide containing at least two terminal saccharide units, wherein at least one terminal saccharide unit is selected from the 20 group consisting of glucose and galactose; and at least one terminal saccharide is selected from the group consisting of galactose and fucose; and b) a digestible galactose saccharide results in a reduced occurrence of respiratory tract infections (page 2, line 15-25). The invention is particularly surprising because until now, it was believed that a low lactose content was essential for the prevention of respiratory disorder in infants (page 2, line 30). In a particularly preferred embodiment the method comprises the administration of transgalactooligosaccharides ([galactose]n-glucose; wherein n is an integer between 1 and 60; preferably n is selected from 2, 3, 4, 5, 6, 7, 8, 9, or 10) (page 5, line 30), meaning the transgalactooligosaccharides having an average degree of polymerization of 7, meeting limitations of the oligosaccharide of claims 1-3. Boehm et al. discloses the working example of the effectiveness of transgalactooligsaccharides in standard infant formulas for prevention of respiratory tract infections in infants (page 16, line 15 to page 17, line 5). The invention provides a method for the treatment and/or prevention of respiratory tract infection, which is typically caused by bacterial, viral or fungal infection. The method is particularly suitable for the treatment and/or prevention of respiratory syncytial virus infection (page 10, line 20-30), where RSV infection is an inflammatory lung disease and meeting limitations of claims 1-3 and 77-78. In a preferred embodiment the method relates to the treatment and/or prevention of respiratory tract infection disease. A particularly preferred embodiment the invention provides a method for the treatment and/or prevention of viral pneumonia and/or bronchitis (page 10, line 30 to page 11, line 5), or treatment and/or prevention an inflammatory lung disease, meeting limitations of claims 1-3 and 77-78. Regarding claim 2, the disclosure of treatment of the inflammatory lung disease in the context of Boehm et al. taken as a whole implies identifying the subject having the disease to be treated. In a further preferred embodiment, the method comprises the administration of the above-described indigestible oligosaccharide(s) and a probiotic. Preferably the probiotic is selected from the group Lactobacillus, Lactococcus, Bifidobacterium, Enterococcus, Propionibacterium, Pediococcus, Bacillus and Streptococcus. The probiotic is preferably a non-pathogenic lactic acid-producing bacterium (page 14, lines 25-30), implying the method wherein the composition comprising both the oligosaccharides and probiotic promotes the abundance of the non-pathogenic bacteria and reducing the abundance of pathogenic bacteria, meeting limitations of claims 30-31. The method is particularly suitable for the treatment and/or prevention of respiratory infections in immunocompromised mammalian subjects or hospitalized patients that are particularly vulnerable for viral infections (page 11, line 20 to page 12, line 1), meeting limitations of claim 32.
Claims 1-3, 6, 26-28, 30-32, and 77-78 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Lawrence et al. (US 12,661,366, filed 29 April 2021, cited in PTO-892).
The applied reference has a common 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). This rejection under 35 U.S.C. 102(a)(2) 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) if the same invention is not being claimed; 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 in the reference 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.
Lawrence et al. discloses methods of using oligosaccharide compositions as microbiome metabolic therapies for treating respiratory viral illnesses, such as COVID-19 (abstract). Specifically, in some embodiments, selected oligosaccharide compositions promote beneficial SCFA profiles in the gut and growth of bacterial taxa that support the ability of a subject to mount an appropriate immune and inflammatory response while, in some embodiments, also preventing an over-aggressive response such as, for example, a cytokine storm, which is characterized by inflammation (column 24, lines 30-60), or the embodiments wherein the respiratory viral illnesses is an inflammatory lung disease or disorder. In some embodiments the oligosaccharide compositions has an average degree of polymerization of 5-20 and comprises a plurality of oligosaccharides selected from Formula (I), Formula (II), and Formula (III) (column 2, line 55 to column 4, line 30), meeting limitations of the oligosaccharide compositions of claims 1-3, where Formula (I), Formula (II), and Formula (III) are glucose, galactose, and mannose, respectively. In some embodiments, a subject being treated with an oligosaccharide composition of the disclosure is at risk of a secondary infection (e.g., a secondary bacterial, fungal or viral infection) (column 7, lines 20-25), meeting limitations of claim 32. In some embodiments the secondary infection is an infection of the lung, and may be caused by Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis (column 7, lines 25-35), meeting limitations of claim 26 and 28, and implying a dysbiosis of the lung microbiome, meeting limitations of claim 6. In some embodiments the oligosaccharide compositions prevent or render the secondary infection less likely (column 52, line 60 to column 53, line 40), meeting limitations of claim 27. In some embodiments, the method reduces the abundance of pathogens and increases the relative of abundance of commensal bacteria (e.g., Parabacteroides and Bacteroides), in a subject, in the gastrointestinal tract of the subject (column 62, lines 10-15), meeting limitations of claims 30-31. In some embodiments, oligosaccharide compositions provided herein effectively prevent a viral infection (e.g., a coronavirus infection) in a subject (column 52, lines 35-55), meeting limitations of claims 77-78.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries 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 6 and 26-28 are rejected under 35 U.S.C. 103 as being unpatentable over Boehm et al. (WO 2006/022542 A1, published 02 March 2006, cited in PTO-892) in view of Avadhanula et al. (Journal of Medical Microbiology, 2007, 56, p1133–1137, cited in PTO-892).
Boehm et al. teaches as above regarding claims 1-3, 30-32, and 77-78. Boehm et al. further teaches in a preferred embodiment the method is for the treatment and/or prevention of respiratory tract infection caused by bacterial, viral or fungal infection such as Staphylococcus or Heamofilis (page 10, lines 20-30).
Boehm et al. does not specifically disclose the method wherein the subject has dysbiosis of the lung microbiome (claim 6). Boehm et al. does not specifically disclose the method wherein the subject has increased relative or absolute abundance of pathogenic bacteria in their lungs relative to a healthy subject (claim 26). Boehm et al. does not specifically disclose the method wherein the subject has increased levels of Moraxella catarrhalis, Haemophilus influenzae and/or Streptococcus pneumoniae in their lungs relative to a healthy subject (claim 28).
Avadhanula et al. teaches respiratory syncytial virus (RSV) infection is associated with secondary bacterial infections caused by nontypeable Haemophilus influenzae (NTHi) and Streptococcus pneumoniae. The pathogenesis of these complications is not completely understood; however, viral infection of respiratory epithelial cells promotes colonization by these bacteria (page 1133, abstract and left column).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Boehm et al. in view of Avadhanula et al. in order to select the treatment of Haemophilus influenzae or Streptococcus pneumoniae infection secondary to RSV infection. One of ordinary skill in the art would have been motivated to combine Boehm et al. in view of Avadhanula et al. with a reasonable expectation of success because Boehm et al. teaches the method for the treatment and/or prevention of respiratory tract infection caused by bacterial, viral or fungal infection such as Staphylococcus or Heamofilis and preferably RSV, and Avadhanula et al. teaches Haemophilus influenzae or Streptococcus pneumoniae secondary infections are often associated with RSV infection, suggesting one of ordinary skill in the art would have been motivated to select the method of treatment of both RSV infection and Haemophilus influenzae or Streptococcus pneumoniae secondary infections in a subject from within the scope of the method of Boehm et al. with a reasonable expectation of success. Regarding claim 6, the teachings of Avadhanula et al. that RSV infection promotes colonization of respiratory epithelial cells by these pathogenic bacteria suggests one of ordinary skill in the art would interpret this as a dysbiosis of the lung microbiome.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3, 30-32, and 77-78 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 11-12 of U.S. Patent No. 12,661,366 in view of Boehm et al. (WO 2006/022542 A1, published 02 March 2006, cited in PTO-892).
Reference claims 1-12 of the reference patent are drawn to a method of treating a subject having one or more symptoms of a viral respiratory illness, the method comprising administering to the gastrointestinal tract of the subject an effective amount of an oligosaccharide composition, wherein the oligosaccharide composition is produced by a process comprising: (a) forming a reaction mixture comprising about 30-60% dextrose monomer, about 30-60% galactose monomer, and about 5-15% mannose monomer with an acid catalyst comprising positively charged hydrogen ions; and (b) promoting acid catalyzed oligosaccharide formation in the reaction mixture by transferring sufficient heat to the reaction mixture to maintain the reaction mixture at its boiling point. Reference claim 3 recites the method of attenuating an immune response in a subject having one or more symptoms of a viral respiratory illness. Reference claim 5 recites the viral respiratory illness or infection is caused by an RNA virus.
Reference claims 1-12 do not specifically recite treating and/or preventing an inflammatory lung disease or disorder in a subject (claims 1-3).
Boehm et al. discloses and teaches as above. Boehm et al. teaches a method for the treatment and/or prevention of respiratory tract infection and/or respiratory tract infection disease, said method comprising orally administering a composition comprising an oligosaccharide to a mammal.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the Reference claims in view of Boehm et al. in order to select the viral respiratory illness to be an inflammatory lung disease or disorder. One of ordinary skill in the art would have been motivated to combine the Reference claims in view of Boehm et al. with a reasonable expectation of success because both the Reference claims and Boehm et al. are drawn to the field of treatment of a respiratory tract infection and/or respiratory tract infection disease comprising administering an oligosaccharide composition, and Boehm et al. provides guidance for selecting the respiratory tract infection to be an RSV, which is an RNA virus, providing guidance to select from within the scope of the Reference claims the method wherein the viral respiratory illness is an inflammatory lung disease or disorder such as RSV infection. Further, regarding claims 30-31 it would have been obvious to one of ordinary skill in the art to combine the method comprising administering an oligosaccharide composition of the Reference claims with the method taught by Boehm et al. further comprising administering a prebiotic composition to arrive at a combined method that is encompassed within the scope of the Reference claims and used for the same purpose. See also MPEP 2144.06 at I. providing “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted)
Claims 6 and 26-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 11-12 of U.S. Patent No. 12,661,366 in view of Boehm et al. (WO 2006/022542 A1, published 02 March 2006, cited in PTO-892), further in view of Avadhanula et al. (Journal of Medical Microbiology, 2007, 56, p1133–1137, cited in PTO-892).
Reference claims 1-12 in view of Boehm et al. teach as above.
Reference claims 1-12 in view of Boehm et al. do not specifically disclose the method wherein the subject has dysbiosis of the lung microbiome (claim 6). Reference claims 1-12 in view of Boehm et al. do not specifically disclose the method wherein the subject has increased relative or absolute abundance of pathogenic bacteria in their lungs relative to a healthy subject (claim 26). Reference claims 1-12 in view of Boehm et al. do not specifically disclose the method wherein the subject has increased levels of Moraxella catarrhalis, Haemophilus influenzae and/or Streptococcus pneumoniae in their lungs relative to a healthy subject (claim 28).
Avadhanula et al. teaches as above. Avadhanula et al. teaches respiratory syncytial virus (RSV) infection is associated with secondary bacterial infections caused by nontypeable Haemophilus influenzae (NTHi) and Streptococcus pneumoniae.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Reference claims 1-12 in view of Boehm et al. further in view of Avadhanula et al. in order to select the method of treating both a viral respiratory illness and secondary bacterial infections by combining the administration of the oligosaccharide composition of Reference claims 1-12 and the administration of the oligosaccharide composition of Boehm et al. One of ordinary skill in the art would have been motivated to combine Reference claims 1-12 in view of Boehm et al. further in view of Avadhanula et al. with a reasonable expectation of success because Boehm et al. teaches the method for the treatment and/or prevention of respiratory tract infection caused by bacterial, viral or fungal infection such as Staphylococcus or Heamofilis and preferably RSV, and Avadhanula et al. teaches Haemophilus influenzae or Streptococcus pneumoniae secondary infections are often associated with RSV infection, suggesting one of ordinary skill in the art would have been motivated to select the method of treatment of both RSV infection and Haemophilus influenzae or Streptococcus pneumoniae secondary infections in a subject from within the scope of the method of Boehm et al. with a reasonable expectation of success. See also MPEP 2144.06 at I. providing “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) In this case it would have been obvious to combine the administration of the oligosaccharide composition of Reference claims 1-12 and the administration of the oligosaccharide composition of Boehm et al. in order to administered the combined composition because both the Reference claims and Boehm et al. teach the same intended purpose of treatment of a respiratory tract infection and/or respiratory tract infection disease comprising administering an oligosaccharide composition.
Conclusion
No claim is found to be allowable.
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/JONATHAN S LAU/ Primary Examiner, Art Unit 1693
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