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 .
Notice of New Examiner
Please note that the correspondence for this application has changed (see Conclusion section).
DETAILED ACTION
This application claims benefit to provisional application No. 63/138,798, filed on 19 Jan 2021, in a language other than English. An English translation of the non-English language provisional application and a statement that the translation is accurate must be filed in provisional application No. 63/138,798. See 37 CFR 1.78. The English translation and a statement that the translation is accurate required by 37 CFR 1.78 is missing. Accordingly, applicant must supply 1) the missing English translation and a statement that the translation is accurate in provisional application No. 63/138,798 and 2) in the present application, a confirmation that the translation and statement were filed in the provisional application. If 1) and 2) are not filed (or if the benefit claim is not withdrawn) prior to the expiration of the time period set in this Office action, the present application will be abandoned. See 37 CFR 1.78.
This application claims benefit to provisional application No. 63/229,077, filed on 4 Aug 2021, in a language other than English. An English translation of the non-English language provisional application and a statement that the translation is accurate must be filed in provisional application No. 63/229,077. See 37 CFR 1.78. The English translation and a statement that the translation is accurate required by 37 CFR 1.78 is missing. Accordingly, applicant must supply 1) the missing English translation and a statement that the translation is accurate in provisional application No. 63/229,077 and 2) in the present application, a confirmation that the translation and statement were filed in the provisional application. If 1) and 2) are not filed (or if the benefit claim is not withdrawn) prior to the expiration of the time period set in this Office action, the present application will be abandoned. See 37 CFR 1.78.
Election/Restrictions
Applicant’s election without traverse of Group 1 (claims 23-26, drawn to a method for treating diseases caused by trypsin or TMPRSS2, comprising: administering, to a patient in need of treatment, an effective amount of bacteria that have 00502 protein, or a protein having 30% or higher sequence identity with an amino acid sequence of the 00502 protein and having a trypsin-binding ability, or an effective amount of bacteria that have 00509 protein, or a protein having 30% or higher sequence identity with an amino acid sequence of the 00509 protein and having a trypsin-binding ability) and the species of Paraprevotella clara and coronavirus as a specific disease in the reply filed on 10 Feb 2026 is acknowledged. Also, Attorney Soffen telephonically elected the species of bacteria that have SEQ ID NO: 5, which is the 00502 protein in the interview conducted 27 April 2026.
Upon further consideration, the species requirement related to the disease is withdrawn. In view of the above noted withdrawal of the restriction requirement, applicant is advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once a restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Claims 27-34 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10 Feb 2026.
Notice relating to rejoinder: MPEP 821.04 states: “In order to be eligible for rejoinder, a claim to a nonelected invention must depend from or otherwise require all the limitations of an allowable claim. A withdrawn claim that does not require all the limitations of an allowable claim will not be rejoined.” Currently, Group 2 (administering bacteria that have a gene consisting of a base sequence set forth in SEQ ID NO: 1, or a gene having 30% or higher sequence identity with the base sequence set forth in SEQ ID NO: 1 and encoding a protein having a trypsin-binding ability, or an effective amount of bacteria that have a gene consisting of a base sequence set forth in SEQ ID NO: 2, or a gene having 30% or higher sequence identity with the base sequence set forth in SEQ ID NO: 2 and encoding a protein having a trypsin-binding ability) is not eligible for rejoinder. It has been noted that SEQ ID NO: 1 is the cDNA sequence encoding the 00502 protein with SEQ ID NO: 5 [0013] and SEQ ID NO: 2 is the cDNA sequence encoding the 00509 protein with SEQ ID NO: 18 [0020]. However, the claimed gene sequences are broader than the protein sequences under examination because a gene sequence with 30% or more sequence identity might be mutated at each codon and have 0% protein sequence identity. Therefore, the claims in Group 2 are not eligible for rejoinder if the invention under examination is found allowable because they do not depend from or require all the limitations of the claims under examination. The claims in Group 2 could be amended to require all limitations the claim under examination by amending the claim to instead recite “bacteria that have a gene encoding [the proteins as defined in claim 23]” or some other amendment consistent with the rejoinder requirements.
Claim Status
The amended claim set filed 12 July 2023 is acknowledged. Claims 23-34 are currently pending. Of those, no claims are currently amended, and claims 23-34 are new. Claims 27-34 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10 Feb 2026. Claims 1-22 are cancelled. Claims 23-26 will be examined on the merits herein.
For clarity of the record, references to the specification herein use paragraph numbers from the specification as filed 12 July 2023.
Priority
The application claims priority to provisional applications 63/138,798 (filed 19 Jan 2021) and 63/229,077 (filed 4 Aug 2021) and is a 371 of PCT/JP2022/001494 (filed 18 Jan 2022). The provisional applications are not effective because they are each lacking an English translation of the non-English language provisional application and a statement that the translation is accurate, as required by 37 CFR 1.78. Therefore, the effective filing date used in this action for claims 23 and 25-26 is 18 Jan 2022.
Information Disclosure Statement
The information disclosure statement filed 12 July 2023 fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. Specifically, the Watanabe references (NPL #2-3) are not in English and do not include a concise explanation of the relevance. The other references have been considered, and a signed copy of the statement is attached with this action
The information disclosure statement (IDS) submitted on 19 Nov 2024 was filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner. A signed copy of the statement is attached with this action.
The listing of references in the PCT international search report is not considered to be an information disclosure statement (IDS) complying with 37 CFR 1.98. 37 CFR 1.98(a)(2) requires a legible copy of: (1) each foreign patent; (2) each publication or that portion which caused it to be listed; (3) for each cited pending U.S. application, the application specification including claims, and any drawing of the application, or that portion of the application which caused it to be listed including any claims directed to that portion, unless the cited pending U.S. application is stored in the Image File Wrapper (IFW) system; and (4) all other information, or that portion which caused it to be listed. In addition, each IDS must include a list of all patents, publications, applications, or other information submitted for consideration by the Office (see 37 CFR 1.98(a)(1) and (b)), and MPEP § 609.04(a), subsection I. states, “the list ... must be submitted on a separate paper.” Therefore, the references cited in the international search report have not been considered. Applicant is advised that the date of submission of any item of information in the international search report will be the date of submission of the IDS for purposes of determining compliance with the requirements for the IDS with 37 CFR 1.97, including all timing statement requirements of 37 CFR 1.97(e). See MPEP § 609.05(a).
Drawings
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).
The drawings are objected to because:
Figure 1 - The data cannot be interpreted because the key shows the colors get darker as data both increases and decreases.
Figure 4 - The image shows three-color microscopy, but the three colors cannot be differentiated from each other in a black-and-white format.
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Figure 7, 44, 47 – The colors chosen for the different samples do not have not enough contrast to differentiate the samples. Applicant may want to use different shapes to denote the different samples, or provide color images.
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Figures 12, 14, 19, 25- The images appear to show light microscopy images with fluorescence microscopy superimposed on the image. However, the colors of the fluorescence microscopy can’t be differentiated from the light microscope image.
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Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 23- 26 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.
Regarding claim 23, the claim recites “treating diseases caused by trypsin or TMPRSS2”. Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “caused by” is used by the claim to mean “diseases where trypsin or TMPRSS is correlated with or promotes the disease,” while the accepted meaning is “the reason for the disease”. For example, although trypsin promotes coronavirus infection by promoting activation of the spike protein as described in the instant specification [0283], the cause of coronavirus infection is the coronavirus itself. The term is indefinite because the specification does not clearly redefine the term, and so one of ordinary skill in the art at the time of filing would not be able to determine which diseases are “caused by trypsin or TMPRSS2” as meant by the claims. Claims 24-26 are also rejected because they depend from claim 23 and do not obviate this grounds of rejection. In the interest of compact prosecution, the claims will be examined using the diseases stated in the dependent claims.
Regarding claim 24, the claim reads “an inflammatory bowel disease (ulcerative colitis, Crohn's disease)”. The parentheses perform a similar function as “for example” or “such as”, and renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 26, the claim recites “disease associated with TMPRSS2 or IgA.” The term “associated with” is a relative term which renders the claim indefinite. The term “associated with” 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. One of ordinary skill in the art at the time of filing would not be able to determine what diseases are encompassed by the claim because the types of “associations” that the disease can have with TMPRSS2 or IgA has not been defined. In the interest of compact prosecution, any disease listed in the claims is interpreted as being “associated with” TMPRSS2 or IgA, because trypsin degrades IgA [instant specification 0258].
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 23-26 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Honda et al. (WO 2020054728 A1; hereafter Honda; PTO-892). A translation is provided for the non-English document. References for this document point to locations within the 371 child publication US 20220047647 A1. Also, claims 23-26 are also rejected under 35 U.S.C. 102(a)(2) as being anticipated by Honda et al. (US 20220047647 A1; hereafter Honda; PTO-892).
Honda teaches the bacterial strains Paraprevotella clara 1C4 and JCM 14859 have trypsin-degrading activity in the cecum of a mouse when administered [0037, Figure 13, 0184]. Honda also teaches formulating P. clara into a pharmaceutical composition and using the composition for “treating, ameliorating, or preventing the following diseases caused by trypsin activity” [0023, <14>] and teaches that the diseases can be inflammatory bowel disease including ulcerative colitis and Crohn’s disease [0023 <19-20>]. Honda also teaches that the bacteria are also useful in a method for treating a bacterial infection (colitis) [Example 3, and specifically 0187-0188]; the “3-mix” used included the 1C4 strain [0034]. As discussed above in the 35 U.S.C. 112(b) rejection (par. 22), the diseases that are specifically discussed in the claims are interpreted as associated with TMPRSS2 or IgA.
The instant specification provides evidence that the P. clara JCM 14859 strain comprises SEQ ID NO: 5 [instant specification 0013], so the bacteria of Honda inherently have the 00502 protein with SEQ ID NO: 5, which has trypsin-binding activity.
Claim Rejections - 35 USC § 102/103
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.
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.
Claims 23-26 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Bushman et al. (US20160243175A1; hereafter Bushman; PTO-892), optionally in view of Morotomi et al. (2009; hereafter Morotomi; IDS filed 19 Nov 2024).
Bushman teaches a method for using a defined microbial consortia to treat Clostridium difficile colitis (i.e. a bacterial infectious disease), and inflammatory bowel disease [Abstract]. Bushman teaches that “In a particularly preferred embodiment, the consortia consists of Paraprevotella clara,…” and other species [0007].
Bushman is silent on what strain of P. clara to use. The instant specification provides evidence that all P. clara strains tested have a 00502 gene and a trypsin-decomposing ability [instant specification 0240], so it appears that the claim limitation “bacteria that have 00502 protein… and having a trypsin-binding ability” is inherently taught by Bushman’s teaching of P. clara. "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). In this case, the additional limitation that P. clara comprises a 00502 protein does not make the method patentable because it appears from the instant specification’s teachings that all P. clara comprise this protein. See MPEP 2112.
If this feature is not inherent in P. clara, then one of ordinary skill in the art at the time of filing would consider it obvious to use the Paraprevotella clara type strain (YIT 11840 =JCM 14859=DSM 19731) as taught by Morotomi. Morotomi teaches that P. clara JCM 14859 is the “type strain” (Abstract), which is the reference strain that is publicly accessible in the culture collections JCM and DSM. The instant specification provides evidence that the P. clara JCM 14859 strain comprises SEQ ID NO: 5 [instant specification 0013], so the bacteria of Morotomi inherently have the 00502 protein with SEQ ID NO: 5, which has trypsin-binding activity.
One of ordinary skill in the art at the time of filing would consider it prima facie obvious to improve the method using P. clara of Bushman by choosing the P. clara type strain of Morotomi, thereby arriving at the claimed invention, because using this strain would be desirable because the strain is publicly available and is reliable because it has been used by other researchers for over 10 years at the time of filing. See MPEP 2144(II): “The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art … that some advantage or expected beneficial result would have been produced by their combination.”
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that the simple substitution of one known element for another to obtain predictable results is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses that "the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results". In the instant case, the prior art (Bushman) teaches a method that only differs from the claimed invention by the substitution of a single component (i.e. substitution of the P. clara used); the substituted element (i.e. the specific P. clara JCM 14859 strain) was already known and already shown to function as an art-recognized P. clara strain, therefore no change in the function of the substituted element occurred; and one of ordinary skill in the art would be capable of substituting a specific, art-recognized strain with a generic strain in the same species with a reasonable expectation of success (i.e. the substitution of the element would lead to predictable results). Therefore, the claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
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 23-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 12,629,395, either alone or in view of Zhou et al. (2017; hereafter Zhou; PTO-892) and/or Hamilton et al. (2014; hereafter Hamilton; PTO-892).
‘395 claim 1 (and dependent claims) teaches a method for suppressing intestinal trypsin activity comprising administering a bacterium belonging to a genus Paraprevotella. ‘395 claim 2 clarifies that the bacteria may be P. clara and ‘395 claim 4 teaches that the bacteria may be the Paraprevotella clara JCM 14859 strain. The instant specification provides evidence that the P. clara JCM 14859 strain comprises SEQ ID NO: 5 [instant specification 0013], so the bacteria of ‘395 inherently have the 00502 protein with SEQ ID NO: 5, which has trypsin-binding activity. The method of suppressing intestinal trypsin activity in those needing such a treatment will also treat diseases caused by trypsin because the trypsin will be present in reduced quantities.
Therefore, the claims of ‘395 anticipate instant claim 23 alone.
The claims of ‘395 do not teach the specific diseases caused by trypsin or TMPRSS2 is an inflammatory bowel disease (ulcerative colitis, Crohn's disease) irritable bowel syndrome, an infectious disease, acute pancreatitis, or chronic pancreatitis, as in claim 24; that the infectious disease is a virus infectious disease or a bacterial infectious disease, as in claim 25; or that the inflammatory bowel disease, the irritable bowel syndrome, or the infectious disease is a disease associated with TMPRSS2 or IgA, as in claim 26.
Zhou teaches that “Multiple studies showed that patients or animals with IBD have increased fecal digestive proteases such as trypsin and chymotrypsin” (pg. 1779 col. 2 par. 3). Zhou teaches that another trypsin inhibitory compound, unconjugated bilirubin (UCB), “ameliorated the inflammation and digestive protease increase in TNBS‑induced colitis”, which is a mouse model for IBD (Abstract).
Hamilton teaches that “targeting trypsin-like, host proteases responsible for HA cleavage in vivo may prove to be an effective therapeutic” and that a specific inhibitor, HAI-2, inhibited influenza virus infection in cell culture and a mouse model (Abstract). Hamilton also teaches that “Trypsin is commonly used as model protease in studies of [flu hemagglutinin] cleavage-activation” (pg. 2 par. 2), including in this study (pg. 5 par. 5). Hamilton concludes that the trypsin inhibitor “has the potential to be an effective, alternative antiviral therapeutic for influenza” (Abstract).
One of ordinary skill in the art at the time of filing would consider it prima facie obvious to improve the method of suppressing trypsin activity from the claims of ‘395 by choosing to administer the therapy to subjects with IBD and/or influenza, thereby arriving at the claimed invention, because Zhou and/or Hamilton teaches that suppressing trypsin activity is beneficial in these subjects. Therefore the combination would be desirable because these references teach which subjects would benefit from a method to suppress intestinal trypsin activity, unlike the claims of ‘395 which do not provide any guidance on which subjects should be treated with the method. See MPEP 2144(II): “The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art … that some advantage or expected beneficial result would have been produced by their combination.”
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that the use of known techniques to improve similar devices, methods or products in the same way is obvious because enhancing a particular class of devices, methods, or products has been made part of the ordinary capabilities of one skilled in the art based upon the teaching of such improvement in other situations. In the instant case, the claims of ‘395 teach a “base” method for suppressing trypsin activity comprising administering the claimed bacteria as a trypsin inhibitor, and Zhou and/or Hamilton teaches a comparable method for suppressing trypsin activity using a trypsin inhibitor wherein the use of subjects with IBD and/or influenza is taught as advantageous. Thus, one of ordinary skill in the art could have applied the known technique of Zhou and/or Hamilton to the base method taught by the claims of ‘395 to yield predictable results (i.e. the same advantages). Therefore, the claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMELIA N DICKENS whose telephone number is (571)272-0381. The examiner can normally be reached M-F 8:30-4:30 (EDT/EST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis can be reached at (571) 270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMELIA NICOLE DICKENS/Examiner, Art Unit 1645
/SAMIRA J JEAN-LOUIS/Supervisory Patent Examiner, Art Unit 1642
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