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 .
Election/Restrictions and Claim Status
Applicant's election with traverse of Group 2 in the reply filed on 7/16/26 is acknowledged. The traversal is on the ground(s) that there is no undue burden to consider all the claims. This is not found persuasive because a search of a peptide or composition can raise different issues under 35 USC 101 as compared to a method. Further, enablement considerations are not necessarily the same for a method of administering to a subject as compared to a peptide. Also, a search of a peptide would not necessarily lead to art reading on administration of that peptide.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-6 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 7/16/26.
Claims 7-11 are being examined.
Priority
The priority information is found in the filing receipt of 4/10/24.
Specification
The disclosure is objected to because of the following informalities:
37 CFR 1.831(c) states that where a sequence is presented in a drawing, reference must be made to the sequence by use of the sequence identifier in the description of the drawings or the drawing. In the instant case, Figure 5a recites numerous sequences but the description of the drawing (page 5 of the substitute specification) does not recite any sequence identifiers.
The substitute specification of 2/23/24 (Substitute Specification_Clean) does not include page numbers as required by 37 CFR 1.52(b)(5).
Appropriate correction is required.
Claim Objections
Claim 9 is objected to because of the following informalities:
Claim 9 recites ‘the microorganism’. For consistency with claim 8, the claim should recite ‘wherein the microorganism’.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 7-11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 7 recites ‘growth of microorganisms’ and claims 8-9 refer to ‘the microorganism’. It is unclear if the intent is more than one type of microorganism (use of the plural ‘microorganisms’ in claim 7) or if the intent is multiple copies of the same type of microorganism. As such, the intended subject of claim 7 and dependent claims is unclear. Although unclear, since the specification refers to preventing (page 2 lines 8-9 of the substitute specification and embodiment 3) the claims have been interpreted such that the subject does not need to have a specific infection.
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 7-11 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 ‘A method comprising administering to a subject with a Streptococcus pyogenes infection an antimicrobial composition comprising a peptide wherein the peptide comprises the amino acid sequence set forth in SEQ ID NO:1’, does not reasonably provide enablement for treating any and all microorganisms or treating using materials that are not publicly available. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
The factors to be considered in determining whether a disclosure meets the enablement requirements of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir., 1988). The court in Wands states, “Enablement is not precluded by the necessity for some experimentation, such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is ‘undue’, not ‘experimentation’” (Wands, 8 USPQ2sd 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. “Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations” (Wands, 8 USPQ2d 1404). Among these factors are: (1) the nature of the invention; (2) the breadth of the claims; (3) the state of the prior art; (4) the predictability or unpredictability of the art; (5) the relative skill of those in the art; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
While all of these factors are considered, a sufficient amount for a prima facie case is discussed below.
(1) The nature of the invention and (2) The breadth of the claims:
Instant claim 7 recites ‘inhibiting growth or microorganisms’ where microorganisms would include bacteria, fungi and protozoa. Since the plural ‘microorganisms’ is used it would appear that all claims including the dependent claims include inhibiting any microorganism.
Claim 7 recites ‘GM-080’.
(3) The state of the prior art and (4) the predictability or unpredictability of the art:
The specification states that a particular peptide is selective for different bacteria and that whether it has bacteriostatic ability needs to be confirmed (page 13 2nd paragraph).
The specification teach that AMP-01240 is not capable of inhibiting growth of Streptococcus pyogenes (page 13 first paragraph). Thus, it is unpredictable for any given agent to necessarily be effective against a broad range of microorganisms.
(5) The relative skill of those in the art:
The level of skill in the art is high.
(6) The amount of direction or guidance presented and (7) the presence or absence of working examples:
The specification teach that AMP-01240 is not capable of inhibiting growth of Streptococcus pyogenes (page 13 first paragraph).
The specification states that a particular peptide is selective for different bacteria and that whether it has bacteriostatic ability needs to be confirmed (page 13 2nd paragraph).
The relevant data appears to relate to a single peptide or strain and a single microorganism.
Office practice related to deposit of biological material is directed by 37 CFR 1.801-1.809 and MPEP 2402-2411.05.
Claim 7 and dependents claims refer to a deposit number. It appears that the biological material (GM-080) can be used to practice the claimed invention. As such the biological material must be readily available or obtainable by a repeatable method set forth in the specification, or otherwise readily available to the public. If it is not so obtainable or available, the requirements of 35 USC 112, first paragraph, may be satisfied by a deposit of the biological material. It is not clear if the biological materials are both known and readily available to the public. The mere reference to a deposit or the biological material itself in any document or publication does not necessarily mean that the deposited biological material is readily available. Further, the 5th paragraph of MPEP 2404.01 recognizes that even if one is able to obtain the material in question that such information did not establish that such material would continue to be accessible to the public.
Further, if a deposit is made under the terms of the Budapest Treaty, then a statement, affidavit, or declaration by Applicants, or a statement by an attorney of record over his or her signature and registration number, or someone empowered to make such a statement, stating that the instant invention will be irrevocably and without restriction released to the public upon the issuance of a patent, would satisfy the deposit requirement made herein.
Deposits made under the Budapest Treaty for patent purposes in the US must include a statement of unrestricted release (see MPEP 2410.01 last paragraph). Ex parte Hildebrand, 15 USPQ2d 1662 (Bd. Pat. App. & Int. 1990) is cited as an authority for this requirement :
The indication that a deposit has been made under conditions prescribed by the Budapest Treaty satisfy all conditions for a deposit with the sole exception for the requirement that all restrictions on access be removed on grant of the patent. Ex parte Hildebrand, 15 USPQ2d 1662 (Bd. Pat. App. & Int. 1990).
In the absence of this statement then a properly made Budapest Treaty deposit is not proper under US patent law.
Further, section 2411.05 of the MPEP states
37 CFR 1.809(d) sets forth the requirements for the content of the specification with
respect to a deposited biological material. Specifically, the specification shall contain the
accession number for the deposit, the date of the deposit, the name and address of the
depository, and a description of the deposited biological material sufficient to specifically
identify it and to permit examination.
In the instant case, the last page of the specification refers to a deposit but does not include the date and address. As such, the requirements of 37 CFR 1.809(d) have not necessarily been met.
MPEP 2404.01 states:
“There are many factors that may be used as indicia that a biological material is known and readily available to the public. Relevant factors include commercial availability, references to the biological material in printed publications, declarations of accessibility by those working in the field, evidence of predictable isolation techniques, or an existing deposit made in accordance with these rules. Each factor alone may or may not be sufficient to demonstrate that the biological material is known and readily available. Those applicants that rely on evidence of accessibility other than a deposit take the risk that the patent may no longer be enforceable if the biological material necessary to satisfy the requirements of 35 U.S.C. 112 ceases to be accessible.” In the instant case, the relevant factors do not support that the biological material is known and readily available to the public.
(8) The quantity of experimentation necessary:
Experimentation and guidance is required in numerous areas particularly related to testing against a wide range of possible microorganisms. The specification teach that AMP-01240 is not capable of inhibiting growth of Streptococcus pyogenes (page 13 first paragraph). The specification states that a particular peptide is selective for different bacteria and that whether it has bacteriostatic ability needs to be confirmed (page 13 2nd paragraph). Taken together, such experimentation and guidance is necessary because the prior art cited above teach that the state of the art is highly unpredictable. Accordingly one would be burdened with undue experimentation to determine which subjects would be suitable. Considering the state of the art as discussed by the references above, particularly with regards to the high unpredictability in the art as evidenced therein, and the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to practice the invention commensurate in the scope of the claims.
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.
Claim(s) 7-11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ahmed et al. (‘Efficacy of probiotic in perennial allergic rhinitis under five year children: A randomized controlled trial’ Pak J Med Sci 2019 v35(6) pages 1538-1543; ‘Ahmed’) as evidenced by Rampal et al. (‘20th Malaysian Society of Allergy & Immunology (MSAI) Virtual Congress: Allergy & Immunology 2021’ The Medical Journal of Malaysia 2021 v76(supplement 2) 44 total pages with the last page numbered 37; ‘Rampal’).
Ahmed teach that the probiotic Lactobacillus paracasei LP-33 was administered to subjects specifically children aged 6 to 60 months (abstract and methods on page 1539).
Rampal is cited as a universal fact (MPEP 2124) specifically to show alternate names for Lactobacillus paracasei LP-33. Rampal teach that Lactobacillus paracasei LP-33 is also known as GM-080 (page 20).
In relation to the administration of Lactobacillus paracasei GM-080 of claims 7-11, Ahmed teach that the probiotic Lactobacillus paracasei LP-33 was administered to subjects specifically children aged 6 to 60 months (abstract and methods on page 1539). Rampal teach that Lactobacillus paracasei LP-33 is also known as GM-080 (page 20). Although unclear (see 112 rejection above), since the specification refers to preventing (page 2 lines 8-9 of the substitute specification and embodiment 3) the claims have been interpreted such that the subject does not have to have a specific infection.
In relation to claims 8-9, although unclear (see 112 rejection above), since the specification refers to preventing (page 2 lines 8-9 of the substitute specification and embodiment 3) the claims have been interpreted such that the subject does not have to have a specific infection.
In relation to claim 10, Ahmed teach a specific formulation of a tablet (page 1539 3rd paragraph of 2nd column).
In relation to claim 11, Ahmed teach that the probiotic Lactobacillus paracasei LP-33 was administered to subjects specifically children aged 6 to 60 months (abstract and methods on page 1539). Rampal teach that Lactobacillus paracasei LP-33 is also known as GM-080 (page 20). Since GM-080 was administered it would be capable of the function as claimed. Ahmed teach probiotics as living microorganisms (page 1539 2nd complete paragraph).
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.
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) 7-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ahmed et al. (‘Efficacy of probiotic in perennial allergic rhinitis under five year children: A randomized controlled trial’ Pak J Med Sci 2019 v35(6) pages 1538-1543; ‘Ahmed’) and Rampal et al. (‘20th Malaysian Society of Allergy & Immunology (MSAI) Virtual Congress: Allergy & Immunology 2021’ The Medical Journal of Malaysia 2021 v76(supplement 2) 44 total pages with the last page numbered 37; ‘Rampal’) and Juhn et al. (‘Streptococcus pyogenes upper respiratory infection and atopic conditions other than asthma: a retrospective cohort study’ Prim Care Respir J 2012 v12(2) pages 153-158).
Ahmed teach that the probiotic Lactobacillus paracasei LP-33 was administered to subjects specifically children aged 6 to 60 months (abstract and methods on page 1539). Ahmed teach that the probiotic was beneficial in treating allergic rhinitis without causing any major side effect (abstract). Ahmed recognizes that allergic rhinitis is an inflammatory disorder (introduction first paragraph).
Ahmed does not teach a subject with a Streptococcus pyogenes infection.
Rampal is cited as a universal fact (MPEP 2124) specifically to show alternate names for Lactobacillus paracasei LP-33. Rampal teach that Lactobacillus paracasei LP-33 is also known as GM-080 (page 20).
Juhn teach that allergic rhinitis is associated with an increased risk of S. pyogenes infections (abstract). Juhn teach that S. pyogenes are a major cause of morbidity and mortality worldwide especially among children (first paragraph of introduction).
It would have been obvious to one or ordinary skill in the art before the effective filing date to modify the teachings of Ahmed because Ahmed teach that the probiotic Lactobacillus paracasei LP-33 was administered to subjects specifically children (abstract and methods on page 1539) and that the probiotic was beneficial in treating allergic rhinitis without causing any major side effect (abstract). Based on the beneficial effects, one would have been motivated to administer to specific subjects. Since Juhn teach that allergic rhinitis is associated with an increased risk of S. pyogenes infections (abstract) one would have been motivated to administer (or continue to administer) to subjects with allergic rhinitis with S. pyogenes infections. One would have had a reasonable expectation of success since Ahmed teach that the probiotic was beneficial in treating allergic rhinitis without causing any major side effect (abstract).
In relation to the administration of Lactobacillus paracasei GM-080 of claims 7-11, Ahmed teach that the probiotic Lactobacillus paracasei LP-33 was administered to subjects specifically children aged 6 to 60 months (abstract and methods on page 1539). Rampal teach that Lactobacillus paracasei LP-33 is also known as GM-080 (page 20). Although unclear (see 112 rejection above), since the specification refers to preventing (page 2 lines 8-9 of the substitute specification and embodiment 3) the claims have been interpreted such that the subject does not have to have a specific infection.
In relation to claims 8-9, although unclear (see 112 rejection above), since the specification refers to preventing (page 2 lines 8-9 of the substitute specification and embodiment 3) the claims have been interpreted such that the subject does not have to have a specific infection. Further, Juhn teach that allergic rhinitis is associated with an increased risk of S. pyogenes infections (abstract) so one would have been motivated to administer to such subjects.
In relation to claim 10, Ahmed teach a specific formulation of a tablet (page 1539 3rd paragraph of 2nd column).
In relation to claim 11, Ahmed teach that the probiotic Lactobacillus paracasei LP-33 was administered to subjects specifically children aged 6 to 60 months (abstract and methods on page 1539). Rampal teach that Lactobacillus paracasei LP-33 is also known as GM-080 (page 20). Since GM-080 was administered it would be capable of the function as claimed. Ahmed teach probiotics as living microorganisms (page 1539 2nd complete paragraph).
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 7-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 6994848. Although the claims at issue are not identical, they are not patentably distinct from each other.
6994848 recites methods of treating an allergy related disease including rhinitis (claims 8 and 14) where Lactobacillus paracasei GM-080 is administered to a subject (claim 1).
In relation to the administration of Lactobacillus paracasei GM-080 of claims 7-11, 6994848 recites methods of treating an allergy related disease including rhinitis (claims 8 and 14) where Lactobacillus paracasei GM-080 is administered to a subject (claim 1). Although unclear (see 112 rejection above), since the specification refers to preventing (page 2 lines 8-9 of the substitute specification and embodiment 3) the claims have been interpreted such that the subject does not have to have a specific infection.
In relation to claims 8-9, although unclear (see 112 rejection above), since the specification refers to preventing (page 2 lines 8-9 of the substitute specification and embodiment 3) the claims have been interpreted such that the subject does not have to have a specific infection.
In relation to claims 10-11, 6994848 teach live microorganisms (claim 17). Since GM-080 is taught it would be capable of the function as claimed.
Claims 7-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 6994848 in view of Ahmed et al. (‘Efficacy of probiotic in perennial allergic rhinitis under five year children: A randomized controlled trial’ Pak J Med Sci 2019 v35(6) pages 1538-1543; ‘Ahmed’) and Rampal et al. (‘20th Malaysian Society of Allergy & Immunology (MSAI) Virtual Congress: Allergy & Immunology 2021’ The Medical Journal of Malaysia 2021 v76(supplement 2) 44 total pages with the last page numbered 37; ‘Rampal’) and Juhn et al. (‘Streptococcus pyogenes upper respiratory infection and atopic conditions other than asthma: a retrospective cohort study’ Prim Care Respir J 2012 v12(2) pages 153-158).
6994848 recites methods of treating an allergy related disease including rhinitis (claims 8 and 14) where Lactobacillus paracasei GM-080 is administered to a subject (claim 1).
6994848 does not teach a subject with a Streptococcus pyogenes infection.
Ahmed teach that the probiotic Lactobacillus paracasei LP-33 was administered to subjects specifically children aged 6 to 60 months (abstract and methods on page 1539). Ahmed teach that the probiotic was beneficial in treating allergic rhinitis without causing any major side effect (abstract). Ahmed recognizes that allergic rhinitis is an inflammatory disorder (introduction first paragraph).
Rampal is cited as a universal fact (MPEP 2124) specifically to show alternate names for Lactobacillus paracasei LP-33. Rampal teach that Lactobacillus paracasei LP-33 is also known as GM-080 (page 20).
Juhn teach that allergic rhinitis is associated with an increased risk of S. pyogenes infections (abstract). Juhn teach that S. pyogenes are a major cause of morbidity and mortality worldwide especially among children (first paragraph of introduction).
It would have been obvious to one or ordinary skill in the art before the effective filing date to modify the teachings of 6994848 because 6994848 teach administering GM-080 specifically to those with allergic rhinitis. Since Ahmed teach that the probiotic Lactobacillus paracasei LP-33 (the same as GM-080) was administered to subjects specifically children (abstract and methods on page 1539) and that the probiotic was beneficial in treating allergic rhinitis without causing any major side effect (abstract), one would have been motivated to administer to specific subjects based on the beneficial effects. Since Juhn teach that allergic rhinitis is associated with an increased risk of S. pyogenes infections (abstract) one would have been motivated to administer (or continue to administer) to subjects with allergic rhinitis who also have a S. pyogenes infection. One would have had a reasonable expectation of success since Ahmed teach that the probiotic was beneficial in treating allergic rhinitis without causing any major side effect (abstract).
In relation to the administration of Lactobacillus paracasei GM-080 of claims 7-11, 6994848 recites methods of treating an allergy related disease including rhinitis (claims 8 and 14) where Lactobacillus paracasei GM-080 is administered to a subject (claim 1). Although unclear (see 112 rejection above), since the specification refers to preventing (page 2 lines 8-9 of the substitute specification and embodiment 3) the claims have been interpreted such that the subject does not have to have a specific infection. Ahmed teach that the probiotic Lactobacillus paracasei LP-33 was administered to subjects specifically children aged 6 to 60 months (abstract and methods on page 1539). Rampal teach that Lactobacillus paracasei LP-33 is also known as GM-080 (page 20). Although unclear (see 112 rejection above), since the specification refers to preventing (page 2 lines 8-9 of the substitute specification and embodiment 3) the claims have been interpreted such that the subject does not have to have a specific infection.
In relation to claims 8-9, although unclear (see 112 rejection above), since the specification refers to preventing (page 2 lines 8-9 of the substitute specification and embodiment 3) the claims have been interpreted such that the subject does not have to have a specific infection. Further, Juhn teach that allergic rhinitis is associated with an increased risk of S. pyogenes infections (abstract) so one would have been motivated to administer to such subjects.
In relation to claim 10, Ahmed teach a specific formulation of a tablet (page 1539 3rd paragraph of 2nd column).
In relation to claim 11, Ahmed teach that the probiotic Lactobacillus paracasei LP-33 was administered to subjects specifically children aged 6 to 60 months (abstract and methods on page 1539). Rampal teach that Lactobacillus paracasei LP-33 is also known as GM-080 (page 20). Since GM-080 was administered it would be capable of the function as claimed. 6994848 teach live microorganisms (claim 17). Ahmed teach probiotics as living microorganisms (page 1539 2nd complete paragraph).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RONALD T NIEBAUER whose telephone number is (571)270-3059. The examiner can normally be reached M - F 6:30 - 2:30 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, Melissa Fisher can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
RONALD T. NIEBAUER
Primary Examiner
Art Unit 1658
/RONALD T NIEBAUER/Examiner, Art Unit 1658
Prosecution Insights