Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Detailed Action
This Office Action is in response to the Applicant’s reply received 6/08/26. Claims 1-15 are pending and considered on the merits.
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 1-15 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.
Claims 3 and 4 are indefinite because they include a wherein clause that limits the combination i) “for simultaneous administration or consumption” or ii) “for sequential administration or consumption”. However, these limitations do not add a structural component to the combination. MPEP 2111.04 I states “Claim scope is not limited …by claim language that does not limit a claim to a particular structure”. It is unclear how combination is modified to meet the goals i) or ii) in claims 3 and 4.
Claims 5, 12, and 14 include “preferable” limitations. These preferable limitations are narrower than the preceding broad limitations. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance:
claim 5 recites the broad recitation “an oral dosage form”, and then also recites “preferably a solid oral dosage form” which is the narrower statement of the range/limitation.
claims 12 and 14 recites the broad recitation of “animal”, and then also recites “preferably a human” which is the narrower statement of the range/limitation.
The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claims 6-15 recite intended uses of the composition without providing additional structural limitations to the combination. These include the following:
wherein said combination is for administration to the large intestine (claim 6).
for use as a medicament, a dietary supplement, or a food supplement (claim 7).
for use in the treatment of a patient that is in need of increasing the concentration of SCP As in the large intestine (claim 8).
wherein said patient is suffering from one or more of the following: irritable bowel syndrome, inflammatory bowel disease, colorectal cancer, graft-versus-host disease, diabetes, obesity, allergy, inflammation, autoimmune disease, and neurodegenerative disorder (claim 9).
for use in the treatment of a patient that is in need of increasing the concentration of butyrate in the large intestine (claim 10).
wherein said patient is suffering from one or more of the following: irritable bowel syndrome, inflammatory bowel disease, colorectal cancer, graft-versus-host disease, diabetes, obesity, and neurodegenerative disorder (claim 11).
for use in increasing the concentration of SCFAs and/or butyrate in the large intestine of an animal, preferably a human, wherein said use comprises administering or delivering the vitamin C and the Bifidobacterium animalis ssp. lactis to the large intestine (claim 12).
wherein the vitamin C and the Bifidobacterium animalis ssp. lactis are administered or delivered to the large intestine by a delayed-release formulation (claim 13).
wherein said use comprises administering or delivering vitamin C and the Bifidobacterium animalis ssp. lactis simultaneously and/or sequentially to the animal, preferably a human (claim 14).
wherein the animal, including a human, is experiencing one or more condition(s) selected from: irritable bowel syndrome, inflammatory bowel disease, colorectal cancer, graft-versus-host disease, diabetes, obesity, allergy, inflammation, autoimmune disease, and neurodegenerative disorder.
These intended uses do not appear to recite any structural limitations to the claims and merely state the purpose of the invention. This makes it difficult to determine the metes and bounds of the claim and how they further limit their parent claims. Also, these limitations are not afforded significant patentable weight since the body of the claim fully and intrinsically sets forth all the structural limitations of the invention (MPEP 2111.02 II). Therefore since compositions are defined by their components and not by their intended use any composition that contains the ingredients listed in claims will inherently meet the intended uses (MPEP 2112.01 II).
Claim Interpretation
Art reading on the structural limitations of the claims will also read on the intended uses and treating the various diseases recited in the claims. This follows the guidance in MPEP 2112.01 II where if the composition is physically the same, it must have the same properties including its ability to treat the claimed diseases.
Claim Rejections - 35 USC § 102
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) 1-3, 5-12, 14, and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Akin et al. (Mljekarstvo 2015).
Akin et al. teach a probiotic ice cream fortified with ascorbic acid (vitamin C) and Bifidobacterium animalis subsp. lactis BB-12 (see Abstract and Figure 2). Ice cream is considered an oral dosage form.
Therefore, the invention as a whole is anticipated by Akin et al.
Claim(s) 1-3 and 5-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Penhasi et al. (WO 2012/077038).
Penhasi et al. at teach the following delayed release capsule in Figure 2:
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Label #1 on this figure represents cores of probiotic bacteria and other excipients (page 12, lines 20-25). The other layers (Labels #2-4) are coatings to delay the release of the probiotic in the gastrointestinal system (pg. 12, lines 20-30, pg. 37 lines 19-30 and pg. 39 lines 5-10). The probiotic cores comprise Bifidobacterium animalis subsp. lactis BB-12 (pg. 13, line 20 and Example 1) with a stabilizer including the antioxidant ascorbic acid (Vitamin C) (pg. 15, lines 14-15).
Therefore, the invention as a whole is anticipated by Akin et al.
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.
Claims 1-15 is/are rejected under 35 U.S.C. 103 as being obvious over Penhasi et al. (WO 2012/077038).
Penhasi et al. at teach the following delayed release capsule in Figure 2:
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Label #1 on this figure represents cores of probiotic bacteria and other excipients (page 12, lines 20-25). The other layers (Labels #2-4) are coatings to delay the release of the probiotic in the gastrointestinal system (pg. 12, lines 20-30, pg. 37 lines 19-30 and pg. 39 lines 5-10). The probiotic cores comprise Bifidobacterium animalis subsp. lactis BB-12 (pg. 13, line 20 and Example 1) with a stabilizer including the antioxidant ascorbic acid (Vitamin C) (pg. 15, lines 14-15).
While Penhasi et al. teach administering BB-12 with vitamin C in a simultaneous dosage form, they do not teach a sequential dosage form. This would be obvious in view of Otten et al. who teach administering high dose vitamin C without other probiotics increases the concentration of Bifidobacterium in the intestine based on bacteria quantification in fecal samples (Otten, Materials and Methods and Fig. 2). One of ordinary skill would recognize that administering Vitamin C separately from BB-12 would advantageously increase the population of all Bifidobacerium in the gut. They would consider it obvious to administer Vitamin C separately either before or after administering BB-12 since Otten et al. teach that independent administration of these two components enhances Bifidobacterium growth in the gut. One of ordinary skill would recognize this as simply applying a known technique to enhance Bifidobacterial growth in the gut which would enhance growth of BB-12. This would be seen by one of ordinary skill as an obvious improvement to increase BB-12 growth in the gut to enhance its probiotic activity (MPEP 2141 III (C)).
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of 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.
Claim 1-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of copending Application No. 18/871675 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims teach a composition comprising vitamin C and Bifidobacterium animalis subsp. lactis BB-12 to treat various aliments of the digestive system.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Additional References Cited
Chaikham et al. and Tapia et al. are cited as relevant prior art with teachings close in scope to the claims.
In response to this office action the applicant should specifically point out the support for any amendments made to the disclosure, including the claims (MPEP 714.02 and 2163.06).
CONTACT INFORMATION
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THANE E UNDERDAHL whose telephone number is (303) 297-4299. The examiner can normally be reached Monday through Thursday, M-F 8-5 MST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at (571) 272-3311.The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THANE UNDERDAHL/Primary Examiner, Art Unit 1699
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