DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Applicants’ claim amendment of 8/15/2023 is acknowledged. Claims 8 and 16-22 have been canceled. Claims 1-7, and 9-15 have been amendment.
Status of Claims
3. Claims 1-7 and 9-15 are pending in this application. Claims 8 and 16-22 have been canceled. Claims 1-7, and 9-15 have been amendment.
Drawings
4. The drawings submitted 8/23/2023 have been objected to by the examiner. No detailed description of the drawings has not mentioned in the specification.
Information Disclosure Statement
5. Applicants’ information disclosure statement of 8/15/2023 is acknowledged. The references have been considered; Initialed copy is enclosed.
Double Patenting
6. The non-statutory 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 non-statutory 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 non-statutory 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 non-statutory 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 e-Terminal Disclaimer may be filled out completely online using web-screens. An e-Terminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about e=Terminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
7. Claim 1 is provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claim 1 of co-pending Application No. 18/881,563.
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of instant application is drawn to:
Claim 1. A method for use in treating and/or preventing and/or alleviating respiratory allergy symptoms and/or a respiratory allergy reaction in an individual comprising administering a composition comprising at least one of polyphenol and at least one of Bifidobacterium longum to an individual in need of same.
Claim 1 of Application No. 18/881,563 is drawn to:
Claim 1. A method of treating and/or preventing an allergy and/or allergic sensitization in an infant or young child, the method comprising administering a Bifidobacterium longum transitional microorganism to the infant or young child.
The claims of both applications are drawn to a method of treating and/or preventing an allergy and/or allergic symptoms.
This is a provisional non-statutory double patenting rejection.
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.
Claim rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. This is deposit rejection.
Instant claim 9 recites the that the composition comprises Bifidobacterium longum ATCC BAA-999. As a required element, the specifically recited strain must be known and be readily available to the public, or obtainable by a reproducible method set forth in the specification. The specification lacks complete deposit information for the deposit of this strain. Because it is not clear that the properties of these strains are known and publicly available or can be reproducibly isolated from nature without undue experimentation.
If the deposit has been made under the provisions of the Budapest Treaty, filing of an affidavit or declaration by applicant or assignees or a statement by an attorney of record who has authority and control over the conditions of the deposit over his or her signature and registration number stating that the deposit has been accepted by an International Depository Authority under the provisions of the Budapest Treaty, that all restrictions upon public access to the deposit will be replaced if viable samples cannot be dispensed by the depository is required. This requirement is necessary when deposits are made under the provisions of the Budapest Treaty as the Treaty leaves this specific matter to the discretion of each State. Amendment of the specification to recite the date of the deposit and the complete name and full street address of the depository is required.
If the deposits have not been made under the provisions of the Budapest Treaty, then in order to certify that the deposits comply with the criteria set forth in 37 CFR §1.801-1.809, assurances regarding availability and permanency of deposits are required. Such assurance may be in the form of an affidavit or declaration by applicants or assignees or in the form of a statement by an attorney of record who has the authority and control over the conditions of deposit over his or her signature and registration number averring:
(a) during the pendency of this application, access to the deposits will be afforded to the Commissioner upon request;
(b) all restrictions upon the availability to the public of the deposited biological material will be irrevocably removed upon the granting of a patent on this application;
© the deposits will be maintained in a public depository for a period of at least thirty years from the date of the deposit or for the enforceable life of the patent or for a period of five years after the date of the most recent request for the furnishing of a sample of the deposited biological material, whichever is longest; and
(d) the deposits will be replaced if they should become non-viable or non-replicable.
In addition, a deposit of the biological material that is capable of self-replication either directly or indirectly must be viable at the time of the deposit and during the term of deposit. Viability may be tested by the depository. The test must conclude only that the deposited material is capable of reproduction. A viability statement for each deposit of a biological material not made under the Budapest Treaty must be filed in the application and must contain:
1)The name and address of the depository;
2)The name and address of the depositor;
3)The date of deposit;
4)The identity of the deposit and the accession number given by the depository;
5)The date of the viability test;
6)The procedures used to obtain a sample if the test is not done by the depository; and
7)A statement that the deposit is capable of reproduction.
If the deposit was made under the provisions of the Budapest Treaty, filing of an affidavit or declaration by Applicants, assignees or a statement by an attorney of record over his or her signature and registration number stating that deposit has been accepted by an International Depository Authority under the provisions of the Budapest Treaty, that all restrictions upon public access to the deposit will be irrevocably removed upon the grant of a patent on this application and that the deposit will be replaced if viable samples cannot be dispensed by the depository is required. This requirement is necessary when a deposit is made under the provisions of the Budapest Treaty as the Treaty leaves this specific matter to the discretion of each State. Amendment of the specification to recite the date of the deposit and the complete name and address of the depository is required.
As a possible means for completing the record, applicant may submit a copy of the contract with the depository for deposit and maintenance of each deposit.
If the deposit was made after the effective filing date of the application for patent in the United States, a verified statement is required from a person in a position to corroborate that the cell line described in the specification as filed is the same as that deposited in the depository. Corroboration may take the form of a showing of a chain of custody from applicant to the depository coupled with corroboration that the deposit is identical to the biological material described in the specification and in the applicant's possession at the time the application was filed.
Applicant's attention is directed to In re Lundak, 773 F.2d. 1216, 227 USPQ 90 (CAFC 1985) and 37 CFR §1.801-1.809 for further information concerning deposit practice.
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 1-7 and 9-15 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.
The phrases “respiratory allergy reaction”, “respiratory allergy symptoms” in claim 1 are vague and thus unclear, as they do not define which diseases, conditions and/or symptoms should be considered as being “respiratory allergy reaction” and “respiratory allergy symptoms”, respectively. Therefore, - the phrase “respiratory allergy” was interpreted as relating to allergic rhinitis, dust mite allergy, or asthma (as in claim 2), - the phrase “respiratory allergy symptoms” was interpreted as relating to ocular symptoms, sneezing, stuffy nose, asthma, fatigue and/or tiredness, anxiety, sleep disorder, mood disorder, depression, anxiety, swing/mood disorder and/or depression associated with respiratory allergy (as in claims 2 and 3).
Claim Rejections - 35 USC § 112
Claims 1-7 and 9-15 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 treating allergic sensitization in a human, does not reasonably provide enablement for the prevention and treating of all allergic symptoms and respiratory reactions in a human as instantly claimed. 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 use the invention commensurate in scope with these claims.
A conclusion of lack of enablement means that, based on the evidence regarding each of the factors below, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation.
The instant specification fails to provide information that would allow the skilled artisan to fully practice the instant invention without undue experimentation. Attention is directed to In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the 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.
The most relevant factors are discussed below.
The nature of the invention
The instant invention pertains to a method for preventing or treating allergy symptoms in a human comprising administration to said human a nutritional composition comprising at least one polyphenol and at least on Bifidobacterium longum.
The breadth of the claims
Instant claims recite preventing, i.e. absolute prevention and treating of allergy symptoms and reactions.
The amount of direction provided or guidance presented by the inventor
The instant specification fails to give directions for preventing or treating all respiratory allergies symptoms and/or respiratory allergy reactions in any type of individual. There is no enablement for preventing runny or congested nose, sneezing, itchy throat, eyes, and nose, and coughing, wheezing, chest tightness, shortness of breath, and throat swelling, or anaphylaxis. In dogs and cats, respiratory allergy symptoms include sneezing, runny nose, coughing, wheezing, and noisy breathing. Other signs can include watery eyes, facial pain, hives, otitis media, rhinorrhea, skin infection or irritation, itch, diarrhea, vomiting, face swelling and even lethargy. There is no prevention of all these symptoms or reactions in all types of individuals.
The level of Predictability or Unpredictability in the Art
It is noted that the pharmaceutical art is unpredictable, requiring each embodiment to be individually assessed. Prevention is seen to include the administration of the claimed compounds to a healthy mammal, and subsequent exposure to conditions at any age that would cause allergic symptoms, wherein the said compounds prevent said exposure from manifesting itself in said mammal so exposed. Any therapy which merely reduces the number or severity of symptoms, or which is effective for a period shorter than the subject’s remaining lifespan, is considered to be ineffective at preventing a disease/disorder. In general, preventing diseases/disorders according to the definition of prevention given above is not possible as any so-called preventive effects of a drug therapy are expected to cease when the drug is cleared from the patient’s system. More generally, prevention of any disorder in the sense being used herein is not a recognized clinical outcome in the art, as no treatment is perfectly effective.
The presence or absence of working examples
There are no examples of preventing or treating said claimed symptoms. No data or experimental in vitro or in vivo assay is presented to back up absolute prevention of allergic symptoms as claimed. Thus, the specification fails to provide clear and convincing evidence in sufficient support of the prevention/prophylaxis as recited in the instant claims.
The quantity of experimentation needed to make or use the invention based on the content of the disclosure
In view of the information set forth, the instant disclosure is not sufficient to enable the prevention of allergy symptoms in a human using the instant composition as recited in the instant claims. One of ordinary skill in the art will not consider the results disclosed as prevention.
Genentech, 108 F.3d 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 discussed above, to practice the claimed invention herein, a person of skill in the art would have to engage in undue experimentation, with no assurance of success.
Claim Rejections - 35 USC § 103
13. 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.
14. Claims 1-7 and 9-15 are rejected under 35 U.S.C. 103 as being unpatentable over Benyacoub et al. WO 2020/127579 A1 in view of Mercenier et al. WO 2013/026897 A1, Art of record search report.
The claims are drawn to:
Claim 1. A method for use in treating and/or preventing and/or alleviating respiratory allergy symptoms and/or a respiratory allergy reaction in an individual comprising administering a composition comprising at least one of polyphenol and at least one of Bifidobacterium longum to an individual in need of same.
Claim 2. Method for use according to claim 1, wherein the respiratory allergy is selected from the group consisting of allergic rhinitis, dust mite allergy er-and asthma.
Claim 3. Method for use according to claim 1, wherein the symptoms are selected from the group consisting of ocular symptoms, sneezing, stuffy nose, asthma, fatigue and/or tiredness, anxiety, sleep disorder, mood disorder, and depression.
Benyacoub et al. teach method and composition comprising Bifidobacterium longum ATCC BAA-999 for treating and preventing allergic disorder (see abstract and claims). Benyacoub et al. teach comprising Bifidobacterium longum ATCC BAA-999 (see claims 2,15,17). Benyacoub et al. teach respiratory allergy symptoms and disorders (see abstract, clams 3,4, 5, 6, 16 and page 4). Benyacoub et al. teach limitations of claims 2, 3 allergic rhinitis, asthma, dust mite (see claims 5, 6, pages 4, 9, 15). Benyacoub et al. teach limitations of claims 5 and 6 pollen (see pages 4,5,16). Benyacoub et al. teach limitations of claim 7, Vitamin C (see pages 21,22,23 and 26). Benyacoub et al. teach limitations of claims 14 and 15 pharmaceutical compositions, food supplements, food products, pet food and prepackaged unit dosage forms (see pages 10,15,17 and 18). Benyacoub et al. teach the composition additionally comprising antioxidants [para 119]. Benyacoub et al. teach do not teach the antioxidant is polyphenol which is epicatechin.
Mercenier et al. teach epicatechin for alleviating symptoms of allergic disorder and/ or allergic reaction (see abstract and claims 1-14). Epicatechin is a polyphenol. Polyphenols are a large group of small compounds with antioxidant activity that are commonly found in plants and fruits. Epicatechin is capable of reducing or preventing symptoms of an allergic disorder and/or allergic reaction. No undesired side-effects e.g. resulting from a strong corticosteroid or anti-histaminic activity are expected from a moderate use of epicatechin. Mercenier et al. teach limitations of claims 2, 3 allergic rhinitis, asthma, ocular symptoms, runny nose, sneezing and dust mite (see claims 1-3 and page 9). Mercenier et al. teach pollen (see page 9). Mercenier et al. teach limitation of claim 11, plant extract (see pages 11,12,14 and claim 7). Mercenier et al. teach limitations of claims 12 and 13 at least 0.1w% and a range of 25 mg to 10 mg administered (see pages 10,11,12,15 and claims 6 and 9). Mercenie et al. teach limitations of claims 14 and 15 pharmaceutical compositions, food supplements, food products, pet food and prepackaged unit dosage forms (see claims 11-15).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention by taking the advantage of the teaching of the above cited references and to make the instantly claimed method with a reasonable expectation of success. Because, Benyacoub et al. teach method and composition comprising Bifidobacterium longum ATCC BAA-999 for treating and preventing allergic disorder with antioxidants while Mercenier et al. teach the antioxidant, epicatechin alleviaties symptoms of allergic disorder and/ or allergic reaction without any side effects. The motivation to combine Bifidobacterium longum ATCC BAA-999 of Benyacoub et al. with an antioxidant comes from the teachings of Benyacoub et al. where the composition further contains an antioxidant. The antioxidant of Mercenier et al., has the same purpose of treating/alleviating symptoms of allergy; thus no more than routine skill is required to combine compositions useful for the same purpose.
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses combining prior art elements according to known methods to yield predictable results, thus the combination 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, "The combination of familiar element according to known methods is likely to be obvious when it does no more than yield predictable results". It is well known to combine known methods and compositions, which function in a predictable manner to yield a reasonable expectation of success along with predictable results to one of ordinary skill in the art at the time of the invention. Thus, it would have been obvious to a person of ordinary skill in the art to combine prior art elements according to known compositions and methods that is ready for improvement to yield predictable results. The claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Conclusion
15. No claims are allowed.
16. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KHATOL S SHAHNAN SHAH whose telephone number is (571)272-0863. The examiner can normally be reached on Mon-Tue, Thurs-Fri 12pm-8pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gary B. Nickol can be reached on 571-272-0835. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Khatol S Shahnan-Shah/
Examiner, Art Unit 1645
September 264, 2025
/JANA A HINES/Primary Examiner, Art Unit 1645