DETAILED ACTION
Claims 1-20 are currently pending.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Information Disclosure Statement
No Information Disclosure Statement has been filed at this time.
The listing of references in the specification (pages 55-57) is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
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.
Scope of Enablement:
Claims 1-20 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 of treating a respiratory tract illness in a human, wherein the method comprises administering to the human a composition comprising a therapeutically effective amount of Bifidobacterium lactis BL04 and/or a fermentation product of Bifidobacterium lactis BL04 and/or a cell lysate of Bifidobacterium lactis BL04;
and the Bifidobacterium lactis BL04 and/or fermentation product of Bifidobacterium lactis BL04 and/or cell lysate of Bifidobacterium lactis BL04 is the only probiotic bacterium, probiotic fermentation product and/or probiotic cell lysate in the composition, wherein the respiratory tract illness is selected from one or more of the group consisting of tonsillitis, rhinitis, rhinosinusitis, sinusitis, nasopharyngitis, rhinopharyngitis, a common cold, pharyngitis, epiglottitis, supraglottitis, laryngitis, laryngotracheitis and tracheitis,
does not reasonably provide enablement for a method of prophylaxis of a respiratory tract illness in a human, wherein: the method comprises administering to the human a composition comprising any amount of Bifidobacterium lactis BL04 and/or a fermentation product of Bifidobacterium lactis BL04 and/or a cell lysate of Bifidobacterium lactis BL04; and the Bifidobacterium lactis BL04 and/or fermentation product of Bifidobacterium lactis BL04 and/or cell lysate of Bifidobacterium lactis BL04 is the only probiotic bacterium, probiotic fermentation product and/or probiotic cell lysate in the composition.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The claims recite limitations directed to prophylactic treatment, it is noted the specification describes “prophylaxis” is in relation to the respiratory illness (page 7), however the specification does not provide a specific definition of the parameters of “prophylaxis” being limited to reducing symptoms or attenuating the progression of the illness, thus given the plain meaning of the term “prophylaxis” is taken to mean preventive or prevention of a disease (as evidenced by VeryWellHealth (see PTO-892) and Dictionary.Cambridge (see PTO-892)), Applicant’s claims as currently written encompass absolute prevention.
It is further noted that claims 16 and 20 encompass treatment of healthy adults, which would further encompass preventative treatment.
The factors to be considered in determining whether undue experimentation is required are summarized In re Wands, 8 USPQ2d 1400 (CAFC 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 USPQ2d 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). The factors to be considered in determining whether undue experimentation is required include: (1) the quantity of experimentation necessary; (2) the amount or direction or guidance presented; (3) the presence or absence of working examples; (4) the nature of the invention; (5) the state of the prior art; (6) the relative skill of those in the art; (7) the predictability or unpredictability of the art; and (8) the breadth of the claims. While all these factors are considered, a sufficient number are discussed below so as to create a prima facie case.
Nature of the invention: The claims are directed to method of treating or prophylaxis of any respiratory tract illness in a human, wherein: the method comprises administering to the human a composition comprising any amount of Bifidobacterium lactis BL04 and/or a fermentation product of Bifidobacterium lactis BL04 and/or a cell lysate of Bifidobacterium lactis BL04; and the Bifidobacterium lactis BL04 and/or fermentation product of Bifidobacterium lactis BL04 and/or cell lysate of Bifidobacterium lactis BL04 is the only probiotic bacterium, probiotic fermentation product and/or probiotic cell lysate in the composition.
Breadth of the claims: Claim 1 broadly encompasses preventing any/all upper and lower respiratory tract illnesses or disorders such as tracheal cancer, lung cancer, nasal cancer, pneumonia, tracheomalacia, cystic fibrosis or pulmonary fibrosis, for example, wherein any amount of Bifidobacterium lactis BL04 and/or a cell lysate of Bifidobacterium lactis BL04 is administered. That is, the method would entirely stop the onset of any and all upper and lower respiratory tract illnesses or disorders in all cases at all times.
The relative skill of those in the art: The relative skill of those in the art is high.
Amount or direction or guidance presented: The claims are drawn to a method of preventing any/all upper and lower respiratory tract illnesses or disorders such as tracheal cancer, lung cancer, nasal cancer, pneumonia, tracheomalacia, cystic fibrosis or pulmonary fibrosis, for example, wherein any amount of Bifidobacterium lactis BL04 and/or a cell lysate of Bifidobacterium lactis BL04 is administered.
While the person of ordinary skill in the art would have a reasonable expectation of successfully treating a respiratory tract illness in a human, wherein the method comprises administering to the human a composition comprising a therapeutically effective amount of Bifidobacterium lactis BL04 and/or a fermentation product of Bifidobacterium lactis BL04 and/or a cell lysate of Bifidobacterium lactis BL04;
and the Bifidobacterium lactis BL04 and/or fermentation product of Bifidobacterium lactis BL04 and/or cell lysate of Bifidobacterium lactis BL04 is the only probiotic bacterium, probiotic fermentation product and/or probiotic cell lysate in the composition, wherein the respiratory tract illness is selected from one or more of the group consisting of tonsillitis, rhinitis, rhinosinusitis, sinusitis, nasopharyngitis, rhinopharyngitis, a common cold, pharyngitis, epiglottitis, supraglottitis, laryngitis, laryngotracheitis and tracheitis, he or she would not have had an expectation for preventing the onset of any respiratory tract illness and administering any amount of Bifidobacterium lactis BL04 and/or fermentation product of Bifidobacterium lactis BL04 and/or cell lysate of Bifidobacterium lactis BL04.
Prevention, for the purpose of examination, is taken in the absolute sense. Thus, in order to prevent respiratory tract illness, the method would entirely stop the onset of the respiratory tract illness in all cases at all times. The skilled artisan would view the prevention of respiratory tract illness as highly unlikely since all cases would not be preventable by the administration of Bifidobacterium lactis BL04 and/or fermentation product of Bifidobacterium lactis BL04 and/or cell lysate of Bifidobacterium lactis BL04. Thus, it would be highly unpredictable to prevent all cases of any respiratory tract illness. It would further be highly unpredictable to prevent all cases of any respiratory tract illness by administering any amount of the claimed probiotic. Rather, it would be more appropriate to limit the claims to a method of treating a respiratory tract illness in a human, wherein the method comprises administering to the human a composition comprising a therapeutically effective amount of Bifidobacterium lactis BL04 and/or a fermentation product of Bifidobacterium lactis BL04 and/or a cell lysate of Bifidobacterium lactis BL04;
and the Bifidobacterium lactis BL04 and/or fermentation product of Bifidobacterium lactis BL04 and/or cell lysate of Bifidobacterium lactis BL04 is the only probiotic bacterium, probiotic fermentation product and/or probiotic cell lysate in the composition, wherein the respiratory tract illness is selected from one or more of the group consisting of tonsillitis, rhinitis, rhinosinusitis, sinusitis, nasopharyngitis, rhinopharyngitis, a common cold, pharyngitis, epiglottitis, supraglottitis, laryngitis, laryngotracheitis and tracheitis.
State of the prior art: As noted by McCoy et al., (The Science Creative Quarterly, 2004; see PTO-892), an extensive search for the cause of the common cold (respiratory tract illness) led to the discovery of over 100 different Rhinoviruses, which are only responsible for half of all colds, with adenovirus and several other viruses causing the remaining half of colds (Introduction). McCoy notes that the first symptoms of rhinovirus infection are within 8-10 hours of infection, the peak being 1-3 days. Upon virus infection the local area becomes inflamed as immune cells invade resulting in local edema, or swelling and the nasal mucus membranes begin to secret large volumes of fluid, the end result being the symptoms of the common cold: sore throat, runny nose, watering eyes, sneezing, coughing, congestion and headache (Infection & the Immune Response, page 1). McCoy does teach that zinc nasal sprays and lozenges have been proven to reduce the length of a cold in a very simple manner by blocking viral access since zinc is able to bind the viral ICAM-1 receptor (Zinc: Have they finally found a cure?, page 3). Applicant’s disclosure does not comment on whether or not the Bifidobacterium lactis BL04 and/or a fermentation product of Bifidobacterium lactis BL04 and/or a cell lysate of Bifidobacterium lactis BL04 in any way binds to rhinovirus, or other cold causing viruses, in order to block or inhibit viral infection, thus providing prophylaxis of the common cold infection.
Working Examples: Applicants have provided no direction for the claimed method to prevent any and all respiratory tract illnesses. The experiments provided in the specification (see Tables 5a and 5b, pages 46-47) demonstrate the ability of therapeutically effective amounts of the Bifidobacterium lactis BL04 and/or fermentation product of Bifidobacterium lactis BL04 and/or cell lysate of Bifidobacterium lactis BL04 to reduce symptoms and illness duration, as well as reduce the need for additional cold and flu medications (Table 9, pages 53-54), thus treating the respiratory tract illness. Applicants have provided no results demonstrating prevention of any and all respiratory tract illnesses by administration of the Bifidobacterium lactis BL04 and/or fermentation product of Bifidobacterium lactis BL04 and/or cell lysate of Bifidobacterium lactis BL04. Applicants have provided no long-term results showing that all cases of respiratory tract illness are prevented by the administration of the Bifidobacterium lactis BL04 and/or fermentation product of Bifidobacterium lactis BL04 and/or cell lysate of Bifidobacterium lactis BL04, as would be required to support the “prophylactic” treatment. While lack of a working embodiment cannot be a sole factor in determining enablement, the absence of substantial evidence provides additional weight to the lack of enablement in consideration of the Wands factors as a whole. Thus, one of ordinary skill in the art would not have a reasonable expectation of successfully preventing any respiratory tract illness in a human, wherein: the method comprises administering to the human a composition comprising any amount of Bifidobacterium lactis BL04 and/or a fermentation product of Bifidobacterium lactis BL04 and/or a cell lysate of Bifidobacterium lactis BL04; and the Bifidobacterium lactis BL04 and/or fermentation product of Bifidobacterium lactis BL04 and/or cell lysate of Bifidobacterium lactis BL04 is the only probiotic bacterium, probiotic fermentation product and/or probiotic cell lysate in the composition.
Further regarding claims 13, 16 and 20, the specification does not provide any examples of a healthy human that has been prevented from contracting a respiratory illness, or specifically the illnesses disclosed in the specification at pages 4-5, e.g., tonsillitis or the common cold, by administering any dosage of the Bifidobacterium lactis BL-04 and/or a fermentation product of Bifidobacterium lactis BL-04 and/or a cell lysate of Bifidobacterium lactis BL-04.
The quantity of experimentation necessary: Accordingly, in view of the lack of teachings or guidance provided by the specification, with regard to prevention of any respiratory tract illness in a human by administration of any amount of Bifidobacterium lactis BL04 and/or a fermentation product of Bifidobacterium lactis BL04 and/or a cell lysate of Bifidobacterium lactis BL04, at the time of filing the skilled artisan would need to perform an undue amount of experimentation without a predictable degree of success to implement the invention as claimed.
Therefore, a method of prophylaxis of a respiratory tract illness in a human, wherein: the method comprises administering to the human a composition comprising any amount of Bifidobacterium lactis BL04 and/or a fermentation product of Bifidobacterium lactis BL04 and/or a cell lysate of Bifidobacterium lactis BL04; and the Bifidobacterium lactis BL04 and/or fermentation product of Bifidobacterium lactis BL04 and/or cell lysate of Bifidobacterium lactis BL04 is the only probiotic bacterium, probiotic fermentation product and/or probiotic cell lysate in the composition, is not enabled by the instant specification. Accordingly, claims 1-20 are properly rejected.
Written Description:
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1 recites the following:
“A method of treating or prophylaxis of a respiratory tract illness in a human, wherein: the method comprises administering to the human a composition comprising Bifidobacterium lactis BL04 and/or a fermentation product of Bifidobacterium lactis BL04 and/or a cell lysate of Bifidobacterium lactis BL04; and the Bifidobacterium lactis BL04 and/or fermentation product of Bifidobacterium lactis BL04 and/or cell lysate of Bifidobacterium lactis BL04 is the only probiotic bacterium, probiotic fermentation product and/or probiotic cell lysate in the composition.”
Dependent claims 2-20 either depend directly from claim 1, or incorporate the method of claim 1.
The specification shows that Applicants have not provided sufficient description of the invention to support they were in possession of a method of treating or prophylaxis of any respiratory tract illness in a human, wherein: the method comprises administering to the human a composition comprising any amount of Bifidobacterium lactis BL04 and/or a fermentation product of Bifidobacterium lactis BL04 and/or a cell lysate of Bifidobacterium lactis BL04; and the Bifidobacterium lactis BL04 and/or fermentation product of Bifidobacterium lactis BL04 and/or cell lysate of Bifidobacterium lactis BL04 is the only probiotic bacterium, probiotic fermentation product and/or probiotic cell lysate in the composition.
Applicant’s claims as currently written encompass treating any respiratory tract illness, including tracheal cancer, various types of lung cancer, cystic fibrosis, or pulmonary fibrosis by administering any amount of the Bifidobacterium lactis BL04 and/or fermentation product of Bifidobacterium lactis BL04 and/or cell lysate of Bifidobacterium lactis BL04. The claims encompass preventing any respiratory tract illness, including tracheal cancer, various types of lung cancer, cystic fibrosis, pulmonary fibrosis, or preventing the common cold, by administering any amount of the Bifidobacterium lactis BL04 and/or fermentation product of Bifidobacterium lactis BL04 and/or cell lysate of Bifidobacterium lactis BL04.
In the instant case Applicant’s specification (see Tables 5a and 5b, pages 46-47) demonstrates the ability of therapeutically effective amounts (page 32) of the Bifidobacterium lactis BL04 and/or fermentation product of Bifidobacterium lactis BL04 and/or cell lysate of Bifidobacterium lactis BL04 to reduce or ameliorate symptoms and illness duration, as well as reduce the need for additional cold and flu medications (Table 9, pages 53-54), thus treating respiratory tract illnesses selected from one or more of the group consisting of tonsillitis, rhinitis, rhinosinusitis, sinusitis, nasopharyngitis, rhinopharyngitis, a common cold, pharyngitis, epiglottitis, supraglottitis, laryngitis, laryngotracheitis and tracheitis.
A review of the specification shows that Applicants have not provided sufficient description of the invention to support they were in possession of treating or preventing any respiratory tract illness (e.g., tracheal cancer, cystic fibrosis), and more specifically preventing the common cold, by administering to the human a composition comprising any amount of Bifidobacterium lactis BL04 and/or a fermentation product of Bifidobacterium lactis BL04 and/or a cell lysate of Bifidobacterium lactis BL04.
Further regarding claims 13, 16 and 20, the specification does not provide any examples of a healthy human that has been prevented from contracting a respiratory illness, or specifically the illnesses disclosed in the specification at pages 4-5, e.g., tonsillitis or the common cold, by administering any dosage of the Bifidobacterium lactis BL-04 and/or a fermentation product of Bifidobacterium lactis BL-04 and/or a cell lysate of Bifidobacterium lactis BL-04.
Accordingly, the claims are considered to lack sufficient written description and are properly rejected under 35 USC 112, first paragraph.
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.
Claim 5, 6, 16 and 20 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 5 recites the following:
5. The method according to claim 1, wherein the respiratory tract illness is selected from one or more of the group consisting of tonsillitis, otitis media, rhinitis, rhinosinusitis, sinusitis, nasopharyngitis, rhinopharyngitis, a common cold, pharyngitis, epiglottitis, supraglottitis, laryngitis, laryngotracheitis and tracheitis.
The limitation directed to treating otitis media renders claim 5 indefinite since otitis media is a middle-ear infection and NIH-Respiratory Tract (see PTO-892) evidences the respiratory tract does not include the middle-ear.
Regarding claim 6, Claim 6 recites the limitation “wherein the human has displayed symptoms of the respiratory tract illness for more than 7 days”. Claim 6 is indefinite since it is unclear as to how the method is a prophylactic method if the human has displayed symptoms of the respiratory tract illness for more than 7 days.
Regarding claims 16 and 20, as to the limitation "…the human is a healthy, physically active adult", it is noted claims 16 and 20 depend directly from claim 1 and recites the method treats a respiratory tract illness in a human. This limitation renders claims 16 and 20 indefinite since it is unclear how a human having a respiratory tract illness is “healthy”. The specification does not provide a specific definition for a “healthy” human as being one with an active respiratory tract illness.
Applicant’s specification (page 20) discloses subjects are healthy, in contrast to being immunosuppressed individuals.
Therefore, in the interest of compact prosecution, claims 16 and 20 are interpreted as “the human is not an immunosuppressed adult human”. However, despite the above interpretation, such treatment does not relieve Applicant of the responsibility of responding to this rejection. If the actual interpretation of the claims is different than that posited by the Examiner, additional rejections and art may be readily applied in a subsequent final Office action. The rejection to claims 16 and 20 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, stands and must be addressed.
Appropriate clarification is appreciated.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-12 and 14-19 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Ebel et al., (WO 2009/100331; see PTO-892) ("Ebel"), in view of Van Benten et al., (Allergy, 2001; see PTO-892) (“Van Benten"), Isolauri (WO 2008/122892; see PTO-892) (“Isolauri”) and Smith et al., (US 2009/0253790; see PTO-892) (“Smith”).
For the reasons discussed above claims 1-20 are not found to be enabled for prophylaxis of a respiratory tract illness in a human, but rather only enabled for treating a respiratory tract illness in a human, wherein the method comprises administering to the human a composition comprising a therapeutically effective amount of Bifidobacterium lactis BL04 and/or a fermentation product of Bifidobacterium lactis BL04 and/or a cell lysate of Bifidobacterium lactis BL04;
and the Bifidobacterium lactis BL04 and/or fermentation product of Bifidobacterium lactis BL04 and/or cell lysate of Bifidobacterium lactis BL04 is the only probiotic bacterium, probiotic fermentation product and/or probiotic cell lysate in the composition, wherein the respiratory tract illness is selected from one or more of the group consisting of tonsillitis, rhinitis, rhinosinusitis, sinusitis, nasopharyngitis, rhinopharyngitis, a common cold, pharyngitis, epiglottitis, supraglottitis, laryngitis, laryngotracheitis and tracheitis.
The following rejection is being made over the claims in so far as they read on treating a respiratory tract illness in a human.
Further regarding claims 13 and 20, given that claims 13 and 20 are directed to prophylactic treatment, it is noted that claims 13 and 20 are not included in the rejection under 35 USC 103(a).
Ebel is directed to methods for treating respiratory conditions (page 4, first paragraph) or reducing the risk of, preventing, mitigating, inhibiting or ameliorating the respiratory tract illness (page 5, third and fifth full paragraphs), wherein the respiratory conditions include upper respiratory illnesses such as rhinitis, sinusitis (page 5, third paragraph), nasal congestion, sneezing, cough, sore throat and runny nose (page 6, second paragraph) that are associated with a cold or influenza (page 6, second and third paragraphs).
Regarding claims 1 and 2, Ebel teaches administering a therapeutic probiotic composition to humans (page 5, second full paragraph) that treats or reduces the risk of acquiring the upper respiratory illness (page 8 paragraphs 4-6), wherein the probiotic is a Bifidobacterium (page 9, first paragraph), specifically Bifidobacterium lactis LAFTI® 94 (i.e., CBS 118529) (page 10, last paragraph). Ebel’s Examples 4-6 exemplify the therapeutic compositions formulated as capsules, freeze-dried powders or powder filled pouches, wherein Bifidobacterium lactis is the only probiotic bacterium in the composition.
Thus, Ebel has established it was well known in the art that compositions comprising Bifidobacterium lactis as the only probiotic bacterium are administered to humans for treating upper respiratory illnesses such as rhinitis, sinusitis, nasal congestion, sneezing, cough, sore throat and runny nose that result from a cold or influenza, for example. Thus, Ebel’s method reads on a method of treating a respiratory tract illness in a human, wherein the method administers to the human a composition comprising Bifidobacterium lactis, and the Bifidobacterium lactis is the only probiotic bacterium in the composition.
As to the limitation that the Bifidobacterium lactis is the strain indicated as Bl-04, it is noted that although Ebel exemplifies using a probiotic of the same genus and species as that instantly claimed, i.e., Bifidobacterium lactis, Ebel does not further teach whether or not the disclosed Bifidobacterium lactis LAFTI® 94 is the same as Bifidobacterium lactis Bl-04, as recited in the instant claims.
However, Van Benten teaches that a variety of viruses cause common cold symptoms (Introduction, left column, 2nd paragraph, page 949) and during the acute phase of the common cold infection (in non-allergic patients) there is a significant increase in the number of eosinophils (i.e. eosinophilia) (Eosinophils, mast cells and eotaxin- and RANTES positive cells, 1st paragraph, page 952).
Isolauri is directed to a method for reducing nasal and respiratory eosinophilia associated with allergic rhinitis (Abstract; page 10, paragraphs [52]-[53] and [64]) and teaches administration of the probiotic composition comprising Bifidobacterium lactis Bl-04 and Lactobacillus acidophilus NCFM™ was effective at preventing infiltration, i.e. increase of eosinophils into the nasal mucosa, thus reducing nasal symptoms associated with nasal inflammation, i.e. rhinitis (CONCLUSION, page 3261; DISCUSSION, left column, first paragraph, page 3267).
Smith is directed to the preparation of beneficial probiotic compositions (paragraph [0003]). Smith specifically teaches it is well-known that foods containing probiotics have been shown to have beneficial health effects including decreasing the incidence of respiratory tract infections (paragraph [0004]). Thus, there is a need for dairy products capable of providing beneficial probiotic cultures (paragraph [0008]). Smith specifically exemplifies a composition comprising B. lactis (Bl-04) as the only probiotic bacterium in the composition.
Therefore, given that Ebel is directed to administering a therapeutic probiotic composition to humans for treating or reducing the risk of acquiring the upper respiratory illness, wherein the probiotic is specifically Bifidobacterium lactis, and knowing the following:
i) that common cold infection increases the number of eosinophils (which contribute to inflammation symptoms), as taught by Van Benten;
ii) administering a probiotic composition comprising B. lactis strain Bl-04 is effective at reducing nasal inflammation symptoms by reducing the eosinophil infiltration/increase, as taught by Isolauri; and
iii) it is well-known that foods containing probiotics have been shown to have beneficial health effects including decreasing the incidence of respiratory tract infections, and these compositions can comprise B. lactis (Bl-04) as the only probiotic bacterium in the composition, as taught by Smith, it would have been prima facie obvious to one having ordinary skill in the art at the time of the invention to substitute B. lactis strain Bl-04, as taught by Isolauri and Smith, as the B. lactis strain in the method of Ebel for the predictable result of successfully reducing nasal inflammation symptoms by reducing the eosinophil infiltration/increase, as well as decreasing the incidence of respiratory tract infections, thus meeting the limitation of claims 1 and 2.
The person of ordinary skill in the art would have been motivated to use B. lactis strain Bl-04, as taught by Isolauri and Smith, for the predictable result of providing a probiotic that reduces nasal inflammation by reducing the number of eosinophils and at the same time reduce the incidence of respiratory infections
The skilled artisan would have had a reasonable expectation of success in substituting the B. lactis strain Bl-04,, for the B. lactis of Ebel because Isolauri has shown that B. lactis strain Bl-04 is effective at reducing nasal inflammation symptoms by reducing the eosinophil infiltration/increase and Smith has shown that the that foods containing probiotics have been shown to have beneficial health effects including decreasing the incidence of respiratory tract infections, and these compositions can comprise B. lactis (Bl-04) as the only probiotic bacterium in the composition.
Therefore, substitution of the B. lactis strain Bl-04 as taught by Isolauri and Smith, in the treatment composition of Ebel would have been expected to yield the predictable result of treating the upper respiratory inflammation. Substitution of one element for another known in the field is considered to be obvious, absent a showing that the result of the substitution yields more than predictable results. See KSR International Co. v Teleflex Inc 82 USPQ2d 1385 (US 2007) at page 1395.
Regarding claims 3, 5 and 7, as set forth above, Ebel teaches treating upper respiratory illnesses such as rhinitis, sinusitis (page 5, third paragraph), nasal congestion, sneezing, sore throat and runny nose (page 6, second paragraph) that are associated with a cold or influenza (page 6, second and third paragraphs), thus meeting the limitations of claims 3, 5 and 7.
Regarding claim 8, Ebel teaches treating bacterial pneumonia (page 6, fourth paragraph), thus meeting the limitation of claim 8.
Regarding claims 4 and 9, Ebel teaches treating chest congestion and cough (page 6, second paragraph), thus meeting the limitations of claims 4 and 9.
Regarding claim 6, as set forth above, Ebel explicitly teaches treatment for respiratory tract illness. Ebel teaches administration of the therapeutic probiotic can be daily, including multiple times per day (page 48, third paragraph) which encompasses for more than 7 days as recited in claim 6. As to the limitation “wherein the human has displayed symptoms of the respiratory tract illness for more than 7 days”, in view of Ebel’s teaching of treatment on a daily basis, it would have been within the purview of one of ordinary skill in the art at the time of the invention to administer the treatment when the human has displayed symptoms of the respiratory tract illness for more than 7 days. One of ordinary skill in the art would continue treatment based on observed symptoms of the patient for the instantly claimed time period.
Applicant is reminded that “[a] person of ordinary skill in the art is also a person of ordinary creativity, not an automaton.” KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385, 1397 (2007). “[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle.” Id. Office personnel may also take into account “the inferences and creative steps that a person of ordinary skill in the art would employ.” Id., 82 USPQ2d at 1396 (see MPEP § 2141.03).
Regarding claims 10-12, and the limitations directed to increasing granulocyte phagocytic activity and/or monocyte phagocytic activity in the subject, these limitations are directed to an intended result. It is noted that a whereby/wherein clause in a method claim “is not given weight when it simply expresses the intended result of a process step positively recited” (MPEP 2111.04).
As discussed above, the combined references teach the same method step of administering a composition comprising Bifidobacterium lactis Bl-04, as disclosed in the instant specification, thus the method disclosed by the combined references would necessarily result in the increasing granulocyte phagocytic activity and/or monocyte phagocytic activity in the subject.
Regarding claim 14, Ebel teaches administration of at least about 1 x 104 to at least about 5 x 1010 cells per day (claimed range overlaps the prior art range) of the probiotic strain of bacteria, which can be administered in a single dose or a plurality of doses (page 49, fifth paragraph to page 50, first paragraph). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05
Regarding claim 15, Ebel teaches treating humans between the ages of 2 and 18 (claimed range overlaps the prior art range) (page 49, fourth paragraph). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05
Regarding claim 16, as to the limitation "wherein the human is a healthy, physically active adult", it is noted as set forth above at the rejection under 35 USC 112 (second paragraph) claim 16 is interpreted as “the human is not an immunosuppressed adult human”.
As set forth immediately above regarding claim 15, Ebel renders obvious treating a human subject that is 18 years of age, i.e. an adult.
Ebel does not comment on whether or not the adults are suffering from a specific unhealthy condition or they are immunosuppressed, thus the patient population of Ebel are considered healthy, physically active adults, absent evidence to the contrary.
Accordingly, it would have been obvious to one of ordinary skill in the art at the time the invention was made to include treating healthy, physically active adults with a reasonable expectation of success. Thus, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
Regarding claim 17, Ebel teaches formulating the therapeutic probiotic composition as capsules or freeze-dried powders which reads on “the composition is formulated as a medicament”, thus meeting the limitation of claim 17.
Regarding claims 18 and 19, Ebel teaches the composition may be orally administered in any convenient form including powders which are suitable for admixture with milk, juice, hot and/or cold beverage, hot chocolate, cold cereal, hot cereal, yogurt, ice cream or the like thus serving as food or the compositions may be used as a supplement to ordinary diet (e.g., a dietary supplement) (page 48, second and third paragraphs), thus meeting the limitations of claims 18 and 19.
Claim 6 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Ebel, in view of Van Benten, Isolauri and Smith, as set forth above, and further in view of Hellgren et al., (Allergy, 2010; see PTO-892) ("Hellgren").
The following is an alternative rejection to claim 6.
The teachings of Ebel, in view of Van Benten, Isolauri and Smith are set forth above.
Regarding claim 6, as to the limitation "wherein the human has displayed symptoms of the respiratory tract illness for greater than seven days", although Ebel explicitly teaches the method prevents, mitigates, inhibits or ameliorates the respiratory tract illness (page 5, last paragraph) and Ebel teaches administration of the therapeutic probiotic can be daily, including multiple times per day (page 48, third paragraph), and that one of ordinary skill in the art would continue prophylactic treatment based on observed symptoms of the patient for the instantly claimed time period, if it is determined the cited prior art does not specifically teach the “human has displayed symptoms of the respiratory tract illness for greater than seven days", it is noted that, given that Ebel, in view of Van Benten, Isolauri and Smith, teaches the common cold infection causes inflammation of the mucosa in the nasal cavity and pharynx, and the administration of the probiotic treatment alleviates the nasal symptoms, it would be obvious to provide the treatment to subjects having symptoms for greater than seven days since Hellgren teaches that the common cold imposes an economic burden on society because of absence from work and reduced working capacity. The mean productivity loss in Sweden was estimated at 5.1 days which was equivalent to € 653 per worker (i.e., € 130 per day) (Abstract).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide treatment to the human who has displayed symptoms of the respiratory tract illness for more than 7 days.
The person of ordinary skill in the art would have been motivated to modify the method of the prior art to include treatment to the human who has displayed symptoms of the respiratory tract illness for more than 7 days for the predictable result of successfully reducing the economic burden on society because of absence from work and reduced working capacity, thus meeting the limitation of claim 6.
The skilled artisan would have had a reasonable expectation of success in combining the teachings of the cited prior art and Hellgren because each of these teachings are directed at the effects of respiratory tract illnesses associated with the common cold.
Since Hellgren has shown that the duration of the common cold imposes an economic burden on society because of lost wages due to absence from work and reduced working capacity, the claimed invention as a whole was prima facie obvious 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.
Claims 1-3 and 17-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 12 and 13 of U.S. Patent No. 10,668,117 (“US ‘117”), as evidenced by Cleveland Clinic, Common Cold (2023) (see PTO-892) (“Cleveland Clinic”).
Although the claims at issue are not identical, they are not patentably distinct from each other because US ‘117 is directed to reducing a rhinovirus or influenza virus infection (claims 1-3) by administering to a subject a composition comprising Bifidobacterium lactis BL-04, and the treatment includes administering to a therapeutically effective amount (claim 12) to humans (claim 13).
Cleveland Clinic evidences that a rhinovirus (common cold) is a respiratory tract infection affecting the nose, sinuses, throat and windpipe.
Thus, claims 1, 3, 12 and 13 of US ‘117 does render obvious instant claims 1-3 and 17-19, that is, claims 1, 3, 12 and 13 of US ‘117 teach the limitations required by the current claims and as all limitations are found in one reference it is held that the method of instant claims 1-3 and 17-19 is within the scope of the teachings of claims 1, 3, 12 and 13 of US ‘117, and thus renders the invention of claims 1-3 and 17-19 prima facie obvious. The rationale to support this conclusion of obviousness is that the single reference provides the teachings and suggestion to treat a respiratory tract illness by administering to the human subject a composition comprising Bifidobacterium lactis BL-04 and/or fermentation product of Bifidobacterium lactis BL-04 and/or a cell lysate of Bifidobacterium lactis BL-04. Furthermore, there is no evidence on the record that shows that the claimed limitation has any greater or unexpected results than that exemplified by US ‘117.
Conclusion
No claim is allowed. No claim is free of the prior art.
Examiner Contact Information
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E. YVONNE PYLA
Primary Examiner
Art Unit 1633
/EVELYN Y PYLA/Primary Examiner, Art Unit 1633
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