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 .
Final Rejection
The Status of Claims:
Claims 1, 60-65 are pending.
Claims 1, 60-65 are rejected.
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 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.
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.
The rejection of Claims 1-5, 7, 9-16, 49, and 55-56 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn due to the modification of the claim 1 and cancelation of the claims.
The rejection of Claims 1-16 under 35 U.S.C. 112, first paragraph, is withdrawn due to the modification of the claim 1 and cancelation of the claims.
The rejection of Claims 1-16 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, is withdrawn due to the modification of the claim 1 and cancelation of the claims.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
The rejection of Claim(s) 1, 5-9. 11, 17-25, 27-41, 49, 54-55 under 35 U.S.C. 102(a)(1) as being anticipated clearly by Toledo et al (British ournal of Pharmacology, 2013, vol. l68, pages 736-749) is withdrawn due to the modification of the claim 1 and cancelation of the claims.
The rejection of Claim(s) 1-11, 14-16, 49, 54-56 under 35 U.S.C. 102[(a)(2) as being anticipated clearly by Dimaio (WO 2019/180635 A1) is withdrawn due to the modification of the claim 1 and cancelation of the claims.
The rejection of Claim(s) 1-16, 49, 54-56 under 35 U.S.C. 102(a)(2)as being anticipated clearly by Yang et al (CN 109806256 A) is withdrawn due to the modification of the claim 1 and cancelation of the claims.
..
The rejection of Claim(s) 1-7, 9, 11-16, 49, and 55 under 35 U.S.C. 102(a)(2) as being anticipated clearly by Ren-Zhong et al (CN 104906120) is withdrawn due to the modification of the claim 1 and cancelation of the claims.
The rejection of Claim(s) 1-9, l l- 13, 49, and 55 under 35 U.S.C. 102(a)(2) as being anticipated clearly by Liang et al (EP 2163247 A1) is withdrawn due to the modification of the claim 1 and cancelation of the claims.
However, in view of the modification of the claim 1 and the addition of the new claims , another 103 rejection seems necessary in the following:
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.
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 35 U.S.C. 103 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, 60-65 are rejected under 35 U.S.C. 103 as being unpatentable over Boufadi et al (Journal of Food Biochemistry (2018), 42(1), p. 1-14) in view of Wikipedia (Nebulizer, Fer. 12 2020, p. 1-8),
Determination of the scope and content of the prior art
Boufadi et al discloses that propolis is a resinous mixture which honey bees collect from buds and bark of some trees. It contains several antioxidant compounds. such as polyphenols and flavonoids. It describes the antioxidant capacity of propolis extracts and pure polyphenols which contains pinocembrin and pinostrobin (see page 3 , table 1). All the homeostasis changes and liver, kidney, and lung damage were restored by propolis extract (see page 1 ,abstract).
The current invention, however, differs from the prior art in that the claimed wound healing response occurs in a tissue comprising epithelial and/or endothelial cells of the lung and the pinocembrin or pinocembrin-7-methylether formulated as an inhalable powder or a solution deliverable by a nebulizer are unspecified in the prior art.
Wikipedia teaches that nebulizers accept their medicine in the form of a liquid solution, which is often loaded into the device upon use. The pharmaceuticals are inhaled instead of ingested is in order to target their effect to the respiratory tract, which speeds onset of action of the medicine and reduces side effects, compared to other alternative intake routes(see page 4, a section of use and attachements).
Ascertainment of the difference between the prior art and the claims
1. The difference between the instant application and the applied art is that the applied art do not expressly teach the claimed wound healing response occurring in a tissue comprising epithelial and/or endothelial cells of the lung.
The difference between the instant application and the applied Boufadi et al art is that the Boufadi et al does not expressly teach the claimed the claimed wound healing response occurs in a tissue comprising epithelial and/or endothelial cells of the lung and the pinocembrin or pinocembrin-7-methylether formulated as an inhalable powder or a solution deliverable by a nebulizer. The deficiencies of the Boufadi et al are partially cured by the Wikipedia.
The difference between the instant application and the applied Wikipedia art is that the Wikipedia does not expressly teach the method of treating a lung having an impaired lung function by using pinocembrin or pinocembrin-7-methylether and the claimed wound healing response occurring in a tissue comprising epithelial and/or endothelial cells of the lung. The deficiencies of the Wikipedia are partially cured by the Boufadi et al.
Resolving the level of ordinary skill in the pertinent art.
Regarding the Claim 63 , with respect to the lack of disclosing the claimed wound healing response occurring in a tissue comprising epithelial and/or endothelial cells of the lung, the prior art is silent about it, However, it is a well-known knowledge in the skilled artisan in the field of medicine that lung tissues are comprised of epithelial and endothelial cells of the lung. Furthermore, Boufadi et al does teach that the composition containing pinocembrin or pinocembrin-7-methylether can restore the lung damage. Thus, it is very reasonable for the skilled artisan in the art to have assumed that the wound healing response can occur in those tissues.
Regarding the Claim 65, with respect to the lack of disclosing the pinocembrin or pinocembrin-7-methylether formulated as a solution deliverable by a nebulizer, Wikipedia does teach the advantage of using nebulizers for medicine to target their effect to the respiratory tract, which speeds onset of action of the medicine and reduces side effects. Furthermore, Boufadi et al does teach that the composition containing pinocembrin or pinocembrin-7-methylether can restore the lung damage. So, if the skilled artisan in the art had desired to promote the speedy onset of action of a composition containing pinocembrin or pinocembrin-7-methylether and reduce side effects, it would have been obvious to the skilled artisan in the art to be motivated to apply the nebulizer for the effective delivery of the composition containing pinocembrin or pinocembrin-7-methylether. This is because the skilled artisan in the art would expect such a manipulation to be within the purview of the skilled artisan in the art.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
Boufadi et al expressly discloses that propolis contains pinocembrin and pinostrobin (see page 3 , table 1) ,which can restored the lung damage, whereas Wikipedia does teach the advantage of using nebulizers for a medicine to target their effect to the respiratory tract.
Both prior art are commonly related to each other with respect to the method of treating the damaged lung vs. the delivery device of nebulizers for the lung.
So, if the skilled artisan in the art had desired to promote the speedy onset of action of a composition containing pinocembrin or pinocembrin-7-methylether and reduce side effects, it would have been obvious to the skilled artisan in the art to be motivated to apply the nebulizer for the effective delivery of the composition containing pinocembrin or pinocembrin-7-methylether. This is because the skilled artisan in the art would expect such a manipulation to be within the purview of the skilled artisan in the art.
Applicants argue the following issues:
Claims 1-16 are rejected because the specification does not provide enablement for prophylaxis fibrotic or inflammatory condition. Applicant respectfully disagrees with this contention. However, appropriate correction via amendment to claim 1 is submitted herewith and the remaining rejected claims are cancelled. It is respectfully submitted the amended claim 1 and its dependent claims are enabled and thus it is respectfully requested this rejection be withdrawn and the claims allowed.
Claims 1-16 are rejected as failing to comply with the enablement requirement. . Applicant respectfully disagrees with this contention. However, appropriate correction via amendment to claim 1 is submitted herewith and the remaining rejected claims are cancelled. It is respectfully submitted the amended claim 1 and its dependent claims comply with the enablement requirement and thus it is respectfully requested this rejection be withdrawn and the claims allowed.
The option for prophylaxis does not appear in the currently amended claims. Applicant respectfully submits that the subject matter defined by the currently amended claims conforms closely to the experimental work detailed in the Examples section of the specification. The experimental work employed pinocembrin as the flavonoid. Pincoembrin-7-methylether is closely related structurally to pinocembrin, the only difference being the latter compound having an -O-CH 3 group substituted at the R7 position.
Claims 1, 5-9, 11, 17-25, 27-41, 49,54-55 are rejected as being anticipated by Toledo et al. (British Journal of Pharmacology, 2013, vol.168, pages 736-749). Applicant respectfully disagrees with this contention. However, the claims have been amended for clarification.
Toledo et al. fails to disclose any use whatsoever of pinocembrin or pinocembrin-7-methyl ether. As such, Toledo et al. fails to teach each any every element of claim 1 which recites "A method for the treatment of an of an impairment in lung function, the method comprising contacting an effective amount of pinocembrin or pinocembrin-7-methylether to a lung having an impaired lung function." It is respectfully requested this rejection be withdrawn and the claims allowed.
Claims 1-11, 14-16, 49, and 54-56 are rejected as being anticipated by W02019/180635A1, hereinafter "Dimaio." Applicant respectfully disagrees with this contention. However, the claims have been amended for clarification.
Dimaio fails to disclose any method step of contacting propolis to a lung having any impairment in lung function (claim 1), much less any impairment related to compliance of a lung segment (claim 60) or inflation of a lung (claim 61). As such, Dimaio fails to teach each any every element of claim 1 which recites "A method for the treatment of an of an impairment in lung function, the method comprising contacting an effective amount of pinocembrin or pinocembrin- 7-methylether to a lung having an impaired lung function." It is respectfully requested this rejection be withdrawn and the claims allowed.
Claims 1-16, 49, and 54-56 are rejected as being anticipated by CN109806256A, hereinafter "Yang." Applicant respectfully disagrees with this contention. However, the claims have been amended for clarification.
Yang discloses the use of pinocembrin in an animal model of pulmonary disease. The document is completely silent to contacting pinocembrin to a lung having any impairment in lung
function. The disclosure of Yang is limited to disclosing only that pinocembrin has an effect on weight, collagen content, and the presence of fibrosis. The investigation of these parameters by Yang dos not establish (explicitly or implicitly) any step of contacting of pinocembrin to a lung having impaired lung function.
Lung function is dependent on how well or how poorly the whole organ fulfills its function of inflating to admit air of a high oxygen level and expelling air of a relatively low oxygen level. The combined tissues of the lungs must have sufficient flexibility (or expressed in a different way, low stiffness), to facilitate that function. Any stiffness in the lungs creates a resistance to expansion of the lungs by the diaphragm. The lungs become more difficult for the animal to fully expand, and inhalation of air also becomes more difficult. Breathing becomes shallow, and the individual becomes hypoxic.
It would be impossible to determine how resistant the lungs would be to inflation based on any measurement of weight, collagen content or amount of fibrosis. For example, fibrosis may be limited to a very low level which would not affect the function of the lung in any way.
Subclinical pulmonary fibrosis (where fibrosis is present, but does not lead to any material change in lung function) is well known. Reference is made to the publication Chida et al., Subclinical idiopathic pulmonary fibrosis is also a risk factor of postoperative acute respiratory distress syndrome following thoracic surgery, European Journal of Cardio-Thoracic Surgery, Volume 34, Issue 4, October 2008, Pages 878-881.
Subclinical pulmonary inflammation (where inflammation is present, but does not lead to any material change in lung function) is also well known. Reference is made to the publication Doyle et al, Subclinical Interstitial Lung Disease Am J Respir Crit Care Med. 2012 Jun 1;185(11):1147-1153.
It cannot be concluded that the animal subject of Yang must have had impaired lung function when being treated because of the bleomycin-induced injury to the lungs. Lung function is simply not measured at any stage of the study. Fibrosis (by way of collagen assay) is measured, but as discussed above there is no necessary link between fibrosis and lung function.
It cannot be concluded from any cited prior document of a treatment of a lung exhibiting inflammation or fibrosis must have been performed on a subject having impaired lung function.
The fact that a certain result or characteristic may occur or be present in the prior art is not sufficient to establish the inherency of that result or characteristic. In re Rijckaert, 9 F.3d 1531, 1534, 28 USPQ2d 1955, 1957 (Fed. Cir. 1993). The burden falls to the Office to establish by evidence or some reasonable rational that the allegedly inherent feature was necessarily present in the prior art.
Applicant submits that the cited prior art fails to provide the required evidence, and no reasonable rational is available. As such, it is respectfully requested this rejection be withdrawn and the claims allowed.
Claims 1-7, 9, 11-16, 49, and 55 are rejected as being anticipated by CN104906120, hereinafter "Ren-Zhong." Applicant respectfully disagrees with this contention. However, the claims have been amended for clarification.
Ren-Zhong fails to disclose pinocembrin or pinocembrin-7-methyl ether as claimed. Instead, Ren-Zhong discloses compositions comprising hesperidin for use in treating pulmonary fibrosis. As such, Ren-Zhong fails to teach each any every element of claim 1 which recites "A method for the treatment of an of an impairment in lung function, the method comprising contacting an effective amount of pinocembrin or pinocembrin-7-methylether to a lung having an impaired lung function." It is respectfully requested this rejection be withdrawn and the claims allowed.
Claims 1-9, 11-13, 49 and 55 are rejected as being anticipated by EP2163247A1, hereinafter "Liang." Applicant respectfully disagrees with this contention. However, the claims have been amended for clarification.
Liang fails to disclose pinocembrin or pinocembrin-7-methyl ether as claimed. Instead, Liang discloses the use of naringenin and naringin in the manufacture of medicaments. As such, Liang fails to teach each any every element of claim 1 which recites "A method for the treatment of an of an impairment in lung function, the method comprising contacting an effective amount of pinocembrin or pinocembrin-7-methylether to a lung having an impaired lung function." It is respectfully requested this rejection be withdrawn and the claims allowed.
Applicants’ arguments have been noted. The arguments were persuasive. .However, as indicated in the above, another 103 rejection seems necessary in view of the revised claim1 and the addition of new claims,
Conclusion
Claims 1, 60-65 are rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
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/TAYLOR V OH/Primary Examiner, Art Unit 1625 11/1/2025