DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-4, 8, 10-13 are pending and were examined on the merits.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. The priority date is September 30, 2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on March 27th, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Non-patent literature references 3 and 4 on the IDS were crossed out and not considered because they have illegible text. Compromised legibility may be caused by inadequate scanning resolution and conversion from color to grayscale.
The IDS contains references in a foreign language which have been considered to the
extent presented in the English language; as presented and accompanied by reference document
which is an English language equivalent or translation, to the extent cited in the instant
Application' s disclosure, or as cited by the Examiner in a PTO-892. Additional references which
have been considered have been initialed (fully considered) or also annotated in the IDS (to
indicate the extent considered). References which have not been considered have been lined
through. An initialed copy of the IDS has been placed in the instant Application file.
Drawings
The drawings were received on October 10, 2024. These drawings are acceptable.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art.
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.
Claims 1-4, 8, and 10-13 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 neurogenic pulmonary edema, does not reasonably provide enablement for preventing neurogenic pulmonary edema. 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 factors to be considered in determining whether a disclosure meets the enablement requirements of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir., 1988). The court in Wands states, “Enablement is not precluded by the necessity for some experimentation, such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is ‘undue’, not ‘experimentation’” (Wands, 8 USPQ2sd 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. “Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations” (Wands, 8 USPQ2d 1404). Among these factors are: (1) the nature of the invention; (2) the breadth of the claims; (3) the state of the prior art; (4) the predictability or unpredictability of the art; (5) the relative skill of those in the art; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
(1) The nature of the invention and (2) the breadth of the claims:
The claims are drawn to a method for preventing and treating neurogenic pulmonary edema. Thus, the claims taken together with the specification imply that performing the claimed method reduces the likelihood of neurogenic pulmonary edema to zero, and has a healing effect on existing neurogenic pulmonary edema cases.
(3) The state of the prior art and (4) the predictability or unpredictability of the art:
Xu et al. (Chin J Crit Care Med 2000, 20 (20), 626-627; 4/2/2024 IDS, NPL document 4, considered to the extent of legibility) recites "Many causes of NPE [neurogenic pulmonary edema], such as cerebrocranial injury, intracranial hemorrhage, epilepsy, fibrin injection into the cisternae, cerebral hypoxia, increased intracranial pressure, aspiration, etc."(under heading 2).
Since the injury of the cerebrocranium can occur by chance, in accidents, and a preventable, intermediating cause between certain injuries and neurogenic pulmonary edema remains largely unsolved, means for preventing neurogenic pulmonary edema is highly unpredictable.
(5) The relative skill of those in the art:
The relative skill of those in the art is high. Shi (Journal of Integrated Chinese and Western Medicine 2015, 3 (21), 116-117; 4/2/2024 IDS, NPL document 2) has disclosed a treatment of neurogenic pulmonary edema (Abstract), but does not disclose a means of preventing neurogenic pulmonary edema. Duan et al. (Northern Animal Husbandry 2020, 14, 20; 4/2/2024 IDS, NPL document 1) recites certain strategies that may be partially effective to prevent and control respiratory diseases in pigs (under heading 2), but they do not address preventing the cereborocranial injuries that can cause neurogenic pulmonary edema or preventing any possible intermediating cause between the injury and the edema.
Accordingly, one would have turned to the instant disclosure for additional direction and guidance.
(6) The amount of direction or guidance presented and (7) the presence or absence of working examples:
The specification has provided examples of treating neurogenic pulmonary edema (paragraphs [181]-[236]). However, the specification does not provide examples of preventing neurogenic pulmonary edema.
(8) The quantity of experimentation necessary:
Considering the state of the art as discussed by Shi and the high unpredictability and the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to develop a method of preventing neurogenic pulmonary edema.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4, 8, and 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (CN-112386635-A; 4/2/2024 IDS, foreign patent document 2; examiner relied upon Google translation document) as further supported by Archer et al. (Circulation 2020, 142 (2), 101-104).
Instant Claim 1 recites a method of treating neurogenic pulmonary edema (NPE), comprising administering to a subject in need thereof a composition comprising herba schizonepetae, radix saposhnikoviae, notopterygium root, angelicae pubescentis radix, radix bupleuri, common hog fennel root, rhizoma chuanxiong, fructus aurantii, poria cocos, platycodonis radix, and licorice root. Instant Claim 2 recites the method according to claim 1 where the NPE is caused by craniocerebral injury or a central nervous system disease. Instant Claim 3 recites the method according to claim 1 where the NPE recited in claim 1 occurs after injury to a central nervous system. Instant Claim 4 recites the method according to claim 1 where the NPE recited in claim 1 is caused by one or more of the following: craniocerebral trauma, a surgery, subarachnoid hemorrhage, cerebral embolism, cerebral hemorrhage, brainstem infarction, an intracranial tumor, acute cerebral edema, epilepsy, and virus infection combined with a central nervous system lesion. Instant Claim 8 recites preparing the composition recited in claim 1 as one or more of the following forms: a tablet, a capsule, a pill, a granule, a mixture, and an oral liquid by adding one or more pharmaceutically acceptable pharmaceutic adjuvants. Instant Claims 10-13 recite combining in specific weight proportions the materials recited in independent claim 1, where claim 10 recites a combination of materials for the method of claim 1, claim 11 recites a combination of materials for the method of claim 2 (dependent on claim 1), claim 12 recites a combination of materials for the method of claim 3 (dependent on claim 1), and claim 13 recites a combination of materials for the method of claim 4 (dependent on claim 1).
Zhang et al. recites a composition (Jingfang) comprising “schizonepeta, divaricate saposhnikovia root, incised notopterygium rhizome, doubleteeth pubescent angelica root, Chinese thorowax root, whiteflower hogfennel root, Szechuan lovage rhizome, bitter orange, Indian buead, platycodon root, liquoric root and the like …” (Zhang et al., Google translation, Background, paragraph 3); where the following are understood by the examiner as terms at least overlapping in scope, if not equivalents: schizonepeta and herba schizonepetae, divaricate saposhnikovia root and radix saposhnikoviae, incised notopterygium rhizome and notopterygium root, doubleteeth pubescent angelica root and angelicae pubescentis radix, Chinese thorowax root and radix bupleuri, whiteflower hogfennel root and common hog fennel root (Peucedanum officinale), Szechuan lovage rhizome and rhizoma chuanxiong, bitter orange and fructus aurantii, Indian buead and poria cocos, platycodon root and platycodonis radix, liquoric root and licorice root (instant claims 1 and 10-13). Therefore, the materials comprising the compositions recited in instant claims 1 and 10-13 would have been obvious to combine to one of ordinary skill in the art before the effective filing date of the instantly claimed invention.
Zhang et al. also describes an experiment in which a model acute respiratory distress syndrome (ARDS) is induced in rats by distributing a liquid into their lungs: “7.5mg/kg LPS (prepared by using sterile physiological saline) is instilled into the trachea of the rats of other groups, then the rats are overturned, the liquid medicine is uniformly distributed in the two lungs of the rats, an ARDS model is constructed, and the same amount of sterile physiological saline is instilled into the trachea of the rats of the normal control group” (Zhang et al., Google translation, Experimental example 4, subheading 2.1). ARDS is broadly understood in the art either as noncardiogenic pulmonary edema or a type of noncardiogenic pulmonary edema (as evidenced by Archer et al., p. 103, left column, second paragraph). The model ARDS was treated using three different dosages of Jingfang granules: 9 g/kg, 4.5 g/kg, and 2.25 g/kg (Zhang et al., Google translation, Experimental example 4, subheading 2.2). The results are recited “Compared with the model control group, the positive control group and the experimental high, medium and low dose groups have obviously reduced TNF-alpha and IL-1 beta levels in the serum of rats, and the difference has statistical significance (P is less than 0.05). The above results suggest that Jingfang granules have a certain inhibitory effect on ARDS inflammatory response” (Zhang et al., Google translation, Experimental example 4, subheading 3). Considering the suggestion that Jingfang granules inhibit the inflammatory response of ARDS, a type of pulmonary edema, it would have at least been obvious to try treating NPE by administering a composition comprising the Jingfang materials recited by Zhang et al. to a subject in need thereof (instant claims 1 and 10-13); this obviousness would be evident to one of skill in the art before the effective filing date of the claimed invention.
Regarding instant claims 2-4; although these claims further specify the NPE of claim 1 by reciting the cause of the NPE, the instant claims do not recite variation in the material characteristics of the NPE. Therefore, the NPE recited in claims 2-4 is understood by the examiner as equivalent to that recited in claim 1, and claims 2-4 are rejected under 35 U.S.C. 103 on the same grounds as claim 1, above.
Zhang et al. recites possible Jingfang preparations as preferably one of: granules, tablets, capsules, and microcapsules (Zhang et al., claim 2). Therefore, it would have been obvious to prepare a composition comprising the Jingfang materials recited by Zhang et al. as a tablet, capsule, or granule (instant claim 8); this obviousness would be evident to one of ordinary skill in the art before the effective filing date of the claimed invention.
Regarding the weight proportions of different materials recited in instant claims 10-13, these were achievable for one of ordinary skill in the art through the use of a scale instrument for measuring weight and through testing compositions comprising different weight proportions of the materials recited in claims 10-13 for their effects on lung index in model NPE cases (instant specification, paragraphs [108] and [183] – [203]). Therefore, the weight proportions recited in claims 10-13 are considered obvious over routine optimization to one of ordinary skill in the art before the effective filing date of the claimed invention.
Zhang et al. and Archer et al. are relied upon for the reasons discussed above. If not expressly taught thereby, based upon the overall beneficial teachings provided by the references with respect to providing the combination of materials as recited in instant claims 1 and 10-13 and the utility of this combination for treating noncardiogenic pulmonary edema, the adjustments of particular conventional working conditions (e.g., the selection from among known components and determining one or more suitable ranges (amounts, proportions, ratios thereof) in which to provide the composition used in a method of treating NPE), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
From the teachings of Zhang et al. and Archer et al., the invention as a whole, drawn to a method of treating NPE as described in Claim 1, would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, and one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Please note, since the Office does not have the facilities for examining and comparing Applicants’ methods with the methods (including compositions thereof) of the prior art, the burden is on applicant to show a novel or unobvious difference between the claimed methods and the methods of the prior art (and compositions thereof). See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980), and “as a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
Conclusion
No claims are allowed.
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/R.F.S./Examiner, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655