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 .
Election/Restrictions
Applicant’s election without traverse of polysaccharides and 5 specific agents include fucoidan, Chaga, Devil’s claw, Chondroitin sulfate and glucosamine sulfate in the reply filed on 2/24/25 was previously acknowledged.
In the reply filed 9/22/25, Applicants amended claims 1-4 and 10.
Claim 7 is rejoined because prior art was found that encompasses the limitations of claim 7.
Claims 6 and 8-9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim.
Claims 1-4 and 6-10 are pending.
Claims 1-4, 7 and 10 read on the elected species and are under consideration.
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 16/787,460, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The prior filed application does not provide support for a phytochemical complex comprising boswellic acid. The prior filled application does not have one recitation of boswellic acid or phytochemical complex. According claims 1-10 are not entitled to the benefit of the prior application.
Claim Objections-Withdrawn
The objections to claim 4 and 10 are withdrawn due to amendment of the claims.
Claim Rejections-Withdrawn
The rejection of claims 3, 5 and 10 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn due to amendment of the claims.
The rejection of claims 1-3 and 5 under 35 U.S.C. 103 as being unpatentable over Li et al. (Journal of Experimental & Clinical cancer research (2018) 37:132) and Hwang et al. (Biochemical and biophysical research communications (2010) 111-116) in view of Pawar et al. (International Journal of Pharmaceutics 436 (2012) 183-193) is withdrawn due to Applicants arguments.
The rejection of claims 1-5 under 35 U.S.C. 103 as being unpatentable over Li et al. (Journal of Experimental & Clinical cancer research (2018) 37:132), Hwang et al. (Biochemical and biophysical research communications (2010) 111-116) and Pawar et al. (International Journal of Pharmaceutics 436 (2012) 183-193) in view of Baldwin et al. (Biopolymers, 2010;94:128-140) is withdrawn due to Applicants arguments.
NEW Rejections
Claim Rejections - 35 USC § 112
Claim 3 is 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 osteoarthritis with HA-boswellic acid conjugate, does not reasonably provide enablement for treatment of any disorder. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
As stated in MPEP 2164.01(a), “there are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue.”
The factors to be considered when determining whether a disclosure meets the enablement requirement of 35 USC 112, first paragraph, were described in In re Wands, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988) as:
1. the nature of the invention;
2. the breadth of the claims;
3. the state of the prior art;
4. the relative skill of those in the art;
5. the predictability or unpredictability of the art;
6. the amount of direction or guidance presented [by the inventor];
7. the presence or absence of working examples; and
8. the quantity of experimentation necessary [to make and/or use the invention.
(1) The Nature of the Invention and (2) The Breadth of the claims
Claim 3 claims a medicament for treating a disorder comprising a therapeutically effective amount of boswellic acid and one or more polysaccharides.
The claims will be given its broadest reasonable interpretation. The applicable rule for interpreting the claims is that “each claim must be separately analyzed and given its broadest reasonable interpretation in light of and consistent with the written description.” See MPEP 2163(II)(1), citing In re Morris, 127 F.3d 1048, 1053-1054; 44 USPQ2d 1023, 1027 (Fed. Cir. 1997). In view of this rule, Claim 3 is drawn to treatment of any disorder.
(3) The state of the prior art and (5) The predictability or unpredictability of the art
The instant application is enabling for treatment of osteoarthritis because the prior art is enabled for treatment of osteoarthritis. Husch et al. (presented below in detail) discloses that boswellic acid is a potential treatment for osteoarthritis (Introduction). However, the specification and prior art is not enabled for boswellic acid-polysaccharide conjugates for treatment of every disorder.
For example, the Merck Manual (https://www.merckmanuals.com/home/brain-spinal-cord-and-nerve-disorders/tumors-of-the-nervous-system/overview-of-brain-tumors?gclsrc=aw.ds&&network=x&matchtype=&keyword=&creative=&device=c&devicemodel=&placement=&position=&campaignid=18703109500&adgroupid=&loc_physical_ms=9008150&loc_interest_ms=&gad_source=1&gad_campaignid=18703173298&gbraid=0AAAAADiUobndF82tlhHRF2ILtOvGjtExH&gclid=Cj0KCQiA1JLLBhCDARIsAAVfy7jkC-VjvCYI4LQeEAxSTtlQNdoQSKHQNH3LyD-Mgl7Fx8RzRORtdB4aAkarEALw_wcB#Diagnosis_v740648 accessed 1/12/26) discloses the treatment of brain tumors with surgery, radiation and medications such as chemotherapy and immunotherapy. There was no art found that suggests boswellic acid would be able to treat brain tumors. It would be highly unlikely and require to undue experimentation to determine if boswellic acid conjugates would have the ability to treat all disorders, including cancers.
It is noted that pharmaceutical and biological art is generally unpredictable, requiring each embodiment to be individually assessed for physiological activity. Furthermore, the claimed disorders are not limited to any specific disease or disorder. Given this fact, historically the development of new drugs has been difficult and time-consuming.
Adding to the unpredictability is that many treatment options may show promise in animal models, but may fail to show therapeutic improvement in clinical trials. There is no absolute predictability, even in view of the high level of skill in the art.
Thus, for treatment of any disorder, it would be highly unlikely and require undue experimentation to determine if a single agent would be able to treat all disorders.
(4) The relative skill of those in the art
MPEP 2141.03 states (in part)” A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton.” KSR International Co. v. Teleflex Inc., 127 S.Ct. 1727, 167 LEd2d 705, 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. At 1396, 82 USPQ2d at 1396. The “hypothetical person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988) (disagreeing with the examiner’s definition of one of ordinary skill in the art (i.e. a doctorate level engineer or scientist working at least 40 hours per week in semiconductor research or development), and finding that the hypothetical person is not definable by way of credentials, and that the evidence in the application did not support the conclusion that such a person would require a doctorate or equivalent knowledge in science or engineering). In the instant case, the skill in the art high with respect to physicians and scientists. The level of skill in the art (physicians and scientists) would be high.
(6) The amount of direction or guidance presented (by the inventor) and (7) The presence or absence of working examples
The instant specification lacks working examples, experimental data of sufficient guidance demonstrating that the claimed complex is effective for treating disorders beyond osteoarthritis (known in the art).
(8) The quantity of experimentation necessary (to make and/or use the invention)
Owing to the factors listed above, especially in points 6 and 7, the amount of experimentation needed will be extensive in view of the lack of guidance by the inventor.
MPEP 2164.01(a) states, “A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, 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. In re Wright, 999 F.2d 1557,1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).” That conclusion is clearly justified here.
The instant breadth of the claim is broader than the disclosure, specifically, the instant claims are directed to the treatment of a disorder, but the specification, prior art or instant disclosure does not provide support for this.
In conclusion, the instant application is enabled for the treatment of osteoarthritis with boswellic acid-HA complex, but is not enabled for the treatment of any disorder.
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 4 and 7 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.
Claim 4 is unclear because the claim is identified as both “Currently amended” and “Cancelled”. It is unclear if claim 4 was meant to be amended or cancelled. For purposes of examination, claim 4 is interpreted as “currently amended”.
Claims 4 and 7 recite the limitation "the one or more complexing agent". There is insufficient antecedent basis for this limitation in the claim. Claim 1 recites one or more polysaccharides.
Claim 4 is also indefinite because it is unclear whether the polysaccharides are the complexing agents, the complexing agents are something different or if claim 4 is introducing a new element. The metes and bounds of claim 4 are unclear.
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.
Claim 1-3 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Husch et al. (“Fitoterapia Vol. 84, January 2013, pp 89-98) in view of Zhang et al. (European journal of medicinal chemistry; Vol. 86, Oct 201, pp 310-317).
Husch et al. teach the anti-inflammatory potential of Boswellia serrata gum resin extracts have been demonstrated, but the pharmacokinetic studies has shown low systemic absorption of boswellic acid in rodents and humans (Abstract). Husch et al. teach the potential of boswellic acid for treatment of osteoarthritis (2nd para of Introduction). Husch et al. teach bioavailability is a major hurdle in the translation of the preclinical potential of many botanical extracts into therapeutic effects, especially for those whose active ingredients show poor water solubility and strong tendency to self-aggregate. This is the case for many polyphenolics and triterpenoid acids (First para of Introduction). Husch et al. teach lecithin formulations improves absorption and tissue penetration of boswellic acid (Conclusion).
Husch et al. does not teach boswellic acid conjugated to a polysaccharide, however the teachings of Zhang et al. cure this deficiency.
Zhang et al. teach Hyaluronic acid (HA) is a mucopolysaccharide acid composed of repeating disaccharide units of D-glucuronic acid and N-acetyl-D-glucosamine. Based on numerous characteristics such as viscoelastic properties, water-binding ability, biocompatibility and non-immunogenicity, HA has been approved by FDA for biological and medical applications (Abstract). Zhang et al. teach bioconjugates linking drugs to HA could improve solubility, prolong half-life, provide active targeting capability and then increase the bioavailability of these coupled drugs by pro-drug strategy (Abstract). Zhang et al. teach through numerous trials and attempts, many HA-drug bioconjugates have been studied and developed and the conjugates showed superior characteristics including improved solubility and permeability, strong stabilization, controlled release profiles, enhanced therapeutic effect, less side effects and targeting ability. Zhang et al. teach these results illustrate that HA-drug bioconjugates were potential in delivering drug as reference for further research and development (Conclusion).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to conjugate boswellic acid to the polysaccharide HA to improve delivery properties. A person or ordinary skill in the art would have a clear motivation to address the known bioavailability and solubility limitations identified in Husch. There is a reasonable expectation of success given that HA-drug conjugates are well known in the art and exemplified in Zhang et al.
Furthermore, MPEP 2143 states: Exemplary rationales that may support a conclusion of obviousness include the rationale that simple substitution of one known element for another to obtain predictable results. To reject a claim based on this rationale, Office personnel must resolve the Graham factual inquiries. Then, Office personnel must articulate the following:
(1) a finding that the prior art contained a device (method, product, etc.) which differed from the claimed device by the substitution of some components (step, element, etc.) with other components;
(2) a finding that the substituted components and their functions were known in the art;
(3) a finding that one of ordinary skill in the art could have substituted one known element for another, and the results of the substitution would have been predictable; and
(4) whatever additional findings based on the Graham factual inquiries may be necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness.
In the instant case, Husch acknowledges boswellic acid has low bioavailability and poor water solubility. Husch addresses these deficiencies by creating a formulation of boswellic acid lecithin that improves absorption and tissue penetration of boswellic acid. Zhang et al. teaches that low bioavailability and poor water solubility can be addressed by conjugation to HA. The substituted components are well known in the art and exemplified in Zhang et al. and Husch et al. One of ordinary skill in the art could have substituted conjugation of HA to boswellic acid for lecithin/boswellic acid formulation and the results would have been predictable because HA conjugation has demonstrated improved bioavailability and water solubility.
With respect to the limitation “in a pharmaceutically acceptable excipient, diluent of carrier”, Husch et al. teach the formulations with microcrystalline cellulose (para. 2.1 Materials and Methods) and Zhang et al. teach conjugates were mixed with DMSO (para. 2.1.1). Furthermore, it is obvious to include a carrier, excipient or diluent in a pharmaceutical formulation for stability, and administration. There is a reasonable expectation of success given that it is routine formulation practice to include a carrier, excipient and/or diluent in pharmaceuticals.
With respect to the limitation “a phytochemical complex” (claim 1) and “a nutraceutical composition” (claim 2) and “a medicament” (claim 3), please note that MPEP 2111.02 II states "a preamble generally is not limiting when the claim body describes a structurally complete invention such that deletion of the preamble phrase does not affect the structure or steps of the claimed invention." In the instant case, the body of the claim recites a structurally complete invention, boswellic acid and one or more polysaccharides.
With respect to the limitation “a therapeutically effective amount of boswellic acid”, the instant specification defines “therapeutically effective amount” as an amount that elicits the biological or medicinal response (PGPUB 0026]). In the instant case. Husch et al. teach high tissue and brain levels of boswellic acid.
With respect to claim 3, and the limitation “for treating a disorder", please note that it is regarded that "intended use" of a composition or product will not further limit claims drawn to a composition or product. See, e.g., Ex parte Masham, 2 USPQ2d 1647 (1987) and In Re Hack 114, USPQ 161. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim limitation. In the instant case Husch et al. and Zhang et al. make obvious the claimed composition. Therefore, the same composition would be capable of the same use.
With respect to claim 7, hyaluronic acid (HA) is a polysaccharide made of repeating disaccharide units, and one of those units is N-acetylglucosamine (NAG), alternating with glucuronic acid. Therefore, the polysaccharide comprises NAG.
Claim 1-4 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Husch et al. (“Fitoterapia Vol. 84, January 2013, pp 89-98) and Zhang et al. (European journal of medicinal chemistry; Vol. 86, Oct 201, pp 310-317) in view of Baldwin et al. (Biopolymers, 2010;94:128-140, previously cited).
The teachings of Husch et al. and Zhang et al. do not teach non-covalent conjugation of HA and boswellic acid. However, the teachings of Baldwin et al. cure this deficiency.
Baldwin et al. teach polysaccharide conjugates (Abstract). Baldwin et al. teach some of the most facile methods of imparting biological activity to materials involve the use of polysaccharides derived from non-mammalian or mammalian sources. Baldwin et al. teach that their low cost and their chemical functionality provides ionic charge, which can be employed for noncovalent crosslinking, yields routes for degradation is useful for modification such as crosslinking or grafting (p. 3, 1st para.).
It would have been obvious to a person of ordinary skill in the art to noncovalently conjugate the polysaccharide, HA to the boswellic acid because Baldwin et al. teach noncovalent crosslinking of polysaccharides. A person of ordinary skill in the art would have a motivation for noncovalent crosslinking because Baldwin et al. teach their chemical functionality provides ionic charge, which can be employed for noncovalent crosslinking, yields routes for degradation and is useful for modification. There is a reasonable expectation of success given that method of conjugation including covalent and noncovalent conjugation are well known in the art and provide predictable results.
Claim 1-3, 7 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Husch et al. (“Fitoterapia Vol. 84, January 2013, pp 89-98) and Zhang et al. (European journal of medicinal chemistry; Vol. 86, Oct 201, pp 310-317) in view of McAlindon et al. (JAMA. 2000 Mar 15;283(11):1469-75), Brien et al. (J. Altern complement Med. 2006 Dec;12(10):981-93), Shashkina et al. (Pharmaceutical Chemistry Journal Vol. 40 (10)2006) and Lee et al. (Journal of Medicinal Food Vol 18m no. 9, 2015).
The teachings of Husch et al. and Zhang et al. are presented above in detail.
The references do not teach the complex comprises fucoidan, Chaga, devil’s claw, chondroitin sulfate and glucosamine sulfate. However, the teachings of McAlindon et al., Brien et al., Shashkina et al. and Lee et al. cure this deficiency.
McAlindon et al. teach glucosamine and chondroitin for treatment of osteoarthritis (Abstract).
Brien et al. et al. teach Devil’s claw for osteoarthritis (Abstract).
Shashkina et al. teach Chaga is anti-inflammatory and produces pain relieving action (p. 566, top of 2nd col.).
Lee et al. teach fucoidan prevents progression of osteoarthritis (Abstract).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to include glucosamine sulfate, chondroitin sulfate, devil’s claw, chaga and fucoidan in the boswellic acid-HA conjugate in order to address joint inflammation and pain in osteoarthritis. There is a reasonable expectation of success given each component is known in the art for treatment of osteoarthritis or inflammation.
Conclusion
No claims are allowed.
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/TARA L MARTINEZ/Examiner, Art Unit 1654