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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/18/2025 has been entered.
Response to Amendment
Applicant's amendment and argument filed 11/18/2025 in response to the final rejection, are acknowledged and have been fully considered. Any previous rejection or objection not mentioned herein is withdrawn.
Claims 1-6, 8, 11-29 are pending of which claims 5 and 17-24 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/08/2024.
Claims 1-4, 6, 8, 11-16 and 25-29 are being examined on the merits.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 23 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
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 Applicant's attention is drawn to In re Wands, 8 USPQ2d 1400 (CAFC1988) at 1404 where the court set forth eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors:
(1) The nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
Nature of the invention: Claim 23 recites a composition in the form of a thermoformed extrudate according to claim 1 for use in the preventive and/or curative treatment, in human and/or in animal, of pathologies related to inflammations, pathologies related to the premature aging of cells, pathologies related to the cardiovascular system, pathologies related to the blood system, pathologies related to the gastrointestinal system, pathologies related to the endocrine system, pathologies related to the immune system, pathologies related to the central nervous system, skin diseases, diseases due to the presence of microorganisms and cancers and in the preventive and/or curative treatment of diabetes. The claims are directed to a composition with varying components and none of which are claimed in any “effective” amounts or ranges for curing and/or preventing any particular disease. Preventing and curing a disease would not be expected from any of the combinations of claimed components as they appear to be directed to mere formulation types and not to cures for diseases.
The state of the prior art: The prevention and curing of pathologies related to inflammation, premature aging of cells, cardiovascular, GI, endocrine, central nervous system, skin diseases and infections and cancers, generally speaking require very specific amounts of effective drugs, chemical compounds, herbal compositions combined in synergistic ratios, etc. The current claims are directed to no such components. The only components which can be considered as an active ingredient are the broad group of triterpene and/or at least one triterpenoid. Although triterpenes and triterpenoids may have previously been mentioned in literature as having benefits to humans for treating diseases in some form they are generally not known to cure and prevent the list of diseases claimed.
The relative skill of those in the art: The relative skill of those in the art is high.
The predictability or unpredictability of the art: The art, even if predictable about certain triterpene/triterpenoids being used as treatments against particular diseases would be unpredictable in regards to any triterpene/triterpenoids being used as a curative/preventative agent for the list of diseases claimed. Many triterpene/triterpenoids may be poorly bioavailable and although they are known to have exert certain effects on specific cells, they may never actually reach the target in amounts that would correlate to in vitro success.
“Many various factors have an influence on the bioavailability of polyphenols, including the properties and sizes of the molecules, their chemical states, interactions with other substances, and the food matrix during the digestion process taking place at variable pH conditions depending on its stage. During stomach digestion (low pH), flavonoid oligomers are decomposed into smaller units to undergo reactions in the small intestine (higher pH), including, among others, methylation, deglycosylation, hydroxylation, and sulfonation of flavonoids”
“It has been shown that the digestion process itself reduces the amount of ingested active compounds that can potentially be absorbed in the small intestine, which may be caused by binding reactions between phenolics and mixtures of pancreatin/bile salt and can be related to the above-mentioned factors affecting this process”, as discussed by Zagorska et. al. in their paper “Influence of Diet on the Bioavailabity of Active Components from Zingiber officinale Using an In Vitro Digestion Model” (see 4. Discussion).
The breadth of the claims. The scope of the claim is broad in the sense that there are no administration routes and effective dosage amounts that tie the composition to the activity of curing and preventing. It is also noted that there is no specific definition of the term “preventing” in the specifications, so it is given its broadest reasonable interpretation of stopping something from happening or arising (see Oxford dictionary, https://www.oed.com/dictionary/prevent_v?tab=meaning_and_use#28270689). Curing any one of these diseases would be a remarkable feat of its own accord however not claiming any particular triterpene/triterpenoid and laying claim to a prevention and/or cure for so many wildly different diseases is clearly not enabled.
The amount of direction or guidance presented: Persons having ordinary skill in the art would need considerable guidance in determining which particular triterpene/triterpenoid is beneficial for which particular disease. The determining what amounts and what administration routes are effective. As previously discussed, there would need to be additional guidance on determining how the active components interact with other proteins, lipids and carbohydrates during digestion and made available to the consumer. Basic diets may hinder benefits of the active components. Exercise and lifestyles too may increase/decrease metabolism and absorption.
The presence or absence of working examples: The specification provides no working examples of any treatments stemming from the compositions which they claim and so it is impossible to say if indeed any composition would have a preventative or curative effect.
The quantity of experimentation necessary: There would not necessarily need undue experimentation done in the case of figuring out which active components may potentially help prevent which disease however there would need to be considerable experimentation done in determining amounts that exert preventative effects and for determining absorption, distribution, metabolism, and excretion rates. Determining administration routes and if the active components may be taken alone or with a meal, how frequently it needs to be taken and in what amounts and at what duration.
Therefore, in view of the Wands factors, as discussed above, Applicants fail to provide information sufficient to practice the claimed invention for preventing and curing any of the claimed diseases.
Claims 25 and 29 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 25 recites “non-hydrolyzed collagens” and there appears to be no support in the specifications or in the application for this broad limitation at the time of filing, therefore making it new subject matter.
Claim 29 recites the limitation “acid-hydrolyzed amylopectin” and this limitation is not supported by the originally filed application. Although amylopectin is noted in the specifications being recited once on page 19, the specifications or the application does not have support for “acid-hydrolyzed amylopectin” and therefore this limitation is new subject matter.
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 3 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “predominantly” in claim 3 is a relative term which renders the claim indefinite. The term “predominantly” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The metes and bounds cannot be determined with the use of this limitation and thus is indefinite.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 2 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 1 already requires the same components thermoformed extruded together and these components are expected to be in a “mixture” as they are being claimed together in a form which is extruded. Claim 2 therefore does not further limit claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-4, 6, 11-14, 16 and 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Brough et. al. (US20140039031A1). These rejections are maintained with slight modifications to take into the amendments filed on 11/18/2025.
Regarding claims 1-3, 6, 11, 24, Brough discloses a pharmaceutical composition comprising an active pharmaceutical ingredient selected from the group consisting of acetyl-11-keto-β-boswellic acid, (instantly claimed triterpenes also known as 3-acetyl-11-keto- β-boswellic acid) diindolylmethane, and curcumin, and one or more pharmaceutically acceptable excipients (see claims 1, 11, 17) and Brough teaches wherein the excipient can be selected from a group of excipients and wherein one selection can be cyclodextrin, which is a known derivative of dextrin (see 065-066). Brough discloses that the composition is created through a hot melt extrusion process (see claim 13). Brough discloses that the active pharmaceutical ingredients (APIs) have an amorphous, crystalline, or intermediate morphology (see 0020, Fig. 7-8) and discloses that the composite made by the thermokinetic compounding (TKC) creates an amorphous composite (see 0019).
Brough discloses wherein the composition can be in a heterogeneous and amorphous (see 0050) and teaches wherein the amorphous is AKBA (Acetyl-11-keto-β-boswellic acid) while dispersing in a polymeric, nonpolymeric or combination excipient carrier (see 0102).
Regarding claims 12, Brough discloses that the TKC may be conducted with a processing agent which can include a plasticizer and a lubricant (see 0019, 0050, 0070, 0109, claim 14).
Regarding claim 13, Brough discloses water, sucrose esters, diethylphthalate as a pharmaceutical excipient agent (see 0065, 0070) which would also act as the instantly claimed plasticizer.
Regarding claim 14, Brough discloses antioxidants in the composition (see curcumin in 0010 and see 0014).
Regarding claim 16, Brough teaches the composition to be in the form of pellets (see 0055), ointments (see 0063), powders (see 0112).
Brough teaches that “it is also understood that acetyl-11-keto-β-boswellic acid (AKBA) possesses potent anti-inflammatory properties by inhibiting 5-lipoxygenase, human leukocyte elastase and the nuclear factor κB pathway, without exerting the adverse effects known for steroids. For example, AKBA has been indicated in the treatment of peritumoral brain edema accompanying brain tumors. AKBA has been found to induce apoptosis in prostate cancer cells, as well as to potently inhibit prostate tumor growth through inhibition of angiogenesis. AKBA has also shown effectiveness against multiple myeloma, colon cancer, prostate cancer, meningioma, ileitis, nociception and atherosclerosis (see 0008).
Regarding claim 23, pertaining to wherein the use of the composition is for preventative or curative treatment to human and/or animals for certain pathologies, this limitation is an intended use of the claimed product and does not structurally or functionally change the composition. 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. In this case, the composition rendered obvious by the prior art would be structurally the same as the claimed composition. Therefore, the composition rendered obvious by the prior art would be capable of performing the claimed intended use if applicant’s invention functions as claimed.
Regarding claim 4, Brough does not specifically teach that triterpenoids to be between 51 and 100% by mass of an amorphous phase and between 0 and 49% by mass of a crystalline phase. It would have also been obvious to persons having ordinary skill in the art to optimize the active components such as the triterpenoids to be between 51 and 100% by mass of an amorphous phase and between 0 and 49% by mass of a crystalline phase, because Brough teaches in certain embodiments the active pharmaceutical ingredients to be as amorphous or as crystalline phases. An amorphous phase so broadly claimed can be granules or powders of heterogenous sizes which are typical in compositions in the art and Brough teaches methods of hot melt extrusion and melt granulation which ultimately implements these active ingredients into amorphous phase. So having 100% of the active ingredients (triterpenes) in an amorphous phase would have been obvious to persons skilled in the art. Additionally, Brough teaches the triterpenes to be in heterogenous and amorphous phase which when considered would be in amounts that differ from each other such as the instantly claimed range, which is prima facie obvious given Brough’s teachings.
It would have also been obvious to select cyclodextrin as the excipient among a list of excipients listed from Brough as this is prima facie obvious to those having ordinary skill in the art.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable Brough et. al. (US20140039031A1) as applied to claims 1-4, 6, 11-14, 16 and 23-24 and further in view of Reinisalo et. al. (Polyphenol Stilbenes: Molecular Mechanisms of Defense against Oxidative Stress Aging-Related Diseases, Oxidative Medicine and Cellular Longevity, Vol 2015, p 1-24).
Brough teaches the instantly claimed composition as discussed above, however is silent on wherein the composition further comprises stilbenes.
Reinisalo teaches “There is convincing data that stilbene compounds, a diverse group of natural defense phenolics, abundant in grapes, berries, and conifer bark waste, may confer a protective effect against aging-related diseases” (see abstract).
Reinisalo teaches “there is emerging in vitro and preclinical data to indicate that stilbene compounds are capable of suppressing oxidative stress, inflammation, and energy expenditure as well as modulating the secretion of neurotropic factors” (see conclusions).
Therefore, it would have been obvious to persons having skill in the art to include stilbenes in the composition taught by Brough because these are a diverse group of phenolics which are known to suppress inflammation, oxidative stress and energy expenditure as discussed by Reinisalo. Brough teaches including components such as AKBA in the composition for having anti-inflammatory properties and so including stilbenes in Brough’s composition and expecting the composition to have enhanced anti-inflammatory properties with the addition of an additional ingredient known for reducing inflammation would have been prima facie obvious.
Claims 8 and 26-28 are rejected under 35 U.S.C. 103 as being unpatentable over Brough et. al. (US20140039031A1) as applied to claims 1-4, 6, 11-14, 16 and 23 above, and further in view of Byung Soo, Chun (WO2015182859A1).
Brough teaches the instant invention however is silent on the proteins being fish collagen as instantly claimed.
Chun teaches “a method for obtaining low molecular weight collagen derived from fish, comprising the step of hydrothermally hydrolyzing a high molecular weight collagen powder extracted from at least one fish processing by-product selected from the group consisting of fish bones, shells and intestines” (see page 4, para. 6) and teaches that it is economically beneficial to use collagens recovered from fish waste (see page 6, para. 7).
Chun teaches “collagen is a biomaterial for tissue regeneration due to its excellent bio-compatibility, bio-degrability and anti-aging properties, and is widely used in industries such as food, cosmetics, biopharmaceuticals, and pharmaceuticals” (see page 6, para. 3).
Chun teaches wherein the molecular weight of the hydrolyzed fish collagen is about 3 kDa (see at least page 6, 2nd para.).
Therefore it would have been obvious to persons having ordinary skill in the art to use fish collagen which is hydrolyzed and not having the ability to gel because as Chun teaches it is economically beneficial to use hydrolyzed fish collagen for its many pharmaceutical and cosmetic effects. It would have also been obvious to optimize the molecular weight of the collagen to be 5000 Da as Chun teaches methods of hydrolyzing the collagen to low molecular weights through the use of high pressure and temperature and for creating collagens that can be absorbed through the skin. This optimization, given the prior art would have been one which any skilled artisan could do without any undue experimentation.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Brough et. al. (US20140039031A1) as applied to claims 1-4, 6, 11-14, 16 and 23 above, and further in view of BlueCross BlueShield (https://www.fepblue.org/news/2019/05/20/13/12/5-health-benefits-of-collagen-supplements).
Brough teaches the instant invention however is silent on the use of non-hydrolyzed collagens.
BlueCross BlueShield’s web article teaches of 5 reasons to use collagen supplements for promoting healthy skin, relieving joint pain, fighting osteoporosis, supporting muscle health and improving heart health (see article).
Therefore it would have been obvious to those having ordinary skill in the art to use non-hydrolyzed collagens because BlueCross BlueShield teaches of the many health benefits which comes from the application of collagens which are not discussed as being hydrolyzed.
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Brough et. al. (US20140039031A1) as applied to claims 1-4, 6, 11-14, 16 and 23 above, and further in view of Gary N. Nickel (US20090317513A1).
Brough teaches the instant invention however is silent on the use of acid-hydrolyzed amylopectin.
Gary teaches of methods for harvesting amylose host material comprising enzymatically treating starch after chemically modifying it (see abstract and claim 18). In this manner the starch is modified to a product that can be dried and then rehydrated to retain its meltable, thermoreversable characteristics (see 0002). Gary teaches wherein “acid hydrolysis is a very crude method of shortening the amylose chains. It is very temperature dependant and somewhat uncontrollable resulting in mixtures of varying chain lengths. Low pH environments also result in the dismantling or removal of the substituent acetyl groups thus removing the amylose stabilizing components. Without a predictable substituent construction the resulting gels will release gust material in a haphazard fashion. The use of a suitable enzyme, when combined with specific temperature thresholds to cleave bonds selectively, preserves these substituents, thereby resulting in a product of much more predictable uniformity and effectiveness. The host molecule can thus be engineered in this fashion to yield a material that can act as a host to hydrophobic materials at a much wider range of temperatures and concentrations and can be dried while retaining its hosting/emulsification capabilities” (see 0088).
Therefore it would have been obvious to persons having ordinary skill in the art before the effective filing date to use acid-hydrolyzed amylopectin along with suitable enzymes and temperature thresholds to selectively cleave bonds which would result in a product with much more predictability and uniformity when creating the product taught by Brough.
Response to Arguments
Applicant's arguments filed 11/18/2025 have been fully considered but they are not persuasive.
The affidavit/declaration under 37 CFR 1.132 filed 11/18/2025 is insufficient to overcome the rejection of claims 1-4, 6, 8, 11-16 based upon the 103 rejections as set forth in the last Office action because: the filing is improper and there is no argument directed to any information in the declaration.
As described in the MPEP 717.0 (c) II, an affidavit is a statement in writing made under oath before a notary public, magistrate, or officer authorized to administer oaths. See 602 et seq. for additional information regarding formal requirements of affidavits. 37 CFR 1.68 permits a declaration to be used instead of an affidavit. The declaration must include an acknowledgment by the declarant that willful false statements and the like are punishable by fine or imprisonment, or both (18 U.S.C. 1001) and may jeopardize the validity of the application or any patent issuing thereon. The declarant must set forth in the body of the declaration that all statements made of the declarant’s own knowledge are true and that all statements made on information and belief are believed to be true.
Exhibits, such as those filed as part of an affidavit or declaration under 37 CFR 1.130, must comply with the requirements of 37 CFR 1.91 to be entered into an application file. Exhibits that do not comply with the requirements of 37 CFR 1.91 will be disposed of or returned to applicant at the discretion of the Office. See also MPEP § 608.03(a).
The declaration is not being considered.
The applicant argues that Brough does not teach the newly amended limitations which try to overcome the art by requiring the hydrolyzed collagens and collagen peptides to not have the ability to gel. The Office no longer relies on these limitations which can be appreciated from the above rejection. The applicant makes arguments to the starch being previously argued as not being the same as the starch being claimed. The Office no longer relies on starch as a component being argued in the invention.
Conclusion
Currently no claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACOB ANDREW BOECKELMAN whose telephone number is (571)272-0043. The examiner can normally be reached Monday-Friday 8am-5pm.
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JACOB A BOECKELMANExaminer, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655