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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/18/2026 has been entered.
Response to Amendment
Applicant's amendment and argument filed 03/18/2025, in response to the final rejection, are acknowledged and have been fully considered. Any previous rejection or objection not mentioned herein is withdrawn.
Claims 1-7, 8, 10, 12, 14-18 are pending of which claims 1-7 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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 05/12/2025.
Claims 8, 10, 12, 14-18 are being examined on the merits.
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.
Claim 16 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.
Claim 16 contains the trademark/trade names FlavourzymeTM and ProtamexTM. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe enzymes and, accordingly, the identification/description is indefinite.
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 8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Yun Eun Young et. al. (KR101424125B1).
Young describes a composition for treating an inflammatory bowel disease comprising a larva of Tenebrio molitor (see abstract and claim 1). Young also describes wherein the solvent used to extract the larva is ethanol and sterilized water (see page 9, example 1).
Young discloses “preferably, the preferred total dose of the brown duck larvae of the invention or a pharmaceutically acceptable salt thereof may be about 0.01 to 1,000 mg, most preferably 0.1 to 100 mg per patient body weight per day” (see last para. page 7) and this would be the same effective dose as described by the applicant as can be appreciated from the applicant’s specifications at instant para. 49. The applicant recites “the effective dose is generally 0.01 mg to 5000 mg per day per 1 kg of the body weight of an administered subject”. Thus, the effect of improving a bowel movement in a subject would have been inherent even if not recognized at the time. In the broadest reasonable interpretation, treating and preventing inflammation pertaining to Inflammatory Bowel Disease would improve a bowel movement as instantly claimed because it is a well-known symptom of the disease, especially since the effective ranges are the same.
Young does not specifically teach that the method would improve a bowel movement function as claimed, however Young teaches administering the Tenebrionidae larvae extract to patients suffering from IBS. IBS sufferer’s have inconsistent bowel movements and thus treating this disease would be expected to improve a bowel movement function. Additionally, Young teaches administering the same extract of the same larva and within the same effective range as taught by the applicant, therefore the same effect of improving a bowel movement function would have been inherent to the prior art’s teaching.
Therefore it would have been obvious to persons having ordinary skill in the art before the effective filing date to administer the composition taught by Young for treating a bowel movement function and with a reasonable expectation of success.
Claims 12 is rejected under 35 U.S.C. 103 as being unpatentable over Yun Eun Young et. al. (KR101424125B1) and further in view of Sarah Ballou et. al. (Effects of Irritable Bowel Syndrome on Daily Activities Vary Among Subtypes Based on Results from the IBS in America Survey, Clinical Gastroenterology and Hepatology, 2019; Vol. 17, No. 12: 2471-2478).
Regarding claim 12, Young describes a Tenebrio molitor extract however is silent on using the extract for improving constipation.
Young describes a composition for treating an inflammatory bowel disease comprising a larva of Tenebrio molitor (see abstract and claim 1). Young also describes wherein the solvent used to extract the larva is ethanol and sterilized water (see page 9, example 1).
Young discloses “preferably, the preferred total dose of the brown duck larvae of the invention or a pharmaceutically acceptable salt thereof may be about 0.01 to 1,000 mg, most preferably 0.1 to 100 mg per patient body weight per day” (see last para. page 7) and this would be the same effective dose as described by the applicant as can be appreciated from the applicant’s specifications at instant para. 49. The applicant recites “the effective dose is generally 0.01 mg to 5000 mg per day per 1 kg of the body weight of an administered subject”. Thus, the effect of improving a bowel movement in a subject would have been inherent even if not recognized at the time. In the broadest reasonable interpretation, treating and preventing inflammation pertaining to Inflammatory Bowel Disease would improve a bowel movement as instantly claimed because it is a well-known symptom of the disease, especially since the effective ranges are the same.
Ballou teaches that in a survey conducted in America on IBS symptoms that 73% of person reported infrequent stools and 72% reported hard or lump stools and 75% reported straining, with 83% reporting abdominal pain (see Table 3, page 2474). Ballou also teaches wherein 53% of IBS patients reported they were extremely bothered by their symptoms from Inflammatory bowel disease with constipation (IBS-C) and 36% were somewhat bothered by their symptoms (see Figure 1, page 2475).
Ballou teaches “IBS-C was associated with more interpersonal impairment (eg, feeling self-conscious, avoiding sex, difficulty concentrating), which also remained significant when control ling for the above-mentioned factors” (see discussion, page 2475).
Ballou teaches “responses to a hypothetical question asking what respondents would be willing to give up in exchange for 1 month of symptom relief provide insight into the distress caused by IBS symptoms. For example, 25% of the sample reported willingness to give up their cell phone for 1 month, and 22% reported willingness to give up the Internet. Forty percent reported willingness to give up sex for 1 month (although this may be inflated by those who are already avoiding sex because of symptoms), and more than half of the sample reported that they would give up alcohol or caffeine for 1 month in exchange for symptom relief” (see 1st para. of page 2477).
Therefore it would have been obvious to persons having ordinary skill in the art before the effective filing date to administer the composition taught by Young for treating IBS to patients suffering from constipation because as Ballou teaches IBS is often accompanied by constipation and IBS patients suffering from constipation often feel bothered from their symptoms and would be willing to give up internet, sex, their cell phones or alcohol for symptom relief (see Figure 3, page 2477), so why would they not try a treatment which is known to treat IBS for symptom relief if they are indeed suffering?
Furthermore, administering the composition to patients affected from different types of constipation would have been obvious to those skilled in the art because constipation is a known symptom of inflammatory bowel disease and can be due to inflammation and narrowing of the intestine caused by IBD. It would have been obvious to use the Tenebrio molitor extract for treating inflammation from IBD and for those who are suffering from constipation.
Claims 14-15 and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Yun Eun Young et. al. (KR101424125B1) and Jeong Myeong Soo et. al. (KR101852840B1).
Young describes a composition for treating an inflammatory disease comprising a larva of Tenebrio molitor (see abstract and claim 1). Young also describes wherein the solvent used to extract the larva is ethanol and sterilized water (see page 9, example 1).
Young discloses “preferably, the preferred total dose of the brown duck larvae of the invention or a pharmaceutically acceptable salt thereof may be about 0.01 to 1,000 mg, most preferably 0.1 to 100 mg per patient body weight per day” (see last para. page 7) and this would be the same effective dose as described by the applicant as can be appreciated from the applicant’s specifications at instant para. 49. The applicant recites “the effective dose is generally 0.01 mg to 5000 mg per day per 1 kg of the body weight of an administered subject”. Thus, the effect of improving a bowel movement in a subject would have been inherent even if not recognized at the time. In the broadest reasonable interpretation, treating and preventing inflammation pertaining to Inflammatory Bowel Disease would improve a bowel movement as instantly claimed because it is a well-known symptom of the disease, especially since the effective ranges are the same.
Young teaches “the composition for feed according to the present invention can be produced in the form of a fermented feed, a compounded feed, a pellet form, a silage or the like. The fermented feed can be prepared by adding various fermenting microorganisms or enzymes, and the compounded feed can be prepared for prevention and improvement of inflammatory diseases by mixing various kinds of general feeds and the brown larvae of the present invention” (see para. 7 page 3).
Young does not specifically teach the extract is an enzyme-treated product.
Soo’s general disclosure is to compositions of enzyme treated larva for having hepatoprotective effects (see abstract).
Soo teaches “Brown duck (Tenebrio molitor) is a species of beetle neck and insect. The brown goose is distributed all over the world including Korea. The larvae of brown goat larvae contain 45 ~ 57% of protein, 25 ~ 34% of fat, and 8 ~ 11% of carbohydrate on the basis of dry weight. Although the pharmacological efficacy of brown goat larvae has not been documented in the memorandum, research into brown goat dogs has been actively conducted recently” (see 2nd to last para. on page 5).
“The enzyme-treated product of the slug enzyme-treated product or the brown goat larva may be an enzyme selected from Flavozyme, Alcalase, or Protease in a slug or a brown duck larva as a raw material sample have” (see page 6, para. 10) and teaches where it is preferable to use protease N as the protease (see 3rd para. of page 7).
Regarding claims 17-18, Soo teaches fasting the larva (see para. 10 page 7) and teaches sterilizing: “if the heating temperature is less than 100 ° C, the sterilizing action may not be performed well. If the heating temperature exceeds 150 ° C, the change in the property of the protein may occur and the quality of the proteolytic composition may deteriorate. Likewise, sterilization may be difficult even if the heating condition is less than 0.5 hour, and if the heating time exceeds 2 hours, the property of the protein may be changed” (see para. 7 of page 7), and Soo teaches crushing the larva (see para. 8, page 7) and treating with a protease (see 3rd para. of page 7).
Therefore it would have been obvious before the effective filing date to persons having skill in the art to use the method of enzyme treating the brown duck (Tenebrio molitor ) as discussed by Soo, for the invention taught by Young, because Young teaches that that the brown duck (Tenebrio molitor ) larva can be enzyme treated and thus one can look to Soo’s invention for the process which is also the same as instantly claimed.
There would have been a reasonable expectation of success in arriving at the instant invention given the relied upon art.
Claim 16 are rejected under 35 U.S.C. 103 as being unpatentable over Young et. al. (KR101424125B1) and Jeong Myeong Soo et. al. (KR101852840B1) as applied to claims 14-15 and 17-18 above, and further in view of DrugBank (https://go.drugbank.com/drugs/DB13198).
Young describes a composition for treating improving a bowel movement comprising a larva of Tenebrio molitor extract and enzyme-treated product, however is silent on using the enzymes described in the instant claim.
DrugBank teaches that pepsin “Pepsin is a potent enzyme in gastric juice that digests proteins such as those in meat, eggs, seeds, and dairy products 12.
Studies on gastric digestion from 1820-1840 led to the discovery of pepsin as the substance which, in the presence of stomach acid, causes nutrients including meat or coagulated egg whites to dissolve. Soon afterward, it was shown that these protein nutrients were cleaved by pepsin to products called peptones 2. Pepsin is often used as a replacement enzyme for those with pancreatic insufficiency 11. Stimulation of the pancreas and therefore enzymatic digestion of food is a tightly controlled and is a hormonally mediated process. Any changes or conditions affecting metabolic steps for successful digestion and absorption negatively affect pancreatic enzymatic secretion, entry into the intestine, functionality once inside the intestine, and appropriate mixing with foods/nutrients. Many causes of pancreatic insufficiency require that enzyme replacement therapy is started, including cystic fibrosis, pancreatic cancer, acute and chronic pancreatitis, as well as pancreatic surgery 11.
Pepsin is approved by the FDA and is used in food at levels not to exceed current good manufacturing practice 17.
Interestingly, recent research has suggested that pepsin participates in the digestion of nucleic acids 22.” (see article).
Therefore it would have been obvious before the effective filing date to persons having skill in the art to use pepsin as an enzyme because it is FDA approved and well tolerated for digesting proteins into nucleic acids or peptides especially since it is found naturally derived from humans and other animals.
Response to Arguments
Applicant's arguments filed 03/18/2026 have been fully considered but they are not persuasive. The applicant argues that Young fails to teach or suggest “a method of improving a bowel movement function in a subject in need thereof” as required by the instant set of claims. Young teaches administering the same extract of Tenebrionidae larva to treat IBS. This is expected to improve a bowel movement as it is treating a disease known for disruptive bowel movements. Also it is within the same effective range as taught by the applicant and so it would inherently do so.
The applicant argues that in order to establish a prima facie case of obviousness there must be a reasonable expectation of success in combining the references. The reasonable expectation of success is the effective range taught in the prior art is the same as disclosed by the applicant. The effect therefore would be the same and there would be more than a reasonable expectation of success. The claims stand rejected.
The applicant has supplied non-patent literature for consideration. The applicant must include an IDS form with the literature reference documented to be considered.
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 BOECKELMAN Examiner, Art Unit 1655
/ANAND U DESAI/ Supervisory Patent Examiner, Art Unit 1655
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