DETAILED ACTION
Applicant’s amendment to the claims in the Response filed on 11/04/2025, adding newly presented limitations, is acknowledged.
The rejection of record under 35 U.S.C. § 101 is withdrawn in view of Applicant’s cancelation of claims 1-9 in the Response filed on 11/04/2025.
The rejections of record under 35 U.S.C. § 102 are withdrawn in view of Applicant’s cancelation of claims 7-10 in the Response filed on 11/04/2025.
The provisional obviousness-type double patenting rejections of record are withdrawn in view of Applicant’s cancelation of claims 1-9 and amendment to the claims in the Response filed on 11/04/2025.
The rejection of record under 35 U.S.C. § 103 is maintained and modified in view of Applicant’s amendment to the claims in the Response filed on 11/04/2025, adding newly presented limitations, as set forth below.
Claim Objections
Claim 15 is objected to because it lacks markings to show all changes. All claims being currently amended must be presented with markings to indicate the changes that have been made relative to the immediate prior version. The changes in any amended claim must be shown by strike-through (for deleted matter) or underlining (for added matter). See MPEP § 714(II)(C). Here, “the protease comprises at least one selected from the group consisting of pepsin, trypsin, FlavourzymeTM, ProtamexTM, papain, alphachymotrypsin, and pancrease” was added to claim 15 without proper underlining to indicate the addition.
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.
Applicant’s amendment to the claims in the Response filed on 11/04/2025, adding newly presented limitations, has necessitated the new ground of rejection set forth below.
Claims 15 and 21 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.
Claims 15 and 21 contains the trademarks 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 trademarks are used to identify/describe proteases and, accordingly, the identification/description is indefinite.
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.
Claims 10 and 12-21 are rejected under 35 U.S.C. 103 as being unpatentable over Young, et al. (KR101533600B1- English Machine translation, hereinafter “Young”) in view of Jin, et al. (WO2019088774- English Machine Translation, hereinafter “Jin”), Deyrup et al. (Biomol. Ther., 29(2):105-126 (2021), hereinafter “Deyrup”) and Jamshed, et al. (“Am. Fam. Physician., 84(3):299-306 (2011), hereinafter “Jamshed”). All references previously made prior art of record.
Young teaches a pharmaceutical composition comprising a 70% ethanol (C2 organic solvent) extract of Allomyrina dichotoma larvae (Claims 1-2).
Jin teaches an Allomyrina dichotoma larval extract prepared by proteolytic treatment using, e.g., pepsin, trypsin, pepsin, trypsin, papain, alpha Chymotrypsin, pancreatase, etc. (See Abstract; Background art; Claims 1-3).
The references do not explicitly teach using the extracts to treat a disorder in bowel movement function and/or constipation. However, Deyrup teaches the important role of beetles in Traditional Chinese medicine (TCM) and Traditional Korean Medicine (TKM), which has been in practice for thousands of years (see Abstract). For example, Deyrup broadly teaches the genus Scarabaeidae (i.e., Allomyrina dichotoma) has many traditional uses in TCM comprising treating constipation, indigestion, nausea, pain, and swelling (see Table 1; pages 114-115, broadly teaching treating a disorder in bowel function (i.e., constipation) comprising an increase in fecal weight and/or water content in feces).
Similarly, Jamshed teaches a finite number of sub-types of constipation (e.g., bowel movement impaired constipation, i.e., outlet constipation).
It would have been prima facie obvious at the time of filing to use the Allomyrina dichotoma beetle larval extract taught by Young and/or Jin to treat a disorder in bowel movement function, including constipation, as taught by Deyrup and Jamshed because the references teach how to use the Allomyrina dichotoma larva extract compositions for improving a bowel movement function and/or improving constipation (e.g., constipation, indigestion, nausea). Moreover, it would have been obvious to a person of ordinary skill in the art that there are a finite number of subtypes of constipation (e.g. bowel movement impaired constipation, i.e., outlet constipation), as evidenced by Jamshed, et al., and that treating constipation would comprise treating one of the subtypes.
A person of ordinary skill would have been motivated to use Allomyrina dichotoma larva extract compositions for treating bowel movement function disorder and/or constipation as claimed because the references broadly teach Allomyrina dichotoma beetle and/or extract thereof in a composition and/or health functional food and where the references teach the expected benefit of using the Allomyrina dichotoma beetle and/or extract compositions.
Young, Jin, Deyrup, and Jamshed are relied upon for the reasons discussed above. If not expressly taught by the references, based upon the overall beneficial teaching provided by these references with respect to the ingredients of the composition(s) and method(s) of making and/or using disclosed therein, including adjustments of particular conventional working conditions (e.g. determining one or more suitable solvents and/or proteases for extraction) is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. In this particular case, there is no evidence that the solvents and/or proteases for extraction and/or the sub-types of constipation produces an unexpected result. Thus, absent some demonstration of unexpected results or criticality from the claimed parameters, this optimization would have been obvious before the effective filing date of Applicant’s claimed invention.
From the teachings of the references, it is apparent one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was filed, as evidenced by the references, especially in the absence of evidence to the contrary.
Accordingly, the claimed invention as a whole was at least prima facie obvious by the references, especially in the absence of sufficient, clear and convincing evidence to the contrary.
Please note, since the Office does not have the facilities for examining and comparing Applicants' composition with the composition of the prior art (including
compositions within the processes thereof), the burden is on applicant to show a novel or
unobvious difference between the claimed product and the product of the prior art. 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).
Response to Arguments
Applicant’s arguments filed 11/04/2025 have been fully considered but they are not persuasive. Applicant’s arguments are discussed to the extent they apply to the current grounds of rejection set forth above.
On page 5 of the Response, Applicant urges that neither Young nor Jin disclose any use of Allomyrina dichotoma larva extract for treating bowel movement disorders or constipation and, therefore, do not render obvious the presently claimed methods. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Here, the claims currently are rejected over Young, Jin, Deyrup, and Jamshed, which, for the reasons discussed above, render the claimed method prima facie obvious.
On page 6 of the Response, Applicant urges that “it is clear from Table 1 that Deyrup refers to the adult beetles of Allomyrina dichotoma and not the Allomyrina dichotoma larva required in the present claims.” To rebut Applicant’s argument, it is noted that Allomyrina dichotoma is in the family Scarabaeidae, and Deyrup explicitly teaches that “[b]eetles in the family Scarabaeidae along with those in the Geotrupidae are used in both the adult and larval form in [Traditional Chinese medicine], but the larval stage is primarily used in [Traditional Korean Medicine] (page 115, Scarabaeidae and Geotrupidae, first column, emphasis added). As such, Deyrup provides a clear teaching, suggestion, and motivation to utilize either adult or larval extracts with larval extracts being preferred in TKM.
On page 6 of the Response, Applicant urges that “Deyrup fails to disclose any extraction method or enzyme treatment of Allomyrina dichotoma larva.” As discussed above, this limitation is taught by the combination of Young, Jin, Deyrup, and Jamshed.
On page 6 of the Response, Applicant urges that “Deyrup provides no experimental evidence of the therapeutic effect of Allomyrina dichotoma larva on constipation.” As discussed above, Deyrup teaches the important role of beetles in Traditional Chinese medicine (TCM) and Traditional Korean Medicine (TKM), which has been in practice for thousands of years, including the treatment of constipation using Allomyrina dichotoma. As such, Deyrup provides a clear teaching, suggestion, and motivation to utilize the larval Allomyrina dichotoma extract taught by Young and/or Jin to treat constipation with a reasonable expectation of success.
Moreover, increased fecal weight and water content, increased digestive tract mobility, and increased length and area of the large intestine mucosa are not active method steps, but, rather, the underlying mechanism of action of practicing the claimed method or the method taught by Young, Jin, Deyrup, and Jamshed. Stated another way, the only active method step of the claimed method is administration of the larval Allomyrina dichotoma extract with, e.g., increased fecal weight and water content inherently resulting from administration.
On page 7 of the Response, Applicant urges that “Jamshed relates to diagnostic methods for chronic constipation in adults, and while it discloses types of constipation Jamshed does not disclose treating bowel movement function disorders or constipation with beetle larvae or their extracts.” As discussed above, this limitation is taught by the combination of Young, Jin, Deyrup, and Jamshed.
Applicant’s remaining arguments concerning the dependent claims were fully considered, but were not found persuasive for the reasons set forth above.
Conclusion
NO CLAIMS ARE ALLOWED
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS J VISONE whose telephone number is (571)270-0684. The examiner can normally be reached Monday-Thursday, 8:30 AM to 6:30 PM.
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/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1672
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