DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . Applicant should note that the Examiner assigned to this case has changed.
Pro Se
It appears the inventor(s) filed the current application pro se (i.e., without the benefit of representation by a registered patent practitioner). While inventors named as applicants in a patent application may prosecute the application pro se, lack of familiarity with patent examination practice and procedure may result in missed opportunities in obtaining optimal protection for the invention disclosed. The inventor(s) are strongly encouraged to secure the services of a registered patent practitioner to prosecute the application, because the value of a patent is largely dependent upon skilled preparation and prosecution. The Office cannot aid in selecting a patent practitioner.
A listing of registered patent practitioners is available at https://oedci.uspto.gov/OEDCI/. Applicants may also obtain a list of registered patent practitioners located in their area by writing to Mail Stop OED, Director of the U.S. Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450.
Response to Amendments
Applicant's amendments filed 12/20/2025 to claim 1 have been entered. Claims 1-14 remain pending, and are subject to the election requirement dated 10/16/2025. References not included with this Office action can be found in a prior action.
Election/Restrictions
Applicant’s election of Group I, presently claims 1-13, in the reply filed on 12/20/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim 14 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/20/2025.
Claims 1-13 are under consideration on the merits.
Information Disclosure Statement
No information disclosure statement has been filed in the instant application. Applicant is reminded of the duty to disclose information material to patentability as set forth in 37 C.F.R 1.56 and M.P.E.P. § 609 and 2001-2002.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
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.
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.
Claims 5 and 10 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 5 contains the trademark/trade name “Zindol”. 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 pharmaceutical preparations for the treatment of nausea and vomiting and, accordingly, the identification/description is indefinite. Presuming original support, Applicant might overcome this rejection by replacing Zindol® with the equivalent generic language.
Claim 10 recites “the assay of performed with”, which blurs the metes and bounds of this phrase as the quoted phrase appears to be incomplete and does not set forth which step(s) of claim 1 require bovine turbinate cells. Applicant might overcome this rejection by replacing the claimed phrase with “wherein the assay of step (X) is further performed with” and wherein X denotes the step or steps of claim 1. The examiner’s suggested amendments are not intended to be limiting of claim scope, only exemplary of language that would likely address the indefiniteness rejection above. Correction is required.
Claim 3 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 3 depends from claim 1 and recites plural “collagen matrices”. However, claim 1 is already limited to a singular “collagen-matrix”, and so claim 3 broadens the scope of and fails to further limit the scope of the claim from which it depends. Applicant might overcome this rejection by either amending claim 3 to recite “collagen-matrix” or by amending claim 1 to recite “collagen matrices”.
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 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.
Claims 1, 2, 7, 9, and 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (Korean J. Physiol Pharmacol. (2011), 15, 267-272; Reference U) in view of Graham et al. (Gastroenterology (1987), 92, 400-405; Reference V).
Wang teaches a method or assay for measuring the effectiveness of test compounds for blocking or inhibiting 5-hydroxytryptamine (5-HT) induced contraction of feline intestinal smooth muscle cells (HISMCs), comprising the steps of: (a) providing an in vitro sample of feline smooth muscle cells in a culture media (p268, subheading “Preparation of tissue”), (b) inducing contraction of the feline smooth muscle cells by applying multiple concentrations of 5-hydroxytryptamine (5-HT) (p268, subheading “Experimental Protocol”), (c) providing Ondansetron in a DMSO solvent (p268, subheadings “Drugs and Chemicals”), (d) adding the Ondansetron at different concentrations to the feline smooth muscle cell culture and quantitatively measuring the contractile response of the feline smooth muscle cells (Fig. 5C and p270, left column, paragraph starting “To test whether…”), thus determining the efficacy of Ondansetron on 5-HT-induced contractions in feline smooth muscle cells and thus providing a quantitative screening assay predictive of anti-nausea efficacy and so reading in-part on claims 1, 7, and 9. Wang teaches a control sample wherein the feline smooth muscle cells are only treated with 5-HT (Fig. 5C), reading on claim 2.
Regarding claims 11-13, claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. See M.P.E.P. § 2111.02 and 2111.04. In this case, the wherein clauses of these dependent claims only recite the intended result of the positively-recited steps of claim 1 and so these claims have been fully considered but not afforded any patentable weight.
Regarding claim 1, Wang does not teach human intestinal smooth muscle cells.
Graham teaches methods of obtaining primary human intestinal smooth muscle cells (p400, subheading “Cell Isolation and Culture”), reading on claim 1.
Regarding claim 1, it would have been obvious to a person of ordinary skill in the art before the invention was filed to substitute the feline intestinal smooth muscle cells of Wang with the human intestinal smooth muscle cells of Graham in Wang’s methods. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because both Graham and Wang are directed towards methods of obtaining and culturing intestinal smooth muscle cells. The skilled artisan would have been motivated to do so because although not explicitly stated, the substitution of the human cells would predictably improve the methods of Wang as a more physiologically relevant in vitro model of human intestinal disease(s); see the 1st four paragraphs of M.P.E.P. § 2143.
Regarding claim 1, Wang is silent regarding any collagen matrix. However, Graham teaches that human intestinal smooth muscle cells inherently produce collagen in cell culture in vitro (Abstract and Fig. 1). Therefore, the human intestinal smooth muscle cells of Graham substituted into the methods of Wang would inherently produce collagen and so reads on the generic collagen matrix of claim 1. See M.P.E.P. § 2112.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Wang and Graham as applied to claim 1 above, and further in view of Ford et al. (Life Sciences (2019), 222, 69-77; Reference W).
The teachings of Wang and Graham are relied upon as set forth above.
Regarding claim 3, Wang and Graham do not teach any collagen matrix formulated as a gel.
Ford teaches methods of culturing human intestinal smooth muscle cells (HIMSCs) in collagen gel matrices to measure collagen gel contraction (p70, left column, subheadings 2 2.1), reading on claim 3. Ford teaches that IFN-γ significantly reduces HIMSC contractility in vitro (Abstract), and that the HIMSC-collagen gel system is useful to study GI motility mechanisms and to provide a method for evaluating treatments for inflammatory bowel syndrome (IBD) (Abstract and subheading 5 spanning p75-76), reading on claim 3.
It would have been obvious to a person of ordinary skill in the art before the invention was filed to add the collagen gel matrices of Ford to the methods of Wang in view of Graham. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because Wang, Graham, and Ford are all directed in-part towards culturing intestinal smooth muscle cells in vitro, and because Graham teaches that human intestinal smooth muscle cells inherently produce collagen in cell culture in vitro. The skilled artisan would have been motivated to do so because the addition predictably improve the methods of Wang in view of Graham to study GI motility mechanisms and to provide a method for evaluating treatments for inflammatory bowel syndrome (IBD)
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Claims 4 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Wang and Graham as applied to claim 1 above, and further in view of Dadey et al. (US 2014/0073678; Reference A).
The teachings of Wang and Graham are relied upon as set forth above.
Regarding claim 4, Wang and Graham do not teach gingerol or ginger-based compounds. Regarding claim 4, Wang and Graham do not teach Aprepitant.
Dadey teaches methods of treating subjects for nausea (Abstract). Dadey teaches that ginger-based compounds, 5-HT3 receptor antagonists such as Ondansetron, and NK1 receptor antagonists such as Aprepitant are useful as anti-nausea and/or anti-vomiting medication (¶0028-0029 and ¶0031), reading on claims 4 and 8 respectively.
It would have been obvious to a person of ordinary skill in the art before the invention was filed to substitute the ginger-based compounds or the Aprepitant of Dadey for the Ondansetron in the methods of Wang in view of Graham. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because both Wang and Dadey are in-part directed towards anti-nausea and/or anti-vomiting compositions. The skilled artisan would have been motivated to do so because substitution would be predictably advantageous to further screen the functionally-related anti-nausea compounds of Dadey for their potential impact on intestinal smooth muscle cell contractility in the methods of Wang.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Wang and Graham as applied to claim 1 above, and further in view of Castor (Planta Med (2015), 81, IL46; Reference X).
The teachings of Wang and Graham are relied upon as set forth above.
Regarding claim 5, Wang and Graham do not teach Zindol. Regarding claim 6, Wang and Graham do not teach Z-oil. Claim 6 is read in light of the specification in that the broadest reasonable interpretation of Zindol would also then inherently comprise Z-oil (see the specification at page 11, the paragraph underneath Table 2). Therefore, any teaching in the prior art towards Zindol® will also inherently read on Z-oil. See M.P.E.P. § 2111 for a review of the “broadest reasonable interpretation” standard used during patent examination.
Castor teaches that Zindol is a product obtained from ginger comprises gingerols and shogaols as the bioactive constituents and is a functional anti-nausea medicine and effective as an adjuvant to treat for nausea in cancer patients undergoing chemotherapy (see the Abstract on the first page), reading on claims 5 and 6.
It would have been obvious to a person of ordinary skill in the art before the invention was filed to substitute the Zindol (which inherently comprises Z-oil) of Castor for the Ondansetron in the methods of Wang in view of Graham. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because both Wang and Castor are in-part directed towards anti-nausea and/or anti-vomiting compositions. The skilled artisan would have been motivated to do so because substitution would be predictably advantageous to further screen the functionally-related anti-nausea compounds of Castor for their potential impact on intestinal smooth muscle cell contractility in the methods of Wang.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Wang and Graham as applied to claim 1 above, and further in view of O’Connor et al. (WO 2018/106966; Reference N).
The teachings of Wang and Graham are relied upon as set forth above.
Regarding claim 5, in view of the indefiniteness rejection above and in the interest of compact prosecution, Wang and Graham do not teach a method further comprising bovine turbinate cells.
O’Connor teaches methods and compositions for treating infections cause by Apicomplexa sp. (e.g. apicomplexian) (Abstract). O’Connor teaches either treating or preventing disease symptoms such as nausea and vomiting (¶00077), reading in-part on claim 10. O’Connor teaches screening bovine turbinate cells for the toxicity of test compounds (Example 11), reading in-part on claim 10.
It would have been obvious to a person of ordinary skill in the art before the invention was filed to add the bovine turbinate cells of O’Connor to the methods of Wang in view of Graham. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because both Wang and O’Connor are in-part directed towards anti-nausea and/or anti-vomiting compositions and methods of in vitro cell culture. The skilled artisan would have been motivated to do so because addition would be predictably advantageous to further screen the functionally-related anti-nausea compounds such as the Ondansetron of Wang of Castor for their potential impact on cellular toxicity in addition to the potential impact on intestinal smooth muscle cell contractility in the methods of Wang.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Conclusion
No claims are allowed. No claims are free of the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN C BARRON whose telephone number is (571)270-5111. The examiner can normally be reached 7:30am-3:30pm EDT/EST (M-F).
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/Sean C. Barron/Primary Examiner, Art Unit 1653