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 .
Claim Status
Claims 1 and 5-16 are pending.
Claims 5-12 are withdrawn.
Claims 1 and 13-16 are under examination.
Withdrawn Objections to Specification
The objection to the specification because it does not conform to sequence rules, requiring the use of “SEQ ID NO:” (37 CFR 1.821-1.825) as set forth in the previous office action is withdrawn in view of Applicant’s amendments.
Withdrawn Claim Objections
The objection to claim 4 due to informalities as set forth in the previous office action is withdrawn in view of the cancellation of this claim.
New Claim Objections
Claims 1 and 14 are objected to because of the following informalities:
Claim 1 recites “erythropoietin-producing hepatocyte receptor B4” in line 4 and claim 1 later recites “EphB4” which appear to be the abbreviation for the previously recited ““erythropoietin-producing hepatocyte receptor B4.” It is recommended to add (EphB4) in line 4 to indicate that it is the abbreviation as “erythropoietin-producing hepatocyte receptor B4 (EphB4).”
Claim 14 recites “a method for preparation a drug” which appears to be missing a preposition between “a” and “drug.” This objection can be overcome by addition a preposition in that location, such as “a method for preparation of a drug.”
Appropriate correction is required.
Duplicate Claim Warning
Claim 1 and claim 14 appear to be substantially duplicate claims because the only difference between the claims is the preamble of “A method for screening and obtaining” (claim 1) versus “A method for preparation” (claim 14). The remainder of the preambles and the bodies of claims 1 and 14 otherwise appear identical. Since the preambles of claims 1 and 14 merely set forth the purpose or intended use of the claimed invention, the claims appear to be substantially duplicates.
Applicant is advised that should claim 1 be found allowable, claim 14 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
New Claim Rejections - 35 USC § 112(a)
Written Description
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.
Claims 1 and 13-16 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.
In the amendment filed on 12th, December, 2025, the claim 1 was amended and new claim 14 was added. Claims 1 and 14 contain limitations that appears to be new matter. By nature of their dependency on claims 1 and 14, claims 13 and 15-16 are also rejected.
A review of the originally filed specification by the Examiner did NOT find any explicit basis for the recited limitations. The disclosure (including the specification, claims and sequence listing) as originally filed, does not contain a specific recitation of the limitation.
The limitations that appear to be new matter and the closest support for this limitation are listed below.
A method for screening and “obtaining” (claim 1)
The closest support for this limitation is the disclosure of screening steps and detecting steps of the method which are not “obtaining” steps. There is no disclosure of “obtaining steps.”
Applicant has not provided the location of support for this amendment. When filing an amendment an applicant should show support in the original disclosure for new or amended claims. See MPEP §§ 714.02 and 2163.06 ("Applicant should ... specifically point out the support for any amendments made to the disclosure.") The claim is a new or amended claim, the support for the limitation is not apparent, and applicant has not pointed out where the limitation is supported (see MPEP 2163 (I).
“test candidate” (claims 1 and 14)
The closest support for this limitation is the disclosure of “a biological agent or a drug” (pg. 1-3). “Test candidate” is broader than biological agents or drugs and includes other embodiments such as but not limited to behavioral therapies like diets and exercise and further includes all possible tests candidates of all possible types that could be used to prevent, alleviate or treat diabetes mellitus. The disclosure of two sub-genera of this broad genus does not provide support for the full breadth of the new claims limitation and accordingly this limitation appears to be new matter.
Applicant has not provided the location of support for this amendment. When filing an amendment an applicant should show support in the original disclosure for new or amended claims. See MPEP §§ 714.02 and 2163.06 ("Applicant should ... specifically point out the support for any amendments made to the disclosure.") The claim is a new or amended claim, the support for the limitation is not apparent, and applicant has not pointed out where the limitation is supported (see MPEP 2163 (I).
As noted by MPEP 608.04(a), new matter includes not only the addition of wholly unsupported subject matter, but may also include adding specific percentages or compounds after a broader original disclosure, or even the omission of a step from a method. In the instant case one skilled in the art would NOT consider the new limitations to be explicitly, implicitly, or inherently supported by Applicant’s disclosure.
Hence, there is insufficient written descriptions support for the instantly claimed limitation of and Applicant has not shown possession of the invention.
Response to Arguments
Applicant’s arguments, filed 12th, December, 2025, have been fully considered but are not found persuasive.
Applicant argues “Support for the amendments can at least be found in original claims, paragraphs at page 1, lines 18-24; page 2, lines 21-22; and page 2, lines 23-25 of the specification, and the original Sequence Listing. No new matter is added.” (pg. 5).
In response, the original claims, paragraphs at page 1, lines 18-24; page 2, lines 21-22; and page 2, lines 23-25 of the specification, and the original Sequence Listing do not provide support for “obtaining” steps.
In response, the original claims disclose only a biological agent or drug which does not provide support for the full breadth of “test candidate” as discussed above. Page 1, lines 18-24; page 2, lines 21-22; and page 2, lines 23-25 also do not recite support for a “test agent.”
The claims are new or amended claims, the support for the limitations is not apparent, and applicant has not pointed out where the limitations are supported and therefore the new limitation appears to be new matter (see MPEP 2163 (I)).
Withdrawn Claim Rejections - 35 USC § 112(b)
The rejection of claim 1 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite as set forth in the previous office action is withdrawn in view of Applicant’s amendments.
The rejection of claims 2-4 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite as set forth in the previous office action is withdrawn in view of the cancellation of these claims.
Withdrawn Claim Rejections - 35 USC § 112
Improper Markush
The rejection of claim 1 on the basis that it contains an improper Markush grouping of alternatives as set forth in the previous office action is withdrawn in view of Applicant’s amendments.
The rejection of claims 2-4 on the basis that they contain an improper Markush grouping of alternatives as set forth in the previous office action is withdrawn in view of the cancellation of these claims.
New Claim Rejections - 35 USC § 112(b)
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 1 and 13-16 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 1 and 14 each recite the step of “using erythropoietin-producing hepatocyte receptor B4 as a target of a test candidate.” However, this step does not contain description of how erythropoietin-producing hepatocyte receptor B4 is used as a target of a test candidate and therefore it is unclear what method steps are encompassed by “using” and metes and bounds of the claim are unclear. This step merely recites a use without any active, positive steps delimiting how this use is actually practiced and therefore the scope of this step is indefinite (see Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986) and MPEP § 2173.05(q)).
By nature of their dependency on claims 1 and 14, dependent claims 13 and 15-16 are also rejected because they do not clarify the issue.
Claim 1 recites “a method for screening and obtaining” in the preamble. However, the body of claim 1 recites screening steps and does not recite obtaining steps. The method steps in claim 1 do not result in “obtaining” a drug and therefore are not commensurate in scope with the preamble of “screening and obtaining.” Since no obtaining steps are recited, it is unclear how the method can be a method for obtaining and it is unclear what the metes and bounds of claim 1 are intended to encompass.
By nature of their dependency on claim 1, dependent claims 13 and 16 are also rejected because they do not clarify the issue.
The preamble of claim 14 recites “A method for preparation a drug for preventing, alleviating or treating diabetes mellitus, comprising the following steps:” However, the body of claim 14 recites method steps that are steps of screening a drug. The method steps in claim 14 do not result in “preparation” of a drug and therefore are not commensurate in scope with the preamble of “for preparation a drug.” Therefore, because the body of claim 14 does not recite preparation steps, it is unclear how the method of claim 14 is a “method for preparation” as claimed and it is unclear what the metes and bounds of claim 14 are intended to encompass.
By nature of their dependency on claim 14, dependent claim 15 is also rejected because it does not clarify the issue.
Withdrawn Claim Rejections - 35 USC § 102
The rejection of claim 1 under 35 U.S.C. 102(a)(1) as being anticipated by Zhu et al. (J Chromatogr A. 2019 Feb 8:1586:82-90. Epub 2018 Dec 4.; see IDS filed 27th, June. 2024; henceforth “Zhu”) as evidenced by Yin et al. (Metabolism. 2008 May;57(5):712–717.; henceforth “Yin”) as set forth in the previous office action is withdrawn in view of Applicant’s amendments.
The rejection of claims 2-4 under 35 U.S.C. 102(a)(1) as being anticipated by Zhu et al. (J Chromatogr A. 2019 Feb 8:1586:82-90. Epub 2018 Dec 4.; see IDS filed 27th, June. 2024; henceforth “Zhu”) as evidenced by Yin et al. (Metabolism. 2008 May;57(5):712–717.; henceforth “Yin”) as set forth in the previous office action is withdrawn in view of the cancellation of these claims.
The rejection of claims 2-4 under 35 U.S.C. 102(a)(1) as being anticipated by Lammert et al. (WO-2008087035-A2; henceforth “Lammert”) as set forth in the previous office action is withdrawn in view of the cancellation of these claims.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1 and 13-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lammert et al. (WO-2008087035-A2; henceforth “Lammert”).
Regarding claims 1 and 14, Lammert discloses a method for screening a drug for preventing or treating (“treatment and/or prevention” abstract) diabetes mellitus (abstract; pg. 1 1st and 3rd para.; pg. 2 1st and 3rd para.; pg. 3 1-2nd para, last para.; pg. 4 1st para.; pg. 9 2nd para.; pg. 19 2nd para.; pg. 21 2nd para.; pg. 23 2nd para.; pg. 24 1st para.; pg. 26 3rd para.; pg. 27 last para.; pg. 29 last para.; pg. 35 last para.; pg. 37 last para.; claims 1-5 and 8) (“Screening-method for anti-diabetic compounds” Title; see also “identifying a compound suitable as a lead compound and/or as a medicament for the treatment and/or prevention of diabetes” abstract) comprising the following steps:
using erythropoietin-producing hepatocyte receptor B4 as a target of a test candidate (“determining whether said test compound, upon contacting in step (a) inhibits the Eph receptor tyrosine kinase activity of said protein” abstract; EphB4; SEQ ID NO: 24-26 and 83-85; see In particular Claim 1; Table 1); and
detecting interaction of EphB4 with insulin receptors (“(b) determining whether said test compound, upon contacting in step (a) inhibits the Eph receptor tyrosine kinase activity of said protein”; abstract; pg. 1, 19, 21, pg. 23 2nd para., pg. 24 1st para.; claims 1-5 and 7-8) or protein level of insulin receptors (“determining whether said test compound inhibits the Eph receptor tyrosine kinase activity” refers to the determination of secreted insulin from said cell”; pg. 17 1st para. and “determining in step (b) comprises quantifying insulin secretion” pg. 25 4th para. and pg. 28 2nd para.; claim 11).
wherein detection of inhibition of the interaction of EphB4 with insulin receptor or increased protein level of insulin receptors identifies the test candidate as a drug for preventing or treating diabetes mellitus (“said inhibition indicates a compound suitable as a lead compound and/or as a medicament for the treatment and/or prevention of diabetes” abstract; claims 1-5).
Regarding the preambles of claims 1 and 14, the preambles merely state, the purpose or intended use of the invention (“a method for screening and obtaining a drug for preventing, alleviating, or treating diabetes mellitus” instant claim 1 and “a method for preparation a drug for preventing, alleviating or treating diabetes mellitus” instant claim 14 ), rather than any distinct definition of any of the claimed invention’s limitations, and therefore the preamble is not considered a limitation and is of no significance to claim construction (see MPEP 2111.02) See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) ("where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation"). Additionally, as discussed above, Lammert discloses all the active method steps of the instantly claimed method and therefore the method disclosed by Lammert is capable of meeting the purpose or intended use of “a method for preparation a drug for preventing, alleviating or treating diabetes mellitus” (instant claim 1) and “a method for preparation a drug for preventing, alleviating or treating diabetes mellitus” (instant claim 14) as claimed.
Regarding claims 13 and 15, further to the discussion of claims 1 and 14 above, respectively, Lammert discloses the drug is a biological agent (“antisense nucleic acid molecule, a miRNA, an siRNA or an shRNA” and “antibody or aptamer” pg. 34 5th para.; see also “RNA interference” pg. 34 last para.; “Ribozymes” pg. 36 2nd para.; Figure 2 and pg. 39 1st para.; pg. 46 1st para. which are all species of the claimed genus of “biological agent”).
Regarding claim 16, further to the discussion of claim 1 above, Lammert discloses the diabetes mellitus is type 2 diabetes mellitus (“type Il diabetes mellitus” pg. 1 3rd para., pg. 2 1st para., pg. 3 2nd para., pg. 9 3rd para., pg. 37 5th para.).
Accordingly, Lammert anticipates instant claims.
Response to Arguments
Applicant’s arguments, filed 12th, December, 2025, have been fully considered but are not found persuasive.
Applicant argues “Lammert et al. discloses "a method of identifying a compound suitable as a lead compound and/or as a medicament for the treatment and/or prevention of diabetes" (Abstract). However, Lammert et al. further discloses that the method comprises step "(b) determining whether said test compound, upon contacting in step (a) inhibits the Eph receptor tyrosine kinase activity of said protein wherein said inhibition indicates a compound suitable as a lead compound and/or as a medicament for the treatment and/or prevention of diabetes" (Abstract)”).
In response, Lammert discloses all the limitations of the amended claims as discussed above and therefore anticipates instant claims.
Furthermore the fact that Lammert discloses the method comprises step "(b) determining whether said test compound, upon contacting in step (a) inhibits the Eph receptor tyrosine kinase activity of said protein wherein said inhibition indicates a compound suitable as a lead compound and/or as a medicament for the treatment and/or prevention of diabetes" (Abstract)” falls under the instantly claimed method for the reasons stated above. Additionally, it is noted that instant claims use the open-ended transitional phrase “comprising.” The transitional term "comprising", which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See, e.g., Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004) ("[L]ike the term ‘comprising,’ the terms ‘containing’ and ‘mixture’ are open-ended.") (see MPEP 2111.03 (I)). Therefore, because instant claims are open-ended, additional elements or method steps in the anticipatory rejection are not excluded.
Applicant argues “Lammert does not disclose the steps of amended claim 1. Therefore, the current claim 1 possesses novelty over the cited prior art reference” (pg. 7).
In response, Lammert discloses all the limitations of the amended claims as discussed above and therefore anticipates instant claims.
Conclusion
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.
No claim is allowable.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIANA N EBBINGHAUS whose telephone number is (703)756-4548. The examiner can normally be reached M-F 9:30 AM to 5:30 PM ET.
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/BRIANA N EBBINGHAUS/Examiner, Art Unit 1632 /VALARIE E BERTOGLIO/Primary Examiner, Art Unit 1632