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 .
Election/Restrictions and Claim Status
As set forth in the document dated 2/7/25 an interview was held on 2/4/25. Although no additional formal interview request has been made based on page 23 of the 12/15/25 reply the examiner called the office of applicants representative. However, the examiner was unable to reach the representative. Since numerous issues remain, the examiner proceeded with the office action.
Applicants’ amendments and arguments filed 12/15/25 are acknowledged. Any objection or rejection from the 8/14/25 office action that is not addressed below is withdrawn based on the amendments. Instant claim 1 recites ‘wherein the rod molecule L and the rod molecule R comprise or consist of alpha-helical polypeptides’ (page 2) and then recites ‘the rod molecule L consists of an amino acid sequence and the rod molecule R consists of the same sequence in reverse order’ (page 3). Since the rod molecules are alpha-helical polypeptides (as recited on page 2), the language used on page 3 is interpreted such that the rod molecules consist of alpha-helical polypeptides and are the same sequence in reverse order.
Previously, Group 1 and SEQ ID NO: 1 were elected.
Claims 2-13, 17-27, 31-32, 34-36, 39-53 and 57-59 have been cancelled.
Claims 1, 14-16, 28-30, 33, 37-38, 54-56 and 60 are being examined.
Priority
The priority information is found in the filing receipt dated 6/30/21.
Claim Warning
This section is updated because the claims have been amended.
Applicant is advised that should claim 54 be found allowable, claim 56 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). In the last paragraph of page 31 of the arguments of 4/9/25, applicants refer to functional features as being an inherent property.
Response to Arguments – Claim Warning
Applicant's arguments filed 12/15/25 have been fully considered but they are not persuasive.
Although applicants argue that claims 54 and 56 have been amended, claims 54 and 56 appear to have been amended in the same way. 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). In the last paragraph of page 31 of the arguments of 4/9/25, applicants refer to functional features as being an inherent property.
Claim Objections
Claim 60 is objected to because of the following informalities:
The 4th to last line of claim 60 recites ‘via’. There is no need to italicize this word. For consistency with claim 1 line 22 the word ‘via’ should be used.
Appropriate correction is required.
Claims 29-30 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim Rejections - 35 USC § 112
This rejection is updated since claim 55 has been amended.
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 55 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 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
This rejection is a ‘new matter’ rejection. Section 2163 of the MPEP states: ‘While there is no in haec verba requirement, newly added claim limitations must be supported in the specification through express, implicit, or inherent disclosure’.
Claim 55 refers to a distribution of charges of the amino acid sequence as being the same.
The instant specification makes no mention of charge distributions as being the same.
Although applicants point to support at pages 16, lines 4-8 and page 16 lines 21-27, such sections make no mention of charge distributions. A mere mention of a charged residue does not require a specific charge distribution.
There is no reason to conclude that instant claim 55 is supported in the specification through express, implicit, or inherent disclosure for at least the reasons discussed above.
Response to Arguments – 112
Applicant's arguments filed 12/15/25 have been fully considered but they are not persuasive.
Although applicants argue that the specification refers to charged amino acids, a mere mention of a charged residue does not require a specific charge distribution.
Although applicants argue that the specification refers to sequences that mirror each other, the amino acids Lys and Arg can be positively charged under certain conditions. The fact that they are positively charged does not mean that they mirror one another since they have different structures.
Double Patenting
Since the claims have been amended, the double patenting rejection is updated.
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 14-16, 28, 33, 37-38 and 54-56 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11,428,687 (687; first cited 4/17/23). Although the claims at issue are not identical, they are not patentably distinct from each other.
687 recites a sensor molecule (claim 1) which comprises A and A’ which further comprises B and B’ (claims 4-8). 687 recites species sequences for L and R (claim 13) and for C (claim 17).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of 687 based on the teachings and suggestions of 687. Since 687 recites a sensor molecule (claim 1) with specific variable groups one would have been motivated to make such sensor with the variable groups as suggested (see claims 4-8, 13 and 17 for example). One would have had a reasonable expectation of success based on the express suggestions of 687.
In relation to instant claims 1 and 54-56, 687 recites a sensor molecule (claim 1) which comprises A and A’ and which further comprises B and B’ (claims 4-8). 687 recites specific sequences for L and R (claim 13) and for C (claim 17). Claim 13 recites sequences for L and R that are reverse sequences (for example EAAAK and KAAAE). In relation to the functional language of claims 1 and 54-58, 687 teach components as claimed (compare claim 13) so the components would function as claimed. In the last paragraph of page 31 of the arguments of 4/9/25, applicants refer to functional features as being an inherent property.
In relation to claims 14-16, 687 recites a sensor molecule (claim 1) which further comprises B and B’ which can be split molecules (claims 4-8).
In relation to claims 28, 33 and 37, 687 recites species sequences for L and R (claim 13) and for C (claim 17).
In relation to claim 38, 687 recites a nucleic acid (claim 1).
Response to Arguments – Double Patenting
Applicant's arguments filed 12/15/25 have been fully considered but they are not persuasive with respect to the rejection set forth above.
Although applicants argue about figures 19-23 and about binding of the same or different epitopes, it is noted that the features upon which applicant relies (i.e., figures 19-23 and epitopes) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The instant claims merely refer to ‘binding molecule’. The word epitope is not used in the instant claims. In the last paragraph of page 31 of the arguments of 4/9/25, applicants refer to functional features as being an inherent property. Since molecules as claimed are suggested they would function as claimed. Instant claim 1 recites “A is arranged to bind to the target molecule” and “A’ is arranged to bind to : i) the same target molecule as target binding molecule A”. Thus, applicants assertion about binding different epitopes is unfounded.
Although applicants argue about how the discoveries were achieved, the history of the discoveries is not recited in the instant claim language.
Although applicants argue that the present application is a dominant application over USP ‘687, the claim limitations are addressed above and the rejection does not rely on domination by itself. As set forth in the rejection: “In relation to claim 38, 687 recites a nucleic acid (claim 1)”. Claim 1 of US 11,428,687 expressly recites that target molecule A (as well as A’) binds a nucleic acid sequence. A nucleic acid is a target molecule as recited in instant claim 1.
Although applicants argue that there must be a reason to modify to target different epitopes, it is noted that the features upon which applicant relies (i.e., different epitopes) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The instant claims merely refer to ‘binding molecule’. As set forth above, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of 687 based on the teachings and suggestions of 687.
Although applicants argue about timewise extension and an unrelated patent, MPEP 804 II B 3 recognizes that an obviousness analysis (as set forth above) is an appropriate analysis. Further, applicants own arguments (page 22) show that the patent is not unrelated.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RONALD T NIEBAUER whose telephone number is (571)270-3059. The examiner can normally be reached M - F 6:30 - 2:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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RONALD T. NIEBAUER
Primary Examiner
Art Unit 1658
/RONALD T NIEBAUER/Examiner, Art Unit 1658