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 .
Amendment after Non-final office action filed on February 25, 2026 is acknowledged.
Claims 1-2, 4-12 and 15-18 are pending in this application.
Applicant elected with traverse of Group 1 (claims 1-2, 4-5 and 13-18) in the reply filed on May 8, 2024. The traversal was not found persuasive, and the restriction was deemed to be proper and was made FINAL in the previous office action. Claims 6-12 remain withdrawn from consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim. Claims 1-2, 4-5 and 15-18 are examined on the merits in this office action.
This application contains claims 6-12, drawn to an invention nonelected with traverse in the paper of 5/8/2024. A complete reply to the final rejection must include cancellation of nonelected claims or other appropriate action (37 CFR 1.144). See MPEP § 821.01.
Maintained Objection
Please note, the specification has not been checked to the extent necessary to determine the presence of all possible error. Applicant’s cooperation is required in correcting any errors of which applicant may become aware in the specification. MPEP § 608.01.
Maintained and Revised Rejections
35 U.S.C. 112(d)
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 15 and 17-18 remain 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. 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. This rejection is maintained and revised in view of Applicant’s amendment to the claims.
Claim 15 recites, “The fusion protein of claim 1, wherein the (X)n is u8, u9…u7-u2-u5-u11 or u3-u4-u7-u10.” Claim 15 depends from claim 1. Claim 1 recites, “…
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. The (X)n has been defined as a “single b-folding unit of fluorescent protein or combination of 2 to 8 b-folding units…wherein n is a positive integer from 1 to 8…” Claim 15 recites, “…wherein the (X)n is u8, u9…” The two different definitions of (X)n and “X” does not correlate with the recitation of (X)n in claim 15. Therefore, claim 15 does not further limit instant claim 1.
Claim 17 recites, “…wherein the (X)n is u8, u2-u3…or u3-u4-u6.” Claim 17 depends from claim 1. Claim 1 recites, “…
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. The (X)n has been defined as a “single b-folding unit of fluorescent protein or combination of 2 to 8 b-folding units…wherein n is a positive integer from 1 to 8…” Claim 17 recites, “…wherein the (X)n is u8, u2-u3…” The two different definitions of (X)n and “X” does not correlate with the recitation of (X)n in claim 17. Therefore, claim 17 does not further limit instant claim 1.
Claim 18 recites, “…wherein the (X)n is u2-u3, u4-u5…or u3-u4-u6.” Claim 18 depends from claim 1. Claim 1 recites, “…
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. The (X)n has been defined as a “single b-folding unit of fluorescent protein or combination of 2 to 8 b-folding units…wherein n is a positive integer from 1 to 8…” Claim 18 recites, “…wherein the (X)n is u2-u3, u4-u5…” The two different definitions of (X)n and “X” does not correlate with the recitation of (X)n in claim 18. Therefore, claim 18 does not further limit instant claim 1.
Response to Applicant’s Arguments
Applicant argues that “By this amendment, Applicant has amended claim 1 to clarify the definitions for “Xn” and “X”. Amened claim 1 recites:
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…(i) When n is 1, “(X)n” refers to one single said “X”…(ii) When n is a positive integer from 2 to 8, “(X)n” refers to a combination of 2 to 8 said “X” and each “X” in “(X)n” is independently selected from u1 to u11.”
Applicant’s arguments have been fully considered but are not found persuasive. The amended claim of “each X in (X)n is independently a single b-folding unit of fluorescent protein selected form the group consisting of…wherein n is a positive integer from 1 to 8…” is interpreted as, for example, (u1)n, wherein n is 1 then the formula would have one (1) u1 sequence (i.e., VPILVELDGDVNG (SEQ ID NO: 1)); if n is 2, then the formula would have two (2) u1 sequence (i.e., VPILVELDGDVNGVPILVELDGDVNG). Therefore, the recitation of “wherein the (X)n is u2-u3, u4-u5…or u3-u4-u7-u10” of claim 15, the recitation of “wherein the (X)n is u2-u3, u4-u5…or u3-u4-u6”, and the recitation of “wherein the (X)n is u2-u3, u4-u5…or u3-u4-u6” do not further limit instant claim 1. Please note: instant claims recite “(X)n” not “Xn”. The variable (X)n is different than Xn. For example, in (X)n, when X is V and n is 5, then this implies VVVVV; In this situation, the X cannot be different as Applicant appears to be indicating.
35 U.S.C. 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 1-2, 4-5 and 15-18 remain 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. This rejection is maintained and revised in view of Applicant’s amendment to the claims.
Claim 1 recites, “A fusion protein, comprising the structure as shown in Formula I:
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. Claim 1 has 2 different definitions for the variable “X”. Therefore, it is unclear what X in (X)n is referring to. The amended claim recites “wherein n is a positive integer from 1 to 8…” It is unclear how (X)n is a single b-folding unit or a combination of 2 to 8 b-folding units…” when n is a positive integer from 1 to 8. Claim 1 recites both that “(X)n is a single b-folding unit” and “each X in (X)n is independently a single b-folding unit”. Each X in the table form has different peptide sequences. Thus, claim 1 recites that both (X)n and X are a single b-folding unit. Because claims 2, 4-5 and 15-18 depend from indefinite claim 1 without clarifying the point of confusion, claims 2, 4-5 and 15-18 are also rejected under 35 U.S.C. 112(b).
Response to Applicant’s Arguments
Applicant argues that “As explained above, Applicant has amended claim 1 to clarify the definition for “Xn” and “X”. As the amendment removes any ambiguity regarding the identity of ‘X” and its relationship to “(X)n”, a person of ordinary skill in the art should be able to recognize the metes and bounds of the claim.”
Applicant’s arguments have been fully considered but are not found persuasive. The definition of “Xn” is not the same as the definition of “(X)n”. Instant claims recite “(X)n” not “Xn”. The variable (X)n is different than Xn. For example, in (X)n, when X is V and n is 5, then this implies VVVVV; In this situation, the X cannot be different as Applicant appears to be indicating. Additionally, claim 1 recites both that “(X)n is a single b-folding unit” and “each X in (X)n is independently a single b-folding unit”. Therefore, the metes and bounds of the claims is still unclear for “X” and “(X)n”.
DOUBLE PATENTING
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1-2, 4-5 and 15-18 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of copending Application No. 18/001254 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because if one of ordinary skill in the art practiced the claimed invention of instant claims, one would necessarily achieve the claimed invention of copending claims, and vice versa.
Instant claims are drawn to:
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Copending claims are drawn to:
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The fusion protein having the structure as shown in Formula I of instant claims is similar to the fusion protein having the structure as shown in Formula I of copending claims. Additionally, the b-folding unit of fluorescent proteins is the same in both applications. Therefore, if one of ordinary skill in the art practiced the claimed invention of instant claims, one would necessarily achieve the claimed invention of copending claims, and vice versa.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2, 4-5 and 15-18 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of copending Application No. 18/001257 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because if one of ordinary skill in the art practiced the claimed invention of instant claims, one would necessarily achieve the claimed invention of copending claims, and vice versa.
Instant claims are drawn to:
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Copending claims are drawn to:
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The fusion protein having the structure as shown in Formula I of instant claims is similar to the fusion protein having the structure as shown in Formula I of copending claims. Additionally, the b-folding unit of fluorescent proteins is the same in both applications. Therefore, if one of ordinary skill in the art practiced the claimed invention of instant claims, one would necessarily achieve the claimed invention of copending claims, and vice versa.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2, 4-5 and 15-18 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of copending Application No. 18/000986 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because if one of ordinary skill in the art practiced the claimed invention of instant claims, one would necessarily achieve the claimed invention of copending claims, and vice versa.
Instant claims are drawn to:
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Copending claims are drawn to:
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The fusion protein having the structure as shown in Formula I of instant claims is similar to the fusion protein having the structure as shown in Formula I of copending claims. Additionally, the b-folding unit of fluorescent proteins is the same in both applications. Therefore, if one of ordinary skill in the art practiced the claimed invention of instant claims, one would necessarily achieve the claimed invention of copending claims, and vice versa.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Applicant’s Arguments
Applicant argues the following:
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. For the reasons discussed above, the rejection of claims 1-2, 4-5 and 15-18 over 112(b) and 112(d) are overcome. Thus, the obviousness-type double patenting rejection is the only rejection remaining…this rejection should be withdrawn and the application should be allowed.”
Applicant’s arguments have been fully considered but are not found persuasive. The rejections under 35 U.S.C. 112(b) and 35 U.S.C. 112(d) have been maintained above. Therefore, the obviousness-type double patenting rejection is not the only rejection remaining. Until a proper terminal disclaimer is filed, the double patenting rejection is maintained herein.
New Rejection
35 U.S.C. 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 1-2, 4-5 and 15-18 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 1 recites, “
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”. . Claim 1 recites parenthetical expression “(when n is 1)” and “(when n is a positive integer from 2 to 8)". The metes and bounds of claim 1 is rendered vague and indefinite by the parenthetical recitation of “(when n is 1)” and “(when n is a positive integer from 2 to 8)" because it is unclear as to whether the limitation is part of the instantly claimed subject matter. See MPEP § 2173.05(d). Because claims 2, 4-5 and 15-18 depend from indefinite claim 1 without clarifying the point of confusion, these claims are also rejected under 35 U.S.C. 112(b).
CONCLUSION
No claim is 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 JULIE HA whose telephone number is (571)272-5982. The examiner can normally be reached Monday-Thursday 5:00 am- 6:30 pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LIANKO GARYU can be reached at 571-270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JULIE HA/Primary Examiner, Art Unit 1654
5/5/2026
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