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 .
DETAILED ACTION
RESPONSE TO AMENDMENT
Status of Application/Amendments/claims
2. Applicant’s amendment filed July 30, 2025 is acknowledged. Claims 1-49, 51 and 81 are canceled. Claims 50, 52-64, 66-67 and 77 are amended. Claims 50 and 52-80 are pending in this application. Claims 64-65, 74-75 and 79-80 are withdrawn without traverse (filed 10/9/2024) from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was treated as without traverse in the reply filed on October 9, 2024.
3. Claims 50, 52-63, 66-73 and 76-78 are under examination with respect to SEQ ID NO:46 for fusion protein, SEQ ID NO:35 for polypeptide, SEQ ID NOs: 1-3 for CDR1-3, SEQ ID NO:17 for antibody and SEQ ID NO:40 for Fc fragment in this office action.
4. Applicant’s arguments filed on July 30, 2025 have been fully considered but they are not deemed to be persuasive for the reasons set forth below.
Claim Rejections/Objections Withdrawn
5. The rejection of claims 36, 50-63, 66-73, 76-78 and 81 on the basis that it contains an improper Markush grouping of alternatives is withdrawn in response to Applicant’s amendment to the claims, cancelation of claims 36, 51 and 81 and Applicant’s arguments on p. 9-11 of the response.
The rejection of claims 36, 51, 77-78 and 81 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112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn in response to Applicant’s amendment to the claims and cancelation of claims 36, 51 and 81.
The rejection of claim 36 under 35 U.S.C. 102(a)(1) & (a)(2) as being anticipated by Chakravarthy (US8323925) is moot because the claim is canceled.
The rejection of claims 50, 54-57, 66, 77 and 81 under 35 U.S.C. 103 as being unpatentable over Chakravarthy (US8323925) in view of Muruganandam et al. (WO200257445) is withdrawn in response to Applicant’s amendment to the claims and cancelation of claim 81.
The rejection of claims 50-52, 54-63, 66, 68-73, 77-78 and 81 under 35 U.S.C. 103 as being unpatentable over Chakravarthy (US8323925) in view of Stanimirovic (WO2018007950) is withdrawn in response to Applicant’s amendment to the claims and cancelation of claims 51 and 81, and Applicant’s declaration filed 7/30/2025.
The rejection of claims 53, 67-73 and 76 under 35 U.S.C. 103 as being unpatentable over Chakravarthy (US8323925) in view of Stanimirovic et al. (WO2018007950) and further in view of Boone et al. (US6294170) is withdrawn in response to Applicant’s amendment to the claims and cancelation of claims 51 and 81, and Applicant’s declaration filed 7/30/2025.
The rejection of claims 36, 50-63, 66-73, 76-78 and 81 on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 11702466 is withdrawn in response to Applicant’s amendment to the claims and cancelation of claims 36, 51 and 81, and Applicant’s arguments on p. 16 of the response.
The rejection of claims 36, 50-52, 54-63, 66, 68-73, 76-78 and 81 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 and 9-20 of US8323925 in view of Stanimirovic et al. (WO2018007950) and Boone et al. (US6294170) is withdrawn in response to Applicant’s amendment to the claims and cancelation of claims 36, 51 and 81, and Applicant’s arguments on p. 16-17 of the response.
The provisional rejection of claims 36, 50-63, 66-73, 76-78 and 81 on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 9, 13, 15, 20, 22, 28, 31-32, 39, 44-45, 59-64, 66-68 of copending Application No. 16/965885 is moot because Application No. 16/965885 was abandoned.
Claim Rejections/Objections Maintained
In view of the amendment filed on July 30, 2025, the following rejections are maintained.
Claim Objections
6. Claim 77 is objected to because of the following informalities: Claim 77 depends from claim 51, which is canceled. Appropriate correction is required.
Claim Rejections - 35 USC § 112
7. 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 50, 52-63, 66-73 and 76 stand 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. The rejection is maintained for the reasons of record and the reasons set forth below.
Claims 50, 52-63, 66-73 and 76 as amended encompass a genus of compound binding b-amyloid, wherein the compound comprises a fusion protein comprising a) a sdAb or fragment thereof that transmigrate the BBB; b) a human Fc fragment; c) a polypeptide that binds b-amyloid, wherein the sdAb comprises CDR1-3 sequences of recited SEQ ID NOs:; wherein the polypeptide binding b-amyloid includes SEQ ID NOs: 32-38 and wherein a fusion protein comprising SEQ ID NO:47 is excluded.
The claims encompass a genus of structurally and functionally undefined fragments of sdAb comprising recited SEQ ID NOs:.
Claim 56 encompasses a genus of sdAb variants comprising at least 95% identity to recited SEQ ID NOs:
Applicant has not disclosed sufficient species for the broad genus of compounds comprising the broad genus of fragments of sdAb and the broad genus of SdAb variants comprising at least 95% identity to recited SEQ ID NOs:
Response to Arguments
On p.12-13 of the response, Applicant argues that the rejection has been overcome because the claims are limited to a three-part fusion protein comprising any one of four sdAb’s defined by CDR1-3 sequences, a human Fc fragment, and any one of 7 ABP variants defined by SEQ ID NOs:.
Applicant's arguments have been fully considered but they are not found persuasive. Contrary to Applicant's arguments, the examiner asserts that based on MPEP §2163, MPEP §§2163.01-2163.03, the specification fails to provide sufficient description or information or evidence to demonstrate that Applicant is in possession of the claimed genus of compounds/fusion proteins because:
i. The structural and functional relationship or correlation between the claimed genus of fragments of sdAb and the sdAb comprising recited CDR1-3 sequences is unknown.
The limitation “or fragment thereof that transmigrate the BBB…comprises recited CDR1-3 sequences” is not limited to sdAb having the structure of sdAb” but also encompasses any structures with sdAb comprising recited CDR1-3 sequences.
However, neither the specification nor the prior art provides sufficient species for the broad genus of sdAb fragment that transmigrate the BBB.
The specification fails to teach what other common sequences and features are required by the claimed genus of fragments of sdAb in order to preserve the binding activity of sdAb with the wild type sequences of recited SEQ ID NOs: or the fusion protein of SEQ ID NO: 46 or 47. It is not known what other common sequences and features can or cannot be changed or included in order to preserve the binding activity of fragments of sdAb to transmigrate the BBB.
ii. The structural and functional relationship or correlation between the claimed genus of sdAb variants having at least 95% identity to recited SEQ ID NOs: recited in claim 56 and the sdAb comprising the full length of recited SEQ ID NOs: is unknown.
The specification fails to teach what other common sequences and features are required by the claimed genus of sdAb variants in order to preserve the binding activity of sdAb with the wild type sequences of recited SEQ ID NOs: or the fusion protein of SEQ ID NO: 46 or 47. It is not known what 5% sequences within recited SEQ ID NOs: can or cannot be changed or included in order to preserve the binding activity of sdAb with the wild type sequences of recited SEQ ID NOs:.
Since the common characteristics/features of fragments of SdAb or other sdAb variants are unknown, a skilled artisan cannot envision the functional correlations of the genus with the claimed invention in view of Burgess et al. (J of Cell Bio. 1990, 111:2129-2138, cited previously), Bowie et al. (see col 2, p. 1306, Bowie et al. Science, 1990, 247:1306-1310, cited previously), Pawson et al. (see p. 445 the second column, first paragraph, Pawson et al. 2003, Science 300:445-452, cited previously), Alaoui-lsmaili et al. (see p. 502, right col., 2th paragraph; Alaoui-lsmaili et al., Cytokine Growth Factor Rev. 2009; 20:501-507, cited previously) and Guo et al. (see p. 9207, left col., 2th paragraph, Guo et al., PNAS 2004; 101:9205-9210, cited previously).
Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the genus of fragments of sdAb that transmigrate the BBB or the genus of sdAb variants with at least 95% identity to recited SEQ ID NOs:.
Based on MPEP § 2161.01 and §2163, “to satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116”.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116).
As discussed above, the skilled artisan cannot envision the detailed chemical structure of the encompassed genus of fusion proteins, fragments of sdAb and sdAb variants, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483 and Centocor v. Abbott, 636 F.3d1341 (Fed. Cir. 2011) and AbbVie v. Janssen, 759 F.3d 1285 (Fed. Cir.2014). One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483.
Therefore, the claimed fusion proteins have not met the written description provision of 35 U.S.C. §112, first paragraph. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision (see page 1115). Applicant is directed to the Guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112, ¶ 1 "Written Description" Requirement. See MPEP § 2161.01 and 2163.
Accordingly, the rejection of claims 50, 52-63, 66-73 and 76 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 is maintained.
New Grounds of Rejection Necessitated by the Amendment
The following rejections are new grounds of rejections necessitated by the amendment filed on July 30, 2025.
Claim Rejections - 35 USC § 112
8. 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 77-78 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 pre-AIA the applicant regards as the invention.
Claims 77-78 are indefinite because claim 77 depends from a canceled claim 51, which renders the claim indefinite because it is unclear on what claim 77 depends. Claim 78 is indefinite as depending from an indefinite claim 77.
Claim Rejections - 35 USC § 112
9. 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 35 U.S.C. 112 (pre-AIA ), fourth paragraph:
Subject to the [fifth paragraph of 35 U.S.C. 112 (pre-AIA )], 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 77-78 are 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. Claims 77-78 depend from a canceled claim 51, which do not further limit the subject matter of the claims upon which they depend. 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.
Conclusion
20. NO CLAIM IS ALLOWED.
11. 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.
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Chang-Yu Wang whose telephone number is (571)272-4521. The examiner can normally be reached on Monday-Thursday, 7:00am-5:30pm 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, Jeffrey Stucker, can be reached on 571-272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Chang-Yu Wang
December 20, 2025
/CHANG-YU WANG/Primary Examiner, Art Unit 1675
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