RESPONSE TO APPLICANT’S AMENDMENT
1. Applicant's amendment, filed 04/28/2026, is acknowledged.
2. Claims 1-18 are pending and under examination.
3. Claims 9-18 stand withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions.
4. Claims 1-8 are under examination as they read on anti-fibronectin (FN) antibodies.
5. The rejection of claims 1-2 and 4-8 under 35 U.S.C. 102(a)(1) as being anticipated by Cao et al (ACS Nano. 2017 July 25; 11(7): 7110-7117) as is evidenced by the specification on page 12, lines 24-25 is hereby withdrawn in view of the Barker declaration un under 7 CFR §1.130, filed 04/28/2026 stating that Baker, Cao and Niccosia are co-inventors of certain subject matter that is disclosed in Cao that this also part of the subject matter disclosed and/or claimed in the Subject Application 93. Further, the declaration states that Co-authors Jacqueline Larouche, Yuanyuan Zhang, Haylee Bachman, Ashley C. Brown, and Lars Holmgren provided technical assistance with respect to experiments described in Cap, and/or editorial assistance with respect to the preparation of Cap. However, co-authors Jacqueline Larouche, Yuanyuan Zhang, Hayice Bachman, Ashley C. Brown, and Lars Holmgren did not contribute to the conception of any subject matter disclosed and/or claimed in the Subject Application. Accordingly, the declaration is sufficient to overcome this rejection.
6. The rejection of claims 1-8 on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 12410245 B1 is hereby withdrawn in view of the Terminal Disclaimer filed 04/28/2026.
7. In view of the amendment filed on 04/28/2026, only the following rejections are remained.
8. 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.
9. Claims 1-8 stand provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 27-30 of copending Application No. 18573975 (reference application) for the same reasons set forth in the previous Office Action mailed 01/28/2026.
Applicant’s arguments, filed 04/28/2026, have been fully considered, but have not been found convincing.
Applicant submits that the instant application has an earlier patent term filing date than
the '975 Application. Moreover, in view of the amendments and remarks presented herein,
applicant submits that this double patenting rejection should be the only remaining rejection in
the instant application. Per M.P.E.P. §804(1)(B)(1)(b)(i), if a provisional non-statutory double patenting rejection is the only rejection remaining in an application having the earlier patent term filing date, the Patent Office should withdraw the rejection in the application having the earlier patent term filing date and permit that application to issue as a patent.
However, this is not the only rejection remains in the application. The rejection remains until all rejections are resolved.
10. 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.
11. Claims 1-2, 4-8 stand rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lizhi Cao (Dissertation May 2014), as is evidenced by the specification on page 12, lines 24-25 for the same reasons set forth in the previous Office Action mailed 01/28/2026.
Applicant’s arguments, filed 04/28/2026, have been fully considered, but have not been found convincing.
Applicant argues that a claim is anticipated only if each and every element as set forth in the claim is found, either expressly or inherently described in a single prior art reference. Applicant point that the Non-final Office Action states that the Cao dissertation “does not teach the sequences for H5 scFv and its CDRs”. Applicant concluded that the Patent Office has admitted in the record that the Cao Dissertation fails to explicitly teach each and every element of the rejected claims. The Patent Office attempts to cure these deficiencies in the explicit teachings b putting forth an anticipation rejection based on inherency. That is, the Office has asserts that the claimed H5 sequences and its CDRs are intrinsic properties of the H5 scFv.
The M.P.E.P. puts forth strict requirements for rejections that are based on inherency. The M.P.E.P. is clear that the Patent Office must provide rationale or evidence to show
inherency. Importantly, the fact that a certain result or characteristic may occur or be present in
the prior art is not sufficient to establish the inherency of that result or characteristic.⁵ That is, to
establish that a prior art reference inherently - rather than expressly - discloses a claim
limitation, "the limitation at issue necessarily must be present or [is] the natural result of the combination of elements explicitly disclosed by the prior art."⁶ Moreover, inherency "may not be
established by probabilities or possibilities. That is, the mere fact that a certain thing may result
from a given set of circumstances is not sufficient.
Applicant submits that the Patent Office has not met the legal burden for putting forth a case of anticipation based on inherency.
More specifically, the Patent Office relies solely upon In re Crish (73 USPQ2d 1364,
CAFC, 2004) to support their finding of anticipation based on inherency. More specifically, the
Patent Office asserts that:
Like the references in Crish, the prior art of [the] Cao dissertation discloses a
material containing the same sequence recited in the claims. It is undisputed that
Cao discloses a H5 scFv that contains the amino acid recited in Applicant claims.
That disclosure is anticipatory, even if it was not until the present application that
Applicant characterized H5 scFv by its amino acid sequences.
Applicant disagrees and submits that the Patent Office's analogization of the instant claims to those in issue in In re Crish is legal error.
The claims at issue in In re Crish were directed to the nucleic acid sequence of a naturally occurring promoter of the human involucrin (HiNV) gene. That is, the references that were held to be anticipatory in In re Crish disclosed the structure of the HiNV gene as well as
the approximate size of the promoter region. Because the HiNV gene is a defined, naturally
occurring sequence, the Court found that the record was clear that the promoter sequence
claimed in the later filed patent application was necessarily described in the previous
application. Accordingly, because the promoter sequences is a naturally occurring, fixed
sequence, there was no possibility that it could be any other sequence. (emphasis added by the Examiner).
Applicant submits that these facts are completely distinct from the facts surrounding the instant application. The H5 scFv is not a naturally occurring sequence like the HiNV gene in In re Crish. In fact, the H5 scFv comprises a completely synthetic sequence that is not way “fixed’ in the same way that the sequence of the HiNV gene is. That is, and contrary to the assertions of the Office, there is no reason why the sequences claimed in the instant application are necessarily the same sequences that are utilized in the Cao Dissertation.
This is not found persuasive because In re Crish, the applicant claimed an hINV promoter region based on its nucleotide sequence (i.e., recombinant/not a naturally occurring sequence). The claims at issue in re Crish “related to purified DNA molecules having promoter activity for the human involcrine gene (hINV)”. Id., 73 USPQ2d at 1365. The court held that the claimed promoter sequence designated as SEQ ID NO: 1 was obtained by sequencing the same prior art plasmid and was therefore anticipated by the prior art plasmid which necessarily possessed the same DNA sequence as the claimed oligonucleotides. Id. At 1256 and 1259, 73 USPQ2d at 1366 and 1369. The Courts have held that there is no requirement that those of ordinary skill in the art know of the inherent property. See MPEP 2131.01(d) and MPEP 2112-2113.
Like the references in Crish, the prior art of Cao Dissertation discloses a material containing the same sequence recited in the claims. It is undisputed that Cao Dissertation discloses an antibody that contains the amino acids recited in Applicant’s claims. That disclosure is anticipatory, even if it was not until the present application that Applicants characterized H5 scFv by its amino acid sequences.
The disclosure of the CDRs, VH and VL of H5 scFv is only further characterization of otherwise old product.
Applicant submits that the facts surrounding the instant claims are better analogized to those of Endo Pharms. Sols., Inc. v. Custopharm Inc., 894 F.3d 1374, 1381 (Fed. Cir. 2018). The Endo decision is submitted herewith as Exhibit A for the convenience of the Patent Office.
The patent claims in Endo were directed to pharmaceutical formulations for testosterone
and methods of using these pharmaceutical formulations to treat testosterone deficiency. In
addition to testosterone, these pharmaceutical formulations also contained castor oil and the co-
solvent benzyl benzoate.
The patent challenger in Endo asserted that these pharmaceutical formulations would
have been obvious to the skilled artisan in view of three scientific articles describing clinical
trials of a pharmaceutical composition comprising testosterone (hereafter "the Articles"). The
Articles described a pharmaceutical formulation comprising testosterone and castor oil and
presented data with respect to the pharmacokinetic performance of the pharmaceutical
formulation. Importantly, the Articles were completely silent with respect to the use of a co-
solvent.
However, in reality, the pharmaceutical formulation that were used in the Articles were
actually the pharmaceutical compositions claimed in the patents at issue in Endo, as confirmed
by later publications that explained the exact ingredients of the pharmaceutical compositions in
the clinical trials.
Ultimately the court in Endo found that the Articles could not be found to inherently
disclose claimed pharmaceutical compositions for several reasons including:
the skilled artisan could not necessarily extrapolate the pharmaceutical
formulations based on the pharmacokinetic data presented in the Articles;
the skilled artisan would have had numerous choices with respect to a co-solvent
and there was nothing in the Articles to inform the skilled artisan that the co-
solvent should be benzyl benzoate.
Moreover, the court in Endo distinguished the facts at issue from those presented in In re
Crish. More specifically, the court explained:
Importantly, Crish [was] about inherently present properties or characteristics
for a "known" prior art product. But here, the TU injection composition recounted
in the Articles cannot be said to be "known" in the same way; the Articles failed
to disclose that the composition's vehicle formulation included another, key
ingredient, benzyl benzoate, let alone the ratio of benzyl benzoate to castor oil.
And there was no evidence in the record that a skilled artisan could determine the
nondisclosed vehicle formulation based on the reported pharmacokinetic
performance profile, or that the nondisclosed vehicle formulation was necessarily
a feature of the TU injection studied in the Articles. Under the circumstances of
this case, the incomplete description of the TU injection composition elements
denied skilled artisans from having access to that composition, thereby precluding
use of the inherency doctrine to fill in disclosure about the product missing from
the Articles.
Applicant submits that the same analysis that the court in Endo applied to the
Articles should be applied to the Cao Dissertation. That is, there is nothing in the Cao
Dissertation that would allow the skilled artisan to necessarily extrapolate the sequences of the
CDRs that are instantly claimed. Similar to the Articles in Endo, the Cao Dissertation simply
refers to a generic scFv using a generic term "H5". In fact, the Cao Dissertation actually provides
less information than the Articles in Endo, which described at least part of the pharmaceutical
composition in question.
Applicant submits that there is no way that the skilled artisan could have reached the instantly
claimed CDRs based on the binding data that is presented in the Cao Dissertation. That is, the
Patent Office has not provided any objective evidence as to how the skilled artisan could take the
data presented in the Cao Dissertation and "transform" it into specific sequences in order to reach the instantly claimed antibodies.
Applicant submits that the skilled artisan would readily appreciate that a multitude of different
antibodies could actually exhibit the same binding data in the Cao Dissertation. Accordingly, it is
not necessary that the instantly claimed sequences correspond to those that were used in the Cao
Dissertation to generate the data presented therein.
Applicant concluded that just like the court in Endo found that "the incomplete description of the TU injection composition elements denied skilled artisans from having access to that
composition, applicant respectfully submits that submits that the Cao Dissertation's failure to
disclose any sequences related to the scFvs described therein prevents the skilled artisan from
having access to the scFvs described therein. Accordingly, applicant respectfully submits that the
inherency doctrine cannot be used to support a rejection that relies on the Cao Dissertation.
This not found persuasive because Endo is distinguished form the instant claims because the facts of the present claims could not be analogized to Endo.
Like In re Crish, the issue is about inherently present properties or characteristics for a “known” prior art product taught by Cao Dissertation, i.e., H5 scFv. However, the solvent in Endo cannot be said to be “known”. In the same way, the articles failed to disclose that the composition’s vehicle formulation included another, key ingredient, benzyl benzoate, let alone the ration of benzyl benzoate to castor oil. And there was no evidence in the record that a skilled artisan could determine the nondisclosed vehicle formulation based on the reported pharmacokinetic performance profile, or that the non-disclosed vehicle formulation was necessarily a feature of the TU injection studied in the Articles. Under the circumstances of this case, the incomplete description of the TU injection composition elements denied skilled artisans from having access to that composition, thereby precluding use of the inherency doctrine to fill in disclosure about the product missing from the Articles.
12. Claims 1-2 and 4-8 stand rejected under 35 U.S.C. 102(a)(1) as being anticipated by Leandro Moretti (Thesis, December 2016), as is evidenced by the specification on page 12, lines 24-25 for the same reasons set forth in the previous Office Action mailed 01/28/2026.
Applicant’s arguments, filed 04/28/2026, have been fully considered, but have not been found convincing.
Applicant submits that the instant application claims priority to, and the benefit of, United
States Patent Application Serial No. 62/690,992, filed on June 28, 2018. Accordingly, the
effective filing date of the instant claims is June 28, 2018.
As described in the Barker Declaration submitted herewith, the Moretti Thesis was not
made available to the public until January 22, 2018. That is, the Moretti Thesis was published
less than one year prior to June 28, 2018.
Also, as described in the Barker Declaration, Leandro Moretti is a co-inventor of
the instant application. Thus, the disclosure of the Moretti Thesis is a disclosure by a co-inventor
of their own work.
In view of the above, Applicant submits that the Moretti Thesis is disqualified as prior art under the exception put forth in 35 U.S.C. §102(b)(1)(A) (see M.P.E.P. § 2155.01).
Accordingly, applicant respectfully submits that the instant rejection of claims 1, 2, and
4-8 under 35 U.S.C. §102(a)(1) over the Moretti Thesis as evidenced by the specification on
page 12, lines 24-25 has been addressed, and respectfully requests that it be withdrawn at this
time. Reconsideration of the claims is also respectfully requested.
This is not found persuasive simply because Applicant did not explain the December 2016 date of the Leandro Moretti master degree. There is no evidence on the record that the Moretti Thesis was not available to the public since December 2016. No explanation of the December 2016 date printed on the Thesis. Where was the thesis between Dec. 2016 and June 2018.
13. 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.
14. Claim 3 stands rejected under 35 U.S.C. 103 as being unpatentable over Lizhi Cao (Dissertation May 2014) or Moretti (Thesis, December 2016), as is evidenced by the specification on page 12, lines 24-25, as applied to claims 1-2 and 4-8, above, and further in view of Bujak et al (Methods Mol Biol. 2014:1131:315-34. doi: 10.1007/978-1-62703-992-5_20) for the same reasons set forth in the previous Office Action mailed 01/28/2026.
Applicant’s arguments, filed 04/28/2026, have been fully considered, but have not been found convincing.
Applicant submits that claim 3 is also novel and inventive in view of the remarks
put forth above as set forth in M.P.E.P. $2143.03 ("If an independent claim is nonobvious under
35 U.S.C. 103, then any claim depending therefrom is nonobvious").
Applicant submits that the instant rejection of claim 3 under 35 U.S.C. §103 over Cao or the Cao Dissertation or the Moretti Thesis as evidenced by the specification on page 12, lines 24-25 and further in view of Bujak has been addressed, and respectfully requests that it be withdrawn at this time. Reconsideration of the claims is also respectfully requested.
However, it remains the Examiner’s position that it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to format the referenced H5 scFv taught by Cao dissertation and Moretti reference into scFv-Fc format taught by Bujak et al which offers several advantages over the phage display-derived scFv, including bivalent binding, longer half-life, and Fc-mediated effector functions.
15. No claim is allowed.
16. THIS ACTION IS MADE FINAL. 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 extension fee 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.
17. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAHER M HADDAD whose telephone number is (571)272-0845. The examiner can normally be reached on Monday-Friday from7:00AM to 4:30PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu, can be reached at telephone number 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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May 4, 2026
/MAHER M HADDAD/ Primary Examiner, Art Unit 1644
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