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 1-10 and 12-17 are pending and presently subject a restriction/election requirement. Claims 3-9 and 12-17 are withdrawn. Claims 1-2 and 10 are presently considered.
Election/Restriction
Applicant’s election without traverse of Group I (claims 1-2 and 10, directed to polypeptides) and the species of SEQ ID NO:2 in the reply filed on 7/02/2026 is acknowledged.
Notably, claims 1-2 and 10 were amended in the Reply filed 7/02/2026 to remove reference to “SEQ ID NO: 2” (see, e.g., Response filed 7/20/2026 at claims 1-2 and 10), but have stated that “Applicant also submits that claims 1-2 and 10 as currently amended read on the elected species” (see, e.g., Response filed 7/20/2026 at 5 at final ¶). Accordingly, the Applicant’s statement and choice of phrasing in the amended claims (e.g., “comprising an amino acid sequence as shown in SEQ ID NO: 1”, rather than “comprising SEQ ID NO: 1” or “comprising the sequence of SEQ ID NO: 1”) is understood in a manner consistent with both the election and amendments, and therefore the usage of “an” rather than “the” is understood to be relevant in the instant case1
The originally elected species is understood to be SEQ ID NO: 2, which is
EDPEFQASNIMHSINGYVFDSLQLSVCLHEVAYWYILSIGAQTDFLSVFFSGYTFKHKMVYEDTLTLFPFSGETVFMSMENPGLWILGCHNSDFRNRGMTALLKVSSCDKNTGDYYEDSYEDISAYLLSKNNAIEPRSFSQNSRHPSTRQKQFNATTIPENDIEKTDPWFAHRTPMPKIQNVSSSDLLMLLRQSPTPHGLSLSDLQEAKYETFSDDPSPGAIDSNNSLSEMTHFRPQLHHSGDMVFTPESGLQLRLNEKLGTTAATELKKLDFKVSSTSNNLISTIPSDNLAAGTDNTSSLGPPSMPVHYDSQLDTTLFGKKSSPLTESGGPLSLSEENNDSKLLESGLMNSQESSWGKNVSSTESGRLFKGKRAHGPALLTKDNALFKVSISLLKTNKTSNNSATNRKTHIDGPSLLIENSPSVWQNILESDTEFPPVLKRHQREITRTTLQSDQEEIDYDDTISVEMKKEDFDIYDEDENQSPRSFQKKTRHYFIAAVERLWDYGMSSSPHVLRNRAQSGSVPQFKKVVFQEFTDGSFTQPLYRGELNEHLGLLGPYIRAEVEDNIMVT
In view of the usage of “an” and Applicant’s statement, the elected species is understood to read upon instant claims 1 and 10, because SEQ ID NO: 2 is understood to comprise “an amino acid sequence as shown in SEQ ID NO: 1”2, namely
EDPEFQASNIMHSINGYVFDSLQLSVCLHEVAYWYILSIGAQTDFLSVFFSGYTFKHKMVYEDTLTLFPFSGETVFMSMENPGLWILGCHNSDFRNRGMTALLKVSSCDKNTGDYYEDSYEDISAYLLSKNNAIEPRSFSQN
(positions 1-142 of SEQ ID NO: 1) and also
PPVLKRHQREITRTTLQSDQEEIDYDDTISVEMKKEDFDIYDEDENQSPRSFQKKTRHYFIAAVERLWDYGMSSSPHVLRNRAQSGSVPQFKKVVFQEFTDGSFTQPLYRGELNEHLGLLGPYIRAEVEDNIMVT
(positions 437-571 of SEQ ID NO: 1), which are each “an amino acid sequence as shown in SEQ ID NO: 1” as required by claim 1. Although the originally elected species of SEQ ID NO: 2 does not comprise SEQ ID NO: 8, the originally elected species of instant SEQ ID NO: 2 is understood to comprise “an amino acid sequence as shown in SEQ ID NO: 8”, namely, the originally elected species comprises PPVLKRHQR (positions 437-445) and SEENNDSK (positions 336-344), which are each “an amino acid sequence as shown in SEQ ID NO: 8”. Accordingly, the originally elected species reads upon instant claims 1-2 and 10.
Following extensive search and examination, the originally elected species consisting of SEQ ID NO: 2 (CAS No. 2712661-42-0) has been deemed free of the prior art3.
Per MPEP § 803.02(III)
If the examiner determines that the elected species is allowable over the prior art, the examination of the Markush claim will be extended. If prior art is then found that anticipates or renders obvious the Markush claim with respect to a nonelected species, the Markush claim shall be rejected; claims to the nonelected species would still be held withdrawn from further consideration. The prior art search will not be extended unnecessarily to cover all nonelected species.
Accordingly, Examination was extended to a non-elected subgenus of species comprising instant SEQ ID NO: 2 (CAS No. 2712661-42-0), which was subsequently deemed free of the art. Examination was extended to a non-elected subgenus of species consisting of, or comprising, instant SEQ ID NO: 1 (CAS No. 2712661-41-9), which was subsequently deemed free of the art4.
Examination was then extended to the non-elected species comprising “an amino acid sequence as shown in SEQ ID NO: 1”, namely the species of sequence corresponding to SEQ ID NO: 6 of US 9447168. Following extensive search and examination, the non-elected species was deemed anticipated and/or obvious in view of the prior art as applied below. Per MPEP § 803.02(III), claims directed to other nonelected species have been withdrawn.
Claims 3-9, and 12-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/02/2026.
Claims 1-2 and 10 are presently considered.
Priority
Examiner notes that no certified translation of the Foreign Application CN202110455812.5 (04/26/2021) and CN202110762308.X (7/06/2021) has been placed on record. If applicant wants the application to be accorded benefit of the non-English language application, a certified translation is required (see 35 U.S.C. 119(b)(3), 37 CFR 1.55(g)(1)-(4)). Applicant is advised that any showing of priority that relies on a non-English language application is prima facie insufficient if no certified translation of the application is on file. See 37 CFR 41.154(b).
Information Disclosure Statement
The IDS filed 10/25/2023 is acknowledged and presently considered.
Claim Interpretation
For purposes of examination, the claim scope has been interpreted as set forth below per the guidance set forth at MPEP § 2111. If Applicant disputes any interpretation, Applicant is invited to unambiguously identify any alleged misinterpretations or specialized definitions in the subsequent response to the instant action. Applicant is advised that a specialized definition should be properly supported and specifically identified (see, e.g., MPEP § 2111.01(IV), describing how Applicant may act as their own lexicographer).
Claim 1 is representative of the pending claim scope and presently recites:
1. (Currently amended) A recombinant coagulation factor VIII, comprising an amino acid sequence as shown in SEQ ID NO: 1.
Accordingly, the claims are directed to products, namely polypeptide sequence. Additional claim interpretations are set forth below.
“Comprising” is an open-ended transitional term (see, e.g., MPEP § 2111.03(I)), wherein additional steps or components are not excluded. However, “‘[c]omprising’ is a term of art used in claim language which means that the named elements are essential” (see, e.g., id.; see also Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d 1608, 1613 (Fed. Cir. 1997)).
Claims 1 recites the phrase “comprising an amino acid sequence as shown in SEQ ID NO: 1”, and claim 2 recites the phrase “comprising an amino acid sequence as shown in SEQ ID NO: 8”. This phrasing, and the use of the term "an" rather than "the" impacts the claim scope and interpretation as follows: The phrase
"A biopolymer comprising a sequence of SEQ ID NO: 1"
encompasses biopolymers comprising the full-length SEQ ID NO: 1 and also any subsequence of 2 or more units within SEQ ID NO: 1. However, the phrase
"A biopolymer comprising the sequence of SEQ ID NO: 1"
encompasses only biopolymers comprising the full-length of SEQ ID NO: 1. If the language is changed to closed, replacing "comprising” with “consisting of”, then the first example above would encompass any biopolymer sequence of two or more units fully contained within SEQ ID NO: 1, whereas the second example would be limited to the exact biopolymer as specified by SEQ ID NO: 1, and nothing more or less. If qualifying language is present (i.e., polynucleotide", "protein", "polypeptide", "oligopeptide", etc.), then the specification is consulted to determine whether or not an explicit definition is provided that imposes a lower limit on the size of biopolymer encompassed by the qualifying terminology. For purposes of examining and interpreting the instant claim scope, the preamble of claims 1-2 each recite and require a “recombinant coagulation factor VIII”, which is reasonably understood to limit the claim scope to either a sequence explicitly identified in the prior art as a coagulation factor VIII polypeptide, or otherwise to a sequence sharing at least 80% sequence identity with either instant SEQ ID NO: 1 or 2 (see, e.g., Spec. filed 10/25/2023 at 2 at lines 1-10). Accordingly, the present claims reciting “comprising an amino acid sequence as shown in SEQ ID NO: 1”, or “comprising an amino acid sequence as shown in SEQ ID NO: 8” are reasonably understood to encompass any “recombinant coagulation factor VIII” comprising any subsequence of 2 or more units within SEQ ID NO: 1 (or SEQ ID NO: 8 at claim 2). This interpretation is consistent with the originally elected species and amended claim scope as filed 7/02/2026, and is consistent with instant claim 2, which would otherwise be rejected under 35 USC 112(d) since sequences comprising SEQ ID NO: 1 inherently and necessarily comprise SEQ ID NO: 8.
If Applicant wishes to limit the claim scope to only sequences comprising SEQ ID NO: 1, Applicant should amend the claims to recite language such as “comprising SEQ ID NO: 1” or “comprising the sequence of SEQ ID NO: 1”.
Additional claim interpretations are discussed below.
Drawings
The drawings filed 10/25/2023 are acknowledged and accepted.
Claim Rejections
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2 and 10 are rejected under 35 U.S.C. 102(b) as being clearly anticipated by US9447168 (Sep. 20, 2016)
Claim interpretation: The applicable claim interpretation has been set forth in a preceding section above, and those interpretations are incorporated into the instant rejection. The interpretation of “an” compared to “the” is discussed above. Additional claim interpretations are set forth below.
Regarding instant claims 1-2, and 10, US’168 teaches and discloses SEQ ID NO: 6, which is identified as a Coagulation Factor VIII (see, e.g., US’168 at 7 at lines 50-65, SEQ ID NO: 6, claims 1 and 6). A sequence alignment between the prior art sequence and instant SEQ ID NO: 1 is provided below:
PNG
media_image1.png
310
680
media_image1.png
Greyscale
The prior art sequence satisfies instant claim 1 because the prior art sequence comprises “an amino acid sequence as shown in SEQ ID NO: 1”, including, for example, the sequences at positions 623 to 743 (i.e., corresponding to positions 1-121 of instant SEQ ID NO: 1). The prior art sequence satisfies instant claim 2 because the prior art sequences comprises “an amino acid sequence as shown in SEQ ID NO: 8”, including “SFSQNAT” and “PPVLKRHQR” within positions 743 and 800 of SEQ ID NO: 6 (see, e.g., sequence alignment above; compare id. with instant SEQ ID NO: 8). In summary, US’168 clearly teaches and discloses a Coagulation Factor VIII sequence comprising “an amino acid sequence as shown in SEQ ID NO: 1” and comprising “an amino acid sequence as shown in SEQ ID NO: 8”, as required by instant claims 1-2. Regarding instant claim 10, US’168 explicitly teaches that SEQ ID NO: 6 is a coagulation factor VIII sequence (see, e.g., US’168 at 7 at lines 50-65, SEQ ID NO: 6, claims 1 and 6), explicitly identifies that such proteins are usable in the treatment of hemophilia (see, e.g., US’168 at col. 17 at lines 4-15, noting that the invention includes administering an effective amount of a protein according to the invention to a patient suffering from hemophilia). Accordingly, an artisan would at once envisage SEQ ID NO: 6 in combination with a pharmaceutically acceptable carrier as necessary and required to practice such treatment methods.
Accordingly, claims 1-2 and 10 are anticipated by the prior art.
Examiner Notes
The following notes should not be interpreted as indicative that additional claims have been examined on the merits at this time; rather, such notes represent concerns incidentally noted during the examination of the originally elected invention and species. However, these notes have been set forth on record to facilitate compact prosecution by permitting the Applicant an opportunity to review potential issues that may arise prior to allowance.
Examiner suggests amending claim 1 to limit the claim scope to sequences comprising the full-length sequences of instant SEQ ID NO: 1 and SEQ ID NO: 2, such as follows:
1. A recombinant coagulation factor VIII, comprising either or SEQ ID NO: 2.
This resolves the issue of “an” versus “the” by excluding subsequences, and also limits claim 1 to allowable subject matter.
At claim 10, the phrase “further comprises any one or a combination of at least two of a pharmaceutically acceptable carrier, excipient or diluent” may be drafted in a clearer manner. For example, “further comprises at least a pharmaceutically acceptable carrier, excipient or diluent” or “further comprises a pharmaceutically acceptable carrier, excipient and/or diluent” more concisely conveys the claim scope.
Claim 13 recites “pEGWI”, but it is unclear if this is an unambiguous, art-recognized sequence or not. Figure 1 does not provide a SEQ ID NO, Genbank number, CAS No., or other art-recognized identifier. Upon examination, this may raise issues under 35 USC 112(a) and (b).
Claim 14 has not yet been examined, but appears to raise concerns because it depends from claim 13, but appears to exclude the limitations of claim 13 (i.e., claim 14 appears to exclude pEGWI), which raises concerns under 35 USC 112(d).
Claim 15 has not yet been examined, but appears to raise concerns because “U3” is not fully spelled out, and because claim 15 depends from claim 13, but appears to exclude the limitations of claim 13 (i.e., claim 15 appears to exclude pEGWI), which raises concerns under 35 USC 112(d).
Claim 17 has not yet been examined, but appears to raise concerns because it depends from claim 1, which is not limited to pharmaceutical compositions but instead includes pure protein powders. Examiner notes that claim 17 could be simply amended to depend from claim 10, which would address this potential concern by limiting claim 17 to pharmaceutical compositions.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RANDALL L BEANE whose telephone number is (571)270-3457. The examiner can normally be reached Mon.-Fri., 7 AM to 2 PM ET.
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 G. 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/RANDALL L BEANE/Primary Examiner, Art Unit 1654
1 Notice that “an” and “the” impact the pending claim scope as explained in the claim interpretation section, below.
2 Notice that “an” and “the” impact the pending claim scope as explained in the claim interpretation section, below.
3 The point of novelty is understood to be the transition point between positions around 439 and 440, which includes, for example, the novel subsequence from positions around position 400 to positions 496, which is NRKTHIDGPSLLIENSPSVWQNILESDTEFPPVLKRHQREITRTTLQSDQEEIDYDDTISVEMKKEDFDIYDEDENQSPRSFQKKTRHYF. See search notes.
4 The point of novelty is understood to be instant SEQ ID NO: 8. See search notes.
Prosecution Insights