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 .
Drawings
The drawings submitted on 08/24/2022 are accepted.
Priority
This application claims benefit of priority to Provisional Application 62/983,077 filed on 02/28/2020 and is also a 371 of PCT/US2021/019338 filed on 02/24/2021. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Amendment and Claim Status
In the reply filed on 09/02/2025, Applicant amended claims 1-3 and 7 and added new claims 18-19. Claims 4-6 and 8-17 were previously withdrawn by the Examiner as not being encompassed by the elected group.
Claims 1-19 are currently pending.
Claims 4-6 and 8-17 are withdrawn from consideration.
Claims 1-3, 7 and 18-19 are under examination.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-3 and 7 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims do not fall within at least one of the four categories of patent eligible subject matter because the claims are directed to a product of nature.
Claims 1-3 and 7 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a non-eligible natural product as supported below.
STEP 1: Is the claim to a process, machine, manufacture or composition of matter?
Answer to STEP 1: Yes, claim 1 is directed toward a Fibrinogen C Domain Containing 1 (Fibcd1) fragment and is thus a product.
STEP 2: Is the claim directed to a law of nature, a natural phenomenon or an abstract idea (judicially recognized exceptions)?
Step 2 comprises two, respective steps: Step 2A Prong 1 and Step 2A Prong 2.
STEP 2A, PRONG 1: Does the claim recite an abstract idea, law of nature or natural phenomenon?
A claimed product is ‘directed to’ a natural phenomenon if the product of the claim is not ‘markedly different’ from its closest-occurring natural counterpart.
With regard to STEP 2A, PRONG 1:
The invention of claim 1 is an Fibcd1 fragment. This amino acid sequence, according to a preponderance of evidence, is a naturally-occurring amino acid sequence from a human. The evidence to support the claimed Fibcd1 fragment is naturally-occurring comes from the instant Specification which states Fibcd1 is a conserved type II transmembrane endocytic receptor and Fibcd1 includes isoforms and orthologs of human Fibcd1 which are naturally expressed by cells (Specification, Paragraph [0015]). Additionally, instant claim 1 recites a Fibcd1 fragment, variant and/or derivative thereof, and as amended, recites SEQ ID NO. 2. Instant SEQ ID NO. 2 shares 100% sequence identity with human Fibcd1. However, the instant Specification does state the sequence of the wild-type human Fibcd1 protein is known and available (Specification, Paragraph [0015]).
Although the preamble recited a recombinant Fibcd1, since there is no evidence the sequence is artificial in any way, Fibcd1 is interpreted as a naturally-occurring amino acid sequence. Thus, as the sequence is naturally-occurring, there is no difference in the Fibcd1 fragment as claimed and Fibcd1 as it occurs in nature. Therefore, when compared to its closest-naturally-occurring counterpart which is the naturally-occurring Fibcd1, there is no difference between the amino acid sequence of Fibcd1 as-claimed and the naturally-occurring counterpart within a human.
Even when considering the fragment lacks at least N-terminal residues 1-175 of Fibcd1 and has a length of at least 270 amino acid residues, the claims are still not eligible. Removing N-terminal residues 1-175 does not make the claims eligible as the fragment is still a naturally occurring fragment wherein the fragment was created by removing a portion of the naturally occurring Fibcd1. Similarly, the fragment being at least 270 amino acids in length does not make the claims eligible because the fragment is still a naturally occurring fragment wherein a specific number of amino acids of the naturally occurring Fibcd1 are present. Therefore, as a whole, the claims are ineligible as they are drawn to a naturally occurring Fibcd1 fragment.
Additionally, dependent claim 3, which further narrows independent claim 1, states the Fibcd1 fragment comprises residues 241-457 of SEQ ID NO: 2. Applicant indicates in the sequence file that SEQ ID NO: 2 is an artificial sequence. However, in the instant Specification Applicant indicates SEQ ID NO: 2 is defined as the human Fibcd1 protein (Specification, Paragraph [0017]). For further clarification, an alignment was performed using ABSS with instant SEQ ID NO: 2 and the known wild-type human Fibcd1 protein represented by UniProt Accession No. Q8N539. The amino acid sequence alignment showed 100% sequence identity between the two sequences. Thus, this is further evidence the Fibcd1 fragment as claimed is a naturally-occurring amino acid sequence.
Regarding dependent claim 7, which includes a pharmaceutically acceptable carrier in admixture with the Fibcd1 fragment, water is a pharmaceutically acceptable carrier. Water, generally, is present in all cells in the body. Thus, the claimed Fibcd1 fragment admixed with water, which is also naturally occurring, is no different than the Fibcd1 fragment as it occurs in nature, being the human body.
The claimed Fibcd1 is no different from the protein as it is found naturally within humans. Even if it was ‘isolated’ or ‘purified’ such a ‘hand of man’ is not demonstrative of a marked difference between the natural amino acid sequence of Fibcd1 as-claimed as there is nothing present within the claim which specifically focuses on any chemical changes due to isolating the protein from its natural habitat, the human cell; nor do Applicants disclose if such a protein were isolated, that any such chemical changes would manifest a marked difference from the naturally-occurring protein counterpart.
Court in Myriad*:
Nor are Myriad's claims saved by the fact that isolating DNA from the human genome severs chemical bonds and thereby creates a nonnaturally occurring molecule. Myriad's claims are simply not expressed in terms of chemical composition, nor do they rely in any way on the chemical changes that result from the isolation of a particular section of DNA. Instead, the claims understandably focus on the genetic information encoded in the BRCA1 and BRCA2 genes. …claim is concerned primarily with the information contained in the genetic sequence, not with the specific chemical composition of a particular molecule.(Id., emphasis added)
Identical to the issue in Myriad, Applicants did not create or alter the sequence of the Fibcd1 protein derived from humans which occurs in nature; on the contrary, the location and order of amino acids as-claimed existed in nature before Applicants’ invention. The information contained in Fibcd1 as-claimed is the same amino acid sequence that occurs in nature, in humans from which Fibcd1 was derived, and the instant claim, like the claim in Myriad, sets forth no additional characteristics which would account for any structure or function that would be different from the naturally-occurring sequence.
Answer to STEP 2A, PRONG 1: Yes, the claim recites a natural product (‘natural phenomenon’).
STEP 2A, PRONG 2: Does the claim recite additional elements that integrate the natural product into a practical application?
‘Integration into a practical application” according to the most recent PEG guidance:
Requires an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the exception.
Uses the considerations laid out by the Supreme Court and the Federal Circuit to evaluate whether the judicial exception is integrated into a practical application.
With regard to STEP 2A, PRONG 2:
The Examiner contends that there is no additional element in claim 1 aside from the naturally-occurring product and thus concludes that the naturally-occurring protein of claim 1 cannot demonstrate integration into a practical application. Moreover, claim 1 is a product claim and not a method claim and does not recite any physical manifestation of any application whatsoever. Thus:
-There is no showing of an improvement,
- The claim does not apply the product of nature to a particular treatment,
- The claim does not effect a transformation or reduction to a different state or thing.
The claim is directed toward a Fibcd1 protein amino acid sequence and nothing more. As discussed in Step 2A, Prong 1, at least claim 1 states nothing with regard to the structure of the amino acid sequence aside from the sequence itself which is a naturally-occurring amino acid sequence from humans. Even if the TC were to argue the amino acid must be isolated, the claim is not directed to an isolated or purified protein. The claim is also not directed to a method for treating or even applying the naturally-occurring genetic information.
In Myriad, the fact that identification and isolation of the BRCA1 and BRCA2 genes was novel and useful for diagnostic procedures was not enough to surmount non-eligibility since it is the scope of the claimed product which is compared to its naturally-occurring counterpart to determine if the claimed product is a Judicial Exception. There is no difference between the characteristics of the Myriad case and the characteristics of the instant case: claim 1 is directed to a Judicial Exception, a naturally-occurring Fibcd1 protein having a naturally-occurring amino acid sequence which was not altered in any way as-was the case in Myriad.
The evidence set forth in the instant Disclosure is enough to determine that the sequence as-claimed is in-fact naturally-occurring and is not artificial. Therefore, the claim contains no element(s) in addition to the JE and therefore does not integrate the JE into a practical application.
Answer to STEP 2A, PRONG 2: No, the claim does not recite additional elements that integrate the JE into a practical application.
Answer to STEP 2A: Yes, the claim is directed to a Judicial Exception.
STEP 2B: Does the claim recite additional elements that amount to significantly more than the JE?
As discussed under Step 2A, prong 1, there are no additional elements claimed in addition to the JE and for this reason, claim 1 does not set forth ‘significantly more’ than the JE. This conclusion is consistent with the decision in Myriad and as recapitulated in Eligibility Example 2 as presented in the Federal Register Vo. 79, No. 241 (commencing on page 74625).
Thus, the claimed amino acid sequence is not different from what exists in nature to avoid non-eligibility. Applicants did not invent the claimed sequence, rather, the claimed sequence was made by nature. The claimed sequence further imparts no structural characteristics that are not found in the sequence as it occurs in nature.
The claim is focused on the Fibcd1 protein having the amino acid sequence itself which was made by nature. Again, even if the protein were ‘isolated’ or ‘purified,’ amino acids explained by the Court in Myriad:
…[the] act of separating [the] gene from surrounding genetic material is not act of invention, since discovery of location of gene sequence does not render isolated genes new compositions of matter, since extensive effort alone does not satisfy Section 101 patent eligibility requirements, since claims are not patent eligible on grounds that isolating DNA from human genome severs chemical bonds and thus creates non-naturally occurring molecule, in that claims are not expressed in terms of chemical composition and do not rely on chemical alterations that result from DNA isolation, but instead focus on genetic information encoded in BRCA1 and BRCA2 genes, and since U.S. Patent and Trademark Office's past practice of awarding gene patents is not entitled to deference, in that U.S. Congress has not endorsed views of PTO in legislation, and U.S. government has argued against patent eligibility for isolated DNA. (emphasis added).
Answer to STEP 2B: No, the claims do not recite any additional elements that amount to significantly more than the judicial exception.
For the foregoing reasons, claim 1 is rejected under 35 USC 101 for being directed toward non-eligible subject matter because the claim merely identifies a Fibcd1 protein having an amino acid sequence which is naturally-occurring; a Judicial Exception, which is not markedly different from its naturally-occurring counterpart and does not recite additional elements which integrate the natural product into a ‘practical application’ or which contributes ‘significantly more’ than the judicial exception itself .
35 USC § 101 – Response to Arguments
In the reply filed on 09/02/2025, Applicant made multiple arguments which will be addressed below.
Applicant argued claim 1 is not drawn to the full-length Fibcd1 protein, but rather, a fragment comprising a fibrinogen-related domain consisting of residues 241-457 of Fibcd1 of SEQ ID NO. 2, or an ortholog thereof, that lacks N-terminal residues 1-175 of Fibcd1 of SEQ ID NO. 2 or an ortholog thereof, and has a length of at least 270 amino acids (Page 2, Paragraph 2 under 101).
The Examiner agrees claim 1, as amended, is drawn to the fragment described above, not the entire Fibcd1 protein. However, as the fragment described above is a part of the Fibcd1 in humans, it is still a naturally-occurring amino acid sequence.
Applicant further argued “the key to the eligibility of all non-naturally occurring products is whether they possess markedly different characteristics from any naturally occurring counterpart” and pointed to MPEP 2106.04(II) (Page 2, Paragraph 3 under 101).
Applicants argument have been fully considered, but are not persuasive. It is the Examiner’s position that this is an overgeneralization of the 101 analysis because while ‘markedly different characteristics’ is a part of the analysis, it is not the only part of the analysis. As stated above, and in the Non-Final mailed on 06/04/2025, Applicants did not create nor alter the sequence of the Fibcd1 fragment which is derived from humans, the location and order of amino acids as-claimed existed in nature before Applicant’s invention. The information contained in the claimed fragment is the same amino acid sequence that occurs in nature, and similar to the Myriad case (cited above) sets forth no additional characteristics which would account for any structure or function that would be different from the naturally-occurring sequence. Thus, there are not markedly different characteristics seen.
Additionally, the courts have emphasized that to show a marked difference, a characteristic must be changed as compared to nature, and cannot be an inherent or innate characteristic of the naturally occurring counterpart or an incidental change in a characteristic of the naturally occurring counterpart. Myriad, 569 U.S. at 580, 106 USPQ2d at 1974-75. Thus, in order to be markedly different, the inventor must have caused the claimed product to possess at least one characteristic that is different from that of the counterpart. See also MPEP 2106.04(c). Applicant has not shown, nor does Applicant argue in the response, how the claimed fragment is ‘markedly different.’
Applicant argued the Office Action does not provide evidence establishing the existence of a naturally occurring counterpart of a fragment of Fibcd1 that lacks N-terminal residues 1-175 of Fibcd1 of SEQ ID NO. 2 or an ortholog thereof, as-claimed (Page 3, Paragraph 2).
Applicant’s arguments have been fully considered but are not persuasive. UniProt discloses A0A4X2L358_VOMUR, a Fibrinogen C domain containing 1 from Vombatus ursinus (Common wombat), reading on an ortholog of the instantly claimed Fibcd1 from humans, which shares 91.9% sequence identity to instant SEQ ID NO. 2, has a length of at least 270 amino acid residues and lacks N-terminal residues 1-175 of Fibcd1 of SEQ ID NO. 2 and consists of residues 241-457 of Fibcd1 of SEQ ID NO. 2 or an ortholog thereof. A sequence alignment is provided below wherein Qy represents amino acids 241-457 of instant SEQ ID NO. 2 (1 is the 241st amino acid and 217 is the 457th amino acid) and Db represents A0A4X2L358_VOMUR.
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Claim Rejections - 35 USC § 112
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 1-3, 7 and 18-19 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.
Amended claim 1 recites “a recombinant Fibcd1 fragment, variant and/or derivative thereof” in the preamble and then defines only what the fragment is. The fragment, as-amended, comprises residues 241-457 of SEQ ID NO. 2 or an ortholog thereof, lacks N-terminal residues 1-175 of SEQ ID NO. 2 or an ortholog thereof and has a length of at least 270 amino acid residues. It is noted the instant Specification states a fragment refers to a Fibcd1 protein having an amino-terminal and/or carboxyl-terminal deletion (Paragraph [0021]), variants can have amino acid deletions (Paragraph [0022]) and also states derivatives can include amino acid deletions (Paragraph [0023]). As such, the variant or derivative of the fragment can comprise less than 270 amino acids and still read on instant claim 1 as only the fragment must contain the new limitation of 270 amino acids in length. Overall, the scope of the claims itself are unclear since it is not clear if the FibCd1 variant/derivative/fragment itself must have the structural limitations defined in (i), (ii), and (iii).Therefore claim 1, and all claims dependent upon claim 1, are rendered indefinite.
Claim 2, as-amended, recites “recombinant Fibcd1 fragment, variant and/or derivative thereof, of claim 1, wherein said fragment, variant and/or derivative thereof, is less than 400 amino acid residues in length.” It is unclear whether the fragment itself is less than 400 amino acids in length or if variant of the fragment and derivative of the fragment are all required to be less than 400 amino acids in length. Thus, claim 2 is indefinite as it is unclear exactly what is less than 400 amino acids in length.
35 USC § 112 – Response to Arguments
In the reply filed on 09/02/2025, Applicant argued paragraphs [0023] – [0029] of the instant Specification along with new claims 18-19 unambiguously define “derivative.”
Applicant’s arguments have been fully considered; however in light of the amendments of 9/2/2025, the claims are still rejected under 112b for the rationale provided above.
Claim Rejections - 35 USC § 102
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 1-3 and 7 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Fernandes et al. (US 20020168716 A1, 11/14/2002).
For the purposes of compact prosecution, the following rejection is being made on the variant embodiment and is based on claim interpretation. See 112b above.
Regarding claims 1-3, Fernandes et al. disclose SEQ ID NO: 26 which shares 100% sequence identity with residues 241-457 of the Fibcd1 fragment of instant SEQ ID NO: 2 and lacks N-terminal residues 1-175 of instant SEQ ID NO: 2. Additionally, SEQ ID NO: 26 is 269 amino acids long, reading on the fragment being less than 400 amino acid residues in length. As shown below in the alignment, Qy represents instant SEQ ID NO: 2 and Db represents SEQ ID NO: 26 of Fernandes et al.
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As stated above in the 112b, claim 1 is interpreted as meaning the fragment must comprise residues 241-457 of SEQ ID NO: 2, lack N-terminal residues 1-175 of SEQ ID NO: 2 and have a length of at least 270 amino acid residues, not the variant and/or derivative of the fragment. It is further reiterated that the instant Specification specifically states variants can include amino acid deletions of the fragment. Therefore, under the broadest reasonable interpretation, SEQ ID NO. 26 of Fernandes et al. reads on a variant of the claimed fragment with an amino acid deletion.
Regarding claim 7, Fernandes et al. disclose the proteins of the invention, and derivatives, fragments, analogs and homologs thereof, can be incorporated into pharmaceutical compositions suitable for administration (Paragraph [0236]). Further, such compositions comprise the protein and a pharmaceutically acceptable carrier (Paragraph [0236]).
Claim 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by UniProt (A0A4X2L358_VOMUR, 09/18/2019).
For the purposes of compact prosecution, the following rejection is being made on the ortholog embodiment.
Regarding claims 1-3, UniProt discloses A0A4X2L358_VOMUR, a Fibrinogen C domain containing 1 (Fibcd1) from Vombatus ursinus (Common wombat), reading on an ortholog of the instantly claimed Fibcd1 from humans, which shares 91.9% sequence identity to instant SEQ ID NO. 2, has a length of at least 270 amino acid residues and lacks N-terminal residues 1-175 of Fibcd1 of SEQ ID NO. 2 and consists of residues 241-457 of Fibcd1 of SEQ ID NO. 2 or an ortholog thereof. The sequence alignment was provided above under the 35 USC § 101 response to arguments. It is noted Applicant has not defined an ‘ortholog.’ The instant Specification states “human Fibcd1 protein as defined herein by SEQ ID NO: 2, may also include orthologs that share at least 90% identity with SEQ ID NO: 1” and goes on to give examples of orthologs to human Fibcd1. Thus, the Fibcd1 from Vombat ursinus reads on an ortholog of human Fibcd1 as it is the same gene in another species.
Therefore, UniProt anticipates instant claims 1 and 3 insofar as disclosing A0A4X2L358_VOMUR, a Fibcd1 ortholog of instant SEQ ID NO: 2 that comprises residues 241-457 of Fibcd1 of SEQ ID NO. 2, lacks N-terminal residues 1-175 of Fibcd1 of SEQ ID NO. 2 or an ortholog thereof and has a length of at least 270 amino acids. Uniprot anticipates instant claim 2 as A0A4X2L358_VOMUR is less than 400 amino acids in length.
35 USC § 102 – Response to Arguments
In the reply filed on 09/02/2025, Applicant argued Fernandes et al. do not describe a recombinant Fibcd1 fragment as claimed because the amended to instant claim 1 requires the fragment have a length of at least 270 amino acid residues.
Applicant’s arguments have been fully considered. While the Examiner agrees that the prior art does not teach a fragment of at least 270 aa residues, the 35 USC § 102 rejection over Fernandes et al. is made over the variant embodiment, not the fragment embodiment. For compact prosecution, anew rejection has been set forth below over the fragment embodiment. Per the Examiner’s claim interpretation, see 112b above, Fernandes et al. still anticipate instant claim 1-3 and 7.
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 7 and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Fernandes et al. (US 20020168716 A1, 11/14/2002) (Of Record).
For the purposes of compact prosecution, the following rejection is being made on the fragment embodiment and is based on claim interpretation. See 112b above.
Regarding claims 1 - 3, Fernandes et al. disclose novel amino acid sequences for mammalian polypeptides that have sequence similarity to human microfibril-associated glycoprotein 4 (MAG4) (Abstract). Fernandes et al. disclose SEQ ID NO: 26 which shares 100% sequence identity with residues 241-457 of the Fibcd1 fragment of instant SEQ ID NO: 2 and lacks N-terminal residues 1-175 of instant SEQ ID NO: 2. As shown below in the alignment, Qy represents instant SEQ ID NO: 2 and Db represents SEQ ID NO: 26 of Fernandes et al.
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Fernandes et al. further disclose fusion of a 6x His tag and T7 epitope to a protein for protein analysis via Western blotting (Paragraph [0459]).
Fernandes et al. do not disclose a Fibcd1 fragment that has a length of at least 270 amino acid residues.
However, as discussed above, Fernandes et al. do disclose SEQ ID NO. 26 which is 269 amino acids in length and further the fusion of a 6x His tag and T7 epitope for protein analysis. Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have fused SEQ ID NO. 26 with a 6x His tag and a T7 epitope motivated by the desire to analyze the protein and the addition of the 6x His tag and T7 epitope would create a protein with a length of at least 270 amino acid residues as the 6x His tag is 6 histidines in length and the T7 epitope is an 11 amino acid polypeptide sequence. Additionally, SEQ ID NO. 26 of Fernandes et al. with the addition of the 6x His tag and T7 epitope would still be less than 400 amino acid residues in length.
Regarding claim 7, Fernandes et al. disclose the proteins of the invention, and derivatives, fragments, analogs and homologs thereof, can be incorporated into pharmaceutical compositions suitable for administration (Paragraph [0236]). Further, such compositions comprise the protein and a pharmaceutically acceptable carrier (Paragraph [0236]).
Regarding claim 18-19, as disclosed above, Fernandes et al. disclose fusing a protein with a 6x His tag and a T7 epitope, both of which read on a polypeptide and an epitope.
Conclusion
Claims 1-3, 7 and 18-19 are rejected.
No claims are 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.
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/A.T.W./Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653