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 .
Support for the amendments is within the instant application specification.
Applicant’s amendment to the claims filed on 12/5/2025 in response to the Non-Final Rejection mailed on 9/10/2025 is acknowledged. This listing of claims replaces all prior listings of claims in the application.
Claims 1-6 are examined on the merits
Claims 7-10 stands withdrawn pursuant to 37 CFR 1.142(b).
Applicant’s remarks filed on 12/5/2025 in response to the Non-Final Rejection mailed on 9/10/2025 have been fully considered and are deemed persuasive to overcome at least one of the rejections and/or objections as previously applied.
The text of those sections of Title 35 U.S. Code not included in the instant action can be found in the prior Office Action.
Withdrawn Objections
The objection to the sequence listing is withdrawn in view of Applicant’s amendment specifically directing entry of the "Sequence Listing" part of the disclosure into the application in accordance with 1.825(b)(2).
Withdrawn Rejections
The rejection of claims 1-6 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, is withdrawn in view of Applicant’s amendment of claim 1 to recite, ‘the amino acid sequence of the recombinant human collagen is SEQ ID NO. 1: GPAGARGNDGATGAAGPPGPTGPAGPPGFP.’
The rejections of claims 1-6 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, is withdrawn in view of Applicant’s amendment of claim 1 to recite, ‘the amino acid sequence of the recombinant human collagen is SEQ ID NO. 1: GPAGARGNDGATGAAGPPGPTGPAGPPGFP.’
Maintained 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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The rejection of claims 1-6 under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter is maintained. The rejection has been modified in view of Applicant’s amendment of claim 1 to recite ‘the amino acid sequence of the recombinant human collagen is SEQ ID NO. 1: GPAGARGNDGATGAAGPPGPTGPAGPPGFP.’ The claims do not fall within at least one of the four categories of patent eligible subject matter because the claimed invention is a naturally occurring microorganism.
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
Yes, the claim is drawn to a composition of matter, which is one of the four statutory categories.
Step 2, Prong One: Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Yes, the claim is directed to a natural phenomenon (product of nature). Said natural phenomenon is a recombinant human collagen (Appendix B).
As amended, claims 1-6 are drawn to a recombinant human collagen, wherein, the amino acid sequence of the recombinant human collagen is SEQ ID NO. 1: GPAGARGNDGATGAAGPPGPTGPAGPPGFP. In the broadest reasonable interpretation of the claim, said recombinant protein is genetically unmodified and naturally occurring as it is human collagen alpha 1 (appendix B). The claim includes a nature-based product that does not exhibit markedly different characteristics from its naturally occurring counterpart in its natural state, the claim recites a "product of nature," which is a judicial exception.
Step 2, Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application?
Claim 2 includes the additional element of the recombinant human collagen has a single-chain single-helix structure, presents a sequence feature of a collagen "Gly-X-Y", X and Y being any amino acids other than glycine, has a full length of 30 amino acids. Such a limitation is native to the protein (appendix B). Therefore, it does not integrate the judicial exception into a practical application.
Claim 3 merely recites the recombinant human collagen has a molecular mass of 2526.71Da and a theoretical isoelectric point of 5.84. Again, such a limitation is native to the protein as it is merely a measure of its amino acid composition. Therefore, it does not integrate the judicial exception into a practical application.
Claim 4 recites the additional element of the recombinant human collagen not having a signal peptide and a transmembrane domain and is a hydrophilic protein. Said limitation is native to the protein. Therefore, it does not integrate the judicial exception into a practical application.
Claim 5 recites the additional element of the recombinant human collagen being free of an antigenic determinant and is a low- immunogenic protein. Said limitation is native to the protein. Therefore, it does not integrate the judicial exception into a practical application.
Claim 6 recites the additional element of the recombinant human collagen being capable of forming a random coil structure. Again, said limitation is native to the protein. Therefore, it does not integrate the judicial exception into a practical application.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
No. The judicial exception is recited without additional limitations amounting to significantly more than the exception. All of the signified additional elements to the judicial exception are considered to be native to the protein on which the judicial exception is to be performed as noted in Step 2A, Prong 2, and, therefore, do not amount to significantly more than the judicial exception that is claimed.
As the instant claims recite judicial exceptions that are not integrated into practical application, and no elements that amount to significantly more than the judicial exception as recited, the claims were found not to be drawn to eligible subject matter under 35 U.S.C. 101.
RESPONSE TO REMARKS: Applicant's arguments filed 12/5/2025 have been fully considered but they are not persuasive. Beginning on p. 7 of Applicants’ remarks, Applicants in summary contends that the claimed invention, a recombinant human collagen consisting of the amino acid sequence of SEQ IDNO: 1, is patent-eligible subject matter because it is a non-naturally occurring, man-made composition with "markedly different characteristics" from any naturally existing substance. Applicant contends that in nature, this exact sequence does not exist as a discrete, isolated molecule but is embedded within a complex, full-length protein. As a standalone entity, it is structurally distinct, lacking the complex triple-helical quaternary structure of native collagen.
These arguments are found to be not persuasive. Examiner contends that Applicant has not has claimed a ‘discreet’ recombinant human collagen. Absent evidence otherwise, Examiner contends that Applicant does not have ‘consisting of’ language with the claim that would define the claimed recombinant amino acid sequence as ONLY consisting of SEQ ID NO: 1. Examiner contends that as written, the claim language can be interpreting as ‘comprising’ recombinant human collagen SEQ ID NO:1. Examiner contends that the recitation ‘the’ amino acid sequence merely limits the recombinant protein to also contain SEQ ID NO: 1. Examiner contends that said recitation does not limit the recombinant protein to only consisting of SEQ ID NO: 1. In order to make the record clear, if Applicant amends the claim to “consisting of”, it still does not overcome the rejection, becoming eligible under 35 USC 101 because it is a fragment of the full length natural collagen and whatever characteristic that comes out of such fragment would be inherent to that natural fragment.
Applicant contends that the amino acid was specifically selected and designed to achieve a particular technical purpose, namely, free of antigenic determinants to exhibit low immunogenicity, a property that is not inherent to the native, full-length protein in its natural environment.
These arguments are found to be not persuasive. Examiner contends that Applicant has not adequately disclosed within the breadth of the instant application claims how SEQ ID NO: 1 is ‘specifically selected and designed’ differently than the naturally occurring peptide as the instant application SEQ ID NO: 1 is 100% identical to aa 317-346 of human collagen type I (appendix B), which is indeed naturally occurring. Additionally, Applicant appears to be claiming a fragment of the natural full length collagen which may impart these characteristics inherently. Calling this product “recombinant” is misplaced, as Applicant has not disclosed any genetically engineered macromolecule that would make it ‘distinctly different’ from the naturally occurring protein.
Applicant contends that all naturally occurring proteins require localization signals to function within a cell. The complete absence of such signals demonstrates that this molecule is not functional and does not exist in any natural biological system; it is an artificial construct designed for industrial application.
These arguments are found to be not persuasive. Examiner contends that Applicant’s own admission is that the instant application SEQ ID NO: 1 lacks a ‘localizing signal,’ and is therefore non-functional. Applicant is reminded that a product must have a "useful" function to pass the initial eligibility test under 35 U.S.C. § 101, meaning it needs a specific, substantial, and credible utility; otherwise, it can be rejected for lack of utility, even if it's a physical item, as it must provide a practical benefit and not just be an abstract idea or frivolous concept, requiring clear demonstration in the patent application. Applicant assertation that ‘it is an artificial construct designed for industrial application’ is not enough to overcome the 101 rejection. Additionally, if Applicant is claiming collagen, it needs to have the properties of collagen. If Applicant is claiming non-functional protein, then Applicant should not be calling the protein collagen.
Maintained 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.
The rejection of claims 1-6 under 35 U.S.C. 102(a)(1) as being anticipated by Gao et al (CN102925451A, Date of Publication: 2014-06-04, cited on PTO-892 dated 9/10/2025) {herein Gao} is maintained. The rejection has been modified in view of Applicant’s amendment of claim 1 to recite ‘the amino acid sequence of the recombinant human collagen is SEQ ID NO. 1.’
As amended, claims 1-6 are drawn to a recombinant human collagen, wherein, the amino acid sequence of the recombinant human collagen is SEQ ID NO. 1: GPAGARGNDGATGAAGPPGPTGPAGPPGFP.
With respect to claims 1-3, 6, Gao teaches a recombinant type I human collagen segment comprised of 30 amino acids that is able to drive protein expression (page 2, para 3-4; page 5, para 7). The amino acid sequence of the motif of amino acids 302 to 346 of type I human collagen is: GPRGLPGERG RPGAPGPAGA RGNDGATGAA GPPGP TGPAG PPGFP (same as instant application SEQ ID NO: 1; appendix A) (page 2, para 3-4). Said human collagen is comprised of 30 amino acids and a sequence feature of a collagen "Gly-X-Y", X and Y being any amino acids other than glycine (Appendix A and page 5, para 7, page 6, para 1). Examiner is interpreting the type I human collagen segment (page 5, para 7) as a recombinant human collagen as it is produced in a laboratory using genetic engineering techniques. Absent evidence otherwise, It is the Examiner’s position that the recombinant human collagen taught by Gao would necessarily have a single-chain single-helix structure, a molecular mass of 2526.71Da, a theoretical isoelectric point of 5.84 and be capable of forming a random coil structure. Since the Office does not have the facilities for examining and comparing Applicants’ recombinant human collagen with the recombinant human collagen of the prior art, the burden is on the Applicant to show a novel or unobvious difference between the claimed product and the product of the prior art (i.e., that the recombinant human collagen of the prior art does not possess the same material structural and functional characteristics of the claimed recombinant human collagen). See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald et al., 205 USPQ 594. ‘ Examiner is interpreting the recitation of ‘the recombinant human collagen is capable of forming a random coil structure’ as said invention not being required to be in the process of ‘forming a random coil structure.’ Said recombinant human collagen does not need to be in the process of forming a random coil structure. They only need to be capable of forming a random coil structure. As such, Examiner is interpreting said invention to be capable of forming a random coil structure since Gao encompasses the limitations of the claims.
With respect to claim 4, Gao teaches during the process of protein fermentation and secretion, proteases in the cell wall cleave the signal peptide cleavage site, releasing human growth hormone (page 5, para 1). As such, Examiner is interpreting the recombinant human collagen as not having a signal peptide, as the signal peptide is cleaved during experimentation. Absent evidence otherwise, It is the Examiner’s position that the recombinant human collagen taught by Gao would necessarily not have a transmembrane domain and be a hydrophilic protein. Since the Office does not have the facilities for examining and comparing Applicants’ recombinant human collagen with the recombinant human collagen of the prior art, the burden is on the Applicant to show a novel or unobvious difference between the claimed product and the product of the prior art (i.e., that the recombinant human collagen of the prior art does not possess the same material structural and functional characteristics of the claimed recombinant human collagen). See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald et al., 205 USPQ 594. ‘
With respect to claim 5, Gao teaches the amino acid sequence of the human growth hormone fused to the human collagen type I is synthesized in mammalian cells (page 2, para 1). Gao further teaches that since the peptide is synthesized in mammalian cells, not E. coli, it poses no risk of contamination and reduces antigenicity (page 2, para 1). As such, Examiner is interpreting the recombinant human collagen to be free of antigenic determinant and be a low-immunogenic protein.
For the reasons stated herein, the teachings of Gao anticipate claims 1-6.
RESPONSE TO REMARKS: Applicant's arguments filed 12/5/2025 have been fully considered but they are not persuasive. Beginning on p. 8 of Applicants’ remarks, Applicants in summary contends that
Gao et al. does not anticipate claims 1-6 because it fails to disclose the claimed invention: a discrete recombinant human collagen consisting of the 30-amino-acid sequence SEQ IDNO: 1.
These arguments are found to be not persuasive. Examiner contends that Gao does anticipate claims 1-6 with the teaching of the amino acid sequence of the motif of amino acids 302 to 346 of type I human collagen is: GPRGLPGERG RPGAPGPAGA RGNDGATGAA GPPGP TGPAG PPGFP (same as instant application SEQ ID NO: 1; appendix A) (page 2, para 3-4) as Applicant has not has claimed a ‘discreet’ recombinant human collagen. Absent evidence otherwise, Examiner contends that Applicant does not have ‘consisting of’ language with the claim that would define the claimed recombinant amino acid sequence as ONLY consisting of SEQ ID NO: 1. Examiner contends that as written, the claim language can be interpreting as ‘comprising’ recombinant human collagen SEQ ID NO:1. Examiner contends that the recitation ‘the’ amino acid sequence merely limits the recombinant protein to also contain SEQ ID NO: 1. Examiner contends that said recitation does not limit the recombinant protein to only consisting of SEQ ID NO: 1.
Applicant contends Gao et al discloses a much longer, different sequence-a motif spanning amino acids 302-346 of the native collagen preproprotein. Applicant contends that the Examiner's analysis, which relies on extracting a sequence fragment from Gao et al's longer disclosure, constitutes an impermissible hindsight reconstruction of the prior art.
These arguments are found to be not persuasive. Examiner contends that although Gao also discloses a longer peptide that encompassed SEQ ID NO: 1, it does not negate the fact that based on the teaching of the amino acid sequence of the motif of amino acids 302 to 346 of type I human collagen is: GPRGLPGERG RPGAPGPAGA RGNDGATGAA GPPGP TGPAG PPGFP (same as instant application SEQ ID NO: 1; appendix A) (page 2, para 3-4), Gao also clearly teaches the truncated type I human collagen. Examiner contends that Examiner’s reasoning takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant’s disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Applicant contends the specification demonstrates that the specific, isolated 30- amino-acid peptide of SEQ ID NO:1 possesses unique and beneficial properties, such as the ability to form a stable single-chain, single-helix structure that is free of antigenic determinants, low immunogenicity (does not elicit immunological rejection when applied to human body), making it suitable for specific industrial applications and is soluble in water.
These arguments are found to be not persuasive. Examiner contends that since Gao teaches the structure of SEQ ID NO: 1, it would inherently have the recited characteristics as Applicant has not claimed ANY differences in the design of the polypeptide, as encompassed by the claims (Appendix A).
Conclusion
Status of the claims:
Claims 1-6 are pending and examined on the merits
Claims 7-10 stands withdrawn pursuant to 37 CFR 1.142(b).
Claims 1-6 are rejected.
No claims are in condition for allowance.
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 ERICA NICOLE JONES-FOSTER whose telephone number is (571)270-0360. The examiner can normally be reached mf 7:30a - 4:30p.
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, Manjunath Rao can be reached at 571-272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERICA NICOLE JONES-FOSTER/Examiner, Art Unit 1656
/MANJUNATH N RAO/Supervisory Patent Examiner, Art Unit 1656
Appendix A
SEQ ID NO: 1 vs Gao et al
Query Match 100.0%; Score 173; Length 242;
Best Local Similarity 100.0%;
Matches 30; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 GPAGARGNDGATGAAGPPGPTGPAGPPGFP 30
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Db 16 GPAGARGNDGATGAAGPPGPTGPAGPPGFP 45
Appendix B
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