Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Detailed Action
Amended Claims 1-19 (dated 11/26/2024) are pending and now under consideration.
Priority
Acknowledgment is made of applicants’ claim for foreign priority under 35 U.S.C. 119(a)-(d). This application is a 371 of PCT/CN2023/079951 filed on 03/07/2023 and claims the priority date of China application 202210619454.1 filed on 06/01/2022; however, no English translation of said foreign priority application has been provided. Therefore, the priority date for instant claims under consideration is deemed to be the filing date of 371 of PCT/CN2023/079951 filed on 03/07/2023.
Information disclosure statement
The information disclosure statements (IDS) submitted on 11/26/2024, 05/28/2025 and 11/17/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS statements are considered and initialed by the examiner.
Claims Objections
I. Claim 3 and claims 4-5 depending therefrom; claim 12 and claim 18 are objected to, due to the following informality: Claims 3 and 18 recite the phrase “…a sequence set forth in SEQ ID NO.4, SEQ ID NO.5, or SEQ ID NO. 6”; and claim 12 reciters “…an amino acid sequence set forth in SEQ ID NO.1, SEQ ID NO.2, or SEQ ID NO.3”, as such, given that the claim language recites “… a nucleotide sequence”; and “an amino acid sequence”, it is deemed to encompass and reads on polypeptides comprising “any two/dipeptide sequences of SEQ ID NO: 1, 2 and 3 and having the recited activity. Examiner suggests amending the claim to recite “… the sequence”: “the polynucleotide sequence” and “the amino acid sequence”. Appropriate correction is required. For examination purposes claim 3 and claims 4-5 depending therefrom; claim 12 and claim 18 are interpreted to encompass variants and mutants of the recited sequence(s).
II. Furthermore, Claim 6 and claims 7-9 depending therefrom are objected for the following informality; recitation of “and/or” in claim 6 and claims 7-9 depending therefrom makes the claims indefinite, as it is not clear what limitations must be present. Correction and clarification is required. Examiner suggests amending the claim to recite “…or …”.
Claim Rejections: 35 USC § 112(b)
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.
I. Claim 3 and claims 4-5 depending therefrom; claim 12 and claim 18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claims 3 and 18 recite the phrase “…a sequence set forth in SEQ ID NO.4, SEQ ID NO.5, or SEQ ID NO. 6”; and claim 12 reciters “…an amino acid sequence set forth in SEQ ID NO.1, SEQ ID NO.2, or SEQ ID NO.3”, as such, given that the claim language recites “an amino acid sequence”, it is deemed to encompass and read on polypeptides comprising “any two/dipeptide sequences of SEQ ID NO: 1, 2 and 3” and having recited activity. Examiner suggests amending the claim to recite “the amino acid sequence” and “the polynucleotide sequence”. Appropriate correction is required. For examination purposes claims 3 and claims 4-5 depending therefrom; claim 12 and claim 18 depending therefrom are interpreted to encompass variants and mutants of the recited sequence(s). The scope of the claims are unclear, as such it is unclear how homologous/identical to the amino acid sequences of SEQ ID NOs: 1, 2, and 3; and the polynucleotide sequence of SEQ ID NOs: 4, 5 and 6 a sequence of interest must be to be included within the scope of the claims and furthermore, it is not clear whether a full-length or a partial fragments of SEQ ID NOs: of SEQ ID NOs: 1, 2, and 3 and SEQ ID NOs: 4, 5 and 6 is encompassed within the scope of the claims.
II. Claim 6 and claim 7 depending therefrom; and claim 8 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Regarding claims 6 and 8, the phrase "optionally" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
III. Claim 6 and claims 7-9 depending therefrom 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 applicant regards as the invention. Claim 6 recites the phrase “… and/or …”. The metes and bounds of claims 6-7 is not clear and thus, it would not be possible to one of ordinary skill in the art to define the metes and bounds of the desired patent protection. The rejection may be overcome by amending the claims to recite “… or …”. Clarification and correction is required
IV. Claim 12 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 12 recites the phrase “… hybridizes under medium, or high stringency conditions …”, but does not recite the conditions under which the hybridization must occur. In the art what is considered “… stringency condition being a medium stringency condition, a medium-high stringency condition, a high stringency condition or a very high stringency condition” varies widely depending on the individual situation as well as the person making the determination and nucleic acids which hybridize under one set of conditions and having partial complementarity to a target sequence may not hybridize under other conditions. It is not clear to the examiner as to what type of stringency hybridization conditions and percentage of identity of the complementary polynucleotide sequence that is hybridizing to the target sequences of SEQ ID NOs: 1, 2, and 3 are encompassed in the above phrase. Thus, the scope of the claim is unclear. A perusal of the specification describes on page 10, some exemplary hybridization conditions and claim 12 as written does not recite the specific conditions the applicants' intend to encompass. As such it is unclear how homologous to the nucleotide sequences of SEQ ID NOs: 1, 2, and 3 a sequence of interest must be to be included within the scope of the claim. Clarification and correction is required.
Claim Rejections: 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
I. Claims 1-19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1-19, as interpreted are directed to encompass genus of polypeptides and a genus of encoding polynucleotides: i.e., any recombinant type IV humanized collagen, wherein an amino acid sequence of the recombinant type IV humanized collagen comprises n repeating sequence, n being an integer equal to or greater than 1; wherein the repeating sequence is a sequence of a functional domain of a native human type IV collagen of undefined and unlimited structures and a method of making said recombinant type IV humanized collagen (no structure is recited for recombinant type IV humanized collagen in claims 1-2, 4-11, 13-17 and 19); claims 3 and 18 recite “…a sequence set forth in SEQ ID NO.4, SEQ ID NO.5, or SEQ ID NO. 6”; and claim 12 recites “…an amino acid sequence set forth in SEQ ID NO.1, SEQ ID NO.2, or SEQ ID NO.3” (also see claims objections and 35 U.S.C. 112(b), rejection above for claim interpretation).
In University of California v. Eli Lilly & Co., 43 USPQ2d 1938, the Court of Appeals for the Federal Circuit has held that “A written description of an invention involving a chemical genus, like a description of a chemical species, ‘requires a precise definition, such as by structure, formula, [or] chemical name,’ of the claimed subject matter sufficient to distinguish it from other materials”. As indicated in MPEP § 2163, the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show that Applicant was in possession of the claimed genus. In addition, MPEP § 2163 states that a representative number of species means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus
In the instant case, there is no structure associated with function with regard to the members of the genus of polypeptides and a genus of encoding polynucleotides: i.e., any recombinant type IV humanized collagen, wherein an amino acid sequence of the recombinant type IV humanized collagen comprises n repeating sequence, n being an integer equal to or greater than 1; wherein the repeating sequence is a sequence of a functional domain of a native human type IV collagen of undefined and unlimited structures and a method of making said recombinant type IV humanized collagen (no structure is recited for recombinant type IV humanized collagen in claims 1-2, 4-11, 13-17 and 19); claims 3 and 18 recite “…a sequence set forth in SEQ ID NO.4, SEQ ID NO.5, or SEQ ID NO. 6”; and claim 12 recites “…an amino acid sequence set forth in SEQ ID NO.1, SEQ ID NO.2, or SEQ ID NO.3” (also see claims objections and 35 U.S.C. 112(b), rejection above for claim interpretation).
No information, beyond the characterization of an isolated polypeptide comprising the amino acid sequence of SEQ ID NO: 1, 2 and 3 and having the recited activity and encoded by the polynucleotide sequences of SEQ ID NO: 4, 5 and 6 in a specific cellular context E. coli BL21(DE3) cells (see Example 1-3, pages 12-20 of the specification) has been provided by the applicants’, which would indicate that they had possession of the genus of polypeptides and a genus of encoding polynucleotides: i.e., any recombinant type IV humanized collagen, wherein an amino acid sequence of the recombinant type IV humanized collagen comprises n repeating sequence, n being an integer equal to or greater than 1; wherein the repeating sequence is a sequence of a functional domain of a native human type IV collagen of undefined and unlimited structures and a method of making said recombinant type IV humanized collagen (no structure is recited for recombinant type IV humanized collagen in claims 1-2, 4-11, 13-17 and 19); claims 3 and 18 recite “…a sequence set forth in SEQ ID NO.4, SEQ ID NO.5, or SEQ ID NO. 6”; and claim 12 recites “…an amino acid sequence set forth in SEQ ID NO.1, SEQ ID NO.2, or SEQ ID NO.3” (also see claims objections and 35 U.S.C. 112(b), rejection above for claim interpretation).
The claimed genus of polypeptides and the encoding polynucleotides is an extremely large structurally and functionally variable genus. While the argument can be made that the recited genus of polypeptides and the encoding polynucleotides is adequately described by the disclosure of the structures of the amino acid sequence of SEQ ID NO: 1, 2, and 3 having associated activity/function, since one could use structural homology to isolate those encoding polypeptides recited in the claims. The art clearly teaches the “Practical Limits of Function Prediction”: Whisstock et al., (Quarterly Reviews of Biophysics 2003, Vol. 36 (3): 307-340,) also highlight the difficulties associated with “Prediction of protein function from protein sequence and structure”; “To reason from sequence and structure to function is to step onto much shakier ground”, closely related proteins can change function, either through divergence to a related function or by recruitment for a very different function, in such cases, assignment of function on the basis of homology, in the absence of direct experimental evidence, will give the wrong answer (page 309, paragraph 4), it is difficult to state criteria for successful prediction of function, since function is in principle a fuzzy concept. Given three sequences, it is possible to decide which of the three possible pairs is most closely related. Given three structures, methods are also available to measure and compare similarity of the pairs. However, in many cases, given three protein functions, it would be more difficult to choose the pair with most similar function, although it is possible to define metrics for quantitative comparisons of different protein sequences and structures, this is more difficult for proteins of different functions (page 312, paragraph 5), in families of closely related proteins, mutations usually conserve function but modulate specificity i.e., mutations tend to leave the backbone conformation of the pocket unchanged but to affect the shape and charge of its lining, altering specificity (page 313, paragraph 4), although the hope is that highly similar proteins will share similar functions, substitutions of a single, critically placed amino acid in an active-site residue may be sufficient to alter a protein’s role fundamentally (page 323, paragraph 1).
As the claimed genera of polypeptides and encoding polynucleotides include widely variable structure and associated function, since minor changes in structure may result in changes affecting function and no additional information (species/variant/mutant) correlating structure with function has been provided. Furthermore, “Possession may not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features” (See University of Rochester, 358 F.3d at 927, 69 USPQ2d at 1895).
Therefore, one skilled in the art cannot reasonably conclude that applicant had possession of the claimed invention at the time the instant application was filed. Applicants’ are referred to the revised guidelines concerning compliance with the written description requirement of 35 U.S.C. 112(a) or 35 U.S.C. 112, first paragraph, published in the Official Gazette and also available at www.uspto.gov.
Enablement
II. Claims 1-19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, scope of enablement, because the specification, while being enabling for the characterization of an isolated polypeptide comprising the amino acid sequence of SEQ ID NO: 1, 2 and 3 and having the recited activity and encoded by the polynucleotide sequences of SEQ ID NO: 4, 5 and 6 in a specific cellular context E. coli BL21(DE3) cells (see Example 1-3, pages 12-20 of the specification), does not reasonably provide enablement for genus of polypeptides and a genus of encoding polynucleotides: i.e., any recombinant type IV humanized collagen, wherein an amino acid sequence of the recombinant type IV humanized collagen comprises n repeating sequence, n being an integer equal to or greater than 1; wherein the repeating sequence is a sequence of a functional domain of a native human type IV collagen of undefined and unlimited structures and a method of making said recombinant type IV humanized collagen (no structure is recited for recombinant type IV humanized collagen in claims 1-2, 4-11, 13-17 and 19); claims 3 and 18 recite “…a sequence set forth in SEQ ID NO.4, SEQ ID NO.5, or SEQ ID NO. 6”; and claim 12 recites “…an amino acid sequence set forth in SEQ ID NO.1, SEQ ID NO.2, or SEQ ID NO.3” (also see claims objections and 35 U.S.C. 112(b), rejection above for claim interpretation). The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
The factors to be considered in determining whether undue experimentation is required are summarized In re Wands 858 F.2d 731, 8 USPQ2nd 1400 (Fed. Cir, 1988). The Court in Wands states: "Enablement is not precluded by the necessity for some experimentation such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is 'undue,' not 'experimentation.' " (Wands, 8 USPQ2d 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. "Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations." (Wands, 8 USPQ2d 1404). The factors to be considered in determining whether undue experimentation is required include: (1) the quantity of experimentation necessary, (2) the amount or direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims. While all of these factors are considered, a sufficient amount for a prima facie case are discussed below.
The breadth of claims includes overly broad genus, applicants’ disclose no direction or guidance on how to design and make any polypeptide and the encoding polynucleotide of undefined structure having desired activity as noted in the breadth above. Thus, instant specification and prior art failed to describe how to make and use the claimed genus of polypeptides and the encoding polynucleotides sufficiently. Although, it is possible to display and create any protein structure in computer (in silico) and manipulate in any possible way, such as inserting any amino acid(s) into preexisting three-dimensional scaffold; the creation of desired catalytic/biologic activity in a solution is highly unpredictable.
According to MPEP § 2164.02: “All questions of enablement are evaluated against the claimed subject matter. The focus of the examination inquiry is whether everything within the scope of the claim is enabled.”; “The Federal Circuit has repeatedly held that “the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation’.” In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993). Nevertheless, not everything necessary to practice the invention need be disclosed. In fact, what is well-known is best omitted. In re Buchner, 929 F.2d 660, 661, 18 USPQ2d 1331, 1332 (Fed. Cir. 1991). All that is necessary is that one skilled in the art be able to practice the claimed invention, given the level of knowledge and skill in the art. Further the scope of enablement must only bear a “reasonable correlation” to the scope of the claims. See, e.g., In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).”; and “As concerns the breadth of a claim relevant to enablement, the only relevant concern should be whether the scope of enablement provided to one skilled in the art by the disclosure is commensurate with the scope of protection sought by the claims. > AK Steel Corp. v. Sollac, 344 F.3d 1234, 1244, 68 USPQ2d 1280, 1287 (Fed. Cir. 2003); < In re Moore, 439 F.2d 1232, 1236, 169 USPQ 236, 239 (CCPA 1971). See also Plant Genetic Sys., N.V. v. DeKalb Genetics Corp., 315 F.3d 1335, 1339, 65 USPQ2d 1452, 1455 (Fed. Cir. 2003) (alleged “pioneer status” of invention irrelevant to enablement determination).”
Instant claims are so broad such that, instant disclosure of instant specification and a general knowledge in the art are not commensurate with the scope of instant claims for one skilled in the art to make and use claimed invention without undue experimentation. As noted above, the breadth of instant claims encompass an overly broad genus of undefined structure including variants, mutants and homologs.
Therefore, taking into consideration the extremely broad scope of the claims, the lack of guidance, the amount of information provided, the lack of knowledge about a correlation between structure and the desired function, and the high degree of unpredictability of the prior art in regard to structural variability and its effect on function, one of ordinary skill in the art would have to go through the burden of undue experimentation in order to practice the claimed invention. Thus, applicants’ have not provided sufficient guidance to enable one of ordinary skill in the art to make and use the claimed invention in a manner reasonably correlated with the scope of the claims. The scope of the claim must bear a reasonable correlation with the scope of enablement (In re Fisher, 166 USPQ 19 24 (CCPA 1970)). Without sufficient guidance, determination of genus of polypeptides and a genus of encoding polynucleotides: i.e., any recombinant type IV humanized collagen, wherein an amino acid sequence of the recombinant type IV humanized collagen comprises n repeating sequence, n being an integer equal to or greater than 1; wherein the repeating sequence is a sequence of a functional domain of a native human type IV collagen of undefined and unlimited structures and a method of making said recombinant type IV humanized collagen (no structure is recited for recombinant type IV humanized collagen in claims 1-2, 4-11, 13-17 and 19); claims 3 and 18 recite “…a sequence set forth in SEQ ID NO.4, SEQ ID NO.5, or SEQ ID NO. 6”; and claim 12 recites “…an amino acid sequence set forth in SEQ ID NO.1, SEQ ID NO.2, or SEQ ID NO.3” (also see claims objections and 35 U.S.C. 112(b), rejection above for claim interpretation), comprising any heterologous nucleic acid molecule of undefined and unlimited structures and encoding said protein of undefined and unlimited structures having the desired biological characteristics is unpredictable and the experimentation left to those skilled in the art is unnecessarily, and improperly, extensive and undue. See In re Wands 858 F.2d 731, 8 USPQ2nd 1400 (Fed. Cir, 1988).
III. Claim 5 recites “a recombinant… eukaryotic host cell…” as interpreted is directed to the use of multicellular organisms including transgenic animals and plants and is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112, first paragraph, as failing to comply with the enablement requirement when given the broadest reasonable interpretation, because, while claim 5 is enabling for an isolated prokaryotic, yeast or eukaryotic host cell transformed with the recombinant expression vector encoding polypeptide(s) of interest, does not reasonably provide enablement for any transgenic multi-cellular organisms or host cells within a multi-cellular organism that have been transformed with the synthetic nucleic acid/expression vector or any transgenic plant that have been transformed with the synthetic nucleic acid/expression vector and expressing the polypeptide of interest. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with the claims.
Claim 5 is so broad as to encompass transgenic multi-cellular organisms and host cells transformed with specific nucleic acids, including cells in vitro culture as well as within any multi-cellular organism and transgenic plants. The enablement provided is not commensurate in scope with the claim due to the extremely large number of transgenic multicellular organisms encompassed by the claims which the specification fails to teach how to generate. While methods for transforming cells in vitro are well known in the art, methods for successfully transforming cells within complex multi-cellular organisms are not routine and are highly unpredictable. Furthermore, methods for producing a successfully transformed cell within the multi-cellular organism are unlikely to be applicable to transformation of other types of multi-cellular organism, as multi-cellular organisms vary widely. However, in this case the disclosure is limited to only isolated cells. Thus, applicant has not provided sufficient guidance to enable one of ordinary skill in the art to make and use the claimed invention in a manner reasonably correlated with the scope of the claims broadly including the use of host cells within a multi-cellular organism for the production of said polypeptides in the claimed method. The scope of claims must bear a reasonable correlation with the scope of enablement (In re Fisher, 166 USPQ 19 24 (CCPA)). Without sufficient guidance, expression of genes in a particular host cell and having the desired biological characteristics is unpredictable, the experimentation left to those skilled in the art is unnecessarily, and improperly, extensive and undue. See In re Wands 858 F. 2d 731, 8 USPQ 2nd 1400 (Fed. Cir., 1988). It is suggested that the applicant limit the claim to “An isolated host cell …”.
Although the claims are examined in the light of the specification, specification cannot be read into the claims, i.e., the limitations of the specification cannot be read into the claims (see MPEP 2111 R-5).
415 F.3d at 1316, 75 USPQ2d at 1329. See also In re Hyatt, 211 F.3d 1367, 1372,54 USPQ2d 1664, 1667 (Fed. Cir. 2000). Applicant always has the opportunity to amend the claims during prosecution, and broad interpretation by the examiner reduces the possibility that the claim, once issued, will be interpreted more broadly than is justified. In re Prater, 415 F.2d 1393, 1404-05, 162 USPQ 541, 550-51 (CCPA 1969) (Claim 9 was directed to a process of analyzing data generated by mass spectrographic analysis of a gas. The process comprised selecting the data to be analyzed by subjecting the data to a mathematical manipulation. The examiner made rejections under 35 U.S.C. 101 and 102. In the 35 U.S.C. 102 rejection, the examiner explained that the claim was anticipated by a mental process augmented by pencil and paper markings. The court agreed that the claim was not limited to using a machine to carry out the process since the claim did not explicitly set forth the machine. The court explained that “reading a claim in light of the specification, to thereby interpret limitations explicitly recited in the claim, is a quite different thing from reading limitations of the specification into a claim,’ to thereby narrow the scope of the claim by implicitly adding disclosed limitations which have no express basis in the claim.” The court found that applicant was advocating the latter, i.e., the impermissible importation of subject matter from the specification into the claim.). See also In re Morris, 127 F.3d 1048, 1054-55, 44 USPQ2d 1023, 1027-28 (Fed. Cir. 1997) (The court held that the PTO is not required, in the course of prosecution, to interpret claims in applications in the same manner as a court would interpret claims in an infringement suit. Rather, the “PTO applies to verbiage of the proposed claims the broadest reasonable meaning of the words in their ordinary usage as they would be understood by one of ordinary skill in the art, taking into account whatever enlightenment by way of definitions or otherwise that may be afforded by the written description contained in applicant’s specification.”). The broadest reasonable interpretation of the claims must also be consistent with the interpretation that those skilled in the art would reach.
Claim Rejections: 35 USC § 102 (AIA )
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, 4-11, 13-14, 16-17 and 19 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Yang et al., (US 11,396,537 B2; priority 11/28/2018), said reference discloses recombinant type IV humanized collagen, wherein an amino acid sequence of the recombinant type IV humanized collagen comprises n repeating sequence, n being an integer equal to or greater than 1; wherein the repeating sequence is a sequence of a functional domain of a native human type TV collagen (see Abstract; Fig. 1-7; and entire document); wherein the amino acid sequence excisable by the TEV protease is directly linked to the repeating sequence and the reference polypeptide sequence is expressed, the sequence of ENLYFQ added at its N-terminus, which can be cut by TEV protease to directly obtain the reference polypeptide( Summary, col. 2, lines 35-37 to col. 3, lines 1-26; col. 6, lines 3-16 and lines 60-67); a recombinant expression vector, wherein the recombinant expression vector comprises the polynucleotide, and the recombinant expression vector comprises a pET series vector, a shuttle vector, a phage or a viral vector (col. 6, lines 29-46); expression of reference protein, collecting the protein and purifying the protein (col. 3, lines 14-31; col. 6, lines 40-67 to col. 7, lines 1-8; Example 1, cols. 9-16; Example 4, col. 19); said reference protein comprised in a product including a medical device, a cosmetic, a healthcare product, or a medicament (col. 4, lines 20-29; Claim 7).
Therefore, Yang et al., (US 11,396,537 B2; priority 11/28/2018) is deemed to anticipate claims 1-2, 4-11, 13-14, 16-17 and 19 as written and when given the broadest reasonable interpretation.
Claim Rejections: 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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.
Claims 1-17 and 19 are rejected under 35 U.S.C. 103(a) as being unpatentable over Yang et al., (US 11,396,537 B2; priority 11/28/2018) as applied to claims 1-2, 4-11, 13-14, 16-17 and 19 (see 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) rejection above) and further in view of Bella J., (US 2013/0237486 A1) and Kuo et al., (Appl Microbiol Biotechnol., 2013, Vol. 97: 237-246).
The disclosure of Yang et al., is silent regarding type IV humanized collagen comprises an amino acid sequence set forth in SEQ ID NO: 1…” (as in claims 3 and 12); and wherein the recombinant expression vector is pET-28a-Trx-His (as in claim 15).
Regarding claims 3 and 12, Bella J., (US 2013/0237486 A1) provide teaching, suggestion and motivation to a skilled artisan i.e., disclose a trimeric fusion protein comprising three polypeptide chains, wherein each polypeptide chain comprises a eukaryotic collagen or collagen-like domain (see Abstract; and entire document), said collagen domain comprising an amino acid sequence having 100% sequence identity to SEQ ID NO: 1 of the instant invention (see provided sequence alignment); said reference also discloses said reference fusion polypeptide comprising TEV protease for purifying the protein of interest (¶ [0184]).
Regarding claim 15, wherein the recombinant expression vector is pET-28a-Trx-His, Kuo et al., (Appl Microbiol Biotechnol., 2013, Vol. 97: 237-246) provides teaching, suggestion and motivation for the use of expression vector derived from pET-28a comprising Trx-His for expressing proteins of interest (see Abstract; Table 1-2, col. 1, page 239; and entire document).
Therefore, it would have been obvious to a person of ordinary skill in the art to combine and modify the teachings of Yang et al., and employ the collagen domain comprising an amino acid sequence having 100% sequence identity to SEQ ID NO: 1 and an expression vector derived from pET-28a comprising Trx-His for expressing proteins of interest, as taught in the references of Bella J., and Kuo et al., that teach structural and functional elements for expression of polypeptides of interest depending on the experimental need. Motivation to generate such a modified polypeptide chain comprising a eukaryotic collagen or collagen-like domain derives from the fact that eukaryotic collagen or collagen-like domain is of pharmaceutical significance (Yang et al., and Bella J.,). The expectation of success is high, because the combined teachings of Yang et al., Bella J., and Kuo et al., teach the structural and functional elements of the instant invention (Teaching, Suggestion and Motivation).
Given this extensive teaching in prior art (Yang et al., and Bella J.,) genus of polypeptides and a genus of encoding polynucleotides: i.e., any recombinant type IV humanized collagen, wherein an amino acid sequence of the recombinant type IV humanized collagen comprises n repeating sequence, n being an integer equal to or greater than 1; wherein the repeating sequence is a sequence of a functional domain of a native human type IV collagen of undefined and unlimited structures and a method of making said recombinant type IV humanized collagen… (also see rejection under 35 U.S.C. 112(b) for claims interpretation), as taught by the instant invention and as claimed in claims 1-17 and 19 is not of innovation but of ordinary skill in the art and the expectation of success is extremely high i.e., “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103.”KSR, 550 U.S. at, 82 USPQ2d at 1397”.
Therefore, claims 1-17 and 19 are rejected under 35 U.S.C. 103(a) as being unpatentable over Yang et al., (US 11,396,537 B2; priority 11/28/2018) as applied to claims 1-2, 4-11, 13-14, 16-17 and 19 (see 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) rejection above) and further in view of Bella J., (US 2013/0237486 A1) and Kuo et al., (Appl Microbiol Biotechnol., 2013, Vol. 97: 237-246).
Allowable Subject Matter/Conclusion
None of the claims are allowable.
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/GANAPATHIRAMA RAGHU/ Primary Examiner, Art Unit 1652
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