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 .
Status of the Claims
The preliminary amendment filed 05/01/2024 is acknowledged. Claims 10-15 are amended. No restriction requirement is being imposed in this case. Claims 1-15 are pending and under examination.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 365(c), PCT/KR2022/016661, is acknowledged. In addition, receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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 1-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. The first step in considering whether claims are patent eligible is to establish the broadest reasonable interpretation of the claims as a whole and to determine the statutory category of the claims (see Step 1 of the Revised Guidelines). The claims recite a peptide comprising an amino acid sequence of SEQ ID NO: 1, which is contained within the naturally occurring bone morphogenetic protein or BMP. Claims 10-13 recite pharmaceutical compositions comprising the peptide and claims 13-15 recite health functional foods comprising the peptide. Therefore, the claims are drawn to products.
The first prong of the two-prong inquiry for determining whether a claim is patent eligible is to consider whether it is directed to a law of nature, a natural phenomenon (nature-based product) or an abstract idea. In evaluating whether the encompassed peptide/nucleotide is drawn to a nature-based product, the standard is whether or not the invention as claimed is markedly different from the closest corresponding product of nature. See MPEP 2106(c)(II), which instructs how to conduct this analysis:
The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties, and are evaluated based on what is recited in the claim on a case-by-case basis. If the analysis indicates that a nature-based product limitation does not exhibit markedly different characteristics, then that limitation is a product of nature exception. If the analysis indicates that a nature-based product limitation does have markedly different characteristics, then that limitation is not a product of nature exception.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because SEQ ID NO: 1 is contained within naturally occurring BMP-5, isoform X2, as evidenced by the NCBI Reference Sequence: XP_034622190.1 (on Applicant’s IDS form filed 05/01/2024). The peptide comprising SEQ ID NO: 1 is disclosed in the instant specification as having bone and cartilage regenerating properties (see paragraph [0014]), thus, there is no marked difference in activity and function of the instantly claimed peptide and the native BMP.
The courts have emphasized that to show a marked difference from a natural phenomenon, a characteristic in said phenomenon 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. See Myriad, 569 U.S. at 580, 106 USPQ2d at 1974-75. Thus, in order to be markedly different, applicant must have caused the claimed product/ manufacture to possess at least one characteristic that is different from that of the naturally occurring counterpart. In the instant case, the truncation of a native BMP protein peptide to the 11mer set forth in instant SEQ ID NO: 1 does not render it markedly different from what is found in nature.
In Myriad, the Supreme Court made clear that not all changes in characteristics will rise to the level of a marked difference, e.g., the incidental changes resulting from isolation of a gene sequence are not enough to make the isolated gene markedly different. In Myriad, 569 U.S. at 580, 106 USPQ2d at 1974-75, the patentee had discovered the location of the BRCA1 and BRCA2 genes in the human genome, and isolated them, i.e., separated those specific genes from the rest of the chromosome on which they exist in nature. As a result of their isolation, the isolated genes had a different structural characteristic than the natural genes, i.e., the natural genes had covalent bonds on their ends that connected them to the rest of the chromosome, but the isolated genes lacked these bonds. However, the claimed genes were otherwise structurally identical to the natural genes, e.g., they had the same genetic structure and nucleotide sequence as the BRCA genes in nature. Similar to Myriad, the truncation of a BMP protein does not render it markedly different from said natural products.
The second prong of Step 2A is to consider whether the claim recites additional elements that integrate the natural phenomenon into a practical application (see MPEP 2106.04(d)(II)). Claims 2-9 do not recite any additional elements other than the inherent characteristics of the peptide. Claims 10-12 recite a pharmaceutical composition comprising the peptide of claim 1 as an active ingredient. According to the instant specification, pharmaceutically acceptable carriers include many naturally occurring agents, for instance, “lactose, dextrose, sucrose, sorbitol, mannitol, starch, acacia, rubber, calcium phosphate, alginate, gelatin, calcium silicate, microcrystalline cellulose, polyvinylpyrrolidone, cellulose, water, syrup, methylcellulose, methyl hydroxybenzoate, propyl hydroxybenzoate, talc, magnesium stearate and mineral oil” (see paragraph [0076]). The suspension into solution the naturally occurring BMP peptide does not integrate it into a practical application. Similarly, claims 13-15 recite a health functional food comprising the peptide of claim 1 as an active ingredient, however, incorporating the BMP peptide into a food (e.g., cheese, chocolate) does not integrate it into a practical application (see paragraph [0089] of the instant specification). The final step in evaluating whether a claim is patent eligible is to consider whether there are additional elements in the claims sufficient to amount to significantly more than the judicial exception (see Step 2B of the Revised Guidelines). As noted above, the claims are silent with respect to any additional elements other than the BMP peptide itself. Thus, the claims are not patent-eligible.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(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.
Claims 11, 12, 14 and 15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the claimed peptide for the purpose of treating inflammatory disease or osteoporosis, does not reasonably provide enablement for preventing inflammatory disease or osteoporosis. 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 or use the invention commensurate in scope with these claims.
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue.” (See In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 Fed. Cir. 1988). These factors include, but are not limited to: (a) the breadth of the claims; (b) the nature of the invention; (c) the state of the prior art; (d) the level of one of ordinary skill; (e) the level of predictability in the art; (f) the amount of direction provided by the inventor; (g) the existence of working examples; and (h) the quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Claims 11, 12, 14 and 15 recite the peptides are used for preventing inflammatory disease or osteoporosis in the alternative. Although the claims are drawn products, namely, pharmaceutical compositions and health functional foods comprising SEQ ID NO: 1, it is appropriate to evaluate the intended use under 35 USC 112(a), particularly since a pharmaceutical composition and a health functional food are inherently intended for treatment. A non-limiting list of the contemplated inflammatory diseases is disclosed at paragraph [0072]:
In the present invention, the inflammatory disease may refer to a pathological condition that causes inflammation caused by neutrophil chemotaxis among white blood cells, and may include, but is not limited to, any disease caused by an inflammatory response or accompanied by an inflammatory response. Examples of the inflammatory disease include, but are not limited to, rhinitis, bronchitis, periodontitis, pancreatitis, gastritis, gastric ulcer, an inflammatory skin disease, atopic dermatitis, encephalitis, sepsis, inflammatory enteritis, a chronic obstructive pulmonary disease, septic shock, pulmonary fibrosis, undifferentiated spondyloarthropathy, undifferentiated arthropathy, arthritis, inflammatory osteolysis, a chronic inflammatory disease caused by a chronic virus or bacterial infection, colitis, an inflammatory bowel disease, type 1 diabetes,
arthritis, rheumatoid arthritis reactive arthritis, osteoarthritis, scleroderma, osteoporosis, endocarditis, pericarditis, atherosclerosis, cystic fibrosis, psoriasis, myocarditis, Hashimoto's thyroiditis, Graves' disease, leprosy, syphilis, Lyme disease, borreliosis, neurological borrelia, tuberculosis, sarcoidosis, lupus, discoid lupus, chilblain lupus, lupus nephritis, systemic lupus erythematosus, macular degeneration, uveitis, irritable bowel syndrome, Crohn's disease, Sjogren's syndrome, fibromyalgia, chronic fatigue syndrome, chronic fatigue immune dysfunction syndrome, myalgic encephalomyelitis, amyotrophic lateral sclerosis, Parkinson's disease, and multiple sclerosis.
Thus, the specification contemplates a vast list of potential inflammatory diseases. The term preventing is defined at paragraph [0073]:
The pharmaceutical composition of the present invention may be used for promoting regeneration of cartilage, preventing an inflammatory disease from occurring by inhibiting the expression or secretion of factors that cause inflammatory responses, preventing osteoporosis from occurring by inhibiting osteoclast differentiation, or preventing the worsening of the condition and treating the diseases by inhibiting inflammatory responses that occur additionally in damaged or scarred cells in patients with inflammatory diseases or the differentiation into osteoclasts in patients with osteoporosis.
Thus, the specification encompasses a definition of “preventing” in which inflammatory disease and osteoporosis are prevented from ever occurring. Given the high level of required effect, a high level of evidence showing prevention is also required.
In contrast to the broad scope of the claims, what is provided in the specification is quite narrow. The specification teaches how to make the peptide set forth in SEQ ID NO: 1 (Example 1, paragraphs [0093]-[0094]) and teaches studies in which C28/I2 chondrocyte cells were treated with the peptide of the invention:
Example, paragraphs
Results
2, paragraphs [00100]-[00103]
promoted the expression of collagen type II, COMP, and PCP genes associated with ECM production in chondrocytes (see FIG. 2)
3, paragraphs [00105]-[00107]
increased the expression of SOX5, SOX6, and SOX9 proteins (ECM regulators—see FIGS. 3A to 3C)
4, paragraphs [00109]-[00111]
promoted the formation of glycosaminoglycan (ECM component—see FIGS. 4A and 4B)
The specification also teaches studies in which human adipose-derived mesenchymal stem cells (AD-MSCs) were treated with the peptide of the invention:
Example, paragraphs
Results
5, paragraphs [00113]-[00115]
promoted the chondrogenic differentiation and the production of glycosaminoglycan (ECM component—see FIG. 5)
6, paragraphs [00116]-[00120]
promoted the expression of COL2A1, COMP, COLIIA, ACP, PCP, and ACAN genes (associated with ECM production), and Sox9 gene (ECM regulator—see FIGS. 6A to 6C).
7, paragraphs [00121]-[00124]
increased production of SOX9 protein (ECM regulator—see FIGS. 7A to 7C)
Further, the specification teaches experiments using the mouse RAW264.7 macrophage cell line:
Example, paragraphs
Results
8, paragraphs [00126]-[00130]
inhibited the expression of inflammatory cytokine genes induced by the treatment with inflammatory cytokines (see FIG. 8)
9, paragraphs [00132]-[00134]
inhibited the increase in inflammatory proteins caused by the treatment with inflammatory cytokines (see FIG. 9)
10, paragraphs [00137]-[00147]
inhibited the differentiation into osteoclasts induced by RANKL; further the peptide was not toxic to macrophages. Finally, the peptide inhibited the activity of TRAP (marker of osteoclasts) in a concentration-dependent manner (see FIG. 10C)
11, paragraphs [00149]-[00151]
inhibited the formation of actin rings (essential for differentiation into osteoclasts—see FIG. 11).
In summary, the specification provides in vitro evidence that the peptide of the invention promotes ECM synthesis, increases chondrocyte activity, inhibits cytokine expression in a mouse macrophage cell line and inhibits macrophages from differentiating into osteoclasts, but does not provide any evidence of preventing the encompassed diseases.
The claimed methods do not achieve the goal of preventing either the vast list of inflammatory diseases or osteoporosis. For example, the specification contemplates the prevention of rheumatoid arthritis. Denk et al. (Arthritis Research & Therapy 2010, 12:R45, http://arthritis-research.com/content/12/2/R45) teach “[t]he chronic autoimmune disease RA [rheumatoid arthritis] is of unknown origin but finally leads to joint destruction.” In other words, it is not known who will develop rheumatoid arthritis; thus, it cannot be prevented with the claimed peptide. The guidance in the instant specification present in vitro data that the peptide of the invention promotes ECM synthesis, increases chondrocyte activity, inhibits cytokine expression in a mouse macrophage cell line and inhibits macrophages from differentiating into osteoclasts. These data suggest that the peptide of the invention may ameliorate inflammation and osteoporosis. However, the specification and the art is silent with respect to 100% prevention of either inflammatory disease or osteoporosis from occurring. Thus, the relevant art recognizes the complexity and unpredictability of preventing disease. Although the specification prophetically considers general methodologies of using the claimed peptide in methods for prevention, the disclosure is not considered fully enabling for the claimed invention.
The test of enablement is not whether any experimentation is necessary, but whether, if experimentation is necessary, it is undue. Due to the large quantity of experimentation necessary to establish a preventive effect using the claimed peptide, the breadth of the claims which encompasses a vast array of diseases to be prevented, the state of the art which establishes the complexity and unpredictability of preventing inflammatory disease, undue experimentation would be required of the skilled artisan to use the claimed peptides in the intended use of prevention.
Notice for all US Patent Applications filed on or after March 16, 2013: 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.
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.
Claims 1-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Welting et al. (US Patent 10,639,352—of IDS filed 05/01/2024; also published as WO2017/178253—on IDS filed 08/20/2025). For the sake of brevity, this rejection will refer to the US Patent. The instant claims are drawn to a peptide comprising an amino acid sequence of SEQ ID NO: 1. Welting et al. teach SEQ ID NOs: 10, 18, 29 (among others), which share 100 sequence identity with instant SEQ ID NO: 1 (see Table 2 at columns 13 and 14). For example, see the alignment between SEQ ID NO: 10 of Welting et al. with instant SEQ ID NO: 1:
RESULT 1
US-16-092-680-10
(NOTE: this sequence has 1 duplicate in the database searched)
Sequence 10, US/16092680
Patent No. 10639352
GENERAL INFORMATION
APPLICANT: Universiteit Maastricht and Academisch Ziekenhuis
APPLICANT: Maastricht
TITLE OF INVENTION: METHOD FOR THE TREATMENT OR PREVENTION OF OSTEOARTHRITIS
FILE REFERENCE: 338 WO
CURRENT APPLICATION NUMBER: US/16/092,680
CURRENT FILING DATE: 2018-10-10
NUMBER OF SEQ ID NOS: 64
SEQ ID NO 10
LENGTH: 20
TYPE: PRT
ORGANISM: Homo sapiens
Query Match 100.0%; Score 55; Length 20;
Best Local Similarity 100.0%;
Matches 11; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 NAISVLYFDDS 11
|||||||||||
Db 4 NAISVLYFDDS 14
Current claims 2-9 depend from claim 1 and recite various physiological activities, characteristics and functions of the peptide, summarized in the table below:
Claim
Activity/Characteristic/Function
2
cartilage regenerative activity, anti-inflammatory activity, and osteoporosis inhibitory activity
3 & 4
promotes differentiation of cord blood-derived stem cells, peripheral blood-derived stem cells, bone marrow-derived stem cells, and mesenchymal stem cells into chondrocytes
5
increases synthesis of an extracellular matrix (ECM) in chondrocytes
6
increases expression of one or more genes selected from the group consisting of collagen type II (COL2A1), cartilage oligomeric matrix protein (COMP), and proteoglycan core protein (PCP) in chondrocytes
7 & 8
inhibits expression of one or more inflammatory cytokines selected from the group consisting of TNFα, IL-6, IL-17, IL-1p, and IFNγ
9
inhibits differentiation of macrophages into osteoclasts
According to MPEP 2111.02, an intended use/preamble that merely recites a property inherent in an old product defined by the remainder of the claim does not impart a structural difference in a claim directed to a product. Therefore, although the teachings of Welting and colleagues do not address the recited characteristics, they are nevertheless inherent in the prior art product. Further, “[f]rom the standpoint of patent law, a compound and all its properties are inseparable”, (see In re Papesch, 315 F.2d 381, 391, 137 USPQ 43, 51 (CCPA 1963). See also In re Swinehart and Sfiligoj, 169 USPQ 226 (CCPA 1971); In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978). Additionally, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable (In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977)).
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 1-16 are rejected under 35 U.S.C. 103 as being unpatentable over Welting et al. (US Patent 10,639,362) in view of Ling et al. (US 2015/0231052). The first factor to consider when making a rejection under 35 U.S.C. 103(a) is to determine the scope and contents of the prior art. The instant claims are drawn to a peptide comprising an amino acid sequence of SEQ ID NO: 1. Welting et al. teach SEQ ID NOs: 10, 18, 29 (among others), which share 100 sequence identity with instant SEQ ID NO: 1 (see Table 2 at columns 13 and 14). For example, see the alignment between SEQ ID NO: 10 of Welting et al. with instant SEQ ID NO: 1:
RESULT 1
US-16-092-680-10
(NOTE: this sequence has 1 duplicate in the database searched)
Sequence 10, US/16092680
Patent No. 10639352
GENERAL INFORMATION
APPLICANT: Universiteit Maastricht and Academisch Ziekenhuis
APPLICANT: Maastricht
TITLE OF INVENTION: METHOD FOR THE TREATMENT OR PREVENTION OF OSTEOARTHRITIS
FILE REFERENCE: 338 WO
CURRENT APPLICATION NUMBER: US/16/092,680
CURRENT FILING DATE: 2018-10-10
NUMBER OF SEQ ID NOS: 64
SEQ ID NO 10
LENGTH: 20
TYPE: PRT
ORGANISM: Homo sapiens
Query Match 100.0%; Score 55; Length 20;
Best Local Similarity 100.0%;
Matches 11; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 NAISVLYFDDS 11
|||||||||||
Db 4 NAISVLYFDDS 14
Current claims 2-9 depend from claim 1 and recite various physiological activities, characteristics and functions of the peptide, summarized in the table below:
Claim
Activity/Characteristic/Function
2
cartilage regenerative activity, anti-inflammatory activity, and osteoporosis inhibitory activity
3 & 4
promotes differentiation of cord blood-derived stem cells, peripheral blood-derived stem cells, bone marrow-derived stem cells, and mesenchymal stem cells into chondrocytes
5
increases synthesis of an extracellular matrix (ECM) in chondrocytes
6
increases expression of one or more genes selected from the group consisting of collagen type II (COL2A1), cartilage oligomeric matrix protein (COMP), and proteoglycan core protein (PCP) in chondrocytes
7 & 8
inhibits expression of one or more inflammatory cytokines selected from the group consisting of TNFα, IL-6, IL-17, IL-1p, and IFNγ
9
inhibits differentiation of macrophages into osteoclasts
According to MPEP 2111.02, an intended use/preamble that merely recites a property inherent in an old product defined by the remainder of the claim does not impart a structural difference in a claim directed to a product. Therefore, although the teachings of Welting and colleagues do not address the recited characteristics, they are nevertheless inherent in the prior art product. Similarly, although claims 11-15 recite different intended uses for the pharmaceutical composition and the health functional food, the MPEP 2111.02(II) states that if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.
The second factor to consider is to ascertain the differences between the prior art and the instant claims. Although Welting et al. teach the treatment of osteoarthritis (see claim 1), they do not explicitly teach a pharmaceutical composition or a health food composition. Ling et al. teach formulations comprising stem cell extract and a bone morphogenetic protein that may be formulated as a pharmaceutical composition or a health functional food (see paragraphs [0010]; [0024]; [0030]; [0034]-[0036]; claim 1). It would have been obvious to the person of ordinary skill in the art at the time of the filing of the invention to modify the teachings of Welting and colleagues by formulating the peptide as a pharmaceutical composition or a health functional food because they specifically taught treating osteoarthritis (see claim 1). The person of ordinary skill in the art would have been motivated to formulate the peptide as a pharmaceutical composition or a health functional food because biologics, like other drugs, are typically formulated for injection or oral use. Furthermore, the person of ordinary skill in the art could have reasonably expected success because Ling et al. demonstrate the high level of skill in the art with respect to formulation of biologics (see paragraphs [0034]-[0036]).
Thus, the claims do not contribute anything non-obvious over the prior art.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA M BORGEEST whose telephone number is (571)272-4482. The examiner can normally be reached M-F 9-5:30 EDT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at 5712720911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTINA M BORGEEST/Primary Examiner, Art Unit 1675
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